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`Valeant 2014 Form 10K
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`10K 1 valeant2014form10k.htm FORM 10K
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`_____________________________
`
`FORM 10K
`
` ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2014
`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 00114956
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
`(Exact Name of Registrant as Specified in its Charter)
`
`BRITISH COLUMBIA, CANADA
`State or other jurisdiction of
`incorporation or organization
`
`980448205
`(I.R.S. Employer Identification No.)
`
`2150 St. Elzéar Blvd. West
`Laval, Quebec
`Canada, H7L 4A8
`(Address of principal executive offices)
`Registrant's telephone number, including area code (514) 7446792
`
`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 wellknown 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 ST 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 SK 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 10K or any amendment to this Form 10
`K.
`
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, or a smaller reporting company. See the
`definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b2 of the Exchange Act. (Check one):
`
`Large accelerated filer
`
`Nonaccelerated filer
`Accelerated filer
`(Do not check if a smaller reporting company)
`
`Smaller reporting company
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes No
`
`The aggregate market value of the common shares held by nonaffiliates of the registrant as of the last business day of the registrant’s most recently completed
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`second fiscal quarter was $37,219,586,000 based on the last reported sale price on the New York Stock Exchange on June 30, 2014.
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`The number of outstanding shares of the registrant’s common stock as of February 18, 2015 was 336,202,718.
`
`DOCUMENTS INCORPORATED BY REFERENCE
`
`Part III incorporates certain information by reference from the registrant’s proxy statement for the 2015 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, 2014.
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`TABLE OF CONTENTS
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`GENERAL INFORMATION
`
`PART I
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
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`Item 5.
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`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
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`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
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` 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
`
` Exhibits and Financial Statement Schedules
`Item 15.
`SIGNATURES
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`PART IV
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`Basis of Presentation
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`General
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`Except where the context otherwise requires, all references in this Annual Report on Form 10K (“Form 10K”) 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 10K, references to “$” and “US$” are to United States dollars. Unless otherwise indicated, the
`statistical and financial data contained in this Form 10K are presented as of December 31, 2014.
`
`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®, ANTIANGIN®, ANTIGRIPPIN®, ARESTIN®, ATRALIN®, B&L®, B+L®,
`BAUSCH & LOMB®, BAUSCH + LOMB®, BAUSCH + LOMB ULTRA®, BEDOYECTA®, BENZACLIN®, BESIVANCE®,
`BIAFINE®, BIOTRUE®, BIOVAIL®, BOSTON®, CALADRYL®, CARAC®, CARDIZEM®, CEFZIL®, CERAVE®,
`CESAMET®, CLEAR + BRILLIANT®, CLINDAGEL®, CLODERM®, COLDFX®, COLDSOREFX®, COMFORTMOIST®,
`CONDITION & ENHANCE®, CORTAID®, CRYSTALENS®, DERMAGLOW®, DERMIK®, DIASTAT®, DIFFLAM®,
`DURACEF®, DUROMINE®, DUROTUSS®, EFUDEX®, ELASTIDERM®, ENVISTA®, ERTACZO®, FRAXEL®,
`HYPERGEL™, JUBLIA®, LACRISERT®, LIPOSONIX®, LOCOID®, LODALIS™, LOTEMAX®, LUZU®, MEDICIS®,
`MEGACE®, MEPHYTON®, METERMINE®, MOISTURESEAL®, MONOPRIL®, NUDERM®, OBAGI®, OBAGI
`CLENZIDERM®, OBAGIC®, OBAGI NUDERM®, OCUVITE®, ONSET DERMATOLOGICS®, ORTHO
`DERMATOLOGICS®, POTIGA®, PRESERVISION®, PROLENSA®, PUREVISION®, PURPOSE®, RENU®, RENU
`MULTIPLUS®, RETINA®, RETINA MICRO®, RIKODEINE®, SHOWER TO SHOWER®, SOFLENS®, SOLODYN®,
`SOLTA MEDICAL®, STELLARIS®, SYPRINE®, TARGRETIN®, THERMAGE®, THERMAGE CPT®, TIAZAC®,
`VALEANT®, VALEANT V & DESIGN®, VALEANT PHARMACEUTICALS & DESIGN®, VANOS®, VESNEO™,
`VICTUS®, XENAZINE®, ZIANA®, and ZYCLARA®.
`
`WELLBUTRIN®, 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. BENSAL HP® is a registered trademark and is used by us under license from SMG Pharmaceuticals,
`LLC. EMERADE® is a registered trademark of Medeca Pharma AB and is used by us under license from Namtall AB.
`
`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.
`
`ForwardLooking Statements
`
`Caution regarding forwardlooking information and statements and “SafeHarbor” statements under the U.S. Private
`Securities Litigation Reform Act of 1995:
`
` To the extent any statements made in this Annual Report on Form 10K contain information that is not historical, these
`statements are forwardlooking 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 forwardlooking information within the meaning
`defined under applicable Canadian securities legislation (collectively, “forwardlooking statements”).
`
` These forwardlooking statements relate to, among other things: the expected benefits of our acquisitions and other
`transactions (including the proposed acquisition of Salix Pharmaceuticals, Ltd. (“Salix”)), 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 proceedings; general market conditions;
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`and our expectations regarding our financial performance, including revenues, expenses, gross margins, liquidity and
`income taxes.
`
` Forwardlooking 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”,
`“tentative”, “positioning”, “designed”, “create”, “predict”, “project”, “seek“, “ongoing”, “increase”, or “upside” and
`variations or other similar expressions. In addition, any statements that refer to expectations, projections or other
`characterizations of future events or circumstances are forwardlooking statements. These forwardlooking statements may not
`be appropriate for
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`other purposes. Although we have indicated above certain of these statements set out herein, all of the statements in this
`Form 10K that contain forwardlooking 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 forwardlooking 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 large complex
`business;
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`our ability to retain, motivate and recruit executives and other key employees;
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`the introduction of products that compete against our products that do not have patent or data exclusivity rights;
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`our ability to compete against companies that are larger and have greater financial, technical and human resources
`than we do, as well as other competitive factors, such as technological advances achieved, patents obtained and new
`products introduced by our competitors;
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`our ability to identify, finance, acquire, close and integrate acquisition targets successfully and on a timely basis;
`
`factors relating to the acquisition and integration of the companies, businesses and products acquired by the Company,
`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, as well as risks
`associated with the acquired companies, businesses and products;
`
`factors relating to our ability to achieve all of the estimated synergies from our acquisitions 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;
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`factors relating to our proposed acquisition of Salix, including our ability to consummate such transaction on a timely
`basis, if at all; the impact of substantial additional debt on our financial condition and results of operations; our ability
`to effectively and timely integrate the operations of the Company and Salix; our ability to achieve the estimated
`synergies from this proposed transaction; and, once integrated, the effects of such business combination on our future
`financial condition, operating results, strategy and plans;
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`our ability to secure and maintain third party research, development, manufacturing, marketing or distribution
`arrangements;
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`our eligibility for benefits under tax treaties and the continued availability of low effective tax rates for the business
`profits of certain of our subsidiaries;
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`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, our ability to raise additional funds, if needed,
`and any restrictions that are or may be imposed as a result of our current and future indebtedness, in light of our current
`and projected levels of operations, acquisition activity and general economic conditions;
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`any downgrade by rating agencies in our corporate credit ratings, which may impact, among other things, our ability to
`raise additional debt capital and implement elements of our growth strategy;
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`interest rate risks associated with our floating rate debt borrowings;
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`the risks associated with the international scope of our operations, including our presence in emerging markets and the
`challenges we face when entering new geographic markets (including the challenges created by new and different
`regulatory regimes in such countries);
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`adverse global economic conditions and credit market and foreign currency exchange uncertainty in the countries in
`which we do business (such as the recent instability in Russia, Ukraine and the Middle East);
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`economic factors over which the Company has no control, including changes in inflation, interest rates, foreign
`currency rates, and the potential effect of such factors on revenues, expenses and resulting margins;
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`the introduction of generic competitors of our branded products;
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`our ability to obtain and maintain sufficient intellectual property rights over our products and defend against
`challenges to such intellectual property;
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`the outcome of legal proceedings, arbitrations, investigations and regulatory proceedings;
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`the risk that our products could cause, or be alleged to cause, personal injury and adverse effects, leading to potential
`lawsuits, product liability claims and damages and/or withdrawals of products from the market;
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`the availability of and our ability to obtain and maintain adequate insurance coverage and/or our ability to cover or
`insure against the total amount of the claims and liabilities we face, whether through third party insurance or self
`insurance;
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`the difficulty in predicting the expense, timing and outcome within our legal and regulatory environment, including
`with respect to approvals by the U.S. Food and Drug Administration, Health Canada and similar agencies in other
`countries, legal and regulatory proceedings and settlements thereof, the protection afforded by our patents and other
`intellectual and proprietary property, successful generic challenges to our products and infringement or alleged
`infringement of the intellectual property of others;
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`the results of continuing safety and efficacy studies by industry and government agencies;
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`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;
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`the inclusion of our products on formularies or our ability to achieve favorable formulary status, as well as the impact
`on the price 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;
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`the success of preclinical and clinical trials for our drug development pipeline or delays in clinical trials that adversely
`impact the timely commercialization of our pipeline products, as well as factors impacting the commercial success of
`our currently marketed products, which could lead to material impairment charges;
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`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;
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`negative publicity or reputational harm to our products and business;
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`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;
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`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 or marketed 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 antibribery 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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`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.
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` Additional information about these factors and about the material factors or assumptions underlying such forward
`looking statements may be found elsewhere in this Form 10K, under Item 1A. “Risk Factors” and in the Company’s other filings
`with the SEC and CSA. When relying on our forwardlooking 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 or revise any of these forwardlooking
`statements to reflect events or circumstances after the date of this Form 10K or to reflect actual outcomes, except as required by
`law. We caution that, as it is not possible to predict or identify all relevant factors that may impact forwardlooking statements,
`the foregoing list of important factors that may affect future results is not exhaustive and should not be considered a complete
`statement of all potential risks and uncertainties.
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`Item 1. Business
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`PART I
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`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. In connection with the acquisition of Valeant Pharmaceuticals
`International (“Valeant”) in September 2010, Biovail was renamed “Valeant Pharmaceuticals International, Inc.”
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`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. As a result of this continuance, our legal domicile became the Province of
`British Columbia, the Canada Business Corporations Act ceased to apply to us and we became subject to the British Columbia
`Business Corporations Act.
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`Unless the context indicates otherwise, when we refer to “we”, “us”, “our” or the “Company” in this Annual Report on
`Form 10K (“Form 10K”), we are referring to Valeant Pharmaceuticals International, Inc. and its subsidiaries on a consolidated
`basis.
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`Introduction
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`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, overthecounter (“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 geographies we serve.
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`Business Strategy
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`Our strategy is to focus our 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
`products have the potential for strong operating margins and solid growth and are particularly attractive for a number of reasons
`including:
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`They are largely cash pay, or are reimbursed through private insurance, and, as a result, are less dependent on increasing
`government reimbursement pressures than other products;
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`They tend to have established brand names and do not rely primarily on patent or regulatory exclusivity;
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`They tend to have the potential for line extensions and lifecycle management programs; and
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`They tend to be smaller on an individual basis, and therefore typically not the focus of larger pharmaceutical companies.
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`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 valueadded
`business development opportunities as they arise.
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`The growth of our business is further augmented through our lower risk, outputfocused research and development model.
`This model allows us to advance certain development programs to drive future commercial growth, while minimizing our research
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`and development expense. This is achieved primarily by:
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`focusing on innovation through our internal research and development, acquisitions, and inlicensing;
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`focusing on productivity through measures such as leveraging industry overcapacity and outsourcing commodity
`services;
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`focusing on critical skills and capabilities needed to bring new technologies to the market;
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`pursuing lifecycle management programs for currently marketed products to increase such products’ value during their
`commercial lives; and
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`acquiring dossiers and registrations for branded generic products, which require limited manufacturing startup 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.
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`We believe this strategy will allow us to maximize both the growth rate and profitability of the Company and to enhance
`shareholder value.
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`Segment Information
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`We have two operating and reportable segments: (i) Developed Markets and (ii) Emerging Markets. Comparative segment
`information for 2014, 2013 and 2012 is presented in note 22 of notes to consolidated financial statements in Item 15 of this
`Form 10K.
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`Our current product portfolio comprises approximately 1,600 products.
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`Developed Markets
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`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.
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`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, pusfilled
`pimples of moderate to severe acne in patients 12 years of age and older, as well as Ziana®, Acanya®, Atralin®, RetinA
`Micro® Microsphere 0.08% and ONEXTON™ Gel, a fixed combination 1.2% clindamycin phosphate and 3.75%
`benzoyl peroxide medication for the oncedaily treatment of comedonal (noninflammatory) and inflammatory acne in
`patients 12 years of age and older.
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`• Wellbutrin XL® is an extendedrelease formulation of bupropion indicated for the treatment of major depressive disorder
`in adults.
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`Jublia® (efinaconazole 10% topical solution), is a topical azole approved for the treatment of onychomycosis of the
`toenails (toenail fungus).
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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.
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`Targretin® Capsules is a retinoid indicated for treatment of Cutaneous TCell Lymphoma.
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`Arestin® (minocycline hydrochloride) is a subgingival sustainedrelease 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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`Zovirax® is a prescription topical antiviral which is 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®
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`Ointment is indicated for the management of initial genital herpes.
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`Syprine® is a chelating agent indicated for treatment of patients with Wilson's disease (disorder of copper metabolism)
`who are intolerant of the firstline treatment.
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`Elidel® is a topical formulation used to treat mild to moderate atopic dermatitis, a form of eczema. Elidel® Cream 1% is
`indicated as secondline therapy for the shortterm and noncontinuous chronic treatment of mild to moderate atopic
`dermatitis in nonimmunocompromised adults and children 2 years of age and older, who have failed to respond
`adequately to other topical prescription treatments, or when those treatments are not advisable.
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`Prolensa® is a nonsteroidal antiinflammatory ophthalmic solution for the treatment of inflammation and pain following
`cataract surgery.
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`Duromine® is a weight loss drug that acts through appetite suppression. Duromine® contains the active ingredient,
`phentermine, in a once daily formulation.
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`Lotemax® Gel is a topical corticosteroid indicated for the treatment of postoperative inflammation and pain following
`ocular surgery. This 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.
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`OTC Products — Our principal OTC products are:
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`PreserVision® is an antioxidant eye vitamin and mineral supplement.
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`CeraVe® is a range of OTC products with essential ceramides and other skinnourishing and skinmoisturizing
`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