throbber
RESULTS MATTER
`
`2 0 13 A N N U A L R E P O R T
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`

`

`Allergan is a company that consistently delivers solid results. Financially, we have achieved
`
`mid-teens sales growth on a compounded annual basis over the past 15 years, with strong
`
`year-over-year earnings growth as well. Commercially, we have benefited from a broad
`
`and balanced portfolio of products that are market leaders in several important and growing
`
`categories. And scientifically, we continue to deliver on our promising pipeline. These are
`
`signifi cant results, and they matter. They demonstrate Allergan’s winning formula for achieving
`
`consistent growth despite a challenging business and health care environment. They illustrate
`
`the value of rooting our success in strong and durable relationships with our customers.
`
`And they point to a promising future. Results matter to the many people who have a stake
`
`in Allergan – our customers, patients, investors, employees and partners. That is why we will
`
`stay focused on delivering strong results: day after day, quarter after quarter, year after year.
`
`Table of Contents
`Letter To Our Investors
`Eye Care
`Facial Aesthetics
`Pipeline
`Emerging Markets
`2013 Accolades
`
`1
`6
`8
`10
`12
`14
`
`16
`Financial Summary
`18
`Reconciliation of Non-GAAP Adjustments
`20
`Board of Directors
`22
`Executive Committee
`Corporate Overview and Stockholders’ Information 24
`
`36205.indd 2
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`
`

`

`To Our Investors
`
`RESULTS THAT MATTER
`
`In 2013, we were once again able to deliver strong results, in line with our long term aspirations of growing revenues in local currencies
`in excess of 10% per annum and growing adjusted Earnings per Share around the mid teens. In fact, we reported strong 12.4% revenue
`growth in local currencies and 11.7% growth in U.S. Dollars. Adjusted non-GAAP Diluted Earnings per Share increased 18.1% in 2013
`over 2012, after we continued to invest into the long term drivers of success, namely Research & Development (R&D), where we increased
`our investment to $1,034.7 million, an increase of 13.1%, all on a non-GAAP basis.1 We were encouraged by the acceleration of
`revenue growth in the second half of the year as the company benefi ted from many product approvals since 2010 from the U.S. Food
`& Drug Administration (FDA) and the commensurate regulatory agencies around the world; and furthermore, from a strengthening of
`many major economies, buoyant market conditions, as well as from market share gains in most of our product categories. In general,
`we observed weakening competition from the principal players in our markets, as they adjusted to imperatives under new ownership,
`focused on improving short term fi nancial performance or made cutbacks after losing patent exclusivities. In ophthalmology, Merck & Co,
`a key competitor for decades, announced their exit by divesting their products in the U.S. to another company.
`
`Our operating performance throughout 2013 was strong. In fact, this performance got progressively stronger during the year driven
`by a broad array of products across virtually all of our regions. We reported a record adjusted non-GAAP gross margin at 87.3%,
`an increase of 80 basis points from 2012, as we benefi ted from decreased royalty payments to third parties and a decrease in the
`manufacturing cost of goods by 0.3%, as a percentage of product net sales. In fact, as a testament to our long term investment in R&D
`and the creation of intellectual property, for the fi rst time in 2013 our royalty payments were exceeded by royalties received, principally
`from Senju and GlaxoSmithKline in Japan and from Alcon regarding our out-license of certain brimonidine glaucoma technology.
`Reduction in cost of goods was the result of leveraging the small number of highly capitalized pharmaceutical and medical plants in
`our global network with rising volumes, high capacity utilization and targeted investments in automation and effi ciency. In addition,
`we generated a record of just over $1.5 billion in free cash fl ow, which has provided us considerable balance sheet strength for
`making potential acquisitions and in-licensing technology to further drive the prospects for long term growth of the company. In the last
`15 months we acquired SkinMedica for approximately $350 million and MAP Pharmaceuticals (MAP) for approximately $870 million.
`The SkinMedica acquisition brought us the leading position in the fast growing U.S. physician dispensed category 2 and an ability to
`expand our already very broad offering of medical aesthetics products; the MAP acquisition brought us LEVADEX®, a self-administered
`breath activated orally inhaled dihydroergotamine product, currently under review by the FDA, for the acute treatment of migraine.
`This is a complementary product to BOTOX® (onabotulinumtoxinA) for chronic migraine. Whilst the product indications are distinct, there
`is a considerable overlap in the physician groups treating migraine patients. Given the pressures facing the worldwide pharmaceutical
`and medical device industries, we are pleased with the earnings results achieved after absorbing considerable mandated taxes and
`fees. As our contribution to the costs of healthcare reform in the U.S., Allergan paid approximately $130 million to the U.S. Government
`in terms of increased rebates, fees and taxes including the Medical Device tax, an increase of approximately $30 million from 2012.
`
`
`1 The adjusted amounts represent certain non-GAAP financial measures. For a reconciliation of these non-GAAP financial measures to GAAP financial measures, please refer to pages 18 and 19 of this Annual Report.
`2 Physician-Dispensed Topicals: Ongoing Product Innovation, Medical Insight, Inc., July 2013
`
`Worldwide Sales – Broad and Balanced Portfolio
`FY 2013 – $6.2 Billion1 (+12%)*
`~62% Reimbursed vs. ~38% Cash Pay
`
`Global Reach
`Balanced Revenue Growth Across All Operating Regions
`(in billions of dollars)
`
`1
`
`Ophthalmics 47%
`(Reimbursed 39%, Cash 8%)
`BOTOX® Therapeutic 17%
`(Reimbursed 17%)
`
`BOTOX® Cosmetic 15%
`(Cash 15%)
`
`Facial Aesthetics 8%
`(Cash 8%)
`Breast Aesthetics 6%
`(Reimbursed 1%, Cash 5%)
`LATISSE® 2%
`(Cash 2%)
`Skin Care 5%
`(Reimbursed 5%)
`
`$5.5*
`
`$5.1*
`
`$4.6*
`
`$4.2*
`
`4 YR CAGR
`
`$6.2*
`
`+10%
`
`North America
`Europe, Africa &
`Middle East
`Asia Pacific
`Latin America
`
`+9%
`
`+11%
`
`+19%
`
`+11%
`
`09
`
`10
`
`11
`
`12
`
`13
`
`* Excludes Obesity Intervention product net sales in all periods
`
`1 Excludes Obesity Intervention product net sales
`* Growth in Local Currency
`
`36205.indd 3
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`
`

`

`SOME CHALLENGES IN 2013
`
`Of course, the year was not without some challenges. As a company focused on delivering long term revenue growth, we regularly
`and objectively review where we should focus our fi nancial and managerial resources. In spite of the clear need to address obesity
`worldwide, sales of our obesity intervention products were recently in decline, principally due to patients experiencing barriers to
`access in terms of coverage by their healthcare plans, to patient co-pays and, in addition, to recent surgeon adoption of an alternative
`bariatric procedure. Having declared the LAP-BAND® System and ORBERA® gastric balloon, the latter sold outside the United
`States, as a discontinued business in early 2013, we were pleased that we were able to divest this product line in December to
`Apollo Endosurgery. This divestiture will enable us to concentrate our management resources on the many growth products in our
`businesses. Strategically, we have no interest in maintaining product lines with declining sales growth in our portfolio.
`
`Although we have been highly successful in securing product approvals, with no less than 11 such FDA approvals since the
`beginning of 2010, the R&D process in pharmaceuticals and medical devices abounds with technical and scientifi c challenges.
`We experienced some of these, resulting in delays in 2013. Regarding LEVADEX®, which we had acquired from MAP, we received
`input from the FDA regarding the manufacturing process and required additional data from additional production lots. In order to fully
`satisfy the FDA’s demands and to control quality standards, we acquired MAP’s third-party canister fi lling supplier in early 2013.
`Our response to the FDA’s complete response letter was fi led in December 2013 and we expect to receive FDA approval for the
`product in the second quarter of 2014.
`
`Subsequent to our in-license of DARPin® technology, for the treatment of macular degeneration, from Molecular Partners in Zurich
`in 2012, we conducted our initial clinical trial that could have provided data to allow us to advance directly into phase 3 trials,
`demonstrate longer duration compared to existing products, and allow us to decrease overall development time. Unfortunately, we did
`not have the results to support going directly into phase 3 and decided to adopt a new clinical protocol that is similar to those used by
`earlier competitive products, which has led to a one to two year delay in the program. We remain excited, however, by the promise of
`this technology to bring a differentiated, superior product to market to lessen the burden of this disease for patients.
`
`Regarding bimatoprost scalp, the same active pharmaceutical ingredient (API) in LATISSE® (bimatoprost ophthalmic solution) 0.03%,
`approved for the growth of eyelashes, the results of our phase 2 trial for male and female scalp hair loss were insuffi cient to proceed to
`phase 3. As the formulation was well tolerated, a decision was made to conduct an additional phase 2 trial with a higher concentration
`of API from the previous phase 2. Male patients with androgenic alopecia have been enrolling in this trial, and we expect the trial to
`complete by mid-year 2015.
`
`2
`
`Finally, investors experienced some concerns regarding Allergan’s ability to defend its patents regarding RESTASIS® (cyclosporine
`ophthalmic emulsion) 0.05% for therapeutic chronic dry eye and LUMIGAN® 0.01% for glaucoma. In early 2014, a U.S. District Court
`in Texas ruled that all fi ve of the LUMIGAN® 0.01% patents in suit are valid and infringed, and enjoined the generics from launching their
`products until the patents expire, the last of which expires in 2027. Several generic companies have fi led appeals to the U.S. Court
`of Appeals but would need to convince the Court to invalidate or fi nd non-infringement of all fi ve patents to be successful. Regarding
`RESTASIS®, we believe it will remain the only product approved by FDA and several regulatory agencies abroad for therapeutic chronic
`dry eye for some length of time. The clinical requirements were onerous for Allergan and we too did not receive approval upon our fi rst
`
`Mid Teens EPS Growth Aspiration
`Non-GAAP Diluted Earnings Per Share1
`
`Ability to Leverage SG&A
`Non-GAAP SG&A as a Percentage of Sales1
`
`39.1
`
`39.2
`
`40.0
`
`40.5
`
`41.1
`
`$4.77
`
`$4.04
`
`$3.55
`
`$3.16
`
`$2.78
`
`8%
`
`14%
`
`12%
`
`14%
`
`18%
`
`09
`
`10
`
`11
`
`12
`
`13
`
`09
`
`10
`
`11
`
`12
`
`13
`
`1 The adjusted amounts represent certain non-GAAP fi nancial measures. For a reconciliation of these non-GAAP fi nancial measures to GAAP fi nancial measures, please refer to pages 18 and 19 of this Annual Report. 2009 and 2010 include the obesity intervention business.
`
`36205.indd 4
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`
`

`

`David E.I. Pyott, CBE, Chairman of the Board & Chief Executive Offi cer
`
`3
`
`submission to FDA. Several other programs from other companies have suffered similar issues. Given the value of RESTASIS® with
`sales approaching $1 billion in the U.S. alone, it is not so surprising that the Offi ce of Generics Drugs at FDA issued a draft guidance
`for public comment on how generic companies could present a clinical package to secure approval for a generic of RESTASIS®.
`Given earlier comments by offi cials both in the Review Division, the group responsible for approving new drugs, as well as by others
`in the Generics Division, it was however surprising that this Draft Guidance established a pathway based solely on in vitro assays. In
`addition to Allergan, 22 medical societies, patient groups and consumer groups submitted comments, all raising concerns about public
`health and safety if generics were to be approved of our complex “oil in water” emulsion formulation. Given the key importance of our
`formulation, method of use and manufacturing process in ophthalmic pharmaceuticals, Allergan was able to secure four new patents,
`originally fi led in the early 2000’s at the U.S. Patent Offi ce, and listed in the Orange Book in January and February 2014. We have
`also fi led a Citizen’s Petition with the Generics Division of the FDA. All of this provides us several legal avenues to vigorously defend
`RESTASIS®. Whilst Watson Pharmaceuticals (Actavis) notifi ed us that they submitted a generic RESTASIS® fi ling with FDA, they also
`admitted the agency refused to receive that submission for fi ling. The status of any generic fi lings is currently unclear but the situation may
`become more clear by the middle of 2014, and we are confi dent that we have taken all of the appropriate steps to protect our therapeutic
`dry eye franchise.
`
`POWER AND SUSTAINABILITY OF GROWING MARKETS
`
`Notwithstanding these challenges, Allergan remains in an extremely strong and enviable position. We are the No. 1 or No. 2 player in
`each of our therapeutic areas with our markets enjoying strong growth and continuing growth potential3 as we address the therapeutic
`needs of an aging world population that, aesthetically, would also like to maintain a youthful appearance. These market positions,
`combined with our presence in all continents of the world and considerable investment in R&D, makes us an ideal partner or natural
`purchaser for companies with technology assets in our fi elds. Our long term track record has demonstrated our ability to not only invent
`products internally, but also to shepherd externally acquired technologies through the processes of clinical development, approval by
`regulatory agencies and to successful reimbursement and adoption in the marketplace.
`
`BALANCED GROWTH ACROSS SPECIALTIES AND GEOGRAPHIES
`
`A strong company built to last demonstrates strong growth across countries as well as product lines, and this was the case for
`Allergan in 2013. Most of our operating regions, namely North America pharmaceuticals; the U.S. Medical Aesthetics business unit;
`3 Mixture of public information (earnings releases, earnings calls, 10Ks, 10Qs), AGN internal data, syndicated marketing research reports, analyst reports, Internet searches, competitive intelligence, market trackers, etc. for U.S. Dollar sales at actual rates for four quarters
` ending September 2013.
`
`36205.indd 5
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`
`

`

`Europe, Africa, and Middle East; and Asia Pacifi c, all enjoyed double digit sales growth in local currencies. The only exception was
`Latin America, where we made the strategic decision to lower inventories of breast aesthetics products in Mexico and Columbia in
`advance of terminating our distributor arrangements and going direct in January 2014, and we were additionally held back by the lack
`of foreign exchange for imports in Venezuela.
`
`BOTOX® sales continued their trajectory of double digit growth in 2013, increasing by 13.2% in local currencies and 12.2% in U.S.
`Dollars to almost $2 billion. With recent approvals by FDA and many global regulatory agencies, for chronic migraine and two urological
`conditions: neurogenic overactive, or spastic bladder and idiopathic overactive bladder, or severe incontinence, therapeutic sales of
`BOTOX® further accelerated, growing 16% in local currencies. In the U.S., BOTOX® now has eight approved therapeutic indications
`along with the well-known aesthetic indications for BOTOX® Cosmetic (onabotulinumtoxinA) for moderate to severe glabellar lines and
`a newly approved indication for moderate to severe lateral canthal lines, or crow’s feet lines. Worldwide, BOTOX® enjoys more than 27
`different approved indications across approximately 88 countries. Aesthetic global sales accounted for approximately 46% of BOTOX®
`global sales and increased by 10% in local currencies. Our other consumer-facing franchises also performed well in 2013, even in
`economically challenged markets such as in Southern Europe. Dermal fi llers sales were propelled by the introduction of the unique
`and technologically advanced VYCROSS® lines – made up of JUVÉDERM VOLUMA® XC to correct age-related volume loss in the
`cheek area, VOLBELLA® for lip augmentation, and VOLIFT® for nasolabial folds. FDA approved the fi rst of these products, JUVÉDERM
`VOLUMA® XC at the end of 2013. Physicians and their patients appreciate the softness and duration of these products everywhere
`where they have been introduced, leading to an upswing in market growth and market share gains for Allergan. In breast aesthetics,
`sales growth at only 0.2% in U.S. Dollars was on the surface low but was affected by the one time surge in growth in Europe in 2012
`as patients chose Allergan’s NATRELLE® high quality products for revision surgery upon explantation of silicone implants fraudulently
`produced by a French manufacturer. Sales were also negatively affected by the abovementioned drawdown of inventory in Mexico and
`Colombia and import restrictions into Venezuela. Offsetting this were initial shipments to Japan, where NATRELLE® is the only implant
`line approved, and major expansion in China. Within the skincare segment, ACZONE® (dapsone) gel 5%, responded to an investment
`in direct to consumer advertising as well as focused detailing to dermatologists, and is poised to become the largest acne brand in the
`U.S. by value.4
`
`4
`
`Representing almost half of our worldwide revenues, ophthalmic pharmaceuticals grew 8% in local currencies in 2013, with Allergan
`being the fastest growing global company, excluding retinal therapeutics.5 With growing appreciation by healthcare providers that
`therapeutic dry eye is a progressive disease and merits early treatment, RESTASIS® sales grew strong at 19% in local currencies, and
`RESTASIS® became the No. 1 eye drop worldwide and further consolidated its position as the No. 1 branded product by value in the
`U.S. market.6 In addition, Allergan’s artifi cial tears franchise as reported by IMS Global, grew 2%, with growth accelerating across the
`year as Allergan benefi ts from the introduction of OPTIVE® Advanced (marketed as OPTIVE PLUS™ in many overseas markets, as
`well as OPTIVE FUSION™ in Europe). The latter, a powerful combination of hyaluronic acid and carboxy methyl cellulose polymers, is
`Allergan’s fi rst entry into the hyaluronic acid category, which accounts for nearly 30% of the overall market in Europe and about a 60%
`share in the Asia Pacifi c Region.7 In the glaucoma market, Allergan, per IMS Global, was the fastest growing global company,8 as we
`
`4 IMS NPA TRx Pharmacy $ Dermatology Segment Full Year 2013
`5 IMS YTD Q3-2013 worldwide (53-country rollup) U.S.$ growth estimates at Q3-13 constant exchange rates (among top six companies)
`6 IMS MAT Q3-2013 worldwide (53-country rollup) U.S.$ sales estimates at Q3-13 constant exchange rates
`7 IMS 53-country rollup and selected OTC CE data YTD Q3-2013 sales @ AGN 13 Budget rates
`8 IMS MAT Q3-2013 worldwide (53-country rollup) U.S.$ growth estimates at Q3-13 constant exchange rates (among top six companies)
`
`Leading Market Share Positions in Growing Markets
`Worldwide Market in Billions of Dollars With Aggregate Growth 2009-2013
`Ophthalmics
`Neuromodulators*
`Fillers
`+37%
`+59%
`+71%
`
`Breast Aesthetics
`+13%
`
`Allergan
`J&J/Mentor
`Others
`
`$0.9
`
`AGN #1
`
`$0.8
`
`AGN #2
`
`Allergan
`Valeant/Medicis
`Merz/BioForm
`Others
`
`$1.2
`
`AGN #1
`
`$0.7
`
`AGN #2
`
`Allergan
`Valeant/Medicis
`Merz
`Others
`
`$2.7
`
`AGN #1
`
`$1.7
`
`AGN #1
`
`Allergan
`Novartis/Alcon
`Pfizer
`Others
`
`$20.2
`
`AGN #2
`
`$14.7
`
`AGN #2
`
`09
`
`Q3 13
`MAT
`
`09
`
`Q3 13
`MAT
`
`09
`
`Q3 13
`MAT
`
`09
`
`Q3 13
`MAT
`
`Sources: Ophthalmics – IMS Global (53 countries) at Q3 2013 constant exchange rates. Neuromodulator/Filler/Breast/Banding – Mixture of public information (earnings releases, earnings calls, 10Ks, 10Qs), AGN internal data, syndicated marketing research
`reports, analyst reports, internet searches, competitive intelligence, market trackers, etc. * Neuromodulators include Therapeutic and Cosmetic
`
`36205.indd 6
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`
`

`

`benefi ted from a very broad product offering, for both fi rst line and combination glaucoma treatments, with LUMIGAN® (bimatoprost
`ophthalmic solution) 0.01%, GANFORT™ (which is not approved in the U.S.), ALPHAGAN® P (brimonidine tartrate ophthalmic
`solution) 0.1% and COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%. Sales in Europe benefi ted
`from the introduction in 2013 in several markets of LUMIGAN® and GANFORT® unit dose, offering a preservative free alternative to
`ophthalmologists. In the U.S., physicians recognized the benefi ts of the newer LUMIGAN® 0.01% product offering the same effi cacy
`as the fi rst generation product, but with less hyperemia. Consequently, Allergan no longer markets LUMIGAN® 0.03% in the U.S..
`In the retina segment, OZURDEX® (dexamethasone intravitreal implant), a steroid delivered in a bioerodable implant to the back of the
`eye and indicated for the relatively small indications of retinal vein occlusion and uveitis, grew strongly in Europe and the U.S.. We fi led
`for approval of the larger indication of diabetic macular edema in both the U.S. and Europe in 2013 and anticipate approval in the
`U.S. in Q2 of 2014 and in early 2015 for Europe.
`
`PROMISING OUTLOOK
`
`As we address the challenges of 2013 and benefi t from our strong diversifi ed portfolio of products, we intend to continue to invest
`heavily in the future. We plan to increase our expenditure on R&D from $1 billion in 2013 to approximately $1.5 billion in the coming
`fi ve years, focusing in particular on our key areas of new indications and new forms of botulinum toxin, retinal therapeutics, dry eye,
`glaucoma, medical and aesthetic dermatology and plastic surgery. In pursuing these goals, we constantly strive to adapt our business
`processes and gain new business effi ciencies. To this end, we announced in early 2014 a modest restructuring program impacting
`approximately 300 associates worldwide, with a net reduction of 150 positions, and entailing a charge of between approximately
`$40 million and $45 million with less than a two year payback. In addition to reducing the size of our U.S. glaucoma sales force due to
`changing market conditions heavily infl uenced by the universe of payors, we also moved some back offi ce operations from high cost
`California to Texas.
`
`In delivering the strong results for 2013, I wish to thank the management team and employees around the world for their attention to
`detail in executing our clearly defi ned corporate and product strategies. I wish also to acknowledge our strong Board of Directors, with
`their broad range of professional and geographical skill sets, in guiding the long term direction of Allergan.
`
`Sincerely,
`Sincerely,
`
`David E.I. Pyott, CBE
`Chairman of the Board & Chief Executive Offi cer
`
`
`
`Major Product Approvals
`
`5
`
`PRODUCT
`
`INDICATION1
`
`BOTOX® (onabotulinumtoxinA)
`
`BOTOX® (onabotulinumtoxinA)
`
`Treatment of overactive bladder with symptoms of urinary
`incontinence, urgency and frequency in adults who have
`had an inadequate response to or are intolerant of an
`anticholinergic medication
`
`Temporary treatment of moderate to severe lateral canthal
`lines, commonly known as “crow’s feet” lines
`
`COUNTRY
`
`United States and
`other global markets
`
`United States and 19 countries
`of the European Union, Norway,
`Iceland2
`
`JUVÉDERM VOLUMA® XC Dermal Filler
`
`Temporary correction of age-related volume loss in the cheek
`area in adults over the age of 21
`
`United States
`
`NATRELLE® 410 Highly Cohesive Anatomically
`Shaped Silicone-Filled Breast Implants
`
`Women undergoing breast augmentation, revision or
`reconstructive surgery
`
`United States, Japan
`
`1 Specific indication verbiage varies by country.
`2 Approvals as of February 5, 2014.
`
`36205.indd 7
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`

`6
`
`A Proud History, A Promising Future:
`Allergan’s Leadership in Eye Care
`
`36205.indd 8
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`

`

`For more than 60 years Allergan has been a pioneer in innovative eye treatments. While other companies have entered
`and exited the fi eld over this time, we have remained committed to developing and providing important products for
`serious eye conditions. Today we are the fastest growing ophthalmics company and the second largest in the world.1
`And the solid results we have consistently delivered in this business have formed the foundation of Allergan’s success
`as a specialty- and patient-focused company.
`
`In 2013, prescription and over-the-counter eye care treatments accounted for nearly 50 percent of Allergan’s total
`global sales. Key product highlights for the year include:
`
`• RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%, for chronic dry eye due to infl ammation and the only
` prescription dry eye product in the U.S., reached nearly $1 billion in sales.
`• In glaucoma, we obtained approval in the European Union (EU) for LUMIGAN® (bimatoprost ophthalmic solution)
` 0.01% unit dose and GANFORT® (bimatoprost timolol maleate) 0.01% unit dose, which provide important new
`
`treatment options to eye care professionals in the region.
`• We fi led with the U.S. Food and Drug Administration and with EU regulatory authorities for approval of OZURDEX®
`
`(dexamethasone intravitreal implant) to treat Diabetic Macular Edema, a serious eye disorder that is on the increase
` due to rising rates of type 2 diabetes. We anticipate U.S. approval of this important new indication this year and in
` early 2015 for Europe.
`
`“The Allergan story begins with strong science, leading to a steady stream of innovative new products that can make
`a real difference for many people,” says Julian Gangolli, Corporate Vice President and President of North America.
`“Innovation and partnership with the medical community have driven the success of Allergan’s eye care business and
`will continue doing so.”
`
`1 Mixture of public information (earnings releases, earnings calls, 10Ks, 10Qs), AGN internal data, syndicated market research reports, analyst reports, internet searches, competitive intelligence, market trackers, etc.
`
`“The positive results we achieve in eye care
`will not only benefi t patients but further strengthen
`our company’s leadership and future.”
`Doug Ingram, President of Allergan
`
`7
`
`OZURDEX® (dexamethasone intravitreal implant) is currently approved in the
`U.S. for macular edema following retinal vein occlusion and non-infectious
`ocular infl ammation, or uveitis.
`
`Worldwide RESTASIS® Sales
`(in millions of dollars)
`
`$940
`
`$792
`
`$697
`
`$621
`
`$523
`
`09
`
`10
`
`11
`
`12
`
`13
`
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`

`

`8
`
`Driving Results Through
`Innovation in Facial Aesthetics
`
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`
`

`

`In 2013, Allergan’s Facial Aesthetics business delivered strong results by innovating, adapting and staying close to the
`customer. Sales of BOTOX® Cosmetic (onabotulinumtoxinA) – already the number-one minimally invasive aesthetic
`medical treatment globally1 – are benefi ting from its latest approved indication, to temporarily treat moderate to severe
`lateral canthal lines, commonly known as “crow’s feet” lines. We received U.S. Food and Drug Administration approval
`for this new indication in 2013, and also have secured national licenses in 19 countries of the European Union as well as
`Norway and Iceland. BOTOX® Cosmetic is the fi rst and only product of its kind approved for this use.
`
`Allergan is also the world leader in dermal fi llers.2 Global sales of Allergan’s JUVÉDERM® family of products, which
`address the mid and lower parts of the face, are growing robustly, thanks to market expansion and innovative products.
`These include the new line of products using Allergan’s proprietary VYCROSS® technology, which results in a smooth gel
`that fl ows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss.
`
`VYCROSS® technology is available in JUVÉDERM VOLUMA® XC for cheeks, VOLBELLA® for lips and VOLIFT® for
`nasolabial folds. Many of these products are available outside of the U.S. in markets such as Europe, Asia Pacifi c and
`Latin America. “The science behind these products, as well as the extensive education and training we undertake
`with our customers, translates into very strong results for this business,” says Simone Agra, Vice President, Medical
`Aesthetics, Latin America.
`
`In October 2013, JUVÉDERM VOLUMA® XC was approved in the U.S. as the fi rst and only dermal fi ller for deep injection
`to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. “Gauging from the strong
`interest in these fi rst few months on the market, we believe it will be an important transformative product in the U.S., just
`as it has been in many international markets,” says Philippe Schaison, President of Allergan Medical U.S.
`
`1 Allergan data on file.
`2 Mixture of public information (earnings releases, earnings calls, 10Ks, 10Qs), AGN internal data, syndicated market research reports, analyst reports, internet searches, competitive intelligence, market trackers, etc.
`
`Our winning formula for achieving
`strong results is constantly innovating and
`listening closely to our customers.
`
`9
`
`Worldwide Aesthetic Market
`Innovation Stimulates Both Market and Allergan Growth
`(in billions of dollars)
`
`$5.0*
`
`Neuromodulators
`Fillers
`Breast
`LATISSE®
`
`$3.2
`
`$2.3
`
`09
`
`12
`
`17
`
`* Market projections based on Allergan estimates
`
`36205.indd 11
`
`3/11/14 10:27 AM
`
`APOTEX 1057, pg.
`
`

`

`1 0
`
`Investing for Future Results:
`The Allergan Pipeline
`
`36205.indd 12
`
`3/11/14 10:27 AM
`
`APOTEX 1057, pg.
`
`

`

`Allergan’s pipeline represents our long-term strategy of investing signifi cantly in R&D while rigorously reviewing and culling
`our portfolio of candidates. By doing this – and through targeted acquisitions – we look to ensure a steady stream of new
`products across our fi ve medical specialties: eye care, medical aesthetics, medical dermatology, neurology and urologics.
`
`“Results matter for Allergan’s R&D organization,” says Scott Whitcup, MD, Executive Vice President, R&D, and Chief
`Scientifi c Offi cer. “Generating, measuring and interpreting data drive the decisions regarding our research programs and
`lead to the approval of new therapies.”
`
`For an R&D organization, success is measured by product approvals. Dr. Whitcup adds: “New products are critical to our
`patients as well as to supporting overall company performance, allowing us to invest in R&D and constantly fuel the pipeline.”
`
`Our pipeline also includes important acquired and in-licensed products, such as DARPin®, for age-related macular
`degeneration, and LEVADEX®, a self-administered, orally inhaled and breath activated therapy for the acute treatment of
`migraines in adults.
`
`In addition, in January 2014 we completed a licensing agreement with Medytox, Inc., of South Korea, to develop and,
`if approved, commercialize certain neurotoxin product candidates currently in development, including a potential liquid-
`injectable product.
`
`Allergan’s R&D strategy concentrates on developing differentiated, commercially successful treatments. To that end,
`we employ an effi cient R&D model – one focused on our specialties and yielding products that are localized in their
`impact and do not have a systemic effect in the body. This focused strategy and unique product development approach
`enables Allergan to bring products through the worldwide regulatory processes and onto the market at a rate above the
`industry average.
`
`In 2013, Allergan secured a record
`180+ approvals for a variety of products
`and indications across the world.
`
`1 1
`
`Significant R&D Investment
`Consistently Fueling the Pipeline
`(in millions of dollars)
`
`Anticipated Near Term Product Approvals
`and Clinical Data
`
`LEVADEX® U.S.
`FDA expected approval – Q2 2014
`
`OZURDEX® for Diabetic Macular Edema U.S.
`FDA expected approval – Q2 2014
`
`BOTOX® (onabotulinumtoxinA) for Depression
`Entering Phase II – 2nd half of 2014
`
`DARPin®
`Phase II Stage III data – 2nd half of 2014
`
`Bimatoprost Sustained Release Glaucoma
`Phase II Data – late 2014 / early 2015
`
`$1,5002
`
`$1,0351
`
`$9151
`
`$8261
`
`1 The adjusted amounts represent certain non-GAAP
` fi

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