`
`10K 1 agn10k.htm FORM 10K
`Table of Contents
`
`AGN 10K
`
`
`
`(Mark One)
`
`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, 2011
`
`or
`
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
`1934
`
`Commission File Number 110269
`
`Allergan, Inc.
`
`(Exact Name of Registrant as Specified in its Charter)
`
`Delaware
`(State or Other Jurisdiction of
`Incorporation or Organization)
`
`2525 Dupont Drive
`Irvine, California
`(Address of Principal Executive Offices)
`
`(714) 2464500
`(Registrant’s Telephone Number, Including Area Code)
` Securities Registered Pursuant to Section 12(b) of the Act:
`
`951622442
`(I.R.S. Employer Identification No.)
`
`
`
`92612
`(Zip Code)
`
`Name of Each Exchange on Which Registered
`Title of Each Class
`New York Stock Exchange
`Common Stock, $0.01 Par Value
`Securities Registered Pursuant to Section 12(g) of the Act: None
`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 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 (§232.405 of this chapter) 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 (§229.405 of this chapter) 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 10K.
`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.
`
` Large accelerated filer
` Nonaccelerated filer (Do not check if a smaller reporting company)
`
`Accelerated filer
`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
`As of June 30, 2011, the aggregate market value of the registrant’s common stock held by nonaffiliates of the registrant was approximately $25,365 million
`based on the closing sale price as reported on the New York Stock Exchange.
`Common stock outstanding as of February 22, 2012 — 307,527,460 shares (including 3,084,689 shares held in treasury).
`DOCUMENTS INCORPORATED BY REFERENCE
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`MYLAN - EXHIBIT 1112
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc. - IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`Part III of this report incorporates certain information by reference from the registrant’s proxy statement for the annual meeting of stockholders to be held on
`May 1, 2012, which proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2011.
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`
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`PART I.
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`
`PART II.
`Item 5.
`
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`
`
`PART III.
`Item 10.
`Item 11.
`Item 12.
`
`Item 13.
`Item 14.
`
`
`PART IV.
`Item 15.
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`SIGNATURES
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`AGN 10K
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`TABLE OF CONTENTS
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`
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`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`
`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
`
`
`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
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`Statements made by us in this report and in other reports and statements released by us that are not historical facts constitute
`“forwardlooking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21 of the
`Securities Exchange Act of 1934, as amended. These forwardlooking statements are necessarily estimates reflecting the judgment of
`our management based on our current estimates, expectations, forecasts and projections and include comments that express our
`current opinions about trends and factors that may impact future operating results. Disclosures that use words such as we “believe,”
`“anticipate,” “estimate,” “intend,” “could,” “plan,” “expect,” “project” or the negative of these, as well as similar expressions, are
`intended to identify forwardlooking statements. These statements are not guarantees of future performance and rely on a number of
`assumptions concerning future events, many of which are outside of our control, and involve known and unknown risks and
`uncertainties that could cause our actual results, performance or achievements, or industry results, to differ materially from any
`future results, performance or achievements expressed or implied by such forwardlooking statements. We discuss such risks,
`uncertainties and other factors throughout this report and specifically under the caption “Risk Factors” in Item 1A of Part I of this
`report below. Any such forwardlooking statements, whether made in this report or elsewhere, should be considered in the context of
`the various disclosures made by us about our businesses including, without limitation, the risk factors discussed below. Except as
`required under the federal securities laws and the rules and regulations of the U.S. Securities and Exchange Commission, we do not
`have any intention or obligation to update publicly any forwardlooking statements, whether as a result of new information, future
`events, changes in assumptions or otherwise.
`
`
`Item 1. Business
`
`General Overview of our Business
`
`PART I
`
`
`We are a multispecialty health care company focused on developing and commercializing innovative pharmaceuticals,
`biologics, medical devices and overthecounter products that enable people to live life to its full potential to see more clearly, move
`more freely and express themselves more fully. We discover, develop and commercialize a diverse range of products for the
`ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other
`specialty markets in more than 100 countries around the world.
`
`We are also a pioneer in specialty pharmaceutical, biologic and medical device research and development. Our research and
`development efforts are focused on products and technologies related to the many specialty areas in which we currently operate as
`well as new specialty areas where unmet medical needs are significant. In 2011, our research and development expenditures were
`approximately 16.9% of our product net sales, or approximately $902.8 million. We supplement our own research and development
`activities with our commitment to identify and obtain new technologies through inlicensing, research collaborations, joint ventures
`and acquisitions.
`
`Our diversified business model includes products for which patients may be eligible for reimbursement and cash pay products
`that consumers pay for directly outofpocket. Based on internal information and assumptions, we estimate that in fiscal year 2011,
`approximately 60% of our product net sales were derived from reimbursable products and 40% of our product net sales were derived
`from cash pay products, including products in emerging markets that would typically be reimbursed in North America and Europe.
`
`We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont
`Drive, Irvine, California, 92612, and our telephone number at that location is (714) 2464500. Our website address is
`www.allergan.com (the information available at our website address is not incorporated by reference into this report). We make our
`periodic and current reports available on our website, free of charge, as soon as reasonably practicable after such reports are
`electronically filed with, or furnished to, the U.S. Securities and Exchange Commission, or SEC. The SEC maintains a website at
`www.sec.gov that contains the reports and other information that we file electronically with the SEC.
`
`Operating Segments
`
`
`We operate our business on the basis of two reportable segments specialty pharmaceuticals and medical devices. The
`specialty pharmaceuticals segment produces a broad range of pharmaceutical products, including: ophthalmic products for dry eye,
`glaucoma, inflammation, infection, allergy and retinal disease; Botox® for certain therapeutic and aesthetic indications; skin care
`products for acne, psoriasis, eyelash growth and other prescription and overthecounter skin care products; and urologics products.
`The medical devices segment produces a broad range of medical devices, including: breast implants for augmentation, revision and
`reconstructive surgery and tissue expanders; obesity intervention products; and facial aesthetics products. The following table sets
`forth, for the periods indicated, product net sales for each of our product lines within our specialty pharmaceuticals and medical
`devices segments, segment operating income for our specialty pharmaceuticals and medical devices
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`segments, domestic and international sales as a percentage of total product net sales, and domestic and international longlived assets:
`
`
`2011
`
`Year Ended December 31,
`2010
`
`
`(dollars in millions)
`
`2009
`
`
`
`
`Specialty Pharmaceuticals Segment Product Net Sales by Product Line
`Eye Care Pharmaceuticals
`Botox®/Neuromodulators
`Skin Care
`Urologics
`Total Specialty Pharmaceuticals Segment Product Net Sales
`
`Medical Devices Segment Product Net Sales by Product Line
`Breast Aesthetics
`Obesity Intervention
`Facial Aesthetics
`Total Medical Devices Segment Product Net Sales
`
`Specialty Pharmaceuticals Segment Operating Income (1)
`Medical Devices Segment Operating Income (1)
`
`Consolidated Product Net Sales
`Domestic
`International
`
`
`$
`
`$
`
`
`$
`
`$
`
`$
`
`
`
`
`
`
`$
`
`2,520.2
`1,594.9
`260.1
`56.8
`4,432.0
`
`
`349.3
`203.1
`362.7
`915.1
`
`1,763.3
`286.0
`
` $
`
`
`
` $
`
`
` $
`
`
` $
`
` $
`
`
`
`60.2%
`39.8%
`
`
` $
`
`
`
`3,500.9
`617.5
`
`2,262.0
`1,419.4
`229.5
`62.5
`3,973.4
`
`
`319.1
`243.3
`283.8
`846.2
`
`1,501.9
`284.7
`
` $
`
`
`
` $
`
`
` $
`
`
` $
`
` $
`
`
`
`62.6%
`37.4%
`
`
` $
`
`
`
`3,222.4
`688.1
`
`2,100.6
`1,309.6
`208.0
`65.6
`3,683.8
`
`
`287.5
`258.2
`218.1
`763.8
`
`1,370.8
`189.2
`
`65.4%
`34.6%
`
`
`3,678.3
`572.3
`
`
`Consolidated LongLived Assets
`Domestic
`International
` ——————————
`(1) Management evaluates business segment performance on an operating income basis exclusive of general and administrative
`expenses and other indirect costs, legal settlement expenses, impairment of intangible assets and related costs, restructuring
`charges, inprocess research and development expenses, amortization of certain identifiable intangible assets related to business
`combinations and asset acquisitions and related capitalized licensing costs and certain other adjustments, which are not
`allocated to our business segments for performance assessment by our chief operating decision maker. Other adjustments
`excluded from our business segments for purposes of performance assessment represent income or expenses that do not reflect,
`according to established companydefined criteria, operating income or expenses associated with our core business activities.
`
`We do not discretely allocate assets to our operating segments, nor does our chief operating decision maker evaluate operating
`segments using discrete asset information.
`
`See Note 17, “Business Segment Information,” in the notes to the consolidated financial statements listed under Item 15 of
`Part IV of this report, “Exhibits and Financial Statement Schedules,” for further information concerning our foreign and domestic
`operations.
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`Specialty Pharmaceuticals Segment
`
`Eye Care Pharmaceuticals
`
`We develop, manufacture and market a broad range of prescription and nonprescription products designed to treat diseases
`and disorders of the eye, including dry eye, glaucoma, inflammation, infection, allergy and retinal disease.
`
`Dry Eye
`
`Restasis® (cyclosporine ophthalmic emulsion) 0.05%, our best selling eye care product, is the largest prescription ophthalmic
`pharmaceutical by sales value in the United States and is the first, and currently the only, prescription eye drop to help increase tear
`production, in cases where tear production may be reduced by inflammation due to chronic dry eye. Chronic dry eye is a painful and
`irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. The incidence of chronic
`dry eye increases markedly with age, after menopause in women and in people with systemic diseases. We launched Restasis® in the
`United States in 2003 and Restasis® is currently approved in approximately 40 countries.
`
`Our Refresh® line of overthecounter artificial tears products, including Refresh® Optive™ lubricant eye drops, treats dry eye
`symptoms including irritation and dryness due to pollution, computer use, aging and other causes. We launched Refresh® over 25
`years ago and today the Refresh® product line includes a wide range of preserved and nonpreserved drops as well as ointments to
`treat dry eye symptoms. In early 2012, we launched Refresh Optive™ Advanced lubricant eye drops in the United States and as Optive
`Plus® in some countries in Europe.
`
`Glaucoma
`
`Our Lumigan® (bimatoprost ophthalmic solution) product line is our second best selling eye care product line. Lumigan®
`0.03% and Lumigan® 0.01% are topical treatments indicated for the reduction of elevated intraocular pressure in patients with
`glaucoma or ocular hypertension. Lumigan® 0.01% is an improved reformulation of Lumigan® 0.03% that was approved in 2009 by
`Health Canada and in 2010 by the U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA. We
`currently sell Lumigan® 0.01% and Lumigan® 0.03% in the United States and over 80 countries worldwide. Senju Pharmaceutical
`Co., Ltd., or Senju, is responsible for the development and commercialization of Lumigan® in Japan pursuant to an exclusive
`licensing agreement.
`
`Ganfort™ (bimatoprost/timolol maleate ophthalmic solution) is a bimatoprost and timolol maleate combination designed to
`treat glaucoma and ocular hypertension in patients who are not responsive to treatment with only one medication. We received a
`license from the EMA to market Ganfort™ in the European Union in 2006 and Ganfort™ is now sold in approximately 65 countries.
`
`Our Alphagan® (brimonidine tartrate ophthalmic solution) products are our third best selling eye care product line. Alphagan®
`P 0.1%, Alphagan® P 0.15% and Alphagan® P 0.2% are ophthalmic solutions that lower intraocular pressure by reducing aqueous
`humor production and increasing uveoscleral outflow. Alphagan® P 0.1% was approved by the FDA in 2005 and is an improved
`reformulation of Alphagan® P 0.15% and Alphagan® 0.2%. Alphagan® P 0.1% is currently approved in approximately 10 countries,
`Alphagan® P 0.15% is approved in approximately 50 countries and Alphagan® 0.2% is approved in approximately 70 countries.
`Alphagan® P 0.15% and Alphagan® 0.2% face generic competition in the United States and other parts of the world. Senju is
`responsible for the development and commercialization of our Alphagan® products in Japan pursuant to an exclusive licensing
`agreement between us and Kyorin Pharmaceuticals Co., Ltd., or Kyorin, that Kyorin subsequently sublicensed to Senju. In January
`2012, Senju received approval from the Japanese Ministry of Health, Labor and Welfare for Aiphagan® P 0.1% for the reduction of
`intraocular pressure in patients with ocular hypertension or glaucoma.
`
`Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is a brimonidine and timolol combination
`designed to treat glaucoma and ocular hypertension in patients who are not responsive to treatment with only one medication. The
`FDA approved Combigan® in 2007 and it is now sold in approximately 70 countries worldwide.
`
`Inflammation
`
`Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45% is a nonsteroidal, antiinflammatory indicated for the treatment
`of ocular pain and inflammation following cataract surgery that was approved by the FDA in 2009. Acular LS® (ketorolac ophthalmic
`solution) 0.4% is a nonsteroidal antiinflammatory indicated to reduce ocular pain, burning and stinging following corneal refractive
`surgery. Acular LS® is a reformulated version of Acular ® that was approved by the FDA in 2007. Acular ® and Acular LS® face
`generic competition in the United States. Pred Forte® (prednisolone acetate ophthalmic suspension, USP) 1% is a topical steroid that
`was approved by the FDA over 35 years ago and faces generic competition in the United States.
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`Infection
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`Zymaxid® (gatifloxacin ophthalmic solution) 0.5% is our nextgeneration antiinfective product indicated for the treatment of
`bacterial conjunctivitis. The FDA approved Zymaxid® in 2010 and, in February 2011, we announced the discontinuation of Zymar®
`(gatifloxacin ophthalmic solution) 0.3% in the United States due to strong physician acceptance of Zymaxid®.
`
`Allergy
`
`Lastacaft® (alcaftadine ophthalmic solution) 0.25% is a topical allergy medication for the prevention and treatment of itching
`associated with allergic conjunctivitis. We acquired the global license to manufacture and commercialize Lastacaft® in 2010 from
`Vistakon Pharmaceuticals, LLC, Janssen Pharmaceutica N.V. and Johnson & Johnson Vision Care Inc., or, collectively, Vistakon, and
`launched Lastacaft® in the first quarter of 2011.
`
`Elestat® (epinastine HCL ophthalmic solution) 0.05% is used for the prevention of itching associated with allergic
`conjunctivitis. We license Elestat® from Boehringer Ingelheim AG, and hold worldwide ophthalmic commercial rights excluding
`Japan. Elestat®, together with sales under its brand names Relestat® and Purivist®, is currently approved in approximately 50
`countries. A generic version of Elestat® was approved by the FDA in the second quarter of 2011 and Elestat® currently faces generic
`competition in the United States.
`
`Retinal Disease
`
`Ozurdex® (dexamethasone intravitreal implant) 0.7 mg is a novel bioerodable formulation of dexamethasone in our proprietary
`Novadur® sustainedrelease drug delivery system that can be used to locally and directly administer medications to the retina. The
`FDA approved Ozurdex® in 2009 as the first drug therapy indicated for the treatment of macular edema associated with retinal vein
`occlusion, or RVO, and, in 2010, the EMA granted marketing authorization for Ozurdex® for RVO. Ozurdex® is now approved for
`RVO in approximately 45 countries, including Argentina, Brazil, Canada, India, Korea and Mexico. In 2010, the FDA approved
`Ozurdex® for the treatment of noninfectious uveitis affecting the posterior segment of the eye and, in the second quarter of 2011, the
`EMA granted marketing authorization for Ozurdex® for this additional indication. Ozurdex® is now approved for uveitis in
`approximately 40 countries.
`
`Neuromodulators
`
`Botox®
`Botox® (onabotulinumtoxinA) was first approved by the FDA in 1989 for the treatment of strabismus and blepharospasm, two
`eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, Botox® has
`been approved by regulatory authorities worldwide as a treatment for approximately 25 unique indications in approximately 85
`countries, benefiting millions of patients. Botox® was first approved for certain aesthetic uses in 2002. In addition to over 20 years of
`clinical experience, the safety and efficacy of Botox® have been wellestablished in approximately 65 randomized, placebo
`controlled clinical trials and in approximately 15,000 patients treated with Botox® and Botox® Cosmetic in Allergan's clinical
`trials. Worldwide, approximately 30 million vials of Botox® and Botox® Cosmetic have been distributed and approximately 29
`million treatment sessions have been performed in a span of 20 years (19892009). There have been approximately 2,500 articles on
`Botox® or Botox® Cosmetic in scientific and medical journals. Since the FDA's approval of Dysport®, a competing product, in 2009,
`the FDA has required that all botulinum toxins marketed in the United States include a boxed warning regarding the symptoms
`associated with the spread of botulinum toxin beyond the injection site along with a corresponding Risk Evaluation and Mitigation
`Strategies, or REMS, program which addresses the lack of interchangeability of botulinum toxin products.
`
`For the year ended December 31, 2011, therapeutic uses accounted for approximately 51% of Botox® total sales and aesthetic
`uses accounted for approximately 49% of Botox® total sales. Sales of Botox® represented approximately 30%, 29% and 29% of our
`total consolidated product net sales in 2011, 2010 and 2009, respectively.
`
`Botox® is used therapeutically for the treatment of certain neuromuscular disorders which are characterized by involuntary
`muscle contractions or spasms as well for hyperhydrosis and the prophylactic treatment of headaches in adults with chronic migraine.
`In the third quarter of 2011, the FDA approved Botox® for the treatment of urinary incontinence due to detrusor overactivity
`associated with a neurologic condition, such as a spinal cord injury or multiple sclerosis, in adults who have an inadequate response
`to or are intolerant of an anticholinergic medication. The currentlyapproved therapeutic indications for Botox® in the United States
`are as follows:
`•
`urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an
`inadequate response to or are intolerant of an anticholinergic medication;
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`•
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`the prophylactic treatment of headaches in adults with chronic migraine;
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`•
`•
`•
`
`•
`
`•
`
`the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity;
`severe primary axillary hyperhidrosis, or underarm sweating, that is inadequately managed with topical agents;
`cervical dystonia, or sustained contractions or spasms of muscles in the shoulders or neck, in adults, and associated neck
`pain;
`blepharospasm, or the uncontrollable contraction of the eyelid muscles; and
`
`strabismus, or misalignment of the eyes, in people 12 years of age and over.
`
`Botox® is also available outside the United States for various indications. Botox® is now approved for the prophylactic
`treatment of adult chronic migraine in approximately 25 countries, including the United Kingdom and almost all other countries in
`the European Union as well as Australia, Brazil, Canada, India and Korea. Botox® has also been approved for the treatment of urinary
`incontinence due to detrusor overactivity associated with a neurologic condition in approximately 17 countries, including Brazil,
`Canada, France, Germany and Spain. Botox® is also approved in many countries outside of the United States for treating hemifacial
`spasm, cervical dystonia, adult spasticity and spasticity associated with pediatric cerebral palsy.
`
`In 2005, we licensed to GlaxoSmithKline, or GSK, our rights to develop and sell Botox® in Japan and China, but, in 2010, we
`reacquired from GSK the rights to develop and sell Botox® in Japan and China for all current and future cosmetic indications. GSK
`retained the rights to develop and sell Botox® in Japan and China for all current and future therapeutic indications. Botox® was
`approved in Japan for equinus foot due to lower limb spasticity in juvenile cerebral palsy patients in 2009 and for the treatment of
`upper and lower limb spasticity in 2010.
`
`Botox® Cosmetic
`
`The FDA approved Botox® Cosmetic in 2002 for the temporary improvement in the appearance of moderate to severe glabellar
`lines in adult men and women age 65 or younger. Depending on the country of approval, this product is referred to as Botox®, Botox®
`Cosmetic, Vistabel®, Vistabex® or Botox Vista®, and is administered in small injections to temporarily reduce the muscle activity that
`causes the formation of glabellar lines between the eyebrows that often develop during the aging process. Currently, over 75
`countries have approved facial aesthetic indications for Botox®, Botox® Cosmetic, Vistabel®, Vistabex® or Botox Vista®. Botox® is
`approved for upper facial lines in Australia, Canada, New Zealand, and certain countries in East Asia and Latin America. In 2009,
`Botox® was approved in Japan and China for glabellar lines.
`
`Skin Care
`
`Our skin care products focus on the acne, psoriasis, physiciandispensed skin care and eyelash growth markets, particularly in
`the United States and Canada.
`
`Aczone® (dapsone) gel 5% is approved for sale in both the United States and Canada and is indicated for the treatment of acne
`vulgaris in patients age 12 and older. We launched Aczone® in the United States in 2008. In the first quarter of 2011, we outlicensed
`our Canadian rights to Aczone® to Biovail Laboratories International SRL, a subsidiary of Valeant Pharmaceuticals, Inc.
`
`Tazorac® (tazarotene) gel is approved for sale in the United States for the treatment of acne and plaque psoriasis, a chronic skin
`disease characterized by dry red patches. We also market a cream formulation of Tazorac® in the United States for the topical
`treatment of acne and for the treatment of psoriasis. We have also engaged Pierre Fabre Dermatologie as our promotion partner for
`Zorac® (tazarotene) in certain parts of Europe, the Middle East and Africa. In 2007, we entered into a strategic collaboration
`agreement with Stiefel Laboratories, Inc., which was acquired by GSK in 2009, to develop and market new products involving
`tazarotene for dermatological use worldwide.
`
`Vivité® is an advanced antiaging skin care line that uses proprietary GLX Technology™, creating a highly specialized blend of
`glycolic acid and natural antioxidants. We launched Vivité® in 2007 and market our Vivité® line of skin care products to physicians in
`the United States.
`
`Latisse® (bimatoprost ophthalmic solution) 0.03%, is the first, and currently the only, FDAapproved prescription treatment for
`insufficient or inadequate eyelashes. The FDA approved Latisse® in 2008 and we launched Latisse® in the United States in 2009.
`Latisse® is also approved for sale in Canada, Russia and certain markets in Latin America, Asia Pacific and the Middle East.
`
`Urologics
`
`Sanctura XR® is our oncedaily anticholinergic for the treatment of overactive bladder, or OAB. Sanctura XR® was approved
`by the FDA in 2007 and Health Canada in 2010. In connection with our 2007 acquisition of Esprit Pharma Holdings Company,
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`Inc., we obtained an exclusive license to market Sanctura® and Sanctura XR® in the United States and its territories from Indevus
`Pharmaceuticals, Inc., or Indevus, which was subsequently acquired by Endo Pharmaceuticals. In the United States, we promote
`Sanctura XR® to the urology specialty channel. We acquired the right to commercialize Sanctura XR® in Canada from Indevus and
`Madaus GmbH in 2008. Sanctura®, our twiceaday anticholinergic for OAB, began facing generic competition in the United States
`in 2010.
`
`Medical Devices Segment
`
`Breast Aesthetics
`
`Our silicone gel and saline breast implants, consisting of a variety of shapes, sizes and textures, have been available to women
`for more than 30 years and are currently sold in approximately 75 countries for breast augmentation, revision and reconstructive
`surgery. Our breast implants consist of a silicone elastomer shell filled with either a saline solution or silicone gel with varying
`degrees of cohesivity. This shell can consist of either a smooth or textured surface. We market our breast implants and tissue
`expanders under the trade names Natrelle®, Inspira®, and CUI™ and the trademarks BioCell®, MicroCell™ and BioDimensional®. We
`currently market over 1,000 breast implant product variations worldwide to meet our patients' preferences and needs. In 2006, the
`FDA and Health Canada lifted a moratorium on the sale of silicone gel breast implants that had been in place since the early 1990's
`and the majority of the breast implants we now sell are silicone gel breast implants. We also sell a line of tissue expanders primarily
`for breast reconstruction and also as an aid to skin grafting to cover burn scars and correct birth defects.
`
`Obesity Intervention
`
`LapBand®
`
`The LapBand® System is designed to provide minimally invasive longterm treatment of severe obesity and is used as an
`alternative to more invasive procedures such as gastric bypass or sleeve gastrectomy. The LapBand® System is an adjustable silicone
`band that is laparoscopically placed around the upper part of the stomach through a small incision, creating a small pouch at the top
`of the stomach, which slows the passage of food and creates a sensation of fullness. The FDA approved the LapBand® System in
`2001 to treat severe obesity in adults who have failed more conservative weight reduction alternatives. In 2007, we launched the
`LapBand AP® System, a nextgeneration of the LapBand® System. The LapBand AP® System