UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`_____________________________
`FORM 10-K
`☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`
`☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`
`For the Fiscal Year Ended December 31, 2020
`OR
`
`For the transition period from ____________ to ____________
`
`Commission File Number: 001-14956
`Bausch Health Companies Inc.
`(Exact Name of Registrant as Specified in its Charter)
`
`British Columbia , Canada
`(State or other jurisdiction of incorporation or organization)
`
`98-0448205
`(I.R.S. Employer Identification No.)
`
`2150 St. Elzéar Blvd. West, Laval, Québec, Canada H7L 4A8
`(Address of Principal Executive Offices) (Zip Code)
`
`Registrant's telephone number, including area code (514) 744-6792
`Securities registered pursuant to Section 12(b) of the Act:
`
`Securities registered pursuant to section 12(g) of the Act:
`
`Title of each class
`Common Shares, No Par Value
`
`Trading Symbol(s)
`BHC
`
`Name of each exchange on which registered
`New York Stock Exchange ,
`Toronto Stock Exchange
`
`None
`(Title of class)
`
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ý No o
`
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No ý
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
`requirements for the past 90 days. Yes ý No o
`Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ý No o
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in
`Rule 12b-2 of the Exchange Act.
`☐
`☐
`☐
`☐
`
`Smaller reporting company
`
`Emerging growth company
`
`Large accelerated filer
`
`x
`
`Accelerated filer
`
`Non-accelerated filer
`
`(Do not check if a smaller
`reporting company)
`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. ☐
`Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its
`audit report. ☒
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
`The aggregate market value of the common shares held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed second fiscal quarter was $5,664,997,951 based on the last reported sale price on the New York Stock Exchange on June 30, 2020.
`The number of outstanding shares of the registrant’s common stock as of February 18, 2021 was 355,619,826.
`
`DOCUMENTS INCORPORATED BY REFERENCE
`Part III incorporates certain information by reference from the registrant’s proxy statement for the 2021 Annual Meeting of Shareholders. Such proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2020.
`
`Exhibit 2160
`Page 001 of 168
`
`

`

`
`
`Item 1
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`Item 5.
`Item 6
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`
`Item 10
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`
`Item 15.
`Item 16.
`SIGNATURES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`GENERAL INFORMATION
`
`PART I
`
`
`
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`PART II
`Market for Registrant s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Selected Financial Data
`Management s Discussion and Analysis of Financial Condition and Results of Operations
`Quantitative and Qualitative Disclosures About Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
`PART III
`
`Directors Executi e Officers and Corporate Go ernance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accounting Fees and Services
`
`Exhibits and Financial Statement Schedules
`Form 10-K Summary
`
`PART IV
`
`i
`
`
`
`Page
`
`1
`18
`45
`45
`46
`46
`
`47
`51
`52
`103
`103
`103
`103
`103
`
`104
`104
`104
`104
`104
`
`105
`105
`110
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit 2160
`Page 002 of 168
`
`

`

`Basis of Presentation
`General
`
`Except where the context otherwise requires, all references in this Annual Report on Form 10-K (“Form 10-K”) to the “Company”, “we”, “us”, “our” or similar words or phrases are to Bausch Health Companies Inc. and its subsidiaries, taken
`together. In this Form 10-K, references to “$” or “USD” are to United States dollars, references to “€” are to Euros, and references to “CAD” are to Canadian dollars. Unless otherwise indicated, the statistical and financial data contained in this
`Form 10-K are presented as of December 31, 2020.
`
`Trademarks
`The following words are some of the trademarks in our Company s trademark portfolio and are the subject of either registration, or application for registration, in one or more of Canada, the United States of America (the “U.S.”) or certain
`other jurisdictions AERGEL , AKREOS , ALAWAY , ALREX , ALTRENO , AMMONUL , APLENZIN , APRISO , AQUALOX , ARAZLO , ARESTIN , ARTELAC , ATIVAN , B & L , B + L , BAUSCH & LOMB , BAUSCH +
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`LOMB , BAUSCH + LOMB ULTRA , BAUSCH HEALTH , BAUSCH HEALTH COMPANIES , BEDOYECTA , BENZACLIN , BEPREVE , BESIVANCE , BIOTRUE , BISOCARD , BOSTON , BRYHALI , BUPAP , CARAC ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`CARDIZEM , CLEAR + BRILLIANT , CLINDAGEL , COLD FX . COMFORTMOIST , CRYSTALENS , CUPRIMINE , DIASTAT , DUOBRII , EDECRIN , ENVISTA , ESPAVEN , FRAXEL , GLUMETZA , ISTALOL , IVEXTERM ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`JUBLIA , LIBRAX , LOTEMAX , LUMIFY , LUXGOOD , LUXSMART , LUZU , MEDICIS , MEPHYTON , MIGRANAL , MOISTURESEAL , NEUTRASAL , NORITATE , OCUVITE , ONEXTON , OPTICALIGN , ORTHO
`®
`®
`®
`®
`™
`™
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`DERMATOLOGICS , PRESERVISION , PROLENSA , PUREVISION , RELISTOR , RENU , RENU MULTIPLUS , RETIN-A , RETIN-A MICRO , SALIX , SCLERALFIL , SECONAL SODIUM , SHOWER TO SHOWER , SILIQ ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`SILSOFT , SOFLENS , SOLODYN , SOLTA MEDICAL , STELLARIS , STELLARIS ELITE , SYNERGETICS , SYPRINE , TARGRETIN , THERMAGE , THERMAGE FLX , THROMBO ASS , TRULANCE , TRULIGN , UCERIS ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`VALEANT , VASERLIPO , VICTUS , VIRAZOLE , VITESSE , VYZULTA , XENAZINE , ZEGERID , ZIANA , and ZYLET .
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`
`In addition to the trademarks previously noted, we have filed trademark applications and/or obtained trademark registrations for many of our other trademarks in the U.S., Canada and in other jurisdictions and have implemented, on an ongoing
`basis, a trademark protection program for new trademarks.
`
`WELLBUTRIN , WELLBUTRIN XL and ZOVIRAX are trademarks of GlaxoSmithKline LLC and are used by us under license. ELIDEL and XERESE are registered trademarks of Meda Pharma SARL and are used by us under license.
`®
`®
`®
`®
`®
`EMERADE is a registered trademark of Medeca Pharma AB and is used by us under license. ISUPREL and NITROPRESS are registered trademarks of Hospira, Inc. and are used by us under license. XIFAXAN is a registered trademark of
`®
`®
`®
`®
`Alfasigma S.p.A. and is used by us under license. PEPCID is a brand of Johnson & Johnson and is used by us under license. MOVIPREP is a registered trademark of Velinor AG and is used by us under license. PLENVU is a registered trademark
`®
`®
`®
`of Velinor AG and is used by us under license. LOCOID is a registered trademark of Leo Pharma A/S and is used by us under license. TANGIBLE and HYDRA-PEG are registered trademarks of Tangible Science, LLC and are used by us under
`®
`®
`®
`license. LUMINATE is a registered trademark of Allegro Ophthalmics, LLC and we have entered into an agreement for an option to acquire all ophthalmology assets of Allegro Ophthalmics, LLC. XIPERE is a trademark of Clearside Biomedical,
`®
`™
`Inc. and is used by us under license. CONTRAVE and MYSIMBA are used by us under license.
`®
`®
`Forward-Looking Statements
`Caution regarding forward-looking information and statements and “Safe-Harbor” statements under the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws
`
`To the extent any statements made in this Form 10-K contain information that is not historical these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended and Section 21E of
`the Securities Exchange Act of 1934 as amended and may be forward-looking information within the meaning defined under applicable Canadian securities laws (collectively “forward-looking statements”).
`These forward-looking statements relate to among other things our business strategy business plans and prospects and forecasts and changes thereto product pipeline prospective products and product approvals product development and
`future performance and results of current and anticipated products anticipated revenues for our products anticipated growth in our Ortho Dermatologics business expected research and development ( R&D ) and marketing spend our expected
`primary cash and working capital requirements for 2021 and beyond our plans for continued improvement in operational efficiency and the anticipated impact of such plans our liquidity and our ability to satisfy our debt maturities as they become
`due our ability to reduce debt levels our ability to meet the financial and other covenants contained in our Fourth Amended and Restated Credit
`
`ii
`
`Exhibit 2160
`Page 003 of 168
`
`

`

`and Guaranty Agreement (the Restated Credit Agreement ) and senior notes indentures the impact of our distribution fulfillment and other third-party arrangements proposed pricing actions exposure to foreign currency exchange rate changes
`and interest rate changes the outcome of contingencies such as litigation subpoenas investigations reviews audits and regulatory proceedings the anticipated impact of the adoption of new accounting standards general market conditions our
`expectations regarding our financial performance including revenues expenses gross margins and income taxes our impairment assessments including the assumptions used therein and the results thereof the anticipated impact of the evolving
`COVID-19 pandemic and related responses from governments and private sector participants on the Company its supply chain third-party suppliers project development timelines costs revenue margins liquidity and financial condition the
`anticipated timing speed and magnitude of recovery from these COVID-19 pandemic related impacts and the Company s planned actions and responses to this pandemic and the Company s plan to separate its eye-health business including the
`structure and timing of completing such separation transaction.
`Forward-looking statements can generally be identified by the use of words such as “believe” “anticipate” “expect” “intend” “estimate” “plan” “continue” “will” “may” “could” “would” “should” “target” “potential”
`“opportunity” “designed” “create” “predict” “project” “forecast” “seek” “strive” “ongoing” or “increase” and variations or other similar expressions. In addition any statements that refer to expectations intentions projections or other
`characterizations of future events or circumstances are forward-looking statements. These forward-looking statements may not be appropriate for other purposes. Although we have previously indicated certain of these statements set out herein all of
`the statements in this Form 10-K that contain forward-looking statements are qualified by these cautionary statements. These statements are based upon the current expectations and beliefs of management. Although we believe that the expectations
`reflected in such forward-looking statements are reasonable such statements involve risks and uncertainties and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making such forward-
`looking statements including but not limited to factors and assumptions regarding the items previously outlined those factors risks and uncertainties outlined below and the assumption that none of these factors risks and uncertainties will cause
`actual results or events to differ materially from those described in such forward-looking statements. Actual results may differ materially from those expressed or implied in such statements. Important factors risks and uncertainties that could cause
`actual results to differ materially from these expectations include among other things the following
`
`•
`
`•
`
`•
`
`the risks and uncertainties caused by or relating to the evolving COVID-19 pandemic the fear of that pandemic the availability and effectiveness of vaccines for COVID-19 the rapidly evolving reaction of governments private sector
`participants and the public to that pandemic and the potential effects and economic impact of the pandemic and the reaction to it the severity duration and future impact of which are highly uncertain and cannot be predicted and which
`may have a significant adverse impact on the Company including but not limited to its supply chain third-party suppliers project development timelines employee base liquidity stock price financial condition and costs (which may
`increase) and revenue and margins (both of which may decrease)
`
`with respect to the proposed separation of the Company s eye-health business the risks and uncertainties include but are not limited to the expected benefits and costs of the separation transaction the expected timing of completion of the
`separation transaction and its terms the Company s ability to complete the separation transaction considering the various conditions to the completion of the separation transaction (some of which are outside the Company s control
`including conditions related to regulatory matters and a possible shareholder vote if applicable) that market or other conditions are no longer favorable to completing the transaction that any shareholder stock exchange regulatory or
`other approval (if required) is not obtained on the terms or timelines anticipated or at all business disruption during the pendency of or following the separation transaction diversion of management time on separation transaction-related
`issues retention of existing management team members the reaction of customers and other parties to the separation transaction the qualification of the separation transaction as a tax-free transaction for Canadian and/or U.S. federal
`income tax purposes (including whether or not an advance ruling from either or both of the Canada Revenue Agency and the Internal Revenue Service will be sought or obtained) potential dyssynergy costs resulting from the separation
`transaction the impact of the separation transaction on relationships with customers suppliers employees and other business counterparties general economic conditions conditions in the markets the Company is engaged in behavior of
`customers suppliers and competitors technological developments as well as legal and regulatory rules affecting the Company s business
`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 a number of pending non-class securities litigations (including certain pending opt-out actions in the U.S. related to the previously settled
`securities class action (which remains subject to an objector's appeal of the Court's final approval order) and certain opt-out actions in Canada relating to the recently settled class action in Canada) and purported class actions
`
`iii
`
`Exhibit 2160
`Page 004 of 168
`
`

`

`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 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 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 equivalent agencies outside of the U.S. and the
`results thereof
`
`actions by the FDA or other regulatory authorities with respect to our products or facilities
`our substantial debt (and potential additional future indebtedness) and current and future debt service obligations our ability to reduce our outstanding debt levels and the resulting impact on our financial condition cash flows and results
`of operations
`
`our ability to meet the financial and other covenants contained in our Restated Credit Agreement senior notes indentures 2023 Revolving Credit Facility (as defined below) and other current or future debt agreements and the limitations
`restrictions and prohibitions such covenants impose or may impose on the way we conduct our business including prohibitions on incurring additional debt if certain financial covenants are not met limitations on the amount of additional
`obligations we are able to incur pursuant to other covenants our ability to draw under our 2023 Revolving Credit Facility 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 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 2021 or beyond including as a result of the impacts of the COVID-19 pandemic on our business and operations which could lead to among other things
`(i) a failure to meet the financial and/or other covenants contained in our Restated Credit Agreement and/or senior notes indentures and/or (ii) impairment in the goodwill associated with certain of our reporting units or impairment charges
`related to certain of our products or other intangible assets which impairments could be material
`
`changes in the assumptions used in connection with our impairment analyses or assessments which would lead to a change in such impairment analyses and assessments and which could result in an impairment in the goodwill associated
`with any of our reporting units or impairment charges related to certain of our products or other intangible assets
`the uncertainties associated with the acquisition and launch of new products including but not limited to our ability to provide the time resources expertise and funds 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
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`iv
`
`Exhibit 2160
`Page 005 of 168
`
`

`

`•
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`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 success of recently launched products (such as Arazlo ) expected geographic expansion in our Solta business (including with
`®
`respect to Next Generation Thermage FLX ) the ability to successfully implement and operate our 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 the approval of pending and pipeline products (and the timing of such approvals) changes in estimates on market potential for dermatology products and continued investment in
`and success of our sales force
`
`factors impacting our ability to achieve anticipated revenues for our products including changes in anticipated marketing spend on such products and launch of competing products
`
`the challenges and difficulties associated with managing a large complex business which has in the past grown rapidly
`our ability to compete against companies that are larger and have greater financial technical and human resources than we do as well as other competitive factors such as technological advances achieved patents obtained and new
`products introduced by our competitors
`
`our ability to effectively operate and grow our businesses in light of the challenges that the Company has faced and market conditions including with respect to its substantial debt pending investigations and legal proceedings scrutiny of
`our past pricing and other practices limitations on the way we conduct business imposed by the covenants contained in our Restated Credit Agreement senior notes indentures and the agreements governing our other indebtedness and the
`impacts of the COVID-19 pandemic
`
`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 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 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 (such as in connection with the filing by Norwich Pharmaceuticals
`Inc. (“Norwich”) of its Abbreviated New Drug Application (“ANDA”) for Xifaxan (rifaximin) 550 mg tablets and the Company s related lawsuit filed against Norwich in connection therewith)
`®
`
`v
`
`Exhibit 2160
`Page 006 of 168
`
`

`

`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`the introduction of generic biosimilar or other competitors of our branded products and other products including the introduction of products that compete against our products that do not have patent or data exclusivity rights
`our ability to identify finance acquire close and integrate acquisition targets successfully and on a timely basis and the difficulties challenges time and resources associated with the integration of acquired companies businesses and
`products
`
`any divestitures of our assets or businesses and our ability to successfully comple e 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 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 Walgreen Co. (“Walgreens”)
`our ability to effectively promote our own products and those of our co-promotion partners
`
`the success of our fulfillment arrangements with Walgreens including market acceptance of or market reaction to such arrangements (including by customers doctors patients PBMs third-party payors and governmental agencies) and
`the continued compliance of such arrangements with applicable laws
`
`our ability to secure and maintain third-party research development manufacturing licensing marketing or distribution arrangements
`the risk that our products could cause or be alleged to cause personal injury and adverse effects leading to potential lawsuits product liability claims and damages and/or recalls or withdrawals of products from the market
`
`the mandatory or voluntary recall or withdrawal of our products from the market and the costs associated therewith
`
`the availability of and our ability to obtain and maintain adequate insurance coverage and/or our ability to cover or insure against the total amount of the claims and liabilities we face whether through third-party insurance or self-
`insurance
`the difficulty in predicting the expense timing and outcome within our legal and regulatory environment including with respect to approvals by the FDA 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
`
`the results of continuing safety and efficacy studies by industry and government agencies
`the success of preclinical and clinical trials for our drug development pipeline or delays in clinical trials that adversely impact the timely commercialization of our pipeline products as well as other factors impacting the commercial success
`of our products which could lead to material impairment charges
`
`vi
`
`Exhibit 2160
`Page 007 of 168
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`the results of management reviews of our research and development portfolio (including following the receipt of clinical results or feedback from the FDA or other regulatory authorities) which could result in terminations of specific
`projects which in turn could lead to material impairment charges
`the seasonality of sales of certain of our products
`
`declines in the pricing and sales volume of certain of our products that are distributed or marketed by third parties over which we have no or limited control
`
`compliance by the Company or our third-party partners and service providers (over whom we may have limited influence) or the failure of our Company or these third parties to comply with health care “fraud and abuse” laws and other
`extensive regulation of our marketing promotional and business practices (including with respect to pricing) worldwide anti-bribery laws (including 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
`the impacts of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010 (the “Health Care Reform Act”) and potential amendment thereof and other legislative and regulatory
`health care reforms in the countries in which we operate including with respect to recent government inquiries on pricing
`
`the impact of any changes in or reforms to the legislation laws rules regulation and guidance that apply to the Company and its businesses and products or the enactment of any new or proposed legislation laws rules regulations or
`guidance that will impact or apply to the Company or its businesses or products
`
`the impact of changes in federal laws and policy that may be undertaken following the change in the U.S. administrat