Bausch Health Companies Inc.
−Removed: (“we”, “us”, “our”, the “Company” or “Bausch Health”) is a multinational, specialty pharmaceutical and medical device company that 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.
+Added: (“we”, “us”, “our”, the “Company” or “Bausch Health”) is a global, diversified specialty pharmaceutical and medical device company that develops, manufactures and markets, primarily in the therapeutic areas of gastroenterology (“GI”), hepatology, neurology and dermatology, a broad range of branded, generic and branded generic pharmaceuticals, over-the-counter (“OTC”) products and aesthetic medical devices and, through its approximately 88% ownership of Bausch + Lomb Corporation (“Bausch + Lomb”), branded, and branded generic pharmaceuticals, OTC products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment) in the therapeutic area of eye health.
The Company’s products are marketed directly or indirectly in approximately 90 countries.
Our portfolio of products falls into five reportable segments:
−Removed: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified Products and (v) Bausch + Lomb.
+Added: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified and (v) Bausch + Lomb.
These segments are discussed in detail in Note 22, “SEGMENT INFORMATION” to our audited Consolidated Financial Statements.
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of GI products.
−Removed: Sales of the Xifaxan ® product line represented approximately 80% of the Salix segment’s revenues.
−Removed: • 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.
−Removed: • The Solta Medical segment consists of global sales of Solta Medical (“Solta”) aesthetic medical devices.
−Removed: • The Diversified Products segment consists of sales in the U.S.
−Removed: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products, (iii) Ortho Dermatologics (dermatological products) and (iv) dentistry products.
−Removed: • The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision Care, Surgical and Ophthalmic Pharmaceuticals products.
+Added: Sales of the Xifaxan ® product line represented approximately 80% of Salix segment revenues.
+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 and Puerto Rico of branded pharmaceutical products, branded generic pharmaceutical products and OTC products.
+Added: • The Solta Medical segment consists of global sales of Solta Medical aesthetic medical devices.
+Added: • The Diversified segment consists of sales in the U.S.
+Added: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) dermatology products, (iii) generic pharmaceutical products and (iv) dentistry products.
+Added: • The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision Care, Surgical and Pharmaceuticals products.
For additional discussion of our reportable segments, see the discussion in Item 1.
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Separation of the Bausch + Lomb Eye Health Business
−Removed: On August 6, 2020, we announced our plan to separate our eye health business consisting of our Bausch + Lomb Global Vision Care (formerly Vision Care/Consumer Health), Global Surgical and Global Ophthalmic Pharmaceuticals businesses into an independent publicly traded entity, Bausch + Lomb, separate from the remainder of Bausch Health (the “B+L Separation”).
−Removed: During May 2022, a wholly owned subsidiary of the Company (the “Selling Shareholder”) sold shares of Bausch + Lomb pursuant to the initial public offering (“IPO”) of Bausch + Lomb (the “B+L IPO”).
−Removed: The underwriters partially exercised the over-allotment option granted by the Selling Shareholder.
−Removed: The Company indirectly holds 310,449,643 common shares of Bausch + Lomb, which represents approximately 89% of Bausch + Lomb’s outstanding common shares.
−Removed: We continue to believe that completing the B+L Separation makes strategic sense.
+Added: On August 6, 2020, we announced our plan to separate our eye health business consisting of our Bausch + Lomb global Vision Care, Surgical and Pharmaceuticals (formerly known as Ophthalmic Pharmaceuticals) businesses into an independent publicly traded entity, Bausch + Lomb, from the remainder of Bausch Health Companies Inc.
+Added: (the “B+L Separation”).
+Added: On May 5, 2022, the registration statement related to the initial public offering of Bausch +Lomb (the “B+L IPO”) was declared effective, and Bausch + Lomb’s common stock began trading on the New York Stock Exchange and the Toronto Stock Exchange, in each case under the ticker symbol “BLCO” on May 6, 2022.
+Added: Prior to the effectiveness of the registration statement, Bausch + Lomb was an indirect wholly-owned subsidiary of Bausch Health.
+Added: On May 10, 2022, a wholly owned subsidiary of Bausch Health sold 35,000,000 common shares of Bausch + Lomb pursuant to the B+L IPO.
+Added: 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 16, 2024.
+Added: We continue to believe the B+L Separation, which includes the transfer of all or a portion of our remaining direct or indirect equity interest in Bausch + Lomb to our shareholders, makes strategic sense.
The completion of the B+L Separation is subject to the achievement of targeted debt leverage ratios and the receipt of applicable shareholder and other necessary approvals.
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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 devices.
−Removed: The remaining pharmaceutical entity will comprise a diversified portfolio of our leading durable brands across the Salix, International, dentistry, neurology, medical dermatology and generics, and aesthetic medical devices businesses;
−Removed: • Bausch + Lomb - a fully integrated, “pure play” eye health company built on the iconic Bausch + Lomb brand and long history of innovation.
−Removed: We believe the B+L IPO was a large step in creating two attractive but dissimilar businesses.
+Added: • Bausch Health excluding Bausch + Lomb - a diversified pharmaceutical company with leading positions in gastroenterology, hepatology, dermatology, neurology and international pharmaceuticals, and aesthetic medical
+Added: The remaining pharmaceutical entity will comprise a diversified portfolio of our brands across the Salix, International, dentistry, neurology, dermatology, generics, and aesthetic medical devices businesses;
+Added: • Bausch + Lomb - a fully integrated eye health company built on the iconic Bausch + Lomb brand and its long history of innovation.
As independent entities, management believes that each company will be better positioned to individually focus on its core businesses to drive additional growth, more effectively allocate capital and better manage its respective capital needs.
−Removed: Further, the B+L Separation will allow us and the market to compare the operating results of each entity with other “pure play” peer companies.
+Added: Further, the B+L Separation will allow us and the market to compare the operating results of each entity with other peer companies.
Although management believes the B+L Separation will unlock value, there can be no assurance that it will be successful in doing so.
−Removed: At the time of our announcement of the B+L Separation, we emphasized that it is important that the post-separation entities be well capitalized, with appropriate leverage and with access to additional capital, if and when needed, to provide each entity with the ability to independently allocate capital to areas that will strengthen their own competitive positions in their respective lines of business and position each entity for sustainable growth.
−Removed: Therefore, we see the appropriate capitalization and leverage of these businesses post-separation as a key to maximizing value across our portfolio of assets and, as such, it is a primary objective of our plan of separation.
−Removed: 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.
+Added: 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.
+Added: “Risk Factors — Risk Relating to the B+L Separation” of this Form 10-K.
Business Strategy
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Although we primarily rely on our R&D organization to build-out and refresh our product portfolio, to supplement those efforts, we continually seek out opportunities, such as co-promotions, licensing agreements and strategic acquisitions, to leverage our commercial footprint, particularly our sales force, by strategically aligning ourselves with other innovative product solutions that, when coupled with our existing product portfolio, address specific needs in the market.
−Removed: “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.
+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.
Segment Information
Our revenues for 2023, 2022 and 2021 were $8,757 million, $8,124 million and $8,434 million, respectively.
−Removed: We have approximately 1,100 products in our portfolio of products, which fall into five reportable segments:
−Removed: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified Products and (v) Bausch + Lomb.
+Added: Currently, we have approximately 1,000 products in our portfolio of products, which fall into five reportable segments:
+Added: (i) Salix, (ii) International, (iii) Solta Medical, (iv) Diversified and (v) Bausch + Lomb.
Segment revenues for the years 2023, 2022 and 2021 were as follows:
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Solta Medical 347 4 % 300 4 % 308 4 %
−Removed: Diversified Products 978 12 % 1,121 13 % 1,274 16 %
+Added: Diversified 943 11 % 978 12 % 1,121 13 %
Bausch + Lomb 4,146 47 % 3,768 46 % 3,765 45 %
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Comparative segment information for 2023, 2022 and 2021 is further presented in Note 22, “SEGMENT INFORMATION” to our audited Consolidated Financial Statements.
−Removed: The Salix segment consists of sales in the U.S.
+Added: Our Salix segment consists of sales in the U.S.
of GI products and includes our Xifaxan ® product.
−Removed: We have been making investments in our Salix business since 2017, including:
−Removed: (i) hiring 200 trained and experienced sales representatives to expand the commercial field force for Xifaxan ® , (ii) increasing the focus on the development of next generation formulations of our Salix products to address new indications, (iii) completing the strategic acquisition of certain assets of Synergy Pharmaceuticals Inc.
−Removed: (“Synergy”), which included the Trulance ® product, and (iv) increasing the number of sales force representatives for Trulance ® .
−Removed: In addition, we have 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 we anticipate will contribute to our future growth.
−Removed: Each of these opportunities potentially provides us with the ability to expand our GI portfolio and allows us to leverage our existing GI sales force, supply channel and distribution channel.
+Added: 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.
+Added: We have increased our investment in Xifaxan ® direct-to-consumer (“DTC”) advertising and new sales force capabilities.
+Added: We also continue to invest in our product line.
+Added: Our rifaximin soluble solid dispersion (“SSD”) formulation is under development for the prevention of overt hepatic encephalopathy (“OHE”) and other complications in patients with early decompensation in liver cirrhosis (RED-C).
+Added: 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.
On August 10, 2022, the Norwich Legal Decision was issued, that held, among other matters, that certain U.S.
−Removed: Patents protecting the composition and use of Xifaxan ® for treating IBS-D were invalid.
+Added: Patents protecting the composition and use of Xifaxan ® for treating irritable bowel syndrome with diarrhea (“IBS-D”) were invalid.
On August 16, 2022, the Company appealed this decision and intends to vigorously defend its Xifaxan ® intellectual property.
−Removed: See “ Xifaxan ® Paragraph IV Proceedings ” of Note 20, “LEGAL PROCEEDINGS” for details of this litigation matter and the Company’s response.
−Removed: Currently our principal products in the Salix segment (including products of our third-party co-promotion partners) include:
+Added: See “ Xifaxan ® Paragraph IV Proceedings ” of Note 20, “LEGAL PROCEEDINGS” to our audited Consolidated Financial Statements for details of this litigation matter and the Company’s response.
+Added: Our principal products in this segment (including products of our third-party co-promotion partners) include:
• Xifaxan ® which includes:
−Removed: (i) 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 (ii) tablets indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age and older.
+Added: (i) tablets indicated for the treatment of IBS-D in adults and for the reduction in risk of overt hepatic encephalopathy recurrence in adults and (ii) tablets indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age and older.
Our Xifaxan ® product accounted for revenues of $1,810 million, $1,692 million and $1,644 million for 2023, 2022 and 2021, respectively.
−Removed: • 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.
−Removed: • Trulance ® (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation, or IBS-C.
+Added: • Trulance ® (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation.
International
−Removed: Our International business includes, with the exception of our 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, which in aggregate accounted for approximately 12%, 14% and 15% of our Company’s revenues for 2022, 2021 and 2020, respectively.
+Added: 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.
Our 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.
−Removed: • 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.
−Removed: Thrombo ASS ® is a leading brand in Russia.
+Added: • Thrombo ASS ® (gastroprotective coated form of acetylsalicylic acid 50mg and 100mg) is an antithrombotic agent dosed once daily for primary prevention of cardiovascular disease and secondary prophylaxis of thrombotic complications after such events as a stroke or heart attack.
+Added: Thrombo ASS ® is a leading brand in Russia and Kazakhstan.
• Contrave ® /Mysimba ® is a fixed-dose combination prolonged-release tablet for the treatment of obesity.
−Removed: Used alongside diet and exercise, it is designed to help manage weight in adults who are obese or overweight.
−Removed: 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.
+Added: Used alongside diet and exercise, it is designed to help manage weight in adults who are overweight or obese.
+Added: The formulation is designed to initiate weight loss and sustain it over a longer period of time by working in the areas of the brain regulating food intake to reduce hunger and cravings.
Contrave ® / Mysimba ® is commercialized in Canada, Poland and other Central Eastern European countries.
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• Espaven ® (Dimethicone tablets, drops, suspension) is a complete line of gastrointestinal treatments for diverse digestive indications such as:
−Removed: antiflatulence, dyspepsia, absolute or relative enzyme deficiency, steatorrhea, irritable colon syndrome, pancreatic insufficiency and poor fat digestion.
−Removed: Espaven ® is commercialized primarily in Mexico and South America.
−Removed: • 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.
−Removed: • 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.
−Removed: 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.
+Added: flatulence, dyspepsia, absolute or relative enzyme deficiency, steatorrhea, irritable colon syndrome, pancreatic insufficiency and poor fat digestion.
+Added: Espaven ® is commercialized primarily in Mexico and Central America.
+Added: • 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.
+Added: • 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
+Added: been shown to provide a good tolerability profile.
+Added: 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 is available to patients through most private and provincial public drug plans as well as the Canadian government’s Non-Insured Health Benefits drug plan, which serves Canada’s First Nations and Inuit populations.
Solta Medical
−Removed: Our Solta business is dedicated to the development of innovative treatment technologies that provide proven and effective aesthetic medical and therapeutic benefits to consumers.
−Removed: Global Solta revenues were $300 million, $308 million and $253 million for 2022, 2021 and 2020, respectively.
−Removed: 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.
−Removed: Next Generation Thermage FLX ® has been launched in the U.S., Hong Kong, Japan, Korea, Chinese Taipei, Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, Australia and various parts of Europe.
+Added: Our Solta Medical business is dedicated to the development of innovative treatment technologies that provide proven and effective aesthetic medical and therapeutic benefits to consumers.
+Added: We continue to invest in expanding our presence in key markets, including broadening the reach of our DTC campaigns in the U.S., the expansion of Thermage ® FLX and the strengthening of our sales force in the U.S.
+Added: Solta Medical’s revenue is primarily attributable to the Thermage ® product lines, including Next Generation Thermage ® FLX, a fourth-generation non-invasive treatment option using a radiofrequency platform designed to optimize key functional characteristics of Thermage ® .
+Added: Next Generation Thermage ® FLX has been launched in the U.S., Hong Kong, Japan, Korea, Taiwan, Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, Australia and various parts of Europe.
We plan to continue to expand into other regions, paced by country-specific regulatory registrations.
−Removed: Currently our principal products in the Solta business include:
−Removed: • Thermage ® is a non-invasive radiofrequency treatment that can smooth, tighten and contour skin for an overall younger-looking appearance.
−Removed: • Fraxel ® is a treatment that improves tone, texture and radiance for aging, sun damaged or scarred skin.
−Removed: • 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.
−Removed: • VASERlipo ® for minimally invasive aesthetic body contouring that yields dramatic results with less pain and downtime than traditional liposuction.
−Removed: Diversified Products
−Removed: The Diversified Products segment consists of sales in the U.S.
−Removed: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products, (iii) Ortho Dermatologics (dermatological) products and (iv) dentistry products.
−Removed: 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.
Our principal products in this segment include:
−Removed: Neurology and Other Pharmaceuticals
+Added: • The Thermage ® product - a non-invasive radiofrequency treatment that can smooth, tighten and contour skin for an overall younger-looking appearance.
+Added: • The Fraxel ® product - a treatment that improves tone, texture and radiance for aging, sun damaged or scarred skin.
+Added: • The Clear + Brilliant ® product - 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.
+Added: • The VASERlipo ® product - a minimally invasive aesthetic body contouring system that yields dramatic results with less pain and downtime than traditional liposuction.
+Added: Our Diversified segment consists of sales in the U.S.
+Added: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) dermatology products, (iii) generic pharmaceutical products and (iv) dentistry products.
+Added: Our principal products in this segment include:
• Wellbutrin ® XL is an extended release formulation of bupropion indicated for the treatment of major depressive disorder in adults.
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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.
−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: • 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: • Elidel ® AG (pimecrolimus) is a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis.
−Removed: Ortho Dermatologics
• Jublia ® (efinaconazole 10% topical solution) is a topical azole approved for the treatment of onychomycosis of the toenails (toenail fungus).
+Added: • CABTREO TM Topical Gel is an acne product with a fixed combination of benzoyl peroxide, clindamycin phosphate and adapalene.
+Added: On October 20, 2023, the U.S.
+Added: Food and Drug Administration (the “FDA”) approved the New Drug Application (“NDA”) for CABTREO TM Topical Gel, the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne.
+Added: CABTREO TM Topical Gel was launched in the U.S.
+Added: in the first quarter of 2024.
+Added: A New Drug Submission was submitted to Health Canada on May 30, 2023.
• 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.
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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.
−Removed: • Arestin ® (minocycline hydrochloride) is a subgingival sustained-release antibiotic.
+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 the loss of exclusivity, by launching and selling authorized generic versions of certain branded assets.
+Added: Principal products include:
+Added: • 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.
+Added: • Uceris ® AG (budesonide) extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control (induce remission).
+Added: • Elidel ® AG (pimecrolimus) is a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis.
+Added: • Arestin ® (minocycline hydrochloride) is a subgingival sustained-release antibiotic and accounted for approximately 90% of the Dentistry business revenues for 2023 and 2022.
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.
−Removed: • 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.
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Our Bausch + Lomb segment includes our global Bausch + Lomb eye health business.
−Removed: Our global Bausch + Lomb eye health business includes our Vision Care, Surgical and Ophthalmic Pharmaceuticals products, which in aggregate accounted for approximately 46%, 45% and 42% of our Company’s revenues for 2022, 2021 and 2020, respectively.
+Added: Our global Bausch + Lomb eye health business includes our Vision Care, Surgical and Pharmaceuticals products.
Our 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.
−Removed: Currently our principal products in the eye health business include:
−Removed: • 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.
+Added: Our principal products in this segment include:
+Added: • SiHy Daily, a silicone hydrogel daily disposable contact lens designed to provide outstanding comfort and clear vision throughout the day.
+Added: To date SiHy Daily has been launched in approximately 50 countries, under the brand names INFUSE ® , Bausch + Lomb ULTRA ® ONE DAY and AQUALOX ® ONE DAY.
+Added: Bausch + Lomb launched our first silicone hydrogel daily disposable multifocal contact lens in May 2023, and plan to launch a toric lens in 2024.
+Added: • XIIDRA ® (lifitegrast ophthalmic solution) 5% is a non-steroid eye drop specifically approved to treat the signs and symptoms of dry eye disease focusing on inflammation associated with dry eye.
+Added: • MIEBO ® (perfluorohexyloctane ophthalmic solution) is the first and only FDA-approved eye drop that directly targets the leading cause of dry eye:
+Added: tear evaporation and is used to treat the signs and symptoms of dry eye disease.
+Added: Bausch + Lomb launched MIEBO ® in the U.S.
+Added: during the third quarter of 2023.
+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.
• 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.
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Biotrue ® multi-purpose solution contains hyaluronic acid (sodium hyaluronate) a lubricant naturally found in eyes and is pH balanc ed to match healthy tears.
−Removed: • 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.
−Removed: • LUMIFY ® (brimonidine tartrate ophthalmic solution, 0.025%) is an OTC eye drop developed as an ocular redness reliever.
−Removed: • 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 TM to help maintain ocular surface homeostasis and help reduce symptoms of contact lens dryness.
−Removed: 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.
+Added: • 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.
+Added: • Lumify ® (brimonidine tartrate ophthalmic solution, 0.025%) is an OTC redness reliever eye drop that significantly reduces redness to help eyes look whiter and brighter.
• Bausch + Lomb ULTRA ® , a silicone hydrogel frequent replacement contact lens for patients with myopia or hyperopia that uses our proprietary MoistureSeal ® technology, which allows the contact lens to retain 95% of moisture after 16 hours of wear, limiting lens dryness and resulting symptoms.
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This single laser platform enables surgeons to perform capsulotomies, fragmentation, arcuate incisions, corneal incisions and LASIK flaps .
−Removed: • Lotemax ® SM (loteprednol etabonate ophthalmic gel 0.38%), a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron (SM) technology for efficient penetration to key ocular tissues at a low
−Removed: 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.
+Added: • Lotemax ® SM (loteprednol etabonate ophthalmic gel 0.38%), a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron (SM) 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
Our R&D organization focuses on the development of products through clinical trials.
−Removed: Currently, we have approximately 140 R&D projects in our pipeline.
+Added: Currently, we have over 90 R&D projects in our pipeline.
As of December 31, 2023, approximately 1,450 dedicated R&D and quality assurance employees in 24 R&D facilities were involved in our R&D efforts.
Our R&D expenses for 2023, 2022 and 2021, were $604 million, $529 million and $465 million, respectively.
−Removed: R&D expenses as a percentage of revenue were approximately 7% in 2022 as compared to approximately 6% in 2021 and 2020.
+Added: R&D expenses as a percentage of revenue were approximately 7%, 7% and 6% in 2023, 2022 and 2021, respectively.
We have rebalanced our portfolio to better align with our long-term plans and focus on core businesses.
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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 Core Businesses” of this Form 10-K.
−Removed: Trademarks, Patents, Exclusivity and Proprietary Know-How
+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.
+Added: Trademarks and Patent Exclusivity
We rely on a combination of contractual provisions, confidentiality policies and procedures and patent, trademark, copyright and trade secrecy laws to protect the proprietary aspects of our technology and business.
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Other countries generally have similar but varying terms and renewal policies with respect to trademarks registered in those countries.
−Removed: Data and Patent Exclusivity
+Added: Patent Exclusivity
For certain of our products, we rely on a combination of regulatory and patent rights to protect the value of our investment in the development of these products.
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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, FDA approval or marketing clearance must be obtained in the U.S., approval by Health Canada must be obtained in Canada, 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
−Removed: 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 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.
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.
Regulation by other federal agencies, such as the Drug Enforcement Administration, and state and local authorities in the U.S., and by comparable agencies in certain foreign countries, is also required.
−Removed: In the U.S., the Federal Trade Commission (the “FTC”), the U.S.
−Removed: Food and Drug Administration (the “FDA”) and state and local authorities regulate the advertising of medical devices, prescription drugs, OTC drugs and cosmetics.
+Added: In the U.S., the Federal Trade Commission (the “FTC”), FDA and state and local authorities regulate the advertising of medical devices, prescription drugs, OTC drugs and cosmetics.
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 our products.
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While EU law is applicable in Northern Ireland, the UK Medical Devices Regulations 2002/68 also needs to be complied with in Great Britain.
−Removed: Medical device manufacturers who have CE marked devices will be able to continue to place them on the market in the whole of the United Kingdom (the “UK”) until July 1, 2023 without a change in labeling.
−Removed: After that, devices destined for Great Britain will be required to follow the UK regulatory regime and to be labeled with the UKCA mark.
+Added: Before July 1, 2023, medical device manufacturers who had CE marked devices were able to continue to place them on the market in the whole of the United Kingdom (the “UK”) without a change in labeling.
+Added: As of July 1, 2023, devices destined for Great Britain are required to follow the UK regulatory regime and to be labeled with the UKCA mark.
Northern Ireland will, however, continue to accept CE marked devices.
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However, as of May 26, 2021, the EU no longer applies the Mutual Recognition Agreement between the EEA and Switzerland.
−Removed: Accordingly, legal manufacturers in Switzerland will be required to appoint a European Union authorized representative, and manufacturers outside of Switzerland will be required to appoint a Swiss authorized representative in compliance with the Medical Device Ordinance.
−Removed: As a consequence, beginning in January 2022 through August 2022 (depending on the class of the device or system in question), we have been required to appoint an authorized representative in Switzerland in order to export our CE-marked medical devices to Switzerland.
+Added: Accordingly, legal manufacturers in Switzerland are now required to appoint a European Union authorized representative, and manufacturers outside of Switzerland are required to appoint a Swiss authorized representative in compliance with the Medical Device Ordinance.
+Added: As a consequence, we have been 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.
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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.
−Removed: federal Anti-Kickback Statute prohibits persons or entities from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal or state health care program such as the Medicare and Medicaid programs.
+Added: federal Anti-
+Added: Kickback Statute prohibits persons or entities from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal or state health care program such as the Medicare and Medicaid programs.
Some state anti-kickback laws also prohibit such conduct where commercial insurance, rather than federal or state, programs are involved.
−Removed: Due to recent legislative changes, violations of the U.S.
+Added: Due to legislative changes, violations of the U.S.
federal Anti-Kickback Statute also carry potential federal False Claims Act liability.
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These and other laws and regulations, rules and policies may significantly impact the manner in which we are permitted to market our products.
−Removed: If our operations are found to be in violation of any of these laws, regulations, rules or policies or any other law or governmental regulation, or if interpretations of the foregoing change, we may
−Removed: be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs, the curtailment or restructuring of our operations or other sanctions, including consent orders or corporate integrity agreements.
+Added: If our operations are found to be in violation of any of these laws, regulations, rules or policies or any other law or governmental regulation, or if interpretations of the foregoing change, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs, the curtailment or restructuring of our operations or other sanctions, including consent orders or corporate integrity agreements.
In addition, the U.S.
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Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which may complicate compliance efforts.
−Removed: For example, the California Consumer Privacy Act (the “CCPA”), which went into effect on January 1, 2020, imposes 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 provides 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.
−Removed: The CCPA has been amended from time to time, and, further a new privacy law, the California Privacy Rights Act (“CPRA”), which took effect on January 1, 2023, significantly modifies the CCPA, including by expanding consumers’ rights with respect to certain sensitive personal information.
+Added: 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.
+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.
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Moreover, states have been frequently amending existing laws, requiring attention to changing regulatory requirements.
−Removed: Internationally, laws and regulations in many jurisdictions apply broadly to the collection, transmission, dissemination, use, privacy, confidentiality, security, retention, availability, integrity and other processing of health-related and other sensitive and personal information.
+Added: Internationally, laws and regulations in many jurisdictions apply broadly to the collection, transmission, dissemination, use, privacy, confidentiality, security, retention, availability, integrity and other processing of health-related and other sensitive
+Added: and personal information.
For example, in the European Economic Area (the “EEA”), the collection and use of personal data, including clinical trial data, is governed by the provisions of the General Data Protection Regulation (the “GDPR”).
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In July 2020, the Court of Justice of the European Union issued a decision that struck down the EU-U.S.
−Removed: Privacy Shield framework, which provided companies with a
−Removed: mechanism to comply with data protection requirements when transferring personal data from the EU to the United States and additionally called into question the validity of the European Commission’s Standard Contractual Clauses, on which U.S.
−Removed: companies rely to transfer personal data from EU member states to the United States and elsewhere.
−Removed: In September 2020, the Swiss Federal Data Protection and Information Commissioner issued an opinion that stated it no longer considers the Swiss-U.S.
−Removed: Privacy Shield adequate for the purposes of personal data transfers from Switzerland to the United States.
+Added: Privacy Shield framework, which provided companies with a mechanism to comply with data protection requirements when transferring personal data from the EU to the United States.
+Added: The United States subsequently implemented a Data Privacy Framework (DPF) program, overseen by the Department of Commerce’s International Trade Administration, which is intended to replace the Privacy Shield framework and has been recognized with an adequacy decision by the European Commission.
+Added: Bausch Health has self-certified and is a participant in the DPF program.
+Added: However, the DPF program is the subject of threatened litigation.
These developments may result in European data protection regulators applying differing standards for, and requiring ad hoc verification of, transfers of personal data from EU member states to the United States.
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Further, following the United Kingdom’s withdrawal from the EU and the EEA, and the expiry of the transition period, companies have to comply with both the GDPR and the GDPR as incorporated into the United Kingdom national law, the Data Protection Act of 2018, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover.
−Removed: The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, for example around how data can lawfully be transferred between each jurisdiction, which exposes us to further compliance risk.
−Removed: Beginning in 2021, the United Kingdom is a “third country” under the GDPR.
We may incur liabilities, expenses, costs and other operational losses under the GDPR and privacy laws of the applicable EU and EEA Member States and the United Kingdom in connection with any measures we take to comply with them.
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Complying with all of these laws and regulations involves costs to our business, and failure to comply with these laws and regulations can result in the imposition of significant civil and criminal penalties, as well as litigation.
−Removed: In addition, in China, the Personal Information Protection Law (the “PIPL”) came into force in November 2021.
+Added: In addition, in China, the Personal Information Protection Law (the “PIPL”) came into effect in November 2021.
The PIPL is the first national-level law comprehensively regulating issues in relation to personal information protection.
The PIPL provides for very specific administrative requirements and security controls when transferring personal data outside the Peoples Republic of China.
−Removed: These transfer requirements come into effect on March 1, 2023.
+Added: These transfer requirements came into effect on March 1, 2023.
Successful commercialization of our products may depend, in part, on the availability of governmental and third-party payor reimbursement for the cost of our products.
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In countries outside the U.S., the success of our products may depend, at least in part, on obtaining and maintaining government reimbursement because, in many countries, patients are unlikely to use prescription drugs that are not reimbursed by their governments.
−Removed: In addition, negotiating prices with certain governmental authorities for newly developed products can delay commercialization.
+Added: In addition, negotiating prices with certain governmental authorities for
+Added: newly developed products can delay commercialization.
In Canada and many international markets, governments control the prices of prescription pharmaceuticals, including through the implementation of reference pricing, price cuts, rebates, revenue-related taxes, tenders and profit control, and they expect prices of prescription pharmaceuticals to decline over the life of the product or as volumes increase.
and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could impact our ability to sell our products profitably.
−Removed: The Patient Protection and
−Removed: Affordable Care Act (the “PPACA”), as amended by the Health Care Reform Act, may affect the operational results of companies in the pharmaceutical and medical device industries, including the Company and other health care related industries, by imposing on them additional costs.
+Added: The Patient Protection and Affordable Care Act (the “PPACA”), as amended by the Health Care Reform Act, may affect the operational results of companies in the pharmaceutical and medical device industries, including the Company and other health care related industries, by imposing on them additional costs.
Effective January 1, 2010, the Health Care Reform Act increased the minimum Medicaid drug rebates for pharmaceutical companies, expanded the 340B drug discount program, and made changes to affect the Medicare Part D coverage gap, or “donut hole.” The law also revised the definition of “average manufacturer price” for reporting purposes, which may affect the amount of our Medicaid drug rebates to states.
Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded prescription drug products.
−Removed: More recently, 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.
+Added: 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.
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.
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government to set prices for certain drugs in Medicare.
−Removed: We continue to evaluate the impact of the IRA legislation on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations.
+Added: We continue to evaluate the impact of the IRA and other legislation on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations.
Although efforts at replacing the Health Care Reform Act have stalled in Congress, there could still be changes to this legislation in the near term.
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Certain of our development and manufacturing activities involve the use of hazardous substances.
−Removed: If we fail to comply with these environmental, health and safety laws and regulations, including failing to obtain any necessary permits, we could incur substantial civil or criminal fines or penalties or enforcement actions, including regulatory or judicial orders enjoining or curtailing our operations or requiring us to conduct or fund remedial or corrective measures, install pollution control equipment, reformulate or cease the marketing of our products or perform other actions.
+Added: If we fail to comply with these environmental, health and safety laws and regulations, including failing to obtain any necessary permits, we could incur substantial civil or criminal fines or penalties or enforcement actions, including regulatory or judicial orders enjoining or curtailing our operations or requiring us to conduct or fund remedial or corrective measures, install pollution control equipment,
+Added: reformulate or cease the marketing of our products or perform other actions.
Under certain laws, we may be subject to joint and several liability for environmental investigations and cleanups, including at properties that we currently or previously owned or operated, or at sites at which waste we generated was disposed, even if the contamination was not caused by us or was legal at the time it occurred.
We are also subject to extensive and evolving regulations regarding the manufacturing, processing, distribution, importing, exporting and labeling of our products and their raw materials.
−Removed: In the EU, the REACH regulations came into effect in 2007, with implementation rolling out over time.
+Added: In the EU, the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) came into effect in 2007, with implementation rolling out over time.
Registered chemicals then can be subject to further evaluation and potential restrictions.
−Removed: Since the promulgation of REACH, other countries have enacted or are in the process of
−Removed: implementing similar comprehensive chemical regulations.
+Added: Since the promulgation of REACH, other countries have enacted or are in the process of implementing similar comprehensive chemical regulations.
These laws and regulations may materially affect our operations by subjecting our products or raw materials to testing or reporting requirements or restrictions, moratoria, phase outs or other limitations on their sale or use.
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2023 2022 2021
−Removed: AmerisourceBergen Corporation 18% 18% 17%
+Added: (formerly AmerisourceBergen Corporation) 19% 18% 18%
McKesson Corporation 15% 15% 16%
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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 customer 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 direct to consumer 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
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With respect to the GI market, generic entrants continue to capture significant share for treatment of many GI conditions.
−Removed: In the area of irritable bowel syndrome (“IBS”) and opioid induced constipation (“OIC”), competitors have recently launched new competing products, which should increase the size of these markets and intensify competition.
+Added: In the area of irritable bowel syndrome and opioid induced constipation, competitors have launched new competing products, which should increase the size of these markets and intensify competition.
The market for Bausch + Lomb products is very competitive, both across product categories and geographies.
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These competitors may have greater financial, R&D or marketing resources than we do.
−Removed: If competitors introduce new products, delivery systems or processes with therapeutic or cost advantages, our products can be subject to progressive price reductions or decreased volume of sales, or both.
+Added: If competitors introduce new products, delivery systems or
+Added: processes with therapeutic or cost advantages, our products can be subject to progressive price reductions or decreased volume of sales, or both.
Most new products that we introduce must compete with other products already on the market or products that are later developed by competitors.
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We continue to make capital investments in these facilities as discussed in Item 7.
−Removed: “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.
+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.
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: In August 2022, we received a non-compliant rating from Health Canada related to our pharmaceutical manufacturing facility in Laval, Quebec.
−Removed: This rating was received without any restrictive conditions on plant operations so the production of important treatments for Canadians and for export continues without interruption as we work on remediating the non-compliant rating.
−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 other operating sites are in good compliance standing with all relevant notified bodies and global health authorities.
+Added: Through the date of this filing, except as discussed below, 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.
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).
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.
−Removed: A Form 483 is issued at the end of each inspection when FDA investigators have observed any condition that in their judgment may constitute violations of current good manufacturing practices
+Added: In October 2023, following a good manufacturing practices inspection of our Tecnofarma manufacturing facility in Mexico, the Mexico regulatory authority COFEPRIS suspended all cephalosporin manufacturing operations as a result of their observation that the cephalosporin manufacturing facility design no longer complies with current standards.
+Added: No other manufacturing areas of our Tecnofarma facility are impacted.
+Added: This action is not expected to have a material impact to the Company, as revenues from production of the impacted products were not material for 2023.
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 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 our Siliq ® , Duobrii ® , Bryhali ® , Trulance ® , Vyzulta ® , Xenazine ® , Aplenzin ® , and Relistor ® Oral 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 Siliq ® , Lumify ® , Trulance ® , Vyzulta ® , SofLens ® , MEIBO ® , XIIDRA ® , Wellbutrin XL ® , Jublia ® , Aplenzin ® , Relistor ® Oral, Arestin ® 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 ingredient for each of our Siliq ® , Trulance ® , Vyzulta ® , MEIBO ® , Preservision ® Aplenzin ® , Relistor ® Oral, Arestin ® and Bedoyecta ® products are also only
+Added: 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.
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Our global supply team worked diligently to stay ahead of the challenges presented by the COVID-19 pandemic.
−Removed: “Management’s Discussion and Analysis — Impacts of COVID-19 Pandemic” for further information.
+Added: “Management’s Discussion and Analysis — Business Trends — COVID-19 Update” for further information.
Human Capital Resources
In order to achieve our vision of being a trusted health care partner, we strive to ensure our employees around the world feel proud to be a part of Bausch Health Companies Inc.
+Added: and champion our purpose to enrich lives through our relentless drive to improve healthcare outcomes for our patients and customers.
As of December 31, 2023, we had approximately 20,270 employees, of which approximately 13,300 were Bausch + Lomb employees.
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We consider our relations with our employees to be good and have not experienced any work stoppages, slowdowns or other serious labor problems that have materially impeded our business operations.
−Removed: In 2022 our turnover trended higher than our target turnover rate, but we have not experienced any significant disruption to date as a result of turnover.
+Added: In 2023, our turnover was modestly lower than our 2022 turnover rate.
+Added: We have not experienced any significant disruption to date as a result of turnover.
Health, Safety and Wellness
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This was higher than the goal we established for DAR of less than 9 days per 100 employees but was favorable to our industry’s average DAR of 22 days per 100 employees.
−Removed: The higher than target DAR was primarily attributable to two extended absences and DAR stabilized and trended downward in the 2nd half of 2022.
−Removed: In 2022, Bausch + Lomb’s DAR was 5.6, which met its goal not to exceed 7.17 and is far below similar industry standard DAR of 21.7.
−Removed: We also recognize that physical, emotional and financial wellbeing are significant contributors to our employees’ success at work and home.
−Removed: We aim to support our employees in their everyday life by centering programs and activities around these three pillars of wellbeing.
−Removed: Across each of these pillars, we offer a range of resources to help our employees be healthy and feel successful in both their professional and personal lives, including through employee assistance programs.
+Added: In 2023, Bausch + Lomb’s DAR was 6, which met its goal of not exceeding 6 on an annual basis and is far below similar industry standard DAR of 22.
+Added: In 2023 we introduced a new global wellness initiative with activities aimed at improving the physical, emotional and financial wellbeing of our employees.
+Added: The initiative includes designating the month of May for mental health wellness.
+Added: Across each of these pillars, we offer a range of resources to help our employees be healthy and feel successful in both their professional and personal lives.
Diversity and Inclusion
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Our Bausch Health Diversity, Equity & Inclusion (“DE&I”) 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.
−Removed: We strive to advance candid conversations among employees regarding such key topics as inclusion, racism and gender equality.
−Removed: Through our diversity and inclusion training and education efforts, all employees have been provided with educational tools and resources to understand how to talk about these topics at work and how to become more aware of unconscious biases they may have.
−Removed: During 2022, all employees were invited to participate in interactive workshops on various topics including equitable leadership, understanding and managing conflict styles, building awareness, skills and confidence to support LGBTQ+ colleagues, and creating and fostering inclusive environments.
Talent Development
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We provide a variety of development programs to support our employees at every stage of their career and incorporate individual development plans that aim to help our employees reach their career goals.
−Removed: We also have a robust, global succession planning process that allows us to define talent needs based on business strategy, identify talent and drive their development and growth, strengthen the pipeline for critical leadership positions, and optimize talent deployment across the business.
+Added: We also have a robust, global succession planning process that allows us to define talent needs based on business strategy, identify talent and drive their development and growth, strengthen the pipeline for critical leadership positions, and
+Added: optimize talent deployment across the business.
As detailed in its charter, the Talent and Compensation Committee of the Board of Directors assists the Board with oversight of our Company’s talent management and succession planning process.
The Board of Directors reviews succession planning progress and specifically the plans for Executive Committee roles.
−Removed: To support this
−Removed: process, the Board interacts with leaders and managers throughout the organization during the year to get to know these employees and their work.
+Added: To support this process, the Board interacts with leaders and managers throughout the organization during the year to get to know these employees and their work.
Total Rewards
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prescription product(s) at no cost to them for up to one year and may be able to reapply to the program annually if they continue to meet eligibility requirements and have a valid prescription.
−Removed: “Management’s Discussion and Analysis — Overview — Focus on Core Businesses — Improve Patient Access” for additional discussion regarding Company programs to address the affordability and availability of our products.
+Added: “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.
Product Liability Insurance
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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
−Removed: 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 Securities Exchange Act of 1934, as amended.
All such filings are available through our website free of charge.
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You are invited to read and copy any reports, statements or other information, other than confidential filings, that we file with the provincial securities commissions.
−Removed: These filings are also electronically available from the Canadian System for Electronic Document Analysis and Retrieval (“SEDAR”) at www.sedar.com , the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.
+Added: These filings are also electronically available from the Canadian System for Electronic Document Analysis and Retrieval (“SEDAR+”) at www.sedarplus.ca , the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.
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.