Bausch Health Companies Stock

Bausch Health Companies Inc. and its subsidiaries operate as a multinational, specialty pharmaceutical and medical device company.

The company develops, manufactures, and markets, primarily in the therapeutic areas of gastroenterology (‘GI’) and dermatology, a broad range of branded, generic and branded generic pharmaceuticals, over-the-counter (‘OTC’) products and medical aesthetic devices and, through its majority ownership of Bausch + Lomb Corporation (‘Bausch + Lomb’), branded, and branded generic pharmaceuticals, OTC products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment) in the therapeutic area of eye health. The company’s products are marketed directly or indirectly in approximately 100 countries.

The company has approximately 1,100 products in the company’s portfolio of products, which fall into five reportable segments: Salix, International, Solta Medical, Diversified Products, and Bausch + Lomb.

The Salix segment consists of sales in the U.S. of GI products. Sales of the Xifaxan product line represented approximately 80% of the Salix segment’s revenues.

The International segment consists of sales, with the exception of sales of Bausch + Lomb products and Solta aesthetic medical devices, outside the U.S. and Puerto Rico of branded pharmaceutical products, branded generic pharmaceutical and OTC products.

The Solta Medical segment consists of global sales of Solta Medical (‘Solta’) aesthetic medical devices.

The Diversified Products segment consists of sales in the U.S. of pharmaceutical products in the areas of neurology and certain other therapeutic classes, generic products, Ortho Dermatologics (dermatological products), and (iv) dentistry products.

The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision Care, Surgical and Ophthalmic Pharmaceuticals products.

Business Strategy

The company’s strategy is to focus its business on core therapeutic classes and geographies that offer attractive growth opportunities.

Salix

The Salix segment consists of sales in the U.S. of GI products and includes the company’s Xifaxan product. The company has been making investments in the company’s Salix business since 2017, including: hiring 200 trained and experienced sales representatives to expand the commercial field force for Xifaxan; increasing the focus on the development of next generation formulations of the company’s Salix products to address new indications; completing the strategic acquisition of certain assets of Synergy Pharmaceuticals Inc. (‘Synergy’), which included the Trulance product; and increasing the number of sales force representatives for Trulance. In addition, the company has entered into licensing agreements for investigational products, which, once developed and if approved by the FDA, will be new treatments for certain GI and liver diseases and the company anticipates will contribute to its future growth. Each of these opportunities potentially provides the company with the ability to expand the company’s GI portfolio and allows the company to leverage its existing GI sales force, supply channel and distribution channel.

The company’s principal products in the Salix segment (including products of the company’s 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 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.

Glumetza (metformin hydrochloride) extended release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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, or IBS-C.

International

The company’s International business includes, with the exception of the company’s Bausch + Lomb and Solta 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:

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.

Thrombo ASS (gastroprotective coated form of acetylsalicylic acid 50mg and 100mg) is an antithrombotic agent dosed once daily for secondary prophylaxis of thrombotic complications after such events as a stroke or heart attack. Thrombo ASS is a leading brand in Russia.

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 obese or overweight. The formulation is designed to initiate weight loss and sustain it over a longer period of time by switching off natural compensatory mechanisms involved in the typical weight loss plateau stage. Contrave / Mysimba is commercialized in Canada, Poland and other Central Eastern European countries.

Jublia (efinaconazole 10% topical solution) is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus). Jublia is commercialized in Canada (the only market outside the U.S.).

Espaven (Dimethicone tablets, drops, suspension) is a complete line of gastrointestinal treatments for diverse digestive indications, such as: antiflatulence, dyspepsia, absolute or relative enzyme deficiency, steatorrhea, irritable colon syndrome, pancreatic insufficiency and poor fat digestion. Espaven is commercialized primarily in Mexico and South America.

Bedoyecta is a multivitamin 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.

Arazlo (tazarotene) Lotion, 0.045% is an acne treatment available in a lotion formulated with PRISMATREX technology (formulation with known hydrating and moisturizing effects, which may alleviate dryness of skin) and has shown to provide a good tolerability profile. It 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 and in January 2023, became available to patients throughout Quebec, Ontario, Alberta, Saskatchewan and federal NIHB public drug plans.

Solta Medical

The company’s Solta business is dedicated to the development of innovative treatment technologies that provide proven and effective aesthetic medical and therapeutic benefits to consumers.

Solta’s revenue is primarily attributable to Next Generation Thermage FLX, a fourth-generation non-invasive treatment option using a radiofrequency platform designed to optimize key functional characteristics of Thermage and improve patient outcomes. Next Generation Thermage FLX has been launched in the U.S., Hong Kong, Japan, Korea, Chinese Taipei, the Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, Australia and various parts of Europe. The company plans to continue to expand into other regions, paced by country-specific regulatory registrations.

The company’s principal products in the Solta business include:

Thermage is a non-invasive radiofrequency treatment that can smooth, tighten and contour skin for an overall younger-looking appearance.

Fraxel is a treatment that improves tone, texture and radiance for aging, sun damaged or scarred skin.

Clear + Brilliant is a laser treatment that can help prevent the visible signs of aging and address the overall effects time and the environment can have on skin.

VASERlipo for minimally invasive aesthetic body contouring that yields dramatic results with less pain and downtime than traditional liposuction.

Diversified Products

The Diversified Products segment consists of sales in the U.S. of pharmaceutical products in the areas of neurology and certain other therapeutic classes, generic products, Ortho Dermatologics (dermatological) products, and dentistry products. The company utilizes the Diversified Products segment to extend the long-term cash flows from a number of assets that are expected to decline over time due to the loss of exclusivity, by launching and selling authorized generic versions of certain branded assets. The company’s principal products in this segment include:

Neurology and Other Pharmaceuticals

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.

Cuprimine is a treatment for Wilson’s disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), cystinuria (a condition which leads to cystine stones in the kidneys) and for patients with severe rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Mysoline (Primidone) is an anticonvulsant drug used to control seizures.

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.

Xenazine is indicated for the treatment of chorea associated with Huntington’s disease. In the U.S., Xenazine is distributed for the company by Lundbeck LLC under an exclusive marketing, distribution and supply agreement.

Syprine is a treatment for Wilson’s disease in patients who cannot take the medication known as penicillamine.

Librax (chlordiazepoxide and clidinium) is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Generics

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.

Uceris AG (budesonide) extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control (induce remission).

Elidel AG (pimecrolimus) is a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis.

Ortho Dermatologics

Jublia (efinaconazole 10% topical solution) is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus).

Arazlo (tazarotene) Lotion, 0.045% is an acne product containing lower concentration of tazarotene in a lotion form to help reduce irritation while maintaining efficacy and was launched in the U.S. in June 2020.

Duobrii was launched in the U.S. in June 2019 and is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene for the treatment of moderate-to-severe plaque psoriasis in adults.

Siliq was launched in the U.S. in 2017 and is an IL-17 receptor blocker monoclonal antibody for patients with moderate-to-severe plaque psoriasis.

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.

Bryhali was launched in the U.S. in November 2018 and is a novel product that contains a unique, lower concentration of halobetasol propionate for the treatment of moderate-to-severe psoriasis.

An acne franchise, which includes Altreno (tretinoin 0.05%), launched in the U.S. in October 2018 and is a lotion approved for the topical treatment of acne vulgaris in patients 9 years of age and older, and Solodyn, a prescription oral antibiotic approved to treat only the red, pus-filled pimples of moderate to severe acne in patients 12 years of age and older, as well as Retin-A, Clindagel and Onexton Gel, a fixed combination 1.2% clindamycin phosphate and 3.75% benzoyl peroxide medication for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 years of age and older.

Dentistry

Arestin (minocycline hydrochloride) is a subgingival sustained-release antibiotic. Arestin 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.

NeutraSal is indicated for dryness of the mouth (hyposalivation, xerostomia) and dryness of the oral mucosa due to drugs that suppress salivary secretion.

OSSIX is a line of cross-linked collagen regenerative products that provide biocompatibility and bio-durability to perform a diverse range of guided bone and tissue regeneration procedures.

Bausch + Lomb

The company’s Bausch + Lomb segment includes the company’s global Bausch + Lomb eye health business. The company’s global Bausch + Lomb eye health business includes the company’s Vision Care, Surgical and Ophthalmic 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 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 the eye health business include:

PreserVision AREDS 2 is a patented eye vitamin formula 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.

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.

Bausch + Lomb Renu Advanced Formula multi-purpose solution was launched in 2017 and is a novel soft and silicone hydrogel contact lens solution that makes use of three disinfectants and two moisture agents.

LUMIFY (brimonidine tartrate ophthalmic solution, 0.025%) is an OTC eye drop developed as an ocular redness reliever.

Bausch + Lomb INFUSE (known as BAUSCH + LOMB ULTRA ONE DAY in Canada, Australia and Hong Kong), a silicone hydrogel daily disposable contact lens designed with a next generation material infused with ProBalance Technology to help maintain ocular surface homeostasis and help reduce symptoms of contact lens dryness. Bausch + Lomb INFUSE was launched in the United States in August 2020 and BAUSCH + LOMB ULTRA ONE DAY was launched in Canada, Australia, and Hong Kong in November 2020 and in Europe during 2022.

Bausch + Lomb ULTRA, a silicone hydrogel frequent replacement contact lens for patients with myopia or hyperopia that uses the company’s proprietary MoistureSeal technology, which allows the contact lens to retain 95% of moisture after 16 hours of wear, limiting lens dryness and resulting symptoms.

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.

Vitreoretinal Surgery

Stellaris Elite vision enhancement system is a combined system with cataract and vitreoretinal capability featuring the Bi-Blade vitrectomy handpiece.

Synergetics instruments include reusable and single use devices and are marketed for use in vitreoretinal surgery.

Cataract Surgery and Laser Systems

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 FluidicsTM, which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient cataract lens removal. The company’s Stellaris Elite vision enhancement system was launched in the United States in 2017 and internationally in 2018.

VICTUS femtosecond laser for cataract and corneal refractive surgery, which delivers multi- mode versatility for cataract and corneal procedures on a single platform. This single laser platform enables surgeons to perform capsulotomies, fragmentation, arcuate incisions, corneal incisions, and LASIK flaps.

Lotemax (loteprednol etabonate ophthalmic gel 0.38%), a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron technology for efficient penetration to key ocular tissues at a low preservative (BAK) level (3.5-10) and a pH close to human tears, indicated for the treatment of postoperative inflammation and pain following ocular surgery.

Research and Development

The company’s research and development expenses for 2022 were $529 million.

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.

Government Regulations

The 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.

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. The federal False Claims Act imposes civil and criminal liability on individuals or entities who submit (or cause the submission of) false or fraudulent claims for payment to the government.

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. The effects on the company’s business of the California Consumer Privacy Act, the California Privacy Rights Act, and other similar state laws are potentially significant to modify its data processing practices and policies and to incur substantial costs and expenses in an effort to comply.

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 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 from Canada or to electronic addresses in Canada. Canada’s Anti-Spam Legislation contains prescriptive consent, form, content and unsubscribe mechanism requirements.

Customers and Marketing

In 2022, the U.S. and Puerto Rico accounted for approximately 60% and China accounted for approximately 5% of the company’s total revenue, respectively.

Customers that accounted for 10% or more of the company’s total revenue for 2022 were AmerisourceBergen Corporation; McKesson Corporation; and Cardinal Health, Inc.

The company promotes its pharmaceutical products to physicians, hospitals, pharmacies and wholesalers through the company’s own sales force and sell through wholesalers. In some markets, the company additionally sells directly to physicians, hospitals and large drug store chains and the company 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, the company uses direct to customer 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 the company’s Siliq, Duobrii, Bryhali, Lumify, Trulance, Vyzulta, SofLens, Wellbutrin XL, Renu, Xenazine, Aplenzin, Relistor Oral and PureVision products are only available from a single source and the supply of active pharmaceutical ingredient for each of the company’s Siliq, Duobrii, Bryhali, Trulance, Vyzulta, Xenazine, Aplenzin, and Relistor Oral 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 2022). Sales in the first quarter tend to be lower as patient co-pays and deductibles reset at the beginning of each year. Sales in the fourth quarter tend to be higher based on consumer and customer purchasing patterns associated with health care reimbursement programs.

Geographic Areas

A significant portion of the company’s revenues is generated from operations or otherwise earned outside the U.S. and Canada.

History

The company was incorporated in 2013. It was formerly known as Valeant Pharmaceuticals International, Inc. and changed its name to Bausch Health Companies Inc. in 2018.