Tue, 30 Sep 2025 08:00:00 GMTThe Balancing Act airing on Lifetime will showcase how innovative treatments Thermage® FLX, Clear + Brilliant®, and Fraxel FTX™ offer energy-based treatment options that help maintain a youthful appearance while enhancing natural beauty.
LAVAL, QC, September 30, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, and its aesthetic business, Solta Medical, a global leader in the medical aesthetics market, will be featured on The Balancing Act, airing on Lifetime, in a special episode spotlighting its portfolio of non-invasive skin rejuvenation and tightening technologies: Thermage® FLX, Clear + Brilliant® and Fraxel FTX™. Hosted by Montel Williams and Olga Villaverde, The Balancing Act offers viewers real-world solutions to uplift and empower more confident living.
“We want patients to see results that enhance their natural beauty,” said Dean Sollami, Vice President and General Manager, Solta Medical North America, Bausch Health. “We were excited to show Olga, Montel, and The Balancing Act viewers what’s possible with Solta’s portfolio of solutions.”
During the episode, Williams and Villaverde sit down with Michael Abrouk, MD, Dermatologist and Medical Director of Abrouk Aesthetics, to learn how Solta’s patented devices help address skin concerns from early sun damage to fine lines, wrinkles, and scarring:
Thermage FLX – Since 2002, Thermage has been the pioneer for non-invasive skin rejuvenation. Thermage FLX, the latest generation of the technology, harnesses advanced radiofrequency technology designed to help smooth, tighten, and contour skin for a more youthful appearance. With over five million tips used worldwide, Thermage has become recognized as a trusted solution for achieving a firmer, smoother look.
Clear + BrilliantTouch – Clear + Brilliant Touch is a targeted yet versatile laser treatment that helps address the early signs of aging skin. Clinically proven to refresh and revitalize, it leaves the complexion smoother, brighter, and more radiant — making it a trusted choice for patients seeking a subtle, youthful glow.
Fraxel FTX – The next generation of fractional laser technology, Fraxel FTX is clinically proven to help diminish the look of fine lines, reduce visible surgical and acne scars, and results in a smoother, more even complexion. As the latest innovation in the Fraxel portfolio, Fraxel FTX continues the Fraxel legacy with advancements in design and user experience.
"I’ve been performing Solta treatments for years because the brand has a long history of innovation and proven results,” said Dr. Abrouk. “Their expertise in non-invasive technologies gives me the confidence to help achieve my patients' aesthetic goals time and time again."
Within the episode, Villaverde visits Shino Bay CosmeticDermatology & Laser Institute in Fort Lauderdale, Florida where she is treated by renowned cosmetic dermatologist Dr. Shino Bay Aguilera and medical aesthetician Melinda Levya, LFA, LME for a “Tighten and Brighten” treatment series - Thermage FLX and Clear + Brilliant Touch.
“For patients seeking smoother skin with a refreshed glow, we often recommend an entry-level laser treatment like Clear + Brilliant,” said Dr. Aguilera. “For patients seeking to stimulate new collagen regeneration, Thermage stands out as the only radiofrequency technology FDA-cleared to non-invasively treat the eyelid skin, helping to smooth fine lines and support a naturally youthful, refreshed appearance.”
“At Solta Medical, we believe in enhancing natural beauty through innovative, non-invasive technologies,” said Jiny Kim, Senior Vice President, Solta Medical, Bausch Health. “At the heart of our work is the belief that everyone deserves to see the beauty in their skin.”
The segment is scheduled to air on Lifetime TV on October 2 and October 24, 2025, at 7:30 a.m. ET and will re-air at 7:30 a.m. PT. Additionally, the program will air on streaming networks Sling TV, Hulu, Live, and Fubu. Solta Medical is a sponsor of this segment and some of the participants have received consideration in exchange for their participation.
Thermage® FLX system Indications and Important Safety Information
INDICATIONS
The radiofrequency energy only delivery components of Thermage® FLX system and accessories are indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
Non-invasive treatment of wrinkles
The simultaneous application of radiofrequency energy and skin vibration by the Thermage® FLX system and accessories are indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
Non-invasive treatment of wrinkles around the eye
Non-invasive treatment of wrinkles
Temporary improvement in the appearance of cellulite
Relief of minor muscle aches and pain
Relief of muscle spasms
Temporary improvement of local circulation (blood circulation)
IMPORTANT SAFETY INFORMATION
Do not undergo Thermage® treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator, or any other electrical implant. Let your doctor know if you have an electrical implant or if you have any questions about whether you should undergo a Thermage® treatment.
Solta Medical has not studied the use of the Thermage® system:
Over skin fillers (lips, cheeks, facial wrinkles and skin folds)
In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy
In people who have permanent make-up and/or tattoos
In children
The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated.
The most commonly reported adverse effects after treatment include the following:
Mild redness may occur and typically resolves within 24 hours.
Swelling may occur and typically resolves within 5 days, but can remain up to several weeks.
The following adverse effects occur infrequently:
The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation.
Skin surface irregularities may appear up to 1 or more months post-treatment.
Numbness, tingling or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks.
Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications.
Skin may darken, but normally resolves within several months.
Talk to your doctor for more information about Thermage, and see www.thermage.com for additional details.
Clear + Brilliant® system Indications and Important Safety Information
INDICATION
The Clear + Brilliant® system is a non-ablative laser for general skin resurfacing.
IMPORTANT SAFETY INFORMATION
You may not be an appropriate candidate for a Clear + Brilliant® system treatment if you:
Have been diagnosed with or possibly have actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g., skin cancer, active infections, cold sores, open wounds or a sore that has not or will not heal, rashes, burns, inflammation, eczema, psoriasis);
Are predisposed to keloid formation or excessive scarring.
Have a condition that may compromise the immune system, or your ability to fight infections, such as HIV, lupus, scleroderma, or infections in the blood stream.
Have a known sensitivity to light or if you are taking any medications that may make your skin more sensitive to UV or artificial light.
Are on oral/systemic steroids (e.g., prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment.
Are using retinoids, which should be avoided for at least 2 weeks prior to and during treatment.
Are undergoing isotretinoin acne treatment or taking drugs in a similar class.
Have skin that is still recovering from a cosmetic procedure, such as a chemical or mechanical peel, or laser resurfacing; and
Have had botulinum toxin injections, or dermal fillers (such as collagen or hyaluronic acid) within the past 2 weeks.
Common side effects include mild to moderate redness and swelling which typically develops immediately after treatment and diminishes or resolves within 12 to 24 hours after treatment, itching or dryness, increased skin sensitivity, pain or discomfort, and rarely pinpoint bleeding.
Talk to your doctor for more information about Clear + Brilliant® and visit www.clearandbrilliant.com for Important Safety Information.
Fraxel FTX™ Laser System Indications and Important Safety Information
INDICATION
The Fraxel FTX™ Laser System isused for:
Fraxel® 1550nm wavelength is indicated for skin resurfacing procedures, including the treatment of dyschromia (an alteration in the color of the skin) and for local inflamed, benign skin lesions, such as, but not limited to, age spots, sun spots, actinic keratosis (pre-cancerous skin lesions), and melasma; and for the treatment of wrinkles around the eyes, acne scars, and surgical scars.
Fraxel® 1927nm wavelength is indicated for skin resurfacing including for the treatment of actinic keratosis (pre-cancerous skin lesions); treatment of pigmented lesions, such as age spots, sun spots, and freckles.
IMPORTANT SAFETY INFORMATION
If you have the following conditions, you should not have a Fraxel® laser treatment:
Are predisposed to keloid formation or excessive scarring;
Have experienced changes following surgery;
Have had skin indentations and textural changes following surgery;
Are on systemic steroids (e.g. prednisone, dexamethasone), which should be avoided prior to and throughout the course of treatment; and
Are undergoing isotretinoin acne treatment or are taking drugs in a similar class.
Possible Adverse Events from Fraxel® treatment include:
Blistering and Burns: May develop over the treated areas.
Discoloration: The possibility of temporary and permanent skin color change is known to exist with any laser treatment and may occur.
Eye Injury: Protective eyewear or goggles should be worn. It is important to keep the eye protection on at all times during treatment in order to protect your eyes from accidental laser exposure and serious injury.
Infection: A risk of infection exists whenever the skin is wounded and exists even with non-ablative fractional laser devices such the Fraxel®.
Keloid Formation: A thickened scar can result from excessive growth of fibrous tissue.
Prolonged Redness: Mild to moderate temporary redness is expected. However, if it is severe or persists significantly longer than expected, you should not have another treatment until it goes away.
Scarring: Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.
Delayed Wound Healing / Skin Textural Changes: Following laser treatment, restoration of the skin may not occur as expected due to poor wound healing ability or post-treatment care. This may result in undesirable textural changes to the skin.
Temporary Bruising: May develop over the treated areas.
Fraxel FTX™ Laser System treatment is by prescription only. Talk to your doctor for more information about Fraxel® and see www.fraxel.com for additional details.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our aesthetic business, Solta Medical, is a global leader in the aesthetics market, whose vision is to develop and support trusted aesthetic brands that provide value to our customers and patients. More information about Solta Medical can be found at www.solta.com. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About The Balancing Act
The Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on TheBalancingAct.com.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Tue, 30 Sep 2025 07:00:00 GMTLAVAL, QC, September 30, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) will release third quarter 2025 financial results after market close on Wednesday, October 29, 2025. Bausch Health will host a live conference call and webcast at 5:00 p.m. U.S. EDT to discuss results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Mon, 29 Sep 2025 08:00:00 GMTDesigned for dental professionals, OraTalks connects leading voices with insights to spark meaningful dialogue.
Nine-episode inaugural season hosted by industry thought leader Melissa K. Turner, BASDH, RDHEP, EFDA, CHO.
Candid conversations with leading clinicians on the trends shaping today’s dental landscape.
Episodes launch on September 29 on major podcast platforms; register now at oratalks.com for episode alerts and exclusive updates.
LAVAL, QC, September 29, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, and its dentistry business, OraPharma, today announced the launch of OraTalks, a new podcast created to ignite meaningful dialogue and explore the challenges shaping modern dentistry.
Season One of OraTalks features nine episodes covering timely topics in oral health and patient care, such as sleep disorders, women’s health, social determinants, and patient education. Hosted by Melissa K. Turner, BASDH, RDHEP, EFDA, CHO—a nationally recognized industry thought leader—the series combines her expertise with candid conversations from leading clinicians, researchers, and influencers. Listeners will also gain exclusive insights into emerging strategies shaping the future of dentistry.
“The goal of OraTalks is clear: to spark the conversations that truly matter in dentistry—conversations that are bold and timely,” said Melissa K. Turner, BASDH, RDHEP, EFDA, CHO, Host, OraTalks Podcast. “OraTalks allows us to amplify these ideas and bring them directly to the clinicians, leaders, and visionaries shaping our industry. In today’s rapidly evolving landscape, it’s not enough to keep pace—we have to set the pace. OraTalks exists to challenge assumptions, spotlight innovation, and ensure we remain relevant to the needs of the dental community.”
According to the American Dental Association, gum disease affects nearly 65 million Americans nationwide.1 This means millions of Americans may unknowingly have gum disease, underscoring the critical role dental professionals play in highlighting this serious condition.
“We’re excited to introduce OraTalks as a new way to support dental professionals as they prioritize periodontal disease,” said Tom Stern, General Manager and Vice President, Bausch Health. “This podcast reflects our commitment to listening, learning, and sharing insights that matter. We hope that by creating a space for meaningful conversations, we can help clinicians navigate the challenges of modern dentistry and continue delivering the best possible care for their patients.”
OraTalks debuts on September 29, 2025, and is available on major platforms, including Apple Podcasts and Spotify. Upcoming episodes are listed on oratalks.com, where dental professionals can register to receive alerts and exclusive updates.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. More information can be found at www.orapharma.com For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 11 Sep 2025 08:45:00 GMTThe transaction adds larsucosterol, an FDA Breakthrough Therapy for alcohol-associated hepatitis with a registrational Phase 3 clinical trial in development, to Bausch Health’s hepatology pipeline
LAVAL, QC, and CUPERTINO, CA, September 11, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (“Bausch Health”), a global, diversified pharmaceutical company, today announced the successful completion of its previously announced tender offer to acquire DURECT Corporation (“DURECT”). Under the terms of the agreement, Bausch Health acquired all outstanding shares of DURECT for $1.75 per share in cash, representing a total upfront cash payment of approximately $63 million at closing. The transaction also includes the potential for two additional net sales milestone payments of up to $350 million in the aggregate (subject to certain adjustments in respect of a retention plan) if the milestones are achieved before the earlier of the 10-year anniversary of the first commercial sale in the United States and December 31, 2045.
The acquisition adds DURECT’s lead asset, larsucosterol, a novel epigenetic modulator with FDA Breakthrough Therapy Designation for treatment of alcohol-associated hepatitis (“AH”), to Bausch Health’s hepatology pipeline. Currently, there are no approved therapies indicated to treat AH, and patients must rely on supportive care such as corticosteroids, which are often inadequate for long-term treatment and result in about 30% mortality within 90 days of hospitalization. A registrational Phase 3 program is currently being planned to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH.
“We are pleased to complete the acquisition of DURECT, which brings larsucosterol into our hepatology pipeline as a promising advanced-stage therapy,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “There is an urgent need for treatments for alcohol-associated hepatitis, a disease that leads to a significant number of hospitalizations each year. This addition supports our ongoing efforts to develop innovative therapies for liver diseases with limited or no current treatment options. The acquisition aligns with our strategic focus on purposeful R&D and advancing solutions in areas of unmet medical need.”
The tender offer for all outstanding shares of DURECT expired at 5:00 p.m., New York City time, on September 10, 2025. Equiniti Trust Company, LLC, the depositary for the tender offer, has advised Bausch Health that approximately 19,984,767 shares of DURECT common stock were validly tendered and not properly withdrawn in the tender offer, representing approximately 62% of the then-outstanding shares of DURECT’s common stock. All of the conditions to the tender offer have been satisfied, and on September 11, 2025, a wholly owned subsidiary of Bausch Health (“Merger Sub”) accepted for payment and will as promptly as practicable pay for all shares validly tendered and not properly withdrawn in the tender offer. Following the consummation of the tender offer, Merger Sub merged with and into DURECT in accordance with Section 251(h) of the Delaware General Corporation Law without a vote of DURECT stockholders (the “Merger”), with DURECT continuing as the surviving corporation in the Merger under the name DURECT Corporation. In the Merger, shares of DURECT that were not tendered in the tender offer were converted into the right to receive $1.75 per share in cash plus one CVR.
Following the closing of the tender offer and Merger, DURECT Corporation became a wholly owned subsidiary of Bausch Health. Prior to the opening of trading on The Nasdaq Stock Market LLC (“Nasdaq”) on September 11, 2025, all shares of DURECT common stock will cease trading on Nasdaq, and DURECT intends to promptly cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.
Advisors
Centerview Partners LLC acted as exclusive financial advisor and Sullivan & Cromwell LLP acted as legal advisor to Bausch Health. Locust Walk acted as exclusive financial advisor and Orrick, Herrington & Sutcliffe LLP acted as legal advisor to DURECT.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About DURECT Corporation
DURECT Corporation is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT’s lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH has also been explored. For more information about DURECT, please visit www.durect.com and follow DURECT on X (formerly Twitter) at https://x.com/DURECTCorp.
Forward Looking Statements
This news release may contain forward-looking statements about the proposed transaction with DURECT and the future performance of Bausch Health (Bausch Health and DURECT, collectively, “the Parties”), which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Parties' overall businesses, including those more fully described in the Parties’ most recent annual reports on Form 10-K and quarterly reports on Form 10-Q and detailed from time to time in the Parties’ other filings with the U.S. Securities and Exchange Commission and, in the case of Bausch Health, the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the success of larsucosterol and its path to regulatory approval; achievement of the net sales milestone payments; reliance on third parties, which increases the risk that submissions for regulatory approval of larsucosterol may be delayed or that we will not have sufficient quantities of larsucosterol available at an acceptable cost, which could delay, prevent or impair our development and commercialization efforts of larsucosterol; future clinical trials for larsucosterol may be delayed and may not demonstrate efficacy or safety; and open-label trials of larsucosterol in AH have inherent limitations. Additional information regarding certain of these material factors and assumptions may be found in the Parties’ filings described above. These forward-looking statements speak only as of the date hereof. The Parties undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Fri, 05 Sep 2025 08:00:00 GMTLAVAL, QC, September 5, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, and Solta Medical, a global leader in the medical aesthetics market, today announced that the Company’s proven Thermage technology has successfully been used to perform more than 5 million skin tightening and smoothing treatments.
Thermage utilizes monopolar radiofrequency energy that can safely heat layers of skin and stimulate collagen production, naturally. With every Thermage treatment, patients embrace a non-invasive path to visibly smoother, tighter skin—rooted in proven technology, backed by patented innovation, and trusted around the globe. Patients rely on Thermage for their yearly facial, body, and eye treatments. It is the only non-invasive technology indicated for use on the upper and lower eyelids for wrinkles.
“Thermage has surpassed 5 million tips used worldwide, a testament to the trusted science behind every treatment,” said Jiny Kim, Senior Vice President, Solta Medical, Bausch Health. “We want to thank every patient, consumer, healthcare provider, and employee for being part of a global story that keeps growing. Thermage is dedicated to helping individuals enhance their natural beauty through non-invasive skin tightening solutions. We will continue to advance our technology by investing in research and development, as well as gathering clinical evidence. We are just only getting started.”
“We are proud to celebrate this incredible milestone achieved by Thermage technology,” said Thomas J. Appio, Chief Executive Office, Bausch Health. “This accomplishment reflects our commitment to innovative solutions in aesthetics and demonstrates the trust that patients and providers place in our products globally.”
About Thermage® FLX system
INDICATIONS
The radiofrequency energy only delivery components of the Thermage® FLX system and accessories are indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis
Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
Non-invasive treatment of wrinkles
The simultaneous application of radiofrequency energy and skin vibration by the Thermage® FLX system and accessories are indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis
Non-invasive treatment of wrinkles around the eye
Non-invasive treatment of wrinkles
Temporary improvement in the appearance of cellulite
Relief of minor muscle aches and pain
Relief of muscle spasms
Temporary improvement of local circulation (blood circulation)
IMPORTANT SAFETY INFORMATION
Do not undergo Thermage® treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator, or any other electrical implant. Let your doctor know if you have an electrical implant or if you have any questions about whether you should undergo a Thermage® treatment.
Solta Medical has not studied the use of the Thermage® system:
Over skin fillers (lips, cheeks, facial wrinkles and skin folds)
In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy
In people who have permanent make-up and/or tattoos
In children
The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated.
The most commonly reported adverse effects after treatment include the following:
Mild redness may occur and typically resolves within 24 hours.
Swelling may occur and typically resolves within 5 days, but can remain up to several weeks.
The following adverse effects occur infrequently:
· The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation.
· Skin surface irregularities may appear up to 1 or more months post-treatment.
· Numbness, tingling” or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks.
· Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications.
· Skin may darken, but normally resolves within several months.
Talk to your doctor for more information about Thermage, and see thermage.com for additional details.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our aesthetic business, Solta Medical, is a global leader in the aesthetics market, whose vision is to develop and support trusted aesthetic brands that provide value to our customers and patients. More information about Solta Medical can be found at www.solta.com. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Mon, 01 Sep 2025 01:00:00 GMTNew probiotic and prebiotic skincare products offer a natural and effective solution for managing acne-prone skin.
Following the partnership announcement with YUN NV, Bausch Health has introduced the YUN ACN skincare line in Poland, featuring probiotic and prebiotic formulations designed for acne-prone skin.
The product range includes YUN ACN Repair Cream, Wash gel, and Micellar water, all supporting the skin’s natural microbiome without the drawbacks of traditional acne treatments.
Recent scientific research demonstrates that incorporating probiotics into skincare significantly reduces pimples without side effects¹, offering a natural and innovative alternative.
LAVAL, QC, September 1, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced the launch of the YUN ACN skincare line in Poland, offering probiotic and prebiotic formulations designed for acne-prone skin. Following Bausch Health’s partnership announcement with YUN NV last June, YUN Probiotherapy™ ACN products are now available in pharmacies across Poland. The skincare product range includes YUN ACN Repair Cream, Wash gel, and Micellar water, all supporting the skin’s natural microbiome.
Building on the latest advancements in microbiome science, the YUN ACN line offers a suite of products tailored to support healthy skin. The YUN ACN Repair Cream is a probiotic face cream that helps restore the skin's natural microbiome balance and improves hydration. The YUN ACN Wash is a prebiotic cleansing gel that gently cleanses the skin and supports the skin’s good bacteria, and the YUN ACN Micel is a prebiotic micellar cleaning water that effectively removes impurities.
"We are excited to bring the YUN ACN probiotherapeutical skincare line to the Polish market”, said Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health. “These next-generation dermatological products leverage groundbreaking microbiome science for natural and effective management of acne-prone skin. This launch underscores our dedication to bringing innovative, science-driven solutions to more people worldwide.”
A recent study published in the scientific journal Cell Reports Medicine demonstrated the powerful effect of probiotics incorporated into a skin cream through microcapsules. The findings showed the skin cream with microcapsules containing probiotics significantly reduced pimples without any side effects. ¹ The YUN ACN skincare line offers a safe and effective alternative to traditional acne treatments.
"At YUN, we embrace good bacteria to support healthy skin. Our novel microcapsule technology keeps these helpful bacteria alive in our ACN skincare products, helping to naturally reduce pimples and impurities. This groundbreaking method offers a safe alternative to traditional ones," explained Ingmar Claes, Chief Scientific Officer, YUN NV.
To learn more about the YUN ACN products available at select pharmacies across Poland, please visit yun-probiotherapy.com.
Reference:
Lebeer S, et al. Selective targeting of skin pathobionts and inflammation with topically applied lactobacilli. Cell Rep Med. 2022 Feb 15;3(2):100521. doi:10.1016/j.xcrm.2022.100521.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About Yun NV
YUN is a Belgian biotech company redefining everyday care through microbiome science. Founded in 2016, YUN developed the patented YUN Probiotherapy™ platform, featuring live probiotics and microbiome-friendly formulations designed to respect and support the skin’s natural balance. With innovations across dermatological, oral, baby, intimate, and ear care, YUN delivers science- and quality-driven, nature-powered solutions for health-conscious patients and consumers, today and for generations to come. For more information about YUN, visit www.yun-probiotherapy.com and connect with us on LinkedIn.
Forward Looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Mon, 01 Sep 2025 01:00:00 GMTNowe produkty zawierające probiotyki i prebiotyki stanowią naturalne i skuteczne rozwiązanie do pielęgnacji skóry skłonnej do trądziku.
Po ogłoszeniu współpracy z YUN NV firma Bausch Health wprowadza w Polsce linię kosmetyków YUN ACN, obejmującą preparaty probiotyczne i prebiotyczne przeznaczone dla skóry skłonnej do trądziku.
Linia produktów obejmujeYUN ACN Repair Cream krem probiotyczny, YUN ACN Wash oczyszczający żel do mycia twarzy oraz YUN ACN Micel płyn micelarny, które wspomagają naturalny mikrobiom skóry
Najnowsze badania naukowe wykazują, że stosowanie probiotyków w kosmetykach do pielęgnacji skóry istotnie redukuje liczbę niedoskonałości i wyprysków bez skutków ubocznych1, co oznacza, że stanowią one naturalną i innowacyjną pielęgnację skóry.
LAVAL, QC, 1 września 2025 r. – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), globalna, zdywersyfikowana firma farmaceutyczna, ogłosiła wprowadzenie na polski rynek linii kosmetyków YUN ACN, zawierających preparaty probiotyczne i prebiotyczne przeznaczone do pielęgnacji skóry skłonnej do trądziku. Po ogłoszeniu współpracy partnerskiej z YUN NV w czerwcu tego roku, produkty YUN Probiotherapy™ ACN są już dostępne w aptekach w całej Polsce. Linia produktów obejmuje YUN ACN krem probiotyczny YUN ACN oczyszczający żel do mycia oraz YUN ACN płyn micelarny, które wspierają naturalny mikrobiom skóry.
Linia YUN ACN jest oparta na najnowszych osiągnięciach naukowych dotyczących mikrobiomu i oferuje produkty ułatwiające utrzymanie zdrowej skóry. YUN ACN repair krem to probiotyczny krem do twarzy, który pomaga przywrócić naturalną równowagę mikrobiomu skóry oraz poprawia jej nawilżenie. Oczyszczający żel do mycia YUN ACN to prebiotyczny preparat, który delikatnie oczyszcza skórę i wspomaga rozwój korzystnych dla niej bakterii. Płyn micelarny YUN ACN również zawiera prebiotyki i skutecznie usuwa zanieczyszczenia.
— Cieszymy się, że możemy zaoferować linię dermokosmetyków probiotycznych YUN ACN na rynku polskim — powiedział Cees Heiman, starszy wiceprezes w Europie i Kanadzie firmy Bausch Health. — Te produkty dermatologiczne nowej generacji wykorzystują przełomowe odkrycia w dziedzinie mikrobiomu, umożliwiając naturalną i efektywną pielęgnację skóry skłonnej do trądziku. Wprowadzenie tych kosmetyków podkreśla nasze dążenie do oferowania innowacyjnych, opartych na nauce rozwiązań dla jak największej liczby osób na całym świecie.
Badanie opublikowane niedawno w czasopiśmie Cell Reports Medicine wykazało skuteczne działanie kremu do skóry zawierającego probiotyki w postaci mikrokapsułek. Wyniki dowiodły, że krem zawierający mikrokapsułki z probiotykami istotnie redukował liczbę wyprysków bez powodowania skutków ubocznych.1 Linia produktów YUN ACN to bezpieczna i skuteczna pielęgnacja skóry skłonnej do trądziku.
— W firmie YUN stawiamy na dobre bakterie wspomagające zdrową skórę. Nasza innowacyjna technologia mikrokapsułek utrzymuje je przy życiu w produktach ACN, co pozwala naturalnie zmniejszać liczbę wyprysków oraz zanieczyszczeń. Ta przełomowa metoda stanowi bezpieczną alternatywę dla tradycyjnych rozwiązań — wyjaśnił Ingmar Claes, dyrektor naukowy YUN NV.
Więcej informacji o produktach YUN ACN dostępnych w wybranych aptekach w Polsce można znaleźć na stronie yun-probiotherapy.com.
Piśmiennictwo:
Lebeer S i wsp. Selective targeting of skin pathobionts and inflammation with topically applied lactobacilli. Cell Rep Med. 15 lutego 2022 r.;3(2):100521. doi:10.1016/j.xcrm.2022.100521.
Informacje o Yun NV
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) to globalna, zdywersyfikowana firma farmaceutyczna wzbogacająca życie dzięki nieustannemu dążeniu do zapewniania lepszych wyników klinicznych w opiece zdrowotnej. Opracowujemy, wytwarzamy i wprowadzamy na rynek szeroką gamę produktów, głównie w dziedzinach gastroenterologii, hepatologii, neurologii, dermatologii, stomatologii, medycyny estetycznej, międzynarodowych produktów farmaceutycznych oraz zdrowia oczu, poprzez nasze dominujące udziały w korporacji Bausch + Lomb. Naszą ambicją jest być zintegrowaną w skali globalnej firmą w branży opieki zdrowotnej, darzoną zaufaniem przez pacjentów, pracowników ochrony zdrowia, własnych pracowników i inwestorów. Więcej informacji na temat firmy Bausch Health znajduje się na stronie www.bauschhealth.com a także w serwisie LinkedIn.
Informacje o Yun NV
YUN to belgijska firma biotechnologiczna redefiniująca codzienną higienę dzięki nauce o mikrobiomie. Założona w 2016 r. firma YUN opracowała opatentowaną platformę YUN Probiotherapy™, obejmującą żywe probiotyki i formuły przyjazne mikrobiomowi zaprojektowane w taki sposób, by respektować i wspomagać naturalną równowagę skóry. Dzięki innowacjom w obszarze dermatologii, higieny jamy ustnej, zdrowia niemowląt, higieny intymnej oraz pielęgnacji uszu, firma YUN dostarcza oparte na nauce i jakości, inspirowane naturą rozwiązania dla świadomych pod względem zdrowotnym pacjentów i konsumentów — dziś i dla przyszłych pokoleń. Więcej informacji na temat firmy YUN znajduje się na stronie www.yun-probiotherapy.com a także w serwisie LinkedIn.
Stwierdzenia odnoszące się do przyszłości
Niniejszy komunikat prasowy może zawierać stwierdzenia odnoszące się do przyszłości w rozumieniu obowiązujących przepisów prawa dotyczących papierów wartościowych, w tym przepisów dotyczących „bezpiecznej przystani” amerykańskiej ustawy o reformie przepisów procesowych dotyczących papierów wartościowych z 1995 r. Stwierdzenia odnoszące się do przyszłości zazwyczaj zawierają słowa typu „nastąpi”, „oczekiwać”, „mieć nadzieję”, „spodziewać się”, „zamierzać”, „planować”, „należy”, „może”, „można by”, „uważać, że...”, „przy założeniu, że…” oraz ich odmiany bądź podobne określenia. Stwierdzenia te nie są faktami historycznymi ani nie gwarantują przyszłych wyników; są one oparte na aktualnych przewidywaniach i przekonaniach zarządu i podlegają pewnym czynnikom ryzyka i niepewności, które mogą spowodować, że rzeczywiste wyniki będą znacznie różnić się od opisanych. Rzeczywiste wyniki podlegają również innym czynnikom ryzyka i niepewności, które w szerszym ujęciu odnoszą się do całokształtu działalności Bausch Health, w tym bardziej szczegółowo opisanym w najnowszych rocznych i kwartalnych sprawozdaniach Bausch Health oraz wyszczególnione w innej dokumentacji Bausch Health składanej okresowo w Komisji Papierów Wartościowych i Giełd Stanów Zjednoczonych oraz kanadyjskim organie ds. papierów wartościowych; czynniki te są tu uwzględnione przez odwołanie. Odbiorców przestrzega się przed nadmiernym opieraniem się na tego typu stwierdzeniach odnoszących się do przyszłości. Odnoszą się one bowiem jedynie do stanu na dzień publikacji niniejszej informacji prasowej. Spółka nie zobowiązuje się do aktualizacji któregokolwiek z tych stwierdzeń odnoszących się do przyszłości w celu odzwierciedlenia zdarzeń, informacji lub okoliczności zaistniałych po dacie publikacji niniejszej informacji prasowej lub w celu odzwierciedlenia rzeczywistych wyników, chyba że wymaga tego prawo.
]]>Tue, 26 Aug 2025 08:00:00 GMTLAVAL, QC and CUPERTINO, CA, August 26, 2025 – Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), a global, diversified pharmaceutical company, and DURECT Corporation (NASDAQ: DRRX) today announced that BHC Lyon Merger Sub, Inc. (“Purchaser”), a wholly owned subsidiary of Bausch Health Americas, Inc. (“BHA”), and an indirect subsidiary of Bausch Health Companies Inc. (“BHC”), has extended the expiration date of its tender offer (the “Offer”) to acquire all of the outstanding shares of common stock of DURECT Corporation for $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate (subject to certain adjustments in respect of a retention plan) if the milestones are achieved before the earlier of the 10 year anniversary of the first commercial sale of larsucosterol (5-cholesten-3ß, 25-diol 3-sulfate sodium salt) in the United States and December 31, 2045.
The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on September 9, 2025, has been extended until 5:00 p.m., New York City time, on September 10, 2025. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to this extension.
The Offer is being made pursuant to the terms and conditions described in the Offer to Purchase, dated August 12, 2025 (as it may be amended or supplemented from time to time, the “Offer to Purchase”), the related letter of transmittal and certain other offer documents, copies of which are attached to the tender offer statement on Schedule TO filed by BHC, BHA and Purchaser with the U.S. Securities and Exchange Commission (the “SEC”) on August 12, 2025. The Offer is conditioned upon the fulfilment of certain conditions described in “The Tender Offer—Section 15—Conditions to the Offer” of the Offer to Purchase, including but not limited to, a majority of the outstanding shares of DURECT Corporation’s common stock being tendered into the Offer and not withdrawn, as well as other customary closing conditions.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About DURECT Corporation
DURECT Corporation (Nasdaq: DRRX) is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT’s lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.
Forward Looking Statements
This news release may contain forward-looking statements about the proposed transaction with DURECT (the “Transaction”) and the future performance of Bausch Health (Bausch Health and DURECT, collectively, “the Parties”), which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Parties' overall businesses, including those more fully described in the Parties’ most recent annual reports on Form 10-K and detailed from time to time in the Parties’ other filings with the U.S. Securities and Exchange Commission and, in the case of Bausch Health, the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the proposed Transaction; the possibility that any or all of the conditions to the consummation of the Transaction may not be satisfied or waived; the failure to obtain requisite stockholder approval of DURECT, the effect of the announcement or pendency of the Transaction on Parties’ ability to maintain relationships with customers, suppliers, and other business partners; the impact of the Transaction if consummated on Bausch’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; and risks relating to potential diversion of management attention away from the Parties’ ongoing business operations. There can be no assurance that the conditions to closing the Transaction will be satisfied or that the tender offer and the Transaction will be consummated. Additional information regarding certain of these material factors and assumptions may be found in the Parties’ filings described above as well as the filings made in connection with the Transaction described below. These forward-looking statements speak only as of the date hereof. The Parties undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
Additional Information
On August 12, 2025, the Purchaser filed with the SEC a tender offer statement on Schedule TO and DURECT Corporation filed with the SEC a solicitation/recommendation statement on Schedule 14D-9 regarding the Offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS THEY MAY BE AMENDED FROM TIME TO TIME, CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The tender offer materials are available at no charge on the SEC’s website at www.sec.gov. The tender offer materials and related materials also may be obtained for free under the “Corporate Governance—SEC Filings” section of our investor website at https://ir.bauschhealth.com/, and the Solicitation/Recommendation Statement and such other documents also may be obtained for free from DURECT under the “SEC Filings” section of DURECT’s investor website at https://www.durect.com/investors/.
]]>PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan ]]>Thu, 21 Aug 2025 07:00:00 GMTLAVAL, QC, August 21, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Quebec and Saskatchewan.
This new public drug plan availability of CABTREO is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada.
CABTREO is a new Canadian-made triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1
“The addition of CABTREO to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment – joining those already covered under most private insurance plans,” said Amy Cairns, General Manager, Bausch Health Canada. “Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage.”
CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3
CABTREO Clinical Data and Safety Information
CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1
The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1
Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1
About Dermatology at Bausch Health, Canada Inc.
Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products.
CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4
All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>PrCABTREOMC (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan (French) ]]>Thu, 21 Aug 2025 07:00:00 GMTLAVAL, QC, le 21 août 2025 – Bausch Health, Canada Inc., une filiale de Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a annoncé aujourd'hui que PrCABTREOMC en gel 1,2 %/0,15 %/3,1 % (phosphate de clindamycine, adapalène et peroxyde de benzoyle), pour le traitement de l'acné vulgaire1, est désormais couvert pour les bénéficiaires des régimes publics d’assurance médicaments du Québec et de la Saskatchewan.
Cette nouvelle inscription de CABTREO aux régimes publics d'assurance-médicaments s'ajoute à celle annoncée le mois dernier pour les personnes inscrites aux régimes publics d'assurance-médicaments de l'Ontario et de la Nouvelle-Écosse, ainsi que du programme fédéral des services non assurés (PMNA) destiné aux populations autochtones, de celui du Service correctionnel du Canada (SCC), et de celui d'Anciens Combattants Canada.
CABTREO est un nouveau traitement topique sur ordonnance combinant trois ingrédients, fabriqué au Canada, indiqué pour l’acné vulgaire chez les patients âgés de 12 ans et plus. Il s’agit du premier et unique traitement topique à triple combinaison approuvé par Santé Canada pour l’acné, réunissant trois mécanismes d’action — un antibiotique, un rétinoïde et un agent antibactérien — afin d’offrir une option thérapeutique sûre et efficace1.
« L’ajout de CABTREO aux régimes publics d’assurance-médicaments du Québec et de la Saskatchewan signifie que davantage de Canadiens ont maintenant accès à ce traitement novateur contre l’acné, en plus de ceux déjà couverts par la plupart des régimes privés », a déclaré Amy Cairns, directrice générale de Bausch Health, Canada. « L’acné peut affecter grandement la vie de ceux qui en souffrent, et la forte demande pour de nouvelles options de traitement rend la couverture publique d’autant plus essentielle. »
CABTREO est un gel topique sur ordonnance à appliquer une fois par jour sur les zones affectées de la peau. Ses ingrédients actifs sont l'antibiotique phosphate de clindamycine, le rétinoïde topique adapalène et l'agent oxydant peroxyde de benzoyle qui a une activité bactéricide à large spectre1.
À propos de l’acné vulgaire
L’acné vulgaire (« vulgaire » signifie « commune ») est le problème cutané le plus fréquemment observé par les médecins au Canada. Elle se développe lorsque les pores se bouchent de sébum et de cellules cutanées, entraînant souvent des points blancs, des points noirs, des boutons ou des kystes sur le visage, le front, la poitrine, le haut du dos et les épaules. L’acné touche environ 5,6 millions de Canadiens, ou près de 20 % de la population, dont environ 90 % des adolescents. On estime que pour environ 25 % des adolescents, l’acné peut persister jusqu’à l’âge de 25 ans. L’acné peut causer une détresse émotionnelle ainsi que des cicatrices permanentes² et entraîner des troubles de pigmentation cutanée3.
Données cliniques et informations de sécurité de CABTREO
CABTREO a fait l'objet de deux études cliniques multicentriques de phase 3, aléatoires et contrôlées par placebo, menées auprès de 363 patients présentant de l'acné vulgaire faciale. Les deux études ont atteint tous les critères d'efficacité primaires, notamment le changement absolu du nombre de lésions inflammatoires et non inflammatoires par rapport à l’inclusion, ainsi que le pourcentage de patients ayant atteint le succès du traitement prédéfini. Les résultats d'efficacité combinés des deux études pour CABTREO ont démontré un taux de réussite du traitement d'environ 50 % et une réduction de plus de 70 % des lésions inflammatoires et non inflammatoires à la semaine 121.
Les réactions indésirables les plus fréquentes pouvant survenir avec CABTREO sont des réactions légères ou modérées au niveau du site d'application. Par exemple, une irritation cutanée caractérisée par une desquamation, une sécheresse, un érythème (rougeur) et une sensation de brûlure ou de picotement. CABTREO ne doit pas être utilisé par les personnes hypersensibles à l'un des ingrédients qu'il contient (phosphate de clindamycine, adapalène, peroxyde de benzoyle ou à tout autre ingrédient dans la préparation), par les patients ayant des antécédents d'entérite régionale (maladie de Crohn), de colite ulcéreuse ou de colite associée aux antibiotiques, ni par les femmes enceintes ou celles qui planifient une grossesse. CABTREO peut décolorer les cheveux et les tissus colorés. Il convient donc de faire preuve de prudence lors de l'application du produit près de la racine des cheveux1.
Santé Canada n'a pas autorisé l'utilisation de CABTREO chez les enfants de moins de 12 ans. CABTREO est destiné à un usage topique uniquement et n'est pas destiné à un usage oral, ophtalmique ou intravaginal1.
À propos de la dermatologie chez Bausch Health, Canada Inc.
Bausch Health, Canada Inc. possède l'un des plus grands portefeuilles de dermatologie sur ordonnance au Canada, dédié à aider les patients dans le traitement de diverses affections thérapeutiques, notamment le psoriasis, la kératose actinique, l'acné, la dermatite atopique et d'autres dermatoses. Le portefeuille dermatologique de Bausch Health, Canada comprend plusieurs produits de pointe contre l'acné, le psoriasis, les mycoses et les dermatoses sensibles aux corticostéroïdes.
CABTREO devient ainsi le quatrième traitement dermatologique de Bausch Health, Canada approuvé par Santé Canada et mis à la disposition des Canadiens au cours des quatre dernières années, enrichissant ainsi la gamme de produits de pointe de l’entreprise dans ce domaine thérapeutique important. Les autres produits approuvés sont la lotion ARAZLOMC (tazarotène), 0,045 % p/p, pour le traitement topique de l'acné vulgaire chez les patients âgés de 10 ans et plus ; BRYHALIMC (lotion au propionate d'halobétasol 0,01 % p/p), pour les dermatoses répondant aux corticostéroïdes et le traitement topique du psoriasis en plaques chez les adultes ; et DUOBRIIMC (propionate d'halobétasol 0,01% p/p et tazarotène 0,045 % p/p) pour traiter les adultes atteints de psoriasis en plaque de degré modéré ou sévère4.
Les quatre traitements (CABTREO, ARAZLO, BRYHALI et DUOBRII) sont fabriqués à l'usine de Bausch Health à Laval, au Québec, et distribués au Canada et aux États-Unis.
À propos de Bausch Health
Bausch Health Companies Inc. (NYSE et TSX : BHC) est une société pharmaceutique mondiale à exploitation diversifiée ayant pour mission d’améliorer la vie des gens grâce à ses produits de santé. Elle met au point, fabrique et commercialise une gamme de produits, principalement dans les domaines de la gastroentérologie, de l’hépatologie, de la neurologie, de la dermatologie, les dispositifs médicaux esthétiques, la dentisterie, l'esthétique, les produits pharmaceutiques internationaux, ainsi que la santé oculaire, à travers sa participation majoritaire dans Bausch + Lomb. Nous aspirons à devenir une entreprise de soins de santé intégrée à l'échelle mondiale, reconnue et appréciée par les patients, les professionnels de la santé, les employés et les investisseurs. Pour plus de renseignements, visitez le site www.bauschhealth.com et communiquez avec nous sur LinkedIn.
La gamme de médicaments d’ordonnance de Bausch Health, Canada Inc. cible principalement la dermatologie, les troubles gastro-intestinaux et les affections cardiométaboliques. Bausch Health possède deux usines de fabrication pour les médicaments d’ordonnance au Canada, une à Laval, au Québec, et l’autre à Steinbach, au Manitoba. Vous trouverez de plus amples renseignements sur le site Web de la société au www.bauschhealth.ca.
Déclarations prospectives
Ce communiqué de presse peut contenir des déclarations prospectives au sens des lois sur les valeurs mobilières applicables, y compris les dispositions de protection prévues par le U.S. Private Securities Litigation Reform Act de 1995. Les déclarations prospectives peuvent généralement être identifiées par l'utilisation de termes tels que « prévoit », « anticipe », « espère », « s'attend à », « à l'intention de », « planifie », « devrait », « pourrait », « voudrait », « peut », « croit », « sous réserve de », ainsi que par des expressions similaires ou des variations. Ces déclarations ne constituent ni des faits historiques ni des garanties de performance future. Elles sont fondées sur les attentes et les croyances actuelles de la direction et sont sujettes à certains risques et incertitudes qui pourraient entraîner des écarts significatifs entre les résultats réels et ceux décrits dans ces déclarations. Les résultats réels sont soumis à d'autres risques et incertitudes qui se rapportent plus généralement aux activités de Bausch Health, y compris ceux décrits de façon plus détaillée dans les rapports annuels et trimestriels les plus récents de Bausch Health, ainsi que dans les autres documents déposés de temps à autre auprès des Autorités canadiennes en valeurs mobilières et de la U.S. Securities and Exchange Commission, lesquels facteurs sont incorporés aux présentes par référence. Les lecteurs sont priés de ne pas accorder une trop grande confiance à ces déclarations prospectives. Ces déclarations prospectives ne sont valables qu'à la date du présent communiqué. La société ne s'engage aucunement à mettre à jour ces déclarations prospectives pour tenir compte d'événements, d'informations ou de circonstances survenus après la date de ce communiqué ou pour refléter des résultats réels, sauf si la loi l'exige.
]]>Fri, 15 Aug 2025 08:00:00 GMTLAVAL, QC, August 15, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) ("Bausch Health" or the "Company") today announced that Paulson Capital Inc. and certain affiliates and managed funds have increased their ownership of the Company’s common shares.
The increase reflects the acquisition by Paulson Capital Inc. and certain affiliates and managed funds of the net long position of 34,721,118 common shares previously held by Mr. Carl C. Icahn and his affiliates (collectively, “Icahn Group”). The Company is not a party to any agreement or arrangement with Paulson Capital Inc. or its affiliates or the Icahn Group in connection with these transactions. Based on information provided to the Company, Paulson Capital Inc. and certain affiliates and managed funds beneficially owns approximately 19.13% of the Company’s outstanding common shares as of the date hereof.
The Company further announced that the Director Appointment and Nomination Agreement, dated as of February 23, 2021, between the Company and Icahn Group, terminated pursuant to its terms when the Icahn Group’s net long position in the Company’s shares fell below the specified threshold. In connection with the termination, Brett M. Icahn and Steven D. Miller have resigned from the Board of Directors (the “Board”).
“I believe there is significant value in Bausch Health and am confident in the Company’s efforts to maximize shareholder value. I am excited about the underlying business prospects in both Bausch Health and its subsidiary, Bausch + Lomb Corporation,” John A. Paulson, Chairperson of the Bausch Health Board, said. “I also want to thank Brett and Steven for their dedication and valuable contributions to the Company.”
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 07 Aug 2025 08:00:00 GMTFor the Sixth Consecutive Year, 10 Students with Gastrointestinal Disease Will Each Receive a $10,000 Scholarship
LAVAL, QC, August 7, 2025– Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the recipients of its 2025 Salix Gastrointestinal Health Scholars Program. For the sixth year, Bausch Health is proud to award 10 deserving students living with a GI disease $10,000 each to further their higher education.
"The overwhelming response to our scholarship program reflects the unwavering drive and determination of students within the GI community. These remarkable individuals refuse to let their illness define their path," said Aimee Lenar, Executive Vice President, US Pharma, Bausch Health. "Each year, we are inspired by their stories of resilience, which serve as powerful reminders of true strength. Bausch Health is proud to continue providing meaningful financial support to help ease their burden and empower their academic success."
The 2025 scholarship recipients were chosen from a competitive pool of over 370 applicants. As part of the selection process, candidates submitted personal essays detailing how their gastrointestinal condition has shaped their educational journey and highlighting the support provided by their health care providers in helping them achieve their academic and personal milestones. All applications were thoroughly evaluated by an independent panel of judges.
The program recognizes students across a wide range of educational pursuits, with scholarships in three categories, including the Undergraduate Scholar Awards, for those pursuing undergraduate degrees; the Graduate Scholar Awards, for those pursuing graduate degrees; and the Working and/or Single Parent’s Scholar Award, for students who are working and/or single parents pursuing undergraduate, vocational/technical, or graduate degrees.
This year’s recipients shared powerful reflections on what Bausch Health’s Salix Gastrointestinal Health Scholars Award means to them and how it’s helping shape their academic journey.
“Although my diagnosis has provided many challenges, it has ultimately fueled my desire to become a physician. I have found a passion for helping others, and I plan to become a pediatric gastroenterologist,” said Alexis Weary, a scholarship recipient. “I truly appreciate the company for their work in gastrointestinal healthcare and for providing me with this scholarship to help me turn my dreams into a reality.”
Another scholarship recipient, Samantha Smith said, “This scholarship affirms my belief that chronic illness can be a source of resilience and innovation. I'm deeply grateful to Bausch Health’s Salix Gastrointestinal Health Scholars Program for empowering me to continue advocating for inclusive policy reformation."
Their words reflect the heart of the program—empowering students to pursue their goals with confidence, support, and pride.
Bausch Health’s 2025 Salix Gastrointestinal Health Scholars Program recipients are:
Undergraduate Scholar Awards
Krish Desai – University of California Los Angeles (UCLA)
Maya Fischler – Brown University
Annie Jones – Colorado State University
Ethan Leicht – Louisville State University
Maggie Schaefer – Creighton University
Keaton Van Nostrand – Florida State University
Graduate Scholar Awards
Kunika Chahal – SUNY Downstate College of Medicine
Samantha Smith – Harvard Business School
Alexis Weary – Nova Southeastern University College of Osteopathic Medicine
Working and/or Single Parent’s Scholar Award
Miriam McCarter – Brigham Young University Law School
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Second Quarter Consolidated Revenues of $2.53 billion, up 5% on a Reported basis and 4% on an Organic (non-GAAP)1 basis over the prior year period
GAAP Net Income Attributable to Bausch Health Companies of $148 million and GAAP Net Income of $128 million
Consolidated Adjusted EBITDA Attributable to Bausch Health Companies (non-GAAP)1 of $842 million, up 6% on a Reported basis over the prior year period
BAUSCH HEALTH EXCLUDING BAUSCH + LOMB SECOND QUARTER 2025 RESULTS
Delivered ninth consecutive quarter of year-over-year Revenue and Adjusted EBITDA (non-GAAP)1 growth, with 5% both Reported and Organic (non-GAAP)1 Revenue growth, and 10% Adjusted EBITDA (non-GAAP)1 growth
Announced upcoming repayment of approximately $900 million dollars of debt using cash on hand after quarter-end
Entered into an agreement to acquire DURECT Corporation in July, which if all closing conditions are satisfied and the acquisition closes, will enable Bausch Health to use its hepatology expertise to seek to gain approvals and commercialize DURECT's main treatment for alcohol-induced hepatitis
Reaffirming full-year 2025 Revenue, Adjusted EBITDA (non-GAAP)1, and Adjusted Cash Flow from Operations (non-GAAP)1 guidance
LAVAL, QC, July 30, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its second quarter 2025 financial results and other key updates from the quarter.
"In the second quarter, we achieved our ninth consecutive quarter of year-over-year growth in Revenue and Adjusted EBITDA for Bausch Health, excluding Bausch + Lomb. This consistent performance highlights our operational excellence and the strength of our diverse portfolio across therapeutic areas and geographies. As we look toward the second half of 2025, we remain focused on executing against our strategic priorities to drive continued growth and unlock long-term value for our shareholders," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Second Quarter 2025 Revenue Performance
Total consolidated reported revenues were $2.53 billion for the second quarter of 2025, compared with $2.40 billion in the second quarter of 2024, an increase of $127 million, or 5%. Excluding the impact of foreign exchange of $21 million, acquisitions of $6 million, and divestitures and discontinuations which negatively impacted the prior year by $2 million, revenue increased 4% on an organic1 basis compared with the second quarter of 2024.
1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure.
Reported revenues by segment were as follows:
Three Months Ended June 30,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic Revenue1 (Non-GAAP)
(in millions)
2025
2024
Amount
Pct.
Total Bausch Health Revenues
$2,530
$2,403
$127
5%
4%
4%
Bausch Health (excl. B+L)
$1,252
$1,187
$65
5%
5%
5%
Salix segment
$627
$558
$69
12%
12%
12%
International segment
$278
$276
$2
1%
—
1%
Solta Medical segment
$128
$102
$26
25%
26%
26%
Diversified segment
$219
$251
($32)
(13%)
(13%)
(13%)
Bausch + Lomb segment
$1,278
$1,216
$62
5%
3%
3%
Salix Segment
Salix segment reported revenues were $627 million for the second quarter of 2025, compared with $558 million for the second quarter of 2024, an increase of $69 million, or 12%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $4 million, segment revenues increased 12% on an organic1 basis compared with the second quarter of 2024. Xifaxan® was the primary driver of segment growth, with 10% revenue growth in the second quarter of 2025 compared with the prior year period.
International Segment
International segment reported revenues were $278 million for the second quarter of 2025, compared with $276 million for the second quarter of 2024, an increase of $2 million, or 1%. Excluding the impact of foreign exchange of $1 million and divestitures and discontinuations of $2 million, segment revenues increased 1% on an organic1 basis compared with the second quarter of 2024, led by growth in Canada and EMEA.
Solta Medical Segment
Solta Medical segment reported revenues were $128 million for the second quarter of 2025, compared with $102 million in the second quarter of 2024, an increase of $26 million, or 25%. Excluding the impact of foreign exchange of $1 million, segment revenues increased on an organic1 basis by 26% compared with the second quarter of 2024, led by growth in South Korea.
Diversified Segment
Diversified segment reported revenues were $219 million for the second quarter of 2025, compared with $251 million for the second quarter of 2024, a decrease of $32 million, or 13%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $2 million, segment revenues decreased 13% on an organic1 basis compared with the second quarter of 2024.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1.28 billion for the second quarter of 2025, compared with $1.22 billion for the second quarter of 2024, an increase of $62 million, or 5%. Excluding the impact of foreign exchange of $21 million, acquisitions of $6 million and divestitures and discontinuations of $2 million, segment revenues increased 3% on an organic1 basis compared with the second quarter of 2024.
]]>Tue, 29 Jul 2025 09:00:00 GMTBausch Health to Acquire DURECT Corporation, Strengthening Commitment to Developing Innovative Solutions for Patients with Liver Disease
DURECT's lead asset, Larsucosterol, is an epigenetic modulator with FDA Breakthrough Therapy Designation
Potential to be the first FDA-approved therapeutic option for the treatment of patients with alcoholic hepatitis
Proposed acquisition strengthens Bausch Health’s commitment to hepatology and patients suffering with liver disease complications globally
LAVAL, Quebec and CUPERTINO, California, July 29, 2025 – Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), a global, diversified pharmaceutical company, and DURECT Corporation (NASDAQ: DRRX) today announced a definitive agreement under which Bausch Health will indirectly acquire DURECT Corporation, including a novel therapeutic molecule, larsucosterol, which can harness the power of epigenetic modulation. Larsucosterol, an endogenous sulfated oxysterol and an epigenetic modulator, has demonstrated promising results for the treatment of alcoholic hepatitis (AH) in Phase 2 trials. Bausch Health’s hepatology development and commercial capabilities are well-suited to support the clinical development and potential commercialization of larsucosterol.
AH is a life-threatening form of alcohol-associated liver disease (ALD), which can occur in individuals who chronically misuse alcohol. It is characterized by severe inflammation and destruction of liver tissue (i.e., necrosis). AH accounted for roughly 164,000 hospital admissions in the U.S. in 2021. There is currently no Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment for AH, and novel therapeutic strategies are needed to improve patient survival.
"This announcement is fundamental progress on our Strategic Priority - Innovation, which is to intensify focus and operating rigor behind R&D and business development and demonstrates our commitment to hepatology and finding new ways to address unmet medical needs, living our purpose of enriching lives through our relentless drive to deliver better health outcomes for patients,” said Thomas J. Appio, Chief Executive Officer, Bausch Health.
“There is a significant unmet need in the treatment of patients with AH given the high mortality rate and that there are no currently approved treatments. We are very excited to add larsucosterol, an asset which has FDA Breakthrough Therapy Designation, to our pipeline, particularly as it builds on our existing expertise within the hepatology space. It is complementary to our ongoing Phase 3 program of soluble solid dispersion of rifaximin (rifaximin SSD) being studied in cirrhotic patients globally,” stated Jonathan Sadeh M.D., M.Sc. as Executive Vice President, Chief Medical Officer and Head of R&D at Bausch Health.
“AH, by our estimates, is responsible for about 100 deaths per day in the US and billions of dollars in healthcare costs,” stated James E. Brown, D.V.M., President and CEO of DURECT. “Since we reported results from our Phase 2b AHFIRM clinical trial for larsucosterol in AH, our primary focus has been advancing larsucosterol towards the completion of clinical development. We chose this transaction with Bausch Health because we believe it provides significant value for our stakeholders, both immediately and in the long term, should larsucosterol be approved and achieve commercial success. We view Bausch Health as the right partner to advance larsucosterol due to their expertise in hepatology, commercial success with Xifaxan and experienced development team. We look forward to the potential impact larsucosterol could have for patients with AH and the medical community that cares for them. Thank you to our team at DURECT and our partners that have helped advance larsucosterol to this point."
A registrational Phase 3 program to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH is being planned. The trial will be a randomized, double-blind, placebo-controlled, multi-center study. The primary endpoint will be 90-day survival. The trial design will incorporate feedback received from the FDA during a Type B meeting under Breakthrough Therapy Designation as well as learnings from the prior Phase 2b AHFIRM trial in AH.
The acquisition of the clinical development program for larsucosterol in AH compliments the ongoing Bausch Health RED-C clinical program which is designed to assess the efficacy of a next generation therapeutic, rifaximin SSD, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization and all-cause mortality. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Patient enrollment in two global Phase 3, randomized, double-blind, placebo-controlled studies is now complete with efficacy and safety results expected to be announced in early 2026.
"The addition of larsucosterol to our pipeline is a strategic fit with our focus in hepatology and underscores our continued dedication to exploring and identifying new treatments for individuals who are suffering with liver disease and its complications," stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. "We are excited to continue investment in bringing these breakthrough options to market, not just in the US, but also globally.”
Transaction Terms and Financial Considerations
Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate (subject to certain adjustments in respect of a retention plan) if the milestone is achieved before the earlier of the 10 year anniversary of the first commercial sale in the United States and December 31, 2045. The purchase price payable at closing represents a premium of approximately 191% to the 30-day volume-weighted average trading price of DURECT’s common stock ended on July 28, 2025, the last trading day before the announcement of the transaction. This upfront consideration represents a premium of approximately 217% to the trading price of DURECT’s common stock ended on July 28, 2025.
The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation’s common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Assuming the closing of the tender offer, Bausch Health will acquire any shares of DURECT not tendered into the tender offer through a merger of a wholly owned subsidiary with and into DURECT for the same per share consideration payable in the tender offer.
Advisors
Centerview Partners LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Bausch Health. Locust Walk is serving as exclusive financial advisor and Orrick, Herington and Sutcliffe LLP is serving as legal advisor to DURECT.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About DURECT Corporation
DURECT Corporation (Nasdaq: DRRX) is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT’s lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.
Forward Looking Statements
This news release may contain forward-looking statements about the proposed transaction with DURECT (the “Transaction”) and the future performance of Bausch Health (Bausch Health and DURECT, collectively, “the Parties”), which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Parties' overall businesses, including those more fully described in the Parties’ most recent annual reports on Form 10-K and detailed from time to time in the Parties’ other filings with the U.S. Securities and Exchange Commission and, in the case of Bausch Health, the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the proposed Transaction; the possibility that any or all of the conditions to the consummation of the Transaction may not be satisfied or waived; the failure to obtain requisite stockholder approval of DURECT, the effect of the announcement or pendency of the Transaction on Parties’ ability to maintain relationships with customers, suppliers, and other business partners; the impact of the Transaction if consummated on Bausch’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; and risks relating to potential diversion of management attention away from the Parties’ ongoing business operations. There can be no assurance that the conditions to closing the Transaction will be satisfied or that the tender offer and the Transaction will be consummated. Additional information regarding certain of these material factors and assumptions may be found in the Parties’ filings described above as well as the filings made in connection with the Transaction described below. These forward-looking statements speak only as of the date hereof. The Parties undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
Additional Information
This news release is for information purposes only and not intended to be a recommendation to buy, sell or hold securities and does not constitute an offer for the sale of, or the solicitation of an offer to buy, securities in any jurisdiction, including the United States. At the time the tender offer is commenced, we will file, or will cause to be filed, tender offer materials on Schedule TO with the SEC and DURECT will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, in each case with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS THEY MAY BE AMENDED FROM TIME TO TIME, WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY WHEN THEY BECOME AVAILABLE AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Those materials and all other documents filed by, or caused to be filed by, BHC and DURECT with the SEC will be available at no charge on the SEC’s website at www.sec.gov. The tender offer materials and related materials also may be obtained for free (when available) under the “Corporate Governance—SEC Filings” section of our investor website at https://ir.bauschhealth.com/, and the Solicitation/Recommendation Statement and such other documents also may be obtained for free (when available) from DURECT under the “SEC Filings” section of DURECT’s investor website at https://www.durect.com/investors/.
]]>Mon, 28 Jul 2025 08:41:28 GMTBausch Health to Reduce Debt by Approximately $900 Million Using Cash On Hand
LAVAL, QC, July 28, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) ("Bausch Health" or the "Company") today announced that its subsidiary, Bausch Health Americas, Inc., has issued an irrevocable notice of redemption pursuant to which it will redeem approximately $602 million of aggregate principal amount of its outstanding 9.25% Senior Notes due 2026, CUSIP Nos. 91911XAV6 and U9098VAN2 (the “Notes”), using cash on hand. The redemption date is August 28, 2025. The notice of redemption has been issued to the record holders of such Notes. Nothing contained herein shall constitute a notice of redemption of the Notes. Payment of the redemption price and surrender of the Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company. The name and address of the U.S. paying agent are as follows: The Bank of New York Mellon, 240 Greenwich Street, Floor 7E, New York, New York 10286; Attn: Corporate Trust Administration. In connection with the redemption, the indenture pursuant to which the Notes were issued will be terminated.
In addition, the Company today announced that its subsidiary, Bausch Receivables Funding LP, has given notice to the administrative agent under its Credit and Security Agreement, dated as of June 30, 2023, as amended, of its intention to repay all outstanding amounts in respect of the receivables financing facility thereunder (the “Receivables Facility”), and to terminate the Receivables Facility and the related agreements as of October 27, 2025. As of July 28, 2025, the aggregate principal amount outstanding under the Receivables Facility was $300 million.
These measures are consistent with the Company’s focus on optimizing its capital structure.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 24 Jul 2025 08:02:00 GMTBausch Health Announces the Appointment of Two New Members to Its Board of Directors
LAVAL, QC, July 24, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced the appointment of Michael Goettler and Sandra Leung to its Board of Directors, effective July 22, 2025. The appointments increase the size of the Board from ten to twelve members.
Michael Goettler is an accomplished executive with extensive leadership experience in the pharmaceutical industry. Most recently, he served as Chief Executive Officer of Viatris, where he guided the company through transformation and renewed focus. He is recognized for his expertise in steering multinational corporations and advancing healthcare solutions worldwide. Mr. Goettler will serve on the Talent and Compensation Committee and Science and Technology Committee.
Sandra Leung brings decades of experience and insight from her distinguished career in the pharmaceutical industry, most recently as Executive Vice President and General Counsel of Bristol Myers Squibb Company. Ms. Leung has provided strategic legal counsel at the highest levels, helping to guide corporate governance, compliance, and regulatory initiatives. Ms. Leung will serve on the Nominating and Corporate Governance Committee.
“On behalf of our Board, I am delighted to welcome Michael and Sandra to the Bausch Health Board. Their deep industry knowledge and leadership experience will provide invaluable guidance as the organization continues to evolve and strengthen,” said John A. Paulson, Chairperson of the Bausch Health Board. “We are confident that their insights will help accelerate the strategy and reinforce the Company’s commitment to patients, customers, and shareholders.”
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 10 Jul 2025 16:15:00 GMTLAVAL, QC, July 10, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced the appointment of Steven Lee as Senior Vice President, Controller and Chief Accounting Officer, effective Monday, July 14.
Steven brings extensive experience in financial transformation, mergers and acquisitions, and operational execution. With over two decades of experience, Steven has consistently demonstrated his proficiency in capital strategy to drive long-term value. Before joining Bausch Health, he served as Vice President and Chief Financial Officer of the Industrial and Energy Division and the North America Division, for BrandSafway, a portfolio company of Clayton, Dubilier & Rice and Brookfield Business Partners. He also served as Vice President and Chief Accounting Officer at BrandSafway. Previously, at Mohawk Industries, he held the roles of Vice President, Corporate Controller, and Chief Accounting Officer, along with other senior financial and operational management positions.
"We are excited to add Steven to our finance leadership team as our new Controller and Chief Accounting Officer," said JJ Charhon, Chief Financial Officer, Bausch Health. “His depth and breadth of experience will be a great addition to the finance function as we continue to support Bausch Health's transformation journey toward continued innovation and profitable growth."
In his new role, Steven will oversee the company's financial reporting and corporate controllership.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Ontario, Nova Scotia and two federal programs ]]>Wed, 09 Jul 2025 08:00:00 GMTLAVAL, QC, July 9, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREO™ (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Ontario and Nova Scotia as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and that of the Correctional Service of Canada (CSC).
CABTREO is a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1
"It is very encouraging for people with acne vulgaris who use the Ontario, Nova Scotia and federal drug plans to now have access to CABTREO along with those on most private drug insurance plans,” said Amy Cairns, General Manager, Bausch Health, Canada Inc. “We look forward to completing listing arrangements in the near future with other public drug plans across Canada.”
"We are pleased that public drug plans are ensuring Canadians with acne have access to new treatments, recognizing the importance of making different options available," said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. “Acne can significantly impact a person’s mental and physical health, so this is a big win for the patient community.”
CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3
CABTREO Clinical Data and Safety Information
CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1
The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1
Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1
About Dermatology at Bausch Health, Canada Inc.
Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products.
CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLO™ (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4
All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>PrCABTREOMC (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Ontario, Nova Scotia and two federal programs (French) ]]>Wed, 09 Jul 2025 08:00:00 GMTLAVAL, QC, le 9 juillet 2025 – Bausch Health, Canada Inc., une filiale de Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a annoncé aujourd'hui que PrCABTREOMC (phosphate de clindamycine, adapalène et peroxyde de benzoyle) gel à 1,2 % p/p, 0,15 % p/p et 3,1 % p/p,pour le traitement de l'acné vulgaire1, est maintenant offert aux patients dans le cadre des régimes d’assurance médicaments publics provinciaux de l’Ontario et de la Nouvelle-Écosse ainsi que dans le cadre du régime d’assurance médicaments des Services de santé non assurés (SSNA) pour les Premières Nations et les Inuit et aussi dans le cadre du Service correctionnel du Canada (SCC).
CABTREO est un nouveau traitement topique sur ordonnance à triple combinaison contre l’acné vulgaire destiné aux patients de 12 ans et plus. Il s’agit du premier et unique traitement topique à triple combinaison approuvé par Santé Canada pour l’acné, réunissant trois mécanismes d’action — un antibiotique, un rétinoïde et un agent antibactérien — afin d’offrir une option thérapeutique sûre et efficace1.
« C’est très encourageant pour les personnes atteintes d’acné vulgaire qui dépendent des régimes publics d’assurance médicaments de l’Ontario, de la Nouvelle-Écosse et des programmes fédéraux de pouvoir désormais avoir accès à CABTREO, au même titre que les personnes déjà couvertes par la plupart des régimes d’assurance privée », a déclaré Amy Cairns, directrice générale de Bausch Health, Canada Inc. « Nous avons hâte de conclure prochainement les ententes d’inscription avec les autres régimes publics partout au pays. »
« Nous sommes heureux que les régimes publics élargissent l’accès aux traitements de l’acné, reconnaissant l’importance d’offrir un éventail d’options », souligne Kathy Giangaspero, directrice générale de la Société canadienne de l’acné et de la rosacée. « L’acné peut avoir des répercussions considérables sur la santé mentale et physique. C’est donc une grande victoire pour la communauté des patients. »
CABTREO est un gel topique sur ordonnance à appliquer une fois par jour sur les zones affectées de la peau. Ses ingrédients actifs sont l'antibiotique phosphate de clindamycine, le rétinoïde topique adapalène et l'agent oxydant peroxyde de benzoyle qui a une activité bactéricide à large spectre1.
À propos de l’acné vulgaire
L’acné vulgaire (« vulgaire » signifie « commune ») est le problème cutané le plus fréquemment observé par les médecins au Canada. Elle se développe lorsque les pores se bouchent de sébum et de cellules cutanées, entraînant souvent des points blancs, des points noirs, des boutons ou des kystes sur le visage, le front, la poitrine, le haut du dos et les épaules. L’acné touche environ 5,6 millions de Canadiens, ou près de 20 % de la population, dont environ 90 % des adolescents. On estime que pour environ 25 % des adolescents, l’acné peut persister jusqu’à l’âge de 25 ans. L’acné peut causer une détresse émotionnelle ainsi que des cicatrices permanentes² et entraîner des troubles de pigmentation cutanée3.
Données cliniques et informations de sécurité de CABTREO
CABTREO a fait l'objet de deux études cliniques multicentriques de phase 3, aléatoires et contrôlées par placebo, menées auprès de 363 patients présentant de l'acné vulgaire faciale. Les deux études ont atteint tous les critères d'efficacité primaires, notamment le changement absolu du nombre de lésions inflammatoires et non inflammatoires par rapport à l’inclusion, ainsi que le pourcentage de patients ayant atteint le succès du traitement prédéfini. Les résultats d'efficacité combinés des deux études pour CABTREO ont démontré un taux de réussite du traitement d'environ 50 % et une réduction de plus de 70 % des lésions inflammatoires et non inflammatoires à la semaine 121.
Les réactions indésirables les plus fréquentes pouvant survenir avec CABTREO sont des réactions légères ou modérées au niveau du site d'application. Par exemple, une irritation cutanée caractérisée par une desquamation, une sécheresse, un érythème (rougeur) et une sensation de brûlure ou de picotement. CABTREO ne doit pas être utilisé par les personnes hypersensibles à l'un des ingrédients qu'il contient (phosphate de clindamycine, adapalène, peroxyde de benzoyle ou à tout autre ingrédient dans la préparation), par les patients ayant des antécédents d'entérite régionale (maladie de Crohn), de colite ulcéreuse ou de colite associée aux antibiotiques, ni par les femmes enceintes ou celles qui planifient une grossesse. CABTREO peut décolorer les cheveux et les tissus colorés. Il convient donc de faire preuve de prudence lors de l'application du produit près de la racine des cheveux1.
Santé Canada n'a pas autorisé l'utilisation de CABTREO chez les enfants de moins de 12 ans. CABTREO est destiné à un usage topique uniquement et n'est pas destiné à un usage oral, ophtalmique ou intravaginal1.
À propos de la dermatologie chez Bausch Health, Canada Inc.
Bausch Health, Canada Inc. possède l'un des plus grands portefeuilles de dermatologie sur ordonnance au Canada, dédié à aider les patients dans le traitement de diverses affections thérapeutiques, notamment le psoriasis, la kératose actinique, l'acné, la dermatite atopique et d'autres dermatoses. Le portefeuille dermatologique de Bausch Health, Canada comprend plusieurs produits de pointe contre l'acné, le psoriasis, les mycoses et les dermatoses sensibles aux corticostéroïdes.
CABTREO devient ainsi le quatrième traitement dermatologique de Bausch Health, Canada approuvé par Santé Canada et mis à la disposition des Canadiens au cours des quatre dernières années, enrichissant ainsi la gamme de produits de pointe de l’entreprise dans ce domaine thérapeutique important. Les autres produits approuvés sont la lotion ARAZLOMC (tazarotène), 0,045 % p/p, pour le traitement topique de l'acné vulgaire chez les patients âgés de 10 ans et plus ; BRYHALIMC (lotion au propionate d'halobétasol 0,01 % p/p), pour les dermatoses répondant aux corticostéroïdes et le traitement topique du psoriasis en plaques chez les adultes ; et DUOBRIIMC (propionate d'halobétasol 0,01% p/p et tazarotène 0,045 % p/p) pour traiter les adultes atteints de psoriasis en plaque de degré modéré ou sévère4.
Les quatre traitements (CABTREO, ARAZLO, BRYHALI et DUOBRII) sont fabriqués à l'usine de Bausch Health à Laval, au Québec, et distribués au Canada et aux États-Unis.
À propos de Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), est une société pharmaceutique mondiale à exploitation diversifiée ayant pour mission d’améliorer la vie des gens grâce à ses produits de santé. Elle met au point, fabrique et commercialise une gamme de produits, principalement dans les domaines de la gastroentérologie, de l’hépatologie, de la neurologie, de la dermatologie, les dispositifs médicaux esthétiques, la dentisterie, l'esthétique, les produits pharmaceutiques internationaux, ainsi que la santé oculaire, à travers sa participation majoritaire dans Bausch + Lomb. Nous aspirons à devenir une entreprise de soins de santé intégrée à l'échelle mondiale, reconnue et appréciée par les patients, les professionnels de la santé, les employés et les investisseurs. Pour plus de renseignements, visitez le site www.bauschhealth.com et communiquez avec nous sur LinkedIn.
La gamme de médicaments d’ordonnance de Bausch Health, Canada Inc. cible principalement la dermatologie, les troubles gastro-intestinaux et les affections cardiométaboliques. Bausch Health possède deux usines de fabrication pour les médicaments d’ordonnance au Canada, une à Laval, au Québec, et l’autre à Steinbach, au Manitoba. Vous trouverez de plus amples renseignements sur le site Web de la société au www.bauschhealth.ca.
Déclarations prospectives
Ce communiqué de presse peut contenir des déclarations prospectives au sens des lois sur les valeurs mobilières applicables, y compris les dispositions de protection prévues par le U.S. Private Securities Litigation Reform Act de 1995. Les déclarations prospectives peuvent généralement être identifiées par l'utilisation de termes tels que « prévoit », « anticipe », « espère », « s'attend à », « à l'intention de », « planifie », « devrait », « pourrait », « voudrait », « peut », « croit », « sous réserve de », ainsi que par des expressions similaires ou des variations. Ces déclarations ne constituent ni des faits historiques ni des garanties de performance future. Elles sont fondées sur les attentes et les croyances actuelles de la direction et sont sujettes à certains risques et incertitudes qui pourraient entraîner des écarts significatifs entre les résultats réels et ceux décrits dans ces déclarations. Les résultats réels sont soumis à d'autres risques et incertitudes qui se rapportent plus généralement aux activités de Bausch Health, y compris ceux décrits de façon plus détaillée dans les rapports annuels et trimestriels les plus récents de Bausch Health, ainsi que dans les autres documents déposés de temps à autre auprès des Autorités canadiennes en valeurs mobilières et de la U.S. Securities and Exchange Commission, lesquels facteurs sont incorporés aux présentes par référence. Les lecteurs sont priés de ne pas accorder une trop grande confiance à ces déclarations prospectives. Ces déclarations prospectives ne sont valables qu'à la date du présent communiqué. La société ne s'engage aucunement à mettre à jour ces déclarations prospectives pour tenir compte d'événements, d'informations ou de circonstances survenus après la date de ce communiqué ou pour refléter des résultats réels, sauf si la loi l'exige.
]]>Mon, 07 Jul 2025 08:00:00 GMTFocused on highlighting real patient experiences, Salix continues to lead the charge in educating and advocating for the hepatic encephalopathy community
LAVAL, QC, July 7, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced its new direct-to-consumer (DTC) “I Wish I Knew” campaign for Xifaxan® (rifaximin), the first and only medicine FDA approved for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults. Designed to raise awareness about OHE and the role of Xifaxan, “I Wish I Knew” seeks to educate and empower patients and caregivers to take proactive steps in managing their liver disease.
In patients with cirrhosis, overt hepatic encephalopathy (OHE) is one of the key complications that is associated with worsening outcomes, morbidity, and mortality.1 In cirrhosis a damaged liver does not function normally, leading to toxins from the gut entering the bloodstream, and traveling to the brain, which can cause damage, some of which may be irreversible. These OHE episodes may present as alterations in consciousness, cognition, and behavior.2,3 Up to 80% of patients with cirrhosis will eventually develop some form of HE.1
Salix remains steadfast in its mission to educate, empower and provide solutions for individuals at risk for recurrence of OHE. The new 60-second “I Wish I Knew” spot tells the story of a woman with a history of OHE, who reflects on her experience with symptoms of disorientation and confusion. She “wasn’t herself” during this time, but over the course of her treatment with Xifaxan, she experienced a reduction in risk of her OHE episodes.
“We want people to know that the risk of recurring OHE episodes can be managed despite the complex nature of the condition,” said Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. “Salix aims to spread knowledge about the progression of chronic liver disease (CLD) to cirrhosis and overt hepatic encephalopathy. Our hope is for a future where fewer patients and loved ones ‘wish they knew’ cirrhosis could affect their brain, and more patients can access the care they need sooner.”
Salix is dedicated to amplifying patient voices and bringing authentic experiences to the forefront of the OHE community. In addition to ongoing efforts with patient advocacy organizations including Global Liver Institute (GLI) and American Liver Foundation (ALF), Salix also recently unveiled three patient stories. These testimonials feature real, lived experiences with OHE and Xifaxan, offering diverse perspectives about managing the condition and providing hope for others battling OHE.
Click here to see the new spot and hear patient stories about managing OHE.
##
About XIFAXAN INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
Please click here for full Prescribing Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
References
Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-735. doi:10.1002/hep.27210
Vince AJ, Burridge SM. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. doi:10.1099/00222615-13-2-177
Khan A, Ayub M, Khan WM. Hyperammonemia is associated with increasing severity of both liver cirrhosis and hepatic encephalopathy. Int J Hepatol. 2016;2016:6741754. doi:10.1155/2016/6741754
]]>Wed, 02 Jul 2025 07:00:00 GMTLAVAL, QC, July 2, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) will release second quarter 2025 financial results after market close on Wednesday, July 30, 2025. Bausch Health will host a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
This strategic partnership introduces new probiotherapy solutions for managing acne-prone skin to the Polish market, with plans for future expansion.
LAVAL, QC, June 23, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, announced today it has entered a strategic partnership with YUN NV, an innovative leader in microbiome skincare solutions. This collaboration is set to transform the skincare landscape, starting with the launch of YUN’s probiotic-based products for acne-prone skin to the Polish market later this year.
YUN, known for its pioneering probiotherapeutical skincare products, and Bausch Health, a leader in the market, are combining their strengths to bring microbiome skincare solutions to new patients. The first phase of the partnership will introduce YUN’s probiotic-based acne-prone skincare range to Poland later this year. These microbiome skincare solutions use live probiotics to help restore the skin’s natural microbiome balance, offering a modern, science-driven approach to managing acne-prone skin. This partnership marks a significant step in expanding Bausch Health’s portfolio into the emerging space of probiotherapy, a microbiome skincare approach.
“At Bausch Health, we constantly seek innovative solutions that enrich people’s lives. Partnering with YUN is an exciting step forward in delivering cutting-edge microbiome technologies for acne-prone skincare in Poland, with plans to expand into other countries,” said Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health
“We're honored to partner with Bausch Health, whose strong market presence and commitment to patient well-being align with our mission to empower people and restore balance by supporting the microbiome and offering natural, effective solutions that go beyond symptoms,” said Tom Verlinden, Chief Executive Officer and Founder, YUN NV. “This partnership validates our scientific and therapeutic vision, sharing a joint ambition to unlock the full potential of microbiome in skincare.”
Both companies share a commitment to enhancing health through innovative, science-backed solutions. By joining forces, they aim to improve skin health through the science of the microbiome.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About Yun NV
YUN is a Belgian biotech company redefining everyday care through microbiome science. Founded in 2016, YUN developed the patented YUN Probiotherapy™ platform, featuring live probiotics and microbiome-friendly formulations designed to respect and support the skin’s natural balance. With innovations across dermatological, oral, baby, intimate, and ear care, YUN delivers science- and quality-driven, nature-powered solutions for health-conscious patients and consumers, today and for generations to come. For more information about YUN, visit www.yun-probiotherapy.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
Ta strategiczna współpraca wprowadza na polski rynek nowe rozwiązania z zakresu probioterapii do pielęgnacji skóry ze skłonnością do trądziku, z planami dalszej ekspansji.
LAVAL, QC, 23 czerwca 2025 r. – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), globalna, zdywersyfikowana firma farmaceutyczna, poinformowała dziś o zawarciu strategicznego partnerstwa z YUN NV, innowacyjnym liderem w dziedzinie rozwiązań pielęgnacji skóry opartej na mikrobiomie. Współpraca ta ma zrewolucjonizować sektor pielęgnacji skóry, rozpoczynając od wprowadzenia jeszcze w tym roku na polski rynek probiotycznych produktów YUN do pielęgnacji skóry ze skłonnością do trądziku.
YUN, spółka znana z pionierskich probioterapii, oraz Bausch Health, lider rynku, łączą siły, aby dostarczyć nowym pacjentom oparte na mikrobiomie rozwiązania do pielęgnacji skóry. Pierwsza faza partnerstwa będzie związana z wprowadzeniem na polski rynek jeszcze w tym roku opartej na probiotykach linii produktów YUN przeznaczonych do pielęgnacji skóry ze skłonnością do trądziku. Te oparte na mikrobiomie rozwiązania dermokosmetyczne wykorzystują żywe probiotyki w celu przywrócenia naturalnej równowagi mikrobiomu skóry, oferując nowoczesne, oparte na nauce podejście do pielęgnacji skóry ze skłonnością do powstawania trądziku. Partnerstwo to stanowi istotny krok w rozszerzaniu portfolio firmy Bausch Health o rozwijającą się przestrzeń probioterapii – podejścia do pielęgnacji skóry opartego na mikrobiomie.
— W Bausch Health nieustannie poszukujemy innowacyjnych rozwiązań, które wzbogacają życie ludzi. Partnerstwo z YUN to ekscytujący krok naprzód w dostarczaniu najnowocześniejszych technologii opartych na mikrobiomie, przeznaczonych do pielęgnacji skóry ze skłonnością do trądziku w Polsce, z planami ekspansji na inne kraje — powiedział Cees Heiman, starszy wiceprezes w Europie i Kanadzie firmy Bausch Health.
— Jesteśmy zaszczyceni możliwością współpracy z firmą Bausch Health, której silna pozycja rynkowa i troska o dobro pacjentów współgrają z naszą misją wspierania ludzi i przywracania równowagi poprzez wspomaganie mikrobiomu oraz oferowanie naturalnych, skutecznych rozwiązań wykraczających poza leczenie samych objawów — powiedział Tom Verlinden, dyrektor generalny i założyciel YUN NV. — To partnerstwo potwierdza naszą wizję naukową i terapeutyczną, łącząc wspólną ambicję pełnego wykorzystania potencjału mikrobiomu w pielęgnacji skóry.
Obie firmy łączy zaangażowanie w poprawę zdrowia dzięki innowacyjnym, opartym na dowodach naukowych rozwiązaniom. Łączą one siły, aby oferować możliwość poprawy zdrowia skóry, wykorzystując wiedzę o mikrobiomie.
Informacje o Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) to globalna, zdywersyfikowana firma farmaceutyczna wzbogacająca życie dzięki nieustannemu dążeniu do zapewniania lepszych wyników klinicznych w opiece zdrowotnej. Opracowujemy, wytwarzamy i wprowadzamy na rynek szeroką gamę produktów, głównie w dziedzinach gastroenterologii, hepatologii, neurologii, dermatologii, stomatologii, medycyny estetycznej, międzynarodowych produktów farmaceutycznych oraz zdrowia oczu, poprzez nasze dominujące udziały w korporacji Bausch + Lomb. Naszą ambicją jest być zintegrowaną w skali globalnej firmą w branży opieki zdrowotnej, darzoną zaufaniem przez pacjentów, pracowników ochrony zdrowia, własnych pracowników i inwestorów. Więcej informacji na temat firmy Bausch Health znajduje się na stronie www.bauschhealth.com, a także w serwisie LinkedIn.
Informacje o Yun NV
YUN to belgijska firma biotechnologiczna redefiniująca codzienną higienę dzięki nauce o mikrobiomie. Założona w 2016 r. firma YUN opracowała opatentowaną platformę YUN Probiotherapy™, obejmującą żywe probiotyki i formuły przyjazne mikrobiomowi zaprojektowane w taki sposób, by respektować i wspomagać naturalną równowagę skóry. Dzięki innowacjom w obszarze dermatologii, higieny jamy ustnej, zdrowia niemowląt, higieny intymnej oraz pielęgnacji uszu, firma YUN dostarcza oparte na nauce i jakości, inspirowane naturą rozwiązania dla świadomych pod względem zdrowotnym pacjentów i konsumentów — dziś i dla przyszłych pokoleń. Więcej informacji na temat firmy YUN znajduje się na stronie www.yun-probiotherapy.com, a także w serwisie LinkedIn.
Stwierdzenia odnoszące się do przyszłości
Niniejszy komunikat prasowy może zawierać stwierdzenia odnoszące się do przyszłości w rozumieniu obowiązujących przepisów prawa dotyczących papierów wartościowych, w tym przepisów dotyczących „bezpiecznej przystani” amerykańskiej ustawy o reformie przepisów procesowych dotyczących papierów wartościowych z 1995 r. Stwierdzenia odnoszące się do przyszłości zazwyczaj zawierają słowa typu „nastąpi”, „oczekiwać”, „mieć nadzieję”, „spodziewać się”, „zamierzać”, „planować”, „należy”, „może”, „można by”, „uważać, że...”, „przy założeniu, że…” oraz ich odmiany bądź podobne określenia. Stwierdzenia te nie są faktami historycznymi ani nie gwarantują przyszłych wyników; są one oparte na aktualnych przewidywaniach i przekonaniach zarządu i podlegają pewnym czynnikom ryzyka i niepewności, które mogą spowodować, że rzeczywiste wyniki będą znacznie różnić się od opisanych. Rzeczywiste wyniki podlegają również innym czynnikom ryzyka i niepewności, które w szerszym ujęciu odnoszą się do całokształtu działalności Bausch Health, w tym bardziej szczegółowo opisanym w najnowszych rocznych i kwartalnych sprawozdaniach Bausch Health oraz wyszczególnione w innej dokumentacji Bausch Health składanej okresowo w Komisji Papierów Wartościowych i Giełd Stanów Zjednoczonych oraz kanadyjskim organie ds. papierów wartościowych; czynniki te są tu uwzględnione przez odwołanie. Odbiorców przestrzega się przed nadmiernym opieraniem się na tego typu stwierdzeniach odnoszących się do przyszłości. Odnoszą się one bowiem jedynie do stanu na dzień publikacji niniejszej informacji prasowej. Spółka nie zobowiązuje się do aktualizacji któregokolwiek z tych stwierdzeń odnoszących się do przyszłości w celu odzwierciedlenia zdarzeń, informacji lub okoliczności zaistniałych po dacie publikacji niniejszej informacji prasowej lub w celu odzwierciedlenia rzeczywistych wyników, chyba że wymaga tego prawo.
]]>Wed, 14 May 2025 16:06:44 GMTLAVAL, QC, May 14, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the election of the 10 directors nominated at its 2025 annual meeting of shareholders (“Annual Meeting”) held on May 13, 2025. The detailed results of the vote for the election of directors are set out below:
Name
For
Withheld
Broker Non-Votes
Thomas J. Appio
208,400,572
5,943,436
56,339,806
Christian A. Garcia
207,181,762
7,162,246
56,339,806
Brett M. Icahn
199,179,508
15,164,500
56,339,806
Sarah B. Kavanagh
208,164,244
6,179,764
56,339,806
Frank D. Lee
207,489,891
6,854,117
56,339,806
Steven D. Miller
206,805,726
7,538,282
56,339,806
Richard C. Mulligan, Ph.D.
202,866,703
11,477,305
56,339,806
John A. Paulson
205,916,286
8,427,722
56,339,806
Robert N. Power
202,283,418
12,060,590
56,339,806
Amy B. Wechsler, M.D.
207,392,798
6,951,210
56,339,806
At the Annual Meeting, shareholders also approved the non-binding advisory vote on the compensation of the Company’s named executive officers, approved the Bausch Health Companies Inc. 2025 Employee Stock Purchase Plan (“ESPP”), and appointed PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm until the close of the Company's 2026 annual meeting of shareholders.
For the purposes of Toronto Stock Exchange (“TSX”) approval with respect to the ESPP, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as the NYSE.
The final vote tabulation on all matters voted on at the meeting will be reported to the U.S. Securities and Exchange Commission on a current report on Form 8-K, and such report will be made available on the Company’s SEDAR profile and on the Company’s website at www.bauschhealth.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Tue, 06 May 2025 08:00:00 GMTNew analysis suggests efficacy of Xifaxan to mitigate OHE rehospitalizations irrespective of treatment history
LAVAL, Quebec, May 6, 2025 – Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), a global, diversified pharmaceutical company, and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced new data showing that people hospitalized due to overt hepatic encephalopathy (OHE) had a reduced risk of OHE-related rehospitalization within 30 days if treated with Xifaxan® (rifaximin) following hospital discharge regardless of prior treatment. These findings, based on a claims-based analysis, will be presented today at Digestive Disease Week® (DDW) 2025 in San Diego, CA.
“This analysis reinforces the use of Xifaxan to help prevent OHE rehospitalizations,” said Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell. “Cases of chronic liver disease and cirrhosis are growing, and these conditions can be debilitating for patients and their families. Providing patients with optimal, guideline-based treatment regimens is imperative because preventing recurrence and rehospitalizations not only benefits patients but also helps reduce burden on the broader healthcare system.”
In patients with cirrhosis, an occurrence of fully symptomatic overt hepatic encephalopathy (OHE) is one of the key complications that defines the decompensated phase of the disease and is associated with worsening outcomes, morbidity, and mortality.1 Because in cirrhosis a damaged liver does not function normally, toxins from the gut can enter the bloodstream and travel to the brain, where they can affect neurotransmission precipitating OHE episodes. These episodes may present as alterations in consciousness, cognition, and behavior.2,3 Up to 80% of patients with cirrhosis will eventually develop some form of HE.1 American Association for the Study of Liver Diseases (AASLD) treatment guidelines recommend the use of Xifaxan as an add-on treatment to lactulose after a breakthrough OHE episode to prevent further OHE recurrence.1
Results of this claims-based analysis showed that patients who received lactulose only upon hospital discharge had a higher risk of 30-day OHE rehospitalization compared to those who received Xifaxan (adjusted OR: 1.63-2.73, p<0.05) regardless of pre-hospitalization treatment. Additionally, the risk of 30-day OHE rehospitalization increased with descending tiers of quality of care (QoC), defined as high-, intermediate- or low-quality based on AASLD guidelines (intermediate vs. high QoC: OR = 1.44, low vs. high QoC: OR = 2.45, all p<0.05). Results remained consistent for Medicare- and Medicaid-insured patients.
“Xifaxan has been proven to effectively reduce the risk of OHE recurrence, so it is concerning to know that some patients leave the hospital without guideline-based treatment recommendations,” said Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. “It is vital to recognize hepatic encephalopathy in people with liver disease in the hospital setting and to ensure they have access to high-quality, holistic care upon discharge.”
The analysis used claims data from the Komodo Research Data (January 2016 – September 2023) to identify commercially-insured patients with an initial OHE hospitalization. Of the 7,880 OHE patient claims data analyzed, prior to hospitalization, 27.1 percent (n=2,135) were treated with Xifaxan, 24.1 percent with lactulose and 48.8% (n=3,848) received no treatment.
About XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
Please click here for full Prescribing Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
References
Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-735. doi:10.1002/hep.27210
Vince AJ, Burridge SM. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. doi:10.1099/00222615-13-2-177
Khan A, Ayub M, Khan WM. Hyperammonemia is associated with increasing severity of both liver cirrhosis and hepatic encephalopathy. Int J Hepatol. 2016;2016:6741754. doi:10.1155/2016/6741754
First Quarter Consolidated Revenues of $2.26 billion, up 5% on a Reported basis and 6% on an Organic (non-GAAP)1 basis over the prior year period
GAAP Net Loss Attributable to Bausch Health Companies of $58 million and GAAP Net Loss of $86 million
Consolidated Adjusted EBITDA Attributable to Bausch Health Companies (non-GAAP)1 of $661 million, in line with prior year period
BAUSCH HEALTH EXCLUDING BAUSCH + LOMB FIRST QUARTER 2025 RESULTS
Eighth consecutive quarter of year-over-year Revenue and Adjusted EBITDA (non-GAAP)1 growth, with 6% and 14% growth versus the prior year period, respectively
With strong financial momentum, remain committed to evaluating all options to unlock shareholder value, including maximizing the value of assets and share buybacks
Successfully completed $7.9B refinancing in early April to extend near- and medium- term maturities
Received favorable ruling from D.C. District Court in Norwich's case against the FDA
Maintaining full-year 2025 Revenue and Adjusted EBITDA (non-GAAP)1 guidance, with Adjusted Cash Flow from Operations (non-GAAP)1 guidance updated primarily to reflect higher interest expense
LAVAL, QC, April 30, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its first quarter 2025 financial results and other key updates from the quarter.
"We started the year strong, delivering our eighth consecutive quarter of year-over-year growth in Revenue and Adjusted EBITDA for Bausch Health, excluding Bausch + Lomb, highlighting the broad momentum across our diverse businesses and geographies. Alongside our healthy financial and operating performance, in early April we successfully closed a comprehensive refinancing transaction, delivering on our commitment to continue to improve our capital structure and maturity profile. We are laser focused on growing profitably and executing against our strategic priorities, including evaluating all options to unlock shareholder value," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
First Quarter 2025 Revenue Performance
Total consolidated reported revenues were $2.26 billion for the first quarter of 2025, compared with $2.15 billion in the first quarter of 2024, an increase of $106 million, or 5%. Excluding the impact of foreign exchange of $37 million, acquisitions of $6 million, and divestitures and discontinuations which negatively impacted the prior year by $8 million, revenue increased 6% on an organic1 basis compared with the first quarter of 2024.
1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure.
Reported revenues by segment were as follows:
Three Months Ended
March 31,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic Revenue1 (Non-GAAP)
(in millions)
2025
2024
Amount
Pct.
Total Bausch Health Revenues
$2,259
$2,153
$106
5%
7%
6%
Bausch Health (excl. B+L)
$1,122
$1,054
$68
6%
8%
7%
Salix segment
$542
$499
$43
9%
9%
6%
International segment
$262
$265
($3)
(1%)
4%
5%
Solta Medical segment
$113
$88
$25
28%
33%
33%
Diversified segment
$205
$202
$3
1%
1%
- %
Bausch + Lomb segment
$1,137
$1,099
$38
3%
5%
5%
Salix Segment
Salix segment reported revenues were $542 million for the first quarter of 2025, compared with $499 million for the first quarter of 2024, an increase of $43 million, or 9%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $10 million, segment revenues increased 6% on an organic1 basis compared with the first quarter of 2024. Xifaxan® was the primary driver of segment growth, with 8% revenue growth in the first quarter of 2025 compared with the prior year period.
International Segment
International segment reported revenues were $262 million for the first quarter of 2025, compared with $265 million for the first quarter of 2024, a decrease of $3 million, or 1%. Excluding the impact of foreign exchange of $14 million and divestitures and discontinuations of $3 million, segment revenues increased 5% on an organic1 basis compared with the first quarter of 2024, led by growth in Canada.
Solta Medical Segment
Solta Medical segment reported revenues were $113 million for the first quarter of 2025, compared with $88 million in the first quarter of 2024, an increase of $25 million, or 28%. Excluding the impact of foreign exchange of $4 million, segment revenues increased on an organic1 basis by 33% compared with the first quarter of 2024, led by growth in South Korea and China.
Diversified Segment
Diversified segment reported revenues were $205 million for the first quarter of 2025, compared with $202 million for the first quarter of 2024, an increase of $3 million, or 1%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $2 million, segment revenues were flat on an organic1 basis compared with the first quarter of 2024.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1.14 billion for the first quarter of 2025, compared with $1.10 billion for the first quarter of 2024, an increase of $38 million, or 3%. Excluding the impact of foreign exchange of $19 million, acquisitions of $6 million and divestitures and discontinuations of $1 million, segment revenues increased 5% on an organic1 basis compared with the first quarter of 2024.
]]>Tue, 29 Apr 2025 08:00:00 GMTA Long-Awaited Advancement in Non-Invasive Radiofrequency Skin Tightening Is Now Approved for the Canadian Market
LAVAL, Quebec, April 29, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), a global, diversified pharmaceutical company, and its aesthetic business, Solta Medical, announced today that Health Canada has granted medical device license clearance for Thermage® FLX, the latest generation of the globally-recognized Thermage® system for non-invasive skin tightening and contouring.
“The clearance of Thermage FLX in Canada is a positive development for our company and important for the continued growth of our aesthetic business”, said Thomas J. Appio, Chief Executive Officer, Bausch Health. “As the pioneer in non-invasive skin tightening, Thermage has earned trust worldwide—and we’re thrilled to bring the latest generation of this globally recognized technology to Canadian providers and patients who have been waiting for it.”
Thermage FLX represents the fourth generation of innovation in monopolar radiofrequency (RF) technology from Solta Medical. With a long legacy of trust among providers and patients, the Thermage platform is a globally established system trusted by providers for more than 20 years. In Canada, providers have eagerly awaited the next evolution of this system, and they will now gain access to the same smart technology already in use by leading aesthetic clinics around the world.
“Thermage FLX was designed with both providers and patients in mind. With enhanced ergonomics, smart impedance feedback, and improved comfort, it delivers the personalized treatment experience patients are seeking and the reliable results providers expect from Thermage,” said Jiny Kim, Senior Vice President, Solta Medical, Bausch Health.
Key Features of Thermage FLX:
Larger Treatment Tip: The 4.0 cm² Total Tip 4.0 delivers 25% faster treatments compared to previous generations, increasing efficiency while maintaining consistent results.
Enhanced Patient Comfort: Integrated vibration and cooling improve patient experience during treatment.
Smart Impedance Technology: AccuREP™ technology reads skin impedance and adjusts RF energy output with each pulse, tailoring treatment to each patient’s unique skin needs.
Ergonomic Design: A redesigned handpiece improves ease of use for providers, supporting precise delivery and a more comfortable workflow.
Versatile Applications: For the non-invasive treatments of wrinkles and rhytids on the face, eyes, and body—including areas with thinner or more delicate skin.
With the approval of Thermage FLX, Solta Medical continues to build on its legacy of science-backed, non-invasive technologies—and support providers with smart systems that deliver consistent results across a range of patient needs.
To learn more about Thermage and the full Solta Medical portfolio, visit ca.solta.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our aesthetic business, Solta Medical, is a global leader in medical aesthetics with a portfolio of well-known, science-backed technologies. Thermage FLX has been cleared for use by Health Canada. Solta Medical has device clearances in 80 countries globally. For information about your specific region, visit www.bauschhealth.com and www.solta.com. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Tue, 29 Apr 2025 08:00:00 GMTBausch Health annonce l’homologation du système ThermageMD FLX de Solta Medical par Santé Canada
Une technologie avancée et non effractive de raffermissement de la peau par radiofréquence attendue depuis longtemps est maintenant approuvée pour le marché canadien.
LAVAL (Québec), le 29 avril 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), une entreprise pharmaceutique mondiale et diversifiée, et sa filiale en soins esthétiques, Solta Medical, ont annoncé aujourd’hui une autorisation de mise en marché d’instruments médicaux par Santé Canada pour le système ThermageMD FLX, la dernière génération du système ThermageMD mondialement reconnu en matière de raffermissement de la peau et de remodelage.
« L’homologation du système Thermage FLX au Canada est une étape importante pour notre compagnie et la croissance continue de nos activités commerciales dans le domaine de l’esthétique, a indiqué Thomas J. Appio, chef de la direction de Bausch Health. En tant que pionnier dans le domaine du raffermissement de la peau non effractif, Thermage inspire confiance partout dans le monde depuis longtemps – et nous sommes ravis de pouvoir enfin offrir cette technologie de dernière génération reconnue mondialement aux fournisseurs de soins et aux patients du Canada. »
Thermage FLX est la quatrième génération de la technologie innovante de radiofréquence (RF) monopolaire de Solta Medical. Les fournisseurs de soins et les patients font confiance à cette plateforme reconnue mondialement depuis plus de 20 ans. Au Canada, les fournisseurs de soins attendaient cette nouvelle génération du système avec impatience et pourront maintenant avoir accès à cette technologie intelligente déjà utilisée par les cliniques d’esthétique les plus en vue dans le monde.
« La conception de Thermage FLX tient compte à la fois des besoins des fournisseurs de soins et de ceux des patients. Grâce à une ergonomie améliorée, une technologie intelligente de retour d’impédance et un confort accru, le système ThermageMD offre l’expérience de traitement personnalisé que les patients recherchent et garantit les résultats fiables auxquels les fournisseurs de soins s’attendent », a déclaré Jiny Kim, première vice-présidente de Solta Medical, Bausch Health.
Principales caractéristiques de Thermage FLX
Embout plus large : L’embout Total Tip 4.0 de 4,0 cm² raccourcit de 25 % la durée des traitements par rapport aux générations précédentes, ce qui accroît l’efficacité tout en garantissant des résultats constants.
Confort du patient amélioré : Des vibrations et un refroidissement intégrés améliorent l’expérience du patient durant le traitement.
Technologie d’impédance intelligente : La technologie AccuREPMC mesure l’impédance de la peau et ajuste automatiquement la production d’énergie RF à chaque pulsation, offrant ainsi un traitement personnalisé adapté aux besoins cutanés de chaque patient.
Conception ergonomique : Une poignée de conception nouvelle offre un confort amélioré aux fournisseurs de soins lors de l’utilisation du système, tout en augmentant la précision de l’intervention.
Applications polyvalentes : Le système permet le traitement non effractif des rides et ridules du visage, de la région périorbitaire et d’autres parties du corps – y compris des régions où la peau est plus fine et plus délicate.
Avec l’homologation de Thermage FLX, Solta Medical continue de capitaliser sur son héritage de technologies non effractives fondées sur la science – et offre aux fournisseurs de soins des systèmes intelligents qui garantissent des résultats constants chez une grande diversité de patients.
Pour en apprendre plus sur Thermage et la gamme complète de produits de Solta Medical, visitez le https://ca.solta.com/fr-CA/.
À propos de Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), est une compagnie mondiale de produits pharmaceutiques diversifiés qui améliorent la vie des gens et dont la détermination sans faille vise à améliorer les résultats en matière de soins de santé. Nous mettons au point, fabriquons et commercialisons un large éventail de produits pharmaceutiques, principalement dans les domaines thérapeutiques de la gastroentérologie, de l’hépatologie, de la neurologie, de la dermatologie, de la médecine dentaire et de l’esthétique, de même qu’en santé oculaire à l’échelle internationale par le biais de notre participation majoritaire dans la société Bausch + Lomb. Nous avons l’ambition de devenir une entreprise de soins de santé intégrée à l’échelle mondiale, digne de confiance et valorisée par les patients, professionnels de la santé, employés et investisseurs. Dans le domaine de l’esthétique, Solta Medical, est un chef de file mondial en médecine esthétique, qui propose une gamme de technologies réputées, fondées sur la science. L’emploi de Thermage FLX a été autorisé par Santé Canada et les dispositifs de Solta Medical sont homologués dans 80 pays à travers le monde. Pour de plus amples renseignements relatifs à votre marché local, visitez les sites www.bauschhealth.com et www.solta.com. Pour de plus amples renseignements au sujet de Bausch Health, visitez le www.bauschhealth.com et suivez-nous sur LinkedIn.
Déclarations de nature prospective
Ce communiqué de presse pourrait contenir des déclarations de nature prospective au sens des lois sur les valeurs mobilières applicables, y compris les règles d’exonération de la Private Securities Litigation Reform Act de 1995 des États-Unis. Les déclarations de nature prospective se caractérisent généralement par l’utilisation du futur ou du conditionnel, ou des verbes « anticiper », « espérer », « s’attendre à », « avoir l’intention de », « prévoir », « croire », de l’expression « sous réserve de » ou de leurs variantes ou d’expressions similaires. Ces déclarations ne constituent pas des faits historiques ni une garantie de rendement futur; elles sont fondées sur les attentes et les croyances actuelles de la direction et sont sujettes à certains risques et incertitudes qui pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux décrits dans les déclarations de nature prospective. Les résultats réels sont soumis à d’autres risques et incertitudes qui dépendent plus largement des activités globales de Bausch Health, y compris celles décrites plus en détail dans les rapports annuel et trimestriel les plus récents de Bausch Health et les rapports détaillés de Bausch Health ou autres documents déposés régulièrement à la Securities and Exchange Commision des États-Unis ou aux Autorités canadiennes en valeurs mobilières, dont les facteurs sont intégrés aux présentes par renvoi. Les lecteurs sont avertis de ne pas se fier indûment à ces déclarations de nature prospective. Ces déclarations de nature prospective ne s’appliquent qu’à la date des présentes. Bausch Health n’a aucune obligation de mettre à jour ces déclarations de nature prospective pour refléter des événements, des circonstances ou des renseignements postérieurs à la date du présent communiqué de presse ou pour refléter les résultats réels, sauf si la loi l’exige.
]]>Fri, 25 Apr 2025 08:00:00 GMTThe next generation of skin resurfacing technology will debut at the ASLMS 2025 Conference
LAVAL, QC, April 25, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, and its aesthetics business, Solta Medical, announced today Fraxel FTX™ will launch at the American Society for Laser Medicine & Surgery, Inc. (ASLMS) 2025 Annual Conference on April 25 in Orlando, FL. This event begins the rollout of Fraxel FTX™ to dermatologists, plastic surgeons, and other licensed aesthetic professionals across the United States, with plans to expand globally in the coming months.
Fraxel® is a leading treatment in skin rejuvenation, addressing common skin concerns such as sun damage, wrinkles, acne scars, and pigmentation irregularities. With the introduction of Fraxel FTX™, the next generation of skin resurfacing technology, Bausch Health is setting a new standard in laser skin resurfacing. Designed to offer an even more precise, efficient, and comfortable treatment experience, this next generation product provides dermatologists and aesthetic professionals with advanced tools and is designed to deliver noticeable results after a single treatment in all skin types.
"We are pleased to unveil Fraxel FTX™ at the ASLMS 2025 Conference," said Thomas J. Appio, CEO of Bausch Health. "This improved technology marks a significant milestone in our commitment to advancing aesthetic medicine and enhancing the patient experience. Fraxel FTX™ embodies our dedication to providing healthcare professionals with the cutting-edge tools they need to help deliver exceptional care.”
“Fraxel FTX™ retains its trusted, proven laser technology offering customized treatments to deliver noticeable results, while combining a modern design, ergonomic enhancements, and efficiency to support today’s aesthetic practices.” said Jiny Kim, Senior Vice President, Solta Medical, Bausch Health.
Key Features and Benefits of Fraxel FTX™:
Dual Wavelength Fractional Laser: Fraxel FTX™ utilizes a highly refined fractional laser system that targets aging and sun-damaged skin, leaving surrounding healthy tissue intact to promote rapid healing. The 1550 nm erbium-glass laser and 1927 nm thulium laser treat superficial and deeper skin layers.
Redesigned Ergonomic Handpiece: Featuring a 20% reduction in weight and size and new integrated cooling technology, Fraxel FTX™ is designed for patient comfort during treatment.
Visible Results with Minimal Downtime: Patients can expect noticeable improvements in skin texture, tone, and clarity with minimal disruption to their daily routines.
Fast Tracking Experience: Intelligent Optical Tracking® with AccuTRAC™ provides efficient and consistent treatment delivery utilizing patented technology for efficient firing of the laser.
Redesigned Console: A modern design with an integrated arm and cable assembly.
Refreshed User Interface: The redesigned color touch screen and user interface are designed for flexible, personalized treatment settings, catering to aesthetic goals, as well as common skin concerns due to sun damage and aging.
With the launch of Fraxel FTX™, Solta Medical continues to lead the industry in innovation, providing solutions that aim to help practitioners deliver best-in-class results while improving patient satisfaction.
For more information about Fraxel FTX™ and other Solta Medical products, please visit www.soltamedical.com.
INDICATIONS
The Fraxel FTX™ Laser System is indicated for:
Fraxel® 1550 nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; skin resurfacing procedures; treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos, solar lentigos, actinic keratosis, and melasma; and treatment of periorbital wrinkles, acne scars, and surgical scars.
Fraxel® 1927 nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; treatment of actinic keratosis; treatment of pigmented lesions, specifically lentigos, solar lentigos, and ephelides.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not use on any patient who is ineligible for general surgery.
Pre-screening should include, but not be limited to:
Predisposition to keloid formation or excessive scarring.
Changes following surgery.
Skin indentations and textural changes following surgery.
Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment.
Patients undergoing isotretinoin acne treatment or with drugs in a similar class.
Medical judgement should be used when treating patients with a predisposition to post inflammatory hyperpigmentation (PIH).
Warnings and Cautions
Protective eyewear or goggles should be worn by any patient, operator and assistant.
Medical judgement should be used when treating patients with certain medical conditions.
Improper use of Fraxel® may cause personal injury or damage to the system.
Adverse Events
The following may be associated with Fraxel® laser treatment: Blistering and burns; Temporary or permanent skin discoloration; Eye injury; Infection; Keloid formation; Prolonged redness; Scarring; Delayed wound healing / skin textural changes and Temporary bruising.
The Fraxel FTX™ Laser System is Rx Only. See the Operator Manual for detailed directions, proper use, and full risk and safety information. For additional product information see www.fraxel.com/hcp.
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. To learn more about the Fraxel FTX™ and how it can benefit your practice, contact Solta Medical.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology,
dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our aesthetic business, Solta Medical, is a global leader in the aesthetics market, whose vision is to develop and support trusted aesthetic brands that provide value to our customers and patients. More information about Solta Medical can be found at www.solta.com. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Tue, 22 Apr 2025 06:39:24 GMTSupplement In Response to Company Learning that Carl Icahn and Affiliates Have Cash-Settled Equity Swaps for Approximately 90 Million of Its Common Shares
LAVAL, QC, April 22, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) today announced that it has filed a supplement (the “Proxy Statement Supplement”) to its proxy statement dated April 2, 2025 (the “Proxy Statement”) in respect of the Company’s upcoming annual general meeting of shareholders on May 13, 2025. The Company is updating the Proxy Statement to disclose, in addition to the 34,721,118 common shares reported as being beneficially owned (9.4%), Mr. Carl C. Icahn and his affiliates (collectively, “Icahn”) had entered into cash-settled equity swap agreements covering 90,720,000 of the Company’s common shares (24.6%), with a single maturity date of February 28, 2028. Taken together Icahn now has an economic interest covering approximately 34% of the Company’s outstanding common shares.
On March 12, 2025, the Board of Directors of the Company (the “Board”) adopted a resolution directing the Company’s General Counsel to review the Icahn’s position in equity swaps and certain bonds held by John Paulson, the Chairman of the Board. The General Counsel hired Sidley Austin, LLP (“Sidley”), as independent counsel, to conduct such review. Sidley presented its findings to the Board on April 9, 2025. As part of its review, Sidley sought information regarding Icahn’s swap positions and requested copies of the swap agreements themselves. Icahn refused to provide the copies of the swap agreements, but Icahn informed Sidley that (i) their additional long economic exposure to 90.72 million Company shares through equity swaps was accumulated over more than one hundred trades, executed between May 26, 2021 and September 8, 2023; (ii) the agreements provide for early termination via cash settlement; (iii) the agreements do not confer voting or dispositive power over the referenced shares; and (iv) the agreements do not “allow for” physical settlement.
Regarding Mr. Paulson’s bond position, (i) Mr. Paulson purchased an aggregate of $50 million Bausch Health bonds prior to rejoining the Board of Bausch Health; (ii) he purchased the bonds in the open market; and (iii) he obtained pre-approval for the bond purchase from the General Counsel of Bausch + Lomb, where he was a Board member. Based on the available facts and the review conducted by Sidley, the Company determined that Mr. Paulson’s bond purchase was not required to be disclosed under Item 404 of Regulation S-K as a related party transaction. Nevertheless, Mr. Paulson has requested that the Company update the Proxy Statement to reflect his bond position and informed the Company that he intends to dispose of his debt securities when the Company’s trading window is open in order to eliminate even the appearance of a conflict of interest and to demonstrate that his interests have always been fully aligned with those of all the Company’s shareholders.
Finally, as previously announced on April 14, 2025, the Company adopted a shareholder rights plan agreement (the “SRP”). The SRP is intended to prevent a person or group from acquiring beneficial ownership of 20% or more of the Company’s outstanding common shares (including by way of a “creeping” take-over bid) without complying with the permitted exemptions under the plan. The SRP protects against such “creeping” take-over bids that may serve to benefit certain shareholders to the detriment of others. The SRP provides the Board with an opportunity to identify, solicit, develop and negotiate value-enhancing alternatives that benefit all shareholders. Bausch Health is confident that the SRP is in the best interests of the Company and its shareholders.
Except as expressly provided in the Proxy Statement Supplement, the Proxy Statement remains unchanged from the version that was previously filed on SEDAR+ and EDGAR. The Proxy Statement Supplement is available under the Company’s profile on the SEDAR+ website at www.sedarplus.ca and the EDGAR website at www.sec.gov/edgar.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees, and investors.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. Forward-looking statements, by their nature, are based on assumptions and are subject to known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the forward-looking statement will not occur. The forward-looking statements in this press release speak only as of the date hereof and reflect several material factors, expectations and assumptions. Undue reliance should not be placed on any predictions or forward-looking statements as these may be affected by, among other things, changing external events and general uncertainties of the business. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the SEC and the Canadian Securities Administrators, which factors are incorporated herein by reference. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information, or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.
]]>Thu, 17 Apr 2025 15:45:01 GMTLAVAL, Quebec, April 17, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Kennedy, et al. (Case No. 25-cv- 00091), denied Norwich’s motion for a preliminary injunction treated as a motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration (FDA).
Norwich had asked the District Court for a judgment declaring the FDA’s decision to issue tentative approval for Norwich’s Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg and failure to determine Teva Pharmaceuticals USA, Inc. (Teva) had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich’s ANDA for XIFAXAN® (rifaximin) 550 mg. Norwich argued that if upheld, FDA’s determination will prohibit Norwich from marketing those products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028.
Today, the District Court denied Norwich’s motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case.
“We are pleased with the ruling issued today by the U.S. District Court. We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to XIFAXAN,” said Thomas J. Appio, CEO of Bausch Health.
Management will release first quarter financial results after market close on Wednesday, April 30, 2025, followed by a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss results and provide a business update.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Mon, 14 Apr 2025 16:30:00 GMTLAVAL, QC, April 14, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) announces today that its board of directors (the “Board”) has approved the adoption of a shareholder rights plan (the “SRP”) pursuant to a shareholder rights plan agreement entered into with TSX Trust Company, as rights agent, dated April 14, 2025 (the “Effective Date”).
The SRP has been adopted to help ensure that all shareholders of the Company are treated fairly and equally in connection with any unsolicited take-over bid or other acquisition of control of the Company (including by way of a “creeping” take-over bid) and that the Board has the opportunity to identify, solicit, develop and negotiate value-enhancing alternatives to any unsolicited take-over bid or similar transaction. The SRP is not being adopted in response to any specific proposal or intention to acquire control of the Company, and the Board is not aware of any pending or threatened take-over bid for the Company.
Pursuant to the SRP, one right will attach to each common share of the Company outstanding as of the effective time under the SRP. Subject to the terms of the SRP, in the event that rights become exercisable under the SRP, holders of the rights (other than the acquiring person and its related parties) will be permitted to exercise their rights to purchase additional common shares of the Company at a substantial discount to the then market price of the Company’s common shares. Taking up common shares pursuant to a “Permitted Bid” would not trigger the SRP.
The SRP is subject to the acceptance of the Toronto Stock Exchange and is subject to ratification by the shareholders of the Company within six months of its Effective Date. The Company will be seeking shareholder ratification of the Rights Plan on a to-be-determined date. If the SRP is not approved by the shareholders within six months of its adoption, the plan, together with the outstanding rights, will terminate and cease to be effective. The SRP is similar to shareholder rights plans adopted by other Canadian public companies and ratified by their shareholders.
A summary of the principal terms and conditions of the SRP will be set out in the Company’s management information circular to be mailed to the Company’s shareholders prior to the Meeting. A copy of the SRP will be available under the Company’s profile on the SEDAR+ website at www.sedarplus.ca and the EDGAR website at www.sec.gov/edgar.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors.
Forward-Looking Statements About Bausch Health
This press release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. Forward-looking statements in this press release include, but are not limited to, statements with respect to the implementation of, and potential effects of implementing, the SRP, as well as acceptance of the TSX and ratification by the shareholders of the Company. Forward-looking statements, by their nature, are based on assumptions and are subject to known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the forward-looking statement will not occur. The forward-looking statements in this press release speak only as of the date hereof and reflect several material factors, expectations and assumptions. Undue reliance should not be placed on any predictions or forward-looking statements as these may be affected by, among other things, changing external events and general uncertainties of the business. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.
]]>Thu, 10 Apr 2025 08:00:00 GMTBausch Health is offering scholarships to six students impacted by dermatologic conditions, with application submissions open through June 11, 2025
LAVAL, Quebec, April 10, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its dermatology business, Ortho Dermatologics, today announced the 2025 ASPIRE HIGHER Scholarship Program is now open for application submissions through June 11, 2025. The program will award six exceptional students, impacted by dermatologic conditions, a scholarship of up to $10,000 in support of their higher education goals.
"It is our distinct honor to continue the ASPIRE HIGHER Scholarship Program to help support students affected by dermatologic conditions, and to recognize and thank the dedicated healthcare providers who treat them. We are truly inspired by our students’ perseverance as they work to achieve their educational dreams," said Donald Pearl, Senior Vice President, Ortho Dermatologics, Bausch Health.
Students can apply for this scholarship by completing the online application, writing an essay on the impact of having a diagnosed dermatologic condition and the role that a health care provider played in helping to manage their condition, and two reference letters. Scholarships are offered to school applicants or current attendees of a two- or four-year college, university, or an advanced (post-high school) vocational or technical school for the 2025 – 2026 academic year and are available in the following categories:
3 Undergraduate Scholar Awards—for students pursuing undergraduate or vocational/technical degrees.
3 Graduate Scholar Awards—for students pursuing graduate degrees.
The application period for the ASPIRE HIGHER Scholarship Program will close on June 11, 2025, and scholarship recipients will be notified in July of 2025. To learn more about the scholarship, including eligibility criteria, terms and conditions, and stories from previous winners, please visit www.aspirehigherscholarships.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our dermatology business, Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at https://www.ortho-dermatologics.com and connect with us on LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Wed, 02 Apr 2025 08:00:00 GMTBausch Health’s gastroenterology business, Salix Pharmaceuticals, recognizes the complexities of irritable bowel syndrome (IBS) and seeks to make a difference in how the condition is perceived, diagnosed and treated.
LAVAL, Quebec, April 2, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the launch of IBS Symptoms Aren’t Black and White: Living in the Gray, an authentic storytelling campaign that addresses the complexities of living with irritable bowel syndrome (IBS). Throughout April, which is IBS Awareness Month, Salix will be sharing patient stories on LinkedIn, highlighting the unique journeys of individuals living with IBS.
Irritable bowel syndrome is more than just a common condition that affects up to an estimated 10% of the global population – it is a complex condition with unpredictable symptoms that can impact every aspect of patients' lives, including one’s physical, emotional, social and professional well-being.1,2 Navigating the road to proper care can be a long and complicated process; Salix seeks to bring greater understanding to help improve how IBS is perceived, diagnosed and treated.
“We recognize that every patient’s experience is unique and has the potential to inspire others in the IBS community to seek the care they deserve,” said Nicola Kayel, Senior Vice President, Marketing, Salix. “Our campaign, IBS Symptoms Aren’t Black & White: Living in the Gray, underscores our ongoing commitment to supporting patients by amplifying their voices to raise visibility, build a community of empowered individuals and destigmatize the narrative that surrounds this condition.”
Many people with IBS agree that their symptoms, such as diarrhea and hard to pass bowel movements, can be hard to talk about, and as a result, unresolved symptoms cause the burden of IBS to persist.2 Patient advocacy group, the International Foundation for Gastrointestinal Disorders (IFFGD), recognizes this obstacle and is partnering with Salix to generate conversation and share authentic stories. By normalizing open and honest discussions about IBS and reducing stigma, Salix and IFFGD hope to motivate patients to talk to their healthcare providers about the full range of their IBS symptoms, including less obvious experiences like abdominal pain, bloating and urgency.
President of IFFGD, Ceciel T. Rooker, stated, “At IFFGD, we are committed to broadening patient understanding of GI disorders like IBS. We are proud to support Salix in their effort to illuminate real patient stories to help raise visibility of the authentic patient experience and the multi-faceted nature of IBS symptoms. We believe it will encourage patients to speak up about their symptoms and ultimately receive appropriate care for their condition.”
Click here to read about real patients’ experiences on Salix Pharmaceuticals’ LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Thu, 27 Mar 2025 07:00:00 GMTLAVAL, Quebec, March 27, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) will release first quarter financial results after market close on Wednesday, April 30, 2025. Bausch Health will host a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Tue, 25 Mar 2025 13:40:26 GMTLAVAL, QC, March 25, 2025 — Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) today announced that it has priced its previously announced offering (the “Offering”) of $4.4 billion aggregate principal amount of 10.000% senior secured notes due 2032 (the “Notes”) through its indirect wholly-owned subsidiary, 1261229 B.C. Ltd. (the “Issuer”), a company incorporated under the laws of British Columbia, Canada (the “Issuer”) that, at the closing of the transactions will be a non-guarantor restricted subsidiary under the indentures that govern the Company’s existing senior notes. The Offering was upsized from an initial offering size of $4.0 billion aggregate principal amount. The Offering is expected to close on April 8, 2025, subject to the satisfaction of customary closing conditions.
As previously announced, the Company, through the Issuer, is also seeking to enter into new senior secured credit facilities that are expected to consist of (i) a $500 million 5-year senior secured revolving credit facility (the “New Revolving Facility”) and (ii) a $3.0 billion 5.5-year senior secured term loan B facility (the “New Term Loan Facility” and, together with the New Revolving Facility, the “New Senior Secured Credit Facilities”). The size of the New Term Loan Facility was reduced from $3.4 billion to $3.0 billion. The New Senior Secured Credit Facilities are expected to be entered into concurrently with the closing of the Offering.
The Company intends to use the proceeds from the Offering, together with the borrowings under the New Term Loan Facility, (i) to repay in full and terminate the Company’s existing credit agreement, (ii) to redeem all of its 5.500% Senior Secured Notes due 2025, 9.000% Senior Notes due 2025, 6.125% Senior Secured Notes due 2027, 5.750% Senior Secured Notes due 2027 and its indirect subsidiary’s 9.000% Senior Secured Notes due 2028 (collectively, the “Existing Notes”), (iii) to pay related fees, premiums and expenses and (iv) for general corporate purposes.
The Notes will be (i) secured, subject to customary limitations, by a first priority lien on substantially all assets of the Issuer, including a pledge of its 52.5% equity interest in Bausch + Lomb and (ii) guaranteed by (x) the Company and subsidiaries of the Company that guarantee the Company’s existing senior notes, with such guarantees secured by the assets of such guarantors, subject to customary limitations, by a first-priority lien that will rank pari passu with the liens securing the Company’s existing first-lien senior secured notes and the New Senior Secured Credit Facilities and (y) certain subsidiaries of the Company that do not guarantee the Company’s existing senior notes, with such guarantees secured by the assets of such guarantors, subject to customary limitations, by a first-priority lien that will rank pari passu with the liens securing the New Senior Secured Credit Facilities.
The redemption of the Existing Notes is conditioned upon the closing of debt financing transactions satisfactory to the Company prior to the applicable redemption dates (which redemption dates may be delayed in the Company’s sole discretion if this condition is not satisfied, pursuant to the terms of the indentures governing the Existing Notes). The Company expects to satisfy this condition with the completion of the Offering and the closing of the New Senior Secured Credit Facilities. The Company intends to discharge the applicable indentures governing each of the Existing Notes to the extent any such Existing Notes are not redeemed on the closing date of the Offering and the New Senior Secured Credit Facilities. This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.
The Notes will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act that are also qualified purchasers within the meaning of Section 2(a)(51) of the Investment Company Act of 1940, as amended, and to non-U.S. persons outside of the United States pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.
This press release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors.
Forward-Looking Statements About Bausch Health
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, the Company can offer no assurance that the separation (including a potential sale of Bausch + Lomb) will occur on terms or timelines acceptable to the Company or at all, or as to the ultimate composition of any near-term financing activities, including the proposed use of proceeds therefrom, whether the conditions precedent to the redemption of the Existing Notes will occur, or as to the Offering, and our ability to close such Offering, the entry into the New Senior Secured Credit Facilities, and details thereof. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Fri, 21 Mar 2025 15:48:45 GMTLAVAL, QC, March 21, 2025 — Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) today announced that (i) it has delivered conditional notices of redemption for all of its outstanding 5.500% Senior Secured Notes due 2025, 9.000% Senior Notes due 2025, 5.750% Senior Secured Notes due 2027 and 6.125% Senior Secured Notes due 2027 (collectively, the “BHC Notes”) and (ii) 1375209 B.C. Ltd., the Company’s indirect wholly-owned subsidiary (“HoldCo”), has delivered a conditional notice of redemption for all of its outstanding 9.000% Senior Secured Notes due 2028 (collectively with the BHC Notes, the “Notes”). Each of the redemptions is conditioned upon the closing of debt financing transactions satisfactory to the Company (the “Financing Transactions”). The Company expects to satisfy this condition with its recently announced financing transaction, which includes (i) $4,000 million aggregate principal amount of new senior secured notes due 2032 and (ii) $3,400 million in borrowings under a new 5.5-year senior secured term loan B facility.
A copy of each conditional notice of redemption was issued to the record holders of each series of Notes. Payment of the redemption price and surrender of the Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company.
The obligation to redeem the Notes is conditioned upon the consummation of the Financing Transactions on or before each of the applicable redemption dates (which redemption dates may be delayed in the Company’s sole discretion if this condition is not satisfied, pursuant to the terms of the indentures governing the Notes). Concurrently with the consummation of the Financing Transactions, the Company or HoldCo, as applicable, intends to discharge the applicable indentures governing each of the Notes to the extent any such Notes are not redeemed on the date on which the Financing Transactions are consummated. This press release does not constitute a notice of redemption of the Notes.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors.
Forward-Looking Statements About Bausch Health
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, the Company can offer no assurance that the separation (including a potential sale of Bausch + Lomb) will occur on terms or timelines acceptable to the Company or at all, or as to the ultimate composition of the Financing Transactions or any near-term financing activities, including the proposed use of proceeds therefrom or whether the conditions precedent to the redemption of the Notes will occur. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Wed, 19 Mar 2025 12:16:31 GMTLAVAL, QC, March 19, 2025 — Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) today announced that it has launched an offering (the “Offering”) of $4.0 billion aggregate principal amount of new senior secured notes due 2032 (the “Notes”) through its indirect wholly-owned subsidiary, 1261229 B.C. Ltd., a company incorporated under the laws of British Columbia, Canada (the “Issuer”) that, at the closing of the transactions will be a non-guarantor restricted subsidiary under the indentures that govern the Company’s existing senior notes. In addition, the Company, through the Issuer, is seeking to enter into new senior secured credit facilities that are expected to consist of (i) a 5-year senior secured revolving credit facility in an amount of at least $400 million (the “New Revolving Facility”) and (ii) a $3,400 million 5.5-year senior secured term loan B facility (the “New Term Loan Facility” and, together with the New Revolving Facility, the “New Senior Secured Credit Facilities”). The Offering and the entry into the New Senior Secured Credit Facilities are subject to market and other conditions.
The Notes will be (i) secured, subject to customary limitations, by a first priority lien on substantially all assets of the Issuer, including a pledge of its direct equity interest in Bausch + Lomb and (ii) guaranteed by (x) the Company and subsidiaries of the Company that guarantee the Company’s existing senior notes, with such guarantees secured by the assets of such guarantors, subject to customary limitations, by a first-priority lien that will rank pari passu with the liens securing the Company’s existing first-lien senior secured notes and the New Senior Secured Credit Facilities and (y) certain subsidiaries of the Company that do not guarantee the Company’s existing senior notes, with such guarantees secured by the assets of such guarantors, subject to customary limitations, by a first-priority lien that will rank pari passu with the liens securing the New Senior Secured Credit Facilities.
The Company intends to use the proceeds from the offering of the Notes, together with the borrowings under the New Term Loan Facility, (i) to repay in full and terminate the Company’s existing credit agreement, (ii) to redeem all of its 5.500% Senior Secured Notes due 2025, 9.000% Senior Notes due 2025, 6.125% Senior Secured Notes due 2027, 5.750% Senior Secured Notes due 2027 and its indirect subsidiary’s 9.000% Senior Secured Notes due 2028 (collectively, the “Existing Notes”), (iii) to pay related fees, premiums and expenses and (iv) for general corporate purposes.
The Company also intends, or a subsidiary of the Company intends, as applicable, to deliver a notice of conditional redemption for all of the Existing Notes at the redemption prices specified in the applicable indentures, plus accrued and unpaid interest, if any, to, but not including, the redemption date of the applicable series of Existing Notes. The obligation to redeem the Existing Notes will be conditioned upon the consummation of the Offering and the funding of the New Term Loan Facility on or before each of the applicable redemption dates (which redemption dates could be delayed in the Company’s sole discretion if this condition is not satisfied pursuant to the terms of the applicable indentures). Concurrently with the consummation of the Offering and the funding of the New Term Loan Facility, the Company or a subsidiary of the Company, as applicable, intends to discharge the applicable indentures governing each of the Existing Notes to the extent any such Existing Notes are not redeemed prior to the Closing Date. This press release does not constitute a notice of redemption of the Existing Notes.
The Notes will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act that are also qualified purchasers within the meaning of Section 2(a)(51) of the Investment Company Act of 1940, as amended, and to non-U.S. persons outside of the United States pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.
This press release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors.
Forward-Looking Statements About Bausch Health
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, the Company can offer no assurance that the separation (including a potential sale of Bausch + Lomb) will occur on terms or timelines acceptable to the Company or at all, or as to the ultimate composition of any near-term financing activities, including the proposed use of proceeds therefrom, whether the conditions precedent to the redemption of the Existing Notes will occur, or as to the offering of the Notes, the entry into the New Senior Secured Credit Facilities, and details thereof. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Wed, 19 Mar 2025 12:16:31 GMTTransaction is part of a broader refinancing initiative aimed at opportunistically accessing capital markets to address near- and mid-term maturities
LAVAL, QC, March 19, 2025 – Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) (the “Company” or “Bausch Health”) today announced that it has launched the syndication of new senior secured credit facilities totaling at least $3.8 billion.
The new senior secured credit facilities are expected to consist of (i) a 5-year senior secured revolving credit facility in an amount of at least $400 million (the “New Revolving Facility”) and (ii) a $3,400 million 5.5-year secured term loan B facility (the “New Term Loan Facility” and, together with the New Revolving Facility, the “New Senior Secured Credit Facilities”) through its indirect wholly-owned subsidiary, 1261229 B.C. Ltd., a company incorporated under the laws of British Columbia, Canada (the “Borrower”) that, at the closing of the transactions, will be a non-guarantor restricted subsidiary under the indentures that govern the Company’s existing notes.
JPMorgan Chase Bank, N.A. is the lead arranger for the New Senior Secured Credit Facilities.
“The launch of this syndication is the result of a thorough process led by our Board, management team, and independent advisors to evaluate several debt financing alternatives and is consistent with Bausch Health’s previously stated objective to comprehensively improve our debt maturity profile. The transaction is part of a broader initiative aimed at opportunistically accessing capital markets to address our near- and mid-term maturities,” said Bausch Health CEO, Thomas J. Appio. “The Company has a diverse, substantial portfolio of assets and, with seven consecutive quarters of top- and bottom-line growth, strong momentum to build on our success in 2025.”
Commitment to Paying Down Debt
Bausch Health (excluding Bausch + Lomb) reduced net debt by nearly $1 billion in 2024. The Company remains committed to optimizing its capital structure, strategically reducing debt leverage, and extending maturities to fortify its financial position for long-term success.
Transaction Details
The New Senior Secured Credit Facilities will be (i) secured, subject to customary limitations, by a first priority lien on substantially all assets of the Borrower, including a pledge of its direct equity interest in Bausch + Lomb and (ii) guaranteed by the Company and subsidiaries of the Company that guarantee the Company’s existing indebtedness and secured by the assets of the guarantors, subject to customary limitations, by a first-priority lien that will rank pari passu with the liens securing the Company’s existing first lien secured indebtedness.
The Company intends to use the proceeds of the New Term Loan Facility, together with the proceeds of other additional secured indebtedness intended to be raised in connection with the New Senior Secured Credit Facilities, to repay in full and terminate the Company’s existing credit agreement, and (i) to redeem all of its 5.500% Senior Secured Notes due 2025, 9.000% Senior Notes due 2025, 6.125% Senior Secured Notes due 2027, 5.750% Senior Secured Notes due 2027 and its indirect subsidiary’s 9.000% Senior Secured Notes due 2028, (ii) to pay related fees, premiums and expenses and (iii) for general corporate purposes. The Company will use any amounts borrowed from time to time under the New Revolving Facility, which will replace its existing revolving facility, for general corporate purposes.
These proposed refinancing transactions, including but not limited to the principal amount, interest rate and maturity of the New Senior Secured Credit Facilities and any concurrent financings, are subject to market conditions and to a number of significant conditions, and there can be no assurance that the Company will consummate any of these transactions on the anticipated terms or timing, or at all.
The Company was advised by Evercore, Proskauer, and Norton Rose Fulbright Canada.
U.S. lenders under the New Senior Secured Credit Facilities must be qualified purchasers within the meaning of Section 2(a)(51) of the Investment Company Act of 1940, as amended.
This press release is not an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-Looking Statements About Bausch Health
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, the Company can offer no assurance that the separation (including a potential sale of Bausch + Lomb) will occur on terms or timelines acceptable to the Company or at all, or any assurance as to our ability to market, negotiate or close the New Senior Secured Credit Facilities on favorable terms or at all, or whether the Company will be able to obtain any new secured revolving credit facility or other additional secured indebtedness, or as to the ultimate composition of any near-term financing activities. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch
Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward- looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Fri, 14 Mar 2025 09:25:00 GMTLAVAL, Quebec, March 14, 2025 - Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), a global,
diversified pharmaceutical company enriching lives through a relentless drive to deliver better health
outcomes, today provided an update on its financing plans. The Company announced that it has engaged
J.P. Morgan in connection with the Company's previously announced financing objectives.
Any transactions would be subject to market and other conditions and there can
be no assurance that the Company will be able to successfully complete any
transaction on acceptable terms or at all.
This news release does not constitute an offer to sell or the solicitation of
an offer to buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale, would be unlawful
prior to registration or qualification under the securities laws of any such
jurisdiction.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), is a global, diversified
pharmaceutical company enriching lives through our relentless drive to deliver
better health care outcomes. We develop, manufacture and market a range of
products primarily in gastroenterology, hepatology, neurology, dermatology,
dentistry, aesthetics, international pharmaceuticals and eye health, through
our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a
globally integrated healthcare company, trusted and valued by patients, HCPs,
employees and investors. For more information about Bausch Health, visit
www.bauschhealth.com and
connect with us on
LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of
applicable securities laws, including the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Forward-looking statements
may generally be identified by the use of the words "will," "anticipates,"
"hopes," "expects," "intends," "plans," "should," "could," "would," "may,"
"believes," "subject to" and variations or similar expressions. These
statements are neither historical facts nor assurances of future performance,
are based upon the current expectations and beliefs of management and are
subject to certain risks and uncertainties that could cause actual results to
differ materially from those described in the forward-looking statements.
Actual results are subject to other risks and uncertainties that relate more
broadly to Bausch Health's overall business, including those more fully
described in Bausch Health's most recent annual and quarterly reports and
detailed from time to time in Bausch Health's other filings with the U.S.
Securities and Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. Readers are cautioned not
to place undue reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. The Company
undertakes no obligation to update any of these forward-looking statements to
reflect events, information or circumstances after the date of this news
release or to reflect actual outcomes, unless required by law.
Seventh consecutive quarter of year-over-year growth in both Revenue and Adjusted EBITDA (non-GAAP)1, delivering results at the high-end and/or exceeding 2024 guidance
Fourth Quarter Consolidated Revenues of $2.56 billion, up 6% on a Reported basis and up 9% on an Organic (non-GAAP)1 basis over the prior year period
Full-Year Consolidated Revenues of $9.63 billion, up 10% on a Reported basis and 8% on an Organic (non-GAAP)1 basis, with growth in all segments
GAAP Net Income Attributable to Bausch Health Companies Inc. of $93 million for the quarter and GAAP Net Loss of $46 million for the year
Consolidated Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $935 million for the quarter, up 8%, and $3.31 billion for the year, up 10%
LAVAL, QC, February 19, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" the "Company," "we" or "our") today announced its fourth quarter and full-year 2024 financial results and other key updates for the quarter.
“2024 was a year of delivering on our commitments, where we achieved the high-end of our revenue guidance range, and exceeded our adjusted EBITDA excluding Bausch + Lomb, and adjusted operating cash flow guidance expectations. We generated growth across all our business segments, highlighting the broad strength of our diverse portfolio that is supported by our strategic investments in the business. We also made progress on key initiatives, positioning us well to carry our momentum into 2025 as we pursue additional opportunities to deliver innovative solutions for patients.” said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Fourth Quarter and Full-Year 2024 Revenue Performance
Total consolidated reported revenues were $2.56 billion for the fourth quarter of 2024, compared with $2.41 billion in the fourth quarter of 2023, an increase of $151 million, or 6%. Excluding the impact of foreign exchange of $28 million, acquisitions of $5 million, and divestitures and discontinuations of $29 million, revenue increased by 9% on an organic1 basis compared with the fourth quarter of 2023.
Total consolidated reported revenues were $9.63 billion for the full year of 2024, compared with $8.76 billion for the full year of 2023, an increase of $868 million, or 10%. Excluding the impact of foreign exchange of $70 million, acquisitions of $293 million, and divestitures and discontinuations of $77 million, revenues increased 8% on an organic1 basis compared with the full year of 2023.
Revenues by segment were as follows:
Three Months Ended
December 31,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic1 Revenue (Non-GAAP)
(in millions)
2024
2023
Amount
Pct.
Total Bausch Health Revenues
$2,559
$2,408
$151
6%
7%
9%
Bausch Health (excl. B+L)
$1,279
$1,235
$44
4%
4%
7%
Salix segment
$634
$583
$51
9%
9%
12%
International segment
$279
$290
($11)
(4%)
- %
1%
Solta Medical segment
$138
$103
$35
34%
35%
35%
Diversified segment
$228
$259
($31)
(12%)
(12%)
(11%)
Bausch + Lomb segment
$1,280
$1,173
$107
9%
11%
10%
Twelve Months Ended
December 31,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic1 Revenue (Non-GAAP)
(in millions)
2024
2023
Amount
Pct.
Total Bausch Health Revenues
$9,625
$8,757
$868
10%
11%
8%
Bausch Health (excl. B+L)
$4,834
$4,611
$223
5%
5%
6%
Salix segment
$2,333
$2,250
$83
4%
4%
5%
International segment
$1,111
$1,071
$40
4%
3%
4%
Solta Medical segment
$440
$347
$93
27%
29%
29%
Diversified segment
$950
$943
$7
1%
1%
3%
Bausch + Lomb segment
$4,791
$4,146
$645
16%
17%
10%
Salix Segment
Salix segment reported revenues were $634 million for the fourth quarter and $2.33 billion for the full year of 2024, compared with $583 million for the fourth quarter and $2.25 billion for the full year of 2023, an increase of 9% in the fourth quarter, and 4% for the full year. Excluding the impact of divestitures and discontinuations of $19 million for the fourth quarter, and $37 million for the full year, segment revenues increased 12% and 5% on an organic1 basis for the fourth quarter and full year, respectively. Xifaxan® drove sales in the fourth quarter with 16% growth and was the primary contributor to segment growth for the full year.
International Segment
International segment reported revenues were $279 million for the fourth quarter and $1.11 billion for the full year of 2024, compared with $290 million for the fourth quarter and $1.07 billion for the full year of 2023, a decrease of $11 million, or (4%), in the fourth quarter, and an increase of $40 million, or 4%, for the full year. Excluding the impact of foreign exchange of $10 million for the fourth quarter and $6 million for the full year, and divestitures and discontinuations of $5 million for the fourth quarter and $11 million for the full year, segment revenues increased by 1% on an organic1 basis for the fourth quarter, and 4% for the full year, compared with the fourth quarter and full year of 2023, led by solid growth in Canada and EMEA.
Solta Medical Segment
Solta Medical segment reported revenues were $138 million for the fourth quarter and $440 million for the full year of 2024, compared with $103 million for the fourth quarter and $347 million for the full year of 2023, an increase of $35 million, or 34%, in the fourth quarter, and $93 million, or 27%, for the full year. Excluding the impact of foreign exchange of $1 million for the fourth quarter and $7 million for the full year 2024, segment revenues increased 35% on an organic1 basis for the fourth quarter and 29% for the full year, compared with the fourth quarter and the full year of 2023, led by growth in South Korea and China.
Diversified Segment
Diversified segment reported revenues were $228 million for the fourth quarter and $950 million for the full year of 2024, compared with $259 million for the fourth quarter and $943 million for the full year of 2023, a decrease of $31 million, or (12%), in the fourth quarter, and an increase of $7 million, or 1% for the full year. Segment revenues decreased organically1 by (11%) for the fourth quarter and increased 3% for the full year, compared with the fourth quarter and the full year of 2023. The fourth quarter of 2023 included the impact of higher Ativan sales, reflecting competitor supply disruptions.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1.28 billion for the fourth quarter and $4.79 billion for the full year of 2024, compared with $1.17 billion for the fourth quarter and $4.15 billion for the full year of 2023, an increase of $107 million, or 9%, in the fourth quarter, and an increase of $645 million, or 16%, for the full year. Excluding the impact of foreign exchange of $17 million for the fourth quarter and $69 million for the full year of 2024, acquisitions of $5 million for the quarter and $293 million for the full year 2024, and divestitures and discontinuations of $1 million for the fourth quarter and $8 million for the full year, segment revenues increased 10% on an organic1 basis for the fourth quarter and 10% for the full year, compared with the fourth quarter and the full year of 2023.
1This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the “Non-GAAP Information” section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the most directly comparable GAAP measure.
]]>Fri, 14 Feb 2025 08:24:29 GMTBausch Health to Participate in the J.P. Morgan Global Leveraged Finance Conference
LAVAL, Quebec, February 14, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced that it will participate in the 2025 J.P. Morgan Global Leveraged Finance Conference in Miami Beach, Florida on February 24. A live audio webcast of the event will be accessible on the Investor Relations section of Bausch Health’s website.
A replay of the event will be available on the investor relations website following the event.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology,
dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch
Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Mon, 10 Feb 2025 08:36:17 GMTBausch Health to Provide Scholarships to 10 Students Living with GI
Diseases
LAVAL, Quebec, February 10, 2025 - Bausch Health Companies Inc.
(NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix
Pharmaceuticals ("Salix"), today announced the opening of the 2025 Salix
Gastrointestinal Health Scholars Program application period. The program will
award 10 exceptional students living with GI disease a scholarship of up to
$10,000 as they work to pursue their higher education goals.
"For the sixth consecutive year, Bausch Health is honored to offer The Salix
Gastrointestinal Health Scholarship to financially support students who are
driven to persevere through their GI diseases and disorders while still
exceling in their academic goals. Through this scholarship program, Salix is
able to uphold our commitment to support GI patients and make a difference in
the lives of all communities we serve," said Aimee Lenar, Executive Vice
President, US Pharma, Bausch Health.
Students can apply for this scholarship by completing the online application,
submitting letters of reference, and writing an essay on the impact having a
diagnosed GI condition has had on their life and the role that a health care
provider played in helping to manage their condition. Scholarships are offered
to school applicants or current attendees of a two- or four-year college,
university, or an advanced (post-high school) vocational or technical school
for the 2025 - 2026 academic year and are available in the following
categories:
Undergraduate Scholar Awards for students pursuing
undergraduate degrees.
Graduate Scholar Awards for students pursuing graduate
degrees.
Working and/or Single Parents Scholar Award for students
who are working parents and/or single parents pursuing undergraduate,
vocational/technical, or graduate degrees.
The application period for the Salix Gastrointestinal Health Scholars Program
will close on May 5, 2025, and scholarship recipients will be notified in the
summer of 2025. To learn more about the scholarship, including eligibility
criteria, terms and conditions, please visit
www.salix.com/scholarship.
About Bausch Health Bausch Health Companies Inc.
(NYSE:BHC)(TSX:BHC) is a global, diversified pharmaceutical company enriching
lives through our relentless drive to deliver better health outcomes. We
develop, manufacture and market a range of products primarily in
gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics,
international pharmaceuticals and eye health, through our controlling interest
in Bausch + Lomb Corporation. Our ambition is to be a globally integrated
healthcare company, trusted and valued by patients, HCPs, employees and
investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the
largest specialty pharmaceutical businesses in the world and has licensed,
developed and marketed innovative products for the treatment of
gastrointestinal diseases for more than 30 years. For more information about
Salix, visit
www.Salix.com and connect
with us on Twitter and
LinkedIn. For more
information about Bausch Health, visit
www.bauschhealth.com and
connect with us on
LinkedIn
]]>Thu, 06 Feb 2025 07:35:46 GMTLAVAL, QC, February 6, 2025 - Bausch Health Companies Inc. (NYSE/TSX: BHC) (the "Company" or "Bausch Health"), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, issued the following update on a potential sale of its subsidiary, Bausch + Lomb Corporation (NYSE/TSX: BLCO), which was disclosed in December 2024 following a regulatory request:
"In the second half of 2024, Bausch Health engaged with its financial advisors to work on various liability management alternatives. At the same time, Bausch + Lomb was approached by a private equity firm with an indication of interest for a potential sale of Bausch + Lomb at a compelling valuation. In light of Bausch Health's desire to complete the full separation of Bausch + Lomb, the Bausch Health and Bausch + Lomb management teams and their boards considered a sale transaction. However, the process did not lead to an offer that reflected Bausch + Lomb's long-term value and the boards determined not to move forward with a sale. The process will not result in a transaction at this time. Bausch Health will continue to own its 88% interest in Bausch + Lomb.
Bausch Health, along with its financial and legal advisors, will continue its efforts to work on various liability management alternatives, including raising new debt financing.
Our priority is to continue to improve the performance of our businesses, which have been performing well in 2024 as evidenced by the raise of our full-year guidance for revenue, adjusted EBITDA and adjusted operating cash flow communicated in our last earnings release issued on October 30, 2024. Bausch Health looks forward to reporting fourth quarter and full year 2024 earnings as well as providing guidance for the 2025 fiscal year after market close on February 19, 2025."
Bausch + Lomb has also issued its own press release on this subject.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, the Company can offer no assurance that the separation (including a potential sale of Bausch + Lomb) will occur on terms or timelines acceptable to the Company or at all, or as to the ultimate composition of any near-term financing activities. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 23 Jan 2025 07:16:55 GMT.Feb {background-color: white}
LAVAL, Quebec, January 23, 2025 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release fourth quarter and full year 2024 financial results after market close on Wednesday, February 19, 2025. Bausch Health will host a conference call and live webcast at 5:00 p.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive an email confirming your registration.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
LAVAL, Quebec, January 17, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today acknowledged that the Centers for Medicare and Medicaid Services (CMS) has selected XIFAXAN® (rifaximin) 550 mg tablets as one of the medicines for the second round of negotiation as part of the Inflation Reduction Act with an initial price applicability in 2027 of the Drug Price Negotiation program.
We look forward to engaging in open and transparent conversations with CMS, where we will share
information on the value that XIFAXAN® delivers for the healthcare system in addition to sharing recommendations from The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) who gave XIFAXAN® the highest possible recommendation (Grade I, A,1) via their practice guidelines. We will continue to be driven by our commitment to patients in advocating for a healthcare environment that supports patient access to critical medications as well as encouraging future innovation.
About XIFAXAN INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin
antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic
impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly.
Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the value or benefits of our pharmaceutical products. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
LAVAL, QC, December 12, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (the “Company” or “Bausch Health”), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, issued the following statement in response to a request from the Canadian Investment Regulatory Organization (CIRO):
As previously disclosed, the Company believes that completing the full separation of its subsidiary, Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), makes strategic sense. The Bausch Health Board of Directors authorized management and management of its subsidiary, Bausch + Lomb, to explore a potential sale, which is one of several options being considered to complete the separation. That process is ongoing. No decision has been reached to proceed with any particular transaction, and there can be no assurance that it will result in a transaction.
While the Company normally would not comment on deal negotiations, CIRO requested confirmation of a potential sale process given stock volatility often associated with market rumors. Bausch Health does not intend to provide additional detail until further disclosure is appropriate or necessary.”
Bausch Health is traded on both the New York Stock Exchange and Toronto Stock Exchange.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about the potential sale or full separation of Bausch + Lomb. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to whether the full separation
of Bausch + Lomb will occur (including as a result of a potential sale or otherwise) or the timing or approval of any such separation. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward- looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 05 Dec 2024 09:35:39 GMTLAVAL, Quebec, December 5, 2024 - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), alongside the U.S. Pain Foundation (USPF), the International Foundation for Gastrointestinal Disorders (IFFGD), and the American Chronic Pain Association (ACPA) have united to recognize today, Thursday, December 5, as the second annual Opioid-Induced Constipation (OIC) Awareness Day. This important day is dedicated to bringing awareness to a commonly overlooked side effect of opioids. By raising awareness and fostering open conversations, OIC Awareness Day seeks to reduce the stigma surrounding this condition and offer support to the many patients impacted by OIC.
"As an organization dedicated to supporting individuals living with pain conditions, we're proud to participate in this year's OIC Awareness Day," said Kathy Sapp, CEO of ACPA. "By increasing awareness and improving communication between healthcare providers, patients, and caregivers, we can make a meaningful difference for those affected by this commonly occurring condition."
In 2021, about 21% of adults in the U.S. experienced chronic pain. In 2019, 22% of adults with chronic pain were treated with a prescription opioid in the past three months. Opioids can cause OIC, which is a common side effect of opioid treatment. The annual recognition of OIC Awareness Day provides a platform for patients, caregivers, and healthcare providers to discuss this condition and encourage them to join the #OICAwarenessDay movement.
"We're deeply committed to bringing attention to those affected by OIC on this annual awareness day," said Ceciel Rooker, President and Executive Director of IFFGD. "Empowering patients to speak openly about their symptoms is crucial. It's the first step toward helping to ensure they receive the appropriate treatment, and not suffer in silence."
In honor of the second annual OIC Awareness Day, Salix has refreshed the OICAwarenessDay.com website to offer valuable information and resources for healthcare providers, patients, and caregivers, addressing the causes, symptoms, and management of OIC. Additionally, Salix has partnered with influencers to spread the word online using the hashtag #vOICesOfOIC, launched a content program with Chronicon, a global community for people with chronic illnesses, and shared posts across their social media channels to increase awareness about OIC.
"We're honored to be a part of OIC Awareness Day for the second year in a row," said Nicole Hemmenway, CEO of USPF. "By continuing to raise awareness about this condition, we aim to educate both healthcare providers and patients about OIC, a commonly overlooked side effect."
For more information on OIC and to learn how you can join the #OICAwarenessDay movement, please visit www.OICAwarenessDay.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
About The U.S. Pain Foundation
The U.S. Pain Foundation is a 501(c)(3) nonprofit with a mission to empower, educate, connect, and advocate for individuals living with chronic illnesses and serious injuries that cause pain, as well as their care partners and clinicians. Through its multiple programs and services, the organization works to elevate the patient voice, increase disease-state education, improve pain care through policy change, expand outreach to underserved and marginalized communities, and provide comprehensive resources to ensure individuals are supported and empowered along their journeys. Learn more at uspainfoundation.org.
About The International Foundation for Gastrointestinal Disorders
The International Foundation for Gastrointestinal Disorders (IFFGD) is a nonprofit education and research organization dedicated to improving the lives of people affected by chronic gastrointestinal illnesses. Founded in 1991, IFFGD helps improve patient outcomes by enhancing awareness, improving education, and supporting and encouraging research into treatments and cures for chronic digestive disorders.
About The American Chronic Pain Association
The American Chronic Pain Association (ACPA) is a non-profit, 501(c) (3) organization. Our Mission is to facilitate peer support, education, hope, and motivation for individuals living with pain and those treating pain conditions. We strive to raise awareness among the health care community, policymakers, and the public at large about issues of living with physical and emotional pain. Our vision is to motivate those with pain conditions to seek quality care, to optimize healthcare office visits, and to prevent chronic disease.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Mon, 02 Dec 2024 10:22:56 GMTLAVAL, QC, December 2, 2024 - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is pleased to announce the appointment of Jonathan Sadeh M.D., M.Sc as Executive Vice President, Chief Medical Officer and Head of R&D. This strategic addition to our leadership team underscores our commitment to innovation, excellence, and enriching lives.
Jonathan brings a wealth of experience and a proven track record of success both as a physician-scientist and a leader in the pharmaceutical industry. With over 20 years of expertise in clinical research and drug development, he has consistently demonstrated the ability to drive growth and foster innovation. Most recently, at Bristol-Meyers Squibb, he was responsible for multiple drug approvals in dermatology and gastroenterology and held several key roles including Senior Vice President and Global Programs Head for Immunology, Cardiovascular and Neuroscience, Immunology Therapeutic Area Head, as well as the China R&D Head. Jonathan received a master's degree in clinical research from Harvard Medical School and earned his medical degree from the Mount Sinai School of Medicine. He has held key positions at Sanofi, Astra-Zeneca and Schering-Plough.
"We are delighted to welcome Jonathan as our new Head of Research and Development," said CEO, Thomas J. Appio. "His extensive experience and innovative vision will be invaluable as we continue to enhance our pipeline and strive for groundbreaking advancements."
In his new role, Jonathan will be responsible for overseeing the entire R&D process, working closely with our scientists and engineers. He will set the strategic direction and ensure alignment with our overall goal of enriching lives through our relentless drive to deliver better health outcomes. We are confident that Jonathan will make a significant contribution to our company's success and commitment to being an innovative healthcare company.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Mon, 18 Nov 2024 10:27:08 GMTNext generation product may increase gastrointestinal luminal concentration while limiting system exposure
LAVAL, Quebec, November 18, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the first look at its late-stage RED-C clinical trial program which will be presented at the American Association for the Study of Liver Disease (AASLD), The Liver Meeting® in San Diego, CA. This clinical program was designed to assess the efficacy of a next generation therapeutic, a soluble solid dispersion (SSD) immediate-release rifaximin product, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Another objective of this study is to assess the effects of treatment with this next generation therapeutic on the time to the onset of significant clinical events, including all-cause hospitalization rates, first occurrence of OHE event requiring hospitalization, and all-cause mortality.
The RED-C program is evaluating a next generation therapeutic designed to enhance the gastrointestinal luminal solubility of a unique form of rifaximin in order to preserve epithelial function, limit bacterial translocation to the bloodstream and liver, and reduce proinflammatory cytokine production. The RED-C program includes two global Phase 3, randomized, double-blind, placebo-controlled studies conducted in over 1,000 patients, over 398 study sites, and across 17 countries. Patient enrollment on both trials is now complete with efficacy and safety results to be announced at future congresses.
"The RED-C program underscores our dedication to exploring and identifying new treatments for individuals with cirrhosis," stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. "Considering the significant unmet need for cirrhotic patients, the RED-C phase 3 trials have been rigorously designed to assess a potential new option to delay the onset of the first overt hepatic encephalopathy event, and to potentially, delay time to all-cause hospitalization. Enrollment in both trials is now complete, and the trials are progressing at study sites worldwide."
The Salix research to be presented at AASLD 2024 is as follows:
Rifaximin SSD-40IR
Bajaj, Jasmohan S. et.al. Rifaximin Soluble Solid Dispersion Immediate-Release Tablets for Prevention and Delay of the First Episode of Hepatic Encephalopathy: RED-C Phase 3 Study Design
Poster #4198
Monday, November 18, 8:00 AM - 5:00 PM PT
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Sixth consecutive quarter of year-over-year growth in both Revenue and Adjusted EBITDA (non-GAAP)1
Third quarter consolidated revenues of $2.51 billion, up 12% on a Reported basis and 9% on an Organic (non-GAAP)1 basis, with growth in all segments
Consolidated GAAP Net Loss Attributable to Bausch Health Companies Inc. of $85 million
Consolidated Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $909 million, up 10%
Raising full-year 2024 guidance
LAVAL, QC, October 30, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its third quarter 2024 financial results and other key updates from the quarter.
"Our team at Bausch Health continued to execute against our commitments in the third quarter, delivering a sixth consecutive quarter of year-over-year growth in both revenue and Adjusted EBITDA. This was accomplished while we continued to advance our R&D pipeline, including the approval and launch of CABTREO® in Canada. These results reflect the strength of our diverse and robust portfolio of products, both geographically and across therapeutic areas," said Thomas J. Appio, Chief Executive Officer.
Third Quarter 2024 Revenue Performance
Total consolidated reported revenues were $2.51 billion for the third quarter of 2024, compared with $2.24 billion in the third quarter of 2023, an increase of $272 million, or 12%. Excluding the impact of foreign exchange of $9 million, acquisitions of $96 million, and divestitures and discontinuations of $16 million, revenue increased by 9% on an organic1 basis compared with the third quarter of 2023.
Reported revenues by segment were as follows:
Three Months Ended
September 30,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic Revenue1 (Non-GAAP)
(in millions)
2024
2023
Amount
Pct.
Total Bausch Health Revenues
$2,510
$2,238
$272
12%
13%
9%
Bausch Health (excl. B+L)
$1,314
$1,231
$83
7%
7%
8%
Salix segment
$642
$614
$28
5%
5%
5%
International segment
$291
$275
$16
6%
7%
8%
Solta Medical segment
$112
$83
$29
35%
36%
36%
Diversified segment
$269
$259
$10
4%
4%
7%
Bausch + Lomb segment
$1,196
$1,007
$189
19%
19%
10%
Salix Segment
Salix segment reported revenues were $642 million for the third quarter of 2024, compared with $614 million for the third quarter of 2023, an increase of $28 million, or 5%. Excluding the impact of divestitures and discontinuations of $4 million, segment revenues increased 5% on an organic1 basis. Xifaxan® revenues grew 7%, and Relistor® and Trulance® revenues each grew 9% compared with the third quarter of 2023, which were partially offset by declines in certain non-promoted products.
International Segment
International segment reported revenues were $291 million for the third quarter of 2024, compared with $275 million for the third quarter of 2023, an increase of $16 million, or 6%. Excluding the impact of foreign exchange of $3 million and divestitures and discontinuations of $2 million, segment revenues increased on an organic1 basis by 8% compared with the third quarter of 2023, led by double-digit growth in Canada and solid organic1 growth in Latin America.
Solta Medical Segment
Solta Medical segment reported revenues were $112 million for the third quarter of 2024, compared with $83 million in the third quarter of 2023, an increase of $29 million, or 35%. Excluding the impact of foreign exchange of $1 million, segment revenues increased on an organic1 basis by 36% compared with the third quarter of 2023, led by growth in South Korea and China.
Diversified Segment
Diversified segment reported revenues were $269 million for the third quarter of 2024, compared with $259 million for the third quarter of 2023, an increase of $10 million, or 4%. Excluding the impact of divestitures and discontinuations of $7 million, segment revenues increased 7% on an organic1 basis, primarily attributable to increases in revenue in Neurology.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1,196 million for the third quarter of 2024, compared with $1,007 million for the third quarter of 2023, an increase of $189 million, or 19%. Excluding the impact of foreign exchange of $5 million, acquisitions of $96 million and divestitures and discontinuations of $3 million, segment revenues increased on an organic1 basis by 10% compared with the third quarter of 2023, driven by increases across all business units.
1This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure.
]]>® (rifaximin) Risk Reduction of Overt Hepatic Encephalopathy (OHE) Recurrence ]]>Mon, 28 Oct 2024 10:14:42 GMTAdditional ACG presentation to focus on impact of Xifaxan on OHE rehospitalizations
LAVAL, QC / ACCESSWIRE / October 27, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its
gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), announced that results of an analysis of Xifaxan®
(rifaximin) monotherapy will be presented during a Presidential Plenary Session of The American College of
Gastroenterology® 2024 Annual Scientific Meeting taking place October 25-30 in Philadelphia, PA. This post hoc
analysis of data from two randomized trials evaluated the efficacy of Xifaxan monotherapy compared to lactulose
monotherapy for risk reduction of overt hepatic encephalopathy (OHE) recurrence and all-cause mortality.
During ACG, Salix will also present new data on the impact of Xifaxan use on rehospitalizations following an OHE
hospitalization discharge in both commercially insured and Medicare patient populations.
Two posters to be presented at the ACG meeting will also share findings for Plenvu® (polyethylene glycol 3350, sodium
ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) as a bowel
preparation medication, including efficacy findings from colonoscopy patients who have either comorbid conditions or
are taking concomitant medications that are known to impact bowel prep quality.
"These presentations at ACG 2024 can give healthcare professionals confidence that treatments from Salix have
potential to improve outcomes for their patients" said Aimee Lenar, Executive Vice President, US Pharma at Bausch
Health. "Bausch Health remains dedicated to pursuing life-changing solutions and continues to invest in expanding
the body of evidence for our medicines today and in the future."
The complete list of Salix research and analyses to be presented at ACG 2024 is as follows:
XIFAXAN
Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the
Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized
Trials
Presidential Plenary Session 2; Presentation #9
Monday, October 28, 10:06 - 10:18 AM ET
Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations
Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients
Poster #P1162
Sunday, October 27, 3:30 PM - 7:00 PM ET
PLENVU
Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults
With Comorbid Conditions That May Impact Prep Quality
Poster #P3667
Tuesday, October 29, 10:30 AM - 4:00 PM ET
Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients
Taking Concomitant Medications Known to Impact Prep Quality
Poster #P3657
Tuesday, October 29, 10:30 AM - 4:00 PM ET
About XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic
encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in
adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents,
or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis,
angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If
CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to
be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment.
Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors
is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly
increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive
effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to
rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose)
were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and
prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
Please click here for full Prescribing
Information.
About PLENVU
INDICATION
PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium
chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.
IMPORTANT SAFETY INFORMATION
Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of
your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach
(gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated
large intestine, or an allergy to any of the ingredients in PLENVU®.
PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid
(dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal
heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems.
Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart
problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal
anti-inflammatory drugs (NSAIDS).
Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your
healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including
vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal;
headache, or feel faint, weak, or lightheaded, especially when you stand up.
PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider
right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your
skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems.
The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain
or discomfort.
Tell your healthcare provider about all of your medical conditions and medicines you take, including
prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU®
These are not all the possible side effects of PLENVU®. Ask your healthcare provider for more information.
Please click here for full Prescribing
Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives
through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of
products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye
health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated
healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business,
Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed,
developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years.
For more information about Salix, visit www.Salix.com and
connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Wed, 09 Oct 2024 16:49:20 GMTLAVAL, Quebec, October 9, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release third quarter 2024 financial results after market close on Wednesday, October 30, 2024. Bausch Health will host a conference call and live webcast at 5:00 p.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive an email confirming your registration with further details.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Tue, 08 Oct 2024 10:15:40 GMTFindings show care for chronic liver disease patients is falling on non-specialists who need stronger education and support to ensure patients receive timely, optimal care1
LAVAL, Quebec, October 8, 2024 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today released Liver Health Trends Report in Action, the latest Liver Health Annual Trends Report dedicated to sparking actionable change to improve liver disease management and outcomes for patients. Healthcare provider (HCP) survey participants called for holistic, multi-disciplinary treatment approaches, consistent use of non-invasive screening tools (e.g., FIB-4 Index) and better education to identify at-risk patients sooner and prevent future complications of severe liver disease.1
Approximately 4.5 million adults in the United States are diagnosed with chronic liver disease (CLD), which can lead to cirrhosis.2 Often, cirrhosis indicates permanent liver damage, so earlier diagnosis and prevention are critical for patients living with liver disease. As of 2022, CLD is the tenth leading cause of death in the U.S. with mortality associated with CLD projected to nearly triple by 2030.2,3 When compared to patients with chronic heart failure, people with cirrhosis have nearly double the post-emergency department visit mortality rate (6.9% vs 12.2%, respectively), reinforcing the need for broader use of risk-stratification tools and for increased awareness of cirrhosis-associated risks by all HCPs. 4
“Recent liver disease trends are alarming, and as the number of patients needing care rises and the number of specialists declines, too often patients are left waiting or lost to follow-up until they have symptoms of irreversible liver disease,” said Nancy Reau, MD, section chief of hepatology at Rush Medical Center. “While progress in liver disease management has been made, it is evident that challenges remain. More consistent use of diagnostic tests and scores helps identify severe disease earlier, and elevated national attention on liver disease as a public health priority may help lessen the burden of illness on the broader healthcare system.”
Liver Health Trends Report in Action encompasses key learnings from 2020-2023 Liver Health Annual Trends Reports, new secondary and primary market insights, as well as forty in-depth interviews with physicians who treat liver disease across various practice settings to reveal insights on diagnosis, management and barriers to liver disease care. Physicians participating in this survey report that advances in liver disease management are achievable given the provision of resources and tools by their practice or organization’s leadership.1
The Liver Health Annual Trend Reports have provided profound insights, and now we must take action and champion the practical solutions outlined by participants in this survey to slow or reverse the distressing trends from the past four years,” said Aimee Lenar, Executive Vice President, US Pharma,
Bausch Health. “Bausch Health and Salix have been leaders in driving awareness and therapies for patients suffering from severe forms of liver disease and we are investing in the development of new therapies for the future.”
Additional findings highlighted in the 2024 report include the need for1:
Awareness of the shift away from single-specialty management (hepatologist) to a multidisciplinary care model
Greater adoption of user-friendly, evidence-based guidelines for the management of liver disease that may be adapted for all practice settings
Investing in resources to support a shift from high-cost inpatient care to community-based care
Better understanding of the current screening guidelines for metabolic dysfunction-associated steatotic liver disease (MASLD) in adult patients
Increased awareness of the importance of risk stratifying liver disease patients using noninvasive screening tools and risk scores
More access to continuing education material and tools
Expanding the use of electronic health record (EHR), artificial intelligence (AI), and other appropriate digital tools to improve communication and alignment with evidence-based care
Findings from the interviews were analyzed to determine key themes and organized into 3 sections: Action Steps for (1) Physicians Practicing in the Primary Care Setting, (2) Hospital-based Physicians, and (3) Leadership of Group Practices, Hospitals, and Health Systems. A resource section is included that contains evidence-based guidelines in screening and managing MASLD and cirrhosis and examples of provider and/or patient resources.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the prevention and treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
References
Aventria Health Group. (2024). Liver Health Trends Report in Action. Salix Pharmaceuticals. LiverHEalthNow.com
Estes, C., Razavi, H., Loomba, R., Younossi, Z., & Sanyal, A. J. (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology (Baltimore, Md.), 67(1), 123–133. https://doi.org/10.1002/hep.29466
Elhence, H., Dodge, J. L., Flemming, J. A., & Lee, B. P. (2024). Emergency Department Utilization and Outcomes among Adults with Cirrhosis from 2008 to 2022 in the United States. Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association, S1542-3565(24)00764-X. Advance online publication. https://doi.org/10.1016/j.cgh.2024.07.029
]]>Tue, 13 Aug 2024 09:30:34 GMTFor Fifth Consecutive Year, 10 Students with Gastrointestinal Disease Will Each Receive a $10,000 Scholarship
LAVAL, Quebec, August 13, 2024 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the recipients of its 2024 Salix Gastrointestinal Health Scholars Program. For the fifth year, Bausch Health is proud to award 10 deserving students living with a GI disease $10,000 each to further their higher education.
“Bausch Health is proud of the number of applications we received in our fifth year of the program – a true testament to the unrelenting strength of the GI community,” said Aimee Lenar, Executive Vice President, US Pharma, Bausch Health. “We know it can be difficult to juggle higher education with GI challenges, so we remain dedicated to providing financial assistance to students who have not allowed their disease to stand in the way of their academic achievements.”
The 2024 awardees were selected from more than 275 applications. As part of the process, applicants were required to submit essays describing how their GI condition has impacted their educational journey, as well as explore the role their health care provider(s) played in helping them reach both their personal and educational goals. All scholarship applications were reviewed by an independent panel of judges.
The program recognizes students across a wide range of educational pursuits, with scholarships in four categories, including the Undergraduate Scholar Awards, for those pursuing undergraduate degrees; the Graduate Scholar Awards, for those pursuing graduate degrees; the Single Parent’s Scholar Award, for students who are single parents; and the Working Parent’s Scholar Award, for parents pursuing undergraduate, vocational/technical, or graduate degrees.
"Receiving this scholarship has been a tremendous honor. I feel proud to live in a world where I am able to achieve great things even with this condition,” said Milo Eaton, a scholarship recipient. "I’d like to thank Bausch Health for helping me pursue my dreams."
The 2024 Salix Gastrointestinal Health Scholars Program recipients are:
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health through our approximately 90% ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical businesses in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
Second quarter consolidated revenues of $2.40 billion, up 11% on a Reported and 8% on an Organic (non-GAAP)1 basis
Consolidated GAAP Net Income Attributable to Bausch Health Companies Inc. of $10 million
Consolidated Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $798 million, up 10%
Raising consolidated full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance
LAVAL, QC, August 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its second quarter 2024 financial results and other key updates from the quarter.
"We continued our momentum in the second quarter, delivering our fifth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA, underscoring the strength of our product and geographic footprint and reinforcing our strategy. We remain focused on advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive growth globally. I'm proud of the hard work and accomplishments of our team, who work tirelessly to improve the health of patients worldwide," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Second Quarter 2024 Revenue Performance
Total consolidated reported revenues were $2.40 billion for the second quarter of 2024, compared with $2.17 billion in the second quarter of 2023, an increase of $236 million, or 11%. Excluding the impact of foreign exchange of $25 million, acquisitions of $104 million, and divestitures and discontinuations of $14 million, revenue increased by 8% organically1 compared with the second quarter of 2023.
Reported revenues by segment were as follows:
Three Months Ended
June 30,
Reported Change
Change at Constant Currency1 (Non-GAAP)
Change in Organic Revenue1 (Non-GAAP)
(in millions)
2024
2023
Amount
Pct.
Total Bausch Health Revenues
$2,403
$2,167
$236
11%
12%
8%
Bausch Health (excl. B+L)
$1,187
$1,132
$55
5%
5%
6%
Salix segment
$558
$557
$1
—%
—%
1%
International segment
$276
$259
$17
7%
5%
6%
Solta Medical segment
$102
$88
$14
16%
19%
19%
Diversified segment
$251
$228
$23
10%
10%
12%
Bausch + Lomb segment
$1,216
$1,035
$181
17%
20%
10%
Salix Segment
Salix segment reported revenues were $558 million for the second quarter of 2024, compared with $557 million for the second quarter of 2023. Excluding the impact of divestitures and discontinuations of $5 million, segment revenues increased 1% on an organic1 basis. Xifaxan® revenues grew 10% compared with the second quarter of 2023, which was offset by declines in Relistor®, Trulance®, and certain non-promoted products.
International Segment
International segment reported revenues were $276 million for the second quarter of 2024, compared with $259 million for the second quarter of 2023, an increase of $17 million, or 7%. Excluding the impact of foreign exchange of $5 million and divestitures and discontinuations of $3 million, segment revenues increased organically1 by 6% compared with the second quarter of 2023, led by double-digit growth in Canada and solid growth in Latin America.
Solta Medical Segment
Solta Medical segment reported revenues were $102 million for the second quarter of 2024, compared with $88 million in the second quarter of 2023, an increase of $14 million, or 16%, which was driven by growth in Asia-Pacific, led by South Korea. Excluding the impact of foreign exchange of $3 million, segment revenues increased organically1 by 19% compared with the second quarter of 2023.
Diversified Segment
Diversified segment reported revenues were $251 million for the second quarter of 2024, compared with $228 million for the second quarter of 2023, an increase of $23 million, or 10%. Excluding the impact of divestitures and discontinuations of $4 million, segment revenues increased 12% on an organic1 basis, primarily attributable to increases in sales in Dermatology and Neurology.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1,216 million for the second quarter of 2024, compared with $1,035 million for the second quarter of 2023, an increase of $181 million, or 17%. Excluding the impact of foreign exchange of $27 million, acquisitions of $104 million and divestitures and discontinuations of $2 million, the Bausch + Lomb segment revenues increased organically1 by 10% compared with the second quarter of 2023, driven by increases across all business units.
1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure.
]]>Wed, 24 Jul 2024 13:06:44 GMTLaval, QC, July 24, 2024 -- Bausch Health Companies Inc. (NYSE/TSX: BHC) (the “Company”) has become aware of a news article issued by Reorg® today, citing unnamed sources.
The article contains unsubstantiated rumors, including that the Company is considering a bankruptcy or insolvency proceeding of any kind - it is not.
We understand that Reorg® has subsequently issued an update to its original news article to clarify that the Company has not been involved in discussions with its creditors regarding bankruptcy proceedings.
The Company’s policy is not to provide further comment on speculation.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward- looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Fri, 19 Jul 2024 07:29:36 GMTLAVAL, Quebec, July 19, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the appointment of two new members to its Executive Leadership Team (ELT).
Jean-Jacques Charhon (“JJ”) will join the Company as Chief Financial Officer on August 19, 2024. JJ has over 25 years of experience in financial leadership roles with public and private companies across healthcare, high tech and services, primarily at General Electric, Hewlett Packard, Novartis and Purdue Pharma. Upon JJ’s arrival, John Barresi, the Company’s Interim Chief Financial Officer, will resume his role as SVP, Controller.
Aimee Lenar joined the Company on July 15, 2024 as Executive Vice President, US Pharma. Aimee’s new role includes leadership of Salix Pharmaceuticals, Bausch Health’s gastroenterology (GI) business, as well as Neurology, Generics, Market Access and Commercial Operations. Aimee brings over 20 years of experience in the pharmaceutical industry, most recently as Head of US Prescription Medicine at Galderma.
“We are delighted to welcome JJ and Aimee to our ELT. They are both proven leaders bringing extensive experience and expertise to their respective roles that will drive our transformation and achieve our ambition to be a globally integrated and innovative healthcare company, trusted and valued by patients, HCPs, employees, and investors,” said CEO, Thomas J. Appio. “I want to thank John Barresi for all his hard work and dedication as he stepped in as Interim Chief Financial Officer along with his other responsibilities. I am grateful to have John on the team; he is an integral part of our Financial Leadership Team.”
About Jean-Jacques Charhon
On August 19, 2024, JJ will join the Company from Signant Health where he was Executive Vice President and Chief Financial Officer and was primarily responsible for financial planning and analysis, accounting & controllership, treasury, tax and procurement. JJ has over 25 years of experience in financial leadership roles with public and private companies such as General Electric, Hewlett Packard, Novartis and Purdue Pharma. JJ is passionate about driving business enablement through the finance function for both strategy shaping and operational execution. JJ holds a master’s degree in business administration from the Solvay School of Management in Brussels, Belgium.
About Aimee Lenar
Aimee joined the Company from her most recent role as Head of US Prescription Medicine at Galderma. At Galderma, Aimee was responsible for sales, marketing, market access, and business analytics, overseeing both a portfolio of established prescription products and a new immunology asset. Prior to this role, Aimee held leadership roles with AbbVie and Allergan, where she served most recently as a VP and General Manager of CNS. Prior to this role, she was VP Gastroenterology at AbbVie for over 5 years. Aimee has a proven track record across several roles and brings a wealth of
marketing and sales execution to Bausch Health. Aimee holds a master’s degree in public health from Emory University.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "will," "anticipates," "hopes," This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's succession plan for its chief financial officer position. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward- looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 11 Jul 2024 08:10:34 GMTLAVAL, Quebec, July 11, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release second quarter 2024 financial results on Thursday, August 1, 2024. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive an email confirming your registration.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Thu, 20 Jun 2024 17:44:14 GMTLAVAL, QC, June 20, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the
"Company") and its gastroenterology business, Salix Pharmaceuticals, today announced that it has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Norwich Pharmaceuticals, Inc.
This lawsuit was filed in connection with the Notice of Paragraph IV Certification, dated May 10, 2024, received from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Bausch Health continues to defend challenges to its XIFAXAN® intellectual property. In the first Norwich lawsuit, the U.S. District Court for the District of Delaware issued a ruling in August 2022 that barred Norwich’s first ANDA for XIFAXAN® 550 mg from approval by the U.S. Food and Drug Administration until October 2029. On appeal, the ruling was confirmed.
Since the District Court’s ruling, Bausch Health received additional patents related to XIFAXAN® 550 mg that protect the innovative treatment of IBS-D. As part of the applications to the U.S. Patent and Trademark Office the Company provided information related to the ongoing dispute between the Company and Norwich, including the District Court’s August 2022 decision.
As a leader in gastrointestinal health, Bausch Health will continue to vigorously defend our intellectual property and is committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN®. We look forward to continuing to serve our patients, as every patient deserves better health outcomes and the chance to make the most of life.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
“expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions, including statements about the Company’s actions and plans to vigorously defend its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or as to the outcome of any patent litigation. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Fri, 14 Jun 2024 14:56:59 GMTLAVAL, Quebec, June 14, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health’s gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy.
Amiselimod at DDW
Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebocontrolled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients.
Specifically:
In the primary endpoint measure – both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to - 1.6 points in the placebo group (p-score <0.01)
In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (pscore <0.01). Similarly, over 31% of patients on Amiselimod experienced clinical remission compared to 18% in the placebo group (p-score = 0.03).
In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated.
“Our recent trial results are a testament to the dedication and expertise of our research teams,” said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. “The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development.”
Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1
Rifaximin at EASL
At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that:
Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P<0.0001).
Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment.
Rifaximin monotherapy was well tolerated.
These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations.
About Amiselimod
Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on
S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.2
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Thu, 23 May 2024 09:00:00 GMTLAVAL, QC, May 23, 2024 - Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), today announced additional Canadian public drug plan listings for PrUCERIS® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.1
UCERIS has most recently become available for patients through the public drug plans of Alberta, Prince Edward Island and Newfoundland and Labrador, as well as to beneficiaries of the federal drug plans for Indigenous people through the Non-Insured Health Benefit (NIHB) and Veterans Affairs Canada.
Earlier this year, UCERIS was made available for patients through the public drug plans of Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia.
“We are very pleased that these further public drug plan listings for UCERIS mean more Canadians with distal ulcerative colitis now have access to this new therapy,” said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. “It is encouraging that these public drug plans have moved quickly to finalize their listings after our agreement in principle following negotiations with the pan-Canadian Pharmaceutical Alliance.”
UCERIS, part of the Company’s growing gastrointestinal franchise, has been available in Canada by prescription since September 2023 and is also covered by the majority of private insurance drug plans in Canada.
UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.1 In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.2
Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.3 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).3
In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.1
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, healthcare professionals, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
]]>Fri, 17 May 2024 08:38:49 GMTLAVAL, Quebec, May 17, 2024– Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today announced that they will be presenting data from its Phase 2 trial evaluating Amiselimod as treatment for active ulcerative colitis (UC). The data will be presented at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on Sunday, May 19, 2024, in Washington, D.C.
“We are pleased to present late-breaking data on Amiselimod, our investigational, oral, sphingosine 1- phosphate (S1P) receptor modulator as a potential treatment for the induction of remission in UC,” said Tage Ramakrishna, M.D., Chief Medical Officer and President of Research & Development, Bausch Health. “The abstract underscores our steadfast commitment to developing new and innovative therapies for patients with UC.”
The research to be featured at DDW 2024 and available via the meeting's online platform is as follows:
Hanauer, Stephen B. et al. “Amiselimod for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled trial” Abstract #4094796
The Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to- moderately active UC. Bausch Health announced positive topline results from this study in December 2023.
About Amiselimod
Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.3
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and Linkedin
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.comand connect with us on Twitter and LinkedIn.
About DDW
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
References
Kunio Sugahara, Yasuhiro Maeda. Amiselimod, a novel sphingosine 1‐phosphate receptor‐1 modulator, has potent therapeutic efficacy for autoimmune diseases, with low bradycardia risk. British Journal of Pharmacology. January 2017.
Peyrin-Biroulet, Ronald Christopher Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmunity Reviews. February 2017.
BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019.
]]>Wed, 15 May 2024 08:00:00 GMTLAVAL, Quebec, May 15, 2024– Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the results of its 2024 annual meeting of shareholders.
Annual Meeting Results
The 10 directors nominated at the Company’s 2024 annual meeting of shareholders held on May 14, 2024, were elected by a vote of the shareholders. The detailed results of the vote for the election of directors are set out below:
Name
For
Withheld
Broker Non-Votes
Thomas J. Appio
181,373,219
10,918,741
70,931,303
Christian A. Garcia
181,143,285
11,148,675
70,931,303
Brett M. Icahn
170,144,670
22,147,290
70,931,303
Sarah B. Kavanagh
180,316,464
11,975,496
70,931,303
Frank D. Lee
173,147,642
19,144,318
70,931,303
Steven D. Miller
177,700,669
14,591,291
70,931,303
Dr. Richard C. Mulligan
175,256,854
17,035,106
70,931,303
John A. Paulson
179,422,691
12,869,269
70,931,303
Robert N. Power
173,228,670
19,063,290
70,931,303
Amy B. Wechsler, M.D.
181,626,477
10,665,483
70,931,303
At the annual meeting of shareholders, shareholders also approved, in a non-binding advisory vote, the compensation of the Company’s named executive officers, an amendment to the Company’s 2014 Omnibus Incentive Plan to increase the number of common shares authorized for issuance thereunder, and appointed PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm until the close of the Company's 2025 annual meeting of shareholders.
For the purposes of Toronto Stock Exchange (TSX) approval with respect to the Plan, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as the NYSE.
The final vote tabulation on all matters voted on at the meeting will be reported to the U.S. Securities and Exchange Commission on a current report on Form 8-K, and such report will be made available on the Company’s SEDAR profile and on the Company’s website at www.bauschhealth.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
]]>Tue, 14 May 2024 16:46:13 GMTLAVAL, QC, May 14, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business Salix Pharmaceuticals, today announced certain updates related to its litigation with Norwich Pharmaceuticals, Inc.
With respect to the April 11, 2024, decision of the US Court of Appeals for the Federal Circuit, both Bausch Health and Norwich have filed petitions for panel rehearing or rehearing en banc. The Company anticipates a decision on whether a rehearing will be granted within the next three months.
The Company has also received notice of a new Paragraph IV certification (the “Notice”), dated May 10, 2024, from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea in adults.
Bausch Health is reviewing the Notice and has 45 days from receipt of the Notice to commence a patent infringement lawsuit against Norwich. Bausch Health understands that such a lawsuit would automatically preclude the FDA from approving Norwich’s ANDA for up to 30 months or until the issuance of a decision by the district court in this matter that is adverse to Bausch Health, whichever occurs first.
Bausch Health intends to vigorously enforce its intellectual property rights relating to XIFAXAN®.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions, including statements about the Company’s actions and plans to vigorously defend its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or as to the outcome of any patent litigation. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Xifaxan is the first and only FDA approved medication for the reduction in risk of OHE recurrence in adults
Overt Hepatic Encephalopathy is caused by cirrhosis of the liver
As complications from chronic liver disease increase, recognizing OHE is critical so that patients can work with their healthcare providers to find the right management plan for them
LAVAL, QC / May 9, 2024 / Bausch Health Companies Inc. (NYSE: BHC) (TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced award-winning actor, Bellamy Young, as the brand ambassador in a new campaign to raise awareness of Xifaxan, the first and only FDA approved medication to reduce the risk of overt hepatic encephalopathy (OHE) recurrence in adults. Overt hepatic encephalopathy is a complication of cirrhosis that can happen when the liver cannot filter toxins from the blood, and the toxins build up and reach the brain. It is projected that as many as four out of five people with cirrhosis may eventually develop some form of HE.
“When I first started talking about OHE, the most common response I received from people was ‘I wish I knew’, a sentiment that echoed my experience when my father was diagnosed with OHE. We didn’t know the symptoms of OHE could persist or that it could worsen over time. But when my dad had OHE we also didn’t know as much as we do today, and we didn’t have the same management options,” said Bellamy Young, whose father suffered from OHE when she was in high school. “I want to help today’s patients and caregivers to know more than my family did with my father, and I encourage them to talk to their health care providers about managing the risk of OHE recurrence. I hope people will go to Xifaxan.com to know more.”
To kick off the new Xifaxan marketing campaign, Bellamy is sharing her personal OHE story on www.Xifaxan.com/ohe/ and is in a multi-channel advertising campaign that will be seen across digital mediums, including a 60-second TV spot. Bellamy will also be engaging with HCPs, caregivers, and patients to exchange learnings about OHE by chronicling these experiences and sharing insights on her social media handles throughout the year to support others in knowing more about OHE so they can make informed decisions about disease management. As an ambassador, she will be encouraging caregivers to take an active role as a health advocate for their loved ones.
“With patients at the center of all we do, Salix is committed to driving increased conversation and education about OHE to support patients, caregivers, and Healthcare Professionals in finding the right options,” said Nicola Kayel, Senior Vice President, GI Marketing, Salix.
About Overt Hepatic Encephalopathy: Overt Hepatic encephalopathy (OHE) is a complication of cirrhosis, a chronic liver disease, which can have various causes. One of the important functions of the liver is to clean the blood. When the liver is damaged, it can no longer properly clean toxins (like ammonia) from the blood. This buildup of toxins can reach the brain, potentially causing OHE and worsening brain function. Symptoms of OHE can be both physical and mental. Medications and appropriate lifestyle management, with the help of a doctor, may help manage the disease.
Symptoms of Overt Hepatic Encephalopathy may include:
Mental:
Lack of energy or interest
Confusion
Not knowing where you are or where you’re going
Inappropriate behavior
Severe personality changes
Physical:
Sleepiness or change in sleep patterns
Worsening of handwriting
Loss of small hand movements
Tremors or shaking of hands or arms
Breath with a musty or sweet odor
ABOUT XIFAXAN INDICATION
XIFAXAN®(rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
In clinical studies, the most common side effects for XIFAXAN were:
HE: Peripheral edema (swelling, usually in the ankles or lower limbs), constipation, nausea (feeling sick to your stomach), fatigue (feeling tired), insomnia (trouble sleeping), ascites (a buildup of fluid in the abdomen), dizziness, urinary tract infection, anemia (low red blood cell levels), and itching
XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center Phone: 1-800-321-4576
Fax: 1-510-595-8183
Please click here for full Prescribing Information.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life- changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to
U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Thu, 02 May 2024 07:00:00 GMT
First quarter revenues of $2.15 billion, up 11% on a Reported and 8% on an Organic1 basis
Year-over-year revenue growth in all segments on both a Reported and Organic1 Basis
GAAP Net Loss Attributable to Bausch Health Companies Inc. of $64 Million
Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $665 Million, up 13%
Xifaxan® Appeal Decision Represents a Significant Milestone related to Full Separation of Bausch + Lomb
Reaffirmed full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance
LAVAL, QC, May 2, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its first quarter 2024 financial results and other key updates from the quarter.
"We are pleased with our strong start to the year, delivering solid first-quarter performance, and our fourth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA. Furthermore, all our business segments posted year-over-year revenue growth on both a reported and organic basis. I'm very proud of what our team has accomplished and we remain focused on continuing our momentum by advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
“We are also pleased with other key developments for our business during the quarter, including the appeal decision in the Norwich matter in respect of Xifaxan®, which represents a significant milestone as it relates to achieving the full separation of Bausch + Lomb.
“We will continue to focus on the foundation we set across the enterprise to deliver results and improve the health of patients worldwide,” continued Mr. Appio.
Bausch Health (excl. B+L) R&D Update
Amiselimod (S1P modulator): once-daily oral treatment of mild to moderate ulcerative colitis
Positive top-line Phase 2 data results announced in December 2023
Selected for Podium Presentation at Digestive Disease Week 2024 Conference on May 19
Met with the U.S. Food and Drug Administration (“FDA”) for end of Phase 2 meeting and Phase 3 planning for mild to severe UC patients, with plans to meet with other international authorities
Advancing plans for Phase 2 study for Crohn's disease
RED-C: prevention and delay of first episode of hepatic encephalopathy
Enrollment of the second global Phase 3 trial completed in April 2024. Enrollment of both global Phase 3 studies are now complete and currently in the treatment phase
CABTREO®: first triple combination product for the treatment of acne vulgaris
U.S. commercial launch in late January 2024
New Drug Submission was submitted to Health Canada on May 30, 2023 with anticipated approval in the second half of 2024
Thermage® FLX: uses radiofrequency technology to help tighten and improve the smoothness and texture of the skin’s surface
Thermage® FLX and the TR-4 Return Pad approved by China’s National Medical Products Administration in January 2024
Clear + Brilliant® Touch: fractionated laser device for skin rejuvenation
Planned regulatory submissions on track for Europe, Canada, and Asia Pacific markets in 2024
Approved in Australia and New Zealand - first approvals outside of the U.S.
Next Generation Fraxel®: fractionated laser device for skin resurfacing
FDA submission planned in Q2 2024 and approval could occur in the second half of 2024
Xifaxan® Appeal Decision Reinforces the Company’s Salix Growth Strategy
On April 11, 2024, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware in the Norwich matter. In its ruling, the Court denied Norwich Pharmaceuticals, Inc.’s motion for modification of the court’s final order. As a result, the FDA cannot approve Norwich’s abbreviated new drug application for Xifaxan® (rifaximin) 550 mg until October 2029.
The Company will continue to vigorously defend its intellectual property.
LAVAL, Quebec, Apr. 11, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release first-quarter 2024 financial results on Thursday, May 2, 2024. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Thu, 11 Apr 2024 13:21:28 GMTLAVAL, Quebec, April 11, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. Court of Appeals for the Federal Circuit in the matter of Salix Pharmaceuticals, LTD. et al v. Norwich Pharmaceuticals, Inc., affirmed the May 17, 2023 decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals, Inc.’s motion for modification of the court’s final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 550 mg before Oct. 2, 2029. The Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of XIFAXAN® for treating IBS-D. As a result of the Federal Circuit’s decision, Norwich’s abbreviated new drug application for XIFAXAN (rifaximin) 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029.
“We are pleased that the Federal Circuit maintained the judgment preventing the approval of Norwich’s abbreviated new drug application for XIFAXAN (rifaximin) 550 mg by the U.S. Food and Drug Administration until October 2029,” said Thomas J. Appio, Chief Executive Officer. “While we are disappointed that the Federal Circuit affirmed the invalidity of certain XIFAXAN IBS-D patents and disagree with this aspect of the Court’s decision, we will continue to vigorously defend our intellectual property. We remain committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN, and we look forward to continuing to serve those patients.”
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company’s appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Thu, 11 Apr 2024 08:51:23 GMTLAVAL, QC, April 11 2024 - Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), today announced that its topical prescription treatment for acne vulgaris, PrARAZLOTM (tazarotene lotion, 0.045% w/w), is now available to patients through BC PharmaCare, the public drug program of British Columbia.
ARAZLO is the only tazarotene lotion treatment approved by Health Canada for the topical treatment of acne vulgaris in patients 10 years of age and older.1 The listing by BC PharmaCare means ARAZLO is now available to patients on all public drug plans across Canada.
"We are very pleased that British Columbia residents who rely on BC PharmaCare now have access to ARAZLO, a retinoid lotion with a unique vehicle technology for the treatment of acne vulgaris,” Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health said. “It is an important part of our large dermatology portfolio to help meet Canadians’ skin care needs.”
ARAZLO is the only tazarotene acne treatment available in a lotion formulated with PRISMATREXTM technology (formulation with known hydrating and moisturizing effects, which may alleviate dryness of skin).1 Retinoids like tazarotene are a core component of acne treatment. Providing the treatment in a lotion form helps limit the dryness and irritation that has historically been a barrier to the long-term use of tazarotene by patients.2
“The technology in ARAZLO lotion can help with patient tolerability of their acne treatment which can lead to better effectiveness and results for the patient, so it is very positive that ARAZLO is now available to patients through BC PharmaCare,” said Dr. Christina Han, a dermatologist practicing in Vancouver and Clinical Assistant Professor with the Department of Dermatology and Skin Science at the University of British Columbia. “In treating acne, it’s important to have a variety of treatment options to find the right one for each patient.”
Approximately 5.6 million Canadians are impacted by acne3 and often need to try different treatment options to find one that is effective for them.
"It's encouraging and useful for people with acne to have new treatment options available to them through our public drug plans as acne can have a negative impact on their lives," said Sue Sherlock, Executive Director of the Acne and Rosacea Society of Canada. "It is good news when a new treatment becomes accessible to everyone."
ARAZLO is produced by Bausch Health, Canada for Canadian patients and for export at the company’s manufacturing facility in Laval, Quebec.
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population and causes emotional distress and can cause permanent scarring1 or pigmentation
changes.4 Acne affects about 90 per cent of adolescents and about 25 per cent of teens will still have acne at age 25.3
About ARAZLO
ARAZLO tazarotene lotion, 0.045% w/w is a topical prescription indicated for the topical treatment of acne vulgaris. ARAZLO can be used on affected areas in patients 12 years and older and on affected areas of the face only of those aged 10 and 11. The safety and efficacy of ARAZLO in children below the age of 10 years has not been established.1
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, healthcare professionals, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
REFERENCES
PrARAZLO® (Tazarotene Lotion, 0.045% w/w) Product Monograph, July 7, 2021.
"Targeted Topical Delivery of Retinoids in the Management of Acne Vulgaris: Current Formulations and Novel Delivery Systems." Pharmaceutics. Gemma Latter et al, October 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6835300/, accessed Nov. 1, 2022.
]]>Fri, 05 Apr 2024 19:14:40 GMTLAVAL, QC, April 5, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) along with its gastroenterology business, Salix Pharmaceuticals, Inc., announced that it filed a lawsuit today in the United States District Court for the District of New Jersey against Amneal Pharmaceuticals of New York, LLC, Amneal EU, Limited, Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals Private Limited, and Amneal Pharmaceuticals, Inc. This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets. Amneal asserts that certain patents listed in the FDA’s Orange Book for XIFAXAN® are unenforceable, invalid, and/or not infringed by Amneal’s ANDA product. This action formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Amneal’s ANDA.
“Bausch Health remains confident in its XIFAXAN® intellectual property and we will continue to defend our XIFAXAN® franchise for the benefit of patients,” Thomas J. Appio, CEO, Bausch Health said. “As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies.”
Bausch Health has previously received Paragraph IV Certifications for XIFAXAN® (rifaximin) 550 mg tablets from Teva Pharmaceuticals, Sandoz Inc., Sun Pharmaceuticals and Norwich Pharmaceuticals. The Company has since settled the matters with Teva, Sandoz and Sun in September 2018, May 2020 and September 2020, respectively, while litigation with Norwich remains ongoing.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and
connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions, including statements about the Company’s actions and plans to vigorously defend its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or as to the outcome of any patent litigation. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>PrUCERIS® (budesonide) aerosol foam to help address the unmet need for the treatment of mild to moderate distal ulcerative colitis in adults ]]>Wed, 03 Apr 2024 09:59:34 GMTLAVAL, QC, April 3, 2024 - Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") today announced the first public drug plan listings for PrUCERIS® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.1
UCERIS is now available for patients through the public drug plans of five Canadian provinces: Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia.
These first public drug plan listings for UCERIS come following the signing of a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) early this year, setting out the parameters for listing of the treatment by the public drug plans of the provinces, territories and federal government.
“Bausch Health is very pleased that patients with distal ulcerative colitis in five provinces, including the two largest, will now have access to UCERIS and we look forward to the rapid completion of listing agreements with other public drug plans so more Canadians will have insured access to this new therapy,” said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. “We want to provide additional effective treatment options to Canadians.”
UCERIS, part of the Company’s growing gastrointestinal franchise, has been available in Canada by prescription since September 2023 and is covered by the majority of private insurance drug plans in Canada.
“Living with ulcerative colitis means experiencing painful, frequent bowel movements, which can also be bloody. Effective treatments for this chronic inflammatory bowel disease are vital to have any quality of life,” said Gail Attara, President and Chief Executive Officer of the Gastrointestinal Society, a patient group known by its badgut.org website. “We are pleased that public drug plans in Canada are starting to make the new ulcerative colitis treatment UCERIS available as a covered benefit and look forward to their example being followed by all drug insurance plans across Canada.”
UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.1 In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.2
Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.3 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).3
In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.1
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, healthcare professionals, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
LAVAL, QC / ACCESSWIRE / April 2, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today for IBS Awareness Month announced the results from the fourth edition of its annual survey of U.S adults living with irritable bowel syndrome (IBS) or chronic idiopathic constipation (CIC). Developed as a nationwide survey conducted in partnership with Fairleigh Dickinson University Poll (FDU Poll), more than 850 IBS/CIC patients were surveyed to better understand their experiences. The findings illustrate the current behaviors and experiences of the IBS and CIC patient population.
Notably, more than half of IBS/CIC patients surveyed said they feel alone in their experience and try to hide symptoms from family and friends. Additionally, 7 out of 10 respondents stated that their IBS symptoms cause them to skip events. Patients went on to reveal not only do they struggle to talk to their doctor about all of their symptoms, but also that their treatments often do not address the totality of those symptoms. The report unveiled trends related to social media too, suggesting it may bolster a sense of community and inspire more authentic conversations with their healthcare provider.
"For 35 years, we've been working to make a difference in the lives of millions of Americans living with GI disease," shares Nicola Kayel, Senior Vice President, Marketing, Salix. "Our fourth annual IBS Impact Report underscores our steadfast commitment to improving patient lives. The findings of this year's survey highlight the need for more authentic conversation around IBS experiences and impact on daily living. We are confident the findings will encourage more productive dialogue between healthcare providers and their patients, and also across social media platforms where patients can truly foster community."
Patient advocacy group, the International Foundation for Gastrointestinal Disorders (IFFGD), has been at the forefront of these patient conversations since its founding in 1991. President of IFFGD, Ceciel T. Rooker, stated "At IFFGD, we are committed to broadening patient understanding about GI disorders, like IBS, and insights such as those from the 2024 IBS Impact Report by Salix help us raise visibility of the patient experience and validate what we hear from patients firsthand. IBS symptoms change over time and are hard to talk about. The fact that most patients aren't addressing all of their symptoms with their healthcare provider emphasizes that there is work to be done to reduce stigma around this condition. We recommend patients find a healthcare provider that they feel comfortable being open with and that will work with them long-term to manage and treat their IBS."
Additional findings include:
94% of respondents find it helpful when healthcare providers post to social media and the vast majority (92%) say the content of these posts aligns with their understanding of IBS
Over 90% of IBS respondents find it informative when people post on social media about what they're going through; seeing posts about IBS helps to normalize it
8 out of 10 respondents think their healthcare providers make them feel comfortable discussing their symptoms, however, 88% typically focus on talking about their primary symptom
Approximately 8 out of 10 surveyed believe their healthcare providers make the best treatment choice for them, while about 2 out of 10 believe they do not
More specifically:
96% of IBS-C/CIC respondents want their healthcare provider to understand all the symptoms they are experiencing rather than just the primary one
More than three-quarters of IBS-C/CIC patients report their current treatment is not meeting all treatment goals, citing the top 3 unresolved symptoms as bloating, abdominal discomfort and stomach pain
95% of IBS-D respondents want their healthcare providers to ask about how their symptoms impact daily living
Roughly 3 in 4 IBS-D respondents report their current treatment was not meeting all treatment goals citing the top 2 unresolved symptoms as diarrhea and stomach pain
###
About the Methodology
The survey was conducted online in January 2024 in the U.S. by Fairleigh Dickinson University Polls on behalf of Salix Pharmaceuticals among 852 U.S. residents aged 18+, including 416 who have been diagnosed with IBS-C or CIC, and 436 who have been diagnosed with IBS-D. Respondents for this survey were selected from among those who have agreed to participate in our surveys. Respondents were compensated for their time up to $4.00. Due to the limitations of this survey, results may not be representative of everyone in the U.S. who have been diagnosed with IBS-C, CIC and/or IBS-D.
About FDU Poll
Since 2001, FDU Poll (a division of Fairleigh Dickinson University) has conducted survey research on issues of public importance. Utilizing best practices in survey methodology, the Poll produces research that is conducted nationally and statewide. Findings from FDU's surveys have been reported on numerous regional, national and international media outlets such as the New York Times, Washington Post, Wall Street Journal, Star-Ledger, as well as local and national broadcast media outlets. The FDU Poll is in the top tier of polls nationwide. Poll aggregator Five Thirty-Eight has released its new rankings of polls ranking FDU 31st in the country, out of more than 500.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Investor Contact:
Media Contact:
ir@bauschhealth.com (877) 281-6642
(toll-free)
Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785
]]>® (methylnaltrexone bromide: MNTX) in Patients with Resectable Head and Neck Squamous Cell Carcinoma ]]>Wed, 06 Mar 2024 10:01:53 GMTLAVAL, Quebec, March 6, 2024 –– Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to Bausch Health/Salix who assumes full responsibility for the study.
The clinical study is being led by Juan P. Cata, M.D. at The University of Texas MD Anderson Cancer Center. The trial is designed to evaluate the potential of treating oral cavity squamous cell carcinoma patients with MNTX. It is a prospective, nonrandomized pilot “proof of concept” study where patients receive subcutaneous MNTX two weeks preoperatively and two weeks postoperatively.
"The preclinical data and clinical suggestions point to potential activity against cancer,” Robert Israel, M.D., Senior Vice President, Clinical and Medical Affairs, said. “Having Dr. Cata study this drug in head and neck cancer will shed light on how and if this agent could be further developed as a potential treatment option in neoplastic disease."
Upon completion of the study, participants will be monitored every 3 months during the first two years. The primary endpoint is the successful administration of MNTX for two weeks preoperatively and postoperatively without interruption due to adverse events. Secondary endpoints include tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes. https://clinicaltrials.gov/ Identifier: NCT06162377.
About RELISTOR
RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
IMPORTANT SAFETY INFORMATION
RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their health care provider.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
In the clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer pain
RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).
OIC in adult patients with advanced illness
RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch
Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration, and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward- looking statements. These forward-looking statements speak only as of the date hereof.
Tue, 05 Mar 2024 14:09:35 GMTSalix Pharmaceuticals Releases Findings from First Colonoscopy Awareness Survey
LAVAL, Quebec, March 5, 2024 –– Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced findings from its first colonoscopy awareness and perspective survey conducted in partnership with The Harris Poll. Survey findings come in time for Colorectal Cancer Awareness Month and offer patient perspectives on colonoscopies and the preparation process.
The survey was conducted among 506 U.S. residents aged 45+, including 302 who have had a colonoscopy in the past 5 years and 204 who have not. Survey responses showed that preparing for the procedure is one of the barriers preventing people from getting a colonoscopy, specifically in those who have not had a colonoscopy in the last 5 years. Direct conversations and information about colonoscopy preparation may help overcome barriers as over half (58%) of adults aged 45 years and older who have had a colonoscopy in the last five years report wishing they had known more information before their first colonoscopy – including prep medication options and how to prepare for the procedure.
Additionally, the majority of adults 45 and older surveyed (78%) said they rely on their healthcare provider for information about colonoscopies and the process of colonoscopy preparation. Notably, nearly three quarters (73%) of all adults 45+ said their healthcare provider recommended they get a colonoscopy; however, about a third (34%) said their healthcare provider discussed the different colonoscopy prep medication options with them.
“The findings from this survey underscore the need for greater communication and knowledge-sharing between healthcare providers and their patients about the colonoscopy preparation process,” said Nicola Kayel, Senior Vice President, Marketing. “Colorectal cancer is the third most common cancer in the United States, and colonoscopy screening is a critical tool in helping detect colon cancer. These insights help us deliver on our goal to provide doctors with resources and solutions to address patient concerns.”
Additional survey findings include:
65% of adults 45+ who have had a colonoscopy in the last 5 years report preparing for the colonoscopy was worse than the actual procedure
When thinking about preparing for a colonoscopy, 30% of adults 45+ described themselves as feeling prepared and 58% reported having negative feelings about preparing for a colonoscopy
84% of all adults 45+ surveyed say the amount of colonoscopy prep medication liquid they have to consume is important or somewhat important to them
Additional omnibus research was conducted by The Harris Poll on behalf of Salix Pharmaceuticals among 2,058 adults ages 18 and older. This research found 77% of U.S. adults 18+ who have not had a colonoscopy in the past five years would like more information before having their first colonoscopy.
###
About the Methodology
The survey was conducted online from December 7-15, 2023 in the U.S. by The Harris Poll on behalf of Salix Pharmaceuticals among 506 U.S. residents aged 45+, including 302 who have had a colonoscopy in the past 5 years and 204 who have not. Respondents for this survey were selected from among those who have agreed to participate in The Harris Poll surveys. Additional omnibus research was conducted online from January 2-4, 2024 in the U.S. by The Harris Poll on behalf of Salix Pharmaceuticals among 2,058 adults ages 18 and older. No respondents received a cash incentive for their time. Due to the limitations of this survey, results may not be representative of everyone in the U.S. that has or has not gotten a colonoscopy.
About Harris Insights & Analytics
Since 1956, Harris Insights & Analytics’ The Harris Poll has conducted survey research on issues of public opinion, motivations and social sentiments. Partnering with media, nonprofits and universities to deepen their missions and work with businesses to transform their marketing, The Harris Poll is one of the longest running surveys in the U.S.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Fri, 01 Mar 2024 08:00:00 GMTLAVAL, Quebec, March 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced that members of company management will participate at the Cowen Annual Health Care Conference in Boston on March 5, 2024. The Bausch Health team will be hosting a fireside chat at 12:50 p.m. EST, and a live webcast will be accessible through the Investor Relations section of the Bausch Health website at https://ir.bauschhealth.com/. A replay of the webcast will be posted after the presentation and will be available for a limited time following the event.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn
Fourth-Quarter revenues of $2.41 billion, up 10% on a Reported basis and up 4% on an Organic1 basis
Full-Year revenues of $8.76 billion, up 8% on a Reported basis and 7% on an Organic1 basis
Full-Year revenue growth in Salix, International, Solta and Bausch + Lomb segments on both a Reported and Organic1 basis
GAAP Net Loss Attributable to Bausch Health Companies Inc. of $39 million for the quarter and
$592 million for the year
Adjusted EBITDA Attributable to Bausch Health Companies Inc.1 of $869 million for the quarter, up 6%, and $3.0 billion for the year, in line with prior year
LAVAL, QC, February 22, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" the "Company," "we" or "our") today announced its fourth-quarter and full-year 2023 financial results.
“I am pleased that we delivered against the financial guidance we established at the beginning of 2023. During the year, we made meaningful progress in driving performance across each of our business segments, continued to focus on our balance sheet and liquidity, and made significant progress on our key R&D initiatives, all helping to position the Company for continued growth and performance. We are excited about the positive momentum in our business as we enter 2024 and will continue to prioritize advancing our pipeline, investing in initiatives to continue to drive growth, and positioning the Company for long-term success,” said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Bausch Health (excl. B+L) R&D Update
Amiselimod (S1P modulator): once-daily oral treatment of mild to moderate ulcerative colitis
Phase 2 study completed enrollment in July 2023 and positive topline data results announced in December 2023
RED-C: prevention and delay of first episode of hepatic encephalopathy
Enrollment of one of two global Phase 3 trials completed, with enrollment of the second trial on track and expected to be completed in the first half of 2024
CABTREOTM: first triple combination product for the treatment of acne vulgaris
Received FDA approval on October 20, 2023
U.S. commercial launch occurred the week of January 29, 2024
New Drug Submission was submitted to Health Canada on May 30, 2023
Thermage®FLX: uses radiofrequency technology to help tighten and improve the smoothness and texture of the skin’s surface
Thermage® FLX and the TR-4 Return Pad approved by China’s National Medical Products Administration in January 2024
Clear + Brilliant®Touch: fractionated laser device for skin rejuvenation
Planned regulatory submissions on track for Europe, Canada, and Asia Pacific markets in 2024
Next Generation Fraxel®: fractionated laser device for skin resurfacing
FDA submission planned in Q2 2024 and approval could occur in the second half of 2024
Fourth-Quarter and Full-Year 2023 Revenue Performance
Total reported revenues were $2.41 billion for the fourth quarter of 2023, compared with $2.19 billion in the fourth quarter of 2022, an increase of $215 million, or 10%. Excluding the favorable impact of foreign exchange totaling $6 million and the impact of acquisitions of $122 million, revenue increased by 4% organically1 compared with the fourth quarter of 2022.
Total reported revenues were $8.76 billion for the full year of 2023, compared with $8.12 billion in the full year of 2022, an increase of $633 million, or 8%. Excluding the unfavorable impact of foreign exchange of $45 million and the impact of acquisitions of $141 million, revenue increased organically1 by 7% compared with the full year of 2022.
]]>Mon, 12 Feb 2024 08:44:54 GMTSalix to Provide Scholarships to 10 Students Living with GI Diseases
LAVAL, Quebec, Feb. 12, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the opening of the 2024 Salix Gastrointestinal Health Scholars Program application period. The program will award 10 exceptional students living with GI disease a scholarship of up to $10,000 as they work to pursue their higher education goals.
“The Salix Gastrointestinal Health Scholars is proud to be able to provide financial support to students who continue to persevere through their GI diseases and disorders while still exceling in their academic achievements. We are determined to make a difference in the lives of the communities we serve by continuing to provide financial support and alleviate some of the burden,” said Nicola Kayel, Senior Vice President, Marketing, Salix.
Students can apply for this scholarship by completing the online application, submitting letters of reference, and writing an essay on the impact having a diagnosed GI condition has had on their life and the role that a health care provider played in helping to manage their condition. Scholarships are offered to school applicants or current attendees of a two- or four-year college, university, or an advanced
(post-high school) vocational or technical school for the 2024-2025 academic year and are available in four categories:
Undergraduate Scholar Awards for students pursuing undergraduate degrees
Graduate Scholar Awards for students pursuing graduate degrees
Working Parent's Scholar Award for students who are parents pursuing undergraduate, vocational/technical or graduate degrees
Single Parent's Scholar Award for students who are single parents pursuing undergraduate, vocational/technical, or graduate degrees
The application period for the Salix Gastrointestinal Health Scholars Program will close on May 6, 2024, and scholarship recipients will be notified in the summer of 2024. To learn more about the scholarship, including eligibility criteria, terms and conditions, please visit www.salix.com/scholarship.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn. ]]>Thu, 01 Feb 2024 08:01:00 GMTLAVAL, Quebec, Feb. 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced, as part of its ongoing commitment to board refreshment and board diversity, its nomination of two independent and diverse candidates to stand for election to its Board of Directors at the Company’s 2024 Annual Meeting of Shareholders: Christian A. Garcia, Former Executive Vice President and Chief Financial Officer of BrandSafway Industries, LLC, and Frank D. Lee, Chief Executive Officer of Pacira Biosciences, Inc.
In addition, Russel C. Robertson and Thomas W. Ross, Sr. will be retiring from the Board and will not stand for re-election at the Company’s 2024 Annual Meeting. They will, however, continue to serve on the Board of Bausch + Lomb Corporation. Messrs. Robertson and Ross have served as members of the Board since 2016. To fill the resulting committee vacancies, subject to the election of Messrs. Garcia and Lee to the Board, the Company expects that Mr. Garcia will serve as the Audit and Risk Committee chair and Mr. Lee will serve on the Talent and Compensation Committee. Mr. Lee is also expected to serve on the Science and Technology Committee.
“The nomination of these two new independent directors demonstrates Bausch Health’s ongoing commitment to refreshment, excellence and board diversity,” John A. Paulson, Chairperson of the Bausch Health Board, said. “Additionally, I want to thank Russ and Tom, two long-term, valued members of our Board, who helped navigate the Company through periods of significant change. Their service to the Company has been greatly appreciated.”
Bausch Health’s 2024 Annual Meeting has not yet been scheduled. Additional information regarding Messrs. Garcia and Lee, as well as the Company’s other director nominees, will be included in the Company’s proxy statement for its 2024 Annual Meeting, when available.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Thu, 01 Feb 2024 08:00:00 GMT.Feb {background-color: white}
LAVAL, Quebec, Feb. 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release fourth-
quarter and full-year 2023 financial results on Thursday, Feb. 22, 2024. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>TM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris Now Available in the U.S. ]]>Tue, 30 Jan 2024 12:10:18 GMTLAVAL, Quebec, Jan. 30, 2024 -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, today announced the U.S. launch of CABTREO™ (clindamycin, adapalene, benzoyl peroxide) Topical Gel, 1.2%/0.15%/3.1% indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
"With today’s launch of CABTREO, millions of Americans who suffer from acne each year have access to a new once-daily triple-combination topical acne treatment,” Thomas J. Appio, Chief Executive Officer, said. “In many instances, acne treatment requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen.”
CABTREO Topical Gel is the first and only U.S. Food and Drug Administration-approved fixed-dose, once- daily triple-combination topical treatment for acne and offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment.
The FDA approved CABTREO Topical Gel on Oct. 20, 2023, based on data from two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated CABTREO Topical Gel resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. At week 12, 50.0% of participants achieved treatment success with CABTREO versus 22.6% with vehicle gel (P<0.001). CABTREO resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9%% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P<0.001, both).
The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.
About Acne Vulgaris
Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2
What is CABTREO?
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina.
IMPORTANT SAFETY INFORMATION
Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn’s disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use.
Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin.
What should I avoid while using CABTREO?
Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight.
Cold weather and wind may irritate skin treated with CABTREO.
Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema.
Avoid skin products that may dry or irritate your skin.
Avoid the use of “waxing” as a hair removal method on skin treated with CABTREO.
What are the possible serious and most common side effects of CABTREO?
Tell your doctor right away if you experience side effects, including:
Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded.
Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO.
Sensitivity to sunlight. See “What should I avoid while using CABTREO”.
Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling.
These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch
Please click here for full Prescribing Information, Patient Information and Instructions for Use.
About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at
https://www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international
pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
References
American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from
]]>Thu, 18 Jan 2024 08:40:50 GMTApproval Represents an Important Breakthrough in One of the Largest Medical Aesthetics Markets
LAVAL, Quebec, January 18, 2024 -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and Solta Medical, a global leader in the medical aesthetics market, today announced the approval of Thermage® FLX and the TR-4 Return Pad by China’s National Medical Products Administration (NMPA). The TR-4 Return Pad is approved for use by the U.S. Food & Drug Administration (as part of the Thermage FLX device registration)
"The approval of Thermage FLX, and the TR-4 return pad, marks a significant milestone for Solta Medical,” Thomas J. Appio, Bausch Health Chief Executive Officer, said. “Not only is this important for growing our business, but it also represents an enormous achievement for our R&D and Regulatory Teams, who worked tirelessly with the NMPA.”
Thermage is a non-invasive treatment that uses radiofrequency technology to help tighten and improve the smoothness and texture of the skin’s surface to optimize a patient’s appearance. Thermage is a versatile and effective treatment that can be used on all skin types and genders, on a wide range of areas on the face, body and around the eyes. Globally, more than two million Thermage treatments have been performed.
"The approval from NMPA means we are able to continue the momentum of the growth of Thermage in China,” Jiny Kim, Senior Vice President, Solta Medical, said. "Building on the legacy of Thermage CPT, which has been serving Chinese institutions and consumers effectively since 2015, we look forward to delivering the Thermage FLX proven technology to the Chinese market."
Indications
The radiofrequency energy only delivery components of the Thermage® CPT and FLX system and accessories are indicated for use in:
Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
Non-invasive treatment of wrinkles
The simultaneous application of radiofrequency energy and skin vibration by the Thermage® CPT and FLX system and accessories are indicated for use in:
Non-invasive treatment of wrinkles around the eye
Non-invasive treatment of wrinkles
Temporary improvement in the appearance of cellulite
Important Safety Information
Do not undergo Thermage treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator, or any other electrical implant. Let your doctor know if you have an electrical implant or if you have any questions about whether you should undergo a Thermage® treatment.
Solta Medical has not studied the use of the Thermage system:
Over skin fillers (lips, cheeks, facial wrinkles and skin folds)
In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy
In people who have permanent make-up and/or tattoos
In children
The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated.
The most commonly reported adverse effects after treatment include the following:
Mild redness may occur and typically resolves within 24 hours.
Swelling may occur and typically resolves within 5 days but can remain up to several weeks.
The following adverse effects occur infrequently:
The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation.
Skin surface irregularities may appear up to 1 or more months post-treatment.
Numbness, tingling” or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks.
Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications.
Skin may darken, but normally resolves within several months.
Ask your doctor for more information about Thermage FLX and see www.thermage.com for additional details.
About Solta Medical
Solta Medical, a business unit of Bausch Health, is a global leader in the medical aesthetics market. Our vision at Solta is to develop and support trusted aesthetic brands that provide value to our customers and their patients. The Thermage® RF systems, Fraxel® laser, Clear + Brilliant® laser, and VASER® ultrasonic system provide exceptional results for patients and lasting growth to physicians due to our foundation of brands that have stood the test of time. More than five million procedures have been performed with Solta Medical's portfolio of products around the world. More information can be found at www.solta.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the expected results of, and market for, the Company’s Thermage® treatment. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
###
]]>Mon, 08 Jan 2024 11:45:58 GMTLAVAL, Quebec, January 8, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, as scheduled, oral arguments were heard today at the U.S. Court of Appeals for the Federal Circuit (the “Court”) in the matter of Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc. As expected, no ruling was issued by the Court following these oral arguments.
“We were pleased to have had the opportunity to present our oral arguments to the Court of Appeals today,” Thomas J. Appio, Chief Executive Officer, said. “We look forward to the Court’s decision in due course. We will continue to advocate for the safety of patients who have benefited from continued access to XIFAXAN, and look forward to continuing to serve those patients.”
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company’s appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Thu, 21 Dec 2023 07:24:11 GMTTrial Meets Both Primary and Key Secondary Endpoints
LAVAL, Quebec, December 21, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") today announced positive topline results from the Company’s Phase 2 study evaluating Amiselimod, an investigative S1P antagonist, for the treatment of ulcerative colitis (UC).
“We are thrilled with these impressive topline results, and believe that this could offer a much needed improvement in therapy available for patients with ulcerative colitis,” said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Amiselimod met the primary and key secondary endpoints including clinical and endoscopic measures in the double-blind period of the study; the open-label extension up to 52 weeks is currently ongoing. Efficacy results were similar for both dose groups (0.2 mg QD and 0.4 mg QD).
The topline results for the key endpoints were as follows:
The primary endpoint, mean change in modified Mayo Score at Day 85 (-2.3) versus placebo (-1.6), (p = 0.002).
32.4% of patients on Amiselimod achieved clinical remission, compared to 17.8% on placebo, (p=0.007)
42.7% of patients on Amiselimod achieved endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 23.4% on placebo, (p<0.001).
Amiselimod was well-tolerated, with no unexpected adverse events; coupled with the previous thorough QT study, this indicates that Amiselimod has a favorable safety profile. The full data set from this trial will be available early next year.
Bausch Health’s Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to- moderately active UC.
“Our R&D team will be presenting detailed results at upcoming medical conferences, and we plan to meet with regulatory agencies to advance the program into Phase 3,” said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D, Bausch Health.
About Amiselimod
Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1, S1P4 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.
3
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn.
Forward-looking Statements
This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, “forward-looking statements”), including, but not limited to, statements relating to the Company’s ongoing research and development efforts. Forward-looking statements may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” "estimates,” “potential,” “target,” or “continue” and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward- looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company’s most recent annual and quarterly reports and detailed from time to time in the Company’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company’s filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward- looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
REFERENCES
1. Kunio Sugahara, Yasuhiro Maeda. Amiselimod, a novel sphingosine 1‐phosphate receptor‐1 modulator, has potent therapeutic efficacy for autoimmune diseases, with low bradycardia risk. British Journal of Pharmacology. January 2017.
2. Peyrin-Biroulet, Ronald Christopher Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmunity Reviews. February 2017.
3. BiseraStepanovska,AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019.
]]>Mon, 18 Dec 2023 10:21:00 GMTLAVAL, QC, December 18, 2023 - Bausch Health, Canada, part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") today announced that DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene), the company’s novel topical prescription drug for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe disease,1 is now available to patients enrolled in Quebec’s public drug plan operated by the Régie de l’assurance maladie du Québec (RAMQ).
DUOBRII is already available as a benefit on most other public drug plans in the rest of Canada, including the federal government’s Non-Insured Health Benefits (NIHB) program, as well as most private drug insurance plans.
"It is very good news for Quebecers with plaque psoriasis to have a new topical treatment option available to them through the Quebec public drug plan," said Dr. Steve Mathieu, a dermatologist at Hôpital Saint-Sacrement in Quebec City. "DUOBRII is a combination treatment for people with moderate to severe plaque psoriasis so it is a valuable new addition to our treatment options."
DUOBRII is manufactured for distribution throughout Canada and the United States at the Company's Quebec manufacturing facility in Laval. It has been available in Canada by prescription since August 2020.
“Bausch Health, Canada is very pleased that DUOBRII is now available to public drug plan beneficiaries in Quebec so they will be able to benefit from this innovative therapy for plaque psoriasis that is manufactured right here in Quebec,” said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. “We want to help Quebecers with moderate to severe plaque psoriasis to achieve their goal of a clear skin.”
About DUOBRII
DUOBRII works in a unique way by combining halobetasol propionate, which reduces inflammation, and tazarotene that contributes to the normalization of skin cell growth.
These well-known ingredients have long-established efficacy profiles. When halobetasol propionate and tazarotene are administered together in DUOBRII, they provide complementary effects due to their individual modes of action targeting different receptors and pathways to achieve anti-inflammatory control and epidermal morphologic restoration. The improvement that is seen in psoriatic patients appears to occur in association with the restoration of normal cutaneous morphology and the reduction of the inflammatory markers ICAM-1 and HLA-DR.2
DUOBRII is also distinct based on its Prismatrex™ technology, a polymeric emulsification system which provides a stable condition where emulsion droplets retained their distribution across time and temperature.3
About Psoriasis
Psoriasis is a common, chronic and life-altering skin disease that affects approximately one million Canadians, with 90% of those affected suffering from plaque psoriasis.4
Plaque psoriasis disease is characterized by red elevated patches and flaking silvery scales, and symptoms can range from mild to severe. While the plaques can appear anywhere on the body, the most common places include the elbows, knees, scalp, chest and lower back.
Because the disease typically affects visible parts of the body, the impact on patients extends well beyond the physical symptoms. Psoriasis can impact nearly every aspect of an individual's life including their ability to work and maintain social and intimate relationships. In addition to the tremendous medical burden experienced while trying to find a medication that controls the disease, the psychological impact is high. Approximately 70 per cent of individuals suffer from low self-confidence and approximately 50 percent of patients experience anxiety, and depression, respectively.5
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn.
Bausch Health, Canada Inc.’s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca
]]>Tue, 05 Dec 2023 10:21:47 GMTBridgewater, N.J., Dec. 5, 2023 – Salix Pharmaceuticals, the gastroenterology division of Bausch Health Companies Inc. (NYSE/TSX: BHC), The U.S. Pain Foundation (USPF), and The International Foundation for Gastrointestinal Disorders (IFFGD) today announced they are joining forces to declare Tuesday, Dec. 5, Opioid-Induced Constipation (OIC) Awareness Day. OIC Awareness Day aims to bring awareness to an often-overlooked side effect of opioids. This day will help patients suffering from OIC by breaking down the stigma and silence surrounding this condition.
“OIC Awareness Day will help bridge the gap between healthcare providers (HCPs), patients, and caregivers by providing them with the information needed to guide conversations about symptoms and management strategies,” said Megan Filoramo, RN, MSN, APN-C. “I’m excited to be a part of this awareness initiative and help shed light on this underdiagnosed patient population.”
The first annual OIC Awareness Day will provide a platform for patients, caregivers, and HCPs to discuss this condition and encourage them to join the #OICAwarenessDay movement.
“As an organization committed to helping individuals living with chronic pain, we understand the challenges individuals living with OIC experience," said Nicole Hemmenway, CEO of the U.S. Pain Foundation. "We are passionate about awareness and education that empowers those impacted by OIC to feel comfortable having a conversation with their HCP."
More than 20 percent of American adults experience chronic pain and utilize prescribed medications, such as opioids, to help manage their conditions. These opioids can cause debilitating side effects including OIC, a specific type of constipation, and one of the most common side effects of opioid use.
“For over three decades, IFFGD has championed the need for research to enhance the management options available for patients with gastrointestinal (GI) disorders such as OIC,” said Ceciel Rooker, President and Executive Director of IFFGD. “The symptoms, burdens, and challenges that many face while living with OIC can be debilitating, and their voices must be heard.”
The first annual OIC Awareness Day will kick off with a proclamation in Bridgewater, NJ – the town where Salix is headquartered. Dec. 5 is now also officially recognized as OIC Awareness Day in the National Day Archives. A new website, OICAwarenessDay.com, was created to provide information and resources to HCPs, patients, and caregivers about the causes, symptoms, and management of OIC. Salix also partnered with influencers to share online about the movement using the hashtag #vOICesOfOIC.
For more information on OIC and to learn how you can join the #OICAwarenessDay movement, please visit www.OICAwarenessDay.com
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter (X) and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn.
About U.S. Pain Foundation
The U.S. Pain Foundation is a 501(c)(3) nonprofit with a mission to empower, educate, connect, and advocate for individuals living with chronic illnesses and serious injuries that cause pain, as well as their care partners and clinicians. Through its multiple programs and services, the organization works to elevate the patient voice, increase disease-state education, improve pain care through policy change, expand outreach to underserved and marginalized communities, and provide comprehensive resources to ensure individuals are supported and empowered along their journeys. Learn more at uspainfoundation.org.
About The International Foundation for Gastrointestinal Disorders
The International Foundation for Gastrointestinal Disorders (IFFGD) is a nonprofit education and research organization dedicated to improving the lives of people affected by chronic gastrointestinal illnesses. Founded in 1991, IFFGD helps improve patient outcomes by enhancing awareness, improving education, and supporting and encouraging research into treatments and cures for chronic digestive disorders.
]]>Fri, 10 Nov 2023 09:14:21 GMTLack of OHE-specific diagnostic code in hospitals may increase risk of additional cost, length of hospitalization and additional burdens for patients compared to those with a previous primary OHE diagnosis
LAVAL, Quebec, November 10, 2023 –– Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced findings from a descriptive analysis of a hospital database (October 2015-June 2022) showing that the absence of an overt hepatic encephalopathy-specific diagnosis code may have resulted in increased OHE-related length of stay (LOS) and hospitalization-related costs due to OHE rate underestimation. The analysis of hospital data showed that OHE hospitalizations identified using in-hospital Xifaxan® (rifaximin) or lactulose use combined with a diagnosis for altered mental status, unspecified encephalopathy, or cirrhosis, had a mean hospital billing charge 2.5 times higher and mean length of stay (LOS) 2.0 times longer than solely relying on OHE as a primary diagnosis. Findings from the analysis, “Systematic undercounting of overt hepatic encephalopathy hospitalizations identified by using hospital-administered medication data,” will be presented during the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting.
“OHE is a serious complication of hepatic impairment and the absence of an OHE-specific ICD-10 code often led to underestimation of hospitalizations and overall economic burden of OHE. Findings from this analysis of hospital databases indicate that an OHE event identified using in-hospital rifaximin or lactulose in conjunction with diagnosis codes for altered mental status, unspecified encephalopathy, or cirrhosis, rather than solely relying on OHE as a primary diagnosis code only, was costlier and associated with a longer length of hospital stay. This analysis highlights that the absence of a specific ICD-10 code may lead to potential underestimation of the burden of OHE.” said Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell in New York who led the analysis.
This analysis identified OHE hospitalizations using two definitions: OHE as a primary diagnosis (definition 1), or in-hospital rifaximin or lactulose use combined with a diagnosis for altered mental status, unspecified encephalopathy, or cirrhosis (definition 2). There were approximately 3.0 times additional OHE hospitalizations identified based on definition 2 (N=99,217) compared to definition 1 (N=33,127). OHE hospitalizations based on definition 2 had a mean hospital billing charge 2.5 times higher ($139,870 vs $56,648) and a mean LOS 2.0 times longer (10.4 days vs 5.2 days) than those based on definition 1. Patients admitted to the hospital under definition 2 received in-hospital first dose treatment with rifaximin within an average of 2.6 days, compared to patients admitted under definition 1 who received treatment within an average of 0.7 days. Findings from this study highlight that the burden of OHE (rate, length of stay and associated costs) has been likely underestimated.
“At Salix, our priority is improving the patient journey by ensuring patients receive the critical medicines they may need,” said Nicola Kayel, Senior Vice President, Marketing, Salix. “By increasing awareness of OHE, more patients will avoid the unnecessary burdens of increased hospital-related costs and length of stays. We hope the recent implementation of K76.82 as an OHE-specific ICD-10 code will ensure a clearer identification of patients in order to reduce these burdens on patients and allow them to receive the proper care they need.”
OHE hospitalizations were identified in the PINC AI™ Healthcare Database (PHD; 2015–2022) with 33,127 patients being treated for OHE versus 99,217 OHE hospitalizations classified as in-hospital rifaximin/lactulose use combined with a diagnosis for altered mental status, unspecified encephalopathy, or cirrhosis. Hospitalizations with a diagnosis for other rifaximin indications were excluded.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Wed, 08 Nov 2023 09:08:25 GMTCompany Introduces Multimedia Resources to Bring Awareness of SAD
LAVAL, QC, November 8, 2023 – As daylight saving time concluded for much of the US on November 5, and as the seasons change and the days grow shorter, many people may find themselves grappling with the onset symptoms of seasonal affective disorder (SAD). SAD is a type of depression that follows a seasonal pattern and most often occurs with the change to the fall-winter season. Bausch Health Companies Inc. (NYSE/TSX: BHC), a global diversified pharmaceutical company dedicated to advancing global health, is helping to raise awareness about the importance of SAD symptom recognition and dialogue with a healthcare professional.
Specifically, Bausch Health has introduced several comprehensive initiatives to raise awareness for SAD symptoms and prevention, including a national television ad for its antidepressant APLENZIN® (bupropion hydrobromide) extended-release tablets, the only FDA-approved bupropion hydrobromide that is indicated for the prevention of SAD. The campaign is designed to inform individuals about SAD symptoms during the autumn and winter months and to encourage people diagnosed with SAD to engage in a dialogue with a healthcare professional about potential prevention and treatment- related strategies as needed.
“SAD is a seasonal type of depression that manifests itself in the fall and winter months. When there’s less sunlight outside, a person’s natural ability to regulate certain chemicals can be disrupted which may impact depression,” said Eric Guenin, PharmD, Ph.D., MPH, executive director, medical affairs, Bausch Health. “Prevention is key, when possible, so people must be aware of some of the symptoms of SAD, such as feeling depressed most of the day almost every day, losing interest in activities they once enjoyed, experiencing low energy, facing difficulty sleeping, weight changes, and be encouraged to discuss them with a healthcare professional as preventive treatment options exist.”
In addition to the ad campaign, there is a revamped APLENZIN website, which features a SAD fact sheet as well as a new patient engagement program called “Real Talk with APLENZIN” that provides subscribers with helpful tools and support. The site also includes a downloadable health questionnaire and “mood tracker” that provides patients practical tools to share and discuss with a healthcare professional, who can determine if there is a seasonal pattern to their symptoms. To learn more about APLENZIN please see Important Safety Information including boxed warning below and visit www.APLENZIN.com.
About SAD
SAD is a type of depression that follows a seasonal pattern. Symptoms often occur during the fall and winter months. SAD is more than the “winter blues,” it is a serious mental health condition. When there’s less sunlight outside, a person’s natural ability to regulate certain chemicals can be disrupted which may impact depression. And that may lead to symptoms of SAD. The seasonal symptoms of SAD can include but are not limited to feeling depressed most of the day, nearly every day; losing interest in activities you once enjoyed; feeling hopeless or worthless; withdrawing socially; overeating, particularly craving carbohydrates; weight gain; and oversleeping.
About APLENZIN
APLENZIN (bupropion hydrobromide) is an antidepressant indicated for the treatment of major depressive disorder and prevention of SAD. APLENZIN is the only FDA- approved bupropion hydrobromide and offers extensive clinical experience in patients with MDD or SAD. APLENZIN is a once-daily, single tablet available in 3 dosage strengths, with no generic substitute. Recommended dosing for patients with SAD includes initiating treatment in the fall and discontinuing in early spring, as prescribed by a healthcare professional. For more information, visit www.APLENZIN.com.
INDICATION
APLENZIN® (bupropion hydrobromide extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).
IMPORTANT SAFETY INFORMATION
WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS
Suicidal Thoughts or Actions and Antidepressant Drugs
Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. APLENZIN has not been evaluated for use in patients under the age of 18.
Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking.
Some people have had serious side effects while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
Stop taking APLENZIN and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take APLENZIN. In many people, these symptoms went away after stopping APLENZIN, but in some people, symptoms continued after stopping APLENZIN. It is important for you to follow-up with your healthcare provider until your symptoms go away.
Before taking APLENZIN, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.
What Other Important Information Should I Know About APLENZIN?
Seizures: There is a chance of having a seizure (convulsion, fit) with APLENZIN, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking APLENZIN unless your healthcare provider has said it is okay to take them. If you have a seizure while taking APLENZIN, stop taking the tablets and call your healthcare provider right away.
High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking APLENZIN.
Manic episodes: Some people may have periods of mania while taking APLENZIN. If you have any of the following symptoms of mania, call your healthcare provider:
greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual
Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking APLENZIN, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take APLENZIN. You should see an eye doctor to determine whether you are at risk prior to starting therapy.
Severe allergic reactions: Some patients have severe allergic reactions to APLENZIN. Stop taking APLENZIN and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
Do not take APLENZIN if you:
have or had a seizure disorder or epilepsy
have or had an eating disorder such as anorexia nervosa or bulimia
are taking any other medicines that contain bupropion, including WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in APLENZIN
drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
do not take an MAOI within 2 weeks of stopping APLENZIN unless directed to do so by your healthcare provider
do not start APLENZIN if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider
are allergic to the active ingredient in APLENZIN, bupropion, or to any of the inactive ingredients
Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking APLENZIN, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you:
have liver problems, especially cirrhosis of the liver
have kidney problems
have, or have had, an eating disorder such as anorexia nervosa or bulimia
have had a head injury
have had a seizure (convulsion, fit)
have a tumor in your nervous system (brain or spine)
have had a heart attack, heart problems, or high blood pressure
are a diabetic taking insulin or other medicines to control your blood sugar
drink alcohol
abuse prescription medicines or street drugs
are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take APLENZIN during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185
are breastfeeding. APLENZIN passes into your milk in small amounts
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using APLENZIN.
The most common side effects of APLENZIN include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
Click here to read the Medication Guide carefully before you start using APLENZIN. If you have any questions about APLENZIN, ask your healthcare provider or pharmacist.
Click herefor full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchor call 1-800-FDA-1088. You may also contact Bausch Health Customer Service at 1-800-321-4576.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
References
Hansen BT, et al. Daylight Savings Time Transitions and the Incidence Rate of Unipolar Depressive Episodes. Epidemiology. 2017;28(3):346-353.
Revenue of $2.24 billion, up 9% on both a Reported and Organic1 basis
Year-over-year revenue growth in all segments on both a Reported and Organic Basis
GAAP Net Loss Attributable to Bausch Health Companies Inc. of $378 Million
Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $830 Million, up 8%
Provides updated full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance
Received U.S. Food and Drug Administration ("FDA") approval for CABTREOTM (IDP-126), the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne
LAVAL, QC, November 2, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its third-quarter 2023 financial results and other key updates from the quarter.
"We are pleased with our solid third-quarter performance, as each of our business segments posted year- over-year revenue growth on both a reported and organic basis. We remain focused on advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
Bausch Health (excl. B+L) R&D Update
RED-C: prevention and delay of first episode of hepatic encephalopathy
Enrollment of two global Phase 3 trials on track and expected to be completed in Q1 2024
Amiselimod (S1P modulator): treatment of mild to moderate Ulcerative Colitis
Phase 2 study completed enrollment in July 2023 and induction portion of the study is expected to be completed in Q4 2023
CABTREOTM: first triple combination product for the treatment of acne vulgaris
Received FDA approval on October 20, 2023
Commercial launch expected in Q1 2024
New Drug Submission was submitted to Health Canada on May 30, 2023
Clear + Brilliant® Touch: fractionated laser device for skin rejuvenation
Planned regulatory submissions on track for Europe, Canada, and Asia Pacific markets in 2024
Next Generation Fraxel®: fractionated laser device for skin resurfacing
FDA submission planned in Q1 2024 and approval is expected 1H 2024
Third Quarter 2023 Revenue Performance
Total reported revenues were $2.24 billion for the third quarter of 2023, compared with $2.05 billion in the third quarter of 2022, an increase of $192 million, or 9%. Excluding the impact of foreign exchange of $6 million and acquisitions, divestitures, and discontinuations of $19 million, revenue increased by 9% organically1 compared with the third quarter of 2022.
]]>Wed, 01 Nov 2023 15:02:27 GMTLAVAL, Quebec, November 1, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced that the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Becerra, et al. (Case No. 23-cv- 01611), denied Norwich Pharmaceuticals, Inc.’s (Norwich) motion in their lawsuit against the U.S. Food and Drug Administration (FDA). Norwich had asked the District Court to direct the FDA to immediately grant Final Approval to Norwich’s Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg.
Today, the District Court denied Norwich’s motion and granted summary judgment in favor of the FDA and Salix.
The Company is pleased with this outcome at the District Court. Its appeal of the final judgment in the matter of Salix Pharmaceuticals, Ltd. et al. v. Norwich Pharmaceuticals, Inc. (Case No. No. 22-2153) remains pending at the U.S. Court of Appeals for the Federal Circuit. The Company expects a decision on the appeal from the Federal Circuit in Q1 2024.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company’s appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Wed, 25 Oct 2023 17:42:00 GMTFirst-Ever Television Ad Campaign for APLENZIN® (bupropion hydrobromide) Airs in October
LAVAL, QC, October 25, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the new release of “Looking Forward,” the television ad campaign for APLENZIN® (bupropion hydrobromide) extended-release tablets for individuals diagnosed with seasonal
affective disorder (SAD), a type of depression that follows a seasonal pattern. This represents the first-ever television commercial for a prescription medication indicated for the prevention of autumn-winter SAD. The ad is scheduled to run on connected TV including mid-October and throughout the winter months when SAD symptoms are most prevalent.
The product commercial, available to view here, aims to illuminate the seasonality of SAD symptoms, which present themselves with the changing seasons. The new campaign will be available on multiple platforms.
“Our creative approach for ‘Looking Forward’ is inspired by consumer research that suggests many people experiencing SAD symptoms frequently endure symptoms without seeking appropriate medical intervention from their healthcare professional,” said Jeff Hartness, executive vice president, Market Access, Commercial Operations, Neurology/Diversified, Bausch Health. “With this in mind, we created a campaign designed to help people understand SAD symptoms during the autumn and winter months and foster a dialogue with their healthcare professional about treatment options that may help prevent SAD.”
In addition to the television campaign, Bausch Health updated the APLENZIN product website which now features a patient engagement campaign called “Real Talk” that provides subscribers with helpful tools and support, as well as a downloadable questionnaire, SAD fact sheet, mood tracker and health questionnaire to help patients start a conversation with their healthcare professional. To learn more about APLENZIN, please see the Important Safety Information including boxed warning below, visit www.APLENZIN.com and speak with your healthcare provider.
About SAD
SAD is a type of depression that follows a seasonal pattern. Symptoms often occur during the fall and winter months. SAD is more than the “winter blues,” it is a serious mental health condition. When there’s less sunlight outside, a person’s natural ability to regulate certain chemicals, can be disrupted which may impact depression. And that may lead to symptoms of SAD. The seasonal symptoms of SAD can include but are not limited to feeling depressed most of the day, nearly every day; losing interest in activities you once enjoyed; feeling hopeless or worthless; withdrawing socially; overeating, particularly craving carbohydrates; weight gain; and oversleeping.
About APLENZIN
APLENZIN (bupropion hydrobromide) is an antidepressant indicated for the treatment of major depressive disorder and prevention of SAD. APLENZIN is the only FDA-approved bupropion hydrobromide and offers extensive clinical experience in patients with MDD or SAD. APLENZIN is a once-daily, single tablet available in 3 dosage strengths, with no generic substitute. Recommended dosing for patients with SAD includes initiating treatment in the fall and discontinuing in early spring, as prescribed by a healthcare professional. For more information, visit www.APLENZIN.com.
INDICATION
APLENZIN® (bupropion hydrobromide extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).
IMPORTANT SAFETY INFORMATION
WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS Suicidal Thoughts or Actions and Antidepressant Drugs Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. APLENZIN has not been evaluated for use in patients under the age of 18.
Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking.
Some people have had serious side effects while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
Stop taking APLENZIN and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take APLENZIN. In many people, these symptoms went away after stopping APLENZIN, but in some people, symptoms continued after stopping APLENZIN. It is important for you to follow-up with your healthcare provider until your symptoms go away.
Before taking APLENZIN, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.
What Other Important Information Should I Know About APLENZIN?
Seizures: There is a chance of having a seizure (convulsion, fit) with APLENZIN, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking APLENZIN unless your healthcare provider has said it is okay to take them. If you have a seizure while taking APLENZIN, stop taking the tablets and call your healthcare provider right away.
High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking APLENZIN.
Manic episodes: Some people may have periods of mania while taking APLENZIN. If you have any of the following symptoms of mania, call your healthcare provider:
greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual
Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking APLENZIN, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take APLENZIN. You should see an eye doctor to determine whether you are at risk prior to starting therapy.
Severe allergic reactions: Some patients have severe allergic reactions to APLENZIN. Stop taking APLENZIN and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
Do not take APLENZIN if you:
have or had a seizure disorder or epilepsy
have or had an eating disorder such as anorexia nervosa or bulimia
are taking any other medicines that contain bupropion, including WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in APLENZIN
drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
do not take an MAOI within 2 weeks of stopping APLENZIN unless directed to do so by your healthcare provider
do not start APLENZIN if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider
are allergic to the active ingredient in APLENZIN, bupropion, or to any of the inactive ingredients
Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking APLENZIN, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you:
have liver problems, especially cirrhosis of the liver
have kidney problems
have, or have had, an eating disorder such as anorexia nervosa or bulimia
have had a head injury
have had a seizure (convulsion, fit)
have a tumor in your nervous system (brain or spine)
have had a heart attack, heart problems, or high blood pressure
are a diabetic taking insulin or other medicines to control your blood sugar
drink alcohol
abuse prescription medicines or street drugs
are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take APLENZIN during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185
are breastfeeding. APLENZIN passes into your milk in small amounts
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using APLENZIN.
The most common side effects of APLENZIN include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
Click here to read the Medication Guide carefully before you start using APLENZIN. If you have any questions about APLENZIN, ask your healthcare provider or pharmacist.
Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatchor call 1-800-FDA-1088. You may also contact Bausch Health Customer Service at 1-800-321-4576.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
References
American Psychiatric Association. Seasonal affective disorder
]]>TM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel For The Treatment Of Acne Vulgaris In Patients Twelve Years Of Age And Older ]]>Fri, 20 Oct 2023 17:42:11 GMTFirst and only FDA-approved fixed-dose, triple-combination topical treatment
LAVAL, Quebec, Oct. 20, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for CABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. CABTREO is expected to be available to patients in Q1 2024.
“With today’s approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen.”
CABTREO offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment.
“While most acne treatments currently available utilize multiple therapies and regimens, we are excited to see that the triple combination in CABTREO has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne,” said Julie C. Harper, MD., Dermatology & Skin Care Center of Birmingham, Birmingham, AL. “With the approval of CABTREO, physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option.”
CABTREO Comprehensive Clinical Data
CABTREO was studied in two Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success (2 grade reduction of the EGSS (evaluators global severity score) from baseline with an EGSS score of clear (0) or almost clear (1)).
Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12.
In Study 1, 49.6% of participants achieved treatment success with CABTREO compared to 24.9% with vehicle. Mean percent reduction for inflammatory lesions was 75.7% (27.7 mean absolute reduction) vs. 59.6% (21.7 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 72.7% (35.4 mean absolute reduction) vs. 47.6% (23.5 mean absolute reduction) with vehicle.
In Study 2, 50.5% of participants achieved treatment success with CABTREO compared to 20.5% with vehicle. Mean percent reduction for inflammatory lesions was 80.1% (30.1 mean absolute reduction) vs. 56.2% (20.8 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 73.3% (35.2 mean absolute reduction) vs. 49.0% (22.0 mean absolute reduction) with vehicle.
The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.
About Acne Vulgaris
Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2
What is CABTREO?
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina.
IMPORTANT SAFETY INFORMATION
Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin.
Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn’s disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use.
What should I avoid while using CABTREO?
Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight.
Cold weather and wind may irritate skin treated with CABTREO.
Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema.
Avoid skin products that may dry or irritate your skin.
Avoid the use of “waxing” as a hair removal method on skin treated with CABTREO.
What are the possible serious and most common side effects of CABTREO?
Tell your doctor right away if you experience side effects, including:
Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded.
Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO.
Sensitivity to sunlight. See “What should I avoid while using CABTREO”.
Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling.
These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch
Please click here for full Prescribing Information, Patient Information and Instructions for Use.
About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Tue, 17 Oct 2023 09:45:04 GMTHurdles Led to Almost All Patients Having At Least One Day Delay to Receive Treatment with Xifaxan®
LAVAL, Quebec, October 17, 2023 –– Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced findings from a retrospective database analysis of adjudicated claims data that examined the impact of access barriers for commercially-insured adults prescribed Xifaxan® (rifaximin) for reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults. Results suggest potentially critical treatment gaps due to access barriers, which may result in increased rates of OHE-related hospitalizations. Findings from the analysis, “Assessment of Access Barriers to Rifaximin Among Patients with Overt Hepatic Encephalopathy Using Adjudicated Claims Data,” were presented today at the AMCP Nexus 2023 meeting.
“This study was designed to identify barriers to Xifaxan access among patients with OHE. The study results highlight that rejection of Xifaxan claims led to delay in treatment initiation as well as gaps in active treatment. Such access barriers to Xifaxan may result in increased rates of OHE related hospitalizations,” said Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell in New York who led the analysis.
Treatment gaps were assessed across a 12-month period that began at the first observed attempt to access rifaximin, which is defined as a paid, reversed or rejected prescription claim.
Across the study period, patients had 8.8 average attempts to access rifaximin with an average 6.4 claims paid, 1.5 rejected and 0.9 reversed
Nearly all patients (97.0%) experienced a treatment gap of at least one day, with an average of 2.9 gaps per patient leading to a total duration of 157.4 days without exposure to rifaximin (medication possession ratio: 56.9%)
Treatment-initiated delays in receiving rifaximin were experienced by 34.8% of patients with more than three-quarters (77.7%) of initiation delays experienced due to rejected claims with the most common rejection reported as Prior Authorization (PA) Required (61.8%)
Following initial paid claim, active treatment gaps were experienced by nearly three-quarters of patients (72.7%) with an average gap duration of 22.9 days
“Xifaxan is the only FDA-approved medicine indicated for the reduction in risk of overt hepatic encephalopathy recurrence in adults and this analysis shows that many OHE patients continue to face barriers in receiving the vital care they may require,” said Nicola Kayel, Senior Vice President, Marketing, Salix. “For the Salix team, our highest priority is patient care. Patients living with OHE continue to be at risk for recurrence and we are committed to understanding and improving the patient journey.”
The retrospective database analysis used the IQVIA PharMetrics Plus database linked with Longitudinal Access and Adjudicated Data and identified 1,711 commercially insured adults (aged 18-64) with OHE who had at least one paid rifaximin prescription fill and 12-month continuous eligibility.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN were:
HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
IBS-D (≥2%): Nausea (3%), ALT increased (2%)
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the management and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our approximately 90% ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Thu, 12 Oct 2023 09:41:12 GMTLAVAL, Quebec, Oct. 12, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release its third- quarter financial results on Thursday, Nov. 2, 2023. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Salix Pharmaceuticals’ Liver Health Annual Trends Report Findings Suggest Chronic Liver Disease (CLD) Deaths Could Triple Before the End of the Decade
Based Primarily on HCP-Market Research, Report Finds a Growing Concern of Staffing Shortages Across Multiple Healthcare Professions that Treat Liver Disease
LAVAL, Quebec, October 10, 2023 –– Salix Pharmaceuticals, the gastroenterology business of Bausch Health Companies Inc. (NYSE/TSX: BHC), today released the Salix Liver Health Trends Report, Third Edition, which documents the evolving crisis of chronic liver disease (CLD), showing a 9% increase in CLD and cirrhosis mortality marking these as the ninth leading cause of death in the United States in 2021.
The report, based on a survey of 400 health care providers (HCPs) who treat CLD, qualitative interviews with HCPs and secondary research from peer-reviewed publications, also stresses the ongoing disparities and gaps in CLD care that affect different populations and geographies, including a shortage of liver specialists in rural areas.
“Over its first three editions, the Salix Liver Health Trends Report has described the enduring disparities and tremendous burden seen across the treatment of chronic liver disease,” said Nicola Kayel, senior vice president, Marketing, Salix. “The report makes clear that increased education and awareness on the issues facing CLD care, as well as distinct and practical treatment guidelines are vital tools to help health care providers improve CLD management and provide for better experiences and outcomes for people
living with CLD.”
Complete findings from Salix's Liver Health Annual Trends Report as well as health care provider resources to help identify and manage patients with CLD and cirrhosis can be viewed
at LiverHEalthNow.com.
Select findings from the Salix Liver Health Trends Report, Third Edition include:
A 9% increase in CLD and cirrhosis-related deaths is contributed by the growing prevalence of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) with mortality expected to nearly triple by 2030
Racial and ethnic disparities exist within the NAFLD population, with an increased burden among Hispanics with an estimated prevalence of 1 in 4 (22.9%) as compared to Whites (14.4%) and Blacks (13%)
Staffing shortages are a growing concern as 72% of respondents reported chronic staffing shortages across many roles, including 80% reporting nursing shortages, 29% of gastroenterologist shortages and 26% of hepatologist shortages
Where CLD patients live may impact the care available as 43% of respondents working in a rural setting reported shortages of primary care physicians as compared to 28% of respondents working in an urban/suburban setting
Thirty-one percent of all respondents were unaware of any national guidelines for the management of CLD
About the Liver Health Trends Report, Third Edition Methodology
The Liver Health Trends Report, Third Edition on chronic liver disease (CLD) includes information collected from an online survey, qualitative telephone interviews and secondary research from peer- reviewed publications. An independent third-party recruiting firm invited over 400 health care providers to participate in this research during April and May 2023. Provident participation (N=400) required national representation and was comprised of 100 gastroenterologists, 100 hospital-based specialists, 100 primary care physicians (PCPs) and 100 nurse practitioners/physician assistants (NPs/PAs). Analysis of the survey data was conducted by utilizing QPSMR data analysis software. Follow-up telephone interviews were conducted with 20 providers comprised of 16 physicians and 4 NPs/PAs. Quotes from the in-depth interviews throughout the report represent the opinions of those responders.
The report strives to be representative of all physician segments’ lived experience and the diversity that exists within the United States with respect to patient management and the economic and social factors that impact the management of CLD patients. Due to the limitations of this report, not all findings may be generalizable to the larger CLD provider and patient populations. In addition, this report does not contain all questions asked in the survey and in-depth interviews.
Secondary Research from Peer-Reviewed Publications
Secondary research was conducted utilizing Google and PubMed searches to identify relevant peer- reviewed publications and sources as noted in the report. Furthermore, treatment utilization claims data were sourced from IQVIA. Secondary research may not reflect all published data. A systematic review was not performed.
About Salix in CLD and HE
To raise awareness and knowledge of CLD/cirrhosis and hepatic encephalopathy (HE), which is a complication of cirrhosis, Salix offers other online resources, including:
UnderstandingHE.com: offering patients/caregivers HE information and resources on how to work with their HCP to help manage the disease
Liverhealthnow.com: offering HCP’s information and resources to help identify and manage patients with CLD, cirrhosis and HE
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the management and treatment of gastrointestinal diseases. For more than 30 years, Salix has
licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on
gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
###
]]>Wed, 04 Oct 2023 09:01:35 GMTBELLAMY YOUNG IS MOVING PAST STIGMA AS SHE SPEAKS CANDIDLY ABOUT HER FATHER’S STRUGGLE WITH CHRONIC LIVER DISEASE/CIRRHOSIS AND RESULTING HEPATIC ENCEPHALOPATHY
80% of people with chronic liver disease develop some form of HE
9 in 10 HE patient caregivers report “they did not realize what they were in for at the time of diagnosis”
UnderstandingHE.com provides educational tools and resources to support patients and caregivers
LAVAL, QC, October 4, 2023 - Bausch Health Companies Inc. (NYSE/TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced its partnership with award-winning actor Bellamy Young, who is speaking out to help educate people who are impacted by hepatic encephalopathy (HE), caused by cirrhosis. Bellamy wants those affected to know they are not alone and to help them overcome stigma that can interfere with disease education.
Timed with the kickoff of liver awareness month, Bellamy is sharing her personal experience of living with a father who was suffering from HE. Bellamy’s goal is to help educate patients, families and caregivers to better understand the disease and is encouraging people to visit UnderstandingHE.com, where they can access educational tools including an interactive symptom tracker and discussion guides that patients and caregivers can use to facilitate a conversation with their doctors and others.
“Hepatic encephalopathy is an insidious disease that can be extremely difficult for patients and families to deal with on their own. After my father was diagnosed with HE, we could never have expected the impact it would have on his cognition and personality, we weren’t prepared for what was to come. I don’t want other families to experience the isolation that we felt. I want people who are faced with an HE diagnosis and their loved ones to know more about the disease and, importantly, that they are not alone,” said Bellamy.
“Through the patient and caregiver stories on UnderstandingHE.com, we’ve seen the power of shared experience in fostering education. With the rate of cirrhosis-related complications on the rise, having the strength and authenticity of a partner like Bellamy will help patients and their loved ones to move past stigma and lead to patients having important conversations with their health care providers about the disease and how to manage it,” said Nicola Kayel, Senior Vice President, GI Marketing, Salix. ]
About Chronic Liver Disease/Cirrhosis:
While many associate liver disease with alcohol use, the fact is that liver disease can have various causes and affects as many as 30 million people in the United States. When liver disease progresses into chronic liver disease, which affects more than 5 million Americans, it commonly falls into four categories:
Alcohol related liver disease – Resulting from drinking too much alcohol
Non-alcoholic fatty liver disease – Often caused by obesity, insulin resistance or imbalance of lipids in the blood
Hepatitis - Inflammation of the liver caused by viruses (most commonly classified as A, B, or C)
Liver Cancer - When cells in the liver grow out of control
Living with liver disease, or a liver injury, for a long time can lead to cirrhosis – a condition when scar tissue replaces healthy tissue. As cirrhosis becomes worse, the liver has less healthy tissue, which is needed to help your body process food and nutrients into energy and to remove harmful toxins. As the liver damage gets worse, it can no longer remove toxins from the blood and HE symptoms may develop.
About Hepatic Encephalopathy:
Hepatic encephalopathy (HE) is a complication of cirrhosis. One of the important functions of the liver is to clean the blood. When the liver is damaged, it can no longer properly clean toxins (like ammonia) from the blood. This buildup of toxins can reach the brain, potentially causing HE and worsening brain function. Early HE symptoms can start slowly and may go unnoticed. Symptoms of HE can be both physical and mental. Medications and appropriate lifestyle management, with the help of a doctor, may help manage the disease.
It is projected that as many as four out of five people with cirrhosis may eventually develop some form of HE. The disease is often misdiagnosed, or diagnosed too late, and can be associated with increased mortality rates. When asked, a majority of HE patients and HE caregivers say that they were not able to find all the information they need, and 9 in 10 of HE caregivers said that they did not realize what they were in for, and most did not know that HE can progress.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the management and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>® ]]>Fri, 29 Sep 2023 09:47:27 GMTLAVAL, Quebec, September 29, 2023 – Bausch + Lomb Corporation (“Bausch + Lomb”) (NYSE/TSX: BLCO), a subsidiary of Bausch Health Companies Inc. (the “Company” or “Bausch Health”) (NYSE/TSX: BHC), today announced it has completed its acquisition of XIIDRA® (lifitegrast ophthalmic solution) 5%, a non- steroid eye drop specifically approved to treat the signs and symptoms of dry eye disease focusing on inflammation associated with dry eye, and certain other ophthalmology assets.
Under the terms of the agreement, Bausch + Lomb, through an affiliate, acquired XIIDRA® and the other ophthalmology assets from Novartis for up to $2.5 billion, including an upfront payment of $1.75 billion in cash with potential milestone obligations of up to $750 million based on sales thresholds and pipeline commercialization. Bausch + Lomb also acquired the sales force supporting XIIDRA®. Bausch + Lomb funded the acquisition with the previously announced offering of $1.4 billion aggregate principal amount of 8.375% senior secured notes due 2028 (“Notes”) and $500 million of new term B loans under an incremental term loan facility (“Term Loan Facility”). The issuance of the Notes and the closing of the Term Loan Facility occurred substantially concurrently with the closing of the acquisition.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: the effect of the announcement or closing of the transactions described in this press release (collectively, the “Transactions”) on the market price of the Company’s common stock and Bausch + Lomb’s ability to maintain relationships with customers, suppliers, other business partners or governmental entities; the impact of the Transaction on Bausch + Lomb’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; the possibility that the expected benefits of the Transaction will not be realized or will not be realized within the expected time period; and risks relating to potential diversion of management attention away from Bausch + Lomb’s ongoing business operations. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
]]>Thu, 21 Sep 2023 08:00:00 GMTLAVAL, Quebec, September 20, 2023 – In honor of Hispanic Heritage Month, Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health care business, OraPharma, today announced its collaboration with the League of United Latin American Citizens (LULAC) – the largest and oldest Hispanic organization in the United States – to foster a greater understanding of gum disease detection, and treatment within the Hispanic community.
Gum disease, also known as periodontal disease, is a chronic bacterial infection that affects nearly 65 million American adults and is even more common among Latinos. The most common symptoms of gum disease are bleeding during or after brushing and red or swollen gums. Further, studies show gum disease may be associated with increased risk for other chronic conditions throughout the body such as diabetes and cardiovascular disease, which may considerably affect the Hispanic community.
This partnership includes LULAC’s involvement in supporting the Cover Your Bases campaign, a national awareness initiative featuring patient ambassador and World Series Champion, Alex Rodriguez, who is helping to raise disease awareness by encouraging people to talk to their dentist about their oral health, including screening for gum disease.
“I’m proud to welcome LULAC to the Cover Your Bases campaign to help educate the Latino community on the importance of identifying the signs and symptoms of gum disease,” said Rodriguez. “I was lucky my dentist diagnosed my gum disease early and implemented a comprehensive treatment plan. I hope that by sharing my story I can help more people do the same, especially since we know gum disease is more prevalent in men and within the Latino community.”
OraPharma’s work with LULAC includes a range of educational resources featuring Alex Rodriguez that will be distributed across the organization’s social and digital channels. OraPharma will also be at LULAC’s National Health Summit in Dallas, TX on October 21st to help educate attendees about gum disease and treatment options.
“As an organization dedicated to advancing the health of the Hispanic population in the United States, LULAC is honored to join hands with OraPharma and Alex Rodriguez to share this important message,” said Juan Proaño, LULAC Interim-CEO. “Millions of Hispanic Americans suffer from gum disease, yet many individuals are unaware and undiagnosed. Coupled with the potential associated health risks, gum disease is a chronic condition, so we must help heighten awareness surrounding this condition and arm our members with information that encourages them to take action and talk to their dentist.
For patients with gum disease, it’s important to consider a comprehensive treatment plan to help fight the bacteria that causes gum disease. Like other bacterial infections, a dentist can treat gum disease. A treatment option for adults with gum disease is an antibiotic called ARESTIN® (minocycline HCI), which is used in combination with scaling and root planing (SRP) and applied at the site of infection. ARESTIN is part of an overall oral health program that includes good brushing and flossing habits.
“As we celebrate Hispanic Heritage Month, OraPharma is proud to partner with respected organizations like LULAC to address gum disease as an often-overlooked health disparity in the Latino community,” said Tom Stern, Vice President and General Manager at OraPharma. “Though there is no cure for gum disease, we hope that the mission we’re on together will help to bridge the information gap and empower the Hispanic community to take control of their oral health by speaking with their dentist and seeking a treatment plan that may help manage the condition.”
To learn more, visit www.Arestin.com or follow us on Instagram and Facebook.
About ARESTIN®
INDICATION
ARESTIN (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.
IMPORTANT SAFETY INFORMATION
• Do not take ARESTIN if you are allergic to minocycline or tetracyclines. Ask your dentist or pharmacist for a list of these drugs if you are not sure. Swelling of the face, itching of the skin, fever and enlarged lymph nodes have been reported with the use of ARESTIN. Some of these reactions were serious. Tell your dentist right away if you have any signs of allergic reaction, such as skin reactions or trouble breathing, or if you have an exaggerated sunburn reaction.
• THE USE OF TETRACYCLINE CLASS DRUGS, INCLUDING ARESTIN, DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
• ARESTIN has not been studied in patients with weakened immune systems (such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation). Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndrome with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness. Tell your doctor about any health problems you have, including whether you have had oral candidiasis ("thrush") in the past, and about all medications you are taking.
• In clinical studies, the most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease, and multiple regenerative solutions for oral surgery. More information can be found at https://www.orapharma.com/.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
About LULAC
The League of United Latin American Citizens (LULAC) is the nation's largest and oldest Hispanic civil rights volunteer-based organization that empowers Hispanic Americans and builds strong Latino communities. Headquartered in Washington, DC, with 1,000 councils around the United States and Puerto Rico, LULAC's programs, services, and advocacy address the most important issues for Latinos, meeting the critical needs of today and the future.For more information, visit https://lulac.org/
Mon, 18 Sep 2023 18:25:07 GMTLAVAL, Quebec, Sept. 18, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“BHC” or the “Company”) today announced that Tom Vadaketh, Executive Vice President, Chief Financial Officer, has resigned from his role to pursue another opportunity, and will be leaving the Company effective October 13, 2023. The Company thanks Mr. Vadaketh for his significant contributions and leadership during a period of transition at the Company.
A formal search process to identify Mr. Vadaketh’s permanent replacement has been initiated.
If a permanent replacement is not in place at the time of Mr. Vadaketh’s departure, the Company intends to appoint John S. Barresi, who is currently serving as the Company’s Senior Vice President, Controller and Chief Accounting Officer, to the role of interim Chief Financial Officer. Mr. Barresi has more than 15 years of experience as a corporate finance executive.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, “forward-looking statements”), including, but not limited to, statements relating to the Company’s succession plan for its chief financial officer position. Forward-looking statements may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company’s most recent annual and quarterly reports and detailed from time to time in the Company’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company’s filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
PrUCERIS® (budesonide) aerosol foam now available across Canada to treat mild to moderate distal ulcerative colitis in adults ]]>Tue, 12 Sep 2023 08:00:00 GMT
LAVAL, QE / ACCESSWIRE / September 12, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is pleased to announce that following its approval by Health Canada the new treatment PrUCERIS® (budesonide) aerosol foam is now available across Canada to treat mild to moderate distal ulcerative colitis in adults.
UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.[1] In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.[2]
"Bausch Health is pleased to make this new treatment for ulcerative colitis available to Canadians, providing an innovative therapy option using a convenient aerosol foam," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "This is part of our commitment to being a trusted partner in the healthcare of Canadians."
Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.3 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).[3]
"Distal ulcerative colitis can be challenging for patients to live with and gastroenterologists to treat. Our goal is to put the disease into remission so that patients can improve their quality of life," said Dr. Brian Bressler, Founder of The IBD Centre of BC in Vancouver and Clinical Associate Professor of Medicine in the Division of Gastroenterology at the University of British Columbia. "UCERIS can help overcome current treatment limitations by reaching the affected area of the distal colon and keeping the medication there long enough to be effective. People suffering from distal ulcerative colitis will have another option to consider when facing this disease."
"Living with ulcerative colitis can mean painful, frequent and, at times, bloody stools." said Gail Attara, president and chief executive officer of the Gastrointestinal Society, a patient group known by its badgut.org website. "We look forward to this product being widely available for individuals living with ulcerative colitis who need a good treatment option that is easy to use, which targets the disease directly. UCERIS is an effective solution, meeting the disease right where it happens."
UCERIS is available in one strength: 2 mg budesonide per metered dose and is applied starting twice a day for two weeks followed by once a day for the next four weeks.[4]
In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.[5]
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
[2] Gross V, et al, Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis, Ailment Pharmacol Ther. 2006;23(2):303-312
]]>® ]]>Mon, 11 Sep 2023 08:33:19 GMTLAVAL, Quebec, Sept. 11, 2023 – Bausch + Lomb Corporation (“Bausch + Lomb”) (NYSE/TSX: BLCO), a subsidiary of Bausch Health Companies Inc. (the “Company”) (NYSE/TSX: BHC), announced today that, in connection with the financing of its pending acquisition (the “Acquisition”) of XIIDRA® and certain other ophthalmology assets, Bausch + Lomb Escrow Corp. (the “Escrow Issuer”), a wholly owned subsidiary of Bausch + Lomb, launched an offering of $1.4 billion aggregate principal amount of new senior secured notes due 2028 (the “Notes”) and that Bausch + Lomb is seeking to enter into an incremental term loan facility (“Term Loan Facility”), which will be secured on a pari passu basis with Bausch + Lomb’s existing term loan facility and will either be in the form of an incremental amendment to Bausch + Lomb’s existing term loan facility or a separate credit agreement. Bausch + Lomb is expected to borrow $500 million of new term B loans (the “New Term B Loans”) under the Term Loan Facility upon the closing of the Acquisition.
The net proceeds of the New Term B Loans and the offering of the Notes are expected to fund the Acquisition, to pay fees and expenses related to the Acquisition, the borrowings of the New Term B Loans and the offering of the Notes and for general corporate purposes, including the repayment of existing debt.
Closing of the Term Loan Facility will be conditioned upon completion of the Acquisition and will occur concurrently with the closing of the Acquisition. Closing of the Notes offering will not be conditioned upon completion of the Acquisition, but if the Acquisition does not occur on or prior to September 30,2024, the Escrow Issuer will be required to redeem the Notes at such time at a redemption price equal to the principal amount of the Notes plus accrued and unpaid interest.
The foregoing transactions are subject to market and other conditions. There can be no assurance that Bausch + Lomb will be able to successfully complete the transactions, on the terms described above, or at all.
The Notes will not be registered under the Securities Act of 1933, as amended (“Securities Act”), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Company has filed a Current Report on Form 8-K in connection with the above, a copy of which is also available on its SEDAR+ (www.sedarplus.ca) profile. This news release does not constitute an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, including statements relating to Bausch + Lomb’s proposed financing and the closing of the Acquisition, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the Acquisition; the possibility that any or all of the conditions to the consummation of the Acquisition may not be satisfied or waived; the effect of the announcement or pendency of the Acquisition on Bausch + Lomb’s ability to maintain relationships with customers, suppliers, and other business partners; the impact of the Acquisition if consummated on Bausch + Lomb’s business, financial position and results of operations; risks relating to potential diversion of management attention away from Bausch + Lomb’s ongoing business operations; Bausch + Lomb’s ability to finance the transaction as anticipated and risks relating to increased levels of debt as a result of debt expected to be incurred to finance such transaction, such as the Notes and the New Term B Loans; and risks that Bausch + Lomb may not realize the expected benefits of that transaction on a timely basis or at all. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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]]>® ]]>Wed, 06 Sep 2023 18:42:36 GMTLAVAL, Quebec, Sept. 6, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), announced that it has disclosed certain historical and pro forma financial information with respect to its previously announced proposed acquisition of XIIDRA® (lifitegrast ophthalmic solution) 5% and certain other ophthalmology assets (the “Acquisition”) on a Current Report on Form 8-K and on its SEDAR+ (www.sedarplus.ca) profile. In connection with the Acquisition, as previously disclosed, Bausch + Lomb anticipates incurring indebtedness (expected to be comprised principally of an incremental term loan and the issuance of senior secured notes), which is discussed in further detail in its Current Report on Form 8-K. The Company has filed a Current Report on Form 8-K in connection with the above, a copy of which is also available on its SEDAR+ (www.sedarplus.ca) profile.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements, including statements related to the proposed Acquisition and the anticipated indebtedness to be incurred in connection with the Acquisition, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the proposed acquisition (the “Transaction”); the possibility that any or all of the conditions to the consummation of the Transaction may not be satisfied or waived, including failure to receive required regulatory approvals; the effect of the announcement or pendency of the Transaction on Bausch + Lomb’s ability to maintain relationships with customers, suppliers, and other business partners; and risks relating to potential diversion of management attention away from Bausch + Lomb’s ongoing business operations. Readers are cautioned not to place undue reliance on any of these forward-looking statements; Bausch + Lomb’s ability to finance the transaction as anticipated, the terms of such financing and risks relating to increased levels of debt as a result of debt expected to be incurred to finance such transaction; and risks that Bausch + Lomb may not realize the expected benefits of that transaction on a timely basis or at all. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
Balance Sheet Initiatives Further Enhance Liquidity Profile
Continued Evaluation of Optimal Implementation of Potential Bausch + Lomb Distribution
Revenue of $2.17 billion, Up 10% Reported and 11% Organic1
GAAP Net Income Attributable to Bausch Health Companies Inc. of $26 Million
Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $727 Million, Up 4%
Raises Full-Year Revenue Outlook and Reaffirms Adjusted EBITDA (non-GAAP)1 Guidance Range
LAVAL, QC, August 3, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company” or “we” or “our”) today announced its second-quarter 2023 financial results and various other key updates from the quarter.
“We are encouraged by our strong performance in the second quarter as we continue to see the results from our focus on commercial excellence and investments in key businesses with growth opportunities, such as Salix” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “We are also encouraged by various other key positive developments for our business during the quarter, including the favorable motion ruling in respect of Xifaxan® and the continued success our initiatives to proactively manage our balance sheet. We also continue to advance our R&D pipeline as we look forward to bringing new products to the patients who can benefit from them,” concluded Appio.
In May 2023, the U.S. District Court of Delaware denied Norwich Pharmaceuticals Inc.’s motion for reconsideration in the matter of Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc., which therefore prevents the U.S. Food and Drug Administration (“FDA”) from approving Norwich’s abbreviated new drug application (“ANDA”) for Xifaxan® (rifaximin) 550 mg before October 2029. Norwich has appealed the denial of its motion for reconsideration. In June 2023, the FDA granted tentative approval for the ANDA, but confirmed that it is enjoined from granting final approval until October 2029. This favorable ruling reinforces Salix’s continuing growth strategy.
On June 5, 2023, Norwich sued the FDA in the United States District Court for the District of Columbia challenging the FDA’s decision to follow the August 10, 2022 final judgment and withhold final approval for the Norwich ANDA until October 2029. The FDA opposed Norwich’s action and the Company intervened in the lawsuit. A decision in the District Court for the District of Columbia is expected by the end of 2023.
Norwich’s appeal of the U.S. District Court of Delaware’s denial of its motion for reconsideration and Bausch Health’s appeal of the IBS-D and polymorph patent rulings from the August 10, 2022 final judgment have been consolidated, and are pending at the Court of Appeals for the Federal Circuit. A decision is expected on the appeals as early as Q1 2024.
The Company remains confident in the strength of the Xifaxan® patents and intends to vigorously defend its intellectual property.
Proactive Balance Sheet Initiatives, Including New Accounts Receivable Credit Facility, Further Enhance Liquidity of Bausch Health (excl. Bausch + Lomb) to Greater than $1 Billion
In June 2023, the Company entered into a non-recourse receivables financing facility for up to $600 million with KKR and its credit funds and accounts. Following the closing of the receivables facility Bausch Health (excl. Bausch + Lomb) has liquidity in excess of $1 billion, inclusive of cash and cash equivalents, availability under the Company’s existing revolving credit facility and availability under the receivables facility. The strength of our current liquidity profile, coupled with our continued generation of cash flow from operations, provides the Company with flexibility to assess strategic opportunities to further improve our balance sheet and pursue key growth opportunities.
Update on Potential Bausch + Lomb Distribution
The Company continues to believe that completing a separation of Bausch + Lomb Corporation (“Bausch + Lomb”) makes strategic sense and is committed to creating two strong companies following any potential distribution.
As the Company continues to evaluate all relevant factors and circumstances related to any Bausch + Lomb distribution, it is exploring options for optimizing the structure of any Bausch + Lomb distribution, if and when such a distribution is completed. The Company’s initial intent was to effectuate any potential distribution by way of plan of arrangement. The Company has since determined that the optimal way to implement the distribution may instead be through a tax-free reduction of capital, which also provides additional flexibility to the Company and Bausch + Lomb with respect to strategic alternatives after any distribution has occurred. The Company continues to evaluate the structure of any distribution and its other related details. Any distribution of Bausch + Lomb continues to be subject to receipt of applicable shareholder and other required approvals.
Bausch Health (excl. B+L) R&D Update
RED-C: global program for Reduction of Early Decompensation in Cirrhosis
Expect to complete enrollment of two global Phase 3 trials in Q1 2024
Received feedback on the program from the National Medical Products Administration in China and we are currently planning to meet with authorities in Japan later this year
Amiselimod (S1P modulator): treatment of mild to moderate Ulcerative Colitis
Phase 2 study completed enrollment in July 2023 and the study is expected to be completed in Q4 2023
IDP-126: first triple combination product for the treatment of acne vulgaris
PDUFA date set for October 2023
New Drug Submission was submitted to Health Canada on May 30, 2023
Clear and Brilliant® Touch: fractionated laser device for skin rejuvenation
Regulatory submissions on-track in Europe and Canada in 2024 and Asia Pacific in 2025
Next Generation Fraxel®: fractionated laser device for skin resurfacing
FDA submission is expected in Q4 2023
Second Quarter 2023 Revenue Performance
Total reported revenues were $2.17 billion for the second quarter of 2023, compared with $1.97 billion in the second quarter of 2022, an increase of $200 million, or 10%. Excluding the unfavorable impact of foreign exchange of $17 million and the favorable impact of acquisitions, divestitures, and discontinuations of $4 million, revenue increased by 11% organically1 compared with the second quarter of 2022.
]]>Thu, 27 Jul 2023 08:00:00 GMTScholarships Awarded to Six Students Affected by Dermatologic Conditions
LAVAL, Quebec, July 27, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, today announced the recipients of their 2023 Aspire Higher Scholarship program. The program, which has provided a total of $978,000 in scholarships since launching in 2013, will award six students who have been treated for a dermatologic condition with a scholarship of up to $10,000 to pursue their undergraduate or graduate degrees.
“This year marks the 10-year anniversary of the Aspire Higher Program. Over the last decade, Ortho Dermatologics and our Aspire Higher Scholarship program have supported 75 students who have been affected by dermatologic conditions by helping them achieve their higher education goals,” said Don Pearl, senior vice president, Ortho Dermatologics. “We are thrilled to announce the 2023 recipients and were deeply moved and inspired by their personal stories. We are truly honored to have the opportunity to help them pursue their academic aspirations through this scholarship, and we also thank the health care providers who had a critical hand in helping to treat their conditions.”
The 2023 honorees were chosen from 216 applications and were selected in part due to their essays that provided an overview of their educational journeys while living with dermatologic conditions and the role a health care professional played in treating the condition. The program recognizes students nationwide across a wide range of educational pursuits, with scholarships in two categories, including the Undergraduate Scholar Awards and the Graduate Scholar Awards.
The 2023 Aspire Higher Scholarship Program recipients are:
Undergraduate Scholar Awards
Serena Goyal, Clarksville, Maryland – Virginia Commonwealth University
Arianna Kaas, Pewaukee, Wisconsin – University of Wisconsin Madison
Elle Tondo, Denton, Texas – University of New Haven
Graduate Scholar Awards
Erynn Taylor, McDonough, Georgia – Georgia College and State University
Matthew Kaczynski, Providence, Rhode Island – Warren Alpert Medical School of Brown University
Katrina Hertz, Glenn Heights, Texas – University of Pennsylvania
"Living with atopic dermatitis has proven a daily physical, mental and emotional challenge. However, through my experience battling a skin condition, and through the life-changing connection with my dermatologist that facilitated my overcoming of these challenges, I grew motivated to leverage my personal experience as a bridge to connect with and extend healing to others as a future physician. With this scholarship, Ortho Dermatologics is directly supporting my journey through medical school, and enabling the fulfillment of my purpose,” said Matthew Kaczynski, Providence, Rhode Island – Warren Alpert Medical School of Brown University.
To learn more about the Aspire Higher Scholarship Program and to see stories from previous scholarship recipients, please visit www.AspireHigherScholarships.com.
About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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]]>Thu, 13 Jul 2023 08:00:00 GMTLAVAL, Quebec, April 13, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release its second-quarter financial results on Thursday, Aug. 3, 2023. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Tue, 11 Jul 2023 08:41:05 GMTFor Fourth Consecutive Year, 10 Students with Gastrointestinal Disease Will Each Receive a $10,000 Scholarship
LAVAL, Quebec, July 11, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced the winners of its 2023 Salix Gastrointestinal Health Scholars Program. For the fourth consecutive year, Salix will be awarding $10,000 each to 10 students living with a GI disease.
“At Salix, we understand it can be incredibly difficult to balance both the pursuit of higher education and the challenges associated with living with a gastrointestinal condition,” said Nicola Kayel, vice president, Marketing, Salix. “That is why Salix is dedicated to reducing the stress and financial burden for these students. We congratulate this year’s 10 scholarship recipients for whom we are proud to support in the advancement of their academic goals.”
The 2023 awardees were selected from more than 225 applications. As part of the process, applicants were required to submit essays describing how their GI condition has impacted their educational journey, as well as delve into the role their health care provider played in helping them reach their personal and educational goals. All scholarship applications were reviewed by an independent panel of judges.
The Salix Gastrointestinal Health Scholars Program recognizes students across a wide range of educational pursuits, with scholarships in four categories, including the Undergraduate Scholar Awards, for those pursuing undergraduate degrees; the Graduate Scholar Awards, for those pursuing graduate degrees; the Working Parent’s Scholar Award, for parents pursuing undergraduate, vocational/technical or graduate degrees, and the Single Parent’s Scholar Award, for students who are single parents pursuing undergraduate, vocational/technical, or graduate degrees.
The 2023 Salix Gastrointestinal Health Scholars Program recipients are:
Undergraduate Scholar Awards
Kate Paden, Colorado Springs, CO – Creighton University
Alexander Myers, San Diego, CA – Northwestern University
Charlie Harker, Lebanon, OH – University of Cincinnati
Lena Stoltzfus, Tucson, AZ – Haverford College
Graduate Scholar Awards
Kaitlyn Mi, Brentwood, TN – Vanderbilt University School of Medicine
Emmanuel Dean, Stone Mountain, GA – Morehouse School of Medicine
Caroline Casola, Orlando, FL – Washington University in St. Louis School of Law
Raina Levin, Jamaica Plain, MA – Boston University School of Public Health
Working Parent’s Scholar Award
Juanita Ramirez, Edinburg, TX – University of Texas Rio Grande Valley
Single Parent Scholar Award
Kimberly Sperry, Mesquite, TX – Texas Women’s University
“I am so grateful to have been selected for this generous scholarship which allows me to continue pursuing my higher education goals,” said a 2022 scholarship recipient. “Receiving this honor has empowered me to view the world as one where I am not limited by my disease.”
To learn more about the Salix Gastrointestinal Health Scholars Program, visit www.salix.com/scholarship.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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]]>Fri, 07 Jul 2023 08:00:00 GMTOral Health Care Companies Celebrate the 100th ADHA Conference by Highlighting New Data for the Treatment of Periodontal Disease
LAVAL, Quebec, July 7, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health care business, OraPharma, today announced its presence at the American Dental Hygienists’ Association (ADHA®) Annual Conference held in Chicago, IL from July 7-9, 2023. ADHA is the largest and oldest organization representing the professional interests of more than 226,000 dental hygienists in the United States. OraPharma will join ADHA to celebrate 100 years of advancing the dental hygiene profession, oral health, and overall health by participating in the first-ever Research and Technology Pavilion, sponsored by Pacific Dental Services® (PDS) – one of the country’s leading dental and medical support organizations. During the three-day conference, OraPharma will share new research that will shape dental hygiene practices for years to come.
Dr. Richard Nagelberg, DDS and Director of Medical Affairs at Bausch Health, will host two presentations to showcase the findings of a recent study conducted by the University of Minnesota School of Dentistry and published in the Journal of Periodontology. This study represents an important path forward in helping to manage periodontal disease, while setting a foundation for further research in the area of periodontal disease progression and how it may relate to the oral-systemic connection.
“OraPharma is honored to partner with respected organizations such as PDS to continue educating and empowering our colleagues in the dental health profession to make a positive impact on public oral and overall health,” said Dr. Nagelberg. “We look forward to joining the ADHA as it celebrates 100 years of driving excellence in dental hygiene at this year’s conference and sharing the impactful results of this research, which will help shape dental health practices in the future.”
Dr. Nagelberg will also be available at booth #723 to discuss key points of the study and the latest innovations in dental healthcare. To learn more, visit www.OraPharma.com.
About OraPharma OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease, malocclusion and multiple regenerative solutions for oral surgery. More information can be found at https://www.orapharma.com/.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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]]>Fri, 07 Jul 2023 07:02:54 GMTLAVAL, Quebec, July 7, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and KKR today announced that Bausch Receivables Funding LP, an Ontario limited partnership and wholly-owned subsidiary of Bausch Health, has entered into a $600 million non-recourse financing facility with KKR and its credit funds and accounts. The facility will be collateralized by certain accounts receivables originated by a wholly-owned subsidiary of Bausch Health.
Bausch Health expects to utilize the proceeds from the facility for general corporate purposes. The facility provides access to additional liquidity for a term of approximately five years.
Houlihan Lokey, Inc. acted as the Company's financial advisor. Finacity Corporation acted as the administrator for the program, providing analytic and execution support, and is responsible for ongoing program administration and reporting.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements About Bausch Health This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
About KKR
KKR is a leading global investment firm that offers alternative asset management as well as capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR's insurance subsidiaries offer retirement, life and reinsurance products under the management of Global Atlantic Financial Group. References to KKR's investments may include the activities of its sponsored funds and insurance subsidiaries. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR's website at www.kkr.com and on Twitter @KKR_Co.
About Finacity
Finacity, a White Oak Global Advisors Company, specializes in the structuring and provision of efficient capital markets receivables funding programs, supplier and payables finance, back-up servicing, and program administration. Finacity currently facilitates the financing and administration of an annual receivables volume of approximately US $150 billion. With resources in the USA, Europe, Latin America, and Asia, Finacity conducts business throughout the world with obligors in 175 countries. Finacity is affiliated with White Oak Global Advisors, LLC, a leading alternative debt manager specializing in originating and providing financing solutions to facilitate the growth, refinancing, and recapitalization of small and medium enterprises. For further information, please visit www.finacity.com.
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]]>Fri, 30 Jun 2023 08:30:00 GMTLAVAL, Quebec, June 30, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), announced that it has entered into a definitive agreement with Novartis to acquire XIIDRA® (lifitegrast ophthalmic solution) 5%, a non-steroid eye drop specifically approved to treat the signs and symptoms of dry eye disease (DED) focusing on inflammation associated with dry eye.
Under the terms of the agreement, Bausch + Lomb, through an affiliate, has agreed to acquire XIIDRA, libvatrep and AcuStream from Novartis for up to $2.5 billion, including an upfront payment of $1.75 billion in cash with potential milestone obligations up to $750 million based on sales thresholds and pipeline commercialization. Bausch + Lomb will also bring on the sales force supporting XIIDRA. Bausch + Lomb has obtained fully committed financing from J.P. Morgan for the transaction and intends to finance the $1.75 billion upfront cash purchase price with new debt prior to closing. The transaction is expected to close by the end of 2023 and be immediately accretive to Bausch + Lomb. The transaction was approved by the Board of Directors at each of the respective companies and is subject to receipt of regulatory approval and other customary closing conditions.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the proposed transaction with Novartis (the “Transaction”); the possibility that any or all of the conditions to the consummation of the Transaction may not be satisfied or waived, including failure to receive required regulatory approvals; the effect of the announcement or pendency of the Transaction on Bausch + Lomb’s ability to maintain relationships with customers, suppliers, and other business partners; the impact of the Transaction if consummated on Bausch + Lomb’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; and risks relating to potential diversion of management attention away from Bausch + Lomb’s ongoing business operations.
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]]>Mon, 19 Jun 2023 08:00:00 GMTLAVAL, Quebec, June 19, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced its presence at the European Association for the Study of the Liver (EASL) Congress 2023. XIFAXAN® (rifaximin) data was selected for inclusion in the Cirrhosis and its complication’s session. EASL Congress 2023 will be held virtually and in-person in Vienna, Austria, from June 21-24, 2023.
The Salix research to be featured at EASL Congress 2023 and available in person and via the meeting's online platform is as follows:
XIFAXAN
Bajaj, Jasmohan S. et al. “Rifaximin plus lactulose is more effective than lactulose alone for the prevention of overt hepatic encephalopathy in patients with or without diabetes”
Wednesday, 21 Jun, 09:00 - 09:00 CEST
Bajaj, Jasmohan S. et al. “Serum ammonia levels do not correlate with overt hepatic encephalopathy severity and time to resolution in hospitalized patients with cirrhosis”
Wednesday, 21 Jun, 09:00 - 09:00 CEST
Heimanson, Zeev. et al. “Impact of rifaximin use post-discharge of an overt hepatic encephalopathy (OHE) hospitalization on the annual rates of OHE-related inpatient stays”
Saturday, 24 Jun, 09:00 - 09:00 CEST
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information. About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Tue, 06 Jun 2023 08:00:00 GMTLAVAL, Quebec, June 6, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, understand that in a June 2, 2023, letter, the U.S. Food and Drug Administration (FDA) granted Norwich Pharmaceuticals Inc. Tentative Approval of its Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg. At the same time, the FDA confirmed in its Letter that it cannot grant Final Approval until Oct. 2, 2029 – the date specified by the presiding judge in his Final Judgment in Salix Pharmaceuticals, LTD et al. v. Norwich Pharmaceuticals, Inc.
Having recently failed in its attempt to modify the Final Judgment (see May 17 Press Release), Norwich has now sued the FDA in the United States District Court for the District of Columbia requesting that the Court direct the FDA to immediately grant Final Approval to the ANDA. Like its failed motion for modification of the Final Judgment, Norwich’s lawsuit is another attempt to avoid the Final Judgment.
Bausch Health intends to intervene in Norwich’s lawsuit against the FDA and will continue to take all steps to vigorously defend its intellectual property.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company’s appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Wed, 31 May 2023 08:00:00 GMTCover Your Bases Campaign Kicks Off Oral Health Month
with ARESTIN (minocycline HCI) Patient Ambassador Alex Rodriguez
LAVAL, Quebec, May 31, 2023 -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health care business, OraPharma, today announced its collaboration with World Series Champion and 3-time American League MVP, Alex Rodriguez, to launch a national awareness campaign about the prevalence and impact of gum disease. The Cover Your Bases campaign includes educational content about the disease and encourages patients to talk to their dentist about comprehensive treatment options. The campaign launch is timed to Oral Health Month recognized throughout June and features Alex as a patient ambassador.
According to the American Dental Association, gum disease affects nearly 65 million Americans nationwide. More specifically, nearly half of Americans aged 30 and older and 70% of those aged 75 and older have some form of gum disease. The most common symptoms of gum disease include bleeding during or after brushing and red or swollen gums. Some studies suggest that gum disease may be associated with an increased risk for other chronic conditions throughout the body, such as diabetes and heart disease.
“Throughout my life and career, I’ve always put a great deal of energy into prioritizing my health, which is why I was shocked when my dentist told me I had early-stage gum disease,” said Rodriguez. “My dentist also informed me that gum disease is more common in men and in Latino communities, which is why I felt it was really important for me to share my story. I was lucky to catch it early, and if it can happen to me, it can happen to anyone.”
While there is no cure for gum disease, it is important to consider comprehensive treatment plans that may include ARESTIN – an antibiotic used in combination with scaling and root planing (SRP) to treat adult periodontitis, also known as gum disease. ARESTIN is applied at the site of infection, helping to fight the bacteria that cause gum disease. ARESTIN may be used as part of an overall health program that includes good brushing and flossing habits and SRP.
“This campaign is the first of its kind for OraPharma, and we couldn’t be more excited to have Alex on the team to share his experience not only to help educate patients about this often misunderstood and underdiagnosed disease, but also to encourage them to talk to their dentist,” said Tom Stern, Vice President and General Manager at OraPharma. “We hope that this campaign will help bring awareness to gum disease and empower others to take charge of their dental health by seeking out appropriate treatment options that may help manage this serious disease.”
To learn more about a treatment option and to hear Alex’s story, visit www.Arestin.com.
About ARESTIN®
INDICATION
ARESTIN® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.
IMPORTANT SAFETY INFORMATION
Do not take ARESTIN if you are allergic to minocycline or tetracyclines. Ask your dentist or pharmacist for a list of these drugs if you are not sure. Swelling of the face, itching of the skin, fever and enlarged lymph nodes have been reported with the use of ARESTIN. Some of these reactions were serious. Tell your dentist right away if you have any signs of allergic reaction, such as skin reactions or trouble breathing, or if you have an exaggerated sunburn reaction.
THE USE OF TETRACYCLINE CLASS DRUGS, INCLUDING ARESTIN, DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
ARESTIN has not been studied in patients with weakened immune systems (such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation). Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndrome with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness. Tell your doctor about any health problems you have, including whether you have had oral candidiasis ("thrush") in the past, and about all medications you are taking.
In clinical studies, the most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About OraPharma
OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease, malocclusion and multiple regenerative solutions for oral surgery. More information can be found at https://www.orapharma.com/.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Thu, 18 May 2023 08:00:00 GMTNovel Trial to Study the Reduction of Certain Pathogens Following Scaling and Root Planing Procedure
LAVAL, Quebec, May 18, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health care business, OraPharma, today announced the publication of a new study, which showed that ARESTIN® (minocycline HCI) microspheres, 1mg decreased certain pathogenic burdens, also known as infection burdens, in adults with periodontitis when applied immediately after scaling and root planning (SRP) and again at a three-month reapplication, versus SRP alone. ARESTIN is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
The investigator-initiated trial, sponsored in part by Bausch Health, and conducted by researchers from the University of Minnesota School of Dentistry, appeared today in the Journal of Periodontology. The study showed minocycline application immediately after initial SRP and reapplication at 3-months after SRP decreased certain key pathogens and may have contributed to improvements in probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP) and gingival index (GI) compared to SRP alone.
“Dental practices need to think about periodontal disease and the role of keystone pathogens that originate in the mouth, can travel, and may be associated with other systemic outcomes such as diabetes and cardiovascular disease,” said Richard Nagelberg, DDS, Director of Medical Affairs at Bausch Health. “This study represents an important path forward in helping to manage periodontal disease and we hope it encourages further research in the area of periodontal disease progression and how it may relate to the oral-systemic connection.”
Since the pivotal trial, there was a gap in the literature on whether minocycline HCI microspheres, 1mg reduced specific periodontal pathogens. This study identified that the administration of minocycline HCI microspheres, 1mg did significantly decrease specific periodontal pathogens.
The objective of the study entitled, Effect of Scaling and Root Planing With and Without Minocycline HCl Microspheres on Periodontal Pathogens and Clinical Outcomes: A Randomized Clinical Trial, was to determine if minocycline HCl plus SRP contributed to the improvement of certain clinical measures commonly seen in patients with gum disease. A secondary endpoint was to determine if minocycline microspheres HCl with SRP lowered specific pathogens responsible for periodontitis compared to SRP alone. Saliva and clinical outcomes were collected for both groups at baseline before SRP, 1-month reevaluation, and at 3 and 6-month periodontal recall. Minocycline microspheres (MM) were delivered to pockets ≥5 mm immediately after SRP and immediately after the 3-month periodontal maintenance. This study reported that of the 11 pathogens that play an instrumental role in periodontitis, there were six periodontal pathogens that had a statistically significant decrease at 1-month and four periodontal pathogens with a statistically significant decrease at the 6-month periodontal maintenance versus the SRP group alone. This study also reported that minocycline HCI plus SRP achieved greater improvement for probing depth, bleeding on probing, gingival index, and improvement in clinical attachment loss by the six-month periodontal maintenance versus SRP alone.
Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (PI) collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis.
“There was a larger decrease of Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum/periodonticum, Prevotella intermedia, Parvimonas micra and Eikenella corrodens in the SRP + MM group,” said Dr. Nagelberg. It is notable that minocycline HCl microspheres, 1mg immediately following SRP procedures reduced these specific periodontal pathogens by the 1-month reevaluation.
The previous pivotal study (Williams et al., 2001) was conducted to determine if minocycline HCI plus SRP reduced pocket depth in patients with generalized moderate to advanced adult periodontitis versus SRP alone. Subjects treated with minocycline HCI plus SRP were found to have statistically significantly reduced probing pocket depth compared with those treated with SRP alone or SRP + vehicle at 9 months after initial treatment.
About the Study
A total of 70 participants were randomized to receive SRP alone, or SRP with minocycline HCl microspheres, 1mg following the procedure, and again at the 3-month periodontal visit. Participants in both groups received periodontal evaluations at baseline, one month, three months and six months following the initial SRP procedure. The primary goal of this study was to determine the adjunctive effects of minocycline microspheres (MM) on clinical outcomes of PD, CAL, BOP, and GI after SRP+MM compared to SRP alone. Secondary outcome variables were the relative numbers of 11 periodontal pathogens in saliva after SRP+MM compared to SRP alone. The bacterial load and pathogenic burden were determined using a salivary test.
Microorganisms and secondary periodontal measurements were compared between groups using generalized linear mixed-effects models, with fixed effects for group, visit, site (for clinical measurements), and group-by-visit and group-by-site interactions, and random effects for participant and site within participant. Mean changes from baseline were compared between groups via group-by-visit interaction tests.
The six periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the one-month follow-up visit were Tannerella forsythia (Tf) (0.003), Treponema denticola(Td) (0.01), Fusobacterium nucleatum/periodonticum (Fn/Fp)(0.0009), Prevotella intermedia (Pi) (0.04), Parvimonas micra (Pm) (<0.0001), andEikenella corrodens (Ec) (0.02). Further, the four periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the final six-month visit were Fusobacterium nucleatum/periodonticum (Fn/Fp) (0.02), Prevotella intermedia (0.05), Campylobacter rectus (Cr) (0.04) and Eikenella corrodens (0.0002).
Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis.
The statistical analysis for this research was supported by a grant from the National Institutes of Health’s National Center for Advancing Translational Science.
Important Safety Information for ARESTIN®
INDICATION
ARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.
IMPORTANT SAFETY INFORMATION
ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present. Swelling of the face, pruritus, fever and lymphadenopathy have been reported with the use of ARESTIN. Some of these reactions were serious. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with oral minocycline, as well as acute photosensitivity reactions.
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
Tetracyclines, including oral minocycline, have been associated with development of autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise. In symptomatic patients, diagnostic tests should be performed and ARESTIN treatment discontinued.
The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied.
The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis. Use with caution if there is a predisposition to oral candidiasis.
In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ARESTIN® is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
In 2001, a pivotal study was conducted to: 1) determine whether the administration of minocycline microspheres would enhance the therapeutic effect of scaling and root planing in patients with chronic periodontitis, and 2) determine whether the compound was safe and well tolerated.
Seven hundred forty-eight (748) patients with moderate to advanced periodontitis were enrolled in an investigator-blind, multi-center trial and randomized to 1 of 3 treatment arms: 1) scaling and root planing (SRP) alone; 2) SRP plus vehicle; or 3) SRP plus minocycline microspheres. The primary outcome measure was probing depth reduction at 9 months. Clinical assessments were performed at baseline and 1, 3, 6, and 9 months.
Minocycline microspheres plus scaling and root planing provided substantially more probing depth reduction than either SRP alone or SRP plus vehicle. The difference reached statistical significance after the first month and was maintained throughout the trial. The improved outcome was observed to be independent of patients' smoking status, age, gender, or baseline disease level. There was no difference in the incidence of adverse effects among treatment groups.
About Periodontitis Risks According to the National Health and Nutrition Examination Survey (NHANES), 42.2% of United States adults have periodontitis. There are certain factors that increase the risk for developing gum disease which include smoking, diabetes, poor oral hygiene, obesity and diabetes. In addition, gum disease may provide a gateway for bacteria to enter the body and trigger systemic health issues and inflammation in the body, though further research is necessary.
About OraPharma
OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease and multiple regenerative solutions for oral surgery. More information can be found at https://www.orapharma.com/.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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]]>Wed, 17 May 2023 13:35:17 GMTLAVAL, Quebec, May 17, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. District Court of Delaware in the matter of Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc., has denied Norwich Pharmaceuticals’ motion to modify the Court’s final judgment that prevents the U.S. Food and Drug Administration (FDA) from approving Norwich’s abbreviated new drug application (ANDA) for XIFAXAN® (rifaximin) 550 mg before Oct. 2, 2029. As a result of this decision, Norwich’s ANDA cannot be approved until Oct. 2, 2029.
“This decision is important for patients who continue to depend on a proven and highly effective drug to treat gastro-intestinal disorders,” Thomas J. Appio, Chief Executive Officer stated. “It is our long- standing position that the XIFAXAN patent claims are valid and infringed by Norwich’s ANDA. We will continue to advocate for the safety of patients who have benefited from the continued access to XIFAXAN, and we look ahead to the appeal process.”
To date, Norwich has not received tentative or final approval of its ANDA from the FDA.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its
product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company’s appeal with respect to, and actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
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]]>Wed, 17 May 2023 08:00:00 GMTLAVAL, Quebec, May 17, 2023– Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the results of its 2023 annual meeting of shareholders (the “Annual Meeting”).
The 10 directors nominated at the Company’s Annual Meeting held on May 16, 2023, were elected by a vote of the Company’s shareholders. The detailed results of the vote for the election of directors are set out below:
Name
For
Withheld
Broker Non-Votes
Thomas J. Appio
190,930,071
2,850,553
69,221,265
Brett M. Icahn
169,686,359
24,094,265
69,221,265
Sarah B. Kavanagh
189,301,790
4,478,834
69,221,265
Steven D. Miller
181,093,705
12,686,919
69,221,265
Dr. Richard C. Mulligan
174,330,012
19,450,612
69,221,265
John A. Paulson
182,711,655
11,068,969
69,221,265
Robert N. Power
183,421,864
10,358,760
69,221,265
Russel C. Robertson
189,249,474
4,531,150
69,221,265
Thomas W. Ross, Sr.
190,210,369
3,570,255
69,221,265
Amy B. Wechsler, M.D.
190,174,239
3,606,385
69,221,265
Shareholders also approved the non-binding advisory vote on the compensation of the Company’s named executive officers and an annual frequency of future advisory votes on the compensation of the Company’s named executive officers approved an amendment to the Company’s 2014 Omnibus Incentive Plan (the “Plan”) to increase the number of common shares authorized for issuance thereunder, and appointed PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm until the close of the Company's 2024 annual meeting of shareholders.
For the purposes of Toronto Stock Exchange (TSX) approval with respect to the Plan, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as the NYSE.
The final vote tabulation on all matters voted on at the meeting will be reported to the U.S. Securities and Exchange Commission on a current report on Form 8-K, and such report will be made available on the Company’s SEDAR profile and on the Company’s website at www.bauschhealth.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about Bausch Health and Bausch + Lomb, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the timing and details of the future plans for Bausch + Lomb and its future performance. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's and Bausch + Lomb's overall business, including those more fully described in Bausch + Lomb's and Bausch Health's respective filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health and Bausch + Lomb undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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]]>Wed, 10 May 2023 08:00:00 GMTLAVAL, Quebec, May 10, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) is proud to recognize May as Mental Health Awareness Month by continuing efforts that highlight the importance of educating and supporting those with mental health care needs.
With more people finding value in speaking with a mental health professional and seeking treatment, this heightened focus on mental health has never been more important.1 By the end of 2022, 37% of Americans rated their mental health as “fair or poor”—a 6% increase from 2021. Twenty-six percent expect to experience more stress throughout 2023.2 Dedicating the month of May to mental health offers those with concerns the reminder and opportunity to prioritize self-awareness and self-care.
This year, Bausch Health is also proud to highlight 20 years of trusted legacy with WELLBUTRIN XL.3,4 Since its FDA approval in 2003, WELLBUTRIN XL has been prescribed by more than 440,000 healthcare professionals to more than 7 million patients for a total of more than 51 million prescriptions filled.5-7
WELLBUTRIN XL offers a proven clinical profile, convenient dosing for patients, and comprehensive support for eligible patients.3 Visit wellbutrinXL.com to access information regarding mental health and depression.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
INDICATION
WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).
IMPORTANT SAFETY INFORMATION
Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.
WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS
Suicidal Thoughts or Actions and Antidepressant Drugs Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. WELLBUTRIN XL has not been evaluated for use in patients under the age of 18.
Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
Although WELLBUTRIN XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking.
Some people have had serious side effects while taking bupropion to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
Stop taking WELLBUTRIN XL and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take WELLBUTRIN XL. In many people, these symptoms went away after stopping WELLBUTRIN XL, but in some people, symptoms continued after stopping WELLBUTRIN XL. It is important for you to follow-up with your healthcare provider until your symptoms go away.
Before taking WELLBUTRIN XL, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.
Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.
What Other Important Information Should I Know About WELLBUTRIN XL?
Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking WELLBUTRIN XL unless your healthcare provider has said it is okay to take them. If you have a seizure while taking WELLBUTRIN XL, stop taking the tablets and call your healthcare provider right away.
High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking WELLBUTRIN XL.
Manic episodes: Some people may have periods of mania while taking WELLBUTRIN XL. If you have any of the following symptoms of mania, call your healthcare provider:
greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual
Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking WELLBUTRIN XL, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take WELLBUTRIN XL. You should see an eye doctor to determine whether you are at risk prior to starting therapy.
Severe allergic reactions: Some patients have severe allergic reactions to WELLBUTRIN XL. Stop taking WELLBUTRIN XL and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
Do not take WELLBUTRIN XL if you:
have or had a seizure disorder or epilepsy
have or had an eating disorder such as anorexia nervosa or bulimia
are taking any other medicines that contain bupropion, including WELLBUTRIN or WELLBUTRIN SR, APLENZIN®, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in WELLBUTRIN XL
drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
do not take an MAOI within 2 weeks of stopping WELLBUTRIN XL unless directed to do so by your healthcare provider
do not start WELLBUTRIN XL if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider
are allergic to the active ingredient in WELLBUTRIN XL, bupropion, or to any of the inactive ingredients
Although WELLBUTRIN XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking WELLBUTRIN XL, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you:
have liver problems, especially cirrhosis of the liver
have kidney problems
have, or have had, an eating disorder such as anorexia nervosa or bulimia
have had a head injury
have had a seizure (convulsion, fit)
have a tumor in your nervous system (brain or spine)
have had a heart attack, heart problems, or high blood pressure
are a diabetic taking insulin or other medicines to control your blood sugar
drink alcohol
abuse prescription medicines or street drugs
are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take WELLBUTRIN XL during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185
are breastfeeding. WELLBUTRIN XL passes into your milk in small amounts
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using WELLBUTRIN XL.
The most common side effects of WELLBUTRIN XL include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
Click here to read the Medication Guide carefully before you start using WELLBUTRIN XL. If you have any questions about WELLBUTRIN XL, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact Bausch Health Customer Service at 1-800-321-4576.
References
1. American Psychological Association. Demand for mental health treatment continues to increase, say psychologists. https://www.apa.org/news/press/releases/2021/10/mental-health-treatment-demand. Accessed March 29, 2023.
2. American Psychiatric Association. Americans anticipate higher stress at the start of 2023 and grade their mental health worse. https://www.psychiatry.org/news-room/news-releases/americans-anticipate-higher-stress-at-the-start-of. Accessed March 29, 2023.
3. WELLBUTRIN XL (bupropion hydrochloride extended-release) Prescribing Information. Bausch Health Companies Inc.
4. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf. Accessed March 29, 2023.
5. Data on File. IQVIA: Unique prescribers. 2022.
6. Data on File. IQVIA: Total patients. 2022.
7. Data on File. IQVIA: Total prescriptions. 2022.
Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.
]]>® 2023 ]]>Mon, 08 May 2023 08:00:00 GMTFive XIFAXAN® (rifaximin) and TRULANCE® (plecanatide) Research Posters Also to Be Presented
LAVAL, Quebec, May 8, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, (“Salix”), the gastroenterology (GI) business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and one of the largest specialty pharmaceutical companies in the world committed to the management and treatment of gastrointestinal diseases, today will deliver a podium presentation of its research titled “Impact of Rifaximin Use During The 30-Day Post-Discharge Period Following an Overt Hepatic Encephalopathy Hospitalization on Healthcare Utilization And Costs” during Digestive Disease Week® (DDW) 2023, which will be held virtually and in-person in Chicago, IL through Tuesday, May 9, 2023.
The study led by Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell, describes and compares healthcare resource utilization, including the rate of overt hepatic encephalopathy (OHE) hospitalizations, and costs during the 30-day period following an OHE hospitalization among patients who are treated with Xifaxan versus those who are not. Results showed that initiation of Xifaxan after an OHE hospitalization resulted in reduced OHE-related hospitalizations in the 30-day period following an OHE hospitalization. Further, initiation of Xifaxan immediately upon discharge after the OHE hospitalization showed a high quality of care, with a lower rate of OHE-related hospitalizations. Additionally, reduced medical costs associated with fewer hospitalizations offset the increased pharmacy costs of Xifaxan.
“The research was designed to help establish optimal clinical practices and patient health outcomes post an OHE-related hospitalization,” said Dr. Jesudian. “Adding to a growing body of evidence, the study supports the use of Xifaxan to both reduce re-hospitalizations and their associated medical costs after an initial OHE-related hospitalization.”
In addition, on Sunday, May 7, lead author Robert Wong, MD, MS Clinical Associate Professor (Affiliated) of Medicine in the division of Gastroenterology and Hepatology at the Stanford University School of Medicine and Staff Physician in the Gastroenterology Section at the Veterans Affairs Palo Alto Healthcare System, presented a poster titled “Real-World Trends in The Prevalence of Cirrhosis and Rates of Overt Hepatic Encephalopathy Among Commercially Insured Adults in The United States From 2006-2020” that showed an increasing trend in the prevalence of diagnosed cirrhosis from 0.20% in 2006 to 0.45% in 2020. Among adults with cirrhosis, the rate of decompensation increased by 27% from 35.6% in 2006 to 45.2% in 2020 and the rate of OHE nearly doubled from 11.8% in 2006 to 21.4% in 2020. Based on the study findings, there were approximately 900,000 adults with cirrhosis, 450,000 with decompensated cirrhosis, and 200,000 with OHE in the US in 2020.
A complete list of research being presented by Salix at DDW 2023 on behalf of XIFAXAN® (rifaximin) and TRULANCE® (plecanatide), includes:
HEALTH POLICY
Wong, Robert. et al. “Real-World Trends in the Prevalence of Cirrhosis and Rates of Hepatic Encephalopathy Among Commercially Insured Adults in the United States From 2006-2020”
May 7, 2023 – 12:30 –1:30 PM (CDT); Embargo Time-12:01 a.m. CDT May 7
Abstract #-3859401 / Poster #-Su1546
Jesudian, Arun. et al. “Perception of Moderate to High Risk Factors for Developing Overt Hepatic Encephalopathy Across Physician Specialties in The United States”
May 9, 2023 – 12:30 –1:30 PM (CDT); Embargo Time- 12:01 a.m. CDT May 9
Abstract #-3853017 / Poster #-Tu1524
XIFAXAN
Kowdley, Kris. et al. “Rifaximin Plus Lactulose Is More Efficacious Than Lactulose Alone for The Prevention of Overt Hepatic Encephalopathy in Patients With Or Without Ascites”
May 7, 2023 – 12:30-1:30 PM (CDT); Embargo Time-12:01 a.m. CDT May 7
Abstract #-3862864 / Poster #-Su1548
Jesudian, Arun. et al. “Impact of Rifaximin Use During The 30-Day Post-Discharge Period Following an Overt Hepatic Encephalopathy Hospitalization on Healthcare Utilization And Costs”
May 8, 2023 – 2:30-2:45 PM (CDT); Embargo Time-12:01 a.m. CDT May 8
Abstract #-3857579
Gagnon-Sanschagrin, Patrick. et al.“Long Term Care Services Use Among Medicare Patients Treated with Rifaximin for Overt Hepatic Encephalopathy”
May 9, 2023 – 12:30 –1:30 PM (CDT); Embargo Time-12:01 a.m. CDT May 9
Abstract #-3862445 / Poster #-Tu1522
TRULANCE
Brenner, Darren. et al. “Plecanatide Improves Abdominal Pain, Bloating, And Straining Symptoms in Adults with Irritable Bowel Syndrome with Constipation (IBS-C): A New Composite Endpoint Analysis of Two Randomized, Phase 3 Trials”
May 9, 2023 – 12:30-1:30 PM (CDT); Embargo Time- 12:01 a.m. CDT May 9
Abstract #-3860993 / Poster #-Tu1617
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN were:
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information. About TRULANCE
Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Contraindications
Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients
Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of Trulance-treated CIC patients, and in 1% of Trulance-treated IBS-C patients.
If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
In the two combined IBS-C clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1- 800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
First-Quarter revenues of $1.94 billion, up 1% reported and 4% organic1
Solid revenue growth across core products, led by Xifaxan with 7% reported growth
Mid- and late-stage product pipeline advancing
Bausch Health provides consolidated full-year guidance, and Bausch Health (excl. B+L) confirms 2023 guidance
LAVAL, QC, May 4, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company” or “we” or “our”) today announced its first-quarter 2023 financial results.
“We are encouraged with the top-line improvement in the first quarter, with four out of five segments delivering revenue growth on both a reported revenue and organic basis1 and are pleased that demand for key products has remained resilient in the current macro environment,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “We are progressing our mid- and late-stage pipeline, and we look forward to bringing new products to the patients who can benefit from them.”
Bausch Health (excl. B+L) Pipeline Update
Amiselimod: Phase 2 trial is progressing and expected to be completed in the second half of 2023.
RED-C: Investments related to Reduction of Early Decompensation in Cirrhosis (RED-C) program have accelerated. Two global Phase 3 studies are currently underway and enrollment is on-track. The Company held scientific advisory meetings with the Medicines Evaluation Board (MEB) in the Netherlands and with Health Canada, and plans to engage with relevant authorities in Japan and China later this year.
IDP-126: The FDA accepted the Company's new drug application and received an October 20, 2023, PDUFA date. If approved by the FDA, IDP-126 would be a first-in-class treatment with a triple combination of benzoyl peroxide, clindamycin phosphate and adapalene. A submission in Canada is planned for the second quarter of this year.
Solta Medical: We are planning a regulatory submission for Clear and Brilliant Touch in Europe and Canada in 2024 and for Asia Pacific markets in 2025. FDA submission is expected for Next Generation Fraxel in Q4 2023.
First Quarter 2023 Revenue Performance
Total reported revenues were $1.94 billion for the first quarter of 2023, compared with $1.92 billion in the first quarter of 2022, an increase of $26 million, or 1%. Excluding the unfavorable impact of foreign exchange of $40 million and the impact of acquisitions, divestitures, and discontinuations of $7 million, revenue increased by 4% organically1 compared with the first quarter of 2022.
]]>Mon, 01 May 2023 08:00:00 GMTPDUFA Action Date is October 20, 2023
LAVAL, Quebec, May 1, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel with a Prescription Drug User Fee Act (PDUFA) action date of October 20, 2023. If approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination treatment for acne vulgaris.
“In requesting approval from the FDA, we are hopeful that we may be able to bring a first-of-its kind triple-combination acne treatment to the millions of Americans who suffer from acne each year,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “The treatment of acne can be challenging and may often require multiple therapies. With the potential of a triple-combination product, we believe IDP-126, if approved, could not only help alleviate the existing burden of treatment but also potentially help patient outcomes.”
The NDA submitted for IDP-126 includes data from two successfully completed Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count and percentage of patients achieving treatment success (2 grade reduction of the EGSS with a final score of clear (0) or almost clear (1)). Both studies showed treatment-emergent adverse events were of mild to moderate severity.
Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples to appear on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2
About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis,onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
References
American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed March 13, 2023.
Mayo Clinic. (2020). Acne. Retrieved from https://www.mayoclinic.org/diseasesconditions/acne/symptoms-causes/syc-20368047. Accessed March 13, 2023.
]]>Mon, 24 Apr 2023 08:00:00 GMTProgram Seeks to Increase the Number of People
Screened to Help Prevent Colorectal Cancer Diagnoses in Philadelphia
LAVAL, Quebec, April 24, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced a partnership with the Colorectal Cancer Alliance (Alliance), the nation's nonprofit leader dedicated to combatting colorectal cancer, to increase awareness and access to preventative colorectal screenings in medically underserved communities.
This May, the Alliance is launching a colorectal cancer screening and prevention initiative in Philadelphia with a focus on the communities facing the greatest disparities in health outcomes. In support of the Alliance’s efforts to improve access to these screenings, Salix will donate its prescription bowel preparation product to individuals who require a colonoscopy. Colonoscopies are a critical tool in the early detection of colorectal cancer1. Research shows colorectal cancer can have a 90% survival rate if caught early2.
“The importance of early detection and prevention in colorectal cancer cannot be overstated, and Salix is committed to working with the Colorectal Cancer Alliance in its endeavors to address health inequities and to break down barriers to prevention and treatment among those who lack access to care,” said Nicola Kayel, vice president, GI Marketing, Salix.
According to the American Cancer Society, excluding skin cancers, colorectal cancer (CRC) is the third most common cancer diagnosed in both men and women – and the second leading cause of cancer deaths in men and women combined in the U.S.; and in 2023, it is estimated there will be 106,970 new cases of colon cancer and 46,050 new cases of rectal cancer3.
The disparities in colorectal cancer outcomes are largely driven by socioeconomic inequities that result in differences in access to early detection tests and receiving timely, high-quality care. In fact, 44% of the socioeconomic disparity is attributed to differences in the prevalence of risk factors associated with CRC, such as smoking and obesity, and a similar proportion is due to differences in screening4.
"As the largest nonprofit organization dedicated to ending colorectal cancer, the Colorectal Cancer Alliance is proud to collaborate with Salix on this important public health initiative,” said Marcie Klein, Senior Vice President, Prevention at the Alliance. “Breaking down barriers to prevention and screening among those at greater risk of diagnosis and death from colorectal cancer is a shared goal of our two organizations. The donation of product by Salix will greatly assist in the program’s success.”
About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients’ lives and arm healthcare providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. healthcare providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
For 30 years, Salix Pharmaceuticals has been committed to the prevention and treatment of gastrointestinal diseases. Salix licenses, develops, and markets innovative products to improve patients’ lives and arm healthcare providers with life-changing solutions. Salix is headquartered in Bridgewater, New Jersey.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
About the Colorectal Cancer Alliance The Colorectal Cancer Alliance is a national nonprofit committed to ending colorectal cancer. Working with our nation of passionate allies, we diligently support the needs of patients and families, caregivers, and survivors; eagerly raise awareness of preventive screening; and continually strive to fund critical research. As allies in the struggle, we are fiercely determined to end colorectal cancer within our lifetime. For more information, visit ccalliance.org.
Forward-Looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Thu, 13 Apr 2023 08:00:00 GMTLAVAL, Quebec, April 13, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) will release its first-quarter financial results on Thursday, May 4, 2023. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
LAVAL, Quebec, April 4, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today announced the results from the third edition of its patient perspectives survey, an annual survey of U.S. adults living with irritable bowel syndrome (IBS) or chronic idiopathic constipation (CIC). The report, Patient Perspectives: Impacts of Living with IBS, offers a current understanding of the behaviors and experiences of the IBS and CIC patient population, including insights on diagnosis, barriers to provider discussions, and symptom management.
The report, which was developed based on a nationwide survey conducted in partnership with the Fairleigh Dickinson University Poll in January 2023, found most notably that more than half of survey respondents (54%) waited 1 year or more before mentioning their symptoms to healthcare providers. Additionally, many were unaware that IBS was a chronic condition (43%), assumed their symptoms would resolve with diet modification (43%), over-the-counter medications (39%), or felt awkward talking about their symptoms to their doctor (32%).
“The findings from this year’s survey demonstrate the need for continued awareness and education about the multiple symptoms associated with IBS and CIC, which are chronic conditions that have prescription treatment options available. It also underscores the need for a more proactive HCP-patient dialogue around IBS symptoms,” said Nicola Kayel, Vice President, GI Marketing. “With IBS affecting between 25 and 45 million people in the United States1, Salix remains steadfast in its commitment to encourage meaningful provider-patient interactions that open the lines of communications to a collaborative approach to symptom management and guideline-based treatments.”
Additional key findings from the report include:
Overall, 1 out of 5 (23%) adult patients were not aware that there were prescription treatment options available to address their IBS symptoms
Only 30% of IBS-diagnosed survey respondents reported that they were initially offered a prescription
Surprisingly, more than one-quarter of respondents reported that it took more than 3 years to be prescribed a medication or hadn’t yet been prescribed treatment at all
The vast majority (90%) of adult IBS-D patients reported that they would consider a limited course medication to treat their symptoms
More than 8 out of 10 (86%) adult patients reported that they want their healthcare practitioner to proactively ask them if all of their symptoms have been relieved during their follow-up appointments
To view key insights from Salix’s Patient Perspectives: Impacts of Living with IBS Report, visit here.
About the Methodology Behind Patient Perspectives: Impacts of Living with IBS
Data is from a non-probability online sample of U.S. residents and was carried out in January 2023 by Fairleigh Dickinson University’s FDU Poll. Participants were recruited based on previously reported gastrointestinal issues. The overall sample size of the survey was 724 respondents and was screened to include only those who self-reported having IBS with constipation, chronic idiopathic constipation or IBS with diarrhea. Respondents were drawn from multiple panels of U.S. residents and were compensated for their time (maximum $3.00). Due to the limitations of this survey, results may not be representative of the general IBS or CIC population.
About Fairleigh Dickinson University
Since 2001, Fairleigh Dickinson University’s FDU Poll has conducted survey research on issues of public importance. Utilizing best practices in survey methodology, FDU Poll produces authoritative statewide and national public polling. In addition, FDU Poll engages in research for corporate, non-profit and government entities. As a charter member of the American Association for Public Opinion Research’s Transparency Initiative, the FDU Poll is devoted to building public confidence in polling by embracing the open science of survey research.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. healthcare providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Wed, 01 Mar 2023 08:00:00 GMTLAVAL, Quebec, March 1, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced that Richard De Schutter and Dr. Argeris Karabelas are retiring from the Company’s Board of Directors, effective as of the upcoming 2023 annual meeting of shareholders of the Company. Following the retirements of Mr. De Schutter and Dr. Karabelas, the size of the Board will be reduced to 10 directors.
“Dick and Jerry have been valued members of our Board and their service to the Company has been greatly appreciated. The Company and entire Board are grateful for their contributions.” John A. Paulson, Chairperson of the Bausch Health Board said.
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Thu, 23 Feb 2023 07:00:00 GMT
Fourth-Quarter revenues of $2.2 billion, flat reported, up 4% organic1
Full-Year revenues of $8.1 billion, down 4% reported, up 2% organic1
Unrestricted B+L from BHC covenants
Reduced debt by $464 million in the fourth quarter
Provides 2023 guidance for Bausch Health (excl. B+L)
LAVAL, Quebec, Feb. 23, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”, “BHC”, the “Company”, or “we”) today announced its fourth-quarter and full-year 2022 financial results.
“2022 was a transformative year for Bausch Health, as we executed on our strategic priorities,” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “Since completing the initial public offering of Bausch + Lomb last May, we have made significant progress in de-levering our balance sheet, reducing our debt principal net of unrestricted cash by $3.2 billion. We are encouraged by our second half performance and look to build on this momentum. We will invest in sustainable growth drivers across our products and pipeline to position us for long-term success,” concluded Appio.
Fourth-Quarter and Full-Year 2022 Revenue Performance
Total reported revenues were $2.2 billion for the fourth quarter of 2022, flat compared with the fourth quarter of 2021. Excluding the unfavorable impact of foreign exchange of $78 million and the impact of divestitures and discontinuations of $6 million, revenue increased by 4% organically1 compared with the fourth quarter of 2021.
Total reported revenues were $8.1 billion for the full year of 2022, compared with $8.4 billion in the full year of 2021, a decrease of $310 million, or 4%. Excluding the unfavorable impact of foreign exchange of $264 million and the impact of divestitures and discontinuations of $178 million, revenue increased organically1 by 2% compared with the full year of 2021.
]]>Mon, 13 Feb 2023 09:02:10 GMTSalix to Provide Scholarships to 10 Students Living with GI Diseases
LAVAL, QC / ACCESSWIRE / February 13, 2023 / Bausch Health Companies Inc. (NYSE/TSX:BHC) today announced the opening of the 2023 Salix Gastrointestinal Health Scholars Program application period. The program will award 10 exceptional students living with GI disease a scholarship of up to $10,000 as they work to pursue their higher education goals.
"At Salix, we are honored to grant scholarships to commendable students living with GI disease to aid them in the pursuit of their higher education goals. Now in its fourth year, Salix is committed to advancing the Salix Gastrointestinal Health Scholars Program, as we look toward providing more students with the support they need," said Nicola Kayel, vice president, GI Marketing, Salix.
Students can apply for this scholarship by completing the online application, submitting letters of reference, and writing an essay on the impact having a diagnosed GI condition has had on their life and the role that a health care provider played in helping to manage their condition. Scholarships are offered to school applicants or current attendees of a two- or four-year college, university, or an advanced (post-high school) vocational or technical school for the 2023-2024 academic year and are available in four categories:
Undergraduate Scholar Awards for students pursuing undergraduate degrees
Graduate Scholar Awards for students pursuing graduate degrees
Working Parent's Scholar Award for students who are parents pursuing undergraduate, vocational/technical or graduate degrees
Single Parent's Scholar Award for students who are single parents pursuing undergraduate, vocational/technical or graduate degrees
The application period for the Salix Gastrointestinal Health Scholars Program will close on May 15, 2023, and scholarship recipients will be notified in the summer of 2023. To learn more about the scholarship, including eligibility criteria, terms and conditions, please visit www.salix.com/scholarship.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Wed, 01 Feb 2023 12:21:00 GMTLAVAL, QC / ACCESSWIRE / February 1, 2023 / Bausch Health Companies Inc. (NYSE/TSX: BHC) will release its fourth-quarter and full-year financial results on Thursday, Feb. 23, 2023. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
]]>Thu, 22 Dec 2022 12:21:00 GMTLAVAL, QC / December 22, 2022 / Bausch Health Companies Inc. (NYSE/TSX: BHC) and its Canadian dermatology division, one of the largest prescription dermatology health care businesses in Canada, today announced that its new topical prescription treatment for acne vulgaris, ARAZLOTM (tazarotene lotion, 0.045% w/w), is now available to patients through the provincial public drug plans of Quebec, Ontario, Alberta and Saskatchewan, as well as the federal government’s Non-Insured Health Benefits (NIHB) drug plan, which serves Canada’s First Nations and Inuit populations.1
ARAZLO is the first tazarotene lotion treatment approved by Health Canada for the topical treatment of acne vulgaris in patients 10 years of age and older.2 The listings by the four public drug plans are the first for ARAZLO in Canada, with others expected to follow as a result of the successful conclusion of listing negotiations with the panCanadian Pharmaceutical Alliance, representing the drug plans of the federal government and all provinces and territories.
"We are very pleased to have achieved agreements for these first public drug plan listings in Canada for ARAZLO,” said Cees Heiman, Bausch Health, Senior Vice President, Europe and Canada. “It is an important further step in helping to provide new treatment options for the approximately 5.6 million Canadians who are impacted by acne.4 We are very proud to have a large dermatology portfolio to help meet Canadians’ needs.”
“While tazarotene is not a new retinoid, the vehicle in ARAZLO is a true innovation in topical technology and enhances the tolerability, and thus effectiveness, of this new product for acne patients,” said Dr. Jerry Tan, MD, FRCPC, of Windsor, Ontario, President of the Acne and Rosacea Society of Canada, Adjunct Professor, Western University.
ARAZLO is the first tazarotene acne treatment available in a lotion formulated with PRISMATREXTM technology (formulation with known hydrating and moisturizing effects, which may alleviate dryness of skin)2 and has been shown to provide a good tolerability profile. Retinoids like tazarotene are a core component of acne treatment. Providing the treatment in a lotion form helps limit the dryness and irritation that has historically been a barrier to the long-term use of tazarotene by patients.3
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population and causes emotional distress and can cause permanent scarring2 or pigmentation changes.5 Acne affects about 90 per cent of adolescents and about 25 per cent of teens will still have acne at age 25.4
About ARAZLOTM
ARAZLO tazarotene lotion, 0.045% w/w is a topical prescription indicated for the topical treatment of acne vulgaris. ARAZLO can be used on affected areas in patients 10 years and older. The safety and efficacy of ARAZLO in children below the age of 10 years has not been established.2
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Bausch Health, Canada Inc.’s prescription treatment portfolio is focused on dermatology -, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada, in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Investor Contact:
Christina Cheng ir@bauschhealth.com
(514) 856-3855
(877) 281-6642 (toll free)
2. ARAZLO (Tazarotene Lotion) Product Monograph, July 7, 2021.
3. "Targeted Topical Delivery of Retinoids in the Management of Acne Vulgaris: Current Formulations and Novel Delivery Systems." Pharmaceutics. Gemma Latter et al, October 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6835300/, accessed Nov. 1, 2022.
]]>Fri, 02 Dec 2022 12:21:00 GMTLAVAL, QC / ACCESSWIRE / December 2, 2022 /Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced that the US District Court for the District of New Jersey issued a favorable decision regarding DUOBRII® and BRYHALI®, in a suit filed against Padagis Israel Pharmaceuticals LTD and Padagis US LLC. According to the ruling, the District Court found all the asserted patents valid and infringed. The current decision will serve to prevent approval of Padagis BRYHALI® and DUOBRII® generics until patent expiry in 2031 and 2036, respectively.
DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. BRYHALI® (halobetasol propionate) Lotion, 0.01% is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis.
Seana Carson, Executive Vice President and General Counsel stated, “We are pleased with this outcome. This decision is a reflection of the strength of our intellectual property, and our commitment to defending our patent portfolio.”
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Launching in December for Constipation Awareness Month, Initiatives Include Partnerships with Well-Known Lifestyle and Health Care Practitioner Influencers
Campaign Coincides with Salix’s Continued Support of Advocacy Groups Building Innovative Patient Education Programs and Advancing Disease State Research in 2023
LAVAL, QC / ACCESSWIRE / Dec. 1, 2022 / Salix Pharmaceuticals (“Salix”), the gastroenterology business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), today announced the launch of a series of social media and digital initiatives to raise awareness during Constipation Awareness Month in December. The initiatives will discuss constipation diseases, including opioid-induced constipation (OIC), irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It is estimated that approximately up to 80% of patients receiving opioid medications for chronic pain experience OIC,1 30 million adults have CIC,2,3 and 3.4 million have IBS-C.2,3
The initiatives launching this month culminate a year in which Salix invested in a multipronged educational campaign that included the publication of digital content reaching more than 240 million consumers with valuable information about the symptoms of OIC, IBS-C, and CIC and treatment options they can discuss with their health care providers.
Constipation Awareness Month initiatives included partnerships with Johanna Grange, a lifestyle influencer who is sharing her perspectives about living with IBS-C with her 73,000 Instagram followers and in her blog, and Ethan Melillo, a pharmacist with more than 189,000 TikTok followers, who over the past year has been working with Salix to share a series of informative videos on TikTok discussing OIC and treatment options.
“As an industry leader in the gastroenterology space, Salix is continually identifying innovative ways to connect with the patient communities we serve,” said Nicola Kayel, vice president, Gastroenterology Marketing, Salix. “In 2022, in addition to continuing to work with social media influencers lending their voice to raise awareness of gastrointestinal (GI) diseases, Salix became the first organization to partner with the creators of the PLOP app, a new and creative bowel movement tracker digital solution that monitors and analyzes daily symptoms. The collaboration, which raises awareness about the connection between opioid pain medications and constipation, supports valuable conversations between patients and health care providers that may help lead to improved regularity in bowel movements.”
To further support patients with chronic GI disorders in 2023, Salix will extend its partnerships with prestigious patient advocacy groups to advance public awareness and education for patients and health care providers. Salix will continue its collaboration with the International Foundation for Gastrointestinal Disorders (IFFGD), the U.S. Pain Foundation, the American Chronic Pain Association (ACPA), and the American College of Emergency Physicians (ACEP). Through its 2023 medical grant contributions program, Salix will continue to work with organizations such as the American Gastroenterological Association (AGA) to advance research that will improve understanding of GI conditions.
Salix will continue to host patient resources at UnderstandingOIC.com and ConfrontConstipation.com which also offer information about treatment options to be discussed with health care providers.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients’ lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health including the proposed plan to fully separate its eye health business, including the timing thereof, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
1 Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med. 2009;10(1):35-42. doi:10.1111/j.1526-4637.2008.00495.x
2 Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021;160(1):99-114.e3. doi:10.1053/j.gastro.2020.04.014
3 Bureau USC. National Demographic Analysis Tables: 2020. Census.gov. https://www.census.gov/data/tables/2020/demo/popest/2020-demographic-analysis-tables.html. Published March 10, 2022. Accessed November 22, 2022.
]]>Tue, 29 Nov 2022 12:21:00 GMTLAVAL, QC / ACCESSWIRE / November 29, 2022 /Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) has designated 1261229 B.C. Ltd., the entity that directly or indirectly holds 88.7% of the issued and outstanding shares of Bausch + Lomb Corporation (“Bausch + Lomb”), as an unrestricted subsidiary of the Company in accordance with the terms of the Company’s debt documents. In connection therewith, all of the subsidiaries of 1261229 B.C. Ltd., including Bausch + Lomb and its subsidiaries, are also now unrestricted subsidiaries of the Company and, as a result, are no longer subject to the covenants under the Bausch Health debt documents.
The Company continues to evaluate potential options to maximize stakeholder value, which include its ongoing focus on its balance sheet and liquidity.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health including the proposed plan to fully separate its eye health business, including the timing thereof, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
]]>Fri, 04 Nov 2022 12:21:00 GMTLAVAL, QC / ACCESSWIRE / November 4, 2022 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals ("Salix"), today announced one de novo abstract that is being presented at The Liver Meeting® 2022, organized by the American Association for the Study of Liver Diseases (AASLD), which is taking place November 4-8 in Washington, D.C.
The abstract being presented at AASLD's The Liver Meeting 2022 is:
Sanyal, A. et al. "Rifaximin Plus Lactulose Versus Lactulose Alone for Reducing the Risk of Overt Hepatic Encephalopathy Recurrence: A Pooled Subgroup Analysis."
About XIFAXAN® Indications
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN were:
HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
IBS-D (≥2%): Nausea (3%), ALT increased (2%)
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of the Company, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Company's overall business, including those more fully described in the Company's most recent annual report on Form 10-K and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.
Nine Poster Presentations Include New Analyses of SILIQ® and JUBLIA®
LAVAL, QC / ACCESSWIRE / November 1, 2022 / - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, today announced the presentation of nine posters during the Innovations in Dermatology Conference, which takes place Nov. 3-5, 2022, in Las Vegas, Nev. The presentations will feature new data around JUBLIA® (efinaconazole) Topical Solution, 10%, and SILIQ® (brodalumab) Injection, 210 mg/1.5 mL. There will also be six encore presentations, including analyses of DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, ARAZLO® (tazarotene) Lotion, 0.045%, and the investigational medicine IDP-126 Gel-a combination retinoid, antibacterial and antibiotic topical.
"Continued research around our products is a top priority for us at Ortho Dermatologics to ensure our portfolio meets the needs of patients," said Richard Lajoie, vice president and general manager, Ortho Dermatologics. "At this year's Innovations in Dermatology Conference, we look forward to the opportunity to directly engage with dermatologists and share new data on JUBLIA®, which received the APMA Seal of Approval in December 2021, as well as our biologic psoriasis medication, SILIQ®. "
The complete list of Ortho Dermatologics' poster presentations is as follows:
JUBLIA® (efinaconazole) Topical Solution, 10%
"Combination Therapy With Efinaconazole for the Treatment of Toenail Onychomycosis." Lipner et al.
"Therapeutic Recommendations for the Treatment of Toenail Onychomycosis in the US." Lipner et al.
SILIQ® (brodalumab) Injection, 210 mg/1.5 mL
"Brodalumab Provides Rapid Onset of Therapeutic Response for Patients With Moderate-to-Severe Psoriasis." Armstrong et al.
"Long-term Skin Clearance Achieved in Moderate-to-Severe Psoriasis Through Interleukin-17 Receptor A Blockade." Lain et al.
"Brodalumab: 4-Year US Pharmacovigilance Report." Lebwohl et al.
ARAZLO® (tazarotene) Lotion, 0.045%
"Tazarotene 0.045% Lotion for Truncal Acne: Efficacy, Tolerability, and Spreadability." Kircik et al.
DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%
"Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for the Treatment of Plaque Psoriasis in Patients With Affected Body Surface Area of 3% to 5% and Poor Quality of Life." Stein Gold et al.
"Importance of Topical Vehicle Design for the Treatment of Psoriasis: A Review of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion." Stein Gold et al.
IDP-126 Gel (Investigational Drug)
"Efficacy and Safety of a Fixed-Dose Clindamycin 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: Randomized Phase 2 and Phase 3 Studies of the First Triple-Combination Drug." Stein Gold et al.
Important Safety Information for JUBLIA® (efinaconazole) Topical Solution, 10%
INDICATION
JUBLIA (efinaconazole) Topical Solution, 10% is a prescription medicine used to treat fungal infections of the toenails.
IMPORTANT SAFETY INFORMATION
JUBLIA is for use on nails and surrounding skin only. Do not use JUBLIA in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor.
The safety and efficacy of JUBLIA have not been established in children under six years old.
Before you use JUBLIA, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether JUBLIA can harm an unborn fetus or nursing infant.
Tell your doctor about all medications you are taking, and whether you have any other nail infections.
JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your doctor about any side effects that bother you or do not go away.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for full Prescribing Information, including Patient Information.
Important Safety Information for SILIQ® (brodalumab) Injection, 210 mg/1.5 mL
What is SILIQ? SILIQ (brodalumab) injection is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
What is the most important information I should know about SILIQ?
Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening depression, anxiety, or mood problems; thoughts of suicide, dying, or hurting yourself; attempt to commit suicide, or acting on dangerous impulses; other unusual changes in your behavior or mood.
Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.
This is not all the Important Safety Information you need to know about SILIQ. Please click here for full Prescribing Information for SILIQ, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.
Important Safety Information for ARAZLO® (tazarotene) Lotion, 0.045%
What is ARAZLO?
ARAZLO® (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.
It is not known if ARAZLO is safe and effective in children under 9 years of age.
Important Safety Information
ARAZLO is for use on skin only. Do not use ARAZLO in youreyes, mouth, the corners of your nose, or vagina.
What is the most important information I should know about ARAZLO?
ARAZLO may cause birth defects if used during pregnancy.
You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
Use effective birth control during treatment.
Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.
Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:
have eczema or any other skin problems.
are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure.
Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.
What should I avoid while using ARAZLO?
You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
Minimize exposure to sunlight; you could get severe sunburn.
If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.
Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.
ARAZLO may cause side effects, including:
Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.
These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Click here for full Prescribing Information, including Patient Information.
Important Safety Information for DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.
DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.
DUOBRII Lotion may cause birth defects if used during pregnancy.
Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.
DUOBRII may cause side effects, including:
If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
Cushing's syndrome, a condition from too much exposure to the hormone cortisol
High blood sugar (hyperglycemia)
The most common side effects of DUOBRII Lotion include redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This is not all of the Important Safety Information you need to know about DUOBRII; please click here for full Prescribing Information, including Patient Information.
About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis,onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
JUBLIA, SILIQ, ARAZLO, and DUOBRII are trademarks of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities.
New Educational Resource Designed to Help Support the Podiatry Community
Company Also Adds 300 Questions to Existing Dermatology Board Review Challenge
LAVAL, QC / ACCESSWIRE / October 31, 2022 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, recently announced the launch of the Podiatry Board Review Challenge, a new professional educational resource. Developed alongside practicing podiatrists, the Podiatry Board Review Challenge is designed to help support residents preparing for their board certification exams, podiatric healthcare professionals preparing for re-certifications and podiatrists who are looking to refresh their skills and knowledge.
"As part of our continuous collaboration with podiatrists and residents, we understand the importance of and need for educational resources to help aspiring and existing podiatric heath care professionals have the tools they need to excel," said Richard Lajoie, vice president and general manager, Ortho Dermatologics. "We developed the Podiatry Board Review Challenge to address this need, and we look forward to helping many upcoming and current podiatrists by testing their knowledge so they can provide the highest quality care for patients."
The Podiatry Board Review Challenge is available to health care professionals free-of-charge and includes 200 pre-board questions covering a range of topics, including radiology, neurology, vascular, infections, wounds, internal medicine, dermatology, pediatrics and miscellaneous medicine.
"Preparing for board exams is a necessity, not only for residents, but also for previously certified podiatrists needing to brush up on their skills. The Podiatry Board Review Challenge is an easy-to-use, well-referenced and comprehensive series of sample questions covering a wide range of topics that are typically included in board exams," said Warren Joseph, DPM, Consultant in Lower Extremity Infectious Disease. "As someone involved in both student and resident education my entire career, I know many will benefit from using this new resource to continue to sharpen their knowledge on a variety of tested categories."
In addition to the Podiatry Board Review Challenge, Ortho Dermatologics has added 300 questions to its existing Dermatology Board Review Challenge, which is designed to help dermatologists and dermatology residents prepare for their board certification exams. New questions were added to every category of the Challenge, including board review, clinical photos, same site differentials and dermoscopy.
"As a leader in providing dermatology and podiatry products, Ortho Dermatologics is proud to offer these two challenges to residents and health care professionals and help support their health care journeys," Lajoie continued.
About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
SOURCE: Bausch Health Companies Inc.
]]>Mon, 24 Oct 2022 08:38:45 GMTSalix Will Present XIFAXAN(R) (Rifaximin), TRULANCE(R) (Plecanatide) and RELISTOR(R) (Methylnaltrexone Bromide) Data at The American College of Gastroenterology(R) 2022 Annual Scientific Meeting-->
LAVAL, QC / ACCESSWIRE / October 24, 2022 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals ("Salix"), today announced four posters and one abstract featuring data for XIFAXAN® (rifaximin), TRULANCE® (plecanatide) and RELISTOR® (methylnaltrexone bromide) that are being presented at the American College of Gastroenterology® (ACG) 2022 Annual Scientific Meeting, which is taking place October 21-26 in Charlotte, North Carolina.
The complete list of Salix research being featured at ACG 2022 includes:
XIFAXAN
Staller, Kyle et al. "The Strong Association Between Bloating, Abdominal Pain, and Global Irritable Bowel Syndrome Symptom Scores in IBS With Diarrhea: A Phase 3 Trial Pooled Correlation Analysis of Individual Symptoms."
Cash, Brooks D. et al. "Rifaximin Improves Both Fecal Urgency and Stool Consistency in Adults With Irritable Bowel Syndrome With Diarrhea: A Composite Endpoint Analysis of Two Randomized, Phase 3 Trials."
TRULANCE
Sayuk, Gregory S. et al. "Plecanatide Improves Severe Abdominal Pain and Severe Bloating in Individuals With Irritable Bowel Syndrome With Constipation: A Pooled Analysis of Two Phase 3 Trials."
Staller, Kyle et al. "Plecanatide Improves Symptoms of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation Across Age Subgroups: an Analysis of Four Phase 3 Trials."
RELISTOR
Shah, Mehta N, et al. "Impact of Patient Subgroups on the Efficacy and Safety of Methylnaltrexone for Opioid-induced Constipation in Patients With Advanced Illness."
About XIFAXAN®
Indications
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN were:
HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
IBS-D (≥2%): Nausea (3%), ALT increased (2%)
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About TRULANCE
Indication
Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Contraindications
Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of Trulance-treated CIC patients, and in 1% of Trulance-treated IBS-C patients.
If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
In the two combined IBS-C clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).
RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
IMPORTANT SAFETY INFORMATION
RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
In the clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer pain
RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%),hyperhidrosis (3%),anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%),diarrhea (6%), hyperhidrosis (6%), hot flush (3%),tremor (1%), and chills (1%).
OIC in adult patients with advanced illness
RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%),dizziness (7%), and diarrhea (6%).
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch
[Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.] OR
[Please see accompanying full Prescribing Information for RELISTOR tablets and RELISTOR injection.]
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of the Company, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to the Company's overall business, including those more fully described in the Company's most recent annual report on Form 10-K and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.
Investor Contact:
Christina Cheng ir@bauschhealth.com
(514) 856-3855
(877) 281-6642 (toll free)
TRULANCE and RELISTOR are trademarks of Salix Pharmaceuticals or its affiliates.
The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A. to Salix Pharmaceuticals or its affiliates.
SAL.0113.USA.22
SOURCE: Bausch Health Companies Inc.
]]>Thu, 20 Oct 2022 09:08:00 GMTEleven Poster Presentations Include New Analyses of ARAZLO®, DUOBRII®, and IDP-126 Gel
LAVAL, QC / ACCESSWIRE / October 20, 2022 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, today announced the presentation of eleven posters during the Fall Clinical Dermatology Conference, which takes place Oct. 20-23, 2022 in Las Vegas, Nev. The presentations will feature new data around ARAZLO® (tazarotene) Lotion, 0.045%, DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, and the investigational medicine IDP-126 Gel-a combination retinoid, antibacterial and antibiotic topical. Two other presentations are adaptations featuring research on SILIQ® (brodalumab) Injection, 210 mg/1.5 mL. Please see below for warning about suicidal ideation and behavior with SILIQ. There will also be five encore presentations, including a systemic review of onychomycosis dermatophytoma treatment.
"Ortho Dermatologics remains committed to research to ensure the safety and efficacy of our portfolio with patients top of mind," said Richard Lajoie, vice president and general manager, Ortho Dermatologics. "At this year's Fall Clinical Dermatology Conference, we look forward to the opportunity to personally connect with dermatologists to share new data on our investigational acne medicine, IDP-126 Gel, as well as new analyses on two of our prominent acne and psoriasis medications, ARAZLO® and DUOBRII®."
The complete list of Ortho Dermatologics' poster presentations is as follows:
ARAZLO® (tazarotene) Lotion, 0.045%
"Impact of Seasonal Variation on the Efficacy and Safety of Tazarotene 0.045% Lotion for Acne: Post Hoc Analysis of Pooled Phase 3 Data." Draelos et al.
"Tazarotene 0.045% Lotion for Truncal Acne: Efficacy, Tolerability, and Spreadability." Kircik et al.
DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%
"Use of Combination Halobetasol Propionate/Tazarotene Lotion in Difficult-to-Treat Psoriasis and TNF-α Mechanism of Action." Kircik et al.
"Efficacy and Safety of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for Plaque Psoriasis from Real-World Patient Perspectives"Lain et al.
"Fixed-Combination Halobetasol Propionate and Tazarotene Lotion Decreases TNF-α Levels Within Psoriatic Lesions." Draelos et al.
IDP-126 Gel (Investigational Drug)
"Benefit of Topical Combination Therapy for Acne Treatment: Analysis of Effect Size Using Number Needed to Treat." Feldman et al.
"Efficacy and Safety of Triple-Combination Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Polymeric Mesh Gel in Pediatric Participants." Eichenfield et al.
SILIQ® (brodalumab) Injection, 210 mg/1.5 mL
"Unique Mechanism of Action of Brodalumab May Correlate With Efficacy vs Ustekinumab." Armstrong et al.
"Inhibition of Interleukin-17 Cytokines With Brodalumab May Correlate With Efficacy in Patients With Psoriasis and Prior Biologic Exposure." Lain et al.
"Brodalumab: 4-Year US Pharmacovigilance Report." Lebwohl et al.
JUBLIA® (efinaconazole) Topical Solution, 10%
"Onychomycosis Dermatophytoma Treatment: A Systematic Review of the Literature." Lipner et al.
Important Safety Information for ARAZLO® (tazarotene) Lotion, 0.045%
What is ARAZLO?
ARAZLO® (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.
It is not known if ARAZLO is safe and effective in children under 9 years of age.
Important Safety Information
ARAZLO is for use on skin only. Do not use ARAZLO in youreyes, mouth, the corners of your nose, or vagina.
What is the most important information I should know about ARAZLO?
ARAZLO may cause birth defects if used during pregnancy.
You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
Use effective birth control during treatment.
Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.
Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:
have eczema or any other skin problems.
are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure.
Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.
What should I avoid while using ARAZLO?
You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
Minimize exposure to sunlight; you could get severe sunburn.
If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.
Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.
ARAZLO may cause side effects, including:
Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.
These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Click here for full Prescribing Information, including Patient Information.
Important Safety Information for DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%
What is DUOBRII® Lotion?
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.
Important Safety Information
DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.
What is the most important Information I should know about DUOBRII Lotion?
DUOBRII Lotion may cause birth defects if used during pregnancy.
A negative pregnancy test must be obtained before females of child-bearing age start using DUOBRII Lotion and they must use effective birth control during treatment. Begin treatment during a normal menstrual period.
Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.
Before you use DUOBRII Lotion, tell your healthcare provider if you:
have eczema or any other skin problems, including skin infections, which may need to be treated before using DUOBRII.
have diabetes, adrenal gland problems or liver problems.
are breastfeeding or plan to breastfeed. If you use DUOBRII and breastfeed, do not apply DUOBRII to your nipple area.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take corticosteroids by mouth or injection or use other skin products that contain corticosteroids.
Ask your healthcare provider for a list of medicines that may make your skin more sensitive to sunlight.
What should I avoid during treatment with DUOBRII?
To avoid a severe sunburn, avoid sunlight, including sunlamps and tanning beds, as much as possible, and use sunscreen, protective clothing and a hat while in sunlight. Talk to your healthcare provider if you get sunburn, and do not use DUOBRII Lotion until your sunburn is healed.
Avoid using DUOBRII on skin with eczema because it may cause severe irritation.
DUOBRII may cause side effects, including:
If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
Cushing's syndrome, a condition from too much exposure to the hormone cortisol
High blood sugar (hyperglycemia)
Effects of growth and weight in children
Skin irritation. If you get too much skin irritation at the site of application, your healthcare provider may tell you to interrupt or stop using DUOBRII or to use it less often.
Vision problems, including an increased chance of developing cataracts and glaucoma. Tell your healthcare provider about any vision problems during treatment.
The most common side effects of DUOBRII Lotion include: redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This is not all of the Important Safety Information you need to know about DUOBRII; please click here for full Prescribing Information, including Patient Information.
Important Safety Information for SILIQ® (brodalumab) Injection, 210 mg/1.5 mL
What is SILIQ?
SILIQ® injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:
who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and
who have tried another systemic therapy that didn't work or stopped working
It is not known if SILIQ is safe and effective in children.
What is the most important information I should know about SILIQ?
Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms:
new or worsening depression, anxiety, or mood problems
thoughts of suicide, dying, or hurting yourself
attempt to commit suicide, or acting on dangerous impulses
other unusual changes in your behavior or mood
Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.
Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections:
Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it
You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination
Who should not use SILIQ?
Do not use SILIQ if you have Crohn's disease. Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness as these may be symptoms of Crohn's disease.
Before starting SILIQ, tell your healthcare provider if you:
have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems
have an infection that does not go away or keeps coming back
have TB or have been in close contact with someone with TB
have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ
are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use SILIQ?
See the detailed "Instructions for Use" that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes. Use SILIQ exactly as your healthcare provider tells you to use it.
What are possible side effects of SILIQ?
SILIQ may cause serious side effects. See "What is the most important information I should know about SILIQ?" and "Who should not take SILIQ?"
The most common side effects of SILIQ include:
Joint pain Muscle pain
Headache Injection site reactions
Tiredness Flu
Diarrhea Low white blood cell count (neutropenia)
Mouth or throat pain Fungal infections of the skin
Nausea
Call your doctor for medical advice on side effects. You are encouraged to report negative side effects of prescription drugs to Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for accompanying full Prescribing Information, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.
Important Safety Information for JUBLIA® (efinaconazole) Topical Solution, 10%
INDICATION
JUBLIA (efinaconazole) Topical Solution, 10% is a prescription medicine used to treat fungal infections of the toenails.
IMPORTANT SAFETY INFORMATION
JUBLIA is for use on nails and surrounding skin only. Do not use JUBLIA in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor.
The safety and efficacy of JUBLIA have not been established in children under six years old.
Before you use JUBLIA, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether JUBLIA can harm an unborn fetus or nursing infant.
Tell your doctor about all medications you are taking, and whether you have any other nail infections.
JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your doctor about any side effects that bother you or do not go away.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for full Prescribing Information, including Patient Information.
About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis,onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
ARAZLO, DUOBRII, SILIQ, and JUBLIA are trademarks of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities.
]]>Thu, 13 Oct 2022 09:08:20 GMTLAVAL, Quebec, Oct. 13, 2022 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) will release its third quarter financial results on Thursday, Nov. 3, 2022. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
A replay of the conference call will be available on the investor relations website.
To participate in the live Q&A session, please register using this link to receive a PIN, which will be sent an hour before the conference call.
Supplemental Disclosure
At the Company’s annual meeting of shareholders held on June 21, 2022, the Company’s shareholders approved amendments to the Company’s Amended and Restated 2014 Omnibus Incentive Plan (the “Plan”). The Company has relied on the exemption for “Eligible Interlisted Issuers" under Section 602.1 of the Toronto Stock Exchange (“TSX”) Company Manual, the effect of which is that, subject to the satisfaction of certain conditions prescribed by the TSX, the Company will not have to comply with certain Canadian requirements in connection with the Plan.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
