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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Quarterly Period Ended March 31, 2019
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from
to
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British Columbia, Canada
(State or other jurisdiction of incorporation or organization) |
98-0448205
(I.R.S. Employer Identification No.) |
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2150 St. Elzéar Blvd. West, Laval, Québec
(Address of principal executive offices) |
H7L 4A8
(Zip Code) |
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Large accelerated filer
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x
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Accelerated filer
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o
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Non-accelerated filer
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o
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Smaller reporting company
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o
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Emerging growth company
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o
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
o
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Shares, No Par Value
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BHC
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New York Stock Exchange, Toronto Stock Exchange
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Part I.
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Financial Information
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Item 1.
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Consolidated
Financial Statements (unaudited)
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Item 2.
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Item 3.
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Item 4.
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Part II
.
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Other Information
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Item 1.
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Item 1A.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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•
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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 the U.S. Attorney's Office for the District of Massachusetts and the U.S. Attorney's Office for the Southern District of New York, the pending investigations by the U.S. Securities and Exchange Commission (the “SEC”) of the Company, the investigation order issued by the Company from the Autorité des marchés financiers (the “AMF”) (the Company’s principal securities regulator in Canada), a number of pending putative securities class action litigations in the U.S. (including
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•
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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;
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•
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the past and ongoing scrutiny of our legacy business practices, including with respect to pricing (including the investigations by the U.S. Attorney's Offices for the District of Massachusetts and the Southern District of New York), and any pricing controls or price adjustments that may be sought or imposed on our products as a result thereof;
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•
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pricing decisions that we have implemented, or may in the future elect to implement, whether as a result of recent scrutiny or otherwise, such as the Patient Access and Pricing Committee’s commitment 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 Access and Pricing Committee (which is responsible for the pricing of our drugs);
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•
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legislative or policy efforts, including those that may be introduced and passed by the U.S. Congress, designed to reduce patient out-of-pocket costs for medicines, which could result in new mandatory rebates and discounts or other pricing restrictions, controls or regulations (including mandatory price reductions);
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•
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ongoing oversight and review of our products and facilities by regulatory and governmental agencies, including periodic audits by the U.S. Food and Drug Administration (the "FDA") and the results thereof;
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•
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actions by the FDA or other regulatory authorities with respect to our products or facilities;
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•
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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;
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•
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our ability to meet the financial and other covenants contained in our Restated Credit Agreement, 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 debt we are able to incur where not prohibited, and restrictions on our ability to make certain investments and other restricted payments;
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•
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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;
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•
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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;
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•
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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;
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•
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any reductions in, or changes in the assumptions used in, our forecasts for fiscal year 2019 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 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;
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•
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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;
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•
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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;
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•
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the uncertainties associated with the acquisition and launch of new 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
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•
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our ability or inability to extend the profitable life of our products, including through line extensions and other life-cycle programs;
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•
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our ability to retain, motivate and recruit executives and other key employees;
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•
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our ability to implement effective succession planning for our executives and key employees;
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•
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factors impacting our ability to achieve anticipated growth in our Ortho Dermatologics business, including the approval of pending and pipeline products (and the timing of such approvals), the ability to successfully implement and operate our new cash-pay prescription program for certain of our Ortho Dermatologics branded products and the ability of such program to achieve the anticipated goals respecting patient access and fulfillment, expected geographic expansion, changes in estimates on market potential for dermatology products and continued investment in and success of our sales force;
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•
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factors impacting our ability to achieve anticipated revenues for our Significant Seven products, including changes in anticipated marketing spend on such products and launch of competing products;
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•
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the challenges and difficulties associated with managing a large complex business, which has, in the past, grown rapidly;
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•
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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;
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•
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our ability to effectively operate, stabilize and grow our businesses in light of the challenges that the Company currently faces, including with respect to its substantial debt, pending investigations and legal proceedings, scrutiny of our past pricing, distribution and other practices, reputational harm and limitations on the way we conduct business imposed by the covenants in our Restated Credit Agreement, indentures and the agreements governing our other indebtedness;
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•
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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 with Walgreen 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;
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•
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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;
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•
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the consolidation of wholesalers, retail drug chains and other customer groups and the impact of such industry consolidation on our business;
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•
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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;
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•
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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;
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•
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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);
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•
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adverse global economic conditions and credit markets and foreign currency exchange uncertainty and volatility in certain of the countries in which we do business;
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•
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the impact of the recently signed United States-Mexico-Canada Agreement (“USMCA”) and any potential changes to other trade agreements;
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•
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the final outcome and impact of Brexit negotiations;
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•
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the trade conflict between the United States and China;
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•
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our ability to obtain, maintain and license sufficient intellectual property rights over our products and enforce and defend against challenges to such intellectual property;
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•
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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;
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•
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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;
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•
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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;
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•
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our ability to negotiate the terms of or obtain court approval for the settlement of certain legal and regulatory proceedings;
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•
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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;
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•
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the disruption of delivery of our products and the routine flow of manufactured goods;
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•
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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;
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•
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interest rate risks associated with our floating rate debt borrowings;
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•
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our ability to effectively distribute our products and the effectiveness and success of our distribution arrangements, including the impact of our arrangements with Walgreens;
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•
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our ability to effectively promote our own products and those of our co-promotion partners, such as Doptelet
®
(Dova Pharmaceuticals, Inc.) and Lucemyra
TM
(US WorldMeds, LLC);
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•
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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), the continued compliance of such arrangements with applicable laws, and our ability to successfully negotiate any improvements to our arrangements with Walgreens;
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•
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our ability to secure and maintain third-party research, development, manufacturing, licensing, marketing or distribution arrangements;
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•
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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;
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•
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the mandatory or voluntary recall or withdrawal of our products from the market and the costs associated therewith;
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•
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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;
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•
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the difficulty in predicting the expense, timing and outcome within our legal and regulatory environment, including with respect to approvals by the FDA, Health Canada and similar agencies in other countries, legal and 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;
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•
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the results of continuing safety and efficacy studies by industry and government agencies;
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•
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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;
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•
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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;
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•
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the seasonality of sales of certain of our products;
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•
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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;
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•
|
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 the U.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;
|
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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;
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•
|
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;
|
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•
|
the impact of changes in federal laws and policy under consideration by the Trump administration and Congress, 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);
|
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•
|
illegal distribution or sale of counterfeit versions of our products;
|
|
•
|
interruptions, breakdowns or breaches in our information technology systems; and
|
|
•
|
risks in Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018, filed on February 20, 2019, and risks detailed from time to time in our other filings with the SEC and the Canadian Securities Administrators (the “CSA”), as well as our ability to anticipate and manage the risks associated with the foregoing.
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|
March 31,
2019 |
|
December 31,
2018 |
||||
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Assets
|
|
|
|
||||
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Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
782
|
|
|
$
|
721
|
|
|
Restricted cash
|
2
|
|
|
2
|
|
||
|
Trade receivables, net
|
1,786
|
|
|
1,865
|
|
||
|
Inventories, net
|
1,012
|
|
|
934
|
|
||
|
Prepaid expenses and other current assets
|
693
|
|
|
689
|
|
||
|
Total current assets
|
4,275
|
|
|
4,211
|
|
||
|
Property, plant and equipment, net
|
1,341
|
|
|
1,353
|
|
||
|
Intangible assets, net
|
11,683
|
|
|
12,001
|
|
||
|
Goodwill
|
13,121
|
|
|
13,142
|
|
||
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Deferred tax assets, net
|
1,754
|
|
|
1,676
|
|
||
|
Other non-current assets
|
377
|
|
|
109
|
|
||
|
Total assets
|
$
|
32,551
|
|
|
$
|
32,492
|
|
|
Liabilities
|
|
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|
||||
|
Current liabilities:
|
|
|
|
||||
|
Accounts payable
|
$
|
429
|
|
|
$
|
411
|
|
|
Accrued and other current liabilities
|
3,255
|
|
|
3,197
|
|
||
|
Current portion of long-term debt and other
|
257
|
|
|
228
|
|
||
|
Total current liabilities
|
3,941
|
|
|
3,836
|
|
||
|
Acquisition-related contingent consideration
|
264
|
|
|
298
|
|
||
|
Non-current portion of long-term debt
|
23,924
|
|
|
24,077
|
|
||
|
Deferred tax liabilities, net
|
880
|
|
|
885
|
|
||
|
Other non-current liabilities
|
763
|
|
|
581
|
|
||
|
Total liabilities
|
29,772
|
|
|
29,677
|
|
||
|
Commitments and contingencies (Note 19)
|
|
|
|
|
|
||
|
Equity
|
|
|
|
||||
|
Common shares, no par value, unlimited shares authorized, 351,873,984 and 349,871,102 issued and outstanding at March 31, 2019 and December 31, 2018, respectively
|
10,151
|
|
|
10,121
|
|
||
|
Additional paid-in capital
|
374
|
|
|
413
|
|
||
|
Accumulated deficit
|
(5,716
|
)
|
|
(5,664
|
)
|
||
|
Accumulated other comprehensive loss
|
(2,116
|
)
|
|
(2,137
|
)
|
||
|
Total Bausch Health Companies Inc. shareholders’ equity
|
2,693
|
|
|
2,733
|
|
||
|
Noncontrolling interest
|
86
|
|
|
82
|
|
||
|
Total equity
|
2,779
|
|
|
2,815
|
|
||
|
Total liabilities and equity
|
$
|
32,551
|
|
|
$
|
32,492
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2019
|
|
2018
|
||||
|
Revenues
|
|
|
|
||||
|
Product sales
|
$
|
1,989
|
|
|
$
|
1,965
|
|
|
Other revenues
|
27
|
|
|
30
|
|
||
|
|
2,016
|
|
|
1,995
|
|
||
|
Expenses
|
|
|
|
||||
|
Cost of goods sold (excluding amortization and impairments of intangible assets)
|
524
|
|
|
560
|
|
||
|
Cost of other revenues
|
13
|
|
|
13
|
|
||
|
Selling, general and administrative
|
587
|
|
|
591
|
|
||
|
Research and development
|
117
|
|
|
92
|
|
||
|
Amortization of intangible assets
|
489
|
|
|
743
|
|
||
|
Goodwill impairments
|
—
|
|
|
2,213
|
|
||
|
Asset impairments
|
3
|
|
|
44
|
|
||
|
Restructuring and integration costs
|
20
|
|
|
6
|
|
||
|
Acquired in-process research and development costs
|
1
|
|
|
1
|
|
||
|
Acquisition-related contingent consideration
|
(21
|
)
|
|
2
|
|
||
|
Other (income) expense, net
|
(4
|
)
|
|
11
|
|
||
|
|
1,729
|
|
|
4,276
|
|
||
|
Operating income (loss)
|
287
|
|
|
(2,281
|
)
|
||
|
Interest income
|
4
|
|
|
3
|
|
||
|
Interest expense
|
(406
|
)
|
|
(416
|
)
|
||
|
Loss on extinguishment of debt
|
(7
|
)
|
|
(27
|
)
|
||
|
Foreign exchange and other
|
—
|
|
|
27
|
|
||
|
Loss before benefit from income taxes
|
(122
|
)
|
|
(2,694
|
)
|
||
|
Benefit from income taxes
|
74
|
|
|
115
|
|
||
|
Net loss
|
(48
|
)
|
|
(2,579
|
)
|
||
|
Net income attributable to noncontrolling interest
|
(4
|
)
|
|
(2
|
)
|
||
|
Net loss attributable to Bausch Health Companies Inc.
|
$
|
(52
|
)
|
|
$
|
(2,581
|
)
|
|
|
|
|
|
||||
|
Loss per share attributable to Bausch Health Companies Inc.:
|
|
|
|
||||
|
Basic
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
Diluted
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
|
|
|
|
||||
|
Weighted-average common shares
|
|
|
|
||||
|
Basic
|
351.3
|
|
|
350.7
|
|
||
|
Diluted
|
351.3
|
|
|
350.7
|
|
||
|
|
Three Months Ended
March 31, |
||||||
|
|
2019
|
|
2018
|
||||
|
Net loss
|
$
|
(48
|
)
|
|
$
|
(2,579
|
)
|
|
Other comprehensive income
|
|
|
|
||||
|
Foreign currency translation adjustment
|
21
|
|
|
46
|
|
||
|
Pension and postretirement benefit plan adjustments, net of income taxes
|
—
|
|
|
—
|
|
||
|
Other comprehensive income
|
21
|
|
|
46
|
|
||
|
Comprehensive loss
|
(27
|
)
|
|
(2,533
|
)
|
||
|
Comprehensive income attributable to noncontrolling interest
|
(4
|
)
|
|
(4
|
)
|
||
|
Comprehensive loss attributable to Bausch Health Companies Inc.
|
$
|
(31
|
)
|
|
$
|
(2,537
|
)
|
|
|
|
Bausch Health Companies Inc. Shareholders' Equity
|
|
|
|
|
|||||||||||||||||||||||||
|
|
|
Common Shares
|
|
|
|
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Bausch Health
Companies Inc.
Shareholders'
Equity
|
|
|
|
|
|||||||||||||||||
|
|
|
Shares
|
|
Amount
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Deficit
|
|
Noncontrolling
Interest
|
|
Total
Equity
|
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance, January 1, 2019
|
|
349.9
|
|
|
$
|
10,121
|
|
|
$
|
413
|
|
|
$
|
(5,664
|
)
|
|
$
|
(2,137
|
)
|
|
$
|
2,733
|
|
|
$
|
82
|
|
|
$
|
2,815
|
|
|
Common shares issued under share-based compensation plans
|
|
2.0
|
|
|
30
|
|
|
(29
|
)
|
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
|||||||
|
Share-based compensation
|
|
—
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
24
|
|
|||||||
|
Employee withholding taxes related to share-based awards
|
|
—
|
|
|
—
|
|
|
(34
|
)
|
|
—
|
|
|
—
|
|
|
(34
|
)
|
|
—
|
|
|
(34
|
)
|
|||||||
|
Net (loss) income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(52
|
)
|
|
—
|
|
|
(52
|
)
|
|
4
|
|
|
(48
|
)
|
|||||||
|
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21
|
|
|
21
|
|
|
—
|
|
|
21
|
|
|||||||
|
Balance, March 31, 2019
|
|
351.9
|
|
|
$
|
10,151
|
|
|
$
|
374
|
|
|
$
|
(5,716
|
)
|
|
$
|
(2,116
|
)
|
|
$
|
2,693
|
|
|
$
|
86
|
|
|
$
|
2,779
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance, January 1, 2018
|
|
348.7
|
|
|
$
|
10,090
|
|
|
$
|
380
|
|
|
$
|
(2,725
|
)
|
|
$
|
(1,896
|
)
|
|
$
|
5,849
|
|
|
$
|
95
|
|
|
$
|
5,944
|
|
|
Effect of application of new accounting standard: Income taxes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,209
|
|
|
—
|
|
|
1,209
|
|
|
—
|
|
|
1,209
|
|
|||||||
|
Common shares issued under share-based compensation plans
|
|
0.5
|
|
|
13
|
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
|
Share-based compensation
|
|
—
|
|
|
—
|
|
|
21
|
|
|
—
|
|
|
—
|
|
|
21
|
|
|
—
|
|
|
21
|
|
|||||||
|
Employee withholding taxes related to share-based awards
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
(6
|
)
|
|||||||
|
Net (loss) income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,581
|
)
|
|
—
|
|
|
(2,581
|
)
|
|
2
|
|
|
(2,579
|
)
|
|||||||
|
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
44
|
|
|
44
|
|
|
2
|
|
|
46
|
|
|||||||
|
Balance, March 31, 2018
|
|
349.2
|
|
|
$
|
10,103
|
|
|
$
|
382
|
|
|
$
|
(4,097
|
)
|
|
$
|
(1,852
|
)
|
|
$
|
4,536
|
|
|
$
|
99
|
|
|
$
|
4,635
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2019
|
|
2018
|
||||
|
Cash Flows From Operating Activities
|
|
|
|
||||
|
Net loss
|
$
|
(48
|
)
|
|
$
|
(2,579
|
)
|
|
Adjustments to reconcile net loss to net cash provided by operating activities:
|
|
|
|
||||
|
Depreciation and amortization of intangible assets
|
532
|
|
|
786
|
|
||
|
Amortization and write-off of debt premiums, discounts and issuance costs
|
17
|
|
|
23
|
|
||
|
Asset impairments
|
3
|
|
|
44
|
|
||
|
Acquisition-related contingent consideration
|
(21
|
)
|
|
2
|
|
||
|
Allowances for losses on trade receivable and inventories
|
13
|
|
|
17
|
|
||
|
Deferred income taxes
|
(116
|
)
|
|
(152
|
)
|
||
|
Gain on sale of assets
|
(10
|
)
|
|
—
|
|
||
|
Additions to accrued legal settlements
|
2
|
|
|
11
|
|
||
|
Payments of accrued legal settlements
|
(1
|
)
|
|
(170
|
)
|
||
|
Goodwill impairments
|
—
|
|
|
2,213
|
|
||
|
Share-based compensation
|
24
|
|
|
21
|
|
||
|
Foreign exchange gain
|
—
|
|
|
(25
|
)
|
||
|
Loss on extinguishment of debt
|
7
|
|
|
27
|
|
||
|
Other
|
9
|
|
|
(3
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Trade receivables
|
89
|
|
|
204
|
|
||
|
Inventories
|
(68
|
)
|
|
—
|
|
||
|
Prepaid expenses and other current assets
|
(15
|
)
|
|
(70
|
)
|
||
|
Accounts payable, accrued and other liabilities
|
(4
|
)
|
|
89
|
|
||
|
Net cash provided by operating activities
|
413
|
|
|
438
|
|
||
|
|
|
|
|
||||
|
Cash Flows From Investing Activities
|
|
|
|
||||
|
Acquisition of businesses, net of cash acquired
|
(180
|
)
|
|
5
|
|
||
|
Payments for intangible and other assets
|
—
|
|
|
(14
|
)
|
||
|
Purchases of property, plant and equipment
|
(47
|
)
|
|
(33
|
)
|
||
|
Purchases of marketable securities
|
(2
|
)
|
|
—
|
|
||
|
Proceeds from sale of marketable securities
|
1
|
|
|
2
|
|
||
|
Proceeds from sale of assets and businesses, net of costs to sell
|
25
|
|
|
(8
|
)
|
||
|
Net cash used in investing activities
|
(203
|
)
|
|
(48
|
)
|
||
|
|
|
|
|
||||
|
Cash Flows From Financing Activities
|
|
|
|
||||
|
Net proceeds from the issuances of long-term debt
|
1,514
|
|
|
1,481
|
|
||
|
Repayments of long-term debt
|
(1,621
|
)
|
|
(1,731
|
)
|
||
|
Repayments of short-term debt
|
—
|
|
|
(1
|
)
|
||
|
Payments of employee withholding taxes related to share-based awards
|
(34
|
)
|
|
(5
|
)
|
||
|
Payments of acquisition-related contingent consideration
|
(9
|
)
|
|
(11
|
)
|
||
|
Debt extinguishment costs
|
(1
|
)
|
|
(20
|
)
|
||
|
Other
|
1
|
|
|
(1
|
)
|
||
|
Net cash used in financing activities
|
(150
|
)
|
|
(288
|
)
|
||
|
Effect of exchange rate changes on cash and cash equivalents
|
1
|
|
|
10
|
|
||
|
Net increase in cash and cash equivalents and restricted cash
|
61
|
|
|
112
|
|
||
|
Cash and cash equivalents and restricted cash, beginning of period
|
723
|
|
|
797
|
|
||
|
Cash and cash equivalents and restricted cash, end of period
|
$
|
784
|
|
|
$
|
909
|
|
|
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
782
|
|
|
$
|
909
|
|
|
Restricted cash, current
|
2
|
|
|
—
|
|
||
|
Cash and cash equivalents and restricted cash, end of period
|
$
|
784
|
|
|
$
|
909
|
|
|
1.
|
DESCRIPTION OF BUSINESS
|
|
2.
|
SIGNIFICANT ACCOUNTING POLICIES
|
|
(in millions)
|
As Previously Reported
|
|
Adjustment
|
|
As Revised
|
||||||
|
Deferred tax liabilities, net
|
$
|
1,139
|
|
|
$
|
(112
|
)
|
|
$
|
1,027
|
|
|
Total liabilities
|
31,275
|
|
|
(112
|
)
|
|
31,163
|
|
|||
|
Accumulated deficit
|
(4,209
|
)
|
|
112
|
|
|
(4,097
|
)
|
|||
|
Total Bausch Health Companies Inc. shareholders' equity
|
4,424
|
|
|
112
|
|
|
4,536
|
|
|||
|
Total equity
|
4,523
|
|
|
112
|
|
|
4,635
|
|
|||
|
(in millions, except per share amounts)
|
As Previously Reported
|
|
Adjustment
|
|
As Revised
|
||||||
|
Consolidated Statement of Operations
|
|
|
|
|
|
||||||
|
Benefit from income taxes
|
$
|
(3
|
)
|
|
$
|
(112
|
)
|
|
$
|
(115
|
)
|
|
Net loss
|
(2,691
|
)
|
|
112
|
|
|
(2,579
|
)
|
|||
|
Net loss attributable to Bausch Health Companies Inc.
|
(2,693
|
)
|
|
112
|
|
|
(2,581
|
)
|
|||
|
Basic and diluted loss per share attributable to Bausch Health Companies Inc.
|
(7.68
|
)
|
|
0.32
|
|
|
(7.36
|
)
|
|||
|
Consolidated Statement of Comprehensive Loss
|
|
|
|
|
|
||||||
|
Foreign currency translation adjustment
|
(46
|
)
|
|
92
|
|
|
46
|
|
|||
|
Other comprehensive (loss) income
|
(46
|
)
|
|
92
|
|
|
46
|
|
|||
|
Comprehensive loss
|
(2,737
|
)
|
|
204
|
|
|
(2,533
|
)
|
|||
|
Comprehensive loss (income) attributable to noncontrolling interest
|
2
|
|
|
(6
|
)
|
|
(4
|
)
|
|||
|
Comprehensive loss attributable to Bausch Health Companies Inc.
|
(2,735
|
)
|
|
198
|
|
|
(2,537
|
)
|
|||
|
3.
|
REVENUE RECOGNITION
|
|
|
|
Three Months Ended March 31, 2019
|
||||||||||||||||||||||
|
(in millions)
|
|
Discounts
and
Allowances
|
|
Returns
|
|
Rebates
|
|
Chargebacks
|
|
Distribution
Fees
|
|
Total
|
||||||||||||
|
Reserve balances, January 1, 2019
|
|
$
|
175
|
|
|
$
|
813
|
|
|
$
|
1,024
|
|
|
$
|
209
|
|
|
$
|
163
|
|
|
$
|
2,384
|
|
|
Acquisition of Synergy
|
|
—
|
|
|
3
|
|
|
12
|
|
|
—
|
|
|
1
|
|
|
16
|
|
||||||
|
Current period provisions
|
|
204
|
|
|
33
|
|
|
533
|
|
|
443
|
|
|
48
|
|
|
1,261
|
|
||||||
|
Payments and credits
|
|
(210
|
)
|
|
(55
|
)
|
|
(568
|
)
|
|
(497
|
)
|
|
(85
|
)
|
|
(1,415
|
)
|
||||||
|
Reserve balances, March 31, 2019
|
|
$
|
169
|
|
|
$
|
794
|
|
|
$
|
1,001
|
|
|
$
|
155
|
|
|
$
|
127
|
|
|
$
|
2,246
|
|
|
|
|
Three Months Ended March 31, 2018
|
||||||||||||||||||||||
|
(in millions)
|
|
Discounts
and
Allowances
|
|
Returns
|
|
Rebates
|
|
Chargebacks
|
|
Distribution
Fees
|
|
Total
|
||||||||||||
|
Reserve balances, January 1, 2018
|
|
$
|
167
|
|
|
$
|
863
|
|
|
$
|
1,094
|
|
|
$
|
274
|
|
|
$
|
148
|
|
|
$
|
2,546
|
|
|
Current period provisions
|
|
184
|
|
|
88
|
|
|
635
|
|
|
477
|
|
|
48
|
|
|
1,432
|
|
||||||
|
Payments and credits
|
|
(199
|
)
|
|
(75
|
)
|
|
(620
|
)
|
|
(474
|
)
|
|
(81
|
)
|
|
(1,449
|
)
|
||||||
|
Reserve balances, March 31, 2018
|
|
$
|
152
|
|
|
$
|
876
|
|
|
$
|
1,109
|
|
|
$
|
277
|
|
|
$
|
115
|
|
|
$
|
2,529
|
|
|
4.
|
ACQUISITION
|
|
(in millions)
|
|
||
|
Accounts receivable
|
$
|
7
|
|
|
Inventories
|
24
|
|
|
|
Prepaid expenses and other current assets
|
5
|
|
|
|
Product brand intangible assets (7 years)
|
159
|
|
|
|
Accounts payable
|
(1
|
)
|
|
|
Accrued expenses
|
(17
|
)
|
|
|
Total identifiable net assets
|
177
|
|
|
|
Goodwill
|
3
|
|
|
|
Total fair value of consideration transferred
|
$
|
180
|
|
|
•
|
amounts for intangible assets, property and equipment, inventories, receivables and other working capital adjustments pending finalization of the valuation;
|
|
•
|
amounts for income tax assets and liabilities, pending finalization of estimates and assumptions in respect of certain tax aspects of the transaction; and
|
|
•
|
amount of goodwill pending the completion of the valuation of the assets acquired and liabilities assumed.
|
|
5.
|
RESTRUCTURING AND INTEGRATION COSTS
|
|
6.
|
FAIR VALUE MEASUREMENTS
|
|
•
|
Level 1 — Quoted prices in active markets for identical assets or liabilities;
|
|
•
|
Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
|
|
•
|
Level 3 — Unobservable inputs that are supported by little or no market activity and that are financial instruments whose values are determined using discounted cash flow methodologies, pricing models, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
(in millions)
|
|
Carrying
Value
|
|
Quoted
Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Carrying
Value
|
|
Quoted
Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Cash equivalents
|
|
$
|
263
|
|
|
$
|
235
|
|
|
$
|
28
|
|
|
$
|
—
|
|
|
$
|
197
|
|
|
$
|
166
|
|
|
$
|
31
|
|
|
$
|
—
|
|
|
Restricted cash
|
|
$
|
2
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Acquisition-related contingent consideration
|
|
$
|
309
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
309
|
|
|
$
|
339
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
339
|
|
|
(in millions)
|
|
2019
|
|
2018
|
||||||||||||
|
Balance, beginning of period
|
|
|
|
$
|
339
|
|
|
|
|
$
|
387
|
|
||||
|
Adjustments to Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
||||||||
|
Accretion for the time value of money
|
|
$
|
6
|
|
|
|
|
$
|
6
|
|
|
|
||||
|
Fair value adjustments due to changes in estimates of other future payments
|
|
(27
|
)
|
|
|
|
(4
|
)
|
|
|
||||||
|
Acquisition-related contingent consideration
|
|
|
|
(21
|
)
|
|
|
|
2
|
|
||||||
|
Foreign currency translation adjustment included in other comprehensive loss
|
|
|
|
—
|
|
|
|
|
1
|
|
||||||
|
Payments
|
|
|
|
(9
|
)
|
|
|
|
(12
|
)
|
||||||
|
Balance, end of period
|
|
|
|
309
|
|
|
|
|
378
|
|
||||||
|
Current portion included in Accrued and other current liabilities
|
|
|
|
45
|
|
|
|
|
58
|
|
||||||
|
Non-current portion
|
|
|
|
$
|
264
|
|
|
|
|
$
|
320
|
|
||||
|
7.
|
INVENTORIES
|
|
(in millions)
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
Raw materials
|
|
$
|
291
|
|
|
$
|
275
|
|
|
Work in process
|
|
136
|
|
|
95
|
|
||
|
Finished goods
|
|
585
|
|
|
564
|
|
||
|
|
|
$
|
1,012
|
|
|
$
|
934
|
|
|
8.
|
INTANGIBLE ASSETS AND GOODWILL
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||
|
(in millions)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
and
Impairments
|
|
Net
Carrying
Amount
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
and
Impairments
|
|
Net
Carrying
Amount
|
||||||||||||
|
Finite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Product brands
|
|
$
|
21,066
|
|
|
$
|
(12,376
|
)
|
|
$
|
8,690
|
|
|
$
|
20,891
|
|
|
$
|
(11,958
|
)
|
|
$
|
8,933
|
|
|
Corporate brands
|
|
927
|
|
|
(281
|
)
|
|
646
|
|
|
926
|
|
|
(263
|
)
|
|
663
|
|
||||||
|
Product rights/patents
|
|
3,293
|
|
|
(2,713
|
)
|
|
580
|
|
|
3,292
|
|
|
(2,658
|
)
|
|
634
|
|
||||||
|
Partner relationships
|
|
165
|
|
|
(163
|
)
|
|
2
|
|
|
168
|
|
|
(166
|
)
|
|
2
|
|
||||||
|
Technology and other
|
|
208
|
|
|
(177
|
)
|
|
31
|
|
|
208
|
|
|
(173
|
)
|
|
35
|
|
||||||
|
Total finite-lived intangible assets
|
|
25,659
|
|
|
(15,710
|
)
|
|
9,949
|
|
|
25,485
|
|
|
(15,218
|
)
|
|
10,267
|
|
||||||
|
Acquired IPR&D not in service
|
|
36
|
|
|
—
|
|
|
36
|
|
|
36
|
|
|
—
|
|
|
36
|
|
||||||
|
Bausch + Lomb Trademark
|
|
1,698
|
|
|
—
|
|
|
1,698
|
|
|
1,698
|
|
|
—
|
|
|
1,698
|
|
||||||
|
|
|
$
|
27,393
|
|
|
$
|
(15,710
|
)
|
|
$
|
11,683
|
|
|
$
|
27,219
|
|
|
$
|
(15,218
|
)
|
|
$
|
12,001
|
|
|
(in millions)
|
|
|
||
|
April through December 2019
|
|
$
|
1,410
|
|
|
2020
|
|
1,639
|
|
|
|
2021
|
|
1,389
|
|
|
|
2022
|
|
1,237
|
|
|
|
2023
|
|
1,088
|
|
|
|
2024
|
|
954
|
|
|
|
Thereafter
|
|
2,232
|
|
|
|
Total
|
|
$
|
9,949
|
|
|
(in millions)
|
|
Bausch + Lomb/ International
|
|
Branded Rx
|
|
U.S. Diversified Products
|
|
Salix
|
|
Ortho Dermatologics
|
|
Diversified Products
|
|
Total
|
||||||||||||||
|
Balance, January 1, 2018
|
|
$
|
6,016
|
|
|
$
|
6,631
|
|
|
$
|
2,946
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,593
|
|
|
Impairment of the Salix and Ortho Dermatologics reporting units
|
|
—
|
|
|
(2,213
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,213
|
)
|
|||||||
|
Realignment of Global Solta reporting unit goodwill
|
|
(82
|
)
|
|
115
|
|
|
(33
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
|
Goodwill reclassified to assets held for sale and subsequently disposed
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|||||||
|
Realignment of segment goodwill
|
|
—
|
|
|
(4,533
|
)
|
|
(2,913
|
)
|
|
3,156
|
|
|
1,267
|
|
|
3,023
|
|
|
—
|
|
|||||||
|
Impairment of the Dentistry reporting unit
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(109
|
)
|
|
(109
|
)
|
|||||||
|
Foreign exchange and other
|
|
(127
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(127
|
)
|
|||||||
|
Balance, December 31, 2018
|
|
5,805
|
|
|
—
|
|
|
—
|
|
|
3,156
|
|
|
1,267
|
|
|
2,914
|
|
|
13,142
|
|
|||||||
|
Acquisition of certain assets of Synergy
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
|
—
|
|
|
—
|
|
|
3
|
|
|||||||
|
Foreign exchange and other
|
|
(24
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24
|
)
|
|||||||
|
Balance, March 31, 2019
|
|
$
|
5,781
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,159
|
|
|
$
|
1,267
|
|
|
$
|
2,914
|
|
|
$
|
13,121
|
|
|
9.
|
ACCRUED AND OTHER CURRENT LIABILITIES
|
|
(in millions)
|
|
March 31,
2019 |
|
December 31, 2018
|
||||
|
Product rebates
|
|
$
|
974
|
|
|
$
|
998
|
|
|
Product returns
|
|
794
|
|
|
813
|
|
||
|
Interest
|
|
387
|
|
|
273
|
|
||
|
Employee compensation and benefit costs
|
|
238
|
|
|
301
|
|
||
|
Income taxes payable
|
|
167
|
|
|
167
|
|
||
|
Other
|
|
695
|
|
|
645
|
|
||
|
|
|
$
|
3,255
|
|
|
$
|
3,197
|
|
|
10.
|
FINANCING ARRANGEMENTS
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||||||||||
|
(in millions)
|
|
Maturity
|
|
Principal Amount
|
|
Net of Premiums, Discounts and Issuance Costs
|
|
Principal Amount
|
|
Net of Premiums, Discounts and Issuance Costs
|
||||||||
|
Senior Secured Credit Facilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
2023 Revolving Credit Facility
|
|
June 2023
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
75
|
|
|
$
|
75
|
|
|
June 2025 Term Loan B Facility
|
|
June 2025
|
|
4,222
|
|
|
4,104
|
|
|
4,394
|
|
|
4,269
|
|
||||
|
November 2025 Term Loan B Facility
|
|
November 2025
|
|
1,425
|
|
|
1,402
|
|
|
1,481
|
|
|
1,456
|
|
||||
|
Senior Secured Notes:
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
6.50% Secured Notes
|
|
March 2022
|
|
1,250
|
|
|
1,239
|
|
|
1,250
|
|
|
1,239
|
|
||||
|
7.00% Secured Notes
|
|
March 2024
|
|
2,000
|
|
|
1,980
|
|
|
2,000
|
|
|
1,979
|
|
||||
|
5.50% Secured Notes
|
|
November 2025
|
|
1,750
|
|
|
1,731
|
|
|
1,750
|
|
|
1,730
|
|
||||
|
5.75% Secured Notes
|
|
August 2027
|
|
500
|
|
|
493
|
|
|
—
|
|
|
—
|
|
||||
|
Senior Unsecured Notes:
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
5.625%
|
|
December 2021
|
|
182
|
|
|
181
|
|
|
700
|
|
|
697
|
|
||||
|
5.50%
|
|
March 2023
|
|
784
|
|
|
780
|
|
|
1,000
|
|
|
995
|
|
||||
|
5.875%
|
|
May 2023
|
|
2,666
|
|
|
2,650
|
|
|
3,250
|
|
|
3,229
|
|
||||
|
4.50% euro-denominated debt
|
|
May 2023
|
|
1,683
|
|
|
1,673
|
|
|
1,720
|
|
|
1,709
|
|
||||
|
6.125%
|
|
April 2025
|
|
3,250
|
|
|
3,227
|
|
|
3,250
|
|
|
3,226
|
|
||||
|
9.00%
|
|
December 2025
|
|
1,500
|
|
|
1,470
|
|
|
1,500
|
|
|
1,469
|
|
||||
|
9.25%
|
|
April 2026
|
|
1,500
|
|
|
1,482
|
|
|
1,500
|
|
|
1,482
|
|
||||
|
8.50%
|
|
January 2027
|
|
1,750
|
|
|
1,757
|
|
|
750
|
|
|
738
|
|
||||
|
Other
|
|
Various
|
|
12
|
|
|
12
|
|
|
12
|
|
|
12
|
|
||||
|
Total long-term debt and other
|
|
|
|
$
|
24,474
|
|
|
24,181
|
|
|
$
|
24,632
|
|
|
24,305
|
|
||
|
Less: Current portion of long-term debt and other
|
|
|
|
257
|
|
|
|
|
|
228
|
|
|||||||
|
Non-current portion of long-term debt
|
|
|
|
|
|
$
|
23,924
|
|
|
|
|
|
$
|
24,077
|
|
|||
|
(in millions)
|
|
||
|
April through December 2019
|
$
|
182
|
|
|
2020
|
303
|
|
|
|
2021
|
303
|
|
|
|
2022
|
1,553
|
|
|
|
2023
|
5,436
|
|
|
|
2024
|
2,303
|
|
|
|
Thereafter
|
14,394
|
|
|
|
Total debt obligations
|
24,474
|
|
|
|
Unamortized premiums, discounts and issuance costs
|
(293
|
)
|
|
|
Total long-term debt and other
|
$
|
24,181
|
|
|
11.
|
PENSION AND POSTRETIREMENT EMPLOYEE BENEFIT PLANS
|
|
|
|
Pension Benefit Plans
|
|
Postretirement
Benefit Plan |
||||||||||||||||||||
|
|
U.S. Plan
|
|
Non-U.S. Plans
|
|
||||||||||||||||||||
|
|
|
Three Months Ended March 31,
|
||||||||||||||||||||||
|
(in millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||||||
|
Service cost
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Interest cost
|
|
2
|
|
|
2
|
|
|
1
|
|
|
1
|
|
|
—
|
|
|
—
|
|
||||||
|
Expected return on plan assets
|
|
(3
|
)
|
|
(4
|
)
|
|
(1
|
)
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
||||||
|
Net periodic (benefit) cost
|
|
$
|
(1
|
)
|
|
$
|
(2
|
)
|
|
$
|
1
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
12.
|
LEASES
|
|
(in millions)
|
|
||
|
Right-of-use assets included in:
|
|
||
|
Other non-current assets
|
$
|
274
|
|
|
Lease liabilities included in:
|
|
||
|
Accrued and other current liabilities
|
$
|
55
|
|
|
Other non-current liabilities
|
238
|
|
|
|
Total lease liabilities
|
$
|
293
|
|
|
(in millions)
|
|
||
|
Operating lease costs
|
$
|
16
|
|
|
Variable operating lease costs
|
$
|
4
|
|
|
(dollars in millions)
|
|
||
|
Cash paid from operating cash flows for amounts included in the measurement of lease liabilities
|
$
|
20
|
|
|
Right-of-use assets obtained in exchange for new operating lease liabilities
|
$
|
7
|
|
|
Weighted-average remaining lease term
|
8.6 years
|
|
|
|
Weighted-average discount rate
|
6.2
|
%
|
|
|
(in millions)
|
|
||
|
Remainder of 2019
|
$
|
54
|
|
|
2020
|
57
|
|
|
|
2021
|
42
|
|
|
|
2022
|
36
|
|
|
|
2023
|
32
|
|
|
|
2024
|
27
|
|
|
|
Thereafter
|
138
|
|
|
|
Total
|
386
|
|
|
|
Less: Imputed interest
|
93
|
|
|
|
Present value of remaining lease payments
|
293
|
|
|
|
Less: Current portion
|
55
|
|
|
|
Non-current portion
|
$
|
238
|
|
|
(in millions)
|
|
||
|
2019
|
$
|
78
|
|
|
2020
|
60
|
|
|
|
2021
|
44
|
|
|
|
2022
|
39
|
|
|
|
2023
|
32
|
|
|
|
Thereafter
|
166
|
|
|
|
Total
|
$
|
419
|
|
|
13.
|
SHARE-BASED COMPENSATION
|
|
|
Three Months Ended
March 31, |
||||||
|
(in millions)
|
2019
|
|
2018
|
||||
|
Stock options
|
$
|
6
|
|
|
$
|
5
|
|
|
RSUs
|
18
|
|
|
16
|
|
||
|
|
$
|
24
|
|
|
$
|
21
|
|
|
|
|
|
|
||||
|
Research and development expenses
|
$
|
2
|
|
|
$
|
2
|
|
|
Selling, general and administrative expenses
|
22
|
|
|
19
|
|
||
|
|
$
|
24
|
|
|
$
|
21
|
|
|
14.
|
ACCUMULATED OTHER COMPREHENSIVE LOSS
|
|
(in millions)
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
Foreign currency translation adjustments
|
|
$
|
(2,090
|
)
|
|
$
|
(2,111
|
)
|
|
Pension and postretirement benefit plan adjustments, net of tax
|
|
(26
|
)
|
|
(26
|
)
|
||
|
|
|
$
|
(2,116
|
)
|
|
$
|
(2,137
|
)
|
|
15.
|
RESEARCH AND DEVELOPMENT
|
|
|
|
Three Months Ended
March 31, |
||||||
|
(in millions)
|
|
2019
|
|
2018
|
||||
|
Product related research and development
|
|
$
|
107
|
|
|
$
|
83
|
|
|
Quality assurance
|
|
10
|
|
|
9
|
|
||
|
|
|
$
|
117
|
|
|
$
|
92
|
|
|
16.
|
OTHER (INCOME) EXPENSE, NET
|
|
|
|
Three Months Ended
March 31, |
||||||
|
(in millions)
|
|
2019
|
|
2018
|
||||
|
Net gain on sale of assets
|
|
$
|
(10
|
)
|
|
$
|
—
|
|
|
Acquisition-related costs
|
|
8
|
|
|
—
|
|
||
|
Litigation and other matters
|
|
2
|
|
|
11
|
|
||
|
Other, net
|
|
(4
|
)
|
|
—
|
|
||
|
|
|
$
|
(4
|
)
|
|
$
|
11
|
|
|
17.
|
INCOME TAXES
|
|
18.
|
LOSS PER SHARE
|
|
|
Three Months Ended
March 31, |
||||||
|
(in millions, except per share amounts)
|
2019
|
|
2018
|
||||
|
Net loss attributable to Bausch Health Companies Inc.
|
$
|
(52
|
)
|
|
$
|
(2,581
|
)
|
|
|
|
|
|
||||
|
Basic weighted-average common shares outstanding
|
351.3
|
|
|
350.7
|
|
||
|
Diluted effect of stock options and RSUs
|
—
|
|
|
—
|
|
||
|
Diluted weighted-average common shares outstanding
|
351.3
|
|
|
350.7
|
|
||
|
|
|
|
|
||||
|
Loss per share attributable to Bausch Health Companies Inc.:
|
|
|
|
||||
|
Basic
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
Diluted
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
19.
|
LEGAL PROCEEDINGS
|
|
20.
|
SEGMENT INFORMATION
|
|
•
|
The Bausch + Lomb/International segment
consists of: (i) sales in the U.S. of pharmaceutical products, OTC products and medical device products, primarily comprised of Bausch + Lomb products, with a focus on the Vision Care, Surgical, Consumer and Ophthalmology Rx products and (ii) with the exception of sales of Solta products, sales in Canada, Europe, Asia, Australia, Latin America, Africa and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products, OTC products, medical device products and Bausch + Lomb products.
|
|
•
|
The Salix segment
consists of sales in the U.S. of GI products.
|
|
•
|
The Ortho Dermatologics
segment
consists of: (i) sales in the U.S. of Ortho Dermatologics (dermatological) products and (ii) global sales of Solta medical aesthetic devices.
|
|
•
|
The Diversified Products segment
consists of sales in the U.S. of: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products and (iii) dentistry products.
|
|
|
Three Months Ended March 31,
|
||||||
|
(in millions)
|
2019
|
|
2018
|
||||
|
Revenues:
|
|
|
|
||||
|
Bausch + Lomb/International
|
$
|
1,118
|
|
|
$
|
1,103
|
|
|
Salix
|
445
|
|
|
422
|
|
||
|
Ortho Dermatologics
|
138
|
|
|
140
|
|
||
|
Diversified Products
|
315
|
|
|
330
|
|
||
|
|
$
|
2,016
|
|
|
$
|
1,995
|
|
|
|
|
|
|
||||
|
Segment profits:
|
|
|
|
||||
|
Bausch + Lomb/International
|
$
|
319
|
|
|
$
|
297
|
|
|
Salix
|
288
|
|
|
272
|
|
||
|
Ortho Dermatologics
|
57
|
|
|
44
|
|
||
|
Diversified Products
|
236
|
|
|
240
|
|
||
|
|
900
|
|
|
853
|
|
||
|
Corporate
|
(125
|
)
|
|
(114
|
)
|
||
|
Amortization of intangible assets
|
(489
|
)
|
|
(743
|
)
|
||
|
Goodwill impairments
|
—
|
|
|
(2,213
|
)
|
||
|
Asset impairments
|
(3
|
)
|
|
(44
|
)
|
||
|
Restructuring and integration costs
|
(20
|
)
|
|
(6
|
)
|
||
|
Acquired in-process research and development costs
|
(1
|
)
|
|
(1
|
)
|
||
|
Acquisition-related contingent consideration
|
21
|
|
|
(2
|
)
|
||
|
Other income (expense), net
|
4
|
|
|
(11
|
)
|
||
|
Operating income (loss)
|
287
|
|
|
(2,281
|
)
|
||
|
Interest income
|
4
|
|
|
3
|
|
||
|
Interest expense
|
(406
|
)
|
|
(416
|
)
|
||
|
Loss on extinguishment of debt
|
(7
|
)
|
|
(27
|
)
|
||
|
Foreign exchange and other
|
—
|
|
|
27
|
|
||
|
Loss before benefit from income taxes
|
$
|
(122
|
)
|
|
$
|
(2,694
|
)
|
|
|
Three Months Ended March 31, 2019
|
|
Three Months Ended March 31, 2018
|
||||||||||||||||||||||||||||||||||||
|
(in millions)
|
Bausch + Lomb/ International
|
|
Salix
|
|
Ortho Dermatologics
|
|
Diversified Products
|
|
Total
|
|
Bausch + Lomb/ International
|
|
Salix
|
|
Ortho Dermatologics
|
|
Diversified Products
|
|
Total
|
||||||||||||||||||||
|
Pharmaceuticals
|
$
|
217
|
|
|
$
|
445
|
|
|
$
|
95
|
|
|
$
|
211
|
|
|
$
|
968
|
|
|
$
|
203
|
|
|
$
|
422
|
|
|
$
|
105
|
|
|
$
|
236
|
|
|
$
|
966
|
|
|
Devices
|
366
|
|
|
—
|
|
|
38
|
|
|
—
|
|
|
404
|
|
|
363
|
|
|
—
|
|
|
29
|
|
|
—
|
|
|
392
|
|
||||||||||
|
OTC
|
324
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
324
|
|
|
326
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
326
|
|
||||||||||
|
Branded and Other Generics
|
191
|
|
|
—
|
|
|
—
|
|
|
102
|
|
|
293
|
|
|
191
|
|
|
—
|
|
|
—
|
|
|
90
|
|
|
281
|
|
||||||||||
|
Other revenues
|
20
|
|
|
—
|
|
|
5
|
|
|
2
|
|
|
27
|
|
|
20
|
|
|
—
|
|
|
6
|
|
|
4
|
|
|
30
|
|
||||||||||
|
|
$
|
1,118
|
|
|
$
|
445
|
|
|
$
|
138
|
|
|
$
|
315
|
|
|
$
|
2,016
|
|
|
$
|
1,103
|
|
|
$
|
422
|
|
|
$
|
140
|
|
|
$
|
330
|
|
|
$
|
1,995
|
|
|
|
Three Months Ended March 31,
|
||||||
|
(in millions)
|
2019
|
|
2018
|
||||
|
U.S. and Puerto Rico
|
$
|
1,200
|
|
|
$
|
1,176
|
|
|
China
|
89
|
|
|
84
|
|
||
|
Canada
|
79
|
|
|
77
|
|
||
|
Poland
|
58
|
|
|
63
|
|
||
|
Japan
|
55
|
|
|
51
|
|
||
|
France
|
53
|
|
|
55
|
|
||
|
Egypt
|
53
|
|
|
45
|
|
||
|
Germany
|
45
|
|
|
50
|
|
||
|
Mexico
|
44
|
|
|
43
|
|
||
|
Russia
|
36
|
|
|
28
|
|
||
|
United Kingdom
|
28
|
|
|
27
|
|
||
|
Italy
|
22
|
|
|
22
|
|
||
|
Spain
|
21
|
|
|
21
|
|
||
|
Other
|
233
|
|
|
253
|
|
||
|
|
$
|
2,016
|
|
|
$
|
1,995
|
|
|
|
Three Months Ended March 31,
|
||
|
|
2019
|
|
2018
|
|
McKesson Corporation (including McKesson Specialty)
|
17%
|
|
18%
|
|
AmerisourceBergen Corporation
|
16%
|
|
18%
|
|
Cardinal Health, Inc.
|
14%
|
|
11%
|
|
•
|
Dermatology - In April 2019, the FDA approved 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 are limited in duration of use. Halobetasol propionate may be used for up to two weeks and tazarotene may be limited due to irritation. However, the combination of these ingredients in Duobrii™, with a dual mechanism of action, allows for expanded duration of use, with reduced adverse events. We expect to launch Duobrii™ in June 2019.
|
|
•
|
Dermatology - Bryhali™ is a novel product that 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 in duration of use. We launched Bryhali™ in November 2018.
|
|
•
|
Dermatology - Internal Development Project ("IDP") 133 is a project to expand the indication for Bryhali™ (halobetasol propionate lotion 0.01%) from plaque psoriasis to corticosteroid responsive dermatoses. A Phase 3 study is planned to start in the second half of 2019.
|
|
•
|
Dermatology - IDP-131 is a new chemical entity, KP-470, for the topical treatment of psoriasis. On February 27, 2018, we announced that we entered into an exclusive license agreement with Kaken Pharmaceutical Co., Ltd. to develop and commercialize the compound.
Early proof of concept studies are planned for 2019.
If approved by the FDA, KP-470 could represent a novel drug with an alternative mechanism of action in the topical treatment of psoriasis.
|
|
•
|
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.
|
|
•
|
Dermatology - On July 27, 2017, we launched Siliq™ in the U.S. Siliq™ is 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 the U.S. The FDA approved the Biologics License Application for Siliq™ injection for subcutaneous use for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. 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.
|
|
•
|
Bausch + Lomb - SiHy Daily AQUALOX
TM
is a silicone hydrogel daily disposable contact lens designed to provide clear vision throughout the day. Product validation was completed in June 2018 and SiHy Daily AQUALOX
TM
was launched in Japan in September 2018.
|
|
•
|
Dermatology - IDP-126 is an acne product with a fixed combination of benzoyl peroxide, clindamycin phosphate and adapalene, currently in Phase 2 testing.
|
|
•
|
Bausch + Lomb - Lumify
®
(brimonidine tartrate ophthalmic solution, 0.025%) is an OTC eye drop developed as an ocular redness reliever. Lumify
®
was approved by the FDA in December 2017 and launched in May 2018.
|
|
•
|
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.
|
|
•
|
Gastrointestinal - We plan to initiate a Phase 2 study evaluating Xifaxan
®
550mg tablets for the treatment of small intestinal bacterial overgrowth or SIBO. The study is targeted to start in the second half of 2019.
|
|
•
|
Gastrointestinal - We plan to initiate a Phase 2/3 study for the treatment of postoperative Crohns disease using a novel rifaximin extended release formulation. The study is scheduled to start in the second half of 2019.
|
|
•
|
Gastrointestinal - We plan to initiate a Phase 2 study evaluating Xifaxan
®
550mg tablets for the prevention of complications of decompensation cirrhosis. The study is scheduled to start in the first half of 2019.
|
|
•
|
Dermatology - On August 23, 2018, the FDA approved Altreno™ (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Altreno™ is the first tretinoin formulation in a lotion, approved for patients 9 years of age and older. We launched Altreno™ in the U.S. in October 2018.
|
|
•
|
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 - IDP-123 is an acne product containing lower concentration of tazarotene in a lotion form to help reduce irritation while maintaining efficacy. We submitted a New Drug Application (“NDA”) with the FDA on February 22, 2019.
|
|
•
|
Dermatology - IDP-124 is a topical lotion product designed to treat moderate to severe atopic dermatitis, with pimecrolimus, currently in Phase 3 testing.
|
|
•
|
Dermatology - IDP-135 is a topical retinoid product in development. We are seeking guidance from the FDA to develop this product for OTC use for the treatment of acne. The guidance meeting is targeted for 2019.
|
|
•
|
Gastrointestinal - On September 11, 2018, we announced the launch of Plenvu
®
in the U.S. We license Plenvu
®
from Norgine B.V. Plenvu
®
is a novel, lower-volume polyethylene glycol-based bowel preparation developed to help provide complete bowel cleansing, with an additional focus on the ascending colon.
|
|
•
|
Bausch + Lomb - In April 2017, we launched our Stellaris Elite™ Vision Enhancement System. The Stellaris Elite™ Vision Enhancement System is our next generation phacoemulsification cataract platform, which offers new innovations, as well as the opportunity to add upgrades and enhancements every one to two years. Stellaris Elite™ is the first phacoemulsification platform on the market to offer Adaptive Fluidics™, which combines aspiration control with predictive infusion management to create a responsive and controlled surgical environment for efficient cataract lens removal.
|
|
•
|
Bausch + Lomb - Vitesse
®
is a hypersonic vitrectomy system for the removal of the vitreous humor gel that fills the eye cavity to provide better access to the retina and allows for a variety of repairs, including the removal of scar tissue, laser repair of retinal detachments and treatment of macular holes. Available exclusively on the Stellaris Elite™ system, Vitesse
®
liquefies tissue in a highly-localized zone at the edge of the port to increase the level of surgical control and precision to vitrectomies. We launched this product on a limited basis in October 2017.
|
|
•
|
Dermatology - Next Generation Thermage FLX
®
is a fourth-generation non-invasive treatment option using a radiofrequency platform designed to optimize key functional characteristics and improve patient outcomes. On September 22, 2017, we received 510(k) clearance from the FDA and launched this product in the United States. During 2018 and 2019, Next Generation Thermage FLX
®
was launched in Hong Kong, Japan, Korea, Taiwan, Philippines, Singapore, Indonesia, Malaysia, China, Thailand, Vietnam, and Australia as part of our Solta medical aesthetic devices portfolio. During 2019, we expect additional worldwide launches of the Next Generation Thermage FLX
®
in Asia, Canada and Europe, paced by country-specific regulatory registrations.
|
|
•
|
Bausch + Lomb - On May 1, 2018, we received Premarket Approval from the FDA for, and subsequently launched, 7-day extended wear for our Bausch + Lomb ULTRA
®
monthly planned replacement contact lenses.
|
|
•
|
Bausch + Lomb - Biotrue
®
ONEday for Astigmatism is a daily disposable contact lens for astigmatic patients. The Biotrue
®
ONEday lenses incorporate Surface Active Technology
TM
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 December 2016 and launched an extended power range in 2017. During 2018, we launched a further extended power range for this product.
|
|
•
|
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. In April 2018, we initiated an investigative device exemption (“IDE”) study for this product and completed enrollment in December 2018.
|
|
•
|
Dermatology - Traser™ is an energy-based platform device with significant versatility and power capabilities to address various dermatological conditions, including vascular and pigmented lesions. We are planning to launch this product in the second half of 2022 as part of our Solta business.
|
|
•
|
Bausch + Lomb - Lotemax
®
SM (loteprednol etabonate ophthalmic gel) 0.38% is a new formulation for the treatment of post-operative inflammation and pain following ocular surgery. Lotemax
®
SM is the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery in the U.S. Lotemax
®
SM was approved by the FDA in February 2019 and launched in April 2019.
|
|
•
|
Bausch + Lomb - enVista
®
Trifocal intraocular lens is an innovative lens design. We have initiated an IDE study for this product in May 2018 and completed patient enrollment for a Phase 1 study in December 2018.
|
|
•
|
Bausch + Lomb - enVista
®
Toric intraocular lens received FDA approval in June 2018 and was launched in July 2018.
|
|
•
|
Bausch + Lomb - We are developing a preloaded intraocular lens injector platform for enVista interocular lens. The Premarket Approval application was submitted to the FDA in July 2018 and the CE Mark notification was submitted in Europe in February 2019.
|
|
•
|
Bausch + Lomb - An ULTRA
®
Multifocal for Astigmatism lens combining the benefits of our ULTRA
®
for Presbyopia design with our ULTRA
®
for Astigmatism OpticAlign™ design engineered for lens stability for presbyopic/astigmatic patients. We received FDA approval for this product in November 2018.
|
|
•
|
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 Korea, India, Mexico, Indonesia, Malaysia and Singapore.
|
|
•
|
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 may launch as early as the first half of 2020.
|
|
•
|
Bausch + Lomb - Zen™ Multifocal Scleral Lens 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. We launched this product in January 2019.
|
|
•
|
Bausch + Lomb - Tangible
®
Hydra-PEG
®
is 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. We launched this product in March 2019.
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||||||||||
|
(in millions)
|
|
Maturity
|
|
Principal Amount
|
|
Net of Premiums, Discounts and Issuance Costs
|
|
Principal Amount
|
|
Net of Premiums, Discounts and Issuance Costs
|
||||||||
|
Senior Secured Credit Facilities:
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
2023 Revolving Credit Facility
|
|
June 2023
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
75
|
|
|
$
|
75
|
|
|
June 2025 Term Loan B Facility
|
|
June 2025
|
|
4,222
|
|
|
4,104
|
|
|
4,394
|
|
|
4,269
|
|
||||
|
November 2025 Term Loan B Facility
|
|
November 2025
|
|
1,425
|
|
|
1,402
|
|
|
1,481
|
|
|
1,456
|
|
||||
|
Senior Secured Notes:
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
5.75% Secured Notes
|
|
August 2027
|
|
500
|
|
|
493
|
|
|
—
|
|
|
—
|
|
||||
|
All other Senior Secured Notes
|
|
March 2022 through November 2025
|
|
5,000
|
|
|
4,950
|
|
|
5,000
|
|
|
4,948
|
|
||||
|
Senior Unsecured Notes:
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
5.625%
|
|
December 2021
|
|
182
|
|
|
181
|
|
|
700
|
|
|
697
|
|
||||
|
5.50%
|
|
March 2023
|
|
784
|
|
|
780
|
|
|
1,000
|
|
|
995
|
|
||||
|
5.875%
|
|
May 2023
|
|
2,666
|
|
|
2,650
|
|
|
3,250
|
|
|
3,229
|
|
||||
|
8.50%
|
|
January 2027
|
|
1,750
|
|
|
1,757
|
|
|
750
|
|
|
738
|
|
||||
|
All other Senior Unsecured Notes
|
|
May 2023 through April 2026
|
|
7,933
|
|
|
7,852
|
|
|
7,970
|
|
|
7,886
|
|
||||
|
Other
|
|
Various
|
|
12
|
|
|
12
|
|
|
12
|
|
|
12
|
|
||||
|
Total long-term debt and other
|
|
|
|
$
|
24,474
|
|
|
$
|
24,181
|
|
|
$
|
24,632
|
|
|
$
|
24,305
|
|
|
(in millions)
|
|
March 31, 2019
|
|
December 31, 2018
|
||||
|
2019
|
|
$
|
182
|
|
|
$
|
228
|
|
|
2020
|
|
303
|
|
|
303
|
|
||
|
2021
|
|
303
|
|
|
1,003
|
|
||
|
2022
|
|
1,553
|
|
|
1,553
|
|
||
|
2023
|
|
5,436
|
|
|
6,348
|
|
||
|
2024
|
|
2,303
|
|
|
2,303
|
|
||
|
Thereafter
|
|
14,394
|
|
|
12,894
|
|
||
|
Gross maturities
|
|
$
|
24,474
|
|
|
$
|
24,632
|
|
|
|
|
Three Months Ended March 31,
|
||||||||||
|
(in millions, except per share data)
|
|
2019
|
|
2018
|
|
Change
|
||||||
|
Revenues
|
|
$
|
2,016
|
|
|
$
|
1,995
|
|
|
$
|
21
|
|
|
Operating income (loss)
|
|
$
|
287
|
|
|
$
|
(2,281
|
)
|
|
$
|
2,568
|
|
|
Loss before benefit from income taxes
|
|
$
|
(122
|
)
|
|
$
|
(2,694
|
)
|
|
$
|
2,572
|
|
|
Net loss attributable to Bausch Health Companies Inc.
|
|
$
|
(52
|
)
|
|
$
|
(2,581
|
)
|
|
$
|
2,529
|
|
|
Loss per share attributable to Bausch Health Companies Inc.:
|
|
|
|
|
|
|
||||||
|
Basic
|
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
$
|
7.21
|
|
|
Diluted
|
|
$
|
(0.15
|
)
|
|
$
|
(7.36
|
)
|
|
$
|
7.21
|
|
|
•
|
an increase
in contribution (Product sales revenue less Cost of goods sold, excluding amortization and impairments of intangible assets) of
$60 million
primarily due to: (i) higher gross selling prices and lower sales deductions, (ii) an increase in net volumes and (iii) better inventory management, partially offset by the unfavorable
effect of foreign currencies
;
|
|
•
|
a decrease
in Selling, general and administrative expenses (“SG&A”) of
$4 million
primarily due to: (i) the favorable impact of foreign currencies, (ii) lower costs related to professional services and (iii) lower compensation expense. The decrease was partially offset by: (i) higher advertising and promotion expenses, (ii)
costs in 2019 attributable to our IT infrastructure improvement projects
and (iii)
the impact of the acquisition of certain assets of Synergy
;
|
|
•
|
an increase
in R&D of
$25 million
;
|
|
•
|
a decrease
in
Amortization of intangible assets
of
$254 million
primarily due to: (i) the impact of the change in the estimated useful life of the Xifaxan
®
related intangible assets made in September 2018 to reflect management's changes in assumptions and (ii) lower amortization as a result of impairments to intangible assets in prior periods
;
|
|
•
|
a decrease
in
Goodwill impairments
of
$2,213 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 January 1, 2018 and (ii) Ortho Dermatologics reporting unit due to unforeseen changes in business dynamics during the
three months ended March 31, 2018
;
|
|
•
|
a decrease
in
Asset impairments
of
$41 million
, primarily related to the decrease in forecasted sales during the
three months ended March 31, 2018
for a certain product line facing generic competition; and
|
|
•
|
a favorable change in
Other (income) expense, net
of
$15 million
primarily attributable to: (i)
Net gain on sale of assets
of
$10 million
during the three months ended March 31, 2019 and (ii) a decrease in
Litigation and other matters
, partially offset by acquisition-related costs incurred in 2019.
|
|
|
Three Months Ended March 31,
|
||||||||||
|
(in millions)
|
2019
|
|
2018
|
|
Change
|
||||||
|
Revenues
|
|
|
|
|
|
||||||
|
Product sales
|
$
|
1,989
|
|
|
$
|
1,965
|
|
|
$
|
24
|
|
|
Other revenues
|
27
|
|
|
30
|
|
|
(3
|
)
|
|||
|
|
2,016
|
|
|
1,995
|
|
|
21
|
|
|||
|
Expenses
|
|
|
|
|
|
||||||
|
Cost of goods sold (excluding amortization and impairments of intangible assets)
|
524
|
|
|
560
|
|
|
(36
|
)
|
|||
|
Cost of other revenues
|
13
|
|
|
13
|
|
|
—
|
|
|||
|
Selling, general and administrative
|
587
|
|
|
591
|
|
|
(4
|
)
|
|||
|
Research and development
|
117
|
|
|
92
|
|
|
25
|
|
|||
|
Amortization of intangible assets
|
489
|
|
|
743
|
|
|
(254
|
)
|
|||
|
Goodwill impairments
|
—
|
|
|
2,213
|
|
|
(2,213
|
)
|
|||
|
Asset impairments
|
3
|
|
|
44
|
|
|
(41
|
)
|
|||
|
Restructuring and integration costs
|
20
|
|
|
6
|
|
|
14
|
|
|||
|
Acquired in-process research and development costs
|
1
|
|
|
1
|
|
|
—
|
|
|||
|
Acquisition-related contingent consideration
|
(21
|
)
|
|
2
|
|
|
(23
|
)
|
|||
|
Other (income) expense, net
|
(4
|
)
|
|
11
|
|
|
(15
|
)
|
|||
|
|
1,729
|
|
|
4,276
|
|
|
(2,547
|
)
|
|||
|
Operating income (loss)
|
287
|
|
|
(2,281
|
)
|
|
2,568
|
|
|||
|
Interest income
|
4
|
|
|
3
|
|
|
1
|
|
|||
|
Interest expense
|
(406
|
)
|
|
(416
|
)
|
|
10
|
|
|||
|
Loss on extinguishment of debt
|
(7
|
)
|
|
(27
|
)
|
|
20
|
|
|||
|
Foreign exchange and other
|
—
|
|
|
27
|
|
|
(27
|
)
|
|||
|
Loss before benefit from income taxes
|
(122
|
)
|
|
(2,694
|
)
|
|
2,572
|
|
|||
|
Benefit from income taxes
|
74
|
|
|
115
|
|
|
(41
|
)
|
|||
|
Net loss
|
(48
|
)
|
|
(2,579
|
)
|
|
2,531
|
|
|||
|
Net income attributable to noncontrolling interest
|
(4
|
)
|
|
(2
|
)
|
|
(2
|
)
|
|||
|
Net loss attributable to Bausch Health Companies Inc.
|
$
|
(52
|
)
|
|
$
|
(2,581
|
)
|
|
$
|
2,529
|
|
|
|
|
Three Months Ended March 31,
|
||||||||||||
|
|
|
2019
|
|
2018
|
||||||||||
|
(in millions)
|
|
Amount
|
|
Pct.
|
|
Amount
|
|
Pct.
|
||||||
|
Gross product sales
|
|
$
|
3,250
|
|
|
100.0
|
%
|
|
$
|
3,397
|
|
|
100.0
|
%
|
|
Provisions to reduce gross product sales to net product sales
|
|
|
|
|
|
|
|
|
||||||
|
Discounts and allowances
|
|
204
|
|
|
6.3
|
%
|
|
184
|
|
|
5.4
|
%
|
||
|
Returns
|
|
33
|
|
|
1.0
|
%
|
|
88
|
|
|
2.6
|
%
|
||
|
Rebates
|
|
533
|
|
|
16.4
|
%
|
|
635
|
|
|
18.7
|
%
|
||
|
Chargebacks
|
|
443
|
|
|
13.6
|
%
|
|
477
|
|
|
14.1
|
%
|
||
|
Distribution fees
|
|
48
|
|
|
1.5
|
%
|
|
48
|
|
|
1.4
|
%
|
||
|
Total provisions
|
|
1,261
|
|
|
38.8
|
%
|
|
1,432
|
|
|
42.2
|
%
|
||
|
Net product sales
|
|
1,989
|
|
|
61.2
|
%
|
|
1,965
|
|
|
57.8
|
%
|
||
|
Other revenues
|
|
27
|
|
|
|
|
30
|
|
|
|
||||
|
Revenues
|
|
$
|
2,016
|
|
|
|
|
$
|
1,995
|
|
|
|
||
|
•
|
discounts and allowances as a percentage of gross product sales was higher primarily due to the sales mix of our generics business. Increased gross product sales of higher discounted products such as Glumetza
®
AG, and to a lesser extent Tobramycin
®
AG a
nd
Migranal
®
AG, drove the increase despite the year-over-year decrease in the discount rate for Glumetza
®
AG. These increases were partially offset by the impact of lower sales of other higher discounted generics, such as Xenazine
®
AG and Targretin
®
AG;
|
|
•
|
returns as a percentage of gross product sales was lower primarily due to: (i) lower return rates for products, such as Glumetza
®
SLX, Mephyton
®
and Xifaxan
®
and (ii) lower sales of Isuprel
®
;
|
|
•
|
rebates as a percentage of gross product sales were lower primarily due to decreases in volumes for certain products which carry higher rebate rates such as Solodyn
®
, Retin-A Micro
®
0.06%, Elidel
®
and Jublia
®
. The decreases in year-over-year volumes were due in part to generic competition. These decreases were partially offset by increases in rebates for: (i)
sales of our Trulance
®
product, which we added to our portfolio in March 2019 as part of the acquisition of certain assets of Synergy
and (ii) increased 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
®
, Apriso
®
, Glumetza
®
AG and Prolensa
®
;
|
|
•
|
chargebacks as a percentage of gross product sales were lower primarily due to lower sales of certain branded products, such as Isuprel
®
and Nifediac and certain generic products, such as Zegerid
®
AG, and were partially offset by higher sales of Glumetza
®
AG, Xifaxan
®
and Glumetza
®
SLX; and
|
|
•
|
distribution service fees as a percentage of gross product sales were higher due to: (i) higher sales of Xifaxan
®
, Apriso
®
, Ativan
®
and other branded products and (ii)
sales of our Trulance
®
product, which we added to our portfolio in March 2019 as part of the acquisition of certain assets of Synergy
. These increases were partially offset by lower distribution fees due to lower sales of Isuprel
®
, Solodyn
®
and Mephyton
®
. Price appreciation credits are offset against the distribution service fees we pay wholesalers and were $0 and $15 million during the
three months ended March 31, 2019 and 2018
, respectively.
|
|
|
|
Three Months Ended
March 31, |
||||||
|
(in millions)
|
|
2019
|
|
2018
|
||||
|
Net gain on sale of assets
|
|
$
|
(10
|
)
|
|
$
|
—
|
|
|
Acquisition-related costs
|
|
8
|
|
|
—
|
|
||
|
Litigation and other matters
|
|
2
|
|
|
11
|
|
||
|
Other, net
|
|
(4
|
)
|
|
—
|
|
||
|
|
|
$
|
(4
|
)
|
|
$
|
11
|
|
|
•
|
The Bausch + Lomb/International segment
consists of: (i) sales in the U.S. of pharmaceutical products, OTC products and medical device products, primarily comprised of Bausch + Lomb products, with a focus on the Vision Care, Surgical, Consumer and Ophthalmology Rx products and (ii) with the exception of sales of Solta products, sales in Canada, Europe, Asia, Australia, Latin America, Africa and the Middle East of branded pharmaceutical products, branded generic pharmaceutical products, OTC products, medical device products and Bausch + Lomb products.
|
|
•
|
The Salix segment
consists of sales in the U.S. of GI products.
|
|
•
|
The Ortho Dermatologics
segment
consists of: (i) sales in the U.S. of Ortho Dermatologics (dermatological) products and (ii) global sales of Solta medical aesthetic devices.
|
|
•
|
The Diversified Products segment
consists of sales in the U.S. of: (i) pharmaceutical products in the areas of neurology and certain other therapeutic classes, (ii) generic products and (iii) dentistry products.
|
|
|
|
Three Months Ended March 31,
|
|||||||||||||||||||
|
|
|
2019
|
|
2018
|
|
Change
|
|||||||||||||||
|
(in millions)
|
|
Amount
|
|
Pct.
|
|
Amount
|
|
Pct.
|
|
Amount
|
|
Pct.
|
|||||||||
|
Segment Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Bausch + Lomb/International
|
|
$
|
1,118
|
|
|
55
|
%
|
|
$
|
1,103
|
|
|
55
|
%
|
|
$
|
15
|
|
|
1
|
%
|
|
Salix
|
|
445
|
|
|
22
|
%
|
|
422
|
|
|
21
|
%
|
|
23
|
|
|
5
|
%
|
|||
|
Ortho Dermatologics
|
|
138
|
|
|
7
|
%
|
|
140
|
|
|
7
|
%
|
|
(2
|
)
|
|
(1
|
)%
|
|||
|
Diversified Products
|
|
315
|
|
|
16
|
%
|
|
330
|
|
|
17
|
%
|
|
(15
|
)
|
|
(5
|
)%
|
|||
|
Total revenues
|
|
$
|
2,016
|
|
|
100
|
%
|
|
$
|
1,995
|
|
|
100
|
%
|
|
$
|
21
|
|
|
1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Segment Profits / Segment Profit Margins
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Bausch + Lomb/International
|
|
$
|
319
|
|
|
29
|
%
|
|
$
|
297
|
|
|
27
|
%
|
|
$
|
22
|
|
|
7
|
%
|
|
Salix
|
|
288
|
|
|
65
|
%
|
|
272
|
|
|
64
|
%
|
|
16
|
|
|
6
|
%
|
|||
|
Ortho Dermatologics
|
|
57
|
|
|
41
|
%
|
|
44
|
|
|
31
|
%
|
|
13
|
|
|
30
|
%
|
|||
|
Diversified Products
|
|
236
|
|
|
75
|
%
|
|
240
|
|
|
73
|
%
|
|
(4
|
)
|
|
(2
|
)%
|
|||
|
Total segment profits
|
|
$
|
900
|
|
|
45
|
%
|
|
$
|
853
|
|
|
43
|
%
|
|
$
|
47
|
|
|
6
|
%
|
|
|
|
Three Months Ended March 31, 2019
|
|
Three Months Ended March 31, 2018
|
|
Change in
Organic Revenue
|
|||||||||||||||||||||||||||||
|
|
|
Revenue
as
Reported
|
|
Changes in Exchange Rates
|
|
Acquisition
|
|
Organic Revenue (Non-GAAP)
|
|
Revenue
as
Reported
|
|
Divestitures and Discontinuations
|
|
Organic Revenue (Non-GAAP)
|
|
||||||||||||||||||||
|
(in millions)
|
|
Amount
|
|
Pct.
|
|||||||||||||||||||||||||||||||
|
Bausch + Lomb/International
|
|
$
|
1,118
|
|
|
$
|
58
|
|
|
$
|
—
|
|
|
$
|
1,176
|
|
|
$
|
1,103
|
|
|
$
|
(14
|
)
|
|
$
|
1,089
|
|
|
$
|
87
|
|
|
8
|
%
|
|
Salix
|
|
445
|
|
|
—
|
|
|
(6
|
)
|
|
439
|
|
|
422
|
|
|
(3
|
)
|
|
419
|
|
|
20
|
|
|
5
|
%
|
||||||||
|
Ortho Dermatologics
|
|
138
|
|
|
1
|
|
|
—
|
|
|
139
|
|
|
140
|
|
|
—
|
|
|
140
|
|
|
(1
|
)
|
|
(1
|
)%
|
||||||||
|
Diversified Products
|
|
315
|
|
|
—
|
|
|
—
|
|
|
315
|
|
|
330
|
|
|
(1
|
)
|
|
329
|
|
|
(14
|
)
|
|
(4
|
)%
|
||||||||
|
Total
|
|
$
|
2,016
|
|
|
$
|
59
|
|
|
$
|
(6
|
)
|
|
$
|
2,069
|
|
|
$
|
1,995
|
|
|
$
|
(18
|
)
|
|
$
|
1,977
|
|
|
$
|
92
|
|
|
5
|
%
|
|
|
|
Three Months Ended March 31,
|
|||||||||||||||||||
|
|
|
2019
|
|
2018
|
|
Change
|
|||||||||||||||
|
(in millions)
|
|
Amount
|
|
Pct.
|
|
Amount
|
|
Pct.
|
|
Amount
|
|
Pct.
|
|||||||||
|
Wellbutrin
®
Franchise
|
|
$
|
58
|
|
|
18
|
%
|
|
$
|
62
|
|
|
19
|
%
|
|
$
|
(4
|
)
|
|
(6
|
)%
|
|
Cuprimine
®
|
|
25
|
|
|
8
|
%
|
|
16
|
|
|
5
|
%
|
|
9
|
|
|
56
|
%
|
|||
|
Arestin
®
|
|
21
|
|
|
7
|
%
|
|
24
|
|
|
7
|
%
|
|
(3
|
)
|
|
(13
|
)%
|
|||
|
Aplenzin
®
|
|
16
|
|
|
5
|
%
|
|
12
|
|
|
4
|
%
|
|
4
|
|
|
33
|
%
|
|||
|
Ativan
®
|
|
15
|
|
|
5
|
%
|
|
13
|
|
|
4
|
%
|
|
2
|
|
|
15
|
%
|
|||
|
Migranal
®
Franchise
|
|
12
|
|
|
4
|
%
|
|
11
|
|
|
3
|
%
|
|
1
|
|
|
9
|
%
|
|||
|
Syprine
®
|
|
9
|
|
|
3
|
%
|
|
18
|
|
|
5
|
%
|
|
(9
|
)
|
|
(50
|
)%
|
|||
|
Latanoprost
|
|
8
|
|
|
2
|
%
|
|
4
|
|
|
1
|
%
|
|
4
|
|
|
100
|
%
|
|||
|
Tobramycin/Dexamethasone
|
|
7
|
|
|
2
|
%
|
|
5
|
|
|
2
|
%
|
|
2
|
|
|
40
|
%
|
|||
|
Mephyton
®
Franchise
|
|
7
|
|
|
2
|
%
|
|
14
|
|
|
4
|
%
|
|
(7
|
)
|
|
(50
|
)%
|
|||
|
Other product revenues
|
|
135
|
|
|
43
|
%
|
|
147
|
|
|
45
|
%
|
|
(12
|
)
|
|
(8
|
)%
|
|||
|
Other revenues
|
|
2
|
|
|
1
|
%
|
|
4
|
|
|
1
|
%
|
|
(2
|
)
|
|
(50
|
)%
|
|||
|
Total Diversified Products revenues
|
|
$
|
315
|
|
|
100
|
%
|
|
$
|
330
|
|
|
100
|
%
|
|
$
|
(15
|
)
|
|
(5
|
)%
|
|
|
|
Three Months Ended March 31,
|
||||||||||
|
(in millions)
|
|
2019
|
|
2018
|
|
Change
|
||||||
|
Net loss
|
|
$
|
(48
|
)
|
|
$
|
(2,579
|
)
|
|
$
|
2,531
|
|
|
Adjustments to reconcile net loss to net cash provided by operating activities
|
|
459
|
|
|
2,794
|
|
|
(2,335
|
)
|
|||
|
Changes in operating assets and liabilities
|
|
2
|
|
|
223
|
|
|
(221
|
)
|
|||
|
Net cash provided by operating activities
|
|
413
|
|
|
438
|
|
|
(25
|
)
|
|||
|
Net cash used in investing activities
|
|
(203
|
)
|
|
(48
|
)
|
|
(155
|
)
|
|||
|
Net cash used in financing activities
|
|
(150
|
)
|
|
(288
|
)
|
|
138
|
|
|||
|
Effect of exchange rate on cash and cash equivalents
|
|
1
|
|
|
10
|
|
|
(9
|
)
|
|||
|
Net increase in cash, cash equivalents and restricted cash
|
|
61
|
|
|
112
|
|
|
(51
|
)
|
|||
|
Cash, cash equivalents and restricted cash, beginning of period
|
|
723
|
|
|
797
|
|
|
(74
|
)
|
|||
|
Cash, cash equivalents and restricted cash, end of period
|
|
$
|
784
|
|
|
$
|
909
|
|
|
$
|
(125
|
)
|
|
(in millions)
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
2019
|
|
$
|
182
|
|
|
$
|
228
|
|
|
2020
|
|
303
|
|
|
303
|
|
||
|
2021
|
|
303
|
|
|
1,003
|
|
||
|
2022
|
|
1,553
|
|
|
1,553
|
|
||
|
2023
|
|
5,436
|
|
|
6,348
|
|
||
|
2024
|
|
2,303
|
|
|
2,303
|
|
||
|
Thereafter
|
|
14,394
|
|
|
12,894
|
|
||
|
Gross maturities
|
|
$
|
24,474
|
|
|
$
|
24,632
|
|
|
Rating Agency
|
|
Corporate Rating
|
|
Senior Secured Rating
|
|
Senior Unsecured Rating
|
|
Outlook
|
|
Moody’s
|
|
B2
|
|
Ba2
|
|
B3
|
|
Stable
|
|
Standard & Poor’s
|
|
B
|
|
BB-
|
|
B-
|
|
Stable
|
|
Fitch
|
|
B
|
|
BB
|
|
B
|
|
Stable
|
|
•
|
Debt service
—We expect to make principal and interest payments of approximately
$1,439 million
during the remainder of 2019. As a result of prepayments and a series of refinancing transactions we have extended the maturities of a substantial portion of our long-term debt, and as a result, as of the date of this filing, scheduled principal repayments of our debt obligations through 2021 are less than
$610 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;
|
|
•
|
Capital expenditures
—We expect to make payments of approximately
$225 million
for property, plant and equipment during the remainder of 2019;
|
|
•
|
Contingent consideration payments
—We expect to make contingent consideration and other approval/sales-based milestone payments of approximately $32 million during the remainder of 2019;
|
|
•
|
Restructuring and integration payments
—We expect to make payments of $17 million during the remainder of 2019 for employee separation costs and lease termination obligations associated with restructuring and integration actions we have taken through
March 31, 2019
; and
|
|
•
|
Benefit obligations
—We expect to make payments under our pension and postretirement obligations of $11 million during the remainder of 2019.
|
|
(in millions)
|
|
Total
|
|
Remainder of 2019
|
|
2020
|
|
2021 and 2022
|
|
2023 and 2024
|
|
Thereafter
|
||||||||||||
|
Long-term debt obligations, including interest
|
|
$
|
33,709
|
|
|
$
|
1,439
|
|
|
$
|
1,840
|
|
|
$
|
4,831
|
|
|
$
|
10,077
|
|
|
$
|
15,522
|
|
|
•
|
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 the U.S. Attorney's Office for the District of Massachusetts and the U.S. Attorney's Office for the Southern District of New York, the pending investigations by the U.S. Securities and Exchange Commission (the “SEC”) of the Company, the investigation order issued by the Company from the Autorité des marchés financiers (the “AMF”) (the Company’s principal securities regulator in Canada), a number of pending putative securities class action litigations in the U.S. (including related opt-out actions) and Canada (including related opt-out actions) and 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 U.S. Attorney's Offices for the District of Massachusetts and the Southern District of New York), and any pricing controls or price adjustments that 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, whether as a result of recent scrutiny or otherwise, such as the Patient Access and Pricing Committee’s commitment 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 Access and Pricing Committee (which is responsible for the pricing of our drugs);
|
|
•
|
legislative or policy efforts, including those that may be introduced and passed by the U.S. Congress, designed to reduce patient out-of-pocket 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 U.S. Food and 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, 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 debt we are able to incur where not prohibited, 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 2019 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 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;
|
|
•
|
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;
|
|
•
|
the uncertainties associated with the acquisition and launch of new 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 our Ortho Dermatologics business, including the approval of pending and pipeline products (and the timing of such approvals), the ability to successfully implement and operate our new cash-pay prescription program for certain of our Ortho Dermatologics branded products and the ability of such program to achieve the anticipated goals respecting patient access and fulfillment, 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 Significant Seven 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;
|
|
•
|
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, stabilize and grow our businesses in light of the challenges that the Company currently faces, including with respect to its substantial debt, pending investigations and legal proceedings, scrutiny of our past pricing, distribution and other practices, reputational harm and limitations on the way we conduct business imposed by the covenants in our Restated Credit Agreement, 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 with Walgreen 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 the recently signed United States-Mexico-Canada Agreement (“USMCA”) and any potential changes to other trade agreements;
|
|
•
|
the final outcome and impact of Brexit negotiations;
|
|
•
|
the trade conflict between the United States and China;
|
|
•
|
our ability to obtain, maintain and license sufficient intellectual property rights over our products and enforce and defend against challenges to such intellectual property;
|
|
•
|
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;
|
|
•
|
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, such as Doptelet
®
(Dova Pharmaceuticals, Inc.) and Lucemyra
TM
(US WorldMeds, LLC);
|
|
•
|
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),
|
|
•
|
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, Health Canada and similar agencies in other countries, legal and 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;
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•
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the results of continuing safety and efficacy studies by industry and government agencies;
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•
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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;
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•
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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;
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•
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the seasonality of sales of certain of our products;
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•
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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;
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|
•
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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 the U.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;
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•
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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;
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•
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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;
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•
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the impact of changes in federal laws and policy under consideration by the Trump administration and Congress, 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);
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•
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illegal distribution or sale of counterfeit versions of our products;
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•
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interruptions, breakdowns or breaches in our information technology systems; and
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•
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risks in Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018, filed on February 20, 2019, and risks detailed from time to time in our other filings with the SEC and the Canadian Securities Administrators (the “CSA”), as well as our ability to anticipate and manage the risks associated with the foregoing.
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*101.INS
|
XBRL Instance Document
|
|
*101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
*101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
*101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
*101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
*101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
††
|
One or more exhibits or schedules to this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. We undertake to furnish supplementally a copy of any omitted exhibit or schedule to the SEC upon request.
|
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Bausch Health Companies Inc.
(Registrant) |
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|
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Date: May 6, 2019
|
/s/ JOSEPH C. PAPA
|
|
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Joseph C. Papa
Chief Executive Officer (Principal Executive Officer and Chairman of the Board) |
|
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|
|
|
|
|
Date: May 6, 2019
|
/s/ PAUL S. HERENDEEN
|
|
|
Paul S. Herendeen
Executive Vice President and Chief Financial Officer (Principal Financial Officer) |
|
Exhibit
Number
|
Exhibit Description
|
|
*101.INS
|
XBRL Instance Document
|
|
*101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
*101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
*101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
*101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
*101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
††
|
One or more exhibits or schedules to this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. We undertake to furnish supplementally a copy of any omitted exhibit or schedule to the SEC upon request.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|