Bausch Health Companies Inc. operates as a global, diversified specialty pharmaceutical and medical device company.
The company develops, manufactures, and markets, primarily in the therapeutic areas of gastroenterology (GI), hepatology, neurology and dermatology, a broad range of branded, generic and branded generic pharmaceuticals, over-the-counter (OTC) products and aesthetic medical devices, and through its approximately 88% ownership of Bausch + Lomb Corporation (Bausch + Lomb) branded, an...
Bausch Health Companies Inc. operates as a global, diversified specialty pharmaceutical and medical device company.
The company develops, manufactures, and markets, primarily in the therapeutic areas of gastroenterology (GI), hepatology, neurology and dermatology, a broad range of branded, generic and branded generic pharmaceuticals, over-the-counter (OTC) products and aesthetic medical devices, and through its approximately 88% ownership of Bausch + Lomb Corporation (Bausch + Lomb) branded, and branded generic pharmaceuticals, OTC products and medical devices (contact lenses, intraocular lenses, and ophthalmic surgical equipment) in the therapeutic area of eye health. The company’s products are marketed directly or indirectly in approximately 90 countries.
The company’s portfolio of products falls into five reportable segments: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified and (v) Bausch + Lomb. The following is a brief description of the company’s segments:
The Salix segment consists of sales in the U.S. of GI products. Sales of the Xifaxan product line represent approximately 85% of the Salix segment revenues.
The International segment consists of sales, with the exception of sales of Bausch + Lomb products and Solta Medical aesthetic medical devices, outside the U.S and Puerto Rico of branded pharmaceutical products, branded generic pharmaceutical products and OTC products.
The Solta Medical segment consists of global sales of Solta Medical aesthetic medical devices.
The Diversified segment consists of sales in the U.S. of: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) dermatology products, (iii) generic pharmaceutical products, and (iv) dentistry products.
The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision Care, Surgical and Pharmaceuticals products.
Business Strategy
The company’s strategy is to focus its business on core therapeutic classes and geographies that offer attractive growth opportunities. Within the company’s chosen therapeutic classes, it prioritizes durable products which have the potential for strong operating margins and evidence of growth opportunities. The company’s continued success is dependent upon its ability to refresh its pipeline on an ongoing basis and bring new product solutions to the market that meet changing demands and replace other products that have lost momentum.
The company has focused its research and development (R&D) to advance development programs that will drive growth in its core businesses, while creating efficiencies in its R&D efforts and expenses. Although the company primarily relies on its R&D organization to build-out and refresh its product portfolio, to supplement those efforts, it continually seeks out opportunities, such as co-promotions, licensing agreements and strategic acquisitions, to leverage its commercial footprint, particularly its sales force, by strategically aligning itself with other innovative product solutions that, when coupled with its existing product portfolio, address specific needs in the market.
Segments
Salix
The company’s Salix segment consists of sales in the U.S. of GI products and includes its Xifaxan product. The company has implemented initiatives, including increasing its marketing investment in Xifaxan, to seek to further capitalize on the value of the infrastructure it has built around these products to extend its market share. The company’s principal products in this segment (including products of its third-party co-promotion partners) include:
Xifaxan which includes tablets indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults and tablets indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age and older.
Relistor (methylnaltrexone) is given to adults who use narcotic medicine to treat severe chronic pain that is not caused by cancer to prevent constipation without reducing the pain-relieving effects of the narcotic.
Trulance (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation.
The company has increased its investment in Xifaxan direct-to-consumer (DTC) advertising and new sales force capabilities. It also continues to invest in its product line. The company’s rifaximin soluble solid dispersion (SSD) formulation is under development for the prevention of OHE and other complications in patients with early decompensation in liver cirrhosis (RED-C). The drug candidate is administered orally and is a next-generation rifaximin formulation that acts by targeting the beta-subunit of bacterial DNA-dependent ribonucleic acid (RNA) polymerase.
The company has filed lawsuits against third-party generic manufacturers that have sent it Notices of Paragraph IV Certification for Trulance and Xifaxan.
International
The company’s International business includes, with the exception of its Bausch + Lomb and Solta Medical products, sales in Canada, Europe, Asia, Latin America, Africa, and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products and OTC products. The company’s principal products in this segment include:
Bedoyecta is a multivitamin line with Complex B vitamin that is used to obtain sufficient energy and have optimal performance during the day, by avoiding deficiencies of the nutrients that the body requires to function properly, indicated as adjuvant for diabetic patients.
Jublia (efinaconazole 10% topical solution) is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus) and is commercialized in Canada.
Bisocard (bisoprolol fumarate) is an orally administered tablet dosed once daily for patients with hypertension, angina pectoris or heart failure and is a leading brand in Poland.
Diclofenac is a nonsteroidal anti-inflammatory drug used to treat mild-to-moderate pain and helps to relieve symptoms of arthritis. This product is sold in several Eastern European countries.
Contrave/Mysimba is a fixed-dose combination prolonged-release tablet for the treatment of obesity. Used alongside diet and exercise, it is designed to help manage weight in adults who are overweight or obese. The formulation is designed to initiate weight loss and sustain it over a longer period of time by working in the areas of the brain regulating food intake to reduce hunger and cravings. Contrave / Mysimba is commercialized in Canada, Poland and other Central Eastern European countries.
Espaven (Dimethicone tablets, drops, suspension) is a complete line of gastrointestinal treatments for diverse digestive indications, such as: flatulence, dyspepsia, absolute or relative enzyme deficiency, steatorrhea, irritable colon syndrome, pancreatic insufficiency and poor fat digestion. Espaven is commercialized primarily in Mexico and Central America.
Solta Medical
Solta Medical is a global leader in the medical aesthetic market focused on innovative aesthetic medical treatment technologies. Solta Medical’s revenue is primarily attributable to the skin tightening market, which is driven by its Thermage product lines. The latest generation of this product line, Thermage FLX, has been launched in the company’s key markets and expansion is expected to continue into other countries, paced by country-specific regulatory registrations. The company’s principal products in this segment include:
The Thermage system is a non-invasive radiofrequency treatment that can smoothen, tighten and contour skin for an overall younger-looking appearance.
The Clear + Brilliant system is a laser treatment that can help address the visible signs of aging and the overall effects that time and the environment can have on skin.
The Fraxel system is a treatment that improves tone, texture and radiance for aging, sun damaged or scarred skin.
The VASERlipo system is a minimally invasive aesthetic body contouring system that yields dramatic results with less pain and downtime than traditional liposuction.
The company continues to invest in expanding access to Solta Medical technologies for medical aesthetic providers and consumers in its key markets, including broadening the reach of Thermage FLX and strengthening its sales force in the U.S., Europe and Asia.
Diversified
The company’s Diversified segment consists of sales in the U.S. of pharmaceutical products in the areas of neurology and certain other therapeutic classes, dermatology products, generic pharmaceutical products and dentistry products. The company’s principal products in this segment include:
Neurology
Wellbutrin XL is an extended release formulation of bupropion indicated for the treatment of major depressive disorder in adults.
Aplenzin (bupropion hydrobromide extended release tablets) is indicated for the treatment of major depressive disorder, and for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.
Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Mysoline (Primidone) is an anticonvulsant drug used to control seizures.
Xenazine is indicated for the treatment of chorea associated with Huntington’s disease. In the U.S., Xenazine is distributed for it by Lundbeck LLC under an exclusive marketing, distribution and supply agreement.
Dermatology
Jublia (efinaconazole 10% topical solution) is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus).
Siliq is an IL-17 receptor blocker monoclonal antibody for patients with moderate-to-severe plaque psoriasis.
Arazlo (tazarotene) Lotion, 0.045% is an acne product containing a lower concentration of tazarotene in a lotion form to help reduce irritation while maintaining efficacy.
Targretin (bexarotene) capsules and gel are prescription medicines used to treat the skin problems arising from the disease cutaneous T-cell lymphoma, or CTCL, in patients who have not responded well to other treatments.
CABTREO is the first and only U.S. Food and Drug Administration (FDA) approved fixed-dose, triple-combination topical treatment for acne. CABTREO Topical Gel was launched in the U.S. in the first quarter of 2024 and was launched in Canada in October 2024.
Generics
The company utilizes the Generics business to extend the long-term cash flows from a number of assets that are expected to decline over time due to their loss of exclusivity, by launching and selling authorized generic versions of certain branded assets. Principal products include:
Diastat authorized generic (AG) (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.
Elidel AG (pimecrolimus) is a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis.
Uceris AG (budesonide) extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control (induce remission).
Dentistry
Arestin (minocycline hydrochloride) is a subgingival sustained-release antibiotic. Arestin is indicated as an adjunct to scaling and root planning (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.
Bausch + Lomb
The company’s Bausch + Lomb segment includes its global Bausch + Lomb eye health business. The company’s global Bausch + Lomb eye health business includes its Vision Care, Surgical and Pharmaceuticals products.
The company’s Bausch + Lomb business is a fully integrated eye health business with a portfolio of established lines of contact lenses, intraocular lenses (IOL) and other medical devices, surgical systems and devices, vitamin and mineral supplements, lens care products, prescription eye-medications and other consumer products. Bausch + Lomb takes a holistic approach to solving eye health problems, including by investing in physician training, patient and customer education, disease prevention and other initiatives through both traditional and digital platforms to continue to advance eye health.
The company’s principal products in this segment include:
XIIDRA (lifitegrast ophthalmic solution) 5%, is 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. Bausch + Lomb completed the acquisition of XIIDRA during the third quarter of 2023.
PreserVision AREDS 2 is a patented eye vitamin and mineral supplement that contains the exact nutrient formula recommended by the National Eye Institute for people with moderate to advanced age-related macular degeneration (AMD) following the landmark AREDS 2 clinical study.
Ocuvite is a family of nutritional supplements that contain antioxidant vitamins and minerals and other nutrients beneficial for eye health, including lutein and zeaxanthin (antioxidant carotenoids), nutrients that support macular health by helping filter harmful blue light.
Lumify (brimonidine tartrate ophthalmic solution, 0.025%) is an OTC redness reliever eye drop that significantly reduces redness to help eyes look whiter and brighter, revealing eyes’ natural beauty. To date, Bausch + Lomb has launched and acquired the right to launch Lumify in various countries. A new line extension formulation, Lumify Preservative Free, for which the New Drug Application (NDA) was approved by the FDA in April 2024, began launching in the first quarter of 2025.
MIEBO (perfluorohexyloctane ophthalmic solution) (formerly known as NOV03) – In December 2019, Bausch + Lomb acquired an exclusive license from Novaliq GmbH for the commercialization and development in the U.S. and Canada of MIEBO for the treatment of the signs and symptoms of DED. MIEBO launched in the U.S. in September 2023 and was approved in Canada during September 2024. MIEBO is the first and only FDA approved treatment for DED that directly targets tear evaporation and the addition of MIEBO is expected to help build upon Bausch + Lomb’s strong portfolio of integrated eye health products.
Bausch + Lomb Renu Advanced Formula multi-purpose solution is a novel soft and silicone hydrogel contact lens solution that makes use of three disinfectants and two moisture agents.
Biotrue multi-purpose solution helps prevent certain tear proteins from denaturing and fights germs for healthy contact lens wear. Biotrue multi-purpose solution contains hyaluronic acid (sodium hyaluronate) a lubricant naturally found in eyes and is pH balanced to match healthy tears.
Biotrue ONEday daily disposable contact lenses for patients with myopia or hyperopia, which are made of a unique material inspired by the natural biology of the eye and feature Surface Active Technology, a patented dehydration barrier. The lens contains 78% water, more moisture than any other soft contact lens and the same water content as the cornea and maintains nearly 100% of its moisture for up to 16 hours.
Bausch + Lomb ULTRA, a silicone hydrogel frequent replacement contact lens for patients with myopia or hyperopia that uses the proprietary MoistureSeal technology, which allows the contact lens to retain 95% of moisture after 16 hours of wear, limiting lens dryness and resulting symptoms.
SiHy Daily, a silicone hydrogel daily disposable contact lens designed to provide outstanding comfort and clear vision throughout the day. To date SiHy Daily has been launched in over 50 countries, under the brand names INFUSE, BAUSCH + LOMB ULTRA ONE DAY and AQUALOX ONE DAY and Bausch + Lomb is continuing its global roll out. In addition, Bausch + Lomb launched its first silicone hydrogel daily disposable multifocal contact lens in May 2023, and launched a toric lens in the U.S. in June 2024.
Stellaris Elite vision enhancement system is a combined system with cataract and vitreoretinal capability featuring the Bi-Blade vitrectomy handpiece. The Stellaris Elite vision enhancement system configured for cataract procedures is the company’s latest generation phacoemulsification cataract platform, Stellaris Elite is the first phacoemulsification platform on the market to offer Adaptive Fluidics, which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient cataract lens removal. Bausch + Lomb’s Stellaris Elite vision enhancement system was launched in the United States in 2017 and internationally in 2018.
Research and Development (R&D)
The company’s R&D expenses were $616 million for 2024.
Trademarks
The company owns or licenses a number of registered trademarks and trademark applications in the U.S., Canada and in various other countries throughout the world. The U.S. federal registrations for trademarks remain in force for 10 years and may be renewed every 10 years after issuance, provided the mark is still being used in commerce. Trademark registrations in Canada issued on or before June 17, 2019 remain in force for 15 years and may be renewed for 10-year terms, provided that, as in the case of the U.S. federal trademark registrations, the mark is still being used in commerce. Trademark registrations in Canada issued after June 17, 2019, remain in force for 10 years and may be renewed every 10 years after issuance, provided that, as in the case of the U.S. federal trademark registrations, the mark is still being used in commerce.
Customers and Marketing
In 2024, the U.S. and Puerto Rico accounted for approximately 60% and China accounted for approximately 5% of the company’s total revenue, respectively.
The company promotes its pharmaceutical products to physicians, hospitals, pharmacies and wholesalers through its own sales force and sell through wholesalers. In some markets, the company additionally sells directly to physicians, hospitals and large drug store chains and it sells through distributors in countries where the company does not have its own sales staff. As part of the company’s marketing program for pharmaceuticals, it uses direct to consumer advertising, direct mailings, advertise in trade, social media and medical periodicals, exhibit products at medical conventions and sponsor medical education symposia.
Manufacturing
With respect to some of the company’s largest or most significant products, the supply of the finished product for each of its Lumify, Vyzulta, SofLens, MIEBO, XIIDRA, Wellbutrin XL, Relistor Oral and injection, Trulance, Jublia, Aplenzin, Arestin, Bedoyecta, and PureVision products are only available from a single source (either one of its internal manufacturing sites or third party manufacturers) and the supply of active pharmaceutical ingredients for each of its Lumify, Vyzulta, MIEBO, Preservision, Relistor Oral and injection, Trulance, Aplenzin, Arestin, Bedoyecta and Siliq products are also only available from a single source.
Seasonality of Business
Historically, revenues from the company’s business tend to be weighted toward the second half of the year (year ended December 31, 2024).
Geographic Areas
A significant portion of the company’s revenues is generated from operations or otherwise earned outside the U.S. and Canada.
Government Regulations
Pursuant to the Swiss Medical Device Ordinance, the company is required to appoint an authorized representative in Switzerland in order to export its CE-marked medical devices to Switzerland.
The U.S. Federal Food, Drug and Cosmetic Act, as amended and the regulations promulgated thereunder, and other federal and state statutes and regulations, govern, among other things, the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, sale, distribution, advertising and promotion of the company’s products.
Manufacturers of pharmaceutical products and medical devices are required to comply with manufacturing regulations, including current good manufacturing practices and quality system management requirements, enforced by the FDA and Health Canada, in the U.S. and Canada, respectively, and similar regulations enforced by regulatory agencies in other countries and the company faces periodic audits of its facilities and plants and those of its contract manufacturers by the FDA and such other regulatory agencies. In addition, the company is subject to price control restrictions on its pharmaceutical products in many countries in which the company operates.
The company is also subject to extensive U.S. federal and state health care marketing and fraud and abuse regulations, such as the federal False Claims Act, federal and provincial marketing regulations in Canada and similar regulations in foreign countries in which it may conduct its business.
The company is also subject to the U.S. Foreign Corrupt Practices Act (‘FCPA’), the Canadian Corruption of Foreign Public Officials Act, and similar worldwide anti-bribery laws, which generally prohibit companies and their intermediaries from making improper payments to officials for the purpose of obtaining or retaining business.
The company is also subject to various state, federal and international laws and regulations governing the collection, transmission, dissemination, use, privacy, confidentiality, security, retention, availability, integrity and other processing of health-related and other sensitive and personal information, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, ‘HIPAA’). HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions (e.g., health care claims information and plan eligibility, referral certification and authorization, claims status, plan enrollment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information. These standards require the adoption of administrative, physical and technical safeguards to protect such information. Many states in which the company operates have laws that protect the privacy and security of sensitive and personal information, including health-related information.
The company is also subject to Canada’s federal Personal Information Protection and Electronic Documents Act and substantially similar equivalents at the provincial level with respect to the collection, use and disclosure of personal information in Canada. Such federal and provincial legislation impose data privacy and security obligations on the company’s processing of personal information of Canadian residents. The federal, Quebec and Alberta legislation include mandatory data breach notification requirements. Canada’s Anti-Spam Legislation (‘CASL’) also applies to the extent that the company sends commercial electronic messages to electronic addresses in Canada.
Various U.S. health care and other laws regulate the company’s interactions with government agencies, private insurance companies, and other third-party payors regarding coverage and reimbursement for the company’s products.
Environmental and Other Regulation
The company’s facilities and operations are subject to a broad range of federal, state and local environmental and occupational health and safety laws and regulations in both the U.S. and countries outside the U.S. (including Canada), including those governing the discharge of substances into the air, water and land, the handling, treatment, storage and disposal of hazardous substances and wastes, wastewater and solid waste, the cleanup of contaminated properties and other environmental matters. Certain of the company’s development and manufacturing activities involve the use of hazardous substances.
The company is also subject to extensive and evolving regulations regarding the manufacturing, processing, distribution, importing, exporting and labeling of its products and their raw materials. In the EU, the company is subject to the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’).
In light of the rapid and ongoing global regulations and expectations relating to environmental, social and governance (‘ESG’) matters, the company is making appropriate investments in its ESG program to position the company for timely reporting for the EU’s Corporate Sustainability Reporting Directive and Corporate Sustainability Due Diligence Directive, California’s Climate Corporate Data Accountability Act (SB 253) and Climate-Related Financial Risk Report (SB 261) regulations, and other pending requirements, if and when they come into force.
History
The company was formerly known as Valeant Pharmaceuticals International, Inc. and changed its name to Bausch Health Companies Inc. in 2018.