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
`For the Fiscal Year Ended December 31, 2021
`OR
`☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`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:
`
`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
`
`Securities registered pursuant to section 12(g) of the Act:
`
`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
`Accelerated filer ☐
`☐
`Smaller reporting company ☐
`Emerging growth company ☐
`Large accelerated filer x
`
`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 $8,713,713,918 based on the last reported sale price on the New York Stock Exchange on June 30, 2021
`The number of outstanding shares of the registrant’s common stock as of February 17, 2022 was 359,646,496
`DOCUMENTS INCORPORATED BY REFERENCE
`Part III incorporates certain information by reference from the registrant’s proxy statement for the 2022 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, 2021
`
`Eye Therapies Exhibit 2074, 1 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`
`
`
`
`
`
`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
`Reserved
` 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
`
`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 9C.
`
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`
`Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
`PART III
` Directors, Executive Officers and Corporate Governance
`
`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
`
`PART IV
`
`Exhibits and Financial Statement Schedules
`
`Item 15.
`Form 10-K Summary
`
`Item 16.
`SIGNATURES
`
`i
`
`
`
`Page
`
`1
`21
`56
`56
`57
`57
`
`58
`61
`62
`113
`113
`113
`113
`114
`114
`
`115
`115
`115
`115
`115
`
`116
`116
`121
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Eye Therapies Exhibit 2074, 2 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`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, 2021.
`
`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 INFUSE , BAUSCH + LOMB
`®
`®
`®
`®
`®
`®
`®
`ULTRA , BAUSCH HEALTH , BAUSCH HEALTH COMPANIES , BEDOYECTA , BENZACLIN , BEPREVE , BESIVANCE ,
`®
`®
`®
`®
`®
`®
`®
`BIOTRUE , BISOCARD , BOSTON , BRYHALI , BUPAP , CARDIZEM , CLEAR + BRILLIANT , CLEARVISC , CLINDAGEL ,
`®
`®
`®
`®
`®
`®
`®
`™
`®
`COMFORTMOIST , CRYSTALENS , CUPRIMINE , DEMSER , DIASTAT , DUOBRII , EDECRIN , ENVISTA , ESPAVEN ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`FRAXEL , GLUMETZA , INFUSE , ISTALOL , IVEXTERM , JUBLIA , LIBRAX , LOTEMAX , LUMIFY , MEPHYTON ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`®
`MIGRANAL , MINIMS , MOISTURESEAL , MYSOLINE , NEUTRASAL , NORITATE , OCUDOSE , OCUVITE , ONEXTON ,
`®
`®
`®
`®
`®
`®
`®
`®
`®
`OPTICALIGN , ORAFIT , ORTHO DERMATOLOGICS , PRESERVISION , PROLENSA , PUREVISION , RELISTOR , RENU ,
`®
`TM
`®
`®
`®
`®
`®
`®
`RENU MULTIPLUS , RETIN-A , RETIN-A MICRO , SALIX , SHOWER TO SHOWER , SILIQ , SILSOFT , SIMPLIFEYE ,
`®
`®
`®
`®
`®
`®
`®
`®
`SOFLENS , SOLODYN , SOLTA MEDICAL , STELLARIS , STELLARIS ELITE , SYNERGETICS , SYPRINE , TARGRETIN ,
`®
`®
`®
`®
`®
`®
`®
`®
`THERMAGE , THERMAGE FLX , THROMBO ASS , TIMOPTIC , TRULANCE , TRULIGN , UCERIS , VALEANT ,
`®
`®
`®
`®
`®
`®
`®
`®
`VASERLIPO , VICTUS , VIRAZOLE , VYZULTA , XENAZINE , YELLOX , ZEGERID , 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. 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. 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, expected launches of new products, product development and
`future performance and results of current and anticipated products; anticipated revenues for our products; expected research and
`development ("R&D") and marketing spend; our expected primary cash and working capital requirements for 2022 and beyond; the
`Company's 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 comply with the financial and other
`covenants contained in our Fourth Amended and Restated Credit and Guaranty Agreement, as amended by the First Incremental Amendment
`to the Restated Credit Agreement, dated as of November 27, 2018 (the "Restated Credit Agreement"), and senior notes indentures; the impact
`of our distribution,
`
`ii
`
`Eye Therapies Exhibit 2074, 3 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`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, revenues, 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; the Company’s plan to separate its eye-health business, including the
`structure and timing of completing such separation transaction; and the proposed initial public offering (“IPO”) of the Company’s Solta
`aesthetic medical device business, including the timing of such IPO.
`
`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”, "decrease" 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 (including with respect to current or future variants), COVID-19 vaccine immunization
`rates, the emergence of variant strains of COVID-19, the 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, (including the Company’s expectation that it will launch the IPO of the Bausch + Lomb entity when financial market
`conditions are favorable, subject to receipt of regulatory, stock exchange and other approvals, and the Company’s expectation that
`the separation transaction will be completed following the expiry of customary lock-ups related to the B+L IPO and achievement of
`targeted debt leverage ratios, subject to receipt of applicable shareholder and other necessary approvals), 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 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 the Canada Revenue Agency will be sought or obtained), the ability of the
`Company and the separated entity to satisfy the conditions required to maintain the tax-free status of the separation transaction
`(some of which are beyond their control), the potential dissynergy 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. In particular, the Company can offer no
`assurance that any IPO or separation will occur at all, or that any such transaction will occur on the timelines anticipated by the
`Company;
`
`iii
`
`Eye Therapies Exhibit 2074, 4 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`with respect to the proposed IPO of the Company’s Solta aesthetic medical device business, the risks and uncertainties include, but
`are not limited to, risks relating to the expected timing of completion of such transaction (including the Company’s expectation that
`it will launch such IPO when financial market conditions are favorable, subject to receipt of regulatory, stock exchange and other
`approvals) and the Company’s ability to complete such transaction, that market or other conditions are no longer favorable to
`completing the transaction on a timely basis or at all, the receipt of (or failure to receive) any shareholder, stock exchange,
`regulatory and other approvals required in connection with the transaction and the timing of receipt of such approvals, business
`disruption during the pendency of or following such transaction, diversion of management time on transaction-related issues,
`retention of Solta aesthetic medical device management team members, the reaction of customers and other parties to such
`transaction, the impact of such transaction on relationships with customers, suppliers, employees and other business counterparties,
`and other events that could adversely impact the completion of such transaction, including industry or economic conditions outside
`of Bausch Health’s control. In particular, the Company can offer no assurance that any IPO will occur at all, or that any such
`transaction will occur on the timelines anticipated by the Company;
`
`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), certain pending lawsuits 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 historic practice of limiting the average annual price increase for our branded prescription pharmaceutical products to
`single digits, or any future pricing actions we may take in 2022 or beyond 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;
`compliance with the legal and regulatory requirements of our marketed products;
`
`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 comply with 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 credit and/or 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 other current or future credit and/or
`debt agreements) and our ability, if any, to cure or obtain waivers of such default;
`
`iv
`
`Eye Therapies Exhibit 2074, 5 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`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 2022 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 other current
`or future credit and/or debt agreements) 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, assets and businesses, 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 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 stabilize and reposition our Ortho Dermatologics business to generate additional value, including
`the success of recently launched products and the approval of pipeline products (and the timing of such approvals);
`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;
`
`factors impacting our ability to achieve anticipated market acceptance for our products, including acceptance of the pricing,
`effectiveness of promotional efforts, reputation of our 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 ability to maintain strong relationships with physicians and other healthcare professionals;
`
`v
`
`Eye Therapies Exhibit 2074, 6 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`•
`
`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 implementation of the Organisation for Economic Co-operation and Development inclusive framework on Base Erosion and
`Profit Shifting, including the global minimum corporate tax rate, by the countries in which we operate;
`
`the outcome of any audits by taxation authorities, which outcomes may differ from the estimates and assumptions that we may use in
`determining our consolidated tax provisions and accruals;
`
`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;
`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 trade conflict between the United States and China;
`the potential conflict between Russia and Ukraine and any restrictive actions that may be taken by the U.S. and/or other countries in
`response thereto, such as sanctions or export controls;
`
`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);
`
`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 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 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;
`our ability to effectively promote our own products and those of our co-promotion partners;
`
`vi
`
`Eye Therapies Exhibit 2074, 7 of 216
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`the success of our fulfillment arrangements with Walgreen Co. 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 m