Valeant 2013 Form 10-K
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`https://www.sec.gov/Archives/edgar/data/885590/000088559014000025/...
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`10-K 1 valeant2013form10-k.htm 10-K
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`_____________________________
`
`FORM 10-K
`
`ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2013
`OR
`o 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
`VALEANT PHARMACEUTICALS INTERNATIONAL, 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, Quebec
`Canada, H7L 4A8B
`(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:
`
`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 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 ý No o
`
`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. o
`
`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):
`
`Large accelerated filer ý
`
`Non-accelerated filer o
`Accelerated filer o
`(Do not check if a smaller reporting company)
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`Smaller reporting company o
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`ACRUX DDS PTY LTD. et al.
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`EXHIBIT 1603
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`IPR Petition for
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`U.S. Patent No. 7,214,506
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`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý
`
`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 $25,293,645,000 based on the last reported sale price on the New York Stock Exchange on June 28, 2013.
`
`The number of outstanding shares of the registrant’s common stock, as of February 21, 2014 was 334,869,413.
`
`DOCUMENTS INCORPORATED BY REFERENCE
`
`Part III incorporates certain information by reference from the registrant’s proxy statement for the 2014 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, 2013.
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`Valeant 2013 Form 10-K
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`https://www.sec.gov/Archives/edgar/data/885590/000088559014000025/...
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`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, 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
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
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`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.
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`Exhibits and Financial Statement Schedules
`Item 15.
`SIGNATURES
`
`PART IV
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`Page
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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 Valeant Pharmaceuticals International, Inc. and its subsidiaries,
`taken together. In this Form 10-K, references to “$” and “US$” are to United States dollars, references to “C$” are to Canadian
`dollars, references to “€” are to Euros, references to “AUD$” are to Australian dollars, references to “R$” are to Brazilian real,
`references to “MXN$” are to Mexican peso, references to “PLN” are to Polish zloty and references to “¥” are to Japanese yen.
`Unless otherwise indicated, the statistical and financial data contained in this Form 10-K are presented as of December 31, 2013.
`
`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®, AFEXA®, AKREOS®, AMBI®, ANTI-ANGIN®, ANTIGRIPPIN®, ARESTIN®, ATRALIN®,
`B&L®, B+L®, BAUSCH & LOMB®, BAUSCH + LOMB®, BEDOYECTA®, BENZACLIN®, BESIVANCE®, BIAFINE®,
`BIOTRUE®, BIOVAIL®, CALADRYL®, CARAC®, CARDIZEM®, CERAVE®, CESAMET®, CLEAR + BRILLIANT®,
`CLODERM®, COLD-FX®, COLDSORE-FX®, COMFORTMOIST®, CONDITION & ENHANCE®, CORN HUSKERS®,
`CORTAID®, CRYSTALENS®, DERMAGLOW®, DERMIK®, DIASTAT®, DIFFLAM®, DUROMINE®, DURO-TUSS®,
`EFUDEX®, ELASTIDERM®, ERTACZO®, FRAXEL®, HYPERGEL™, JUBLIA®, LACRISERT®, LIPOSONIX®,
`LODALIS™, LOTEMAX®, LUZU™, MEDICIS®, MEPHYTON®, METERMINE®, MOISTURESEAL™, NU-DERM®,
`OBAGI®, OBAGI NU-DERM®, OBAGI CLENZIDERM®, OBAGI-C®, OCUVITE®, ORTHO DERMATOLOGICS®,
`PERLANE®, PERLANE-L®, POTIGA®, PRESERVISION®, PROLENSA®, PUREVISION®, PURPOSE®, RENOVA®,
`RENU®, RENU MULTIPLUS®, RESTYLANE®, RESTYLANE-L®, RETIN-A MICRO®, RIKODEINE®, SCULPTRA®,
`SCULPTRA AESTHETIC®, SHOWER TO SHOWER®, SOFLENS®, SOLODYN®, SOLTA MEDICAL®, STELLARIS®,
`SYPRINE®, TARGRETIN®, THERMAGE®, THERMAGE CPT®, TIAZAC®, TROBALT®, VALEANT®, VALEANT V &
`DESIGN®, VALEANT PHARMACEUTICALS & DESIGN®, VANOS®, VICTUS®, XENAZINE®, ZIANA®, and
`ZYCLARA®.
`
`WELLBUTRIN®, WELLBUTRIN® XL, WELLBUTRIN XL® and ZOVIRAX® are trademarks of The GlaxoSmithKline
`Group of Companies and are used by us under license. ULTRAM® is a trademark of Johnson & Johnson and is used by us under
`license. MVE® is a registered trademark of DFB Technology Ltd. and is used by us under license. ELIDEL® and XERESE® are
`registered trademarks of Meda Pharma SARL and are used by us under license. VISUDYNE® is a registered trademark of Novartis
`Pharma AG and is used by us under license. DYSPORT® is a registered trademark of Ipsen Biopharm Limited and is used by us
`under license. MONOPRIL®, CEFZIL®, DURACEF® and MEGACE® are registered trademarks of Bristol-Myers Squibb
`Company and are used by us under license. BENSAL HP® is a registered trademark and is used by us under license from SMG
`Pharmaceuticals, LLC. EMERVEL® is a registered trademark of Galderma S.A. and is used by us under license. NEOTENSIL™ is
`a trademark of Living Proof, Inc. and is used by us under license. OPANA® is a registered trademark of Endo Pharmaceuticals Inc.
`and is used by us under license.
`
`In addition to the trademarks noted above, 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.
`
`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:
`
`To the extent any statements made in this Annual Report on 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 legislation (collectively, “forward-looking statements”).
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`These forward-looking statements relate to, among other things: the expected benefits of our acquisitions and other
`transactions, such as cost savings, operating synergies and growth potential of the Company; business plans and prospects,
`prospective products or product approvals, future performance or results of current and anticipated products; exposure to foreign
`currency exchange rate changes and interest rate changes; the outcome of contingencies, such as certain litigation and regulatory
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`proceedings; general market conditions; and our expectations regarding our financial performance, including revenues, expenses,
`gross margins, liquidity and income taxes.
`
`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”, “target”, “potential” and other similar expressions.
`In addition, any statements that refer to expectations, 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
`indicated above 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. 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 forward-looking statements, including, but not limited to,
`factors and assumptions regarding the items outlined above. Actual results may differ materially from those expressed or implied in
`such statements. Important factors that could cause actual results to differ materially from these expectations include, among other
`things, the following:
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`the challenges and difficulties associated with managing the rapid growth of our Company and a larger, more complex
`business;
`
`the introduction of generic competitors of our brand products;
`
`the introduction of products that compete against our products that do not have patent or data exclusivity rights, which
`products represent a significant portion of our revenues;
`
`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 identify, acquire, close and integrate acquisition targets successfully and on a timely basis;
`
`factors relating to the integration of the companies, businesses and products acquired by the Company (including the
`integration relating to our recent acquisitions of Solta Medical, Inc. (“Solta Medical”), Bausch & Lomb Holdings
`Incorporated (“B&L”), Obagi Medical Products, Inc. (“Obagi”), and Medicis Pharmaceutical Corporation ("Medicis”)),
`such as the time and resources required to integrate such companies, businesses and products, the difficulties associated
`with such integrations (including potential disruptions in sales activities and potential challenges with information
`technology systems integrations), the difficulties and challenges associated with entering into new business areas and new
`geographic markets, the difficulties, challenges and costs associated with managing and integrating new facilities,
`equipment and other assets, and the achievement of the anticipated benefits from such integrations;
`
`factors relating to our ability to achieve all of the estimated synergies from our acquisitions, including from our recent
`acquisition of B&L (which we anticipate will be greater than $850 million), as a result of cost-rationalization and
`integration initiatives. These factors may include greater than expected operating costs, the difficulty in eliminating certain
`duplicative costs, facilities and functions, and the outcome of many operational and strategic decisions, some of which have
`not yet been made;
`
`our ability to secure and maintain third party research, development, manufacturing, marketing or distribution
`arrangements;
`
`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;
`
`our substantial debt and debt service obligations and their impact on our financial condition and results of operations;
`
`our future cash flow, our ability to service and repay our existing debt and our ability to raise additional funds, if needed,
`in light of our current and projected levels of operations, acquisition activity and general economic conditions;
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`•
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`•
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`•
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`interest rate risks associated with our floating debt borrowings;
`
`the risks associated with the international scope of our operations, including our presence in emerging markets and the
`challenges we face when entering new geographic markets (including the challenges created by new and different
`regulatory regimes in those markets);
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`adverse global economic conditions and credit market and foreign currency exchange uncertainty in the countries in which
`we do business;
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`economic factors over which the Company has no control, including changes in inflation, interest rates, foreign currency
`rates, and the potential effect of such factors on revenues, expenses and resulting margins;
`
`our ability to retain, motivate and recruit executives and other key employees;
`
`our ability to obtain and maintain sufficient intellectual property rights over our products and defend against challenge to
`such intellectual property;
`
`the outcome of legal proceedings, investigations and regulatory proceedings;
`
`the risk that our products could cause, or be alleged to cause, personal injury and adverse effects, leading to potential
`lawsuits and/or withdrawals of products from the market;
`
`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;
`
`the difficulty in predicting the expense, timing and outcome within our legal and regulatory environment, including, but not
`limited to, the U.S. Food and Drug Administration, Health Canada and other regulatory approvals, legal and regulatory
`proceedings and settlements thereof, the protection afforded by our patents and other intellectual and proprietary property,
`successful generic challenges to our products and infringement or alleged infringement of the intellectual property
`of others;
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`the results of continuing safety and efficacy studies by industry and government agencies;
`
`the availability and extent to which our products are reimbursed by government authorities and other third party payors, as
`well as the impact of obtaining or maintaining such reimbursement on the price 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 of our products in connection therewith;
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`the impact of price control restrictions on our products, including the risk of mandated price reductions;
`
`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 factors impacting the commercial success of our
`currently marketed products, which could lead to material impairment charges;
`
`the results of management reviews of our research and development portfolio, conducted periodically and in connection
`with certain acquisitions, the decisions from which could result in terminations of specific projects which, in turn, could
`lead to material impairment charges;
`
`negative publicity or reputational harm to our products and business;
`
`the uncertainties associated with the acquisition and launch of new products, including, but not limited to, the acceptance
`and demand for new pharmaceutical products, and the impact of competitive products and pricing;
`
`our ability to obtain components, raw materials or finished products supplied by third parties and other manufacturing and
`related supply difficulties, interruptions and delays;
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`the disruption of delivery of our products and the routine flow of manufactured goods;
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`the seasonality of sales of certain of our products;
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`declines in the pricing and sales volume of certain of our products that are distributed by third parties, over which we have
`no or limited control;
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`compliance with, or the failure to comply with, health care “fraud and abuse” laws and other extensive regulation of our
`marketing, promotional and pricing practices, worldwide anti-bribery laws (including the U.S. Foreign Corrupt Practices
`Act), worldwide environmental laws and regulation and privacy and security regulations;
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`the impacts of the Patient Protection and Affordable Care Act (as amended) and other legislative and regulatory healthcare
`reforms in the countries in which we operate;
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`interruptions, breakdowns or breaches in our information technology systems; and
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`•
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`other risks detailed from time to time in our filings with the U.S. Securities and Exchange Commission (the “SEC”) and the
`Canadian Securities Administrators (the “CSA”), as well as our ability to anticipate and manage the risks associated with
`the foregoing.
`
`Additional information about these factors and about the material factors or assumptions underlying such forward-looking
`statements may be found elsewhere in this Form 10-K, under Item 1A. “Risk Factors”, and in the Company’s other filings with the
`SEC and CSA. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying
`on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider
`the foregoing factors and other uncertainties and potential events. These forward-looking statements speak only as of the date made.
`We undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this
`Form 10-K or to reflect actual outcomes, except as required by law.
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`Item 1. Business
`
`PART I
`
`Biovail Corporation (“Biovail”) was formed under the Business Corporations Act (Ontario) on February 18, 2000, as a result
`of the amalgamation of TXM Corporation and Biovail Corporation International. Biovail was continued under the Canada Business
`Corporations Act (the “CBCA”) effective June 29, 2005. On September 28, 2010 (the “Merger Date”), Biovail completed the
`acquisition of Valeant Pharmaceuticals International (“Valeant”) through a wholly-owned subsidiary pursuant to an Agreement and
`Plan of Merger, dated as of June 20, 2010, with Valeant surviving as a wholly-owned subsidiary of Biovail (the “Merger”). In
`connection with the Merger, Biovail was renamed “Valeant Pharmaceuticals International, Inc.”
`
`Effective August 9, 2013, we continued from the federal jurisdiction of Canada to the Province of British Columbia, meaning
`that we became a company registered under the laws of the Province of British Columbia as if we had been incorporated under the
`laws of the Province of British Columbia.
`
`Unless the context indicates otherwise, when we refer to “we”, “us”, “our” or the “Company” in this Annual Report on
`Form 10-K (“Form 10-K”), we are referring to Valeant Pharmaceuticals International, Inc. and its subsidiaries on a consolidated
`basis.
`
`Introduction
`
`We are a multinational, specialty pharmaceutical and medical device company that develops, manufactures, and markets a
`broad range of branded, generic and branded generic pharmaceuticals, over-the-counter (“OTC”) products, and medical devices
`(contact lenses, intraocular lenses, ophthalmic surgical equipment, and aesthetics devices), which are marketed directly or indirectly
`in over 100 countries. In the Developed Markets segment, we focus most of our efforts in the eye health, dermatology, and
`neurology therapeutic classes. In the Emerging Markets segment, we focus primarily on branded generics, OTC products, and
`medical devices. We are diverse not only in our sources of revenue from our broad drug and medical device portfolio, but also
`among the therapeutic classes and geographic segments we serve.
`
`Business Strategy
`
`Our strategy is to focus the business on core geographies and therapeutic classes that offer attractive growth opportunities
`while maintaining our lower selling, general and administrative cost model and decentralized operating structure. We have an
`established portfolio of durable products with a focus in the eye health and dermatology therapeutic areas. We believe these areas are
`particularly attractive given that many of the products in these areas:
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`have potential for strong operating margins and solid growth;
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`are marked by a higher insured and self-pay component than other therapeutic areas and are less dependent on increasing
`government reimbursement pressures;
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`have limited patent risk;
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`have the potential for line extensions and life-cycle management opportunities; and
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`are smaller on an individual basis, and therefore typically not the focus of larger pharmaceutical companies.
`
`Another critical element of our strategy is business development. We have completed numerous transactions over the past few
`years to expand our portfolio offering and geographic footprint, including, among others, the acquisitions of Bausch & Lomb
`Holdings Incorporated (“B&L”) and Medicis Pharmaceutical Corporation (“Medicis”). We will continue to pursue value-added
`business development opportunities as they arise.
`
`The growth of our business is further augmented through our lower risk research and development model. This model allows
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`us to advance certain development programs to drive future commercial growth, while minimizing our research and development
`expense. This is achieved primarily as follows:
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`focusing our efforts on niche therapeutic areas such as eye health, dermatology and podiatry, aesthetics, and dentistry,
`including life-cycle management programs for currently marketed products; and
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`acquiring dossiers and registrations for branded generic products, which require limited manufacturing start-up and
`development activities.
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`In addition to selective acquisitions and product development, our strategy also involves deploying cash through debt
`repayments and repurchases, as well as share buybacks.
`
`We believe this strategy will allow us to maximize both the growth rate and profitability of the Company and to enhance
`shareholder value.
`
`Acquisitions
`
`We have completed a number of transactions to expand our product portfolio including, among others, the following
`acquisitions of businesses and product rights in 2013: B&L, Obagi Medical Products, Inc. (“Obagi”), Natur Produkt International,
`JSC (“Natur Produkt”) and certain assets from Eisai Inc. (“Eisai”). In addition, in January 2014, we acquired Solta Medical Inc
`(“Solta Medical”).
`
`For more information regarding our acquisitions, see note 3, note 4 and note 27 of notes to consolidated financial statements in
`Item 15 of this Form 10-K.
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`Segment Information
`
`As a result of our acquisition strategy and continued growth, impacted by the December 2012 Medicis acquisition, our Chief
`Executive Officer (“CEO”), who is our Chief Operating Decision Maker (“CODM”), began to manage the business differently,
`which necessitated a realignment of the segment structure, effective in the first quarter of 2013. Pursuant to this change, we now
`have two operating and reportable segments: (i) Developed Markets, and (ii) Emerging Markets. Accordingly, we have restated prior
`period segment information to conform to the current period presentation. Comparative segment information for 2013, 2012, and
`2011 is presented in note 26 of notes to consolidated financial statements in Item 15 of this Form 10-K.
`
`Our current product portfolio comprises approximately 1,500 products.
`
`Developed Markets
`
`The Developed Markets segment consists of (i) sales in the U.S. of pharmaceutical products, OTC products, and medical
`device products, as well as alliance and contract service revenues, in the areas of eye health, dermatology and podiatry, aesthetics,
`and dentistry, (ii) sales in the U.S. of pharmaceutical products indicated for the treatment of neurological and other diseases, as well
`as alliance revenue from the licensing of various products we developed or acquired, and (iii) pharmaceutical products, OTC
`products, and medical device products sold in Canada, Australia, New Zealand, Western Europe and Japan.
`
`Pharmaceutical Products — Our principal pharmaceutical products are:
`
`•
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`An Acne franchise, which includes Solodyn®, a prescription oral antibiotic approved to treat only the red, pus-filled
`pimples of moderate to severe acne in patients 12 years of age and older, as well as Ziana®, Acanya®, and Atralin®.
`
`• Wellbutrin XL®, an extended-release formulation of bupropion indicated for the treatment of major depressive disorder in
`adults.
`
`•
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`•
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`Xenazine® is indicated for the treatment of chorea associated with Huntington’s disease. In the U.S., Xenazine® is
`distributed for us by Lundbeck Inc. under an exclusive marketing, distribution and supply agreement.
`
`Zovirax® Cream and Zovirax® Ointment are prescription topical antivirals which are active against herpes viruses.
`Zovirax® Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years
`of age and older). Zovirax® Ointment is indicated for the management of initial genital herpes. See note 5 of notes to
`consolidated financial statements in Item 15 of this Form 10-K for information regarding the agreement with Actavis to
`launch the authorized generic ointment for Zovirax®.
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`The Lotemax® franchise was acquired as part of the acquisition of B&L in August 2013 (the “B&L Acquisition”).
`Lotemax® Gel is a topical corticosteroid indicated for the treatment of post-operative inflammation and pain following
`ocular surgery. The gel formulation was launched in the first quarter of 2013. This new formulation is a technology that
`allows the drug to adhere to the ocular surface and offers dose uniformity, which eliminates the need to shake the product in
`order to ensure the drug is in suspension, a low concentration of preservative, and two known moisturizers.
`
`Arestin® (minocycline hydrochloride) is a subgingival sustained-release antibiotic. Arestin® is indicated as an adjunct to
`scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. Arestin® may
`be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.
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`2
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`•
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`Prolensa®, acquired as part of the B&L Acquisition in August 2013, is a non-steroidal anti-inflammatory ophthalmic
`solution for the treatment of inflammation and pain following cataract surgery.
`
`OTC Products — Our principal OTC products are:
`
`•
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`•
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`•
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`•
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`•
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`PreserVision®, acquired as part of the B&L Acquisition in August 2013, is an antioxidant eye vitamin and mineral
`supplement.
`
`ReNu Multiplus®, acquired as part of the B&L Acquisition in August 2013, is a sterile, preserved solution used to lubricate
`and rewet soft (hydrophilic) contact lenses. ReNu Multiplus® product contains povidone, a lubricant that can be used with
`daily, overnight, and disposable soft contact lenses.
`
`Ocuvite®, acquired as part of the B&L Acquisition in August 2013, is a lutein eye vitamin and mineral supplement that
`contains lutein (an antioxidant carotenoid), a nutrient that supports macular health by helping filter harmful blue light.
`
`Artelac™, acquired as part of the B&L Acquisition in August 2013, is a solution in the form of eye drops to treat dry eyes
`caused by chronic tear dysfunction.
`
`CeraVe® is a range of OTC products with essential ceramides and other skin-nourishing and skin-moisturizing ingredients
`(humectants and emollients) combined with a unique, patented Multivesicular Emulsion (MVE®) delivery technology that,
`together, work to rebuild and repair the skin barrier. CeraVe® formulations incorporate ceramides, cholesterol and fatty
`acids, all of which are essential for skin barrier repair and are used as adjunct therapy in the management of various skin
`conditions.
`
`Device Products — Our principal device products are:
`
`•
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`•
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`•
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`•
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`•
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`SofLens® Daily Disposable Contact Lenses, acquired as part of the B&L Acquisition in August 2013, use
`ComfortMoist® Technology (a combination of thin lens design and slow releasing packaging solution) and High Definition
`Optics™, an aspheric design that reduces aspheric aberration over the range of powers.
`
`