Alkermes
Annual Report 2012

Plain-text annual report

QuickLinks -- Click here to rapidly navigate through this documentUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549Form 10-KCommission file number: 1-14131ALKERMES PUBLIC LIMITED COMPANY(Exact name of registrant as specified in its charter)Ireland(State or other jurisdiction ofincorporation or organization) 98-1007018(I.R.S. EmployerIdentification No.)Connaught House1 Burlington RoadDublin 4, Ireland(Address of principal executiveoffices) (Zip code)+353-1-772-8000(Registrant's telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act:Ordinary shares, $0.01 par valueTitle of each class NASDAQ Global Select Stock MarketName of each exchange on whichregistered Securities registered pursuant to Section 12(b) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No  Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o 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 preceding12 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 o Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and postedpursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post suchfiles): Yes  No o Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant'sknowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "largeaccelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one): Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No (Mark One)  ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended March 31, 2012ORo TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Large accelerated filer o Accelerated filer o Non-accelerated filer (Do not check if asmaller reporting company) Smaller Reporting company o The aggregate market value of the registrant's ordinary shares held by non-affiliates of the registrant (without admitting that any person whose shares are not included in suchcalculation is an affiliate) computed by reference to the price at which the ordinary shares was last sold as of the last business day of the registrant's most recently completed second fiscalquarter was $1,947,523,774. As of May 11, 2012, 130,241,192 shares of ordinary shares were issued and outstanding.DOCUMENTS INCORPORATED BY REFERENCE Portions of the definitive proxy statement for our Annual General Meeting of Shareholders' for the fiscal year ended March 31, 2012 are incorporated by reference into Part III of thisreport. ALKERMES PLC AND SUBSIDIARIESANNUAL REPORT ON FORM 10-KFOR THE FISCAL YEAR ENDED MARCH 31, 2012INDEX 2PART I 5 Item 1. Business 5 Item 1A. Risk Factors 32 Item 1B. Unresolved Staff Comments 54 Item 2. Properties 54 Item 3. Legal Proceedings 55 Item 4. Mine Safety Disclosures 55 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities 56 Item 6. Selected Financial Data 60 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 62 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 82 Item 8. Financial Statements and Supplementary Data 84 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures 85 Item 9A. Controls and Procedures 85 Item 9B. Other Information 86 PART III Item 10. Directors, Executive Officers and Corporate Governance 87 Item 11. Executive Compensation 87 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters 87 Item 13. Certain Relationships and Related Transactions, and Director Independence 87 Item 14. Principal Accounting Fees and Services 87 PART IV Item 15. Exhibits and Financial Statement Schedules 87 SIGNATURES 88 FORWARD-LOOKING STATEMENTS This document contains and incorporates by reference "forward-looking statements" within the meaning of Section 27A of the Securities Act of1933 and Section 21E of the Securities Exchange Act of 1934. In some cases, these statements can be identified by the use of forward-lookingterminology such as "may," "will," "could," "should," "would," "expect," "anticipate," "continue" or other similar words. These statements discussfuture expectations, and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forwardlooking information. Forward-looking statements in this Annual Report on Form 10-K include, without limitation, statements regarding:•our expectations regarding our financial performance, including revenues, expenses, gross margins, liquidity, capital expenditures andincome taxes; •our expectations regarding the commercialization of our products, including the sales and marketing efforts of our partners and, forVIVITROL® (naltrexone for extended-release injectable suspension), our ability to establish and maintain successful sales andmarketing, reimbursement and distribution arrangements; •our efforts and ability to evaluate and license products and build our pipeline; •our expectations regarding our products, including the development, regulatory review (including expectations about regulatory approvaland regulatory timelines) and therapeutic and commercial potential of such products and the costs and expenses related thereto; •our expectations regarding the initiation, timing and results of clinical trials of our products; •our expectations regarding the successful manufacture of our products, by us or our partners, for commercial sale; •the continuation of our collaborations and other significant agreements and our ability to establish and maintain successful developmentcollaborations; •our expectations regarding the financial impact of healthcare reform legislation and currency exchange rate fluctuations and valuations; •the impact of new accounting pronouncements; •our ability to protect our intellectual property rights, not infringe third-party intellectual property rights and the impact of recent patentlegislation; •our expectations regarding near-term changes in the nature of our market risk exposures or in management's objectives and strategieswith respect to managing such exposures; •our ability to comply with restrictive covenants of our indebtedness and our ability to fund our debt service obligations; •our expectations concerning the status, intended use and financial impact of, and arrangements involving, our properties, includingmanufacturing facilities; •our future capital requirements and capital expenditures and our ability to finance our operations and capital requirements; and •other risk factors described in "Item 1A—Risk Factors" in this prospectus. Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-lookingstatements are subject to risks, assumptions and uncertainties. You are cautioned not to place undue reliance on forward-looking statements, whichspeak only as of the date of this Annual Report. All subsequent written and oral forward-looking statements concerning3the matters addressed in this Annual Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by thecautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation toupdate publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks,uncertainties and assumptions, the forward-looking events discussed in this Annual Report might not occur. For more information regarding the risksand uncertainties of our business, see "Item 1A—Risk Factors." Unless otherwise indicated, information contained in this Annual Report concerning the disorders targeted by our products and the markets inwhich we operate is based on information from various sources (including industry publications, medical and clinical journals and studies, surveys andforecasts and our internal research), on assumptions that we have made, which we believe are reasonable, based on those data and other similar sourcesand on our knowledge of the markets for our products and development programs. Our internal research has not been verified by any independentsource, and we have not independently verified any third-party information. These projections, assumptions and estimates are necessarily subject to ahigh degree of uncertainty and risk due to a variety of factors, including those described in "Item 1A—Risk Factors." These and other factors couldcause results to differ materially from those expressed in the estimates included in this Annual Report.4PART I Item 1. Business The following discussion contains forward-looking statements. Actual results may differ significantly from those projected in the forward-lookingstatements. See "Forward-Looking Statements." Factors that might cause future results to differ materially from those projected in the forward-lookingstatements also include, but are not limited to, those discussed in "Item 1A—Risk Factors" and elsewhere in this Annual Report. On September 16, 2011, the business of Alkermes, Inc. ("Old Alkermes") and the drug technologies business ("EDT") of Elan Corporation, plc("Elan") were combined (this combination is referred to as the "Business Combination," the "acquisition of EDT," or the "EDT acquisition") underAlkermes plc. As part of the Business Combination, Antler Acquisition Corp., a wholly owned subsidiary of Alkermes plc, merged with and into OldAlkermes (the "Merger"), with Old Alkermes surviving as an indirect, wholly-owned subsidiary of the Company. Prior to the Merger, EDT wascarved-out of Elan and reorganized under the Company. Use of the terms such as "us," "we," "our" or the "Company" in this prospectus is meant to refer to Alkermes plc ("Alkermes") and itsconsolidated subsidiaries, except when the context makes clear that the time period being referenced is prior to September 16, 2011, in which casesuch terms shall refer to Old Alkermes. Prior to September 16, 2011, Old Alkermes was an independent biotechnology company incorporated in theCommonwealth of Pennsylvania and traded on the NASDAQ Global Select Stock Market (the "NASDAQ") under the symbol "ALKS."Overview Alkermes develops medicines that address the unmet needs and challenges of people living with serious chronic disease. A fully integrated globalbiopharmaceutical company, Alkermes applies proven scientific expertise, proprietary technologies and global development capabilities to createinnovative treatments for major clinical conditions with a focus on central nervous system ("CNS") disorders, such as schizophrenia, addiction anddepression. We create new, proprietary pharmaceutical products for our own account, and we collaborate with other pharmaceutical and biotechnologycompanies. We are increasingly focused on maintaining rights to commercialize our leading product candidates in certain markets. We are an Irish public limited company incorporated in Dublin, Ireland, with a research and development ("R&D") center in Waltham,Massachusetts and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, Ohio. Our corporate headquarters are located atConnaught House, 1 Burlington Road, Dublin 4, Ireland. For a more detailed discussion of the Business Combination, please refer to the notes to our consolidated financial statements, including Note 1,The Company, and Note 3, Acquisitions, in the accompanying consolidated financial statements.Our Strengths and Strategy The products that we develop leverage multiple proprietary technologies to create new medicines that are designed to address therapeutic areas ofsignificant unmet medical need and improve patient outcomes. As of March 31, 2012, we and our pharmaceutical and biotechnology partners had morethan 20 commercialized products sold worldwide, including the United States ("U.S."). We earn manufacturing and/or royalty revenues on net sales ofproducts commercialized by our partners and earn revenue on net sales of VIVITROL, which is a proprietary product that we manufacture, market andsell in the U.S. Our five key products are expected to generate significant revenues for us in the5near- and medium-term, as they possess long patent lives, are singular or competitively advantaged products in their class and are generally in the launchphases of their commercial lives. These five key products are: RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, bothantipsychotics marketed by Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International AG("Janssen"); AMPYRA®/FAMPYRA® for the improvement of walking in patients with multiple sclerosis and marketed by Acorda Therapeutics, Inc.("Acorda") in the U.S. and by Biogen Idec, Inc. ("Biogen Idec") outside the U.S.; BYDUREONTM, the only once-weekly treatment for type 2diabetes, which in the U.S. is, and outside the U.S. will soon be, marketed by Amylin Pharmaceuticals, Inc. ("Amylin"); and VIVITROL, the onlyonce-monthly, injectable, non-addictive treatment available for the prevention of relapse to opioid dependence and for alcohol dependence, which ismarketed by us. We have a portfolio of product candidates across all stages of development. Backed by decades of experience, we are able to streamline thetraditional drug development process with a goal of increasing the probability of late-stage product success. Our R&D approach involves little basicdiscovery and allows us to assess the viability of new pipeline candidates early and devote our resources to advancing the most promising candidatesquickly to registration-stage trials. Our R&D efforts have been highly productive and have yielded a pipeline that we expect will generate meaningfulnew drugs that will become sources of significant revenue for our company into the next decade and beyond. We are increasingly focused onmaintaining rights to commercialize our leading product candidates in certain markets.Our Competitive Strengths We believe our principal competitive strengths include:•our broad and diverse product portfolio and pipeline, which, as of March 31, 2012, included more than 20 marketed products as well assix proprietary pipeline candidates and partnered pipeline programs; •our five key commercial products that are expected to generate significant revenues for the company in the near- and medium-term; •our focused R&D approach that leverages proprietary technologies and our extensive experience in developing CNS treatments, with theproven ability to advance candidates from well-informed preclinical testing to cost-effective proof-of-concept studies; •our extensive and long-lived intellectual property covering composition of matter, process, formulation and/or methods-of-use for ourcurrently marketed products and for our product candidates in development; •our three established manufacturing facilities that are compliant with current Good Manufacturing Practices ("cGMP"), can producemultiple dosage forms and are fully scaled to meet the manufacturing needs of ourselves and our collaborative partners; and •our experienced management team and personnel who have grown our business to be an established biopharmaceutical company with atrack record of more than 40 years of development, regulatory, manufacturing and partnering expertise.Our Strategy Capitalize on growth from our five key commercial products. Our key commercialized products are generally in their launch stages for largeand growing disease areas, with significant opportunity for growth. We expect that the revenues that we earn from the portfolio—RISPERDALCONSTA and INVEGA SUSTENNA/XEPLION, AMPYRA/FAMPYRA, BYDUREON and VIVITROL—will6continue to increase in the near- and medium-term, as they address large and growing markets and are competitively advantaged. We expect thatrevenues generated from these products will enable us to meet our near- and medium-term financial goals and position the company for sustainableprofitability. Continue to advance our pipeline. Our R&D approach is based on return on investment and, between us and our partners, we have a broad anddiverse pipeline of new drug candidates. We currently have clinical studies underway for a product candidate in phase 3, three candidates that are inphase 2 and one candidate that is in phase 1. We also have one partnered product candidate for which a New Drug Application ("NDA") has beensubmitted to the U.S. Food and Drug Administration ("FDA") and other proprietary candidates in preclinical testing. Our proprietary productcandidates have undergone extensive preclinical testing prior to reaching the clinical development stage, which we believe improves these candidates'probability of success in later-stage drug development. Grow revenues and manage our expenses to expand our margins. We intend to manage our business with the goal of achieving continuedmargin expansion. Our five key products are expected to grow our revenues in the near- and medium-term, and we will seek to manage our expenses togrow at a slower pace than revenues.7Products and Development ProgramsCommercial Products Our commercial products are described in the table below, including, among other things, the territory where currently sold and the source ofrevenues for us.Product Indication Technology Territory Revenue Source MarketerRISPERDALCONSTA SchizophreniaBipolar I Disorder Extended-releasemicrosphere Worldwide Manufacturing andRoyalty JanssenINVEGASUSTENNAXEPLION Schizophrenia NanoCrystal® Worldwide Royalty JanssenAMPRYAFAMPYRA Treatment for multiple sclerosis("MS") OCR(MXDAS®) U.S.United Kingdom,Australia,Germany,Norway,DenmarkIceland, Canada Manufacturing andRoyalty AcordaTherapeutics, Inc. inU.S.Biogen Idec (ex-U.S.under sublicense fromAcorda)BYDUREON Type 2 diabetes Extended-releasemicrosphere U.S.European UnionU.A.E. Royalty AmylinVIVITROL Alcohol dependenceOpioid dependence Extended-releasemicrosphere U.S.Russia andCommonwealth ofIndependent States("CIS") Product salesManufacturing andRoyalty Alkermes plcJanssenTRICOR®LIPANTHYL®LIPIDIL®SUPRALIP® Cholesterol lowering NanoCrystal Worldwide Royalty AbbottZANAFLEX®CAPSULES®ZANAFLEX®TABLETS Muscle spasticity OCR(SODAS®) U.S. Manufacturing andRoyalty AcordaAVINZA® Chronic moderate to severe pain OCR(SODAS) U.S. Manufacturing andRoyalty PfizerEMEND® Nausea associated withchemotherapy and surgery NanoCrystal Worldwide Royalty MerckFOCALIN® XRRITALIN LA® Attention DeficitHyperactivityDisorder OCR(SODAS) Worldwide Manufacturing andRoyalty NovartisMEGACE® ES Cachexia associatedwith AIDS NanoCrystal U.S. Royalty StrativaPharmaceuticals(a business divisionofPar PharmaceuticalCompanies, Inc.)LUVOX CR® Obsessive-compulsivedisorder OCR(SODAS) U.S. Manufacturing andRoyalty JazzPharmaceuticals plcRAPAMUNE® Prevention of renal transplantrejection NanoCrystal Worldwide Manufacturing PfizerNAPRELAN® Various mild to moderate OCR U.S. Manufacturing ShionogiNAPRELANpain indications(IPDAS®)CanadaSunovionPharmaceuticalsCanada,Inc.VERAPAMIL SRVERELAN®VERELAN® PMVERAPAMIL PMVERECAPS®UNIVER® Hypertension OCR(SODAS) Licensed oncountry/regionbasis throughoutthe world Manufacturing UCBKremers-UrbanWatson;Cephalon;Aspen;Orient EuropharmaDILZEM SRDILZEM XLDILTELANACALIX CDDINISORTILAZEM CRCARDIZEM CD Hypertension and/or Angina OCR(SODAS) Licensed oncountry/regionbasis throughoutthe world Manufacturing andRoyalty (forCARDIZEMCD only) Cephalon;Pfizer;Roemmers;Kun Wha;Orient Europharma;Sanofi-AventisAFE Ditab® CR(AB Rated to AdalatCC®)(Nifedipine) (A) Hypertension OCR(MXDAS®) U.S. Manufacturing WatsonPharmaceutical8 We have five principal commercial products which either currently, or in the future, are expected to contribute meaningfully to our revenues.RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION, which are two long-acting atypical antipsychotics, incorporate our extended-release injectable technology. They are products of Janssen. RISPERDAL CONSTA is the first and only long-acting, atypical antipsychotic approved by the U.S. Food and Drug Administration ("FDA") forthe treatment of schizophrenia and for the treatment of bipolar I disorder. INVEGA SUSTENNA/XEPLION is a once-monthly, long-acting injectableatypical antipsychotic approved by the FDA for the acute and maintenance treatment of schizophrenia in adults. Revenues from Janssen accounted for approximately 48%, 83% and 83% of our consolidated revenues for the fiscal years ended March 31, 2012,2011 and 2010, respectively. See "Collaborative Arrangements" below for information about our relationship with Janssen.For the treatment of schizophrenia RISPERDAL CONSTA (risperidone long-acting injection) uses our polymer-based microsphere injectable extended-release technology to deliverand maintain therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL CONSTA is exclusivelymanufactured by us and is marketed and sold by Janssen in more than 90 countries, including the U.S., United Kingdom ("UK"), Japan, Italy, Spainand Germany. It was first approved for the treatment of schizophrenia in the U.S. in 2003 and in countries in Europe in 2002. INVEGA SUSTENNA (paliperidone palmitate) uses our nanoparticle injectable extended-release technology to increase the rate of dissolution andenable the formulation of an aqueous suspension for once-monthly intramuscular administration. INVEGA/SUSTENNA was approved in the U.S. in2009. Paliperidone palmitate extended-release for injectable suspension is also approved in the European Union ("EU") and other countries worldwide,and is marketed and sold in the EU under the trade name XEPLION. INVEGA SUSTENNA/XEPLION is manufactured and commercialized byJanssen.What is schizophrenia? Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) andnegative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americanshave schizophrenia, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia. Studieshave demonstrated that as many as 75% of patients with schizophrenia have difficulty taking their oral medication on a regular basis, which can lead toworsening of symptoms.For the treatment of bipolar I disorder The FDA approved RISPERDAL CONSTA as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment ofbipolar I disorder in May 2009. RISPERDAL CONSTA is also approved for the maintenance treatment of bipolar I disorder in Canada, Australia andSaudi Arabia.What is bipolar I disorder? Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized bydebilitating mood swings, from extreme highs (mania) to9extreme lows (depression). Bipolar I disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of amajor depressive episode. Bipolar disorder is believed to affect approximately 5.7 million American adults, or about 2.6% of the U.S. population aged18 and older in a given year. The median age of onset for bipolar disorder is 25 years.AMPYRA/FAMPYRA Dalfampridine extended-release tablets are marketed and sold in the U.S. under the trade name AMPYRA by Acorda. Prolonged-releasefampridine tablets are marketed and sold outside the U.S. under the trade name FAMPYRA by Biogen Idec. AMPYRA was approved by the FDA inJanuary 2010 as a treatment to improve walking in patients with MS as demonstrated by an increase in walking speed. Efficacy was shown in peoplewith all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). It is the first and,currently, only product to be approved for this indication. A product of Acorda, it incorporates our Oral Controlled Release ("OCR") technology.FAMPYRA received conditional marketing approval in the EU in July 2011 and is currently being sold by Biogen Idec in select European countries, aswell as Australia. AMPYRA and FAMPYRA are manufactured by us.What is multiple sclerosis? MS is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinalcord. These nerve fibers consist of long, thin fibers, or axons, surrounded by a myelin sheath, which facilitates the transmission of electrical impulses.In MS, the myelin sheath is damaged by the body's own immune system, causing areas of myelin sheath loss, also known as demyelination. Thisdamage, which can occur at multiple sites in the CNS, blocks or diminishes conduction of electrical impulses. People with MS may suffer impairmentsin any number of neurological functions. These impairments vary from individual to individual and over the course of time, depending on which partsof the brain and spinal cord are affected, and often include difficulty walking. Individuals vary in the severity of the impairments they suffer on a day-to-day basis, with impairments becoming better or worse depending on the activity of the disease on a given day.BYDUREON We collaborated with Amylin on the development of a once-weekly formulation of exenatide, BYDUREON, for the treatment of type 2 diabetes.BYDUREON, an injectable formulation of Amylin's BYETTA® (exenatide), uses our polymer-based microsphere injectable extended-releasetechnology. Amylin is responsible for commercializing exenatide products, including BYDUREON, in the U.S. Eli Lilly and Company ("Lilly") hasexclusive rights to commercialize exenatide products outside of the U.S. until December 31, 2013 or such earlier date as agreed upon between Lilly andAmylin pursuant to the terms of their transition agreement, following which Amylin will have such exclusive rights. In June 2011, the European Commission granted marketing authorization for BYDUREON for the treatment of type 2 diabetes in adult patients incombination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione. In July 2011,Lilly launched BYDUREON in the UK, and in September 2011, BYDUREON was launched in Germany. We received a $7.0 million milestonepayment upon first commercial sale of BYDUREON in the EU, which was recognized during the quarter ended September 30, 2011. In January 2012, the FDA approved BYDUREON as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.We received a $7.0 million milestone payment upon first commercial sale of BYDUREON in the U.S., which was recognized as revenue during thequarter ended March 31, 2012. BYDUREON was launched in the U.S. in February 2012.10What is type 2 diabetes? Diabetes is a disease in which the body does not produce or properly use insulin. Diabetes can result in serious health complications, includingcardiovascular, kidney and nerve disease. Diabetes is believed to affect nearly 26 million people in the U.S. and an estimated 347 million adultsworldwide. Approximately 90-95% of those affected have type 2 diabetes. According to the U.S. Centers for Disease Control and Prevention's NationalHealth and Nutrition Examination Survey, approximately 60% of people with diabetes do not achieve their target blood sugar levels with their currenttreatment regimen. In addition, 85% of type 2 diabetes patients are overweight and 55% are considered obese. Data indicate that weight loss (even amodest amount) supports patients in their efforts to achieve and sustain glycemic control.VIVITROL VIVITROL is the first and only once-monthly injectable medication for the treatment of alcohol dependence and the prevention of relapse to opioiddependence, following opioid detoxification. The medication uses our polymer-based microsphere injectable extended-release technology to deliver andmaintain therapeutic medication levels in the body through just one injection every four weeks. We developed, and currently market and sell,VIVITROL in the U.S. VIVITROL was approved by the FDA for the treatment of alcohol dependence in April 2006 and was launched in the U.S. for this indication inJune 2006. The FDA approved VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification, in October 2010. In December 2007, we exclusively licensed the right to commercialize VIVITROL for the treatment of alcohol dependence and opioid dependencein Russia and other countries in the CIS to Cilag. In August 2008, the Russian regulatory authorities approved VIVITROL for the treatment of alcoholdependence, and Cilag launched VIVITROL in Russia in March 2009. The Russian regulatory authorities approved VIVITROL for the prevention ofrelapse to opioid dependence following opioid detoxification in April 2011.What are opioid dependence and alcohol dependence? Opioid dependence is a serious and chronic brain disease characterized by compulsive, prolonged self-administration of opioid substances that arenot used for a medical purpose. According to the 2010 U.S. National Survey on Drug Use and Health, an estimated 1.5 million people aged 18 or olderwere dependent on pain relievers or heroin. Alcohol dependence is a serious and chronic brain disease characterized by cravings for alcohol, loss of control over drinking, withdrawalsymptoms and an increased tolerance for alcohol. Approximately 18 million people in the U.S. are dependent on or abuse alcohol, half of whom areconsidered to be alcohol dependent. Adherence to medication is particularly challenging with this patient population.Other Commercial Products We expect revenues from our other commercial products will decrease in the future due to existing and expected competition from genericmanufacturers. For a more detailed discussion of current and expected future revenue contribution of such products, please see "Management'sDiscussion and Analysis of Financial Condition and Results of Operations" elsewhere in this Annual Report.11Key Development ProgramsALKS 9070 We are studying ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is an injectable, sustained-release product candidate designed toprovide once-monthly dosing of a medication that converts in vivo into aripiprazole, a molecule that is commercially available under the nameABILIFY®. ALKS 9070 is our first product candidate to leverage our proprietary LinkeRxTM product platform. In June 2011, we announced positiveresults from a phase 1b, double-blind, randomized, placebo- controlled, 20-week study that assessed the safety, tolerability and pharmacokinetic profileof a single administration of three ascending doses of ALKS 9070 in 32 patients with chronic, stable schizophrenia. Data from the study showed thatALKS 9070 was generally well tolerated, achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile thatsupports once-monthly dosing. In December 2011, based on these results, we advanced ALKS 9070 into a multicenter, double-blind, placebo-controlled phase 3 study designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acuteexacerbation of schizophrenia; these patients will be randomized to receive one of two doses of ALKS 9070 or placebo. The clinical data from thisstudy, which are expected mid-calendar year 2013, may form the basis of an NDA to the FDA for ALKS 9070 for the treatment of schizophrenia. During the three months ended March 31, 2012, we transferred ALKS 9070, including all ALKS 9070 intellectual property, from the U.S. toIreland.ALKS 37 We are developing ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation ("OIC").According to IMS Health information, an estimated 280 million prescriptions were written for opioids in the U.S. during 2010. Many studies indicatethat a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility. OIC can be severe andadversely impact quality of life, compromising patient compliance with opioid therapy in order to achieve pain management. In May 2011, we presented positive results from a phase 2 double-blind, randomized, placebo-controlled, multidose clinical study of ALKS 37 forthe treatment of OIC. Data from the study showed that ALKS 37 significantly improved gastrointestinal motility, demonstrated by increased frequencyof bowel movements in patients with OIC, while simultaneously preserving the analgesic effects of opioid treatment. The study also demonstrated thatALKS 37 was generally well tolerated. In July 2011, we announced the initiation of a multicenter, randomized, double-blind, placebo-controlled, repeat-dose phase 2b study of ALKS 37 to assess the safety, tolerability, efficacy and pharmacokinetic profile of ALKS 37 in approximately 150 patients. InOctober 2011, we announced the initiation of a second phase 2b study of ALKS 37. This multicenter, randomized, double-blind, placebo-controlled,fixed-dose study is designed to assess the safety and efficacy of daily administration of a 100 mg dose of ALKS 37 versus placebo for 12 weeks inapproximately 80 patients with OIC. The results of this phase 2b study, along with those from the repeat-dose, four-week phase 2b study initiatedearlier in 2011, are expected in mid-calendar year 2012.ALKS 33 ALKS 33 is an oral opioid modulator characterized by limited hepatic metabolism and durable pharmacologic activity in modulating brain opioidreceptors. We conducted two phase 1 studies and one phase 2 study of ALKS 33. The first phase 1 study was a randomized, double-blind, placebo-controlled, multidose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. In the study, ALKS 33demonstrated rapid oral12absorption and sustained pharmacologically active plasma levels supporting once-daily dosing. The second phase 1 study was a randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the subjective and objective effects of a potent opioidagonist, remifentanil, a commercially available analgesic. Data showed that the onset of action of ALKS 33 was rapid and observed as early as 15minutes following oral administration. A full blockade of the opioid agonist was observed and sustained for more than 24 hours following a singleadministration of ALKS 33. ALKS 33 was generally well tolerated in both studies. The phase 2 study of ALKS 33 was designed to assess the safety, tolerability, pharmacokinetics and efficacy of daily oral administration of threedifferent dose levels of ALKS 33 compared to placebo in 400 alcohol dependent patients. The phase 2 study showed that ALKS 33 was generally welltolerated and characterized by its potential for daily dosing, non-hepatic metabolism, extended pharmacologic benefit in the event of missed doses andpharmacologic activity in reducing heavy drinking behavior. ALKS 33 is currently being evaluated as a potential treatment for alcohol dependence.There are currently no ongoing clinical trials of ALKS 33 for the treatment of alcohol dependence.ALKS 5461 ALKS 5461 is a combination of ALKS 33 and buprenorphine that we are developing to be a non-addictive therapy for the treatment of majordepressive disorder ("MDD"), in patients who have an inadequate response to standard antidepressant therapies, and for the treatment of cocainedependence.Major Depressive Disorder In January 2012, we announced positive results from a phase 1/2 study of ALKS 5461 compared to placebo in 32 patients with MDD who did notadequately respond to standard antidepressant therapies. In the study, ALKS 5461 was shown to significantly reduce depressive symptoms, asmeasured by the Hamilton Depression Rating Scale (HAM-D17; a standard, clinician-assessed measure of depression severity), in patients whoreceived ALKS 5461 for the seven-day treatment period. In addition, data from the study showed that ALKS 5461 was generally well tolerated. Basedon these results, we initiated a randomized, double-blind, multicenter, placebo-controlled phase 2 study to evaluate the efficacy and safety of ALKS5461 when administered once daily for four weeks in approximately 130 patients with MDD who have inadequate response to antidepressant therapy.Data from the study are expected in the first half of calendar year 2013.Cocaine Dependence Our randomized, double-blind, multidose, placebo-controlled phase 1 clinical study assessed the safety, tolerability and pharmacodynamic effectsof the combination of ALKS 33 and buprenorphine when administered alone, and in combination as ALKS 5461, to 12 opioid-experienced users. Datafrom the study showed that ALKS 5461 was generally well-tolerated and sublingual administration of ALKS 33 effectively blocked the agonist effectsof buprenorphine. Based on these positive results, we filed an Investigational New Drug application ("IND") for ALKS 5461 for the treatment of cocaine dependencein June 2011. In the second half of 2011, we initiated a phase 1b study of ALKS 5461 for cocaine dependence, which is being funded through a grantfrom the National Institute on Drug Abuse ("NIDA"). NIDA has granted us up to $2.4 million to accelerate the clinical development of ALKS 5461 forthe treatment of cocaine dependence. Currently, there are no medications approved for the treatment of cocaine dependence. The results of this phase 1bstudy are expected in mid-calendar year 2012.13ZOHYDROTM ZOHYDRO (hydrocodone bitartrate) extended-release capsules is a novel, oral, single-entity (without acetaminophen), controlled-releaseformulation of hydrocodone in development by Zogenix, Inc. ("Zogenix") for the U.S. market. ZOHYDRO utilizes our oral controlled-releasetechnology, which potentially enables longer-lasting and more consistent pain relief with fewer daily doses than the commercially available formulationsof hydrocodone. In August 2011, Zogenix announced positive top-line results from its pivotal phase 3 efficacy study of ZOHYDRO for the treatmentof moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. On May 2, 2012, Zogenix announced that it submitted a NDAto the FDA for ZOHYDRO. We will earn manufacturing revenues in the U.S. for ZOHYDRO and are entitled to receive a royalty on U.S. sales ofZOHYDRO, if approved. We have maintained all rights to the product in territories outside the U.S. and will seek to develop and license the productthrough commercial partnerships in those territories.Our Research and Development Expenditures We devote significant resources to R&D programs. We focus our R&D efforts on identifying novel therapeutics in areas of high unmet medicalneed. Please see "Item 6. Selected Financial Data" for our R&D expenditures for our previous five fiscal years.Collaborative Arrangements Our business strategy includes forming collaborations to develop and commercialize our products and, in so doing, access technological, financial,marketing, manufacturing and other resources. We have entered into several collaborative arrangements, as described below.JanssenRISPERDAL CONSTA Under a product development agreement, we collaborated with Janssen on the development of RISPERDAL CONSTA. Under the developmentagreement, Janssen provided funding to us for the development of RISPERDAL CONSTA, and Janssen is responsible for securing all necessaryregulatory approvals for the product. Under license agreements, we granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA.Under our license agreements with Janssen, we receive royalty payments equal to 2.5% of Janssen's net sales of RISPERDAL CONSTA in eachcountry where the license is in effect based on the quarter when the product is sold by Janssen. This royalty may be reduced in any country based onlack of patent coverage and significant competition from generic versions of the product. Janssen can terminate the license agreements upon 30 days'prior written notice to us. The licenses granted to Janssen expire on a country-by-country basis upon the later of (i) the expiration of the last patentclaiming the product in such country or (ii) fifteen years after the date of the first commercial sale of the product in such country, provided that in noevent will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of the product in such country, with theexception of certain countries where the fifteen-year limitation shall pertain regardless. After expiration, Janssen retains a non-exclusive, royalty-freelicense to manufacture, use and sell RISPERDAL CONSTA. We exclusively manufacture RISPERDAL CONSTA for commercial sale. Under ourmanufacturing and supply agreement with Janssen, we record manufacturing revenues when product is shipped to Janssen, based on 7.5% of Janssen'snet unit sales price for RISPERDAL CONSTA for the calendar year.14 The manufacturing and supply agreement terminates on expiration of the license agreements. In addition, either party may terminate themanufacturing and supply agreement upon a material breach by the other party, which is not resolved within 60 days after receipt of a written noticespecifying the material breach or upon written notice in the event of the other party's insolvency or bankruptcy. Janssen may terminate the agreementupon six months' written notice to us. In the event that Janssen terminates the manufacturing and supply agreement without terminating the licenseagreements, the royalty rate payable to us on Janssen's net sales of RISPERDAL CONSTA would increase from 2.5% to 5.0%.INVEGA SUSTENNA/XEPLION Under our license agreement with Janssen Pharmaceutica N.V., we granted Janssen a worldwide exclusive license under our NanoCrystaltechnology to develop, commercialize and manufacture INVEGA SUSTENNA/XEPLION and related products. Under our license agreement, we receive certain development milestone payments from Janssen and tiered royalty payments between 5% and 9%of INVEGA SUSTENNA net sales in each country where the license is in effect, with the exact royalty percentage determined based on worldwide netsales. These royalty payments may be reduced in any country based on lack of patent coverage or patent litigation, or where competing products achievecertain minimum sales thresholds. The licenses granted to Janssen expire on a country-by-country basis upon the later of (i) March 31, 2019 or (ii) theexpiration of the last of the patents claiming the product in such country. After expiration, Janssen retains a non-exclusive, royalty-free license todevelop, manufacture and commercialize the products. Janssen may terminate the license agreement in whole or in part upon three months' notice to us. We and Janssen have the right to terminate theagreement upon a material breach of the other party, which is not cured within a certain time period or upon the other party's bankruptcy or insolvency.Acorda Under an amended and restated license agreement, we granted Acorda an exclusive worldwide license to use and sell and, solely in accordancewith our supply agreement, to make or have made, AMPYRA/FAMPYRA. Under our license agreement with Acorda, we receive certain commercialand development milestone payments, license revenues and a royalty of approximately 10% based on sales of AMPYRA/FAMPYRA by Acorda or itssub-licensee, Biogen Idec. This royalty payment may be reduced in any country based on lack of patent coverage, competing products achieving certainminimum sales thresholds, and whether Alkermes manufactures the product. Acorda has the right to terminate the license agreement upon 90 days' written notice. We have the right to terminate the license agreement forcountries in which Acorda fails to launch a product within a specified time after obtaining the necessary regulatory approval or fails to file regulatoryapprovals within a commercially reasonable time after completion and receipt of positive data from all preclinical and clinical studies required for filing amarketing authorization application. If we terminate Acorda's license in any country, we are entitled to a license from Acorda of its patent rights andknow-how relating to the product as well as the related data, information and regulatory files, and to market the product in the applicable country,subject to an initial payment equal to Acorda's cost of developing such data, information and regulatory files and to ongoing royalty payments toAcorda. Subject to the termination of the license agreement, licenses granted under the license agreement terminate on a country-by-country basis on thelater of (i) September 2018 or (ii) the expiration of the last to expire of our patents or the existence of a threshold level of competition in the marketplace. Under our commercial manufacturing supply agreement with Acorda, we manufacture and supply AMPYRA/FAMPYRA for Acorda (and itssub-licensees). Under the terms of the agreement, Acorda may obtain up to 25% of its total annual requirements of product from a second sourcemanufacturer.15We receive royalties equal to 8% of net selling price for all product manufactured by us and a compensating payment for product manufactured andsupplied by a third party. We may terminate the supply agreement upon 12 months' prior written notice to Acorda, and either party may terminate thesupply agreement following a material and uncured breach of the supply or license agreement or the entry into bankruptcy or dissolution proceedings ofthe other party. In addition, subject to early termination of the supply agreement noted above, the supply agreement terminates upon the expiry ortermination of the license agreement. In January 2011, we entered into a development and supplemental agreement to our amended and restated license agreement with Acorda. Underthe terms of this agreement, we granted Acorda the right, either with us or with a third party, in each case in accordance with certain terms andconditions, to develop new formulations of dalfampridine or other aminopyridines. Under the terms of the agreement, Acorda has the right to selecteither a formulation developed by us or by a third party for commercialization. If Acorda selects and commercializes a formulation developed by us, weare entitled to development fees, milestone payments (for new indications if not previously paid), license revenues and royalties in accordance with ouramended and restated license agreement, and either manufacturing fees as a percentage of net selling price for product manufactured by us orcompensating fees for product manufactured by third parties. If Acorda selects a formulation not developed by us, then we will be entitled to variouscompensation payments and have the first option to manufacture such third-party formulation. The agreement expires upon the expiry or termination ofthe 2003 license agreement or may be earlier terminated by either party following an uncured breach of the agreement by the other party. Acorda's financial obligations under this development and supplemental agreement continue for a minimum of ten years from the first commercialsale of such new formulation, and may extend for a longer period of time, depending on the intellectual property rights protecting the formulation,regulatory exclusivity and/or the absence of significant market competition. These financial obligations survive termination.Amylin In May 2000, we entered into a development and license agreement with Amylin for the development of exendin products falling within the scopeof our patents, which includes the once-weekly formulation of exenatide, BYDUREON. Pursuant to the development and license agreement, Amylinhas an exclusive, worldwide license to our polymer-based microsphere technology for the development and commercialization of injectable extended-release formulations of exendins and other related compounds. We receive funding for research and development and milestone payments consisting ofcash and warrants for Amylin common stock upon achieving certain development and commercialization goals and will also receive royalty paymentsbased on future product sales, if any. In October 2005 and in July 2006, we amended the development and license agreement. Under the amendedagreement, we are responsible for formulation and are principally responsible for non-clinical development of any products that may be developedpursuant to the agreement and for manufacturing these products for use in early-phase clinical trials. Amylin is responsible for commercializing exenatide products, including BYDUREON, in the U.S. and for U.S. regulatory matters relating toBYDUREON. Lilly, Amylin's former worldwide collaboration partner with respect to exenatide products, continues to have exclusive rights tocommercialize exenatide products outside of the U.S. until December 31, 2013 or such earlier date as agreed by the parties pursuant to the terms of theirtransition agreement, following which Amylin will have such exclusive rights. Subject to these arrangements with Lilly, Amylin is responsible forconducting clinical trials, securing regulatory approvals and marketing any products resulting from the collaboration on a worldwide basis.16 In conjunction with the 2005 amendment of the development and license agreement with Amylin, we reached an agreement regarding Amylin'sconstruction of a manufacturing facility for BYDUREON and certain technology transfer related thereto. The facility and technology transfer of ourmanufacturing processes was completed in 2009. Amylin will be responsible for the manufacture of BYDUREON and will operate the facility. Until December 31, 2021, we will receive royalties equal to 8% of net sales from the first 40 million units of BYDUREON sold in any particularyear and 5.5% of net sales from units sold beyond the first 40 million units for that year. Thereafter, during the term of the development and licenseagreement, we will receive royalties equal to 5.5% of net sales of products sold. We received a $7.0 million milestone payment in July 2011 upon thefirst commercial sale of BYDUREON in the EU, and we received a $7.0 million milestone payment upon the first commercial sale of BYDUREON inthe U.S. BYDUREON was launched in the U.S. in February 2012. The development and license agreement terminates on the later of (i) 10 years from the first commercial sale of the last of the products covered bythe development and license agreement, or (ii) the expiration or invalidation of all of our patents covering such product. Upon termination, all licensesbecome non-exclusive and royalty-free. Amylin may terminate the development and license agreement for any reason upon 180 days' written notice tous. In addition, either party may terminate the development and license agreement upon a material default or breach by the other party that is not curedwithin 60 days after receipt of written notice specifying the default or breach.Cilag In December 2007, we entered into a license and commercialization agreement with Cilag to commercialize VIVITROL for the treatment of alcoholdependence and opioid dependence in Russia and other countries in the CIS. Under the terms of the agreement, Cilag has primary responsibility forsecuring all necessary regulatory approvals for VIVITROL, and Janssen-Cilag, an affiliate of Cilag, commercializes the product. Under the terms of theagreement, we granted an exclusive license to Janssen-Cilag to use and sell VIVITROL in Russia and certain other countries in the CIS for thetreatment of alcohol and opioid abuse/dependence. We are responsible for the manufacture of VIVITROL and receive manufacturing and royaltyrevenues based upon product sales. Cilag has paid us $6.0 million to date in nonrefundable payments, and our agreement provides that we could be eligible for up to an additional$33.0 million in milestone payments upon the receipt of regulatory approvals for the product, the occurrence of certain agreed-upon events and theachievement of certain VIVITROL sales levels. Commencing five years after the effective date of the agreement, Cilag will have the right to terminate the agreement at any time by providing90 days' written notice to us, subject to certain continuing rights and obligations between the parties. Cilag will also have the right to terminate theagreement at any time upon 90 days' written notice to us if a change in the pricing and/or reimbursement of VIVITROL in Russia and other countries ofthe CIS has a material adverse effect on the underlying economic value of commercializing the product such that it is no longer reasonably profitable toCilag. In addition, either party may terminate the agreement upon a material breach by the other party, which is not cured within 90 days after receipt ofwritten notice specifying the material breach or, in certain circumstances, a 30-day extension of that period.Rensselaer Polytechnic Institute In September 2006, we and Rensselaer Polytechnic Institute ("RPI") entered into a license agreement granting us rights to a family of opioidreceptor compounds discovered at RPI. These compounds represent an opportunity for us to develop therapeutics for a broad range of diseases andmedical conditions, including addiction, pain and other CNS disorders.17 Under the terms of the agreement, RPI granted us an exclusive worldwide license to certain patents and patent applications relating to itscompounds designed to modulate opioid receptors. We will be responsible for the continued research and development of any resulting productcandidates. We paid RPI a nonrefundable upfront payment of $0.5 million and are obligated to pay annual fees of up to $0.2 million, and tiered royaltypayments of between 1% and 4% of annual net sales in the event any products developed under the agreement are commercialized. In addition, we areobligated to make milestone payments in the aggregate of up to $9.1 million upon certain agreed-upon development events. In July 2008, the partiesamended the agreement to expand the license to include certain additional patent applications. We paid RPI an additional nonrefundable payment of$0.1 million and slightly increased the annual fees in consideration of this amendment. In May 2009, the parties further amended the agreement toexpand the license to include a patent application covering a joint invention made by the parties.Other ArrangementsCivitas In December 2010, we entered into an asset purchase and license agreement and equity investment agreement with Civitas Therapeutics, Inc.("Civitas"). Under the terms of these agreements, we sold, assigned and transferred to Civitas our right, title and interest in our pulmonary patentportfolio and certain of our pulmonary drug delivery equipment, instruments, contracts and technical and regulatory documentation and licensed certainrelated know-how in exchange for 15% of the issued shares of the Series A Preferred Stock of Civitas and a royalty on future sales of any productsdeveloped using this pulmonary drug delivery technology. Civitas also entered into an agreement to sublease our pulmonary manufacturing facilitylocated in Chelsea, Massachusetts and has an option to purchase our pulmonary manufacturing equipment located at this facility. In addition, we have aseat on the Civitas board of directors. Commencing six months after its effective date, Civitas may terminate the asset purchase and license agreement for any reason upon 90 days'written notice to us. We may terminate the asset purchase and license agreement for default in the event Civitas does not meet certain minimumdevelopment performance obligations. Either party may terminate the asset purchase and license agreement upon a material default or breach by the otherparty that is not cured within 45 days after receipt of written notice specifying the default or breach.Proprietary Product Platforms Our proprietary product platforms, which include technologies owned and exclusively licensed to us, address several important developmentopportunities. We have used these technologies as platforms to establish drug development, clinical development and regulatory expertise.Injectable Extended-Release Microsphere Technology Our injectable extended-release technology allows us to encapsulate small molecule pharmaceuticals, peptides and proteins, in microspheres madeof common medical polymers. The technology is designed to enable novel formulations of pharmaceuticals by providing controlled, extended release ofdrugs over time. Drug release from the microsphere is controlled by diffusion of the drug through the microsphere and by biodegradation of thepolymer. These processes can be modulated through a number of formulation and fabrication variables, including drug substance and microsphereparticle sizing and choice of polymers and excipients.18LinkeRx Technology The long-acting LinkeRx technology platform is designed to enable the creation of extended-release injectable versions of antipsychotic therapiesand may also be useful in other disease areas in which long action may provide therapeutic benefits. The technology uses proprietary linker-tailchemistry to create New Molecular Entities ("NMEs") derived from known agents. These NMEs are designed to have improved clinical utility,manufacturing and ease-of-use compared to other long-acting medications.NanoCrystal Technology Our NanoCrystal technology is applicable to poorly water-soluble compounds and involves formulating and stabilizing drugs into particles that arenanometers in size. A drug in NanoCrystal form can be incorporated into a range of common dosage forms and administration routes, including tablets,capsules, inhalation devices and sterile forms for injection, with the potential for enhanced oral bioavailability; increased therapeutic effectiveness;reduced/eliminated fed/fasted variability; and sustained duration of intravenous/intramuscular release.Oral Controlled Release Technology Platform Our OCR technologies are used to formulate, develop and manufacture oral dosage forms of pharmaceutical products that improve and control therelease characteristics and efficacy of standard dosage forms. Our OCR platform includes technologies for tailored pharmacokinetic profiles including SODAS® technology, IPDAS® technology, CODAS®technology and the MXDAS® drug absorption system, each as described below.•SODAS Technology: SODAS (Spheroidal Oral Drug Absorption System) technology involves producing uniform spherical beads of1 mm to 2 mm in diameter containing drug plus excipients and coated with product-specific modified-release polymers. Varying thenature and combination of polymers within a selectively permeable membrane enables varying degrees of modified release dependingupon the required product profile. •CODAS Technology: CODAS (Chronotherapeutic Oral Drug Absorption System) enables the delayed onset of drug releaseincorporating the use of specific polymers, resulting in a drug release profile that more accurately complements circadian patterns. •IPDAS Technology: IPDAS (Intestinal Protective Drug Absorption System) technology conveys gastrointestinal protection by a widedispersion of drug candidates in a controlled and gradual manner, through the use of numerous high-density controlled-release beadscompressed into a tablet form. Release characteristics are modified by the application of polymers to the micro matrix and subsequentcoatings, which form a rate-limiting semi-permeable membrane. •MXDAS Technology: MXDAS (Matrix Drug Absorption System) formulates the drug candidate in a hydrophilic matrix andincorporates one or more hydrophilic matrix-forming polymers into a solid oral dosage form, which controls the release of drug througha process of diffusion and erosion in the gastrointestinal tract.Manufacturing and Product Supply We own and occupy manufacturing, office and laboratory facilities in Wilmington, Ohio; Athlone, Ireland; and Gainesville, Georgia. We eitherpurchase active drug product from third parties or receive it from our third-party collaborators to formulate product using our technologies. Themanufacture of our product for clinical trials and commercial use is subject to cGMP and other regulatory agency19regulations. Our manufacturing and development capabilities include formulation through process development, scale-up and full-scale commercialmanufacturing and specialized capabilities for the development and manufacturing of controlled substances. Although some materials for our drug products are currently available from a single source or a limited number of qualified sources, we attempt toacquire an adequate inventory of such materials, establish alternative sources and/or negotiate long-term supply arrangements. We believe we do nothave any significant issues obtaining suppliers. However, we cannot be certain that we will continue to be able to obtain long-term supplies of ourmanufacturing materials. Our third-party service providers involved in the manufacture of our products are subject to inspection by the FDA or comparable agencies inother jurisdictions. Any delay, interruption or other issues that arise in the acquisition of active pharmaceutical ingredients ("API"), manufacture, fill-finish, packaging, or storage of our products or product candidates, including as a result of a failure of our facilities or the facilities or operations of thirdparties to pass any regulatory agency inspection, could significantly impair our ability to sell our products or advance our development efforts, as thecase may be. For information about risks relating to the manufacture of our products and product candidates, see "Risk Factors" and specifically thosesections entitled "—Our revenues largely depend on the actions of our third party collaborators, and if they are not effective, our revenues could bematerially adversely affected," "—We are subject to risks related to the manufacture of our products," "—We rely on third parties to provide services inconnection with the manufacture and distribution of our products," "—If we or our third party providers fail to meet the stringent requirements ofgovernmental regulation in the manufacture of our products, we could incur substantial remedial costs and a reduction in sales and/or revenues" and "—We rely heavily on collaborative partners to develop and commercialize our products."Commercial Products We manufacture RISPERDAL CONSTA, VIVITROL and polymer for BYDUREON in our Wilmington, Ohio facility. We are currentlyoperating two RISPERDAL CONSTA lines and one VIVITROL line at commercial scale. Janssen has granted us an option, exercisable upon 30 days'advance written notice, to purchase the most recently constructed and validated RISPERDAL CONSTA manufacturing line at its then-current net bookvalue. We source our packaging operations for VIVITROL to a third-party contractor. Janssen is responsible for packaging operations forRISPERDAL CONSTA. The facility has been inspected by U.S., European, Japanese, Brazilian and Saudi Arabian regulatory authorities forcompliance with required cGMP standards for continued commercial manufacturing. We manufacture AMPYRA/FAMPYRA, NAPRELAN, LUVOX CR, RAPAMUNE and other products in our Athlone, Ireland facility. Thefacility has been inspected by U.S., Irish and Mexican regulatory authorities for compliance with required cGMP standards for continued commercialmanufacturing. We manufacture FOCALIN XR, RITALIN LA, AVINZA, VERAPAMIL and other products in our Gainesville, Georgia facility. The facility hasbeen inspected by U.S., Danish and Brazilian regulatory authorities for compliance with required cGMP standards for continued commercialmanufacturing. For more information about our manufacturing facilities, see "—Properties."Clinical Products We have established and are operating facilities with the capability to produce clinical supplies of our injectable extended-release products at ourWilmington, Ohio facility; our NanoCrystal and OCR technology products at our Athlone, Ireland facility; and our OCR technology products at ourGainesville, Georgia facility. We have also contracted with third-party manufacturers to formulate certain products for clinical use. We require that ourcontract manufacturers adhere to cGMP in the manufacture of products for clinical use.20Research & Development We devote significant resources to research and development programs. We focus our research and development efforts on finding noveltherapeutics in areas of high unmet medical need. Our research and development efforts include, but are not limited to, areas such as pharmaceuticalformulation, analytical chemistry, process development, engineering, scale-up and drug optimization/delivery. Please see "Management's Discussionand Analysis of Financial Condition and Results of Operations—Results of Operations of Alkermes" for our research and development expendituresfor our prior three fiscal years.Permits and Regulatory Approvals We hold various licenses in respect of our manufacturing activities conducted in Wilmington, Ohio; Athlone, Ireland; and Gainesville, Georgia.The primary licenses held in this regard are FDA Registrations of Drug Establishment and Drug Enforcement Administration ("DEA"), ControlledSubstance Registration. We also hold a Manufacturers Authorisation (No. M516), an Investigational Medicinal Products Manufacturers Authorisation(No. IMP008) and Certificates of Good Manufacturing Practice Compliance of a Manufacturer (Ref. 2010-096 and 2010-097) from the Irish MedicinesBoard ("IMB") in respect of our Athlone facility, and a number of Controlled Substance Licenses granted by the Minister for Health and Children inIreland. Due to certain U.S. state law requirements, we also hold certain state licenses to cover distribution activities through certain states and not inrespect of any manufacturing activities conducted in those states. We do not generally act as the product authorization holder for products incorporating our drug delivery technologies that have been developed onbehalf of a collaborator. In such cases, our collaborator would hold the relevant authorization from the FDA or other national regulator, and we wouldsupport this authorization by furnishing a copy of the Drug Master File ("DMF"), or the chemistry, manufacturing and controls data to the relevantregulator to prove adequate manufacturing data in respect of the product. We would generally update this information annually with the relevantregulator. In other cases where we are developing proprietary product candidates, such as VIVITROL, we may hold the appropriate regulatorydocumentation ourselves.Marketing, Sales and Distribution We focus our sales and marketing efforts on specialist physicians in private practice and in public treatment systems. We use customarypharmaceutical company practices to market our product and to educate physicians, such as sales representatives calling on individual physicians,advertisements, professional symposia, selling initiatives, public relations and other methods. We provide customer service and other related programsfor our product, such as product-specific websites, insurance research services and order, delivery and fulfillment services. Our sales force forVIVITROL in the U.S. consists of approximately 70 individuals. VIVITROL is sold directly to pharmaceutical wholesalers, specialty pharmacies and aspecialty distributor. Product sales of VIVITROL during the fiscal year ended March 31, 2012, to McKesson Corporation, AmerisourceBergen DrugCorporation, CVS Caremark Corporation and Cardinal Health ("Cardinal"), represented approximately 19%, 16%, 14% and 13%, respectively, of totalVIVITROL sales. Effective April 1, 2009, we entered into an agreement with Cardinal Health Specialty Pharmaceutical Services ("Cardinal SPS"), a division ofCardinal, to provide warehouse, shipping and administrative services for VIVITROL. Our expectation for fiscal year 2013 is to continue to distributeVIVITROL through Cardinal SPS. Under our collaboration agreements with Janssen, Cilag, Amylin, Acorda and other collaboration partners, these companies are responsible for thecommercialization of any products developed thereunder if and when regulatory approval is obtained.21Competition We face intense competition in the development, manufacture, marketing and commercialization of our products and product candidates from manyand varied sources, such as academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies,including other companies with similar technologies. Some of these competitors are also our collaborative partners, who control the commercializationof products for which we receive manufacturing and royalty revenues. These competitors are working to develop and market other systems, products,vaccines and other methods of preventing or reducing disease, and new small-molecule and other classes of drugs that can be used with or without adrug delivery system. The biotechnology and pharmaceutical industries are characterized by intensive research, development and commercialization efforts and rapid andsignificant technological change. Many of our competitors are larger and have significantly greater financial and other resources than we do. We expectour competitors to develop new technologies, products and processes that may be more effective than those we develop. The development oftechnologically improved or different products or technologies may make our product candidates or product platforms obsolete or noncompetitivebefore we recover expenses incurred in connection with their development or realize any revenues from any commercialized product. There are other companies developing extended-release product platforms. In many cases, there are products on the market or in development thatmay be in direct competition with our products or product candidates. In addition, we know of new chemical entities that are being developed that, ifsuccessful, could compete against our product candidates. These chemical entities are being designed to work differently than our product candidatesand may turn out to be safer or to be more effective than our product candidates. Among the many experimental therapies being tested around the world,there may be some that we do not now know of that may compete with our proprietary product platforms or product candidates. Our collaborativepartners could choose a competing technology to use with their drugs instead of one of our product platforms and could develop products that competewith our products. With respect to our proprietary injectable product platform, we are aware that there are other companies developing extended-release deliverysystems for pharmaceutical products. RISPERDAL CONSTA and INVEGA SUSTENNA may compete with a number of other injectable productsincluding ZYPREXA® RELPREVV® ((olanzapine) For Extended Release Injectable Suspension), which is marketed and sold by Lilly in the U.S., theEU and Australia/New Zealand, and other products currently in development, including a once-monthly injectable formulation of ABILIFY®(aripiprazole) developed by Otsuka Pharmaceutical Co., Ltd. ("Otsuka") which is currently under FDA review. RISPERDAL CONSTA and INVEGASUSTENNA may also compete with new oral compounds currently on the market or being developed for the treatment of schizophrenia. In the treatment of alcohol dependence, VIVITROL competes with CAMPRAL® (acamprosate calcium) sold by Forest Laboratories andANTABUSE® sold by Odyssey as well as currently marketed drugs also formulated from naltrexone. Other pharmaceutical companies are developingproduct candidates that have shown some promise in treating alcohol dependence and that, if approved by the FDA, would compete with VIVITROL. In the treatment of opioid dependence, VIVITROL competes with methadone, oral naltrexone, and SUBOXONE® (buprenorphone HCl/naloxoneHCl dehydrate sublingual tablets), SUBOXONE® (buprenorphone/naloxone) Sublingual Film, and SUBUTEX® (buprenorphine HCl sublingualtablets), each of which is marketed and sold by Reckitt Benckiser Pharmaceuticals, Inc. in the U.S. It also competes with other buprenorphine-basedproducts on the market. Other pharmaceutical companies are developing product candidates that have shown promise in treating opioid dependence andthat, if approved by the FDA, would compete with VIVITROL.22 BYDUREON competes with established therapies for market share. Such competitive products include sulfonylureas, metformin, insulins,thiazolidinediones, glinides, dipeptidyl peptidase type IV inhibitors, insulin sensitizers, alpha-glucosidase inhibitors and sodium-glucose transporter-2inhibitors. BYDUREON also competes with other glucagon-like peptide-1 ("GLP-1") agonists, including VICTOZA® (liraglutide (rDNA origin)injection), which is marketed and sold by Novo Nordisk A/S. Other pharmaceutical companies are developing product candidates for the treatment oftype 2 diabetes that, if approved by the FDA, could compete with BYDUREON. AMPYRA/FAMPYRA is, to our knowledge, the first product that is approved as a treatment to improve walking in patients with MS. However,there are a number of FDA-approved therapies for MS disease management that seek to reduce the frequency and severity of exacerbations or slow theaccumulation of physical disability for people with certain types of MS. These products include AVONEX® from Biogen Idec, BETASRON® fromBayer HealthCare Pharmaceuticals, COPAXONE® from Teva Pharmaceutical Industries Ltd., REBIF® from Merck Serono, TYSABRI® from BiogenIdec and Elan, and GILENYATM and EXTAVIA® from Novartis AG. With respect to our NanoCrystal technology, we are aware that other technology approaches similarly address poorly water soluble drugs. Theseapproaches include nanoparticles, cyclodextrins, lipid-based self-emulsifying drug delivery systems, dendrimers and micelles, among others, any ofwhich could limit the potential success and growth prospects of products incorporating our NanoCrystal technology. In addition, there are manycompeting technologies to our OCR technology, some of which are owned by large pharmaceutical companies with drug delivery divisions and othersmaller drug delivery specific companies.Patents and Proprietary Rights Our success will be dependent, in part, on our ability to obtain and maintain patent protection for our product candidates and those of ourcollaborators, to maintain trade secret protection and to operate without infringing upon the proprietary rights of others. We have a proprietary portfolioof patent rights and exclusive licenses to patents and patent applications. We have filed numerous patent applications in the U.S. and in other countriesdirected to compositions of matter as well as processes of preparation and methods of use, including applications relating to each of our deliverytechnologies. We own more than 200 issued U.S. patents. In the future, we plan to file additional patent applications in the U.S. and in other countriesdirected to new or improved products and processes. We intend to file additional patent applications when appropriate and defend our patent positionaggressively. Our OCR technology is protected by a patent estate including patents and patent applications filed worldwide. Some of our OCR patent familiesare product specific whereas others cover generic delivery platforms (e.g. different release profiles, taste masking, etc.). The latest of the patentscovering AMPYRA/FAMPYRA, which incorporates our OCR technology, expires in 2027 in the U.S. and 2025 in Europe. Our NanoCrystal technology patent portfolio contains a number of patents granted throughout the world, including the U.S. and countries outsideof the U.S. We also have a significant number of pending patent applications covering our NanoCrystal technology. The latest of the patents coveringINVEGA SUSTENNA expires in 2019 in the U.S. and 2018 in the EU. Additional pending applications may provide a longer period of patentcoverage, if granted. We have filed patents worldwide that cover our microsphere technology and have a significant number of patents and pending patent applicationscovering our microsphere technology. The latest of our patents covering VIVITROL, RISPERDAL CONSTA and BYDUREON expire in 2029, 2023and 2025 in the U.S., respectively, and 2021, 2021 and 2024 in Europe, respectively.23 We have exclusive rights through licensing agreements with third parties to issued U.S. patents, a number of U.S. patent applications andcorresponding patents outside the U.S. and patent applications in many countries, subject in certain instances to the rights of the U.S. government to usethe technology covered by such patents and patent applications. Under certain licensing agreements, we are responsible for patent expenses, and we payannual license fees and/or minimum annual royalties. In addition, under these licensing agreements, we are obligated to pay royalties on future sales ofproducts, if any, covered by the licensed patents. We know of several U.S. patents issued to other parties that may relate to our products and product candidates. The manufacture, use, offer forsale, sale or import of some of our product candidates might be found to infringe on the claims of these patents. A party might file an infringementaction against us. The cost of defending such an action is likely to be high, and we might not receive a favorable ruling. We also know of patent applications filed by other parties in the U.S. and various other countries that may relate to some of our product candidatesif issued in their present form. The patent laws of the U.S. and other countries are distinct, and decisions as to patenting, validity of patents andinfringement of patents may be resolved differently in different countries. If patents are issued to any of these applicants, we or our collaborators maynot be able to manufacture, use, offer for sale or sell some of our product candidates without first getting a license from the patent holder. The patentholder may not grant us a license on reasonable terms, or it may refuse to grant us a license at all. This could delay or prevent us from developing,manufacturing or selling those of our product candidates that would require the license. We try to protect our proprietary position by filing patent applications in the U.S. and in other countries related to our proprietary technology,inventions and improvements that are important to the development of our business. Because the patent position of biotechnology and pharmaceuticalcompanies involves complex legal and factual questions, enforceability of patents cannot be predicted with certainty. The ultimate degree of patentprotection that will be afforded to biotechnology products and processes, including ours, in the U.S. and in other important markets, remains uncertainand is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. Patents, if issued, may bechallenged, invalidated or circumvented. Thus, any patents that we own or license from others may not provide any protection against competitors. Ourpending patent applications, those we may file in the future, or those we may license from third parties, may not result in patents being issued. If issued,they may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Furthermore, others mayindependently develop similar technologies or duplicate any technology that we have developed outside the scope of our patents. The laws of certaincountries do not protect our intellectual property rights to the same extent as do the laws of the U.S. We are involved as a plaintiff in various Paragraph IV litigations in the U.S. and similar suits in Canada and France in respect of five differentproducts: TRICOR 145, FOCALIN XR, AVINZA, LUVOX CR and MEGACE ES. We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. We try toprotect this information by entering into confidentiality agreements with parties that have access to it, such as our corporate partners, collaborators,employees and consultants. Any of these parties may breach the agreements and disclose our confidential information or our competitors might learn ofthe information in some other way. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to, orindependently developed by, a competitor, such event could materially adversely affect our business, results of operations, cash flows and financialcondition. For more information, see "Risk Factors—Risks Related to Our Business."24 Our trademarks, including VIVITROL, are important to us and are generally covered by trademark applications or registrations in the U.S. Patentand Trademark Office and the patent or trademark offices of other countries. Our partnered products also use trademarks that are owned by ourpartners, such as the marks RISPERDAL CONSTA and INVEGA SUSTENNA, which are trademarks of Johnson & Johnson Corp., BYDUREON,which is a trademark of Amylin, and AMPYRA and FAMPYRA, which are trademarks of Acorda. Trademark protection varies in accordance withlocal law, and continues in some countries as long as the mark is used and in other countries as long as the mark is registered. Trademark registrationsgenerally are for fixed but renewable terms.Revenues and Assets by Region For fiscal years 2012, 2011 and 2010, our revenue and long-term assets are presented below by geographical area.RegulatoryRegulation of Pharmaceutical Products Our current and contemplated activities, and the products and processes that result from such activities, are subject to substantial governmentregulation. Before new pharmaceutical products may be sold in the U.S. and other countries, preclinical studies and clinical trials of the products mustbe conducted and the results submitted to appropriate regulatory agencies for approval. Clinical trial programs must establish efficacy, determine anappropriate dose and regimen, and define the conditions for safe use. This is a high-risk process that requires stepwise clinical studies in which thecandidate product must successfully meet predetermined endpoints. In the U.S., the results of the preclinical and clinical testing of a product are thensubmitted to the FDA in the form of a Biologics License Application ("BLA"), or an NDA. In response to a BLA or NDA, the FDA may grantmarketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis forapproval. The FDA may require, as a condition of approval, restricted distribution and use, enhanced labeling, special packaging or labeling, expeditedreporting of certain adverse events, pre-approval of promotional materials or restrictions on direct-to-consumer advertising. These criteria are usuallyreferred to as a Risk Evaluation and Mitigation Strategy ("REMS"). Similar submissions are required by authorities in other jurisdictions whoindependently assess the product and may reach the same or different conclusions. There are currently three potential tracks for marketing approval inEU countries: mutual recognition, decentralized procedures, and centralized procedures. These review mechanisms may ultimately lead to approval in allcountries within the EU, but each method grants all participating countries some decision-making authority in product approval.25 Year Ended March 31, (in thousands) 2012 2011 2010 Revenue by region: U.S. $212,859 $76,701 $81,674 Ireland 12,695 805 999 Rest of world 164,423 109,135 95,608 Total long-term assets by region: Ireland $171,751 $— $— U.S. 117,894 106,080 108,502 Rest of world — — —  The receipt of regulatory approval often takes a number of years, involves the expenditure of substantial resources and depends on a number offactors, including the severity of the disease in question, the availability of alternative treatments, potential safety signals observed in preclinical orclinical tests, and the risks and benefits demonstrated in clinical trials. On occasion, regulatory authorities may require larger or additional studies,leading to unanticipated delay or expense. Even after initial FDA approval or approvals from other regulatory agencies have been obtained, furtherclinical trials may be required to provide additional data on safety and effectiveness. Additional trials are required to gain approval for the use of aproduct as a treatment for indications other than those initially approved. Furthermore, the FDA and other regulatory agencies require companies toregister clinical trials and disclose clinical trial results in public databases. Failure to register a trial or disclose study results within the required timeperiods could result in penalties, including civil monetary penalties. In the U.S., the FDA may grant "accelerated approval" status to products that treat serious or life-threatening illnesses and that provide meaningfultherapeutic benefits to patients over existing treatments. Under this pathway, the FDA may approve a product based on surrogate endpoints, or clinicalendpoints other than survival or irreversible morbidity. When approval is based on surrogate endpoints or clinical endpoints other than survival ormorbidity, the sponsor will be required to conduct additional post-approval clinical studies to verify and describe clinical benefit. Under the Agency'sAccelerated Approval regulations, the FDA may also provide approval with a REMS. In addition, for all products approved under accelerated approval,sponsors must submit all copies of their promotional materials, including advertisements, to the FDA at least 30 days prior to initial dissemination. TheFDA may withdraw approval under accelerated approval after a hearing if, for instance, post-marketing studies fail to verify any clinical benefit or itbecomes clear that restrictions on the distribution of the product are inadequate to ensure its safe use. In addition, the FDA may grant "fast track" status to products that treat serious diseases and fill an unmet medical need. Fast track is a processdesigned to expedite the review of such products by providing, among other things, more frequent meetings with the FDA to discuss the product'sdevelopment plan, more frequent written correspondence from the FDA about trial design, eligibility for accelerated approval, and rolling review, whichallows submission of individually completed sections of an NDA for FDA review before the entire NDA is completed. Fast track status does notensure that a product will be developed more quickly or receive FDA approval. If the FDA or other regulatory agency approves a product or new indication, the agency may require us to conduct additional post-marketingstudies. If we fail to conduct the required studies, the agency may withdraw its approval. In addition, the FDA and European Medicines Agency("EMA") can impose financial penalties for failing to comply with certain post-marketing commitments, including REMS. Regulatory authorities track information on side effects and adverse events reported during clinical studies and after marketing approval. Non-compliance with regulatory authorities' safety reporting requirements may result in civil or criminal penalties. Side effects or adverse events that arereported during clinical trials can delay, impede or prevent marketing approval. Regulatory authorities may conduct post-marketing safety surveillanceand may require additional post-approval studies or clinical trials. These requirements may affect our ability to maintain marketing approval of ourproducts or require us to make significant expenditures to obtain or maintain such approvals. In addition, adverse events that are reported aftermarketing approval can result in changes to the product's labeling, additional limitations being placed on the product's use and, potentially, withdrawal orsuspension of the product from the market. If we seek to make certain types of changes to an approved product, such as adding a new indication, making certain manufacturing changes, orchanging manufacturers or suppliers of certain26ingredients or components, regulatory authorities, including the FDA and EMA, will need to review and approve such changes in advance. Suchregulatory reviews can result in denial or modification of the planned changes, or requirements to conduct additional tests or evaluations that cansubstantially delay or increase the cost of the planned changes. In addition, the FDA regulates all advertising and promotion activities for products under its jurisdiction both before and after approval. Acompany can make only those claims relating to safety and efficacy that are approved by the FDA. However, physicians may prescribe legally availabledrugs for uses that are not described in the drug's labeling. Such off-label uses are common across medical specialties and often reflect a physician'sbelief that the off-label use is the best treatment for patients. The FDA does not regulate the behavior of physicians in their choice of treatments, but theFDA regulations do impose stringent restrictions on manufacturers' communications regarding off-label uses. Failure to comply with applicable FDArequirements may subject a company to adverse publicity, enforcement action by the FDA, corrective advertising and the full range of civil and criminalpenalties available to the FDA. Similar regulations are in place outside the U.S.Good Manufacturing Processes The FDA, the EMA, the competent authorities of the EU Member States and other regulatory agencies regulate and inspect equipment, facilitiesand processes used in the manufacturing of pharmaceutical and biologic products prior to approving a product. If, after receiving clearance fromregulatory agencies, a company makes a material change in manufacturing equipment, location, or process, additional regulatory review and approvalmay be required. Companies also must adhere to cGMP and product-specific regulations enforced by the FDA following product approval. The FDA,the EMA and other regulatory agencies also conduct regular, periodic visits to re-inspect equipment, facilities and processes following the initialapproval of a product. If, as a result of these inspections, it is determined that our equipment, facilities or processes do not comply with applicableregulations and conditions of product approval, regulatory agencies may seek civil, criminal or administrative sanctions and/or remedies against us,including the suspension of our manufacturing operations.Good Clinical Practices The FDA, the EMA and other regulatory agencies promulgate regulations and standards, commonly referred to as Good Clinical Practices("GCP"), for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure that the data and results are accurate andthat the trial participants are adequately protected. The FDA, the EMA and other regulatory agencies enforce GCP through periodic inspections of trialsponsors, principal investigators, trial sites, contract research organizations ("CROs") and institutional review boards. If our studies fail to comply withapplicable GCP, the clinical data generated in our clinical trials may be deemed unreliable, and relevant regulatory agencies may require us to performadditional clinical trials before approving our marketing applications. Noncompliance can also result in civil or criminal sanctions. We rely on thirdparties, including CROs, to carry out many of our clinical trial-related activities. Failure of such third party to comply with GCP can likewise result inrejection of our clinical trial data or other sanctions.Hatch-Waxman Act Under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), Congress created an abbreviatedFDA review process for generic versions of pioneer, or brand-name, drug products. The law also provides incentives by awarding, in certaincircumstances, non-patent-related marketing exclusivities to pioneer drug manufacturers. Newly approved drug products and changes to the conditionsof use of approved products may benefit from periods of non-patent-related marketing exclusivity in addition to any patent protection the drug productmay have. The Hatch-Waxman Act provides five years of new chemical entity ("NCE") marketing exclusivity27to the first applicant to gain approval of a NDA for a product that contains an active ingredient not found in any other approved product. The FDA isprohibited from accepting any abbreviated NDA ("ANDA") for a generic drug or 505(b)(2) application for five years from the date of approval of theNCE, or four years in the case of an ANDA or 505(b)(2) application containing a patent challenge. A 505(b)(2) application is an NDA wherein theapplicant relies in part on data from clinical studies not conducted by or for it and for which the applicant has not obtained a right of reference; this typeof application allows the sponsor to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug. Thisexclusivity will not prevent the submission or approval of a full NDA, as opposed to an ANDA or 505(b)(2) application, for any drug, including, forexample, a drug with the same active ingredient, dosage form, route of administration, strength and conditions of use. The Hatch-Waxman Act also provides three years of exclusivity for applications containing the results of new clinical investigations, other thanbioavailability studies, essential to the FDA's approval of new uses of approved products, such as new indications, dosage forms, strengths, orconditions of use. However, this exclusivity only protects against the approval of ANDAs and 505(b)(2) applications for the protected use and will notprohibit the FDA from accepting or approving ANDAs or 505(b)(2) applications for other products containing the same active ingredient. The Hatch-Waxman Act requires NDA applicants and NDA holders to provide certain information about patents related to the drug for listing inthe Orange Book. ANDA and 505(b)(2) applicants must then certify regarding each of the patents listed with the FDA for the reference product. Acertification that a listed patent is invalid or will not be infringed by the marketing of the applicant's product is called a "Paragraph IV certification." Ifthe ANDA or 505(b)(2) applicant provides such a notification of patent invalidity or noninfringement, then the FDA may accept the ANDA or505(b)(2) application four years after approval of the NDA. If a Paragraph IV certification is filed and the ANDA or 505(b)(2) application has beenaccepted as a reviewable filing by the FDA, the ANDA or 505(b)(2) applicant must then, within 30 days, provide notice to the NDA holder and patentowner stating that the application has been submitted and providing the factual and legal basis for the applicant's opinion that the patent is invalid or notinfringed. The NDA holder or patent owner may file suit against the ANDA or 505(b)(2) applicant for patent infringement. If this is done within45 days of receiving notice of the Paragraph IV certification, a one-time 30-month stay of the FDA's ability to approve the ANDA or 505(b)(2)application is triggered. The 30-month stay begins at the end of the NDA holder's data exclusivity period, or, if data exclusivity has expired, on the datethat the patent holder is notified. The FDA may approve the proposed product before the expiration of the 30-month stay if a court finds the patentinvalid or not infringed, or if the court shortens the period because the parties have failed to cooperate in expediting the litigation. In addition, the recently enacted health reform legislation in the U.S. included an abbreviated approval pathway for biosimilars. Similar pathwaysalready exist in the EU.Sales and Marketing Pharmaceutical manufacturers are subject to various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickbacklaws and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration inexchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. Due to the breadth of the U.S. statutoryprovisions and the absence of guidance in the form of regulations and very few court decisions addressing industry practices, it is possible that ourpractices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, orcausing to be presented, for payment to third-party payors (including Medicare and Medicaid) claims for reimbursed drugs or services that are false orfraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or28services. In addition, several U.S. states require that companies implement compliance programs or comply with industry ethics codes, adopt spendinglimits and report to state governments any gifts, compensation and other remuneration provided to physicians. The recently enacted U.S. healthcarereform legislation will require disclosure to the federal government of payments to physicians commencing in 2012. Activities relating to the sale andmarketing of our products may be subject to scrutiny under these laws. Violations of fraud and abuse laws may be punishable by criminal and/or civilsanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal healthcare programs (including Medicare andMedicaid). In addition, under certain federal laws and many state laws, there is the ability for private individuals to bring similar actions. See "RiskFactors" and specifically those sections entitled "—If we fail to comply with the extensive legal and regulatory requirements affecting the healthcareindustry, we could face increased costs, penalties and a loss of business," "—Revenues generated by sales of our products depend on the availability ofreimbursement from third-party payors, and a reduction in payment rate or reimbursement or an increase in our financial obligation to governmentalpayors could result in decreased sales of our products and revenue" and "—We may be exposed to product liability claims and recalls." A pharmaceutical manufacturer's activities could be subject to challenge for the reasons discussed above and due to the broad scope of these lawsand the increasing attention being given to them by law enforcement authorities. Furthermore, there are an increasing number of state laws that requiremanufacturers to make reports to U.S. states on pricing and marketing information. Many of these laws contain ambiguities as to what is required tocomply with the laws. Given the lack of clarity in laws and their implementation, reporting actions could be subject to the penalty provisions of thepertinent state authorities.Pricing and Reimbursement In the U.S. and internationally, sales of our products, including those sold by our collaborators, and our ability to generate revenues on such salesare dependent, in significant part, on the availability and level of reimbursement from third-party payors such as state and federal governments,including Medicare and Medicaid, managed care providers and private insurance plans. The significant governmental reimbursement and cost programsare described below. Private insurers, such as health maintenance organizations and managed care providers, have also implemented cost-cutting andreimbursement initiatives and will likely continue to do so in the future. These include establishing formularies that govern the products that will beoffered and the out-of-pocket obligations for such products. In addition, in the U.S. in particular, we are required to provide discounts and pay rebatesto state and federal governments and agencies in connection with purchases of our products that are reimbursed by such entities. The U.S. government and governments outside the U.S. regularly consider reforming healthcare coverage and costs. Such reform may includechanges to the coverage and reimbursement of our products, which may have a significant impact on our business. In 2010, significant healthcarereform legislation was enacted in the U.S., which has had and will continue to have an impact our business by increasing the Medicaid rebate;expanding our obligation to pay such rebate to Medicaid managed care; expanding eligibility under the 340B/PHS drug pricing program; establishing afee to be paid by manufacturers of branded prescription drugs; requiring manufacturers to offer product discounts to Medicare beneficiaries in theMedicare Part D coverage gap; and changing the calculation of average manufacturer price ("AMP"). Medicare is a federal program that is administered by the federal government that covers individuals age 65 and over as well as those with certaindisabilities. Medicare Part B pays physicians who administer our products under a payment methodology using average sales price ("ASP")information. Manufacturers, including us, are required to provide ASP information to the Centers for Medicare and Medicaid Services ("CMS") on aquarterly basis. This information is used to compute29Medicare payment rates, which are generally set at ASP plus 6% and are updated quarterly. Effective January 1, 2006, Medicare began to use the sameASP plus 6% payment methodology to determine Medicare rates paid for products furnished by hospital outpatient departments. As of January 1, 2009,the reimbursement rate in the hospital outpatient setting was ASP plus 4%. The reimbursement rate in the hospital outpatient setting was increased toASP plus 5% effective January 1, 2011. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the statute provides forcivil monetary penalties for each misrepresentation for each day in which the misrepresentation was applied. The U.S. Medicare Prescription Drug Improvement and Modernization Act of 2003 established the Medicare Part D program to provide voluntaryprescription drug benefit to enrolled Medicare patients. This is a voluntary benefit that is being implemented through private plans under contractualarrangements with the federal government. Similar to pharmaceutical coverage through private health insurance, Part D plans are expected to negotiatediscounts from drug manufacturers and pass on some of those savings to Medicare beneficiaries. Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries. Under the Medicaidrebate program, we are required to pay a rebate for each unit of product reimbursed by the state Medicaid programs. The amount of the rebate for eachproduct is set by law as the greater of 23.1% of AMP or the difference between AMP and the best price available from us to any commercial or non-federal governmental customer. The rebate amount must be adjusted upward where the AMP for a product's first full quarter of sales, when adjusted forincreases in the Consumer Price Index—Urban, is less than the AMP for the current quarter with the upward adjustment equal to the excess amount.The rebate amount is required to be recomputed each quarter based on our report of current AMP and best price for each of our products to CMS. Theterms of our participation in the rebate program imposes a requirement for us to report revisions to AMP or best price within a period not to exceed 12quarters from the quarter in which the data was originally due. Any such revisions could have the impact of increasing or decreasing our rebate liabilityfor prior quarters, depending on the direction of the revision. In addition, if we were found to have knowingly submitted false information to thegovernment, the statute provides for civil monetary penalties per item of false information in addition to other penalties available to the government. The availability of federal funds to pay for our products under the Medicaid and Medicare Part B programs requires that we extend discountsunder the 340B/PHS drug pricing program. The 340B/PHS drug pricing program extends discounts to a variety of community health clinics and otherentities that receive health services grants from Public Health Services ("PHS") as well as hospitals that serve a disproportionate share of poor Medicarebeneficiaries. We also make our products available for purchase by authorized users of the Federal Supply Schedule ("FSS") of the General ServicesAdministration pursuant to our FSS contract with the Department of Veterans Affairs. Under the Veterans Health Care Act of 1992 (the "VHC Act"),we are required to offer deeply discounted FSS contract pricing to four federal agencies—the Department of Veterans Affairs, the Department ofDefense, the Coast Guard and the PHS (including the Indian Health Service)—for federal funding to be made available for reimbursement of any of ourproducts under the Medicaid program and for our products to be eligible to be purchased by those four federal agencies and certain federal grantees.FSS pricing to those four federal agencies must be equal to or less than the "Federal Ceiling Price," which is, at a minimum, 24% off the Non-FederalAverage Manufacturer Price for the prior fiscal year. In addition, if we are found to have knowingly submitted false information to the government, theVHC Act provides for civil monetary penalties per false item of information in addition to other penalties available to the government. Under the 2008 U.S. National Defense Authorization Act, we are required to treat the TRICARE retail pharmacy program, which reimbursesmilitary personnel for drug purchases from retail30pharmacies, as an element of the Department of Defense to ensure the application of the VHC Act's pricing standards.Other Regulations Foreign Corrupt Practices Act: We are subject to the U.S. Foreign Corrupt Practices Act ("FCPA"), which prohibits U.S. corporations and theirrepresentatives from paying, offering to pay, promising, authorizing, or making payments of anything of value to any foreign government official,government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working inan official capacity. In many countries, the health-care professionals we regularly interact with may meet the FCPA's definition of a foreign governmentofficial. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to deviseand maintain an adequate system of internal accounting controls. In 2010, the Bribery Act was passed in the UK, which proscribes giving and receiving bribes in the public and private sectors, bribing a foreignpublic official, and failing to have adequate procedures to prevent employees and other agents from giving bribes. Foreign corporations that conductbusiness in the UK generally will be subject to the Bribery Act. Penalties under the Bribery Act include potentially unlimited fines for corporations andcriminal sanctions for corporate officers under certain circumstances. Environmental, Health and Safety Laws: Our operations are subject to complex and increasingly stringent environmental, health and safety lawsand regulations in the countries where we operate and in particular where we have manufacturing facilities, namely the U.S. and Ireland. Environmentaland health and safety authorities in the relevant jurisdictions, including the Environmental Protection Agency and the Occupational Safety and HealthAdministration in the U.S. and the Environmental Protection Agency and the Health and Safety Authority in Ireland, administer laws which regulate,among other matters, the emission of pollutants into the air (including the workplace), the discharge of pollutants into bodies of water, the storage, use,handling and disposal of hazardous substances, the exposure of persons to hazardous substances, and the general health, safety and welfare ofemployees and members of the public. In certain cases, such laws and regulations may impose strict liability for pollution of the environment andcontamination resulting from spills, disposals or other releases of hazardous substances or waste and/or any migration of such hazardous substances orwaste. Costs, damages and/or fines may result from the presence, investigation and remediation of such contamination at properties currently orformerly owned, leased or operated by us and/or off-site locations, including where we have arranged for the disposal of hazardous substances orwaste. In addition, we may be subject to third-party claims, including for natural resource damages, personal injury and property damage, in connectionwith such contamination. Other Laws: We are subject to a variety of financial disclosure and securities trading regulations as a public company in the U.S., including lawsrelating to the oversight activities of the Securities and Exchange Commission ("SEC") and the regulations of the NASDAQ, on which our shares aretraded. We are also subject to various laws, regulations and recommendations relating to safe working conditions, laboratory practices, the experimentaluse of animals, and the purchase, storage, movement, import and export and use and disposal of hazardous or potentially hazardous substances used inconnection with our research work.31Employees As of May 10, 2012, we had approximately 1,200 full-time employees. A significant number of our management and professional employees haveprior experience with pharmaceutical, biotechnology or medical product companies. We believe that we have been successful in attracting skilled andexperienced scientific and senior management personnel; however, competition for such personnel is intense. None of our employees is covered by acollective bargaining agreement. We consider our relations with our employees to be good.Available Information We were incorporated in Ireland on May 4, 2011 as a private limited company, under the name Antler Science Two Limited (registrationnumber 498284). On July 25, 2011, Antler Science Two Limited was re-registered as a public limited company under the name Antler Science Two plc.On September 14, 2011, we were re-named Alkermes plc. Our principal executive offices are located at Connaught House, 1 Burlington Road, Dublin 4, Ireland. Our telephone number is +353-1-772-8000and our website address is www.alkermes.com. Information that is contained in, and can be accessed through, our website is not incorporated into, anddoes not form a part of, this prospectus. We make available free of charge through the Investors section of our website our Annual Reports onForm 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicableafter such material is electronically filed with, or furnished to, the SEC. We also make available on our website (i) the charters for the committees of ourBoard of Directors, including the Audit and Risk Committee, Compensation Committee, and Nominating and Corporate Governance Committee, and(ii) our Code of Business Conduct and Ethics governing our directors, officers and employees. We intend to disclose on our website any amendmentsto, or waivers from, our Code of Business Conduct and Ethics that are required to be disclosed pursuant to the rules of the SEC. You may read andcopy materials we file with the SEC at the SEC's Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. You may obtain informationon the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an internet site that contains reports, proxyand information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.Item 1A. Risk Factors Investing in our company involves a high degree of risk. In deciding whether to invest in our ordinary shares, you should consider carefully therisks described below in addition to the financial and other information contained in this prospectus, including the matters addressed under thecaption "Forward-Looking Statements." If any events described by the following risks actually occur, they could materially adversely affect ourbusiness, financial condition or operating results. This could cause the market price of our ordinary shares to decline, and could cause you to lose allor a part of your investment.Our revenues largely depend on the actions of our third-party collaborators, and if they are not effective, our revenues could be materiallyadversely affected. The revenues from the sale of our products may fall below our expectations, the expectations of our partners or those of investors, which couldhave a material adverse effect on our results of operations and the price of our ordinary shares, and will depend on numerous factors, many of which areoutside our control.RISPERDAL CONSTA, AMPYRA/FAMPYRA, BYDUREON AND INVEGA SUSTENNA/XEPLION While we manufacture RISPERDAL CONSTA and AMPYRA/FAMPYRA, we are not involved in the commercialization efforts for thoseproducts. RISPERDAL CONSTA is commercialized by Janssen.32AMPYRA/FAMPYRA is commercialized by Acorda in the U.S. and by Biogen Idec outside the U.S. Our revenues depend on manufacturing fees androyalties we receive from Janssen, Acorda and Biogen Idec, each of which relates to sales of such products by or on behalf of our partners.Accordingly, our revenues will depend in large part on the efforts of our partners, and we will not be able to control this. Pursuant to our arrangements with Amylin and Janssen, we are not responsible for the clinical development, manufacture or commercializationefforts for BYDUREON or INVEGA SUSTENNA/XEPLION, respectively. In addition, in November 2011, Lilly terminated their collaborationagreement pursuant to which they collaborated in the global development and commercialization of exenatide, including BYDUREON. Historically,Lilly and Amylin jointly commercialized exenatide products in the U.S., and Lilly solely commercialized such products outside of the U.S. Commencingon November 30, 2011, however, Amylin assumed the exclusive right to commercialize exenatide products in the U.S.. While Lilly continues to haveexclusive rights to commercialize exenatide products outside of the U.S. until December 31, 2013 (or such earlier date as may be agreed by Amylin andLilly), after that time Amylin will assume the exclusive right to commercialize exenatide products outside of the U.S. as well. This transition representsthe first time that Amylin will assume sole responsibility for the commercialization of exenatide products on a global basis, and we cannot assure youthat Amylin will be successful in that role. For these and other reasons outside of our control, our revenues from the sale of RISPERDAL CONSTA, AMPYRA/FAMPYRA,BYDUREON and INVEGA SUSTENNA/XEPLION may not meet our or our partners' expectations or those of investors.VIVITROL In December 2007, we exclusively licensed the right to commercialize VIVITROL for the treatment of alcohol dependence and opioid dependencein Russia and other countries in the CIS to Cilag. Cilag has primary responsibility for securing all necessary regulatory approvals for VIVITROL andJanssen-Cilag, an affiliate of Cilag, has full responsibility for the commercialization of the product in these countries. We receive manufacturingrevenues and royalty revenues based upon product sales. Our revenues from the sale of VIVITROL in Russia and countries of the CIS may not besignificant and will depend on numerous factors, many of which are outside of our control.REMAINING COMMERCIAL PORTFOLIO In addition, we are not responsible for, or involved with, the sales and marketing efforts for many of our other products and, in some instances, weare also not involved in their manufacture.We are substantially dependent on revenues from our principal product. While our dependence on revenues from RISPERDAL CONSTA has decreased following the Business Combination, we still dependsubstantially upon continued sales of RISPERDAL CONSTA by our partner, Janssen. Any significant negative developments relating to this product,such as safety or efficacy issues, the introduction or greater acceptance of competing products, or adverse regulatory or legislative developments, wouldhave a material adverse effect on our business, results of operations, cash flows and financial condition. Although we have developed and continue todevelop additional products for commercial introduction, a decline in sales from this product would adversely affect our business.We rely heavily on collaborative partners to develop and commercialize our products. Our arrangements with collaborative partners are critical to bringing our products to the market and successfully commercializing them. We rely onthese parties in various respects, including providing33funding for product candidate development programs; to conduct preclinical testing and clinical trials; to participate actively in, or manage, the regulatoryapproval process; and to commercialize our products. The process of establishing collaborative arrangements with third parties to develop particular products or to accelerate the development of early-stage product candidates is difficult, time-consuming and involves significant uncertainty. We face, and will continue to face, significant competition inseeking appropriate collaborative partners. If we are unable to establish and maintain collaborative arrangements on acceptable terms, we may have todelay or discontinue further development of one or more of our product candidates or manufacture, seek regulatory approval and/or undertakecommercialization activities for the product at our own expense. Our collaborative partners may also choose to use their own or other technology to develop an alternative product and withdraw their support ofour product candidate, or to compete with our jointly developed product. Alternatively, proprietary products we may develop in the future couldcompete directly with products we developed with our collaborative partners. Disputes may also arise between us and a collaborative partner, and mayinvolve the ownership of technology developed during a collaboration or other issues arising out of collaborative agreements. Such a dispute coulddelay the related program or result in expensive arbitration or litigation, which may not be resolved in our favor. Most of our collaborative partners can terminate their agreements with us without cause, and we cannot guarantee that any of these relationshipswill continue. Failure to make or maintain these arrangements or a delay in a collaborative partner's performance, or factors that may affect a partner'ssales, may materially adversely affect our business, financial condition, cash flows and results of operations.Our revenues may be lower than expected as a result of failure by the marketplace to accept our products or for other factors. We cannot be assured that our products will be, or will continue to be, accepted in the U.S. or in any markets outside the U.S. or that sales of ourproducts will not decline or cease in the future. A number of factors may cause revenues from sales of our products to grow at a slower than expectedrate, or even to decrease or cease, including:•perception of physicians and other members of the healthcare community as to our products' safety and efficacy relative to that ofcompeting products; •the cost-effectiveness of our products; •patient and physician satisfaction with our products; •the successful manufacture of our commercial products on a timely basis; •the cost and availability of raw materials necessary for the manufacture of our products; •the size of the markets for our products; •reimbursement policies of government and third-party payors; •unfavorable publicity concerning our products, similar classes of drugs or the industry generally; •the introduction, availability and acceptance of competing treatments, including treatments marketed and sold by our collaborators; •the reaction of companies that market competitive products; •adverse event information relating to our products or to similar classes of drugs;34•changes to the product labels of our products, or of products within the same drug classes, to add significant warnings or restrictions onuse; •our continued ability to access third parties to vial, label and distribute our products on acceptable terms; •the unfavorable outcome of patent litigation, including so-called "Paragraph IV" litigation, related to any of our products; •regulatory developments related to the manufacture or continued use of our products, including the issuance of a REMS by the FDA; •the extent and effectiveness of the sales and marketing and distribution support our products receive; •our collaborators' decisions as to the timing of product launches, pricing and discounting; •disputes with our collaborators relating to the marketing and sale of partnered products; •exchange rate valuations and fluctuations; and •any other material adverse developments with respect to the commercialization of our products. Our revenues will also fluctuate from quarter to quarter based on a number of other factors, including the acceptance of our products in themarketplace, our partners' orders, the timing of shipments, our ability to manufacture successfully, our yield and our production schedule. The unit coststo manufacture our products may be higher than anticipated if certain volume levels are not achieved. In addition, we may not be able to supply theproducts in a timely manner or at all.We are subject to risks related to the manufacture of our products. The manufacture of pharmaceutical products is a highly complex process in which a variety of difficulties may arise from time to time including,but not limited to, product loss due to material failure, equipment failure, vendor error, operator error, labor shortages, inability to obtain material,equipment or transportation, physical or electronic security breaches, natural disasters and many other factors. Problems with manufacturing processescould result in product defects or manufacturing failures, which could require us to delay shipment of products or recall products previously shipped, orcould impair our ability to expand into new markets or supply products in existing markets. We may not be able to resolve any such problems in atimely fashion, if at all. We rely solely on our manufacturing facility in Wilmington, Ohio for the manufacture of RISPERDAL CONSTA, VIVITROL, polymer forBYDUREON and some of our product candidates. We rely on our manufacturing facility in Athlone, Ireland for the manufacture ofAMPYRA/FAMPYRA and some of our other products using our NanoCrystal and OCR technologies. We rely on our manufacturing facility inGainesville, Georgia for the manufacture of RITALIN LA/FOCALIN XR and some of our other products using our OCR technologies. Due to regulatory and technical requirements, we have limited ability to shift production among our facilities or to outsource any part of ourmanufacturing to third parties. If we cannot produce sufficient commercial quantities of our products to meet demand, there are currently very few, ifany, third-party manufacturers capable of manufacturing our products as contract suppliers. We cannot be certain that we could reach agreement onreasonable terms, if at all, with those manufacturers. Even if we were to reach agreement, the transition of the manufacturing process to a third party toenable commercial supplies could take a significant amount of time and money, and may not be successful. Our manufacturing facilities also require specialized personnel and are expensive to operate and maintain. Any delay in the regulatory approval ormarket launch of product candidates, or suspension35of the sale of our products, to be manufactured in our facilities may cause operating losses as we continue to operate these facilities and retainspecialized personnel. In addition, any interruption in manufacturing could result in delays in meeting contractual obligations and could damage ourrelationships with our collaborative partners, including the loss of manufacturing and supply rights.We rely on third parties to provide services in connection with the manufacture and distribution of our products. We rely on third parties for the timely supply of specified raw materials, equipment, contract manufacturing, formulation or packaging services,product distribution services, customer service activities and product returns processing. Although we actively manage these third-party relationships toensure continuity and quality, some events beyond our control could result in the complete or partial failure of these goods and services. Any suchfailure could materially adversely affect our business, financial condition, cash flows and results of operations. The manufacture of products and product components, including the procurement of bulk drug product, packaging, storage and distribution of ourproducts, require successful coordination among us and multiple third-party providers. For example, we are responsible for the entire supply chain forVIVITROL, up to the sale of final product and including the sourcing of key raw materials and active pharmaceutical agents from third parties. We havelimited experience in managing a complex cGMP supply chain and product distribution network. Issues with our-third party providers, including ourinability to coordinate these efforts, lack of capacity available at such third-party providers or any other problems with the operations of these third-partycontractors, could require us to delay shipment of saleable products, recall products previously shipped or could impair our ability to supply products atall. This could increase our costs, cause us to lose revenue or market share and damage our reputation and have a material adverse effect on ourbusiness, financial condition, cash flows and results of operations. Due to the unique nature of the production of our products, there are several single-source providers of our key raw materials. For example, certainsolvents and kit components used in the manufacture of RISPERDAL CONSTA are single-sourced. We endeavor to qualify new vendors and todevelop contingency plans so that production is not impacted by issues associated with single-source providers. Nonetheless, our business could bematerially and adversely affected by issues associated with single-source providers. We are also dependent in certain cases on third parties to manufacture products. Where the manufacturing rights to the products in which ourtechnologies are applied are granted to or retained by our third-party licensee or approved sub-licensee, we have no control over the manufacturing,supply or distribution of the product.If we or our third-party providers fail to meet the stringent requirements of governmental regulation in the manufacture of our products, wecould incur substantial remedial costs and a reduction in sales and/or revenues. We and our third-party providers are generally required to comply with cGMP and are subject to inspections by the FDA or comparable agenciesin other jurisdictions to confirm such compliance. Any changes of suppliers or modifications of methods of manufacturing require amending ourapplication to the FDA, and ultimate amendment acceptance by the FDA, prior to release of product to the marketplace. Our inability or the inability ofour third-party service providers to demonstrate ongoing cGMP compliance could require us to withdraw or recall products and interrupt commercialsupply of our products. Any delay, interruption or other issues that arise in the manufacture, formulation, packaging or storage of our products as aresult of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could significantly impair ourability36to develop and commercialize our products. This could increase our costs, cause us to lose revenue or market share and damage our reputation. The FDA and various regulatory agencies outside the U.S. have inspected and approved our commercial manufacturing facilities. We cannotguarantee that the FDA or any other regulatory agencies will approve any other facility we or our suppliers may operate or, once approved, that any ofthese facilities will remain in compliance with cGMP regulations. Any third party we use to manufacture bulk drug product, or package, store ordistribute our products to be sold in the U.S., must be licensed by the FDA. Failure to gain or maintain regulatory compliance with the FDA orregulatory agencies outside the U.S. could materially adversely affect our business, financial condition, cash flows and results of operations.Revenues generated by sales of our products depend on the availability of reimbursement from third-party payors, and a reduction in paymentrate or reimbursement or an increase in our financial obligation to governmental payors could result in decreased sales of our products andrevenue. In both U.S. and non-U.S. markets, sales of our products depend, in part, on the availability of reimbursement from third-party payors such asstate and federal governments, including Medicare and Medicaid in the U.S. and similar programs in other countries, managed care providers andprivate insurance plans. Deterioration in the timeliness, certainty and amount of reimbursement for our products, including the existence of barriers tocoverage of our products (such as prior authorization, criteria for use or other requirements), limitations by healthcare providers on how much, or underwhat circumstances, they will prescribe or administer our products or unwillingness by patients to pay any required co-payments could reduce the useof, and revenues generated from, our products and could have a material adverse effect on our business, financial condition, cash flows and results ofoperations. The government-sponsored healthcare systems in Europe and many other countries are the primary payors for healthcare expenditures, includingpayment for drugs and biologics. While mandatory price reductions have been a recurring aspect of business for the pharmaceutical and biotechnologyindustries in Europe, given the current worldwide economic conditions, certain European national governments have increased the frequency and size ofsuch mandatory price reductions to extract further cost savings. We expect that countries may take actions to reduce expenditure on drugs and biologics,including mandatory price reductions, preference for generic or biosimilar products or reduction in the amount of reimbursement. While we cannot fullypredict the extent of price reductions by countries in Europe or the impact such price reductions will have on our business, such reductions in priceand/or the coverage and reimbursement for our products in European countries could have a material adverse effect on our product sales and/orrevenues and results of operations. In addition, public and private insurers have pursued, and continue to pursue, aggressive cost containment initiatives, including increased focus oncomparing the effectiveness, benefits and costs of similar treatments, which may result in lower reimbursement rates for our products. The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 were signed into law in the U.S. onMarch 23, 2010 and March 30, 2010, respectively. A number of the provisions of those laws require further rulemaking action by governmentalagencies to implement. Among other things, this legislation imposes cost containment measures that have adversely affected the amount ofreimbursement for our products. These measures include increasing the minimum rebates we pay to U.S. state Medicaid programs in the U.S. for ourdrugs covered by Medicaid; extending such rebates to drugs dispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations; andexpanding the 340B/PHS drug discount program under which we must provide certain discounts on our drugs to eligible purchasers. Additionalprovisions of the healthcare reform legislation may negatively affect our revenues and prospects for profitability in the future. Beginning in 2011, a newfee also became payable by all branded prescription37drug manufacturers and importers. This fee is calculated based upon each organization's percentage share of total branded prescription drugs sales toqualifying U.S. government programs, including Medicare and Medicaid. In addition, as part of the healthcare reform legislation's provisions closing acoverage gap that currently exists in the Medicare Part D prescription drug program (the "Donut Hole"), we are also required to provide a 50% discounton brand-name prescription drugs sold to beneficiaries who fall within the Donut Hole. Future rulemaking could increase rebates, reduce prices or therate of price increases for healthcare products and services, or require additional reporting and disclosure. We cannot predict the timing or impact of anyfuture rulemaking.Patent protection for our products is important and uncertain. The following factors are important to our success:•receiving and maintaining patent and/or trademark protection for our products, product candidates, technologies and developingtechnologies, including those that are the subject of collaborations with our collaborative partners; •maintaining our trade secrets; •not infringing the proprietary rights of others; and •preventing others from infringing our proprietary rights. Patent protection only provides rights of exclusivity for the term of the patent. We are able to protect our proprietary rights from unauthorized useby third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. Inthis regard, we try to protect our proprietary position by filing patent applications in the U.S. and elsewhere related to our proprietary product inventionsand improvements that are important to the development of our business. Our pending patent applications, together with those we may file in the future,or those we may license from third parties, may not result in patents being issued. Even if issued, such patents may not provide us with sufficientproprietary protection or competitive advantages against competitors with similar technology. The development of new technologies or pharmaceuticalproducts may take a number of years, and there can be no assurance that any patents which may be granted in respect of such technologies or productswill not have expired or be due to expire by the time such products are commercialized. Although we believe that we make reasonable efforts to protect our intellectual property rights and to ensure that our proprietary technology doesnot infringe the rights of other parties, we cannot ascertain the existence of all potentially conflicting claims. Therefore, there is a risk that third partiesmay make claims of infringement against our products or technologies. We know of several U.S. patents issued in the U.S. to third parties that mayrelate to our product candidates. We also know of patent applications filed by other parties in the U.S. and various countries outside the U.S. that mayrelate to some of our product candidates if such patents are issued in their present form. If patents are issued that cover our product candidates, we maynot be able to manufacture, use, offer for sale, import or sell such product candidates without first getting a license from the patent holder. The patentholder may not grant us a license on reasonable terms or it may refuse to grant us a license at all. This could delay or prevent us from developing,manufacturing or selling those of our product candidates that would require the license. A patent holder might also file an infringement action against usclaiming that the manufacture, use, offer for sale, import or sale of our product candidates infringed one or more of its patents. Even if we believe thatsuch claims are without merit, our cost of defending such an action is likely to be high and we might not receive a favorable ruling, and the action couldbe time-consuming and distract management's attention and resources. Claims of intellectual property infringement also might require us to redesignaffected products, enter into costly settlement or license agreements or pay costly damage awards, or face a temporary or permanent injunctionprohibiting us38from marketing or selling certain of our products. Even if we have an agreement to indemnify us against such costs, the indemnifying party may beunable to uphold its contractual obligations. If we cannot or do not license the infringed technology at all, license the technology on reasonable terms orsubstitute similar technology from another source, our revenue and earnings could be adversely impacted. Because the patent positions of pharmaceutical and biotechnology companies involve complex legal and factual questions, enforceability of patentscannot be predicted with certainty. The ultimate degree of patent protection that will be afforded to biotechnology products and processes, includingours, in the U.S. and in other important markets, remains uncertain and is dependent upon the scope of protection decided upon by the patent offices,courts and lawmakers in these countries. The recently enacted America Invents Act, which reformed certain patent laws in the U.S., may createadditional uncertainty. Patents, if issued, may be challenged, invalidated or circumvented. As more products are commercialized using our proprietaryproduct platforms, or as any product achieves greater commercial success, our patents become more likely to be subject to challenge by potentialcompetitors. The laws of certain countries may not protect our intellectual property rights to the same extent as do the laws of the U.S. Thus, any patentsthat we own or license from others may not provide any protection against competitors. Furthermore, others may independently develop similartechnologies outside the scope of our patent coverage. We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. We try toprotect this information by entering into confidentiality agreements with parties that have access to it, such as our collaborative partners, licensees,employees and consultants. Any of these parties may breach the agreements and disclose our confidential information, or our competitors might learn ofthe information in some other way. To the extent that our employees, consultants or contractors use intellectual property owned by others in their workfor us, disputes may arise as to the rights in related or resulting know-how and inventions. If any trade secret, know-how or other technology notprotected by a patent were to be disclosed to, or independently developed by, a competitor, such event could materially adversely affect our business,results of operations, cash flows and financial condition.Uncertainty over intellectual property in the biotechnology industry has been the source of litigation, which is inherently costly and unpredictable. There is considerable uncertainty within the biotechnology industry about the validity, scope and enforceability of many issued patents in the U.S.and elsewhere in the world and, to date, there is not consistency regarding the breadth of claims allowed in biotechnology patents. We cannot currentlydetermine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringedby the manufacture, use and sale of our products. In part as a result of this uncertainty, there has been, and we expect that there may continue to be, significant litigation in the biotechnology industryregarding patents and other intellectual property rights. We may have to enforce our intellectual property rights against third parties who infringe ourpatents and other intellectual property or challenge our patent or trademark applications. For example, in the U.S., putative generics of innovator drugproducts (including products in which the innovation comprises a new drug delivery method for an existing product, such as the drug delivery marketoccupied by us) may file ANDAs and, in doing so, they are not required to include preclinical and clinical data to establish the safety and effectivenessof their drug. Instead, they would rely on such data provided in the innovator drug NDA. However, to benefit from this less costly abbreviatedprocedure, the ANDA applicant must demonstrate that its drug is "generic" or "bioequivalent" to the innovator drug, and, to the extent that patentsprotecting the innovator drug are listed in the "Orange Book," the ANDA applicant must write to the innovator NDA holder and the patent holder (tothe extent that the Orange Book-listed patents are not owned by the innovator NDA holder) certifying that39its product either does not infringe the innovator's and, if applicable, the patent holder's patents and/or that the relevant patents are invalid. The innovatorand the patent holder may sue the ANDA applicant within 45 days of receiving the certification and, if they do so, the FDA may not approve theANDA for 30 months from the date of certification unless, at some point before the expiry of those 30 months, a court makes a final decision in theANDA applicant's favor. This type of litigation is commonly known as "Paragraph IV" litigation in the U.S. We and our collaborative partners areinvolved in a number of Paragraph IV litigations in the U.S. and similar suits in Canada and France in respect of some of our products. These litigationscould result in new or additional generic competition to our marketed products and a potential reduction in product revenue. Litigation and administrative proceedings concerning patents and other intellectual property rights may be expensive, distracting to managementand protracted with no certainty of success. Competitors may sue us as a way of delaying the introduction of our products. Any litigation, including anyinterference or derivation proceedings to determine priority of inventions, oppositions or other post-grant review proceedings to patents in the U.S. or incountries outside the U.S., or litigation against our partners may be costly and time-consuming and could harm our business. We expect that litigationmay be necessary in some instances to determine the validity and scope of certain of our proprietary rights. Litigation may be necessary in otherinstances to determine the validity, scope and/or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, useor sale of our products. Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rightsor hinder our ability to manufacture and market our products.Our level of indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business. In September 2011 we entered into a $310 million first lien term loan facility and a $140 million second lien term loan facility, which areguaranteed by certain of our subsidiaries. Our level of indebtedness and the terms of these financing arrangements could adversely affect our businessby, among other things:•requiring us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing theavailability of our cash flow for other purposes, including business development efforts, research and development and capitalexpenditures; •limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate, thereby placing us ata competitive disadvantage compared to competitors with less debt; •limiting our ability to take advantage of significant business opportunities, such as potential acquisition opportunities; and •increasing our vulnerability to adverse economic and industry conditions. Our term loan facilities impose restrictive covenants on us and require certain payments of principal and interest over time. A failure to complywith these restrictions or to make these payments could lead to an event of default that could result in an acceleration of the indebtedness. Our futureoperating results may not be sufficient to ensure compliance with these covenants or to remedy any such default. In the event of an acceleration of thisindebtedness, we may not have or be able to obtain sufficient funds to make any accelerated payments.40We rely on a limited number of pharmaceutical wholesalers to distribute our product. As is typical in the pharmaceutical industry, we rely upon pharmaceutical wholesalers in connection with the distribution of our products. Asignificant amount of our product is sold to end-users through the three largest wholesalers in the U.S. market, Cardinal Health Inc.,AmerisourceBergen Corp., and McKesson Corp. If we are unable to maintain our business relationships with these major pharmaceutical wholesalerson commercially acceptable terms, if the buying patterns of these wholesalers fluctuate due to seasonality, wholesaler buying decisions or other factorsoutside of our control, our financial condition, cash flows and results of operations may be affected.We have limited experience in the commercialization of products. We assumed responsibility for the marketing and sale of VIVITROL in the U.S. from Cephalon in December 2008. VIVITROL is the firstcommercial product for which we have had sole responsibility for commercialization, including but not limited to sales, marketing, distribution andreimbursement-related activities. We are increasingly focused on maintaining rights to commercialize our leading product candidates in certain markets. We have limited commercialization experience. We may not be able to attract and retain qualified personnel to serve in our sales and marketingorganization, to develop an effective distribution network or to otherwise effectively support our commercialization activities. The cost of establishingand maintaining a sales and marketing organization may exceed its cost-effectiveness. If we fail to develop sales and marketing capabilities, if salesefforts are not effective or if the costs of developing sales and marketing capabilities exceed their cost-effectiveness, such events could materiallyadversely affect our business, results of operations, cash flows and financial condition.Our product platforms or product development efforts may not produce safe, efficacious or commercially viable products and, if we are unable todevelop new products, our business may suffer. Many of our product candidates require significant additional research and development, as well as regulatory approval. To be profitable, we mustdevelop, manufacture and market our products, either alone or by collaborating with others. It can take several years for a product candidate to beapproved, and we may not be successful in bringing additional product candidates to market. A product candidate may appear promising at an earlystage of development or after clinical trials and never reach the market, or it may reach the market and not sell, for a variety of reasons. The productcandidate may, among other things:•be shown to be ineffective or to cause harmful side effects during preclinical testing or clinical trials; •fail to receive regulatory approval on a timely basis or at all; •be difficult to manufacture on a large scale; •be uneconomical; or •infringe on proprietary rights of another party. Because we fund the development of our proprietary product candidates, there is a risk that we may not be able to continue to fund all suchdevelopment efforts to completion or to provide the support necessary to perform the clinical trials, obtain regulatory approvals or market any approvedproducts on a worldwide basis. We expect the development of products for our own account to consume substantial resources. If we are able to developcommercial products on our own, the risks associated with these programs may be greater than those associated with our programs with collaborativepartners.41 For factors that may affect the market acceptance of our products approved for sale, see "—We face competition in the biotechnology andpharmaceutical industries." If our delivery technologies or product development efforts fail to result in the successful development andcommercialization of product candidates, if our collaborative partners decide not to pursue development and/or commercialization of our productcandidates or if new products do not perform as anticipated, our business, financial condition, cash flows and results of operations may be materiallyadversely affected.The FDA or regulatory agencies outside the U.S. may not approve our product candidates or may impose limitations upon any product approval. We must obtain government approvals before marketing or selling our drug candidates in the U.S. and in jurisdictions outside the U.S. The FDAand comparable regulatory agencies in other countries impose substantial and rigorous requirements for the development, production and commercialintroduction of drug products. These include preclinical, laboratory and clinical testing procedures, sampling activities, clinical trials and other costly andtime-consuming procedures. In addition, regulation is not static, and regulatory agencies, including the FDA, evolve in their staff, interpretations andpractices and may impose more stringent requirements than currently in effect, which may adversely affect our planned drug development and/or ourcommercialization efforts. Satisfaction of the requirements of the FDA and of other regulatory agencies typically takes a significant number of years andcan vary substantially based upon the type, complexity and novelty of the drug candidate. The approval procedure and the time required to obtainapproval also varies among countries. Regulatory agencies may have varying interpretations of the same data, and approval by one regulatory agencydoes not ensure approval by regulatory agencies in other jurisdictions. In addition, the FDA or regulatory agencies outside the U.S. may choose not tocommunicate with or update us during clinical testing and regulatory review periods. The ultimate decision by the FDA or other regulatory agenciesregarding drug approval may not be consistent with prior communications. See "—Our revenues may be lower than expected as a result of failure bythe marketplace to accept our products or for other factors." This product development process can last many years, be very costly and still be unsuccessful. Regulatory approval by the FDA or regulatoryagencies outside the U.S. can be delayed, limited or not granted at all for many reasons, including:•a product candidate may not demonstrate safety and efficacy for each target indication in accordance with FDA standards or standards ofother regulatory agencies; •poor rate of patient enrollment, including limited availability of patients who meet the criteria for certain clinical trials; •data from preclinical testing and clinical trials may be interpreted by the FDA or other regulatory agencies in different ways than we orour partners interpret it; •the FDA or other regulatory agencies might not approve our or our partners' manufacturing processes or facilities; •the FDA or other regulatory agencies may not approve accelerated development timelines for our product candidates; •the failure of third-party clinical research organizations and other third-party service providers and independent clinical investigators tomanage and conduct the trials, to perform their oversight of the trials or to meet expected deadlines; •the failure of our clinical investigational sites and the records kept at such sites, including the clinical trial data, to be in compliance withthe FDA's Good Clinical Practices, or EU legislation42governing good clinical practice, including the failure to pass FDA, EMA or EU Member State inspections of clinical trials;•the FDA or other regulatory agencies may change their approval policies or adopt new regulations; •adverse medical events during the trials could lead to requirements that trials be repeated or extended, or that a program be terminated orplaced on clinical hold, even if other studies or trials relating to the program are successful; and •the FDA or other regulatory agencies may not agree with our or our partners' regulatory approval strategies or components of our or ourpartners' filings, such as clinical trial designs. In addition, our product development timelines may be impacted by third-party patent litigation. Moreover, recent events, including complicationsexperienced by patients taking FDA-approved drugs, have raised questions about the safety of marketed drugs and may result in new legislation by theU.S. Congress and increased caution by the FDA and regulatory agencies outside the U.S. in reviewing new drugs. In summary, we cannot be sure thatregulatory approval will be granted for drug candidates that we submit for regulatory review. Our ability to generate revenues from thecommercialization and sale of additional drug products will be limited by any failure to obtain these approvals. In addition, stock prices have declinedsignificantly in certain instances where companies have failed to obtain FDA approval of a drug candidate or if the timing of FDA approval is delayed.If the FDA's or any other regulatory agency's response to any application for approval is delayed or not favorable for any of our product candidates, ourstock price could decline significantly. Even if regulatory approval to market a drug product is granted, the approval may impose limitations on the indicated use for which the drugproduct may be marketed and additional post-approval requirements with which we would need to comply in order to maintain the approval of suchproducts. Our business could be seriously harmed if we do not complete these studies and the FDA, as a result, requires us to change related sections ofthe marketing label for our products. In addition, adverse medical events that occur during clinical trials or during commercial marketing of our productscould result in legal claims against us and the temporary or permanent withdrawal of our products from commercial marketing, which could seriouslyharm our business and cause our stock price to decline.Clinical trials for our product candidates are expensive, and their outcome is uncertain. Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the commercial sale ofany products, we or our partners must demonstrate, through preclinical testing and clinical trials, that our product candidates are safe and effective foruse in humans. We have incurred, and we will continue to incur, substantial expense for preclinical testing and clinical trials. Our preclinical and clinical development efforts may not be successfully completed. Completion of clinical trials may take several years or more.The length of time can vary substantially with the type, complexity, novelty and intended use of the product candidate. The commencement and rate ofcompletion of clinical trials may be delayed by many factors, including:•the potential delay by a collaborative partner in beginning the clinical trial; •the inability to recruit clinical trial participants at the expected rate; •the failure of clinical trials to demonstrate a product candidate's safety or efficacy; •the inability to follow patients adequately after treatment; •unforeseen safety issues;43•the inability to manufacture sufficient quantities of materials used for clinical trials; and •unforeseen governmental or regulatory delays. In addition, we often depend on independent clinical investigators, contract research organizations and other third-party service providers and ourcollaborators in the conduct of clinical trials for our product candidates. We rely heavily on these parties for successful execution of our clinical trials butdo not control many aspects of their activities. For example, while the investigators are not our employees, we are responsible for ensuring that each ofour clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Third parties may not complete activities onschedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols. The results from preclinical testing and early clinical trials often have not predicted results of later clinical trials. A number of new drugs haveshown promising results in early clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatoryapprovals. Clinical trials conducted by us, by our collaborative partners or by third parties on our behalf may not demonstrate sufficient safety andefficacy to obtain the requisite regulatory approvals for our product candidates. If a product candidate fails to demonstrate safety and efficacy in clinical trials or if third parties fail to conduct clinical trials in accordance with theirobligations, the development, approval and commercialization of our product candidates may be delayed or prevented, which may materially adverselyaffect our business, financial condition, cash flows and results of operations.The commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur. We cannot predict whether the commercial use of our products will produce undesirable or unintended side effects that have not been evident in theuse of, or in clinical trials conducted for, such products to date. Additionally, incidents of product misuse may occur. These events, among others, couldresult in product recalls, product liability actions or withdrawals or additional regulatory controls (including additional regulatory scrutiny andrequirements for additional labeling), all of which could have a material adverse effect on our business, results of operations, cash flows and financialcondition. In addition, the reporting of adverse safety events involving our products and public rumors about such events could cause our stock price todecline or experience periods of volatility.If we fail to comply with the extensive legal and regulatory requirements affecting the healthcare industry, we could face increased costs, penaltiesand a loss of business. Our activities, and the activities of our collaborators and third-party providers, are subject to comprehensive government regulation. Governmentregulation by various national, state and local agencies, which includes detailed inspection of, and controls over, research and laboratory procedures,clinical investigations, product approvals and manufacturing, marketing and promotion, adverse event reporting, sampling, distribution, recordkeeping,storage, and disposal practices, and achieving compliance with these regulations, substantially increases the time, difficulty and costs incurred inobtaining and maintaining the approval to market newly developed and existing products. Government regulatory actions can result in delay in therelease of products, seizure or recall of products, suspension or revocation of the authority necessary for their production and sale, and other civil orcriminal sanctions, including fines and penalties. Pharmaceutical and biotechnology companies have been the target of lawsuits and investigationsalleging violations of government regulation, including claims asserting submission of incorrect pricing information, impermissible off-label promotionof pharmaceutical products, payments intended to influence the referral of federal or state healthcare44business, submission of false claims for government reimbursement, antitrust violations or violations related to environmental matters. Changes in laws affecting the healthcare industry could also adversely affect our revenues and profitability, such as new laws, regulations orjudicial decisions, or new interpretations of existing laws, regulations or decisions, related to patent protection and enforcement, healthcare availability,and product pricing and marketing. Changes in FDA regulations and regulations issued by regulatory agencies outside of the U.S., including new ordifferent approval requirements, timelines and processes, may also delay or prevent the approval of new products, require additional safety monitoring,labeling changes, restrictions on product distribution or other measures that could increase our costs of doing business and adversely affect the marketfor our products. The enactment in the U.S. of healthcare reform, new legislation or implementation of existing statutory provisions on importation oflower-cost competing drugs from other jurisdictions and legislation on comparative effectiveness research are examples of previously enacted andpossible future changes in laws that could adversely affect our business. While we continually strive to comply with these complex requirements, we cannot guarantee that we, our employees, our collaborators, ourconsultants or our contractors are or will be in compliance with all potentially applicable U.S. federal and state regulations and/or laws or all potentiallyapplicable regulations and/or laws outside the U.S. and interpretations of the applicability of these laws to marketing practices. If we or our agents fail tocomply with any of those regulations and/or laws, a range of actions could result, including, but not limited to, the termination of clinical trials, thefailure to approve a product candidate, restrictions on our products or manufacturing processes, withdrawal of our products from the market, significantfines, exclusion from government healthcare programs or other sanctions or litigation. Additionally, while we have implemented numerous riskmitigation measures, we cannot guarantee that we will be able to effectively mitigate all operational risks. Failure to effectively mitigate all operationalrisks may materially adversely affect our product supply, which could have a material adverse effect on our product sales and/or revenues and results ofoperations.We face competition in the biotechnology and pharmaceutical industries. We face intense competition in the development, manufacture, marketing and commercialization of our products and product candidates from manyand varied sources, such as academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies,including other companies with similar technologies, and we can provide no assurance that we will be able to compete successfully. Some of thesecompetitors are also our collaborative partners, who control the commercialization of products for which we receive manufacturing and/or royaltyrevenues. These competitors are working to develop and market other systems, products, vaccines and other methods of preventing or reducing disease,and new small-molecule and other classes of drugs that can be used with or without a drug delivery system. The biotechnology and pharmaceutical industries are characterized by intensive research, development and commercialization efforts and rapid andsignificant technological change. Many of our competitors are larger and have significantly greater financial and other resources than we do. As a result,we expect that our competitors may develop new technologies, products and processes that may be more effective than those we develop. They mayalso develop their products more rapidly than us, complete any applicable regulatory approval process sooner than we can or offer their newlydeveloped products at prices lower than our prices. The development of technologically improved or different products or technologies may make ourproduct candidates or product platforms obsolete or noncompetitive before we recover expenses incurred in connection with their development or realizeany revenues from any commercialized product.45 There are other companies developing extended-release product platforms. In many cases, there are products on the market or in development thatmay be in direct competition with our products or product candidates. In addition, we know of new chemical entities that are being developed that, ifsuccessful, could compete against our product candidates. These chemical entities are being designed to work differently than our product candidatesand may turn out to be safer or to be more effective than our product candidates. Among the many experimental therapies being tested around the world,there may be some that we do not now know of that may compete with our proprietary product platforms or product candidates. Our collaborativepartners could choose a competing technology to use with their drugs instead of one of our product platforms and could develop products that competewith our products. With respect to our proprietary injectable product platform, we are aware that there are other companies developing extended-release deliverysystems for pharmaceutical products. RISPERDAL CONSTA and INVEGA SUSTENNA may compete with a number of other injectable productsincluding ZYPREXA RELPREVV ((olanzapine) For Extended Release Injectable Suspension), which is marketed and sold by Lilly in the U.S., the EUand Australia/New Zealand, and other products currently in development, including a once-monthly injectable formulation of ABILIFY (aripiprazole)developed by Otsuka Pharmaceutical Co. Ltd. ("Otsuka"), which is currently under FDA review. RISPERDAL CONSTA and INVEGA SUSTENNAmay also compete with new oral compounds currently on the market or being developed for the treatment of schizophrenia. In the treatment of alcohol dependence, VIVITROL competes with CAMPRAL (acamprosate calcium) sold by Forest Laboratories andANTABUSE sold by Odyssey as well as currently marketed drugs also formulated from naltrexone. Other pharmaceutical companies are developingproduct candidates that have shown some promise in treating alcohol dependence and that, if approved by the FDA, would compete with VIVITROL. In the treatment of opioid dependence, VIVITROL competes with methadone, oral naltrexone, and SUBOXONE (buprenorphone HCl/naloxoneHCl dehydrate sublingual tablets), SUBOXONE (buprenorphone/naloxone) Sublingual Film, and SUBUTEX (buprenorphine HCl sublingual tablets),each of which is marketed and sold by Reckitt Benckiser Pharmaceuticals, Inc. in the U.S. It also competes with other buprenorphine-based products onthe market. Other pharmaceutical companies are developing product candidates that have shown promise in treating opioid dependence and that, ifapproved by the FDA, would compete with VIVITROL. BYDUREON competes with established therapies for market share. Such competitive products include sulfonylureas, metformin, insulins,thiazolidinediones, glinides, dipeptidyl peptidase type IV inhibitors, insulin sensitizers, alpha-glucosidase inhibitors and sodium-glucose transporter-2inhibitors. BYDUREON also competes with other GLP-1 agonists, including VICTOZA (liraglutide (rDNA origin) injection), which is marketed andsold by Novo Nordisk A/S. Other pharmaceutical companies are developing product candidates for the treatment of type 2 diabetes that, if approved bythe FDA, could compete with BYDUREON. AMPYRA/FAMPYRA is, to our knowledge, the first product that is approved as a treatment to improve walking in patients with MS. However,there are a number of FDA-approved therapies for MS disease management that seek to reduce the frequency and severity of exacerbations or slow theaccumulation of physical disability for people with certain types of MS. These products include AVONEX® from Biogen Idec, BETASRON® fromBayer HealthCare Pharmaceuticals, COPAXONE® from Teva Pharmaceutical Industries Ltd., REBIF® from Merck Serono, TYSABRI® from BiogenIdec and Elan, and GILENYATM and EXTAVIA® from Novartis AG. With respect to our NanoCrystal technology, we are aware that other technology approaches similarly address poorly water soluble drugs. Theseapproaches include nanoparticles, cyclodextrins, lipid-based self-emulsifying drug delivery systems, dendrimers and micelles, among others, any ofwhich46could limit the potential success and growth prospects of products incorporating our NanoCrystal technology. In addition, there are many competingtechnologies to our OCR technology, some of which are owned by large pharmaceutical companies with drug delivery divisions and other smaller drugdelivery specific companies. If we are unable to compete successfully in the biotechnology and pharmaceutical industries, it may materially adversely affect our business,financial condition, cash flows and results of operations.We may not become profitable on a sustained basis. At March 31, 2012, our accumulated deficit was $524.9 million, which was primarily the result of net losses incurred from 1987, the year we werefounded, through March 31, 2012, partially offset by net income over previous fiscal years. There can be no assurance we will achieve sustainedprofitability. A major component of our revenue is dependent on our partners' and our ability to commercialize, and our ability to manufacture economically, ourmarketed products. Our ability to achieve sustained profitability in the future depends, in part, on our ability to:•obtain and maintain regulatory approval for our products and product candidates, and for our partnered products, both in the U.S. and inother countries; •efficiently manufacture our products; •support the commercialization of our products by our collaborative partners; •successfully market and sell VIVITROL in the U.S.; •support the commercialization of VIVITROL in Russia and the countries of the CIS by our partner Cilag; •enter into agreements to develop and commercialize our products and product candidates; •develop, have manufactured or expand our capacity to manufacture and market our products and product candidates; •obtain adequate reimbursement coverage for our products from insurance companies, government programs and other third-partypayors; •obtain additional research and development funding from collaborative partners or funding for our proprietary product candidates; and •achieve certain product development milestones. In addition, the amount we spend will impact our profitability. Our spending will depend, in part, on:•the progress of our research and development programs for our product candidates and for our partnered product candidates, includingclinical trials; •the time and expense that will be required to pursue FDA and/or non-U.S. regulatory approvals for our products and whether suchapprovals are obtained; •the time and expense required to prosecute, enforce and/or challenge patent and other intellectual property rights; •the cost of building, operating and maintaining manufacturing and research facilities; •the cost of third-party manufacture; ••the number of product candidates we pursue, particularly proprietary product candidates;47•how competing technological and market developments affect our product candidates; •the cost of possible acquisitions of technologies, compounds, product rights or companies; •the cost of obtaining licenses to use technology owned by others for proprietary products and otherwise; •the costs of potential litigation; and •the costs associated with recruiting and compensating a highly skilled workforce in an environment where competition for suchemployees may be intense. We may not achieve all or any of these goals and, thus, we cannot provide assurances that we will ever be profitable on a sustained basis orachieve significant revenues. Even if we do achieve some or all of these goals, we may not achieve significant or sustained commercial success.We may require additional funds to complete our programs, and such funding may not be available on commercially favorable terms or at all, andmay cause dilution to our existing shareholders. We may require additional funds to complete any of our programs, and we may seek funds through various sources, including debt and equityofferings, corporate collaborations, bank borrowings, arrangements relating to assets, sale of royalty streams we receive on our products or otherfinancing methods or structures. The source, timing and availability of any financings will depend on market conditions, interest rates and other factors.If we are unable to raise additional funds on terms that are favorable to us or at all, we may have to cut back significantly on one or more of ourprograms or give up some of our rights to our product platforms, product candidates or licensed products. If we issue additional equity securities orsecurities convertible into equity securities to raise funds, our shareholders will suffer dilution of their investment, and it may adversely affect the marketprice of our ordinary shares.Our products or product candidates may cause or contribute to injury or dangerous drug interactions, and we may not learn about orunderstand those effects until the product or product candidate has been administered to patients for a prolonged period of time. Claims for or from such injuries or interactions may be brought by consumers, clinical trial participants, our collaborative partners or third partiesselling the products. We currently carry product liability insurance coverage in such amounts as we believe are sufficient for our business. However,this coverage may not be sufficient to satisfy any liabilities that may arise. As our development activities progress and we continue to have commercialsales, this coverage may be inadequate, we may be unable to obtain adequate coverage at an acceptable cost or at all, or our insurer may disclaimcoverage as to a future claim. This could prevent or limit our commercialization of our products. We may not be successful in defending ourselves in thelitigation and, as a result, our business could be materially harmed. These lawsuits may result in large judgments or settlements against us, any of whichcould have a negative effect on our financial condition and business if in excess of our insurance coverage. Additionally, lawsuits can be expensive todefend, whether or not they have merit, and the defense of these actions may divert the attention of our management and other resources that wouldotherwise be engaged in managing our business. Additionally, product recalls may be issued at our discretion or at the direction of the FDA, other government agencies or other entities havingregulatory control for pharmaceutical product sales. We cannot assure you that product recalls will not occur in the future or that, if such recalls occur,such recalls will not adversely affect our business, results of operations, cash flows and financial condition or reputation.48Our business involves environmental, health and safety risks. Our business involves the controlled use of hazardous materials and chemicals and is subject to numerous environmental, health and safety lawsand regulations and to periodic inspections for possible violations of these laws and regulations. Under certain of those laws and regulations, we couldbe liable for any contamination at our current or former properties or third party waste disposal sites. In addition to significant remediation costs,contamination can give rise to third party claims for fines, penalties, natural resource damages, personal injury and damage (including property damage).The costs of compliance with environmental, health and safety laws and regulations are significant. Any violations, even if inadvertent or accidental, ofcurrent or future environmental, health or safety laws or regulations, the cost of compliance with any resulting order or fine and any liability imposed inconnection with any contamination for which we may be responsible could adversely affect our business, financial condition, cash flows and results ofoperations.Adverse credit and financial market conditions may exacerbate certain risks affecting our business. As a result of adverse credit and financial market conditions, organizations that reimburse for use of our products, such as government healthadministration authorities and private health insurers, may be unable to satisfy such obligations or may delay payment. In addition, federal and statehealth authorities may reduce reimbursements (including Medicare and Medicaid reimbursements in the U.S.) or payments, and private insurers mayincrease their scrutiny of claims. We are also dependent on the performance of our collaborative partners, and we sell our products to our collaborativepartners through contracts that may not be secured by collateral or other security. Accordingly, we bear the risk if our partners are unable to payamounts due to us thereunder. Due to the recent tightening of global credit and the volatility in the financial markets, there may be a disruption or delayin the performance of our third-party contractors, suppliers or collaborative partners. If such third parties are unable to pay amounts owed to us orsatisfy their commitments to us, or if there are reductions in the availability or extent of reimbursement available to us, our business and results ofoperations would be adversely affected.Currency exchange rates may affect revenue. We conduct a large portion of our business in international markets. For example, we derive a majority of our RISPERDAL CONSTA revenuesand all of our FAMPYRA and XEPLION revenues from sales in countries other than the U.S. and these sales are denominated in non-U.S. dollar("USD") currencies. Such revenues fluctuate when translated to USD as a result of changes in currency exchange rates. We currently do not hedge thisexposure. An increase in the USD relative to other currencies in which we have revenues will cause our non-USD revenues to be lower than with astable exchange rate. A large increase in the value of the USD relative to such non-USD currencies could have a material adverse affect on ourrevenues, results of operations, cash flows and financial condition. As a result of the Business Combination, we incur substantial operating costs in Ireland. We face exposure to changes in the exchange ratio of theUSD and the Euro arising from expenses and payables at our Irish operations that are settled in Euro. The impact of changes in the exchange ratio of theUSD and the Euro on our USD denominated manufacturing and royalty revenues earned in countries other than the U.S. is partially offset by theopposite impact of changes in the exchange ratio of the USD and the Euro on operating expenses and payables incurred at our Irish operations that aresettled in Euro. For the fiscal year ended March 31, 2012, an average 10% weakening in the USD relative to the Euro would have resulted in anincrease to our expenses denominated in Euro of $4.7 million.49We may not be able to retain our key personnel. Our success depends largely upon the continued service of our management and scientific staff and our ability to attract, retain and motivate highlyskilled technical, scientific, manufacturing, management, regulatory compliance and selling and marketing personnel. The loss of key personnel or ourinability to hire and retain personnel who have technical, scientific, manufacturing, management, regulatory compliance or commercial backgroundscould materially adversely affect our research and development efforts and our business.Future transactions may harm our business or the market price of our ordinary shares. We regularly review potential transactions related to technologies, products or product rights and businesses complementary to our business. Thesetransactions could include:•mergers; •acquisitions; •strategic alliances; •licensing agreements; and •co-promotion agreements. We may choose to enter into one or more of these transactions at any time, which may cause substantial fluctuations in the market price of ourordinary shares. Moreover, depending upon the nature of any transaction, we may experience a charge to earnings, which could also materiallyadversely affect our results of operations and could harm the market price of our ordinary shares. If we are unable to successfully integrate the companies, businesses or properties that we acquire, we could experience a material adverse effect onour business, financial condition or results of operations. Merger and acquisition transactions, including the recent Business Combination of OldAlkermes with EDT involve various inherent risks, including:•uncertainties in assessing the value, strengths and potential profitability of, and identifying the extent of all weaknesses, risks, contingentand other liabilities of, the respective parties; •the potential loss of key customers, management and employees of an acquired business; •the consummation of financing transactions, acquisitions or dispositions and the related effects on our business; •the ability to achieve identified operating and financial synergies from an acquisition in the amounts and within the timeframe predicted; •problems that could arise from the integration of the respective businesses, including the application of internal control processes to theacquired business; •difficulties that could be encountered in managing international operations; and •unanticipated changes in business, industry, market or general economic conditions that differ from the assumptions underlying ourrationale for pursuing the transaction. Any one or more of these factors could cause us not to realize the benefits anticipated from a transaction. Moreover, any acquisition opportunities we pursue could materially affect our liquidity and capital resources and may require us to incur additionalindebtedness, seek equity capital or both. Future acquisitions could also result in our assuming more long-term liabilities relative to the value of theacquired assets than we have assumed in our previous acquisitions. Further, acquisition accounting rules50require changes in certain assumptions made subsequent to the measurement period as defined in current accounting standards, to be recorded in currentperiod earnings, which could affect our results of operations.The recent Business Combination of Old Alkermes and EDT created numerous risks and uncertainties, and we may fail to realize the expectedbenefits of the Business Combination. Strategic transactions like the recent Business Combination of Old Alkermes and EDT create numerous risks and uncertainties. This BusinessCombination entailed many changes, including the integration of EDT and its personnel with those of Old Alkermes, and changes in systems andemployee benefit plans. These transition activities are complex, and we may encounter unexpected difficulties or incur unexpected costs, including:•the diversion of management's attention to integration matters; •difficulties in achieving anticipated cost savings, synergies, business opportunities and growth prospects from combining the business ofEDT with that of Old Alkermes; •difficulties in the integration of operations and systems; •difficulties in managing a significantly larger business; •challenges in controlling additional costs and expenses incurred as a result of the Business Combination; •difficulties in the assimilation of employees; and •deterioration of general industry and business conditions. If any of these factors limits our ability to integrate the operations of EDT with those of Old Alkermes successfully or on a timely basis, theexpectations of future results of operations, including certain cost savings and synergies expected to result from the Business Combination, might not bemet. As a result, we may not be able to realize the expected benefits that we sought to achieve from the Business Combination. In addition, we may berequired to spend additional time or money on integration that otherwise would be spent on the development and expansion of our business. In addition, the market price of our ordinary shares may decline if the integration of EDT and Old Alkermes is unsuccessful, takes longer thanexpected or fails to achieve financial benefits to the extent anticipated by financial analysts or investors, or if the effect of the Business Combination onour financial results is otherwise not consistent with the expectations of financial analysts or investors.Our actual financial position and results of operations may differ materially from the unaudited pro forma financial data included in this AnnualReport. The pro forma financial data contained in this Annual Report are presented for illustrative purposes only and may not be an indication of what ourfinancial condition or results of operations would have been had the Business Combination been completed on the dates indicated. The pro formafinancial data have been derived from the audited and unaudited historical financial statements of Old Alkermes and EDT, and certain adjustments andassumptions have been made regarding the combined company after giving effect to the Business Combination. The information upon which theseadjustments and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with completeaccuracy. For example, the pro forma financial data do not reflect all costs that we expect to incur in connection with the Business Combination.Accordingly, the actual financial condition and results of operations of the combined company following the Business Combination may not beconsistent with, or evident from, this pro forma financial data.51 In addition, the assumptions used in preparing the pro forma financial information may not prove to be accurate, and other factors may affect ourfinancial condition or results of operations. Any potential decline in our financial condition or results of operations may cause significant variations inour share price.If goodwill or other intangible assets become impaired, we could have to take significant charges against earnings. In connection with the accounting for the Business Combination, we recorded a significant amount of goodwill and other intangible assets. Underaccounting principles generally accepted in the U.S. ("GAAP"), we must assess, at least annually and potentially more frequently, whether the value ofgoodwill and other indefinite-lived intangible assets have been impaired. Amortizing intangible assets will be assessed for impairment in the event of animpairment indicator. Any reduction or impairment of the value of goodwill or other intangible assets will result in a charge against earnings, whichcould materially adversely affect our results of operations and shareholders' equity in future periods.Our investments are subject to general credit, liquidity, market and interest rate risks, which may be exacerbated by volatility in the U.S. creditmarkets. As of March 31, 2012, a significant amount of our investments were invested in U.S. government treasury and agency securities. Our investmentobjectives are, first, to preserve liquidity and conserve capital and, second, to generate investment income. Should our investments cease paying orreduce the amount of interest paid to us, our interest income would suffer. In addition, general credit, liquidity, market and interest risks associated withour investment portfolio may have an adverse effect on our financial condition.Our effective tax rate may increase. As a global biotechnology company, we are subject to taxation in a number of different jurisdictions. As a result, our effective tax rate is derivedfrom a combination of applicable tax rates in the various places that we operate. In preparing our financial statements, we estimate the amount of tax thatwill become payable in each of these places. Our effective tax rate may fluctuate depending on a number of factors, including the distribution of ourprofits or losses between the jurisdictions where we operate, differences in interpretation of tax laws, etc. In addition, the tax laws of any jurisdiction inwhich we operate may change in the future which could impact our effective tax rate. Tax authorities in the jurisdictions in which we operate may auditthe Company. If we are unsuccessful in defending any tax positions adopted in our submitted tax returns, we may be required to pay taxes for priorperiods, interest, fines or penalties, and may be obligated to pay increased taxes in the future, any of which could have a material adverse effect on ourbusiness, financial condition, results of operations and growth prospects.The Business Combination of Old Alkermes and EDT may limit our ability to use our tax attributes to offset taxable income, if any, generatedfrom such Business Combination. For U.S. federal income tax purposes, a corporation is generally considered tax resident in the place of its incorporation. Because we areincorporated in Ireland, we should be deemed an Irish corporation under these general rules. However, Section 7874 of the Internal Revenue Code of1986, as amended ("the Code") generally provides that a corporation organized outside the U.S. that acquires substantially all of the assets of acorporation organized in the U.S. will be treated as a U.S. corporation (and, therefore, a U.S. tax resident) for U.S. federal income tax purposes ifshareholders of the acquired U.S. corporation own at least 80% (of either the voting power or the value) of the stock of the acquiring foreigncorporation after the acquisition by reason of holding stock in the domestic corporation, and the "expanded affiliated group" (as defined inSection 7874) that includes the52acquiring corporation does not have substantial business activities in the country in which it is organized. In addition, Section 7874 provides that if a corporation organized outside the U.S. acquires substantially all of the assets of a corporation organizedin the U.S., the taxable income of the U.S. corporation during the period beginning on the date the first assets are acquired as part of the acquisition,through the date which is ten years after the last date assets are acquired as part of the acquisition, shall be no less than the income or gain recognized byreason of the transfer during such period or by reason of a license of property by the expatriated entity after such acquisition to a foreign affiliate duringsuch period, which is referred to as the "inversion gain," if shareholders of the acquired U.S. corporation own at least 60% (of either the voting poweror the value) of the stock of the acquiring foreign corporation after the acquisition by reason of holding stock in the domestic corporation, and the"expanded affiliated group" of the acquiring corporation does not have substantial business activities in the country in which it is organized. Inconnection with the Business Combination, Old Alkermes transferred certain intellectual property to one of our Irish subsidiaries, and it is expected thatOld Alkermes had sufficient net operating loss carryforwards available to substantially offset any taxable income generated from this transfer. If thisrule was to apply to the Business Combination, among other things, Old Alkermes would not have been able to use any of the approximately$274 million of U.S. Federal net operating loss ("NOL") and $38 million of U.S. state NOL carryforwards that it had as of March 31, 2011 to offsetany taxable income generated as part of the Business Combination or as a result of the transfer of intellectual property. We do not believe that either ofthese limitations should apply as a result of the Business Combination. However, the U.S. Internal Revenue Service (the "IRS") could assert a contraryposition, in which case we could become involved in tax controversy with the IRS regarding possible additional U.S. tax liability. If we were to beunsuccessful in resolving any such tax controversy in our favor, we could be liable for significantly greater U.S. federal and state income tax than weanticipate being liable for through the Business Combination, including as a result of the transfer of intellectual property, which would place furtherdemands on our cash needs.Transfers of our ordinary shares may be subject to Irish stamp duty. In certain circumstances, the transfer of shares in an Irish incorporated company will be subject to Irish stamp duty, which is a legal obligation ofthe buyer to pay. This duty is currently charged at the rate of 1.0% of the higher of the price paid and the market value of the shares acquired. However,transfers of book-entry interests in the Depository Trust Company ("DTC") representing our ordinary shares should not be subject to Irish stamp duty.Accordingly, transfers by shareholders who hold their ordinary shares beneficially through brokers, which in turn hold those shares through DTC,should not be subject to Irish stamp duty on transfers to holders who also hold through DTC. This treatment is available because our ordinary sharesare traded on a recognized stock exchange in the U.S. In relation to any transfer of our ordinary shares that is subject to Irish stamp duty, our articles of association allow us, in our absolute discretion,to create an instrument of transfer and pay (or procure the payment of) any stamp duty payable by a buyer or otherwise require an instrument of transferto be executed to effect a transfer. In the event of any such payment, we are (on our behalf or on behalf of our affiliates) entitled to, at our discretion(i) seek reimbursement from the buyer or seller, (ii) set-off the amount of the stamp duty against future dividends payable to the buyer or seller and(iii) claim a first and permanent lien against the ordinary shares on which it has paid stamp duty. Our lien shall extend to all dividends paid on thoseshares.53Litigation and/or arbitration may result in financial losses or harm our reputation and may divert management resources. We may be the subject of certain claims, including product liability claims and those asserting violations of securities laws and derivative actions.We cannot predict with certainty the eventual outcome of any future litigation, arbitration or third-party inquiry. We may not be successful in defendingourselves or asserting our rights in new lawsuits, investigations or claims that may be brought against us and, as a result, our business could bematerially harmed. These lawsuits, arbitrations, investigations or claims may result in large judgments or settlements against us, any of which couldhave a negative effect on our financial performance and business. Additionally, lawsuits, arbitrations and investigations can be expensive to defend,whether or not the lawsuit, arbitration or investigation has merit, and the defense of these actions may divert the attention of our management and otherresources that would otherwise be engaged in running our business.Our business could be negatively affected as a result of the actions of activist shareholders. Proxy contests have been waged against many companies in the biopharmaceutical industry over the last few years. If faced with a proxy contest,we may not be able to respond successfully to the contest, which would be disruptive to our business. Even if we are successful, our business could beadversely affected by a proxy contest involving us because:•responding to proxy contests and other actions by activist shareholders can be costly and time-consuming, disrupting operations anddiverting the attention of management and employees, and can lead to uncertainty; •perceived uncertainties as to future direction may result in the loss of potential acquisitions, collaborations or in-licensing opportunities,and may make it more difficult to attract and retain qualified personnel and business partners; and •if individuals are elected to a board of directors with a specific agenda, it may adversely affect our ability to effectively and timelyimplement our strategic plan and create additional value for our shareholders. These actions could cause the market price of our ordinary shares to experience periods of volatility.Item 1B. Unresolved Staff Comments None.Item 2. Properties We lease approximately 8,500 square feet of corporate office space in Dublin, Ireland, which houses our corporate headquarters. This lease expiresin 2022 and includes a tenant option to terminate in 2017. We lease approximately 115,000 square feet of space in Waltham, Massachusetts, which houses corporate offices, administrative areas andlaboratories. This lease expires in 2020 and has an option to extend the term for up to two five-year periods. We own manufacturing, office and laboratory sites in Wilmington, Ohio (approximately 195,000 square feet); Athlone, Ireland (approximately460,000 square feet); and Gainesville, Georgia (approximately 90,000 square feet). We have entered into sublease agreements with various tenants to occupy space that we lease in Cambridge, Massachusetts under two leases, theoriginal terms of which are effective until mid-calendar54year 2012. These leases contain provisions permitting us to extend their terms for up to two ten-year periods. We also have a sublease agreement inplace for a commercial manufacturing facility we lease in Chelsea, Massachusetts designed for clinical and commercial manufacturing of inhaledproducts based on our pulmonary technology that we are not currently utilizing. The lease term is for fifteen years, expiring in 2015, with an option toextend the term for up to two five-year periods. As we are not currently utilizing these facilities, we have no plans to extend the Cambridge or Chelsealeases beyond their expiration dates. We believe that our current and planned facilities are adequate for our current and near-term preclinical, clinical and commercial manufacturingrequirements.Item 3. Legal Proceedings From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. For example, we are currently involved invarious sets of Paragraph IV litigations in the United States and similar suits in Canada and France in respect of certain of our products. We are notaware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, results ofoperations, cash flows and financial condition.Item 4. Mine Safety Disclosures Not Applicable.55PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market and Shareholder Information Our ordinary shares are traded on the NASDAQ Global Select Stock Market under the symbol "ALKS." Set forth below for the indicated periodsare the high and low closing sales prices for our ordinary shares. The share price for the period prior to September 16, 2011 is that of Old Alkermes,while the share price for the period after September 16, 2011 is that of Alkermes. There were 269 shareholders of record for our ordinary shares on May 11, 2012. In addition, the last reported sale price of our ordinary shares asreported on the NASDAQ Global Select Stock Market on May 11, 2012 was $18.09.Dividends No dividends have been paid on the ordinary shares to date, and we do not expect to pay cash dividends thereon in the foreseeable future. Weanticipate that we will retain all earnings, if any, to support our operations and our proprietary drug development programs. Any future determination asto the payment of dividends will be at the sole discretion of our board of directors and will depend on our financial condition, results of operations,capital requirements and other factors our board of directors deems relevant.Securities authorized for issuance under equity compensation plans For information regarding securities authorized for issuance under equity compensation plans, see Part III, Item 12, "Security Ownership ofCertain Beneficial Owners and Management," which incorporates by reference to the Proxy Statement relating to our 2012 Annual Meeting ofShareholders (the "2012 Proxy Statement").Repurchase of equity securities On September 16, 2011, our board of directors authorized the continuation of the Alkermes, Inc. program to repurchase up to $215.0 million ofour ordinary shares at the discretion of management from time to time in the open market or through privately negotiated transactions. We did notpurchase any shares under this program during the quarter ended March 31, 2012. As of March 31, 2012, we had purchased a total of 8,866,342 sharesat a cost of $114.0 million.Irish Taxes Applicable to U.S. Holders The following is a general summary of the main Irish tax considerations applicable to the purchase, ownership and disposition of our ordinaryshares by U.S. holders. It is based on existing Irish law and practices in effect on 30 April 2012 and on discussions and correspondence with the IrishRevenue Commissioners. Legislative, administrative or judicial changes may modify the tax consequences described below.56 Fiscal 2012 Fiscal 2011 High Low High Low 1st Quarter $18.60 $13.06 $13.75 $10.70 2nd Quarter 19.52 13.91 14.87 12.09 3rd Quarter 18.03 13.88 15.92 10.48 4th Quarter 19.50 16.14 14.63 12.14  The statements do not constitute tax advice and are intended only as a general guide. Furthermore, this information applies only to ordinary sharesheld as capital assets and does not apply to all categories of shareholders, such as dealers in securities, trustees, insurance companies, collectiveinvestment schemes and shareholders who acquire, or who are deemed to acquire their ordinary shares by virtue of an office or employment. Thissummary is not exhaustive and shareholders should consult their own tax advisers as to the tax consequences in Ireland, or other relevant jurisdictionswhere we operate, including the acquisition, ownership and disposition of ordinary shares.Withholding and Income Tax on Dividends. While we have no current plans to pay dividends, dividends on our ordinary shares would generally be subject to Irish dividend withholding tax("DWT") at the standard rate of income tax, which is currently 20%, unless an exemption applies. Dividends on our ordinary shares that are owned byresidents of the U.S. and held beneficially through the Depositary Trust Company ("DTC") will not be subject to DWT provided that the address of thebeneficial owner of the ordinary shares in the records of the broker is in the U.S. Dividends on our ordinary shares that are owned by residents of the U.S. and held directly would be paid on or before one year after the "relevantdate," as defined below without any DWT if the shareholder held shares of Alkermes, Inc. common stock on September 8, 2011, the date on which itwas publicly announced that the last Alkermes, Inc. stockholder vote approving the merger had passed, which is referred to as the "relevant date," andhas provided a valid Form W-9 showing a U.S. address or a valid U.S. taxpayer identification number to our transfer agent or if the shareholder did nothold shares of Alkermes, Inc. common stock on the relevant date and has provided the appropriate Irish dividend withholding tax forms to our transferagent, in either case, by the due date to be determined by us before the record date for the first dividend to which the shareholder is entitled. In addition, all shareholders who hold their ordinary shares directly and who are residents of the U.S., regardless of when such shareholdersacquired their ordinary shares must complete the appropriate Irish DWT forms in order to receive dividends paid later than one year after the relevantdate without DWT. Such shareholders must provide the appropriate Irish forms to their brokers so that such brokers can further transmit the relevantinformation to our qualifying intermediary before the record date for the first dividend paid later than one year after the relevant date, in the case ofordinary shares held beneficially, or to our transfer agent by the due date to be determined by us before such record date, in the case of ordinary sharesheld directly. If any shareholder who is resident in the U.S. receives a dividend subject to DWT, he or she should generally be able to make an application for arefund from the Irish Revenue Commissioners on the prescribed form. Irish income tax, if any, may arise in respect of dividends paid by us. However, a shareholder who is neither resident nor ordinarily resident inIreland and who is entitled to an exemption from DWT, generally has no liability for Irish income tax or to the universal social charge on a dividendfrom us unless he or she holds his or her ordinary shares through a branch or agency in Ireland which carries out a trade on his or her behalf. While the U.S./Ireland Double Tax Treaty contains provisions regarding withholding, due to the wide scope of the exemptions from DWTavailable under Irish domestic law, it would generally be unnecessary for a U.S. resident shareholder to rely on the treaty provisions.Capital Acquisitions Tax Irish capital acquisitions tax ("CAT") is comprised principally of gift tax and inheritance tax. CAT could apply to a gift or inheritance of ourordinary shares irrespective of the place of residence,57ordinary residence or domicile of the parties. This is because our ordinary shares are regarded as property situated in Ireland as our share register mustbe held in Ireland. The person who receives the gift or inheritance has primary liability for CAT. CAT is levied at a rate of 30% above certain tax-free thresholds. The appropriate tax-free threshold is dependent upon (i) the relationship betweenthe donor and the recipient and (ii) the aggregation of the values of previous gifts and inheritances received by the recipient from persons within thesame category of relationship for CAT purposes. Gifts and inheritances passing between spouses are exempt from CAT. Our shareholders shouldconsult their own tax advisers as to whether CAT is creditable or deductible in computing any domestic tax liabilities.Stamp Duty Irish stamp duty, if any, may become payable in respect of ordinary share transfers. However, a transfer of our ordinary shares from a seller whoholds shares through DTC to a buyer who holds the acquired shares through DTC will not be subject to Irish stamp duty. A transfer of our ordinaryshares (i) by a seller who holds ordinary shares outside of DTC to any buyer, or (ii) by a seller who holds the ordinary shares through DTC to a buyerwho holds the acquired ordinary shares outside of DTC, may be subject to Irish stamp duty, which is currently at the rate of 1% of the price paid or themarket value of the ordinary shares acquired, if greater. The person accountable for payment of stamp duty is the buyer or, in the case of a transfer byway of a gift or for less than market value, all parties to the transfer. A shareholder who holds ordinary shares outside of DTC may transfer those ordinary shares into DTC without giving rise to Irish stamp dutyprovided that the shareholder would be the beneficial owner of the related book-entry interest in those ordinary shares recorded in the systems of DTC,and in exactly the same proportions, as a result of the transfer and at the time of the transfer into DTC there is no sale of those book-entry interests to athird party being contemplated by the shareholder. Similarly, a shareholder who holds ordinary shares through DTC may transfer those ordinary sharesout of DTC without giving rise to Irish stamp duty provided that the shareholder would be the beneficial owner of the ordinary shares, and in exactlythe same proportions, as a result of the transfer, and at the time of the transfer out of DTC there is no sale of those ordinary shares to a third party beingcontemplated by the shareholder. In order for the share registrar to be satisfied as to the application of this Irish stamp duty treatment where relevant, theshareholder must confirm to us that the shareholder would be the beneficial owner of the related book-entry interest in those ordinary shares recorded inthe systems of DTC, and in exactly the same proportions or vice-versa, as a result of the transfer and there is no agreement for the sale of the relatedbook-entry interest or the ordinary shares or an interest in the ordinary shares, as the case may be, by the shareholder to a third party beingcontemplated.58Stock Performance Graph The information contained in the performance graph shall not be deemed to be "soliciting material" or to be "filed" with the SEC, and suchinformation shall not be incorporated by reference into any future filing under the Securities Act or Exchange Act, except to the extent that Alkermesspecifically incorporates it by reference into such filing. The following graph compares the yearly percentage change in the cumulative total shareholder return on our ordinary shares for the last five fiscalyears, with the cumulative total return on the Nasdaq Stock Market (U.S. and Foreign) Index and the Nasdaq Biotechnology Index. It is important tonote that information set forth in the graph below with respect to the time period prior to September 16, 2011 refers to the common stock performanceof Old Alkermes, while that information with respect to the time period after September 16, 2011 refers to the ordinary share performance ofAlkermes plc. The comparison assumes $100 was invested on March 31, 2007 in our common stock and in each of the foregoing indices and furtherassumes reinvestment of any dividends. We did not declare or pay any dividends on our common stock during the comparison period.Comparison of Cumulative Total Returns Comparison of Cumulative Total Returns 59 2007 2008 2009 2010 2011 2012 Alkermes, Inc. (until September 16, 2011) and Alkermes plc (as ofSeptember 17, 2011) 100 77 79 84 84 120 NASDAQ Stock Market (U.S. and Foreign) Index 100 95 64 102 119 134 NASDAQ Biotechnology Index 100 101 88 121 134 165 Item 6. Selected Financial Data The selected historical financial data set forth below at March 31, 2012 and 2011 and for the years ended March 31, 2012, 2011 and 2010 arederived from our audited consolidated financial statements, which are included elsewhere in this Annual Report. On September 16, 2011, the businessof Old Alkermes and EDT were combined under Alkermes. The selected historical financial data set forth below at March 31, 2009, 2008 and 2007 andfor the years ended March 31, 2009 and 2008 are derived from audited consolidated financial statements, which are not included in this Annual Report.The selected historical financial data for the period prior to September 16, 2011 is that of Old Alkermes, while the selected historical financial data forthe period after September 16, 2011 is that of Alkermes. The following selected consolidated financial data should be read in conjunction with our consolidated financial statements, the related notes and"Management's Discussion and Analysis of Financial Condition and Results of Operations" included elsewhere in this Annual Report. The historicalresults are not necessarily indicative of the results to be expected for any future period.60 Year Ended March 31, 2012(1) 2011 2010 2009 2008 (In thousands, except per share data) Consolidated Statements of OperationsData: REVENUES: Manufacturing and royalty revenues $326,444 $156,840 $149,917 $150,091 $131,157 Product sales, net 41,184 28,920 20,245 4,467 — Research and development revenue 22,349 880 3,117 42,087 89,510 Net collaborative profit(2) — — 5,002 130,194 20,050 Total revenues 389,977 186,640 178,281 326,839 240,717 EXPENSES: Cost of goods manufactured and sold 127,578 52,185 49,438 43,396 40,677 Research and development 141,893 97,239 95,363 89,478 125,268 Selling, general and administrative(3) 137,632 82,847 76,514 59,008 59,508 Amortization and impairment of acquiredintangible assets(4) 71,155 — — — — Impairment of long-lived assets(5) — — — — 11,630 Restructuring(5) — — — — 6,423 Total expenses 478,258 232,271 221,315 191,882 243,506 OPERATING (LOSS) INCOME (88,281) (45,631) (43,034) 134,957 (2,789)OTHER (EXPENSE) INCOME(6) (26,111) (860) (1,667) (3,945) 175,619 (LOSS) INCOME BEFORE INCOME TAXES (114,392) (46,491) (44,701) 131,012 172,830 INCOME TAX (BENEFIT) PROVISION (714) (951) (5,075) 507 5,851 NET (LOSS) INCOME $(113,678)$(45,540)$(39,626)$130,505 $166,979 (LOSS) EARNINGS PER COMMON SHARE: BASIC $(0.99)$(0.48)$(0.42)$1.37 $1.66 DILUTED $(0.99)$(0.48)$(0.42)$1.36 $1.62 WEIGHTED AVERAGE NUMBER OFCOMMON SHARES OUTSTANDING: BASIC 114,702 95,610 94,839 95,161 100,742 DILUTED 114,702 95,610 94,839 96,252 102,923 61 Year Ended March 31, 2012(1) 2011 2010 2009 2008 (In thousands, except per share data) Consolidated Balance Sheet Data: Cash, cash equivalents and investments $246,138 $294,730 $350,193 $404,482 $460,361 Total assets 1,435,217 452,448 515,600 566,486 656,311 Long-term debt(7) 444,460 — — 75,888 160,371 Unearned milestone revenue—current andlong-term — — — — 117,657 Shareholders' equity 853,852 392,018 412,616 434,888 305,314 (1)On September 16, 2011, the business of Old Alkermes and EDT were combined under Alkermes. We paid Elan $500.0 millionin cash and issued Elan 31.9 million ordinary shares of the Company, which had a fair value of approximately $525.1 million onthe closing date, for the EDT business. Alkermes are included for all periods being presented, whereas the operating results ofthe acquiree, EDT, are included only after the date of acquisition, September 16, 2011, through the end of the period. (2)Includes $120.7 million recognized as revenue upon the termination of the VIVITROL collaboration with Cephalon, Inc. duringthe year ended March 31, 2009. (3)Includes $29.1 million and $1.1 million of expenses in the years ended March 31, 2012 and 2011, respectively, related to theacquisition of EDT, which consists primarily of banking, legal and accounting expenses. (4)Includes $25.4 million of amortization of intangibles in the year ended March 31, 2012, acquired in connection with the BusinessCombination and the impairment of $45.8 million of IPR&D. (5)Represents charges in connection with the termination of the AIR Insulin development program and our March 2008restructuring of operations. In connection with the termination of the AIR Insulin development program, we determined that thecarrying value of the assets at our AIR commercial manufacturing facility exceeded their fair value and recorded an impairmentcharge. The March 2008 restructuring program was substantially completed during fiscal 2009. Certain closure costs related tothe leased facilities exited in connection with the March 2008 restructuring of operations will continue to be paid throughDecember 2015. (6)Includes a gain on the sale of our Series C convertible, redeemable preferred stock of Reliant Pharmaceuticals, Inc. ("Reliant")during the year ended March 31, 2008 of $174.6 million. This gain was recorded upon the acquisition of Reliant byGlaxoSmithKline in November 2007. We purchased the Series C convertible, redeemable preferred stock of Reliant for$100.0 million in December 2001, and our investment in Reliant had been written down to zero prior to the time of the sale. (7)At March 31, 2012, long-term debt includes both the current and long-term portion of the $310.0 million first lien term loanfacility (the "First Lien Term Loan") and the $140.0 million second lien term loan facility (the "Second Lien Term Loan" and,together with the First Lien Term Loan, the "Term Loans"). The Term Loans were issued on September 16, 2011. At March 31,2009 and 2008, long-term debt included both the current and long-term portion of the Non-Recourse RISPERDAL CONSTAsecured 7% Notes (the "non-recourse 7% Notes"). The non-recourse 7% Notes were issued by RC Royalty Sub LLC, a wholly-owned subsidiary of Old Alkermes ("Royalty Sub") on February 1, 2005 and were non-recourse to Alkermes. These notes werefully redeemed on July 1, 2010 in advance of the previously scheduled maturity date of January 1, 2012. Royalty Sub wasdissolved during the year ended March 31, 2012.Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F-1 of this AnnualReport. The following discussion contains forward-looking statements. Actual results may differ significantly from those projected in the forward-looking statements. See "Forward-Looking Statements." Factors that might cause future results to differ materially from those projected in theforward-looking statements also include, but are not limited to, those discussed in "Risk Factors" and elsewhere in this Annual Report.Overview We develop medicines that address the unmet needs and challenges of people living with chronic disease. A fully integrated globalbiopharmaceutical company, we apply proven scientific expertise, proprietary technologies and global development capabilities to the creation ofinnovative treatments for major clinical conditions with a focus on CNS disorders, such as schizophrenia, addiction and depression. We create new,proprietary pharmaceutical products for our own account, and we collaborate with other pharmaceutical and biotechnology companies. We areincreasingly focused on maintaining rights to commercialize our leading product candidates in certain markets. On September 16, 2011, the business of Old Alkermes and EDT were combined under Alkermes. As part of the Business Combination, a whollyowned subsidiary of the Company merged with and into Old Alkermes, with Old Alkermes surviving as a wholly owned subsidiary of the Company.At the effective time of the Business Combination, (i) each share of Old Alkermes common stock then issued and outstanding and all associated rightswere canceled and automatically converted into and became the right to receive one ordinary share of Alkermes and (ii) all issued and outstandingoptions and stock awards to purchase Old Alkermes common stock granted under any equity compensation plan were converted into options and stockawards to purchase on substantially the same terms and conditions the same number of Alkermes ordinary shares at the same exercise price. We paidElan $500.0 million in cash and issued Elan 31.9 million ordinary shares of the Company, which had a fair value of approximately $525.1 million onthe closing date, for the EDT business. Upon consummation of the Business Combination, the former shareholders of Old Alkermes ownedapproximately 75% of the Company, with the remaining approximately 25% of the Company owned by a subsidiary of Elan. On March 13, 2012, Alkermes plc completed an underwritten public offering of 24,150,000 of the ordinary shares of Alkermes plc held by Elan.After completion of the offering, Elan, through its subsidiary, owned 7,750,000 of our ordinary shares, equivalent to 6% of the outstanding equity ofthe Company as of March 31, 2012. For a more detailed discussion of the Business Combination, refer to the notes to our condensed consolidated financial statements, includingNote 1, The Company, and Note 3, Acquisitions, in the accompanying Notes to Consolidated Financial Statements for the year ended March 31, 2012. The Business Combination is being accounted for using the acquisition method of accounting for business combinations with Old Alkermes beingtreated as the accounting acquirer under U.S. GAAP, which means that the operating results of Old Alkermes are included for all periods beingpresented, whereas the operating results of the acquiree, EDT, are included only after the date of acquisition, September 16, 2011, through the end of theperiod.Executive Summary We and our pharmaceutical and biotechnology partners have more than 20 commercialized products sold worldwide, including in the U.S. We earnmanufacturing and/or royalty revenues on net sales of products commercialized by our partners and earn revenue on net sales of VIVITROL, which is aproprietary product that we manufacture, market and sell in the U.S. Our five key products are62expected to generate significant revenues for us in the near- and medium-term, as they possess long patent lives, are singular or competitivelyadvantaged products in their class and are generally in the launch phases of their commercial lives. These five key products are: RISPERDALCONSTA and INVEGA SUSTENNA/XEPLION; AMPYRA/FAMPYRA; BYDUREON; and VIVITROL. For the year ended March 31, 2012, we reported $390.0 million in revenues, which included the revenues generated from products associated withthe former EDT business, and represented an increase of more than 109% over the year ended March 31, 2011 compared to those for Old Alkermes.Revenues from our five key products accounted for 60% of our total consolidated revenues for the year ended March 31, 2012. For the year ended March 31, 2012, total expenses increased by $246.0 million, as compared to the year ended March 31, 2011, due primarily tothe addition of EDT. Expenses from the EDT business were $175.0 million for the year ended March 31, 2012, and we incurred $29.1 million duringthe year ended March 31, 2012 related to the EDT acquisition, which consisted primarily of banking, legal and accounting services. On September 16, 2011, we entered into the Term Loans with MSSF and HSBC. The $310.0 million First Lien Term Loan has an initialapplicable margin for borrowings of three-month LIBOR plus 5.25%, was issued with an original issue discount of $3.1 million and has a term of sixyears. The $140.0 million Second Lien Term Loan has an initial applicable margin for borrowings of three-month LIBOR plus 8.00%, was issued withan original issue discount of $2.8 million, and has a term of seven years. Under each of the Term Loans, LIBOR is subject to an interest rate floor of1.50%. Required quarterly principal payments of $0.8 million on the First Lien Term Loan began during the three months ended March 31, 2012. Inaddition, beginning in fiscal year 2013, we are required to make principal payments on the First Lien Term Loan for amounts up to 50% of excess cashflows as defined in the First Lien Term Loan credit agreement. The principal amount of the Second Lien Term Loan is due and payable in full on thematurity date. If prepayments are made prior to September 16, 2012, we may be subject to prepayment premium of 1% of the amount of the term loansbeing repaid if the prepayment is made in connection with a refinancing transaction or 1% of the amount of the outstanding term loans if the prepaymentis made in connection with an amendment to the agreement resulting in a refinancing transaction.Results of OperationsManufacturing and Royalty Revenues63 Years Ended March 31, ChangeFavorable/(Unfavorable) (in millions) 2012 2011 2010 2012 - 2011 2011 - 2010 Manufacturing and royalty revenues: RISPERDAL CONSTA $168.3 $154.3 $146.0 $14.0 $8.3 TRICOR 145 27.8 — — 27.8 — AMYPRA/FAMPYRA 24.6 — — 24.6 — RITALIN LA/FOCALIN XR 23.1 — — 23.1 — INVEGA SUSTENNA/XEPLION 18.0 — — 18.0 — VERELAN 14.2 — — 14.2 — BYDUREON 1.5 — — 1.5 — Other 48.9 2.5 3.9 46.4 (1.4) Manufacturing and royalty revenues $326.4 $156.8 $149.9 $169.6 $6.9  Manufacturing revenues are earned from the sale of products we manufacture for resale by our collaborative partners. Royalty revenues are earnedon our collaborators' sales of products that incorporate our technologies. Royalties are generally recognized in the period the products are sold by ourcollaborators. Under our RISPERDAL CONSTA supply and license agreements with Janssen, we earned manufacturing revenues at 7.5% of Janssen's unit netsales price of RISPERDAL CONSTA and royalty revenues at 2.5% Janssen's net sales of RISPERDAL CONSTA in the fiscal years endingMarch 31, 2012, 2011 and 2010. The increase in RISPERDAL CONSTA manufacturing and royalty revenues for the year ended March 31, 2012, ascompared to the year ended March 31, 2011, was primarily due to an 8% increase in the number of units shipped to Janssen and a 1% increase inroyalties. The increase in royalties was due to an increase in Janssen's end-market sales of RISPERDAL CONSTA from $1,525.6 million during theyear ended March 31, 2011 to $1,540.3 million during the year ended March 31, 2012. The increase in RISPERDAL CONSTA manufacturing androyalty revenues for the year ended March 31, 2011, as compared to the year ended March 31, 2010, was primarily due to a 16% increase in the numberof units shipped to Janssen and a 3% increase in royalties, partially offset by a 5% decrease in the net unit sales price due to currency fluctuations and a1% decrease in the net unit sales price due in part to the effect from the U.S. healthcare reform law. The increase in royalties was due to an increase inJanssen's end-market sales of RISPERDAL CONSTA from $1,477.6 million during the year ended March 31, 2010 to $1,525.6 million during theyear ended March 31, 2011. Units sold in countries outside the U.S. by Janssen in the years ended March 31, 2012, 2011 and 2010 accounted for 83%,83% and 79% of the total units sold, respectively. See "Item 7A. Quantitative and Qualitative Disclosures about Market Risk" for information oncurrency exchange rate risk related to RISPERDAL CONSTA revenues. We expect revenues from RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION, our long acting atypical antipsychotic franchise, tocontinue to grow, as INVEGA SUSTENNA/XEPLION is launched around the world. A number of companies, including us, are working to developproducts to treat schizophrenia and/or bipolar disorder that may compete with RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION.Increased competition may lead to reduced unit sales of RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION, as well as increasing pricingpressure. RISPERDAL CONSTA is covered by a patent until 2021 in the EU and 2023 in the U.S., and INVEGA SUSTENNA/XEPLION is coveredby a patent until 2018 in the EU and 2019 in the U.S., and as such, we do not anticipate any generic versions in the near-term for either of theseproducts. The increase in royalty revenues from TRICOR 145, AMPYRA/FAMPYRA, RITALIN LA/FOCALIN XR, INVEGASUSTENNA/XEPLION, VERELAN and the other manufacturing and royalty revenues were primarily due to the addition of the portfolio ofcommercialized products from the former EDT business on September 16, 2011, which was the closing date of the Business Combination. A numberof our mature products, including RITALIN LA and VERELAN, are currently facing generic competition and TRICOR 145 and FOCALIN XR willface generic competition in fiscal year 2013. As a result, we expect sales of these products to decline over the next few fiscal years. We expect AMPYRA/FAMPYRA sales to continue to grow as Acorda continues to penetrate the U.S. market with AMPYRA and Biogen Ideccontinues to launch FAMPYRA in the rest of the world. AMPYRA is covered by a patent until 2027 in the U.S. and FAMPYRA is covered by apatent until 2025 in the EU, and as such, we do not anticipate any generic versions of these products in the near-term. A number of companies areworking to develop products to treat multiple sclerosis that may compete with AMPYRA/FAMPYRA, which may negatively impact future sales of theproducts.64Product Sales, Net Our product sales consist of sales of VIVITROL in the U.S. to wholesalers, specialty distributors and specialty pharmacies. The following tablepresents the adjustments to arrive at VIVITROL product sales, net for sales of VIVITROL in the U.S. during the years ended March 31, 2012, 2011and 2010: The increase in product sales, gross for the year ended March 31, 2012, as compared to the year ended March 31, 2011, was primarily due to a34% increase in the number of units sold into the distribution channel and a 9% increase in price. The increase in product sales, gross for the year endedMarch 31, 2011, as compared to the year ended March 31, 2010, was primarily due to a 36% increase in the number of units sold into the distributionchannel and a 17% increase in price. The increases in chargebacks during the year ended March 31, 2012, as compared to the year ended March 31,2011 and the year ended March 31, 2011, as compared to the year ended March 31, 2010, was primarily due to the increase in the price of VIVITROLand increased 340B/PHS pricing discounts. The increases in Medicaid rebates during the year ended March 31, 2011, as compared to the year endedMarch 31, 2010, was primarily due to higher rebates resulting from a price increase in October 2010 and the impact of increased Medicaid rebatepercentage and the extension of Medicaid rebates to Medicaid managed care organizations. We expect VIVITROL sales to continue to grow as we continue to penetrate the opioid dependence indication market in the U.S. In addition, weanticipate that Janssen-Cilag will increase sales of VIVITROL in Russia and the CIS, which are recorded as manufacturing and royalty revenues, andthere exists the potential to launch the product in other countries around the world. A number of companies, including us, are working to developproducts to treat addiction, including alcohol and opioid dependence, that may compete with VIVITROL, which may negatively impact future sales ofVIVITROL. Increased competition may lead to reduced unit sales of VIVITROL, as well as increasing pricing pressure. VIVITROL is covered by apatent that will expire in the U.S. in 2029 and in Europe in 2021 and, as such, we do not anticipate any generic versions of this product in the near-term.65 Year EndedMarch 31, 2012 Year EndedMarch 31, 2011 Year EndedMarch 31, 2010 (in millions) Amount % of Sales Amount % of Sales Amount % of Sales Product sales, gross $57.6 100.0%$39.3 100.0%$24.7 100.0%Adjustments to productsales, gross: Medicaid rebates (4.6) (8.0)% (3.1) (8.0)% (0.9) (3.6)%Chargebacks (4.1) (7.1)% (2.4) (6.1)% (1.2) (4.9)%Wholesaler fees (3.0) (5.2)% (2.2) (5.6)% (0.9) (3.6)%Reserve for inventoryin the channel(1) (1.3) (2.3)% (0.8) (2.0)% (0.5) (2.0)%Other (3.4) (5.9)% (1.9) (4.8)% (1.0) (4.1)% Total adjustments (16.4) (28.5)% (10.4) (26.5)% (4.5) (18.2)% Product sales, net $41.2 71.5%$28.9 73.5%$20.2 81.8% (1)Our reserve for inventory in the channel is an estimate that reflects the deferral of the recognition of revenue on shipments ofVIVITROL to our customers until the product has left the distribution channel as we do not yet have the history to reasonablyestimate returns related to these shipments. We estimate that product shipments out of the distribution channel through dataprovided by external sources, including information on inventory levels provided by our customers as well as prescriptioninformation.Research and Development Revenue R&D revenue is generally earned for services performed and milestones achieved under arrangements with our collaborators. The increase in R&Drevenue for the year ended March 31, 2012, as compared to the year ended March 31, 2011, was primarily due to $14.0 million in BYDUREONmilestone payments we received during the year. Under our agreement with Amylin, we received a $7.0 million milestone payment related to the firstcommercial sale of BYDUREON in the EU and a $7.0 million milestone payment related to the first commercial sale of BYDUREON in the U.S.During the year ended March 31, 2012, we also received a $3.0 million milestone payment upon receipt of regulatory approval for VIVITROL inRussia for the opioid dependence indication.Costs and ExpensesCost of Goods Manufactured and Sold The increase in cost of goods manufactured and sold in the year ended March 31, 2012, as compared to the year ended March 31, 2011, wasprimarily due to the addition of $70.0 million of cost of goods manufactured from the addition of EDT's portfolio of commercialized products and a$3.0 million increase in VIVITROL cost of goods manufactured and sold primarily due to an increase in the number of units sold. The increase in cost of goods manufactured and sold in the year ended March 31, 2011, as compared to the year ended March 31, 2010, wasprimarily due to a 16% increase in the number of units of RISPERDAL CONSTA shipped to Janssen, partially offset by an 11% decrease in the unitcost of RISPERDAL CONSTA. The decrease in the unit cost of RISPERDAL CONSTA was partially due to a $1.7 million decrease in costs incurredfor scrap. We expect an increase in cost of goods manufactured and sold in fiscal year 2013, as compared to fiscal year 2012, as a result of the inclusionof a full year of operations from the former EDT business as well as from an increase in production volumes to support higher sales ofAMPYRA/FAMPYRA and VIVITROL, as well as various other contract manufacturing activities.Research and Development Expense66 ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Research and development programs: BYDUREON $14.1 $0.6 $0.7 $13.5 $(0.1)Other 8.2 0.3 0.4 7.9 (0.1) Research and development revenue $22.3 $0.9 $1.1 $21.4 $(0.2) ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Cost of goods manufactured and sold $127.6 $52.2 $49.4 $(75.4)$(2.8) ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Research and development $141.9 $97.2 $95.4 $(44.7)$(1.8)  The increase in R&D expense in the year ended March 31, 2012, as compared to the year ended March 31, 2011, was primarily due to the additionof $15.5 million of R&D expense for the former EDT business, and an increase in the following expenses from the Old Alkermes business:$13.6 million in clinical study and laboratory expense; $6.8 million in professional service expense; and $9.9 million in employee-related expense,partially offset by a $2.8 million decrease in license and collaboration fees. The increase in clinical study, laboratory and professional service expensewas primarily due to increased activity related to our ALKS 37 and ALKS 9070 development programs, and the increase in employee-related expense isprimarily due to an increase in headcount within the Old Alkermes business and share-based compensation expense as recent equity grants wereawarded with a higher grant-date fair value than older grants. The decrease in license and collaboration fees was primarily due to a decrease in expenseunder a collaboration agreement with Acceleron Pharma, Inc. ("Acceleron"). The increase in R&D expenses for the year ended March 31, 2011, as compared to the year ended March 31, 2010, was primarily due to anincrease of $11.7 million in internal clinical and preclinical study, laboratory and license and collaboration expenses, a $7.3 million increase inprofessional services and a $7.0 million increase in employee-related expenses. The increase in internal clinical and preclinical study, laboratory andlicense and collaboration expenses was primarily due to an increase in the number of, and composition of, ongoing clinical and preclinical studies. Theincrease in professional services was primarily due to activities related to the approval of VIVITROL for opioid dependence, and the increase inemployee-related expenses was primarily due to an increase in share-based compensation expense due to recent equity grants awarded with a highergrant date fair value than older grants, as well as the exclusion of certain prior grants that have vested and are no longer included in share-basedcompensation expense. These increases were partially offset by $24.0 million in savings in depreciation, relocation and occupancy as a result of therelocation of our corporate headquarters from Cambridge, Massachusetts to Waltham, Massachusetts in fiscal year 2010. We expect a modest increase in R&D expense in the year ended March 31, 2013 primarily due to increased R&D investment as certain of our keydevelopment programs, notably ALKS 9070, ALKS 37 and ALKS 5461 continue to advance through the pipeline and due to the inclusion of a full yearof operations from the former EDT business. A significant portion of our R&D expenses (including laboratory supplies, travel, dues and subscriptions, recruiting costs, temporary help costs,consulting costs and allocable costs such as occupancy and depreciation) are not tracked by project as they benefit multiple projects or our technologiesin general. Expenses incurred to purchase specific services from third parties to support our collaborative R&D activities are tracked by project and arereimbursed to us by our partners. We generally bill our partners under collaborative arrangements using a negotiated Full Time Equivalent ("FTE"), orhourly rate. This rate has been established by us based on our annual budget of employee compensation, employee benefits and the billable non-project-specific costs mentioned above and is generally increased annually based on increases in the consumer price index. Each collaborative partner is billedusing a negotiated FTE or hourly rate for the hours worked by our employees on a particular project, plus direct external costs, if any. We account forour R&D expenses on a departmental and functional basis in accordance with our budget and management practices.Selling, General and Administrative Expense The increase in selling, general and administrative ("SG&A") costs for the year ended March 31, 2012, as compared to the year ended March 31,2011, was primarily due to an increase of $24.7 million67 ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Selling, general and administrative $137.6 $82.8 $76.5 $(54.8)$(6.3) in professional service expense, $8.0 million in employee-related expenses and $3.0 million in marketing expense from the Old Alkermes business, aswell as the addition of $18.3 million of SG&A expense for the former EDT business. The increase in professional service was primarily due to costsincurred in connection with the Business Combination. The increase in employee-related expense was primarily due to an increase in headcount andshare-based compensation expense as recent equity grants were awarded with a higher grant-date fair value than older grants, and the increase inmarketing expenses was due to an analysis we performed to determine the marketability of our existing products and product candidates. The increase in SG&A expense for the year ended March 31, 2011, as compared to the year ended March 31, 2010, was primarily due to anincrease in employee-related expenses of $5.2 million and marketing expenses of $4.1 million, partially offset by a reduction in professional services of$3.9 million. The increase in employee-related expenses was primarily due to an increase in share-based compensation as recent equity grants have beenawarded with a higher grant date fair value than older grants. The increase in marketing expenses was primarily due to costs incurred leading up to thelaunch of VIVITROL for opioid dependence, and the decrease in professional services was primarily due to start-up costs related to thecommercialization of VIVITROL for the alcohol indication during the year ended March 31, 2010, that were not incurred during the year endedMarch 31, 2011. We expect an increase in SG&A expense in the year ended March 31, 2013 as a result of the inclusion of a full year of operations from the formerEDT business.Amortization and Impairment of Acquired Intangible Assets In connection with the Business Combination, we acquired certain amortizable intangible assets with a fair value of $643.2 million, which areexpected to be amortized over 12 to 13 years. We amortize our amortizable intangible assets using the economic use method, which reflects the patternthat the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. During the year endedMarch 31, 2012, we had $25.4 million of amortization expense related to the intangible assets acquired as part of the Business Combination. Basedupon our most recent analysis, amortization of intangible assets included within our consolidated balance sheet at March 31, 2012, is expected to be inthe range of approximately $40.0 million to $70.0 million annually through fiscal year 2017. In connection with the Business Combination, we acquired IPR&D of $45.8 million, which related to three EDT product candidates includingMegestrol for use in Europe at a value of $28.8 million. During the fourth quarter of fiscal year 2012, and after finalization of the purchase accountingfor the Business Combination, we identified events and changes in circumstance, such as correspondence from regulatory authorities and further clinicaltrial results related to three product candidates, including Megestrol for use in Europe, acquired as part of the Business Combination which indicatedthat the assets may be impaired. Accordingly, we performed an analysis to measure the amount of the impairment loss, if any. We performed thevaluation of the IPR&D from the viewpoint of a market participant through the use of a discounted cash flow model. The model contained certain keyassumptions including the cost to bring the products through the clinical trial and regulatory approval process; the gross margin a market participantwould likely earn if the product were approved for sale; the cost to sell the approved product and a discount factor based on an industry averageweighted average cost of capital. Based on the analysis performed, we determined that the IPR&D was impaired68 ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Amortization and impairment of acquiredintangible assets $71.2 $— $— $(71.2)$— and recorded an impairment charge of $45.8 million within "Amortization and impairment of acquired intangible assets." We also acquired $92.7 million of goodwill in connection with the Business Combination, which is considered an indefinite-lived asset and is notamortized, but is subject to an annual review for impairment or when circumstances indicate the fair value may be below its carrying value. As a resultof a qualitative assessment we performed as of October 31, 2011, we determined that it was not more-likely-than-not that the fair value of the reportingunit was less than its carrying amount, and an impairment of our goodwill was not recorded.Other (Expense) Income The increase in interest expense for the year ended March 31, 2012, as compared to the year ended March 31, 2011, was primarily due to our entryinto $450.0 million of term loan financing in July 2011. The $310.0 million First Lien Term Loan has a principal amount of $310.0 million and aninterest rate of three-month LIBOR plus 5.25%, and the $140.0 million Second Lien Term Loan has a principal amount of $140.0 million and an interestrate of three-month LIBOR plus 8.00%. Under the Term Loans, three-month LIBOR is subject to an interest rate floor of 1.50%. The Term Loansbecame effective upon the closing of the Business Combination in September 2011. Included in interest expense during the year ended March 31, 2012are commitment fees of $5.9 million which were incurred during the period from when we priced the Term Loans to when the Term Loans werefunded. We expect interest expense to increase in fiscal year 2013, as fiscal year 2013 will include a full year of interest expense on the $450.0 millionprincipal balance of the Term Loans. Beyond fiscal year 2013, we anticipate that interest expense will decrease as the Term Loans are paid down,assuming a consistent LIBOR rate. The decrease in interest expense for the year ended March 31, 2011, as compared to the year ended March 31, 2010, was primarily due to the earlyredemption of our non-recourse 7% Notes on July 1, 2010. As a result of this transaction, we recorded charges of $1.4 million relating to the write-offof the unamortized portion of deferred financing costs and $0.8 million primarily related to the premium paid on the redemption of the non-recourse 7%Notes. The decrease in interest income during the year ended March 31, 2011, as compared to the year ended March 31, 2010, due to a lower averagebalance of cash and investments and lower interest rates earned during the year ended March 31, 2011, as compared to the year ended March 31, 2010.Provision for Income Taxes69 ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Interest income $1.5 $2.7 $4.7 $(1.2)$(2.0)Interest expense (28.1) (3.3) (6.0) (24.8) 2.7 Other income (expense), net 0.5 (0.3) (0.4) 0.8 0.1 Total other expense, net $(26.1)$(0.9)$(1.7)$(25.2)$0.8 ChangeFavorable/(Unfavorable) Years Ended March 31, 2012 - 2011 2011 - 2010 (in millions) 2012 2011 2010 Income tax benefit $(0.7)$(1.0)$(5.1)$(0.3)$(4.1)  Our income tax benefit for the year ended March 31, 2012 consists of a current income tax provision of $14.0 million and a deferred income taxbenefit of $14.7 million. The current income tax provision is primarily due to a provision of $13.1 million on the taxable transfer of the BYDUREONintellectual property from the U.S. to Ireland The deferred tax benefit is primarily due to a benefit of $4.6 million from the partial release of the Irishdeferred tax liability relating to acquired intellectual property that was established in connection with the Business Combination and a benefit of $9.9million due to the partial release of an existing U.S. Federal valuation allowance as a consequence of the Business Combination. In connection with theBusiness Combination, we were incorporated, and are headquartered, in Dublin, Ireland. As a result, our statutory tax rate decreased from 34% in theU.S. to 12.5% in Ireland. The income tax benefit of $1.0 million for the year ended March 31, 2011 was primarily related to a $0.8 million current tax benefit for bonusdepreciation pursuant to the U.S. Small Business Jobs Act of 2010. The income tax benefit of $5.1 million for the year ended March 31, 2010 primarilyconsisted of a current federal income tax benefit of $3.3 million and a deferred federal and state tax benefit of $1.8 million. The current federal incometax benefit was the result of a carryback of our 2010 alternative minimum tax ("AMT") NOL pursuant to the U.S. Worker, Homeownership andBusiness Act of 2009. This law increased the carryback period for certain NOLs from two years to five years. Prior to the adoption of this law, we hadrecorded a full valuation allowance against the credits that were established in prior periods when we were subject to AMT provisions. The deferredfederal and state tax benefit was due to our recognition of a $1.8 million income tax expense associated with the increase in the value of certain securitiesthat we carried at fair market value during the year ended March 31, 2010. This income tax expense was recorded in other comprehensive (loss) income. As of March 31, 2012, we had $441.4 million of Irish NOL carryforwards, $107.3 million of U.S. federal NOL carryforwards, $15.4 million ofstate NOL carryforwards, and $18.7 million of other foreign NOL and capital loss carryforwards, which either expire on various dates through 2032 orcan be carried forward indefinitely. These loss carryforwards are available to reduce certain future Irish, U.S. and foreign taxable income, if any. Theseloss carryforwards are subject to review and possible adjustment by the appropriate taxing authorities. These loss carryforwards, which may be utilizedin any future period, may be subject to limitations based upon changes in the ownership of our stock. We have performed a review of ownershipchanges in accordance with the U.S. Internal Revenue Code and have determined that it is more likely than not that, as a result of the BusinessCombination, we have experienced a change of ownership. As a consequence, our U.S. federal NOL carryforwards and tax credit carryforwards aresubject to an annual limitation of $127.0 million.Liquidity and Capital Resources Our financial condition is summarized as follows:70(in millions) March 31,2012 March 31,2011 Cash and cash equivalents $83.6 $38.4 Investments—short-term 106.8 162.9 Investments—long-term 55.7 93.4 Total cash, cash equivalents and investments $246.1 $294.7 Working capital $250.0 $204.9 Outstanding borrowings—current and long-term $444.5 $—  Our cash flows for the years ended March 31, 2012, 2011 and 2010 were as follows: The decrease in cash used in operating activities during the year ended March 31, 2012, as compared to the year ended March 31, 2011 was due toan increase in the amount of cash received from our customers, partially offset by an increase in the amount of cash paid to our employees andsuppliers. Both the increase in cash from our customers and cash payments to our suppliers and employees is primarily due to the BusinessCombination. The increase in cash used by investing activities in the year ended March 31, 2012, as compared to the year ended March 31, 2011, wasprimarily due to the $500.0 million of cash we paid to acquire EDT and a $7.6 million increase in cash used to acquire property, plant and equipment,partially offset by a $79.7 million increase in the net sales of investments. The increase in cash provided by financing activities during the year endedMarch 31, 2012, as compared to the year ended March 31, 2011, was primarily due to our entry into the Term Loans and an increase of $12.4 million inthe amount of cash received related to the issuance of ordinary shares related to our share-based arrangements. The decrease in cash used in operating activities during the year ended March 31, 2011, as compared to the year ended March 31, 2010, wasprimarily due to an increase in the amount of cash received from our customers, partially offset by an increase in cash paid to our employees andsuppliers and the early redemption of our non-recourse 7% Notes on July 1, 2010. In addition to a scheduled principal payment of $6.4 million, weredeemed the balance of our non-recourse 7% Notes in full in exchange for $39.2 million, representing 101.75% of the outstanding principal balance inaccordance with the terms of the Indenture for the non-recourse 7% Notes. We allocated $6.6 million of the principal payments made during the yearended March 31, 2011 to operating activities to account for the original issue discount on the non-recourse 7% Notes, and the remaining $45.4 millionof principal payments was allocated to financing activities in the consolidated statement of cash flows. The decrease in cash provided by investing activities during the year ended March 31, 2011, as compared to the year ended March 31, 2010, wasprimarily due to a decrease in the net sales of investments, partially offset by a decrease in property, plant and equipment purchases and our investmentin Acceleron. During the year ended March 31, 2010, we moved our corporate headquarters from Cambridge, Massachusetts, to Waltham,Massachusetts and increased cash expenditures for property, plant and equipment to furnish and equip our new headquarters. During the year endedMarch 31, 2010, we also entered into a collaborative arrangement with Acceleron and made an $8.0 million investment in Acceleron. The increase in cash used in financing activities during the year ended March 31, 2011, as compared to the year ended March 31, 2010, wasprimarily due to the early redemption of our non-recourse 7% Notes, as discussed above.71 Years Ended March 31, (in millions) 2012 2011 2010 Cash and cash equivalents, beginning of period $38.4 $79.3 $86.9 Cash (used in) operating activities (2.5) (5.9) (12.3)Cash (used in) provided by investing activities (417.1) 5.6 28.0 Cash provided by (used in) financing activities 464.8 (40.6) (23.3) Cash and cash equivalents, end of period $83.6 $38.4 $79.3  At March 31, 2012, our investments consisted of the following: Our investment objectives are, first, to preserve liquidity and conservation of capital and, second, to obtain investment income. Our available-for-sale investments consist primarily of short and long-term U.S. government and agency debt securities, debt securities issued by foreign agencies andbacked by foreign governments, corporate debt securities and strategic equity investments, which include the common stock of public companies wehave or had a collaborative arrangement with. Our held-to-maturity investments consist of investments that are restricted and held as collateral undercertain letters of credit related to certain of our lease agreements. Our primary sources of liquidity are cash provided by past operating activities,payments we have received under R&D arrangements and other arrangements with collaborators and private placements of debt securities. We classify available-for-sale investments in an unrealized loss position which do not mature within the upcoming 12 months as long-terminvestments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more likely than not that wewould not be required to sell these securities before recovery of their amortized cost. At March 31, 2012, we performed an analysis of our investmentswith unrealized losses for impairment and determined that they were temporarily impaired. At March 31, 2012, 7% of our investments were valuedusing unobservable, or Level 3, inputs to determine fair value as they were not actively trading and fair values could not be derived from quoted marketprices. The illiquidity of our Level 3 investments does not have a material impact on our overall liquidity, operations, financial flexibility or stability. We expect to incur significant additional R&D costs and other costs as we expand the development of our proprietary product candidates,including costs related to preclinical studies and clinical trials. Our costs, including R&D costs for our product candidates, manufacturing, and sales,marketing and promotional expenses for any current or future products marketed by us or our collaborators, if any, may exceed revenues in the future,which may result in losses from operations. We believe that our current cash and cash equivalents and short and long-term investments, combined withanticipated revenues and anticipated interest income, will generate sufficient cash flows to meet our current anticipated liquidity and capital requirementsfor the foreseeable future. We expect to spend approximately $25.0 million during the year ended March 31, 2013 for capital expenditures. Our capital expenditures werehigher in the year ended March 31, 2012, as compared to the year ended March 31, 2011, due to the addition of the former EDT business. Our capitalexpenditures were higher in the year ended March 31, 2010, as compared to the years ended March 31, 2011, due to the relocation of our corporateheadquarters from Cambridge, Massachusetts to Waltham, Massachusetts, which occurred during the fourth quarter of the year ended March 31, 2010. Amounts included as construction in progress in the consolidated balance sheets primarily include costs incurred for the expansion of ourmanufacturing facilities in Ohio. We continue to evaluate our manufacturing capacity based on expectations of demand for our products and willcontinue to record such amounts within construction in progress until such time as the underlying assets are placed into service, or we determine wehave sufficient existing capacity and the assets are no longer required, at which time we would recognize an impairment charge. We continue toperiodically evaluate whether72 GrossUnrealized AmortizedCost EstimatedFair Value (in millions) Gains Losses Investments—short-term $106.7 $0.1 $— $106.8 Investments—long-term available-for-sale 54.5 0.8 (0.8) 54.5 Investments—long-term held-to-maturity 1.2 — — 1.2 Total $162.4 $0.9 $(0.8)$162.5 facts and circumstances indicate that the carrying value of these long-lived assets to be held and used may not be recoverable.Borrowings At March 31, 2012, our borrowings consisted of $450.0 million of term loan financing under the Term Loans. Please refer to Note 10, Long-TermDebt, in the accompanying Notes to Consolidated Financial Statements for a discussion of our outstanding term loans.Contractual Obligations The following table summarizes our obligations to make future payments under our current contracts at March 31, 2012: As the interest rate on our Term Loans is based on three-month LIBOR, we assumed LIBOR to be 1.5%, which is the LIBOR rate floor under theTerm Loans for the purposes of this table. This table excludes any liabilities pertaining to uncertain tax positions as we cannot make a reliable estimateof the period of cash settlement with the respective taxing authorities. We have $0.8 million of liabilities associated with uncertain tax positions atMarch 31, 2012 and we expect a net reduction in our unrecognized tax benefits in the amount of $0.5 million due to the expected resolution of certainmatters over the next twelve months. In September 2006, we entered into a license agreement with RPI which granted us exclusive rights to a family of opioid receptor compoundsdiscovered at RPI. Under the terms of the agreement, RPI granted us an exclusive worldwide license to certain patents and patent applications relating toits compounds designed to modulate opioid receptors. We are responsible for the continued research and development of any resulting productcandidates. We are obligated to pay annual fees of up to $0.2 million, and tiered royalty payments of between 1% and 4% of annual net sales in theevent any products developed under the agreement are commercialized. In addition, we are obligated to make milestone payments in the aggregate of upto $9.1 million upon certain agreed-upon development events. All amounts paid to RPI to date under this license agreement have been expensed and areincluded in R&D expense. In December 2009, we entered into a collaboration and license agreement with Acceleron which granted us an exclusive license to Acceleron'sproprietary long-acting Fc fusion technology platform, called the MEDIFUSIONTM technology, which is designed to extend the circulating half-life ofproteins and peptides in exchange for a nonrefundable upfront payment of $2.0 million and an equity investment in Acceleron of $8.0 million andcertain potential milestone payments and royalties. In addition, we reimburse Acceleron for any time, at an agreed-upon FTE rate, and materials expenseAcceleron incurs on product development, and we are obligated to make developmental and sales milestone payments in the aggregate of up to$110.0 million per product in the event that certain development and sales goals are achieved. We are also obligated to make tiered royalty payments inthe73Contractual Obligations Total Less ThanOne Year(Fiscal 2013) One toThree Years(Fiscal 2014 -2015) Three toFive Years(Fiscal 2016 -2017) More thanFive Years(AfterFiscal 2018) (in thousands) Term Loans—Principal $449,225 $3,100 $6,200 $6,200 $433,725 Term Loans—Interest 198,228 34,094 67,561 66,723 29,850 Operating leaseobligations 33,473 6,190 7,841 7,442 12,000 Purchase obligations 109,738 91,761 17,977 — — Capital expansionprograms 5,034 5,034 — — — Total contractual cashobligations $795,698 $140,179 $99,579 $80,365 $475,575 mid-single digits on annual net sales in the event any products developed under the agreement are commercialized. Since our initial investment inDecember 2009, we invested an additional $0.7 million in Acceleron. All amounts paid to Acceleron to date under this license and collaborationagreement have been expensed and are included in R&D expense, except for our $8.7 million equity investment which is included in other assets in ourconsolidated balance sheet at March 31, 2012. Due to the contingent nature of the payments under the RPI and Acceleron arrangements, we cannot predict the amount or period in which royalty,milestone and other payments may be made and accordingly they are not included in the table of contractual maturities.Off-Balance Sheet Arrangements At March 31, 2012, we were not a party to any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effecton our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources.Critical Accounting Estimates Our consolidated financial statements are prepared in accordance with GAAP, which require management to make estimates, judgments andassumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. We believe that our most criticalaccounting estimates are in the areas of revenue recognition, investments, share-based compensation and income taxes.Operating Revenues We have entered into a number of collaboration agreements with pharmaceutical companies including Janssen for RISPERDAL CONSTA andINVEGA SUSTENNA/XEPLION, Acorda for AMPYRA/FAMPYRA, Amylin for BYDUREON and Cilag for the resale of VIVITROL in Russiaand the other countries in the CIS. These collaborative arrangements typically include funding of R&D, payments based upon achievement of clinicaland pre-clinical development milestones, manufacturing services, sales milestones and royalties on product sales. On April 1, 2011, we adopted new authoritative guidance on revenue recognition for multiple element arrangements. The guidance, which appliesto multiple element arrangements entered into or materially modified on or after April 1, 2011, amends the criteria for separating and allocatingconsideration in a multiple element arrangement by modifying the fair value requirements for revenue recognition and eliminating the use of the residualmethod. The fair value of deliverables under the arrangement may be derived using a "best estimate of selling price" if vendor specific objectiveevidence and third-party evidence are not available. Deliverables under the arrangement will be separate units of accounting provided that (i) a delivereditem has value to the customer on a stand-alone basis and (ii) if the arrangement includes a general right of return relative to the delivered item, deliveryor performance of the undelivered item is considered probable and substantially in the control of the vendor. We did not enter into any significantmultiple element arrangements or materially modify any of our existing multiple element arrangements during the year ended March 31, 2012. Ourexisting collaboration agreements continue to be accounted for under previously issued revenue recognition guidance for multiple element arrangements,as described below. Whenever we determine that an arrangement should be accounted for as a single unit of accounting, we determine the period over which theperformance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportional performance orstraight-line method. We recognize revenue using the proportional performance method when the level of effort required to complete our performanceobligations under an arrangement can be reasonably estimated and such performance obligations are provided on a best-efforts basis. Earnedarrangement74consideration is typically used as the measure of performance. The amount of revenue recognized under the proportional performance method isdetermined by multiplying the total expected payments under the contract, excluding royalties and payments contingent upon achievement of substantivemilestones, by the ratio of earned arrangement consideration to estimated total arrangement consideration to be earned under the arrangement. Revenueis limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the proportionalperformance method, as of the period ending date. If we cannot reasonably estimate the total arrangement consideration to be earned under an arrangement, we recognize revenue under thearrangement on a straight-line basis over the period we are expected to complete our performance obligations. Revenue is limited to the lesser of thecumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method, as of the periodending date. Significant management judgment is required in determining the consideration to be earned under an arrangement and the period over which we areexpected to complete our performance obligations under an arrangement. Steering committee services that are not inconsequential or perfunctory andthat are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement,if any, in determining the level of effort required in an arrangement and the period over which we expect to complete our aggregate performanceobligations. Many of our collaboration agreements entitle us to additional payments upon the achievement of performance-based milestones. If the achievementof a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaborationconsideration, such as upfront fees and research funding, in our revenue model. Milestones that involve substantial effort on our part and theachievement of which are not considered probable at the inception of the collaboration are considered "substantive milestones." On April 1, 2011, we prospectively adopted the accounting guidance related to the milestone method of revenue recognition for R&Darrangements. Under the milestone method, contingent consideration received from the achievement of a substantive milestone is recognized in itsentirety in the period in which the milestone is achieved, which we believe is more consistent with the substance of our performance under our variouscollaboration agreements. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity's performance oron the occurrence of a specific outcome resulting from the entity's performance, (ii) for which there is substantive uncertainty at the date the arrangementis entered into that the event will be achieved, and (iii) that would result in additional payments being due to us. A milestone is substantive if theconsideration earned from the achievement of the milestone is consistent with our performance required to achieve the milestone, or the increase in valueto the collaboration resulting from our performance, relates solely to our past performance, and is reasonable relative to all of the other deliverables andpayments within the arrangement. Our collaboration agreements with our partners provide for payments to us upon the achievement of developmentmilestones, such as the completion of clinical trials or regulatory approval for drug candidates. As of April 1, 2011, our agreements with partnersincluded potential future payments for development milestones aggregating $17.0 million. Given the challenges inherent in developing and obtainingapproval for pharmaceutical and biologic products, there was substantial uncertainty as to whether any such milestones would be achieved at the timethese collaboration agreements were entered into. In addition, we evaluated whether the development milestones met the remaining criteria to beconsidered substantive. As a result of our analysis, we considered $3.0 million of our development milestones to be substantive and, accordingly, weexpect to recognize as revenue future payments received from such milestones as we achieve each milestone. The election to adopt the milestone methoddid not impact our historical financial position at April 1, 2011. This policy election may result in revenue recognition patterns for future milestones75that are materially different from those recognized for milestones received prior to adoption. During the year ended March 31, 2012, we recognized intorevenue $3.0 million upon the achievement of developmental milestones and an aggregate of $14.0 million upon the achievement of milestones existingat April 1, 2011 where there were no remaining performance obligations under the collaborative arrangements. Milestone payments received prior to April 1, 2011 from arrangements where we have continuing performance obligations have been deferred andare recognized through the application of a proportional performance model where the milestone payment is recognized over the related performanceperiod or, in full, when there are no remaining performance obligations. We make our best estimate of the period of time for the performance period. Wewill continue to recognize milestone payments received prior to April 1, 2011 in this manner. As of March 31, 2012, we have deferred revenue of$4.8 million from milestone payments received prior to April 1, 2011 that will be recognized through the use of a proportional performance modelthrough 2018. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidatedbalance sheets. Although we follow detailed guidelines in measuring revenue, certain judgments affect the application of our revenue policy. Forexample, in connection with our existing collaboration agreements, we have recorded on our balance sheet short-term and long-term deferred revenuebased on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognizedas revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferredrevenue. However, this estimate is based on our current operating plan and, if our operating plan should change in the future, we may recognize adifferent amount of deferred revenue over the next 12-month period. The estimate of deferred revenue also reflects management's estimate of the periods of our involvement in certain of our collaborations. Ourperformance obligations under these collaborations consist of participation on steering committees, the performance of other R&D and manufacturingservices. In certain instances, the timing of satisfying these obligations can be difficult to estimate. Accordingly, our estimates may change in the future.Such changes to estimates would result in a change in revenue recognition amounts. If these estimates and judgments change over the course of theseagreements, it may affect the timing and amount of revenue that we recognize and record in future periods. At March 31, 2012, we had short-term andlong-term deferred revenue of $3.1 million and $7.6 million, respectively, related to our collaborations. Our manufacturing revenues are earned from the sale of products we manufacture for resale by our collaborative partners. Manufacturing revenuesare recognized when persuasive evidence of an arrangement exists, delivery has occurred and title to the product and associated risk of loss has passedto the customer, the sales price is fixed or determinable and collectability is reasonably assured. Certain of our manufacturing revenues are recognizedbased on information supplied to us by our collaborative partners and require estimates to be made. Differences between the actual manufacturingrevenues and estimated manufacturing revenues are reconciled and adjusted for in the period in which they become known. Our royalty revenues are related to the sale of products by our collaborative partners that incorporate our technology. Royalties are earned underthe terms of a license agreement in the period the products are sold by our collaborative partner, and the royalty earned can be reliably measured andcollectability is reasonably assured. Sales information is provided to us by our collaborative partners and may require estimates to be made. Differencesbetween actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known. We recognize revenue from product sales of VIVITROL when persuasive evidence of an arrangement exists, and title to the product andassociated risk of loss has passed to the customer,76which is considered to have occurred when the product has been received by the customer, the sales price is fixed or determinable and collectability isreasonably assured. We sell VIVITROL to pharmaceutical wholesalers, specialty distributors and specialty pharmacies. VIVITROL product sales are recorded net of sales reserves and allowances. Sales of many pharmaceutical products in the U.S. are subject toincreased pricing pressure from managed care groups, institutions, government agencies and other groups seeking discounts. We and otherbiotechnology companies selling products in the U.S. market are required to provide statutorily defined rebates and discounts to various U.S.government agencies in order to participate in the Medicaid program and other government-funded programs. The sensitivity of our estimates can varyby program and type of customer. Estimates associated with Medicaid and other U.S. government allowances may become subject to adjustment in asubsequent period. We record VIVITROL product sales net of the following significant categories of product sales allowances:•Medicaid Rebates—we record accruals for rebates to states under the Medicaid Drug Rebate Program as a reduction of sales when theproduct is shipped into the distribution channel. We rebate individual states for all eligible units purchased under the Medicaid programbased on a rebate per unit calculation, which is based on our Average Manufacturer Price ("AMP"). We estimate expected unit sales andrebates per unit under the Medicaid program and adjust our rebate estimates based on actual unit sales and rebates per unit. To date,actual Medicaid rebates have not differed materially from our estimates; •Chargebacks—wholesaler and specialty pharmacy chargebacks are discounts that occur when contracted customers purchase directlyfrom an intermediary wholesale purchaser. Contracted customers, which consist primarily of federal government agencies purchasingunder the federal supply schedule, generally purchase the product at its contracted price, plus a mark-up from the wholesaler. Thewholesaler, in-turn, charges back to us the difference between the price initially paid by the wholesaler and the contracted price paid tothe wholesaler by the customer. The allowance for wholesaler chargebacks is based on actual and expected utilization of these programs.Wholesaler chargebacks could exceed historical experience and our estimates of future participation in these programs. To date, actualwholesaler chargebacks have not differed materially from our estimates; •Wholesaler Fees—cash consideration, including sales incentives, given by us under distribution service agreements with a number ofwholesaler, distributor and specialty pharmacy customers that provide them with the opportunity to earn discounts in exchange for theperformance of certain services; •Inventory in the channel—we defer the recognition of revenue on shipments of VIVITROL to our customers until the product has leftthe distribution channel. We estimate product shipments out of the distribution channel through data provided by external sources,including information on inventory levels provided by our customers in the distribution channel, as well as prescription information. Inorder to match the cost of goods related to products shipped to customers with the associated revenue, we defer the recognition of thecost of goods to the period in which the associated revenue is recognized.77 Our provisions for VIVITROL sales and allowances reduced gross VIVITROL sales as follows:Investments We hold investments in U.S. government and agency obligations, debt securities issued by non-U.S. agencies and backed by governments outsidethe U.S. and corporate debt securities. In addition, we hold strategic equity investments, which include the common stock of public companies we haveor had a collaborative arrangement with. Substantially all of our investments are classified as "available-for-sale" and are recorded at their estimated fairvalue. The valuation of our available-for-sale securities for purposes of determining the amount of gains and losses is based on the specific identificationmethod. Our held-to-maturity investments are restricted investments held as collateral under certain letters of credit related to our lease arrangements andare recorded at amortized cost. The earnings on our investment portfolio may be adversely affected by changes in interest rates, credit ratings, collateral value, the overall strengthof credit markets and other factors that may result in other-than-temporary declines in the value of the securities. On a quarterly basis, we review the fairmarket value of our investments in comparison to amortized cost. If the fair market value of a security is less than its carrying value, we perform ananalysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of theamortized cost basis. Where we intend to sell a security, or may be required to do so, the security's decline in fair value is deemed to be other-than-temporary, and the full amount of the unrealized loss is recorded within earnings as an impairment loss. Regardless of our intent to sell a security, weperform additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit lossesare identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security.78(In millions) MedicaidRebates Chargebacks WholesalerFees Inventory inthe Channel Other Total Balance, April 1, 2010 $0.4 $0.1 $0.2 $1.8 $0.1 $2.6 Provision: Current Period 3.2 2.4 2.2 2.5 1.9 12.2 Prior Period (0.1) — — — — (0.1) Total 3.1 2.4 2.2 2.5 1.9 12.1 Actual: Current Period (1.9) (2.3) (1.8) — (1.1) (7.1)Prior Period (0.3) (0.1) (0.2) (1.8) (0.1) (2.5) Total (2.2) (2.4) (2.0) (1.8) (1.2) (9.6) Balance, March 31,2011 $1.3 $0.1 $0.4 $2.5 $0.8 $5.1 Provision: Current Period 4.6 4.2 3.9 3.8 3.3 19.8 Prior Period — — — — — — Total 4.6 4.2 3.9 3.8 3.3 19.8 Actual: Current Period (3.3) (4.1) (3.2) — (3.2) (13.8)Prior Period (1.1) (0.1) (0.4) (2.5) (0.7) (4.8) Total (4.4) (4.2) (3.6) (2.5) (3.9) (18.6) Balance, March 31,2012 $1.5 $0.1 $0.7 $3.8 $0.2 $6.3  For equity securities, when assessing whether a decline in fair value below our cost basis is other-than-temporary, we consider the fair marketvalue of the security, the duration of the security's decline and the financial condition of the issuer. We then consider our intent and ability to hold theequity security for a period of time sufficient to recover our carrying value. Where we have determined that we lack the intent and ability to hold anequity security to its expected recovery, the security's decline in fair value is deemed to be other-than-temporary and is recorded within earnings as animpairment loss. We classify our financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values determined by Level 1 inputs utilizequoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs are based on a market approachusing quoted prices obtained from brokers or dealers for similar securities or for securities for which we have limited visibility into their tradingvolumes. Valuations of these financial instruments do not require a significant degree of judgment. Fair values determined by Level 3 inputs utilizeunobservable data points for the asset. Our Level 3 investments are valued using discounted cash flow models that include assumptions such asestimates for interest rates, the timing of cash flows, expected holding periods and risk adjusted discount rates, which include provisions for default andliquidity risk. We also consider assumptions market participants would use in their estimate of fair value, such as collateral underlying the securities, thecreditworthiness of the issuers, associated guarantees, bid and ask prices and callability features. While we believe the valuation methodologies areappropriate, the use of valuation methodologies is highly judgmental and changes in methodologies can have a material impact on our results ofoperations.Share-Based Compensation In connection with valuing stock options, we utilize the Black-Scholes option-pricing model, which requires us to estimate certain subjectiveassumptions. These assumptions include the expected option term, which takes into account both the contractual term of the option and the effect of ouremployees' expected exercise and post-vesting termination behavior, expected volatility of our ordinary shares over the option's expected term, which isdeveloped using both the historical volatility of our ordinary shares and implied volatility from our publicly traded options, the risk-free interest rateover the option's expected term, and an expected annual dividend yield. Due to the differing exercise and post-vesting termination behavior of ouremployees and non-employee directors, we establish separate Black-Scholes input assumptions for three distinct employee populations: our seniormanagement; our non-employee directors; and all other employees. For the year ended March 31, 2012, the ranges in weighted-average assumptionswere as follows: In addition to the above, we apply judgment in developing estimates of award forfeitures. For the year ended March 31, 2012, we used anestimated forfeiture rate of zero for our non-employee directors, 5% for members of senior management and 8.25% for all other employees. For all of the assumptions used in valuing stock options and estimating award forfeitures, our historical experience is generally the starting pointfor developing our assumptions, which may be modified to reflect information available at the time of grant that would indicate that the future isreasonably expected to differ from the past.79Expected option term 5 - 7 yearsExpected stock volatility 47% - 51%Risk-free interest rate 0.82% - 2.50%Expected annual dividend yield —Impairment of Long-Lived Assets We review the carrying value of long-lived assets for potential impairment on a periodic basis and whenever events or changes in circumstancesindicate the carrying value of an asset may not be recoverable. We determine impairment by comparing the projected undiscounted cash flows to begenerated by the asset to its carrying value. If an impairment is identified, a loss is recorded equal to the excess of the asset's net book value over its fairvalue, and the cost basis is adjusted. The estimated future cash flows, based on reasonable and supportable assumptions and projections, requiremanagement's judgment. Actual results could vary from these estimates. Included in our impairment assessment is a review of goodwill. In connection with the acquisition of EDT, we recorded goodwill of $92.7 million,which represented the excess cost of our investment in the net assets of acquired companies over the fair value of the underlying identifiable net assets atthe date of acquisition. Our goodwill balance solely relates to the EDT acquisition in fiscal year 2012. We assess our goodwill balance within our singlereporting unit annually and whenever events or changes in circumstances indicate the carrying value of goodwill may not be recoverable to determinewhether any impairment in this asset may exist and, if so, the extent of such impairment. In performing our annual goodwill impairment assessment, wefirst assess qualitative factors to determine whether it is necessary to perform the current two-step test. If we believe, as a result of our qualitativeassessment, that it is more-likely-than-not that the fair value of the reporting unit is less than its carrying amount, the quantitative impairment test isrequired. Otherwise, no further testing is required. If, based on our qualitative assessment, we are required to proceed to the quantitative assessment; wefirst compare the fair value of our reporting unit to its carrying value. If the carrying value of the net assets assigned to our reporting unit exceeds thefair value of our reporting unit, then the second step of the impairment test is performed in order to determine the implied fair value of our reportingunit's goodwill. If the carrying value of our reporting unit's goodwill exceeds its implied fair value, then the company records an impairment loss equalto the difference. We performed our required annual goodwill impairment assessment during the third quarter of fiscal year 2012. Our amortizable intangible assets include technology and collaborative arrangements that were acquired as part of the Business Combination.These intangible assets are being amortized as revenue is generated from these products, which we refer to as the economic benefit amortization model.This amortization methodology involves calculating a ratio of actual current period sales to total anticipated sales for the life of the product and applyingthis ratio to the carrying amount of the intangible asset. An analysis of the anticipated product sales generated from our amortizable intangible assets isperformed at least annually during our planning cycle, and this analysis serves as the basis for the calculation of our economic benefit amortizationmodel. This analysis is based upon certain assumptions that we evaluate on a periodic basis, such as the anticipated product sales and expected impact ofcompetitor products and our own pipeline product candidates, as well as the issuance of new patents or the extension of existing patents. Although webelieve this process allows us to reliably determine the best estimate of the pattern in which we will consume the economic benefits of our amortizableintangible assets, the model could result in deferring amortization charges to future periods in certain instances, due to continued sales of a product at anominal level after patent expiration or otherwise. Our initial model was completed as part of the Business Combination and based upon this analysis,amortization of our amortizable intangible assets is expected to be in the range of approximately $40.0 million to $70.0 million annually through fiscalyear 2017. We monitor events and expectations regarding product performance. If there are any indications that the assumptions underlying our most recentanalysis would be different than those utilized within our current estimates, our analysis would be updated and may result in a significant change in theanticipated lifetime revenue of the products associated with our amortizable intangible assets. For example, the occurrence of an adverse event couldsubstantially increase the amount of amortization80expense associated with our acquired intangible assets as compared to previous periods or our current expectations, which may result in a significantnegative impact on our future results of operations. We review amounts capitalized as IPR&D for impairment at least annually and whenever events or changes in circumstances indicate that thecarrying value of the assets might not be recoverable. In the event the carrying value of the assets are not expected to be recovered, the assets are writtendown to their estimated fair values. During the fourth quarter of fiscal year 2012, and after finalization of the purchase accounting for the Business Combination, we identified eventsand changes in circumstance, such as correspondence from regulatory authorities and further clinical trial results related to three product candidates,including Megestrol for use in Europe, acquired as part of the Business Combination which indicated that the assets may be impaired. Accordingly, werecorded an impairment charge of $45.8 million within "Amortization and impairment of acquired intangible assets" in the accompanying statement ofoperations and comprehensive loss.Valuation of Intangible Assets Our intangible assets consist primarily of collaboration agreements, technology associated with human therapeutic products and IPR&D productcandidates that we acquired as part of the Business Combination. When significant identifiable intangible assets are acquired, we engage an independentthird-party valuation firm to assist in determining the fair values of these assets as of the acquisition date. Discounted cash flow models are typicallyused in these valuations, which require the use of significant estimates and assumptions, including but not limited to:•estimating the timing of and expected costs to complete the in-process projects; •projecting regulatory approvals; •estimating future cash flows from product sales resulting from completed products and in-process projects; and •developing appropriate discount rates and probability rates by project. We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts andcircumstances as of the acquisition dates. If these projects are not successfully developed, the sales and profitability of the company may be adverselyaffected in future periods. Additionally, the value of the acquired intangible assets may become impaired. We believe that the foregoing assumptionsused in the IPR&D analysis were reasonable at the time of the respective acquisition. No assurance can be given, however, that the underlyingassumptions used to estimate expected product sales, development costs or profitability, or the events associated with such products, will transpire asestimated.Income Taxes We use the asset and liability method of accounting for deferred income taxes. Our most significant tax jurisdictions are the Irish and U.S. federalgovernments and states. Significant estimates are required in determining our provision for income taxes. Some of these estimates are based onmanagement's interpretations of jurisdiction-specific tax laws or regulations and the likelihood of settlement related to tax audit issues. Various internaland external factors may have favorable or unfavorable effects on our future effective income tax rate. These factors include, but are not limited to,changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years' items,likelihood of settlement, and changes in overall levels of income before taxes. In evaluating our ability to recover our deferred tax assets, we consider allavailable positive and negative evidence including our past operating results, the existence of81cumulative income in the most recent fiscal years, changes in the business in which we operate and our forecast of future taxable income. In determiningfuture taxable income, we are responsible for assumptions utilized including the amount of state, federal and international pre-tax operating income, thereversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significantjudgment about the forecasts of future taxable income and are consistent with the plans and estimates that we are using to manage the underlyingbusinesses. At March 31, 2012, we determined, on a jurisdiction by jurisdiction basis, that it is more likely than not that a significant portion of the netdeferred tax assets will not be realized, and a valuation allowance has been recorded. We account for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. Theevaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken orexpected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related toa tax position. We evaluate uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in therelevant facts surrounding the uncertain positions. Our liabilities for uncertain tax positions can be relieved only if the contingency becomes legallyextinguished through either payment to the taxing authority or the expiration of the statute of limitations, the recognition of the benefits associated withthe position meet the more-likely-than-not threshold or the liability becomes effectively settled through the examination process. We consider matters tobe effectively settled once the taxing authority has completed all of its required or expected examination procedures, including all appeals andadministrative reviews; we have no plans to appeal or litigate any aspect of the tax position, and we believe that it is highly unlikely that the taxingauthority would examine or re-examine the related tax position. We also accrue for potential interest and penalties related to unrecognized tax benefits inincome tax expense.Recent Accounting Pronouncements Please refer to Note 2, Summary of Significant Accounting Policies, "New Accounting Pronouncements" in our Consolidated Financial Statementsfor a discussion of new accounting standards.Item 7A. Quantitative and Qualitative Disclosures about Market Risk We hold securities in our investment portfolio that are sensitive to market risks. Our securities with fixed interest rates may have their market valueadversely impacted by a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part tothese factors, our future investment income may fall short of expectation due to a fall in interest rates or we may suffer losses in principal if we areforced to sell securities that decline in market value due to changes in interest rates. However, because we classify our investments in debt securities asavailable-for-sale, no gains or losses are recognized due to changes in interest rates unless such securities are sold prior to maturity or declines in fairvalue are determined to be other-than-temporary. Should interest rates fluctuate by 10%, our interest income would change by approximately$0.2 million over an annual period. Due to the conservative nature of our short-term and long-term investments and our investment policy, we do notbelieve that we have a material exposure to interest rate risk as our investment policies specify credit quality standards for our investments and limit theamount of credit exposure from any single issue, issuer or type of investment. We do not believe that inflation and changing prices have had a material impact on our results of operations, and as over 83% of our investmentsare in debt securities issued by the U.S. government and/or agencies of developed countries, our exposure to liquidity and credit risk is not believed tobe significant.82 In September 2011, we and certain of our subsidiaries, as guarantors, entered into the Term Loans with MSSF as administrative agent and ascollateral agent, MSSF and HSBC as co-syndication agents, joint lead arrangers and joint bookrunners, and various other financial institutions, aslenders. The initial applicable margin for borrowings under the First Lien Term Loan is three-month LIBOR plus 5.25% and three-month LIBOR plus8.00% under the Second Lien Term Loan. Under each of the Term Loans, LIBOR is subject to an interest rate floor of 1.50%. Commencing withcompletion of our first fiscal quarter ending after the Business Combination, the applicable margin under the First Lien Term Loan is subject toadjustment each fiscal quarter, based upon meeting a certain consolidated leverage ratio during the preceding quarter. The applicable margin under theSecond Lien Term Loan is not subject to adjustment. In accordance with the terms of the Term Loans, we entered into two interest rate cap agreements and an interest rate swap agreement to mitigatethe interest rate risk on $225.0 million principal amount of the Term Loans. One interest rate cap, with a notional amount of $65.0 million protects us ifthree-month LIBOR were to reach 1.78% from the date of issuance through December 3, 2012. The second interest rate cap, with a notional amount of$160.0 million protects us if three-month LIBOR were to reach 3% from the date of issuance through December 13, 2013. The interest rate swapprotects us if three-month LIBOR were to reach 2.057% from December 3, 2012 through September 3, 2014. As the three-month LIBOR rate was0.47% at March 31, 2012, the LIBOR floor under the agreement is 1.50%; and as our interest rate cap fixes our interest rate at 1.78% for $65.0 millionprincipal amount and 3.0% for $160.0 million principal amount of our term loans, we do not expect changes in the three-month LIBOR to have amaterial effect on our financial statements through March 31, 2013. We do not use derivative financial instruments for speculative trading purposes. The counterparties to our interest rate cap and interest rate swapcontracts are multinational commercial banks. We believe the risk of counterparty nonperformance is remote.Currency Exchange Rate Risk The manufacturing and royalty revenues we receive on RISPERDAL CONSTA, FAMPYRA, INVEGA SUSTENNA, TRICORE 145 andRITALIN LA are a percentage of the net sales made by our collaborative partners. A significant portion of these sales are made in countries outside theU.S. and are denominated in currencies in which the product is sold, which is predominantly the Euro. The manufacturing and royalty payments onthese non-U.S. sales are calculated initially in the currency in which the sale is made and is then converted into USD to determine the amount that ourpartners pay us for manufacturing and royalty revenues. Fluctuations in the exchange ratio of the USD and these non-U.S. currencies will have theeffect of increasing or decreasing our manufacturing and royalty revenues even if there is a constant amount of sales in non-U.S. currencies. Forexample, if the USD weakens against a non-U.S. currency, then our manufacturing and royalty revenues will increase given a constant amount of salesin such non-U.S. currency. For the year ended March 31, 2012, an average 10% strengthening of the USD relative to the currencies in which theseproducts are sold would have resulted in our manufacturing and royalty revenues being reduced by approximately $11.5 million. For the year endedMarch 31, 2011, an average 10% strengthening of the USD relative to the currencies in which RISPERDAL CONSTA are sold would have resulted inour manufacturing and royalty revenues being reduced by approximately $8.1 million. As a result of the Business Combination, we incur substantial operating costs in Ireland. We face exposure to changes in the exchange ratio of theUSD and the Euro arising from expenses and payables at our Irish operations that are settled in Euro. The impact of changes in the exchange ratio of theUSD and the Euro on our USD denominated manufacturing and royalty revenues earned in countries other than the U.S. is partially offset by theopposite impact of changes in the exchange ratio of the USD and the Euro on operating expenses and payables incurred at our Irish operations that are83settled in Euro. For the fiscal year ended March 31, 2012, an average 10% weakening in the USD relative to the Euro would have resulted in anincrease to our expenses denominated in Euro of $4.7 million.Item 8. Financial Statements and Supplementary Data Selected Quarterly Financial Data84 FirstQuarter SecondQuarter ThirdQuarter FourthQuarter (In thousands, except per share data) Year Ended March 31, 2012 REVENUES: Manufacturing and royalty revenues $48,940 54,039 112,780 110,685 Product sales, net 9,686 9,887 10,597 11,014 Research and development revenue 3,257 8,052 2,266 8,774 Total revenues 61,883 71,978 125,643 130,473 EXPENSES: Cost of goods manufactured and sold 16,219 17,530 42,752 51,077 Research and development 28,050 28,160 40,493 45,190 Selling, general and administrative 31,497 36,234 35,469 34,432 Amortization and impairment of acquired intangible assets(1) — 1,817 11,896 57,442 Total expenses 75,766 83,741 130,610 188,141 OPERATING LOSS (13,883) (11,763) (4,967) (57,668)OTHER INCOME (EXPENSE), NET 591 (6,842) (9,763) (10,097) LOSS BEFORE INCOME TAXES (13,292) (18,605) (14,730) (67,765) INCOME TAX (BENEFIT) PROVISION (54) 3,650 98 (4,408) NET LOSS $(13,238)$(22,255)$(14,828)$(63,357) BASIC AND DILUTED NET LOSS PER SHARE $(0.14)$(0.22)$(0.11)$(0.49) Year Ended March 31, 2011 REVENUES: Manufacturing and royalty revenues $35,808 $42,623 $35,932 $42,477 Product sales, net 6,204 6,469 7,729 8,518 Research and development revenue 268 155 314 143 Total revenues 42,280 49,247 43,975 51,138  All financial statements, other than the quarterly financial data as required by Item 302 of Regulation S-K summarized above, required to be filedhereunder, are filed as an exhibit hereto, are listed under Item 15(a) (1) and (2), and are incorporated herein by reference.Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Not applicable.Item 9A. Controls and Procedures Disclosure Controls and Procedures and Internal Control over Financial ReportingControls and Procedures Our management has evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of ourdisclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended), as ofMarch 31, 2012. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the periodcovered by this report, our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to bedisclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the timeperiods specified in the SEC's rules and forms, and (b) such information is accumulated and communicated to our management, including our principalexecutive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating ourdisclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, canprovide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment inevaluating the cost-benefit relationship of possible controls and procedures.85 FirstQuarter SecondQuarter ThirdQuarter FourthQuarter (In thousands, except per share data) EXPENSES: Cost of goods manufactured and sold 12,665 13,911 12,860 12,749 Research and development 22,977 23,932 22,503 27,827 Selling, general and administrative 19,726 18,436 20,521 24,164 Total expenses 55,368 56,279 55,884 64,740 OPERATING LOSS (13,088) (7,032) (11,909) (13,602)OTHER (EXPENSE) INCOME, NET (379) (1,577) 567 529 LOSS BEFORE INCOME TAXES (13,467) (8,609) (11,342) (13,073) INCOME TAX (BENEFIT) PROVISION (58) (943) 41 9 NET LOSS $(13,409)$(7,666)$(11,383)$(13,082) BASIC AND DILUTED NET LOSS PER SHARE $(0.14)$(0.08)$(0.12)$(0.14) (1)Includes an impairment charge of $45.8 million related to IPR&D acquired as part of the Business Combination during the fourthquarter of fiscal year 2012.Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting during the quarter ended March 31, 2012 that have materially affected, or arereasonably likely to materially affect, our internal control over financial reporting.Management's Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over our financial reporting as defined in Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act as a processdesigned by, or under the supervision of, the issuer's principal executive and principal financial officers, or persons performing similar functions, andeffected by the issuer's board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with GAAP and includes those policies and procedures that:•pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of the assetsof the issuer; •provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance withGAAP, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management anddirectors of the issuer; and •provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer'sassets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluationof effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree ofcompliance with the policies or procedures may deteriorate. Our management assessed the effectiveness of our internal control over financial reporting as of March 31, 2012. In making this assessment,management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO") in Internal Control—Integrated Framework. Based on this assessment, our management has concluded that, as of March 31, 2012, our internal control over financial reporting was effective. The effectiveness of our internal control over financial reporting as of March 31, 2012 has been audited by PricewaterhouseCoopers LLP, anindependent registered public accounting firm, as stated in their report, which is included herein.Item 9B. Other Information None.86PART III Item 10. Directors, Executive Officers and Corporate Governance The information required by this item is incorporated herein by reference to the 2012 Proxy Statement.Item 11. Executive Compensation The information required by this item is incorporated herein by reference to the 2012 Proxy Statement.Item 12. Security Ownership of Certain Beneficial Owners and Management The information required by this item is incorporated herein by reference to the 2012 Proxy Statement.Item 13. Certain Relationships and Related Transactions and Director Independence The information required by this item is incorporated herein by reference to the 2012 Proxy Statement.Item 14. Principal Accounting Fees and Services The information required by this item is incorporated herein by reference to the 2012 Proxy Statement.PART IV Item 15. Exhibits and Financial Statement Schedules 87(a)(1) Consolidated Financial Statements—The consolidated financial statements of Alkermes plc, required by this item are submitted in a separatesection beginning on page F-1 of this Form 10-K. (2) Financial Statement Schedules—All schedules have been omitted because the absence of conditions under which they are required or becausethe required information is included in the consolidated financial statements or notes thereto.SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signedon its behalf by the undersigned, thereunto duly authorized.88ALKERMES PLC By: /s/ RICHARD F. POPSRichard F. PopsChairman and Chief Executive Officer May 18, 2012 POWER OF ATTORNEY Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theRegistrant and in the capacities and on the dates indicated. Each person whose signature appears below in so signing also makes, constitutes and appoints Richard F. Pops and James M. Frates, and each ofthem, his true and lawful attorney-in-fact, with full power of substitution, for him in any and all capacities, to execute and cause to be filed with theSecurities and Exchange Commission any and all amendments to this Form 10-K, with exhibits thereto and other documents in connection therewith,and hereby ratifies and confirms all that said attorney-in-fact or his substitute or substitutes may do or cause to be done by virtue hereof.89Signature Title Date /s/ RICHARD F. POPSRichard F. Pops Chairman and Chief Executive Officer(Principal Executive Officer) May 18, 2012/s/ JAMES M. FRATESJames M. Frates Senior Vice President and Chief FinancialOfficer (Principal Financial and AccountingOfficer) May 18, 2012/s/ DAVID W. ANSTICEDavid W. Anstice Director May 18, 2012/s/ FLOYD E. BLOOMFloyd E. Bloom Director May 18, 2012/s/ ROBERT A. BREYERRobert A. Breyer Director May 18, 2012/s/ GERALDINE HENWOODGeraldine Henwood Director May 18, 2012/s/ PAUL J. MITCHELLPaul J. Mitchell Director May 18, 2012/s/ WENDY L. DIXONWendy L. Dixon Director May 18, 2012/s/ MARK B. SKALETSKYMark B. Skaletsky Director May 18, 2012EXHIBIT INDEX 90Exhibit No. Description of Exhibit 1.1++Form of Underwriting Agreement entered into by and among Citigroup Global Markets Inc.,Jefferies & Company, Inc. and Morgan Stanley & Co. LLC as Representatives of the severalUnderwriters; Elan Science Three Limited, as the Selling Shareholder; and Alkermes plc, as theCompany, dated as of March 8, 2012 (Incorporated by reference to Exhibit 1.1 of the RegistrationStatement on Form S-1, as amended (Registration No. 333-179550), which was declared effective bythe Securities and Exchange Commission on March 2, 2012). 2.1++Business Combination Agreement and Plan of Merger, dated as of May 9, 2011, by and among Elan,Alkermes, Inc., Alkermes plc and certain other parties (Incorporated by reference to Annex A to theproxy statement/prospectus forming a part of the Registration Statement on Form S-4, as amended(Registration No. 333-175078), which was declared effective by the Securities and ExchangeCommission on August 4, 2011.) 3.1++Amended and Restated Memorandum and Articles of Association of Alkermes plc (Incorporated byreference to Exhibit 3.1 to the Alkermes plc Current Report on Form 8-K filed on September 16, 2011.) 4.1++Shareholder's Agreement by and among Elan, Elan Science Three Limited and Alkermes plc(Incorporated by reference to Exhibit 4.1 to the Alkermes plc Current Report on Form 8-K filed onSeptember 16, 2011.) 10.1++Lease, dated as of October 26, 2000, between FC88 Sidney, Inc. and Alkermes, Inc. (Incorporated byreference to Exhibit 10.3 to the Alkermes, Inc. Quarterly Report on Form 10-Q for the quarter endedDecember 31, 2000 (File No. 001-14131).) 10.2++Lease, dated as of October 26, 2000, between Forest City 64 Sidney Street, Inc. and Alkermes, Inc.(Incorporated by reference to Exhibit 10.4 to the Alkermes, Inc. Quarterly Report on Form 10-Q for thequarter ended December 31, 2000 (File No. 001-14131).) 10.3++Lease Agreement, dated as of April 22, 2009 between PDM Unit 850, LLC, and Alkermes, Inc.(Incorporated by reference to Exhibit 10.5 to the Alkermes, Inc. Annual Report on Form 10-K for thefiscal year ended March 31, 2009 (File No. 001-14131).) 10.4++First Amendment to Lease Agreement between Alkermes, Inc. and PDM Unit 850, LLC, dated as ofJune 18, 2009 (Incorporated by reference to Exhibit 10.2 to the Alkermes, Inc. Quarterly Report onForm 10-Q for the quarter ended June 30, 2009 (File No. 001-14131).) 10.5++*License Agreement, dated as of February 13, 1996, between Medisorb Technologies International L.P.and Janssen Pharmaceutica Inc. (U.S.) (assigned to Alkermes, Inc. in July 2006). (Incorporated byreference to Exhibit 10.19 to the Alkermes, Inc. Annual Report on Form 10-K for the fiscal year endedMarch 31, 1996 (File No. 000-19267).) 10.6++*License Agreement, dated as of February 21, 1996, between Medisorb Technologies International L.P.and Janssen Pharmaceutica International (worldwide except United States) (assigned to Alkermes, Inc.in July 2006). (Incorporated by reference to Exhibit 10.20 to the Alkermes, Inc. Annual Report onForm 10-K for the fiscal year ended March 31, 1996 (File No. 000-19267).) 91Exhibit No. Description of Exhibit 10.7++**Manufacturing and Supply Agreement, dated August 6, 1997, by and among Alkermes ControlledTherapeutics Inc. II, Janssen Pharmaceutica International and Janssen Pharmaceutica, Inc. (assigned toAlkermes, Inc. in July 2006). (Incorporated by reference to Exhibit 10.19 to the Alkermes, Inc. AnnualReport on Form 10-K for the fiscal year ended March 31, 2002 (File No. 001-14131).) 10.8++***Third Amendment To Development Agreement, Second Amendment To Manufacturing and SupplyAgreement and First Amendment To License Agreements by and between Janssen PharmaceuticaInternational Inc. and Alkermes Controlled Therapeutics Inc. II, dated April 1, 2000 (assigned toAlkermes, Inc. in July 2006) (with certain confidential information deleted). (Incorporated by referenceto Exhibit 10.5 to the Alkermes, Inc. Quarterly Report on Form 10-Q for the quarter endedDecember 31, 2004 (File No. 001-14131).) 10.9++***Fourth Amendment To Development Agreement and First Amendment To Manufacturing and SupplyAgreement by and between Janssen Pharmaceutica International Inc. and Alkermes ControlledTherapeutics Inc. II, dated December 20, 2000 (assigned to Alkermes, Inc. in July 2006) (with certainconfidential information deleted). (Incorporated by reference to Exhibit 10.4 to the Alkermes, Inc.Quarterly Report on Form 10-Q for the quarter ended December 31, 2004 (File No. 001-14131).) 10.10++**Addendum to Manufacturing and Supply Agreement, dated August 2001, by and among AlkermesControlled Therapeutics Inc. II, Janssen Pharmaceutica International and Janssen Pharmaceutica, Inc.(assigned to Alkermes, Inc. in July 2006). (Incorporated by reference to Exhibit 10.19(b) to theAlkermes, Inc. Annual Report on Form 10-K for the fiscal year ended March 31, 2002 (File No. 001-14131).) 10.11++**Letter Agreement and Exhibits to Manufacturing and Supply Agreement, dated February 1, 2002, byand among Alkermes Controlled Therapeutics Inc. II, Janssen Pharmaceutica International and JanssenPharmaceutica, Inc. (assigned to Alkermes, Inc. in July 2006). (Incorporated by reference toExhibit 10.19(a) to the Alkermes, Inc. Annual Report on Form 10-K for the fiscal year ended March 31,2002 (File No. 001-14131).) 10.12++***Amendment to Manufacturing and Supply Agreement by and between JPI Pharmaceutica International,Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, dated December 22, 2003(assigned to Alkermes, Inc. in July 2006) (with certain confidential information deleted). (Incorporatedby reference to Exhibit 10.8 to the Alkermes, Inc. Quarterly Report on Form 10-Q for the quarter endedDecember 31, 2004 (File No. 001-14131).) 10.13++***Fourth Amendment To Manufacturing and Supply Agreement by and between JPI PharmaceuticaInternational, Janssen Pharmaceutica Inc. and Alkermes Controlled Therapeutics Inc. II, datedJanuary 10, 2005 (assigned to Alkermes, Inc. in July 2006) (with certain confidential informationdeleted). (Incorporated by reference to Exhibit 10.9 to the Alkermes, Inc. Quarterly Report on Form 10-Q for the quarter ended December 31, 2004 (File No. 001-14131).) 10.14++***Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc. and AlkermesControlled Therapeutics Inc. II, dated December 21, 2002 (assigned to Alkermes, Inc. in July 2006)(with certain confidential information deleted). (Incorporated by reference to Exhibit 10.6 to theAlkermes, Inc. Quarterly Report on Form 10-Q for the quarter ended December 31, 2004 (FileNo. 001-14131).) 92Exhibit No. Description of Exhibit 10.15++***Amendment to Agreement by and between JPI Pharmaceutica International, Janssen Pharmaceutica Inc.and Alkermes Controlled Therapeutics Inc. II, dated December 16, 2003 (assigned to Alkermes, Inc. inJuly 2006) (with certain confidential information deleted). (Incorporated by reference to Exhibit 10.7 tothe Alkermes, Inc. Quarterly Report on Form 10-Q for the quarter ended December 31, 2004 (FileNo. 001-14131).) 10.16+++Employment agreement, dated as of December 12, 2007, by and between Richard F. Pops andAlkermes, Inc. (Incorporated by reference to Exhibit 10.1 to the Alkermes, Inc. Quarterly Report onForm 10-Q for the quarter ended December 31, 2007 (File No. 001-14131).) 10.17+++Amendment to Employment Agreement by and between Alkermes, Inc. and Richard F. Pops.(Incorporated by reference to Exhibit 10.5 to the Alkermes, Inc. Current Report on Form 8-K filed onOctober 7, 2008 (File No. 001-14131).) 10.18+++Amendment No. 2 to Employment Agreement by and between Alkermes, Inc. and Richard F. Pops,dated September 10, 2009. (Incorporated by reference to Exhibit 10.2 to the Alkermes, Inc. CurrentReport on Form 8-K filed on September 11, 2009 (File No. 001-14131).) 10.19+++Form of Employment Agreement, dated as of December 12, 2007, by and between Alkermes, Inc. andeach of Kathryn L. Biberstein, Elliot W. Ehrich, M.D., James M. Frates, Michael J. Landine, Gordon G.Pugh. (Incorporated by reference to Exhibit 10.3 to the Alkermes, Inc. Quarterly Report on Form 10-Qfor the quarter ended December 31, 2007 (File No. 001-14131).) 10.20+++Form of Amendment to Employment Agreement by and between Alkermes, Inc. and each of each ofKathryn L. Biberstein, Elliot W. Ehrich, M.D., James M. Frates, Michael J. Landine, Gordon G. Pugh.(Incorporated by reference to Exhibit 10.7 to the Alkermes, Inc. Current Report on Form 8-K filed onOctober 7, 2008 (File No. 001-14131).) 10.21+++Form of Covenant Not to Compete, of various dates, by and between Alkermes, Inc. and each ofKathryn L. Biberstein and James M. Frates. (Incorporated by reference to Exhibit 10.15 to theAlkermes, Inc. Annual Report on Form 10-K for the year ended March 31, 2008 (File No. 001-14131).) 10.22+++Form of Covenant Not to Compete, of various dates, by and between Alkermes, Inc. and each of ElliotW. Ehrich, M.D., Michael J. Landine, and Gordon G. Pugh. (Incorporated by reference toExhibit 10.15(a) to the Alkermes, Inc. Annual Report on Form 10-K for the year ended March 31, 2008(File No. 001-14131).) 10.23+++Form of Indemnification Agreement by and between Alkermes, Inc. and each of its directors andexecutive officers (Incorporated by reference to Exhibit 10.1 to the Alkermes, Inc. Current Report onForm 8-K filed on March 25, 2010 (File No. 001-14131).) 10.24+++Alkermes, Inc. 1998 Equity Incentive Plan as Amended and Approved on November 2, 2006.(Incorporated by reference to Exhibit 10.1 to the Alkermes, Inc. Quarterly Report on Form 10-Q for thefiscal quarter ended December 31, 2006 (File No. 001-14131).) 10.25+++Form of Stock Option Certificate pursuant to Alkermes, Inc. 1998 Equity Incentive Plan. (Incorporatedby reference to Exhibit 10.37 to the Alkermes, Inc. Annual Report on Form 10-K for the fiscal yearended March 31, 2006 (File No. 001-14131).)93Exhibit No. Description of Exhibit 10.26+++Alkermes, Inc. Amended and Restated 1999 Stock Option Plan. (Incorporated by reference toAppendix A to the Alkermes, Inc. Definitive Proxy Statement on Form DEF 14/A filed on July 27,2007 (File No. 001-14131).) 10.27+++Form of Incentive Stock Option Certificate pursuant to the 1999 Stock Option Plan, as amended.(Incorporated by reference to Exhibit 10.35 to the Alkermes, Inc. Annual Report on Form 10-K for thefiscal year ended March 31, 2006 (File No. 001-14131).) 10.28+++Form of Non-Qualified Stock Option Certificate pursuant to the 1999 Stock Option Plan, as amended.(Incorporated by reference to Exhibit 10.36 to the Alkermes, Inc. Annual Report on Form 10-K for thefiscal year ended March 31, 2006 (File No. 001-14131).) 10.29+++Alkermes, Inc. 2002 Restricted Stock Award Plan as Amended and Approved on November 2, 2006.(Incorporated by reference to Exhibit 10.3 to the Alkermes, Inc. Quarterly Report on Form 10-Q for thefiscal quarter ended December 31, 2006 (File No. 001-14131).) 10.30+++Amendment to Alkermes, Inc. 2002 Restricted Stock Award Plan. (Incorporated by reference toAppendix B to the Alkermes, Inc. Definitive Proxy Statement on Form DEF 14/A filed on July 27,2007 (File No. 001-14131).) 10.31+++2006 Stock Option Plan for Non-Employee Directors. (Incorporated by reference to Exhibit 10.4 to theAlkermes, Inc. Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2006 (FileNo. 001-14131).) 10.32+++Amendment to 2006 Stock Option Plan for Non-Employee Directors. (Incorporated by reference toAppendix C to the Alkermes, Inc. Definitive Proxy Statement on Form DEF 14/A filed on July 27,2007 (File No. 001-14131).) 10.33+++Alkermes Fiscal 2012 Reporting Officer Performance Pay Plan. (Incorporated by reference toExhibit 10.1 to the Alkermes, Inc. Current Report on Form 8-K filed on March 24, 2011 (File No. 001-14131).) 10.34+++Amended and Restated Alkermes Fiscal 2012 Reporting Officer Performance Pay Plan. (Incorporatedby reference to Exhibit 10.1 to the Alkermes, Inc. Current Report on Form 8-K filed on May 19, 2011(File No. 001-14131).) 10.35+++Amendment to Amended and Restated Alkermes Fiscal 2012 Reporting Officer Performance Pay Plan(Incorporated by reference to the Alkermes plc Current Report on Form 8-K filed on October 7, 2011(File No. 001-35299).) 10.36+++Alkermes, Inc. 2008 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to theAlkermes, Inc. Current Report on Form 8-K filed on October 7, 2008 (File No. 001-14131).) 10.37+++Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option Award Certificate (Incentive StockOption), as amended (Incorporated by reference to Exhibit 10.27(a) to the Alkermes, Inc. AnnualReport on Form 10-K for the fiscal year ended March 31, 2010 (File No. 001-14131).) 10.38+++Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option Award Certificate (Non-QualifiedOption), as amended (Incorporated by reference to Exhibit 10.27(b) to the Alkermes, Inc. AnnualReport on Form 10-K for the fiscal year ended March 31, 2010 (File No. 001-14131).) 94Exhibit No. Description of Exhibit 10.39+++Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option Award Certificate (Non-EmployeeDirector) (Incorporated by reference to Exhibit 10.4 to the Alkermes, Inc. Current Report on Form 8-Kfiled on October 7, 2008 (File No. 001-14131).) 10.40+++Alkermes, Inc. 2008 Stock Option and Incentive Plan, Restricted Stock Unit Award Certificate (TimeVesting Only). (Incorporated by reference to Exhibit 10.1 to the Alkermes, Inc. Current Report onForm 8-K filed on May 22, 2009 (File No. 001-14131).) 10.41+++Alkermes, Inc. 2008 Stock Option and Incentive Plan, Restricted Stock Unit Award Certificate(Performance Vesting Only). (Incorporated by reference to Exhibit 10.2 to the Alkermes, Inc. CurrentReport on Form 8-K filed on May 22, 2009 (File No. 001-14131).) 10.42++****Development and License Agreement, dated as of May 15, 2000, by and between Alkermes ControlledTherapeutics Inc. II and Amylin Pharmaceuticals, Inc., as amended on October 24, 2005 and July 17,2006 (assigned, as amended, to Alkermes, Inc. in July 2006). (Incorporated by reference toExhibit 10.28 to the Alkermes, Inc. Annual Report on Form 10-K for the fiscal year ended March 31,2010 (File No. 001-14131).) 10.43++First Lien Term Loan Credit Agreement, dated as of September 16, 2011, among Alkermes, Inc., theguarantors party thereto, the lenders party thereto, Morgan Stanley Senior Funding, Inc. asAdministrative Agent and Collateral Agent and the arrangers and agents party thereto (Incorporated byreference to Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K filed on September 16,2011.) 10.44++Second Lien Term Loan Credit Agreement, dated as of September 16, 2011, among Alkermes, Inc., theguarantors party thereto, the lenders party thereto, Morgan Stanley Senior Funding, Inc. asAdministrative Agent and Collateral Agent and the arrangers and agents party thereto (Incorporated byreference to Exhibit 10.2 to the Alkermes plc Current Report on Form 8-K filed on September 16,2011.) 10.45++Intellectual Property Transfer Agreement, dated as of September 15, 2011 between Alkermes, Inc.,Alkermes Controlled Therapeutics, Inc. and Alkermes Pharma Holdings Limited (Incorporated byreference to Exhibit 10.3 to the Alkermes plc Current Report on Form 8-K filed on September 16,2011.) 10.46+++Form of Deed of Indemnification for Alkermes plc Officers (Incorporated by reference to Exhibit 10.1to the Alkermes plc Current Report on Form 8-K filed on September 20, 2011.) 10.47+++Form of Deed of Indemnification for Alkermes plc Directors/Secretary (Incorporated by reference toExhibit 10.2 to the Alkermes plc Current Report on Form 8-K filed on September 20, 2011.) 10.48+++Form of Deed of Indemnification for Alkermes, Inc. and Subsidiaries Directors/Secretary (Incorporatedby reference to Exhibit 10.3 to the Alkermes plc Current Report on Form 8-K filed on September 20,2011.) 10.49+++Fiscal 2012 Alkermes plc Affiliated Company Reporting Officer Performance Pay Plan (Incorporatedby reference to Exhibit 10.4 to the Alkermes plc Current Report on Form 8-K filed on September 20,2011.) Exhibit No. Description of Exhibit 10.50+++Shane Cooke Offer Letter, dated as of September 15, 2011 (Incorporated by reference to Exhibit 10.5 tothe Alkermes plc Current Report on Form 8-K filed on September 20, 2011.) 10.51+++Employment Agreement by and between Alkermes Pharma Ireland Limited and Shane Cooke, dated asof September 16, 2011 (Incorporated by reference to Exhibit 10.6 to the Alkermes plc Current Reporton Form 8-K filed on September 20, 2011.) 10.52+++James L. Botkin Offer Letter, dated as of September 15, 2011 (Incorporated by reference toExhibit 10.7 to the Alkermes plc Current Report on Form 8-K filed on September 20, 2011.) 10.53+++Employment Agreement by and between Alkermes Gainesville LLC and James L. Botkin, dated as ofSeptember 16, 2011 (Incorporated by reference to Exhibit 10.8 to the Alkermes plc Current Report onForm 8-K filed on September 20, 2011.) 10.54+++Alkermes plc 2011 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to theAlkermes plc Current Report on Form 8-K filed on December 8, 2011 (File No. 001-35299)). 10.55+++Employment Agreement by and between Alkermes,Inc. and Mark P. Stejbach, dated as of February 29,2012 (Incorporated by reference to Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K filedon March 5, 2012 (File No. 001-35299)). 10.56+++Offer Letter between Alkermes, Inc. and Mark P. Stejbach, effective as of February 15, 2012(Incorporated by reference to Exhibit 10.2 to the Alkermes plc Current Report on Form 8-K filed onMarch 5, 2012 (File No. 001-35299)). 10.57#Waiver and Consent, dated March 7, 2012. 10.58#Second Waiver and Consent, dated March 8, 2012. 10.59+++Fiscal 2013 Alkermes plc Affiliated Company Reporting Officer Performance Plan (Incorporated byreference to Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K filed on March 30, 2012(File No. 001-35299)). 21.1#List of subsidiaries 23.1#Consent of PricewaterhouseCoopers LLP 24.1 Power of Attorney (included on the signature pages hereto) 31.1#Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 31.2#Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 32.1#Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS**XBRL Instance Document 101.SCH+++XBRL Taxonomy Extension Schema Document 101.CAL+++XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF+++XBRL Taxonomy Extension Definition Linkbase Document 101.LAB+++XBRL Taxonomy Extension Label Linkbase Document9596Exhibit No. Description of Exhibit 101.PRE+++XBRL Taxonomy Extension Presentation Linkbase Document+Indicates a management contract or any compensatory plan, contract or arrangement. ++Previously filed. +++XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement orprospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of theSecurities Exchange Act of 1934, and is not otherwise subject to liability under these Sections. #Filed herewith. *Confidential status has been granted for certain portions thereof pursuant to a Commission Order granted September 3, 1996.Such provisions have been filed separately with the Commission. **Confidential status has been granted for certain portions thereof pursuant to a Commission Order granted September 16, 2002.Such provisions have been separately filed with the Commission. ***Confidential status has been granted for certain portions thereof pursuant to a Commission Order granted September 26, 2005.Such provisions have been filed separately with the Commission. ****Confidential status has been granted for certain portions thereof pursuant to a Commission Order granted June 28, 2010. Suchprovisions have been filed separately with the Commission.Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Alkermes plc.: In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations and comprehensive (loss)income, of shareholder's equity and of cash flows present fairly, in all material respects, the financial position of Alkermes plc. and its subsidiaries atMarch 31, 2012 and 2011, and the results of their operations and their cash flows for each of the three years in the period ended March 31, 2012 inconformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all materialrespects, effective internal control over financial reporting as of March 31, 2012, based on criteria established in Internal Control—IntegratedFramework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company's management is responsiblefor these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internalcontrol over financial reporting, included in Management's Annual Report on Internal Control over Financial Reporting under Item 9A. Ourresponsibility is to express opinions on these financial statements and on the Company's internal control over financial reporting based on our integratedaudits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standardsrequire that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement andwhether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements includedexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used andsignificant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financialreporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testingand evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such otherprocedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions. A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company'sinternal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail,accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions arerecorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts andexpenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) providereasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have amaterial effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of anyevaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that thedegree of compliance with the policies or procedures may deteriorate.Boston, MassachusettsMay 18, 2012F-1ALKERMES PLC AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS March 31, 2012 AND 2011 2012 2011 (In thousands, exceptshare and per shareamounts) ASSETS CURRENT ASSETS: Cash and cash equivalents $83,601 $38,394 Investments—short-term 106,846 162,928 Receivables 96,381 22,969 Inventory 39,759 20,425 Prepaid expenses and other current assets 12,566 8,244 Total current assets 339,153 252,960 PROPERTY, PLANT AND EQUIPMENT, NET 302,995 95,020 INTANGIBLE ASSETS—NET 617,845 — GOODWILL 92,740 — INVESTMENTS—LONG-TERM 55,691 93,408 OTHER ASSETS 26,793 11,060 TOTAL ASSETS $1,435,217 $452,448 LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accrued expenses $79,154 $44,934 Deferred revenue—current 6,910 3,123 Long-term debt—current 3,100 — Total current liabilities 89,164 48,057 LONG-TERM DEBT 441,360 — DEFERRED REVENUE—LONG-TERM 7,578 4,837 DEFERRED TAX LIABILITIES—LONG-TERM 34,512 — OTHER LONG-TERM LIABILITIES 8,751 7,536 Total liabilities 581,365 60,430 COMMITMENTS AND CONTINGENCIES (Note 17) SHAREHOLDERS' EQUITY: Preferred stock, par value, $0.01 per share; 50,000,000 and zero shares authorized; noneissued and outstanding at March 31, 2012 and 2011, respectively — — Ordinary shares, par value, $0.01 per share; 450,000,000 and 160,000,000 sharesauthorized; 130,212,530 and 105,771,507 shares issued; 130,177,452 and 95,702,299shares outstanding at March 31, 2012 and 2011, respectively 1,300 1,055 Non-voting common stock, par value, $0.01 per share; zero and 450,000 sharesauthorized; zero and 382,632 shares issued and outstanding at March 31, 2012 and2011, respectively — 4 Treasury stock, at cost (35,078 and 10,069,208 shares at March 31, 2012 and 2011,respectively) (571) (131,095)Additional paid-in capital 1,380,742 936,295 Accumulated other comprehensive loss (2,713) (3,013)Accumulated deficit (524,906) (411,228) Total shareholders' equity 853,852 392,018 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $1,435,217 $452,448  The accompanying notes are an integral part of these consolidated financial statements.F-2ALKERMES PLC AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Years Ended March 31, 2012, 2011 AND 2010 The accompanying notes are an integral part of these consolidated financial statements.F-3 2012 2011 2010 (In thousands, except per shareamounts) REVENUES: Manufacturing and royalty revenues $326,444 $156,840 $149,917 Product sales, net 41,184 28,920 20,245 Research and development revenue 22,349 880 3,117 Other — — 5,002 Total revenues 389,977 186,640 178,281 EXPENSES: Cost of goods manufactured and sold 127,578 52,185 49,438 Research and development 141,893 97,239 95,363 Selling, general and administrative 137,632 82,847 76,514 Amortization and impairment of acquired intangible assets 71,155 — — Total expenses 478,258 232,271 221,315 OPERATING LOSS (88,281) (45,631) (43,034) OTHER EXPENSE, NET: Interest income 1,516 2,728 4,667 Interest expense (28,111) (3,298) (5,974)Other income (expense), net 484 (290) (360) Total other expense, net (26,111) (860) (1,667) LOSS BEFORE INCOME TAXES (114,392) (46,491) (44,701)PROVISION (BENEFIT) FOR INCOME TAXES (714) (951) (5,075) NET LOSS $(113,678)$(45,540)$(39,626) LOSS PER COMMON SHARE: Basic $(0.99)$(0.48)$(0.42) Diluted $(0.99)$(0.48)$(0.42) WEIGHTED AVERAGE NUMBER OF COMMON SHARESOUTSTANDING: Basic 114,702 95,610 94,839 Diluted 114,702 95,610 94,839 COMPREHENSIVE LOSS: Net loss $(113,678)$(45,540)$(39,626)Unrealized losses on marketable securities: Holding gains (losses), net of tax 627 379 2,998 Less: Reclassification adjustment for losses included in net (loss) income — — 94 Unrealized gains (losses) on marketable securities 627 379 3,092 Unrealized losses on derivative contracts, net of tax (327) — — COMPREHENSIVE LOSS $(113,378)$(45,161)$(36,534) ALKERMES PLC AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITYYears Ended March 31, 2012, 2011 AND 2010 Non-votingCommon Stock Ordinary Shares AccumulatedOtherComprehensiveLoss (Income) Treasury Stock AdditionalPaid-InCapital AccumulatedDeficit Shares Amount Shares Amount Shares Amount Total (In thousands, except share data) BALANCE—March31, 2009 104,044,663 $1,040 382,632 $4 $892,415 $(6,484)$(326,062) (9,508,451)$(126,025)$434,888 Issuance ofcommon stockunder employeestock plans 770,665 7 — — 2,586 — — — — 2,593 Receipt ofAlkermes' stockfor the purchaseof stock optionsor to satisfyminimum taxwithholdingobligationsrelated to stockbased awards — — — — 972 — — (108,410) (972) — Repurchase ofcommon stockfor treasury, atcost — — — — — — — (328,404) (2,684) (2,684)Share-basedcompensation — — — — 14,107 — — — — 14,107 Excess tax benefitfrom share-basedcompensation — — — — 246 — — — — 246 Unrealized gainon marketablesecurities, netof tax of $1,831 — — — — — 3,092 — — — 3,092 Net loss — — — — — — (39,626) — — (39,626)BALANCE—March31, 2010 104,815,328 $1,047 382,632 $4 $910,326 $(3,392)$(365,688) (9,945,265)$(129,681)$412,616 Issuance ofcommon stockunder employeestock plans 956,179 8 — — 4,736 — — — — 4,744 Receipt ofAlkermes' stockfor the purchaseof stock optionsor to satisfyminimum taxwithholdingobligationsrelated to stockbased awards — — — — 1,414 — — (123,943) (1,414) — Share-basedcompensation — — — — 19,819 — — — — 19,819 Unrealized gainon marketablesecurities, netof tax of $225 — — — — — 379 — — — 379 Net loss — — — — — — (45,540) — — (45,540)BALANCE—March31, 2011 105,771,507 $1,055 382,632 $4 $936,295 $(3,013)$(411,228) (10,069,208)$(131,095)$392,018 Issuance ofcommon stockto ElanCorporation, plcin connectionwith thepurchase ofElan DrugTechnologies 31,900,000 319 — — 524,755 — — — — 525,074 Issuance ofordinary sharesunder employeestock plans 2,398,422 24 — — 17,164 — — — — 17,188 Receipt ofAlkermes' stockfor the purchaseof stock optionsor to satisfyminimum taxwithholdingobligationsrelated to stockbased awards — — — — 3,676 — — (205,901) (3,676) — Share-basedcompensation — — — — 28,615 — — — — 28,615 Excess tax benefitfrom share-basedcompensation — — — — 4,335 — — — — 4,335 Conversion ofnon-votingcommon stockto commonstock 382,632 4 (382,632) (4) — — — — — — Cancellation oftreasury stock (10,240,031) (102) — — (134,098) — — 10,240,031 134,200 — Unrealized gainson marketablesecurities, netof tax of $372 — — — — — 627 — — — 627 Unrealized loss oncash flowhedge, net oftax of $(194) — — — — — (327) — — — (327)Net loss — — — — — — (113,678) — — (113,678)BALANCE—March31, 2012 130,212,530 $1,300 — $— $1,380,742 $(2,713)$(524,906) (35,078)$(571)$853,852 The accompanying notes are an integral part of these consolidated financial statements.F-4ALKERMES PLC AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS Years Ended March 31, 2012, 2011 AND 2010 2012 2011 2010 (In thousands) CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(113,678)$(45,540)$(39,626)Adjustments to reconcile net loss to cash flows from operating activities: Share-based compensation expense 28,826 19,832 13,921 Depreciation and amortization 93,684 8,652 25,026 Deferred income taxes (14,556) — — Loss on purchase of non-recourse RISPERDAL CONSTA secured 7%Notes — 841 — Other non-cash charges 4,342 1,861 3,833 Changes in assets and liabilities, excluding the effect of acquisitions: Receivables (14,014) 2,347 (728)Inventory, prepaid expenses and other assets (4,879) 5,211 (4,037)Accounts payable and accrued expenses 11,217 6,954 (2,064)Deferred revenue 6,068 635 (4,753)Other long-term liabilities 508 (88) (1,638)Payment or purchase of non-recourse RISPERDAL CONSTA secured 7%notes attributable to original issue discount — (6,611) (2,181) Cash flows used in operating activities (2,482) (5,906) (12,247) CASH FLOWS FROM INVESTING ACTIVITIES: Additions to property, plant and equipment (16,988) (9,401) (15,787)Proceeds from the sale of equipment 35 395 248 Acquisition of Elan Drug Technologies, net of cash acquired (494,774) — — Investment in Acceleron Pharmaceuticals, Inc. (231) (501) (8,000)Purchases of investments (228,229) (370,375) (465,387)Sales and maturities of investments 323,028 385,511 516,935 Cash flows (used in) provided by investing activities (417,159) 5,629 28,009 CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from the issuance of ordinary shares for share-based compensationarrangements 17,188 4,744 2,593 Excess tax benefit from share-based compensation 4,335 — 246 Proceeds from the issuance of long-term debt 444,100 — — Principal payments of long-term debt (775) — — Payment or purchase of non-recourse RISPERDAL CONSTA secured 7%notes — (45,397) (23,486)Purchase of ordinary shares for treasury — — (2,684) Cash flows provided by (used in) financing activities 464,848 (40,653) (23,331) NET DECREASE IN CASH AND CASH EQUIVALENTS 45,207 (40,930) (7,569)CASH AND CASH EQUIVALENTS—Beginning of period 38,394 79,324 86,893 CASH AND CASH EQUIVALENTS—End of period $83,601 $38,394 $79,324 SUPPLEMENTAL CASH FLOW DISCLOSURE: Cash paid for interest $21,658 $1,684 $4,918 Cash paid for taxes $10,068 $60 $114 Non-cash investing and financing activities: Purchased capital expenditures included in accounts payable and accruedexpenses $3,416 $424 $2,798  The accompanying notes are an integral part of these consolidated financial statements.F-5Investment in Civitas Therapeutics, Inc. $1,547 $1,320 $— Issuance of common stock used in the acquisition of Elan DrugTechnologies $525,074 $— $— ALKERMES PLC AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. THE COMPANY Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to developinnovative medicines that improve patient outcomes. The Company has a diversified portfolio of more than 20 commercial drug products and asubstantial clinical pipeline of product candidates that address central nervous system ("CNS") disorders such as addiction, schizophrenia anddepression. Headquartered in Dublin, Ireland, Alkermes plc has a research and development ("R&D") center and corporate offices in Waltham,Massachusetts and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, Ohio. On September 16, 2011, the business of Alkermes, Inc. and the drug technologies business ("EDT") of Elan Corporation, plc ("Elan") werecombined (this combination is referred to as the "Business Combination", the "acquisition of EDT" or the "EDT acquisition") in a transaction accountedfor as a reverse acquisition with Alkermes, Inc. treated as the accounting acquirer. As a result, the historical financial statements of Alkermes, Inc. areincluded in the comparative prior periods. As part of the Business Combination, Antler Acquisition Corp., a wholly owned subsidiary of the Company,merged with and into Alkermes, Inc. (the "Merger"), with Alkermes, Inc. surviving as a wholly owned subsidiary of the Company. Prior to the Merger,EDT was carved-out of Elan and reorganized under the Company. At the effective time of the Merger, (i) each share of Alkermes, Inc. common stockthen issued and outstanding and all associated rights were canceled and automatically converted into the right to receive one ordinary share of theCompany; (ii) all then-issued and outstanding options to purchase Alkermes, Inc. common stock granted under any stock option plan were convertedinto options to purchase, on substantially the same terms and conditions, the same number of ordinary shares of the Company at the same exercise price;and (iii) all then-issued and outstanding awards of Alkermes, Inc. common stock were converted into awards of the same number, on substantially thesame terms and conditions, of ordinary shares of the Company. As a result, upon consummation of the Merger and the issuance of the ordinary sharesof the Company in exchange for the canceled shares of Alkermes, Inc. common stock, the former shareholders of Alkermes, Inc. owned approximately75% of the Company, with the remaining approximately 25% of the Company owned by a subsidiary of Elan pursuant to the terms of a shareholder'sagreement. Use of the terms such as "us," "we," "our," "Alkermes" or the "Company" in this Annual Report on Form 10-K is meant to refer to Alkermes plcand its subsidiaries, except when the context makes clear that the time period being referenced is prior to September 16, 2011, in which case such termsshall refer to Alkermes, Inc. Prior to September 16, 2011, Alkermes, Inc. was an independent pharmaceutical company incorporated in theCommonwealth of Pennsylvania and traded on the NASDAQ Global Select Stock Market under the symbol "ALKS."2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESPrinciples of Consolidation The consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries: Alkermes Ireland HoldingsLimited, Alkermes Pharma Ireland Limited, Alkermes U.S. Holdings, Inc., Alkermes, Inc., Eagle Holdings USA, Inc., Alkermes Gainesville LLC,Alkermes Controlled Therapeutics, Inc., Alkermes Europe, Ltd., Alkermes Finance Ireland Limited, Alkermes Finance S.A R.L. and Alkermes FinanceIreland (No. 2) Limited. Intercompany accounts and transactions have been eliminated.F-6ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Use of Estimates The preparation of the Company's consolidated financial statements in accordance with accounting principles generally accepted in the UnitedStates ("U.S.") ("GAAP") requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets,liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimatesand judgments and methodologies, including those related to revenue recognition and related allowances, its collaborative relationships, clinical trialexpenses, the valuation of inventory, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxesincluding the valuation allowance for deferred tax assets, valuation of investments and derivative instruments, litigation and restructuring charges. TheCompany bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form thebasis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under differentassumptions or conditions.Cash and Cash Equivalents The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates their market value. TheCompany considers only those investments which are highly liquid, readily convertible into cash and that mature within three months from the date ofpurchase to be cash equivalents.Investments The Company has investments in various types of securities including U.S. government and agency obligations, debt securities issued by foreignagencies and backed by foreign governments and corporate debt securities. The Company also has strategic equity investments which includes thecommon stock of a public company with which the Company has a collaborative arrangement. The Company generally holds its interest-bearinginvestments with major financial institutions and in accordance with documented investment policies. The Company limits the amount of credit exposureto any one financial institution or corporate issuer. At March 31, 2012, substantially all these investments are classified as available-for-sale and arerecorded at fair value. Holding gains and losses on these investments are considered "unrealized" and are reported within "Accumulated othercomprehensive (loss) income," a component of shareholders' equity. The Company uses the specific identification method for reclassifying unrealizedgains and losses into earnings when investments are sold. Certain of the Company's money market funds and held-to-maturity investments are restrictedinvestments held as collateral under letters of credit related to certain of the Company's service provider agreements and lease agreements, respectively,and are included in "Investments—short-term" and "Investments—long-term", respectively, in the consolidated balance sheets. The Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning ofother-than-temporary impairment and its application to certain investments, as required by GAAP. An unrealized loss exists when the current fair valueof an individual security is less than its amortized cost basis. Unrealized losses on available-for-sale securities that are determined to be temporary, andnot related to credit loss, are recorded in accumulated other comprehensive loss.F-7ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) For available-for-sale debt securities with unrealized losses, the Company performs an analysis to assess whether it intends to sell or whether itwould more likely than not be required to sell the security before the expected recovery of the amortized cost basis. If the Company intends to sell asecurity, or may be required to do so, the security's decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized lossis recorded within earnings as an impairment loss. Regardless of the Company's intent to sell a security, the Company performs additional analysis onall securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where theCompany does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. For equity securities, when assessing whether a decline in fair value below the cost basis is other-than-temporary, the Company considers the fairmarket value of the security, the duration of the security's decline, and the financial condition of the issuer. The Company then considers its intent andability to hold the equity security for a period of time sufficient to recover its carrying value. Where the Company has determined that it lacks the intentand ability to hold an equity security to its expected recovery, the security's decline in fair value is deemed to be other-than-temporary and is recordedwithin operations as an impairment loss.Fair Value of Financial Instruments The Company's financial assets and liabilities are recorded at fair value and are classified as Level 1, 2 or 3 within the fair value hierarchy, asdescribed in the accounting standards for fair value measurement. The Company's financial assets and liabilities consist of cash equivalents andinvestments and are classified within the fair value hierarchy as follows: Level 1—these valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of theseproducts do not require a significant degree of judgment. Assets utilizing Level 1 inputs include investments in money market funds, U.S.government and agency debt securities, debt securities issued and backed by foreign governments, and strategic equity investments; Level 2—these valuations are based on a market approach using quoted prices obtained from brokers or dealers for similar securities or forsecurities for which the Company has limited visibility into their trading volumes. Valuations of these financial instruments do not require asignificant degree of judgment. Assets utilizing Level 2 inputs include investments in corporate debt securities that are trading in the creditmarkets; Level 3—these valuations are based on an income approach using certain inputs that are unobservable and are significant to the overall fairvalue measurement. Valuations of these products require a significant degree of judgment. Assets utilizing Level 3 inputs primarily consist ofinvestments in certain corporate debt securities, auction rate securities and asset backed securities that are not trading in the credit markets. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other current assets, accountspayable and accrued expenses approximate fair value due to their short-term nature.F-8ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Inventory Inventory is stated at the lower of cost or market value. Cost is determined using the first-in, first-out method. Included in inventory are rawmaterials used in production of pre-clinical and clinical products, which have alternative future use and are charged to R&D expense when consumed.VIVITROL® inventory that is in the distribution channel is classified as "consigned-out inventory."Property, Plant and Equipment Property, plant and equipment are recorded at cost, subject to review for impairment whenever events or changes in circumstances indicate that thecarrying amount of the assets may not be recoverable. Expenditures for repairs and maintenance are charged to expense as incurred and major renewalsand improvements are capitalized. Depreciation is calculated using the straight-line method over the following estimated useful lives of the assets:Business Acquisitions The Company's consolidated financial statements include the operations of an acquired business after the completion of the acquisition. TheCompany accounts for acquired businesses using the acquisition method of accounting. The acquisition method of accounting for acquired businessesrequires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date, andthat the fair value of acquired in-process research and development ("IPR&D") be recorded on the balance sheet. Also, transaction costs are expensed asincurred. Any excess of the purchase price over the assigned values of the net assets acquired is recorded as goodwill. Contingent consideration, if any,is included within the acquisition cost and is recognized at its fair value on the acquisition date. A liability resulting from contingent consideration isremeasured to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in earnings.Goodwill and Intangible Assets Goodwill represents the excess cost of the Company's investment in the net assets of acquired companies over the fair value of the underlyingidentifiable net assets at the date of acquisition. The Company's goodwill balance solely relates to the EDT acquisition in the fiscal year ended March 31,2012, as described in Note 3, Acquisitions. Goodwill is not amortized but is tested for impairment annually or when events or circumstances indicate thefair value of a reporting unit may be below its carrying value. A reporting unit is an operating segment or sub-segment to which goodwill is assignedwhen initially recorded. In September 2011, the Financial Accounting Standards Board ("FASB") issued guidance related to testing goodwill for impairment. Thisaccounting standard allows an entity to first assess qualitativeF-9Asset group TermBuildings and improvements 15 - 40 yearsFurniture, fixtures and equipment 3 - 10 yearsLeasehold improvements Shorter of useful life orlease termALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)factors to determine whether it is necessary to perform the current two-step test. If an entity believes, as a result of its qualitative assessment, that it ismore-likely-than-not that the fair value of a reporting unit is less than its carrying amount, the quantitative impairment test is required. Otherwise, nofurther testing is required. An entity can choose to perform the qualitative assessment on none, some or all of its reporting units. Moreover, an entity canbypass the qualitative assessment for any reporting unit in any period and proceed directly to step one of the impairment test, and then resumeperforming the qualitative assessment in any subsequent period. This standard is effective for annual and interim goodwill impairment tests performedfor fiscal years beginning after December 15, 2011. However, an entity can choose to early adopt the standard if its annual test date is before theissuance of the final standard, provided that the entity has not yet performed its 2011 annual impairment test or issued its financial statements. TheCompany chose to early adopt the provisions of this standard as it had not yet performed its annual impairment test, which the Company performs as ofOctober 31 each year. The adoption of this standard did not impact the Company's financial position or results of operations. As a result of thequalitative assessment performed as of October 31, 2011, the Company determined that it was not more-likely-than-not that the fair value of thereporting unit was less than its carrying amount, and an impairment of the Company's goodwill was not recorded. The Company's finite-lived intangible assets consist of core developed technology and collaboration agreements and are recorded at fair value at thetime of their acquisition and are stated within its consolidated balance sheets net of accumulated amortization and impairments. The finite-lived intangibleassets are amortized over their estimated useful life using the economic use method, which reflects the pattern that the economic benefits of theintangible assets are consumed as revenue is generated from the underlying patent or contract. The useful lives of the Company's intangible assets areprimarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the potential extension orrenewal of the contract or patent. IPR&D represents the fair value assigned to R&D assets that were acquired prior to their completion. IPR&D isconsidered an indefinite-lived asset and is not amortized but is tested for impairment annually or when events or circumstances indicate the fair valuemay be below its carrying value. If and when development is complete, which generally occurs when regulatory approval to market a product isobtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point intime. The Company's intangible assets were all acquired as part of the EDT acquisition in the fiscal year ended March 31, 2012, as described in Note 3,Acquisitions.Impairment of Long-Lived Assets The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carryingamount of the assets may not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observablemarket value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate thatthe carrying amount of an asset or group of assets is not recoverable. Determination of recoverability is based on an estimate of undiscounted futurecash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recoverthe carrying amount of the assets, the assets are written-down to their estimated fair values. Long-lived assets to be disposed of are carried at fair valueless costs to sell them.F-10ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Asset Retirement Obligations The Company recognized an asset retirement obligation for an obligation to remove leasehold improvements and other related activities at theconclusion of the Company's lease for its AIR® manufacturing facility located in Chelsea, Massachusetts, which it presently subleases. The carryingamount of the asset retirement obligation at March 31, 2012 and 2011, was $1.9 million and $1.7 million, respectively, and is included within "OtherLong-Term Liabilities" in the accompanying consolidated balance sheets. The following table shows changes in the carrying amount of the Company's asset retirement obligation for the years ended March 31, 2012 and2011:Revenue RecognitionCollaborative Arrangements The Company has entered into a number of collaboration agreements with pharmaceutical companies including Ortho-McNeil-JanssenPharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International AG ("Janssen") for RISPERDAL® CONSTA® andINVEGA® SUSTENNA®/XEPLION®, Acorda Therapeutics, Inc. ("Acorda") for AMPYRA®/FAMPYRA®, Amylin Pharmaceuticals, Inc.("Amylin") for BYDUREONTM and Cilag GmbH International ("Cilag") for the resale of VIVITROL in Russia and the other countries in theCommonwealth of Independent States ("CIS"). These collaborative arrangements typically include upfront payments, funding of R&D, payments basedupon achievement of pre-clinical and clinical development milestones, manufacturing services, sales milestones and royalties on product sales. On April 1, 2011, the Company adopted new authoritative guidance on revenue recognition for multiple element arrangements. The guidance,which applies to multiple element arrangements entered into or materially modified on or after April 1, 2011, amends the criteria for separating andallocating consideration in a multiple element arrangement by modifying the fair value requirements for revenue recognition and eliminating the use ofthe residual method. The fair value of deliverables under the arrangement may be derived using a "best estimate of selling price" if vendor specificobjective evidence and third-party evidence is not available. Deliverables under the arrangement will be separate units of accounting provided that (i) adelivered item has value to the customer on a stand-alone basis and (ii) if the arrangement includes a general right of return relative to the delivered item,delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. The Company did not enter intoany significant multiple element arrangements or materially modify any of its existing multiple element arrangements during the year ended March 31,2012. TheF-11(In thousands) CarryingAmount Balance, April 1, 2010 $1,537 Accretion expense 155 Balance, March 31, 2011 $1,692 Accretion expense 170 Balance, March 31, 2012 $1,862 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Company's existing collaboration agreements continue to be accounted for under previously issued revenue recognition guidance for multiple elementarrangements, as described below. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, the Company determines the periodover which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportionalperformance or straight-line method. The Company recognizes revenue using the proportional performance method when the level of effort required tocomplete its performance obligations under an arrangement can be reasonably estimated and such performance obligations are provided on a best-effortsbasis. Earned arrangement consideration is typically used as the measure of performance. The amount of revenue recognized under the proportionalperformance method is determined by multiplying the total expected payments under the contract, excluding royalties and payments contingent uponachievement of substantive milestones, by the ratio of earned arrangement consideration to estimated total arrangement consideration to be earned underthe arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, asdetermined using the proportional performance method, as of the period ending date. If the Company cannot reasonably estimate the total arrangement consideration to be earned under an arrangement, the Company recognizesrevenue under the arrangement on a straight-line basis over the period the Company is expected to complete its performance obligations. Revenue islimited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-linemethod, as of the period ending date. Significant management judgment is required in determining the consideration to be earned under an arrangement and the period over which theCompany is expected to complete its performance obligations under an arrangement. Steering committee services that are not inconsequential orperfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required underan arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete itsaggregate performance obligations. Many of the Company's collaboration agreements entitle it to additional payments upon the achievement of performance-based milestones. If theachievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with othercollaboration consideration, such as upfront payments and research funding, in the Company's revenue model. Milestones that involve substantial efforton the Company's part and the achievement of which are not considered probable at the inception of the collaboration are considered "substantivemilestones." On April 1, 2011, the Company prospectively adopted the accounting guidance related to the milestone method of revenue recognition for R&Darrangements. Under the milestone method, contingent consideration received from the achievement of a substantive milestone is recognized in itsentirety in the period in which the milestone is achieved, which the Company believes is more consistent with the substance of its performance under itsvarious collaboration agreements. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity'sperformance or on the occurrence of a specific outcome resulting from the entity's performance, (ii) for which there is substantive uncertainty at the datethe arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to theF-12ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)entity. A milestone is substantive if the consideration earned from the achievement of the milestone is consistent with the Company's performancerequired to achieve the milestone, or the increase in value to the collaboration resulting from the Company's performance, relates solely to theCompany's past performance, and is reasonable relative to all of the other deliverables and payments within the arrangement. The Company'scollaboration agreements with its partners provide for payments to the Company upon the achievement of development milestones, such as thecompletion of clinical trials or regulatory approval for drug candidates. As of April 1, 2011, the Company's agreements with partners included potentialfuture payments for development milestones aggregating $17.0 million. Given the challenges inherent in developing and obtaining approval forpharmaceutical and biologic products, there was substantial uncertainty as to whether any such milestones would be achieved at the time thesecollaboration agreements were entered into. In addition, the Company evaluated whether the development milestones met the remaining criteria to beconsidered substantive. As a result of the Company's analysis, the Company considers $3.0 million of its development milestones to be substantive and,accordingly, the Company expects to recognize as revenue future payments received from such milestones as it achieves each milestone. The election toadopt the milestone method did not impact the Company's historical financial position at April 1, 2011. This policy election may result in revenuerecognition patterns for future milestones that are materially different from those recognized for milestones received prior to adoption. During the yearended March 31, 2012, the Company recognized into revenue $3.0 million upon the achievement of developmental milestones and an aggregate of$14.0 million upon the achievement of milestones existing at April 1, 2011, where there were no remaining performance obligations under thecollaborative arrangements. Milestone payments received prior to April 1, 2011 from arrangements where the Company has continuing performance obligations have beendeferred and are recognized through the application of a proportional performance model where the milestone payment is recognized over the relatedperformance period or, in full, when there are no remaining performance obligations. The Company makes its best estimate of the period of time for theperformance period. The Company will continue to recognize milestone payments received prior to April 1, 2011 in this manner. As of March 31, 2012,the Company has deferred revenue of $4.8 million from milestone payments received prior to April 1, 2011 that will be recognized through the use of aproportional performance model through 2018. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidatedbalance sheets. Although the Company follows detailed guidelines in measuring revenue, certain judgments affect the application of its revenue policy.For example, in connection with the Company's existing collaboration agreements, the Company has recorded on its balance sheet short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that areexpected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months areclassified as long-term deferred revenue. However, this estimate is based on the Company's current operating plan and, if its operating plan shouldchange in the future, the Company may recognize a different amount of deferred revenue over the next 12-month period.F-13ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) The estimate of deferred revenue also reflects management's estimate of the periods of the Company's involvement in certain of its collaborations.The Company's performance obligations under these collaborations consist of participation on steering committees and the performance of otherresearch and development services. In certain instances, the timing of satisfying these obligations can be difficult to estimate. Accordingly, theCompany's estimates may change in the future. Such changes to estimates would result in a change in revenue recognition amounts. If these estimatesand judgments change over the course of these agreements, it may affect the timing and amount of revenue that the Company recognizes and records infuture periods. At March 31, 2012, the Company had short-term and long-term deferred revenue of $3.1 million and $7.6 million, respectively, relatedto its collaborations. Manufacturing revenues—The Company recognizes manufacturing revenues from the sale of products it manufactures for resale by itscollaborative partners. Manufacturing revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred and title to theproduct and associated risk of loss has passed to the customer, the sales price is fixed or determinable and collectability is reasonably assured. Certain ofthe Company's manufacturing revenues are recognized by the Company based on information supplied to the Company by its collaborative partners andrequire estimates to be made. Differences between the actual manufacturing revenues and estimated manufacturing revenues are reconciled and adjustedfor in the period in which they become known. Royalty revenue—The Company recognizes royalty revenues related to the sale of products by its collaborative partners that incorporates theCompany's technology. Royalties are earned under the terms of a license agreement in the period the products are sold by the Company's collaborativepartner and collectibility is reasonably assured. Certain of the Company's royalty revenues are recognized by the Company based on informationsupplied to the Company by its collaborative partners and require estimates to be made. Differences between the actual royalty revenues and estimatedroyalty revenues are reconciled and adjusted for in the period in which they become known. Research and development revenue—R&D revenue consists of funding that compensates the Company for formulation, pre-clinical and clinicaltesting under R&D arrangements. The Company generally bills its partners under R&D arrangements using a single full-time equivalent ("FTE") orhourly rate, plus direct external costs, if any.Product Sales, net The Company's product sales consist of sales of VIVITROL in the U.S. to wholesalers, specialty distributors and specialty pharmacies. Productsales are recognized from the sale of VIVITROL when persuasive evidence of an arrangement exists, title to the product and associated risk of loss haspassed to the customer, which is considered to occur when the product has been received by the customer, the sales price is fixed or determinable, andcollectability is reasonably assured. The Company defers the recognition of product sales on shipments of VIVITROL to its customers until the producthas left the distribution channel, as it does not yet have sufficient sales history to reasonably estimate returns related to these shipments. The Companyestimates product shipments out of the distribution channel through data provided by external sources, including information on inventory levelsprovided by its customers in the distribution channel, as well as prescription information. In order to match the cost of goods sold related to productsshipped to customers with the associated revenue, the Company defers the recognition of the cost of goods sold to the period in which the associatedrevenue is recognized.F-14ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) The Company records its product sales net of the following significant categories of sales discounts and allowances as a reduction of product salesat the time VIVITROL is shipped into the distribution channel, and are adjusted for inventory in the distribution channel:•Medicaid Rebates—the Company records accruals for rebates to states under the Medicaid Drug Rebate Program as a reduction of saleswhen the product is shipped into the distribution channel. The Company rebates individual states for all eligible units purchased underthe Medicaid program based on a rebate per unit calculation, which is based on its Average Manufacturer Price ("AMP"). The Companyestimates expected unit sales and rebates per unit under the Medicaid program and adjusts its rebate estimates based on actual unit salesand rebates per unit. •Chargebacks—wholesaler, specialty pharmacy and distributor, or intermediary, chargebacks are discounts that occur when contractedcustomers purchase directly from an intermediary. Contracted customers, which include federal government agencies purchasing underthe federal supply schedule, generally purchase the product at its contracted price, plus a mark-up from the intermediary. Theintermediary, in-turn, charges back to the Company the difference between the price initially paid by the intermediary and the contractedprice paid to the intermediary by the customer. The allowance for chargebacks is based on actual and expected utilization of theseprograms. Chargebacks could exceed historical experience and the Company's estimates of future participation in these programs. Todate, actual chargebacks have not differed materially from the Company's estimates. •Wholesaler Fees—cash consideration, including sales incentives and discounts, given by the Company under distribution serviceagreements with a number of wholesaler, distributor and specialty pharmacy customers that provide them with the opportunity to earndiscounts in exchange for the performance of certain services.Risk-management instruments On September 16, 2011, the Company entered into a $310.0 million first lien term loan facility (the "First Lien Term Loan") and a $140.0 millionsecond lien term loan facility (the "Second Lien Term Loan" and, together with the First Lien Term Loan, the "Term Loans"). Interest on the TermLoans is at a rate equal to an applicable margin plus three-month LIBOR. The Company addressed its risk to exposure to fluctuations in interest rates byentering into certain derivative financial instruments, the objective of which is to limit the impact of fluctuations in interest rates on earnings. TheCompany's derivative activities are initiated within the guidelines of documented corporate risk management policies and do not create additional riskbecause gains and losses on derivative contracts offset losses and gains on the liabilities being hedged. During the year ended March 31, 2012, the Company entered into an interest rate swap contract that was designated and qualified as a cash flowhedge. The Company reviews the effectiveness of its derivatives on a quarterly basis. The effective portion of gains or losses on the Company's cashflow hedge is reported as a component of accumulated other comprehensive loss and reclassified into earnings in the same period the hedged transactionaffects earnings. Hedge ineffectiveness is immediately recognized in earnings.F-15ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) During the year ended March 31, 2012, the Company entered into two interest rate cap contracts that were not designated as hedging instruments.The interest rate caps are recorded at fair value with associated gains or losses recognized in other income/(expense) during the period of change.Foreign Currency The Company's functional and reporting currency is the U.S. dollar. Transactions in foreign currencies are recorded at the exchange rate prevailingon the date of the transaction. The resulting monetary assets and liabilities are translated into U.S. dollars at exchange rates prevailing on the subsequentbalance sheet date. Gains and losses as a result of translation adjustments are recorded within "Other income (expense)" in the accompanyingconsolidated statement of operations and comprehensive loss. During the years ended March 31, 2012, 2011 and 2010, the Company recorded a gainon foreign currency translation of $0.5 million, none and none, respectively.Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk are accounts receivable and marketable securities.Billings to large pharmaceutical and biotechnology companies account for the majority of the Company's accounts receivable, and collateral is generallynot required from these customers. To mitigate credit risk, the Company monitors the financial performance and credit worthiness of its customers. Thefollowing represents revenue and receivables from the Company's customers exceeding 10% of the total in each category as of, and for the years ended,March 31: The Company generally holds its interest-bearing investments with major financial institutions and in accordance with documented investmentpolicies, the Company limits the amount of credit exposure to any one financial institution or corporate issuer. The Company's investment objectives are,first, to assure liquidity and conservation of capital and, second, to obtain investment income.F-16 2012 2011 2010 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 30% 48% 75% 83% 86% 83%Acorda 11% — — — — — ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Geographic Information Company revenues by geographic location, as determined by the location of the customer, and the location of its long-term assets, excludingfinancial instruments and deferred taxes, are as follows:Research and Development Expenses The Company's R&D expenses include internally and externally generated costs incurred in conjunction with the development of the Company'stechnologies, proprietary product candidates, collaborators' product candidates and in-licensing arrangements. Internally generated costs includeemployee compensation and benefits, laboratory supplies, temporary help costs, external research costs, consulting costs, occupancy costs, depreciationexpense and other allocable costs directly related to the Company's R&D activities. External research costs relate to toxicology and pharmacokineticstudies and clinical trials that are performed for the Company under contract by external companies, hospitals or medical centers as well as upfront feesand milestones paid to collaborators. A significant portion of the Company's internally generated R&D expenses (including laboratory supplies, travel, dues and subscriptions,recruiting costs, temporary help costs, consulting costs and allocable costs such as occupancy and depreciation) are not tracked by project as they benefitmultiple projects or the Company's technologies in general. Externally generated R&D expenses are tracked by project and certain of these expenses arereimbursed to the Company by its partners. The Company accounts for its R&D expenses on a departmental and functional basis in accordance with itsbudget and management practices. All such costs are expensed as incurred.Share-Based Compensation The Company's share-based compensation programs grant awards which include stock options and restricted stock units ("RSU"), which vestwith the passage of time and, to a limited extent, vest based on the achievement of certain performance or market criteria. Certain of the Company'semployees are retirement eligible under the terms of the Company's stock option plans (the "Plans") and stock option awards to these employeesgenerally vest in full upon retirement. Since there are no effective future service requirements for these employees, the fair value of these awards isexpensed in full on the grant date.F-17 Year Ended March 31, (in thousands) 2012 2011 2010 Revenue by region: U.S. $212,859 $76,701 $81,674 Ireland 12,695 805 999 Rest of world 164,423 109,135 95,608 Total long-term assets by region: Ireland $171,751 $— $— U.S. 117,894 106,080 108,502 Rest of world — — — ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Stock Options Stock option grants to employees generally expire ten years from the grant date and generally vest one-fourth per year over four years from theanniversary of the date of grant, provided the employee remains continuously employed with the Company, except as otherwise provided in the plan.Stock option grants to directors are for ten-year terms and generally vest over a one year period provided the director continues to serve on theCompany's board of directors through the vesting date, except as otherwise provided in the plan. The estimated fair value of options is recognized overthe requisite service period, which is generally the vesting period. Share-based compensation expense is based on awards ultimately expected to vest.Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from thoseestimates. The fair value of stock option grants is based on estimates as of the date of grant using a Black-Scholes option valuation model. The Companyuses historical data as the basis for estimating option terms and forfeitures. Separate groups of employees that have similar historical stock optionexercise and forfeiture behavior are considered separately for valuation purposes. The ranges of expected terms disclosed below reflect differentexpected behavior among certain groups of employees. Expected stock volatility factors are based on a weighted average of implied volatilities fromtraded options on the Company's ordinary shares and historical stock price volatility of the Company's ordinary shares, which is determined based on areview of the weighted average of historical daily price changes of the Company's ordinary shares. The risk-free interest rate for periods commensuratewith the expected term of the share option is based on the U.S. treasury yield curve in effect at the time of grants. The dividend yield on the Company'sordinary shares is estimated to be zero as the Company has not paid and does not expect to pay dividends. The exercise price of options granted prior toOctober 7, 2008 equals the average of the high and low of the Company's ordinary shares traded on the NASDAQ Select Stock Global Market on thedate of grant. Beginning with the adoption of the Alkermes, Inc. 2008 Stock Option and Incentive Plan (the "2008 Plan"), the exercise price of optiongrants made after October 7, 2008 is equal to the closing price of the Company's ordinary shares traded on the NASDAQ Select Stock Global Marketon the date of grant. The fair value of each stock option grant was estimated on the grant date with the following weighted-average assumptions:Time-Vested Restricted Stock Units Time-vested RSUs awarded to employees generally vest one-fourth per year over four years from the anniversary of the date of grant, provided theemployee remains continuously employed with the Company. Shares of the Company's ordinary shares are delivered to the employee upon vesting,subject to payment of applicable withholding taxes. The fair value of time-vested RSUs is based on the marketF-18 Year Ended March 31, 2012 2011 2010Expected option term 5 - 7 years 5 - 7 years 5 - 7 yearsExpected stock volatility 47% - 51% 46% - 51% 38% - 49%Risk-free interest rate 0.82% - 2.50% 1.11% - 3.42% 1.83% - 3.05%Expected annual dividend yield — — —ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)value of the Company's stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable serviceperiod.Performance-Based Restricted Stock Units The Company had RSUs that vested upon the achievement of certain performance criteria and RSUs that vested upon the achievement of a marketcondition. Shares of the Company's ordinary shares were delivered to the employee upon vesting, subject to payment of applicable withholding taxes.The estimated fair value of the RSUs that vested upon the achievement of certain performance criteria was based on the market value of the Company'sstock on the date of grant. The estimated fair value of the RSUs that vested upon the achievement of a market condition was determined through the useof a Monte Carlo simulation model, which utilizes input variables that determine the probability of satisfying the market condition stipulated in theaward and calculates the fair market value for the performance award. Compensation expense for RSUs that vest upon the achievement of performance criteria is recognized from the moment the Company determinesthe performance criteria will be met to the date the Company deems the event is likely to occur. Cumulative adjustments are recorded quarterly to reflectsubsequent changes in the estimated outcome of performance-related conditions until the date results are determined. Compensation expense for RSUsthat vest upon the achievement of a market condition is recognized over a derived service period as determined by the Monte Carlo simulation model.The vesting of these awards is subject to the respective employees' continued employment. Both of these awards had been fully expensed prior to thebeginning of the year ended March 31, 2012 and both awards vested during the year ended March 31, 2012.Income Taxes The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between thefinancial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected toreverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. The Companyaccounts for uncertain tax positions using a "more-likely-than-not" threshold for recognizing and resolving uncertain tax positions. The evaluation ofuncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to betaken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position.The Company evaluates this tax position on a quarterly basis. The Company also accrues for potential interest and penalties related to unrecognized taxbenefits in income tax expense.Comprehensive Loss Comprehensive loss consists of net loss and other comprehensive (loss) income. Other comprehensive (loss) income includes changes in equitythat are excluded from net loss, such as unrealized holding gains and losses on available-for-sale marketable securities and unrealized gains and losseson cash flow hedges.F-19ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)Loss per Share Basic loss per share is calculated based upon net loss available to holders of common shares divided by the weighted average number of sharesoutstanding. For the calculation of diluted loss per share, the Company uses the weighted average number of shares outstanding, as adjusted for theeffect of potential dilutive securities, including stock options and RSUs.Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed toyield better therapeutic outcomes and improve the lives of patients with serious diseases. The Company's chief decision maker, the Chairman and ChiefExecutive Officer, reviews the Company's operating results on an aggregate basis and manages the Company's operations as a single operating unit.Employee Benefit Plans401(K) Plan The Company maintains a 401(k) retirement savings plan (the "401(k) Plan"), which covers substantially all of its U.S. based employees. Eligibleemployees may contribute up to 100% of their eligible compensation, subject to certain Internal Revenue Service limitations. Through March 31, 2012,the Company matched 50% of the first 6% of employee pay and beginning April 1, 2012, the Company matches 100% of employee contributions up tothe first 5% of employee pay, up to IRS limits. Employee and Company contributions are fully vested when made. During the years ended March 31,2012, 2011 and 2010, the Company contributed $2.5 million, $2.0 million and $1.8 million, respectively, to match employee deferrals under the 401(k)Plan.Defined Contribution Plan The Company maintains a defined contribution plan for its Ireland based employees (the "defined contribution plan"). The defined contributionplan provides for eligible employees to contribute up to the maximum of 40% of their total taxable earnings, depending upon their age, or €115,000. TheCompany provides a match of up to 18% of taxable earnings depending upon an individual's contribution level. During the years ended March 31,2012, 2011 and 2010, the Company contributed $1.8 million, none and none, respectively, in contributions to the defined contribution plan.New Accounting Pronouncements In January 2010, the Company adopted accounting guidance issued by the FASB related to fair value measurements that requires additionaldisclosure related to transfers in and out of Levels 1 and 2 of the fair value hierarchy. In addition, effective for the Company beginning on April 1,2011, this standard further requires an entity to present disaggregated information about activity in Level 3 fair value measurements on a gross basis,rather than as one net amount. As this accounting standard only requires enhanced disclosure, the adoption of this newly issued accounting standard didnot impact the Company's financial position or results of operations.F-20ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued) In May 2011, the FASB issued accounting guidance that clarifies the application of certain existing fair value measurement guidance and expandsthe disclosures for fair value measurements that are estimated using significant unobservable (Level 3) inputs. This standard was effective on aprospective basis for the Company on January 1, 2012. The adoption of this standard did not have a material impact on the Company's financial positionor results of operations. In June 2011, the FASB issued guidance related to the presentation of comprehensive income. This accounting standard (1) eliminates the optionto present the components of other comprehensive income as part of the statement of changes in stockholders' equity; (2) requires the consecutivepresentation of the statement of net income and other comprehensive income; and (3) requires an entity to present reclassification adjustments on theface of the financial statements from other comprehensive income to net income. The amendments in this accounting standard do not change the itemsthat must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income nor do theamendments affect how earnings per share is calculated or presented. This standard is required to be applied retrospectively and is effective for fiscalyears and interim periods within those years beginning after December 15, 2011. As this accounting standard only requires enhanced disclosure, theadoption of this standard is not expected to have an impact on the Company's financial position or results of operations. In December 2011, the FASB issued accounting guidance that requires an entity to disclose both gross and net information about instruments andtransactions eligible for offset in the statement of financial position as well as instruments and transactions executed under a master netting or similararrangement. The standard was issued to enable users of financial statements to understand the effects or potential effects of those arrangements on itsfinancial position. This standard is required to be applied retrospectively and is effective for fiscal years, and interim periods within those years,beginning on or after January 1, 2013. As this accounting standard only requires enhanced disclosure, the adoption of this standard is not expected tohave an impact on the Company's financial position or results of operations.3. ACQUISITIONS On September 16, 2011, the Company acquired EDT from Elan in a transaction accounted for under the acquisition method of accounting forbusiness combinations, in exchange for $500.0 million in cash and 31.9 million ordinary shares of Alkermes, valued at $525.1 million, based on a stockprice of $16.46 per share on the acquisition date. Under the acquisition method of accounting, the assets acquired and liabilities assumed were recordedas of the acquisition date, at their respective fair values. The reported consolidated financial condition and results of operations after completion of theacquisition reflect these fair values. EDT's results of operations are included in the consolidated financial statements from the date of acquisition. Prior to the acquisition, EDT, which was a division of Elan, developed and manufactured pharmaceutical products that deliver clinical benefits topatients using EDT's experience and proprietary drug technologies in collaboration with other pharmaceutical companies worldwide. EDT's twoprincipal drug technology platforms are the oral controlled release platform ("OCR") and the bioavailability enhancement platform, including EDT'sNanoCrystal® technology. The Company acquired EDT to diversify its commercialized product portfolio and pipeline candidates, enhance itsF-21ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)3. ACQUISITIONS (Continued)financial resources in order to invest in its proprietary drug candidates, pursue additional growth opportunities and reduce its cost of capital. During the year ended March 31, 2012, the Company incurred approximately $29.1 million in expenses related to the EDT acquisition, whichprimarily consist of banking, legal, accounting and valuation-related expenses. These expenses have been recorded within "Selling, general andadministrative" expense in the accompanying consolidated statement of operations and comprehensive loss. During the year ended March 31, 2012, theCompany's results of operations included revenues of $165.0 million and net loss of $6.3 million from the acquired EDT business. The purchase price of the EDT business was as follows (in thousands): The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed at the acquisition datebased upon their respective fair values summarized below (in thousands): Asset categories acquired in the EDT acquisition included working capital, fixed assets and identifiable intangible assets, including IPR&D. The intangible assets acquired included the following (in thousands):F-22Upfront payment in accordance with the merger agreement $500,000 Equity consideration in accordance with the merger agreement 525,074 Total purchase price $1,025,074 Cash $5,225 Receivables 59,398 Inventory 29,669 Prepaid expenses and other current assets 1,806 Property plant and equipment 210,558 Acquired identifiable intangible assets 689,000 Goodwill 92,740 Other assets 4,360 Accounts payable and accrued expenses (18,650)Deferred tax liabilities (48,448)Other long-term liabilities (584) Total $1,025,074 Collaboration agreements $499,700 NanoCrystal technology 74,600 OCR technology 66,300 In-process research and development 45,800 Trademark 2,600 Total $689,000 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)3. ACQUISITIONS (Continued) Intangible assets associated with collaboration agreements relate to the several collaboration agreements EDT has in place with third-partypharmaceutical companies related to the development and commercialization of products or an improvement to existing products based on EDT'sexperience with drug delivery systems and their technology platforms. The estimated useful life of the collaboration agreements is 12 years. TheNanoCrystal and OCR technologies are platform technologies that are used in both currently marketed products and potential future products currentlyunder development. The estimated fair value of these technologies was determined using the relief from royalty method, an approach under which fairvalue is estimated to be the present value of royalties saved because the Company owns the intangible assets and therefore does not have to pay aroyalty for its use. The estimated useful lives of the NanoCrystal and OCR technologies are 13 and 12 years, respectively. Intangible assets associated with IPR&D relate to three EDT product candidates, including Megestrol for use in Europe, which had a value of$28.8 million. The estimated fair value for the collaboration agreements and IPR&D was determined using the excess earnings approach. The excessearnings approach includes projecting revenue and costs attributable to the associated collaboration agreement or product candidate and then subtractingthe required return related to other contributory assets used in the business to determine any residual excess earnings attributable to the collaborationagreement or product candidate. The after-tax excess earnings are then discounted to present value using an appropriate discount rate. During the fourthquarter of fiscal year 2012, and after finalization of the purchase accounting for the Business Combination, the Company identified events and changesin circumstance, such as correspondence from regulatory authorities and further clinical trial results related to three product candidates, includingMegestrol for use in Europe, acquired as part of the Business Combination which indicated that the assets may be impaired. Accordingly, the Companyrecorded an impairment charge of $45.8 million within "Amortization and impairment of acquired intangible assets" in the accompanying statement ofoperations and comprehensive loss. See Note 8, Goodwill and Intangible Assets for additional details. The estimated fair value of the EDT trademark was determined using the relief from royalty method. The Company does not expect to use the EDTtrademark beyond March 31, 2012 and, as a result, the Company amortized the full value of the trademark during the year ended March 31, 2012. The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amountresulting from the acquisition. The Company does not expect any portion of this goodwill to be deductible for tax purposes. The goodwill attributable tothe acquisition of EDT has been recorded as a noncurrent asset and is not amortized, but is subject to an annual review for impairment. The factors thatcontributed to the recognition of goodwill included the synergies that are specific to the Company's business and not available to market participants,including the Company's unique ability to leverage its knowledge in the areas of drug delivery and development of innovative medicines to improvepatients' lives, the acquisition of a talented workforce that brings translational medicine expertise to the Company's preclinical compounds and theCompany's ability to utilize its research capacity to develop additional compounds using the acquired technologies.F-23ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)3. ACQUISITIONS (Continued)Pro forma financial information (unaudited) The following unaudited pro forma information presents the combined results of operations for years ended March 31, 2012, 2011 and 2010 as ifthe acquisition of EDT had been completed on April 1, 2009. The unaudited pro forma results do not reflect any material adjustments, operatingefficiencies or potential cost savings which may result from the consolidation of operations but do reflect certain adjustments expected to have acontinuing impact on the combined results.F-24 Year EndedDecember 31, (In thousands, except per share data) 2012 2011 Revenues $500,105 $450,222 Net (loss) income $(108,782)$10,265 Basic and diluted (loss) earnings per common share $(0.84)$0.08 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)4. INVESTMENTS Investments consist of the following:F-25 Gross Unrealized Losses (In thousands) AmortizedCost Gains Less thanOne Year Greater thanOne Year EstimatedFair Value March 31, 2012 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $62,925 $67 $(17)$— $62,975 International government agency debt securities 25,646 22 (2) — 25,666 Corporate debt securities 12,324 27 — — 12,351 100,895 116 (19) — 100,992 Held-to-maturity securities: Certificates of deposit 4,236 — — — 4,236 U.S. government obligations 417 — — — 417 4,653 — — — 4,653 Money market funds 1,201 — — — 1,201 Total short-term investments 106,749 116 (19) — 106,846 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 35,493 — (70) — 35,423 International government agency debt securities 10,257 — (20) — 10,237 Corporate debt securities 8,009 — — (660) 7,349 Strategic investments 644 838 — — 1,482 54,403 838 (90) (660) 54,491 Held-to-maturity securities: Certificates of deposit 1,200 — — — 1,200 Total long-term investments 55,603 838 (90) (660) 55,691 Total investments $162,352 $954 $(109)$(660)$162,537 March 31, 2011 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $117,298 $129 $(1)$— $117,426 Corporate debt securities 20,973 48 — (4) 21,017 International government agency debt securities 23,048 236 — — 23,284 161,319 413 (1) (4) 161,727 Money market funds 1,201 — — — 1,201 Total short-term investments 162,520 413 (1) (4) 162,928 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 57,709 — (804) 56,905 International government agency debt securities 15,281 — (93) 15,188 Corporate debt securities 15,140 — (29) (328) 14,783 Strategic investments 644 31 — — 675 88,774 31 (926) (328) 87,551 Held-to-maturity securities: Certificates of deposit 5,440 — — — 5,440 U.S. government obligations 417 — — — 417 5,857 — — — 5,857 Total long-term investments 94,631 31 (926) (328) 93,408 Total investments $257,151 $444 $(927)$(332)$256,336 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)4. INVESTMENTS (Continued) The proceeds from the sales and maturities of marketable securities, excluding strategic equity investments, which were primarily reinvested andresulted in realized gains and losses, were as follows: The Company's available-for-sale and held-to-maturity securities at March 31, 2012 have contractual maturities in the following periods: At March 31, 2012, the Company believes that the unrealized losses on its available-for-sale investments are temporary. The investments withunrealized losses consist primarily of corporate debt securities. In making the determination that the decline in fair value of these securities wastemporary, the Company considered various factors, including but not limited to: the length of time each security was in an unrealized loss position; theextent to which fair value was less than cost; financial condition and near-term prospects of the issuers; and the Company's intent not to sell thesesecurities, and the assessment that it is more likely than not that the Company would not be required to sell these securities before the recovery of theiramortized cost basis. The Company's investment in Acceleron Pharma, Inc. ("Acceleron") was $8.7 million and $8.5 million at March 31, 2012 and 2011, respectively,which is recorded within "Other assets" in the accompanying consolidated balance sheets. The Company accounts for its investment in Acceleron underthe cost method as Acceleron is a privately-held company over which the Company does not exercise significant influence. The Company continues tomonitor this investment to evaluate whether any decline in its value has occurred that would be other-than-temporary, based on the implied value fromany recent rounds of financing completed by Acceleron, market prices of comparable public companies and general market conditions. The Company's investment in Civitas Therapeutics, Inc. ("Civitas") was $2.0 million and $1.3 million at March 31, 2012 and 2011, respectively,which is recorded within "Other assets" in the accompanying consolidated balance sheets. The Company accounts for its investment in Civitas under theequity method as the Company has an approximately 11% ownership position in Civitas, has a seat on the board of directors and believes it may be ableto exercise significant influence over the operating and financial policies of Civitas.F-26 Year Ended March 31, (In thousands) 2012 2011 2010 Proceeds from the sales and maturities of marketable securities $323,028 $385,511 $516,935 Realized gains $47 $77 $251 Realized losses $11 $32 $43 Available-for-sale Held-to-maturity (In thousands) AmortizedCost EstimatedFair Value AmortizedCost EstimatedFair Value Within 1 year $60,828 $60,840 $5,853 $5,853 After 1 year through 5 years 93,826 93,161 — — Total $154,654 $154,001 $5,853 $5,853 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)4. INVESTMENTS (Continued) During the year ended March 31, 2012, Civitas issued 14.3 million shares of Series A preferred stock in exchange for $12.5 million. TheCompany did not participate in the financing, however, it received 12.4% of these Series A preferred shares in accordance with the terms of itsarrangement with Civitas and recorded an increase to its investment in Civitas of $1.5 million. The Company has deferred the recognition of the gain onits investment in Civitas and will recognize it into "Other income", ratably over a period of approximately four years, in the Company's consolidatedstatement of operations and comprehensive loss. In addition, during the year ended March 31, 2012, the Company recorded a reduction in its investmentin Civitas of $0.9 million, which represented the Company's proportionate share of Civitas' net losses for this period.5. FAIR VALUE The following table presents information about the Company's assets that are measured at fair value on a recurring basis and indicates the fair valuehierarchy and the valuation techniques the Company utilized to determine such fair value: F-27(In thousands) March 31,2012 Level 1 Level 2 Level 3 Assets: Cash equivalents $1,201 $1,201 $— $— U.S. government and agency debt securities 98,398 98,398 — — International government agency debt securities 35,903 30,902 — 5,001 Corporate debt securities 19,700 — 14,045 5,655 Strategic equity investments 1,482 1,482 — — Interest rate cap contracts 20 — 20 — Total $156,704 $131,983 $14,065 $10,656 Liabilities: Interest rate swap contract $(522) — (522) — Total $(522)$— $(522)$— March 31,2011 Level 1 Level 2 Level 3 Assets: Cash equivalents $1,303 $1,303 $— $— U.S. government and agency debt securities 174,331 174,331 — — Corporate debt securities 35,801 — 34,754 1,047 International government agency debt securities 38,471 38,471 — — Strategic equity investments 675 675 — — Total $250,581 $214,780 $34,754 $1,047 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)5. FAIR VALUE (Continued) The following table is a rollforward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs atMarch 31, 2012: The Company transfers its financial assets and liabilities measured at fair value on a recurring basis between the fair value hierarchies at the end ofeach reporting period. During the year ended March 31, 2012, there was one investment in corporate debt securities transferred into Level 3 fromLevel 2 as trading in this security ceased during the period. Also, during the year ended March 31, 2012, there was one investment in an internationalgovernment agency debt security transferred into Level 3 from Level 1 as trading in this security ceased during the period. During the period, there weretwo corporate debt securities that were transferred into Level 2 from Level 3 as trading in these securities resumed during the period. There were notransfers of investments between Level 1 and Level 2 during the year ended March 31, 2012. In September and December 2011, the Company entered into interest rate cap agreements, and in September 2011, the Company entered into aninterest rate swap agreement. These agreements are described in greater detail in Note 11, Derivative Instruments. The fair value of the Company'sinterest rate cap and interest rate swap agreements were based on an income approach, which excludes accrued interest, and takes into considerationthen-current interest rates and then-current creditworthiness of the Company or the counterparty, as applicable. Substantially all of the Company's corporate debt securities have been classified as Level 2. These securities were initially valued at the transactionprice and subsequently valued, at the end of each reporting period, utilizing market observable data. The market observable data includes reportabletrades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Companyvalidates the prices developed using the market observable data by obtaining market values from other pricing sources, analyzing pricing data in certaininstances and confirming that the relevant markets are active. The Company used a discounted cash flow model to determine the estimated fair value of its Level 3 securities. The assumptions used in thediscounted cash flow model included estimates for interest rates, timing of cash flows, expected holding periods and risk-adjusted discount rates, whichinclude provisions for default and liquidity risk, which the Company believes to be the most critical assumptions utilized within the analysis. Whenavailable, the Company considers bid and ask prices in valuing its Level 3 securities. The carrying amounts reflected in the condensed consolidated balance sheets for cash and cash equivalents, accounts receivable, other currentassets, accounts payable and accrued expenses approximate fair value due to their short-term nature. The fair value of the remaining financialF-28(In thousands) FairValue Balance, April 1, 2011 $1,047 Investments transferred into Level 3 from Level 1 4,995 Investments transferred into Level 3 from Level 2 7,586 Investments transferred out of Level 3 to Level 2 (2,762)Total unrealized losses included in comprehensive loss (210) Balance, March 31, 2012 $10,656 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)5. FAIR VALUE (Continued)instruments not currently recognized at fair value on the Company's consolidated balance sheets consist of the Term Loans. The estimated fair value ofthe Term Loans, which was based on quoted market price indications, is as follows:6. INVENTORY Inventory consists of the following:7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consist of the following:F-29(In thousands) CarryingValue EstimatedFair Value First Lien Term Loan $306,822 $314,265 Second Lien Term Loan $137,638 $144,550 March 31, (In thousands) 2012 2011 Raw materials $12,841 $3,100 Work in process 9,569 5,843 Finished goods(1) 16,968 11,127 Consigned-out inventory(2) 381 355 Inventory $39,759 $20,425 (1)At March 31, 2012 and 2011, the Company had $1.3 million and $2.0 million, respectively, of finished goods inventorylocated at its third party warehouse and shipping service provider. (2)At March 31, 2012 and 2011, consigned-out inventory relates to VIVITROL inventory in the distribution channel forwhich the Company had not recognized revenue. March 31, (In thousands) 2012 2011 Land $8,891 $301 Building and improvements 127,583 36,792 Furniture, fixture and equipment 189,262 62,660 Leasehold improvements 45,798 44,779 Construction in progress 44,768 42,194 Subtotal 416,302 186,726 Less: accumulated depreciation (113,307) (91,706) Total property, plant and equipment, net $302,995 $95,020 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)7. PROPERTY, PLANT AND EQUIPMENT (Continued) Depreciation expense was $22.5 million, $8.7 million and $25.0 million for the years ended March 31, 2012, 2011 and 2010, respectively. TheCompany has $0.5 million of fully depreciated equipment acquired under a capital lease at March 31, 2012 and 2011, respectively. During the year ended March 31, 2012, the Company wrote off furniture, fixtures and equipment that had a carrying value of less than $0.1 millionat the time of disposition and received proceeds from the sales of furniture, fixtures and equipment of less than $0.1 million. During the year endedMarch 31, 2011, the Company wrote off furniture, fixtures and equipment that had a carrying value of $0.1 million at the time of disposition andreceived proceeds from the sales of furniture, fixtures and equipment of $0.4 million. Amounts included as construction in progress in the consolidated balance sheets primarily include costs incurred for the expansion of theCompany's manufacturing facilities in Ohio. The Company continues to evaluate its manufacturing capacity based on expectations of demand for itsproducts and will continue to record such amounts within construction in progress until such time as the underlying assets are placed into service, or theCompany determines it has sufficient existing capacity and the assets are no longer required, at which time the Company would recognize an impairmentcharge. The Company continues to periodically evaluate whether facts and circumstances indicate that the carrying value of these long-lived assets to beheld and used may not be recoverable.8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consists of the following: The Company's goodwill balance solely relates to the Business Combination. As a result of the qualitative assessment performed as of October 31,2011, the Company determined that it was not more-likely-than-not that the fair value of the reporting unit was less than its carrying amount, and animpairment of the Company's goodwill was not recorded. During the fourth quarter of fiscal year 2012 and after finalization of the purchase accounting for the Business Combination, the Companyidentified events and changes in circumstance, such as correspondence from regulatory authorities and further clinical trial results related to threeproductF-30 March 31, 2012 (In thousands) WeightedAmortizable Life GrossCarrying Amount AccumulatedAmortization NetCarrying Amount Goodwill — $92,740 $— $92,740 Finite-lived intangibleassets: Collaboration agreements 12 $499,700 $(17,734)$481,966 NanoCrystal technology 13 74,600 (1,839) 72,761 OCR technology 12 66,300 (3,182) 63,118 Trademark — 2,600 (2,600) — Total finite-livedintangible assets 643,200 (25,355) 617,845 Indefinite-lived intangibleassets: IPR&D — 45,800 (45,800) — Total $689,000 $(71,155)$617,845 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)8. GOODWILL AND INTANGIBLE ASSETS (Continued)candidates, including Megestrol for use in Europe, acquired as part of the Business Combination which indicated that the assets may be impaired. Assuch, the Company performed an analysis to measure the amount of the impairment loss, if any. The Company performed the valuation of its IPR&Dfrom the viewpoint of a market participant through the use of a discounted cash flow model. The model contained certain key assumptions, including thecost to bring the pre-clinical products through the clinical trial and regulatory approval process, the gross margin a market participant would expect toearn if the products were approved for sale, the cost to sell the approved product and a discount factor based on an industry average weighted averagecost of capital. Based on the analysis performed, the Company determined that the IPR&D was impaired and recorded an impairment charge of$45.8 million within "Amortization and impairment of acquired intangible assets" in the accompanying statement of operations and comprehensive loss. The Company recorded $25.4 million of amortization expense related to its finite-lived intangible assets during the year ended March 31, 2012.Based upon the Company's most recent analysis, amortization of intangible assets included within its consolidated balance sheet at March 31, 2012 isexpected to be in the range of approximately $40.0 million to $70.0 million annually through fiscal year 2017.9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consist of the following:10. LONG-TERM DEBT Long-term debt consists of the following:F-31 March 31, (In thousands) 2012 2011 Accounts payable $18,400 $9,269 Accrued compensation 25,023 17,481 Accrued interest 2,472 — Accrued other 33,259 18,184 Total accounts payable and accrued expenses $79,154 $44,934 (In thousands) March 31,2012 March 31,2011 First Lien Term Loan, due September 16, 2017 $306,822 $— Second Lien Term Loan, due September 16, 2018 137,638 — Total 444,460 — Less: current portion (3,100) — Long-term debt $441,360 $— ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)10. LONG-TERM DEBT (Continued)Term Loans On September 16, 2011, the Company entered into the Term Loans with certain of its subsidiaries, as guarantors, Morgan Stanley SeniorFunding, Inc., ("MSSF") as administrative agent and as collateral agent, MSSF and HSBC Securities (USA) Inc., ("HSBC") as co-syndication agents,joint lead arrangers and joint bookrunners, and various other financial institutions, as lenders. The First Lien Term Loan was issued with an originalissue discount of $3.1 million, has a term of six years and is secured by a first priority lien on substantially all of the assets and properties of theCompany and the guarantors. The Second Lien Term Loan was issued with an original issue discount of $2.8 million, has a term of seven years and issecured by a second priority lien on substantially all of the assets and properties of the Company and the guarantors. Scheduled maturities with respect to the Term Loans are as follows (in thousands): The initial applicable margin for borrowings under the First Lien Term Loan is three-month LIBOR plus 5.25% and three-month LIBOR plus8.00% under the Second Lien Term Loan. Under each of the Term Loans, LIBOR is subject to an interest rate floor of 1.50%. Commencing upon thecompletion of the Company's first fiscal quarter ending after the Business Combination, the applicable margin under the First Lien Term Loan is subjectto adjustment each fiscal quarter, based upon meeting a certain consolidated leverage ratio during the preceding quarter. The applicable margin under theSecond Lien Term Loan is not subject to adjustment. Required quarterly principal payments of $0.8 million on the First Lien Term Loan began on March 31, 2012. In addition, beginning in fiscal year2013, the Company is required to make principal payments on the First Lien Term Loan for amounts up to 50% of excess cash flows as defined in theFirst Lien Term Loan credit agreement. The principal amount of the Second Lien Term Loan is due and payable in full on the maturity date. TheCompany may make prepayments of principal without penalty; however, no principal payments may be made on the Second Lien Term Loan until theFirst Lien Term Loan has been repaid in full. If prepayments are made prior to September 16, 2012, the Company may be subject to prepaymentpremium of 1% of the amount of the term loans being repaid if the prepayment is made in connection with a refinancing transaction or 1% of the amountof the outstanding term loans if the prepayment is made in connection with an amendment to the agreement resulting in a refinancing transaction. Each of the Term Loans has incremental capacity in an amount of $50.0 million, plus additional amounts so long as the Company meets certainconditions, including a specified leverage ratio. The agreements governing the Term Loans include a number of restrictive covenants that, among otherthings, and subject to certain exceptions and baskets, impose operating and financial restrictions onF-32Fiscal Year: 2013 $3,100 2014 3,100 2015 3,100 2016 3,100 2017 3,100 Thereafter 433,725 Total $449,225 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)10. LONG-TERM DEBT (Continued)Alkermes, Inc., the Company and the restricted subsidiaries. These financing agreements also contain customary affirmative covenants and events ofdefault. The Company was in compliance with its debt covenants at March 31, 2012. As part of the Term Loans, the Company is required to enter into and thereafter maintain hedge agreements to the extent necessary to provide thatat least 50% of the aggregate principal amount of the Term Loans is subject to either a fixed interest rate or interest rate protection for a period of not lessthan three years. Pursuant to this requirement, the Company entered into an interest rate swap agreement and interest rate cap agreements, which arediscussed in greater detail in Note 11, Derivative Instruments. The Company incurred $11.8 million of offering costs associated with the issuance of the Term Loans which were recorded under the caption"Other assets" in the accompanying consolidated balance sheets. The offering costs and original issue discount related to the Term Loans are beingamortized to interest expense over the estimated repayment terms using the effective interest method. During the year ended March 31, 2012, theCompany had amortization expense of $3.5 million related to the offering costs and original issue discount.Non-Recourse RISPERDAL CONSTA Secured 7% Notes On February 1, 2005, the Company, pursuant to the terms of a purchase and sale agreement, sold, assigned and contributed to Royalty Sub therights of the Company to collect certain royalty payments and manufacturing fees earned under the license and manufacturing and supply agreementswith Janssen, in exchange for approximately $144.2 million in cash. Concurrently with the purchase and sale agreement, on February 1, 2005, RoyaltySub issued an aggregate principal amount of $170.0 million of its non-recourse 7% Notes to certain institutional investors in a private placement, for netproceeds of approximately $144.2 million, after the original issue discount and offering costs of approximately $19.7 million and $6.1 million,respectively. The yield to maturity at the time of the offer was 9.75%. The annual cash coupon rate was 7% and was payable quarterly, beginning onApril 1, 2005, however, portions of the principal amount that were not paid off in accordance with the expected principal repayment schedule wouldhave accrued interest at 9.75% per annum. Through January 1, 2009, the holders received only quarterly cash interest payments. Beginning on April 1,2009, principal payments were made to the holders, subject to certain conditions, and the non-recourse 7% Notes were scheduled to mature onJanuary 1, 2012. On July 1, 2010, in addition to the scheduled principal payment of $6.4 million, the Company fully redeemed the balance of the non-recourse 7%Notes for $39.2 million, representing 101.75% of the outstanding principal balance in accordance with the terms of the Indenture for the non-recourse7% Notes. As a result of this transaction, the Company recorded charges of $1.4 million relating to the write-off of the unamortized portion of deferredfinancing costs and $0.8 million primarily related to the premium paid on the redemption of the non-recourse 7% Notes within "Interest expense" in theaccompanying consolidated statement of operations. During the years ended March 31, 2012, 2011 and 2010, amortization of the original issue discountand offering costs, which were being amortized over the expected principal repayment period ending January 1, 2012, totaled zero, $1.7 million, and$1.7 million, respectively.F-33ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)11. DERIVATIVE INSTRUMENTS In December 2011, the Company entered into an interest rate cap agreement with Morgan Stanley Capital Services LLC ("MSCS") at a cost of$0.1 million to mitigate the impact of fluctuations in the three-month LIBOR rate at which the Company's Term Loans bear interest. The interest rate capagreement expires in December 2013, has a notional value of $160.0 million and is not designated as a hedging instrument. The Company recorded aloss of $0.1 million within "Other expense, net" in the accompanying consolidated statements of operations and comprehensive loss due to the decreasein value of this contract during the year ended March 31, 2012. In July 2011, the Company entered into an interest rate cap agreement with HSBC Bank USA at a cost of less than $0.1 million to mitigate theimpact of fluctuations in the three-month LIBOR rate at which the Company's Term Loans bear interest. The interest rate cap agreement becameeffective upon the issuance of the Term Loans, expires in December 2012, has a notional value of $65.0 million and is not designated as a hedginginstrument. The Company recorded an immaterial amount of loss within "Other expense, net" in the accompanying consolidated statements ofoperations and comprehensive loss due to the decline in value of this contract during the year ended March 31, 2012. In July 2011, the Company entered into an interest rate swap agreement with MSCS to mitigate the impact of fluctuations in the three-monthLIBOR rate at which the Company's Term Loans bear interest. The interest rate swap agreement becomes effective in December 2012, expires inDecember 2014 and has a notional value of $65.0 million. This contract has been designated as a cash flow hedge and accordingly, to the extenteffective, any unrealized gains or losses on this interest rate swap contract is reported in accumulated other comprehensive loss. To the extent the hedgeis ineffective, hedge transaction gains and losses are reported in "Other expense, net" when the interest payment on the related debt is recognized. The following table summarizes the fair value and presentation in the consolidated balance sheets for derivatives designated and not designated ashedging instruments: The following table summarizes the effect of derivatives designated as hedging instruments on the consolidated statements of operations andcomprehensive loss: The cash flow hedge was deemed to be effective at March 31, 2012. Accordingly, the Company included the loss incurred during the year endedMarch 31, 2012 within accumulated other comprehensive loss. The Company expects that when this contract matures any amounts in accumulatedF-34(In thousands) Balance Sheet Location Fair Value atMarch 31, 2012 Interest rate swap Liability derivative designated as a cash flow hedge Other long-term liabilities $(522)Interest rate caps Asset derivatives not designated as a hedging instruments Other long-term assets $20 (In thousands) AmountRecognized inAccumulated OtherComprehensive Loss(Effective Portion) AmountReclassified fromAccumulated OtherComprehensive Lossinto Earnings(Effective Portion) Amount ofLoss Recorded(Ineffective Portion) March 31, 2012 $(522)$— $— ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)11. DERIVATIVE INSTRUMENTS (Continued)other comprehensive loss is to be reported as an adjustment to interest expense. The Company considers the impact of its and MSCS' credit risk on thefair value of the contract as well as the ability of each party to execute its obligations under the contract. At March 31, 2012, credit risk did not materiallychange the fair value of the Company's interest rate swap contract.12. LOSS PER SHARE Basic loss per common share is calculated based upon net loss available to holders of common shares divided by the weighted average number ofshares outstanding. Diluted loss per common share is based upon the weighted-average number of common shares outstanding during the period plusadditional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. Common equivalent shares result fromthe assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using thetreasury stock method) and the vesting of unvested restricted stock units. Common equivalent shares have not been included in the net loss per commonshare calculations because the effect would have been anti-dilutive. The potential common equivalent shares consisted of the following:13. SHAREHOLDERS' EQUITYShare Repurchase Programs On September 16, 2011, the board of directors authorized the continuation of the Alkermes, Inc., share repurchase program to repurchase up to$215.0 million of the Company's ordinary shares at the discretion of management from time to time in the open market or through privately negotiatedtransactions. The objective of the repurchase program is to improve shareholders' returns. At March 31, 2012, approximately $101.0 million wasavailable to repurchase ordinary shares pursuant to the repurchase program. All shares repurchased are recorded as treasury stock. The repurchaseprogram has no set expiration date and may be suspended or discontinued at any time. During the year ended March 31, 2012 and 2011, the Companydid not acquire any shares of outstanding ordinary shares under the repurchase program. During the years ended March 31, 2012, 2011 and 2010, the Company acquired, by means of net share settlements, 205,901, 123,943 and100,449 shares of Alkermes ordinary shares, at an average price of $17.85, $11.41 and $8.68 per share, respectively, related to the vesting of employeestock awards to satisfy withholding tax obligations. In addition, during the year ended March 31, 2010, the Company acquired 7,961 shares ofAlkermes ordinary shares, at an average price of $12.56 per share, tendered by former and current employees as payment of the exercise price of stockoptions granted under the Company's equity compensation plans. During the years ended March 31, 2012 and 2011, there wereF-35 Year Ended March 31, (In thousands) 2012 2011 2010 Denominator: Stock options 8,299 13,357 17,675 Restricted stock units 1,205 936 419 Total 9,504 14,293 18,094 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)13. SHAREHOLDERS' EQUITY (Continued)no shares tendered by former or current employees as payment of the exercise price of stock options granted under the Company's equity compensationplans.14. SHARE-BASED COMPENSATIONShare-based Compensation Expense The following table presents share-based compensation expense included in the Company's consolidated statements of operations andcomprehensive loss: At March 31, 2012, 2011 and 2010, $0.4 million, $0.6 million and $0.6 million, respectively, of share-based compensation cost was capitalizedand recorded as "Inventory" in the consolidated balance sheets.Share-based Compensation Plans The Company has two compensation plans pursuant to which awards are currently being made, the 2011 Stock Option and Incentive Plan (the"2011 Plan"), and the 2008 Plan. The Company has five share-based compensation plans pursuant to which outstanding awards have been made, butfrom which no further awards can or will be made: (i) the 1996 Stock Option Plan for Non-Employee Directors (the "1996 Plan"); (ii) the 1998 EquityIncentive Plan (the "1998 Plan"); (iii) the 1999 Stock Option Plan (the "1999 Plan"); (iv) the 2002 Restricted Stock Award Plan (the "2002 Plan"); and(v) the 2006 Stock Option Plan for Non-Employee Directors (the "2006 Plan"). The 2011 Plan and the 2008 Plan provides for issuance of non-qualified and incentive stock options, restricted stock, restricted stock units, cash-based awards and performance shares to employees, officers anddirectors of, and consultants to, the Company in such amounts and with such terms and conditions as may be determined by the compensationcommittee of the Company's board of directors, subject to provisions of the 2011 Plan and the 2008 Plan. At March 31, 2012, there were 9.4 million shares of ordinary shares available for issuance under the Company's stock plans. The 2011 Planprovides that awards other than stock options will be counted against the total number of shares available under the plan in a 1.8-to-1 ratio and the 2008Plan provides that awards other than stock options will be counted against the total number of shares available under the plan in a 2-to-1 ratio.F-36 Year Ended March 31, (In thousands) 2012 2011 2010 Cost of goods manufactured and sold $2,962 $1,725 $1,506 Research and development 8,784 6,218 3,489 Selling, general and administrative 17,080 11,889 8,926 Total share-based compensation expense $28,826 $19,832 $13,921 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)14. SHARE-BASED COMPENSATION (Continued)Stock Options A summary of stock option activity is presented in the following table: The weighted average grant date fair value of stock options granted during the years ended March 31, 2012, 2011 and 2010 was $8.00, $5.92 and$4.46, respectively. The aggregate intrinsic value of stock options exercised during the years ended March 31, 2012, 2011 and 2010 was $11.1 million,$2.0 million and $2.6 million, respectively. At March 31, 2012, there were 6.1 million stock options expected to vest with a weighted average exercise price of $13.87 per share, a weightedaverage contractual remaining life of 8.6 years and an aggregate intrinsic value of $28.4 million. At March 31, 2012, the aggregate intrinsic value ofstock options exercisable was $56.6 million with a weighted average remaining contractual term of 4.2 years. The number of stock options expected tovest is determined by applying the pre-vesting forfeiture rate to the total outstanding options. The intrinsic value of a stock option is the amount bywhich the market value of the underlying stock exceeds the exercise price of the stock option. At March 31, 2012, there was $23.3 million of unrecognized compensation cost related to unvested stock options, which is expected to berecognized over a weighted average period of approximately 2.1 years. Cash received from option exercises under the Company's award plans duringthe years ended March 31, 2012 and 2011 was $17.2 million and $4.7 million, respectively. The Company issued new shares upon option exercisesduring the years ended March 31, 2012 and 2011.F-37 Number ofShares WeightedAverageExercisePrice Outstanding, April 1, 2011 16,985,009 $13.45 Granted 3,802,100 $16.41 Exercised (1,798,349)$11.63 Forfeited (227,025)$13.50 Expired (1,401,975)$21.60 Outstanding, March 31, 2012 17,359,760 $13.68 Exercisable, March 31, 2012 11,018,060 $13.54 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)14. SHARE-BASED COMPENSATION (Continued)Time-Vested Restricted Stock Units A summary of time-vested RSU activity is presented in the following table: The weighted average grant date fair value of time-vested RSUs granted during the years ended March 31, 2012, 2011 and 2010 was $17.91,$11.74 and $8.83, respectively. The total fair value of time-vested RSUs that vested during the years ended March 31, 2012, 2011 and 2010 was$6.1 million, $4.0 million and $2.4 million, respectively. At March 31, 2012, there was $12.5 million of total unrecognized compensation cost related to unvested time-vested RSUs, which will berecognized over a weighted average remaining contractual term of 1.9 years.Performance-Based Restricted Stock Units In May 2009, the board of directors awarded 45,000 RSUs to certain of the Company's executive officers under the 2006 Plan that vest upon theapproval of BYDUREON by the U.S. Food and Drug Administration ("FDA"), provided the approval by the FDA occurs at least one year after thedate of grant. During the year ended March 31, 2010, 20,000 RSU's were forfeited upon the resignation of an executive officer. The grant date fairvalue of the award was $8.55 per share, which was the market value of the Company's stock on the date of grant. During the year ended March 31,2012, the performance condition was met and the award vested. In May 2008, the board of directors awarded 40,000 RSUs to certain of the Company's executive officers under the 2002 Plan that vest upon theachievement of a market condition specified in the award terms. During the year ended March 31, 2010, 10,000 RSU's were forfeited upon theresignation of an executive officer. The grant date fair value of $9.48 per share was determined through the use of a Monte Carlo simulation model. Thecompensation cost for the award's grant date fair value of $0.4 million was recognized over a derived service period of 1.4 years. During the year endedMarch 31, 2012, the market condition was met and the awards vested.F-38 Number ofShares WeightedAverageGrant DateFair Value Nonvested, April 1, 2011 1,870,515 $10.69 Granted 883,100 $17.91 Vested (544,989)$11.17 Forfeited (94,450)$13.54 Novested, March 31, 2012 2,114,176 $13.45 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)15. COLLABORATIVE ARRANGEMENTS The Company's business strategy includes forming collaborations to develop and commercialize its products, and to access technological, financial,marketing, manufacturing and other resources. The Company significant collaborative arrangements are described below:JanssenRISPERDAL CONSTA Under a product development agreement, the Company collaborated with Janssen on the development of RISPERDAL CONSTA. Under thedevelopment agreement, Janssen provided funding to the Company for the development of RISPERDAL CONSTA, and Janssen is responsible forsecuring all necessary regulatory approvals for the product. Under license agreements, the Company granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDALCONSTA. Under its license agreements with Janssen, the Company receives royalty payments equal to 2.5% of Janssen's net sales of RISPERDALCONSTA in each country where the license is in effect based on the quarter when the product is sold by Janssen. This royalty may be reduced in anycountry based on lack of patent coverage and significant competition from generic versions of the product. Janssen can terminate the license agreementsupon 30 days' prior written notice to the Company. The licenses granted to Janssen expire on a country-by-country basis upon the later of (i) theexpiration of the last patent claiming the product in such country or (ii) fifteen years after the date of the first commercial sale of the product in suchcountry, provided that in no event will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of theproduct in such country, with the exception of certain countries where the fifteen-year limitation shall pertain regardless. After expiration, Janssenretains a non-exclusive, royalty-free license to manufacture, use and sell RISPERDAL CONSTA. We exclusively manufacture RISPERDALCONSTA for commercial sale. Under its manufacturing and supply agreement with Janssen, the Company records manufacturing revenues whenproduct is shipped to Janssen, based on 7.5% of Janssen's net unit sales price for RISPERDAL CONSTA for the calendar year. The manufacturing and supply agreement terminates on expiration of the license agreements. In addition, either party may terminate themanufacturing and supply agreement upon a material breach by the other party, which is not resolved within 60 days after receipt of a written noticespecifying the material breach or upon written notice in the event of the other party's insolvency or bankruptcy. Janssen may terminate the agreementupon six months' written notice to the Company. In the event that Janssen terminates the manufacturing and supply agreement without terminating thelicense agreements, the royalty rate payable to the Company on Janssen's net sales of RISPERDAL CONSTA would increase from 2.5% to 5.0%.INVEGA SUSTENNA/XEPLION Under its license agreement with Janssen Pharmaceutica N.V., the Company granted Janssen a worldwide exclusive license under its NanoCrystaltechnology to develop, commercialize and manufacture INVEGA SUSTENNA/XEPLION and related products. Under its license agreement, the Company receives certain development milestone payments from Janssen and tiered royalty payments between 5%and 9% of INVEGA SUSTENNA net sales in each country where the license is in effect, with the exact royalty percentage determined based onworldwideF-39ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)15. COLLABORATIVE ARRANGEMENTS (Continued)net sales. These royalty payments may be reduced in any country based on lack of patent coverage or patent litigation, or where competing productsachieve certain minimum sales thresholds. The licenses granted to Janssen expire on a country-by-country basis upon the later of (i) March 31, 2019 or(ii) the expiration of the last of the patents claiming the product in such country. After expiration, Janssen retains a non-exclusive, royalty-free license todevelop, manufacture and commercialize the products. Janssen may terminate the license agreement in whole or in part upon three months' notice to the Company. The Company and Janssen have theright to terminate the agreement upon the material breach of the other party, which is not cured within a certain time period or upon the other party'sbankruptcy or insolvency. During the years ended March 31, 2012, 2011 and 2010, the Company recognized $186.6 million, $154.4 million, and $148.8 million,respectively, of revenue from its arrangements with Janssen.Acorda Under an amended and restated license agreement, the Company granted Acorda an exclusive worldwide license to use and sell and, solely inaccordance with its supply agreement, to make or have made AMPYRA/FAMPYRA. Under its license agreement with Acorda, the Company receivescertain commercial and development milestone payments, license revenues and a royalty of approximately 10% based on sales ofAMPYRA/FAMPYRA by Acorda or its sub-licensee, Biogen Idec. This royalty payment may be reduced in any country based on lack of patentcoverage, competing products achieving certain minimum sales thresholds, and whether Alkermes manufactures the product. Acorda has the right to terminate the license agreement upon 90 days' written notice. The Company has the right to terminate the license agreementfor countries in which Acorda fails to launch a product within a specified time after obtaining the necessary regulatory approval or fails to file regulatoryapprovals within a commercially reasonable time after completion and receipt of positive data from all preclinical and clinical studies required for filing amarketing authorization application. If the Company terminates Acorda's license in any country, the Company is entitled to a license from Acorda of itspatent rights and know-how relating to the product as well as the related data, information and regulatory files, and to market the product in theapplicable country, subject to an initial payment equal to Acorda's cost of developing such data, information and regulatory files and to ongoing royaltypayments to Acorda. Subject to the termination of the license agreement, licenses granted under the license agreement terminate on a country-by-countrybasis on the later of (i) September 2018 or (ii) the expiration of the last to expire of our patents or the existence of a threshold level of competition in themarketplace. Under its commercial manufacturing supply agreement with Acorda, the Company manufactures and supplies AMPYRA/FAMPYRA for Acorda(and its sub-licensees). Under the terms of the agreement, Acorda may obtain up to 25% of its total annual requirements of product from a secondsource manufacturer. The Company receives royalties equal to 8% of net selling price for all product manufactured by it and a compensating paymentfor product manufactured and supplied by a third party. The Company may terminate the supply agreement upon 12 months' prior written notice toAcorda and either party may terminate the supply agreement following a material and uncured breach of the supply or license agreement or the entry intobankruptcy or dissolution proceedings of the other party. In addition, subject to early termination of the supply agreement noted above, the supplyagreement terminates upon the expiry or termination of the license agreement.F-40ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)15. COLLABORATIVE ARRANGEMENTS (Continued) In January 2011, the Company entered into a development and supplemental agreement to its amended and restated license agreement with Acorda.Under the terms of this agreement, the Company granted Acorda the right, either with it or with a third party, in each case in accordance with certainterms and conditions, to develop new formulations of dalfampridine or other aminopyridines. Under the terms of the agreement, Acorda has the right toselect either a formulation developed by the Company or by a third party for commercialization. If Acorda selects and commercializes a formulationdeveloped by the Company, the Company is entitled to development fees, milestone payments (for new indications if not previously paid), licenserevenues and royalties in accordance with its amended and restated license agreement, and either manufacturing fees as a percentage of net selling pricefor product manufactured by the Company or compensating fees for product manufactured by third parties. If Acorda selects a formulation notdeveloped by the Company, then the Company will be entitled to various compensation payments and have the first option to manufacture such third-party formulation. The agreement expires upon the expiry or termination of the amended and restated license agreement or may be earlier terminated byeither party following an uncured breach of the agreement by the other party. Acorda's financial obligations under this development and supplemental agreement continue for a minimum of ten years from the first commercialsale of such new formulation, and may extend for a longer period of time, depending on the intellectual property rights protecting the formulation,regulatory exclusivity and/or the absence of significant market competition. These financial obligations survive termination. During the years ended March 31, 2012, 2011 and 2010, the Company recognized $25.8 million, none and none respectively, of revenue from itsarrangements with Acorda.Amylin In May 2000, the Company entered into a development and license agreement with Amylin for the development of exendin products falling withinthe scope of its patents, which includes the once-weekly formulation of exenatide, BYDUREON. Pursuant to the development and license agreement,Amylin has an exclusive, worldwide license to the Company's polymer-based microsphere technology for the development and commercialization ofinjectable extended-release formulations of exendins and other related compounds. The Company receives funding for research and development andmilestone payments consisting of cash and warrants for Amylin common stock upon achieving certain development and commercialization goals andwill also receive royalty payments based on future product sales. In October 2005 and in July 2006, the Company amended the development and licenseagreement. Under the amended agreement, the Company is responsible for formulation and is principally responsible for non-clinical development ofany products that may be developed pursuant to the agreement and for manufacturing these products for use in early-phase clinical trials. Amylin is responsible for commercializing exenatide products, including BYDUREON, in the U.S. and for U.S. regulatory matters relating toBYDUREON. Lilly, Amylin's former worldwide collaboration partner with respect to exenatide products, continues to have exclusive rights tocommercialize exenatide products outside of the U.S. until December 31, 2013 or such earlier date as agreed by the parties pursuant to the terms of theirtransition agreement, following which Amylin will have such exclusive rights. Subject to these arrangements with Lilly, Amylin is responsible forF-41ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)15. COLLABORATIVE ARRANGEMENTS (Continued)conducting clinical trials, securing regulatory approvals and marketing any products resulting from the collaboration on a worldwide basis. In conjunction with the 2005 amendment of the development and license agreement with Amylin, the Company reached an agreement regardingAmylin's construction of a manufacturing facility for BYDUREON and certain technology transfer related thereto. The facility and technology transferof the Company's manufacturing processes was completed in 2009. Amylin will be responsible for the manufacture of BYDUREON and will operatethe facility. Until December 31 of the tenth full calendar year following the year in which the first commercial sale of BYDUREON occurs, the Company willreceive royalties equal to 8% of net sales from the first 40 million units of BYDUREON sold in any particular year and 5.5% of net sales from unitssold beyond the first 40 million units for that year. Thereafter, during the term of the development and license agreement, the Company will receiveroyalties equal to 5.5% of net sales of products sold. The Company received a $7.0 million milestone payment in each of July 2011 and March 2012upon the first commercial sale of BYDUREON in the EU and U.S., respectively. The development and license agreement terminates on the later of (i) 10 years from the first commercial sale of the last of the products covered bythe development and license agreement, or (ii) the expiration or invalidation of all of its patents covering such product. Upon termination, all licensesbecome non-exclusive and royalty-free. Amylin may terminate the development and license agreement for any reason upon 180 days' written notice tothe Company. In addition, either party may terminate the development and license agreement upon a material default or breach by the other party that isnot cured within 60 days after receipt of written notice specifying the default or breach. During the years ended March 31, 2012, 2011 and 2010, the Company recognized $18.8 million, $2.9 million and $4.1 million, respectively, ofrevenue from its arrangements with Amylin.Cilag In December 2007, the Company entered into a license and commercialization agreement with Cilag to commercialize VIVITROL for the treatmentof alcohol dependence and opioid dependence in Russia and other countries in the CIS. Under the terms of the agreement, Cilag has primaryresponsibility for securing all necessary regulatory approvals for VIVITROL and Janssen-Cilag, an affiliate of Cilag, commercializes the product. TheCompany is responsible for the manufacture of VIVITROL and receives manufacturing and royalty revenues based upon product sales. Cilag has paid the Company $6.0 million to date in nonrefundable payments, and the Company's agreement provides that it could be eligible for upto an additional $33.0 million in milestone payments upon the receipt of regulatory approvals for the product, the occurrence of certain agreed-uponevents and the achievement of certain VIVITROL sales levels. Commencing five years after the effective date of the agreement, Cilag will have the right to terminate the agreement at any time by providing90 days' written notice to the Company, subject to certain continuing rights and obligations between the parties. Cilag will also have the right toterminate the agreement at any time upon 90 days' written notice to it if a change in the pricing and/or reimbursement of VIVITROL in Russia and othercountries of the CIS has a material adverse effect on the underlying economic value of commercializing the product such that it is no longer reasonablyprofitable to Cilag. In addition, either party may terminate the agreement upon a material breach byF-42ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)15. COLLABORATIVE ARRANGEMENTS (Continued)the other party, which is not cured within 90 days after receipt of written notice specifying the material breach or, in certain circumstances, a 30-dayextension of that period. During the year ended March 31, 2012, 2011 and 2010, the Company recognized $5.1 million, $0.4 million and $0.8 million of revenue from itsarrangement with Cilag, respectively.16. INCOME TAXES The Company's provision (benefit) for income taxes is comprised of the following: The current income tax provision for the year ended March 31, 2012 is primarily due to a provision of $13.1 million on the taxable transfer of theBYDUREON intellectual property from the U.S. to Ireland, partially offset by a $4.3 million benefit recorded to additional paid-in capital related to theutilization of certain NOL carryforwards resulting from the exercise of employee stock options. The current income tax benefit for the year endedMarch 31, 2011 is primarily related to a tax benefit for bonus depreciation pursuant to the Small Business Jobs Act of 2010. The current income taxbenefit for the year ended March 31, 2010 is primarily the result of a carryback of the Company's 2010 AMT NOL pursuant to the Worker,Homeownership and Business Act of 2009. This law increased the carryback period for certain NOLs from two years to five years. Prior to theadoption of this law, the Company had recorded a full valuation allowance against the credits that were established in prior periods when the Companywas subject to AMT provisions. The deferred tax provision for the year ended March 31, 2012 is primarily due to a benefit of $4.6 million from the partial release of the Irishdeferred tax liability relating to acquired intellectual property that was established in connection with the Business Combination and a benefit of $9.9million due to the partial release of an existing U.S. federal valuation allowance as a consequence of the Business Combination. The deferred taxbenefits for the years ended March 31, 2011 and 2010 are primarily due to the recognition of $0.2 million and $1.8 million of income tax expenseassociated with the increase in the value of certain securities that it carried at fair market value during the year ended March 31, 2011 and 2010,respectively. No provision for income tax has been provided on undistributed earnings of the Company's foreign subsidiaries because the Company considerssuch earnings to be indefinitely reinvested. Cumulative unremitted earnings of overseas subsidiaries totaled approximately $10 million at March 31,2012. In the event of distribution of those earnings in the form of dividends or otherwise, the Company wouldF-43 Year Ended March 31, (In thousands) 2012 2011 2010 Current income tax provision (benefit): U.S. Federal $7,321 $(756)$(3,318)U.S. State 6,649 30 75 Rest of world 28 — — Deferred income tax (benefit) provision: Ireland (4,551) — — U.S. Federal (10,024) (206) (1,674)U.S. State (137) (19) (158) Total tax benefit $(714)$(951)$(5,075) ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)16. INCOME TAXES (Continued)be subject to income taxes, subject to an adjustment, if any, for foreign tax credits, and foreign withholding taxes payable to certain foreign taxauthorities. Determination of the amount of income tax liability that would be incurred is not practicable because of the complexities associated with thishypothetical calculation; however, unrecognized foreign tax credit carryforwards may be available to reduce some portion of the tax liability, if any. The distribution of the Company's net loss before the provision for income taxes by geographical area consisted of the following: The components of the Company's net deferred tax liabilities are as follows: As of March 31, 2012, the Company had $441.4 million of Irish NOL carryforwards, $107.3 million of U.S. federal NOL carryforwards,$15.4 million of state NOL carryforwards, and $18.7 million of other foreign NOL and capital loss carryforwards, which either expire on various datesthrough 2032 or can be carried forward indefinitely. These loss carryforwards are available to reduce certain future Irish and foreign taxable income, ifany. These loss carryforwards are subject to review and possible adjustment by the appropriate taxing authorities. These loss carryforwards, which maybe utilized in any future period, may be subject to limitations based upon changes in the ownership of the company'sF-44 Year Ended March 31, (In thousands) 2012 2011 2010 Ireland $(36,711)$— $— U.S. (84,858) (46,491) (44,701)Rest of world 7,177 — — Loss before provision for income taxes $(114,392)$(46,491)$(44,701) March 31, (In thousands) 2012 2011 Deferred tax assets: Irish NOL carryforwards $55,175 $— Tax benefit from the exercise of stock options 22,089 35,440 Share-based compensation 21,992 18,137 Tax credit carryforwards 12,294 18,038 U.S. federal and state NOL carryforwards 7,365 54,555 Alkermes Europe, Ltd. NOL carryforward 4,675 5,049 Deferred revenue 1,778 2,016 Other 9,774 6,459 Less: valuation allowance (107,128) (133,212) Total deferred tax assets 28,014 6,482 Deferred tax liablilities: Intangible assets (42,857) — Property, plant and equipment (19,049) (6,482) Total deferred tax liabilities (61,906) (6,482) Net deferred tax liabilities $(33,892)$— ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)16. INCOME TAXES (Continued)stock. The Company has performed a review of ownership changes in accordance with the U.S. Internal Revenue Code and the Company hasdetermined that it is more likely than not that, as a result of the Business Combination, the Company has experienced a change of ownership. As aconsequence, the Company's U.S. federal NOL carryforwards and tax credit carryforwards are subject to an annual limitation of $127.0 million. The Company records a deferred tax asset or liability based on the difference between the financial statement and tax basis of assets and liabilities,as measured by enacted tax rates assumed to be in effect when these differences reverse. In evaluating the Company's ability to recover its deferred taxassets, the Company considers all available positive and negative evidence including its past operating results, the existence of cumulative income in themost recent fiscal years, changes in the business in which the Company operates and its forecast of future taxable income. In determining future taxableincome, the Company is responsible for assumptions utilized including the amount of Irish, U.S. and other foreign pre-tax operating income, thereversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significantjudgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage theunderlying businesses. As of March 31, 2012, the Company determined that it is more likely than not that a significant portion of the deferred tax assetswill not be realized and a valuation allowance has been recorded. The $26.1 million decrease in the valuation allowance from the year ended March 31,2011 to the year ended March 31, 2012 was primarily due to the utilization of NOLs. The Company has a $33.9 million deferred tax liability as ofMarch 31, 2012 which is primarily related to book over tax basis differences in acquired intellectual property. The tax benefit from stock option exercises included in the table above represents benefits accumulated prior to the adoption of AccountingStandards Codification ("ASC") Topic 718 ("ASC 718") that have not been realized. Subsequent to the adoption of ASC 718 on April 1, 2006, anadditional $17.1 million of tax benefits from stock option exercises, in the form of NOL carryforwards and tax credit carryforwards, have not beenrecognized in the financial statements and will be once they are realized. In total, the Company has approximately $39.2 million related to certain NOLcarryforwards and tax credit carryforwards resulting from the exercise of employee stock options, the tax benefit of which, when recognized, will beaccounted for as a credit to additional paid-in capital rather than a reduction of income tax expense.F-45ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)16. INCOME TAXES (Continued) As part of the Business Combination, Alkermes plc was incorporated and is headquartered in Dublin, Ireland. The statutory tax rate for tradingincome in Ireland is 12.5%. A reconciliation of the Company's statutory tax rate to its effective rate is as follows: A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Included in unrecognized tax benefits at March 31, 2012 is $2.4 million of tax benefits that, if recognized, would affect the Company's annualeffective tax rate. Of this balance, $1.7 million relates to deferred tax assets for which a full valuation allowance would be recorded, offsetting any taxbenefits that would be realized. The Company expects a net reduction in its unrecognized tax benefits in the amount of $0.5 million due to the expectedresolution of certain matters over the next twelve months. The Company has elected to include interest and penalties related to uncertain tax positions asa component of its provision for taxes. For the year ended March 31, 2012, the Company's accrued interest and penalties related to uncertain taxpositions was not significant. Our major taxing jurisdictions include Ireland and the U.S. (federal and state). These jurisdictions have varying statutes of limitations. In the U.S.,the 2007 through 2012 fiscal years remain subject to examination by the respective tax authorities. In Ireland, fiscal years 2008 to 2012 remain subjectto examination by the Irish tax authorities. Additionally, because of our Irish and U.S. loss carryforwards, certain tax returns from fiscal years 1998onward may also be examined. These years generally remain open for three to four years after the loss carryforwards have been utilized. Fiscal years,2007, 2008 and 2010 for Alkermes, Inc., are currently under examination by the U.S. Internal Revenue Service.F-46 Year Ended March 31, 2012 2011 2010 Statutory rate 12.5% 34.0% 34.0%U.S. State income taxes, net of U.S. federal benefit (6.8)% —% (0.1)%R&D credit —% 1.4% 0.8%Share-based compensation (0.7)% (2.6)% (2.9)%Other permanent items —% (0.6)% (0.5)%Change in valuation allowance 47.3% (30.1)% (19.9)%Foreign rate differential (51.7)% —% —% Effective tax rate 0.6% 2.1% 11.4% (In thousands) UnrecognizedTax Benefits Balance, April 1, 2009 $1,826 Additions based on tax positions related to prior periods 9 Balance, March 31, 2010 1,835 Additions based on tax positions related to prior periods 49 Balance, March 31, 2011 1,884 Additions based on tax positions related to prior periods 624 Decreases due to lapse of statute of limitations (68) Balance, March 31, 2012 $2,440 ALKERMES PLC AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)17. COMMITMENTS AND CONTINGENCIESLease Commitments The Company leases certain of its offices, research laboratories and manufacturing facilities under operating leases with initial terms of one totwenty years, expiring through the year 2020. Certain of the leases contain provisions for extensions of up to ten years. These lease commitments areprimarily related to the Company's corporate headquarters in Ireland and its corporate offices and manufacturing facility in Massachusetts. As ofMarch 31, 2012, the total future annual minimum lease payments under the Company's non-cancelable operating leases are as follows: Rent expense related to operating leases charged to operations was $4.2 million, $5.4 million and $11.2 million for the years ended March 31,2012, 2011 and 2010, respectively. These amounts are net of sublease income of $9.2 million, $7.3 million and $3.5 million earned in the years endedMarch 31, 2012, 2011 and 2010, respectively. In addition to its lease commitments, the Company has open purchase orders totaling $114.8 million atMarch 31, 2012.Litigation From time to time, the Company may be subject to other legal proceedings and claims in the ordinary course of business. For example, theCompany is currently involved in various sets of Paragraph IV litigations in the U.S. and similar suits in Canada and France in respect of certain of itsproducts. The Company is not aware of any such proceedings or claims that it believes will have, individually or in the aggregate, a material adverseeffect on its business, results of operations, cash flows and financial condition.F-47(In thousands) PaymentAmount Fiscal Years: 2013 $6,190 2014 3,773 2015 4,068 2016 3,970 2017 3,472 Thereafter 12,000 33,473 Less: estimated sublease income (4,582) Total future minimum lease payments $28,891 QuickLinksALKERMES PLC AND SUBSIDIARIES ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED MARCH 31, 2012 INDEXFORWARD-LOOKING STATEMENTSPART IItem 1. BusinessItem 1A. Risk FactorsItem 1B. Unresolved Staff CommentsItem 2. PropertiesItem 3. Legal ProceedingsItem 4. Mine Safety DisclosuresPART IIItem 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesComparison of Cumulative Total ReturnsComparison of Cumulative Total ReturnsItem 6. Selected Financial DataItem 7. Management's Discussion and Analysis of Financial Condition and Results of OperationsItem 7A. Quantitative and Qualitative Disclosures about Market RiskItem 8. Financial Statements and Supplementary DataItem 9. Changes in and Disagreements with Accountants on Accounting and Financial DisclosureItem 9A. Controls and ProceduresItem 9B. Other InformationPART IIIItem 10. Directors, Executive Officers and Corporate GovernanceItem 11. Executive CompensationItem 12. Security Ownership of Certain Beneficial Owners and ManagementItem 13. Certain Relationships and Related Transactions and Director IndependenceItem 14. Principal Accounting Fees and ServicesPART IVItem 15. Exhibits and Financial Statement SchedulesSIGNATURESPOWER OF ATTORNEYEXHIBIT INDEXReport of Independent Registered Public Accounting FirmALKERMES PLC AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS March 31, 2012 AND 2011ALKERMES PLC AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Years EndedMarch 31, 2012, 2011 AND 2010ALKERMES PLC AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS Years Ended March 31, 2012, 2011 AND 2010ALKERMES PLC AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTSExhibit 10.57 March 7, 2012 Elan Corporation, plcElan Science Three LimitedTreasury BuildingLower Grand Canal StreetDublin 2Ireland Ladies and Gentlemen: Reference is made to the Shareholder’s Agreement dated as of September 16, 2011 (the “Shareholder’s Agreement”), by and among Alkermes plc, apublic limited company incorporated in Ireland (registered number 498284), whose registered address is Connaught House, 1 Burlington Road, Dublin 4,Ireland (“Alkermes”), Elan Corporation, plc, a public limited company incorporated in Ireland (registered number 30356), whose registered address isTreasury Building, Lower Grand Canal Street, Dublin 2, Ireland (the “Shareholder Parent”), and Elan Science Three Limited, a private limited companyincorporated in Ireland (registered number 477401) and a wholly-owned subsidiary of the Shareholder Parent, whose registered address is Treasury Building,Lower Grand Canal Street, Dublin 2, Ireland (the “Shareholder,” together with the Shareholder Parent and Alkermes, the “Parties”). Unless specifiedotherwise, defined terms in this waiver and consent letter shall have the meaning assigned to them in the Shareholder’s Agreement. The Shareholder Parent has advised Alkermes of the Shareholder’s desire to Transfer 15,985,000 Shareholder Shares, which represents 50.1% ofthe Shareholder Shares, in a marketed, underwritten registered offering pursuant to a registration statement that has been filed with the SEC on Form S-1under File No. 333-179550 (the “Registered Offering”). By execution of this waiver and consent letter in accordance with Section 7.4 of the Shareholder’sAgreement, Alkermes hereby waives the limitations set forth in Section 5.1(b)(i) of the Shareholder’s Agreement that would prohibit both a Transfer ofShareholder Shares prior to the six (6) month anniversary of the Closing Date and following such date, the Transfer of more than 40.75% of the ShareholderShares in such Registered Offering, solely in order to permit, and Alkermes hereby consents to, the Transfer of up to 15,985,000 Shareholder Shares by theShareholder in such Registered Offering. This waiver and consent letter shall not be deemed to modify any other provision of the Shareholder’s Agreement or to constitute a waiver of anyexisting right or remedy thereunder not expressly stated above. Except as expressly stated herein, Alkermes hereby reserves all rights and remedies available toit for the full protection and enforcement of its rights under the Shareholder’s Agreement. The waiver and consent set forth herein shall become effective on and as of the date hereof. In the event the Transfer of Shareholder Sharescontemplated in this waiver and consent letter is not consummated on or prior to March 16, 2012 (other than any Transfer pursuant to any underwriters’option to purchase additional shares in connection with such Registered Offering), this waiver and consent letter shall be revoked and cease to have any effect. [remainder of this page intentionally left blank] Alkermes plc. Registered in Ireland (company number 498284). Registered Office: Connaught House, 1 Burlington Road, Dublin 4, Ireland. Directors:Richard Pops - Chairman (USA), David Anstice (USA), Floyd Bloom (USA), Robert Breyer (USA), Wendy Dixon (USA), Geraldine Henwood (USA), PaulMitchell (USA), Mark Skaletsky (USA) Sincerely, /s/ Shane CookeBy:Alkermes plcName:Shane CookeTitle:President Agreed and acknowledged: /s/ William F. DanielBy:Elan Corporation, plcName:William F. DanielTitle:Executive Vice President and Company Secretary /s/ William F. DanielBy:Elan Science Three LimitedName:William F. DanielTitle:Director [Waiver and Consent] Alkermes plc. Registered in Ireland (company number 498284). Registered Office: Connaught House, 1 Burlington Road, Dublin 4, Ireland. Directors:Richard Pops - Chairman (USA), David Anstice (USA), Floyd Bloom (USA), Robert Breyer (USA), Wendy Dixon (USA), Geraldine Henwood (USA), PaulMitchell (USA), Mark Skaletsky (USA) Exhibit 10.58 March 8, 2012 Elan Corporation, plcElan Science Three LimitedTreasury BuildingLower Grand Canal StreetDublin 2Ireland Ladies and Gentlemen: Reference is made to the Shareholder’s Agreement dated as of September 16, 2011 (the “Shareholder’s Agreement”), by and among Alkermes plc, apublic limited company incorporated in Ireland (registered number 498284), whose registered address is Connaught House, 1 Burlington Road, Dublin 4,Ireland (“Alkermes”), Elan Corporation, plc, a public limited company incorporated in Ireland (registered number 30356), whose registered address isTreasury Building, Lower Grand Canal Street, Dublin 2, Ireland (the “Shareholder Parent”), and Elan Science Three Limited, a private limited companyincorporated in Ireland (registered number 477401) and a wholly-owned subsidiary of the Shareholder Parent, whose registered address is Treasury Building,Lower Grand Canal Street, Dublin 2, Ireland (the “Shareholder,” together with the Shareholder Parent and Alkermes, the “Parties”). Unless specifiedotherwise, defined terms in this waiver and consent letter shall have the meaning assigned to them in the Shareholder’s Agreement. The Shareholder Parent has advised Alkermes of the Shareholder’s desire to Transfer 24,150,000 Shareholder Shares, which represents 75.7% ofthe Shareholder Shares, in a marketed, underwritten registered offering pursuant to a registration statement that has been filed with the SEC on Form S-1under File No. 333-179550 (the “Registered Offering”). Alkermes previously executed and delivered to the Shareholder a Waiver and Consent Letter (the“Waiver and Consent Letter”) with respect to the Shareholder’s Agreement, (i) agreeing to waive certain limitations set forth in Section 5.1(b)(i) of theShareholder’s Agreement in connection with the Registered Offering and (ii) agreeing and consenting to the Transfer of up to 15,985,000 Shareholder Sharesby the Shareholder in the Registered Offering. By execution of this waiver and consent letter in accordance with Section 7.4 of the Shareholder’s Agreement, Alkermes hereby waives the limitationsset forth in Section 5.1(b)(i) of the Shareholder’s Agreement and consents to the Transfer of up to 8,165,000 Shareholder Shares (in addition to the15,985,000 Shareholder Shares for which the waiver and consent were previously provided in the Waiver and Consent Letter), representing a waiver andconsent with respect to the Transfer of an aggregate number of up to 24,150,000 Shareholder Shares, by the Shareholder in the Registered Offering. This waiver and consent letter shall not be deemed to modify any other provision of the Shareholder’s Agreement or to constitute a waiver of anyexisting right or remedy thereunder not expressly stated above. Except as expressly stated herein, Alkermes hereby reserves all rights and remedies available toit for the full protection and enforcement of its rights under the Shareholder’s Agreement. Alkermes plc. Registered in Ireland (company number 498284). Registered Office: Connaught House, 1 Burlington Road, Dublin 4, Ireland. Directors:Richard Pops - Chairman (USA), David Anstice (USA), Floyd Bloom (USA), Robert Breyer (USA), Wendy Dixon (USA), Geraldine Henwood (USA), PaulMitchell (USA), Mark Skaletsky (USA) The waiver and consent set forth herein shall become effective on and as of the date hereof. In the event the Transfer of Shareholder Sharescontemplated in this waiver and consent letter is not consummated on or prior to March 16, 2012 (other than any Transfer pursuant to any underwriters’option to purchase additional shares in connection with such Registered Offering), this waiver and consent letter shall be revoked and cease to have any effect. [remainder of this page intentionally left blank] Sincerely, /s/ Shane CookeBy:Alkermes plcName:Shane CookeTitle:President  Agreed and acknowledged: /s/ William F. DanielBy:Elan Corporation, plcName:William F. DanielTitle:Executive Vice President and Company Secretary /s/ William F. DanielBy:Elan Science Three LimitedName:William F. DanielTitle:Director [Waiver and Consent] QuickLinks -- Click here to rapidly navigate through this documentEXHIBIT 21.1 SUBSIDIARIES Name JurisdictionAlkermes Ireland Holdings Limited IrelandAlkermes Pharma Ireland Limited IrelandAlkermes Finance Ireland Limited IrelandAlkermes Finance S.à r.l. LuxembourgAlkermes Finance Ireland (No.2) Limited IrelandAlkermes US Holdings, Inc. DelawareAlkermes, Inc. PennsylvaniaEagle Holdings USA, Inc. DelawareAlkermes Gainesville LLC MassachusettsAlkermes Controlled Therapeutics, Inc. PennsylvaniaAlkermes Europe, Ltd. United KingdomQuickLinksEXHIBIT 21.1SUBSIDIARIESQuickLinks -- Click here to rapidly navigate through this documentEXHIBIT 23.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form S-1 (No. 333-179550), Form S-4 (No. 333-175078)and Form S-8 (333-179545) of Alkermes plc of our report dated May 17, 2012 relating to the financial statements and the effectiveness of internalcontrol over financial reporting, which appears in this Form 10-K.Boston, MassachusettsMay 18, 2012QuickLinksEXHIBIT 23.1CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMQuickLinks -- Click here to rapidly navigate through this documentEXHIBIT 31.1 CERTIFICATIONS I, Richard F. Pops, certify that:1.I have reviewed this annual report on Form 10-K of Alkermes, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and15d-15(f)) for the registrant and have: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared. b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's mostrecent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant's internal control over financial reporting; and 5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting./s/ RICHARD F. POPSRichard F. PopsChairman and Chief Executive Officer(Principal Executive Officer) May 18, 2012 QuickLinksEXHIBIT 31.1CERTIFICATIONSQuickLinks -- Click here to rapidly navigate through this documentEXHIBIT 31.2 CERTIFICATIONS I, James M. Frates, certify that:1.I have reviewed this annual report on Form 10-K of Alkermes, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and15d-15(f)) for the registrant and have: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared. b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's mostrecent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant's internal control over financial reporting; and 5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting./s/ JAMES M. FRATES James M. Frates Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) May 18, 2012QuickLinksEXHIBIT 31.2CERTIFICATIONSQuickLinks -- Click here to rapidly navigate through this documentEXHIBIT 32.1 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Alkermes plc (the "Company") on Form 10-K for the period ended March 31, 2012 as filed with theSecurities and Exchange Commission on the date hereof (the "Report"), we, Richard F. Pops, Chairman and Chief Executive Officer of the Company,and James M. Frates, Senior Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adoptedpursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to our knowledge that:(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany.May 18, 2012/s/ RICHARD F. POPSRichard F. PopsChairman and Chief Executive Officer(Principal Executive Officer) /s/ JAMES M. FRATESJames M. FratesSenior Vice President and Chief Financial Officer(Principal Financial and Accounting Officer) QuickLinksEXHIBIT 32.1CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEYACT OF 2002

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