INTRODUCTION
This "Management's Discussion and Analysis of Financial Condition and Results of Operations" has been updated throughFebruary 19, 2020 and should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto included elsewhere in this Annual Report on Form 10-K. Additional company information, including this Form 10-K, is available on SEDAR at www.sedar.com and on theU.S. Securities and Exchange Commission (the "SEC") website at www.sec.gov. All currency amounts are expressed inU.S. dollars, unless otherwise noted. OVERVIEWBausch Health Companies Inc. ("we", "us", "our" or the "Company") is a global company whose mission is to improve people's lives with our health care products. 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). We generated revenues for 2019, 2018 and 2017, of$8,601 million ,$8,380 million and$8,724 million , respectively. 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 theU.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 inCanada ,Europe ,Asia ,Australia ,Latin America ,Africa and theMiddle East of branded pharmaceutical products, branded generic pharmaceutical products, OTC products, medical device products and Bausch + Lomb products.
• The Salix segment consists of sales in the
• TheOrtho Dermatologics segment consists of: (i) sales in theU.S. ofOrtho Dermatologics (dermatological) products and (ii) global sales of Solta medical aesthetic devices.
• The Diversified Products segment consists of sales: (i) in the
pharmaceutical products in the areas of neurology and certain other
therapeutic classes, (ii) in the
during 2017 that were not core to the Company's operations, including the
Company's equity interests in
(
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. Focus on Core Businesses Our strategy is to focus our business on core therapeutic classes 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. In order to continue to focus on our core businesses we have: (i) directed capital allocation to drive growth within our core businesses, (ii) made measurable progress in effectively managing our capital structure, (iii) increased our efforts to improve patient access and (iv) continued to invest in sustainable growth drivers to position us for long-term growth. 46 -------------------------------------------------------------------------------- Direct Capital Allocation to Drive Growth Within Our Core Businesses Our capital allocation is driven by our long-term growth strategies. We have been aggressively allocating resources to promote our core businesses globally through: (i) strategic acquisitions, (ii) research and development ("R&D") investment and (iii) strategic investments in our infrastructure. The outcome of this process allows us to better drive value in our product portfolio and generate operational efficiencies. Strategic Acquisitions - We remain very selective when considering any acquisition and pursue only those opportunities that we believe align well with our current organization. In being selective, we seek to enter into only those acquisitions that provide us with significant synergies with our existing business, thereby minimizing risks to our core businesses and providing long-term growth opportunities. Recently, we have entered into transactions that although not immediately impactful to our operating results, are expected to be accretive to our bottom line in future years and contribute to our long-term growth strategies. InMarch 2019 , we completed the acquisition of certain assets ofSynergy Pharmaceuticals Inc. ("Synergy") whereby we acquired the worldwide rights to the Trulance® (plecanatide) product, a once-daily tablet for adults with chronic idiopathic constipation, or CIC and irritable bowel syndrome with constipation, or IBS-C. We believe that the Trulance® product complements our existing Salix products and allows us to effectively leverage our existing GI sales force. OnFebruary 18, 2019 , we acquired theU.S. rights to EM-100 from Eton Pharmaceuticals, Inc. EM-100, is an investigational eye drop that, if approved by the FDA, will be the first OTC preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. A Phase 3 trial has been completed and submitted to the FDA for review and we anticipate their response in the second half of 2020. If approved, EM-100 is expected to complement our broad range of Bausch + Lomb integrated eye-health products. InOctober 2018 , we completed the planned acquisition ofMedpharma Pharmaceutical and Chemical Industries LLC ("Medpharma"). The completion of this acquisition provides us with full control over the business activities of Medpharma and allows us to wholly benefit from the allocation of additional Company resources and the growth, if any, in the Arab Emirates and the surrounding region. We are considering further acquisition opportunities within our core therapeutic areas, some of which could be sizable.R&D Investment - We continuously search for new product opportunities through internal development and strategic licensing agreements, that if successful, will allow us to leverage our commercial footprint, particularly our sales force, and supplement our existing product portfolio and address specific unmet needs in the market. Internal R&D Projects - Our R&D organization focuses on the development of products through clinical trials. As ofDecember 31, 2019 , approximately 1,400 dedicated R&D and quality assurance employees in 23 R&D facilities were involved in our R&D efforts internally. Our R&D expenses for 2019, 2018 and 2017, were$471 million ,$413 million and$361 million , respectively, and was approximately 5% as a percentage of revenue for 2019 and 2018 and approximately 4% for 2017. As part of our turnaround, we removed projects related to divested businesses and 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 have over 225 projects in our global pipeline and anticipate submitting approximately 100 of those projects for regulatory approval in 2020 and 2021. Core assets that have received a significant portion of our R&D investment in current and prior periods are listed below. • Dermatology - InJune 2019 , we launched Duobrii®, 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. Halobetasol propionate and tazarotene are each
approved to treat plaque psoriasis when used separately, but the duration
of halobetasol propionate is limited by
("FDA") labeling constraints and the use of tazarotene can be limited due
to tolerability concerns. However, the combination of these ingredients
in Duobrii®, with a dual mechanism of action, allows for expanded duration
of use, with reduced adverse events.
• Dermatology - In
contains a unique, lower concentration of halobetasol propionate for the treatment of moderate-to-severe psoriasis which is FDA approved for 8 weeks of use. The FDA has previously approved halobetasol propionate to treat plaque psoriasis, but limited duration of use to two weeks. 47
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• Bausch + Lomb - 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. In 2017, we launched this product and the extended
power range for this product. In 2018, we launched the Bausch + Lomb ULTRA® for Astigmatism -2.75 cylinder expanded SKU range. • 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
was launched inJapan inSeptember 2018 . We expect to launch ourSiHy Daily disposable contact lens in theU.S. in the second half of 2020.
• Dermatology -
with a fixed combination of benzoyl peroxide, clindamycin phosphate and adapalene. Phase 3 studies were initiated inDecember 2019 .
• Bausch + Lomb - Lumify® (brimonidine tartrate ophthalmic solution, 0.025%)
is an OTC eye drop developed as an ocular redness reliever. We have
several line extensions currently under development and further clinical
studies are planned to start in 2020.
• Gastrointestinal - We have initiated a Phase 2 study for the treatment of
overt hepatic encephalopathy with a new formulation of rifaximin, which we
acquired as part of the Salix Acquisition. We expect to complete an interim analysis in the first quarter of 2020. • Gastrointestinal - Following the read out of the overt hepatic
encephalopathy study, we are planning to initiate a study potentially
evaluating the new formulation of rifaximin in potential hepatic
encephalopathy and gastrointestinal conditions. The study is expected to
start in the second half of 2020. This study replaces the planned Xifaxan®
550mg tablets Phase 2 study evaluating the prevention of complications of
decompensation cirrhosis referenced in our Quarterly Report on Form 10-Q for the quarterly period endedJune 30, 2019 .
• Gastrointestinal - We are initiating a Phase 2 study to evaluate rifaximin
for the treatment of small intestinal bacterial overgrowth or SIBO. Patient enrollment is expected to begin in the first half of 2020. • Dermatology - IDP-120 is an acne product with a fixed combination of
mutually incompatible ingredients: benzoyl peroxide and tretinoin. Phase 3
clinical studies are ongoing.
• Dermatology - Arazlo™ (tazarotene) Lotion, 0.045% (formerly IDP-123) 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
expect to launch in the first half of 2020. • Gastrointestinal - Our partner Alfasigma S.p.A. ("Alfasigma") is
initiating a Phase 2/3 study for the treatment of postoperative Crohns
disease using a novel rifaximin extended release formulation. The study is
expected to start in the first half of 2020.
• Gastrointestinal - We are developing a probiotic supplement to address
gastrointestinal disturbances. Patient enrollment for clinical trial has been completed and we expect to launch this product in 2020. • Dermatology - IDP-124 is a topical lotion product designed to treat moderate to severe atopic dermatitis, with pimecrolimus, currently in Phase 3 testing.
• Bausch + Lomb - Biotrue® ONEday for Astigmatism is a daily disposable
contact lens for astigmatic patients. The Biotrue® ONEday contact lens
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. We
launched this product in
range and further extended power ranges in 2017, 2018 andNovember 2019 . • Bausch + Lomb - We are developing a new Ophthalmic Viscosurgical Device
product, with a formulation to protect corneal endothelium during
phacoemulsification process during a cataract surgery and to help chamber
maintenance and lubrication during interocular lens delivery. We
anticipate filing a Premarket Approval application for the dispersive
Ophthalmic Viscosurgical Device with the FDA in the first quarter of 2020.
• Bausch + Lomb - In
etabonate ophthalmic gel) 0.38%, a new formulation for the treatment of
post-operative inflammation and pain following ocular surgery. Lotemax® SM
is the 48
-------------------------------------------------------------------------------- lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery in theU.S. • Bausch + Lomb - enVista® Trifocal intraocular lens is an innovative lens design. We initiated an investigative device exemption study for this product inMay 2018 and initiated a Phase 2 study in October of 2019.
• Bausch + Lomb - Enhanced enVista® Toric intraocular lens was launched in
• Bausch + Lomb - We are developing a preloaded intraocular lens injector
platform for enVista interocular lens. We have received approvals from the
anticipate launching this platform in the second quarter of 2020.
• Bausch + Lomb - We are developing an extended depth of focus intraocular
lens which we anticipate launching in 2020, excluding the
with
• Bausch + Lomb ULTRA® Multifocal for Astigmatism contact lens is the first
and only multifocal toric lens available as a standard offering in the eye
care professional's fit set. The new monthly silicone hydrogel lens, which was specifically designed to address the lifestyle and vision needs of
patients with both astigmatism and presbyopia, combines the Company's
unique 3-Zone Progressive™ multifocal design with the stability of its OpticAlign® toric with MoistureSeal® technology to provide eye care professionals and their patients an advanced contact lens technology that offers the convenience of same-day fitting during the initial lens
exam. Bausch + Lomb ULTRA® Multifocal for Astigmatism was launched in June
2019.
• Bausch + Lomb - Renu® Advanced Multi-Purpose Solution ("MPS") contains a
triple disinfectant system that kills 99.9% of germs, and has a dual
surfactant system that provides up to 20 hours of moisture. Renu® Advanced
MPS is FDA cleared with indications for use to condition, clean, remove
protein, disinfectant, rinse and store soft contact lenses including those
composed of silicone hydrogels. Renu® Advanced MPS has gained regulatory
approvals in
• Bausch + Lomb - Custom soft contact lens (Ultra buttons) is a latheable
silicone hydrogel button for custom soft specialty lenses including; Sphere, Toric, Multifocal, Toric Multifocal and irregular corneas. If approved by the FDA, we expect to launch in the first quarter of 2021.
• Bausch + Lomb - In
for presbyopia exclusively available with Zenlens™ and Zen™ RC scleral
lenses and will allow eye care professionals to fit presbyopic patients
with irregular and regular corneas and those with ocular surface disease,
such as dry eye. The Zen™ Multifocal Scleral Lens incorporates decentered
optics, enabling the near power to be positioned over the visual axis. • Bausch + Lomb - InMarch 2019 , we launched Tangible® Hydra-PEG®, a
high-water polymer coating that is bonded to the surface of a contact lens
and designed to address contact lens discomfort and dry eye. Tangible®
Hydra-PEG® coating technology in combination with our Boston® materials
and Zenlens™ family of scleral lenses will help eye care professionals
provide a better lens wearing experience for their patients with
challenging vision needs.
Strategic Licensing Agreements - To supplement our reliance on our internal R&D organization to build-out and refresh our product portfolio, we also search for opportunities to augment our pipeline through arrangements that allow us to gain access to unique products and investigational treatments, by strategically aligning ourselves with other innovative product solutions. In the normal course of business, the Company will enter into select licensing and collaborative agreements for the commercialization and/or development of unique products primarily in theU.S. andCanada . These products are sometimes investigational treatments in early stage development that target unique conditions. The ultimate outcome, including whether the product will be: (i) fully developed, (ii) approved by the FDA, (iii) covered by third-party payors or (iv) profitable for distribution cannot be fairly predicted. OnFebruary 27, 2018 , we announced that we entered into an exclusive license agreement with Kaken Pharmaceutical Co., Ltd. to develop and commercialize a new chemical entity, IDP-131 (KP-470), for the topical treatment of psoriasis. An early proof of concept study was initiated in the first half of 2019. If approved by the FDA, IDP-131 could represent a novel drug with an alternative mechanism of action in the topical treatment of psoriasis. InDecember 2019 , we announced that we had acquired an exclusive license fromNovaliq GmbH for the commercialization and development in theU.S. andCanada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat Dry Eye Disease ("DED") associated with Meibomian gland dysfunction ("MGD"). A Phase 3 study is underway for NOV03, and we anticipate starting an additional Phase 3 study in 2020. 49 -------------------------------------------------------------------------------- If approved by the FDA, we believe the addition of this investigational treatment for DED will help build upon our strong portfolio of integrated eye-health products. InOctober 2019 , we acquired an exclusive license from Clearside Biomedical, Inc. ("Clearside") for the commercialization and development of Xipere™ (triamcinolone acetonide suprachoroidal injectable suspension) in theU.S. andCanada . Xipere™ is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector™ that is being investigated as a targeted treatment of macular edema associated with uveitis. Clearside expects to resubmit its NDA for Xipere™ to the FDA in mid-year 2020. InApril 2019 , we entered into two licensing agreements which present us with unique developmental opportunities to address unmet needs of individuals suffering with certain GI and liver diseases. The first of these two licensing agreements is with theUniversity of California for certain intellectual property relating to an investigational compound targeting the pituitary adenylate cyclase receptor 1 in non-alcoholic fatty liver disease ("NAFLD"), nonalcoholic steatohepatitis ("NASH") and other GI and liver diseases. The second is an exclusive licensing agreement with Mitsubishi Tanabe Pharma Corporation to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate receptor that plays a role in autoimmune diseases, such as inflammatory bowel disease and ulcerative colitis. We plan to initiate a Phase 2 study for the development of MT-1303 in ulcerative colitis in 2020. Strategic Investments in our Infrastructure - In support of our core businesses, we have and continue to make strategic investments in our infrastructure, the most significant of which are at ourWaterford facility inIreland and ourRochester facility inNew York . To meet the forecasted demand for our Biotrue® ONEday lenses, inJuly 2017 , we placed into service a$175 million multi-year strategic expansion project of theWaterford facility. The emphasis of the expansion project was to: (i) develop new technology to manufacture, automatically inspect and package contact lenses, (ii) bring that technology to full validation and (iii) increase the size of theWaterford facility. To address the expected global demand for our Bausch + Lomb ULTRA® contact lens, inDecember 2017 , we completed a multi-year,$200 million strategic upgrade to ourRochester facility. The upgrade increased production capacity in support of our Bausch + Lomb Ultra® and SiHy Daily AQUALOX™ product lines and better supports the production of other well-established contact lenses such as our PureVision®, PureVision®2 (SVS, Toric, and Multifocal), SofLens® 38 and SilSoft®. To address the expected global demand for ourSiHy Daily disposable contact lenses, inNovember 2018 , we initiated$300 million of additional expansion projects to add multiple production lines to ourRochester andWaterford facilities.SiHy Daily disposable contact lenses are expected to be launched in theU.S. in the second half of 2020. We believe the investments in ourWaterford andRochester facilities and related expansion of labor forces further demonstrates the growth potential we see in our Bausch + Lomb products and our eye-health business. Effectively Managing Our Capital Structure We continue to effectively manage our capital structure by: (i) reducing our debt through repayments, (ii) extending the maturities of debt through refinancing and (iii) improving our credit ratings. Financing of Litigation Settlement - InDecember 2019 , we announced that we had agreed to resolve the putative securities class action litigation in theU.S. (the "U.S. Securities Litigation") for$1,210 million , subject to final court approval. Once approved by the court, the settlement will resolve and discharge all claims against the Company in the class action. As part of the settlement, the Company and the other settling defendants admitted no liability as to the claims against it and deny all allegations of wrongdoing. This settlement, once approved by the court, will resolve the most significant of the Company's remaining legacy legal matters and eliminate a material uncertainty regarding our Company. To finance the settlement of theU.S. Securities Litigation, onDecember 30, 2019 we accessed the credit markets and issued: (i)$1,250 million aggregate principal amount of 5.00% Senior Unsecured Notes dueJanuary 2028 (the "5.00%January 2028 Unsecured Notes") and (ii)$1,250 million aggregate principal amount of 5.25% Senior Unsecured Notes dueJanuary 2030 (the "January 2030 Unsecured Notes") in a private placement. The proceeds and cash on hand were used to: (i) redeem$1,240 million of 5.875% Senior Unsecured Notes due 2023 (the "May 2023 Unsecured Notes") onJanuary 16, 2020 , (ii) finance amounts owed under the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation (which is subject to final court approval), of which we paid$200 million duringJanuary 2020 and (iii) pay all fees and expenses associated with these transactions (collectively, the "December 2019 Financing and Refinancing Transactions"). OnDecember 18, 2019 , the Company issued a conditional notice of redemption for$1,240 million ofMay 2023 Unsecured Notes onJanuary 16, 2020 . OnDecember 30, 2019 , the Company received the proceeds associated with theDecember 2019 Financing and Refinancing Transactions, satisfying the condition included in the conditional notice of redemption. Through this financing, we have in effect 50 -------------------------------------------------------------------------------- extended the payment terms of the pending settlement of$1,210 million out to 2028 and 2030, without negatively impacting our working capital available for operations. Debt Repayments - Excluding the impact of the$1,210 million financing of theU.S. Securities Litigation settlement discussed above, we have been able to repay (net of additional borrowings) over$7,700 million of long-term debt during the periodJanuary 1, 2016 through the date of this filing using the net cash proceeds from divestitures of non-core assets, cash generated from operations and cash generated from tighter working capital management. This includes$906 million of repayments with cash on hand during 2019. 2017 Refinancing Transactions - In March, October, November and December of 2017, we accessed the credit markets and completed a series of transactions, whereby we extended approximately$9,500 million in aggregate maturities of certain debt obligations due to mature inApril 2018 throughApril 2022 , out toMarch 2022 throughDecember 2025 . As part of these transactions we also extended commitments under our revolving credit facility, originally set to expire inApril 2018 , out toApril 2020 . 2018 Refinancing Transactions - In March, June andNovember 2018 , we accessed the credit markets and completed a series of transactions, whereby we extended approximately$8,300 million in aggregate maturities of certain debt obligations due to mature inMarch 2020 throughJuly 2022 , out toJune 2025 throughJanuary 2027 . As part of these transactions we obtained less stringent loan financial maintenance covenants under our Senior Secured Credit Facilities and extended commitments under our revolving credit facility by more than three years by replacing our then-existing revolving credit facility, set to expire inApril 2020 with a revolving credit facility of$1,225 million due inJune 2023 (the "2023 Revolving Credit Facility"). 2019 Refinancing Transactions - In March, May andDecember 2019 , we accessed the credit markets and completed a series of transactions, whereby, through the date of this filing, we extended$4,240 million in aggregate maturities of certain debt obligations due to mature inDecember 2021 throughMay 2023 , out toJanuary 2027 throughJanuary 2030 . See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements for the details of our debt portfolio as ofDecember 31, 2019 and 2018. The debt repayments and refinancings outlined above have allowed us to: (i) improve our credit ratings as discussed under "Management's Discussion and Analysis - Liquidity and Capital Resources: Long-term Debt", (ii) to finance amounts owed under the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation without negatively impacting our working capital available for operations and (iii) as of the date of this filing, reduce our mandatory scheduled principal repayments of our debt obligations in 2020 and 2021 to$0 and$103 million , respectively. Our prepayment and refinancings of debt over the last four years translate into lower repayments of principal over the next four years, which, in turn, we believe will permit more cash flows to be directed toward developing our core assets, identifying new product opportunities and repaying additional debt amounts. The mandatory scheduled principal repayments of our debt obligations as ofDecember 31, 2019 andFebruary 19, 2020 , the date of this filing, were as follows: (in millions) 2020 - 2021 2022 - 2023 2024 - 2025
2026 - 2027 2028 - 2029 2030 Total
As of
103 4,148 12,935 3,750 2,762 1,250 24,948 In addition, as a result of the changes in our debt portfolio, approximately 80% of our debt is fixed rate debt as ofDecember 31, 2019 , as compared to approximately 60% as ofJanuary 1, 2016 . The weighted average stated interest rate of the Company's outstanding debt as ofDecember 31, 2019 and 2018 was 6.21% and 6.23%, respectively. We continue to monitor our capital structure and to evaluate other opportunities to simplify our business and improve our capital structure, giving us the ability to better focus on our core businesses. While we anticipate focusing any future divestiture activities on non-core assets, consistent with our duties to our shareholders and other stakeholders, we will consider dispositions in core areas that we believe represent attractive opportunities for the Company. Also, the Company regularly evaluates market conditions, its liquidity profile and various financing alternatives for opportunities to enhance its capital structure. If the Company determines that conditions are favorable, the Company may refinance or repurchase existing debt or issue additional debt, equity or equity-linked securities. See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements for further details and "Management's Discussion and Analysis - Liquidity and Capital Resources: Long-term Debt" for additional discussion of these matters. Cash requirements for future debt repayments including interest can be found in "Management's Discussion and Analysis - Off-Balance Sheet Arrangements and Contractual Obligations." 51 -------------------------------------------------------------------------------- Improve Patient Access Improving patient access to our products, as well as making them more affordable, is at the forefront of our business strategies.Patient Access and Pricing Committee - In 2016, we formed thePatient Access and Pricing Committee which is responsible for setting, changing and monitoring the pricing of our products and evaluating contract arrangements that determine the placement of our products on drug formularies.The Patient Access and Pricing Committee considers new to market product pricing, price changes and their impact across channels on patient accessibility and affordability.The Patient Access and Pricing Committee has been committed to limiting the average annual price increase for our branded prescription pharmaceutical products to no greater than single digits and reaffirmed this commitment for 2020. These pricing changes and programs could affect the average realized pricing for our products and may have a significant impact on our company revenue and profit. Dermatology.com Cash-pay Prescription Program - InFebruary 2019 , we launched Dermatology.com, a cash-pay product acquisition program offering certain brandedOrtho Dermatologics products directly to patients. This program is designed to address the affordability and availability of certain branded dermatology products, when insurers and pharmacy benefit managers are no longer offering those branded prescription pharmaceutical products under their designated pharmacy benefit offerings. Through Dermatology.com, any patient with a valid prescription is able to purchase medicines at prices ranging from$50 to$115 per prescription. By doing so, the program provides branded products that offer proven treatment options for certain disease states that typically encounter insurance coverage challenges and high patient out of pocket costs. This program includes products for acne, actinic keratosis, superficial basal cell carcinoma, barrier repair (e.g. eczema treatments), wounds and corticosteroid-responsive diseases such as rashes, psoriasis and atopic dermatitis. All products included in the Dermatology.com program are eligible for Flexible Spending Accounts or Health Saving Accounts and continue to be supported by the Company'sPatient Assistance Program , which offers free medication for patients who meet income and other eligibility criteria. We currently have 15Ortho Dermatologics branded prescription pharmaceutical products in the Dermatology.com program and anticipate adding additional products in the future, including some investigational therapies that will be added to the program as soon as, and if, they are approved by the FDA. Walgreens Fulfillment Arrangements - In the beginning of 2016, we launched a brand fulfillment arrangement withWalgreen Co. ("Walgreens"). Under the terms of the brand fulfillment arrangement, as amended inJuly 2019 , we made certain dermatology and ophthalmology products available to eligible patients through patient access and co-pay assistance programs at WalgreensU.S. retail pharmacy locations, as well as participating independent retail pharmacies. Our products available under this fulfillment agreement include certainOrtho Dermatologics products, including our Jublia®, Luzu®, Retin-A Micro® Gel, and Onexton® and select branded prescription pharmaceutical products included in our Dermatology.com cash-pay prescription program and certain ophthalmology products, including our Vyzulta®, Besivance®, Lotemax®, Alrex®, Prolensa®, Bepreve® and Zylet® products. Invest in Sustainable Growth Drivers to Position us for Long-Term Growth We are constantly challenged by the changing dynamics of our industry to innovate and bring new products to market. We have divested certain businesses where we saw limited growth opportunities, so that we can be more aggressive in redirecting our R&D spend and other corporate investments to innovate within our core businesses where we believe we can be most profitable and where we aim to be an industry leader. We believe that we have a well-established product portfolio that is diversified within our core businesses and provides a sustainable revenue stream to fund our operations. However, our future success is also dependent upon our ability to continually refresh our pipeline, to provide a rotation of product launches that meet new and changing demands and replace other products that have lost momentum. We believe we have a robust pipeline that not only provides for the next generation of our existing products, but is also poised to bring new products to market. Invest in our Eye-Health Business - 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 to extend our market share through new launches and effective pricing. For instance, there is an 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 theU.S. are reaching the age of 65). To extend our market share in eye-health, we continually identify new products tailored to address these key trends which we develop internally with our own R&D team to generate organic growth. 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). 52 -------------------------------------------------------------------------------- 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. As previously discussed, we acquired exclusive licenses for the commercialization and development in theU.S. andCanada for Xipere™ which, if approved by the FDA, will be the first treatment for patients suffering from macular edema associated with uveitis, and for NOV03, an investigational drug with a novel mechanism of action to treat DED associated with MGD. We also acquired theU.S. rights to EM-100 an investigational eye drop that, if approved by the FDA, will be the first OTC preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. We believe investments in these investigational treatments, if approved by the FDA, will complement, and help build upon, our strong portfolio of integrated eye-health products. As previously discussed, we have also made strategic investments in our infrastructure, the most significant of which are at ourWaterford facility inIreland to meet the forecasted demand for our Biotrue® ONEday lenses and ourRochester facility inNew York to address the expected global demand for our Bausch + Lomb ULTRA® contact lens. During late 2018, we began investing in additional expansion projects at these facilities in order to address the expected global demand for ourSiHy Daily disposable contact lenses expected to be launched in theU.S. in the second half of 2020. We believe our recent product launches, licensing arrangements and the investments in ourWaterford andRochester facilities demonstrate the growth potential we see in our Bausch + Lomb products and our eye-health business and that these investments will position us to further extend our market share in the eye-health market. Leveraging our Salix Infrastructure - As we strongly believe in our GI product portfolio, we have taken initiatives to further capitalize on the value of the infrastructure we built around these products to extend our market share by increasing our marketing presence and identifying additional opportunities outside our existing GI portfolio. In the first quarter of 2017, we hired approximately 250 trained and experienced sales force representatives and managers to create, bolster and sustain deep relationships with primary care physicians ("PCP"). With approximately 70% of IBS-D patients initially presenting symptoms to a PCP, we continue to believe that the dedicated PCP sales force is better positioned to reach more patients in need of IBS-D treatment. This initiative provided us with positive results, as we experienced consistent growth in demand for our GI products throughout 2017 and 2018, which was evident by our growth in Salix revenues of 12% in 2018 when compared to 2017. These results encouraged us to seek out ways to bring out further value through leveraging our existing sales force and in the later portion of 2018 and in 2019 we have identified and executed on certain opportunities which we describe below. Strategic Acquisition - As previously discussed, inMarch 2019 , we completed the acquisition of certain assets of Synergy, whereby we acquired the worldwide rights to the Trulance® product, a once-daily tablet for adults with chronic idiopathic constipation, or CIC and irritable bowel syndrome with constipation, or IBS-C. We believe that the Trulance® product complements our existing Salix products and allows us to effectively leverage our existing GI sales force. As we focus on reestablishing momentum in the Trulance® product, we have reviewed certain strategies for the Salix business and as a result, we mutually agreed withUS WorldMeds, LLC andDova Pharmaceuticals to terminate our arrangements to co-promote Lucemyra® and Doptelet® effectiveSeptember 30, 2019 andDecember 31, 2019 , respectively. Licensing Arrangements - As previously discussed, inApril 2019 , we entered into two licensing agreements. The first is for certain intellectual property relating to an investigational compound targeting the pituitary adenylate cyclase receptor 1 in NAFLD, NASH and other GI and liver diseases. The second is to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate receptor that plays a role in autoimmune diseases, such as inflammatory bowel disease and ulcerative colitis. These licenses present unique developmental opportunities to address unmet needs of individuals suffering with certain GI and liver diseases and if developed and approved by the FDA, will allow us to further utilize our existing sales force and infrastructure to extend our market share in the future and create value. Investment in Next Generation Formulations - We continue to see growth in our Xifaxan® product. Revenues from our Xifaxan® product increased approximately 22%, 22% and 11% in 2019, 2018 and 2017, respectively. In order to extend growth in Xifaxan®, we continue to directly invest in next generation formulations of Xifaxan® and rifaximin, the principal semi-synthetic antibiotic used in our Xifaxan® product. In addition to one R&D program in progress, we have three other R&D programs planned to start in 2020 for next generation formulations of Xifaxan® (rifaximin) which address new indications. We believe that the acquisition and licensing opportunities discussed above, will be accretive to our business by providing us access to products and investigational compounds that are a natural pairing to our Xifaxan® business, allowing us to effectively leverage our existing infrastructure and sales force. We believe these opportunities, coupled with our investment in next generation formulations, will allow our GI franchise to continue to further extend market share. 53 -------------------------------------------------------------------------------- Position the Ortho Dermatologics Business for Growth - In support of ourOrtho Dermatologics business and the opportunities we see for growth in this business, we continue to allocate resources and make additional investments in this business to recruit and retain talent and focus on our core dermatology portfolio of products. To position theOrtho Dermatologics business for growth, we have taken and are taking a number of actions which we believe will help our efforts to stabilize our dermatology business. These actions include: (i) rebranding our dermatology business, (ii) recruiting a new experienced leadership team, (iii) making significant investment in our core dermatology portfolio, (iv) increasing and reorganizing our dermatology sales force around roughly 195 territories, as we work to rebuild relationships with prescribers of our products and (v) improving patient access to ourOrtho Dermatologics products through Dermatology.com, our cash-pay prescription program previously discussed. With these actions substantially complete, we believe ourOrtho Dermatologics business is positioned for growth in 2020. Recruit and Retain Talent - In 2017, we identified and retained a proven leadership team of experienced dermatology sales professionals and marketers. InJanuary 2018 , the leadership team, encouraged by the success of our GI sales force expansion program, increased ourOrtho Dermatologics sales force by more than 25% in support of our growth initiatives for ourOrtho Dermatologics business. We believe the additional sales force is vital to meet the demand we expect from our recently launched products and those we expect to launch in the near term, pending FDA approval. We continue to monitor our pipeline for other near term launches that we believe will create opportunity needs in our other core businesses requiring us to make additional investment to retain people for additional leadership and sales force roles. Investment in Our Core Dermatology Portfolio - We have made significant investments to build out our aesthetics, psoriasis and acne product portfolios, which are the markets within dermatology where we see the greatest opportunities to extend our market share. Aesthetics - In 2017, we launched our Next Generation Thermage FLX® product in theU.S. , 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 inHong Kong ,Japan ,Korea ,Taiwan ,Philippines ,Singapore ,Indonesia ,Malaysia ,China ,Thailand ,Vietnam , andAustralia 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® inAsia andEurope in the near term, paced by country-specific regulatory registrations. Psoriasis - As the number of reported cases of psoriasis in theU.S. has increased, we believe there is a need to make further investments in this market in order to maximize our opportunity and supplement our current psoriasis product portfolio. We have filed NDAs for several new topical psoriasis products, launched Duobrii® inJune 2019 and launched Bryhali® inNovember 2018 . We expect that Duobrii® and Bryhali® will align well with our existing topical portfolio of psoriasis treatments and, supplemented by our injectable biologic products, such as Siliq®, will provide a diverse choice of psoriasis treatments to doctors and patients. InJuly 2017 , we launched Siliq®, an IL-17 receptor blocker monoclonal antibody biologic for treatment of moderate-to-severe plaque psoriasis, which we estimate to be an over$5,000 million market in theU.S. (Siliq® has a Black Box Warning for the risks in patients with a history of suicidal thoughts or behavior and was approved with a Risk Evaluation and Mitigation Strategy involving a one-time enrollment for physicians and one-time informed consent for patients). As previously discussed, we entered into an exclusive license agreement with Kaken Pharmaceutical Co., Ltd. to develop and commercialize products containing a new chemical entity, IDP-131 (KP-470), for the topical treatment of psoriasis. An early proof of concept study was initiated in the first half of 2019. If approved by the FDA, IDP-131 could represent a novel drug with an alternative mechanism of action in the topical treatment of psoriasis. Acne - In support of our established acne product portfolio, we have developed several products, which include Retin-A Micro® 0.06% (launched inJanuary 2018 ) and Altreno® (launched in theU.S. October 2018 ), the first lotion (rather than a gel or cream) product containing tretinoin for the treatment of acne. We also anticipate launching ArazloTM (tazarotene) Lotion in the first half of 2020 and we have three other unique acne projects in earlier stages of development that, if approved by the FDA, we believe will further innovate and advance the treatment of acne. Bolstered by new product launches in our aesthetics, psoriasis and acne product lines and the potential of other products under development, our experienced dermatology sales leadership team, our sales force and our Dermatology.com cash-pay prescription program, we believe we have set the groundwork to position theOrtho Dermatologics business for growth. In early 2018, we identified seven of our products, which we called the "Significant Seven", that, at the time, we believed would be among the key drivers of our future growth and which we anticipated would have significant revenues in the future. In 2019, the reported revenue of the Significant Seven products was approximately$268 million , an increase of 68% as compared to 2018. Additionally, at the end of 2017, we stated that we believed that our Dermatology business,Ortho Dermatologics , had 54 -------------------------------------------------------------------------------- the potential to double its revenue within five years based on new product introductions including Siliq®, Duobrii®, Bryhali®, Altreno®, and Arazlo™. We expect our future company-wide revenue growth will be driven by a broader group of products that have existed or since emerged from within our product portfolio (e.g., Xifaxan®, Thermage®, Biotrue® ONEday, Aplenzin®, Bausch + Lomb Ultra®, Jublia®, enVista®), from our internal development pipeline and/or from business development efforts (e.g. Trulance®). As our portfolio evolves over time our promotional priorities shift based on where we see the greatest potential to drive profitable growth and to improve returns on invested capital. Our company-wide prospects today are different, more wide-ranging, and we believe that they continue to be as attractive as they were at the time we communicated our views for the "Significant Seven" and the near-term prospects forOrtho Dermatologics . While we continue to believe that the "Significant Seven" andOrtho Dermatologics will be important contributors to future growth, we are withdrawing our existing outlook with respect to the anticipated revenue for the Significant Seven group of products and the doubling in revenue of theOrtho Dermatologics business and, going forward, we do not expect to provide any specific qualitative or quantitative outlooks as to the revenue related to these groups. We plan to continue to provide the revenues for our top products, for both the total Company as well as for our reportable segments, in the earnings material prepared by the Company. Business Trends In addition to the actions previously outlined, the following events have affected and may affect our business trends:U.S. Health Care Reform TheU.S. federal and state governments continue to propose and pass legislation designed to regulate the health care industry. InMarch 2010 , the Patient Protection and Affordable Care Act (the "ACA") was enacted in theU.S. The ACA contains several provisions that impact our business, including: (i) an increase in the minimum Medicaid rebate to states participating in the Medicaid program, (ii) the extension of the Medicaid rebates to Managed Care Organizations that dispense drugs to Medicaid beneficiaries, (iii) the expansion of the 340(B)Public Health Services drug pricing program, which provides outpatient drugs at reduced rates, to include additional hospitals, clinics and health care centers and (iv) a fee payable to the federal government based on our prior-calendar-year share relative to other companies of branded prescription drug sales to specified government programs. In addition, in 2013 federal subsidies began to be phased in for brand-name prescription drugs filled in the Medicare Part D cover gap. The ACA also included provisions designed to increase the number of Americans covered by health insurance. In 2014, the ACA's private health insurance exchanges began to operate. The ACA also allows states to expand Medicaid coverage with most of the expansion's cost paid for by the federal government. For 2019, 2018 and 2017, we incurred costs of$20 million ,$36 million and$48 million , respectively, related to the annual fee assessed on prescription drug manufacturers and importers that sell branded prescription drugs to specifiedU.S. government programs (e.g., Medicare and Medicaid). For 2019, 2018 and 2017, we also incurred costs of$137 million ,$90 million and$106 million , respectively, on Medicare Part D utilization incurred by beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the "donut hole"). OnJuly 28, 2014 , theU.S. Internal Revenue Service issued final regulations related to the branded pharmaceutical drug annual fee pursuant to the ACA. Under the final regulations, an entity's obligation to pay the annual fee is triggered by qualifying sales in the current year, rather than the liability being triggered upon the first qualifying sale of the following year. We adopted this guidance in the third quarter of 2014, and it did not have a material impact on our financial position or results of operations. The financial impact of the ACA will be affected by certain additional developments over the next few years, including pending implementation guidance and certain health care reform proposals. 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. Also, it is possible, as discussed further below, that under the current administration, legislation will be passed byCongress repealing the ACA in whole or in part. Adoption of legislation at the federal or state level could materially affect demand for, or pricing of, our products. In 2018, we faced uncertainties due to federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA. However, we believe there is low likelihood of repeal of the ACA, given the recent failure of theSenate's multiple attempts to repeal various combinations of ACA provisions. There is no assurance that any replacement or administrative modifications of the ACA will not adversely affect our business and financial results, particularly if the replacing legislation reduces incentives for employer-sponsored insurance coverage, and we cannot predict how future federal or state legislative or administrative changes relating to the reform will affect our business. In 2019, theU.S. Health and Human Services Administration announced a preliminary plan to allow for the importation of certain lower-cost drugs fromCanada . The preliminary plan excludes insulin, biological drugs, controlled substances and intravenous drugs. The preliminary plan relies on individual states to develop proposals for safe importation of those drugs from 55 --------------------------------------------------------------------------------Canada and submit those proposals to the federal government for approval. Although the preliminary plan has some support from the current administration, at this time, studies to evaluate the related costs and benefits, evaluate the reasonableness of the logistics, and measure the public reaction of such a plan have not been performed. While we do not believe this will have a significant impact on our future cash flows, we cannot provide assurance as to the ultimate context, timing, effect or impact of such a plan. In 2019, theGovernment of Canada (Health Canada ) published in theCanadian Gazette the new pricing regulation for patented drugs. These regulations will become effective onJuly 1, 2020 . The draft application guidelines are available with the final guidelines to be published inFebruary 2020 . The new regulations will change the mechanics of establishing the pricing for products submitted for approval afterAugust 21, 2019 ; they will also require full transparency of discounts agreed with provincial bodies; and finally, will change the number and composition of reference countries used to determine if a drug's price is excessive. While we do not believe this will have a significant impact on our future cash flows, as additional facts materialize, we cannot provide assurance as to the ultimate content, timing, effect or impact of such regulations. Other legislative efforts relating to drug pricing have been proposed and considered at theU.S. federal and state level. We also anticipate thatCongress , 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 affecting additional fundamental changes in the health care delivery system.Generic Competition and Loss of Exclusivity Certain of our products face the expiration of their patent or regulatory exclusivity in 2020 or in later years, following which we anticipate generic competition of these products. In addition, in certain cases, as a result of negotiated settlements of some of our patent infringement proceedings against generic competitors, we have granted licenses to such generic companies, which will permit them to enter the market with their generic products prior to the expiration of our applicable patent or regulatory exclusivity. Finally, for certain of our products that lost patent or regulatory exclusivity in prior years, we anticipate that generic competitors may launch in 2020 or in later years. Following a loss of exclusivity ("LOE") of and/or generic competition for a product, we would anticipate that product sales for such product would decrease significantly shortly following the loss of exclusivity or entry of a generic competitor. Where we have the rights, we may elect to launch an authorized generic of such product (either ourselves or through a third party) prior to, upon or following generic entry, which may mitigate the anticipated decrease in product sales; however, even with launch of an authorized generic, the decline in product sales of such product would still be expected to be significant, and the effect on our future revenues could be material. A number of our products already face generic competition. Prior to and during 2019, in theU.S. , these products include, among others, Ammonul®, Apriso®, Benzaclin®, Bupap®, Cuprimine®, Edecrin®, Elidel®, Glumetza®, Istalol®, Isuprel®, Locoid® Lotion, Lotemax® Suspension, Mephyton®, Nitropress®, Solodyn®, Syprine®, Uceris® Tablet, Virazole®, Wellbutrin XL®, Xenazine®, Zegerid® and Zovirax® cream. InCanada , these products include, among others, Glumetza®, Wellbutrin® XL and Zovirax® ointment. 2019 LOE Branded Products - Branded products that began facing generic competition in theU.S. during 2019 include, Apriso®, Cuprimine®, Lotemax® Suspension, Solodyn® and Zovirax® cream. In aggregate, these products accounted for 3% of our total revenues in 2019. We believe the entrance into the market of generic competition generally would have an adverse impact on the volume and/or pricing of the affected products, however we are unable to predict the magnitude or timing of this impact. 2020 through 2024 LOE Branded Products - Based on current patent expiration dates, settlement agreements and/or competitive information, we have identified branded products that we believe could begin facing potential loss of exclusivity and/or generic competition in theU.S. during the years 2020 through 2024. These products and year of expected loss of exclusivity include, but are not limited to, Clindagel® (2020), Lotemax® Gel (2021), Migranal® (2021), MoviPrep® (2020), Noritate® (2020), Targretin® Gel (2022), Xerese® (2022) and certain other products that are subject to settlement agreements which could impact their exclusivity during the years 2020 through 2024. In aggregate, these products accounted for 3% of our total revenues in 2019. These dates may change based on, among other things, successful challenge to our patents, settlement of existing or future patent litigation and at-risk generic launches. We believe the entrance into the market of generic competition generally would have an adverse impact on the volume and/or pricing of the affected products, however we are unable to predict the magnitude or timing of this impact. 2021 LOE OTC Product - PreserVision® AREDS and PreserVision® AREDS 2 are OTC eye vitamin formulas for those with moderate-to-advanced age-related macular degeneration. PreserVision® products accounted for 2% of our total revenues in 2019. The PreserVision® patent expires in 2021, and whereas the Company cannot predict the magnitude or timing of the impact from its patent expiry, as this is an OTC product the impact is not expected to be as significant as the loss of exclusivity of a branded product. 56 -------------------------------------------------------------------------------- In addition, for a number of our products (including Uceris®, Relistor®, Plenvu®, Xifaxan® 200mg and 550mg and Jublia®, in theU.S. and Jublia® inCanada ), we have commenced (or anticipate commencing) and have ongoing infringement proceedings against potential generic competitors in theU.S. andCanada . If we are not successful in these proceedings, we may face increased generic competition for these products. Bryhali® Lotion, 0/01% - InDecember 2019 , the Company announced that it had reached an agreement to resolve the outstanding intellectual property litigation with Glenmark Pharmaceuticals, Ltd. ("Glenmark"). Under the terms of the agreement, the Company will grantGlenmark a non-exclusive license to its intellectual property relating to Bryhali® in theU.S. and, beginning in 2026 (or earlier under certain circumstances),Glenmark will have the option to market a royalty-free generic version of Bryhali® Lotion, should it receive approval from the FDA. The parties have agreed to dismiss all litigation related to Bryhali® Lotion, and all intellectual property protecting Bryhali® Lotion remains intact. Xifaxan® 550mg Patent Litigation (Sandoz Inc. ) - InOctober 2019 , the Company announced that it and its licensor, AlfaSigma had commenced litigation againstSandoz Inc. ("Sandoz"), a Novartis division, alleging patent infringement of 14 patents by Sandoz's filing of its ANDA for Xifaxan® (rifaximin) 550 mg tablets. Xifaxan® is protected by 23 patents covering the composition of matter and the use of Xifaxan® listed in theFDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Xifaxan® 550mg Patent Litigation (Norwich Pharmaceuticals Inc. ) - OnFebruary 17, 2020 , the Company and Alfasigma received a Notice of Paragraph IV Certification fromNorwich Pharmaceuticals Inc. ("Norwich"), in which Norwich asserted that certainU.S. patents, each of which is listed in theFDA's Orange Book forSalix Pharmaceuticals, Inc.'s ("Salix Inc. ") Xifaxan® tablets, 550 mg, are either invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of Norwich's generic rifaximin tablets, 550 mg, for which an ANDA has been filed by Norwich.Salix Inc. and its affiliates and Alfasigma (the "Plaintiffs") have forty-five (45) days from the date of receipt of notice to file suit against Norwich pursuant to the Hatch-Waxman Act, alleging infringement by Norwich of one or more claims of each of the Xifaxan® Patents, thereby triggering a 30-month stay of the approval of Norwich's ANDA for rifaximin tablets, 550 mg. The Plaintiffs intend to file suit per the regulations. The Company remains confident in the strength of the Xifaxan® patents and will continue to vigorously pursue this matter and defend its intellectual property. Relistor® Tablets Patent Litigation - OnDecember 6, 2016 , the Company initiated litigation againstActavis Laboratories FL, Inc.'s ("Actavis"), which alleged infringement by Actavis of one or more claims ofU.S. Patent No. 8,524,276 (the "276 Patent"), which protects the formulation of RELISTOR® tablets. Actavis had challenged the validity of such patent and alleged non-infringement by its generic version of such product. InJuly 2019 , we announced that theU.S. District Court of New Jersey had upheld the validity of and determined that Actavis infringed the '276 Patent, expiring inMarch 2031 . Xifaxan® 550mg Patent Litigation (Actavis)- OnMarch 23, 2016 , the Company initiated litigation against Actavis, which alleged infringement by Actavis of one or more claims of each of the Xifaxan® patents. OnSeptember 12, 2018 , we announced that we had reached an agreement with Actavis that resolved the existing litigation and eliminated the pending challenges to our intellectual property protecting Xifaxan® (rifaximin) 550 mg tablets. As part of the agreement, the parties agreed to dismiss all litigation related to Xifaxan® (rifaximin), Actavis acknowledged the validity of the licensed patents for Xifaxan® (rifaximin) 550 mg tablets and all intellectual property protecting Xifaxan® (rifaximin) 550 mg tablets will remain intact and enforceable until expiry in 2029. The agreement also grants Actavis a non-exclusive license to the intellectual property relating to Xifaxan® (rifaximin) 550 mg tablets inthe United States beginningJanuary 1, 2028 (or earlier under certain circumstances). The Company will not make any financial payments or other transfers of value as part of the agreement. In addition, under the terms of the agreement, beginningJanuary 1, 2028 (or earlier under certain circumstances), Actavis will have the option to: (1) market a royalty-free generic version of Xifaxan® tablets, 550 mg, should it receive approval from the FDA on its ANDA, or (2) market an authorized generic version of Xifaxan® tablets, 550 mg, in which case, we will receive a share of the economics from Actavis on its sales of such an authorized generic. Actavis will be able to commence such marketing earlier if another generic rifaximin product is granted approval and such other generic rifaximin product begins to be sold or distributed beforeJanuary 1, 2028 .Generic Competition to Uceris® - InJuly 2018 , a generic competitor launched a product which will directly compete with our Uceris® Tablet product. As disclosed in Note 21, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements, the Company initiated various infringement proceedings against this and other generic competitors. The Company continues to believe that its Uceris® Tablet-related patents are enforceable and is proceeding in the ongoing litigation between the Company and the generic competitor; however, the ultimate outcome of the matter is not predictable. The ultimate impact of this generic competitor on our future revenues cannot be predicted; however, Uceris® Tablet revenues for 2019, 2018 and 2017 were approximately$20 million ,$84 million and$134 million , respectively.Generic Competition to Jublia® - OnJune 6, 2018 , theU.S. Patent andTrial Appeal Board completed its inter partes review for an Orange Book-listed patent covering Jublia® and issued a written determination invalidating such patent. Although the Company is not aware of any imminent launches of a generic competitor to Jublia®, the ultimate impact of this decision on our 57 --------------------------------------------------------------------------------
future revenues cannot be predicted. Jublia® revenues for 2019, 2018 and 2017
were approximately
The
Company continues to believe that the Jublia® related patent is valid and enforceable and, onAugust 7, 2018 , an appeal of this decision was filed. The ultimate outcome of this matter is not predictable. Jublia® continues to be covered by eight remaining Orange Book-listed patents owned by the Company, which expire in the years 2028 through 2034. In August andSeptember 2018 , we received notices of the filing of a number of ANDAs with paragraph IV certification, and have timely filed patent infringement suits against these ANDA filers. See Note 21, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements for further details regarding certain infringement proceedings. The risks of generic competition are a fact of the health care industry and are not specific to our operations or product portfolio. These risks are not avoidable, but we believe they are manageable. To manage these risks, our leadership team continually evaluates the impact that generic competition may have on future profitability and operations. In addition to aggressively defending the Company's patents and other intellectual property, our leadership team makes operational and investment decisions regarding these products and businesses at risk, not the least of which are decisions regarding our pipeline. Our leadership team actively manages the Company's pipeline in order to identify what we believe are the proper projects to pursue. Innovative and realizable projects aligned with our core businesses that are expected to provide incremental and sustainable revenues and growth into the future. We believe that our current pipeline is strong enough to meet these objectives and provide future sources of revenues, in our core businesses, sufficient enough to sustain our growth and corporate health as other products in our established portfolio face generic competition and lose momentum. We believe that we have a well-established product portfolio that is diversified within our core businesses. We also believe that we have a robust pipeline that not only provides for the next generation of our existing products, but also brings new solutions into the market. See Item 1A "Risk Factors" of this Form 10-K for additional information on our competition risks. 58 -------------------------------------------------------------------------------- SELECTED FINANCIAL INFORMATION The following table provides selected financial information for each of the last three years: Years EndedDecember 31 , Change
(in millions, except per share data) 2019 2018 2017 2018 to 2019 2017 to 2018 Revenues
$ 8,601 $ 8,380 $ 8,724 $ 221$ (344 ) Operating (loss) income$ (203 ) $ (2,384 ) $ 102 $ 2,181 $ (2,486 ) Loss before benefit from income taxes$ (1,837 ) $ (4,154 ) $ (1,741 ) $ 2,317 $ (2,413 ) Net (loss) income$ (1,783 ) $ (4,144 ) $ 2,404 $ 2,361 $ (6,548 ) Net (loss) income attributable to Bausch Health Companies Inc.$ (1,788 ) $ (4,148 ) $ 2,404 $ 2,360 $ (6,552 ) (Loss) earnings per share attributable toBausch Health Companies Inc. Basic$ (5.08 ) $ (11.81 ) $ 6.86 $ 6.73 $ (18.67 ) Diluted$ (5.08 ) $ (11.81 ) $ 6.83 $ 6.73 $ (18.64 ) Financial Performance Summary of 2019 Compared with 2018 Revenues for 2019 and 2018 were$8,601 million and$8,380 million , respectively, an increase of$221 million , or 3%. The increase was primarily driven by: (i) higher gross selling prices, (ii) higher volumes and (iii) sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy. These increases in Revenues were partially offset by: (i) the unfavorable effect of foreign currencies, primarily inEurope ,Asia andLatin America , (ii) the impact of divestitures and discontinuations and (iii) higher sales deductions. The changes in our segment revenues and segment profits are discussed in further detail in the subsequent section titled "Reportable Segment Revenues and Profits". Operating loss for 2019 and 2018 was$203 million and$2,384 million , respectively, an increase in our operating results of$2,181 million which reflects, among other factors: • an increase in contribution (product sales revenue less cost of goods
sold, exclusive of amortization and impairments of intangible assets) of
selling prices, (ii) higher volumes, (iii) the incremental contribution of
the sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy and
(iv) better inventory management, partially offset by: (i) the unfavorable
effect of foreign currencies, (ii) the impact of divestitures and
discontinuations, (iii) higher sales deductions and (iv) the amortization
of the inventory fair value step-up recorded in acquisition accounting
related to the inventories we acquired as part of the acquisition of certain assets of Synergy;
• an increase in Selling, general, and administrative expenses ("SG&A") of
and promotion expenses, (ii) the impact of the acquisition of certain
assets of Synergy, (iii) costs in 2019 attributable to our IT
infrastructure improvement projects and (iv) the charge associated with
the termination of a co-promotional agreement with
increase was partially offset by: (i) the favorable effect of foreign
currencies, (ii) lower costs related to professional services and (iii)
the impact of divestitures and discontinuations;
• an increase in R&D of
projects within our Bausch + Lomb and GI businesses;
• a decrease in Amortization of intangible assets of
due to: (i) the impact of the change in the estimated useful life of the
Xifaxan® related intangible assets made in
management's changes in assumptions, (ii) fully amortized intangible
assets no longer being amortized in 2019 and (iii) lower amortization as a
result of impairments to intangible assets in prior periods; • a decrease inGoodwill impairments of$2,322 million , as a result of impairments in 2018 to the goodwill of our: (i) Salix reporting unit upon
adopting the new guidance for goodwill impairment accounting at
2018, (ii)
business dynamics during the three months ended
Dentistry reporting unit as a result of revised forecasts due to changing
market conditions during the three months endedDecember 31, 2018 ; 59
--------------------------------------------------------------------------------
• a decrease in Asset impairments of
specific impairments in 2018 as a result of: (i) decreases in forecasted
sales for the Uceris® Tablet product due to generic competition and (ii)
decreases in forecasted sales for the Arestin® product due to changing
market conditions;
• an increase in Other expense (income), net of
attributable to: (i) an increase in net charges to Litigation and other
matters primarily related to the settlement of a legacy
class action matter (which is subject to final court approval) in 2019, to
which the Company and the other settling defendants admitted no liability
as to the claims against it and deny all allegations of wrongdoing and
(ii) Acquired in-process research and development costs ("IPR&D") incurred
during 2019 associated with the upfront payments to enter into certain
exclusive licensing agreements. These increases in other expenses were partially offset by the expected receipt for the achievement of a milestone related to a certain product. Operating loss for 2019 and 2018 was$203 million and$2,384 million , respectively, and includes non-cash charges for Depreciation and amortization of intangible assets of$2,075 million and$2,819 million ,Goodwill impairments of$0 and$2,322 million , Asset impairments of$75 million and$568 million and Share-based compensation of$102 million and$87 million , respectively. Our Loss before benefit from income taxes for 2019 and 2018 was$1,837 million and$4,154 million , respectively, an increase in our results before benefit from income taxes of$2,317 million . The decrease in our Loss before benefit from income taxes is primarily attributable to: (i) the increase in our operating results of$2,181 million previously discussed, (ii) the decrease in the Loss on extinguishment of debt of$77 million and (iii) a decrease in Interest expense of$73 million as a result of lower principal amounts of outstanding debt for most of 2019, partially offset by the effect of higher interest rates during 2019. The decrease in our Loss before benefit from income taxes was partially offset by an unfavorable net change in Foreign exchange and other of$15 million . Net loss attributable toBausch Health Companies Inc. for 2019 and 2018 was$1,788 million and$4,148 million , respectively, an increase in our results of$2,360 million . The increase in our results was primarily due to the decrease in Loss before benefit from income taxes of$2,317 million , as previously discussed, and the increase in the Benefit from income taxes of$44 million . Summary of 2018 Compared with 2017 Revenues for 2018 and 2017 were$8,380 million and$8,724 million , respectively, a decrease of$344 million , or 4%. The decrease was primarily driven by: (i) the impact of 2017 divestitures and discontinuations and (ii) lower volumes primarily as a result of the loss of exclusivity for a number of products in our Diversified Products andOrtho Dermatologics segments which were partially offset by higher volumes in our Bausch + Lomb/International segment. These decreases in Revenue were partially offset by: (i) higher gross selling prices, (ii) lower sales deductions and (iii) the favorable effect of foreign currencies, primarily inEurope andAsia . Operating loss for 2018 was$2,384 million , as compared to operating income for 2017 of$102 million , a decrease of$2,486 million . Our operating loss for 2018 compared to our operating income for 2017 reflects, among other factors: • a decrease in contribution (product sales revenue less cost of goods sold,
exclusive of amortization and impairments of intangible assets) of
million. The decrease was primarily driven by the impact of 2017
divestitures and discontinuations, partially offset by: (i) higher gross
selling prices, (ii) lower sales deductions, (iii) lower third-party royalty costs and (iv) the favorable effect of foreign currencies; • a decrease in SG&A of$109 million , primarily attributable to: (i) the
impact of 2017 divestitures and discontinuations, (ii) a decrease in legal
expenses as we resolved certain legacy legal issues and (iii) a decrease
in bad debt expense. The decrease was partially offset by: (i) higher
advertising and promotion expenses, (ii) higher compensation costs and (iii) the unfavorable impact of the effect of foreign currencies;
• an increase in R&D of
• a decrease in Amortization of intangible assets of
attributable to: (i) the impact of the change in the estimated useful life
of the Xifaxan®-related intangible assets made in
reflect management's changes in assumptions, (ii) lower amortization as a
result of impairments to intangible assets and divestitures and (iii)
discontinuances of product lines during 2017 as the Company focuses on its
core assets. These decreases were partially offset by the impact of
changes in estimates made in 2017 to reduce the remaining useful lives of
certain products and the Salix brand name to reflect management's changes
in assumptions; • an increase inGoodwill impairments of$2,010 million . In 2018, we
recognized
impairment to the goodwill of our Salix reporting unit recognized upon
adopting new accounting guidance at
the goodwill of the
60 -------------------------------------------------------------------------------- changes in business dynamics and (iii) impairment to the goodwill of the Dentistry reporting unit as a result of revised forecasts due to changing market conditions during the three months endedDecember 31, 2018 . In 2017, we recognizedGoodwill impairments of$312 million in connection with a change in reporting unit during the three months endedSeptember 30, 2017 ; • a decrease in Asset impairments of$146 million , as a result of Asset
impairments of
Sprout and Obagi businesses being classified as held for sale, compared to
Asset impairments of$568 million , in 2018, that were primarily due to decreases in forecasted sales for the Uceris® Tablet product and other product lines due to generic competition; • an increase in Acquisition-related contingent consideration of$280
million as a result of a fair value adjustments in 2017 which reflected a
decrease in forecasted sales for specific products, including Addyi®;
• a decrease in the net charges to Litigation and other matters of$253 million . Litigation and other matters are included in Other expense
(income), net, and are primarily associated with estimated settlements of
certain legacy matters; and • a decrease in net gains on sales of businesses and other assets of$586 million . In order to improve our capital structure and simplify our operations, during 2017, we divested certain businesses and assets not aligned with our core business objectives. Included in Other expense
(income), net is the net loss on sales of businesses and other assets of
other assets
Operating loss for 2018 of$2,384 million and Operating income for 2017 of$102 million includes non-cash charges for Depreciation and amortization of intangible assets of$2,819 million and$2,858 million ,Goodwill impairments of$2,322 million and$312 million , Asset impairments of$568 million and$714 million and Share-based compensation of$87 million and$87 million , respectively. Our Loss before benefit from income taxes for 2018 and 2017 was$4,154 million and$1,741 million , respectively, an increase of$2,413 million . The increase in our Loss before benefit from income taxes is primarily attributable to: (i) the decrease in our operating results of$2,486 million , as previously discussed and (ii) an unfavorable net change in Foreign exchange and other of$84 million . These changes in Loss before benefit from income taxes were partially offset by: (i) a decrease in Interest expense of$155 million as a result of lower principal amounts of outstanding debt, partially offset by the effect of higher interest rates during 2018 and (ii) the decrease in the Loss on extinguishment of debt of$3 million . Net loss attributable toBausch Health Companies Inc. for 2018 was$4,148 million as compared to Net income attributable toBausch Health Companies Inc. for 2017 of$2,404 million , a decrease of$6,552 million . The decrease in our results was primarily due to: (i) the decrease in the Benefit from income taxes of$4,135 million which in 2017 included non-cash income tax benefits related to the Company's internal corporate restructuring and the accounting for the Tax Cuts and Jobs Act (the "Tax Act") and (ii) the increase in Loss before benefit from income taxes of$2,413 million previously described. 61 -------------------------------------------------------------------------------- RESULTS OF OPERATIONS Our results for the years 2019, 2018 and 2017 were as follows: Years Ended December 31, Change (in millions) 2019 2018 2017 2018 to 2019 2017 to 2018 Revenues Product sales$ 8,489 $ 8,271 $ 8,595 $ 218 $ (324 ) Other revenues 112 109 129 3 (20 ) 8,601 8,380 8,724 221 (344 ) Expenses Cost of goods sold (excluding amortization and impairments of intangible assets) 2,297 2,309 2,506 (12 ) (197 ) Cost of other revenues 53 42 42 11 - Selling, general and administrative 2,554 2,473 2,582 81 (109 ) Research and development 471 413 361 58 52 Amortization of intangible assets 1,897 2,644 2,690 (747 ) (46 ) Goodwill impairments - 2,322 312 (2,322 ) 2,010 Asset impairments 75 568 714 (493 ) (146 ) Restructuring and integration costs 31 22 52 9 (30 ) Acquisition-related contingent consideration 12 (9 ) (289 ) 21 280 Other expense (income), net 1,414 (20 ) (348 ) 1,434 328 8,804 10,764 8,622 (1,960 ) 2,142 Operating (loss) income (203 ) (2,384 ) 102 2,181 (2,486 ) Interest income 12 11 12 1 (1 ) Interest expense (1,612 ) (1,685 ) (1,840 ) 73 155 Loss on extinguishment of debt (42 ) (119 ) (122 ) 77 3 Foreign exchange and other 8 23 107 (15 ) (84 ) Loss before benefit from income taxes (1,837 ) (4,154 ) (1,741 ) 2,317 (2,413 ) Benefit from income taxes 54 10 4,145 44 (4,135 ) Net (loss) income (1,783 ) (4,144 ) 2,404 2,361 (6,548 ) Net income attributable to noncontrolling interest (5 ) (4 ) - (1 ) (4 ) Net (loss) income attributable to Bausch Health Companies Inc.$ (1,788 ) $ (4,148 ) $
2,404
A detailed discussion of the year-over-year changes of the Company's 2018 results compared with that of 2017 can be found under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year endedDecember 31, 2018 filed onFebruary 20, 2019 . 62 -------------------------------------------------------------------------------- 2019 Compared with 2018 Revenues Our revenues are primarily generated from product sales, primarily in the therapeutic areas of eye-health, GI and dermatology that consist of: (i) branded pharmaceuticals, (ii) generic and branded generic pharmaceuticals, (iii) OTC products and (iv) medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetics devices). Other revenues include alliance and service revenue from the licensing and co-promotion of products and contract service revenue primarily in the areas of dermatology and topical medication. Contract service revenue is derived primarily from contract manufacturing for third parties and is not material. See Note 23, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements for the disaggregation of revenue which depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by the economic factors of each category of customer contracts. Our revenue was$8,601 million and$8,380 million for 2019 and 2018, respectively, an increase of$221 million , or 3%. The increase was primarily driven by: (i) higher gross selling prices of$213 million primarily in our Salix and Bausch + Lomb/International segments, (ii) higher volumes of$130 million primarily in our Bausch + Lomb/International and Salix segments, partially offset by lower volumes in ourOrtho Dermatologics and Diversified Products segments, (iii) the incremental product sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy, of$55 million and (iv) an increase in other revenues of$3 million . The increases in our revenues were partially offset by: (i) the unfavorable effect of foreign currencies, primarily inEurope ,Asia andLatin America , of$112 million , (ii) the impact of divestitures and discontinuations of$54 million and (iii) higher sales deductions of$14 million primarily in our Diversified Products segment. Our segment revenues and segment profits are discussed in detail in the subsequent section titled "Reportable Segment Revenues and Profits". Cash Discounts and Allowances, Chargebacks and Distribution Fees As is customary in the pharmaceutical industry, gross product sales are subject to a variety of deductions in arriving at net product sales. Provisions for these deductions are recognized concurrently with the recognition of gross product sales. These provisions include cash discounts and allowances, chargebacks, and distribution fees, which are paid or credited to direct customers, as well as rebates and returns, which can be paid or credited to direct and indirect customers. Price appreciation credits are generated when we increase a product's wholesaler acquisition cost ("WAC") under our contracts with certain wholesalers. Under such contracts, we are entitled to credits from such wholesalers for the impact of that WAC increase on inventory on hand at the wholesalers. In wholesaler contracts such credits are offset against the total distribution service fees we pay on all of our products to each such wholesaler. In addition, some payor contracts require discounting if a price increase or series of price increases in a contract period exceeds a negotiated threshold. Provision balances relating to amounts payable to direct customers are netted against trade receivables and balances relating to indirect customers are included in accrued liabilities. We actively manage these offerings, focusing on the incremental costs of our patient assistance programs, the level of discounting to non-retail accounts and identifying opportunities to minimize product returns. We also concentrate on managing our relationships with our payors and wholesalers, reviewing the ranges of our offerings and being disciplined as to the amount and type of incentives we negotiate. Provisions recorded to reduce gross product sales to net product sales and revenues for 2019 and 2018 were as follows: Years Ended December 31, 2019 2018 (in millions) Amount Pct. Amount Pct. Gross product sales$ 13,776 100.0 %$ 14,158 100.0 % Provisions to reduce gross product sales to net product sales Discounts and allowances 776 5.6 % 865 6.1 % Returns 113 0.8 % 293 2.1 % Rebates 2,265 16.4 % 2,551 18.0 % Chargebacks 1,938 14.1 % 1,966 13.9 % Distribution service fees 195 1.5 % 212 1.5 % 5,287 38.4 % 5,887 41.6 % Net product sales$ 8,489 61.6 %$ 8,271 58.4 % 63
-------------------------------------------------------------------------------- Cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were 38.4% and 41.6% in 2019 and 2018, respectively. Changes in cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were primarily driven by: • discounts and allowances as a percentage of gross product sales was lower
primarily due to lower gross product sales of higher discounted generics,
such as Glumetza® authorized generic ("AG"), Xenazine® AG, Targretin® AG
and Benzamycin® AG. The lower discounts and allowances as a percentage of
gross product sales was partially offset by the impact of: (i) the
release of certain generics such as Elidel® AG (
AG (
Xifaxan®;
• returns as a percentage of gross product sales was lower primarily due
to: (i) better inventory practices and disciplines and (ii) lower gross product sales of Isuprel® and Mephyton® as a result of generic competition. Additionally, over the last several years the Company
increased its focus on maximizing operational efficiencies and reducing
product returns. The Company continually takes actions to address product
returns including but not limited to: (i) monitoring and reducing
customer inventory levels, (ii) instituting disciplined pricing policies
and (iii) improving contracting. These actions resulted in improved sales
return experience related to current branded products and previously
genericized products. As a result, for the year 2019 as compared to 2018, the provision for sales returns improved by a net of$180 million . During the three months endedSeptember 30, 2019 and 2018 we recorded a
reduction in variable consideration for sales returns of approximately
$80 million and$30 million , respectively, related to past sales. The Company's actual return rate experience in the current period was lower
than its historical rate experience primarily in its: (i) GI business
primarily related to Glumetza® SLX and Xifaxan®, (ii) neurology business,
primarily related to Wellbutrin® and Nitropress® and (iii) generics
business, primarily related to Zegerid® AG and Glumetza® AG. The lower returns as a percentage of gross product sales was partially offset by
the impact of higher return experience for a limited number of products,
primarily Mysoline® and Solodyn® AG. See Note 2, "SIGNIFICANT ACCOUNTING
POLICIES" to our audited Consolidated Financial Statements regarding
further details related to product sales provisions;
• rebates as a percentage of gross product sales were lower primarily due
to decreases in gross product sales of certain products which carry
higher rebate rates, such as Solodyn®, Elidel®, Jublia® and Retin-A
Micro® 0.06%. The decreases in gross product sales for these products
were due in part to generic competition and the release of certain
branded generics. The lower rebates as a percentage of gross product
sales were partially offset by the impact of: (i) increased gross product
sales of products that carry higher contractual rebates and co-pay assistance programs, including the impact of incremental rebates from contractual price increase limitations for promoted products, such as
Xifaxan® and Apriso®, (ii) sales of our Trulance® product, which we added
to our portfolio in
assets of Synergy and (iii) rebates associated with our Duobrii® product
which we launched in
• chargebacks as a percentage of gross product sales were higher primarily
due to the impact of: (i) higher gross product sales of Xifaxan®,
Glumetza® SLX and Syprine® AG, (ii) higher chargeback rates in 2019 as
compared to 2018 for certain products such as Glumetza® AG and (iii) the
release of certain authorized generics, such as Elidel® AG (December
2018) and Uceris® AG (
of gross product sales were partially offset by the impact of lower gross
product sales of certain generic products, such as Zegerid® AG and
Xenazine® AG and certain branded products, such as Isuprel® and Nifediac;
and • distribution service fees as a percentage of gross product sales were unchanged as the impact of lower gross product sales of Solodyn®, Elidel®, Targretin® and Cuprimine® were offset by the impact of: (i) higher sales of Xifaxan® and Apriso® and other branded products, (ii) sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy and (iii)
distribution service fees associated with our Duobrii® product launched
in
distribution service fees we pay wholesalers and were
million for 2019 and 2018, respectively.
Operating Expenses Cost of Goods Sold (exclusive of amortization and impairments of intangible assets) Cost of goods sold primarily includes: manufacturing and packaging; the cost of products we purchase from third parties; royalty payments we make to third parties; depreciation of manufacturing facilities and equipment; and lower of cost or market adjustments to inventories. Cost of goods sold excludes the amortization and impairments of intangible assets. Cost of goods sold was$2,297 million and$2,309 million for 2019 and 2018, respectively, a decrease of$12 million , or 1%. The decrease was primarily driven by: (i) the favorable impact of divestitures and discontinuations, (ii) better inventory management and (iii) the favorable impact of foreign currencies, partially offset by: (i) the net increase in volumes, (ii) the incremental costs of sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of 64 -------------------------------------------------------------------------------- certain assets of Synergy and (iii) the amortization of the inventory fair value step-up recorded in acquisition accounting related to the inventories we acquired as part of the acquisition of certain assets of Synergy. Cost of goods sold as a percentage of Product sales revenue was 27.1% and 27.9% for 2019 and 2018, respectively, a decrease of 0.8 percentage points. Costs of goods sold as a percentage of Product sales revenue was favorably impacted as a result of: (i) higher gross selling prices, (ii) better inventory management and (iii) the impact of divestitures and discontinuations, which generally had lower gross margins than the balance of our product portfolio. These factors were partially offset by: (i) product mix within ourOrtho Dermatologics and Neurology and Other business units, (ii) the incremental costs of sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy and (iii) the amortization of acquisition accounting adjustments related to the inventories we acquired as part of the acquisition of certain assets of Synergy. Our segment revenues and segment profits are discussed in detail in the subsequent section titled "Reportable Segment Revenues and Profits". Selling, General and Administrative Expenses SG&A expenses primarily include: employee compensation associated with sales and marketing, finance, legal, information technology, human resources and other administrative functions; certain outside legal fees and consultancy costs; product promotion expenses; overhead and occupancy costs; depreciation of corporate facilities and equipment; and other general and administrative costs. SG&A was$2,554 million and$2,473 million for 2019 and 2018, respectively, an increase of$81 million , or 3%. The increase was primarily driven by: (i) higher selling, advertising and promotion expenses, (ii) the impact of the acquisition of certain assets of Synergy, (iii) costs in 2019 attributable to our IT infrastructure improvement projects and (iv) the charge associated with the termination of a co-promotional agreement withUS WorldMeds, LLC . The increase was partially offset by: (i) the favorable impact of foreign currencies, (ii) lower costs related to professional services and (iii) the impact of divestitures and discontinuations; Research and Development Expenses Included in Research and development are costs related to our product development and quality assurance programs. Expenses related to product development include: employee compensation costs; overhead and occupancy costs; depreciation of research and development facilities and equipment; clinical trial costs; clinical manufacturing and scale-up costs; and other third-party development costs. Quality assurance are the costs incurred to meet evolving customer and regulatory standards and include: employee compensation costs; overhead and occupancy costs; amortization of software; and other third-party costs. R&D expenses were$471 million and$413 million for 2019 and 2018, respectively, an increase of$58 million , or 14%, primarily attributable to a number of projects within our Bausch + Lomb and GI businesses. Amortization of Intangible Assets Intangible assets with finite lives are amortized using the straight-line method over their estimated useful lives, generally 2 to 20 years. Amortization of intangible assets was$1,897 million and$2,644 million for 2019 and 2018, respectively, a decrease of$747 million , or 28%. The decrease was primarily due to: (i) the impact of$420 million related to the change in the estimated useful life of the Xifaxan® related intangible assets made inSeptember 2018 to reflect management's changes in assumptions, (ii) fully amortized intangible assets no longer being amortized in 2019 and (iii) lower amortization as a result of impairments to intangible assets. Management continually assesses the useful lives related to the Company's long-lived assets to reflect the most current assumptions. See Note 9, "INTANGIBLE ASSETS AND GOODWILL" to our audited Consolidated Financial Statements for further details related to our intangible assets and the change in the estimated useful life of the Xifaxan® related intangible assets. Goodwill ImpairmentsGoodwill is not amortized but is tested for impairment at least annually at the reporting unit level. A reporting unit is the same as, or one level below, an operating segment. The fair value of a reporting unit refers to the price that would be received to sell the unit as a whole in an orderly transaction between market participants. The Company estimates the fair values of all reporting units using a discounted cash flow model which utilizes Level 3 unobservable inputs.Goodwill impairments were$0 and$2,322 million for 2019 and 2018, respectively. 2019 Annual Goodwill Impairment Test 65 -------------------------------------------------------------------------------- The Company conducted its annual goodwill impairment test as ofOctober 1, 2019 by first assessing qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Where the qualitative assessment suggested that it was more likely than not that the fair value of a reporting unit was less than its carrying amount, a quantitative fair value test was performed for that reporting unit. In each quantitative fair value test performed, the fair value was greater than the carrying value of the reporting unit. As a result, there was no impairment to the goodwill of any reporting unit. If market conditions deteriorate, or if the Company is unable to execute its strategies, it may be necessary to record impairment charges in the future. Specifically, the Company continues to assess the performance of theOrtho Dermatologics reporting unit and the Neuro and Other reporting unit as compared to their respective projections and will perform qualitative interim assessments of the carrying value and fair value on a quarterly basis to determine if impairment testing of goodwill will be warranted. The Company performed quantitative fair value tests for theOrtho Dermatologics reporting unit and the Neuro and Other reporting unit as ofOctober 1, 2019 , utilizing long-term growth rates of 2.0% and 1.5%, and discount rates of 9.8% and 9.0%, respectively, in estimation of the fair value of these reporting units. March 31, 2018 InJanuary 2017 , theFinancial Accounting Standards Board issued guidance which simplifies the subsequent measurement of goodwill by eliminating "Step 2" from the goodwill impairment test. Instead, goodwill impairment is measured as the amount by which a reporting unit's carrying value exceeds its fair value. The Company elected to adopt this guidance effectiveJanuary 1, 2018 . Upon adopting the new guidance, the Company tested goodwill for impairment and determined that the carrying value of the Salix reporting unit exceeded its fair value. As a result of the adoption of new accounting guidance, the Company recognized a goodwill impairment of$1,970 million associated with the Salix reporting unit. As ofOctober 1, 2017 , the date of the 2017 annual goodwill impairment test, the fair value of theOrtho Dermatologics reporting unit exceeded its carrying value. However, atJanuary 1, 2018 , unforeseen changes in the business dynamics of theOrtho Dermatologics reporting unit, such as: (i) changes in the dermatology sector, (ii) increased pricing pressures from third-party payors, (iii) additional risks to the exclusivity of certain products and (iv) an expected longer launch cycle for a new product, were factors that negatively impacted the reporting unit's operating results beyond management's expectations as ofOctober 1, 2017 , when the Company performed its 2017 annual goodwill impairment test. In response to these adverse business indicators, as ofJanuary 1, 2018 , the Company reduced its near and long term financial projections for theOrtho Dermatologics reporting unit. As a result of the reductions in the near and long term financial projections, the carrying value of theOrtho Dermatologics reporting unit exceeded its fair value atJanuary 1, 2018 and the Company recognized a goodwill impairment of$243 million . 2018 Annual Goodwill Impairment Test The Company conducted its annual goodwill impairment test as ofOctober 1, 2018 and determined that the carrying value of the Dentistry reporting unit exceeded its fair value and, as a result, the Company recognized a goodwill impairment of$109 million for the Dentistry reporting unit, representing the full amount of goodwill for the reporting unit. Changing market conditions such as: (i) an increasing competitive environment and (ii) increasing pricing pressures negatively impacted the reporting unit's operating results. The Company continues to monitor these changing market and business conditions. See Note 9, "INTANGIBLE ASSETS AND GOODWILL" to our audited Consolidated Financial Statements for further details related to our goodwill impairment analysis. Asset Impairments Long-lived assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Company continues to monitor the recoverability of its finite-lived intangible assets and tests the intangible assets for impairment if indicators of impairment are present. Asset impairments were$75 million and$568 million for 2019 and 2018, respectively, a decrease of$493 million . Asset impairments for 2019 included impairments of: (i)$58 million reflecting decreases in forecasted sales of certain product lines due to generic competition and other factors, (ii)$8 million related to assets being classified as held for sale, (iii)$5 million related to certain product/patent assets associated with the discontinuance of specific product lines not aligned with the focus of the Company's core businesses and (iv)$4 million related to Acquired IPR&D not in service. Asset impairments in 2018 included impairments of: (i)$348 million reflecting decreases in forecasted sales for the Uceris® Tablet product in the Company's Salix reporting unit and other product lines due to generic competition, (ii)$132 million reflecting decreases in forecasted sales for the Arestin® product in the Company's Dentistry reporting unit and other product lines due to changing market conditions, (iii)$55 million related to certain product/patent assets associated with the discontinuance of specific 66 -------------------------------------------------------------------------------- product lines not aligned with the focus of the Company's core businesses, (iv)$28 million to Acquired IPR&D not in service related to a certain product and (v)$5 million related to assets being classified as held for sale. See Note 9, "INTANGIBLE ASSETS AND GOODWILL" to our audited Consolidated Financial Statements regarding further details related to our intangible assets. Restructuring and Integration Costs Restructuring and integration costs primarily consist of costs associated with the implementation of cost savings programs to streamline operations and eliminate redundant processes and expenses. The expenses associated with the implementation of these cost savings programs include expenses associated with: (i) reducing headcount, (ii) eliminating real estate costs associated with unused or under-utilized facilities and (iii) implementing contribution margin improvement and other cost reduction initiatives. Restructuring and integration costs were$31 million and$22 million for 2019 and 2018, respectively, an increase of$9 million . During 2019, these costs included: (i)$11 million of severance costs and other costs associated with the acquisition of certain assets of Synergy, (ii)$11 million of facility closure costs and (iii)$9 million of other severance costs. During 2018 these costs included: (i)$11 million of severance costs, (ii)$10 million of facility closure costs and (iii)$1 million of other costs. The Company continues to evaluate opportunities to streamline its operations and identify additional cost savings globally. Although a specific plan does not exist at this time, the Company may identify and take additional exit and cost-rationalization restructuring actions in the future, the costs of which could be material. See Note 5, "RESTRUCTURING AND INTEGRATION COSTS" to our audited Consolidated Financial Statements for further details regarding these actions. Acquisition-Related Contingent Consideration Acquisition-related contingent consideration primarily consists of potential milestone payments and royalty obligations associated with businesses and assets we acquired in the past. These obligations are recorded in the Consolidated Balance Sheets at their estimated fair values at the acquisition date, in accordance with the acquisition method of accounting. The fair value of the acquisition-related contingent consideration is remeasured each reporting period, with changes in fair value recorded in the Consolidated Statements of Operations. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined in fair value measurement accounting. Acquisition-related contingent consideration was a loss of$12 million in 2019 and included accretion for the time value of money of$22 million , partially offset by net fair value adjustments due to changes in estimates of expected future royalty payments of$10 million , which included net fair value adjustments to expected future royalty payments. Acquisition-related contingent consideration was a net gain of$9 million in 2018 and included net fair value adjustments due to changes in estimates of expected future royalty payments of$33 million , which included net fair value adjustments to expected future royalty payments, partially offset by accretion for the time value of money of$24 million . See Note 6, "FAIR VALUE MEASUREMENTS" to our audited Consolidated Financial Statements for further details. Other expense (income), net Other expense (income), net for 2019 and 2018 consists of the following: (in millions) 2019 2018 Litigation and other matters$ 1,401 $ (27 ) Net (gain) loss on sales of assets (31 ) 6
Acquired in-process research and development costs 41 1 Acquisition-related costs
8 1 Other, net (5 ) (1 ) Other expense (income), net$ 1,414 $ (20 ) In 2019, Litigation and other matters includes the settlement of a legacyU.S. securities class action matter (which is subject to final court approval) discussed below. In 2018, Litigation and other matters includes a favorable adjustment of$40 million related to the Salix legacy litigation matter. InDecember 2019 , we announced that we had agreed to resolve theU.S. Securities Litigation for$1,210 million , subject to final court approval. Once approved by the court, the settlement will resolve and discharge all claims against the Company in this class action. As part of the settlement, the Company and the other settling defendants admitted no liability as to the claims against 67 -------------------------------------------------------------------------------- it and deny all allegations of wrongdoing. This settlement, once approved by the court, will resolve the most significant of the Company's remaining legacy legal matters and eliminate a material uncertainty. In addition to the anticipated resolution of theU.S. Securities Litigation, through the date of this filing, we achieved dismissals and other positive outcomes in a number of litigations, disputes and investigations, as we continue to actively address others. These matters and other significant matters are discussed in further detail in Note 21, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements. In 2019, Net (gain) loss on sales of assets includes$20 million related to the expected receipt for the achievement of a milestone related to a certain product. In 2019, Acquired in-process research and development costs includes$38 million of in-process research and development costs associated with upfront payments to enter into certain licensing agreements. Non-Operating Income and Expense Interest Expense Interest expense primarily consists of interest payments due and amortization of debt discounts and deferred financing costs on indebtedness under our credit facilities and notes. Interest expense was$1,612 million and$1,685 million and included non-cash amortization and write-offs of debt discounts and deferred financing costs of$63 million and$79 million for 2019 and 2018, respectively. The decrease in interest expense is primarily due to lower principal amounts of outstanding long-term debt throughout most of 2019, partially offset by the effect of higher interest rates throughout most of 2019. The weighted average stated rate of interest as ofDecember 31, 2019 and 2018 was 6.21% and 6.23%, respectively. See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements for further details. Loss on Extinguishment of Debt Loss on extinguishment of debt represents the differences between the amounts paid to settle extinguished debts and the carrying value of the related extinguished debt. Loss on extinguishment of debt was$42 million and$119 million for 2019 and 2018, respectively, associated with a series of transactions which allowed us to refinance and extend the maturities of portions of our debt arrangements. See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements for further details. Foreign Exchange and Other Foreign exchange and other was a net gain of$8 million and$23 million for 2019 and 2018, respectively, an unfavorable net change of$15 million . Foreign exchange gains/losses include translation gains/losses on intercompany loans and third-party liabilities, primarily denominated in euros. Income Taxes Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the temporary differences between the financial statement and income tax bases of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets for outside basis differences in investments in subsidiaries are only recognized if the difference will be realized in the foreseeable future. Benefit from income taxes was$54 million and$10 million in 2019 and 2018, respectively, an increase in the Benefit from income taxes of$44 million . Our consolidated foreign rate differential reflects the net total tax cost or benefit on income earned or losses incurred in jurisdictions outside ofCanada as compared to the net total tax cost or benefit of such income (on a jurisdictional basis) at the Canadian statutory rate of 26.9%. Tax costs below the Canadian statutory rate generate a beneficial foreign rate differential as do tax benefits generated in jurisdictions where the statutory tax rate exceeds the Canadian statutory tax rate. The net total foreign rate differentials generated in each jurisdiction in which we operate is not expected to bear a direct relationship to the net total amount of foreign income (or loss) earned outside ofCanada . In 2019, our effective tax rate differed from the Canadian statutory tax rate of 26.9% primarily due to: (i) the recording of valuation allowance on entities for which no tax benefit of losses is expected, (ii) the tax benefit generated from our annualized mix of earnings by jurisdiction and (iii) the discrete treatment of certain tax matters, primarily related to: (a) the net income tax charge related to uncertain tax positions and (b) the adjustments for book to income tax return provisions. In 2018, our effective tax rate differed from the Canadian statutory tax rate of 26.9% primarily due to: (i) the recording of valuation allowance on entities for which no tax benefit of losses is expected, (ii) a charge related to the non-deductibility of goodwill impairments, (iii) a benefit related to internal integrations and restructurings and (iv) a benefit generated from our annualized mix of earnings by jurisdiction. 68 -------------------------------------------------------------------------------- We record a valuation allowance against our deferred tax assets to reduce their net carrying value to an amount that we believe is more likely than not to be realized. In determining our deferred tax asset valuation allowance, we estimate our ability to utilize future sources of income to realize the benefits of our temporary income tax differences including: (i) NOL carryforwards in each jurisdiction, primarily inCanada , theU.S. andIreland , (ii) research and development tax credit carryforwards, (iii) scientific research and experimental development pool carryforwards and (iv) investment tax credit carryforwards. When we establish/increase or reduce/decrease the valuation allowance, the provision for income taxes will increase or decrease, respectively, in the period such determination is made. Our valuation allowance against deferred tax assets as ofDecember 31, 2019 and 2018 was$2,831 million and$2,913 million , respectively, a decrease of$82 million which was primarily driven by NOLs written-off during 2019 for entities which were liquidated. See Note 18, "INCOME TAXES" to our audited Consolidated Financial Statements for further details regarding income taxes. Reportable Segment Revenues and Profits 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 following is a brief description of our segments: • The Bausch + Lomb/International segment consists of: (i) sales in theU.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 inCanada ,Europe ,Asia ,Australia ,Latin America ,Africa and theMiddle East of branded pharmaceutical products, branded generic pharmaceutical products, OTC products, medical device products and Bausch + Lomb products.
• The Salix segment consists of sales in the
• TheOrtho Dermatologics segment consists of: (i) sales in theU.S. ofOrtho Dermatologics (dermatological) products and (ii) global sales of Solta medical aesthetic devices. • The Diversified Products segment consists of sales in theU.S. of: (i) pharmaceutical products in the areas of neurology and certain other
therapeutic classes, (ii) generic products and (iii) dentistry products.
Effective in the first quarter of 2019, one product historically included in the reported results of theOrtho Dermatologics business unit in theOrtho Dermatologics segment is now included in the reported results of the Generics business unit in the Diversified Products segment and another product historically included in the reported results of theOrtho Dermatologics business unit in theOrtho Dermatologics segment is now included in the reported results of the Dentistry business unit in the Diversified Products segment as management believes the products better align with the new respective business units. These changes in product alignment are not material. Prior period presentations of business unit and segment revenues and profits have been conformed to current segment and business unit reporting structures. Segment profit is based on operating income after the elimination of intercompany transactions. Certain costs, such as Amortization of intangible assets, Asset impairments, In-process research and development costs, Restructuring and integration costs, Acquisition-related contingent consideration costs and Other expense (income), net, are not included in the measure of segment profit, as management excludes these items in assessing segment financial performance. See Note 23, "SEGMENT INFORMATION" to our audited Consolidated Financial Statements for a reconciliation of segment profit to Loss before benefit from income taxes. 69 -------------------------------------------------------------------------------- The following table presents segment revenues, segment revenues as a percentage of total revenues and the year over year changes in segment revenues for 2019 and 2018. The following table also presents segment profits, segment profits as a percentage of segment revenues and the year over year changes in segment profits for 2019 and 2018. Years Ended December 31, Change 2019 2018 2018 to 2019 (in millions) Amount Pct. Amount Pct. Amount Pct. Segment Revenue Bausch + Lomb/International$ 4,739 55 %$ 4,664 56 %$ 75 2 % Salix 2,022 23 % 1,749 21 % 273 16 % Ortho Dermatologics 565 7 % 617 7 % (52 ) (8 )% Diversified Products 1,275 15 % 1,350 16 % (75 ) (6 )% Total revenues$ 8,601 100 %$ 8,380 100 %$ 221 3 % Segment Profits / Segment Profit Margins Bausch + Lomb/International$ 1,332 28 %$ 1,330 29 %$ 2 - % Salix 1,349 67 % 1,149 66 % 200 17 % Ortho Dermatologics 222 39 % 257 42 % (35 ) (14 )% Diversified Products 932 73 % 1,012 75 % (80 ) (8 )% Total segment profit$ 3,835 45 %$ 3,748 45 %$ 87 2 % Organic Revenues and Organic Growth Rates (non-GAAP) Organic growth, a non-GAAP metric, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations. Organic revenue growth (non-GAAP) is growth in GAAP Revenue (its most directly comparable GAAP financial measure), adjusted for certain items, of businesses that have been owned for one or more years. Organic revenue (non-GAAP) is impacted by changes in product volumes and price. The price component is made up of two key drivers: (i) changes in product gross selling price and (ii) changes in sales deductions. The Company uses organic revenue (non-GAAP) and organic revenue growth (non-GAAP) to assess performance of its reportable segments, and the Company in total, without the impact of foreign currency exchange fluctuations and recent acquisitions, divestitures and product discontinuations. The Company believes that such measures are useful to investors as they provide a supplemental period-to-period comparison. Organic revenue growth (non-GAAP) reflects adjustments for: (i) the impact of period-over-period changes in foreign currency exchange rates on revenues and (ii) the revenues associated with acquisitions, divestitures and discontinuations of businesses divested and/or discontinued. These adjustments are determined as follows: Foreign currency exchange rates: Although changes in foreign currency exchange rates are part of our business, they are not within management's control. Changes in foreign currency exchange rates, however, can mask positive or negative trends in the underlying business performance. The impact for changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. Acquisitions, divestitures and discontinuations: In order to present period-over-period organic revenues (non-GAAP) on a comparable basis, revenues associated with acquisitions, divestitures and discontinuations are adjusted to include only revenues from those businesses and assets owned during both periods. Accordingly, organic revenue growth (non-GAAP) excludes from the current period, all revenues attributable to each acquisition for twelve months subsequent to the day of acquisition, as there are no revenues from those businesses and assets included in the comparable prior period. Organic revenue growth (non-GAAP) excludes from the prior period (but not the current period), all revenues attributable to each divestiture and discontinuance during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. 70 --------------------------------------------------------------------------------
The following table presents a reconciliation of GAAP revenues to organic revenues (non-GAAP) and presents organic revenue (Non-GAAP) and the year over year changes in organic revenue (Non-GAAP) for 2019 and 2018 by segment.
Year Ended December 31, 2019 Year ended December 31, 2018 Change in Revenue Revenue Organic Revenue as Changes in Organic Revenue as Divestitures and Organic Revenue (in millions) Reported Exchange Rates Acquisition (Non-GAAP) Reported Discontinuations (Non-GAAP) Amount Pct. Bausch + Lomb/International$ 4,739 $ 110 $ - $ 4,849$ 4,664 $ (41 ) $ 4,623$ 226 5 % Salix 2,022 - (55 ) 1,967 1,749 (9 ) 1,740 227 13 % Ortho Dermatologics 565 2 - 567 617 - 617 (50 ) (8 )% Diversified Products 1,275 - - 1,275 1,350 (4 ) 1,346 (71 ) (5 )% Total$ 8,601 $ 112$ (55 ) $ 8,658$ 8,380 $ (54 ) $ 8,326$ 332 4 % Bausch + Lomb/International Segment: Bausch + Lomb/International Segment Revenue The Bausch + Lomb/International segment has a diversified product line with no single product group representing 10% or more of its segment product sales. The Bausch + Lomb/International segment revenue was$4,739 million and$4,664 million for 2019 and 2018, respectively, an increase of$75 million , or 2%. The increase was primarily attributable to: (i) an increase in volume of$168 million , primarily in our Global Consumer and Global Vision Care businesses, (ii) an increase in average realized pricing of$52 million primarily driven by increased selling prices in our International Rx, International Consumer and Global Ophthalmology Rx businesses and (iii) an increase in other revenues of$6 million . The increase in volume in our Global Consumer business is primarily attributable to the launch of Lumify® (May 2018 ) and sales of PreserVision®. The increase in volume in our Global Vision Care business is primarily attributable to our Biotrue® ONEday and Ultra® product lines in theU.S. and internationally. The increase in average realized pricing in our Global Ophthalmology Rx business is primarily attributable to Lotemax® and Vyzulta®. The increase was partially offset by: (i) the unfavorable effect of foreign currencies of$110 million primarily attributable to our revenues inEurope ,Asia andLatin America and (ii) the impact of divestitures and discontinuations of$41 million , primarily related to the divestiture and discontinuance of several products within our International Rx business. Bausch + Lomb/International Segment Profit The Bausch + Lomb/International segment profit was$1,332 million and$1,330 million for 2019 and 2018, respectively, an increase of$2 million , or less than 1%. The increase was primarily driven by an increase in contribution as a result of: (i) the increase in volume and average realized pricing as previously discussed and (ii) better inventory management. The increase was partially offset by: (i) higher selling, advertising and promotion expenses primarily due to the launch of Lumify®, (ii) the unfavorable effect of foreign currencies, (iii) higher R&D expenses and (iv) the impact of divestitures and discontinuations. Salix Segment: Salix Segment Revenue The Salix segment includes the Xifaxan® product line, which accounted for approximately 72% and 68% of the Salix segment product sales and approximately 17% and 14% of the Company's product sales for 2019 and 2018, respectively. No other single product group represents 10% or more of the Salix segment product sales. The Salix segment revenue was$2,022 million and$1,749 million for 2019 and 2018, respectively, an increase of$273 million , or 16%. The increase includes: (i) an increase in average realized pricing of$113 million primarily attributable to higher gross selling prices and lower sales deductions for Xifaxan®, (ii) an increase in volume of$111 million primarily attributable to increased demand for Xifaxan®, Glumetza® SLX, and Plenvu®, partially offset by decreased demand for certain products, primarily Uceris® due to loss of exclusivity, (iii) sales of our Trulance® product, which we added to our portfolio inMarch 2019 as part of the acquisition of certain assets of Synergy, of$55 million and (iv) an increase in other revenues of$3 million . The increase in revenue was partially offset by the impact of divestitures and discontinuations of$9 million . Although Glumetza® SLX contributed to the increase in volumes during 2019 as discussed above, an accelerated shift in channel mix could lead to deteriorating average realized pricing for this product in future periods. Salix Segment Profit The Salix segment profit was$1,349 million and$1,149 million for 2019 and 2018, respectively, an increase of$200 million , or 17%. The increase was primarily driven by a net increase in contribution as a result of the increase in average realized pricing and volume, as previously discussed. The increase in segment profit was partially offset by: (i) higher R&D expenses, (ii) the charge associated with the termination of a co-promotional agreement withUS WorldMeds, LLC and (iii) higher selling, advertising and promotion expenses. 71 -------------------------------------------------------------------------------- Ortho Dermatologics Segment: Ortho Dermatologics Segment Revenue TheOrtho Dermatologics segment revenue was$565 million and$617 million for 2019 and 2018, respectively, a decrease of$52 million , or 8%. The decrease includes: (i) a decrease in volume of$93 million , (ii) a decrease in other revenues of$8 million and (iii) the unfavorable effect of foreign currencies of$2 million . The decrease in volume is primarily due to: (i) the impact of generic competition as certain products lost exclusivity, including Elidel®, Solodyn® and Zovirax® and (ii) decreased demand for Tretinoin®, Onexton®, Jublia®, Retin-A Micro® 0.08% and Targretin®, partially offset by the increased demand for Thermage FLX®, Siliq® and Clindagel® and the launch of Duobrii® (June 2019 ). The decrease in revenue was partially offset by an increase in average realized pricing of$51 million as a result of lower sales deductions primarily attributable to Jublia® and Retin-A Micro® 0.06%. Ortho Dermatologics Segment Profit TheOrtho Dermatologics segment profit was$222 million and$257 million for 2019 and 2018, respectively, a decrease of$35 million , or 14%. The decrease was primarily driven by a decrease in contribution as a result of the decrease in revenue, as previously discussed, partially offset by decreases in: (i) selling expenses and (ii) professional fees. Diversified Products Segment: Diversified Products Segment Revenue The following table displays the Diversified Products segment revenues by product and product revenues as a percentage of segment revenue for 2019 and 2018. Years Ended December 31, Change 2019 2018 2018 to 2019 (in millions) Amount Pct. Amount Pct. Amount Pct. Wellbutrin® Franchise$ 244 19%$ 252 19%$ (8 ) (3)% Arestin® 87 7% 96 7% (9 ) (9)% Aplenzin® 83 6% 54 4% 29 54% Migranal® Franchise 55 4% 62 5% (7 ) (11)% Cuprimine® 49 4% 88 6% (39 ) (44)% Uceris® AG 46 4% 13 1% 33 254% Ativan® 43 3% 54 4% (11 ) (20)% Xenazine® Franchise 38 3% 52 4% (14 ) (27)% Diastat® Franchise 35 3% 36 3% (1 ) (3)% Elidel® AG 34 3% 4 -% 30 750% Other 561 44% 639 47% (78 ) (12)%
Total Diversified Products revenues
The Diversified Products segment revenue was$1,275 million and$1,350 million for 2019 and 2018, respectively, a decrease of$75 million , or 6%. The decrease was primarily driven by: (i) a decrease in volume of$56 million , (ii) a decrease in average realized pricing of$17 million and (iii) the impact of divestitures and discontinuations of$4 million . The decrease was partially offset by an increase in other revenues of$2 million . The decrease in volume was primarily attributable to our Neurology and Other business due to: (i) the loss of exclusivity of Cuprimine®, Isuprel®, Mephyton®, Syprine® and Xenazine® and (ii) lower demand for Wellbutrin® XL and Ativan®, partially offset by increased demand for Aplenzin®. The net decrease in volume in our Neurology and Other business was partially offset by the impact of the launches of Elidel® AG (December 2018 ) and Uceris® AG (July 2018 ) and other increases in product volumes in our Generics business. The decrease in average realized pricing is primarily attributable to the impact of generic competition in our Generics business for Glumetza® AG, Syprine® AG, Targretin® AG, Mephyton® AG and Cardizem® AG, partially offset by an increase in average realized pricing in our Neurology and Other business. Although the launches of Elidel® AG and Uceris® AG positively impacted the product volumes in our Generics business in 2019, generic versions of these products launched by competitors could lead to deteriorating revenues for these and other products in our Generics business in future periods. 72 -------------------------------------------------------------------------------- Diversified Products Segment Profit The Diversified Products segment profit was$932 million and$1,012 million for 2019 and 2018, respectively, a decrease of$80 million , or 8%. The decrease was primarily driven by: (i) the decrease in volume and average realized pricing, as previously discussed and (ii) higher selling, advertising and promotion expenses, partially offset by lower third-party royalty costs. 73 -------------------------------------------------------------------------------- LIQUIDITY AND CAPITAL RESOURCES Cash Flows Summarized cash flow information for the years 2019, 2018 and 2017 is as follows: Years Ended December 31, Change (in millions) 2019 2018 2017 2018 to 2019 2017 to 2018 Net (loss) income$ (1,783 ) $ (4,144 ) $ 2,404 $ 2,361 $ (6,548 ) Adjustments to reconcile net (loss) income to net cash provided by operating activities 3,602 5,627 (958 ) (2,025 ) 6,585 Cash provided by operating activities before changes in operating assets and liabilities 1,819 1,483 1,446 336 37
Changes in operating assets and liabilities (318 ) 18
844 (336 ) (826 ) Net cash provided by operating activities 1,501 1,501 2,290 - (789 ) Net cash (used in) provided by investing activities (419 ) (196 ) 2,887 (223 ) (3,083 ) Net cash provided by (used in) financing activities 1,443 (1,353 ) (4,963 ) 2,796 3,610 Effect of exchange rate changes on cash and cash equivalents (4 ) (26 ) 41 22 (67 ) Net increase (decrease) in cash and cash equivalents and restricted cash 2,521 (74 ) 255 2,595 (329 ) Cash and cash equivalents and restricted cash, beginning of year 723 797 542 (74 ) 255 Cash and cash equivalents and restricted cash, end of year$ 3,244 $ 723
A detailed discussion of the year-over-year changes of the Company's 2018 summarized cash flow information compared with that of 2017 can be found under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year endedDecember 31, 2018 filed onFebruary 20, 2019 . Operating Activities Net cash provided by operating activities was$1,501 million in each of the years 2019 and 2018. Cash provided by operating activities before changes in operating assets and liabilities for the years 2019 and 2018 was$1,819 million and$1,483 million , respectively, an increase of$336 million . The increase is primarily attributable to: (i) Payments of accrued legal settlements during 2018 not recurring in 2019 and (ii) higher revenues, improved gross margins and cash expense reductions in 2019 as compared to 2018 as previously discussed. During 2018, Payments of accrued legal settlements were$224 million and were related to the settlements of the Solodyn® antitrust litigations, the Allergan litigation and other matters. Changes in operating assets and liabilities resulted in a net decrease in cash of$318 million in 2019, as compared to the net increase in cash of$18 million in 2018, a decrease of$336 million . During 2019, Changes in operating assets and liabilities was negatively impacted by: (i) the build-up of inventories of$209 million and (ii) the timing of other payments in the ordinary course of business of$148 million , partially offset by the collection of trade receivables of$39 million . During 2018, Changes in operating assets and liabilities was positively impacted by the collection of trade receivables of$216 million partially offset by the timing of payments in the ordinary course of business of$193 million and the buildup of inventories of$5 million . Investing Activities Net cash used in investing activities was$419 million in 2019 and was driven by: (i) Purchases of property, plant and equipment of$270 million and (ii) Acquisition of businesses, net of cash acquired of$180 million , related to the acquisition of certain assets of Synergy. Net cash used in investing activities was partially offset by Proceeds from sale of assets and businesses, net of costs to sell of$45 million , primarily related to the receipt of a milestone payment associated with a prior year divestiture. Net cash used in investing activities was$196 million in 2018 and was driven by: (i) Purchases of property, plant and equipment of$157 million and (ii) Payments for intangible and other assets previously acquired of$78 million . Financing Activities Our financing activities reflect our leadership's commitment to improve the Company's capital structure. Through debt repayments and refinancings during 2019, we have effectively managed our capital structure which has allowed us to, among other things: (i) improve our credit ratings as discussed under "Credit Ratings" below, (ii) access the credit markets to finance amounts owed under the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation without negatively impacting our working capital available for operations and (iii) as of the date of this filing, reduce our mandatory scheduled principal repayments of our debt obligations through 2021 to$103 million . 74 -------------------------------------------------------------------------------- Net cash provided by financing activities during 2019 was$1,443 million and primarily reflects the aggregate net proceeds from the issuance of the 5.00%January 2028 Unsecured Notes andJanuary 2030 Unsecured Notes of$2,472 million , partially offset by: (i) debt repayments during 2019 with cash on hand of$906 million and (ii) payments for all other financing activities. The aggregate net proceeds from the issuance of theJanuary 2028 Unsecured Notes andJanuary 2030 Unsecured Notes are to be used and were used to: (i) pay the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation (which is subject to final court approval), of which we paid$200 million duringJanuary 2020 and (ii) redeem$1,240 million ofMay 2023 Unsecured Notes onJanuary 16, 2020 . In 2019, net proceeds from the issuances of long-term debt of$5,960 million consists of: (i)$1,236 million from the issuance of$1,250 million in principal amount of 5.00%January 2028 Unsecured Notes, (ii)$1,236 million from the issuance of$1,250 million in principal amount ofJanuary 2030 Unsecured Notes, (iii)$1,018 million from the issuance of$1,000 million in principal amount of 8.50% Senior Unsecured Notes dueJanuary 2027 (the "January 2027 Unsecured Notes"), (iv)$740 million from the issuance of$750 million in principal amount of 7.00% Senior Unsecured Notes dueJanuary 2028 (the "7.00%January 2028 Unsecured Notes"), (v)$740 million from the issuance of$750 million in principal amount of 7.25% Senior Unsecured Notes dueMay 2029 (the "May 2029 Unsecured Notes"), (vi)$492 million from the issuance of$500 million in principal amount of 5.75% Senior Secured Notes dueAugust 2027 (the "August 2027 Secured Notes") and (vii)$500 million of borrowings under our revolving credit facilities. Net proceeds from the issuances of long-term debt is net of$2 million in payments we made in 2019 for issuance costs associated with long-term debt issued in previous years. Repayments of long-term debt during 2019 was$4,406 million consisting of: (i) repayments of principal amounts due under our Senior Notes of$3,100 million , (ii) repayments of term loans under our Senior Secured Credit Facilities of$731 million and (iii) repayments of our revolving credit facility of$575 million . Payments of financing costs associated with the refinancing of certain debt was$28 million . Net cash used in financing activities during 2018 was$1,353 million and included repayments of long-term debt of$10,101 million consisting of: (i) repayments of term loans under our Senior Secured Credit Facilities of$3,711 million , (ii) repayments of principal amounts due under our Senior Notes of$5,465 million , (iii) refinancing$500 million of outstanding amounts under our 2020 Revolving Credit Facility with our 2023 Revolving Credit Facility and (iv) repayments of our revolving credit facilities of$425 million . Issuance of long-term debt, net of discounts for 2018 was$8,944 million and included: (i) the net proceeds of: (a)$4,507 million from the issuance of$4,565 million in principal amount of our seven year Tranche B Term Loan Facility maturing inJune 2025 (the "June 2025 Term Loan B Facility"), (b)$1,480 million from the issuance of$1,500 million in principal amount ofApril 2026 Unsecured Notes, (c)$1,476 million from the issuance of$1,500 million in principal amount of our seven year Tranche B Term Loan Facility maturing inNovember 2025 (the "November 2025 Term Loan B Facility") and (d)$738 million from the issuance of$750 million in principal amount ofJanuary 2027 Unsecured Notes, (ii) refinancing$500 million of outstanding amounts under our 2020 Revolving Credit Facility with our 2023 Revolving Credit Facility and (iii)$250 million of borrowings under our revolving credit facilities. The net proceeds from the Issuance of long-term debt, net of discounts in 2018 is further reduced by$7 million in payments we made in 2018 for issuance costs associated with senior notes issued during 2017. Payments for costs associated with the refinancing of certain debt was$102 million for 2018. See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements for further details regarding the financing activities previously described. Liquidity and Debt Future Sources of Liquidity Our primary sources of liquidity are our cash and cash equivalents, cash collected from customers, funds as available from our revolving credit facility, issuances of long-term debt and issuances of equity and equity-linked securities. We believe these sources will be sufficient to meet our current liquidity needs for the next twelve months. The Company regularly evaluates market conditions, its liquidity profile, and various financing alternatives for opportunities to enhance its capital structure. If opportunities are favorable, the Company may refinance or repurchase existing debt or issue equity or equity-linked securities. We believe our existing cash and cash generated from operations will be sufficient to service our debt obligations in the years 2020 through 2022. Long-term Debt Long-term debt, net of unamortized discounts and finance costs was$25,895 million and$24,305 million as ofDecember 31, 2019 and 2018, respectively. Aggregate contractual principal amounts due under our debt obligations were$26,188 million and$24,632 million as ofDecember 31, 2019 and 2018, respectively, an increase of$1,556 million . Financing of Litigation Settlement - InDecember 2019 , we announced that we had agreed to resolve theU.S. Securities Litigation for$1,210 million , subject to final court approval. Once approved by the court, the settlement will resolve and discharge all claims against the Company in the class action. As part of the settlement, the Company and the other settling defendants admitted 75 -------------------------------------------------------------------------------- no liability as to the claims against it and deny all allegations of wrongdoing. This settlement, once approved by the court, will resolve the most significant of the Company's remaining legacy legal matters and eliminate a material uncertainty regarding our Company. To finance this settlement, onDecember 30, 2019 we accessed the credit markets in a private offering and issued theJanuary 2028 Unsecured Notes (defined below) and theJanuary 2030 Unsecured Notes (defined below), the net proceeds of which, along with cash on hand, are to be used and were used to: (i) finance the$1,210 million pending settlement of theU.S. Securities Litigation and (ii) replace$1,240 million of debt dueMay 2023 onJanuary 16, 2020 . Debt Repayments - Excluding the impact of the financing of the litigation settlement discussed above, using the net cash proceeds from divestitures of non-core assets, cash generated from operations and cash generated from tighter working capital management, we repaid (net of additional borrowings) over$7,700 million of long-term debt during the periodJanuary 1, 2016 through the date of this filing, which includes$906 million of repayments with cash on hand during 2019. 2019 Refinancing Transactions In March, May andDecember 2019 , we accessed the credit markets and completed a series of transactions, whereby we extended$4,240 million in aggregate maturities of certain debt obligations due to mature inDecember 2021 throughMay 2023 , out toJanuary 2027 throughJanuary 2030 . OnMarch 8, 2019 , we issued: (i)$1,000 million aggregate principal amount ofJanuary 2027 Unsecured Notes and (ii)$500 million aggregate principal amount ofAugust 2027 Secured Notes in a private placement. The proceeds and cash on hand were used to: (i) repurchase the remaining$700 million outstanding principal amount of 5.625% Senior Unsecured Notes due 2021 (the "December 2021 Unsecured Notes"), (ii) repurchase$584 million ofMay 2023 Unsecured Notes, (iii) repurchase$216 million of 5.50% Senior Unsecured Notes due 2023 (the "March 2023 Unsecured Notes") and (iv) pay all fees and expenses associated with these transactions (collectively, the "March 2019 Refinancing Transactions"). OnMay 23, 2019 , we issued: (i)$750 million aggregate principal amount of 7.00%January 2028 Unsecured Notes and (ii)$750 million aggregate principal amount ofMay 2029 Unsecured Notes in a private placement. The proceeds and cash on hand were used to: (i) repurchase$1,118 million ofMay 2023 Unsecured Notes, (ii) repurchase$382 million ofMarch 2023 Unsecured Notes and (iii) pay all fees and expenses associated with these transactions (collectively, the "May 2019 Refinancing Transactions"). OnDecember 30, 2019 , we issued: (i)$1,250 million aggregate principal amount of 5.00%January 2028 Unsecured Notes and (ii)$1,250 million aggregate principal amount ofJanuary 2030 Unsecured Notes in a private placement. The proceeds and cash on hand were used to: (i) redeem$1,240 million ofMay 2023 Unsecured Notes onJanuary 16, 2020 , (ii) finance amounts owed under the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation (which is subject to final court approval) and (iii) pay all fees and expenses associated with these transactions. OnDecember 18, 2019 , the Company issued a conditional notice of redemption to redeem$1,240 million ofMay 2023 Unsecured Notes onJanuary 16, 2020 . OnDecember 30, 2019 , the Company received the proceeds associated with theDecember 2019 Financing and Refinancing Transactions, satisfying the condition included in the conditional notice of redemption. The aforementioned repayments, refinancings and other changes in our debt portfolio completed during 2019 have lowered our cash requirements for principal debt repayment over the next five years. The mandatory scheduled principal repayments of our debt obligations as ofDecember 31, 2019 andFebruary 19, 2020 (the date of this filing) were as follows: (in millions) 2020 - 2021 2022 - 2023 2024 - 2025 2026 - 2027 2028 - 2029 2030 Total As of December 31, 2019$ 1,343 $ 4,148 $ 12,935 $ 3,750 $ 2,762 $ 1,250 $ 26,188 As of February 19, 2020 103 4,148 12,935 3,750 2,762 1,250 24,948 See Note 11, "FINANCING ARRANGEMENTS" to our audited Consolidated Financial Statements and "Management's Discussion and Analysis - Liquidity and Capital Resources: Long-term Debt" for further details. The weighted average stated rate of interest as ofDecember 31, 2019 and 2018 was 6.21% and 6.23%, respectively. Senior Secured Credit Facilities OnFebruary 13, 2012 , the Company and certain of its subsidiaries as guarantors entered into the "Senior Secured Credit Facilities" under the Company's Third Amended and Restated Credit and Guaranty Agreement, as amended (the "Third Amended Credit Agreement") with a syndicate of financial institutions and investors. OnJune 1, 2018 , the Company entered into the Restated Credit Agreement, effectuating the Restated Credit Agreement which amended and restated in full the Company's Third Amended Credit Agreement. 76 -------------------------------------------------------------------------------- OnNovember 27, 2018 , the Company entered into the First Incremental Amendment to the Restated Credit Agreement which provided theNovember 2025 Term Loan B Facility of$1,500 million . As ofDecember 31, 2019 , the Company had no outstanding borrowings,$170 million of issued and outstanding letters of credit, and remaining availability of$1,055 million under its 2023 Revolving Credit Facility. Current Description of Senior Secured Credit Facilities Borrowings under the Senior Secured Credit Facilities inU.S. dollars bear interest at a rate per annum equal to, at the Company's option, either: (i) a base rate determined by reference to the highest of: (a) the prime rate (as defined in the Restated Credit Agreement), (b) the federal funds effective rate plus 1/2 of 1.00% or (c) the eurocurrency rate (as defined in the Restated Credit Agreement) for a period of one month plus 1.00% (or if such eurocurrency rate shall not be ascertainable, 1.00%) or (ii) a eurocurrency rate determined by reference to the costs of funds forU.S. dollar deposits for the interest period relevant to such borrowing adjusted for certain additional costs (provided however, that the eurocurrency rate shall at no time be less than 0.00% per annum), in each case plus an applicable margin. Borrowings under the 2023 Revolving Credit Facility in euros bear interest at a eurocurrency rate determined by reference to the costs of funds for euro deposits for the interest period relevant to such borrowing (provided however, that the eurocurrency rate shall at no time be less than 0.00% per annum), plus an applicable margin. Borrowings under the 2023 Revolving Credit Facility in Canadian dollars bear interest at a rate per annum equal to, at the Company's option, either: (i) a prime rate determined by reference to the higher of: (a) the rate of interest last quoted by The Wall Street Journal as the "Canadian Prime Rate" or, if The Wall Street Journal ceases to quote such rate, the highest per annum interest rate published by theBank of Canada as its prime rate and (b) the 1 month BA rate (as defined below) calculated daily plus 1.00% (provided however, that the prime rate shall at no time be less than 0.00%) or (ii) the bankers' acceptance rate for Canadian dollar deposits in theToronto interbank market (the "BA rate") for the interest period relevant to such borrowing (provided however, that the BA rate shall at no time be less than 0.00% per annum), in each case plus an applicable margin. Subject to certain exceptions and customary baskets set forth in the Restated Credit Agreement, the Company is required to make mandatory prepayments of the loans under the Senior Secured Credit Facilities under certain circumstances, including from: (i) 100% of the net cash proceeds of insurance and condemnation proceeds for property or asset losses (subject to reinvestment rights and net proceeds threshold), (ii) 100% of the net cash proceeds from the incurrence of debt (other than permitted debt as described in the Restated Credit Agreement), (iii) 50% of Excess Cash Flow (as defined in the Restated Credit Agreement) subject to decrease based on leverage ratios and subject to a threshold amount and (iv) 100% of net cash proceeds from asset sales (subject to reinvestment rights). These mandatory prepayments may be used to satisfy future amortization. The applicable interest rate margins for theJune 2025 Term Loan B Facility and theNovember 2025 Term Loan B Facility are 2.00% and 1.75%, respectively, with respect to base rate and prime rate borrowings and 3.00% and 2.75%, respectively, with respect to eurocurrency rate and BA rate borrowings. As ofDecember 31, 2019 , the stated rates of interest on the Company's borrowings under theJune 2025 Term Loan B Facility and theNovember 2025 Term Loan B Facility were 4.74% and 4.49% per annum, respectively. The amortization rate for both theJune 2025 Term Loan B Facility and theNovember 2025 Term Loan B Facility is 5.00% per annum. The Company may direct that prepayments be applied to such amortization payments in order of maturity. As ofDecember 31, 2019 , the aggregate remaining mandatory quarterly amortization payments for the Senior Secured Credit Facilities were$1,126 million throughNovember 1, 2025 . The applicable interest rate margins for borrowings under the 2023 Revolving Credit Facility are 1.50%-2.00% with respect to base rate or prime rate borrowings and 2.50%-3.00% with respect to eurocurrency rate or BA rate borrowings. As ofDecember 31, 2019 , the stated rate of interest on the 2023 Revolving Credit Facility was 4.74% per annum. In addition, the Company is required to pay commitment fees of 0.25% - 0.50% per annum with respect to the unutilized commitments under the 2023 Revolving Credit Facility, payable quarterly in arrears. The Company also is required to pay: (i) letter of credit fees on the maximum amount available to be drawn under all outstanding letters of credit in an amount equal to the applicable margin on eurocurrency rate borrowings under the 2023 Revolving Credit Facility on a per annum basis, payable quarterly in arrears, (ii) customary fronting fees for the issuance of letters of credit and (iii) agency fees. The Restated Credit Agreement permits the incurrence of incremental credit facility borrowings, up to the greater of$1,000 million and 28.5% of Consolidated Adjusted EBITDA (as defined in the Restated Credit Agreement), subject to customary terms and conditions, as well as the incurrence of additional incremental credit facility borrowings subject to a secured leverage ratio of not greater than 3.50:1.00, and, in the case of unsecured debt, a total leverage ratio of not greater than 6.50:1.00 or an interest coverage ratio of not less than 2.00:1.00. 77 -------------------------------------------------------------------------------- Senior Secured Notes The Senior Secured Notes are guaranteed by each of the Company's subsidiaries that is a guarantor under the Restated Credit Agreement and existing Senior Unsecured Notes (together, the "Note Guarantors"). The Senior Secured Notes and the guarantees related thereto are senior obligations and are secured, subject to permitted liens and certain other exceptions, by the same first priority liens that secure the Company's obligations under the Restated Credit Agreement under the terms of the indentures governing the Senior Secured Notes. The Senior Secured Notes and the guarantees rank equally in right of repayment with all of the Company's and Note Guarantors' respective existing and future unsubordinated indebtedness and senior to the Company's and Note Guarantors' respective future subordinated indebtedness. The Senior Secured Notes and the guarantees related thereto are effectively pari passu with the Company's and the Note Guarantors' respective existing and future indebtedness secured by a first priority lien on the collateral securing the Senior Secured Notes and effectively senior to the Company's and the Note Guarantors' respective existing and future indebtedness that is unsecured, including the existing Senior Unsecured Notes, or that is secured by junior liens, in each case to the extent of the value of the collateral. In addition, the Senior Secured Notes are structurally subordinated to: (i) all liabilities of any of the Company's subsidiaries that do not guarantee the Senior Secured Notes and (ii) any of the Company's debt that is secured by assets that are not collateral. Upon the occurrence of a change in control (as defined in the indentures governing the Senior Secured Notes), unless the Company has exercised its right to redeem all of the notes of a series, holders of the Senior Secured Notes may require the Company to repurchase such holder's notes, in whole or in part, at a purchase price equal to 101% of the principal amount thereof plus accrued and unpaid interest. 5.75% Senior Secured Notes due 2027 -March 2019 Refinancing Transactions OnMarch 8, 2019 ,Bausch Health Americas, Inc. ("BHA") and the Company issued: (i)$1,000 million aggregate principal amount ofJanuary 2027 Unsecured Notes and (ii)$500 million aggregate principal amount ofAugust 2027 Secured Notes, respectively, in a private placement. A portion of the proceeds and cash on hand were used to: (i) repurchase$584 million ofMay 2023 Unsecured Notes, (ii) repurchase$518 million ofDecember 2021 Unsecured Notes, (iii) repurchase$216 million ofMarch 2023 Unsecured Notes and (iv) pay all fees and expenses associated with these transactions (collectively, the "March 2019 Refinancing Transactions"). DuringApril 2019 , the Company redeemed$182 million of theDecember 2021 Unsecured Notes, representing the remaining outstanding principal balance of theDecember 2021 Unsecured Notes and completing the refinancing of$1,500 million of debt in connection with theMarch 2019 Refinancing Transactions. Interest on theAugust 2027 Secured Notes is payable semi-annually in arrears on eachFebruary 15 andAugust 15 . TheAugust 2027 Secured Notes are redeemable at the option of the Company, in whole or in part, at any time on or afterAugust 15, 2022 , at the redemption prices set forth in the indenture. The Company may redeem some or all of theAugust 2027 Secured Notes prior toAugust 15, 2022 at a price equal to 100% of the principal amount thereof plus a "make-whole" premium. Prior toAugust 15, 2022 , the Company may redeem up to 40% of the aggregate principal amount of theAugust 2027 Secured Notes using the proceeds of certain equity offerings at the redemption price set forth in the indenture. Senior Unsecured Notes The Senior Unsecured Notes issued by the Company are the Company's senior unsecured obligations and are jointly and severally guaranteed on a senior unsecured basis by each of its subsidiaries that is a guarantor under the Senior Secured Credit Facilities. The Senior Unsecured Notes issued by the Company's subsidiary, BHA, are senior unsecured obligations of BHA and are jointly and severally guaranteed on a senior unsecured basis by the Company and each of its subsidiaries (other than BHA) that is a guarantor under the Senior Secured Credit Facilities. Future subsidiaries of the Company and BHA, if any, may be required to guarantee the Senior Unsecured Notes. If the Company experiences a change in control, the Company may be required to make an offer to repurchase each series of Senior Unsecured Notes, in whole or in part, at a purchase price equal to 101% of the aggregate principal amount of the Senior Unsecured Notes repurchased, plus accrued and unpaid interest. 8.50% Senior Unsecured Notes due 2027 -June 2018 Refinancing Transactions andMarch 2019 Refinancing Transactions As part of theMarch 2019 Refinancing Transactions described above, BHA issued$1,000 million aggregate principal amount of 8.50% Senior Unsecured Notes dueJanuary 2027 . These are additional notes and form part of the same series as BHA's existingJanuary 2027 Unsecured Notes. 78 -------------------------------------------------------------------------------- 7.00% Senior Unsecured Notes due 2028 and 7.25% Senior Unsecured Notes due 2029 -May 2019 Refinancing Transactions OnMay 23, 2019 , the Company issued: (i)$750 million aggregate principal amount of 7.00%January 2028 Unsecured Notes and (ii)$750 million aggregate principal amount ofMay 2029 Unsecured Notes, respectively, in a private placement. The proceeds and cash on hand were used to: (i) repurchase$1,118 million ofMay 2023 Unsecured Notes, (ii) repurchase$382 million ofMarch 2023 Unsecured Notes and (iii) pay all fees and expenses associated with these transactions. Interest on theJanuary 2028 Unsecured Notes is payable semi-annually in arrears on eachJanuary 15 andJuly 15 . Interest on theMay 2029 Unsecured Notes is payable semi-annually in arrears on eachMay 30 andNovember 30 . The 7.00%January 2028 Unsecured Notes and theMay 2029 Unsecured Notes are redeemable at the option of the Company, in whole or in part, at any time on or afterJanuary 15, 2023 andMay 30, 2024 , respectively, at the redemption prices set forth in the respective indenture. The Company may redeem some or all of the 7.00%January 2028 Unsecured Notes or theMay 2029 Unsecured Notes prior toJanuary 15, 2023 andMay 30, 2024 , respectively, at a price equal to 100% of the principal amount thereof plus a "make-whole" premium. Prior toJuly 15, 2022 , andMay 30, 2022 , the Company may redeem up to 40% of the aggregate principal amount of the 7.00%January 2028 Unsecured Notes or theMay 2029 Unsecured Notes, respectively, using the proceeds of certain equity offerings at the redemption price set forth in the respective indenture. 5.00% Senior Unsecured Notes due 2028 and 5.25% Senior Unsecured Notes due 2030 -December 2019 Financing Transactions OnDecember 30, 2019 , we issued: (i)$1,250 million aggregate principal amount of 5.00%January 2028 Unsecured Notes and (ii)$1,250 million aggregate principal amount ofJanuary 2030 Unsecured Notes in a private placement. The proceeds and cash on hand were used to: (i) redeem$1,240 million ofMay 2023 Unsecured Notes onJanuary 16, 2020 , (ii) finance amounts owed under the Company's recently announced$1,210 million settlement agreement relating to theU.S. Securities Litigation (which is subject to final court approval) and (iii) pay all fees and expenses associated with these transactions (collectively, the "December 2019 Financing and Refinancing Transactions"). Interest on the 5.00%January 2028 Unsecured Notes is payable semi-annually in arrears on eachJanuary 30 andJuly 30 . Interest on theJanuary 2030 Unsecured Notes is payable semi-annually in arrears on eachJanuary 30 andJuly 30 . The 5.00%January 2028 Unsecured Notes and theJanuary 2030 Unsecured Notes are redeemable at the option of the Company, in whole or in part, at any time on or afterJanuary 30, 2023 andJanuary 30, 2025 , respectively, at the redemption prices set forth in the respective indenture. The Company may redeem some or all of the 5.00%January 2028 Unsecured Notes or theJanuary 2030 Unsecured Notes prior toJanuary 30, 2023 andJanuary 30, 2025 , respectively, at a price equal to 100% of the principal amount thereof plus a "make-whole" premium. Prior toJanuary 30, 2023 andJanuary 30, 2025 , the Company may redeem up to 40% of the aggregate principal amount of the 5.00%January 2028 Unsecured Notes or theJanuary 2030 Unsecured Notes, respectively, using the proceeds of certain equity offerings at the redemption price set forth in the respective indenture. Remaining Senior Unsecured Notes The aggregate principal amount of our other Senior Unsecured Notes as ofDecember 31, 2019 and 2018 was$7,932 million and$7,970 million , respectively, a decrease of$38 million representing the impact of the foreign currency exchange rate on our euro denominated note. Covenant Compliance Any inability to comply with the covenants under the terms of our Restated Credit Agreement, Senior Secured Notes indentures or Senior Unsecured Notes indentures could lead to a default or an event of default for which we may need to seek relief from our lenders and noteholders in order to waive the associated default or event of default and avoid a potential acceleration of the related indebtedness or cross-default or cross-acceleration to other debt. There can be no assurance that we would be able to obtain such relief on commercially reasonable terms or otherwise and we may be required to incur significant additional costs. In addition, the lenders under our Restated Credit Agreement, holders of our Senior Secured Notes and holders of our Senior Unsecured Notes may impose additional operating and financial restrictions on us as a condition to granting any such waiver. During 2018 and 2019, the Company completed several actions which included using cash flows from operations to repay debt and refinancing debt with near term maturities. These actions have reduced the Company's debt balance and positively affected the Company's ability to comply with its financial maintenance covenant. As ofDecember 31, 2019 , the Company was in compliance with the financial maintenance covenant related to its outstanding debt. The Company, based on its current forecast for the next twelve months from the date of issuance of this Form 10-K, expects to remain in compliance with the financial maintenance covenant and meet its debt service obligations over that same period. The Company continues to take steps to improve its operating results to ensure continual compliance with its financial maintenance covenant and take other actions to reduce its debt levels to align with the Company's long-term strategy. The Company 79 -------------------------------------------------------------------------------- may consider taking other actions, including divesting other businesses, refinancing debt and issuing equity or equity-linked securities as deemed appropriate, to provide additional coverage in complying with the financial maintenance covenant and meeting its debt service obligations. The Senior Notes and Secured Notes are guaranteed by a substantial portion of the Company's subsidiaries. On a non-consolidated basis, the non-guarantor subsidiaries had total assets of$2,682 million and$2,954 million and total liabilities of$1,075 million and$1,264 million as ofDecember 31, 2019 and 2018, respectively, and revenues of$1,463 million and$1,689 million and operating income of$121 million and$174 million for years endedDecember 31, 2019 and 2018, respectively. Credit Ratings InDecember 2019 ,Standard & Poor's upgraded our credit ratings and maintained our outlook as stable. As ofFebruary 19, 2020 , the credit ratings and outlook from Moody's,Standard & Poor's and Fitch for certain outstanding obligations of the Company were as follows: Senior Senior Secured Unsecured Rating Agency Corporate Rating Rating Rating Outlook Moody's B2 Ba2 B3 Stable Standard & Poor's B+ BB B Stable Fitch B BB B Stable Any downgrade in our corporate credit ratings or other credit ratings may increase our cost of borrowing and may negatively impact our ability to raise additional debt capital. OFF-BALANCE SHEET ARRANGEMENTS AND CONTRACTUAL OBLIGATIONS We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our results of operations, financial condition, capital expenditures, liquidity, or capital resources. The following table summarizes our contractual obligations as ofDecember 31, 2019 for the years presented: (in millions) Total 2020 2021 and 2022 2023 and 2024 Thereafter Long-term debt obligations, including interest$ 35,548 $ 2,758 $ 4,708 $ 7,568$ 20,514 Operating lease obligations 383 70 97 67 149 Purchase obligations 888 557 201 104 26
Total contractual obligations
Purchase obligations consist of agreements to purchase goods and services that are enforceable and legally binding and include obligations for minimum inventory and capital expenditures, and outsourced information technology, product promotion and clinical research services. The table of contractual obligations excludes payments for: (i) contingent milestone payments to third parties as part of certain development, collaboration and license agreements and (ii) acquisition-related contingent consideration. See Note 22, "COMMITMENTS AND CONTINGENCIES" and Note 6, "FAIR VALUE MEASUREMENTS" to our audited Consolidated Financial Statements for further details related to these contingent payments. The table of contractual obligations excludes payments for unrecognized tax benefits totaling$355 million as ofDecember 31, 2019 because a reliable estimate of the period in which uncertain tax positions will be payable, if ever, cannot be made. Other Future Cash Requirements Our other future cash requirements relate to working capital, capital expenditures, business development transactions (contingent consideration), restructuring and integration, benefit obligations and litigation settlements. In addition, we may use cash to enter into licensing arrangements and/or to make strategic acquisitions. We are considering further acquisition opportunities within our core therapeutic areas, some of which could be sizable. In addition to our working capital requirements and other amounts presented in the contractual obligations table presented above, we expect our primary cash requirements for 2020 to include: 80 --------------------------------------------------------------------------------
• Debt repayments-As a result of prepayments and a series of refinancing
transactions we have reduced and extended the maturities of a substantial
portion of our long-term debt. Payments of Long-term debt obligations,
including interest as presented in the contractual obligations table above
for the year 2020 of
redemption of
Unsecured Notes made on
scheduled principal repayments of our debt obligations through 2021 are
million. We may elect to make additional principal payments under certain
circumstances. Further, in the ordinary course of business, we may borrow and
repay amounts under our 2023 Revolving Credit Facility to meet business
needs;
• IT Infrastructure Investment-We expect to make payments of approximately
million, net of the amounts included in Purchase obligations in the table
above, for licensing, maintenance and capitalizable costs associated with our
IT infrastructure improvement projects during 2020;
• Capital expenditures-We expect to make payments of approximately
for property, plant and equipment during 2020, of which there were
million in committed amounts as of
• Contingent consideration payments-We expect to make contingent consideration
and other development/approval/sales-based milestone payments of
during 2020;
• Restructuring and integration payments-We expect to make payments of
million during 2020 for employee separation costs and lease termination
obligations associated with restructuring and integration actions we have
taken through
• Benefit obligations-We expect to make payments under our pension and
postretirement obligations of
postretirement benefit plan, respectively during 2020. See Note 12, "PENSION
AND POSTRETIREMENT EMPLOYEE BENEFIT PLANS" to our audited Consolidated
Financial Statements for further details of our benefit obligations; and •U.S. Securities Litigation Settlement-As more fully discussed in Note 21,
"LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements, we
expect to make payments of
Litigation during 2020, of which we paid
Litigation for
by the court, the settlement will resolve and discharge all claims against
the Company in the class action. As part of the settlement, the Company and
the other settling defendants admitted no liability as to the claims against
it and deny all allegations of wrongdoing. This settlement, once approved by
the court, will resolve the most significant of the Company's remaining legacy legal matters and eliminate a material uncertainty regarding our Company. We continue to evaluate opportunities to improve our operating results and may initiate additional cost savings programs to streamline our operations and eliminate redundant processes and expenses. These cost savings programs may include, but are not limited to: (i) reducing headcount, (ii) eliminating real estate costs associated with unused or under-utilized facilities and (iii) implementing contribution margin improvement and other cost reduction initiatives. The expenses associated with the implementation of these cost savings programs could be material and may impact our cash flows. In the ordinary course of business, the Company is involved in litigation, claims, government inquiries, investigations, charges and proceedings. See Note 21, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements for further details of these matters. Our ability to successfully defend the Company against pending and future litigation may impact cash flows. OUTSTANDING SHARE DATA Our common shares are listed on the TSX and the NYSE under the ticker symbol "BHC". AtFebruary 13, 2020 , we had 352,704,400 issued and outstanding common shares. In addition, as ofFebruary 13, 2020 , we had 7,049,164 stock options and 5,872,874 time-based RSUs that each represent the right of a holder to receive one of the Company's common shares, and 2,355,100 performance-based RSUs that represent the right of a holder to receive a number of the Company's common shares up to a specified maximum. A maximum of 4,149,539 common shares could be issued upon vesting of the performance-based RSUs outstanding. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Our business and financial results are affected by fluctuations in world financial markets, including the impacts of foreign currency exchange rate and interest rate movements. We evaluate our exposure to such risks on an ongoing basis, and seek ways to manage these risks to an acceptable level, based on management's judgment of the appropriate trade-off between risk, opportunity and cost. We may use derivative financial instruments from time to time as a risk management tool and not for trading or speculative purposes. 81 -------------------------------------------------------------------------------- Inflation; Seasonality We are subject to price control restrictions on our pharmaceutical products in a number of countries in which we now operate. As a result, our ability to raise prices in a timely fashion in anticipation of inflation may be limited in some markets. Historically, revenues from our business tend to be weighted toward the second half of the year. Sales in the first quarter tend to be lower as patient co-pays and deductibles reset at the beginning of each year. Sales in the fourth quarter tend to be higher based on consumer and customer purchasing patterns associated with health care reimbursement programs. However, there are no assurances that these historical trends will continue in the future. Foreign Currency Risk In the year endedDecember 31, 2019 , a majority of our revenue and expense activities and capital expenditures were denominated inU.S. dollars. We have exposure to multiple foreign currencies, including, among others, the Euro, Chinese yuan, Polish zloty, Canadian dollar and Mexican peso. Our operations are subject to risks inherent in conducting business abroad, including price and currency exchange controls and fluctuations in the relative values of currencies. InNovember 2016 , as a result of the Egyptian government's decision to float the Egyptian pound andun -peg it to theU.S. Dollar, the Egyptian pound was significantly devalued. Our exposure to the Egyptian pound is primarily with respect to Amoun Pharmaceutical Company S.A.E., which we acquired inOctober 2015 , and which represented approximately 3% and 2% of our total 2019 and 2018 revenues, respectively. In addition, to the extent that we require, as a source of debt repayment, earnings and cash flows from some of our operations located in foreign countries, we are subject to risk of changes in the value of theU.S. dollar, relative to all other currencies in which we operate, which may materially affect our results of operations. Where possible, we manage foreign currency risk by managing same currency revenues in relation to same currency expenses. Further strengthening of theU.S. dollar and/or further devaluation of foreign currencies will have a negative impact on our reported revenue and reported results. As ofDecember 31, 2019 , a 1% change in foreign currency exchange rates would have impacted our shareholders' equity by approximately$52 million , which could be partially mitigated by our cross-currency swaps discussed below. As ofDecember 31, 2019 , the unrealized foreign exchange loss on the translation of the remaining principal amount ofU.S. denominated senior secured and unsecured notes was$142 million , for Canadian income tax purposes. Additionally, as ofDecember 31, 2019 , the unrealized foreign exchange loss on certain intercompany balances was equal to$5 million . One-half of any realized foreign exchange gain or loss will be included in our Canadian taxable income. Any resulting gain will result in a corresponding reduction in our available Canadian Losses,Scientific Research andExperimental Development Pool , and/or Investment Tax Credit carryforward balances. However, the repayment of the senior notes and the intercompany loans denominated inU.S. dollars does not result in a foreign exchange gain or loss being recognized in our Consolidated Financial Statements, as these statements are prepared inU.S. dollars. We may use derivative financial instruments from time to time to mitigate our foreign currency risk and not for trading or speculative purposes. During 2019, we entered into cross-currency swaps, with aggregate notional amounts of$1,250 million , to mitigate fluctuation in the value of a portion of our euro-denominated net investment in our consolidated financial statements from adverse movements in exchange rates. The euro-denominated net investment being hedged is the Company's investment in certain euro-denominated subsidiaries. Prior to 2019, the Company had no derivative instruments for any period presented. Interest Rate Risk We currently do not hold financial instruments for speculative purposes. Our financial assets are not subject to significant interest rate risk due to their short duration. The primary objective of our policy for the investment of temporary cash surpluses is the protection of principal, and accordingly, we generally invest in high quality, money market investments and time deposits with varying maturities, but typically less than three months. As it is our intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk. As ofDecember 31, 2019 , we had$19,362 million and$5,144 million principal amount of issued fixed rate debt and variable rate debt, respectively, that requiresU.S. dollar repayment, as well as €1,500 million principal amount of issued fixed rate debt that requires repayment in Euros. The estimated fair value of our issued fixed rate debt as ofDecember 31, 2019 , including the foreign currency denominated debt, was$22,351 million . If interest rates were to increase by 100 basis-points, the fair value of our long-term debt would decrease by approximately$248 million . If interest rates were to decrease by 100 basis-points, the fair value of our long-term debt would increase by approximately$441 million . We are subject to interest rate risk on our variable rate debt as changes in interest rates could adversely affect earnings and cash flows. A 100 basis-points increase in interest rates, based on 3-month LIBOR, would have an annualized pre-tax effect of approximately$51 million in our Consolidated Statements of Operations and Consolidated Statements of Cash Flows, based on current outstanding borrowings and effective interest rates on our variable rate debt. While our variable-rate debt may impact earnings and cash flows as interest rates change, it is not subject to changes in fair value. 82 -------------------------------------------------------------------------------- CRITICAL ACCOUNTING POLICIES AND ESTIMATES Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our Consolidated Financial Statements, and which require management's most subjective and complex judgments due to the need to select policies from among alternatives available, and to make estimates about matters that are inherently uncertain. We base our estimates on historical experience and other factors that we believe to be reasonable under the circumstances. On an ongoing basis, we review our estimates to ensure that these estimates appropriately reflect changes in our business and new information as it becomes available. If historical experience and other factors we use to make these estimates do not reasonably reflect future activity, our results of operations and financial condition could be materially impacted. Revenue Recognition InMay 2014 , theFinancial Accounting Standards Board ("FASB") issued guidance on recognizing revenue from contracts with customers. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In applying the revenue model to contracts within its scope, an entity will: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) the entity satisfies a performance obligation. In addition to these provisions, the new standard provides implementation guidance on several other topics, including the accounting for certain revenue-related costs, as well as enhanced disclosure requirements. The new guidance requires entities to disclose both quantitative and qualitative information that enables users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted this guidance effectiveJanuary 1, 2018 using the modified retrospective approach, and therefore, revenue reported for the year 2017 has not been restated. Based upon review of customer contracts, the Company concluded the implementation of the new guidance did not have a material quantitative impact on its 2018 Consolidated Financial Statements as the timing of revenue recognition for product sales did not significantly change. The new guidance did however result in additional disclosures as to the nature, amounts, and concentrations of revenue. Product Sales Provisions The following table presents the activity and ending balances for our product sales provisions for each of the last three years. Discounts and Distribution (in millions) Allowances Returns Rebates Chargebacks Fees Total Reserve balance, January 1, 2017$ 124 $ 708 $ 897 $ 273 $ 197 $ 2,199 Provision 829 423 2,545 2,145 288 6,230 Payments or credits (786 ) (268 ) (2,348 ) (2,144 ) (337 ) (5,883 ) Reserve balance, December 31, 2017 167 863 1,094 274 148 2,546 Provision 865 293 2,551 1,966 212 5,887 Payments or credits (857 ) (343 ) (2,621 ) (2,031 ) (197 ) (6,049 ) Reserve balance, December 31, 2018 175 813 1,024 209 163 2,384 Acquisition of Synergy - 3 12 - 1 16 Provision 776 113 2,265 1,938 195 5,287 Payments or credits (769 ) (238 ) (2,374 ) (1,979 ) (277 ) (5,637 ) Reserve balance, December 31, 2019$ 182 $ 691 $ 927 $ 168 $ 82$ 2,050 Included in Rebates in the table above are cooperative advertising credits due to customers of approximately$29 million and$26 million as ofDecember 31, 2019 and 2018, respectively, which are reflected as a reduction of Trade accounts receivable, net in the Consolidated Balance Sheets. The development and application of the critical accounting policies associated with the new revenue recognition guidance, including the policies associated with each of the above product sales provisions, are discussed in more detail in Note 2, "SIGNIFICANT ACCOUNTING POLICIES". 83 -------------------------------------------------------------------------------- Other Revenues We generate alliance revenue and service revenue from the licensing of products and from contract services mainly in the areas of dermatology and topical medication. Contract service revenue is derived primarily from contract manufacturing for third parties. Acquisition-Related Contingent Consideration Some of the business combinations that we have consummated include contingent consideration to be potentially paid based upon the occurrence of future events, such as sales performance and the achievement of certain future development, regulatory and sales milestones. Acquisition-related contingent consideration associated with a business combination is initially recognized at fair value and remeasured each reporting period, with changes in fair value recorded in the Consolidated Statements of Operations. The estimates of fair value involve the use of acceptable valuation methods, such as probability-weighted discounted cash flow analysis and Monte Carlo Simulation (when appropriate), and contain uncertainties as they require assumptions about the likelihood of achieving specified milestone criteria, projections of future financial performance and assumed discount rates. Changes in the fair value of the acquisition-related contingent consideration result from several factors including changes in the timing and amount of revenue estimates, changes in probability assumptions with respect to the likelihood of achieving specified milestone criteria and changes in discount rates. A change in any of these assumptions could produce a different fair value, which could have a material impact on our results of operations. AtDecember 31, 2019 , the fair value measurements of acquisition-related contingent consideration were determined using risk-adjusted discount rates ranging from 5% to 25%. Intangible Assets We evaluate potential impairments of amortizable intangible assets acquired through asset acquisitions or business combinations if events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. Our evaluation is based on an assessment of potential indicators of impairment, such as: • an adverse change in legal factors or in the business climate that could affect the value of an asset. For example, a successful challenge of our
patent rights resulting in earlier than expected generic competition;
• an adverse change in the extent or manner in which an asset is used or is
expected to be used. For example, a decision not to pursue a product
line-extension strategy to enhance an existing product due to changes in
market conditions and/or technological advances; or • current or forecasted reductions in revenue, operating income, or cash
flows associated with the use of an asset. For example, the introduction
of a competing product that results in a significant loss of market share.
Impairment exists when the carrying value of the asset exceeds the related estimated undiscounted future cash flows expected to be derived from the asset. If impairment exists, the carrying value of the asset is adjusted to its fair value. A discounted cash flow analysis is typically used to determine an asset's fair value, using estimates and assumptions that market participants would apply. Some of the estimates and assumptions inherent in a discounted cash flow model include the amount and timing of the projected future cash flows, and the discount rate used to reflect the risks inherent in the future cash flows. A change in any of these estimates and assumptions could produce a different fair value, which could have a material impact on our results of operations. In addition, an intangible asset's expected useful life can increase estimation risk, as longer-lived assets necessarily require longer-term cash flow forecasts, which for some of our intangible assets can be up to 20 years. In connection with an impairment evaluation, we also reassess the remaining useful life of the intangible asset and modify it, as appropriate. Management continually assesses the useful lives of the Company's long-lived assets. In 2017 and 2018, management revised the estimated useful lives of certain intangible assets in connection with market events and changes in assumptions. In 2017, the useful lives of certain product brands, with an aggregate carrying value of$7,618 million as ofDecember 31, 2017 , were revised to take into consideration, among other factors, various scenarios related to the date each product is anticipated to lose its exclusivity and the resulting potential changes in the forecasted sales. In addition, the useful life of the Salix Brand, with a carrying value of$569 million as ofDecember 31, 2017 , was revised from seventeen years to ten years to reflect a number of possible scenarios related to forecasted sales of its product portfolio. EffectiveSeptember 12, 2018 , the Company changed the estimated useful life of its Xifaxan®-related intangible assets due to the positive impact of an agreement between the Company andActavis Laboratories FL, Inc. ("Actavis") resolving the intellectual property litigation regarding Xifaxan® tablets, 550 mg. Under the agreement, the parties have agreed to dismiss all litigation related to Xifaxan® tablets, 550 mg and all intellectual property protecting Xifaxan® will remain intact and enforceable. As a result, the useful life of the Xifaxan® related intangible assets was extended from 2024 toJanuary 1, 2028 . This change in the estimated useful life is considered a change in accounting estimate and will result in changes to the Company's amortization expense prospectively. As ofDecember 31, 2019 , the net carrying value of the Xifaxan® related intangible assets was$4,309 million . 84 -------------------------------------------------------------------------------- Indefinite-lived intangible assets, including IPR&D and the B&L corporate trademark, are tested for impairment annually, or more frequently if events or changes in circumstances between annual tests indicate that the asset may be impaired. Impairment losses on indefinite-lived intangible assets are recognized based solely on a comparison of their fair value to carrying value, without consideration of any recoverability test. In particular, we will continue to monitor closely the progression of our R&D programs as their likelihood of success is contingent upon the achievement of future milestones. See Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations - Overview - Focus on Core Business" for additional information regarding our R&D programs.Goodwill Goodwill is not amortized but is tested for impairment at least annually as ofOctober 1st at the reporting unit level. A reporting unit is the same as, or one level below, an operating segment. The fair value of a reporting unit refers to the price that would be received to sell the unit as a whole in an orderly transaction between market participants. The Company estimates the fair values of all reporting units using a discounted cash flow model which utilizes Level 3 unobservable inputs. The discounted cash flow method relies on assumptions regarding revenue growth rates, gross profit, projected working capital requirements, selling, general and administrative expenses, research and development expenses, business restructuring costs, capital expenditures, income tax rates, discount rates and terminal growth rates. To estimate fair value, the Company discounts the forecasted cash flows of each reporting unit. The discount rate the Company uses represents the estimated weighted average cost of capital, which reflects the overall level of inherent risk involved in its reporting unit operations and the rate of return a market participant would expect to earn. To estimate cash flows beyond the final year of its model, the Company estimates a terminal value by applying an in-perpetuity growth assumption and discount factor to determine the reporting unit's terminal value. The Company incorporates the present value of the resulting terminal value into its estimate of fair value. The Company forecasted cash flows for each of its reporting units and took into consideration economic conditions and trends, estimated future operating results, management's and a market participant's view of growth rates and product lives, and anticipated future economic conditions. Revenue growth rates inherent in these forecasts were based on input from internal and external market research that compare factors such as growth in global economies, recent industry trends and product life-cycles. Macroeconomic factors such as changes in economies, changes in the competitive landscape including the unexpected loss of exclusivity to the Company's product portfolio, changes in government legislation, product life-cycles, industry consolidations and other changes beyond the Company's control could have a positive or negative impact on achieving its targets. Accordingly, if market conditions deteriorate, or if the Company is unable to execute its strategies, it may be necessary to record impairment charges in the future. InJanuary 2017 , the FASB issued guidance which simplifies the subsequent measurement of goodwill by eliminating "Step 2" from the goodwill impairment test. Instead, goodwill impairment is measured as the amount by which a reporting unit's carrying value exceeds its fair value. The Company elected to early adopt this guidance effectiveJanuary 1, 2018 . Upon adopting the new guidance, the Company tested goodwill for impairment and determined that the carrying value of the Salix reporting unit exceeded its fair value. As a result of the adoption of new accounting guidance, the Company recognized a goodwill impairment of$1,970 million associated with the Salix reporting unit. 2018 Annual Goodwill Impairment Test The Company conducted its annual goodwill impairment test as ofOctober 1, 2018 and determined that the carrying value of the Dentistry reporting unit exceeded its fair value and, as a result, the Company recognized a goodwill impairment of$109 million for the Dentistry reporting unit, representing the full amount of goodwill for the reporting unit. Changing market conditions such as: (i) an increasing competitive environment and (ii) increasing pricing pressures negatively impacted the reporting unit's operating results. The Company is taking steps to address these changing market and business conditions. The Company's remaining reporting units passed the goodwill impairment test as the estimated fair value of each reporting unit exceeded its carrying value at the date of testing and, therefore, there was no impairment to goodwill for any reporting unit other than the Dentistry reporting unit. In order to evaluate the sensitivity of its fair value calculations on the goodwill impairment test, the Company compared the carrying value of each reporting unit to its fair value as ofOctober 1, 2018 , the date of testing. As ofOctober 1, 2018 , the fair value of each reporting unit with associated goodwill exceeded its carrying value by more than 15%. 2019 Annual Goodwill Impairment Test The Company conducted its annual goodwill impairment test as ofOctober 1, 2019 by first assessing qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Where the qualitative assessment suggested that it was more likely than not that the fair value of a reporting unit was less than its carrying 85 -------------------------------------------------------------------------------- amount, a quantitative fair value test was performed for that reporting unit. In each quantitative fair value test performed, the fair value was greater than the carrying value of the reporting unit. As a result, there was no impairment to the goodwill of any reporting unit. If market conditions deteriorate, or if the Company is unable to execute its strategies, it may be necessary to record impairment charges in the future. Specifically, the Company continues to assess the performance of theOrtho Dermatologics reporting unit and the Neuro and Other reporting unit as compared to their respective projections and will perform qualitative interim assessments of the carrying value and fair value on a quarterly basis to determine if impairment testing of goodwill will be warranted. The Company performed quantitative fair value tests for theOrtho Dermatologics reporting unit and the Neuro and Other reporting unit as ofOctober 1, 2019 , utilizing long-term growth rates of 2.0% and 1.5%, and discount rates of 9.8% and 9.0%, respectively, in estimation of the fair value of these reporting units. As previously discussed the Company estimated the fair value of each reporting unit using an income approach which values the unit based on the future cash flows expected from that reporting unit. Future cash flows are based on forward-looking information regarding market share and costs for each reporting unit and are discounted using an appropriate discount rate. Future discounted cash flows can be affected by changes in industry or market conditions or the rate and extent to which anticipated synergies or cost savings are realized with newly acquired entities. The Company performed its annual impairment test as ofOctober 1, 2019 , utilizing long-term growth rates for its reporting units ranging from 1.5% to 3.0% and discount rates applied to the estimated cash flows ranging from 8.0% to 9.8% in estimation of fair value. To estimate cash flows beyond the final year of its model, the Company estimates a terminal value by applying an in-perpetuity growth assumption and discount factor to determine the reporting unit's terminal value. See Note 9, "INTANGIBLE ASSETS AND GOODWILL" to our audited Consolidated Financial Statements for further details on the goodwill impairments recognized in 2018 and 2017. Contingencies In the normal course of business, we are subject to loss contingencies, such as claims and assessments arising from litigation and other legal proceedings, contractual indemnities, product and environmental liabilities and tax matters. Other than loss contingencies that are assumed in business combinations for which we can reliably estimate the fair value, we are required to accrue for such loss contingencies if it is probable that the outcome will be unfavorable and if the amount of the loss can be reasonably estimated. We evaluate our exposure to loss based on the progress of each contingency, experience in similar contingencies and consultation with our legal counsel. We re-evaluate all contingencies as additional information becomes available. Given the uncertainties inherent in complex litigation and other contingencies, these evaluations can involve significant judgment about future events. The ultimate outcome of any litigation or other contingency may be material to our results of operations, financial condition and cash flows. See Note 21, "LEGAL PROCEEDINGS" to our audited Consolidated Financial Statements for further details regarding our current legal proceedings. Income Taxes We have operations in various countries that have differing tax laws and rates. Our tax structure is supported by current domestic tax laws in the countries in which we operate and the application of tax treaties between the various countries in which we operate. Our income tax reporting is subject to audit by domestic and foreign tax authorities. Our effective tax rate may change from year to year based on changes in the mix of activities and income earned under our intercompany arrangements among the different jurisdictions in which we operate, changes in tax laws in these jurisdictions, changes in tax treaties between various countries in which we operate, changes in our eligibility for benefits under those tax treaties and changes in the estimated values of deferred tax assets and liabilities. Such changes could result in an increase in the effective tax rate on all or a portion of our income and/or any of our subsidiaries. Our provision for income taxes is based on a number of estimates and assumptions made by management. Our consolidated income tax rate is affected by the amount of income earned in our various operating jurisdictions, the availability of benefits under tax treaties and the rates of taxes payable in respect of that income. We enter into many transactions and arrangements in the ordinary course of business in which the tax treatment is not entirely certain. We must therefore make estimates and judgments based on our knowledge and understanding of applicable tax laws and tax treaties, and the application of those tax laws and tax treaties to our business, in determining our consolidated tax provision. For example, certain countries could seek to tax a greater share of income than has been provided for by us. The final outcome of any audits by taxation authorities may differ from the estimates and assumptions we have used in determining our consolidated income tax provisions and accruals. This could result in a material effect on our consolidated income tax provision, results of operations, and financial condition for the period in which such determinations are made. Our income tax returns are subject to audit in various jurisdictions. Existing and future audits by, or other disputes with, tax authorities may not be resolved favorably for us and could have a material adverse effect on our reported effective tax rate and after-tax cash flows. We record liabilities for uncertain tax positions, which involve significant management judgment. New laws 86 -------------------------------------------------------------------------------- and new interpretations of laws and rulings by tax authorities may affect the liability for uncertain tax positions. Due to the subjectivity and complex nature of the underlying issues, actual payments or assessments may differ from our estimates. To the extent that our estimates differ from amounts eventually assessed and paid our income and cash flows may be materially and adversely affected. We assess whether it is more likely than not that we will realize the tax benefits associated with our deferred tax assets and establish a valuation allowance for assets that are not expected to result in a realized tax benefit. A significant amount of judgment is used in this process, including preparation of forecasts of future taxable income and evaluation of tax planning initiatives. If we revise these forecasts or determine that certain planning events will not occur, an adjustment to the valuation allowance will be made to tax expense in the period such determination is made. The Company's Benefit from income taxes for the year 2017 included provisional net tax benefits of$975 million attributable to the Tax Act for: (i) the re-measurement of certain deferred tax assets and liabilities based on the rates at which they are expected to reverse in the future of$774 million , (ii) the one-time transition tax on the accumulated previously untaxed earnings of foreign subsidiaries (the "Transition Toll Tax") of$88 million and (iii) the decrease in deferred tax assets attributable to certain legal accruals, the deductibility of which is uncertain forU.S. federal income tax purposes, of$10 million . We provisionally utilized NOLs to offset the provisionally determined$88 million Transition Toll Tax and therefore no amount was recorded as payable. The Company has previously provided for residualU.S. federal income tax on its outside basis differences in certain foreign subsidiaries which, due to the Tax Act, are no longer taxable. As such, our residualU.S. federal income tax liability of$299 million prior to the law change was reversed and we recognized a deferred tax benefit of$299 million in the fourth quarter of 2017. The provisional amounts included in Benefit from income taxes for the year 2017, including the Transition Toll Tax, were finalized during 2018. Differences between the provisional net income tax benefits provided for the year 2017 attributable to the Tax Act of$975 million , as previously disclosed, and the benefit for income taxes as finalized are included in the Benefit from income taxes for 2018 and were not material to the Company's financial results for the year 2018. Share-Based Compensation We recognize employee share-based compensation, including grants of stock options and RSUs, at estimated fair value. As there is no market for trading our employee stock options, we use the Black-Scholes option-pricing model to calculate stock option fair values, which requires certain assumptions related to the expected life of the stock option, future stock price volatility, risk-free interest rate and dividend yield. The expected life of the stock option is based on historical exercise and forfeiture patterns. The expected volatility of our common stock is estimated by using implied volatility in market traded options. The risk-free interest rate is based on the rate at the time of grant forU.S. Treasury bonds with a remaining term equal to the expected life of the stock option. Dividend yield is based on the stock option's exercise price and expected annual dividend rate at the time of grant. Changes to any of these assumptions, or the use of a different option-pricing model, such as the lattice model, could produce a different fair value for share-based compensation expense, which could have a material impact on our results of operations. We determine the fair value of each RSU granted based on the trading price of our common shares on the date of grant, unless the vesting of the RSU is conditional on the attainment of any applicable performance goals based on total shareholder return, in which case we use a Monte Carlo simulation model. The Monte Carlo simulation model utilizes multiple input variables to estimate the probability that the performance condition will be achieved. Changes to any of these inputs could materially affect the measurement of the fair value of the performance-based RSUs. We also have performance-based RSUs that vest upon attainment of certain performance targets. We recognize the expense associated with these performance-based RSUs based on the number of RSUs we expect to vest, which is estimated by comparing our latest forecast to the applicable performance targets. If RSUs do not vest as a result of a determination that the prescribed performance goals failed to be attained, then no expense would be recognized and any expense previously recognized for the RSUs would be reversed upon such determination. NEW ACCOUNTING STANDARDS Information regarding the recently issued new accounting guidance (adopted and not adopted as ofDecember 31, 2019 ) is contained in Note 2, "SIGNIFICANT ACCOUNTING POLICIES" to our audited Consolidated Financial Statements. FORWARD-LOOKING STATEMENTS Caution regarding forward-looking information and statements and "Safe-Harbor" statements under theU.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws: 87 -------------------------------------------------------------------------------- To the extent any statements made in this Form 10-K contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information within the meaning defined under applicable Canadian securities laws (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things: our business strategy, business plans and prospects and forecasts and changes thereto; product pipeline, prospective products and product approvals, product development and future performance and results of current and anticipated products; anticipated revenues for our products; anticipated growth in ourOrtho Dermatologics business; expected R&D and marketing spend; our expected primary cash and working capital requirements for 2020 and beyond; our plans for continued improvement in operational efficiency and the anticipated impact of such plans; our liquidity and our ability to satisfy our debt maturities as they become due; our ability to reduce debt levels; our ability to meet the financial and other covenants contained in our Fourth Amended and Restated Credit and Guaranty Agreement (the "Restated Credit Agreement") and senior notes indentures; the impact of our distribution, fulfillment and other third-party arrangements; proposed pricing actions; exposure to foreign currency exchange rate changes and interest rate changes; the outcome of contingencies, such as litigation, subpoenas, investigations, reviews, audits and regulatory proceedings; the anticipated impact of the adoption of new accounting standards; general market conditions; our expectations regarding our financial performance, including revenues, expenses, gross margins and income taxes; and our impairment assessments, including the assumptions used therein and the results thereof. Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "estimate", "plan", "continue", "will", "may", "could", "would", "should", "target", "potential", "opportunity", "designed", "create", "predict", "project", "forecast", "seek", "strive", "ongoing" or "increase" and variations or other similar expressions. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements may not be appropriate for other purposes. Although we have previously indicated certain of these statements set out herein, all of the statements in this Form 10-K that contain forward-looking statements are qualified by these cautionary statements. These statements are based upon the current expectations and beliefs of management. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making such forward-looking statements, including, but not limited to, factors and assumptions regarding the items previously outlined, those factors, risks and uncertainties outlined below and the assumption that none of these factors, risks and uncertainties will cause actual results or events to differ materially from those described in such forward-looking statements. Actual results may differ materially from those expressed or implied in such statements. Important factors, risks and uncertainties that could cause actual results to differ materially from these expectations include, among other things, the following: • the expense, timing and outcome of legal and governmental proceedings,
investigations and information requests relating to, among other matters,
our past distribution, marketing, pricing, disclosure and accounting
practices (including with respect to our former relationship with Philidor
Rx Services, LLC ("Philidor")), including pending investigations by theU.S. Attorney's Office for the District of Massachusetts and theU.S. Attorney's Office for the Southern District of New York , the pending
investigations by the
of the Company, the investigation order issued by the Company from the
Autorité des marchés financiers (the "AMF") (the Company's principal
securities regulator inCanada ), a number of pending securities litigations (including certain pending opt-out actions in theU.S. (related to the recently settled securities class action, (which is subject to final court approval, and remains subject to the risk and
uncertainty that the
may not approve the
class action litigation in
purported class actions under the federal RICO statute and other claims,
investigations or proceedings that may be initiated or that may be asserted; • potential additional litigation and regulatory investigations (and any costs, expenses, use of resources, diversion of management time and efforts, liability and damages that may result therefrom), negative
publicity and reputational harm on our Company, products and business that
may result from the past and ongoing public scrutiny of our past
distribution, marketing, pricing, disclosure and accounting practices and
from our former relationship with Philidor;
• the past and ongoing scrutiny of our legacy business practices, including
with respect to pricing (including the investigations by the
Attorney's Offices for the District of
District of
may be sought or imposed on our products as a result thereof;
• pricing decisions that we have implemented, or may in the future elect to
implement, such as the
that the average annual price increase for our branded prescription
pharmaceutical products will be set at no greater than single digits, or
any future pricing actions we may take following review by our Patient
drugs); 88
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• legislative or policy efforts, including those that may be introduced and
passed by the
costs for medicines, which could result in new mandatory rebates and discounts or other pricing restrictions, controls or regulations (including mandatory price reductions);
• ongoing oversight and review of our products and facilities by regulatory
and governmental agencies, including periodic audits by the
Drug Administration (the "FDA") and the results thereof; • actions by the FDA or other regulatory authorities with respect to our products or facilities;
• our substantial debt (and potential additional future indebtedness) and
current and future debt service obligations, our ability to reduce our outstanding debt levels and the resulting impact on our financial condition, cash flows and results of operations; • our ability to meet the financial and other covenants contained in our Restated Credit Agreement, senior notes indentures and other current or
future debt agreements and the limitations, restrictions and prohibitions
such covenants impose or may impose on the way we conduct our business,
including prohibitions on incurring additional debt if certain financial
covenants are not met, limitations on the amount of additional obligations
we are able to incur pursuant to other covenants, and restrictions on our
ability to make certain investments and other restricted payments;
• any default under the terms of our senior notes indentures or Restated
Credit Agreement and our ability, if any, to cure or obtain waivers of such default; • any delay in the filing of any future financial statements or other
filings and any default under the terms of our senior notes indentures or
Restated Credit Agreement as a result of such delays;
• any downgrade by rating agencies in our credit ratings, which may impact,
among other things, our ability to raise debt and the cost of capital for
additional debt issuances;
• any reductions in, or changes in the assumptions used in, our forecasts
for fiscal year 2020 or beyond, which could lead to, among other things:
(i) a failure to meet the financial and/or other covenants contained in our Restated Credit Agreement and/or senior notes indentures and/or (ii) impairment in the goodwill associated with certain of our reporting units or impairment charges related to certain of our products or other intangible assets, which impairments could be material;
• changes in the assumptions used in connection with our impairment analyses
or assessments, which would lead to a change in such impairment analyses
and assessments and which could result in an impairment in the goodwill
associated with any of our reporting units or impairment charges related
to certain of our products or other intangible assets; • the uncertainties associated with the acquisition and launch of new
products (such as our recently launched Bryhali®, Duobrii® and Ocuvite®
Eye Performance products), including, but not limited to, our ability to
provide the time, resources, expertise and costs required for the commercial launch of new products, the acceptance and demand for new pharmaceutical products, and the impact of competitive products and pricing, which could lead to material impairment charges;
• our ability or inability to extend the profitable life of our products,
including through line extensions and other life-cycle programs; • our ability to retain, motivate and recruit executives and other key employees;
• our ability to implement effective succession planning for our executives
and key employees; • factors impacting our ability to achieve anticipated growth in ourOrtho Dermatologics business, including the success of recently launched
products (such as Bryhali® and Duobrii®), the ability to successfully
implement and operate Dermatology.com, our new cash-pay prescription program for certain of ourOrtho Dermatologics branded products, and the ability of such program to achieve the anticipated goals respecting patient access and fulfillment, the approval of pending and pipeline products (and the timing of such approvals), expected geographic expansion, changes in estimates on market potential for dermatology products and continued investment in and success of our sales force; • factors impacting our ability to achieve anticipated revenues for our products, including changes in anticipated marketing spend on such products and launch of competing products;
• the challenges and difficulties associated with managing a large complex
business, which has, in the past, grown rapidly; 89
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• our ability to compete against companies that are larger and have greater
financial, technical and human resources than we do, as well as other
competitive factors, such as technological advances achieved, patents
obtained and new products introduced by our competitors;
• our ability to effectively operate and grow our businesses in light of the
challenges that the Company has faced and market conditions, including
with respect to its substantial debt, pending investigations and legal proceedings, scrutiny of our past pricing and other practices, and limitations on the way we conduct business imposed by the covenants contained in our Restated Credit Agreement, senior notes indentures and the agreements governing our other indebtedness;
• the extent to which our products are reimbursed by government authorities,
pharmacy benefit managers ("PBMs") and other third-party payors; the impact our distribution, pricing and other practices (including as it relates to our current relationship withWalgreen Co. ("Walgreens")) may have on the decisions of such government authorities, PBMs and other
third-party payors to reimburse our products; and the impact of obtaining
or maintaining such reimbursement on the price and sales of our products;
• the inclusion of our products on formularies or our ability to achieve
favorable formulary status, as well as the impact on the price and sales of our products in connection therewith;
• the consolidation of wholesalers, retail drug chains and other customer
groups and the impact of such industry consolidation on our business;
• our eligibility for benefits under tax treaties and the continued availability of low effective tax rates for the business profits of certain of our subsidiaries;
• the actions of our third-party partners or service providers of research,
development, manufacturing, marketing, distribution or other services,
including their compliance with applicable laws and contracts, which
actions may be beyond our control or influence, and the impact of such
actions on our Company, including the impact to the Company of our former
relationship with Philidor and any alleged legal or contractual non-compliance by Philidor;
• the risks associated with the international scope of our operations,
including our presence in emerging markets and the challenges we face when
entering and operating in new and different geographic markets (including
the challenges created by new and different regulatory regimes in such
countries and the need to comply with applicable anti-bribery and economic
sanctions laws and regulations);
• adverse global economic conditions and credit markets and foreign currency
exchange uncertainty and volatility in certain of the countries in which we do business;
• the impact of
potential changes to other trade agreements;
• the final outcome and impact of Brexit negotiations;
• the trade conflict between
• the extent and impact of the coronavirus reported to have surfaced in
• our ability to obtain, maintain and license sufficient intellectual
property rights over our products and enforce and defend against challenges to such intellectual property (such as in connection with the recent filing bySandoz Inc. ("Sandoz") andNorwich Pharmaceuticals Inc.
("Norwich") of their respective Abbreviated New Drug Application ("ANDA")
for Xifaxan® (rifaximin) 550 mg tablets and the Company's related lawsuit
filed against Sandoz in connection therewith. The Company intends to file suit against Norwich within the regulated timeframe); • the introduction of generic, biosimilar or other competitors of our branded products and other products, including the introduction of
products that compete against our products that do not have patent or data
exclusivity rights;
• our ability to identify, finance, acquire, close and integrate acquisition
targets successfully and on a timely basis and the difficulties,
challenges, time and resources associated with the integration of acquired
companies, businesses and products;
• any additional divestitures of our assets or businesses and our ability to
successfully complete any such divestitures on commercially reasonable
terms and on a timely basis, or at all, and the impact of any such divestitures on our Company, including the reduction in the size or scope of our business or market share, loss of revenue, any loss on sale, including any resultant impairments of goodwill or other assets, or any
adverse tax consequences suffered as a result of any such divestitures;
90 --------------------------------------------------------------------------------
• the expense, timing and outcome of pending or future legal and
governmental proceedings, arbitrations, investigations, subpoenas, tax and
other regulatory audits, examinations, reviews and regulatory proceedings
against us or relating to us and settlements thereof; • our ability to negotiate the terms of or obtain court approval for the settlement of certain legal and regulatory proceedings;
• our ability to obtain components, raw materials or finished products
supplied by third parties (some of which may be single-sourced) and other
manufacturing and related supply difficulties, interruptions and delays;
• the disruption of delivery of our products and the routine flow of manufactured goods;
• economic factors over which the Company has no control, including changes
in inflation, interest rates, foreign currency rates, and the potential
effect of such factors on revenues, expenses and resulting margins;
• interest rate risks associated with our floating rate debt borrowings;
• our ability to effectively distribute our products and the effectiveness
and success of our distribution arrangements, including the impact of our
arrangements with Walgreens; • our ability to effectively promote our own products and those of our co-promotion partners;
• the success of our fulfillment arrangements with Walgreens, including
market acceptance of, or market reaction to, such arrangements (including
by customers, doctors, patients, PBMs, third-party payors and governmental
agencies), and the continued compliance of such arrangements with applicable laws;
• our ability to secure and maintain third-party research, development,
manufacturing, licensing, marketing or distribution arrangements;
• the risk that our products could cause, or be alleged to cause, personal
injury and adverse effects, leading to potential lawsuits, product
liability claims and damages and/or recalls or withdrawals of products
from the market;
• the mandatory or voluntary recall or withdrawal of our products from the
market and the costs associated therewith;
• the availability of, and our ability to obtain and maintain, adequate
insurance coverage and/or our ability to cover or insure against the total
amount of the claims and liabilities we face, whether through third-party
insurance or self-insurance;
• the difficulty in predicting the expense, timing and outcome within our
legal and regulatory environment, including with respect to approvals by
the FDA,
regulatory proceedings and settlements thereof, the protection afforded by
our patents and other intellectual and proprietary property, successful
generic challenges to our products and infringement or alleged infringement of the intellectual property of others; • the results of continuing safety and efficacy studies by industry and government agencies;
• the success of preclinical and clinical trials for our drug development
pipeline or delays in clinical trials that adversely impact the timely
commercialization of our pipeline products, as well as other factors impacting the commercial success of our products, which could lead to material impairment charges; • the results of management reviews of our research and development
portfolio (including following the receipt of clinical results or feedback
from the FDA or other regulatory authorities), which could result in
terminations of specific projects which, in turn, could lead to material
impairment charges;
• the seasonality of sales of certain of our products;
• declines in the pricing and sales volume of certain of our products that
are distributed or marketed by third parties, over which we have no or limited control; • compliance by the Company or our third-party partners and service
providers (over whom we may have limited influence), or the failure of our
Company or these third parties to comply, with health care "fraud and
abuse" laws and other extensive regulation of our marketing, promotional
and business practices (including with respect to pricing), worldwide
anti-bribery laws (including theU.S. Foreign Corrupt Practices Act and the Canadian Corruption of Foreign Public Officials Act), worldwide economic sanctions and/or export laws, worldwide environmental laws and regulation and privacy and security regulations; 91
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• the impacts of the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Reconciliation Act of 2010 (the "Health
Care Reform Act") and potential amendment thereof and other legislative
and regulatory health care reforms in the countries in which we operate,
including with respect to recent government inquiries on pricing;
• the impact of any changes in or reforms to the legislation, laws, rules,
regulation and guidance that apply to the Company and its business and
products or the enactment of any new or proposed legislation, laws, rules,
regulations or guidance that will impact or apply to the Company or its businesses or products;
• the impact of changes in federal laws and policy under consideration by
the Trump administration andCongress , including the effect that such changes will have on fiscal and tax policies, the potential revision of all or portions of the Health Care Reform Act, international trade
agreements and policies and policy efforts designed to reduce patient
out-of-pocket costs for medicines (which could result in new mandatory
rebates and discounts or other pricing restrictions);
• illegal distribution or sale of counterfeit versions of our products; and
• interruptions, breakdowns or breaches in our information technology systems.
Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found elsewhere in this Form 10-K, under Item 1A. "Risk Factors" and in the Company's other filings with theSEC and the Canadian Securities Administrators (the "CSA"). When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. These forward-looking statements speak only as of the date made. We undertake no obligation to update or revise any of these forward-looking statements to reflect events or circumstances after the date of this Form 10-K or to reflect actual outcomes, except as required by law. We caution that, as it is not possible to predict or identify all relevant factors that may impact forward-looking statements, the foregoing list of important factors that may affect future results is not exhaustive and should not be considered a complete statement of all potential risks and uncertainties. Item 7A. Quantitative and Qualitative Disclosures About Market Risk Information relating to quantitative and qualitative disclosures about market risk is detailed in Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations - Quantitative and Qualitative Disclosures About Market Risk" and is incorporated herein by reference. Item 8. Financial Statements and Supplementary Data The information required by this Item is contained in the financial statements set forth in Item 15 "Exhibits and Financial Statement Schedules" as part of this Form 10-K and is incorporated herein by reference. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Not applicable. Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures The Company's management, with the participation of the Company's Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company's disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) as of December 31, 2019. Based on that evaluation, the Company's Chief Executive Officer and the Company's Chief Financial Officer have concluded that as of December 31, 2019, the Company's disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in theSEC's rules and forms, and that such information is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosure. Management's Annual Report on Internal Control Over Financial Reporting The Company's management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The Company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. 92 -------------------------------------------------------------------------------- Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Under the supervision and with the participation of management, including the Company's Chief Executive Officer and the Company's Chief Financial Officer, the Company conducted an evaluation of the effectiveness of its internal control over financial reporting as of December 31, 2019 based on the framework described in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation, management has concluded that the Company maintained effective internal control over financial reporting as of December 31, 2019. The effectiveness of the Company's internal control over financial reporting as of December 31, 2019 has been audited byPricewaterhouseCoopers LLP , an independent registered public accounting firm, as stated in their report which appears herein. Changes in Internal Control over Financial Reporting There have not been any changes in the Company's internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the last fiscal quarter of 2019 that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting. Item 9B. Other Information None. 93
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