BAUSCH HEALTH COMPANIES INC.
`
`BUILDING
`MOMENTUM
`
`BAUSCH- Health
`
`2O1B ANNUAL REPORT
`
`Eye Therapies Exhibit 2072, 1 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`BAUSCH- Health
`
`BAUSCH HEAL TH COMPANIES INC.
`
`our Vision
`To Be Your Trusted
`Health Care Partner
`
`CORE VALUES
`
`• Accountablllty
`• Aglllty
`• courage
`• Integrity
`• Teamwork
`• Results Orientation
`
`our Mission
`Improving People's Lives
`With our Health Care Products
`
`COMPANY OVERVIEW
`We are a global company whose mission Is to Improve people's lives with our health care products. We develop,
`manufacture and market a range of branded, generic and branded generic pharmaceuticals, medical devices (contact
`lenses, lntraocular lenses, ophthalmic surgical equipment, and aesthetics devices) and over-the-counter (OTC)
`products, primarily In the therapeutic areas of eye-health, gastroenterology and dermatology. we are delivering on
`our commitments as we build an Innovative company dedicated to advancing global health. More Information
`can be found at www.bauschhealth.com
`
`FORWARD-LOOKING STATEMENTS
`This annual report contains forward-looking Information and statements, within the meaning of applloable securities laws (oolleotlvely, '-'forward-looking statements'"), lnolud(cid:173)
`lng, but not Umlted to, statements regarding the Company's future prospects and performance (lnoludlng anticipated growth In 2019 and the expected drivers of that growth.
`and the anticipated 2019 revenue growth for our Significant Seven Products and the expected quantum of such revenue growth), the anticipated Impact of the acquisition of
`certain assets of Synergy Pharmaceuticals Ino. (lnoludlng Trulanoe•), the Company's plans to Increase Investment In R&O and the expected quantum of that Increased Invest(cid:173)
`ment. anticipated product launches and the expected timing of such launches, the anticipated approval for certain of our pipeline products (fncludlng DUOBRRI™), anticipated
`timing for the submission of certain of our plpelfne products and R&O programs, and anticipated Improvements In operational efficiency. Forward-looking statements may
`generally be Identified by the use of the words .. anticipates," °'expects," '-'Intends,"' '-'plans," .. should," '-'could," .. would," '-'may," '-'will," .. believes," '-'estimates," '-'potential." '-'target:
`or '-'continue" and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken,
`or will occur or result, and similar such expressions also Identify forward-looking Information. These forward-looking statements, Including the Company's future performance
`and growth, are based upon the current expectations and beliefs of management and are provided for the purpose of providing additional Information about such expectations
`and beliefs, and readers are cautioned that these statements may not be appropriate for other purposes. These forward-looking statements are subject to certain risks and
`uncertainties that could cause actual results to differ materially from those described In the forward-looking statements. These risks and uncertainties Include. but are not
`limited to. the risks and uncertainties discussed In the Company's most recent annual or quarterly report and detailed from time to time In the Company's other flllngs with the
`Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are Incorporated herein by reference. In addition. certain
`material factors and assumptions have been applied In making these forward-looking statements, lnoludlng, wlthout llmltatlon, the assumption that the risks and uncertainties
`outlined above will not cause actual results or events to differ materially from those described In these forward-looking statements, and additional Information regarding cer(cid:173)
`tain of these material factors and assumptions may also be found In the Company's filings described above. The Company belleves that the material factors and assumptions
`reflected In these forward-looking statements are reasonable In the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking
`statements. These forward-looking statements speak only as of the date hereof. Bausoh Health undertakes no obllgatlon to update any of these forward-looking statements
`to reflect events or circumstances after the date of this annual report or to reflect actual outcomes, unless required by law.
`
`Eye Therapies Exhibit 2072, 2 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`THE BAUSCH FOUNDATION
`
`IMPROVING LIVES
`AROUND THE WORLD
`
`The Bausch Foundation was established In 2017 to Improve the llves of people
`around the world by providing access to safe, effective medicines and by flnanclally
`supporting health care education and causes. The Bausch Foundation Is a charitable
`foundation that oversees and directs all of Bausch Health's global charitable glVlng.
`
`The Bausch Foundation supports Initiatives aimed at disease prevention, Improving
`patient outcomes and llves, and education related to our core businesses. Addttlonally,
`It supports disaster-recovery efforts and those who need help In the communities
`where we nve and work. our goal Is to direct efforts toward contributions that can
`be repeatable, gather crltlcal mass and make Important benefits within our
`therapeutic communities.
`
`Since its inception, the Bausch Foundation has contributed millions of
`dollars• worth of financial and product donations to global charitable
`health organizations, including:
`
`IDPH
`
`IWIIOII OU:M:.JlolCHl'Of f'UMK ttwtM
`
`OPTOMETRYGIVINGSIGHT
`Transforming llws through the gfft of rision
`
`2 0 18 Annu a l Rep o r t
`
`•
`
`•
`11amer1cares
`•
`
` EYE BANK
`
`ASSOCIATION
`OF AMERICA
`
`C,
`
`Red Cross
`
`+ American
`a colorectal
`
`cancer
`alliance
`
`Eye Therapies Exhibit 2072, 3 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`Fellow Shareholders,
`
`I continue to view Bausch Health as the turnaround opportunity
`of a lifetime. The Company made considerable progress in
`2018, and we are still gaining momentum, which we believe
`will carry over into 2019 and beyond.
`
`In the past two years, we'Ve completed a number of divestitures
`to streamline operations, continued to pay down debt, resolved
`numerous key legacy issues, launched new products and
`realigned into four reporting segments.
`
`We also changed our name to Bausch Health Companies Inc.,
`which is a logical step in our transformation. We consider
`Bausch Health to be a new company-one that develops,
`manufactures and markets a wide range of pharmaceutical,
`medical device and over-the-counter products, primarily in
`the therapeutic areas of eye health, gastroenterology and
`dermatology. The Bausch Health name not only reflects a
`long-standing dedication to innovation, but also evokes our
`mission of improving the lives of patients with our health
`care products.
`
`We see 2019 as a year of growth and a strategic pivot to
`offense-driven by several important new products, as well
`as debt paydown and bolt-on opportunities to enhance our
`core businesses. Looking back at 2018, there were several
`major factors that contributed to our transformation.
`
`Executing on our core businesses
`
`Our two largest reporting segments continued to drive our
`performance: Bausch + Lomb/International, which represented
`approximately 56% of the Company's total revenues in
`2018, and Salix, which represented approximately 21% of
`the Company's total revenues in 2018.
`
`Bausch + Lomb is a fully integrated eye care business, with
`extensive product portfolios in Vision Care, Surgical, Prescription
`Ophthalmology and Consumer Health Care. Bausch + Lomb
`maintains a large global footprint with a major presence in
`such rapidly growing emerging markets as China, Japan and
`India. In 2018, our U.S. contact lens business outpaced the
`industry, with greater than 13% market growth1. Additionally,
`PreserVision., and Ocuvite• combined are the No. 1 brands
`and No. 1 drivers of growth in the eye vitamin category.
`
`Growth within our Salix gastroenterology business comes
`primarily from several key brands. The past year saw
`impressive revenue growth for XIFAXAN" (22%), RELISTOR"
`(37%) and APRISO'" (13%). XIFAXAN., notably had a marked
`increase in new prescriptions written by primary care
`physicians as our 2017 investment into building a primary
`care sales team has continued to yield strong results.
`
`In March 2019, we acquired certain assets of Synergy
`Pharmaceuticals Inc., a biopharmaceutical company
`focused on gastrointestinal therapies. Synergy's flagship
`product, TRULANCE.,, is approved for adults with chronic
`
`idiopathic constipation and irritable bowel syndrome with
`constipation. The acquisition of the assets of Synergy will
`enhance our Salix business. We believe TRULANCE., is a natural
`complement to XIFAXAN'" and, with the scale and strength of
`our sales footprint in GI and primary care, our Salix team will
`be able to offer physicians and patients multiple treatment
`options that span the types of irritable bowel syndrome.
`
`The Ortho Dermatologies business continues to stabilize as
`we remain committed to investing in new dermatology solu(cid:173)
`tions, including a continued focus on psoriasis, an area with
`a great unmet need. Today in the United States, there are
`approximately 7.5 million patients suffering from psoriasis,
`with as many as 260,000 new cases diagnosed each year.
`
`We recently moved Solta Medical, our global aesthetics
`business, into our Ortho Dermatologies segment, a shift we
`believe will enable us to better serve both our physician
`customers and patients. During 2018, Solta delivered
`exceptional growth compared to 2017.
`
`Launching new products
`
`Innovation remains critical to our future, and we anticipate
`our R&D investment to grow by approximately 10% in 2019
`versus 2018. Our focus on innovation has yielded a wide
`range of significant launches:
`
`• LUMIFY™ is the only over-the-counter eye drop with low-dose
`brimonidine for the treatment of eye redness. Since its launch
`in May 2018, LUMIFY'" has become the number one product in
`the redness reliever category with an approximately 28%
`market share•
`• In late 2017, we launched VYZULTA•, the first and only FDA-approved
`nitric oxide-releasing agent to lower intraocular pressure in patients
`with glaucoma or ocular hypertension. VYZULTA• is now available
`to a majority of commercial and Part D coverage plans and was
`approved in Canada in January 2019.
`• In September 2018, Bausch + Lomb launched AQUALOX'" daily(cid:173)
`disposable silicone hydrogel (SiHy) contact lenses in Japan.
`• To enhance our Salix business, we have engaged in multiple
`strategic partnerships that we believe will help drive long-term
`growth, including LUCEMYRA'" (our co-promotion arrangement
`with US WorldMeds, LLC), the first and only non-opioid medication
`indicated for mitigation of opioid withdrawal symptoms; DOPTELET(cid:173)
`(our co-promotion arrangement with Dova Pharmaceuticals),
`the first FDA-approved drug for thrombocytopenia in chronic
`liver disease patients scheduled to undergo a procedure; and
`PLENVU" (our license arrangement with Norgine B.V.). a next(cid:173)
`generation bowel cleansing preparation for colonoscopies.
`• In early 2018, we expanded our launch of SILIQ'", the lowest priced
`injectable biologic on the market for moderate-to-severe psoriasis.
`• Ortho Dermatologies launched BRYHALI'" Lotion, a potent to
`super-potent corticosteroid for the topical treatment of plaque
`psoriasis, in November 2018.
`• Ortho Dermatologies also launched two acne treatments in
`2018: RETIN-A MICRO• (in a new strength) and ALTRENO™.
`
`•
`
`Bausch Health Companies Inc.
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`Eye Therapies Exhibit 2072, 4 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`Additionally, Bausch + Lomb ULTRA"' Multifocal for Astigmatism
`contact lenses are expected to launch in mid-2019, along
`with an expansion of our Biotrue• ONEday daily disposable
`lens parameter offerings.
`
`We continue to be strategically focused on our pipeline by
`investing in innovation to bring new products to market,
`which in turn will enable us to continue to invest in our future.
`Some highlights include:
`
`• Loteprednol etabonate ophthalmic gel, 0.38% for ocular
`inflammation, approved by the FDA in late February 2019;
`• DU08Ril'"3, a topical lotion for the treatment of plaque psoriasis,
`for which we expect an FDA decision shortly.
`• Four late-stage dermatology candidates to treat acne and
`atopic dermatitis, including one we anticipate filing in 2019; and
`• Multiple clinical programs to expand the use of rifaximin to
`reach additional patient populations.
`Several products I've already mentioned also make up our
`Significant Seven, which are the key products we believe will
`collectively achieve more than $1 billion in annualized peak
`
`resolving litigation, disputes and investigations in some 68
`matters in 2018. Some key resolutions include the XIFAXAN"'
`intellectual property litigation, which we believe, preserves
`market exclusivity until 2028; the Securities and Exchange
`Commission's legacy investigation of Salix•, the Allergan
`securities litigation; and the outstanding arbitration with
`Alfasigma S.p.A., which has allowed us to continue our
`collaboration on new formulations for rifaximin.
`
`In 2018, we also established our Bausch Foundation, with the
`goal of improving the lives of patients by providing access to
`safe, effective medicines and financially supporting health care
`education and causes around the world. You will find additional
`information about the foundation elsewhere in this report.
`
`In closing, we anticipate further growth and improvements
`in operational efficiency, none of which would be possible
`without the contributions of our more than 21,000 talented
`and dedicated employees worldwide. We are proud that
`every day, more than 150 million people around the world
`use a Bausch Health product.
`
`Quality, innovation and new product launches remain critical to our
`future. Our investment in R&D reflects our commitment to drive
`growth through the internal development of new products.
`
`sales revenue by the end of 2022. The Significant Seven are
`AQUALOX'", BRYHALI'", DUOBRII'"3, LUMIFY'", RELISTOR"' (for
`opioid-induced constipation), SILIQ'" and VYZULTA". In 2019,
`revenue generated by the Significant Seven is expected to
`approximately double compared to 2018.
`
`Resolving legacy Issues and repaying our debt
`
`By the end of 2018, we reduced our debt by more than
`$7.6 billion since the first quarter of 2016. We executed on
`repaying more than $1 billion in debt with cash generated
`from operations in 2018. In addition to dramatically reduc(cid:173)
`ing the amount of our debt, we successfully extended our
`maturities, which have given us more flexibility to make
`strategic decisions, such as the capital investment in our
`Rochester, New York and Waterford, Ireland manufacturing
`sites to support the anticipated global demand for our
`SiHy daily contact lenses.
`
`Our legal team continues to make outstanding contribu(cid:173)
`tions, achieving dismissals or other positive outcomes in
`
`While there is more work to do, we are now a very different
`company-a world-class organization well-positioned to
`return to growth.
`
`I'd like to commend all our employees, and our management
`team, who are making this transformation possible. Their
`hard work and commitment is essential to our success.
`
`I also want to take this opportunity to thank our shareholders,
`who believe in our Company, our strategy and our ability to
`execute. Thank you for your continued confidence and support.
`
`Sincerely, if Joseph c. Papa
`
`Chairman of the Board and Chief Executive Officer
`
`1Thfrd party data on file and Internal estfmates
`2Retall Dollar Share for total United States (MULO) for 4 weeks ending Feb. 10, 2019 , according to IRI.
`SProvlslonal name
`•Subject to approval by the U.S. Olstrlot Court for the Southern District of New York
`
`2018 Annual Rep o rt
`
`•
`
`Eye Therapies Exhibit 2072, 5 of 209
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`0 UR APPROACH TO
`CORPORATE SOCIAL
`RESPONSIBILITY
`
`As a global company dedicated to improving people's lives with our health care products, we take our commitment
`to corporate social responsibility (CSR) seriously. Every day-somewhere in the world-more than 150 million people
`use a Bausch Health product, while our 21,000 employees live and work in more than 100 countries around the world.
`This means Bausch Health has a big opportunity-and an even greater responsibility-to make a difference. We have
`framed our CSR work around five key commitment areas:
`
`Last year, Bausch Health published its inaugural Corporate Social Responsibility Report
`online at https://www.bauschhealth.com/Portals/25/PDF/BauschHealth-CSR-Report.pdf.
`It provides an introduction to our foundational work in each of these areas, featuring
`highlights of success stories from our operations around the globe. Beginning with the
`2019 CSR Report, we will be establishing and reporting consistently on key performance
`indicators within and across these areas.
`
`•
`
`Bausch Health Companies Inc.
`
`Eye Therapies Exhibit 2072, 6 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`BAUSCH HEA LTH COMPANIES INC .
`
`BAUSCI+ Health
`
`FORM 10-K
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`Eye Therapies Exhibit 2072, 7 of 209
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`
`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, 2018
`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
`
`BRITISH COLUMBIA, CANADA
`State or other jurisdiction of
`incorporation or organization
`
`BAUSCH HEALTH COMPANIES INC.
`(Exact Name of Registrant as Specified in its Charter)
`
`
`
`2150 St. Elzéar Blvd. West
`Laval, Québec
`Canada, H7L 4A8
`(Address of principal executive offices)
`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
`Securities registered pursuant to section 12(g) of the Act:
`
`
`
`
`
`
`
`
`
`
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`
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`98-0448205
`(I.R.S. Employer Identification No.)
`
`
`
`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  No 
`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  No 
`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  No 
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
`Data File required to be submitted and posted 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 and post such files). Yes  No 
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
`contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
`Form 10-K or any amendment to this Form 10-K. 
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
`company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
`Exchange Act. (Check one):
`Non-accelerated filer  Smaller reporting company  Emerging growth company 
`Large accelerated filer  Accelerated filer 
`
`
`
`
`
`(Do not check if a smaller
`
`
`
`
`reporting company)
`
`
`
`
`
`
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`
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`
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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. 
`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 $7,208,197,000 based on the last reported sale price on the New York Stock Exchange on
`June 30, 2018.
`The number of outstanding shares of the registrant’s common stock as of February 14, 2019 was 350,993,877.
`DOCUMENTS INCORPORATED BY REFERENCE
`Part III incorporates certain information by reference from the registrant’s proxy statement for the 2019 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, 2018.
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`Eye Therapies Exhibit 2072, 8 of 209
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`Page
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`1
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`42
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`100
`100
`100
`100
`100
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`101
`101
`106
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`TABLE OF CONTENTS
`
`GENERAL INFORMATION
`
`PART I
`
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`Item 5.
`
`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
`
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`
`Exhibits and Financial Statement Schedules
`Item 15.
`Form 10-K Summary
`Item 16.
`SIGNATURES
`
`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
`
`i
`
`Eye Therapies Exhibit 2072, 9 of 209
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`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, 2018.
`
`Effective on July 13, 2018, the Company changed its corporate name from Valeant Pharmaceuticals International, Inc. to
`Bausch Health Companies Inc.
`
`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: ACANYA®, AERGEL®, AKREOS®, ALDARA®, ALREX®, ALTRENO™, AMMONUL®, AMYTAL®,
`APLENZIN®, APRISO®, AQUALOX®, ARESTIN®, ARTELAC®, ATIVAN®, ATRALIN®, B&L®, B+L®, BAUSCH &
`LOMB®, BAUSCH + LOMB®, BAUSCH + LOMB ULTRA®, BAUSCH HEALTH™, BAUSCH HEALTH COMPANIES™,
`BEPREVE®, BESIVANCE®, BIOTRUE®, BOSTON®, BRYHALITM, CARAC®, CARDIZEM®, CLEAR + BRILLIANT®,
`CLINDAGEL®, COLD-FX®, COMFORTMOIST®, CRYSTALENS®, CUPRIMINE®, DIASTAT®, DUOBRII™,
`EDECRIN®, ENVISTA®, GLUMETZA®, IPRIVASK®, ISTALOL®, JUBLIA®, LIPOSONIX®, LOTEMAX®, LUMIFY®,
`LUZU®, MEDICIS®, MEPHYTON®, MESTINON®, MIGRANAL®, MINOCIN®, MOISTURESEAL®, MYSOLINE®,
`NEUTRASAL®, 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™, STORZ®, SYNERGETICS®, SYPRINE®, TARGRETIN®,
`TASMAR®, THERMAGE®, THERMAGE FLX®, TRULIGN®, UCERIS®, VALEANT®, VANOS®, VICTUS®,
`VIRAZOLE®, VITESSE®, VYZULTA®, XENAZINE®, ZEGERID®, ZELAPAR®, 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. DEFLUX® and SOLESTA®
`are registered trademarks of Nestlé Skin Health S.A. and are 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 McNeil Consumer Pharmaceuticals 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 the Norgine group of companies and is used by us under license. LOCOID® is a registered trademark of Leo
`Pharma A/S and is used by us under license. LUCEMYRATM is a trademark of US Worldmeds, LLC and is used by us under
`license. DOPTELET® is a trademark of AkaRx, Inc. and is 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, including the
`Significant Seven; anticipated growth in our Ortho Dermatologics business; expected R&D and marketing spend, including
`in connection with the promotion of the Significant Seven; our expected primary cash and working capital requirements for
`
`ii
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`Eye Therapies Exhibit 2072, 10 of 209
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`2019 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;
`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 ability to meet the financial and other covenants contained in our Fourth Amended and
`Restated Credit and Guaranty Agreement (the “Restated Credit Agreement”), and indentures; and our impairment
`assessments, including the assumptions used therein and the results thereof.
`
`Forward-looking statements can generally be identified by the use of words such as “believe”, “anticipate”, “expect”,
`“intend”, “estimate”, “plan”, “continue”, “will”, “may”, “could”, “would”, “should”, “target”, “potential”,
`“opportunity”, “designed”, “create”, “predict”, “project”, “forecast”, “seek”, “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:
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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 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 t