8 unchanged sentences
Sales of the Xifaxan ® product line currently represent approximately 85% of the Salix segment revenues.
−Removed: • 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.
+Added: • 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.
+Added: 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.
3 unchanged sentences
For additional discussion of our reportable segments, see the discussion in Item 1.
−Removed: “Business — Segment Information” and Note 22, “SEGMENT INFORMATION” to our audited Consolidated Financial Statements for further details on these reportable segments.
+Added: “Business — Segment Information” and Note 23, “SEGMENT INFORMATION” to our audited Consolidated Financial Statements.
Separation of the Bausch + Lomb Eye Health Business
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Upon the closing of the B+L IPO and after giving effect to the subsequent partial exercise of the over-allotment option by the underwriters, Bausch Health indirectly holds 310,449,643 common shares of Bausch + Lomb, which represents approximately 88% of B+L’s outstanding common shares as of February 11, 2026.
−Removed: We continue to believe that the B+L Separation, which may include the transfer of all or a portion of our remaining direct or indirect equity interest in Bausch + Lomb to our shareholders, the monetization of all or a portion of our ownership interest in Bausch + Lomb, or a combination thereof, makes strategic sense.
+Added: We continue to believe that the B+L Separation, which may include the monetization of all or a portion of our ownership interest in Bausch + Lomb, the transfer of all or a portion of our remaining direct or indirect equity interest in Bausch + Lomb to our shareholders, or a combination thereof, makes strategic sense.
The completion of the B+L Separation is subject to the achievement of targeted debt leverage ratios and the receipt of any applicable shareholder and other necessary approvals.
1 unchanged sentence
The B+L Separation, if consummated, will result in two separate, independent companies:
−Removed: • Bausch Health excluding Bausch + Lomb - a diversified pharmaceutical company with leading positions in gastroenterology, hepatology, dermatology, neurology and international pharmaceuticals, and aesthetic medical
+Added: • Bausch Health excluding Bausch + Lomb - a diversified pharmaceutical company with leading positions in gastroenterology, hepatology, dermatology, neurology and international pharmaceuticals, and aesthetic medical devices.
The remaining pharmaceutical entity will comprise a diversified portfolio of our brands across the Salix, International, dentistry, neurology, medical dermatology and generics, and aesthetic medical devices businesses;
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For additional details on the B+L Separation, see “Separation of the Bausch + Lomb Eye Health Business” in Note 2, “SIGNIFICANT ACCOUNTING POLICIES” to our audited Consolidated Financial Statements and Item 1A.
−Removed: “Risk Factors — Risk Relating to the B+L Separation” of this Form 10-K.
+Added: “Risk Factors — Risks Relating to the B+L Separation” of this Form 10-K.
Business Strategy
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Our continued success is dependent upon our ability to refresh our 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.
−Removed: We have a robust pipeline that we believe not only provides for the next generation of our existing products but is also poised to bring new and innovative solutions to market.
+Added: We have a pipeline that we believe not only provides for the next generation of our existing products but is also poised to bring new and innovative solutions to market.
We have focused our research and development (“R&D”) to advance development programs that we believe will drive growth in our core businesses, while creating efficiencies in our R&D efforts and expenses.
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Currently, we have approximately 1,000 products in our portfolio of products, which fall into five reportable segments:
−Removed: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified and (v) Bausch + Lomb.
−Removed: Segment revenues for the years 2024, 2023 and 2022 were as follows:
−Removed: 2024 2023 2022
−Removed: (in millions) Amount Pct.
−Removed: Salix $ 2,333 24 % $ 2,250 26 % $ 2,090 26 %
−Removed: International 1,111 12 % 1,071 12 % 988 12 %
−Removed: Solta Medical 440 5 % 347 4 % 300 4 %
−Removed: Diversified 950 10 % 943 11 % 978 12 %
−Removed: Bausch + Lomb 4,791 50 % 4,146 47 % 3,768 46 %
−Removed: Total revenues $ 9,625 100 % $ 8,757 100 % $ 8,124 100 %
−Removed: Comparative segment information for 2024, 2023 and 2022 is further presented in Note 22, “SEGMENT INFORMATION” to our audited Consolidated Financial Statements.
Our Salix segment consists of sales in the U.S.
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We have implemented initiatives, including increasing our marketing investment in Xifaxan ® , to seek to further capitalize on the value of the infrastructure we have built around these products to extend our market share.
−Removed: Our principal products in this segment (including products of our third-party co-promotion partners) include:
+Added: Our principal products include:
• Xifaxan ® which includes:
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• Trulance ® (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation.
−Removed: We have increased our investment in Xifaxan ® direct-to-consumer (“DTC”) advertising and new sales force capabilities.
−Removed: We also continue to invest in our product line.
−Removed: Our 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).
−Removed: 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.
+Added: We have continued our investment in Xifaxan ® direct-to-consumer (“DTC”) advertising and new sales force capabilities.
+Added: Our ongoing commitment to pipeline investment was exemplified in September 2025, when we completed the acquisition of DURECT Corporation (“DURECT”) a biopharmaceutical firm specializing in the development of epigenetic therapies that address abnormal deoxyribonucleic acid methylation, aiming to revolutionize the management of severe and life-threatening illnesses such as acute organ injury.
+Added: DURECT’s primary drug candidate, Larsucosterol, is a unique therapeutic agent that has
+Added: shown encouraging outcomes in Phase 2 clinical studies for alcohol-associated hepatitis (“AH”).
+Added: Notably, Larsucosterol has received Breakthrough Therapy designation from the U.S.
+Added: Food and Drug Administration (“FDA”).
The Company has filed lawsuits against third-party generic manufacturers that have sent the Company Notices of Paragraph IV Certification for Trulance ® and Xifaxan ® .
−Removed: See “Patent Litigation/Paragraph IV Matters” of Note 20, “LEGAL PROCEEDINGS” to our audited Consolidated Financial Statements for details of these litigation matters.
+Added: See “Intellectual Property Litigation” of Note 21, “LEGAL PROCEEDINGS” to our audited Consolidated Financial Statements for details of these litigation matters.
International
Our International business includes, with the exception of our 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.
−Removed: Our principal products in this segment include:
+Added: Our principal products 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.
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• Diclofenac is a nonsteroidal anti-inflammatory drug used to treat mild-to-moderate pain and helps to relieve symptoms of arthritis.
−Removed: This product is sold in several Eastern European countries.
+Added: This product is sold in Central and Eastern European countries.
• Contrave ® / Mysimba ® is a fixed-dose combination prolonged-release tablet for the treatment of obesity.
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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.
−Removed: Contrave ® / Mysimba ® is commercialized in Canada, Poland and other Central Eastern European countries.
+Added: Contrave ® / Mysimba ® is commercialized in Canada, Poland and other Central and Eastern European countries.
+Added: • Ryaltris ® (olopatadine hydrochloride and mometasone furoate nasal spray) is indicated for the symptomatic treatment of moderate to severe seasonal allergic rhinitis and associated ocular symptoms in adults, adolescents and children aged 6 years and older.
• Espaven ® (Dimethicone tablets, drops, suspension) is a complete line of gastrointestinal treatments for diverse digestive indications such as:
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Solta Medical
−Removed: Solta Medical is a global leader in the medical aesthetic market focused on innovative aesthetic medical treatment technologies.
−Removed: Solta Medical’s revenue is primarily attributable to the skin tightening market, which is driven by our Thermage ® product lines.
−Removed: The latest generation of this product line, Thermage ® FLX, has been launched in our key markets and expansion is expected to continue into other countries, paced by country-specific regulatory registrations.
−Removed: Our principal products in this segment include:
−Removed: • The Thermage ® system is a non-invasive radiofrequency treatment that can smoothen, tighten and contour skin for an overall younger-looking appearance.
−Removed: • 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.
−Removed: • The Fraxel ® system is a treatment that improves tone, texture and radiance for aging, sun damaged or scarred skin.
+Added: Our Solta Medical business is a global leader in the medical aesthetic market focused on innovative aesthetic medical treatment technologies.
+Added: Solta Medical’s revenue is primarily attributable to the skin tightening market, which is driven by our Thermage ® product line.
+Added: The latest generation, Thermage ® FLX, has been launched in our key markets and expansion is expected to continue into other countries, paced by country-specific regulatory registrations.
+Added: Our principal products include:
+Added: • The Thermage ® system is a non-invasive radiofrequency treatment that can smooth, tighten and contour skin for an overall younger-looking appearance.
+Added: • The Clear + Brilliant ® system is a laser treatment that can help address the visible signs of aging and the overall dulling effects that time and the environment can have on skin.
+Added: • The Fraxel ® system is a laser treatment used to address fine lines, wrinkles, acne scars and surgical scars as well as improve tone, texture and radiance of aging and sun damaged skin.
• The VASERlipo ® system is a minimally invasive aesthetic body contouring system that yields dramatic results with less pain and downtime than traditional liposuction.
−Removed: We continue to invest in expanding access to Solta Medical technologies for medical aesthetic providers and consumers in our key markets, including broadening the reach of Thermage ® FLX and strengthening our sales force in the U.S., Europe and Asia.
+Added: We continue to invest in expanding access to Solta Medical technologies for medical aesthetic providers and consumers in our key markets, including broadening the reach of Thermage ® FLX and strengthening our sales force in North America, Europe and Asia.
Our Diversified segment consists of sales in the U.S.
−Removed: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) dermatology products, (iii) generic pharmaceutical products and (iv) dentistry products.
−Removed: Our principal products in this segment include:
−Removed: • Wellbutrin ® XL is an extended release formulation of bupropion indicated for the treatment of major depressive disorder in adults.
−Removed: • 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.
+Added: (i) pharmaceutical products in the areas of neurology (neuroscience) and certain other therapeutic classes, (ii) dermatology products, (iii) generic pharmaceutical products and (iv) dentistry products.
+Added: Our principal products include:
+Added: Neuroscience (formerly Neurology)
+Added: • Wellbutrin ® XL (bupropion hydrochloride) is an extended release formulation of bupropion indicated for the treatment of major depressive disorder in adults.
+Added: • Aplenzin ® (bupropion hydrobromide) is an extended release tablet formulation 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.
−Removed: • Xenazine ® is indicated for the treatment of chorea associated with Huntington’s disease.
+Added: • Xenazine ® (tetrabenazine) is indicated for the treatment of chorea associated with Huntington’s disease.
In the U.S., Xenazine ® is distributed for us by Lundbeck LLC under an exclusive marketing, distribution and supply agreement.
• Jublia ® (efinaconazole) 10% topical solution is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus).
−Removed: • Siliq ® is an IL-17 receptor blocker monoclonal antibody for patients with moderate-to-severe plaque psoriasis.
−Removed: • 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.
−Removed: • 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.
−Removed: • CABTREO ® is the first and only U.S.
−Removed: Food and Drug Administration (“FDA”) approved fixed-dose, triple-combination topical treatment for acne.
+Added: • CABTREO ® (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel is the first and only 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.
−Removed: 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.
−Removed: Principal products include:
−Removed: • 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.
−Removed: • Elidel ® AG (pimecrolimus) is a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis.
−Removed: • Uceris ® AG (budesonide) extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control (induce remission).
−Removed: • Arestin ® (minocycline hydrochloride) is a subgingival sustained-release antibiotic and accounted for approximately 95% of the Dentistry business revenues for 2024 and 2023.
+Added: • Siliq ® (brodalumab) injection is an IL-17 receptor blocker monoclonal antibody for patients with moderate-to-severe plaque psoriasis.
+Added: • 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.
+Added: • 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.
+Added: 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 generic versions of certain branded assets including authorized generics (“AG”).
+Added: • Arestin ® (minocycline hydrochloride) is the only FDA approved subgingival sustained-release antibiotic on the market.
Arestin ® is indicated as an adjunct to scaling and root planing (“SRP”) procedures for reduction of pocket depth in patients with adult periodontitis.
−Removed: Arestin ® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.
+Added: Arestin ® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP and represents approximately 95% of Dentistry revenues.
Bausch + Lomb
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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.
−Removed: Our principal products in this segment include:
+Added: Our principal products 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.
−Removed: Bausch + Lomb completed the acquisition of XIIDRA ® during the third quarter of 2023.
−Removed: • 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.
+Added: • 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 following the landmark AREDS 2 clinical study.
+Added: PreserVision ® AREDS 3, a next generation eye vitamin formulation, is anticipated to launch in 2026.
• 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.
1 unchanged sentence
To date, Bausch + Lomb has launched and acquired the right to launch Lumify ® in various countries.
−Removed: 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.
−Removed: • 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.
+Added: A new line extension formulation, Lumify ® Preservative Free was launched in the U.S.
+Added: In addition, Bausch + Lomb is in the process of submitting a New Drug Application (“NDA”) for Lumify ® next generation in the first half of 2026.
+Added: • MIEBO ® (perfluorohexyloctane ophthalmic solution) (formerly known as NOV03) – In 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.
−Removed: MIEBO ® launched in the U.S.
−Removed: in September 2023 and was approved in Canada during September 2024.
−Removed: MIEBO ® is the first and only FDA approved treatment for
−Removed: 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.
+Added: MIEBO ® is the first and only FDA approved treatment for DED that directly targets tear evaporation.
• 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.
−Removed: • Biotrue ® multi-purpose solution helps prevent certain tear proteins from denaturing and fights germs for healthy contact lens wear.
+Added: • Biotrue ® and Biotrue ® Hydration Plus multi-purpose solutions help 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.
6 unchanged sentences
in June 2024.
−Removed: • Stellaris Elite ® vision enhancement system, is a combined system with cataract and vitreoretinal capability featuring the Bi-Blade vitrectomy handpiece.
−Removed: The Stellaris Elite ® vision enhancement system configured for cataract procedures is our latest generation phacoemulsification cataract platform, Stellaris Elite ® is the first phacoemulsification platform on the market to offer Adaptive Fluidics TM , which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient cataract lens removal.
−Removed: Bausch + Lomb’s Stellaris Elite ® vision enhancement system was launched in the United States in 2017 and internationally in 2018.
+Added: • Stellaris Elite ® , a vision enhancement system configured for cataract procedures is the latest generation phacoemulsification cataract platform, Stellaris Elite ® is the first phacoemulsification platform on the market to offer Adaptive Fluidics TM , which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient cataract lens removal.
Research and Development
Our R&D organization focuses on the development of products through clinical trials.
−Removed: Currently, we have approximately 75 R&D projects in our pipeline.
−Removed: As of December 31, 2024, approximately 1,500 dedicated R&D and quality assurance employees in 24 R&D facilities were involved in our R&D efforts.
−Removed: Our R&D expenses for 2024, 2023 and 2022, were $616 million, $604 million and $529 million, respectively.
−Removed: R&D expenses as a percentage of revenue were approximately 6%, 7% and 7% in 2024, 2023 and 2022, respectively.
−Removed: Our investment in R&D reflects our commitment to drive organic growth through internal development of new products, a pillar of our strategy.
−Removed: We further supplement these efforts by continually seeking out other opportunities, such as co-promotions, licensing agreements and strategic acquisitions.
−Removed: “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Value and Core Businesses” of this Form 10-K.
+Added: As of December 31, 2025, we had approximately 80 R&D projects in our pipeline and approximately 1,400 dedicated R&D and quality assurance employees in 25 R&D facilities were involved in our R&D efforts.
+Added: “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Value and Core Businesses” of this Form 10-K for additional information.
Trademarks and Patent Exclusivity
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“Risk Factors” of this Form 10-K for additional information on the risks associated with our intellectual property and proprietary rights.
−Removed: We believe that trademark protection is an important part of establishing product and brand recognition.
−Removed: We own or license a number of registered trademarks and trademark applications in the U.S., Canada and in various other countries throughout the world.
−Removed: 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.
−Removed: 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 U.S.
−Removed: federal trademark registrations, the mark is still being used in commerce.
−Removed: 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 U.S.
−Removed: federal trademark registrations, the mark is still being used in commerce.
−Removed: Other countries generally have similar but varying terms and renewal policies with respect to trademarks registered in those countries.
+Added: We believe that trademarks, including brand names, logos, and trade dress, are an important part of establishing product and brand recognition.
+Added: We register or license a number of trademarks around the world in support of our operations.
+Added: Trademark registrations are generally for fixed terms which vary by country, subject to use and renewal requirements.
+Added: Trademark protections may remain in place indefinitely in many countries as long as they remain in use.
Patent Exclusivity
9 unchanged sentences
Failure to comply with these regulations could result in, among other things, warning letters, civil penalties, delays in approving or refusal to approve a product candidate, product recall, product seizure, interruption of production, operating restrictions, suspension or withdrawal of product approval, injunctions or criminal prosecution.
−Removed: Prior to human use, the FDA approval or marketing clearance must be obtained in the U.S., approval by Health Canada must be obtained in Canada, European Medicines Agency (the “EMA”) approval (drugs) or a CE Marking (devices) and/or registration under the European Commission’s Medical Device Regulation (“MDR”), must be obtained for countries that are part of the EU and approval must be obtained from comparable agencies in other countries prior to manufacturing or marketing new pharmaceutical products or medical devices.
+Added: Prior to human use, the FDA approval or marketing clearance must be obtained in the U.S., approval by Health Canada must be obtained in Canada, European Medicines Agency (the “EMA”) approval (drugs) or a Conformité Européenne (European Conformity) (“CE”) mark (devices) and/or registration under the European Commission’s Medical Device Regulation (“MDR”), must be obtained for countries that are part of the EU and approval must be obtained from comparable agencies in other countries prior to manufacturing or marketing new pharmaceutical products or medical devices.
Generally, preclinical studies and clinical trials of the products must first be conducted and the results submitted to the applicable regulatory agency (such as the FDA) for approval.
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While EU law is applicable in Northern Ireland, the United Kingdom (“UK”) Medical Devices Regulations 2002/68 also needs to be complied with in Great Britain.
−Removed: Effective July 1, 2023, devices destined for Great Britain are required to follow the UK regulatory regime and to be labeled with the UKCA mark.
+Added: Effective July 1, 2023, devices destined for Great Britain are required to follow the UK regulatory regime and to be labeled with the UK Conformity Assessed (“UKCA”) mark.
Northern Ireland will, however, continue to accept CE marked devices.
There are some additional requirements for manufacturers who are based outside the UK, such as the requirement to appoint a UK Responsible Person to take on certain regulatory responsibilities with respect to the Medicines and Healthcare products Regulatory Agency and users or customers in the UK.
−Removed: Further, pursuant to the Swiss Medical Device Ordinance, we are required to appoint an authorized representative in Switzerland in order to export our CE-marked medical devices to Switzerland.
+Added: Further, pursuant to the Swiss Medical Device Ordinance, we are
+Added: required to appoint an authorized representative in Switzerland in order to export our CE-marked medical devices to Switzerland.
Additionally, the name and address of the Swiss authorized representative must be placed on the packaging.
−Removed: Regulation by other federal agencies, such as the Drug Enforcement Administration, and state and local authorities in the United States, and by comparable agencies in certain foreign countries, is also required.
−Removed: In the United States, the FTC, the FDA and state and local authorities regulate the advertising of medical devices, prescription drugs, OTC drugs and cosmetics.
−Removed: 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 our 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.
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We are also subject to the U.S.
−Removed: 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.
+Added: Foreign Corrupt Practices Act (“FCPA”), the Canadian Corruption of Foreign Public Officials Act (“CFPOA”) 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.
Violations of these laws could result in criminal or civil penalties or remedial measures.
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For example, the California Consumer Privacy Act (the “CCPA”) and the California Privacy Rights Act (the “CPRA”) impose stringent data privacy and security requirements and obligations with respect to the personal information of California residents, including, among other things, new disclosures to California consumers and providing such consumers new data protection and privacy rights, including the ability to opt out of certain sales of personal information.
−Removed: The CCPA and CPRA provide for civil
−Removed: penalties for violations, as well as a private right of action for certain data breaches that result in the loss of personal data that may increase the likelihood of, and risks associated with, data breach litigation.
+Added: The CCPA and CPRA provide for civil penalties for violations, as well as a private right of action for certain data breaches that result in the loss of personal data that may increase the likelihood of, and risks associated with, data breach litigation.
The CPRA also creates a new state agency that will be vested with authority to implement and enforce the CCPA and the CPRA.
34 unchanged sentences
The PIPL is the first national-level law comprehensively regulating issues in relation to personal information protection.
−Removed: provides for very specific administrative requirements and security controls when transferring personal data outside the Peoples Republic of China.
+Added: The PIPL provides for very specific administrative requirements and security controls when transferring personal data outside the Peoples Republic of China.
These transfer requirements came into effect on March 1, 2023.
2 unchanged sentences
In the U.S., the E.U.
−Removed: and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, which has resulted in lower average realized prices.
+Added: and other significant or potentially significant markets for
+Added: our products and product candidates, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, which has resulted in lower average realized prices.
In the U.S., these pressures can arise from rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement policies and pricing in general.
9 unchanged sentences
Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded prescription drug products.
−Removed: The Bipartisan Budget Act of 2018 amended the Patient Protection and Affordable Care Act, effective January 1, 2019, to close the donut hole in most Medicare drug plans.
−Removed: In addition, in April 2018, the Centers for Medicare & Medicaid Services published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the Patient Protection and Affordable Care Act for plans sold through such marketplaces.
−Removed: The Inflation Reduction Act (“IRA”) made significant changes to how drugs are covered and paid for under the Medicare program, including imposing financial penalties if drug prices are increased at a rate faster than inflation, redesigning Medicare Part D benefits to shift a greater portion of the costs to manufacturers and allowing the U.S.
+Added: The Bipartisan Budget Act of 2018 amended the PPACA, effective January 1, 2019, to close the donut hole in most Medicare drug plans.
+Added: In addition, in April 2018, the CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the PPACA for plans sold through such marketplaces.
+Added: The IRA made significant changes to how drugs are covered and paid for under the Medicare program, including imposing financial penalties if drug prices are increased at a rate faster than inflation, redesigning Medicare Part D benefits to shift a greater portion of the costs to manufacturers and allowing the U.S.
government to set prices for certain drugs in Medicare.
1 unchanged sentence
The IRA also provides for (i) the U.S.
−Removed: government to set or “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D and 2023 for Medicare Part B drugs and (iii) Medicare Part D redesign which replaces the current Part D Coverage Gap Discount Program and establishes a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
−Removed: In January 2025, the Center for Medicare and Medicaid Services (“CMS”) selected Xifaxan ® 550 mg tablets as one of the medicines for the second round of negotiation of the drug price negotiation program as part of the IRA with an initial price applicability in 2027.
+Added: government to set or “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D and 2023 for Medicare Part B drugs and (iii) Medicare Part D redesign which replaces the current Part D Coverage Gap Discount Program and established a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, which has increased to $2,100 for 2026, with manufacturers being responsible for 10% of costs up to the $2,100 cap and 20% after that cap is reached.
+Added: In January 2025, the CMS selected Xifaxan ® 550 mg tablets as one of the medicines for the second round of negotiation of the drug price negotiation program as part of the IRA with an initial price applicability in 2027.
It is possible that other of our products could be selected in future years.
−Removed: These negotiations could, among other things, accelerate revenue erosion prior to the expiration of intellectual property protections.
−Removed: The effect of reducing prices and reimbursement for certain of our products could significantly impact our business and consolidated results of operations.
+Added: The Company’s negotiations with CMS have concluded, and CMS published the negotiated maximum fair prices on November 25, 2025.
+Added: The negotiated price for Xifaxan ® will become effective on January 1, 2027 and is expected to negatively impact revenues and operating results for Xifaxan ® primarily in 2027 due to anticipated generic competition beginning in 2028 and is not anticipated to materially affect the Company’s long-term strategies and cash flows.
There have been prior efforts in Congress to amend or replace the IRA and it is possible that there could be new efforts to make changes to this legislation.
Additionally, policy efforts designed specifically to reduce patient out-of-pocket costs for medicines could result in new mandatory rebates and discounts or other pricing restrictions.
−Removed: Legislative efforts relating to drug pricing, the cost of prescription drugs under Medicare, the relationship between pricing and manufacturer patient programs, and
−Removed: government program reimbursement methodologies for drugs have been proposed and considered at the U.S.
+Added: Legislative efforts relating to drug pricing, the cost of prescription drugs under Medicare, the relationship between pricing and manufacturer patient programs, and government program reimbursement methodologies for drugs have been proposed and considered at the U.S.
federal and state level.
The previous Congress and presidential administration have each indicated an intent to continue to seek new legislative or administrative measures to control drug costs.
−Removed: The legislative priorities of the current Congress and the new presidential administration remain uncertain.
−Removed: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
+Added: The legislative priorities of the current Congress and presidential administration remain uncertain and difficult to predict.
+Added: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to
+Added: encourage importation from other countries and bulk purchasing.
We also anticipate that Congress, state legislatures, and third-party payors may continue to review and assess alternative health care delivery and payment systems and may in the future propose and adopt legislation or policy changes or implementations effecting additional fundamental changes in the health care delivery system.
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In particular, some of our products might be characterized as nanomaterials and then be subject to evolving, new nanomaterial regulations.
−Removed: In light of the rapid and ongoing global regulations and expectations relating to environmental, social and governance (“ESG”) matters, we are making appropriate investments in our ESG program to position us 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.
+Added: In light of the rapid and ongoing global regulations and expectations relating to environmental, social and governance (“ESG”) matters, we are making appropriate investments in our ESG program to position us for timely reporting for the EU’s Corporate Sustainability Reporting 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.
We believe we are in compliance in all material respects with applicable environmental and occupational health and safety laws and regulations.
1 unchanged sentence
We cannot assure, however, that environmental liabilities relating to us or facilities owned, leased or operated by us will not develop in the future, and we cannot predict whether any such liabilities, if they were to develop, would require significant expenditures on our part.
−Removed: In addition, we are unable to predict what environmental or and occupational health and safety legislation or regulations may be adopted or enacted in the future.
+Added: In addition, we are unable to predict what environmental or occupational health and safety legislation or regulations may be adopted or enacted in the future.
“Risk Factors” of this Form 10-K for additional information.
1 unchanged sentence
In 2025, the U.S.
−Removed: and Puerto Rico accounted for approximately 60% and China accounted for approximately 5% of our total revenue, respectively.
+Added: accounted for approximately 60% and China accounted for approximately 5% of our total revenues, respectively.
No other country accounted for more than 5%.
6 unchanged sentences
In some markets, we additionally sell directly to physicians, hospitals and large drug store chains and we sell through distributors in countries where we do not have our own sales staff.
−Removed: As part of our marketing program for pharmaceuticals, we use direct to consumer advertising, direct mailings, advertise in trade, social media and medical periodicals, exhibit products at medical conventions and sponsor medical education symposia.
+Added: As part of our marketing program for pharmaceuticals, we use DTC advertising, direct mailings, advertise in trade, social media and medical periodicals, exhibit products at medical conventions and sponsor medical education symposia.
Competitive Landscape for Products and Products in Development
18 unchanged sentences
To successfully compete for business with managed care and pharmacy benefits management organizations, we must often demonstrate that our products offer not only medical benefits, but also cost advantages as compared with other forms of care.
−Removed: For details regarding products that are facing generic competition, products that could potentially face generic competition, the corresponding potential revenue impact and infringement proceedings we initiated against potential generic competition, see Item 7.
+Added: Our ability to obtain, maintain and license sufficient intellectual property rights over our products and enforce and defend against challenges to such intellectual property (such as in connection with the Xifaxan ® Generics Litigation) and related litigation, is critical to our business and financial results.
+Added: A substantial amount of our revenue is derived from the Xifaxan ® product line, and we may be materially impacted by the entry of a generic rifaximin product earlier than January 2028, including a competitor launching a generic rifaximin at risk prior to a final, unappealable decision.
+Added: For further details regarding products that are facing generic competition, products that could potentially face generic competition, the corresponding potential revenue impact and infringement proceedings we initiated against potential generic competition, see Item 7.
“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Business Trends — Generic Competition and Loss of Exclusivity” of this Form 10-K.
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In the normal course of business, our products, devices and facilities are the subject of ongoing oversight and review by regulatory and governmental agencies, including general, for cause and pre-approval inspections by the relevant competent authorities where we have business operations.
−Removed: Through the date of this filing, all of our global operations and facilities have the relevant operational good manufacturing practices certificates and all Company products and all operating sites are in good compliance standing with all relevant notified bodies and global health authorities.
−Removed: Further, all sites under FDA jurisdiction are rated as either No Action Indicated (where there was no Form 483 observation) or Voluntary Action Indicated (“VAI”) (where there was a Form 483 with one or more observations).
−Removed: In the case of VAI inspection outcomes, the FDA has accepted our responses to the issues cited, which will be verified when the agency makes its next inspection of those specific facilities.
+Added: Through the date of this filing, we believe that all of our global operations and facilities have the relevant operational good manufacturing practices certificates and all Company products and all operating sites are in good compliance in all material respects standing with all relevant notified bodies and global health authorities.
We also subcontract the manufacturing of certain of our products, including products manufactured under the rights acquired from other pharmaceutical companies.
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or others may in the future become available from only one source.
−Removed: For example, with respect to some of our largest or most significant products, the supply of the finished product for each of our 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 our internal manufacturing sites or third party manufacturers) and the supply of active pharmaceutical ingredients for each of our Lumify ® , Vyzulta ® , MIEBO ® , Preservision ® , Relistor ® Oral and injection, Trulance ® , Aplenzin ® , Arestin ® , Bedoyecta ® and Siliq ® products are also only available from a single source.
+Added: For example, with respect to some of our largest or most significant products, the supply of the finished product for each of our Lumify ® , Vyzulta ® , SofLens ® , MIEBO ® , XIIDRA ® , Wellbutrin XL ® , Relistor ® injection, Trulance ® , Jublia ® , Aplenzin ® , Arestin ® , Bedoyecta ® , Siliq ® and PureVision ® products are only available from a single source (either one of our internal manufacturing sites or third party manufacturers) and the supply of active pharmaceutical ingredients for each of our Lumify ® , Vyzulta ® , MIEBO ® , PreserVision ® , Relistor ® Oral and injection, Trulance ® , Aplenzin ® , Arestin ® , Bedoyecta ® and Siliq ® products are also only available from a single source.
Any disruption in the supply of any such single-sourced active pharmaceutical ingredient, other raw material or finished product or an increase in the cost of such materials or products could adversely impact our ability to manufacture or sell such products, the ability of our third-party manufacturers to supply us with such products, or our profitability.
−Removed: We attempt to manage the risks associated with reliance on single sources of active pharmaceutical ingredient, other raw materials or finished products by carrying additional inventories or, where possible, developing second sources of supply.
+Added: We attempt to manage the risks associated with reliance on single sources of active pharmaceutical ingredients, other raw materials or finished products by carrying additional inventories or, where possible, developing second sources of supply.
“Risk Factors” for additional information on the risks associated with our manufacturing arrangements.
11 unchanged sentences
Our employees’ health, safety, and wellness are important to us.
−Removed: On an ongoing basis, Bausch Health (excluding Bausch + Lomb) measures how well we foster the health and safety of our employees by measuring Lost Time Incident Rates, which is the number incidents that result in lost time.
−Removed: For 2024, our Lost Time Incident Rate was 1.7 recorded cases per 100 employees, which was consistent with the industry average.
−Removed: Bausch + Lomb measures Days Away Rate (“DAR”), which measures the number of days employees are away from work as a result of a work-related injury or illness.
+Added: On an ongoing basis, Bausch Health (excluding Bausch + Lomb) measures how well we foster the health and safety of our employees by measuring Lost Time Incident Rates, which reflect the number of incidents that result in lost time.
+Added: For 2025, our Lost Time Incident Rate was 0.8 recorded cases per 100 employees, which was slightly higher than the industry average of 0.5 recorded per 100 employees.
+Added: Bausch + Lomb measures Days Away Rate (“DAR”), which measures the number of days employees are away from work due to injury or illness.
In 2025, B+L’s DAR was 5.5, which met its goal of not exceeding 6 on an annual basis and is significantly lower than similar industry standard DAR of 22.
−Removed: Diversity and Inclusion
−Removed: We are dedicated to fostering an inclusive work environment where everyone feels welcomed, supported and valued for their talents and contributions.
−Removed: Our Bausch Health Diversity, Equity & Inclusion strategy centers on connecting our employees to our Company, each other, and our communities to cultivate a sense of trust, respect and belonging for all.
+Added: Equity and Inclusion
+Added: We are dedicated to cultivating a workplace where every individual feels appreciated, respected and empowered to thrive.
+Added: Our aim is to build an environment that nurtures growth, encourages collaboration and fosters a deep sense of belonging.
Talent Development
5 unchanged sentences
The Talent and Compensation Committee of the Board of Directors along with the Board has oversight of our Company’s talent management and succession planning process.
−Removed: The Talent and Compensation Committee of the Board of Directors reviews succession planning progress and specifically, the plans for members of the Executive Leadership team consisting of the CEO and his direct reports.
+Added: The Talent and Compensation Committee of the Board of Directors reviews succession planning progress and specifically, the plans for members of the Executive Leadership team consisting of the Chief Executive Officer and his direct reports.
To support this process, members of the Board interact with senior leaders throughout the organization during the year to get to know these leaders and their work.
12 unchanged sentences
We understand that some patients may face financial obstacles that can keep them from obtaining the prescription products they need.
−Removed: Bausch Health is committed to improving access to medications through our patient assistance programs.
+Added: Bausch Health is committed to improving access to medications through our patient assistance program.
The purpose of the Bausch Health Patient Assistance Program is to provide eligible patients in the U.S.
with certain of our prescription products where their financial circumstances or insurance status would otherwise interfere with their ability to access such products.
−Removed: If approved, patients receive our prescription product(s) at no cost for up to two years and may be able to reapply to the program annually if they continue to meet eligibility requirements and have a valid prescription.
+Added: If approved, and with a valid prescription, patients receive our prescription product(s) at no cost and can reapply to the program annually to confirm they continue to meet eligibility requirements.
“Management’s Discussion and Analysis — Overview — Focus on Value and Core Businesses — Improve Patient Access” for additional discussion regarding Company programs to address the affordability and availability of our products.
10 unchanged sentences
A significant portion of our revenues is generated from operations or otherwise earned outside the U.S.
−Removed: All of our foreign operations are subject to risks inherent in conducting business abroad, including price and currency exchange controls, fluctuations in the relative values of currencies, political and economic instability and restrictive governmental actions including possible nationalization or expropriation.
+Added: All of our foreign operations are subject to risks inherent in conducting business abroad, including price and currency exchange controls, fluctuations in the relative values of currencies, political and economic instability and restrictive governmental actions
+Added: including possible nationalization or expropriation.
Changes in the relative values of currencies may materially affect our results of operations.
7 unchanged sentences
We post links on our website to the following filings as soon as reasonably practicable after they are electronically filed or furnished to the SEC:
−Removed: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendment to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended.
+Added: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendment to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.
All such filings are available through our website free of charge.
4 unchanged sentences
These filings are also electronically available from the Canadian System for Electronic Data Analysis and Retrieval (“SEDAR+”) at www.sedarplus.ca , the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.
−Removed: Our business, financial condition, cash flows and results of operations are subject to various risks and uncertainties.
−Removed: You should carefully consider the risks and uncertainties described below, together with all of the other information in this Form 10-K, including those risks set forth under the heading entitled “Forward-Looking Statements” and in other documents that we file with the SEC and the CSA, before making any investment decision with respect to our common shares or debt securities.
−Removed: If any of the risks or uncertainties actually occur or develop, our business, financial condition, cash flows, results of operations and/or future growth prospects could change, and such change could be materially adverse.
−Removed: Under these circumstances, the market value of our common shares and/or debt securities could decline, and you could lose all or part of your investment in our common shares and/or debt securities.
−Removed: Summary of Risk Factors
−Removed: The following is a summary of the risk factors our business faces.
−Removed: The list below is not exhaustive, and investors should read this “Risk Factors” section in full.
−Removed: Some of the risks we face include:
−Removed: • the impact of the current market and economic conditions in one or more of our markets on our business;
−Removed: • the impact of inflation and other macroeconomic factors on our financial results and operations;
−Removed: • the ongoing litigation and potential additional litigation, claims, challenges and/or regulatory investigations challenging or otherwise relating to the B+L IPO and the B+L Separation and the costs, expenses, use of resources, diversion of management time and efforts, liability and damages that may result therefrom;
−Removed: • the impact on our business from the closing of the B+L IPO, the uncertainties with respect to the expected timing of completion of the B+L Separation, including the impact of a failure to maintain the tax-free treatment of such transaction, any actual or perceived conflict of interest of our directors and officers who also serve roles in Bausch + Lomb and the cross-indemnification obligations on us and Bausch + Lomb;
−Removed: • the ongoing legal proceedings, investigations, and inquiries respecting certain of our historical distribution, marketing, pricing, disclosure and accounting practices;
−Removed: • the impact of changes to our pricing practices, whether imposed, legislated or voluntary;
−Removed: • the potential adverse impact of legal and governmental proceedings that are uncertain, costly and time-consuming;
−Removed: • our dependence on third parties to meet their contractual, legal, regulatory, and other obligations;
−Removed: • the impact of product recalls and related product liability claims;
−Removed: • our ability to comply with extensive regulation concerning marketing, promotional and business practices;
−Removed: • our ability to comply with restrictive covenants in our debt agreements;
−Removed: • our ability to generate cash in order to service our debt;
−Removed: • the impact on our business of restrictions imposed by our significant indebtedness;
−Removed: • our ability to manage the transition of our key management positions;
−Removed: • our ability to recruit and retain executives and key personnel;
−Removed: • the potential increase of our effective tax rates, including as a result of proposed changes to applicable tax laws;
−Removed: • our ability to compete with generic competitors in products that represent a significant amount of our revenue;
−Removed: • our ability to obtain, maintain, enforce or defend the intellectual property rights required to conduct our business;
−Removed: • the impact of current and potential intellectual property litigation;
−Removed: • our ability to develop or acquire more effective or less costly pharmaceutical or OTC products or medical devices than our competitors;
−Removed: • the effect of our commitment to the cessation of or limitation on pricing increases for certain of our products;
−Removed: • the impact of potential divestitures of certain of our assets and businesses;
−Removed: • the potential adverse effect of acquisitions of assets, products and businesses;
−Removed: • our ability to maintain and provide appropriate training in our products to our health care providers;
−Removed: • our ability to successfully commercialize our pipeline products;
−Removed: • our ability to comply with ongoing regulatory review of our marketed drugs, including our dietary products;
−Removed: • the impact on our revenues and profits from generic products as a result of changes to regulatory policy;
−Removed: • the impact on our business of interruptions in our manufacturing processes;
−Removed: • our dependence on a limited number of sources for certain of our finished products and raw materials;
−Removed: • our ability to achieve or maintain expected levels of market acceptance for our new products;
−Removed: • our dependence on reimbursements from governmental and other third-party payors;
−Removed: • the impact of a failure to be included in formularies developed by managed care organizations and third-party payors;
−Removed: • the impact of pricing controls, social or governmental pressure to lower the cost of drugs, and consolidation across the supply chain, such as legislation promulgated by the IRA and the selection in January 2025 by CMS of Xifaxan ® for the second round of negotiation under the drug price negotiation program for initial price applicability in 2027;
−Removed: • the impact of catastrophic events that may disrupt our business;
−Removed: • the illegal distribution and sale of counterfeit versions of our products;
−Removed: • the reduction of profits due to imports from countries where our products are available at lower prices;
−Removed: • the reduction of revenues in future fiscal periods due to our policies regarding returns, allowances, and chargebacks;
−Removed: • the decline in sales volumes or prices of our products as the result of the concentration of sales to wholesalers;
−Removed: • the effect of changes in inventory levels or fluctuations in buying patterns by our large distributor and retail customers;
−Removed: • the decline in pricing and/or volume of our products under our distribution agreements with other companies;
−Removed: • risks associated with the international scope of our operations;
−Removed: • the impact of potential imposition of and adverse changes to duties, tariffs and other trade protection measures (including any retaliations to such measures);
−Removed: • foreign currency exposure on the translation into U.S.
−Removed: dollars of the financial results of our international operations;
−Removed: • risks associated with the ongoing conflict between Russia and Ukraine;
−Removed: • risks associated with the disruption in the global economy caused by the ongoing conflict in the Middle East involving Israel, Hamas and other countries and militant groups in the region;
−Removed: • the breakdown, interruption, breach or other compromise of our information technology systems;
−Removed: • our ability to comply with applicable laws and regulations and prevail in any litigation related to noncompliance;
−Removed: • the impact that reforms of the health care system may have on our ability to sell our products profitably;
−Removed: • our ability to comply with environmental laws and regulations and environmental remediation obligations;
−Removed: • risks associated with climate change;
−Removed: • our ability to maintain adequate internal controls and to provide an assertion as to the effectiveness of such controls on an annual basis;
−Removed: • the potential adverse effect of shareholder activism;
−Removed: • the impact on our profitability from the potential impairment of goodwill and other intangible assets;
−Removed: • our ability to effectively monitor and respond to expectations regarding environmental, social and governance matters;
−Removed: • our potential obligations under our indemnity agreements and arrangements;
−Removed: • the fluctuation of our operating results and financial condition from quarter to quarter.
−Removed: Risks Relating to Economic and Market Conditions
−Removed: Current market and economic conditions in one or more of our markets could impact our business, liquidity, financial condition, cash flows and results of operations.
−Removed: Over the last several years in the U.S.
−Removed: and globally, market and economic conditions have been challenging, particularly in light of public health pandemics and, more recently, as a result of uncertainty concerning government shutdowns, debt ceilings, government funding and potential trade wars.
−Removed: Any negative impact on economic conditions in one or more of our core markets, including volatility or deterioration in the debt and equity capital markets, heightened inflation, deflation or other adverse economic conditions may adversely affect our business, liquidity, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline.
−Removed: Ongoing uncertain economic and financial market conditions may also adversely affect the financial condition of our customers, suppliers and other business partners.
−Removed: When our customers’ financial conditions are adversely affected, it could materially and adversely affect our sales and financial results, which could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline.
−Removed: Our global business may be negatively affected by local economic conditions, including heightened inflation, increasing labor costs, potential recession, the imposition of or adverse amendments to duties, tariffs and other trade restrictions (including any retaliation to such measures) and currency exchange rate fluctuations, which could adversely affect our cost to manufacture and provide our products and services and revenues generated through sales of such products and services.
−Removed: There is no guarantee that we will be able to fully absorb any such additional costs or declines in the prices for our products and services, which may adversely impact our financial condition, cash flows and results of operations.
−Removed: Inflation and other macroeconomic factors could materially adversely affect our financial results and operations.
−Removed: Our operating results could be materially impacted by changes in the overall global macroeconomic environment and other economic factors that impact our cost structure and revenues.
−Removed: Changes in economic conditions, including supply chain constraints, logistics challenges, labor shortages, imposition of or adverse amendments to duties, tariffs and other trade protection mechanisms (including any retaliation to such measures) and steps taken by governments and central banks, including stimulus and spending programs, have, in the past, led to (and could, in the future, lead to) heightened inflation, resulting in an increase in costs and changes in fiscal and monetary policy, including increased interest rates.
−Removed: In a heightened inflationary environment, we may be unable to raise the prices of our products and services sufficiently to keep up with the rate of inflation.
−Removed: Moreover, negative macroeconomic conditions could adversely impact our ability to obtain financing in the future on terms acceptable to us, or at all.
−Removed: In addition, geopolitical instability (such as the imposition of and adverse changes to U.S.
−Removed: duty, tariff and other trade protection measures, the ongoing conflict between Russia and Ukraine and the ongoing conflicts in the Middle East) and related sanctions could continue to have significant ramifications on global financial markets, including volatility in the U.S.
−Removed: and global financial markets.
−Removed: These inflationary pressures and other negative macroeconomic conditions (including the potential impact of tariffs) could impact our revenues and resulting margins and could have an adverse impact on results of operations and could cause the market value of our common shares and/or debt securities to decline.
−Removed: Risks Relating to the B+L Separation
−Removed: The B+L Separation is subject to challenge and could be subject to further challenges in the future, any of which could delay or prevent the consummation of such transactions or cause them to occur on terms that are different or less favorable than we originally anticipated.
−Removed: The B+L Separation, which may include a distribution of all or a portion of our remaining equity interest in Bausch + Lomb to our shareholders, is subject to challenge, which could delay or prevent the consummation of such transactions or cause them to occur on worse terms than we currently expect.
−Removed: For example, in March 2022, the Company and Bausch + Lomb were named in a declaratory judgment action in the Superior Court of New Jersey, Somerset County, Chancery Division, brought by certain individual investors in the Company’s common shares and debt securities who are also maintaining individual securities fraud claims against the Company and certain of its current or former officers and directors.
−Removed: This action seeks a declaratory judgment that alleged transfers of certain Company assets to Bausch + Lomb would constitute a voidable transfer under the New Jersey Voidable Transactions Act and that Bausch + Lomb would be liable for damages, if any, awarded against the Company in the individual opt-out actions.
−Removed: In addition, the Company could, in the future, face additional legal proceedings and investigations and inquiries by governmental agencies relating to these or similar matters.
−Removed: For more information regarding legal
−Removed: proceedings, see Note 20, “LEGAL PROCEEDINGS” to our audited Consolidated Financial Statements elsewhere in this Form 10-K.
−Removed: We are unable to predict the outcome of any such proceedings, investigations and inquiries, but we may incur significant costs and diversion of management attention as a result of these matters, regardless of the outcome.
−Removed: Some or all of these proceedings, investigations and inquiries may lead to damages, settlement payments, fines, penalties, consent orders or other administrative sanctions against us.
−Removed: Furthermore, publicity surrounding these proceedings, investigations and inquiries or any enforcement action as a result thereof, even if ultimately resolved favorably for us could result in additional investigations and legal proceedings.
−Removed: As a result, these proceedings, investigations and inquiries could have a material adverse effect on our reputation, business, financial condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline.
−Removed: The B+L Separation is subject to uncertainties, which could delay or prevent the completion of the B+L Separation, cause the B+L Separation to occur on terms or conditions that are different or less favorable than originally anticipated or affect our ability to realize some or all of the anticipated benefits of the B+L Separation.
−Removed: Unanticipated developments and other challenges could delay or prevent the completion of the B+L Separation (including the Distribution, as defined below), result in changes to the anticipated structure of the B+L Separation (whether by way of “butterfly reorganization” rules in Section 55 of the Canadian Tax Act, return of capital or another form of sale or transfer of the Company’s ownership interest in Bausch +Lomb), cause the B+L Separation to occur on terms or conditions that are different or less favorable than originally anticipated or affect our ability to realize some or all of the anticipated benefits of the B+L Separation.
−Removed: Such developments and other challenges may include possible delays in obtaining any necessary shareholder, stock exchange, regulatory or other approval or the failure to obtain any such approvals, possible delays in obtaining any required tax opinions or rulings or the failure to obtain any such tax opinions or rulings, failure to satisfy conditions, complications arising from the portion of Bausch Health’s ownership of Bausch + Lomb that is pledged as collateral securing the 9.00% Intermediate Holdco Secured Notes (as defined below), negotiating challenges, the uncertainty of the financial markets, disruptions to business and commerce induced by changes in global markets, financial and economic conditions (such as international conflicts) and changes in the law.
−Removed: The Company continues to evaluate the structure of the B+L Separation and other related details, and, subject to the terms of the Company’s agreements with Bausch + Lomb, the Company may consider undertaking the B+L Separation through one or more distributions effected as a dividend or a tax-free reduction of capital, one or more distributions in exchange for Bausch Health shares or other securities, any combination thereof or another form of sale or transfer of the Company’s ownership interest in Bausch +Lomb.
−Removed: Prior to the completion of any B+L Separation, the Company may also sell a portion of its remaining direct or indirect equity interest in Bausch + Lomb through an offering to third parties.
−Removed: Further, our Board of Directors could decide, either because of a failure to satisfy conditions or because of market or other factors, to delay, abandon or alter the structure or manner and terms of the B+L Separation.
−Removed: Additionally, Bausch + Lomb may terminate the existing arrangement agreement between the Company and Bausch + Lomb in accordance with its terms.
−Removed: No assurance can be given as to whether and when the full B+L Separation will occur, on what terms or structure the B+L Separation will occur or whether the B+L Separation will achieve the benefits originally anticipated.
−Removed: As a result, there can be no assurance as to the timing of the completion of the B+L Separation or its structure or terms.
−Removed: Even if the B+L Separation is completed, we may not realize all of the benefits that we originally anticipated.
−Removed: Even if the B+L Separation is completed, we may not be able to achieve the full strategic and financial benefits originally anticipated to result from the B+L Separation.
−Removed: The B+L Separation is intended to unlock value by creating an independent business and distinct investment identity with enhanced strategic and management focus that allows more efficient allocation of resources and capital.
−Removed: In addition, though the proceeds from the B+L IPO facilitated further reductions in the aggregate amount of our outstanding indebtedness, we may not achieve these and other anticipated benefits for a variety of reasons, including, among others:
−Removed: (i) Bausch + Lomb may prove to be less valuable on an independent basis than we anticipate, including because it is more susceptible to economic downturns and other adverse events than if it were still a part of the Company and because its business will be less diversified than the Company’s business prior to the B+L Separation and (ii) other actions required to separate the respective businesses could disrupt our operations.
−Removed: We have and will continue to expend significant resources in pursuing the B+L Separation, which could have a material adverse effect on our business, financial condition, cash flows and results of operations.
−Removed: The B+L Separation has and will continue to require significant resources, time and attention from our senior management and employees, which could cause distractions and divert attention and resources away from other projects and the day-to-day operation of our business.
−Removed: We may also experience increased difficulties in attracting, retaining, and motivating management and employees in connection with the B+L Separation.
−Removed: For more information on these and other related risks, see
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.