What changed in this filing

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Item 1. Business

2021-02-24 compared with 2020-02-19 · 218 added, 102 removed, 311 unchanged (51% of the section changed)

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We develop, manufacture and market, primarily in the therapeutic areas of eye-health, gastroenterology (“GI”) and dermatology, a broad range of:

(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).

Our Company was formed as Biovail Corporation (“Biovail”) under the Business Corporations Act (Ontario) on February 18, 2000, as a result of the amalgamation of TXM Corporation and Biovail Corporation International.

Biovail was continued under the Canada Business Corporations Act effective June 29, 2005.

In connection with the acquisition of Valeant Pharmaceuticals International in September 2010, Biovail was renamed “Valeant Pharmaceuticals International, Inc.”

Effective August 9, 2013, we continued from the federal jurisdiction of Canada to the Province of British Columbia, meaning that we became a company registered under the laws of the Province of British Columbia as if we had been incorporated under the laws of the Province of British Columbia.

As a result of this continuance, our legal domicile became the Province of British Columbia, the Canada Business Corporations Act ceased to apply to us and we became subject to the British Columbia Business Corporations Act.

Effective on July 13, 2018, the Company changed its corporate name from Valeant Pharmaceuticals International, Inc.

to Bausch Health Companies Inc.

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

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

The Diversified Products segment consists of sales:

(i) in the U.S.

of pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) in the U.S.

of generic products, (iii) in the U.S.

of dentistry products and (iv) of certain other businesses divested during 2017 that were not core to the Company's operations, including the Company's equity interests in Dendreon Pharmaceuticals LLC (“Dendreon”) (June 28, 2017) and Sprout Pharmaceuticals, Inc.

(“Sprout”) (December 20, 2017).

As a result of the divestitures of Dendreon and Sprout, the Company exited the oncology and women's health businesses, respectively.

For additional discussion of our reportable segments, see the discussion in Item 1 "Business - Segment Information" and Note 23, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements for further details on these reportable segments.

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

(i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products and (iii) dentistry products.

For additional discussion of our reportable segments, see the discussion in Item 1.

"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.

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 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.

“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.

“Risk Factors — Risk Relating to COVID-19” of this Form 10-K for additional risks relating to the COVID-19 pandemic.

Business Strategy

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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 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.

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Although we primarily rely on our R&D organization to build-out and refresh our product portfolio, to supplement those efforts, we continually seek out opportunities, such as co-promotions, licensing agreements and strategic acquisitions, to leverage our commercial footprint, particularly our sales force, by strategically aligning ourselves with other innovative product solutions that, when coupled with our existing product portfolio, address specific needs in the market.

See Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

Segment Information

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Segment revenues for the years 2020, 2019 and 2018 were as follows:

(in millions)

2020 2019 2018

(in millions) Amount Pct.

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

Salix 1,904 24 % 2,022 23 % 1,749 21 %

Ortho Dermatologics 553 7 % 565 7 % 617 7 %

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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 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.

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.

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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.

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).

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We launched expanded parameters of this product throughout 2017.

Bausch + Lomb - SiHy Daily AQUALOX ™ is 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 ™ was launched in Japan in September 2018.

We expect to launch our SiHy Daily disposable contact lens in the U.S.

in the second half of 2020.

The Stellaris Elite ® Vision Enhancement System is our next generation 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 cataract lens removal.

• 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.

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) intraocular lenses such as Akreos ® , enVista ® , Crystalens ® and Trulign ® , (ii) a suite of surgical instruments including Synergetics ® and (iii) surgical equipment for cataract, refractive and vitreoretinal surgery, such as Stellaris ® PC, a vitreoretinal and cataract surgery system and the VICTUS ® femtosecond laser for cataract surgery.

(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.

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

Lumify ® was launched in May 2018.

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.

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.

• 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 ® 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

• 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.

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 and was launched in December 2017.

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.

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 ® .

International Rx

• Bisocard ® (bisoprolol fumarate) is an orally administered tablet dosed once daily for patients with hypertension, angina pectoris or heart failure and is a leading brand in Poland.

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

Thrombo ASS ® is a leading brand in Russia.

• Contrave ® / Mysimba ® is a fixed-dose combination prolonged-release tablet for the treatment of obesity.

Used alongside diet and exercise it is designed to help manage weight in adults who are obese or overweight.

The formulation is designed to initiate weight loss and sustain it over a longer period of time by switching off natural compensatory mechanisms involved in the typical weight loss plateau stage.

Contrave ® / Mysimba ® is commercialized in Canada, Greece, and Central Eastern Europe.

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

Jublia ® is commercialized in Canada (the only market outside the U.S.).

• Ivexterm ® (Ivermectin 6 mg tablets) is an antiparasitic drug, which is commercialized in Mexico and Central America, and is currently under investigational studies for treating COVID-19 patients.

• Espaven ® (Dimethicone tablets, drops, suspension) is a complete line of gastrointestinal treatments for diverse digestive indications such as:

antiflatulence, dyspepsia, absolute or relative enzyme deficiency, steatorrhea, irritable colon syndrome, pancreatic insufficiency and poor fat digestion.

Espaven ® is commercialized primarily in Mexico and South America.

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

of GI products and includes our Xifaxan ® product.

Our Xifaxan ® product accounted for revenues of $1,452 million, $1,195 million and $979 million for 2019, 2018 and 2017 , respectively.

As part of our acquisition of Salix Pharmaceutical, Ltd.

in April 2015, we acquired the intellectual property to a number of products that have provided us with year-over-year revenue growth, particularly the intellectual property behind Xifaxan ® for, amongst other indications, irritable bowel syndrome with diarrhea (“IBS-D”) and Relistor ® for opioid induced constipation (“OIC”).

Revenues from our Xifaxan ® product increased approximately 22% , 22% and 11% in 2019, 2018 and 2017, respectively.

We attribute the growth in our Salix revenues to the investments we have been making 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 intellectual property to address new indications, (iii) completing the strategic acquisition of certain assets of Synergy Pharmaceuticals Inc.

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

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 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.

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(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.

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

The Ortho Dermatologics business is our medical dermatology business dedicated to the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis, onychomycosis and other dermatoses and includes our Duobrii ® , Bryhali ® , Jublia ® and Siliq ® product lines.

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.

We continue to support and develop injectable biologics;

We continue to support the use of injectable biologics;

however, we believe some patients prefer topical products as an alternative to injectable biologics.

Further, as topical products can, in many cases, defer the use of injectable biologics that often come with associated risk/benefit profiles, a topical product is usually readily adopted by payors, is less expensive and can be more cost-effective than injectable biologics.

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 will ultimately be a key contributing factor of our Ortho Dermatologics business.

During 2017 through 2019, 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 our recently expanded Ortho Dermatologics sales force, will position our Ortho Dermatologics business for growth.

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:

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• 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.

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.

The FDA approved the New Drug Application (“NDA”) for Arazlo ™ on December 18, 2019, which we expect to launch in the first half of 2020.

• 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 June 2020.

• 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.

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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 2019 were in excess of $75 million.

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

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.

Currently our principal products in the Solta business include:

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

In 2018, we began launching Next Generation Thermage FLX ® as previously discussed.

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

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

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

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

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

• VASERlipo ® for minimally-invasive aesthetic body contouring that yields dramatic results with less pain and downtime of traditional liposuction.

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

(i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products, (iii) dentistry products and (iv) certain other businesses divested during 2017 that were not core to the Company's operations, including the Company's equity interests in Dendreon (June 28, 2017) and Sprout (December 20, 2017).

As a result of the divestitures of Dendreon and Sprout, the Company exited the oncology and women's health businesses, respectively.

The Company utilizes the Diversified Products segment to extend the long-term cash flows from a number of assets that are expected to decline over time due to the loss of exclusivity, by launching and selling Authorized Generic (“AG”) versions of certain branded assets.

(i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products and (iii) dentistry products.

The Company utilizes the Diversified Products segment to extend the long-term cash flows from a number of assets that are expected to decline over time due to the loss of exclusivity, by launching and selling authorized generic versions of certain branded assets.

Our principal products in this segment include:

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Librax ® may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Diastat ® AG (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

• Diastat ® authorized generic (“AG”) (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration for certain patients with epilepsy who are already taking antiepileptic medications, and who require occasional use of diazepam to control bouts of increased seizure activity.

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

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Our R&D organization focuses on the development of products through clinical trials.

Currently, we have over 225 R&D projects in our pipeline.

Currently, we have approximately 200 R&D projects in our pipeline.

As of December 31, 2020, approximately 1,300 dedicated R&D and quality assurance employees in 23 R&D facilities were involved in our R&D efforts.

Our R&D expenses for 2020, 2019 and 2018, were $452 million, $471 million and $413 million, respectively.

R&D expenses as a percentage of revenue were approximately 5% in 2019 and 2018 , as compared to approximately 4% in 2017 .

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

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

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

Our investment in R&D reflects our commitment to drive organic growth through internal development of new products, a pillar of our strategy.

We further supplement these efforts by continually seeking out other opportunities, such as co-promotions, licensing agreements and strategic acquisitions.

See Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

Trademarks, Patents and Proprietary Rights

“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

Trademarks, Patents, Exclusivity and Proprietary Know-How

We rely on a combination of contractual provisions, confidentiality policies and procedures and patent, trademark, copyright and trade secrecy laws to protect the proprietary aspects of our technology and business.

Our policy is to vigorously protect, enforce and defend our rights to our intellectual property and proprietary rights, as appropriate.

See Item 1A “Risk Factors” of this Form 10-K for additional information on the risks associated with our intellectual property and proprietary rights.

“Risk Factors” of this Form 10-K for additional information on the risks associated with our intellectual property and proprietary rights.

We believe that trademark protection is an important part of establishing product and brand recognition.

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In the aggregate, our patents are of material importance to our business taken as a whole.

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 NDA.

The FDA, with one exception, is prohibited during those five years from accepting for filing a generic, or ANDA, that references the NDA.

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.

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.

Protection under the Hatch-Waxman Act will not prevent the

filing or approval of another full NDA.

Protection under the Hatch-Waxman Act will not prevent the filing or approval of another full NDA.

However, the NDA applicant would be required to conduct its own pre-clinical and adequate and well-controlled clinical trials to independently demonstrate safety and effectiveness.

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Government Regulations

Government authorities in the U.S., at the federal, state and local level, in Canada, in the EU and in other countries extensively regulate, among other things, the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, advertising and promotion, storage, distribution, marketing and export and import of pharmaceutical products and medical devices.

Government authorities in the U.S., at the federal, state and local level, in Canada, in the EU and in all other countries extensively regulate, among other things, the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, advertising and promotion, storage, distribution, marketing and export and import of pharmaceutical products and medical devices.

As such, our products and product candidates are subject to extensive regulation both before and after approval.

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Generally, preclinical studies and clinical trials of the products must first be conducted and the results submitted to the applicable regulatory agency (such as the FDA) for approval.

Regulation by other federal agencies, such as the Drug Enforcement Administration (“DEA”), and state and local authorities in the U.S., and by comparable agencies in certain foreign countries, is also required.

Regulation by other federal agencies, such as the Drug Enforcement Administration, and state and local authorities in the U.S., and by comparable agencies in certain foreign countries, is also required.

In the U.S., the Federal Trade Commission (the “FTC”), the FDA and state and local authorities regulate the advertising of medical devices, prescription drugs, OTC drugs and cosmetics.

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We are also subject to extensive U.S.

federal and state health care marketing and fraud and abuse regulations, such as the federal False Claims Act, federal and provincial marketing regulation in Canada and similar regulations in foreign countries in which we may conduct our business.

federal and state health care marketing and fraud and abuse regulations, such as the federal False Claims Act, federal and provincial marketing regulations in Canada and similar regulations in foreign countries in which we may conduct our business.

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

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federal Anti-Kickback Statute also carry potential federal False Claims Act liability.

In addition, in the U.S.

and Canada, companies may not promote drugs or medical devices for “off-label” uses - that is, uses that are not described in the product’s labeling and that differ from those that were approved or cleared by the FDA or Health Canada, respectively - and “off-label promotion” in the U.S.

In addition, in the U.S., Canada and various other countries, companies may not promote drugs or medical devices for “off-label” uses - that is, uses that are not described in the product’s labeling and that differ from those that were approved or cleared by the FDA, Health Canada or applicable regulatory agency in such other countries - and “off-label promotion” in the U.S.

has also formed the predicate for False Claims Act liability resulting in significant financial settlements.

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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”).

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.

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

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

Many states in which we operate have laws that protect the privacy and security of sensitive and personal information, including health-related information.

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Guidance on implementation and compliance practices is often updated or otherwise revised.

We are also subject to Canada's federal Personal Information Protection and Electronic Documents Act (“PIPEDA”) and substantially similar equivalents at the provincial level with respect to the collection, use and disclosure of personal information in Canada.

We are also subject to Canada's federal Personal Information Protection and Electronic Documents Act and substantially similar equivalents at the provincial level with respect to the collection, use and disclosure of personal information in Canada.

Such federal and provincial legislation impose data privacy and security obligations on our processing of personal information of Canadian residents.

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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.

to comply with these laws could subject us to civil, criminal and administrative sanctions.

Failure to comply with these laws could subject us to civil, criminal and administrative sanctions.

In countries outside the U.S., the success of our products may depend, at least in part, on obtaining and maintaining government reimbursement because, in many countries, patients are unlikely to use prescription drugs that are not reimbursed by their governments.

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In Canada and many international markets, governments control the prices of prescription pharmaceuticals, including through the implementation of reference pricing, price cuts, rebates, revenue-related taxes, tenders and profit control, and they expect prices of prescription pharmaceuticals to decline over the life of the product or as volumes increase.

See Item 1A “Risk Factors” of this Form 10-K for additional information on the risks associated with these regulations and related matters.

and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could impact our ability to sell our products profitably.

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.

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

Environmental and Other Regulation

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and countries outside the U.S.

(including Canada), including those governing the discharges of substances into the air, water and land, the handling, treatment, storage and disposal of hazardous substances and wastes, wastewater and solid waste, the cleanup of contaminated properties and other environmental matters.

(including Canada), including those governing the discharge of substances into the air, water and land, the handling, treatment, storage and disposal of hazardous substances and wastes, wastewater and solid waste, the cleanup of contaminated properties and other environmental matters.

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

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In addition, we are unable to predict what environmental or and occupational health and safety legislation or regulations may be adopted or enacted in the future.

See Item 1A “Risk Factors” of this Form 10-K for additional information.

“Risk Factors” of this Form 10-K for additional information.

Customers and Marketing

In 2020, the U.S.

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

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

No other country accounted for more than 5%.

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Customers that accounted for 10% or more of our total revenue for 2020, 2019 and 2018 are as follows:

2020 2019 2018

McKesson Corporation 17% 17% 18%

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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 “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.

“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.

See Note 20, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements for further details regarding certain infringement proceedings.

See Item 1A “Risk Factors” of this Form 10-K for additional information on our competition risks.

“Risk Factors” of this Form 10-K for additional information on our competition risks.

Manufacturing

We currently operate approximately 37 manufacturing plants worldwide and continue to make capital investments in these facilities as discussed in Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

In the normal course of business, our products, devices and facilities are the subject of ongoing oversight and review, by regulatory and governmental agencies, including general, for cause and pre-approval inspections by the relevant competent authorities where we have business operations, including the FDA.

Currently, all of our global operations and facilities have the relevant operational certificates.

Through the date of this filing, the Company's operating sites are in good compliance standing, and all sites under FDA jurisdiction are rated as either No Action Indicated (where there was no Form 483 observation) or Voluntary Action Indicated (“VAI”) (where there was a Form 483 with one or more observations).

In the case of VAI inspection outcomes, the FDA has accepted our responses to the issues cited in the Form 483, which will be verified when the agency makes its next inspection of those specific facilities.

A Form 483 is issued at the end of each inspection when FDA investigators have observed any condition that in their judgment may constitute violations of current good manufacturing practice.

We currently operate approximately 38 manufacturing sites worldwide and continue to make capital investments in these facilities as discussed in Item 7.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations — Overview — Focus on Core Businesses” of this Form 10-K.

In the normal course of business, our products, devices and facilities are the subject of ongoing oversight and review by regulatory and governmental agencies, including general, for cause and pre-approval inspections by the relevant competent authorities where we have business operations.

Through the date of this filing, all of our global operations and facilities have the relevant operational good manufacturing practices certificates and all Company products and operating sites are in good compliance standing with all relevant notified bodies and global health authorities.

Further, all sites under FDA jurisdiction are rated as either No Action Indicated (where there was no Form 483 observation) or Voluntary Action Indicated (“VAI”) (where there was a Form 483 with one or more observations).

In the case of VAI inspection outcomes, the FDA has accepted our responses to the issues cited, which will be verified when the agency makes its next inspection of those specific facilities.

A Form 483 is issued at the end of each inspection when FDA investigators have observed any condition that in their judgment may constitute violations of current good manufacturing practices.

We also subcontract the manufacturing of certain of our products, including products manufactured under the rights acquired from other pharmaceutical companies.

Products representing approximately 20% of our product sales for 2020 are produced in total, or in part, by third-party manufacturers under manufacturing arrangements.

In some cases, the principal raw materials, including active pharmaceutical ingredient, used by us (or our third-party manufacturers) for our various products are purchased in the open market or are otherwise available from several sources.

In some cases, the principal raw materials, including active pharmaceutical ingredients, used by us (or our third-party manufacturers) for our various products are purchased in the open market or are otherwise available from several sources.

However, some of the active pharmaceutical ingredients and other raw materials used in our products and some of the finished products themselves are currently only available from a single source;

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Any disruption in the supply of any such single-sourced active pharmaceutical ingredient, other raw material or finished product or an increase in the cost of such materials or products could adversely impact our ability to manufacture or sell such products, the ability of our third-party manufacturers to supply us with such products, or our profitability.

We attempt to manage the risks associated with reliance on single sources of active pharmaceutical ingredient, other raw materials

or finished products by carrying additional inventories or, where possible, developing second sources of supply.

See Item 1A “Risk Factors” of this Form 10-K for additional information on the risks associated with our manufacturing arrangements.

As of December 31, 2019 , we had approximately 21,700 employees.

These employees included approximately 11,000 in production, 7,700 in sales and marketing, 1,600 in general and administrative positions and 1,400 in R&D.

Collective bargaining exists for some employees in a number of countries in which we do business.

We attempt to manage the risks associated with reliance on single sources of active pharmaceutical ingredient, other raw materials or finished products by carrying additional inventories or, where possible, developing second sources of supply.

“Risk Factors” for additional information on the risks associated with our manufacturing arrangements.

Our global supply team worked diligently to stay ahead of the challenges presented by the COVID-19 pandemic once it appeared in Asia.

"Management's Discussion and Analysis — Impacts of COVID-19 Pandemic" for further information.

Human Capital Resources

In order to achieve our vision of being a trusted health care partner, we strive to ensure our employees around the world feel proud to be a part of Bausch Health Companies Inc.

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.

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.

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.

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.

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.

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.

Talent Development

We are committed to the development of our employees and believe that our success coincides with our employees’ achievements of personal and professional goals.

Through our Employee Development Framework, we endeavor to support our employees’ interests to grow to their full potential, achieve career goals, and contribute to the success of our Company.

We empower employees to explore roles that are of interest and gain insights into their strengths and development needs.

We provide a variety of development programs to support our employees at every stage of their career and incorporate individual development plans that aim to help our employees reach their career goals.

We also have a robust, global succession planning process that allows us to define talent needs based on business strategy, identify talent and drive their development and growth, strengthen the pipeline for critical leadership positions, and optimize talent deployment across the business.

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.

Total Rewards

Our Company’s total rewards philosophy is designed to attract, retain, motivate, and engage our employees.

We provide comprehensive and market competitive compensation and benefit programs across our geographies, aligning these programs with the interests of our shareholders and balancing appropriate risk taking.

Collectively, these programs comprise our Total Rewards package.

Our compensation program includes base pay, short-term incentives, and long-term incentives.

We provide the opportunity for our employees to earn more when we deliver against objectives – both as a total company and individually.

We also provide competitive benefit programs based on local practice in the countries where our employees work.

Our programs include medical coverage, retirement benefits, paid time off, and life and other insurances.

Based on local market practice in the geographies in which we operate, we also offer family planning benefits to our employees such as adoption and surrogacy assistance programs.

Corporate Social Responsibility

In 2017, we established The Bausch Foundation, which supports initiatives aimed at disease prevention, improving patient outcomes, and community support related to our core businesses.

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.

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.

If approved, patients receive their Bausch Health Companies Inc.

prescription product(s) at no cost to them for up to one year, and may be able to reapply to the program annually if they continue to meet eligibility requirements and have a valid prescription.

“Management's Discussion and Analysis — Overview — Focus on Core Businesses — Improve Patient Access” for additional discussion regarding Company programs to address the affordability and availability of our products.

Product Liability Insurance

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In the future, we will continue to re-evaluate our decision to self-insure and may purchase additional product liability insurance to cover product liability risk.

See Item 1A “Risk Factors” of this Form 10-K for additional information.

“Risk Factors” of this Form 10-K for additional information.

Seasonality of Business

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Changes in the relative values of currencies may materially affect our results of operations.

For a discussion of these risks, see Item 1A “Risk Factors” of this Form 10-K.

For a discussion of these risks, see Item 1A.

“Risk Factors” of this Form 10-K.

See Note 22, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements for revenues and long-lived assets by geographic area.

A portion of our revenue and income was earned in Canada and Ireland, which have low effective tax rates and represent approximately 4% of our revenues in 2019.

See Item 1A “Risk Factors” of this Form 10-K relating to tax rates for more information.

A portion of our revenue and income was earned in Canada and Ireland, which have low effective tax rates.

“Risk Factors” of this Form 10-K relating to tax rates for more information.

Available Information

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You are invited to read and copy any reports, statements or other information, other than confidential filings, that we file with the provincial securities commissions.

These filings are also electronically available from the Canadian System for Electronic Document Analysis and Retrieval (“SEDAR”) (http://www.sedar.com), the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.

These filings are also electronically available from the Canadian System for Electronic Document Analysis and Retrieval (“SEDAR”) at www.sedar.com , the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.

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