What changed in this filing

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Item 1. Business

2022-02-23 compared with 2021-02-24 · 248 added, 191 removed, 338 unchanged (56% of the section changed)

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(i) branded pharmaceuticals, (ii) generic and branded generic pharmaceuticals, (iii) over-the-counter (“OTC”) products and (iv) medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetics devices), which are marketed directly or indirectly in approximately 100 countries.

Our portfolio of products falls into four operating and reportable segments:

(i) Bausch + Lomb/International, (ii) Salix, (iii) Ortho Dermatologics and (iv) Diversified Products.

• The Bausch + Lomb/International segment consists of:

(i) sales in the U.S.

of pharmaceutical products, OTC products and medical device products, primarily comprised of Bausch + Lomb products, with a focus on the Vision Care, Surgical, Consumer and Ophthalmology Rx products and (ii) with the exception of sales of Solta products, sales in Canada, Europe, Asia, Australia, Latin America, Africa and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products, OTC products, medical device products and Bausch + Lomb products.

Our portfolio of products falls into five operating and reportable segments:

(i) Bausch + Lomb, (ii) Salix, (iii) International Rx, (iv) Ortho Dermatologics and (v) Diversified Products.

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

• The Salix segment consists of sales in the U.S.

of GI products.

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

• The Ortho Dermatologics segment consists of:

(i) sales in the U.S.

of Ortho Dermatologics (dermatological) products and (ii) global sales of Solta medical aesthetic devices.

of Ortho Dermatologics (dermatological) products and (ii) global sales of Solta aesthetic medical devices.

• The Diversified Products segment consists of sales in the U.S.

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"Business — Segment Information" and Note 22, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements for further details on these reportable segments.

As discussed further in Item 7.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Separation of Bausch + Lomb Eye-Health Business” of this Form 10-K, on August 6, 2020, the Company announced that it intends to separate its eye-health business into an independent publicly traded entity from the remainder of Bausch Health Companies Inc.

(the “Separation”).

The Separation will establish two separate companies that include:

(i) a fully integrated eye-health company which will consist of the Company’s Bausch + Lomb Global Vision Care, Global Surgical, Global Consumer and Global Ophthalmology Rx businesses and (ii) a diversified pharmaceutical company which will include the Company’s Salix, International Rx, Solta, generic products, neurology, dentistry and medical dermatology pharmaceutical businesses.

The anticipated separation is subject to regulatory approvals and certain conditions, including final approval by the Company’s Board of Directors and any shareholder vote requirements that may be applicable.

In connection with the Separation, the Company expects to realign and begin managing its operations in a manner consistent with the organizational structure of the two separate entities as proposed by the Separation during the first quarter of 2021.

Accordingly, the Company expects to begin reporting under the following reporting segments on a retrospective basis beginning with its first quarter of 2021:

Bausch + Lomb, International Rx, Salix, Ortho Dermatologics and Diversified Products.

We are in the process of addressing the organization, structure and pro forma capitalizations of the two entities post-separation.

As a result, the information in this Form 10-K relating to the Separation is preliminary and may change as the transaction progresses and any such change may be material.

Further, there can be no assurance that the Separation will occur.

“Risk Factors — Risk Relating to the Separation” of this Form 10-K for additional risks relating to the Separation.

On August 6, 2020, we announced our plan to separate our eye-health business into an independent publicly traded entity, Bausch + Lomb Corporation ("Bausch + Lomb") from the remainder of Bausch Health Companies Inc.

(the "B+L Separation").

On August 3, 2021, we announced our plan to conduct an initial public offering ("IPO") of our aesthetic medical device business, Solta Medical ("Solta") (the "Solta IPO").

We believe separating our pharmaceutical, eye-health and aesthetics medical device businesses is an opportunity to unlock value across our portfolio of assets by creating three highly attractive but dissimilar businesses.

Since making these announcements, we began executing on those plans and, at the end of 2021, had substantially completed the internal objectives to facilitate the IPOs and related separation of these businesses.

We continue to monitor market conditions and aim to launch the Bausch + Lomb IPO (the "B+L IPO") and the Solta IPO when financial market conditions are favorable (subject to receipt of regulatory, stock exchange and other approvals).

However, there can be no assurance as to when we will complete either IPO, if at all.

Until such time, we continue to manage these businesses along with our pharmaceutical portfolio of gastrointestinal, dermatology, neurology and other therapeutics, with our continued commitment to bring out additional value for our shareholders.

Following the B+L IPO, we expect to complete the separation of Bausch + Lomb after the expiry of customary lockups related to the B+L IPO and achievement of targeted debt leverage ratios, subject to the receipt of applicable shareholder and other necessary approvals and market conditions.

Subject to market conditions and receipt of regulatory, stock exchange and other approvals, we expect to launch the B+L IPO and the Solta IPO sometime in the first half of 2022.

Nothing in this Form 10-K shall constitute an offer to sell or the solicitation of an offer to buy any securities of the Bausch + Lomb or Solta Medical entities.

COVID-19 Pandemic

In December 2019, a novel strain of the coronavirus disease, COVID-19, was identified in Wuhan, China.

Since then, COVID-19 has spread to most of the world, including the United States, Canada and Europe, and was declared a global pandemic by the World Health Organization (the "WHO") on March 11, 2020.

As a global health care company, now more than ever, we remain focused on our mission of helping to improve people’s lives with our health care products.

We are and will continue to closely monitor the impacts of the COVID-19 pandemic and related responses from governments and private sector participants on the Company, our customers, supply chain, third-party suppliers, project

development timelines, costs, revenue, margins, liquidity and financial condition and our planned actions and responses to this pandemic.

To date, the Company has been able to continue its operations with limited disruptions in supply and manufacturing.

We continue to closely monitor the impacts of the COVID-19 pandemic and related responses from governments and private sector participants on the Company, our customers, supply chain, third-party suppliers, project development timelines, costs, revenue, margins, liquidity and financial condition and our planned actions and responses to this pandemic.

We believe we have responded quickly to the human and commercial challenges brought on by the COVID-19 pandemic and that our early actions have, so far, enabled us to keep our employees safe and our supply lines largely intact and we believe these actions have laid the foundation for us to work our way through the uncertainties to come.

Importantly, we believe that the steps we took over the last several years to manage our capital structure place us in a strong position to maintain sufficient liquidity to continue operations through an extended pandemic and we believe that our businesses will not see their long-term value diminished by this unprecedented situation.

To date, the Company has been able to continue its operations with limited disruptions in supply and manufacturing.

Although our revenues were adversely affected by the impacts of the COVID-19 pandemic, particularly during the second quarter of 2020, our revenues returned to pre-pandemic

levels for many of our businesses and geographies in 2021 and, at the current pace of recovery, we expect the COVID-19 pandemic to have a minimal impact on the remaining businesses and geographies in 2022.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Impacts of COVID-19” of this Form 10-K for additional information on the impacts of the COVID-19 pandemic and Item 1A.

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Business Strategy

Our strategy is to focus our business on core therapeutic classes that offer attractive growth opportunities.

Our strategy is to focus our business on core therapeutic classes and geographies that offer attractive growth opportunities.

Within our chosen therapeutic classes, we prioritize durable products which we believe have the potential for strong operating margins and evidence of growth opportunities.

We believe this strategy has reduced complexity in our operations and maximizes the value of our:

(i) eye-health, (ii) GI and (iii) dermatology businesses, which collectively now represent a substantial portion of our revenues.

We have found and continue to believe there is significant opportunity in these businesses and we believe our existing portfolio, commercial footprint and pipeline of product development projects position us to successfully compete in these markets and provide us with the greatest opportunity to build value for our shareholders.

We identify these businesses as “core”, meaning that we believe we are best positioned to grow and develop them.

We believe we have a well-established product portfolio that is mixed within our core businesses and provides a sustainable revenue stream to fund our operations.

(i) eye-health, (ii) GI and (iii) dermatology businesses, which collectively represent a substantial portion of our revenues.

We have found and continue to believe there is significant opportunity in each of these businesses and we believe our existing portfolio, commercial footprint and pipeline of product development projects position us to successfully compete in these markets and provide us with the greatest opportunity to build value for our shareholders.

As we continue to prepare for the separation of our eye-health and medical device aesthetics businesses, we remain focused on expanding and deepening our geographic reach of all our businesses.

We continue to search out new markets where our portfolio of products would expect to flourish, while continually revisiting our existing geographies where our portfolio of pharmaceuticals would help fill unmet needs.

As we prepare for the separations of the Bausch + Lomb and Solta businesses, we are looking to right size our presence in these geographies, make additional investments in sales force and advertising, to create a greater presence in these geographies where we can capitalize on our existing and future product portfolios to meet unmet needs and generate future revenue streams and value for our company.

We believe we have a well-established diversified product portfolio across all our businesses that provides a sustainable revenue stream to fund our operations.

Our continued success is dependent upon our ability to continually refresh our pipeline and bring new product solutions to the market that meet changing demands and replace other products that have lost momentum.

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Our revenues for 2021, 2020 and 2019 were $8,434 million, $8,027 million and $8,601 million, respectively.

We have approximately 1,300 products in our portfolio of products, which fall into four operating and reportable segments:

(i) Bausch + Lomb/International, (ii) Salix, (iii) Ortho Dermatologics and (iv) Diversified Products.

We have approximately 1,200 products in our portfolio of products, which fall into five operating and reportable segments:

(i) Bausch + Lomb, (ii) Salix, (iii) International Rx, (iv) Ortho Dermatologics and (v) Diversified Products.

Segment revenues for the years 2021, 2020 and 2019 were as follows:

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(in millions) Amount Pct.

Bausch + Lomb/International $ 4,408 55 % $ 4,739 55 % $ 4,664 56 %

Bausch + Lomb $ 3,765 45 % $ 3,415 42 % $ 3,778 44 %

Salix 2,074 24 % 1,904 24 % 2,022 23 %

International Rx 1,166 14 % 1,181 15 % 1,154 13 %

Ortho Dermatologics 564 7 % 548 7 % 560 7 %

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Comparative segment information for 2021, 2020 and 2019 is further presented in Note 22, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements.

Bausch + Lomb/International

Our Bausch + Lomb/International segment includes our global Bausch + Lomb eye-health business and our International Rx business.

Our global Bausch + Lomb eye-health business includes our Global Vision Care, Global Surgical, Global Consumer and Global Ophthalmology Rx products, which in aggregate accounted for approximately 41%, 42% and 43% of our Company's revenues for 2020, 2019 and 2018, respectively.

Our International Rx business, with the exception of our Solta products, includes sales in Canada, Europe, Asia, Australia, Latin America, Africa and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products and OTC products, which in aggregate accounted for approximately 14%, 13% and 13% of our Company's revenues for 2020, 2019 and 2018, respectively.

Our global Bausch + Lomb business is a fully integrated eye-health business, which we believe is critical to maintaining and developing our position in the global eye-health market.

As a fully integrated eye-health business with a 165-year legacy, Bausch + Lomb has an established line 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 that positions us to compete in all areas of the eye-health market.

Bausch + Lomb

Our Bausch + Lomb segment includes our global Bausch + Lomb eye-health business.

Our global Bausch + Lomb eye-health business includes our Global Vision Care, Global Surgical, Global Consumer and Global Ophthalmic Pharmaceuticals products, which in aggregate accounted for approximately 45%, 42% and 44% of our Company's revenues for 2021, 2020 and 2019, respectively.

As previously discussed, on August 6, 2020, we announced our plan to separate our eye-health business into an independent publicly traded entity, Bausch + Lomb Corporation, from the remainder of Bausch Health Companies Inc.

Since making that announcement, we have been executing on this plan and, at the end of 2021, had substantially completed the internal objectives to facilitate the B+L Separation.

As of the date of this filing, we continue to execute on our plan for the B+L Separation and aim to launch the B+L IPO when market conditions are favorable and subject to receipt of regulatory, stock exchange and other approvals.

Following the B+L IPO, we expect to complete the B+L Separation after the expiry of customary lockups related to the B+L IPO and the achievement of targeted debt leverage ratios, subject to receipt of applicable shareholder and other necessary approvals and market conditions.

Nothing in this Form 10-K shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Our Bausch + Lomb business is a fully integrated eye-health business, which we believe is critical to maintaining and further developing its position in the global eye-health market.

We maintain a fully integrated eye care 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, to holistically approach solving eye-health problems and keep us in a position to compete in all areas of the eye-health market.

Since our beginnings in 1853 as an optical goods shop in Rochester, New York, we have remained focused on advancing eye-health for people all over the world.

As part of our longstanding commitment to eye care professionals and the patients they serve, we invest in physician training, patient and customer education, disease prevention and other initiatives through both traditional and digital platforms to continue to advance eye-health.

As part of our global Bausch + Lomb business strategy, we continually look for key trends in the eye-health market to meet changing consumer/patient needs and identify areas for investment and growth.

For instance, one of these trends is the increasing rate of myopia, and importantly, myopia as a potential risk factor for glaucoma, macular degeneration and retinal detachment.

We continue to see increased demand for new eye-health products that address conditions brought on by factors, such as increased screen time, lack of outdoor activities and academic pressures, as well as conditions brought on by an aging population (for example, as more and more baby-boomers in the U.S.

are reaching the age of 65).

To supplement our well-established Bausch + Lomb product lines, we continue to identify new products tailored to address these key trends, which we develop internally with our own R&D team to generate organic growth.

We also license selective molecules or technology in leveraging our own R&D expertise through development, as well as seek out external product development opportunities.

Recent product launches include Biotrue ® ONEday daily disposable contact lenses, the next generation of Bausch + Lomb ULTRA ® contact lenses, SiHy Daily contact lenses, Lumify ® (an eye redness treatment), Vyzulta ® (a pressure lowering eye drop for patients with angle glaucoma or ocular hypertension) and Ocuvite ® Eye Performance (vitamins to protect the eye from stressors such as sunlight and blue light emitted from digital devices).

We believe that the gap between evolving eye-health needs and effective treatments represents a significant growth opportunity, and we believe that we have the ability to increase demand for our products by educating customers and capturing the rising consumerism in our available markets.

For example, it is estimated that more than 17 million people suffer from visual impairment in China, of which 8 million are blind, yet only 450 cataract surgeries are performed for every 1 million people each year in China.

Myopia represents another significant growth opportunity.

We estimate that myopia affects approximately 25 million children in the United States, and 2.9 billion people globally had some degree of myopia in 2020.

According to the World Health Organization, this population is expected to rise globally by more than 60% between 2020 and 2050.

To increase adoption of our products, we intend to continue our focus on patient, consumer and eye care professional education.

In addition, we believe that we can grow our market opportunity by expanding into emerging therapeutic areas and researching and securing other indications for our products.

We intend to leverage our global regulatory and commercial capabilities to accelerate product approvals and launches across current and future markets.

Currently our principal products in the eye-health business include:

• SofLens ® Daily Disposable Contact Lenses, which use ComfortMoist ® Technology (a combination of thin lens design and moisture-rich packaging solution) and High Definition Optics ™ which is an aspheric design that reduces spherical aberration over a range of powers, especially in low light.

• PureVision ® is a silicone hydrogel frequent replacement contact lens using AerGel ® technology lens material to allow natural levels of oxygen to reach the eye as well as resist protein buildup.

The lens also incorporates an aspheric optical design that reduces spherical aberration.

• Biotrue ® ONEday daily disposable contact lenses, which are made of a unique material that works like the eye to form a dehydration barrier.

The lens maintains over 98% of its moisture for up to 16 hours, it matches the water content of the cornea at 78% and allows for the oxygen a healthy eye needs.

• Biotrue ® ONEday for Astigmatism is a daily disposable contact lens for astigmatic patients.

The Biotrue ® ONEday lenses incorporates Surface Active Technology ™ to provide a dehydration barrier.

The Biotrue ® ONEday for Astigmatism also includes evolved peri-ballast geometry to deliver stability and comfort for the astigmatic patient.

• Bausch + Lomb ULTRA ® is a silicone hydrogel frequent replacement contact lens that uses the proprietary MoistureSeal ® technology which allows the contact lens to retain 95% of moisture after 16 hours of wear, limiting lens dryness and resulting symptoms.

• Bausch + Lomb ULTRA ® for Astigmatism is a monthly planned replacement contact lens for astigmatic patients.

The Bausch + Lomb ULTRA ® for Astigmatism lens was developed using the proprietary MoistureSeal ® technology.

In addition, the Bausch + Lomb ULTRA ® for Astigmatism lens integrates an OpticAlign ® design engineered for lens stability and to promote a successful wearing experience for the astigmatic patient.

• Bausch + Lomb ULTRA ® for Presbyopia is a monthly planned replacement contact lens for presbyopic patients.

The Bausch + Lomb ULTRA ® for Presbyopia lens was developed using the proprietary MoistureSeal ® technology.

In addition, the Bausch + Lomb ULTRA ® for Presbyopia lens integrates a 3-zone progressive design for near, intermediate and distance vision.

We launched expanded parameters of this product throughout 2017.

• SiHy Daily is a silicone hydrogel daily disposable contact lens designed to provide clear vision throughout the day.

In September 2018, we launched SiHy Daily in Japan under the branded name AQUALOX ® ONE DAY.

In August 2020, we launched SiHy Daily in the U.S.

under the branded name Bausch + Lomb INFUSE ™ SiHy Daily Disposable contact lens.

SiHy Daily has also received regulatory approval for Canada, Australia, New Zealand, Hong Kong, South Korea, Singapore and Malaysia where it will be branded as Bausch + Lomb Ultra ® ONE DAY.

• The Stellaris Elite ® Vision Enhancement System is our next phacoemulsification cataract platform, which offers new innovations, as well as the opportunity to add upgrades and enhancements every one to two years.

Stellaris Elite ® is the first phacoemulsification platform on the market to offer Adaptive Fluidics ™ , which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient and safe cataract lens removal.

Our Stellaris Elite ® Vision Enhancement System was launched in April 2017.

• The Vitesse ® hypersonic vitrectomy system advances the process of vitreous removal using an innovative and effective approach.

Available exclusively on the Stellaris Elite ® system, Vitesse ® brings an exceptional level of surgical control and precision to vitrectomies.

• A portfolio of ophthalmic surgical products, including:

(i) pre-loaded intraocular lenses such as Akreos ® , enVista ® , LuxSmart ™ and LuxGood ™ , (ii) handcrafted surgical instruments including Storz ® and Synergetics ® and (iii) a suite of surgical equipment including TENEO ® excimer laser for refractive and VICTUS ® femtosecond laser for cataract surgery and keratoplasty.

• PreserVision ® AREDS 2 is an eye vitamin formula for those with moderate-to-advanced age-related macular degeneration.

• Ocuvite ® is a vitamin and mineral supplement for the eye that contains lutein (an antioxidant carotenoid), a nutrient that supports macular health by helping filter harmful blue light.

Our Consumer eye care business consists of contact lens care products, OTC eye drops and eye vitamins.

Our eye vitamin products include our patented formulas and mineral supplements that address various conditions including eye allergies, conjunctivitis, dry eye, redness and relief.

Key Consumer eye care brands include:

• PreserVision ® AREDS 2 is a patented eye vitamin formula that contains the exact nutrient formula recommended by the National Eye Institute for people with moderate to advanced age-related macular degeneration ("AMD") following the landmark AREDS 2 clinical study.

• Ocuvite ® is a vitamin and mineral supplement for the eye that contains lutein and zeaxanthin (antioxidant carotenoids), a nutrient that supports macular health by helping filter harmful blue light.

• Biotrue ® multi-purpose solution helps prevent certain tear proteins from denaturing and fights germs for healthy contact lens wear.

Biotrue ® multi-purpose solution uses a lubricant found in eyes and is pH balanced to match healthy tears.

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

Lumify ® was launched in the U.S.

We plan to launch Lumify ® in South Korea in the second half of 2021 and in Canada in 2022.

• Bausch + Lomb Renu ® Advanced Formula multi-purpose solution is a novel soft and silicone hydrogel contact lenses solution that makes use of three disinfectants and two moisture agents.

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

• Boston ® solution is a specialty cleansing solution design for gas permeable contact lenses.

• Bedoyecta Tri ® (Injectable Hydroxocobalamine, vitamin B complex) is indicated for the prevention and treatment of certain vitamin deficiencies.

It is useful in the treatment of Neuritis and polyneuritis of nutritional, diabetic, alcoholic and toxic origin due to the use of drugs.

Bedoyecta ® is also available in soft gel and capsule form.

Bedoyecta ® is commercialized in Mexico and South America.

• Cold FX ® is a product derived from the roots of North American ginseng.

COLD-FX ® Daily Support has a clinically proven formula that helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.

• Artelac ® is an eye moisturizer eye drop which enables quick wetting of dry eyes.

Artelac ® contains hypromellose, a known moisturizer, and is used to treat dehydration of the surface of the eye, especially for dry eyes with an unpleasant foreign body sensation.

Artelac ® contains hyaluronic Acid (sodium hyaluronate), a natural lubricant which instantly refreshes and hydrates the eyes.

Artelac ® is particularly suitable for alleviating mild symptoms of dry eyes and can also be used to moisten hard contact lenses while being worn.

Artelac ® is commercialized widely in Europe, the Middle East and Africa, Asia Pacific, Canada and Latin America.

Ophthalmology Rx

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

LUMIFY ® was launched in the U.S.

Our Vision Care portfolio includes contact lenses that span the spectrum of wearing modalities, including daily disposable and frequently replaced contact lenses, and contact lenses that are indicated for therapeutic use and that can also provide optical correction during healing, if required.

Key Vision Care brands include:

• 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.

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.

• AQUALOX TM in Japan, a silicone hydrogel daily disposable contact lens designed to provide clear vision throughout the day.

Product validation was completed in June 2018 and SiHy Daily AQUALOX TM was launched in Japan in September 2018.

• 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.

• Bausch + Lomb ULTRA ® for Astigmatism, a monthly planned replacement contact lens for astigmatic patients developed using our proprietary MoistureSeal ® technology.

Bausch + Lomb ULTRA ® for Astigmatism lenses integrate an OpticAlign ® design engineered for lens stability and to promote a successful wearing experience for the astigmatic patient.

• Bausch + Lomb ULTRA ® for Presbyopia, a monthly planned replacement contact lens for presbyopic patients developed using the Company’s proprietary MoistureSeal ® technology.

Bausch + Lomb ULTRA ® for Presbyopia lenses integrate our 3-Zone Progressive™ multifocal design with seamless transitions between near, far and intermediate distances for clear, comfortable vision across all distances.

• Bausch + Lomb ULTRA ® multifocal for astigmatism, a monthly planned replacement multifocal toric lens combining our 3-Zone Progressive TM multifocal design with the stability of its OpticAlign ® toric design to address the lifestyle and vision needs of patients with both astigmatism and presbyopia.

• Biotrue ® ONEday daily disposable contact lenses for patients with myopia or hyperopia, which are made of a unique material inspired by the natural biology of the eye and feature Surface Active Technology TM , a patented dehydration barrier.

The lens contains 78% water, more moisture than any other soft contact lens and the same water content as the cornea, and maintains nearly 100% of its moisture for up to 16 hours.

• Biotrue ® ONEday for Astigmatism, a daily disposable contact lens for astigmatic patients developed using the Company’s proprietary Surface Active Technology TM .

Biotrue ® ONEday for Astigmatism includes evolved peri-ballast geometry designed to work with natural blink patterns to deliver stability, clear vision and comfort for the astigmatic patient.

• Biotrue ® ONEday for Presbyopia daily disposable contact lens for presbyopic patients developed using the Company’s proprietary Surface Active Technology.

Biotrue ® ONEday for Presbyopia integrates the Company’s 3-Zone Progressive™ design with seamless transitions between near, far and intermediate distances for clear, comfortable vision across all distances.

• PureVision ® , a silicone hydrogel frequent replacement contact lens using AerGel ® technology lens material to allow natural levels of oxygen to reach the eye as well as resist protein buildup.

The lens also incorporates an aspheric optical design that reduces spherical aberration.

• SofLens ® Daily Disposable Contact Lenses, which use ComfortMoist ® Technology (a combination of thin lens design and moisture-rich packaging solution) and High Definition Optics™ which is an aspheric design that reduces spherical aberration over a range of powers, especially in low light.

Ophthalmic Pharmaceuticals

Our Ophthalmic Pharmaceuticals business consists of a broad line of proprietary pharmaceutical products for post-operative treatments and treatments for a number of eye conditions, such as glaucoma, eye inflammation, ocular hypertension, dry eyes and retinal diseases.

Key ophthalmic pharmaceutical brands include:

• Vyzulta ® (latanoprostene bunod ophthalmic solution, 0.024%) is an intraocular pressure lowering single-agent eye drop with dual activity dosed once daily for patients with open angle glaucoma or ocular hypertension and was launched in the U.S.

in December 2017.

• 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.

• Lotemax ® Suspension (loteprednol etabonate ophthalmic suspension, 0.5%) is a topical corticosteroid indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe and for the treatment of post-operative inflammation following ocular surgery.

• Lotemax ® Gel is a topical corticosteroid indicated for the treatment of inflammation and pain following ocular surgery.

This formulation is a technology that allows the drug to adhere to the ocular surface and offers dose uniformity, which

eliminates the need to shake the product in order to ensure the drug is in suspension.

This formulation is a technology that allows the drug to adhere to the ocular surface and offers dose uniformity, which eliminates the need to shake the product in order to ensure the drug is in suspension.

The product contains a low concentration of preservative and two known moisturizers.

Lotemax ® Gel is commercialized globally.

• Vyzulta ® (latanoprostene bunod ophthalmic solution, 0.024%) is an intraocular pressure lowering single-agent eye drop dosed once daily for patients with open angle glaucoma or ocular hypertension.

Vyzulta ® was launched in the U.S.

(December 2017), Canada (July 2019), Hong Kong (2020), Mexico (2020) and Argentina (2020).

We are planning to launch Vyzulta ® in Taiwan in 2021 and in South Korea in 2022.

• Prolensa ® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug indicated to treat inflammation and reduce eye pain in patients after cataract surgery.

This product is commercialized widely in Europe under the brand name Yellox ® .

We also have an ointment formulation (Lotemax ® Ointment) without any preservatives.

• Alrex ® (loteprednol etabonate ophthalmic suspension, 0.2%) is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

• Besivance ® (besifloxacin ophthalmic suspension, 0.6%) is the first and only chloro-fluoroquinolone indicated for the treatment of bacterial conjunctivitis.

It is a new generation potent quinolone antibiotic specifically designed for the ophthalmic use and has no systemic formulation.

• Zylet ® (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) indicated for the steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

• Minims ® portfolio including ocular anaesthetics, corticosteroids, mydriatics, cycloplegics, artificial tears, irrigating solutions and diagnostic stain products.

• Prolensa ® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated to treat inflammation and reduce eye pain in patients after cataract surgery.

In international markets, we market Yellox ® (bromfenac ophthalmic solution, 0.9%) which is indicated for the treatment of postoperative ocular inflammation following cataract extraction.

Our Surgical business consists of medical device equipment, consumables and instrumental tools and technologies for the treatment of corneal, cataracts, and vitreous and retinal eye conditions, and includes intraocular lenses ("IOLs") and delivery systems, phacoemulsification equipment and other surgical instruments and devices necessary for cataract surgery.

Key Surgical brands include:

• Vitreoretinal Surgery

◦ Stellaris ® PC, a combined system with vitreoretinal and cataract surgery capability.

• Cataract Surgery and Laser Systems

◦ The Stellaris Elite ® vision enhancement system is our next 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.

Our Stellaris Elite ® vision enhancement system was launched in the United States in 2017 and internationally in 2018.

◦ VICTUS ® femtosecond laser for cataract, corneal and refractive surgery, which delivers multi- mode versatility for cataract and corneal procedures on a single platform.

This single laser platform enables surgeons to perform capsulotomies, fragmentation, arcuate incisions, corneal incisions, and LASIK flaps.

◦ Teneo VICTUS ® femtosecond laser for cataract, corneal and refractive surgery and Teneo ® Excimer Laser for refractive surgery.

◦ Excimer Laser for refractive surgery.

• Intraocular Lenses

◦ A portfolio of ophthalmic surgical IOLs, including implantable IOLs such as Akreos ® , enVista ® , Crystalens ® and Trulign ® .

• Surgical Instruments

◦ Storz Ophthalmic instruments are our suite of surgical instruments which include precision microsurgical instruments, diamond knives and single-use surgical instruments, as well as instruments customized for individual surgeons under the Storz Ophthalmic Instrument brand, including Synergetics ® , and surgical equipment for cataract, refractive and vitreoretinal surgery.

The Salix segment consists of sales in the U.S.

of GI products and includes our Xifaxan ® product.

We have been making investments in our Salix business since 2017, including:

(i) hiring 200 trained and experienced sales force 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.

(“Synergy”), which included the Trulance ® product, and (iv) increasing the number of sales force representatives for Trulance ® .

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.

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.

Currently our principal products in the Salix segment (including products of our third-party co-promotion partners) include:

• Xifaxan ® which includes:

(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.

Our Xifaxan ® product accounted for revenues of $1,644 million, $1,482 million and $1,452 million for 2021, 2020 and 2019, respectively.

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

• Relistor ® (methylnaltrexone) is given to adults who use narcotic medicine to treat severe chronic pain that is not caused by cancer to prevent constipation without reducing the pain-relieving effects of the narcotic.

• Trulance ® (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation, or IBS-C.

International Rx

Our International Rx business, with the exception of our Solta products, includes sales in Canada, Europe, Asia, Australia, Latin America, Africa and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products and OTC products, which in aggregate accounted for approximately 14%, 15% and 13% of our Company's revenues for 2021, 2020 and 2019, respectively.

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.

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Espaven ® is commercialized primarily in Mexico and South America.

The Salix segment consists of sales in the U.S.

of GI products and includes our Xifaxan ® product.

We have been making investments in our Salix business since 2017, including:

(“Synergy”), which included the Trulance ® product, and (iv) increasing the number of sales force representatives for Trulance ® .

In addition, we have entered into licensing agreements for investigational products, which, once developed and if approved by the U.S.

Food and Drug Administration (the "FDA"), will be new treatments for certain GI and liver diseases and we anticipate will contribute to the future growth.

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.

Currently our principal products in the Salix segment (including products of our third-party co-promotion partners) include:

• Xifaxan ® which includes:

(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 $1,482 million, $1,452 million and $1,195 million for 2020, 2019 and 2018, respectively.

• 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.

• Trulance ® (plecanatide) is a once-daily tablet for adults with chronic idiopathic constipation, or CIC, and irritable bowel syndrome with constipation, or IBS-C.

• Plenvu ® is a novel, lower-volume polyethylene glycol-based bowel preparation developed to help provide complete bowel cleansing, with an additional focus on the ascending colon.

Plenvu ® was launched in September 2018.

• Bedoyecta ® i s 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.

Ortho Dermatologics

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(i) sales in the U.S.

of Ortho Dermatologics (dermatological products) and (ii) global sales of Solta dermatological devices.

of Ortho Dermatologics (dermatological products) and (ii) global sales of Solta aesthetic medical devices.

The Ortho Dermatologics business is our medical dermatology business dedicated to the treatment of a range of therapeutic areas, including aesthetics, psoriasis, actinic keratosis, acne, atopic dermatitis, onychomycosis and other dermatoses.

As part of our business strategy for the Ortho Dermatologics segment, we have made significant investments to build out our psoriasis, atopic dermatitis and acne product portfolios, which are the markets within dermatology where we see the greatest opportunities, with a focus on topical gel and lotion products over injectable biologics.

As part of our business strategy for the Ortho Dermatologics segment, we continue to look for investments to build out our product portfolios, where we see the greatest opportunities, with a focus on topical gel and lotion products over injectable biologics.

We continue to support the use of injectable biologics;

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Therefore, we believe topical products represent alternative treatments for physicians, payors and patients, and as the preferred choice of treatment, have the potential to drive greater volumes, generate better margins and potentially be a key contributing factor of our Ortho Dermatologics business.

During 2017 through 2020, we have made significant investments to build out our aesthetics, psoriasis and acne product portfolios, which we believe, coupled with our experienced dermatology sales leadership team and the reorganization of our Ortho Dermatologics sales force, will position our Ortho Dermatologics business for future growth.

Currently our principal products in the medical dermatology business include:

Currently our principal products in the U.S.

Ortho Dermatologics business include:

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

• Targretin ® (bexarotene) capsules and gel are prescription medicines used to treat the skin problems arising from the disease cutaneous T-cell lymphoma, or CTCL, in patients who have not responded well to other treatments.

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

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

in June 2020.

• Duobrii ® was launched in the U.S.

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

• Siliq ® was launched in the U.S.

in 2017 and is an IL-17 receptor blocker monoclonal antibody for patients with moderate-to-severe plaque psoriasis.

• Altreno ® (tretinoin 0.05%) was launched in the U.S.

in October 2018 and is a lotion approved for the topical treatment of acne vulgaris in patients 9 years of age and older.

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

• An Acne franchise, which includes 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.

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

• Bryhali ® was launched in the U.S.

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

• An acne franchise, which includes Altreno ® (tretinoin 0.05%), launched in the U.S.

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

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

On August 3, 2021, we announced our plan to conduct an IPO of our aesthetic medical device business, Solta Medical.

Since making that announcement, we have been executing on this plan and, at the end of 2021, had substantially completed the internal objectives to facilitate the IPO of Solta Medical.

As of the date of this filing, we continue to monitor market conditions and aim to launch the Solta IPO when market conditions are favorable and subject to receipt of regulatory, stock exchange and other approvals.

Nothing in this Form 10-K shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Global Solta revenues were $308 million, $253 million and $194 million for 2021, 2020 and 2019, respectively.

The increase in 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 and improve patient outcomes.

During 2018 and 2019, Next Generation Thermage FLX ® was launched in Hong Kong, Japan, Korea, Taiwan, Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, and Australia as part of our Solta medical aesthetic devices portfolio.

These launches have been successful as Next Generation Thermage FLX ® revenues for 2020 and 2019 were $142 million and $77 million, respectively.

We expect additional launches of Next Generation Thermage FLX ® in Europe in the near term, paced by country-specific regulatory registrations.

Next Generation Thermage FLX ® was launched in the U.S., Hong Kong, Japan, Korea, Chinese Taipei, Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, Australia and various parts of Europe as part of our Solta aesthetic medical devices portfolio.

These launches have been successful as Next Generation Thermage FLX ® revenues for 2021, 2020 and 2019 were $154 million, $142 million and $77 million, respectively.

We plan to continue to expand into other regions, paced by country-specific regulatory registrations.

Currently our principal products in the Solta business include:

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• Wellbutrin XL ® is an extended release formulation of bupropion indicated for the treatment of major depressive disorder in adults.

• Aplenzin ® (bupropion hydrobromide extended release tablets) is indicated for the treatment of major depressive disorder, and for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

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

• Migranal ® (dihydroergotamine mesylate) Nasal Spray is used to treat an active migraine headache with or without aura.

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

• Ativan ® (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.

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

• Librax ® (chlordiazepoxide and clidinium) is indicated to control emotional and somatic factors in gastrointestinal disorders.

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

• Apriso ® AG is an aminosalicylate anti-inflammatory drug used to treat ulcerative colitis, proctitis and proctosigmoiditis.

Apriso is also used to prevent the symptoms of ulcerative colitis from recurring.

Apriso ® AG was launched in December 2019.

• Tobramycin and Dexamethasone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

• Latanoprost Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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

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• 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.

• OraFit TM is a custom clear aligner treatment to permanently correct crooked and misaligned teeth using high-performance materials in a three-layer design to provide a balance of strength and comfort, while staying clear and crack-resistant, which we launched in the U.S.

in February 2022.

In connection with the planned separation of its Solta business into an independent publicly traded entity from the remainder of Bausch Health Companies Inc., on February 23, 2022, the Company announced its plan to change its segment structure in a manner which is consistent with the organizational structure of the two separate entities as proposed by the Solta IPO during the first quarter of 2022.

The new segment structure will not impact the Company’s reporting units but will realign the two reporting units of the Ortho Dermatologics segment whereby its medical dermatology reporting unit (Ortho Dermatologics) will now be managed by the CODM as part of the Diversified Products segment and the Solta reporting unit will be managed by the CODM as its own operating and reportable segment.

Accordingly, the Company expects to begin reporting under the following reporting segments on a retrospective basis beginning with its first quarter of 2022 as follows:

Bausch + Lomb, Salix, International Rx, Solta and Diversified Products.

Research and Development

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Our R&D expenses for 2021, 2020 and 2019, were $465 million, $452 million and $471 million, respectively.

R&D expenses as a percentage of revenue were approximately 6% in 2020, as compared to approximately 5% in 2019 and 2018.

R&D expenses as a percentage of revenue were approximately 6% in 2021 and 2020, as compared to approximately 5% in 2019.

We have rebalanced our portfolio to better align with our long-term plans and focus on core businesses.

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In the U.S., the Hatch-Waxman Act provides non-patent regulatory exclusivity for five years from the date of the first FDA approval of a new drug compound in a New Drug Application (“NDA”).

The FDA, with one exception, is prohibited

during those five years from accepting for filing a generic, or an Abbreviated New Drug Application (“ANDA”), that references the NDA.

The FDA, with one exception, is prohibited during those five years from accepting for filing a generic, or an Abbreviated New Drug Application (“ANDA”), that references the NDA.

In reference to the foregoing exception, if a patent is indexed in the FDA Orange Book for the new drug compound, a generic may file an ANDA four years from the NDA approval date if it also files a Paragraph IV Certification with the FDA challenging the patent.

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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.

Prior to human use, FDA approval (drugs (in the form of an NDA or ANDA for generic equivalents), biologics (in the form of a Biologics License Application (“BLA”)) and some medical devices) or marketing clearance (other devices) must be obtained in the U.S., approval by Health Canada must be obtained in Canada, EMA approval (drugs) or a CE Marking (devices) 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.

Prior to human use, FDA approval (drugs (in the form of an NDA or ANDA for generic equivalents), biologics (in the form of a Biologics License Application (“BLA”)) and some medical devices) or marketing clearance (other devices) 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") 2017/745, 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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The FDA requires a Boxed Warning (sometimes referred to as a “Black Box” Warning) for products that have shown a significant risk of severe or life-threatening adverse events and similar warnings are also required to be displayed on the product in certain other jurisdictions.

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.

In addition, with respect to medical devices, in May 2017, the European Commission published the MDR, which replaced the Medical Device Directive (MDD).

Pursuant to the terms of the new regulations, in order to continue to market medical device products in the EU, such products must achieve compliance with these new regulations and be re-registered in the EU within a specified transition period, which, for a portion of products, ended as early as May 26, 2021.

While EU law is applicable in Northern Ireland, the UK Medical Devices Regulations 2002/68 also need to be complied with in Great Britain.

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.

After that, devices destined for Great Britain will be 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.

There are some extra hurdles for manufacturers who are based outside the UK, such as the requirement to appoint a UK Responsible Person (“UKRP”) to take on certain regulatory responsibilities with respect to the Medicines and Healthcare products Regulatory Agency (“MHRA”) and users or customers in the UK.

To enable devices to be placed on the market in the UK after January 1, 2021 (even for CE marked devices), a UK manufacturer must register with the MHRA, as must a UKRP for an overseas manufacturer.

Such registering entity will then register each of the devices for which they are responsible for placing on the market in the UK, whether in Great Britain or Northern Ireland.

Until May 25, 2021, our products bearing a CE mark could be exported from the EEA to Switzerland.

However, as of May 26, 2021, the EU no longer applies the Mutual Recognition Agreement between the EEA and Switzerland.

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.

As a consequence, we will be required to appoint an authorized representative in Switzerland in order to export our CE-marked medical devices to Switzerland beginning in January 2022 through August 2022, depending on the class of the device or system in question.

Additionally, the name and address of the Swiss authorized representative must be placed on the packaging.

Canada, in the U.S.

and Canada respectively, and similar regulations enforced by regulatory agencies in other countries and we face annual audits of our facilities and plants and those of our contract manufacturers by the FDA and such other regulatory agencies.

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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.

This statute has been interpreted to apply to arrangements between pharmaceutical or medical device manufacturers, on the one hand, and prescribers, purchasers, formulary managers and other health care related professionals, on the other hand.

Some state anti-kickback laws also prohibit such conduct where commercial insurance, rather than federal or state, programs are involved.

Due to recent legislative changes, violations of the U.S.

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.

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 and the curtailment or restructuring of our operations.

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.

Department of Health and Human Services Office of Inspector General recommends, and increasingly states require pharmaceutical companies to have comprehensive compliance programs.

Moreover, the Physician Payment Sunshine Act enacted in 2010 imposes reporting and disclosure requirements on device and drug manufacturers for any “transfer of value” made or distributed to prescribers and other health care providers.

Failure to submit this required information may result in significant civil monetary penalties.

We are also subject to the U.S.

Foreign Corrupt Practices Act ("FCPA"), the Canadian Corruption of Foreign Public Officials Act and similar worldwide anti-bribery laws, which generally prohibit companies and their intermediaries from making improper payments to officials for the purpose of obtaining or retaining business.

Violations of these laws could result in criminal or civil penalties or remedial measures.

We are also subject to various state, federal and international laws and regulations governing the collection, transmission, dissemination, use, privacy, confidentiality, security, retention, availability, integrity and other processing of health-related and other sensitive and personal information, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”).

authorization, claims status, plan enrollment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information.

HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions (e.g., health care claims information and plan eligibility, referral certification and authorization, claims status, plan enrollment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information.

These standards require the adoption of administrative, physical and technical safeguards to protect such information.

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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.

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.

For example, the California Consumer Privacy Act of 2018 (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.

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.

It remains unclear how various provisions of the CCPA will be interpreted and enforced, and multiple states have enacted or are expected to enact similar laws.

The effects on our business of the CCPA and other similar state laws are potentially significant, and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply.

State laws are changing rapidly and there is discussion in Congress of a new federal data protection and privacy law to which we may be subject.

For instance, the California Privacy Rights Act (“CPRA”) was passed in November 2020.

When it takes effect in January 2023, it will maintain the core framework of the CCPA, while also making a number of substantive changes.

Additionally, some statutory requirements, both in the U.S.

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For example, laws in all 50 U.S.

states require businesses to provide notice to customers whose personal data has been disclosed as a result of a data breach.

states require businesses to provide notice to customers whose

personal data has been disclosed as a result of a data breach.

The laws are not consistent, and compliance in the event of a widespread data breach is difficult and may be costly.

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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.

In particular, sales of our products may be subject to discounts from list price and rebate obligations, as well as formulary

coverage decisions impacting or limiting the types of patients for whom coverage will be provided.

In particular, sales of our products may be subject to discounts from list price and rebate obligations, as well as formulary coverage decisions impacting or limiting the types of patients for whom coverage will be provided.

health care and other laws regulate our interactions with government agencies, private insurance companies and other third-party payors regarding coverage and reimbursement for our products.

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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.

Although efforts at replacing the Health Care Reform Act have stalled in Congress, there are a number of proposals that we expect to be introduced to Congress and put forth by the Biden administration that may result in further changes to the health care system that could materially impact the Company.

For example, on January 28, 2021, President Biden issued the “Executive Order on Strengthening Medicaid and the Affordable Care Act,” which directs federal agencies to review all existing regulations, orders, guidance documents, policies and any other similar agency actions that limit Americans’ access to high-quality health care, and to consider actions that will protect and strengthen Medicaid, the PPACA and access to affordable health care for every American.

Under this order, federal agencies must make determinations as to whether additional actions are necessary to advance President Biden’s overall access policy and specifically examine (i) policies that may undermine protections for people with pre-existing conditions, including complications related to COVID-19, (ii) demonstrations and waivers that may reduce coverage under or otherwise undermine Medicaid or the PPACA, (iii) policies that may undermine the Health Insurance Marketplace or other markets for health insurance, (iv) policies that may present unnecessary barriers to enroll in Medicaid or the PPACA and (v) policies or practices that may reduce the affordability of coverage or financial assistance for coverage, including for dependents.

We cannot predict what changes will result from the Executive Order or when they will take effect, nor is it possible at this time to estimate the impact of any such changes on the Company.

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.

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.

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.

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.

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.

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.

At the federal level, the Trump Administration’s budget proposal for fiscal year 2019 contained further drug price control measures that could be enacted in future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid and to eliminate cost sharing for generic drugs for low-income patients.

While any proposed measures will require authorization through additional legislation to become effective, Congress and the Biden Administration have each indicated an intent to continue to seek new legislative or administrative measures to control drug costs.

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.

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.

“Risk Factors” of this Form 10-K for additional information on the risks associated with these regulations and related matters.

Environmental and Other Regulation

Our facilities and operations are subject to federal, state and local environmental and occupational health and safety laws and regulations in both the U.S.

Our facilities and operations are subject to a broad range of federal, state and local environmental and occupational health and safety laws and regulations in both the U.S.

and countries outside the U.S.

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Certain of our development and manufacturing activities involve the use of hazardous substances.

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.

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.

In the EU, the REACH regulations came into effect in 2007, with implementation rolling out over time.

Registered chemicals then can be subject to further evaluation and potential restrictions.

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.

In particular, some of our products might be characterized as nanomaterials and then be subject to evolving, new nanomaterial regulations.

We believe we are in compliance in all material respects with applicable environmental and occupational health and safety laws and regulations.

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In 2021, the U.S.

and Puerto Rico accounted for approximately 60% of our total revenue.

and Puerto Rico accounted for approximately 58% and China accounted for approximately 6% of our total revenue, respectively.

No other country accounted for more than 5%.

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2021 2020 2019

McKesson Corporation 17% 17% 18%

AmerisourceBergen Corporation 18% 17% 16%

McKesson Corporation 16% 17% 17%

Cardinal Health, Inc.

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With respect to the GI market, generic entrants continue to capture significant share for treatment of many GI conditions.

In the area of irritable bowel syndrome ("IBS") and OIC, competitors have recently launched new competing products, which should increase the size of these markets and intensify competition.

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.

The market for Bausch + Lomb products is very competitive, both across product categories and geographies.

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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.

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.

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 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.

As of December 31, 2020, we had approximately 21,600 employees, which included approximately 11,100 in production, 7,600 in sales and marketing, 1,600 in general and administrative positions and 1,300 in R&D.

These employees are located around the world, with 7,100 in the United States and Canada, 6,500 in Europe, 2,800 in the Middle East and Africa, 2,400 in Asia-Pacific countries, 2,100 in Latin America, and 700 in Russia and Commonwealth of Independent State countries.

As of December 31, 2021, we had approximately 19,600 employees (of which 19,100 were full-time employees), which included approximately 9,900 in production, 7,000 in sales and marketing, 1,400 in general and administrative positions and 1,300 in R&D.

These employees are located around the world, with 7,380 in the United States and Canada, 6,820 in Europe, 2,420 in Asia-Pacific countries, 2,120 in Latin America, 640 in Russia and Commonwealth of Independent State countries and 220 in the Middle East and Africa.

Collective bargaining exists for some employees in several countries in which we do business.

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.

During fiscal 2020, our voluntary turnover rate was lower than in prior years, partially attributable to the impact of the COVID-19 pandemic.

We have not experienced any significant business disruption to date as a result of turnover, and we regularly conduct an employee engagement survey globally in order to keep a pulse on the organization.

Based on the survey results, we believe that our employees are proud to work for Bausch Health Companies Inc.

and 87% would recommend our Company as a good place to work.

In the beginning of 2021, our voluntary turnover rate trended higher than in 2020, but in line with what most companies were experiencing in the industries and geographies in which we operate;

the voluntary turnover rate has since leveled off and is closer to or at targeted rate.

We have not experienced any significant disruption to date as a result of turnover.

Health, Safety and Wellness

Our employees' health, safety, and wellness are important to us.

With the COVID-19 outbreak, a focus in 2020 was protecting the health and safety of our employees and their families.

We broadened our existing remote work policies to enable our global employees to work from home wherever possible.

In circumstances where remote work was not possible (such as at our manufacturing and distribution facilities) we implemented safety measures to ensure we prevented the spread of COVID-19 in the workplace, such as mandatory face coverings, social distancing, hand hygiene, plexiglass barriers, limited face-to-face meetings and other procedures as prescribed by global public health organizations, such as the WHO and U.S.

With the COVID-19 outbreak, a continued focus in 2021 was protecting the health and safety of our employees and their families.

We continued to make available our remote work policies, which had been broadened in 2020 to enable our global employees to work from home wherever possible.

In circumstances where remote work was not possible (such as at our manufacturing and distribution facilities), we continued to implement safety measures, which had been introduced in 2020 to help prevent the spread of COVID-19 in the workplace, such as mandatory face coverings, social distancing, hand hygiene, plexiglass barriers, limited face-to-face meetings and other procedures as prescribed by global public health organizations, such as the WHO and U.S.

Centers for Disease Control and Prevention.

On an ongoing basis, we measure how well we are fostering the health and safety of our employees through our Days Away Rate ("DAR"), which captures globally the number of days that our employees are away from work due to illness or injury.

In 2020, we achieved an annual DAR of 11, which surpassed our annual goal of 13 and exceeds the industry standard of 24 days away.

We also recognize that physical, emotional and financial wellbeing are significant contributors to our employees success at work and home, especially in 2020.

We aim to support our employees in all aspects of their everyday life by centering programs and activities around these three pillars of wellbeing.

On an ongoing basis, we measure how well we are fostering the health and safety of our employees through our Days Away Rate ("DAR"), which is a standard used in our industry to capture the number of days that our employees are away from work as a result of a work-related injury or illness.

For the year 2021, our DAR was 6 days per 100 employees.

This was favorable when compared to the goal we established for DAR of less than 12 days per 100 employees and was favorable to our industry’s average DAR of 24 days per 100 employees.

We also recognize that physical, emotional and financial wellbeing are significant contributors to our employees success at work and home.

We aim to support our employees in their everyday life by centering programs and activities around these three pillars of wellbeing.

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.

For 2020, we also provided resources for our employees specifically in response to COVID-19, including launching a website – Collaborating in the New Normal – to help our employees encourage each other, lead with empathy and adapt as we navigated these unprecedented times.

Diversity and Inclusion

We are dedicated to fostering an inclusive work environment where everyone feels welcomed, supported and valued for their talents and contributions.

Our Bausch Health Diversity & Inclusion ("D&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.

We have a D&I Council that is led by our Company's Executive Committee members sponsored by our Chief Human Resources Officer, General Counsel, and Chief Medical Officer/President R&D that provides oversight for our D&I strategy and initiatives.

We strive to advance candid conversations among our employees about racism and expanding diversity and inclusion training and education for them.

Specifically, we have provided all employees with educational tools and resources to understand how to talk about these topics at work and have introduced training aimed at helping employees become more aware of unconscious biases.

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.

We have a DE&I Council that is led by our Company's Executive Committee members sponsored by our Chief Human Resources Officer, General Counsel, and Chief Medical Officer/President R&D that provides oversight for our DE&I strategy and initiatives.

We strive to advance candid conversations among our employees about diversity and inclusion and expanding training and education on those issues.

Specifically, we have provided all employees with educational tools and resources to understand how to talk about these topics at work and, in 2020, have introduced training aimed at helping employees become more aware of unconscious biases.

We are focused on continuing to expand our Employee Resource Groups ("ERGs"), providing opportunities for professional growth, development and informal networking.

The Bausch Health Women’s Leadership Network advances the growth and leadership development of women at our Company.

In 2020, they facilitated a roundtable discussion with three female members of our Executive Committee – our Chief Human Resources Officer, General Counsel, and President of our Diversified Business – to discuss their views on the most important qualities of leadership.

They also hosted guest speakers focused on the importance of building resilience and practicing mindfulness, as well as effectively managing stress.

Our Bausch Health Military Network Employee Resource Group was recently formed as well, and in their inaugural year they hosted a virtual Veterans Day tribute and organized a Toys for Tots drive to support local communities.

Our ERGs include the following:

Asian Heritage, Black & African Heritage, LGBTQ+, Military, and the Women's Inclusive Network.

In 2021, these ERGs have helped strengthen our focus on DE&I by promoting opportunities for professional growth, development, and informal networking, and providing forums to voice concerns, and multiple perspectives.

Another essential pillar of our ERG program is to establish connections with charities whose missions align with those of our individual ERGs and give back to these communities, which we plan to continue in 2022 and beyond.

Talent Development

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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.

this process, the Board interacts with leaders and managers throughout the organization during the year to get to know these employees and their work.

Board of Directors reviews succession planning progress and specifically the plans for Executive Committee roles.

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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Additionally, it supports global relief efforts and those who need help in the communities in which we live and work.

The support of our employees is essential to the success of the foundation.

For example, in order to offer support to others during the pandemic, we established a campaign for our employees to donate to Feeding America, with the foundation matching up to $100,000 of these contributions.

Our employees may also submit a request to the foundation for a financial contribution to support the charitable efforts of an organization they support.

During 2020, the foundation, which is managed by our employees, donated medicines and health care products to assist in the global fight against the COVID-19 virus.

We are committed to supporting patients who have lost employment health benefits due to the COVID-19 pandemic, and because it is important to continue prescribed treatments, we are proud to offer certain of our prescription medicines through our Bausch Health Assistance Program.

We are committed to supporting patients who have lost employment health benefits due to the COVID-19 pandemic, and because it is essential that our patients continue their prescribed treatments, we are proud to offer certain of our prescription medicines through our Bausch Health Patient Assistance Program.

In the face of the COVID-19 pandemic, some people have financial obstacles that keep them from obtaining and continuing their prescribed treatments.

The purpose of the Bausch Health Patient Assistance Program is to provide eligible unemployed patients in the U.S., who have lost their health insurance due to the COVID-19 pandemic, with certain of our prescription products although their financial circumstances or insurance status may otherwise interfere with their ability to do so.

The purpose of the Bausch Health Patient Assistance Program is to provide eligible unemployed patients in the U.S., who meet stated qualifications and have lost their health insurance due to the COVID-19 pandemic, with certain of our prescription products where their financial circumstances or insurance status would otherwise interfere with their ability to access such products.

If approved, patients receive their Bausch Health Companies Inc.

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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.

What changed 10-K

Item 1. Business