Amarin Corporation Annual Report 2014

Plain-text annual report

Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 Form 10-K þANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2014OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Commission File No. 0-21392 Amarin Corporation plc(Exact name of registrant as specified in its charter) England and Wales Not applicable(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.)2 Pembroke HouseUpper Pembroke Street 28-32, Dublin 2, Ireland(Address of principal executive offices)+353 (0) 1 6699 020(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on Which RegisteredAmerican Depositary Shares, each representing one Ordinary ShareOrdinary Shares, 50 pence par value per share The NASDAQ Stock Market LLCSecurities registered pursuant to Section 12(g) 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 þ NO ¨Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ¨ NO þIndicate 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 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. YES þ NO ¨Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). YES þ NO ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, andwill not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. Seethe definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer ¨ Accelerated filer þNon-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ¨ NO þThe aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2014 was approximately$277.0 million, based upon the closing price on the NASDAQ Capital Market reported for such date.176,228,632 shares held as American Depository Shares (ADS), each representing one Ordinary Share, 50 pence par value per share, and 865,904Ordinary Shares, were outstanding as of March 2, 2015.DOCUMENTS INCORPORATED BY REFERENCECertain information required to be disclosed in Part III of this report is incorporated by reference from the registrant’s definitive proxy statement to befiled not later than 120 days after the end of the fiscal year covered by this report. Table of ContentsTable of Contents Page PART I Item 1. Business 2 Item 1A. Risk Factors 25 Item 1B. Unresolved Staff Comments 55 Item 2. Properties 55 Item 3. Legal Proceedings 55 Item 4. Mine Safety Disclosures 56 PART II Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 57 Item 6. Selected Financial Data 60 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 61 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 85 Item 8. Financial Statements and Supplementary Data 85 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 85 Item 9A. Controls and Procedures 85 Item 9B. Other Information 88 PART III Item 10. Directors, Executive Officers and Corporate Governance 89 Item 11. Executive Compensation 89 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 89 Item 13. Certain Relationships and Related Transactions, and Director Independence 89 Item 14. Principal Accountant Fees and Services 89 PART IV Item 15. Exhibits and Financial Statement Schedules 90 SIGNATURES 99 Table of ContentsPART ISPECIAL NOTE REGARDINGFORWARD-LOOKING STATEMENTS AND INDUSTRY DATAThis Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical fact contained in this AnnualReport on Form 10-K are forward-looking statements, including statements regarding the progress and timing of our clinical programs, regulatory filings andcommercialization activities, and the potential clinical benefits, safety and market potential of our product candidates, as well as more general statementsregarding our expectations for future financial and operational performance, regulatory environment, and market trends. In some cases, you can identifyforward-looking statements by terminology such as “may,” “would,” “should,” “could,” “expects,” “aims,” “plans,” “anticipates,” “believes,” “estimates,”“predicts,” “projects,” “potential,” or “continue”; the negative of these terms; or other comparable terminology. These statements include but are not limitedto statements regarding the commercial success of Vascepa in its first approved indication, the MARINE indication; the potential for, conditions to, andtiming of, approval of the Vascepa Supplemental New Drug Application, or sNDA, by the United States Food and Drug Administration, or FDA, in itspotential second indication, the ANCHOR indication; the timing of enrollment, interim results or final results of our REDUCE-IT study; the safety andefficacy of our product candidates; potential for Vascepa to be marketed by partners outside of the United States; the scope of our intellectual propertyprotection and the likelihood of securing additional patent protection; estimates of the potential markets for our product candidates; the likelihood ofqualifying additional third party manufacturing suppliers and estimates of the capacity of manufacturing and other facilities to support our products; ouroperating and growth strategies; our industry; our projected cash needs, liquidity and capital resources; and our expected future revenues, operations andexpenditures.Forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may causeour or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements.These factors include, among other things, those listed under “Risk Factors” in Item 1A of Part I of this Annual Report on Form 10-K and elsewhere in thisAnnual Report on Form 10-K. These and other factors could cause results to differ materially from those expressed in these forward-looking statements.Although we believe that the expectations reflected in the forward-looking statements contained in this Annual Report on Form 10-K are reasonable,we cannot guarantee future results, performance, or achievements. Except as required by law, we are under no duty to update or revise any of such forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Annual Report on Form 10-K.Unless otherwise indicated, information contained in this Annual Report on Form 10-K concerning our product candidates, the number of patients thatmay benefit from these product candidates and the potential commercial opportunity for our product candidates, is based on information from independentindustry analysts and third-party sources (including industry publications, surveys, and forecasts), our internal research, and management estimates.Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as datafrom our internal research, and based on assumptions made by us based on such data and our knowledge of such industry, which we believe to be reasonable.None of the sources cited in this Annual Report on Form 10-K has consented to the inclusion of any data from its reports, nor have we sought their consent.Our internal research has not been verified by any independent source, and we have not independently verified any third-party information. While we believethat such information included in this Annual Report on Form 10-K is generally reliable, such information is inherently imprecise. In addition, projections,assumptions, and estimates of our future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, includingthose described in “Risk Factors” in Item 1A of Part I of this Annual Report on Form 10-K and elsewhere in this Annual Report on Form 10-K. These andother factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. 1Table of ContentsItem 1.BusinessReferences in this report to “Amarin,” the “Company,” “we,” “our” and “us” refer to Amarin Corporation plc and its subsidiaries, on a consolidatedbasis, unless otherwise indicated.This Annual Report on Form 10-K includes the registered and unregistered trademarks and service marks of other parties.Amarin Corporation plc (formerly Ethical Holdings plc) is a public limited company incorporated under the laws of England and Wales. AmarinCorporation plc was originally incorporated in England as a private limited company on March 1, 1989 under the Companies Act 1985, and re-registered inEngland as a public limited company on March 19, 1993.Our registered office is located at One New Change, London EC4M 9AF, England. Our principal offices are located at 2 Pembroke House, UpperPembroke Street 28-32, Dublin 2 Ireland. Our primary office in the United States is located at 1430 Route 206, Bedminster, NJ 07921, USA. Our telephonenumber at that location is (908) 719-1315.For purposes of this Annual Report on Form 10-K, our ordinary shares may also be referred to as “common shares” or “common stock.”OverviewWe are a biopharmaceutical company with expertise in lipid science focused on the commercialization and development of therapeutics to improvecardiovascular health.Our lead product, Vascepa (icosapent ethyl) capsules, is approved by the U.S. Food and Drug Administration, or FDA, for use as an adjunct to diet toreduce triglyceride levels in adult patients with severe (TG >500 mg/dL) hypertriglyceridemia. Vascepa is available in the United States by prescription only.We began selling and marketing Vascepa in the United States in January 2013. We sell Vascepa principally to a limited number of major wholesalers, as wellas selected regional wholesalers and specialty pharmacy providers, or collectively, its Distributors, that in turn resell Vascepa to retail pharmacies forsubsequent resale to patients and health care providers. We market Vascepa through our sales force of approximately 150 sales professionals, including salesrepresentatives and their managers. In March 2014, we entered into a co-promotion agreement with Kowa Pharmaceuticals America, Inc. under whichapproximately 250 Kowa Pharmaceuticals America, Inc. sales representatives began to devote a substantial portion of their time to promoting Vascepastarting in May 2014. We operate in one business segment.Triglycerides are fats in the blood. Hypertriglyceridemia refers to a condition in which patients have high levels of triglycerides in the bloodstream. Itis estimated that over 40 million adults in the United States have elevated triglyceride levels (TG >200 mg/dL) and approximately 4.0 million people in theUnited States have severely high triglyceride levels (TG >500 mg/dL), commonly known as very high triglyceride levels. According to The American HeartAssociation Scientific Statement on Triglycerides and Cardiovascular Disease (2011), triglycerides also provide important information as a markerassociated with the risk for heart disease and stroke, especially when an individual also has low high-density lipoprotein cholesterol, or HDL-C (often referredto as “good” cholesterol), and elevated levels of LDL-C (often referred to as “bad” cholesterol). Guidelines for the management of very high triglyceridelevels suggest that reducing triglyceride levels is the primary goal in patients to reduce the risk of acute pancreatitis. The effect of Vascepa on cardiovascularmortality and morbidity, or the risk for pancreatitis, in patients with hypertriglyceridemia has not been determined.The potential efficacy and safety of Vascepa (known in its development stage as AMR 101) was studied in two Phase 3 clinical trials, the MARINE trialand the ANCHOR trial. At a daily dose of 4 grams of Vascepa, the dose at which we requested and received FDA approval for Vascepa, these trials showedfavorable clinical 2®Table of Contentsresults in their respective patient populations in reducing triglyceride levels without increasing LDL-C levels in the MARINE trial and with a statisticallysignificant decrease in LDL-C levels in the ANCHOR trial, in each case, relative to placebo. These trials also showed favorable results, particularly with the 4-gram daily dose of Vascepa, in other important lipid and inflammation biomarkers, including apolipoprotein B (apo B), non-high-density lipoproteincholesterol (non-HDL-C), total-cholesterol (TC), very low-density lipoprotein cholesterol (VLDL-C), lipoprotein-associated phospholipase A2 (Lp-PLA2),and high sensitivity C-reactive protein (hs-CRP). In these trials, the most commonly reported adverse reaction (incidence >2% and greater than placebo) inVascepa-treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo).We are also developing Vascepa for the treatment of patients with high (TG 200 mg/dL and <500 mg/dL) triglyceride levels who are also on statintherapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels which we refer to as mixed dyslipidemia. We refer to this second proposedindication for Vascepa as the ANCHOR indication. The FDA has stated that it views the proposed ANCHOR indication as ostensibly and impliedly anindication to reduce cardiovascular risk. In addition, in December 2011, we announced commencement of patient dosing in our cardiovascular outcomesstudy of Vascepa, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial). The REDUCE-IT study is designed to evaluate theefficacy of Vascepa in reducing major cardiovascular events in a high risk patient population on statin therapy.We have a pending supplemental new drug application, or sNDA, with the FDA that seeks marketing approval of Vascepa for use in the ANCHORindication. On October 16, 2013, the FDA convened an advisory committee to review our sNDA. This advisory committee was not asked by the FDA toevaluate whether Vascepa is effective in lowering triglycerides in the studied population, the ANCHOR indication as specified in the sNDA. Rather, theadvisory panel was asked whether Vascepa would improve cardiovascular outcomes or whether approval of the ANCHOR indication should wait forsuccessful completion of the REDUCE-IT study, the first prospective study of cardiovascular outcomes in patients who have high triglyceride levels despitestatin therapy. The advisory committee voted 9 to 2 against recommending approval of the ANCHOR indication based on information presented at themeeting. The FDA considers the recommendation of advisory committees, but final decisions on the approval of new drug applications are made by the FDA.The FDA has communicated to us that Vascepa demonstrated a reduction in triglycerides over placebo in the ANCHOR study and urged us to complete theREDUCE-IT cardiovascular outcomes study.The ANCHOR clinical study was conducted under a special protocol assessment, or SPA, agreement with the FDA. The law governing SPA agreementsrequires that if the results of the trial conducted under the SPA substantiate the hypothesis of the protocol covered by the SPA, the FDA must use the datafrom the protocol as part of the primary basis for approval of the product. A SPA agreement is not a guarantee of FDA approval of the related new drugapplication. A SPA agreement is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issueessential to determining safety or efficacy of the drug after the study begins that rises to the level of a public health concern, or if the study sponsor fails tofollow the protocol that was agreed upon with the FDA. On October 29, 2013, the FDA rescinded the ANCHOR study SPA agreement because the FDAdetermined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testingbegan. As a basis for this determination, the FDA communicated that it determined that the cumulative results from outcome studies of other triglyceride-lowering drugs failed to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among thepopulation studied in the ANCHOR trial. Thus, the FDA stated that while information we submitted supports testing the hypothesis that Vascepa 4 grams/dayversus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in theVascepa REDUCE-IT cardiovascular outcomes study, the FDA no longer considers a change in serum triglyceride levels alone as sufficient to establish theeffectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.Beginning in November 2013, we sought reconsideration and appealed the SPA rescission decision to three levels of increasing authority within theFDA and were denied each time, most recently in September 2014. 3Table of ContentsBased on FDA’s repeated position in its appeal denials and its internal consultation with FDA officials at higher levels, we informed the FDA that we did notintend to appeal the SPA rescission further.The FDA did not take action on the ANCHOR sNDA by the Prescription Drug User Fee Act, or PDUFA, goal date for completion of FDA’s review,December 20, 2013. Given our September 2014 determination to not appeal the SPA rescission further, we expect the FDA to take action on our pendingANCHOR sNDA in the near future. The FDA has not committed to a specific date for this action.We are currently focused on the ongoing REDUCE-IT cardiovascular outcomes study of Vascepa. REDUCE-IT, a multinational, prospective,randomized, double-blind, placebo-controlled study, is the first prospective cardiovascular outcomes study of any drug in a population of patients who,despite stable statin therapy, have elevated triglyceride levels. Based on the results of REDUCE-IT, we plan to seek additional indications for Vascepabeyond the indications studied in the ANCHOR and MARINE trials. In REDUCE-IT, cardiovascular event rates for patients on stable statin therapy plus fourgrams per day of Vascepa will be compared to cardiovascular event rates for patients on stable statin therapy plus placebo. The REDUCE-IT study is designedto be completed after reaching an aggregate number of cardiovascular events. Based on projected event rates, we estimate the REDUCE-IT study can becompleted in or about 2017 with results then expected to be available and published in 2018. An interim review of the efficacy and safety results of the trialis scheduled to occur upon reaching 60% of the target aggregate number of cardiovascular events. We currently expect this interim review by theindependent data monitoring committee (DMC) to occur during 2016. The DMC has been more frequently examining interim reviews of the safety data fromthe study. Based on such safety reviews, the DMC has advised us that we should continue the study as planned. Amarin remains blinded to all data from thestudy. Over 90% of the 8,000 patients targeted for enrollment in the REDUCE-IT study have been enrolled.Our scientific rationale for the REDUCE-IT study is supported by (i) epidemiological data that suggests elevated triglyceride levels correlate withincreased cardiovascular disease risk, (ii) genetic data that suggests triglyceride and/or triglyceride-rich lipoproteins (as well as low-density lipoproteincholesterol (LDL cholesterol), known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data thatsuggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. Our scientificrationale for the REDUCE-IT study is also supported by research on the differentiated effects of the active ingredient in Vascepa, including the antioxidantproperties and effects on inflammation markers associated with atherosclerosis. While various epidemiological data, genetics data, clinical data and outcomesdata support a correlation between triglyceride levels and cardiovascular disease, the cardiovascular benefits of lowering triglycerides in the at-riskpopulation being studied in REDUCE-IT has not previously been evaluated in a prospectively run, double blinded, placebo controlled outcomes study.Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IT outcomes study will be required forlabel expansion for Vascepa. There can be no assurance that we will be successful in our efforts to obtain a label expansion reflecting the ANCHOR clinicaltrial whether or not we obtain final positive results from the REDUCE-IT outcomes study. If the FDA does not approve the ANCHOR indication, it could havea material impact on our future results of operations and financial condition.On October 22, 2013, in an effort to lower operating expenses following the recommendation of the advisory committee to the FDA against approval ofthe ANCHOR indication, we implemented a worldwide reduction in force of approximately 50% of our staff positions. The majority of affected staff memberswere sales professionals who supported the initial commercial launch of Vascepa. We incurred approximately $2.8 million in charges related to the reductionin force, all of which includes cash expenditures for one-time termination benefits and associated costs. The charges were recorded in the fourth quarter of2013 and the related payments were made by the first half of 2014. As part of the reduction in force, we retained approximately 130 sales representatives,excluding sales management, in the United States in sales territories that we believe have demonstrated the greatest potential for Vascepa sales growth. Thisteam covers the target base of physicians responsible for the majority of Vascepa 4Table of Contentsprescription volume and growth since its launch in early 2013. With these changes and the resulting target base coverage, as well as the addition of thepromotional efforts of 250 sales representatives from Kowa Pharmaceuticals America, Inc. that began in May 2014, we anticipate continued Vascepa revenuegrowth over time. We also anticipate that such sales growth may be inconsistent from period to period.Commercialization StrategyVascepa became commercially available in the United States by prescription in January 2013 when we commenced sales and shipments to our networkof U.S.-based wholesalers. We commenced the commercial launch of Vascepa in the United States in January 2013 with approximately 275 salesrepresentatives. Vascepa has not yet been approved or commercially launched outside of the United States. In October 2013, we reduced our number of salesrepresentatives in the United States to approximately 130, excluding sales management, to focus on the sales territories that we believe have demonstratedthe greatest potential for Vascepa sales growth. We now market Vascepa in the United States through our sales force of approximately 150 sales professionalsand their managers. Commencing in the middle of the second quarter of 2014, in addition to promotion by our sales representatives, approximately 250Kowa Pharmaceuticals America, Inc. sales representatives began promoting Vascepa. We also employ various marketing personnel to support ourcommercialization of Vascepa. Our clinical and commercial supply is provided to us under agreements with various third-party suppliers. As of February 1,2015, over 26,000 clinicians had written prescriptions for Vascepa.Under the co-promotion agreement with Kowa Pharmaceuticals America, Inc., under which promotion commenced in May 2014, both parties haveagreed to use commercially reasonable efforts to promote, detail and optimize sales of Vascepa in the United States and have agreed to specific performancerequirements detailed in the related agreement. The performance requirements include a negotiated minimum number of sales details to be delivered by eachparty in the first and second position, the use of a negotiated number of minimum sales representatives from each party, including no less than 250 KowaPharmaceuticals America, Inc. sales representatives and the achievement of minimum levels of Vascepa revenue in 2015 and beyond. Kowa PharmaceuticalsAmerica, Inc. has also agreed to continue to bear the costs incurred for its sales force associated with the commercialization of Vascepa and to pay for certainincremental costs associated with the use of its sales force, such as sample costs and costs for promotional and marketing materials. We will continue torecognize all revenue from sales of Vascepa. In exchange for Kowa Pharmaceuticals America, Inc.’s co-promotional services, Kowa Pharmaceuticals America,Inc. is entitled to a quarterly co-promotion fee based on a percentage of aggregate Vascepa gross margins that increases during the term. The percentage ofaggregate Vascepa gross margins earned by Kowa Pharmaceuticals America, Inc. is scheduled to increase from the high single digits in 2014, to mid-teenpercent levels in 2015, and to the low twenty percent levels in 2018, subject to certain adjustments. The term of this co-promotion agreement expiresDecember 31, 2018.Based on monthly compilations of data provided by a third party, Symphony Health Solutions, the estimated number of normalized total Vascepaprescriptions for the three months ended December 31, 2014 was approximately 146,000 as compared to 132,000, 110,000, 93,000 and 94,000 prescriptionsin the three months ended September 30, 2014, June 30, 2014, March 31, 2014 and December 31, 2013, respectively. According to data from another thirdparty, IMS Health, the estimated number of normalized total Vascepa prescriptions for the three months ended December 31, 2014 was approximately131,000 as compared to 113,000, 93,000, 78,000 and 79,000 prescriptions in the three months ended September 30, 2014, June 30, 2014 and March 31, 2014and December 31, 2013, respectively. Normalized total prescriptions represent the estimated total number of Vascepa prescriptions shipped to patients,calculated on a normalized basis (i.e., total capsules shipped divided by 120 capsules, or one month’s supply). The data reported above is based oninformation made available to us from a third party resource and may be subject to adjustment and may overstate or understate actual prescriptions. Timing ofshipments to wholesalers, as used for revenue recognition purposes, and timing of prescriptions as estimated by these third parties may differ from period toperiod.Although we believe these data are prepared on a period-to-period basis in a manner that is generally consistent and that such results are generallyindicative of current prescription trends, these data are based on 5Table of Contentsestimates and should not be relied upon as definitive. In addition, because we had limited selling history during the year ended December 31, 2013, we onlyrecognized revenue on product that was resold for purposes of filling prescriptions. Those prescription data may differ from data reported by other thirdparties.Prior to commencing our U.S. commercial launch of Vascepa in January 2013, we had no revenue from Vascepa. Because of our limited selling history,changes in the size of our sales force, our co-promotion agreement, and uncertainty regarding resolution of the ANCHOR sNDA with the FDA, we do notcurrently provide quantified revenue guidance. While we expect to be able to grow Vascepa revenues, we provide no quantified guidance regardinganticipated levels of Vascepa prescriptions or revenues and no such guidance should be inferred from the operating metrics described above. We believe thatinvestors should view the above-referenced operating metrics with caution, as data for this limited period may not be representative of a trend consistent withthe results presented or otherwise predictive of future results. Seasonal fluctuations in pharmaceutical sales, for example, may affect future prescription trendsof Vascepa, as could changes in prescriber sentiment and other factors. We believe investors should consider our results over several quarters, or longer,before making an assessment about potential future performance.We secured managed care coverage for over 215 million lives, including as of February 1, 2015 over 125 million lives covered on Tier 2 for formularypurposes.The commercialization of a new pharmaceutical product is a complex undertaking, and our ability to effectively and profitably commercialize Vascepawill depend in part on our ability to generate market demand for Vascepa through education, marketing and sales activities, our ability to achieve marketacceptance of Vascepa, our ability to generate product revenue and our ability to receive adequate levels of reimbursement from third-party payers. See “RiskFactors—Risks Related to the Commercialization and Development of Vascepa.”Research and Development UpdateIn September 2014, we announced our continued commitment to completing the ongoing REDUCE-IT cardiovascular outcomes study and outlinedreasons why we believe that this study is positioned for success. This multinational, prospective, randomized, double-blind, placebo-controlled study is thefirst prospective cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels.We have over 7,300 patients enrolled in the REDUCE-IT study. We currently estimate that we will complete patient enrollment in this study within2015. The REDUCE-IT study is designed to be completed after reaching an aggregate number of cardiovascular events. Based on projected event rates, weestimate the REDUCE-IT study can be completed in or about 2017 with results then expected to be available and published in 2018. Based on the results ofREDUCE-IT, we may seek additional indicated uses for Vascepa beyond the indications studied in the ANCHOR or MARINE trials. An interim review of theefficacy and safety results of the trial is scheduled to occur upon reaching 60% of the target aggregate number of cardiovascular events. We currently expectthis interim review by the independent data monitoring committee (DMC) to occur during 2016. As is typical, the statistical threshold for definingoverwhelming efficacy on the primary endpoint and stopping the study early at the interim analysis is considerably higher than the threshold for definingstatistical significance at the end of the study. Amarin remains blinded to all data from the study.Our scientific rationale for the REDUCE-IT study is supported by (i) epidemiological data that suggests elevated triglyceride levels correlate withincreased cardiovascular disease risk, (ii) genetic data that suggests triglyceride and/or triglyceride-rich lipoproteins (as well as low-density lipoproteincholesterol (LDL cholesterol), known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data thatsuggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. Our scientificrationale for the REDUCE-IT study is also supported by research on the differentiated effects of the active ingredient in Vascepa, including the antioxidantproperties and effects on inflammation markers associated with atherosclerosis. 6Table of ContentsCommercial Supply UpdateDuring 2013 and 2014, all of our active pharmaceutical ingredient, or API, was acquired through two suppliers, Nisshin and Chemport. Much of theinventory sold in 2014 was purchased in 2013 from Nisshin at a price which is higher than expected future average API costs.During 2014, we reached a settlement agreement with a former supplier, BASF, under which we received a refund for previous material purchases of$3.0 million, included within other income in the statement of operations. The amount of supply we seek to purchase in 2014 and beyond will depend on thelevel of growth of Vascepa revenues.Financial PositionWe believe that our cash and cash equivalents balance of $119.5 million at December 31, 2014 is sufficient to fund our projected operations for at leastthe next twelve months.Lipid Disorders and Cardiovascular DiseaseHeart attacks, strokes and other cardiovascular events represent the leading cause of death and disability among men and women in western societies.According to the Heart Disease and Stroke Statistics—2015 Update from the American Heart Association, more than 1 out of every 3 adults in the U.S.(approximately 86 million) currently lives with one or more types of cardiovascular disease; an estimated 935,000 new or recurrent coronary heart diseases(CHD) and 795,000 new or recurrent strokes occur each year; an estimated 31 million adults 20 years of age have high total serum cholesterol levels (240mg/dL), and an estimated 74 million adults 20 years of age have borderline high or high low-density lipoprotein (“bad”) cholesterol, or LDL-C, levels(130 mg/dL).In addition to cholesterol, lipoproteins such as LDL carry fats in the form of triglycerides. Hypertriglyceridemia refers to a condition in which patientshave high levels of triglycerides in the bloodstream and has been recognized as an independent risk factor for cardiovascular disease. Triglyceride levelsprovide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low high densitylipoprotein cholesterol (HDL-C; often called “good” cholesterol) and elevated levels of LDL-C. The effect of Vascepa on cardiovascular mortality andmorbidity in patients with hypertriglyceridemia has not been determined.Guidelines for the management of very high triglyceride levels (500 mg/dL) suggest that reducing triglyceride levels is the primary treatment goal inthese patients to reduce the risk of acute pancreatitis. Treating LDL-C remains an important secondary goal. Other important parameters to consider inpatients with very high triglycerides include levels of apolipoprotein B (apo B), non-HDL-C, very low density lipoprotein cholesterol (VLDL-C), and HDL-C.The effect of Vascepa on the risk for pancreatitis in patients with hypertriglyceridemia has not been determined.It is estimated that over 40 million adults in the United States have elevated triglyceride levels >200 mg/dL and approximately 3 to 4 million people inthe United States have very high triglyceride levels (500 mg/dL). Since 1976, mean triglyceride levels have increased, in concert with the growingepidemic of obesity, insulin resistance, and type 2 diabetes mellitus. In contrast, mean LDL-C levels have decreased.Mixed dyslipidemia refers to a condition in which patients have a combination of two or more lipid abnormalities including elevated triglycerides, lowHDL-C, and/or elevated LDL-C. Both hypertriglyceridemia and mixed dyslipidemia are components of a range of lipid disorders collectively referred to asdyslipidemia. Dyslipidemia has been linked to atherosclerosis, commonly referred to as hardening of the arteries. 7Table of ContentsLimitations of Current TherapiesIt is estimated that approximately 4% or less of U.S. adults with triglyceride levels 200 mg/dL are currently receiving prescription medication forlowering triglycerides. Many of these patients are taking statin therapy directed primarily at lowering their LDL-C levels.The leading treatments to lower triglyceride levels are fibrates (fenofibrate and gemfibrozil), statins and a prescription only omega-3 fatty acid mixture,known as Lovaza in the United States, and as Omacor in Europe. The use of fenofibrates can lead to abnormal liver function tests (an increase in ALT(alanine transaminase) or AST (aspartate transaminase), which are liver enzymes, and are commonly measured clinically as a part of a diagnostic liverfunction test to determine liver health), especially when used with statins. The use of gemfibrozil can lead to rhabdomyolysis (severe breakdown of muscles),especially when used with a statin. Lovaza is comprised of omega-3 ethyl esters, which the FDA has described as a complex mixture of eicosapentaenoic acid,or EPA, docosahexaenoic acid, or DHA, and other fatty acids. We believe that DHA may increase LDL-C levels and thereby partially offset one of thetypically desired benefits of lipid-lowering therapies, which is lowering LDL-C. Also, in 2012, the FDA required an update to Lovaza product labeling toreflect the risk that Lovaza may increase the frequency of a heart rhythm problem known as atrial fibrillation, or heart flutter.Potential Benefits and Market Opportunity for VascepaVascepa is comprised of not less than 96% pure icosapent ethyl, or ethyl-EPA, and contains no DHA. We believe that the removal of DHA mitigatesagainst the LDL-C raising effect observed in omega-3 compositions that include DHA, as well as removing the fishy taste and smell that is sometimesassociated with DHA. Based on the results of the MARINE trial, Vascepa was the first omega-3 based product to demonstrate statistically significanttriglyceride reduction without a statistically significant increase in LDL-C in this very high triglyceride population.We believe that the results of the MARINE trial and Vascepa’s EPA only/DHA-free composition suggest that Vascepa has the potential to become a“best-in-class” triglyceride-lowering agent in the United States and the European Union. In addition, currently no omega-3 based product is approved in theUnited States for lowering high triglycerides in patients with mixed dyslipidemia. If approved in that indication, Vascepa has the potential to become “first-in-class” in the prescription-only omega-3 market for lowering triglycerides in patients with mixed dyslipidemia. If the REDUCE-IT cardiovascular outcomesstudy is successful, Vascepa could be the first omega-3 based therapy approved for prevention of cardiovascular events as an add-on to statin therapy in thispopulation.We believe the potential market for Vascepa is large and growing. We estimate that drug treatment for hypercholesterolemia patients exceeds $57billion per year in the United States, with sales dominated by statin therapies. U.S. sales of fibrates as a class of products were approximately $3.4 billion in2014 with generic fenofibrate and gemfibrozil leading the class. U.S. gross sales of prescription omega-3 therapies in 2014 were over $1.3 billion withLovaza and generic Lovaza leading the class.Clinical TrialsThe MARINE Trial (basis for currently FDA approved label for Vascepa)The MARINE trial, the largest study ever conducted with the omega-3 fatty acid ethyl EPA in treating patients with very high triglycerides (500mg/dL), was a Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week study. Patients were randomized into three treatment arms fortreatment with Vascepa 4 gram/day, 2 gram/day or placebo. Patient enrollment in this trial began in December 2009, and enrollment and randomization wascompleted in August 2010 at 229 patients. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared toplacebo after 12 weeks of treatment. The MARINE study primary endpoint was required to meet a stringent level of statistical significance of 1% (p < 0.01) inour Special Protocol Assessment, or SPA, agreement with the FDA. 8®®Table of ContentsIn November 2010, we reported top-line data for the MARINE trial. In the trial, Vascepa met its primary endpoint at doses of 4 grams and 2 grams perday with median placebo-adjusted reductions in triglyceride levels of 33% (p < 0.0001) compared to placebo for 4 grams and 20% (p = 0.0051) compared toplacebo for 2 grams. The median baseline triglyceride levels were 703 mg/dL, 680 mg/dL and 657 mg/dL for the patient groups treated with placebo, 4 gramsof Vascepa and 2 grams of Vascepa, respectively.In a pre-specified secondary analysis in the subgroup of patients with baseline triglyceride > 750 mg/dL, representing 39% of all patients, the effect ofVascepa in reducing triglyceride levels compared to placebo was 45% for 4 grams and 33% for 2 grams, both statistically significant (p = 0.0001 for 4 gramsand p= 0.0016 for 2 grams, respectively). The median baseline triglyceride levels in this subgroup were 1052 mg/dL, 902 mg/dL and 948 mg/dL for placebo,4-gram and 2-gram groups, respectively. Twenty-five percent of patients in this trial were also on background statin therapy. These patients had greatermedian reduction in triglyceride levels, which was also statistically significant.Importantly, the significant reduction in triglycerides was not associated with a statistically significant increase in median LDL-C compared to placeboat either dose (-2.3% for the 4-gram group and +5.2% for the 2-gram group [both p=NS]). In addition, there was a statistically significant decrease in mediannon-HDL-C (total cholesterol less so-called “good cholesterol”) compared to placebo with both of the Vascepa treated groups (-18% for the 4-gram group [p< 0.001] and -8% for the 2-gram group [p < 0.05]).The MARINE trial results also included statistically significant reductions compared to placebo in several important lipid and inflammatorybiomarkers, including apo B (apolipoprotein B) (8.5%), Lp-PLA2 (lipoprotein-phospholipase A2) (13.6%), VLDL-C (very low-density lipoproteincholesterol) (28.6%), Total Cholesterol (16.3%), and hsCRP (high-sensitivity C-reactive protein) (36.0%) at the 4-gram dose. For these achieved endpoints, p-values were <0.01 for most and <0.05 for all. Apo B (apolipoprotein B) is believed to be a sensitive biomarker of cardiovascular risk and may be a betterpredictor of cardiovascular risk than LDL-C. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in thedevelopment and progression of atherosclerosis. In a post-hoc analysis of MARINE study data, Vascepa 4 g/day and 2 g/day statistically significantlyreduced ApoC-III levels by 25.1% (P < 0.0001) and 14.3% (P=0.0154) versus placebo, respectively. In the MARINE trial, patients treated with 4 grams perday of Vascepa experienced a significant reduction in median placebo-adjusted lipoprotein particle concentrations of total LDL and small LDL. Whenlooking at lipoprotein particle concentrations and sizes as measured with nuclear magnetic resonance spectroscopy, Vascepa 4 grams per day, compared withplacebo, significantly reduced median total LDL particle count by 16.3% (p=0.0006), which is an important factor in atherogenesis. LDL particle count andapo B are important risk markers for the prediction of cardiovascular events. Small LDL particle count, which is a common risk factor for cardiovascularevents in patients with diabetes, was reduced by 25.6% (p<0.0001) compared with placebo. Vascepa 2 grams per day, compared with placebo, significantlyreduced median small LDL particle count by 12.8% (p <0.05) and reduced median total LDL particle count by 1.1% (NS). LDL particle size did not changesignificantly for the 2 or 4 grams doses.Vascepa was well tolerated in the MARINE trial, with a safety profile comparable to placebo and there were no treatment-related serious adverse eventsobserved. No patient discontinued treatment of Vascepa during this study due to Vascepa-related adverse events. No significant changes in fasting bloodglucose, hemoglobin A1C, vital signs, electrocardiograms, or liver or kidney function were observed with either Vascepa dose.Patients enrolled in the MARINE trial were given the option to be treated with Vascepa for a period of up to 40 weeks after their last dose in thedouble-blind portion of the trial. Once participants completed the randomized, double blind, placebo-controlled 12-week MARINE registration trial, patientsin all three randomized groups (4 grams, 2 grams and placebo) were offered the opportunity to participate in the open label extension, or OLE, phase. Patientsin the OLE phase received 4 grams per day of Vascepa for a period of up to an additional 40 weeks. As is typical of such extension phases, the OLE phase wasnot a controlled trial, as differentiated from the randomized, double blind, placebo-controlled 12-week MARINE registration trial. In the 9Table of ContentsOLE phase, participants were not randomized at entry, Vascepa administration was open-label (and thus not blinded), and no placebo group was maintained.Also, once patients entered in the OLE phase, investigators were free to add or modify other lipid-altering nutritional, lifestyle and drug treatment regimens.Given the lack of randomization, the open-label design, the addition of various other lipid-altering drugs and changes to doses of existing lipid-alteringdrugs, as well as the lack of placebo control, neither we nor our independent advisors were able to draw efficacy conclusions from the data. However, we haveconcluded that the MARINE OLE phase revealed no new safety signals after an additional 40 weeks of exposure to Vascepa, whether used alone or incombination with other lipid-altering regimens.The ANCHOR Trial (basis for sNDA submitted to FDA seeking expanded indication for Vascepa)The ANCHOR trial was a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study in patients with high triglycerides (200and <500 mg/dL) who were also receiving optimized statin therapy. Patients were randomized into three arms for treatment with Vascepa 4 gram/day, 2gram/day or placebo. Patient enrollment in this trial began in January 2010, and enrollment and randomization was completed in February 2011 at 702patients. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment.In April 2011, we reported top-line results from the ANCHOR trial. The ANCHOR trial met its primary endpoint at doses of 4 grams and 2 grams perday with median placebo-adjusted reductions in triglyceride levels of 21.5% (p<0.0001 value) for 4 grams and 10.1% (p=0.0005) for 2 grams. The medianbaseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of Vascepa per day,respectively. The analysis of subgroups by baseline triglyceride tertiles showed that higher baseline triglycerides resulted in greater triglyceride reductions.One of the trial’s secondary endpoints was to demonstrate a lack of elevation in LDL-C, the primary target of cholesterol lowering therapy. The trial’snon-inferiority criterion for LDL-C was met at both Vascepa doses. The upper confidence boundaries for both doses were below the pre-specified +6% LDL-Cthreshold limit. At the 4-gram dose the upper confidence boundary was below zero (-1.7%) and at the 2-gram dose the upper confidence boundary was closeto zero (0.5%). For the 4 grams per day group, LDL-C decreased significantly by 6.2% from baseline versus placebo, demonstrating superiority over placebo(p=0.0067). For the 2-gram group, LDL-C decreased by 3.6% from baseline versus placebo (p=0.0867), which is not a statistically significant decrease.Other secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C),apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2). The 4-gram dose was associated with statistically significant reductionsin non-HDL-C (13.6%, p<0.0001), apo B (9.3%, p<0.0001), Lp-PLA2 (19%, p<0.0001) and high-sensitivity C-reactive protein (hsCRP) (22%, p<0.001), atweek 12 compared to placebo. A recently published analysis showed that the Vascepa 4-gram daily dose in the ANCHOR study also significantly decreasedlevels of the inflammatory marker oxidized low-density lipoprotein relative to placebo by 13% (P < 0.0001). In a separate, post-hoc analysis of study data,Vascepa 4 g/day statistically significantly reduced ApoC-III levels by 25.1% in MARINE (P < 0.0001) and by 19.2% in ANCHOR (P < 0.0001) versusplacebo.Vascepa was well tolerated in the ANCHOR trial with a safety profile comparable to placebo and there were no treatment-related serious adverse eventsobserved. No significant changes in fasting blood glucose, hemoglobin A1C, vital signs, electrocardiograms, or liver or kidney function were observed witheither Vascepa dose.We have a pending sNDA with the FDA that seeks marketing approval of Vascepa for use in the ANCHOR indication. On October 16, 2013, the FDAconvened an advisory committee to review our sNDA. This advisory committee was not asked by the FDA to evaluate whether Vascepa is effective inlowering triglycerides in the studied population, the ANCHOR indication as specified in the sNDA. Rather, the advisory panel was asked whether Vascepawould improve cardiovascular outcomes or whether approval of the ANCHOR indication 10Table of Contentsshould wait for successful completion of the REDUCE-IT study, the first prospective study of cardiovascular outcomes in patients who have high triglyceridelevels despite statin therapy. The advisory committee voted 9 to 2 against recommending approval of the ANCHOR indication based on informationpresented at the meeting. The FDA considers the recommendation of advisory committees, but final decisions on the approval of new drug applications aremade by the FDA.The ANCHOR trial clinical study was conducted under an SPA agreement with the FDA. The law governing SPA agreements requires that if the resultsof the trial conducted under the SPA substantiate the hypothesis of the protocol covered by the SPA, the FDA must use the data from the protocol as part ofthe primary basis for approval of the product. A SPA agreement is not a guarantee of FDA approval of the related new drug application. A SPA agreement isgenerally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety orefficacy of the drug after the study begins that rises to the level of a public health concern, or if the study sponsor fails to follow the protocol that was agreedupon with the FDA. On October 29, 2013, the FDA rescinded the ANCHOR study SPA agreement because the FDA determined that a substantial scientificissue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began. As a basis for this determination, theFDA communicated that it determined that the cumulative results from outcome studies of other triglyceride-lowering drugs failed to support the hypothesisthat a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among the population studied in the ANCHOR trial. Thus, the FDAstated that while information we submitted supports testing the hypothesis that Vascepa 4 grams/day versus placebo reduces major adverse cardiovascularevents in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study, theFDA no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk insubjects with serum triglyceride levels below 500 mg/dL. Beginning in November 2013, we sought reconsideration and appealed the SPA rescission decisionto three levels of increasing authority within the FDA and were denied each time, most recently in September 2014. Based on FDA’s repeated position in itsappeal denials and its internal consultation with FDA officials at higher levels, we informed the FDA that we did not intend to appeal the SPA rescissionfurther.The FDA did not take action on the ANCHOR sNDA by the Prescription Drug User Fee Act, or PDUFA, goal date for completion of FDA’s review,December 20, 2013. Given our September 2014 determination to not appeal the SPA rescission further, we expect the FDA to take action on our pendingANCHOR sNDA in the near future. The FDA has not committed to a specific date for this action.Observed Efficacy of Ethyl-EPAIn Japan, ethyl-EPA is marketed under the product name of Epadel by Mochida Pharmaceutical Co. and is indicated for hyperlipidemia and peripheralvascular disease. Clinical data from Japan suggests that Epadel is effective in reducing triglycerides. In addition, in an outcomes study called the Japan EPALipid Intervention Study, or JELIS study, which consisted of more than 18,000 patients followed over multiple years, Epadel, when used in conjunction withstatins, was shown to reduce cardiovascular events by 19% compared to the use of statins alone. In this study, cardiovascular events decreased byapproximately 53% compared to statins alone in the subset of primary prevention patients with triglyceride levels of 150 mg/dL ( median of 272 mg/dL atentry) and HDL-C <40 mg/dL. Epadel has been approved and available by prescription in Japan for over a decade. In 2013, the Japan Ministry of Healthapproved Epadel for over-the-counter sales.Observed Clinical Safety of VascepaPrior to commencing the MARINE and ANCHOR trials, we conducted a pre-clinical program for Vascepa, including toxicology and pharmacologystudies. In addition, we previously investigated Vascepa in central nervous system disorders in several double-blind, placebo-controlled studies, includingPhase 3 trials in Huntington’s disease. Over 1,000 patients have been dosed with Vascepa in these studies, with over 100 11Table of Contentsreceiving continuous treatment for a year or more. In all studies performed to date, Vascepa has shown a favorable safety and tolerability profile. In both theMARINE and ANCHOR trials, patients dosed with Vascepa demonstrated a safety profile similar to placebo. There were no treatment-related serious adverseevents in the MARINE study or in the ANCHOR study. In the MARINE and ANCHOR trials, the most commonly reported adverse reaction (incidence >2%and greater than placebo) in Vascepa treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo). There was no reported adversereaction > 3% and greater than placebo.In addition to the MARINE and ANCHOR trials, we completed a 28-day pharmacokinetic study in healthy volunteers, a 26-week study to evaluate thetoxicity of Vascepa in transgenic mice and multiple pharmacokinetic drug-drug interaction studies in healthy subjects in which we evaluated the effect ofVascepa on certain common prescription drugs. All findings from these studies were consistent with our expectations and confirmed the overall safety profileof Vascepa.The REDUCE-IT Study (currently ongoing cardiovascular outcomes study)In August 2011, we reached agreement with the FDA on an SPA for the design of the REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial) cardiovascular outcomes study. In May 2013, we amended the patient enrollment criteria within the SPA agreement with the FDA. An SPAis an evaluation by the FDA of a protocol with the goal of reaching an agreement that the Phase 3 trial protocol design, clinical endpoints, and statisticalanalyses are acceptable to support regulatory approval. The FDA agreed that, based on the information we submitted to the agency, the design and plannedanalysis of the REDUCE-IT study adequately addressed the objectives necessary to support a regulatory submission. An SPA is generally binding upon theFDA unless a substantial scientific issue essential to determining safety or efficacy of the drug is identified after the testing begins. Moreover, any change to astudy protocol can invalidate an SPA.In September 2011, we engaged a clinical research organization, or CRO, and began initial trial and clinical site preparation for REDUCE-IT. InDecember 2011, we announced that the first patient was dosed in the study. The study duration is dependent on the rate of clinical events in the study whichrate may be affected by the number of patients enrolled in the study, the epidemiology of the patients enrolled in the study, and the length of time that theenrolled patients are followed. Based on preliminary assumptions for patient enrollment rates and the clinical profile of these patients, it is assumed that fewerthan 10,000 patients will be required to complete the study with an optimized target in which the study is completed in approximately six years of 8,000patients.The REDUCE-IT study is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in an at-risk patient population alsoreceiving statin therapy. REDUCE-IT is a multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate theeffectiveness of Vascepa, as an add-on to statin therapy, in reducing first major cardiovascular events in an at-risk patient population compared to statintherapy alone. The control arm of the study is comprised of patients on optimized statin therapy plus placebo. The active arm of the study is comprised ofpatients on optimized statin therapy plus Vascepa. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart diseaseor risk factors for coronary heart disease. This study is being conducted internationally.We currently expect that final positive results of the REDUCE-IT study will be required for FDA approval of Vascepa for the ANCHOR indicationbased on communications from the FDA. Based on the results of REDUCE-IT, we may seek additional indications for Vascepa beyond the indications studiedin the ANCHOR and MARINE trials such as a potential indicated uses for prevention of cardiovascular events, although there can be no assurance as towhether the results of the study will support any such indication.New Lipid Compounds and other Preclinical ProgramsWe are also considering development of other next generation compounds based on our internal lipid science expertise, including potentialcombination and derivative therapies. 12Table of ContentsIn August 2013, we completed dosing of AMR102, a fixed dose combination of Vascepa and a leading statin product. The study is a randomized,open-label, single-dose, 4-way cross-over study to continue testing of the relative bioavailability of AMR102 capsules, Vascepa capsules with the selectedstatin taken concomitantly, Vascepa taken alone and the selected statin taken alone. The results of this study support the feasibility of AMR102. We havesuspended additional development of AMR102 pending resolution of the ANCHOR sNDA with the FDA. If we do not receive FDA approval for theANCHOR indication, we may suspend further development of AMR102.We believe that Vascepa and other lipid-based compositions may have an impact on a number of biological factors in the body such as anti-inflammatory mechanisms, cell membrane composition and plasticity, triglyceride levels and regulation of glucose metabolism. Currently all otherdevelopment activities are at formulation or pre-clinical stages.Manufacturing and Supply for VascepaWe currently use third party manufacturers and suppliers to manufacture clinical and commercial quantities of ethyl-EPA, which constitutes the onlyactive pharmaceutical ingredient, or API, within Vascepa, to encapsulate, bottle and package Vascepa and to maintain inventory of Vascepa. The FDAapproval of Vascepa in July 2012 included the approval of one API manufacturer, Nisshin Pharma, Inc., or Nisshin, and one API encapsulator, Patheon, Inc.,or Patheon (formerly Banner Pharmacaps Europe BV). Nisshin and Patheon are the API manufacturer and API encapsulator, respectively, with which we havehad the longest working relationships. Their facilities were inspected by regulatory authorities as part of the process that led to the FDA’s July 2012 approvalof Vascepa, and we believe that the facilities are qualified to continue to support our commercialization of Vascepa.We currently rely exclusively on Patheon for the encapsulation of Vascepa and we have encapsulation agreements with two other qualified commercialAPI encapsulators.In addition to purchasing API from Nisshin, we have also purchased API from Chemport, Inc., or Chemport. In December 2012, we announced oursubmissions of two sNDAs to the FDA seeking approval for Chemport and BASF (formerly Equateq Limited) as additional Vascepa API suppliers. In April2013, the FDA approved our sNDAs covering Chemport and BASF as additional Vascepa API suppliers. On December 30, 2013, we issued a notice oftermination of our API agreement to BASF as a result of BASF’s non-compliance with the terms of such agreement period and the agreement subsequentlyterminated in the first quarter of 2014. In December 2012, we announced an agreement with an exclusive consortium of companies led by SlanmhorPharmaceutical, Inc., or Slanmhor. Slanmhor was spun-out from Ocean Nutrition Canada, or ONC, prior to the May 2012 acquisition of ONC by Royal DSMN.V. We submitted a sNDA in August 2013 seeking FDA approval for this supplier to manufacture Vascepa API and in July 2014 the FDA approved oursNDA for Slanmhor as an API supplier. If the facility contemplated to manufacture Vascepa API is able to complete the process validation required formanufacture of API, it may become an additional qualified worldwide supplier of API for Vascepa to utilize in supporting the global commercialization ofVascepa.The API material that constitutes ethyl-EPA is a naturally occurring substance which is sourced from qualified producers of fish oil. A limited numberof other manufacturers have the ability, know-how and suitable facilities to produce ethyl-EPA to a similar level of purity. Among the conditions for FDAapproval of a pharmaceutical product is the requirement that the manufacturer’s quality control and manufacturing procedures conform to current GoodManufacturing Practice, or cGMP, which must be followed at all times. The FDA typically inspects manufacturing facilities before regulatory approval of aproduct candidate, such as Vascepa, and on an ongoing basis. In complying with cGMP regulations, pharmaceutical manufacturers must expend resourcesand time to ensure compliance with product specifications as well as production, record keeping, quality control, reporting, and other requirements. 13Table of ContentsOur agreements with our API suppliers include minimum purchase commitments. During 2013 and 2014 we fully met the aggregate minimum purchaserequirements for metric tons of API contained in our supply agreements. We may purchase more than the minimum requirements. Certain of these agreementscontemplate phased capacity expansion aimed at creating sufficient capacity to meet anticipated demand for API material for Vascepa. Accordingly, certainof these suppliers are currently working to expand their production capabilities to manufacture the API for Vascepa. These API suppliers are self-fundingthese expansion and qualification plans with contributions from Amarin. There can be no assurance that additional suppliers will fully fund the capital costsof our engagement or that these additional suppliers will successfully qualify with the FDA. These contracts contain provisions for making lesser payments tothese suppliers in lieu of purchasing the full minimum purchase requirements.Our Marketing PlansIn January 2013, we commenced our full commercial launch of Vascepa in the United States for use in the MARINE indication with a direct sales forceof approximately 275 sales representatives. In October 2013, we lowered our number of sales representatives to approximately 130, excluding salesmanagement, in the United States to focus on the sales territories that we believe have demonstrated the greatest potential for Vascepa sales growth. We nowmarket Vascepa in the United States through our sales force of approximately 150 sales professionals and managers. We also employ various marketing andmedical affairs personnel to support our commercialization of Vascepa. We currently target clinicians who are top prescribers of lipid regulating therapies.Commencing in the middle of the second quarter of 2014, in addition to promotion by our sales representatives, approximately 250 Kowa PharmaceuticalsAmerica, Inc. sales representatives began promoting Vascepa. We also employ various marketing personnel to support our commercialization of Vascepa. Asof February 1, 2015, over 26,000 clinicians had written prescriptions for Vascepa.CompetitionThe biotechnology and pharmaceutical industries are highly competitive. There are many pharmaceutical companies, biotechnology companies,public and private universities and research organizations actively engaged in the research and development of products that may be similar to our products.It is probable that the number of companies seeking to develop products and therapies similar to our products will increase. Many of these and other existingor potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufactureand market products. These companies may develop and introduce products and processes competitive with or superior to ours. In addition, othertechnologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, whichmight render our technology and products noncompetitive or obsolete.Our competitors both in the United States and Europe include large, well-established pharmaceutical companies, specialty pharmaceutical sales andmarketing companies, and specialized cardiovascular treatment companies. GlaxoSmithKline plc, which currently markets Lovaza, a prescription-onlyomega-3 fatty acid indicated for patients with severe hypertriglyceridemia received FDA approval in 2004 and has been on the market in the United Statessince 2005. As described below, generic versions of Lovaza are now available in the United States. Other large companies with competitive products includeAbbVie, Inc., which currently markets Tricor and Trilipix for the treatment of severe hypertriglyceridemia and mixed dyslipidemia and Niaspan, which isprimarily used to raise HDL-C, but is also used to lower triglycerides. Generic versions of Tricor, Trilipix, and Niaspan are also now available in the UnitedStates. In addition, in May 2014, Epanova (omega-3-carboxylic acids) capsules, a free fatty acid form of omega-3 (comprised of 55% EPA and 20% DHA),was approved by the FDA for patients with severe hypertriglyceridemia. Epanova was developed by Omthera Pharmaceuticals, Inc., and is now owned byAstraZeneca Pharmaceuticals LP (AstraZeneca). This product has not yet been launched. However, we expect AstraZeneca will utilize its substantialcommercial resources to market its product. Also, in April 2014, Omtryg, another omega-3-acid fatty acid composition developed by 14®®®®®Table of ContentsTrygg Pharma AS, received FDA approval for severe hypertriglyceridemia. We are not aware of the commercialization plan for Omtryg. Each of thesecompetitors, other than possibly Trygg, has greater resources than we do, including financial, product development, marketing, personnel and otherresources.In April 2014, Teva Pharmaceuticals USA Inc., or Teva, launched a generic version of Lovaza after winning its patent litigation against PronovaBioPharma Norge AS, now owned by BASF, which owns such patents rights. In June 2014 and September 2014, Par Pharmaceutical Inc., or Par, and ApotexInc., or Apotex, received FDA approval of their respective versions of generic Lovaza. In March 2011, Pronova/BASF entered into an agreement with Apotexto settle its patent litigation in the United States related to Lovaza. Pursuant to the terms of the settlement agreement, Pronova/BASF granted Apotex alicense to enter the United States market with a generic version of Lovaza in the first quarter of 2015.In addition, we are aware of other pharmaceutical companies that are developing products that, if approved and marketed, would compete withVascepa. We understand that Acasti Pharma, a subsidiary of Neptune Technologies & Bioresources Inc., announced in late 2012 that it intends to conduct aPhase 3 clinical program to assess the safety and efficacy of its omega-3 prescription drug candidate derived from krill oil for the treatment ofhypertriglyceridemia. Sancilio & Company is preparing to commence Phase 3 clinical testing of its compound SC401B in hypertriglyceridemia. In addition,there are two firms that are developing products in Phase 2 testing, Isis Pharmaceuticals and Catabasis Pharmaceuticals. Isis announced favorable Phase 2results of ISIS-APOCIIIRx a drug candidate administered through weekly subcutaneous injections, in patients with high triglycerides and type 2 diabetes andin patients with moderate to severe high triglycerides (>880 mg/dL). To our knowledge, Catabasis initiated a Phase 2 clinical trial of its product CAT-2003 inDecember 2013 for severe hypertriglyceridemia and rare chylomicronemia. There are other products in Phase 1 development by Thetis Pharmaceuticals andResolyvx Pharmaceuticals. Thetis has TP-943, which is a unique salt form of EPA that is being tested for hypertriglyceridemia. Resolvyx’s compound RX-10001 is being evaluated across various indications, including hypertriglyceridemia. In addition, we are aware that Matinas BioPharma, Inc. is developing anomega-3-based therapeutic MAT-9001 for the treatment of severe hypertriglyceridemia and mixed dyslipidemia. Matinas BioPharma, Inc. is currently testingthe product in Phase 2 studies. Finally, Madrigal Pharmaceuticals has completed Phase 1 clinical testing of MGL-3196 for the treatment of high triglyceridesand various lipid parameters in patients.Vascepa also faces competition from dietary supplement companies marketing omega-3 products as nutritional supplements. We cannot be surephysicians and pharmacists will view the FDA-approved prescription-only status, EPA-only purity of Vascepa and stringent regulatory oversight assignificant advantages versus omega-3 supplements.In addition, we expect that generic drug companies will seek to challenge the validity and enforceability of our patents and work toward FDA approvalfor generic versions of Vascepa.Regulatory MattersGovernment Regulation and Regulatory MattersAny product development activities related to Vascepa or products that we may develop or acquire in the future will be subject to extensive regulationby various government authorities, including the FDA and comparable regulatory authorities in other countries, which regulate the design, research, clinicaland non-clinical development, testing, manufacturing, storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical productsand devices. Generally, before a new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into aformat specific to each regulatory authority, submitted for review and approved by the regulatory authority. The data is generated in two distinctdevelopment stages: pre-clinical and clinical. Our drugs must be approved by the FDA through the NDA process before they may be legally marketed in theUnited States. For new chemical entities, the pre-clinical development stage 15Table of Contentsgenerally involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying out non-human toxicology, pharmacology and drug metabolism studies which support subsequent clinical testing.The clinical stage of development can generally be divided into Phase 1, Phase 2 and Phase 3 clinical trials. In Phase 1, generally, a small number ofhealthy volunteers are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these studies is to assessthe metabolism, pharmacologic action, side effect tolerability and safety of the drug. Phase 2 trials typically involve studies in disease-affected patients todetermine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information iscollected. Phase 3 trials generally involve large numbers of patients at multiple sites, in multiple countries and are designed to provide the pivotal datanecessary to demonstrate the effectiveness of the product for its intended use, its safety in use, and may include comparisons with placebo and/or othercomparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.United States Drug DevelopmentIn the United States, the process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreignstatutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirementsat any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls,product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, orcivil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.Prior to the start of human clinical studies for a new drug in the United States, preclinical laboratory and animal tests are often performed under theFDA’s Good Laboratory Practices regulations, or GLP, and an investigational new drug application, or IND, is filed with the FDA. Similar filings are requiredin other countries; however, data requirements and other information needed for a complete submission may differ in other countries. The amount of data thatmust be supplied in the IND depends on the phase of the study. Phase 1 studies typically require less data than larger Phase 3 studies. A clinical plan must besubmitted to the FDA prior to commencement of a clinical trial. If the FDA has concerns about the clinical plan or the safety of the proposed studies, theymay suspend or terminate the study at any time. Studies must be conducted in accordance with good clinical practice and regular reporting of study progressand any adverse experiences is required. Studies are also subject to review by independent institutional review boards, or IRBs, responsible for overseeingstudies at particular sites and protecting human research study subjects. An independent IRB may also suspend or terminate a study once initiated.NDA and FDA Review ProcessFollowing trial completion, trial data is analyzed to determine safety and efficacy. Data is then filed with the FDA in an NDA along with proposedlabeling for the product and information about the manufacturing and testing processes and facilities that will be used to ensure product quality. The NDAmust contain proof of safety, purity, potency and efficacy, which entails extensive pre-clinical and clinical testing. FDA approval of an NDA must beobtained before marketing a drug in the United States.The FDA will likely re-analyze the clinical trial data, which could result in extensive discussions between the FDA and us during the review process.The review and evaluation of applications by the FDA is extensive and time consuming and may take longer than originally planned to complete. The FDAmay conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with current goodmanufacturing practice requirements and may also audit data from clinical and pre-clinical trials. 16Table of ContentsThere is no assurance that the FDA will ultimately approve a drug product for marketing in the United States. Even if future indications for Vascepa areapproved, the FDA’s review will be lengthy and we may encounter significant difficulties or costs during the review process. After approving any drugproduct, the FDA may require post-marketing testing and surveillance to monitor the effects of approved products or it may place conditions on approvalsincluding potential requirements or risk management plans that could restrict the commercial promotion, distribution, prescription or dispensing of products.Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.European Union Drug DevelopmentIn the European Union, or E.U., our future products may also be subject to extensive regulatory requirements. As in the United States, the marketing ofmedicinal products has been subject to the granting of marketing authorizations by regulatory agencies. Particular emphasis is also being placed on moresophisticated and faster procedures for reporting of adverse events to the competent authorities.Similar to the United States, the various phases of pre-clinical and clinical research in the E.U. are subject to significant regulatory controls. Althoughthe regulatory controls on clinical research are currently undergoing a harmonization process following the adoption of the Clinical Trials Directive2001/20/EC, there are currently significant variations in the member state regimes. However, all member states currently require independent institutionalreview board approval of interventional clinical trials. With the exception of U.K. Phase 1 studies in healthy volunteers, all clinical trials require either priorgovernmental notification or approval. Most regulators also require the submission of adverse event reports during a study and a copy of the final studyreport.European Union Drug Review and ApprovalIn the E.U., approval of new medicinal products can be obtained through one of three processes: the mutual recognition procedure, the centralizedprocedure and the decentralized procedure.Mutual Recognition ProcedureAn applicant submits an application in one E.U. member state, known as the reference member state. Once the reference member state has granted themarketing authorization, the applicant may choose to submit applications in other concerned member states, requesting them to mutually recognize themarketing authorizations already granted. Under this mutual recognition process, authorities in other concerned member states have 55 days to raiseobjections, which must then be resolved by discussions among the concerned member states, the reference member state and the applicant within 90 days ofthe commencement of the mutual recognition procedure. If any disagreement remains, all considerations by authorities in the concerned member states aresuspended and the disagreement is resolved through an arbitration process. The mutual recognition procedure results in separate national marketingauthorizations in the reference member state and each concerned member state.Centralized ProcedureThis procedure is currently mandatory for products developed by means of a biotechnological process and optional for new active substances and other“innovative medicinal products with novel characteristics.” Under this procedure, an application is submitted to the European Agency for the Evaluation ofMedical Products. Two European Union member states are appointed to conduct an initial evaluation of each application. These countries each prepare anassessment report that is then used as the basis of a scientific opinion of the Committee on Proprietary Medical Products. If this opinion is favorable, it is sentto the European Commission, which drafts a decision. After consulting with the member states, the European Commission adopts a decision and grants amarketing authorization, which is valid throughout the European Union and confers the same rights and obligations in each of the member states as amarketing authorization granted by that member state. 17Table of ContentsDecentralized ProcedureThe most recently introduced of the three processes for obtaining approval of new medicinal processes in the E.U., the decentralized procedure issimilar to the mutual recognition procedure described above, but with differences in the timing that key documents are provided to concerned member statesby the reference member state, the overall timing of the procedure and the possibility of “clock stops” during the procedure, among others.Post-Marketing RequirementsFollowing approval of a new product, a pharmaceutical company generally must engage in numerous specific monitoring and recordkeeping activitiesand continue to submit periodic and other reports to the applicable regulatory agencies, including any cases of adverse events and appropriate qualitycontrol records. Modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval of the FDA andother regulators, which may or may not be received or may result in a lengthy review process.Prescription drug advertising is subject to federal, state and foreign regulations. In the United States, the FDA regulates prescription drug promotion,including direct-to-consumer advertising. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use. Anydistribution of prescription drug products and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act, or the PDMA, a part ofthe U.S. Federal Food, Drug, and Cosmetic Act.In the United States, once a product is approved, its manufacture is subject to comprehensive and continuing regulation by the FDA. The FDAregulations require that products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, or cGMPs, andNDA holders must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational,procedural and documentation requirements with respect to manufacturing and quality assurance activities. NDA holders using contract manufacturers,laboratories or packagers are responsible for the selection and monitoring of qualified firms, and, in certain circumstances, qualified suppliers to these firms.These firms and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, includingfailure to conform to cGMPs, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute productsmanufactured, processed or tested by them.Federal and State Fraud and Abuse LawsIn addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws restrict certain marketingpractices in the biopharmaceutical industry. These laws include anti-kickback statutes and false claims statutes.The federal anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration toinduce or in return for a referral or the purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any healthcare facility,item or service reimbursable under Medicare, Medicaid, or other federal healthcare programs. This statute has been interpreted to apply to arrangementsbetween pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. Although there are a number ofstatutory exemptions and regulatory safe harbors protecting certain activities from prosecution, the exemptions and safe harbors are drawn narrowly, andpractices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for anexemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federalgovernment, or knowingly making or using, or causing to be made or used, a 18Table of Contentsfalse statement to get a false claim paid. Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws forallegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies havebeen prosecuted for causing false claims to be submitted because of the company’s marketing of the product for unapproved, and thus non-reimbursable,uses. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and servicesreimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. Sanctions under these federal and state laws mayinclude civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines, and imprisonment.Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject tochallenge under one or more of such laws. Such a challenge could have a material adverse effect on our business, financial condition and results ofoperations. As a company marketing an FDA-approved product in the United States, our operations may be directly, or indirectly through our customers,subject to various federal and state fraud and abuse laws, including, without limitation, the federal anti-kickback statute. These laws may impact, amongother things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federalgovernment and the states in which we conduct our business. The laws that may affect our ability to operate include: • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibitexecuting a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations,which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or servicesreimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information incertain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating complianceefforts.If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may besubject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations, any of which couldadversely affect our ability to operate our business and our results of operations.In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affectour future results of operations. In particular, there have been and continue to be a number of initiatives at the United States federal and state levels that seekto reduce healthcare costs. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposed new requirements for thedistribution and pricing of prescription drugs for Medicare beneficiaries. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offeredby private entities which will provide coverage of outpatient prescription drugs. Part D plans include both stand-alone prescription drug benefit plans andprescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Part A and B, Part D coverage is not standardized. Part Dprescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifieswhich drugs it will cover and at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category andclass of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription drug plan must bedeveloped and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand forour products for which we receive marketing approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will likelybe lower than the prices we might otherwise 19Table of Contentsobtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy andpayment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in paymentsfrom non-governmental payers.The American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of differenttreatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency for HealthcareResearch and Quality and the National Institutes for Health, and periodic reports on the status of the research and related expenditures will be made toCongress. Although the results of the comparative effectiveness studies are not intended to mandate coverage policies for public or private payers, it is notclear what effect, if any, the research will have on the sales of any product, if any such product or the condition that it is intended to treat is the subject of astudy. It is also possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of ourproduct candidates. If third-party payers do not consider our products to be cost-effective compared to other available therapies, they may not cover ourproducts as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.Most recently, in March 2010 the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, orcollectively the PPACA, was enacted, which includes measures to significantly change the way healthcare is financed by both governmental and privateinsurers. Among the provisions of the PPACA of greatest importance to the pharmaceutical and biotechnology industry are the following: • an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic products, apportionedamong these entities according to their market share in certain government healthcare programs, that began in 2011; • new requirements to report certain financial arrangements with physicians and others, including reporting any “transfer of value” made ordistributed to prescribers and other healthcare providers and reporting any investment interests held by physicians and their immediate familymembers; • a licensure framework for follow-on biologic products; • a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research,along with funding for such research; • creation of the Independent Payment Advisory Board which, beginning in 2014, will have authority to recommend certain changes to theMedicare program that could result in reduced payments for prescription drugs and those recommendations could have the effect of law even ifCongress does not act on the recommendations; and • establishment of a Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services to test innovative paymentand service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began onJanuary 1, 2011.Other Regulatory MattersManufacturing, sales, promotion, and other activities following product approval are also subject to regulation by numerous regulatory authorities inaddition to the FDA, including, in the United States, the Centers for Medicare & Medicaid Services, other divisions of the Department of Health and HumanServices, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & HealthAdministration, the Environmental Protection Agency, and state and local governments. Sales, marketing and scientific/educational programs must alsocomply with the U.S. Medicare-Medicaid Anti-Fraud and Abuse Act and similar state laws. Pricing and rebate programs must comply with the Medicaidrebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990. If products are made available to authorized users of the Federal SupplySchedule of the General Services Administration, additional 20Table of Contentslaws and requirements apply. The handling of any controlled substances must comply with the U.S. Controlled Substances Act and Controlled SubstancesImport and Export Act. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.Manufacturing, sales, promotion and other activities are also potentially subject to federal and state consumer protection and unfair competition laws.The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing,storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.The failure to comply with regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure tomeet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total or partialsuspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts.In addition, even if a firm complies with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDAto modify or withdraw a product approval. Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect ourbusiness in an adverse way.Changes in regulations or statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:(i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or(iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.FDA Marketing ExclusivityThe Food Drug and Cosmetic Act, or FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or theHatch-Waxman Amendments, provides for market exclusivity provisions that can help protect the exclusivity of new drugs by delaying the acceptance andfinal approval of certain competitive drug applications. The FDA typically makes a determination on marketing exclusivity in connection with an NDAapproval of a drug for a new indication. We applied to the FDA for five-year, NCE marketing exclusivity for Vascepa in connection with the NDA for ourMARINE indication, which NDA was approved by the FDA on July 26, 2012. On February 21, 2014, in connection with the July 26, 2012 approval of theMARINE indication, the FDA denied a grant of NCE marketing exclusivity to Vascepa and granted three-year marketing exclusivity. Such three-yearexclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay that we believe will extend into September 2016,assuming the related Vascepa patent litigation is not resolved against us sooner.NCE marketing exclusivity, not granted to Vascepa, precludes approval during the five-year exclusivity period of certain 505(b)(2) applications andabbreviated new drug applications, or ANDAs, submitted by another company for another version of the drug. However, an application may be submittedafter four years if it contains a certification of patent invalidity or non-infringement. In this case, the pioneer drug company may be afforded the benefit of a30-month stay against the launch of such a competitive product that would extend from the end of the five-year exclusivity period, and may also be affordedother extensions under applicable regulations, including a six-month pediatric exclusivity extension or a judicial extension if applicable requirements aremet. Another drug sponsor could also gain a form of marketing exclusivity under the provisions of the FDCA, as amended by the Hatch-WaxmanAmendments, if such company can, under certain circumstances, complete a human clinical trial process and obtain regulatory approval of its product.The three-year period of exclusivity granted to Vascepa under the Hatch-Waxman Amendments is for a drug product that contains an active moietythat has been previously approved when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by thesponsor that were essential to approval of the application. Our MARINE clinical trial was a new clinical investigation that was 21Table of Contentsessential to the approval of our new drug application. We are entitled to three-year exclusivity even though FDA determined that the EPA moiety waspreviously approved in Lovaza because our MARINE clinical investigation was essential for the approval of our new drug product, Vascepa.Such three-year exclusivity protection precludes the FDA from approving a marketing application for an ANDA, a product candidate that the FDAviews as having the same conditions of approval as Vascepa (for example, the same indication and/or other conditions of use), or a 505(b)(2) NDA submittedto the FDA with Vascepa as the reference product, for a period of three years from the date of FDA approval. The FDA may accept and commence review ofsuch applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of ourpatents at any time. In this case, Amarin would be, and has been, afforded the benefit of a 30-month stay against the launch of such a competitive product thatextends from the period that Amarin receives notice of the patent challenge (the paragraph IV notice), assuming Amarin responds to the patent challenge with45 days, and Amarin may also be afforded a judicial extension if applicable requirements are met. Currently, Amarin believes its 30-month stay extends untilSeptember 2016. This three-year form of exclusivity may also not prevent the FDA from approving an NDA that relies only on its own data to support thechange or innovation.On February 27, 2014, we commenced a lawsuit against the FDA that challenges FDA’s denial of our request for five-year NCE exclusivity for Vascepabased on our reading of the relevant statute, our view of FDA’s inconsistency with its past actions in this area and the retroactive effect of what we believe is anew policy at FDA as it relates to our situation. Our complaint requests that the court vacate FDA’s decision, declare that Vascepa is entitled to the benefits offive-year statutory exclusivity, bar the FDA from accepting any ANDA or similar application for which Vascepa is the reference-listed drug until after thestatutory exclusivity period and set aside what we contend are—due to the denial of five-year exclusivity to Vascepa—prematurely accepted pending ANDAapplications.We may not be successful in this lawsuit against the FDA. Further, a generic company could enter this litigation, complicating the ultimatedetermination. Even if we are successful at the federal district court level, the FDA may appeal and we may need to win on appeal before the FDA takes, or thecourt imposes on the FDA, the remedies we request in suit. In addition, we may not be able to stay the continuation of currently pending ANDA-related patentlitigation. The legal process can be costly and time-consuming and even if we are successful the remedies available to us diminish in value over time as weapproach the natural expiration of the benefits associated with five-year exclusivity.FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also helpprotect Vascepa against generic competition.We also plan to seek regulatory exclusivity for Vascepa in Europe. There can be no assurance that we will be successful in securing marketing approvalor regulatory exclusivity in the United States or in Europe.Patents, Proprietary Technology, Trade SecretsOur success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how,and to operate without infringing the proprietary rights of others. Our ability to successfully implement our business plan and to protect our products with ourintellectual property will depend in large part on our ability to: • obtain, defend and maintain patent protection and market exclusivity for our current and future products; • preserve any trade secrets relating to our current and future products; • acquire patented or patentable products and technologies; and • operate without infringing the proprietary rights of third parties. 22Table of ContentsAmarin has prosecuted, and is currently prosecuting, multiple patent applications to protect the intellectual property developed during the Vascepacardiovascular program. As of the date of this report, we had 40 patent applications in the United States that have been either issued or allowed and more than30 additional patent applications are pending in the United States. Of such 40 allowed and issued applications, we currently have: • 2 issued U.S. patents directed to a pharmaceutical composition of Vascepa in a capsule that have terms that expire in 2020 and 2030,respectively, • 1 issued U.S. patent covering a composition containing highly pure EPA that expires in 2021, • 35 U.S. patents covering the use of Vascepa in either the MARINE or anticipated ANCHOR indication that have terms that expire in 2030, • 1 additional patent related to the use of a pharmaceutical composition comprised of free fatty acids to treat the ANCHOR patient population witha term that expires in 2030, and • 1 additional patent related to the use of a pharmaceutical composition comprised of free fatty acids to treat the MARINE patient population witha term that expires in 2030.A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. A Notice of Allowance doesnot afford patent protection until the underlying patent is issued by the USPTO. No assurance can be given that applications with issued notices of allowancewill be issued as patents or that any of our pending patent applications will issue as patents. No assurance can be given that, if and when issued, our patentswill prevent competitors from competing with Vascepa. We are also pursuing patent applications related to Vascepa in multiple jurisdictions outside theUnited States. We may be dependent in some cases upon third party licensors to pursue filing, prosecution and maintenance of patent rights or applicationsowned or controlled by those parties. It is possible that third parties will obtain patents or other proprietary rights that might be necessary or useful to us. Incases where third parties are first to invent a particular product or technology, or first to file after various provisions of the America Invents Act of 2011 wentinto effect on March 16, 2013, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent us from utilizing suchtechnology or commercializing our current and future products.Although we intend to make reasonable efforts to protect our current and future intellectual property rights and to ensure that any proprietarytechnology we acquire or develop does not infringe the rights of other parties, we may not be able to ascertain the existence of all potentially conflictingclaims. Therefore, there is a risk that third parties may make claims of infringement against our current or future products or technologies. In addition, thirdparties may be able to obtain patents that prevent the sale of our current or future products or require us to obtain a license and pay significant fees orroyalties in order to continue selling such products.We may in the future discover the existence of products that infringe patents that we own or that have been licensed to us. If we were to initiatelegal proceedings against a third party to stop such an infringement, such proceedings could be costly and time consuming, regardless of the outcome. Noassurances can be given that we would prevail, and it is possible that, during such a proceeding, our patent rights could be held to be invalid, unenforceableor both. Although we intend to protect our trade secrets and proprietary know-how through confidentiality agreements with our manufacturers, employeesand consultants, we may not be able to prevent parties subject to such confidentiality agreements from breaching these agreements or third parties fromindependently developing or learning of our trade secrets.We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patentedtechnologies for regulatory approvals. Competitors may seek to oppose our patent applications to delay the approval process or to challenge our grantedpatents, for example, by requesting a reexamination of our patent at the USPTO, or by filing an opposition in a foreign patent office, even if the opposition orchallenge has little or no merit. Such proceedings are generally highly technical, expensive, and time consuming, and there can be no assurance that such achallenge would not result in the narrowing or complete revocation of any patent of ours that was so challenged. 23Table of ContentsEmployeesAt February 20, 2015 we had 201 full-time employees employed in sales, marketing, general and administrative and research and developmentfunctions. We believe our relations with our employees are good.Organizational StructureAt February 20, 2015, we had the following subsidiaries: Subsidiary Name Country ofIncorporationor Registration Proportion ofOwnership Interest andVoting Power Held Amarin Pharmaceuticals Ireland Limited Ireland 100% Amarin Pharma Inc. United States 100% Amarin Neuroscience Limited Scotland 100% Corsicanto Ltd Ireland 100% Ester Neurosciences Limited Israel 100% Our registered office is located at One New Change, London EC4M 9AF, England. Our principal offices are located at 2 Pembroke House, UpperPembroke Street 28-32, Dublin 2 Ireland. Our primary offices in the United States are located at 1430 Route 206, Bedminster, NJ 07921, USA. Our telephonenumber at that location is (908) 719-1315. Our website address is www.amarincorp.com. No information contained on, or accessible through, our website isincorporated by reference into this Annual Report on Form 10-K.As of the date of this Annual Report on Form 10-K, our principal operating activities were being conducted by Amarin Corporation plc, together withAmarin Pharmaceuticals Ireland Limited and Amarin Pharma, Inc., with little to no operating activity being conducted by Amarin Neuroscience Limited,Corsicanto Ltd, or Ester Neurosciences Limited.On January 9, 2012, Amarin, through its wholly-owned subsidiary Corsicanto Limited, a private limited company incorporated under the laws ofIreland, completed a private placement of $150.0 million in aggregate principal amount of its 3.5% exchangeable senior notes due 2032, a portion of whichwere exchanged in May 2014. The notes are the senior unsecured obligations of Corsicanto and are guaranteed by Amarin Corporation plc. Corsicanto wasformed in November 2011 and was subsequently acquired by Amarin in January 2012 for the sole purpose of facilitating this financing transaction.Financial InformationThe financial information required under this Item 1 is incorporated herein by reference to Item 8 of this Annual Report on Form 10-K.Where You Can Find More InformationYou are advised to read this Annual Report on Form 10-K in conjunction with other reports and documents that we file from time to time with theSecurities and Exchange Commission, or SEC. You may obtain copies of these reports after the date of this annual report directly from us or from the SEC atthe SEC’s Public Reference Room at 100 F Street, N.E. Washington, D.C. 20549. In addition, the SEC maintains information for electronic filers (includingAmarin) at its website at www.sec.gov. The public may obtain information regarding the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. We make our periodic and current reports, as well as any amendments to such reports, available on our internet website, free of charge, assoon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. 24Table of ContentsItem 1A.Risk FactorsThis Annual Report on Form 10-K contains forward-looking information based on our current expectations. Because our actual results may differmaterially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors thatcould affect our actual future results, including, but not limited to, our capital resources, our ability to successfully commercially launch Vascepa, theprogress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potentialclinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects ofhealthcare reform, reliance on third parties, and other risks set forth below.Risks Related to the Commercialization and Development of VascepaOur ability to generate increased revenue over the next few years depends, in part, on our ability to expand marketing approval beyond the currentlyapproved MARINE indication. Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IToutcomes study will be required for label expansion for Vascepa.While we are currently marketing Vascepa for use in the MARINE indication in the United States, our ability to commercialize Vascepa in theANCHOR indication in the United States or market Vascepa for either indication outside of the United States is dependent upon receiving additionalregulatory approvals. In April 2013, the FDA accepted our Supplemental New Drug Application, or sNDA, which seeks approval for the use of Vascepa inpatients with high triglyceride levels (TG >200 mg/dL and <500 mg/dL) who are also on statin therapy, which we refer to as the ANCHOR indication. OnOctober 16, 2013 the FDA convened an advisory committee meeting to review the sNDA for the ANCHOR indication. At the meeting, the advisorycommittee voted 9 to 2 against recommending approval of Vascepa, based on the following question:Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters aresufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD riskequivalent prior to the completion of REDUCE-IT?During the advisory committee meeting, based in part on the briefing materials prepared by the FDA for the meeting, the advisory committee reviewedthe safety and efficacy data observed in the ANCHOR trial. This included a discussion regarding observed nominally statistically significant changes frombaseline in an adverse direction, while on background statin therapy, in certain lipid parameters, including TGs, in the placebo group, raising the possibilitythat the mineral oil placebo used in the ANCHOR trial (and in the REDUCE-IT trial) was not biologically inert and might be viewed as artificiallyexaggerating the clinical effect of Vascepa when measured against placebo in the ANCHOR trial. Because no strong evidence for biological activity ofmineral oil was identified by the FDA in the MARINE trial, ultimately it was concluded that the between-group differences likely provided the mostappropriate descriptions of the treatment effect of Vascepa and that whatever factor(s) led to the within-group changes over time in the placebo group werelikely randomly distributed to all treatment groups. Thus, the FDA approved Vascepa for use in the MARINE indication in July 2012. Following thisdiscussion at the advisory committee meeting, while no formal vote was taken related to the inert nature of the placebo, we believe that the consensus of theadvisory committee, although not unanimous, and the FDA was that, based on the information made available to the advisory committee and FDA at themeeting, Vascepa appeared to be safe and effective for the reduction of TGs in patients with mixed dyslipidemia on statin therapy.However, there was also extensive discussion during the advisory committee meeting regarding the expected clinical benefit of a reduction in TGs inthis patient population. That is, whether the clinical data derived from the ANCHOR trial was a sufficient basis for approval. In particular, the advisorycommittee and FDA noted the lack of prospective, controlled clinical trial data demonstrating that pharmacological reduction of TGs in patients with mixeddyslipidemia on statin therapy significantly reduces residual cardiovascular risk in these patients. The FDA noted that prior clinical outcomes studiesconducted by others, albeit in different patient 25Table of Contentspopulations, evaluating different drugs with different mechanisms of action, failed to demonstrate a statistically significant reduction in cardiovascularevents following concomitant use of drug therapy in patients on statin therapy. We believe that the negative vote of the advisory committee was principallydue to the lack of recent conclusive data in these clinical outcomes studies in favor of the hypothesis that TG reduction will result in reduced cardiovascularrisk. The FDA is not bound by the recommendations of the advisory committee, but it generally follows such recommendations.A Special Protocol Assessment, or SPA, agreement is an agreement with the FDA that Phase 3 trial protocol design, clinical endpoints, and plannedstatistical analyses are acceptable to support regulatory approval. A SPA is generally binding upon the FDA except in limited circumstances, such as if theFDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, or if the study sponsor fails to follow theprotocol that was agreed upon with the FDA. On October 29, 2013, the FDA notified us that it rescinded the SPA agreement we entered into for the ANCHORtrial protocol because the FDA determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied populationwas identified after testing began. The FDA determined, consistent with discussion at the advisory committee meeting, that results from outcome studies ofother triglyceride-lowering drugs failed to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular eventsamong the population studied in the ANCHOR trial. Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient toestablish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.The FDA did not meet the originally assigned Prescription Drug User Fee Act, or PDUFA, goal date of December 20, 2013 for the completion of itsreview of the ANCHOR sNDA because of the pendency of our request to re-instate the ANCHOR SPA agreement. Beginning in November 2013, we soughtreconsideration and appealed the SPA rescission decision to three levels of increasing authority within the FDA and were denied each time, most recently inSeptember 2014. Based on FDA’s repeated position in its appeal denials and its internal consultation with FDA officials at higher levels, we informed theFDA that we did not intend to appeal the SPA rescission further. Given our September 2014 determination to not appeal the SPA rescission further, we expectthe FDA to take action on our pending ANCHOR sNDA in the near future.Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IT outcomes study will be required forFDA approval of label expansion for Vascepa. Any delay in obtaining, or an inability to obtain, expansion of our marketing approval rights could prevent usfrom growing revenue at greater than our current pace and could therefore have a material adverse effect on our operations and financial condition, includingour ability to reach profitability.Even if we obtain additional regulatory approvals for Vascepa, the timing or scope of any approvals may prohibit or reduce our ability tocommercialize the product successfully. For example, if the approval process for the ANCHOR indication takes too long, we may miss market opportunitiesand give other companies the ability to develop competing products or establish market dominance. Additionally, the terms of any approvals, including theapproval received from the FDA in July 2012 for the MARINE indication, may prove to not have the scope or breadth needed for us to successfullycommercialize Vascepa or become profitable.We are dependent upon the success of Vascepa, which we launched commercially in the MARINE indication in early 2013.As a result of our reliance on a single product and our primary focus on the U.S. market in the near-term, much of our near-term results and value as acompany depends on our ability to execute our commercial strategy for Vascepa in the United States, which we launched in January 2013. Ifcommercialization efforts for Vascepa in the MARINE indication are not successful, our business will be materially and adversely affected. Even if we areable to develop additional products from our research and development efforts, the development time cycle for products typically takes several years. Thisrestricts our ability to respond to adverse business conditions for Vascepa. If we are not successful in developing any future product or products, or if there isnot adequate 26Table of Contentsdemand for Vascepa or the market for such product develops less rapidly than we anticipate, we may not have the ability to effectively shift our resources tothe development of alternative products or do so in a timely manner without suffering material adverse effects on our business. As a result, the lack ofalternative products we develop could constrain our ability to generate revenues and achieve profitability.Our current and planned commercialization efforts may not be successful in increasing sales of Vascepa.In January 2013, we began selling and marketing Vascepa in the United States through our own, newly established sales and marketing teams andthrough a newly established third-party commercial distribution infrastructure. We hired key personnel in these areas over the last several years and hired andtrained a professional sales force in early January 2013. In October 2013, following an FDA advisory committee recommendation against approval for theANCHOR indication, we implemented a plan to reduce our workforce and our team of sales professionals in half. In May 2014 we began co-promotingVascepa in the United States with Kowa Pharmaceuticals America, Inc. under a co-promotion agreement we entered into in March 2014. Under the agreement,approximately 250 Kowa Pharmaceuticals America, Inc. sales representatives devote a substantial portion of their time to promoting Vascepa with Amarin’sapproximately 130 sales representatives based on a plan designed to substantially increase both the number of sales targets reached and the frequency ofsales calls on existing sales targets. However, the commercialization of a new pharmaceutical product is a complex undertaking for a company to manage,and we have very limited experience as a company operating in this area and co-promoting a pharmaceutical product with a partner.Factors related to building and managing a sales and marketing organization that can inhibit our efforts to successfully commercialize Vascepainclude: • our inability to attract and retain adequate numbers of effective sales and marketing personnel; • our inability to adequately train our sales and marketing personnel, in particular as it relates to various healthcare regulatory requirementsapplicable to the marketing and sale of pharmaceutical products, and our inability to adequately monitor compliance with these requirements; • the inability of our new sales personnel, working for us as a new market entrant, to obtain access to or persuade adequate numbers of physiciansto prescribe Vascepa; • the effect of our recent reduction in force and regulatory events on our ability to contact potential purchasers of Vascepa in an efficient manner; • the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies withmore extensive product lines; and • unforeseen costs and expenses associated with operating a new independent sales and marketing organization.In addition, we believe that investors should view with caution both the results for the twelve months ended December 31, 2014 and the results forquarterly periods for the foreseeable future, as data for this limited period may not be representative of a trend consistent with the results presented orotherwise predictive of future results, especially in light of competitive developments in the market in which we operate, our interactions with FDA onpotential label expansions with Vascepa, the October 2013 approximately 50% reduction in our sales force, and the March 2014 co-promotion Agreementwith Kowa Pharmaceuticals America, Inc. We commenced our commercial launch of Vascepa on January 28, 2013. Accordingly, there is a very limitedamount of information available at this time to determine the actual number of total prescriptions for Vascepa. We believe investors should consider ourresults to date together with results over several future quarters, or longer, before making an assessment about potential future performance.If we are not successful in our efforts to market and sell Vascepa, our anticipated revenues will be materially and negatively affected, and we may notobtain profitability, may need to cut back on research and development activities or need to raise additional funding that could result in substantial dilution. 27Table of ContentsVascepa may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessaryfor commercial success.We began marketing and selling Vascepa for use in the MARINE indication in January 2013. Vascepa may fail to gain sufficient market acceptance byphysicians, patients, healthcare payors and others in the medical community. If Vascepa does not achieve an adequate level of acceptance, we may notgenerate significant product revenues and we may not become profitable. The degree of market acceptance of Vascepa for the MARINE indication and anyfuture approved indications will depend on a number of factors, including: • the perceived efficacy, safety and potential advantages of Vascepa, as compared to alternative treatments; • our ability to offer Vascepa for sale at competitive prices; • convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; • the scope, effectiveness and strength of product education, marketing and distribution support, including our sales and marketing team (whichwas affected by our recent reduction in force); • publicity concerning Vascepa or competing products; • perception that we will continue to market and sell Vascepa in the MARINE indication and any future approved indications; • sufficient third-party coverage or reimbursement; and • the actual efficacy of the product and the prevalence and severity of any side effects, including any limitations or warnings contained inVascepa’s approved labeling.Our SPA agreement for ANCHOR has been rescinded and our SPA agreement for REDUCE-IT is not a guarantee of FDA approval of Vascepa for theproposed REDUCE-IT indication.A SPA is an evaluation by the FDA of a protocol with the goal of reaching an agreement that the Phase 3 trial protocol design, clinical endpoints, andstatistical analyses are acceptable to support regulatory approval of the drug product candidate with respect to effectiveness for the indication studied. TheANCHOR trial was, and the REDUCE-IT trial is, being conducted under an SPA agreement with the FDA. In each case, the FDA agreed that, based on theinformation we submitted to the agency, the design and planned analysis of the trial is adequate to support use of the conducted study as the primary basis forapproval with respect to effectiveness. A SPA agreement is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies asubstantial scientific issue essential to determining safety or efficacy after the study begins, or if the study sponsor fails to follow the protocol that was agreedupon with the FDA.On October 29, 2013, the FDA notified us that it rescinded the ANCHOR study SPA agreement because the FDA determined that a substantial scientificissue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began. Specifically, consistent withdiscussion at the advisory committee meeting, the FDA determined that results from outcome studies of other drugs failed to support the hypothesis that atriglyceride-lowering drug significantly reduces the risk for cardiovascular events among the population studied in the ANCHOR trial. Beginning inNovember 2013, we sought reconsideration and appealed the SPA rescission decision to three levels of increasing authority within the FDA and were deniedeach time, most recently in September 2014. Based on FDA’s repeated position in its appeal denials and its internal consultation with FDA officials at higherlevels, we informed the FDA that we did not intend to appeal the SPA rescission further.Thus, even though we have received regulatory approval of Vascepa for the MARINE indication under an SPA agreement, our ANCHOR SPAagreement was rescinded and there is no assurance that the FDA will not 28Table of Contentsrescind our REDUCE-IT SPA agreement. The inability to obtain marketing approval in the ANCHOR or REDUCE-IT indications has and would prevent usfrom growing revenue more significantly, and it has had, and could continue to have, a material adverse effect on our operations and financial condition,including our ability to reach profitability.We may not be able to compete effectively against our competitors’ pharmaceutical products.The biotechnology and pharmaceutical industries are highly competitive. There are many pharmaceutical companies, biotechnology companies,public and private universities and research organizations actively engaged in the research and development of products that may be similar to our products.It is probable that the number of companies seeking to develop products and therapies similar to our products will increase. Many of these and other existingor potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufactureand market products. These companies may develop and introduce products and processes competitive with or superior to ours. In addition, othertechnologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, whichmight render our technology and products noncompetitive or obsolete.Our competitors both in the United States and Europe include large, well-established pharmaceutical companies, specialty pharmaceutical sales andmarketing companies, and specialized cardiovascular treatment companies. GlaxoSmithKline plc, which currently markets Lovaza, a prescription-onlyomega-3 fatty acid indicated for patients with severe hypertriglyceridemia was approved by FDA in 2004 and has been on the market in the United Statessince 2005. As described below, generic versions of Lovaza are now available in the United States. Other large companies with competitive products includeAbbVie, Inc., which currently markets Tricor and Trilipix for the treatment of severe hypertriglyceridemia and mixed dyslipidemia and Niaspan, which isprimarily used to raise HDL-C, but is also used to lower triglycerides. Generic versions of Tricor, Trilipix, and Niaspan are also now available in the UnitedStates. In addition, in May 2014, Epanova (omega-3-carboxylic acids) capsules, a free fatty acid form of omega-3 (comprised of 55% EPA and 20% DHA),was approved by the FDA for patients with severe hypertriglyceridemia. Epanova was developed by Omthera Pharmaceuticals, Inc., and is now owned byAstraZeneca Pharmaceuticals LP (AstraZeneca). We expect AstraZeneca will utilize its substantial commercial resources to market its product imminently.Also, in April 2014, Omtryg, another omega-3-acid fatty acid composition developed by Trygg Pharma AS, received FDA approval for severehypertriglyceridemia. We are not aware of the commercialization plan for Omtryg. Each of these competitors, other than Trygg, has greater resources than wedo, including financial, product development, marketing, personnel and other resources.In April 2014, Teva Pharmaceuticals USA Inc., or Teva, launched a generic version of Lovaza after winning its patent litigation against PronovaBioPharma Norge AS, now owned by BASF, which owns such patents rights. In June 2014 and September 2014, Par Pharmaceutical Inc., or Par, and ApotexInc., or Apotex, received FDA approval of their respective versions of generic Lovaza. In March 2011, Pronova/BASF entered into an agreement with Apotexto settle its patent litigation in the United States related to Lovaza. Pursuant to the terms of the settlement agreement, we believe Pronova/BASF grantedApotex a license to enter the United States market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on circumstances, thedetails of which are not known to us.In addition, we are aware of other pharmaceutical companies that are developing products that, if approved and marketed, would compete withVascepa. We understand that Acasti Pharma, a subsidiary of Neptune Technologies & Bioresources Inc., announced in late 2012 that it intends to conduct aPhase 3 clinical program to assess the safety and efficacy of its omega-3 prescription drug candidate derived from krill oil for the treatment ofhypertriglyceridemia. We believe Catabasis Pharmaceuticals, or Catabasis, Resolvyx Pharmaceuticals, or Resolvyx, and Sancilio & Company are alsodeveloping potential treatments for hypertriglyceridemia based on omega-3 fatty acids. To our knowledge, Catabasis initiated a Phase 2 clinical trial of itsproduct in December 2013; Resolvyx’s compound remains in Phase 1 clinical testing; and Sancilio is preparing to commence Phase 3 29®®®®®Table of Contentsclinical testing. In addition, we are aware that Matinas BioPharma, Inc. is developing an omega-3-based therapeutic for the treatment of severehypertriglyceridemia and mixed dyslipidemia. Matinas BioPharma, Inc. has filed an Investigational New Drug Application with the FDA to conduct a humanstudy in the treatment of severe hypertriglyceridemia. Isis Pharmaceuticals announced favorable Phase 2 results of ISIS-APOCIII a drug candidateadministered through weekly subcutaneous injections, in patients with high triglycerides and type 2 diabetes and in patients with moderate to severe hightriglycerides. Finally, Madrigal Pharmaceuticals has completed Phase 1 clinical testing of MGL-3196 for the treatment of high triglycerides and various lipidparameters in patients.Generic company competitors are seeking approval of generic versions of Vascepa.The Food Drug and Cosmetic Act, or FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or theHatch-Waxman Amendments, permit the FDA to approve abbreviated new drug applications, or ANDAs, for generic versions of brand name drugs likeVascepa. We refer to the process of generic drug applications as the “ANDA process.” The ANDA process permits competitor companies to obtain marketingapproval for a drug product with the same active ingredient, dosage form, strength, route of administration, and labeling as the approved brand name drug,but without having to conduct and submit clinical studies to establish the safety and efficacy of the proposed generic product. In place of such clinicalstudies, an ANDA applicant needs to submit data demonstrating that its product is bioequivalent to the brand name product, usually based onpharmacokinetic studies.The Hatch-Waxman Amendments require an applicant for a drug product that relies, in whole or in part, on the FDA’s prior approval of Vascepa, tonotify us of its application, a paragraph IV notice, if the applicant is seeking to market its product prior to the expiration of the patents that claim Vascepa. Abona fide paragraph IV notice may not be given under the Hatch-Waxman Amendments until after the generic company receives from the FDA anacknowledgement letter stating that its ANDA is sufficiently complete to permit a substantive review.The paragraph IV notice is required to contain a detailed factual and legal statement explaining the basis for the applicant’s opinion that the proposedproduct does not infringe our patents, that our patents are invalid, or both. After receipt of a valid notice, we would have the option of bringing a patentinfringement suit in federal district court against any generic company seeking approval for its product within 45 days from the date of receipt of each notice.If such a suit is commenced within this 45 day period, we will be entitled to receive a 30 month stay on FDA’s ability to give final approval to any of theproposed products that reference Vascepa that begins on the date we receive the paragraph IV notice. The stay may be shortened or lengthened if either partyfails to cooperate in the litigation and it may be terminated if the court decides the case in less than 30 months. If the litigation is resolved in favor of theapplicant before the expiration of the 30 month period, the stay will be immediately lifted and the FDA’s review of the application may be completed. Suchlitigation is often time-consuming and costly, and may result in generic competition if such patents are not upheld or if the generic competitor is found not toinfringe such patents.We have received six paragraph IV notices notifying us of submitted ANDAs to Vascepa under the Hatch-Waxman Amendments. We are now engagedin costly litigation with the ANDA applicants to protect our patent rights. If an ANDA filer is ultimately successful in patent litigation against us, it meets therequirements for a generic version of Vascepa to the satisfaction of the FDA under its ANDA (after any applicable regulatory exclusivity period and thelitigation-related 30-month stay period expires), and is able to supply the product in significant commercial quantities, the generic company could introducea generic version of Vascepa. Such a market entry would likely limit our U.S. sales, which would have an adverse impact on our business and results ofoperations. In addition, even if a competitor’s effort to introduce a generic product is ultimately unsuccessful, the perception that such development is inprogress and/or news related to such progress could materially affect the perceived value of our company and our stock price.In addition to the six paragraph notices received to date, in February 2014, prior to the FDA’s three-year exclusivity determination for Vascepa, wereceived a purported paragraph IV notice from a generic drug 30RxTable of Contentscompany with respect to an ANDA to Vascepa. The FDA confirmed with us after we received the notice and before the exclusivity determination was madethat the FDA had not accepted for review any ANDA to Vascepa. The FDA has repeatedly taken the position that paragraph IV notices delivered to pioneercompanies such as Amarin prior to the acceptance by the FDA for review of a submitted ANDA are not effective under the Hatch-Waxman Amendments. Thegeneric company may challenge the FDA’s position on whether the notice is valid in court in connection with patent litigation. Generic companies arethought to send such premature notices to seek to avail themselves of the 180-day generic exclusivity period for an approved product under an ANDA basedon the generic’s view that it would then have first-to-file status and to seek an early end to related patent litigation with the branded drug company and theassociated 30-month stay. Because we and the FDA do not believe this purported paragraph IV notice is an effective notice under the Hatch-WaxmanAmendments we do not plan to initiate patent litigation against the generic company that submitted the ANDA until within the 45-day period after wereceive a valid paragraph IV notice from such applicant.Our suit against FDA challenging its denial of five-year, NCE exclusivity to Vascepa under the Hatch-Waxman Amendments may not achieve itsintended goal to delay generic competition challenges to Vascepa.The timelines and conditions under the ANDA process that permit the start of patent litigation and allow the FDA to approve generic versions of brandname drugs like Vascepa differ based on whether a drug receives three-year, or five-year, new chemical entity (NCE) marketing exclusivity. The FDAtypically makes a determination on marketing exclusivity in connection with an NDA approval of a drug for a new indication. We applied to the FDA forfive-year, NCE marketing exclusivity for Vascepa in connection with the NDA for our MARINE indication, which NDA was approved by the FDA on July 26,2012. On February 21, 2014, in connection with the July 26, 2012 approval of the MARINE indication, the FDA denied a grant of NCE marketingexclusivity to Vascepa and granted three-year marketing exclusivity. Such three-year exclusivity extends through July 25, 2015 and is expected to besupplemented by a 30-month stay that we believe will extend into September 2016, assuming the related Vascepa patent litigation is not resolved against ussooner.NCE marketing exclusivity, not granted to Vascepa, precludes approval during the five-year exclusivity period of certain 505(b)(2) applications andANDAs submitted by another company for another version of the drug. However, an application may be submitted after four years if it contains a certificationof patent invalidity or non-infringement. In this case, the pioneer drug company may be afforded the benefit of a 30-month stay against the launch of such acompetitive product that would extend from the end of the five-year exclusivity period, and may also be afforded other extensions under applicableregulations, including a six-month pediatric exclusivity extension or a judicial extension if applicable requirements are met. Another drug sponsor could alsogain a form of marketing exclusivity under the provisions of the FDCA, as amended by the Hatch-Waxman Amendments, if such company can, under certaincircumstances, complete a human clinical trial process and obtain regulatory approval of its product.The three-year period of exclusivity granted to Vascepa under the Hatch-Waxman Amendments is for a drug product that contains an active moietythat has been previously approved when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by thesponsor that were essential to approval of the application. Our MARINE clinical trial was a new clinical investigation that was essential to the approval of ournew drug application. We are entitled to three-year exclusivity even though FDA determined that the EPA moiety was previously approved in Lovazabecause our MARINE clinical investigation was essential for the approval of our new drug product, Vascepa.Such three-year exclusivity protection precludes the FDA from approving a marketing application for an ANDA, a product candidate that the FDAviews as having the same conditions of approval as Vascepa (for example, the same indication and/or other conditions of use), or a 505(b)(2) NDA submittedto the FDA with Vascepa as the reference product, for a period of three years from the date of FDA approval. The FDA may accept and commence review ofsuch applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of ourpatents at any time. In this 31Table of Contentscase, Amarin would be, and has been, afforded the benefit of a 30-month stay against the launch of such a competitive product that extends from the periodthat Amarin receives notice of the patent challenge (the paragraph IV notice), assuming Amarin responds to the patent challenge with 45 days, and Amarinmay also be afforded a judicial extension if applicable requirements are met. Currently, Amarin believes its 30-month stay extends until September 2016.This three-year form of exclusivity may also not prevent the FDA from approving an NDA that relies only on its own data to support the change orinnovation.On February 27, 2014, we commenced a lawsuit against the FDA that challenges FDA’s denial of our request for five-year NCE exclusivity for Vascepabased on our reading of the relevant statute, our view of FDA’s inconsistency with its past actions in this area and the retroactive effect of what we believe is anew policy at FDA as it relates to our situation. Our complaint requests that the court vacate FDA’s decision, declare that Vascepa is entitled to the benefits offive-year statutory exclusivity, bar the FDA from accepting any ANDA or similar application for which Vascepa is the reference-listed drug until after thestatutory exclusivity period and set aside what we contend are—due to the denial of five-year exclusivity to Vascepa—prematurely accepted pending ANDAapplications.We may not be successful in this lawsuit against the FDA. Further, a generic company could enter this litigation, complicating the ultimatedetermination. Even if we are successful at the federal district court level, the FDA may appeal and we may need to win on appeal before the FDA takes, or thecourt imposes on the FDA, the remedies we request in suit. In addition, we may not be able to stay the continuation of currently pending ANDA-related patentlitigation. The legal process can be costly and time-consuming and even if we are successful the remedies available to us diminish in value over time as weapproach the natural expiration of the benefits associated with five-year exclusivity.Vascepa is a prescription-only omega-3 fatty acid. Omega-3 fatty acids are also marketed by other companies as non-prescription dietary supplements.As a result, Vascepa would be subject to non-prescription competition and consumer substitution.Our only current product, Vascepa, is a prescription-only omega-3 fatty acid. Mixtures of omega-3 fatty acids are naturally occurring substancescontained in various foods, including fatty fish. Omega-3 fatty acids are also marketed by others as non-prescription dietary supplements. We cannot be surephysicians will view the pharmaceutical grade purity and tested safety of Vascepa as having a superior therapeutic profile to naturally occurring omega-3fatty acids and dietary supplements. In addition, the FDA has not enforced what we view as illegal drug claims made by certain supplement manufacturers tothe extent we believe appropriate under applicable law and regulations, for example, claims that such supplements reduce triglyceride levels. Also, for morethan a decade now, the FDA has expressly permitted dietary supplement manufacturers that sell supplements containing the omega-3 fatty acids EPA and/orDHA to make the following qualified health claim directly to consumers: Supportive but not conclusive research shows that consumption of EPA and DHAomega-3 fatty acids may reduce the risk of coronary heart disease. Under FDA’s regulatory regime, we cannot make this clam. These factors enable dietarysupplements to effectively compete with Vascepa. In addition, to the extent the net price of Vascepa after insurance and offered discounts is significantlyhigher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements (through that lack of coverage byinsurers or otherwise), physicians may recommend these commercial alternatives instead of writing prescriptions for Vascepa or patients may elect on theirown to take commercially available omega-3 fatty acids. Either of these outcomes may adversely impact our results of operations by limiting how we priceour product and limiting the revenue we receive from the sale of Vascepa due to reduced market acceptance.We may not be successful in our Vascepa co-promotion effort with Kowa Pharmaceuticals America, Inc.In March 2014, we entered into a co-promotion agreement with Kowa Pharmaceuticals America, Inc. to co-promote Vascepa in the United States underwhich approximately 250 Kowa Pharmaceuticals America, Inc. sales representatives devote a substantial portion of their time to promoting Vascepa withAmarin’s approximately 130 sales representatives. Co-promotion under the agreement commenced in May 2014 based on a plan designed to 32Table of Contentssubstantially increase both the number of sales targets reached and the frequency of sales calls on existing sales targets. While our agreement provides forminimum performance criteria, we have little control over Kowa Pharmaceuticals America, Inc., and it may fail to devote the necessary resources andattention to promote Vascepa effectively. If that were to occur, depending on Vascepa revenues, we may have to curtail the continued development ofVascepa for approval for additional indications or increase our planned expenditures and undertake additional development or commercialization activitiesat our own expense. Or, we may seek to terminate the agreement and search for another commercialization partner. If we elect to increase our expenditures tofund development or commercialization activities on our own, depending on Vascepa’s revenues, we may need to obtain additional capital, which may notbe available to us on acceptable terms, or at all, or which may not be possible due to our other financing arrangements. If we do not generate sufficient fundsfrom the sale of Vascepa or, to the extent needed to supplement funds generated from product revenue, cannot raise sufficient funds, we may not be able todevote resources sufficient to market and sell Vascepa on our own in a manner required to realize the full market potential of Vascepa.The commercial value to us of the MARINE and ANCHOR indications may be smaller than we anticipate.There can be no assurance as to the adequacy for commercial success of the scope and breadth of the MARINE indication or, if approved, the ANCHORindication. Even if we obtain marketing approval for additional indications, the FDA may impose restrictions on the product’s conditions for use, distributionor marketing and in some cases may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials. Also, with regard tothe MARINE indication and any other indications for which we may gain approval, the number of actual patients with the condition included in suchapproved indication may be smaller than we anticipate. If any such approved indication is narrower than we anticipate, the market potential for our productwould suffer.Our products will be subject to extensive post-approval government regulation.Once a product candidate receives FDA marketing approval, numerous post-approval requirements apply. Among other things, the holder of anapproved NDA is subject to periodic and other monitoring and reporting obligations enforced by the FDA and other regulatory bodies, including obligationsto monitor and report adverse events and instances of the failure of a product to meet the specifications in the approved application. Application holders mustalso submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials.With respect to sales and marketing activities including direct-to-consumer advertising and promotional activities involving the internet, advertisingand promotional materials must comply with FDA rules in addition to other applicable federal and local laws in the United States and in other countries.Industry-sponsored scientific and educational activities also must comply with FDA and other requirements. In the United States, the distribution of productsamples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Manufacturing facilities remain subject to FDAinspection and must continue to adhere to the FDA’s current good manufacturing practice requirements, or cGMPs. Application holders must obtain FDAapproval for product and manufacturing changes, depending on the nature of the change. We also are subject to the new federal transparency requirementsunder the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, which require manufacturers ofcertain drugs, devices, biologics, and medical supplies to report to the Centers for Medicare & Medicaid Services, or CMS, information related to paymentsand other transfers of value to physicians and teaching hospitals and physician ownership and investment interests. We may also be subject, directly orindirectly through our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute, U.S. FalseClaims Act, and similar state laws, which impact, among other things, our proposed sales, marketing, and scientific/educational grant programs. If weparticipate in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, or other government drugprograms, we will be subject to complex laws and regulations regarding reporting and payment obligations. We must also comply with requirements tocollect and report adverse events and product complaints associated with our products. For 33Table of Contentsexample, in September 2014, we participated in a routine inspection from the FDA in which the FDA made observations on perceived deficiencies related toour processes for collection and processing of adverse events. We have responded to FDA with respect to these observations and continue to work with FDAto show that we have improved related systems and we believe that we have demonstrated to FDA that we have adequately responded to these observations.Our activities are also potentially subject to U.S. federal and state consumer protection and unfair competition laws. Similar requirements exist in many ofthese areas in other countries.Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines or other penalties,injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal toallow us to enter into supply contracts, including government contracts. We may also be held responsible for the non-compliance of our partners, such asKowa Pharmaceuticals America, Inc. In addition, even if we comply with FDA and other requirements, new information regarding the safety or effectivenessof a product could lead the FDA to modify or withdraw a product approval. Adverse regulatory action, whether pre- or post-approval, can potentially lead toproduct liability claims and increase our product liability exposure. We must also compete against other products in qualifying for coverage andreimbursement under applicable third party payment and insurance programs.The commercial value of Vascepa may be negatively affected by the advisory committee recommendation against approval of Vascepa in the ANCHORindication, the rescission of the ANCHOR SPA agreement or any subsequent rejection of the pending FDA application with the FDA for the use ofVascepa in the ANCHOR indication.Though we are restricted from promoting Vascepa under applicable regulations for any indication other than the FDA-approved MARINE indication,healthcare professionals are not restricted from prescribing Vascepa for such so-called off-labeled uses. A significant amount of the sales of Vascepa are, infact, attributable to so-called off-labeled uses of the drug. We expect that among the off-labeled uses of Vascepa are uses that would fall into, or be closelyrelated to, the proposed ANCHOR indication. The recent negative recommendation of the advisory committee meeting against approval of Vascepa in theANCHOR indication, the recent rescission by the FDA of the ANCHOR SPA, and/or a subsequent decision by the FDA to not approve Vascepa in theANCHOR indication may negatively and materially affect the perception of the utility of Vascepa for use in the ANCHOR indication or for other purposesand thus negatively and materially affect sales of Vascepa.The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. If we or KowaPharmaceuticals America, Inc. are found to have improperly promoted off-label uses of Vascepa, we may become subject to significant fines and otherliability.The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, a productmay not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. Eventhough we received FDA marketing approval for Vascepa for the MARINE indication, physicians may still prescribe Vascepa to their patients for use in thetreatment of conditions that are not included as part of the indication statement in our FDA-approved Vascepa label. If we are found to have promoted suchoff-label uses, we may become subject to significant government fines and other related liability. We may also be held responsible for the non-compliance ofour co-promotion partner, Kowa Pharmaceuticals America, Inc. For example, the Federal government has levied large civil and criminal fines againstcompanies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested thatcompanies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.In addition, incentives exist under applicable laws that encourage competitors, employees and physicians to report violations of rules governingpromotional activities for pharmaceutical products. These incentives could lead to so-called whistleblower lawsuits as part of which such persons seek tocollect a portion of moneys allegedly overbilled to government agencies due to, for example, promotion of pharmaceutical products beyond labeled claims.These incentives could also lead to suits that we have mischaracterized a competitor’s product in 34Table of Contentsthe marketplace and may, as a result, be sued for alleged damages to our competitors. Such lawsuits, whether with or without merit, are typically time-consuming and costly to defend. Such suits may also result in related shareholder lawsuits, which are also costly to defend.The REDUCE-IT cardiovascular outcomes trial may fail to show that Vascepa can reduce major cardiovascular events in an at-risk patient populationon statin therapy, and the long-term clinical results of Vascepa may not be consistent with the clinical results we observed in our Phase 3 clinical trial,in which case our sales of Vascepa may then suffer.In accordance with the SPA for our MARINE and ANCHOR trials, efficacy was evaluated in these trials compared to placebo at twelve weeks. Noplacebo-controlled studies have been conducted regarding the long-term effect of Vascepa on lipids, and no outcomes study has been conducted evaluatingVascepa. The REDUCE-IT study is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in an at-risk patient population onstatin therapy.Outcomes studies of certain other lipid-modifying therapies have failed to achieve the endpoints of such studies. For example, in 2010, the results ofthe ACCORD-Lipid trial were published. This trial studied the effect of adding fenofibrate onto open-label simvastatin therapy on cardiovascular outcomes.The addition of fenofibrate did not show any treatment benefit on cardiovascular outcomes over simvastatin monotherapy in this study. In 2011, the resultsof the AIM-HIGH trial were published. This trial studied the effect of adding a second lipid-altering agent, extended-release niacin, to simvastatin therapy oncardiovascular outcomes in people at high risk for cardiovascular events. No significant incremental treatment benefit with extended-release niacin wasobserved. In addition, in September 2012, researchers published in the Journal of the American Medical Association, or JAMA, the results of a retrospectivemeta-analysis of twenty previously conducted studies regarding the use of omega-3 supplements across various patient populations. This meta-analysissuggested that the use of such supplements was not associated with a lower risk of all-cause death, cardiac death, sudden death, heart attack, or stroke. Webelieve the results of these studies may not be directly applicable to the use of Vascepa over time. For instance, the outcomes studies for fenofibrates andniacin were conducted in patient populations in which the majority of patients studied had triglycerides below 200 mg/dL and fenofibrates and niacin arebelieved to work differently than Vascepa in the body and do not have as favorable a side-effect profile, and nineteen of the twenty studies included in theJAMA meta-analysis involved the use of omega-3 supplements containing a mixture of EPA and DHA, and most were evaluated at relatively lower doses. Inaddition, in May 2013, The New England Journal of Medicine published the results of an outcome study of 1 gram per day of an omega-3 acid ethyl estercomposition. In that study, the composition failed to show a benefit in reducing the rate of death from cardiovascular causes or hospitalization forcardiovascular causes when administered to patients with cardiovascular risk factors under different study conditions than in the REDUCE-IT study. Vascepais comprised of highly-pure ethyl-EPA, and has been approved by the FDA for use in adult patients with severe hypertriglyceridemia at a dose of 4 grams perday and is being studied in REDUCE-IT at 4 grams per day.The only other outcomes study involving the use of a highly-pure formulation of ethyl-EPA, called the Japan EPA Lipid Intervention Study (JELIS),suggested that use of a highly-pure formulation of ethyl-EPA in Japan, when used in conjunction with statins, reduced cardiovascular events by 19%compared to the use of statins alone. However, there are several limitations to the JELIS study. First, the patient population was exclusively Japanese, themajority of the participants were women, and at baseline patients had a much higher LDL, limiting its generalizability to the intended target population.Also, a low dose of statins was used. It is unknown whether the positive treatment effects would have persisted if these patients had been optimally treatedwith statins using contemporary LDL targets in the United States. In addition, JELIS was an open-label trial, which could influence patient and physicianbehavior and reporting of symptoms, decisions regarding hospitalization, and referral of events for adjudication. This may be particularly relevant sincehospitalizations for unstable angina was a primary contributor of the overall positive result, and is considered a softer endpoint than fatal cardiovascularevents. 35Table of ContentsAlthough we believe the results of the JAMA meta-analysis and other studies are not directly applicable to the potential long-term clinical experiencewith Vascepa, there can be no assurance that the endpoints of the REDUCE-IT cardiovascular outcomes study will be achieved or that the lipid-modifyingeffects of Vascepa in REDUCE-IT or any other study of Vascepa will not be subject to variation beyond twelve weeks. If the REDUCE-IT trial fails to achieveits clinical endpoints or if the results of these long-term studies are not consistent with the 12-week clinical results, it could prevent us from expanding thelabel of any approved product or even call into question the efficacy of any approved product.The prospective interim efficacy and safety analysis of the REDUCE-IT cardiovascular outcomes trial may not be completed in the contemplatedtimeframe in 2016 and may not demonstrate to the independent committee monitoring the study a sufficient benefit risk result to warrant theindependent committee recommending stopping the study early for overwhelming efficacy. The study may also be stopped for futility or for safetyconcerns.In accordance with the SPA agreement for our REDUCE-IT cardiovascular outcomes trial, an interim review of the efficacy and safety results of the trialis scheduled to occur upon reaching 60% of the target aggregate number of cardiovascular events. We currently expect this interim review by the study’sindependent data monitoring committee (DMC) to occur during 2016 based on our understanding of the current event rates in the study and expected futureevent rates. It may actually take longer to reach the targeted number of events, which would delay the DMC assessment of data for the interim analysis.Further, as is typical of interim analyses, the statistical threshold for defining overwhelming efficacy on the primary endpoint that would call forstopping the study early in connection with such analysis is considerably higher than the threshold for defining statistical significance after the expectedcompletion of the study in 2017. For example, even if the appropriate studied cardiovascular events in the trial occur at sufficiently low rates in the active,Vascepa, group as compared to the placebo group such that the study would be a success at completion, the more rigorous statistical analysis applied by theDMC at the interim analysis may not warrant stoppage of the study for overwhelming efficacy in connection with the interim analysis. The study may also bestopped pursuant to recommendation by the DMC at this interim analysis for lack of signals of a favorable result at completion, so called stoppage forfutility.Moreover, it is the DMC that will make the formal recommendation as to whether to stop the study early or continue as planned. Amarin is blinded tothe interim analysis and is informed by the DMC of the recommendation to stop the study or to continue as planned. The DMC may consider factors outsidethe pre-specified statistical analysis plan when assessing whether to continue the study as planned. For example, even if study results are sufficiently positiveat the interim analysis to demonstrate overwhelming efficacy, the DMC at its discretion may recommend continuation of the study as planned with the goalof arriving at more robust results at the planned study completion if they believe that waiting for more robust results outweighs the potential medical benefitof stopping and unblinding the study early.The DMC has multiple times per year assessed safety data generated in the ongoing study and has thus far recommended to continue the study asplanned. Thus, multiple safety analyses to date have not warranted study stoppage. Nevertheless, the study may be stopped at any time based onrecommendations of the DMC due to safety concerns identified by the DMC during its ongoing and regularly scheduled safety data assessments.We may not be successful in developing or marketing future products if we cannot meet the extensive regulatory requirements of the FDA and otherregulatory agencies for quality, safety and efficacy.The success of our research and development efforts is dependent in part upon our ability, and the ability of our partners or potential partners, to meetregulatory requirements in the jurisdictions where we or our partners or potential partners ultimately intend to sell such products once approved. Thedevelopment, manufacture and marketing of pharmaceutical products are subject to extensive regulation by governmental authorities in the 36Table of ContentsUnited States, the European Union, Japan and elsewhere. In the United States, the FDA generally requires pre-clinical testing and clinical trials of each drugto establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before its introduction into the market. Regulatoryauthorities in other jurisdictions impose similar requirements. The process of obtaining regulatory approvals is lengthy and expensive and the issuance ofsuch approvals is uncertain. The commencement and rate of completion of clinical trials and the timing of obtaining marketing approval from regulatoryauthorities may be delayed by many factors, including: • the lack of efficacy during clinical trials; • the inability to manufacture sufficient quantities of qualified materials under cGMPs for use in clinical trials; • slower than expected rates of patient recruitment; • the inability to observe patients adequately after treatment; • changes in regulatory requirements for clinical or preclinical studies; • the emergence of unforeseen safety issues in clinical or preclinical studies; • delay, suspension, or termination of a trial by the institutional review board responsible for overseeing the study at a particular study site; • unanticipated changes to the requirements imposed by regulatory authorities on the extent, nature or timing of studies to be conducted onquality, safety and efficacy; • government or regulatory delays or “clinical holds” requiring suspension or termination of a trial; and • political instability affecting our clinical trial sites, such as the potential for political unrest affecting our REDUCE-IT clinical trial sites in theUkraine and Russia.Even if we obtain positive results from early stage pre-clinical or clinical trials, we may not achieve the same success in future trials. Clinical trials thatwe or potential partners conduct may not provide sufficient safety and efficacy data to obtain the requisite regulatory approvals for product candidates. Thefailure of clinical trials to demonstrate safety and efficacy for our desired indications could harm the development of that product candidate as well as otherproduct candidates, and our business and results of operations would suffer. For example, the efficacy results of our Vascepa Phase 3 clinical trials for thetreatment of Huntington’s disease were negative. As a result, we stopped development of that product candidate, revised our clinical strategy and shifted ourfocus to develop Vascepa for use in the treatment of cardiovascular disease.Any approvals that are obtained may be limited in scope, may require additional post-approval studies or may require the addition of labelingstatements focusing on product safety that could affect the commercial potential for our product candidates. Any of these or similar circumstances couldadversely affect our ability to earn revenues from the sale of such products. Even in circumstances where products are approved by a regulatory body for sale,the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead tothe withdrawal of a product from the market or similar use restrictions. The discovery of previously unknown problems with a product or in connection withthe manufacturer of products may result in restrictions on that product or manufacturer, including withdrawal of the product from the market, which wouldhave a negative impact on our potential revenue stream.Legislative or regulatory reform of the health care system in the United States and foreign jurisdictions may affect our ability to profitably sell Vascepa.Our ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage andreimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payors.The continuing efforts of 37Table of Contentsthe U.S. and foreign governments, insurance companies, managed care organizations and other payors of health care services to contain or reduce health carecosts may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintainprofitability.Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change thehealth care system in ways that could affect our ability to sell our products profitably. For example, the Patient Protection and Affordable Care Act, asamended by the Health Care and Education Reconciliation Act, or collectively the PPACA, enacted in March 2010, substantially changes the way healthcareis financed by both governmental and private insurers. Among other cost-containment measures, PPACA establishes: • An annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; • A new Medicare Part D coverage gap discount program, in which pharmaceutical manufacturers who wish to have their drugs covered under PartD must offer discounts to eligible beneficiaries during their coverage gap period; and • A new formula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program.We expect further federal and state proposals and health care reforms to continue to be proposed by legislators, which could limit the prices that can becharged for the products we develop and may limit our commercial opportunity.The continuing efforts of government and other third-party payors to contain or reduce the costs of health care through various means may limit ourcommercial opportunity. It will be time consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicareand private payors. Our products may not be considered cost effective, and government and third-party private health insurance coverage and reimbursementmay not be available to patients for any of our future products or sufficient to allow us to sell our products on a competitive and profitable basis. Our resultsof operations could be adversely affected by PPACA and by other health care reforms that may be enacted or adopted in the future. In addition, increasingemphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. Cost control initiatives coulddecrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our profitability.In some foreign countries, including major markets in the European Union and Japan, the pricing of prescription pharmaceuticals is subject togovernmental control. In these countries, pricing negotiations with governmental authorities can take 6 to 12 months or longer after the receipt of regulatorymarketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a pharmacoeconomic studythat compares the cost-effectiveness of Vascepa to other available therapies. Such pharmacoeconomic studies can be costly and the results uncertain. Ourbusiness could be harmed if reimbursement of our products is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels.As we evolve from a company primarily involved in research and development to a company also focused on establishing an infrastructure forcommercializing Vascepa, we may encounter difficulties in managing our growth and expanding our operations successfully.We hired and trained a professional sales force of approximately 275 sales representatives and commenced our commercial launch of Vascepa in theMARINE indication in the United States in early January 2013. The process of establishing a commercial infrastructure is difficult, expensive and time-consuming. Our October 2013 worldwide reduction in force, which included the termination of approximately 50% of the then-staffed sales force, has madethis process more difficult. As our operations expand with the anticipated growth of our produce sales, we expect that we will need to manage additionalrelationships with various collaborative partners, 38Table of Contentssuppliers and other third parties. Future growth will impose significant added responsibilities on members of management, including the need to identify,recruit, maintain and integrate additional employees. Our future financial performance and our ability to commercialize Vascepa and to compete effectivelywill depend, in part, on our ability to manage our future growth effectively. To that end, we must be able to manage our development efforts effectively, andhire, train, integrate and retain additional management, administrative and sales and marketing personnel. We may not be able to accomplish these tasks, andour failure to accomplish any of them could prevent us from successfully growing our company.Risks Related to our Reliance on Third PartiesOur supply of product for commercial supply and clinical trials is dependent upon relationships with third party manufacturers and key suppliers.We have no in-house manufacturing capacity and rely on contract manufacturers for our clinical and commercial product supply. We cannot assure youthat we will successfully manufacture any product we may develop, either independently or under manufacturing arrangements, if any, with our third partymanufacturers. Moreover, if any manufacturer should cease doing business with us or experience delays, shortages of supply or excessive demands on theircapacity, we may not be able to obtain adequate quantities of product in a timely manner, or at all.Any manufacturing problem, natural disaster affecting manufacturing facilities, or the loss of a contract manufacturer could be disruptive to ouroperations and result in lost sales. Additionally, we will be reliant on third parties to supply the raw materials needed to manufacture Vascepa. Any relianceon suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, deliveryschedules, reliability and quality. Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment ofproducts, increase our cost of goods sold and result in lost sales. If our suppliers were unable to supply us with adequate volumes of active pharmaceuticalingredient (drug substance) or encapsulated bulk product (drug product), it would have a material adverse effect on our ability to continue to commercializeVascepa.We initially purchased all of our supply of the bulk compound (ethyl-EPA), which constitutes the only active pharmaceutical ingredient, or API, ofVascepa, from a single supplier, Nisshin Pharma, or Nisshin, located in Japan. Nisshin was approved by the FDA as a Vascepa API supplier as part of our FDAmarketing approval for the MARINE indication in July 2012. In April 2013, we announced the approval by the FDA of Chemport, Inc. and BASF (formerlyEquateq Limited) as additional Vascepa API suppliers. We purchase and use commercial supply from Chemport in addition to Nisshin. We recentlyterminated our agreement with BASF due to its inability to meet the agreement requirements and may enter into a new development and supply agreementwith BASF and may purchase API from BASF. In 2014, we obtained sNDA approval for Slanmhor, resulting in a total of four FDA-approved suppliers of API.Each of the API manufacturers obtains supply of the key raw material to manufacture API from other third party sources of supply.While we have contractual freedom to source the API for Vascepa and have entered into supply agreements with multiple suppliers who also rely onother third party suppliers of the key raw material to manufacture the API for Vascepa, Nisshin and Chemport currently supply all of our API for Vascepa. Ourstrategy in adding API suppliers beyond Nisshin has been to expand manufacturing capacity and to partially mitigate the risk of reliance on one supplier.Expanding manufacturing capacity and qualifying such capacity is difficult and subject to numerous regulations and other operational challenges. Theresources of our suppliers vary and are limited; costs associated with projected expansion and qualification can be significant. For example, Chemport, whichwas approved as one of our API suppliers in April 2013, is a privately-held company and their commitment to Vascepa supply has required them to seekadditional resources. There can be no assurance that the expansion plans of any of our suppliers will be successful. Our aggregate capacity to produce API isdependent upon the qualification of our 39Table of ContentsAPI suppliers. Each of our API suppliers has outlined plans for potential further capacity expansion. If no additional API supplier is approved by the FDA, ourAPI supply will be limited to the API we purchase from previously approved suppliers. If our third party manufacturing capacity is not expanded andcompliant with application regulatory requirements, we may not be able to supply sufficient quantities of Vascepa to meet anticipated demand. We cannotassure you that we can contract with any future manufacturer on acceptable terms or that any such alternative supplier will not require capital investmentfrom us in order for them to meet our requirements. Alternatively, our purchase of supply may exceed actual demand for Vascepa.We currently rely on Patheon (formerly Banner Pharmacaps) for the encapsulation of Vascepa. We have encapsulation agreements with two othercommercial API encapsulators. These companies have qualified their manufacturing processes and are capable of manufacturing Vascepa. There can be noguarantee that additional other suppliers with which we have contracted to encapsulate API will be qualified to manufacture the product to our specificationsor that these and any future suppliers will have the manufacturing capacity to meeting anticipated demand for Vascepa. We cannot assure you that we cancontract with any future manufacturer on acceptable terms or that any such alternative supplier will not require capital investment from us in order for them tomeet our requirements.We may not be able to maintain our exclusivity with our certain third-party Vascepa suppliers if we do not meet minimum purchase obligations due tolower than anticipated sales of Vascepa.Certain of our agreements with our suppliers include minimum purchase obligations and limited exclusivity provisions based on such minimumpurchase obligations. If we do not meet the respective minimum purchase obligations in our supply agreements, our suppliers, in certain cases, will be free tosell the active pharmaceutical ingredient of Vascepa to potential competitors. Similarly if we terminate certain of our supply agreements, such suppliers maybe free to sell the active pharmaceutical ingredient of Vascepa to potential competitors of Vascepa. While we anticipate that intellectual property barriers andFDA regulatory exclusivity will be the primary means to protect the commercial potential of Vascepa, the availability of Vascepa active pharmaceuticalingredient from our suppliers to our potential competitors would make our competitors’ entry into the market easier and more attractive.We have limited experience with the commercial sale of Vascepa, and such inexperience may cause us to purchase too much or not enough supply tosatisfy actual demand, which could have a material adverse effect on our financial results and financial condition.Certain of our agreements with our suppliers include minimum purchase obligations and limited exclusivity provisions. These purchases are generallymade on the basis of rolling twelve-month forecasts which in part are binding on us and the balance of which are subject to adjustment by us subject tocertain limitations. Certain of our agreements also include contractual minimum purchase commitments regardless of the rolling twelve-month forecasts. Wehave limited experience with the commercial sale of Vascepa, and as such expectations regarding expected demand may be wrong. We may not purchasesufficient quantities of Vascepa to meet actual demand or our purchase of supply may exceed actual demand. In either case, such event could have a materialadverse effect on our financial results and financial condition.The manufacture and packaging of pharmaceutical products such as Vascepa are subject to FDA requirements and those of similar foreign regulatorybodies. If we or our third party manufacturers fail to satisfy these requirements, our product development and commercialization efforts may bematerially harmed.The manufacture and packaging of pharmaceutical products, such as Vascepa, are regulated by the FDA and similar foreign regulatory bodies and mustbe conducted in accordance with the FDA’s current good manufacturing practices, or cGMPs, and comparable requirements of foreign regulatory bodies.There are a limited number of manufacturers that operate under these cGMPs regulations who are both capable of manufacturing Vascepa and willing to doso. Failure by us or our third party manufacturers to comply with 40Table of Contentsapplicable regulations, requirements, or guidelines could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure ofregulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls ofproduct, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. For example, Nisshin plans toexpand its capacity to supply API to us by further expanding their current facility. If we are not able to manufacture Vascepa to required specificationsthrough our current and potential API suppliers, we may be delayed in successfully supplying the product to meet anticipated demand and our anticipatedfuture revenues and financial results may be materially adversely affected.Changes in the manufacturing process or procedure, including a change in the location where the product is manufactured or a change of a third partymanufacturer, may require prior FDA review and approval of the manufacturing process and procedures in accordance with the FDA’s cGMPs. Any newfacility may be subject to a pre-approval inspection by the FDA and would again require us to demonstrate product comparability to the FDA. There arecomparable foreign requirements. This review may be costly and time consuming and could delay or prevent the launch of a product.Furthermore, the FDA and foreign regulatory agencies require that we be able to consistently produce the API and the finished product in commercialquantities and of specified quality on a repeated basis, including proven product stability, and document our ability to do so. This requirement is referred toas process validation. This includes stability testing, measurement of impurities and testing of other product specifications by validated test methods. If theFDA does not consider the result of the process validation or required testing to be satisfactory, the commercial supply of Vascepa may be delayed, or we maynot be able to supply sufficient quantities of Vascepa to meet anticipated demand.The FDA and similar foreign regulatory bodies may also implement new standards, or change their interpretation and enforcement of existing standardsand requirements, for manufacture, packaging or testing of products at any time. If we are unable to comply, we may be subject to regulatory, civil actions orpenalties which could significantly and adversely affect our business.We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet establisheddeadlines for the completion of such clinical trials.Our reliance on third parties for clinical development activities reduces our control over these activities. However, if we sponsor clinical trials, we areresponsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trials. Moreover,the FDA requires us to comply with standards, commonly referred to as good clinical practices, for conducting, recording, and reporting the results of clinicaltrials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Ourreliance on third parties does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with otherentities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we maybe delayed in obtaining regulatory approvals for our product candidates and may be delayed in our efforts to successfully commercialize our productcandidates for targeted diseases.Risks Related to our Intellectual PropertyWe are dependent on patents, proprietary rights and confidentiality to protect the commercial potential of Vascepa.Our success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how,and to operate without infringing the proprietary rights of others. Our ability to successfully implement our business plan and to protect our products with ourintellectual property will depend in large part on our ability to: • obtain, defend and maintain patent protection and market exclusivity for our current and future products; 41Table of Contents • preserve any trade secrets relating to our current and future products; • acquire patented or patentable products and technologies; and • operate without infringing the proprietary rights of third parties.Amarin has prosecuted, and is currently prosecuting, multiple patent applications to protect the intellectual property developed during the Vascepacardiovascular program. As of the date of this report, we had 40 patent applications in the United States that have been either issued or allowed and more than30 additional patent applications are pending in the United States. Of such 40 allowed and issued applications, we currently have: • 2 issued U.S. patents directed to a pharmaceutical composition of Vascepa in a capsule that have terms that expire in 2020 and 2030,respectively, • 1 issued U.S. patent covering a composition containing highly pure EPA that expires in 2021, • 35 U.S. patents covering the use of Vascepa in either the MARINE or anticipated ANCHOR indication that have terms that expire in 2030, • 1 additional patent related to the use of a pharmaceutical composition comprised of free fatty acids to treat the ANCHOR patient population witha term that expires in 2030, and • 1 additional patent related to the use of a pharmaceutical composition comprised of free fatty acids to treat the MARINE patient population witha term that expires in 2030.A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. A Notice of Allowance doesnot afford patent protection until the underlying patent is issued by the USPTO. No assurance can be given that applications with issued notices of allowancewill be issued as patents or that any of our pending patent applications will issue as patents. No assurance can be given that, if and when issued, our patentswill prevent competitors from competing with Vascepa. We are also pursuing patent applications related to Vascepa in multiple jurisdictions outside theUnited States. We may be dependent in some cases upon third party licensors to pursue filing, prosecution and maintenance of patent rights or applicationsowned or controlled by those parties. It is possible that third parties will obtain patents or other proprietary rights that might be necessary or useful to us. Incases where third parties are first to invent a particular product or technology, or first to file after various provisions of the America Invents Act of 2011 wentinto effect on March 16, 2013, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent us from utilizing suchtechnology or commercializing our current and future products.Although we intend to make reasonable efforts to protect our current and future intellectual property rights and to ensure that any proprietarytechnology we acquire or develop does not infringe the rights of other parties, we may not be able to ascertain the existence of all potentially conflictingclaims. Therefore, there is a risk that third parties may make claims of infringement against our current or future products or technologies. In addition, thirdparties may be able to obtain patents that prevent the sale of our current or future products or require us to obtain a license and pay significant fees orroyalties in order to continue selling such products.We may in the future discover the existence of products that infringe patents that we own or that have been licensed to us. If we were to initiate legalproceedings against a third party to stop such an infringement, such proceedings could be costly and time consuming, regardless of the outcome. Noassurances can be given that we would prevail, and it is possible that, during such a proceeding, our patent rights could be held to be invalid, unenforceableor both. Although we intend to protect our trade secrets and proprietary know-how through confidentiality agreements with our manufacturers, employeesand consultants, we may not be able to prevent parties subject to such confidentiality agreements from breaching these agreements or third parties fromindependently developing or learning of our trade secrets.We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patentedtechnologies for regulatory approvals. Competitors may seek to oppose our 42Table of Contentspatent applications to delay the approval process or to challenge our granted patents, for example, by requesting a reexamination of our patent at the USPTO,or by filing an opposition in a foreign patent office, even if the opposition or challenge has little or no merit. Such proceedings are generally highlytechnical, expensive, and time consuming, and there can be no assurance that such a challenge would not result in the narrowing or complete revocation ofany patent of ours that was so challenged.Our issued patents may not prevent competitors from competing with Vascepa, even if we seek to enforce our patent rights.We plan to vigorously defend our rights under issued patents. For example, in March 2014, we filed a patent infringement suit against OmtheraPharmaceuticals, Inc., and its parent company, AstraZeneca Pharmaceuticals LP. The suit sought injunctive relief and monetary damages for infringement ofAmarin’s U.S. Patent No. 8,663,662. The complaint alleged infringement of the patent arising from the expected launch of Epanova, a product that isexpected to compete with Vascepa in the United States. The patent covers methods of lowering triglycerides by administering a pharmaceutical compositionthat includes amounts of EPA as free acid, and no more than about 30% DHA. In November 2014, based on a representation from AstraZenecaPharmaceuticals LP that the commercial launch of Epanova was not imminent, the court dismissed our complaint, without prejudice (i.e., preserving ourability to later re-file the suit). The court required the defendant to notify us before any product launch. We intend to pursue this litigation vigorously andaggressively protect its intellectual property rights. However, patent litigation is a time-consuming and costly process. There can be no assurance that we willbe successful in enforcing this patent or that it will not be successfully challenged and invalidated. Even if we are successful in enforcing this patent, theprocess could take years to reach conclusion.Other drug companies may challenge the validity, enforceability, or both of our patents and seek to design its products around our issued patent claimsand gain marketing approval for generic versions of Vascepa or branded competitive products based on new clinical studies. The pharmaceutical industry ishighly competitive and many of our competitors have greater experience and resources than we have. Any such competition could undermine sales,marketing and collaboration efforts for Vascepa, and thus reduce, perhaps materially, the revenue potential for Vascepa.Even if we are successful in enforcing our issued patents, we may incur substantial costs and divert management’s time and attention in pursuing theseproceedings, which could have a material adverse effect on us. Patent litigation is costly and time consuming, and we may not have sufficient resources tobring these actions to a successful conclusion.There can be no assurance that any of our pending patent applications relating to Vascepa or its use will issue as patents.We have filed and are prosecuting numerous families of patent applications in the United States and internationally with claims designed to protect theproprietary position of Vascepa. For certain of these patent families, we have filed multiple patent applications. Collectively the patent applications includenumerous independent claims and dependent claims. Several of our patent applications contain claims that are based upon what we believe are unexpectedand favorable findings from the MARINE and ANCHOR trials. If granted, many of the resulting granted patents would expire in 2030 or beyond. However, noassurance can be given that any of our pending patent applications will be granted or, if they grant, that they will prevent competitors from competing withVascepa.Securing patent protection for a product is a complex process involving many legal and factual questions. The patent applications we have filed in theUnited States and internationally are at varying stages of examination, the timing of which is outside our control. The process to getting a patent granted canbe lengthy and claims initially submitted are often modified in order to satisfy the requirements of the patent office. This process includes written and publiccommunication with the patent office. The process can also include direct 43Table of Contentsdiscussions with the patent examiner. There can be no assurance that the patent office will accept our arguments with respect to any patent application orwith respect to any claim therein. The timing of the patent review process is independent of and has no effect on the timing of the FDA’s review of our NDAor sNDA submissions. We cannot predict the timing or results of any patent application. In addition, we may elect to submit, or the patent office may require,additional evidence to support certain of the claims we are pursuing. Furthermore, third parties may attempt to submit publications for consideration by thepatent office during examination of our patent applications. Providing such additional evidence and publications could prolong the patent office’s review ofour applications and result in us incurring additional costs. We cannot be certain what commercial value any granted patent in our patent estate will provideto us.Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficultfor us to protect our trade secrets.We will also rely upon trade secrets and know-how to help protect our competitive position. We rely on trade secrets to protect technology in caseswhen we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require certain of our academiccollaborators, contractors and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or otherproprietary information.Risks Related to our BusinessWe and certain of our current and former executive officers have been named as defendants in four lawsuits that could result in substantial costs anddivert management’s attention.The market price of our ADSs declined significantly after the October 2013 decision by the FDA Advisory Committee to recommend against approvalof Vascepa in the ANCHOR indication. We, and certain of our current and former executive officers and directors, have been named as defendants in fourpurported class action lawsuits initiated earlier this year that generally allege that we and certain of our current and former officers and directors violatedSections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleadingstatements or material omissions concerning the ANCHOR sNDA and related FDA regulatory approval process in an effort to lead investors to believe thatVascepa would receive approval from the FDA in the ANCHOR indication. The complaints seek unspecified damages, interest, attorneys’ fees, and othercosts.We have engaged in a vigorous defense of the consolidated lawsuit, we believe that the plaintiffs have failed to state a claim, and we have moved todismiss the lawsuit. However, we are unable to predict the outcome of this matter at this time. Moreover, while we expect insurance to cover any financialexposure from this litigation, the conclusion of this matter in a manner adverse to us could have a material adverse effect on our financial condition andbusiness. For example, we could incur substantial costs not covered by our directors’ and officers’ liability insurance, suffer a significant adverse impact onour reputation and divert management’s attention and resources from other priorities, including the execution of business plans and strategies that areimportant to our ability to grow our business, any of which could have a material adverse effect on our business. In addition, any of these matters couldrequire payments that are not covered by, or exceed the limits of, our available directors’ and officers’ liability insurance, which could have a materialadverse effect on our operating results or financial condition.Potential technological changes in our field of business create considerable uncertainty.We are engaged in the biopharmaceutical field, which is characterized by extensive research efforts and rapid technological progress. Newdevelopments in research are expected to continue at a rapid pace in both industry and academia. We cannot assure you that research and discoveries byothers will not render some or all of our programs or product candidates uncompetitive or obsolete. Our business strategy is based in part upon new andunproven technologies to the development of therapeutics to improve cardiovascular health. We cannot 44Table of Contentsassure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately bedeveloped by us.We are subject to potential product liability.Following the commercial launch of Vascepa, we will be subject to the potential risk of product liability claims relating to the manufacturing andmarketing of Vascepa. Any person who is injured as a result of using Vascepa may have a product liability claim against us without having to prove that wewere at fault.In addition, we could be subject to product liability claims by persons who took part in clinical trials involving our current or former developmentstage products. A successful claim brought against us could have a material adverse effect on our business. We cannot guarantee that a product liability claimwill not be asserted against us in the future.We may become subject to liability in connection with the wind-down of our EN101 program.In 2007, we purchased Ester Neurosciences Limited, an Israeli pharmaceutical company, and its lead product candidate, EN101, an AChE-R mRNAinhibitor for the treatment of myasthenia gravis, or MG, a debilitating neuromuscular disease. In connection with the acquisition, we assumed a license tocertain intellectual property assets related to EN101 from the Yissum Research Development Company of The Hebrew University of Jerusalem. In keepingwith our 2009 decision to re-focus our efforts on developing improved treatments for cardiovascular disease and cease development of all product candidatesoutside of our cardiovascular disease focus, we amended the terms of our acquisition agreement with the original shareholders of Ester.Following our decision to cease development of EN101, Yissum terminated its license agreement with us. In June 2011, Yissum announced that it hadentered into a license agreement with BiolineRX Ltd for the development of EN101 in a different indication, inflammatory bowel disease.In 2011 and early 2012, but not after, we received several communications on behalf of the former shareholders of Ester asserting that we are in breachof our agreement with them as it relates to alleged rights to share in the value of EN101 due to the fact that Yissum terminated its license. We do not believethe circumstances presented constitute a breach of the agreement. If the dispute arises again, we plan to defend our position vigorously, but there can be noassurance as to the outcome of this dispute.A change in our tax residence could have a negative effect on our future profitability.Under current UK legislation, a company incorporated in England and Wales, or which is centrally managed and controlled in the UK, is regarded asresident in the UK for taxation purposes. Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrallymanaged and controlled in Ireland, or, in certain circumstances, if it is incorporated in Ireland. Where a company is treated as tax resident under the domesticlaws of both the UK and Ireland then the provisions of article 4(3) of the Double Tax Convention between the UK and Ireland provides that such enterpriseshall be treated as resident only in the jurisdiction in which its place of effective management is situated. We have sought to conduct our affairs in such a wayso as to be resident only in Ireland for tax purposes by virtue of having our place of effective management situated in Ireland. Trading income of an Irishcompany is generally taxable at the Irish corporation tax rate of 12.5%. Non-trading income of an Irish company (e.g., interest income, rental income or otherpassive income), is taxable at a rate of 25%.However, we cannot assure you that we are or will continue to be resident only in Ireland for tax purposes. It is possible that in the future, whether as aresult of a change in law or the practice of any relevant tax authority or as a result of any change in the conduct of our affairs, we could become, or beregarded as having become resident in a jurisdiction other than Ireland. Should we cease to be an Irish tax resident, we may be subject to a charge to Irishcapital gains tax on our assets. Similarly, if the tax residency of any of our subsidiaries were to change from their current jurisdiction for any of the reasonslisted above, we may be subject to a charge to local capital gains tax charge on the assets. 45Table of ContentsThe loss of key personnel could have an adverse effect on our business.We are highly dependent upon the efforts of our senior management. The loss of the services of one or more members of senior management could havea material adverse effect on us. As a small company with a streamlined management structure, the departure of any key person could have a significant impactand would be potentially disruptive to our business until such time as a suitable replacement is hired. Furthermore, because of the specialized nature of ourbusiness, as our business plan progresses we will be highly dependent upon our ability to attract and retain qualified scientific, technical and keymanagement personnel. As we evolve from a development stage company to a commercial stage company we may experience turnover among members ofour senior management team. We may have difficulty identifying and integrating new executives to replace any such losses. There is intense competition forqualified personnel in the areas of our activities. In this environment, we may not be able to attract and retain the personnel necessary for the development ofour business, particularly if we do not achieve profitability. Furthermore, the lessened probability that we will obtain FDA approval for the ANCHORindication could have an adverse impact on our ability to retain and recruit qualified personnel. In addition, in October 2013, we eliminated approximatelyfifty percent of our staff positions worldwide as part of a restructuring following the FDA advisory committee’s recommendation against the potentialVascepa label expansion. Even though all employees were offered severance pay in exchange for signing a comprehensive release of claims, thisrestructuring could lead to claims by former employees related to their termination. The restructuring could also have an adverse impact on our ability toretain and recruit qualified personnel. The failure to recruit key scientific, technical and management personnel would be detrimental to our ability toimplement our business plan.We could be adversely affected by our exposure to customer concentration risk.A significant portion of our sales are to wholesalers in the pharmaceutical industry. Our top three customers accounted for 95% and 96% of grossproduct sales for the years ended December 31, 2014 and 2013, respectively and represented 96% and 95% of the gross accounts receivable balance as ofDecember 31, 2014 and 2013, respectively. There can be no guarantee that we will be able to sustain our accounts receivable or gross sales levels from ourkey customers. If, for any reason, we were to lose, or experience a decrease in the amount of business with our largest customers, whether directly or throughour distributor relationships, our financial condition and results of operations could be negatively affected.Risks Related to our Financial Position and Capital RequirementsWe have a history of operating losses and anticipate that we will incur continued losses for an indefinite period of time.We have not been profitable in any of the last five fiscal years. For the fiscal years ended December 31, 2014, 2013, and 2012, we reported losses ofapproximately $56.4 million, $166.2 million, and $179.2 million, respectively, and we had an accumulated deficit at December 31, 2014 of $970.2 million.Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs, from general andadministrative costs associated with our operations, costs related to the commercialization of Vascepa, and from non-cash losses on changes in the fair valueof warrant derivative liabilities. Additionally, as a result of our significant expenses relating to research and development and to commercialization, weexpect to continue to incur significant operating losses for an indefinite period. Because of the numerous risks and uncertainties associated with developingand commercializing pharmaceutical products, we are unable to predict the magnitude of these future losses. Our historic losses, combined with expectedfuture losses, have had and will continue to have an adverse effect on our cash resources, shareholders’ deficit and working capital.Although we began generating revenue from Vascepa in January 2013, we may never be profitable.Our ability to become profitable depends upon our ability to generate revenue. In January 2013, we began to generate revenue from the marketing ofVascepa for use in the MARINE indication, but we may not be able to 46Table of Contentsgenerate sufficient revenue to attain profitability. Our ability to generate profits on sales of Vascepa is subject to the market acceptance and commercialsuccess of Vascepa and our ability to manufacture commercial quantities of Vascepa through third parties at acceptable cost levels, and may also dependupon our ability to enter into one or more strategic collaborations to effectively market and sell Vascepa.Even though Vascepa has been approved by the FDA for marketing in the United States in the MARINE indication, it may not gain market acceptanceor achieve commercial success and it may never be approved for the ANCHOR indication or any other indication. In addition, we anticipate continuing toincur significant costs associated with commercializing Vascepa. We may not achieve profitability soon after generating product sales, if ever. If we areunable to generate sufficient product revenues, we will not become profitable and may be unable to continue operations without continued funding.Our historical financial results do not form an accurate basis for assessing our current business.As a consequence of the many years developing Vascepa for commercialization and the recent commercial launch of Vascepa in the MARINEindication in the United States, our historical financial results do not form an accurate basis upon which investors should base their assessment of ourbusiness and prospects. In addition, we expect that our costs will increase substantially as we continue to commercialize Vascepa in the MARINE indicationand seek to obtain additional regulatory approval of Vascepa in the ANCHOR indication, including the continuation of the REDUCE-IT cardiovascularoutcomes study. Accordingly, our historical financial results reflect a substantially different business from that currently being conducted and from thatexpected in the future. In addition, we have a limited history of obtaining regulatory approval for, and no demonstrated ability to successfully commercialize,a product candidate. Consequently, any predictions about our future performance may not be as accurate as they could be if we had a history of successfullydeveloping and commercializing pharmaceutical products.Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, thetrading price of our stock could decline.Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year, and Vascepa prescription figures willlikely fluctuate from month to month. Due to the recent approval by the FDA of Vascepa and the lack of historical sales data, Vascepa sales will be difficult topredict from period to period and as a result, you should not rely on Vascepa sales results in any period as being indicative of future performance, and sales ofVascepa may be below the expectation of securities analysts or investors in the future. We believe that our quarterly and annual results of operations may beaffected by a variety of factors, including: • the level of demand for Vascepa; • the extent to which coverage and reimbursement for Vascepa is available from government and health administration authorities, private healthinsurers, managed care programs and other third-party payers; • the timing, cost and level of investment in our sales and marketing efforts to support Vascepa sales and the resulting effectiveness of those effortswith our new co-promotion partner, Kowa Pharmaceuticals America, Inc.; • additional developments regarding our intellectual property portfolio and regulatory exclusivity protections, if any; • the results of our sNDA application for the ANCHOR indication and the results of the REDUCE-IT study or post-approval studies for Vascepa; • outcomes of litigation and other legal proceedings, including recently initiated shareholder litigation, regulatory matters and tax matters; and • our regulatory dialogue on the REDUCE-IT study. 47Table of ContentsWe may require substantial additional resources to fund our operations. If we cannot find additional capital resources, we will have difficulty inoperating as a going concern and growing our business.We currently operate with limited resources. We believe that our cash and cash equivalents balance of $119.5 million at December 31, 2014 will besufficient to fund our projected operations for at least the next twelve months.In order to fully realize the market potential of Vascepa, we may need to enter into a new strategic collaboration or raise additional capital. We mayalso need additional capital to fully complete our REDUCE-IT cardiovascular outcomes trial.Our future capital requirements will depend on many factors, including: • revenue generated from the commercial sale of Vascepa in the MARINE indication and, subject to FDA approval, the ANCHOR indication; • the costs associated with commercializing Vascepa for the MARINE indication in the United States and for additional indications in the UnitedStates and in jurisdictions in which we receive regulatory approval, if any, including the cost of sales and marketing capabilities with our newco-promotion partner, Kowa Pharmaceuticals America, Inc., and the cost and timing of securing commercial supply of Vascepa and the timing ofentering into any new strategic collaboration with others relating to the commercialization of Vascepa, if at all, and the terms of any suchcollaboration; • the continued cost associated with our REDUCE-IT cardiovascular outcomes study; • continued cost associated with litigation and other legal proceedings, including recently initiated shareholder litigation and patent litigation; • the time and costs involved in obtaining additional regulatory approvals for Vascepa; • the extent to which we continue to develop internally, acquire or in-license new products, technologies or businesses; and • the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.If we require additional funds and adequate funds are not available to us in amounts or on terms acceptable to us or on a timely basis, or at all, ourcommercialization efforts for Vascepa may suffer materially, and we may need to delay the advancement of the REDUCE-IT cardiovascular outcomes trial.As a result of recent worldwide reductions in our workforce, we are in the process of reallocating certain employment responsibilities and mayoutsource certain corporate functions. As a result, we may be more dependent on third parties to perform these corporate functions than we have beenin the past.As a result of the recent worldwide reductions in our workforce, we have been required to outsource certain corporate functions. This has made us moredependent on third-parties for the performance of these functions. Our ongoing results of operations could be adversely affected to the extent that we areunable to effectively reallocate employee responsibilities, retain key employees, maintain effective internal control over financial reporting and effectivedisclosure controls and procedures, establish and maintain agreements with competent third-party contractors on terms that are acceptable to us, andeffectively manage the work performed by any retained third-party contractors.Continued negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms.While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all.There can be no assurance that we will be able to access equity or credit 48Table of Contentsmarkets in order to finance our current operations or expand development programs for Vascepa, or that there will not be a further deterioration in financialmarkets and confidence in economies. We may also have to scale back or further restructure our operations. If we are unable to obtain additional funding on atimely basis, we may be required to curtail or terminate some or all of our research or development programs or our commercialization strategies.Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.To the extent we are permitted under our Purchase and Sale Agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma, wemay seek additional capital through a combination of private and public equity offerings, debt financings and collaboration, strategic and licensingarrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted,and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder.On January 9, 2012, we issued $150 million in aggregate principal amount of 3.50% exchangeable senior notes due 2032, or the notes. In the event ofphysical settlement, the notes would initially be exchangeable into a total of 49,214,841 ADS.Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurringadditional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensingarrangements with third parties, we may have to relinquish valuable rights to our technologies, Vascepa or product candidates beyond the rights we havealready relinquished, or grant licenses on terms that are not favorable to us.Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention.On a regular basis, we explore potential business combination transactions, including an acquisition of us by a third party, exclusive licenses ofVascepa or other strategic transactions or collaborations with third parties. For example, in March 2014, we entered into a co-promotion agreement withKowa Pharmaceuticals America, Inc. related to the commercialization of Vascepa in the United States. The consummation and performance of any such futuretransactions or collaborations will involve risks, such as: • diversion of managerial resources from day-to-day operations; • exposure to litigation from the counterparties to any such transaction, other third parties or our shareholders; • misjudgment with respect to the value; • higher than expected transaction costs; or • an inability to successfully consummate any such transaction or collaboration.As a result of these risks, we may not be able to achieve the expected benefits of any such transaction or collaboration or deliver the value thereof toour shareholders. If we are unsuccessful in consummating any such transaction or collaboration, we may be required to reevaluate our business only after wehave incurred substantial expenses and devoted significant management time and resources.Risks Related to Ownership of our ADSs and Common SharesThe price of our ADSs and common shares may be volatile.The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance ofparticular companies. In addition, the market prices of the securities of 49Table of Contentsmany pharmaceutical and medical technology companies have been especially volatile in the past, and this trend is expected to continue in the future.As of March 2, 2015 we had 177,094,536 common shares outstanding including 176,228,632 shares held as ADSs and 865,904 held as common shares(which are not held in the form of ADSs). In our October 2009 private placement we issued 66.4 million ADSs and warrants to purchase an additional33.2 million ADSs. There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the saleof a large block of our securities. Our ADSs have historically had limited trading volume, which may also result in volatility. If any of our large investors,such as the participants in our October 2009 private placement, seek to sell substantial amounts of our ADSs, particularly if these sales are in a rapid ordisorderly manner, or other investors perceive that these sales could occur, the market price of our ADSs could decrease significantly.The market price of our ADSs and common shares may also be affected by factors such as: • developments or disputes concerning ongoing patent prosecution efforts and any future patent or proprietary rights; • regulatory developments in the United States, the European Union or other countries; • actual or potential medical results relating to our products or our competitors’ products; • interim failures or setbacks in product development; • innovation by us or our competitors; • currency exchange rate fluctuations; and • period-to-period variations in our results of operations.A share price of less than $1.00 may impact our NASDAQ listing.If our closing bid price is less than $1.00 for 30 consecutive trading days, we would receive a NASDAQ staff deficiency letter indicating that we are notin compliance with the minimum bid price requirement for continued listing. Such a letter would trigger an automatic 180 calendar day period within whichthe company could regain compliance. Compliance is regained at any time during this period if the Amarin closing bid price is $1.00 per share or more for aminimum of 10 consecutive trading days. If we do not regain compliance during this period, our ADSs could be delisted from The NASDAQ Global Market,transferred to a listing on The NASDAQ Capital Market, or delisted from the NASDAQ markets altogether. The failure to maintain our listing on TheNASDAQ Global Market could harm the liquidity of our ADSs and could have an adverse effect on the market price of our ADSs.Actual or potential sales of our common shares by our employees, including members of our senior management team, pursuant to pre-arranged stocktrading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons couldbe viewed negatively by other investors.In accordance with the guidelines specified under Rule 10b5-1 of the Securities and Exchange Act of 1934 and our policies regarding stocktransactions, a number of our directors and employees, including members of our senior management team, have adopted and may continue to adopt pre-arranged stock trading plans to sell a portion of our common stock. Generally, sales under such plans by members of our senior management team anddirectors require public filings. Actual or potential sales of our ADSs by such persons could cause the price of our ADSs to fall or prevent it from increasingfor numerous reasons. For example, a substantial amount of our ADSs becoming available (or being perceived to become available) for sale in the publicmarket could cause the market price of our ADSs to fall or prevent it from increasing. Also, actual or potential sales by such persons could be viewednegatively by other investors. 50Table of ContentsWe may be a passive foreign investment company, or PFIC, which would result in adverse U.S. federal tax consequences to U.S. investors.Amarin Corporation plc and certain of our subsidiaries may be classified as “passive foreign investment companies,” or PFICs, for U.S. federal incometax purposes. The tests for determining PFIC status for a taxable year depend upon the relative values of certain categories of assets and the relative amountsof certain kinds of income. The application of these factors depends upon our financial results, which are beyond our ability to predict or control, and whichmay be subject to legal and factual uncertainties.We believe it prudent to assume that we were classified as a PFIC in 2012. We do not believe that we were classified as a PFIC in 2013 or 2014. Ourstatus as a PFIC is subject to change in future years.If we are a PFIC, U.S. holders of notes, ordinary shares or ADSs would be subject to adverse U.S. federal income tax consequences, such as ineligibilityfor any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reportingrequirements under U.S. federal income tax laws and regulations. Whether or not U.S. holders of our ADSs make a timely “QEF election” or “mark-to-marketelection” may affect the U.S. federal income tax consequences to U.S. holders with respect to the acquisition, ownership and disposition of Amarin ADSs andany distributions such U.S. Holders may receive. A QEF election and other elections that may mitigate the effect of our being classified as a PFIC areunavailable with respect to the notes. Investors should consult their own tax advisors regarding all aspects of the application of the PFIC rules to the notes,ordinary shares and ADSs.Failure to meet our obligations under our Purchase and Sale Agreement with BioPharma could adversely affect our financial results and liquidity.Pursuant to our December 2012 Purchase and Sale Agreement with BioPharma, we are obligated to make payments to BioPharma based on the amountof our net product sales of Vascepa and any future products based on ethyl-EPA, or covered products, subject to certain quarterly caps.Pursuant to this agreement, we may not, among other things: (i) incur indebtedness greater than a specified amount, which we refer to as theIndebtedness Covenant; (ii) pay a dividend or other cash distribution, unless we have cash and cash equivalents in excess of a specified amount after suchpayment; (iii) amend or restate our memorandum and articles of association unless such amendments or restatements do not affect BioPharma’s interestsunder the transaction; (iv) encumber any of the collateral securing our performance under the agreement; and (v) abandon certain patent rights, in each casewithout the consent of BioPharma.Upon a transaction resulting in a change of control of Amarin, as defined in the agreement, BioPharma will be automatically entitled to receive anyamounts not previously paid, up to our maximum repayment obligation. As defined in the agreement, “change of control” includes, among other things, (i) agreater than 50 percent change in the ownership of Amarin, (ii) a sale or disposition of any collateral securing our debt with BioPharma and (iii), unlessBioPharma has been paid a certain amount under the indebtedness, certain licensings of Vascepa to a third party for sale in the United States. Theacceleration of the payment obligation in the event of a change of control transaction may make us less attractive to potential acquirers, and the payment ofsuch funds out of our available cash or acquisition proceeds would reduce acquisition proceeds for our stockholders.To secure our obligations under the agreement, we granted BioPharma a security interest in our rights in patents, trademarks, trade names, domainnames, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoing and all proceeds of theforegoing, which we refer to as the collateral. If we (i) fail to deliver a payment when due and do not remedy that failure within specific notice period, (ii) failto maintain a first-priority perfected security interest in the collateral in the United States and do not remedy that failure after receiving notice of such failureor (iii) become subject to an event of bankruptcy, then BioPharma may attempt to collect the maximum amount payable by us under this agreement (afterdeducting any payments we have already made). 51Table of ContentsThere can be no assurance that we will not breach the covenants or other terms of, or that an event of default will not occur under, this agreement and, ifa breach or event of default occurs, there can be no assurance that we will be able to cure the breach within the time permitted. Any failure to pay ourobligations when due, any breach or default of our covenants or other obligations, or any other event that causes an acceleration of payment at a time whenwe do not have sufficient resources to meet these obligations, could have a material adverse effect on our business, results of operations, financial conditionand future viability.Our existing indebtedness could adversely affect our financial condition.Our existing indebtedness consists of $150.0 million in aggregate principal amount of 3.50% exchangeable senior notes due 2032, $31.3 million ofwhich relates to the January 2012 notes with provisions for the notes to be put to us on or after January 19, 2017 while the balance of $118.7 million relatesto the May 2014 notes with provision for the notes to be redeemed by us on or after January 19, 2018 or put to us by the holders on or after January 19, 2019.Our indebtedness and the related annual debt service requirements may adversely impact our business, operations and financial condition in the future.For example, they could: • increase our vulnerability to general adverse economic and industry conditions; • limit our ability to raise additional funds by borrowing or engaging in equity sales in order to fund future working capital, capital expenditures,research and development and other general corporate requirements; • require us to dedicate a substantial portion of our cash to service payments on our debt; or • limit our flexibility to react to changes in our business and the industry in which we operate or to pursue certain strategic opportunities that maypresent themselves.The accounting for convertible debt securities that may be settled in cash, such as our notes, could have a material effect on our reported financialresults.Under the FASB Accounting Standards Codification, or ASC, we are required to separately account for the liability and equity components of theconvertible debt instruments (such as the notes) that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’seconomic interest cost. The effect of ASC on the accounting for our outstanding convertible notes may be that the equity component is required to beincluded in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheets and the value of the equity component would betreated as original issue discount for purposes of accounting for the debt component of the notes. As a result, we are required to record non-cash interestexpense as a result of the amortization of the discounted carrying value of the notes to their face amount over the term of the notes. We may be required toreport higher interest expense in our financial results because ASC may require interest to include both the current period’s amortization of the debt discountand the instrument’s coupon interest, which could adversely affect our reported or future financial results and the trading price of our ADSs.Servicing our debt may require a significant amount of cash, and we may not have sufficient cash flow from our business to provide the funds sufficientto pay our substantial debt.Our ability to make scheduled payments of the principal, to pay interest on or to refinance our indebtedness, including the notes, depends on our futureperformance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not continue to generate cash flowfrom operations in the future sufficient to service our debt and make necessary capital expenditures. If we are unable to generate such cash flow, we may berequired to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous orhighly dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time. We may not be able toengage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, including the notes,and have a material adverse effect on the trading price of our ADSs. 52Table of ContentsWe may be able to incur substantial additional debt in the future, subject to the restrictions contained in our future debt instruments, if any, whichwould intensify the risks discussed above.The conditional exchange feature of the notes, if triggered, may adversely affect our financial condition and operating results.In the event the conditional exchange feature of the notes is triggered, holders of notes will be entitled to exchange the notes at any time duringspecified periods at their option. If one or more holders elect to exchange their notes, unless we elect to satisfy its exchange obligation by delivering solelythe ADSs (other than cash in lieu of any fractional ADS), we would be required to settle a portion or all of its exchange obligation through the payment ofcash, which could adversely affect our liquidity. In addition, even if holders do not elect to exchange their notes, we could be required under applicableaccounting rules to reclassify all or a portion of the outstanding principal of the notes as a current rather than long-term liability, which would result in amaterial reduction of our net working capital.The change in control repurchase feature of the notes may delay or prevent an otherwise beneficial takeover attempt of us.The indenture governing the notes will require us to repurchase the notes for cash upon the occurrence of a change in control of Amarin and, in certaincircumstances, to increase the exchange rate for a holder that exchanges its notes in connection with a make-whole fundamental change. A takeover of usmay trigger the requirement that we purchase the notes and/or increase the exchange rate, which could make it more costly for a potential acquirer to engagein a combinatory transaction with us. Such additional costs may have the effect of delaying or preventing a takeover of us that would otherwise be beneficialto investors.We do not intend to pay cash dividends on the ordinary shares in the foreseeable future.We have never paid dividends on ordinary shares and do not anticipate paying any cash dividends on the ordinary shares in the foreseeable future.Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends mustbe approved by our Board of Directors and, in some cases, our shareholders, and may only be paid from our distributable profits available for the purpose,determined on an unconsolidated basis.The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.We are incorporated under English law. The rights of holders of ordinary shares and, therefore, certain of the rights of holders of ADSs, are governed byEnglish law, including the provisions of the Companies Act 2006, and by our Articles of Association. These rights differ in certain respects from the rights ofshareholders in typical U.S. corporations. The principal differences include the following: • Under English law and our Articles of Association, each shareholder present at a meeting has only one vote unless demand is made for a vote ona poll, in which case each holder gets one vote per share owned. Under U.S. law, each shareholder typically is entitled to one vote per share at allmeetings.Under English law, it is only on a poll that the number of shares determines the number of votes a holder may cast. You should be aware,however, that the voting rights of ADSs are also governed by the provisions of a deposit agreement with our depositary bank. • Under English law, subject to certain exceptions and disapplications, each shareholder generally has preemptive rights to subscribe on aproportionate basis to any issuance of ordinary shares or rights to subscribe for, or to convert securities into, ordinary shares for cash. Under U.S.law, shareholders generally do not have preemptive rights unless specifically granted in the certificate of incorporation or otherwise. 53Table of Contents • Under English law and our Articles of Association, certain matters require the approval of 75% of the shareholders who vote (in person or byproxy) on the relevant resolution (or on a poll shareholders representing 75% of the ordinary shares voting (in person or by proxy)), includingamendments to the Articles of Association. This may make it more difficult for us to complete corporate transactions deemed advisable by ourboard of directors. Under U.S. law, generally only majority shareholder approval is required to amend the certificate of incorporation or toapprove other significant transactions. • In the United Kingdom, takeovers may be structured as takeover offers or as schemes of arrangement. Under English law, a bidder seeking toacquire us by means of a takeover offer would need to make an offer for all of our outstanding ordinary shares/ADSs. If acceptances are notreceived for 90% or more of the ordinary shares/ADSs under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain100% control of us. Accordingly, acceptances of 90% of our outstanding ordinary shares/ADSs will likely be a condition in any takeover offer toacquire us, not 50% as is more common in tender offers for corporations organized under Delaware law. By contrast, a scheme of arrangement, thesuccessful completion of which would result in a bidder obtaining 100% control of us, requires the approval of a majority of shareholders votingat the meeting and representing 75% of the ordinary shares voting for approval. • Under English law and our Articles of Association, shareholders and other persons whom we know or have reasonable cause to believe are, orhave been, interested in our shares may be required to disclose information regarding their interests in our shares upon our request, and the failureto provide the required information could result in the loss or restriction of rights attaching to the shares, including prohibitions on certaintransfers of the shares, withholding of dividends and loss of voting rights. Comparable provisions generally do not exist under U.S. law. • The quorum requirement for a shareholders’ meeting is a minimum of two shareholders entitled to vote at the meeting and present in person or byproxy or, in the case of a shareholder which is a corporation, represented by a duly authorized officer. Under U.S. law, a majority of the shareseligible to vote must generally be present (in person or by proxy) at a shareholders’ meeting in order to constitute a quorum. The minimumnumber of shares required for a quorum can be reduced pursuant to a provision in a company’s certificate of incorporation or bylaws, buttypically not below one-third of the shares entitled to vote at the meeting.U.S. shareholders may not be able to enforce civil liabilities against us.We are incorporated under the laws of England and Wales, and our subsidiaries are incorporated in various jurisdictions, including foreignjurisdictions. A number of the officers and directors of each of our subsidiaries are non-residents of the United States, and all or a substantial portion of theassets of such persons are located outside the United States. As a result, it may not be possible for investors to affect service of process within the UnitedStates upon such persons or to enforce against them judgments obtained in U.S. courts predicated upon the civil liability provisions of the federal securitieslaws of the United States. We have been advised by our English solicitors that there is doubt as to the enforceability in England in original actions, or inactions for enforcement of judgments of U.S. courts, of civil liabilities to the extent predicated upon the federal securities laws of the United States.U.S. holders of the ADSs or ordinary shares may be subject to U.S. federal income taxation at ordinary income tax rates on undistributed earnings andprofits.There is a risk that we will be classified as a controlled foreign corporation, or CFC, for U.S. federal income tax purposes. If we are classified as a CFC,any ADS holder or shareholder that is a U.S. person that owns directly, indirectly or by attribution, 10% or more of the voting power of our outstanding sharesmay be subject to U.S. income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart Fincome.” Such 10% holder may also be taxable at ordinary income tax rates on any 54Table of Contentsgain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares. The CFC rulesare complex and U.S. Holders of the ordinary shares or ADSs are urged to consult their own tax advisors regarding the possible application of the CFC rules tothem in their particular circumstances. Item 1B.Unresolved Staff CommentsNone. Item 2.PropertiesThe following table lists the location, use and ownership interest of our principal properties as of February 20, 2015: Location Use Ownership Size (sq. ft.) Dublin, Ireland Offices Leased 270 Bedminster, New Jersey, USA Offices Leased 21,231 Effective July 1, 2011, we leased 9,747 square feet of office space in Bedminster, New Jersey. The lease, as amended, terminates on March 31, 2018,and may also be terminated with six months prior notice. On December 6, 2011 we leased an additional 2,142 square feet of space in the same location. OnDecember 15, 2012 and May 8, 2013, we leased an additional 2,601 and 10,883 square feet of space, respectively, in the same location. In January 2014 andApril 2014, we entered into separate transactions with the landlord of this property to vacate approximately 2,142 and 2,000 square feet of space in exchangefor discounts on contractual future rent payments. Additionally, in January 2015, we signed an agreement to sublease approximately 4,700 square feet of thisproperty to a third party effective April 1, 2015.Effective November 1, 2011, we leased 320 square feet of office space in Dublin, Ireland. The office space was subsequently reduced to 270 square feet,effective November 1, 2013. The lease terminates on October 31, 2015 and may be renewed annually.We believe our existing facilities are adequate for our current needs and that additional space will be available in the future on commerciallyreasonable terms as needed. Item 3.Legal ProceedingsOn November 1, 2013, a purported investor of Amarin filed a putative class action lawsuit captioned Steven Sklar v. Amarin Corporation plc et al.,No. 13-cv-6954 (D.N.J. Nov. 1, 2013) in the U.S. District Court for the District of New Jersey. Substantially similar lawsuits, captioned Bove v. AmarinCorporation plc, Civ. No. 13-07882 (AT) (S.D.N.Y. Nov. 5, 2013), Bentley v. Amarin Corporation plc, Civ. No. 13-08283 (AT) (S.D.N.Y. Nov. 20, 2013) andSiegel v. Amarin Corporation plc, No. 3:13-cv-07210 (D.N.J. Nov. 27, 2013), were subsequently filed in the U.S. District Court for the District of New Jerseyand U.S. District Court for the Southern District of New York. On December 9, 2013, the cases filed in the Southern District of New York were transferred tothe District of New Jersey and all such cases are now consolidated as In re Amarin Corporation plc, Securities Litigation, No. 3:13-cv-06663 (D.N.J. Nov. 1,2013). The plaintiffs assert claims under the Securities Exchange Act of 1934 and allege that Amarin and certain of its current and former officers anddirectors made misstatements and omissions regarding the FDA’s willingness to approve Vascepa’s ANCHOR indication and related contributing factors andthe potential relevance of data from the ongoing REDUCE-IT trial to that approval. The lawsuit seeks unspecified monetary damages and attorneys’ fees andcosts. We believe that we have valid defenses and we will vigorously defend against this class action suit, but cannot predict the outcome. We are unable toreasonably estimate the loss exposure, if any, associated with the claims. We have insurance coverage that is anticipated to cover any significant lossexposure that may arise from this action after payment by us of the associated deductible obligation under such insurance coverage. 55Table of ContentsOn February 27, 2014, we commenced a lawsuit against the FDA in the U.S. District Court for the District of Columbia captioned AmarinPharmaceuticals Ireland Ltd. v. Food & Drug Administration, et al., Civ. A. No. 14-0324 (D.D.C.) that challenges FDA’s denial of our request for five-yearNCE exclusivity for Vascepa based on our reading of the relevant statute, our view of FDA’s inconsistency with its past actions in this area and the retroactiveeffect of what we believe is a new policy at FDA as it relates to our situation. Our complaint requests that the court vacate FDA’s decision, declare thatVascepa is entitled to the benefits of five-year statutory exclusivity, bar the FDA from accepting any ANDA or similar application for which Vascepa is thereference-listed drug until after the statutory exclusivity period and set aside what we contend are—due to the denial of five-year exclusivity to Vascepa—prematurely accepted pending ANDA applications. We intend to litigate the case vigorously, but we cannot predict the outcome of this lawsuit.In March, April, and May 2014, we received paragraph IV certification notices from six companies contending to varying degrees that certain of ourpatents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of Vascepa as described in thosecompanies’ abbreviated new drug applications, or ANDAs. We have commenced patent infringement lawsuits against each of these ANDA applicants. In eachof the lawsuits, Amarin is seeking, among other remedies, an order enjoining the defendants from marketing generic versions of Vascepa before the last toexpire of the asserted patents expires in 2030. In April 2014, Amarin filed lawsuits against Apotex, Inc. and Apotex Corporation, or collectively, Apotex, inthe U.S. District Court for the District of New Jersey and the U.S. District Court for the Northern District of Illinois. The cases against Apotex are captionedAmarin Pharma, Inc. et al. v. Apotex, Inc. et al., Civ. A. No. 14-2550 (D.N.J) and Amarin Pharma, Inc. et al. v. Apotex, Inc. et al., Civ. A. No. 14-2958 (N.D.Ill.). In April 2014, Amarin also filed lawsuits against Roxane Laboratories, Inc., or Roxane, in the U.S. District Court for the District of New Jersey and theU.S. District Court for the Northern District of Ohio. The cases against Roxane are captioned Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc., Civ. A.No. 14-2551 (D.N.J) and Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc., Civ. A. No. 14-901 (N.D. Ohio). Amarin voluntarily dismissed the NorthernDistrict of Ohio case against Roxane on May 7, 2014. In April 2014, Amarin also filed a lawsuit against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’sLaboratories, Ltd., or collectively, Dr. Reddy’s, in the U.S. District Court for the District of New Jersey. The case against Dr. Reddy’s is captioned AmarinPharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civ. A. No. 14-2760 (D.N.J.). In May 2014, Amarin also filed a lawsuit against WatsonLaboratories, Inc. and Actavis plc, or Watson, in the U.S. District Court for the District of New Jersey. One of our directors, Patrick J. O’Sullivan, is also adirector of Actavis plc. The case against Watson is captioned Amarin Pharma, Inc. et al. v. Watson Laboratories, Inc. et al., Civ. A. No. 14-3259 (D.N.J). OnJuly 17, 2014, Amarin agreed to dismiss Actavis plc but the lawsuit against Watson remains pending. In June 2014, Amarin also filed a case against TevaPharmaceuticals USA, Inc., or Teva, in the U.S. District Court for the District of New Jersey. The case against Teva is captioned Amarin Pharma, Inc. et al. v.Teva Pharmaceuticals USA, Inc., Civ. A. No. 14-3558 (D.N.J.). In June 2014, Amarin also filed a lawsuit against Andrx Labs, LLC, Andrx Corporation, andActavis plc, or collectively, Andrx, in the U.S. District Court for the District of New Jersey. The case against Andrx is captioned Amarin Pharma, Inc. et al v.Andrx Labs, LLC et. al., Civ. A. No. 14-3924 (D.N.J.). As a result of the 30-month stay associated with the filing of these lawsuits under the Hatch-WaxmanAct, the FDA cannot grant final approval to any ANDA before September 2016, unless there is an earlier court decision holding that the subject patents arenot infringed and/or are invalid. We intend to vigorously enforce our intellectual property rights relating to Vascepa, but we cannot predict the outcome ofthese lawsuits.In addition to the above, in the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, andthreats of litigation relating to intellectual property, commercial arrangements and other matters. Item 4.Mine Safety DisclosuresNot applicable. 56Table of ContentsPART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesMarket InformationThe following table sets forth the high and low prices for our ADSs in each of the quarters over the past two fiscal years, as quoted on the NASDAQGlobal Market. Common Stock Price Fiscal 2014 Fiscal 2013 High Low High Low First Quarter $2.75 $1.60 $9.24 $6.77 Second Quarter $1.98 $1.28 $7.98 $5.36 Third Quarter $2.09 $1.07 $7.40 $5.12 Fourth Quarter $1.38 $0.78 $7.39 $1.36 ShareholdersAs of January 31, 2015, there were approximately 390 holders of record of our ordinary shares. Because many ordinary shares are held by brokersnominees, we are unable to estimate the total number of shareholders represented by these record holders. Our depositary, Citibank, N.A., constitutes a singlerecord holder of our ordinary shares.DividendsWe have never paid dividends on common shares and do not anticipate paying any cash dividends on the common shares in the foreseeable future.Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends mustbe approved by our Board of Directors and, in some cases, our stockholders, and may only be paid from our distributable profits available for the purpose,determined on an unconsolidated basis.Under our Purchase and Sale Agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma, we are restricted from paying adividend on our common shares, unless we have cash and cash equivalents in excess of a specified amount after such payment. 57Table of ContentsPerformance Graph—5 YearThe following performance graph and related information shall not be deemed “soliciting material” or to be “filed” with the Securities andExchange Commission, nor shall such information be incorporated by reference into any future filing under the Securities Act of 1933 or SecuritiesExchange Act of 1934, each as amended, except to the extent that we specifically incorporate it by reference into such filing.The following graph compares the cumulative 5-year return provided to stockholders of Amarin’s ADSs relative to the cumulative total returns of theNASDAQ Composite Index and the NASDAQ Biotechnology Index. We believe these indices are the most appropriate indices against which the totalshareholder return of Amarin should be measured. The NASDAQ Biotechnology Index has been selected because it is an index of U.S. quoted biotechnologyand pharmaceutical companies. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our ADSs and in each of theindexes on January 1, 2010 and its relative performance is tracked through December 31, 2014. Company/Market/Peer Company 12/31/2010 12/31/2011 12/31/2012 12/31/2013 12/31/2014 Amarin Corporation PLC $573.43 $523.78 $565.73 $137.76 $68.53 NASDAQ Composite Index $118.02 $117.04 $137.47 $192.62 $221.02 NASDAQ Biotechnology Index $116.06 $130.08 $172.67 $286.67 $385.29 Information about Our Equity Compensation PlansInformation regarding our equity compensation plans is incorporated by reference in Item 12 of Part III of this annual report on Form 10-K.UNITED KINGDOM TAXATIONCapital GainsIf you are not resident or ordinarily resident in the United Kingdom, or UK, for UK tax purposes, you will not be liable for UK tax on capital gainsrealized or accrued on the sale or other disposition of common shares or ADSs unless the common shares or ADSs are held in connection with your tradecarried on in the UK through a branch or agency and the common shares or ADSs are or have been used, held or acquired for the purposes of such trade orsuch branch or agency.An individual holder of common shares or ADSs who ceases to be resident or ordinarily resident in the UK for UK tax purposes for a period of less than5 years and who disposes of common shares or ADSs during that period may also be liable on returning to the UK for UK capital gains tax despite the fact thatthe individual may not be resident or ordinarily resident in the UK at the time of the disposal. 58Table of ContentsInheritance TaxIf you are an individual domiciled in the United States and are not a national of the UK for the purposes of the Inheritance and Gift Tax Treaty 1978between the United States and the UK, any common shares or ADSs beneficially owned by you will not generally be subject to UK inheritance tax on yourdeath or on a gift made by you during your lifetime, provided that any applicable United States federal gift or estate tax liability is paid, except where thecommon share or ADS is part of the business property of your UK permanent establishment.Where the common shares or ADSs have been placed in trust by a settlor who, at the time of the settlement, was domiciled in the United States and nota national of the UK, the common shares or ADSs will not generally be subject to UK inheritance tax.Stamp Duty and Stamp Duty Reserve TaxTransfer of ADSsNo UK stamp duty will be payable on an instrument transferring an ADS or on a written agreement to transfer an ADS provided that the instrument oftransfer or the agreement to transfer is executed and remains at all times outside the UK. Where these conditions are not met, the transfer of, or agreement totransfer, an ADS could, depending on the circumstances, attract a charge to ad valorem stamp duty at the rate of 0.5% of the value of the consideration.No stamp duty reserve tax will be payable in respect of an agreement to transfer an ADS, whether made in or outside the UK.Issue and Transfer of Common SharesThe issue of common shares by Amarin will not give rise to a charge to UK stamp duty or stamp duty reserve tax.Transfers of common shares, as opposed to ADSs, will attract ad valorem stamp duty at the rate of 0.5% of the amount or value of the consideration. Acharge to stamp duty reserve tax, at the rate of 0.5% of the amount or value of the consideration, will arise on an agreement to transfer common shares. Thestamp duty reserve tax is payable on the seventh day of the month following the month in which the charge arises. Where an instrument of transfer isexecuted and duly stamped before the expiry of a period of six years beginning with the date of that agreement, any stamp duty reserve tax that has not beenpaid ceases to be payable.Taxation of DividendsUnder UK law, there is no withholding tax on dividends. 59Table of ContentsItem 6.Selected Financial DataThe selected financial data set forth below as of and for the years ended December 31, 2014, 2013, 2012, 2011, and 2010 have been derived from theaudited consolidated financial statements of Amarin. This data should be read in conjunction with our audited consolidated financial statements and relatednotes which are included elsewhere in this Annual Report on Form 10-K, and “Management’s Discussion and Analysis of Financial Condition and Results ofOperations” included in Item 7 below. Historical results are not necessarily indicative of operating results to be expected in the future. Years Ended December 31, 2014 2013 2012 2011 2010 (In thousands, except per share amounts) Consolidated Statements of Operations Data: Product revenues $54,202 $26,351 $— $— $— Less: Cost of goods sold 20,485 11,912 — — — Gross margin 33,717 14,439 — — — Operating expenses: Selling, general and administrative (1) 79,346 123,795 57,794 22,559 17,087 Research and development 50,326 72,750 58,956 21,602 28,014 Total operating expenses 129,672 196,545 116,750 44,161 45,101 Operating loss (95,955) (182,106) (116,750) (44,161) (45,101) Gain (loss) on change in fair value of derivative liabilities (2) 13,472 47,710 (35,344) (22,669) (205,153) Gain on extinguishment of debt 38,034 — — — — Interest expense (18,575) (34,179) (18,091) (1) (19) Interest income 96 343 544 231 53 Other income (expense), net 3,727 (1,189) (427) (10) 130 Loss from operations before taxes (59,201) (169,421) (170,068) (66,610) (250,090) Benefit from (provision for) income taxes 2,837 3,194 (9,116) (2,516) 501 Net loss $(56,364) $(166,227) $(179,184) $(69,126) $(249,589) Loss per share: Basic $(0.32) $(1.03) $(1.24) $(0.53) $(2.49) Diluted $(0.36) $(1.28) $(1.24) $(0.53) $(2.49) Weighted average shares outstanding: Basic 173,719 161,022 144,017 130,247 100,239 Diluted 173,824 167,070 144,017 130,247 100,239 As of December 31, 2014 2013 2012 2011 2010 (In thousands) Consolidated Balance Sheet Data: Cash and cash equivalents $119,539 $191,514 $260,242 $116,602 $31,442 Total assets 171,107 252,476 310,855 126,379 35,367 Long-term obligations 219,249 248,792 289,650 123,889 230,157 Stockholders’ deficit (88,448) (33,856) (3,997) (5,962) (202,367) (1)Includes non-cash warrant-related compensation expense reflecting the change in the fair value of the warrant derivative liability associated withwarrants issued in October 2009 to former officers of Amarin. See further discussion in Notes 2 and 7 of the Notes to the Consolidated FinancialStatements.(2)Includes non-cash charges resulting from changes in the fair value of derivative liabilities. See further discussion in Notes 2 and 7 of the Notes to theConsolidated Financial Statements. 60Table of ContentsItem 7.Management’s Discussion and Analysis of Financial Condition and Results of OperationsThis Annual Report on Form 10-K contains forward-looking statements concerning future events and performance of the Company. When used in thisreport, the words “may,” “would,” “should,” “could,” “expects,” “aims,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,”“potential,” or “continue” or the negative of these terms or other comparable terminology are included to identify forward-looking statements. Thesestatements include but are not limited to statements regarding the commercial success of Vascepa in its first approved indication, the MARINE indication;,the potential for, conditions to, and timing of, approval of the Vascepa Supplemental New Drug Application, or sNDA, by the United States Food and DrugAdministration, or FDA, in its potential second indication, the ANCHOR indication; the timing of enrollment, interim results or final results of ourREDUCE-IT study; potential for Vascepa to be marketed by partners outside of the United States; the safety and efficacy of our product candidates; thescope of our intellectual property protection and the likelihood of securing additional patent protection; estimates of the potential markets for our productcandidates; the likelihood of qualifying additional third party manufacturing suppliers and estimates of the capacity of manufacturing and other facilitiesto support our products; our operating and growth strategies; our industry; our projected cash needs, liquidity and capital resources; and our expectedfuture revenues, operations and expenditures. These forward-looking statements are based on our current expectations and assumptions and many factorscould cause our actual results to differ materially from those indicated in these forward-looking statements. You should review carefully the factorsidentified in this report in Item 1A, “Risk Factors”. We disclaim any intent to update or announce revisions to any forward-looking statements to reflectactual events or developments, except as required by law. Except as otherwise indicated herein, all dates referred to in this report represent periods or datesfixed with reference to our fiscal year ended December 31.OverviewWe are a biopharmaceutical company with expertise in lipid science focused on the commercialization and development of therapeutics to improvecardiovascular health.Our lead product, Vascepa (icosapent ethyl) capsules, is approved by the U.S. Food and Drug Administration, or FDA, for use as an adjunct to diet toreduce triglyceride levels in adult patients with severe (TG >500 mg/dL) hypertriglyceridemia. Vascepa is available in the United States by prescription only.We began selling and marketing Vascepa in the United States in January 2013. We sell Vascepa principally to a limited number of major wholesalers, as wellas selected regional wholesalers and specialty pharmacy providers, or collectively, its Distributors, that in turn resell Vascepa to retail pharmacies forsubsequent resale to patients and health care providers. We market Vascepa through our sales force of approximately 150 sales professionals, including salesrepresentatives and their managers. In March 2014, we entered into a co-promotion agreement with Kowa Pharmaceuticals America, Inc. under whichapproximately 250 Kowa Pharmaceuticals America, Inc. sales representatives began to devote a substantial portion of their time to promoting Vascepastarting in May 2014. We operate in one business segment.Triglycerides are fats in the blood. Hypertriglyceridemia refers to a condition in which patients have high levels of triglycerides in the bloodstream. Itis estimated that over 40 million adults in the United States have elevated triglyceride levels (TG >200 mg/dL) and approximately 4.0 million people in theUnited States have severely high triglyceride levels (TG >500 mg/dL), commonly known as very high triglyceride levels. According to The American HeartAssociation Scientific Statement on Triglycerides and Cardiovascular Disease (2011), triglycerides also provide important information as a markerassociated with the risk for heart disease and stroke, especially when an individual also has low high-density lipoprotein cholesterol, or HDL-C (often referredto as “good” cholesterol), and elevated levels of LDL-C (often referred to as “bad” cholesterol). Guidelines for the management of very high triglyceridelevels suggest that reducing triglyceride levels is the primary goal in patients to reduce the risk of acute pancreatitis. The effect of Vascepa on cardiovascularmortality and morbidity, or the risk for pancreatitis, in patients with hypertriglyceridemia has not been determined.The potential efficacy and safety of Vascepa (known in its development stage as AMR 101) was studied in two Phase 3 clinical trials, the MARINE trialand the ANCHOR trial. At a daily dose of 4 grams of Vascepa, the 61®Table of Contentsdose at which Vascepa is FDA approved, these trials showed favorable clinical results in their respective patient populations in reducing triglyceride levelswithout increasing LDL-C levels in the MARINE trial and with a statistically significant decrease in LDL-C levels in the ANCHOR trial, in each case, relativeto placebo. These trials also showed favorable results, particularly with the 4-gram dose of Vascepa, in other important lipid and inflammation biomarkers,including apolipoprotein B (apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total-cholesterol (TC), very low-density lipoprotein cholesterol(VLDL-C), lipoprotein-associated phospholipase A2 (Lp-PLA2), and high sensitivity C-reactive protein (hs-CRP). In these trials, the most commonly reportedadverse reaction (incidence >2% and greater than placebo) in Vascepa-treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo).We are also developing Vascepa for the treatment of patients with high (TG 200 mg/dL and <500 mg/dL) triglyceride levels who are also on statintherapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels which we refer to as mixed dyslipidemia. We refer to this second proposedindication for Vascepa as the ANCHOR indication. The FDA has stated that it views the proposed ANCHOR indication as ostensibly and impliedly anindication to reduce cardiovascular risk. In addition, in December 2011, we announced commencement of patient dosing in our cardiovascular outcomesstudy of Vascepa, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial). The REDUCE-IT study is designed to evaluate theefficacy of Vascepa in reducing major cardiovascular events in a high risk patient population on statin therapy.We have a pending supplemental new drug application, or sNDA, with the FDA that seeks marketing approval of Vascepa for use in the ANCHORindication. On October 16, 2013, the FDA convened an advisory committee to review our sNDA. This advisory committee was not asked by the FDA toevaluate whether Vascepa is effective in lowering triglycerides in the studied population, the ANCHOR indication as specified in the sNDA. Rather, theadvisory panel was asked whether Vascepa would improve cardiovascular outcomes or whether approval of the ANCHOR indication should wait forsuccessful completion of the REDUCE-IT study, the first prospective study of cardiovascular outcomes in patients who have high triglyceride levels despitestatin therapy. The advisory committee voted 9 to 2 against recommending approval of the ANCHOR indication based on information presented at themeeting. The FDA considers the recommendation of advisory committees, but final decisions on the approval of new drug applications are made by the FDA.The ANCHOR clinical study was conducted under a special protocol assessment, or SPA, agreement with the FDA. The law governing SPA agreementsrequires that if the results of the trial conducted under the SPA substantiate the hypothesis of the protocol covered by the SPA, the FDA must use the datafrom the protocol as part of the primary basis for approval of the product. A SPA agreement is not a guarantee of FDA approval of the related new drugapplication. A SPA agreement is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issueessential to determining safety or efficacy of the drug after the study begins that rises to the level of a public health concern, or if the study sponsor fails tofollow the protocol that was agreed upon with the FDA. On October 29, 2013, the FDA rescinded the ANCHOR study SPA agreement because the FDAdetermined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testingbegan. As a basis for this determination, the FDA communicated that it determined that the cumulative results from outcome studies of other triglyceride-lowering drugs failed to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among thepopulation studied in the ANCHOR trial. Thus, the FDA stated that while information we submitted supports testing the hypothesis that Vascepa 4 grams/dayversus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in theVascepa REDUCE-IT cardiovascular outcomes study, the FDA no longer considers a change in serum triglyceride levels alone as sufficient to establish theeffectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL. Beginning in November 2013, wesought reconsideration and appealed the SPA rescission decision to three levels of increasing authority within the FDA and were denied each time, mostrecently in September 2014. Based on FDA’s repeated position in its appeal denials and its internal consultation with FDA officials at higher levels, weinformed the FDA that we did not intend to appeal the SPA rescission further. 62Table of ContentsThe FDA did not take action on the ANCHOR sNDA by the Prescription Drug User Fee Act, or PDUFA, goal date for completion of FDA’s review,December 20, 2013. Given our September 2014 determination to not appeal the SPA rescission further, we expect the FDA to take action on our pendingANCHOR sNDA in the near future.We are currently focused on the ongoing REDUCE-IT cardiovascular outcomes study of Vascepa. REDUCE-IT, a multinational, prospective,randomized, double-blind, placebo-controlled study, is the first prospective cardiovascular outcomes study of any drug in a population of patients who,despite stable statin therapy, have elevated triglyceride levels. Based on the results of REDUCE-IT, we plan to seek additional indicated uses for Vascepabeyond the indications studied in the ANCHOR and MARINE trials. In REDUCE-IT, cardiovascular event rates for patients on stable statin therapy plus fourgrams per day of Vascepa will be compared to cardiovascular event rates for patients on stable statin therapy plus placebo. The REDUCE-IT study is designedto be completed after reaching an aggregate number of cardiovascular events. Based on projected event rates, we estimate the REDUCE-IT study can becompleted in or about 2017 with results then expected to be available and published in 2018. An interim review of the efficacy and safety results of the trialis scheduled to occur upon reaching 60% of the target aggregate number of cardiovascular events. We currently expect this interim review by theindependent data monitoring committee (DMC) to occur during 2016. The DMC has been more frequently examining interim reviews of the safety data fromthe study. Following each of these reviews, the DMC has communicated to us that we should continue the study as planned. Amarin remains blinded to alldata from the study. Over 90% of the 8,000 patients targeted for enrollment in the REDUCE-IT study have been enrolled.Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IT outcomes study will be required forlabel expansion for Vascepa. There can be no assurance that we will be successful in our efforts to obtain a label expansion reflecting the ANCHOR clinicaltrial whether or not we obtain final positive results from the REDUCE-IT outcomes study. If the FDA does not approve the ANCHOR indication, it could havea material impact on our future results of operations and financial condition.On October 22, 2013, in an effort to reduce operating expenses following the recommendation of the advisory committee to the FDA against approvalof the ANCHOR indication, we implemented a worldwide reduction in force of approximately 50% of our staff positions. The majority of affected staffmembers were sales professionals who supported the initial commercial launch of Vascepa. We incurred approximately $2.8 million in charges related to thereduction in force, all of which includes cash expenditures for one-time termination benefits and associated costs. The charges were recorded in the fourthquarter of 2013 and the related payments were made by the first half of 2014. As part of the reduction in force, we retained approximately 130 salesrepresentatives, excluding sales management, in the United States in sales territories that we believe have demonstrated the greatest potential for Vascepasales growth. This team covers the target base of physicians responsible for the majority of Vascepa prescription volume and growth since its launch in early2013. With these changes and the resulting target base coverage, as well as the addition of the promotional efforts of 250 sales representatives from KowaPharmaceuticals America, Inc. that began in May 2014, we anticipate continued Vascepa revenue growth over time. We also anticipate that such sales growthmay be inconsistent from period to period.Commercialization StrategyVascepa became commercially available in the United States by prescription in January 2013 when we commenced sales and shipments to our networkof U.S.-based wholesalers. We commenced the commercial launch of Vascepa in the United States in January 2013 with approximately 275 salesrepresentatives. Vascepa has not yet been approved or commercially launched outside of the United States. In October 2013, we reduced our number of salesrepresentatives to approximately 130, excluding sales management, in the United States to focus on the sales territories that we believe have demonstratedthe greatest potential for Vascepa sales growth. We now market Vascepa in the United States through our sales force of approximately 150 sales professionals 63Table of Contentsand their managers. Commencing in the middle of the second quarter of 2014, in addition to promotion by our sales representatives, approximately 250Kowa Pharmaceuticals America, Inc. sales representatives began promoting Vascepa. We also employ various marketing personnel to support ourcommercialization of Vascepa. As of February 1, 2015, over 26,000 clinicians had written prescriptions for Vascepa.Under the co-promotion agreement with Kowa Pharmaceuticals America, Inc., under which promotion commenced in May 2014, both parties haveagreed to use commercially reasonable efforts to promote, detail and optimize sales of Vascepa in the United States and have agreed to specific performancerequirements detailed in the related agreement. The performance requirements include a negotiated minimum number of sales details to be delivered by eachparty in the first and second position, the use of a negotiated number of minimum sales representatives from each party, including no less than 250 KowaPharmaceuticals America, Inc. sales representatives and the achievement of minimal levels of Vascepa revenue in 2015 and beyond. Kowa PharmaceuticalsAmerica, Inc. has also agreed to continue to bear the costs incurred for its sales force associated with the commercialization of Vascepa and to pay for certainincremental costs associated with the use of its sales force, such as sample costs and costs for promotional and marketing materials. We will continue torecognize all revenue from sales of Vascepa. In exchange for Kowa Pharmaceuticals America, Inc.’s co-promotional services, Kowa Pharmaceuticals America,Inc. is entitled to a quarterly co-promotion fee based on a percentage of aggregate Vascepa gross margins that increases during the term. The percentage ofaggregate Vascepa gross margins earned by Kowa Pharmaceuticals America, Inc. is scheduled to increase from the high single digits in 2014, to mid-teenpercent levels in 2015, and to the low twenty percent levels in 2018, subject to certain adjustments. The term of this co-promotion agreement expires onDecember 31, 2018.Based on monthly compilations of data provided by a third party, Symphony Health Solutions, the estimated number of normalized total Vascepaprescriptions for the three months ended December 31, 2014 was approximately 146,000 as compared to 132,000, 110,000, 93,000 and 94,000 prescriptionsin the three months ended September 30, 2014, June 30, 2014, March 31, 2014 and December 31, 2013, respectively. According to data from another thirdparty, IMS Health, the estimated number of normalized total Vascepa prescriptions for the three months ended December 31, 2014 was approximately131,000 as compared to 113,000, 93,000, 78,000 and 79,000 prescriptions in the three months ended September 30, 2014, June 30, 2014, March 31, 2014and December 31, 2013, respectively. Normalized total prescriptions represent the estimated total number of Vascepa prescriptions shipped to patients,calculated on a normalized basis (i.e., total capsules shipped divided by 120 capsules, or one month’s supply). The data reported above is based oninformation made available to us from a third party resource and may be subject to adjustment and may overstate or understate actual prescriptions. Timing ofshipments to wholesalers, as used for revenue recognition purposes, and timing of prescriptions as estimated by these third parties may differ from period toperiod.Although we believe these data are prepared on a period-to-period basis in a manner that is generally consistent and that such results are generallyindicative of current prescription trends, these data are based on estimates and should not be relied upon as definitive. In addition, because we had limitedselling history during the year ended December 31, 2013, we only recognized revenue on product that was resold for purposes of filling prescriptions. Thoseprescription data may differ from data reported by other third parties.Prior to commencing our U.S. commercial launch of Vascepa in January 2013, we had no revenue from Vascepa. Because of our limited selling history,changes in the size of our sales force, our co-promotion agreement, and uncertainty regarding resolution of the ANCHOR sNDA with the FDA, we do notcurrently provide quantified revenue guidance. While we expect to be able to grow Vascepa revenues, we provide no quantified guidance regardinganticipated levels of Vascepa prescriptions or revenues and no such guidance should be inferred from the operating metrics described above. We believe thatinvestors should view the above-referenced operating metrics with caution, as data for this limited period may not be representative of a trend consistent withthe results presented or otherwise predictive of future results. Seasonal fluctuations in pharmaceutical sales, for example, may affect future prescription trendsof Vascepa, as could changes in prescriber sentiment and other factors. We believe investors should consider our results over several quarters, or longer,before making an assessment about potential future performance. 64Table of ContentsWe secured managed care coverage for over 215 million lives, including as of February 1, 2015 over 125 million lives covered on Tier 2 for formularypurposes.The commercialization of a new pharmaceutical product is a complex undertaking, and our ability to effectively and profitably commercialize Vascepawill depend in part on our ability to generate market demand for Vascepa through education, marketing and sales activities, our ability to achieve marketacceptance of Vascepa, our ability to generate product revenue and our ability to receive adequate levels of reimbursement from third-party payers. See “RiskFactors—Risks Related to the Commercialization and Development of Vascepa.”Research and Development UpdateIn September 2014, we announced our continued commitment to completing the ongoing REDUCE-IT cardiovascular outcomes study. Thismultinational, prospective, randomized, double-blind, placebo-controlled study is the first prospective cardiovascular outcomes study of any drug in apopulation of patients who, despite stable statin therapy, have elevated triglyceride levels.We have over 7,300 patients enrolled in the REDUCE-IT study. We currently estimate that we will complete patient enrollment in this study within2015. The REDUCE-IT study is designed to be completed after reaching an aggregate number of cardiovascular events. Based on projected event rates, weestimate the REDUCE-IT study can be completed in or about 2017 with results then expected to be available in 2018. Based on the results of REDUCE-IT,we may seek additional indications for Vascepa beyond the indications studied in the ANCHOR or MARINE trials. An interim review of the efficacy andsafety results of the trial is scheduled to occur upon reaching 60% of the target aggregate number of cardiovascular events. We currently expect this interimreview by the independent data monitoring committee (DMC) to occur during 2016. As is typical, the statistical threshold for defining overwhelmingefficacy on the primary endpoint at the interim analysis is considerably higher than the threshold for defining statistical significance at the end of the study.Amarin remains blinded to all data from the study.Our scientific rationale for the REDUCE-IT study is supported by (i) epidemiological data that suggests elevated triglyceride levels correlate withincreased cardiovascular disease risk, (ii) genetic data that suggests triglyceride and/or triglyceride-rich lipoproteins (as well as low-density lipoproteincholesterol (LDL cholesterol), known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data thatsuggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. Our scientificrationale for the REDUCE-IT study is also supported by research on the differentiated effects of the active ingredient in Vascepa, including the antioxidantproperties and effects on inflammation markers associated with atherosclerosis.Commercial Supply UpdateDuring 2013 and 2014, all of our active pharmaceutical ingredient, or API, was acquired through two suppliers, Nisshin and Chemport. Much of theinventory sold in 2014 was purchased from Nisshin at a price which is higher than expected future average API costs.During 2014, we reached a settlement agreement with a former supplier, BASF, under which we received a refund for previous material purchases of$3.0 million, included as other income in the statement of operations. The amount of supply we seek to purchase in 2014 and beyond will depend on thelevel of growth of Vascepa revenues.Financial PositionWe believe that our cash and cash equivalents balance of $119.5 million at December 31, 2014 is sufficient to fund our projected operations for at leastthe next twelve months. 65Table of ContentsFinancial Operations OverviewProduct Revenues, net. All of our revenue is derived from product sales of Vascepa, net of allowances, discounts, incentives, rebates, chargebacks andreturns. We sell product to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively,our Distributors, who resell the product to retail pharmacies for purposes of their reselling the product to fill patient prescriptions. We commenced ourcommercial launch in the United States in January 2013. In accordance with GAAP, until we had the ability to reliably estimate returns of Vascepa from ourDistributors, revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions, and not based on our sales to suchDistributors. Beginning in January 2014, we concluded that we had developed sufficient history such that we can reliably estimate returns and as a result,began to recognize revenue based on sales to our Distributors. Through December 31, 2014, product returns were de minimis.Cost of Goods Sold. Cost of goods sold includes the cost of API for Vascepa on which revenue was recognized during the period, as well as theassociated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goodssold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of Vascepa API, which throughDecember 31, 2014 was sourced from Nisshin and Chemport.Selling, General and Administrative Expense. Selling, general and administrative expense consists primarily of salaries and other related costs forpersonnel, including stock-based compensation expense, in our sales, marketing, executive, business development, finance and information technologyfunctions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.Research and Development Expense. Research and development expense consists primarily of fees paid to professional service providers inconjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid toindependent researchers, costs of qualifying contract manufacturers, services expenses incurred in developing and testing products and product candidates,salaries and related expenses for personnel, including stock-based compensation expense, costs of materials, depreciation, rent, utilities and other facilitiescosts. In addition, research and development expenses include the cost to support current development efforts, including patent costs and milestonepayments. We expense research and development costs as incurred. In addition, research and development costs include the costs of product supply receivedfrom suppliers when such receipt by the Company is prior to regulatory approval of the supplier.Gain (Loss) on Change in Fair Value of Derivative Liabilities. Gain (loss) on change in fair value of derivative liabilities is comprised of: (i) thechange in fair value of the warrant derivative liability, (ii) the change in fair value of the derivative liability related to the change in control provisionassociated with the December 2012 BioPharma financing and (iii) the change in fair value of the derivative liability related to the change in controlprovision associated with the May 2014 exchangeable senior notes.Interest and Other Income (Expense), Net. Interest expense consists of interest incurred under lease obligations, interest incurred under our 3.5%exchangeable notes and interest incurred under our December 2012 financing arrangement with BioPharma Secured Debt Fund II Holdings Cayman LP, orBioPharma. Interest expense under our exchangeable notes includes the amortization of the conversion option related to our exchangeable debt, theamortization of the related debt discounts and debt obligation coupon interest. Interest expense under our BioPharma financing arrangement is calculatedbased on an estimated repayment schedule. Interest income consists of interest earned on our cash and cash equivalents. Other income (expense), net, consistsprimarily of foreign exchange losses and gains.Critical Accounting Policies and Significant Judgments and EstimatesOur discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements and notes, whichhave been prepared in accordance with accounting principles generally 66Table of Contentsaccepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts ofassets, liabilities, revenue and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative financialliabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, theresults of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actualresults may differ from these estimates under different assumptions or conditions. A summary of our significant accounting policies is contained in Note 2 toour consolidated financial statements included elsewhere in this Annual Report on Form 10-K. We believe the following critical accounting policies affectour more significant judgments and estimates used in the preparation of our consolidated financial statements.Revenue Recognition—We sell Vascepa principally to a limited number of Distributors, that in turn resell Vascepa to retail pharmacies thatsubsequently resell it to patients and health care providers. In accordance with GAAP, our revenue recognition policy requires that: (i) there is persuasiveevidence that an arrangement exists between us and the Distributor, (ii) delivery has occurred, (iii) collectability is reasonably assured and (iv) the price isfixed or determinable.We began recognizing revenue from the sale of Vascepa following our commercial launch in the United States in January 2013. Prior to 2013, werecognized no revenue from Vascepa sales. We sell Vascepa to Distributors. In accordance with GAAP, until we had the ability to reliably estimate returns ofVascepa from our Distributors, revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions, and not based on oursales to such Distributors. Beginning in January 2014, we concluded that we had developed sufficient history such that we can reliably estimate returns andas a result, began to recognize revenue based on sales to our Distributors. Consequently, we recognized revenues of $54.2 million based on sales toDistributors during the year ended December 31, 2014. Through December 31, 2014, product returns were de minimis.We have written contracts with our Distributors, and delivery occurs when a Distributor receives Vascepa. We evaluate the creditworthiness of each ofour Distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements, or whether recognition isrequired to be delayed until receipt of payment. In order to conclude that the price is fixed or determinable, we must be able to (i) calculate our gross productrevenues from the sales to Distributors and (ii) reasonably estimate our net product revenues. We calculate gross product revenues based on the wholesaleacquisition cost that we charge our Distributors for Vascepa. We estimate our net product revenues by deducting from our gross product revenues (a) tradeallowances, such as invoice discounts for prompt payment and distributor fees, (b) estimated government and private payor rebates, chargebacks anddiscounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives offered to certain indirectcustomers, including patients.Derivative Financial Liabilities—Derivative financial liabilities are initially recorded at fair value. They are subsequently held at fair value, with gainsand losses arising for changes in fair value recognized in the statement of operations. The fair value of derivative financial liabilities is determined usingvarious valuation techniques. We use our judgment to select a variety of methods and make assumptions that are mainly based on market conditions existingat each balance sheet date. Fluctuations in the assumptions used in the valuation model would result in adjustments to the fair value of the derivativeliabilities reflected on our balance sheet and, therefore, our statement of operations. If we issue shares to discharge the liability, the derivative financialliability is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. For options and warrants treated asderivative financial liabilities, at settlement date the carrying value of the options and warrants are transferred to equity. The cash proceeds received fromshareholders for additional shares are recorded in common stock and additional paid-in capital. We have recorded financial derivatives related to certainoutstanding warrants, the change in control provision associated with our December 2012 debt financing and the change in control provision associated withour May 2014 exchangeable senior notes. 67Table of ContentsInventory—Prior to July 26, 2012, when we received approval from the FDA to market and sell Vascepa in the United States for the MARINEindication, Vascepa was considered a product candidate under development. All supply of Vascepa purchased prior to July 26, 2012 was not capitalized andinstead charged as a component of research and development expense in the period received. After Vascepa was approved, we began to capitalize inventorypurchased from Nisshin, the API supplier approved in the NDA. Prior to April 2013, only Nisshin was an FDA-approved supplier of API for Vascepa. In April2013, the FDA approved our sNDAs covering Chemport and BASF and in July 2014 the FDA approved our sNDA covering Slanmhor such that there are nowfour suppliers FDA-qualified to produce Vascepa API. All supply from Chemport and BASF prior to FDA approval of these API suppliers was not capitalizedand instead charged as a component of research and development expense in the period received. Subsequent to the approval of these suppliers, we capitalizeAPI purchases from them. Until an API supplier is approved, all Vascepa API purchased from such supplier is included as a component of research anddevelopment expense. Upon sNDA approval of each additional supplier, we capitalize subsequent Vascepa API purchases from such supplier as inventory.Purchases of Vascepa API received and expensed before such regulatory approvals are not subsequently capitalized, and all such purchases are quarantinedand not used for commercial supply until such time as the sNDA for the supplier that produced the API is approved. We state inventories at the lower of costor market value. Cost is determined based on actual cost using the average cost method. An allowance is established when management determines thatcertain inventories may not be saleable. If inventory cost exceeds expected market value due to obsolescence, damage or quantities in excess of expecteddemand, we will reduce the carrying value of such inventory to market value. We expense inventory identified for use as marketing samples when they arepackaged. The average cost reflects the actual purchase price of Vascepa API, as well as a portion of API carried at zero cost for material which was purchasedprior to FDA approval of Vascepa or was purchased prior to the sNDA approval of our suppliers. Additionally, the determination of the classification of ourinventory requires the use of estimates in order to determine the portion of inventories anticipated to be utilized within twelve months of the balance sheetdate.Income Taxes—Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and taxbases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse.Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized.We provide reserves for potential payments of tax to various tax authorities or do not recognize tax benefits related to uncertain tax positions and otherissues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions ismore likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. Our policy is to record interest andpenalties in the provision for income taxes.We assess our ability to realize deferred tax assets at each reporting period. The realization of deferred tax assets depends on generating future taxableincome during the periods in which the tax benefits are deductible or creditable. We have been historically profitable in the United States. When making ourassessment about the realization of its U.S. deferred tax assets at December 31, 2014, we considered all available evidence, placing particular weight onevidence that could be objectively verified. The evidence considered included the (i) historical profitability of our U.S. operations, (ii) sources of futuretaxable income, giving weight to sources according to the extent to which they can be objectively verified and (iii) the risks to our business related to thecommercialization and development of Vascepa. Based on our assessment, we concluded that the U.S. deferred tax assets are more likely than not to berealizable as of December 31, 2014. The majority of our deferred tax assets are held outside of the U.S., for which we have established a full valuationallowance. Changes in historical earnings performance and future earnings projections, among other factors, may cause us to adjust our valuation allowanceon deferred tax assets, which would impact our income tax expense in the period in which we determine that these factors have changed. In the eventsufficient taxable income is not generated in future periods, additional valuation allowances could be required relating to these U.S. deferred tax assets. 68Table of ContentsRecent Accounting PronouncementsFrom time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted by theCompany as of the specified effective date. We considered the following recent accounting pronouncements which were not yet adopted as of December 31,2014:In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” This amendment provides principles forrecognizing revenue for the transfer of promised goods or services to customers with the consideration to which the entity expects to be entitled in exchangefor those goods or services. This amendment will be effective for our fiscal year beginning January 1, 2017. Early adoption is not permitted. We are currentlyevaluating the accounting, transition and disclosure requirements of the standard and cannot currently estimate the financial statement impact of adoption.In June 2014, the FASB issued guidance for accounting for share-based payments when the terms of an award provide that a performance target couldbe achieved after the requisite service period. The standard states that a performance target in a share-based payment that affects vesting and that could beachieved after the requisite service period should be accounted for as a performance condition. As such, the performance target should not be reflected inestimating the grant-date fair value of the award. We are required to adopt this standard in the first quarter of fiscal 2016 and early adoption is permitted. Thisstandard is not expected to have an impact on our consolidated financial statements.In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern, Disclosure of Uncertainties about anEntity’s Ability to Continue as a Going Concern (Subtopic 205-40). ASU 2014-15 requires management to assess an entity’s ability to continue as a goingconcern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the ASU (i) provides a definitionof the term substantial doubt, (ii) requires an evaluation every reporting period including interim periods, (iii) provides principles for considering themitigating effect of management’s plans, (iv)requires certain disclosures when substantial doubt is alleviated as a result of consideration of management’splans, (v) requires an express statement and other disclosures when substantial doubt is not alleviated and (vi) requires an assessment for a period of one yearafter the date that the financial statements are issued (or available to be issued). This standard is effective for the fiscal years ending after December 15, 2016,and for annual periods and interim periods thereafter. Early application is permitted. We are currently evaluating the accounting, transition and disclosurerequirements of the standard and cannot currently estimate the financial statement impact of adoption.We believe that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on consolidatedfinancial position, results of operations, and cash flows, or do not apply to our operations.Effects of InflationWe believe the impact of inflation on operations has been minimal during the past three years.Results of OperationsComparison of Fiscal Years Ended December 31, 2014 versus December 31, 2013Product Revenues, net. We recorded revenue of $54.2 million during the year ended December 31, 2014, versus $26.4 million during the prior yearperiod, an increase of $27.8 million, or 105%. We commenced our full commercial launch of Vascepa in the United States for use in the MARINE indicationin January 2013. All of our revenue in the years ended December 31, 2014 and 2013 was derived from product sales of Vascepa, net of allowances, discounts,incentives, rebates, chargebacks and returns. 69Table of ContentsWe sell Vascepa to Distributors. In accordance with GAAP, until we had the ability to reliably estimate returns of Vascepa from our Distributors,revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions, and not based on our sales to such Distributors.Beginning in January 2014, we concluded that we had developed sufficient history such that we can reliably estimate returns and as a result, began torecognize revenue based on sales to our Distributors. Through December 31, 2014, product returns were de minimis. Timing of shipments to wholesalers, asused for revenue recognition, and timing of prescriptions as estimated by third party sources such as Symphony Health Solutions and IMS Health may differfrom period to period.During the years ended December 31, 2014 and 2013, our net product revenues included an adjustment for co-pay mitigation rebates provided by us tocommercially insured patients. Such rebates are intended to offset the differential for patients of Vascepa not covered by commercial insurers at the time oflaunch on Tier 2 for formulary purposes, resulting in higher co-pay amounts for such patients. Our cost for these co-payment mitigation rebates was up to $75per prescription filled prior to February 20, 2014 and up to $70 per prescription filled after February 20, 2014 to December 31, 2014. Commencing in Marchand April 2013, certain third-party payors added Vascepa to their Tier 2 coverage, which results in lower co-payments for patients covered by these third-party payors. As of February 1, 2015, approximately 125 million lives covered by medical insurance were under insurance plans that have added Vascepa totheir Tier 2 coverage. In connection with the start of such Tier 2 coverage, we have agreed to pay customary rebates to these third-party payors on the resaleof Vascepa to patients covered by these third-party payors.As is typical for the pharmaceutical industry, the majority of Vascepa sales are to major commercial wholesalers which then resell Vascepa to retailpharmacies. As of February 1, 2015, over 26,000 clinicians had written prescriptions for Vascepa. As of February 1, 2015, we are not aware of any clinicianwho is responsible for 10% or more of the aggregate prescriptions written for Vascepa.On October 22, 2013, in an effort to lower operating expenses following the recommendation of the advisory committee to the FDA, we implemented aworldwide reduction in force including a reduction of approximately fifty percent of our sales representatives. Following the reduction in force, we retainedapproximately 130 sales representatives in the United States in sales territories which have demonstrated what we believe is the greatest potential for Vascepasales growth. This team will cover the target base of physicians responsible for the majority of Vascepa prescription volume and growth since its launch inearly 2013. With these changes and resulting target base coverage, as well as the addition of the promotional efforts of 250 sales representatives from KowaPharmaceuticals America, Inc. that began in May 2014, we anticipate continued Vascepa revenue growth over time. We further anticipate that such revenuegrowth may be inconsistent from period to period.Cost of Goods Sold. Cost of goods sold during the year ended December 31, 2014 was $20.5 million, versus $11.9 million during the prior year period,an increase of $8.6 million, or 72%. Cost of goods sold includes the cost of API for Vascepa on which revenue was recognized during the period, as well asthe associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost ofgoods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of Vascepa API, as well as a portion ofAPI carried at zero cost for material which was purchased prior to FDA approval of Vascepa on July 26, 2012 or was purchased prior to the sNDA approval ofour suppliers.The API included in the calculation of the average cost of goods sold during the years ended December 31, 2014 and 2013 was sourced from two APIsuppliers. The contracted cost of supply from our initial API supplier was higher than the contracted cost from our other API supplier. In the future, weanticipate making continued purchases from this initial supplier and to make additional lower unit cost purchases of Vascepa API from other API suppliers.We began purchasing lower unit cost API from Chemport, which was approved by the FDA in April 2013 to produce Vascepa, in the second quarter of 2013.During the years ended December 31, 2014 and 70Table of Contents2013, the cost basis of product sold that had a carrying value of zero was $0.6 million and $4.0 million, respectively. Had such inventories been valued atacquisition cost, it would have resulted in a corresponding increase in cost of goods sold and a decrease in gross margin during such periods. As ofDecember 31, 2014, we maintained no inventory with a carrying value of zero and we classified all of our inventory as current. As a result of lower inventorybalances on hand at the end of 2014 compared to the end of 2013 as well as anticipated increases in revenue during 2015 compared to 2014, we anticipatepurchasing more API during 2015 than in 2014 with the amount of such purchases dependent on the rate of our revenue growth.Our gross margin for the years ended December 31, 2014 and 2013 was 62% and 55%, respectively. This improvement was primarily driven by lowerunit cost API purchases. In addition, over time we expect continued lower average unit cost purchases of API. We also expect that API costs will be lower inthe future due to advantages derived from the mix of our suppliers. The average cost may be variable from period to period depending upon the timing andquantity of API purchased from each supplier.Selling, General and Administrative Expense. Selling, general and administrative expense for the year ended December 31, 2014 was $79.3 million,versus $123.8 million in the prior year, a decrease of $44.5 million, or 36%. Selling, general and administrative expenses for the years ended December 31,2014 and 2013 are summarized in the table below (in thousands): Year EndedDecember 31, 2014 2013 Selling, general and administrative expense (1) $73,528 $113,100 Non-cash stock based compensation expense (2) 6,321 11,848 Non-cash warrant related compensation income (3) (503) (3,703) Severance (4) — 2,550 Total selling, general and administrative expense $79,346 $123,795 (1)Selling, general and administrative expense, excluding non-cash compensation charges for stock compensation and warrants, for the year endedDecember 31, 2014 was $73.5 million, versus $113.1 million in the prior year, a decrease of $39.6 million, or 35%. The decrease is due primarily tocost decreases in 2014 for sales force staffing, marketing program spending and costs for other general and administrative support incurred inconnection with the commercialization of Vascepa. Included in this amount for the year ended 2014 is $1.7 million of expense for co-promotion feespayable to Kowa Pharmaceuticals America, Inc. The year ended December 31, 2013 was the period in which we commenced selling Vascepa and assuch included certain launch-related costs.(2)Stock-based compensation expense for the year ended December 31, 2014 was $6.3 million, versus $11.8 million in the prior year period, a decrease of$5.5 million, or 47%, primarily due to a decrease in the fair value of new stock option and restricted stock awards granted to attract and retain qualifiedemployees as a result of a decrease in our stock price.(3)Warrant-related compensation income for the years ended December 31, 2014 and 2013 was $0.5 million and $3.7 million, respectively. Warrant-related compensation income reflects the non-cash change in fair value of the warrant derivative liability associated with warrants issued in October2009 to three of our former employees, net of warrants exercised. The decrease in fair value in 2014 and 2013 was due primarily to a decrease in ourstock price during each period.(4)Severance costs in 2013 relate to cash expenditures for one-time termination benefits and associated costs incurred in conjunction with a company-wide reduction in force announced in October 2013.The reduction in the level of selling, general and administrative costs in 2014 as compared to 2013 was primarily the result of the reduction in forceannounced in October 2013 and reductions in certain marketing program spend and other overhead costs. Such cost reductions were partially offset by theincremental selling costs associated with the Kowa Pharmaceuticals America, Inc. co-promotion agreement. 71Table of ContentsWe currently anticipate that with our existing indication for Vascepa, our selling, general and administrative costs will be largely flat in future periodswith the exception of anticipated increases in the co-promotion fees earned by Kowa Pharmaceuticals America, Inc. based on anticipated increases in netproduct revenues and the terms of our co-promotion agreement with Kowa Pharmaceuticals America, Inc.Research and Development Expense. Research and development expense for the year ended December 31, 2014 was $50.3 million, versus $72.8million in the prior year period, a decrease of $22.5 million, or 31%. Research and development expenses for the years ended December 31, 2014 and 2013are summarized in the table below (in thousands): Year EndedDecember 31, 2014 2013 REDUCE-IT study (1) $37,672 $46,994 Pre-approval commercial supply (2) 373 5,819 Regulatory filing fees and expenses (3) 1,847 3,819 Internal staffing, overhead and other (4) 7,733 13,281 Research and development expense, excluding non-cash expense 47,625 69,913 Non-cash stock-based compensation (5) 2,701 2,837 Total research and development expense $50,326 $72,750 The decrease in research and development expenses for the year ended December 31, 2014, as compared to the prior year period, is primarily due to adecrease in costs associated with the REDUCE-IT study, a decrease in expenses associated with pre-commercial inventory supply, and a decrease in staffingand overhead costs, as further described below. (1)In December 2011, we announced commencement of patient dosing in our cardiovascular outcomes study of Vascepa, titled REDUCE-IT, which isdesigned to evaluate the efficacy of Vascepa in reducing major cardiovascular events in a high risk patient population on statin therapy. The studyduration is dependent on the rate of clinical events in the study, which rate may be affected by the number of patients enrolled in the study, theepidemiology of the patients enrolled in the study, and the length of time that the enrolled patients are followed. We manage the study through acontract research organization (CRO) through which all costs for this outcomes study are incurred with the exception of costs for clinical trial material(CTM) and costs for internal management. Our internal personnel are responsible for managing multiple projects and their costs are not specificallyallocated to REDUCE-IT or any other individual project. We currently have over 7,300 patients enrolled in REDUCE-IT. We estimate that we willcomplete patient enrollment in this study within 2015. For 2014 and 2013, we incurred expenses through our CRO in connection with this trial ofapproximately $31.0 million and $38.4 million, respectively. Inclusive of CTM costs, the combined CRO and CTM costs in 2014 and 2013 forREDUCE-IT were approximately $37.7 million and $47.0 million, respectively. The reduction in expenses in 2014 as compared to 2013 is primarilythe result of timing variability for REDUCE-IT costs as well as some efficiency savings as the trial is fully operational in 2014 across all countries andclinical sites. We expense costs for CTM upon receipt. The aggregate cost of this outcomes study will depend on the rate of clinical events in the study.We currently estimate that costs incurred for this study in 2015 will continue at approximately the same levels as we have incurred in 2014 but mayvary from quarter to quarter. Based on our current assumptions of CRO and CTM costs, we estimate that aggregate remaining costs to complete theREDUCE-IT study and evaluate its results to likely exceed $100 million through study completion in 2017 and publication of results in 2018. Ouraggregate remaining costs to complete the REDUCE-IT are estimated to be lower than $100 million if the independent DMC recommends thatREDUCE-IT be completed early based on its scheduled interim review of the efficacy and safety results of the study which review we estimate willoccur in 2016 upon reaching 60% of the target aggregate number of cardiovascular events for the study. Amarin remains blinded to all data from thestudy and currently expects the study to be completed in 2017. We anticipate that our costs for this outcomes study will continue to represent the mostsignificant component of our research and development expenditures. 72Table of Contents(2)Until an API supplier is approved by the FDA to manufacture commercial supply of Vascepa, all Vascepa purchased from such supplier is included as acomponent of research and development expense. Upon approval of the supplier, we capitalize subsequent Vascepa API purchases from such supplieras inventory. Purchases of Vascepa API received and expensed before such regulatory approvals are not subsequently capitalized, and all suchpurchases are quarantined and not used for commercial supply until such time as the supplier that produced the API is approved. The commercialsupply expense for the periods shown above represents inventory received from Nisshin prior to NDA approval of Vascepa on July 26, 2012 or receivedfrom our other suppliers prior to their sNDA approvals. The amount of commercial supply that we receive from potential additional API suppliers priorto sNDA approval depends upon production schedules at such suppliers and the timing of regulatory approval, and we are unable to estimate theseamounts at this time. We will continue to expense inventory received from the unapproved supplier until such time as FDA approval is obtained.(3)The regulatory filing fees in each of the years ended December 31, 2014 and 2013 included annual FDA fees for maintaining manufacturing sites. Inaddition, during the year ended December 31, 2013, these fees included regulatory filings associated with the sNDA for the ANCHOR indication aswell as costs associated with preparing for the October 16, 2013 FDA advisory committee meeting.(4)Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research,development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated tospecific projects. Also included are costs related to qualifying suppliers and legal costs. The reduction in the level of such costs in 2014 as compared to2013 is largely the result of decisions announced in October 2013 to reduce headcount and suspend AMR102 development. Other research anddevelopment costs in 2013 included costs related to testing of the relative bioavailability of AMR102 capsules, Vascepa capsules with a selected statintaken concomitantly. We have suspended further development of AMR102 pending resolution of the ANCHOR sNDA with the FDA.(5)Non-cash stock-based compensation expense represents the costs associated with equity awards issued to internal staff supporting our research anddevelopment and regulatory functions.We anticipate that our research and development costs will be slightly higher during 2015 as compared to 2014 as a result of the timing of REDUCE-ITcosts, and that such costs will decline modestly thereafter upon completion of enrollment for REDUCE-IT.Gain (Loss) on Change in Fair Value of Derivative Liabilities. Gain (loss) on change in fair value of derivative liabilities for the year endedDecember 31, 2014 was a gain of $13.5 million versus a gain of $47.7 million in the prior year period. Gain (loss) on change in fair value of derivativeliabilities is comprised of (i) the change in fair value of the warrant derivative liability, (ii) the change in fair value of the derivative liability related to thechange in control provision associated with the December 2012 BioPharma financing, and (iii) the change in fair value of the derivative liability related tothe change in control provision associated with the May 2014 exchangeable senior notes.The warrant derivative liability is related to the change in fair value of warrants issued in conjunction with the October 2009 private placement. InOctober 2009 we issued 36.1 million warrants at an exercise price of $1.50 and recorded a $48.3 million warrant derivative liability, representing the fairvalue of the warrants issued. As these warrants have been classified as a derivative liability, they are revalued at each reporting period, with changes in fairvalue recognized in the statement of operations. The fair value of the warrant derivative liability at December 31, 2014 was $0.1 million and we recognized a$6.3 million gain on change in fair value of derivative liability for the year ended December 31, 2014 for these warrants. The fair value of the warrantderivative liability at December 31, 2013 was $6.9 million and we recognized a $44.2 million gain on change in fair value of derivative liability for the yearended December 31, 2013. The change in fair value of the warrant derivative liability is due primarily to the change in the price of our common stock on thedate of valuation. In October 2014, we and the holders of the remaining October 2009 warrants mutually agreed to extend the expiration date of such warrantsfrom October 16, 2014 to February 27, 2015. 73Table of ContentsOur December 2012 financing agreement with BioPharma contains a redemption feature whereby, upon a change of control, we would be required topay $140 million, less any previously repaid amount, if the change of control occurs on or before December 31, 2013, or required to repay $150 million, lessany previously repaid amount, if the change of control event occurs after December 31, 2013. The fair value of the derivative liability is recalculated at eachreporting period using a probability-weighted model incorporating management estimates for potential change in control, and by determining the fair valueof the debt with and without the change in control provision included. The difference between the two fair values of the debt was determined to be the fairvalue of the embedded derivative. At December 31, 2014, the fair value of the derivative was determined to be $4.8 million, and at December 31, 2013, thefair value of the derivative was determined to be $11.1 million. We recognized a gain on change in fair value of derivative liability of $6.3 million and $3.5million for the years ended December 31, 2014 and 2013, respectively.Our 2014 Notes contain a redemption feature whereby, upon occurrence of a change in control, we would be required to repurchase the notes. The fairvalue of the embedded derivative was calculated using a probability-weighted model incorporating management estimates of the probability of a change incontrol occurring, and by determining the fair value of the debt with and without the change in control provision included. The difference between the twowas determined to be the fair value of the embedded derivative. At December 31, 2014, the fair value of the derivative was determined to be $2.6 million andwe recognized a $0.9 million gain on change in fair value of derivative liability for the year ended December 31, 2014.Any changes in the assumptions used to value the derivative liabilities could result in a material change to the carrying value of such liabilities.Gain on Extinguishment of Debt. On May 15, 2014, we entered into separate, privately negotiated exchange agreements with certain holders of ourexchangeable senior notes pursuant to which we exchanged $118.7 million in aggregate principal amount of existing exchangeable senior notes for $118.7million in aggregate principal amount of new 3.50% exchangeable senior notes due 2032. The key changes in the terms of the new notes included movingthe first put date from January 2017 to January 2019, adding an issuer conversion option whereby we can opt to convert the notes into equity should theDaily VWAP (as defined in the Indenture) exceed $2.86 for a certain number of days and reducing the conversion price (see Note 8 to our consolidatedfinancial statements included in this Annual Report on Form 10-K). As a result of the exchange, we assessed the value of the notes immediately prior to theexchange and immediately after the exchange and determined that the exchange resulted in a substantial modification of the terms of the notes resulting inan extinguishment of the original notes. We subsequently recorded a gain on extinguishment of the original notes of $38.0 million in the year endedDecember 31, 2014. 74Table of ContentsInterest Expense, net. Net interest expense for the year ended December 31, 2014 was $18.5 million, versus $33.8 million in the prior year period, adecrease of $15.3 million, or 45%. Net interest expense for the years ended December 31, 2014 and 2013 is summarized in the table below (in thousands): Year EndedDecember 31, 2014 2013 Exchangeable senior notes (1): Amortization of debt discounts $4,221 $15,067 Contractual coupon interest 5,250 5,250 Total exchangeable senior notes interest expense 9,471 20,317 Long-term debt—BioPharma financing (2): Cash interest—current 5,420 1,843 Cash interest—deferred 1,783 9,451 Non-cash interest 1,900 2,565 Total long-term debt interest expense 9,103 13,859 Other interest expense 1 3 Total interest expense 18,575 34,179 Interest income (3) (96) (343) Total interest expense, net $18,479 $33,836 (1)Cash and non-cash interest expense related to the exchangeable senior notes for the years ended December 31, 2014 and 2013 was $9.5 million and$20.3 million, respectively.(2)Cash and non-cash interest expenses related to the BioPharma financing for the year ended December 31, 2014 were $9.1 million and $13.9 million,respectively. These amounts reflect the assumption that our Vascepa revenue levels will not be high enough to support repayment to BioPharma inaccordance with the repayment schedule without the optional reduction which is allowed to be elected by us if the threshold revenue levels are notachieved. To date, our revenues have been below the contractual threshold amount each quarter such that each payment reflects the calculated optionalreduction amount as opposed to the contractual threshold payments for each quarterly period.(3)Interest income for the year ended December 31, 2014 was $0.1 million, versus $0.3 million in the prior year period. Interest income represents incomeearned on cash balances.Other Income (Expense), net. Other income (expense), net, for the year ended December 31, 2014 was income of $3.7 million versus an expense of $1.2million in the prior year. Other income (expense), net, in the year ended December 31, 2014 primarily consists of $4.1 million received in the second quarterof 2014 with respect to settlement agreements with one of our suppliers and one of our encapsulators that provided for the reimbursement of certain amountspreviously paid by us. Other income (expense), net, for the year ended December 31, 2013 primarily consisted of losses and gains on foreign exchangetransactions, including realized gains and losses on foreign exchange forward contracts. We periodically use foreign exchange forward contracts to hedgeagainst changes in exchange rates for inventory purchases denominated in foreign currency.Benefit From (Provision for) Income Taxes. Benefit from (provision for) income taxes for the year ended December 31, 2014 was a $2.8 million benefitversus a $3.2 million benefit in the prior year. The current benefit relates entirely to the United States subsidiary operations. We are profitable in the UnitedStates as a result of intercompany transactions between our United States subsidiary and our other companies. The 2013 benefit primarily relates to tax creditsfor research and development activities.Comparison of Fiscal Years Ended December 31, 2013 versus December 31, 2012Product Revenues, net. We recorded revenue of $26.4 million during the year ended December 31, 2013. We commenced our full commercial launch ofVascepa in the United States for use in the MARINE indication in 75Table of ContentsJanuary 2013. We recorded no revenue in 2012. All of our revenue in the year ended December 31, 2013 was derived from product sales of Vascepa, net ofallowances, discounts, incentives, rebates, chargebacks and returns.We sell Vascepa to Distributors. In accordance with our revenue recognition policy, until we have more experience with the sale of Vascepa and canbetter estimate product returns, we currently recognize revenue only for product which has been used for of the purpose of filling prescriptions. The excess ofthe amount billed and the amount recognized as revenue for the year ended December 31, 2013, net of applicable discounts and rebates, has been recorded asdeferred revenue.During the year ended December 31, 2013, our net product revenues included an adjustment for co-pay mitigation rebates provided by us tocommercially insured patients. Such rebates are intended to offset the differential for patients of Vascepa not covered by commercial insurers at the time oflaunch on Tier 2 for formulary purposes, resulting in higher co-pay amounts for such patients. Our cost for these co-payment mitigation rebates is up to $75per prescription filled during 2013. Commencing in March and April 2013, certain third-party payors added Vascepa to their Tier 2 coverage, which results inlower co-payments for patients covered by these third-party payors. As of February 1, 2014, approximately 100 million lives covered by medical insurancewere under insurance plans that have added Vascepa to their Tier 2 coverage. In connection with the start of such Tier 2 coverage, we have agreed to paycustomary rebates to these third-party payors on the resale of Vascepa to patients covered by these third-party payors.As is typical for the pharmaceutical industry, the majority of Vascepa sales are to major commercial wholesalers which then resell Vascepa to retailpharmacies. As of February 1, 2014, over 16,000 clinicians had written prescriptions for Vascepa. As of February 1, 2014, we are not aware of any clinicianwho is responsible for 10% or more of the aggregate prescriptions written for Vascepa.On October 22, 2013, in an effort to reduce operating expenses following the recommendation of the advisory committee to the FDA, we implementeda worldwide reduction in force including a reduction of approximately fifty percent of our sales representatives. Following the reduction in force, we retainedapproximately 130 sales representatives in the United States in sales territories which have demonstrated what we believe is the greatest potential for Vascepasales growth. This team will cover the target base of physicians responsible for the majority of Vascepa prescription volume and growth since its launch inearly 2013. With these changes and resulting target base coverage, we anticipate continued Vascepa revenue growth over time. We further anticipate thatsuch revenue growth may be inconsistent from period to period.Cost of Goods Sold. Cost of goods sold during the year ended December 31, 2013 was $11.9 million, and includes the cost of API for Vascepa onwhich revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance andquality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects theactual purchase price of Vascepa API, as well as a portion of API carried at zero cost for material which was purchased prior to FDA approval of Vascepa onJuly 26, 2012 or was purchased prior to the sNDA approval of our suppliers.The majority of API included in the calculation of the average cost of goods sold during the year ended December 31, 2013 was sourced from one APIsupplier. The contracted cost of supply from this API supplier for initial purchase volumes is higher than the contracted cost from our other API suppliers.Contracted purchase costs from this initial API supplier reflect that they were working with Amarin prior to commencement of the MARINE and ANCHORclinical trials and are anticipated to decline as additional API volume is purchased. In the future, we anticipate making continued purchases from this initialsupplier at substantially lower unit pricing than the pricing of the initial purchases from this supplier and to make additional lower unit cost purchases ofVascepa API from other API suppliers. We began purchasing lower unit cost API from Chemport, which was approved by the FDA in April 2013 to produceVascepa, in the three months ended June 30, 2013. During the year ended December 31, 2013, the cost basis of product sold that had a carrying value of zerowas 76Table of Contentsapproximately $4.0 million. Had such inventories been valued at acquisition cost, it would have resulted in an increase in cost of goods sold and a decreasein gross margin during such periods. We expect current inventories with a carrying value of zero to be utilized in 2014. We may have additional zero costinventories in the future to the extent that we receive approval of the sNDA for our fourth commercial supplier. As of December 31, 2013, we maintainedinventory with a carrying value of zero and an acquisition cost of approximately $0.6 million, which has an estimated net realizable value of $2.6 millionbased on our average net selling price for the year ended December 31, 2013.Our gross margin improved during each quarter for the year ended December 31, 2013. This improvement was primarily driven by lower unit cost APIpurchases made during 2013. The gross margin for the year ended December 31, 2013 was 55%. In addition to expected continued lower average unit costpurchases of API, we also expect that API costs will be lower in the future due to recent improvements in foreign currency exchange rates and potentialadvantages derived from the geographical mix of our suppliers. We recorded no cost of goods sold in 2012.Selling, General and Administrative Expense. Selling, general and administrative expense for the year ended December 31, 2013 was $123.8 million,versus $57.8 million in the prior year, an increase of $66.0 million, or 114.2%. Selling, general and administrative expenses for the years ended December 31,2013 and 2012 are summarized in the table below (in thousands): Year EndedDecember 31, 2013 2012 Selling, general and administrative expense (1) $113,100 $43,172 Non-cash stock based compensation expense (2) 11,848 14,375 Non-cash warrant related compensation (income) expense (3) (3,703) 247 Severance (4) 2,550 — Total selling, general and administrative expense $123,795 $57,794 (1)Selling, general and administrative expense, excluding non-cash charges for stock and warrant compensation, for the year ended December 31, 2013was $113.1 million, versus $43.2 million in the prior year, an increase of $69.9 million, or 161.8%. The increase was primarily due to cost increases in2013 for sales force staffing, an increase in marketing program spending and increased general and administrative costs incurred in connection with theinitial commercialization of Vascepa.(2)Non-cash stock based compensation expense for the year ended December 31, 2013 was $11.8 million, versus $14.4 million in the prior year period, adecrease of $2.6 million, due primarily to a decrease in the number of awards outstanding as a result of the company-wide reduction in force announcedin October 2013.(3)Non-cash warrant related compensation (income) expense for the year ended December 31, 2013 was $3.7 million of income, versus $0.2 million ofexpense in the prior year. Warrant related compensation income (expense) reflects the non-cash change in fair value of the warrant derivative liabilityassociated with warrants issued in October 2009 to three former officers of Amarin, net of warrants exercised. The change in fair value in 2013 and 2012was due primarily to the change in our stock price during each period. The value of this warrant derivative liability may increase or decrease fromperiod to period based upon changes in the price of our common stock. Such non-cash changes in valuation could be significant as the history of ourstock price has been volatile. The gain or loss resulting from such non-cash changes in valuation could have a material impact on our reported netincome or loss from period to period. In particular, if the price of our stock increases, the change in valuation of this warrant derivative liability willadd to our history of operating losses.(4)Severance costs in 2013 relate to cash expenditures for one-time termination benefits and associated costs incurred in conjunction with a company-wide reduction in force announced in October 2013. 77Table of ContentsSelling, general and administrative costs in 2013 have increased over 2012 levels as we continue to support the commercialization of Vascepa,including costs for market research, sales force staffing and support costs and investments in infrastructure.Research and Development Expense. Research and development expense for the year ended December 31, 2013 was $72.8 million, versus $59.0million in the prior year period, an increase of $13.8 million, or 23.4%. Research and development expenses for the years ended December 31, 2013 and 2012are summarized in the table below (in thousands): Year EndedDecember 31, 2013 2012 REDUCE-IT study (1) $46,994 $25,563 Other clinical trial programs (2) 1,518 606 Pre-approval commercial supply (3) 5,819 16,141 Regulatory filing fees and expenses (4) 3,819 (256) Internal staffing, overhead and other (5) 11,763 13,202 Research and development expense, excluding non-cash expense 69,913 55,256 Non-cash stock-based compensation (6) 2,837 3,700 Total research and development expense $72,750 $58,956 The increase in research and development expenses for the year ended December 31, 2013, as compared to the prior year period, is primarily due to anincrease in costs associated with the REDUCE-IT study as further described below. (1)In December 2011, we announced commencement of patient dosing in our cardiovascular outcomes study of Vascepa, titled REDUCE-IT, which isdesigned to evaluate the efficacy of Vascepa in reducing major cardiovascular events in a high risk patient population on statin therapy. The studyduration is dependent on the rate of clinical events in the study, which rate may be affected by the number of patients enrolled in the study, theepidemiology of the patients enrolled in the study, and the length of time that the enrolled patients are followed. We manage the study through acontract research organization (CRO) through which all costs for this outcomes study are incurred with the exception of costs for clinical trial material(CTM) and costs for internal management. Our internal personnel are responsible for managing multiple projects and their costs are not specificallyallocated to REDUCE-IT or any other individual project. For 2013, we incurred expenses through our CRO in connection with this trial ofapproximately $38.4 million. Inclusive of CTM costs, the combined CRO and CTM costs in 2013 for REDUCE-IT were approximately $47.0 million.We expense costs for CTM upon receipt.(2)In 2012 and 2013, other clinical trial programs consisted of fixed-dose combination studies. In December 2012, we completed dosing andpharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa capsules and a leading statin which we refer to as AMR102. InAugust 2013, we completed dosing in a randomized, open-label, single-dose, 4-way cross-over study to continue testing of the relative bioavailabilityof AMR102 capsules, Vascepa capsules with a selected statin taken concomitantly, Vascepa taken alone and the selected statin taken alone. The resultsof this study support the feasibility of AMR102. We have suspended additional development of AMR102 pending resolution of the ANCHOR sNDAwith the FDA.(3)Until an API supplier is approved by the FDA to manufacture commercial supply of Vascepa, all Vascepa purchased from such supplier is included as acomponent of research and development expense. Upon approval of the supplier, we capitalize subsequent Vascepa API purchases from such supplieras inventory. Purchases of Vascepa API received and expensed before such regulatory approvals are not subsequently capitalized, and all suchpurchases are quarantined and not used for commercial supply until such time as the supplier that produced the API is approved. The commercialsupply expense for the periods shown 78Table of Contents above represents inventory received from Nisshin prior to NDA approval of Vascepa on July 26, 2012 or received from our other suppliers prior to theirsNDA approvals. In April 2013, sNDAs were approved for two of our additional suppliers, BASF and Chemport. A sNDA was submitted in August 2013for Novasep as part of the Slanmhor consortium. The amount of commercial supply that we receive from Novasep prior to sNDA approval dependsupon production schedules at Novasep and the timing of regulatory approval, and we are unable to estimate these amounts at this time. We willcontinue to expense inventory received from the unapproved supplier until such time as FDA approval is obtained. Additionally, during the yearended December 31, 2013, we wrote off $1.8 million related to product that is not recoverable. This product is from a supplier from which no supplyhas yet been released for commercial use.(4)The regulatory filing fees primarily represent costs incurred in connection with regulatory filings associated with requests for regulatory approvals,such as the sNDA for the ANCHOR indication and annual FDA fees for maintaining manufacturing sites. In the year ended December 31, 2013, suchfees also include costs associated with preparing for the October 16, 2013 FDA advisory committee meeting. In the year ended December 31, 2012, theregulatory filing fees balance included a credit representing the reimbursement of $1.5 million in fees by the FDA related to the NDA filing forVascepa.(5)Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research,development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated tospecific projects. Such costs also include costs related to qualifying suppliers and legal costs. We anticipate a reduction in such costs in 2014compared to 2013 levels as a result of a company-wide reduction in force announced in October 2013. As a result of the reduction in force, we incurredapproximately $0.2 million in severance expenses in 2013.(6)Non-cash stock-based compensation expense represents the costs associated with equity awards issued to internal staff supporting our research anddevelopment and regulatory functions.Gain (Loss) on Change in Fair Value of Derivative Liabilities. Gain (loss) on change in fair value of derivative liabilities for the year ended December,2013 was a gain of $47.7 million versus a loss of $35.3 million in the prior year period. Gain (loss) on change in fair value of derivative liabilities iscomprised of the change in fair value of the warrant derivative liability and the change in fair value of the derivative liability related to the change in controlprovision associated with the December 2012 BioPharma financing.The warrant derivative liability is related to the change in fair value of warrants issued in conjunction with the October 2009 private placement. InOctober 2009 we issued 36.1 million warrants at an exercise price of $1.50 and recorded a $48.3 million warrant derivative liability, representing the fairvalue of the warrants issued. As these warrants have been classified as a derivative liability, they are revalued at each reporting period, with changes in fairvalue recognized in the statement of operations. The fair value of the warrant derivative liability at December 31, 2013 was $6.9 million and we recognized a$44.2 million gain on change in fair value of derivative liability for the year ended December 31, 2013 for these warrants. The fair value of the warrantderivative liability at December 31, 2012 was $54.9 million and we recognized a $35.4 million loss on change in fair value of derivative liability for the yearended December 31, 2012. The change in fair value of the warrant derivative liability is due primarily to the change in the price of our common stock on thedate of valuation.Our December 2012 financing agreement with BioPharma contains a redemption feature whereby, upon a change of control, we would be required topay $140 million, less any previously repaid amount, if the change of control occurs on or before December 31, 2013, or required to repay $150 million, lessany previously repaid amount, if the change of control event occurs after December 31, 2013. The fair value of the derivative liability is recalculated at eachreporting period using a probability-weighted model incorporating management estimates for potential change in control, and by determining the fair valueof the debt with and without the change in control provision included. The difference between the two fair values of the debt was determined to be the fairvalue of the embedded derivative. At December 31, 2013, the fair value of the derivative was determined to be $11.1 million, and at December 31, 2012, thefair value of the derivative was determined to be $14.6 million. We recognized a gain on change in fair value of derivative liability of $3.5 million and $0.02million for the years ended December 31, 2013 and 2012, respectively. 79Table of ContentsInterest Expense, net. Net interest expense for the year ended December 31, 2013 was $33.8 million, versus $17.5 million in the prior year period, anincrease of $16.3 million, or 93.1%. Net interest expense for the years ended December 31, 2013 and 2012 is summarized in the table below (in thousands): Year EndedDecember 31, 2013 2012 Exchangeable senior notes: Amortization of debt discount created upon allocation of proceeds to the conversion option $12,546 $10,686 Contractual coupon interest 5,250 5,119 Amortization of the discount from the underwriter’s discounts and offering costs 2,521 2,147 Total Exchangeable senior notes interest expense 20,317 17,952 Long-term debt—BioPharma financing (1): Cash interest—current 1,843 114 Cash interest—deferred 9,451 — Non-cash interest 2,565 23 Total long-term debt interest expense 13,859 137 Other interest expense 3 2 Total interest expense 34,179 18,091 Interest income (2) (343) (544) Total interest expense, net $33,836 $17,547 (1)Cash and non-cash interest expenses related to the BioPharma financing for the year ended December 31, 2013 were $11.3 million and $2.6 million,respectively. These amounts reflect the assumption that our Vascepa revenue levels will not be high enough to support repayment to BioPharma inaccordance with the repayment schedule without the optional reduction which is allowed to be elected by us if the threshold revenue levels are notachieved. For the three months ended September 30, 2013 and December 31, 2013, our revenues were below the contractual threshold amount suchthat we made a cash payment of $0.8 million in November 2013 based on $8.4 million in revenue recognized in the third quarter of 2013 and we willmake a cash payment of $1.0 million in February 2014 based on $10.1 million in revenue recognized in the fourth quarter of 2013, reflecting thecalculated optional reduction amount as opposed to the contractual threshold payments of $2.5 million for each quarterly period.(2)Interest income for the year ended December 31, 2013 was $0.3 million, versus $0.5 million in the prior year period, a decrease of $0.2 million, or40.0%. Interest income represents income earned on cash balances.Other Income (Expense), net. Other income (expense), net for the year ended December 31, 2013 was a $1.2 million expense versus a $0.4 millionexpense in the prior year. Other income (expense), net primarily consists of losses and gains on foreign exchange transactions, including realized gains andlosses on foreign exchange forward contracts. We use foreign exchange forward contracts to hedge against changes in exchange rates for inventory purchasesdenominated in foreign currency. The unrealized gains and losses on such contracts are recorded within gain (loss) on change in fair value of derivativeliability. As of December 31, 2013, all such contracts had been settled. For the year ended December 31, 2013, we recognized a realized loss of $1.1 millionrelated to the settlement of the foreign exchange forward contracts, which was included as a component of other income (expense), net. There were no foreignexchange forward contracts outstanding in 2012. Other income (expense) for the year ended December 31, 2012 was a net expense of $0.4 million.Benefit from (Provision for) Income Taxes. Benefit from (provision for) income taxes for the year ended December 31, 2013 was a $3.2 million benefitversus a $9.1 million provision in the prior year. The current benefit relates entirely to our United States subsidiary operations. We are profitable in theUnited States as a 80Table of Contentsresult of intercompany transactions between our United States subsidiary and our other companies. The 2013 benefit primarily relates to tax credits forresearch and development activities. The 2012 provision for income taxes primarily relates to the exercise of stock options of which the excess benefitsrelated to the option exercises are recorded to additional-paid-in capital.Liquidity and Capital ResourcesOur sources of liquidity as of December 31, 2014 include cash and cash equivalents of $119.5 million. Our projected uses of cash includecommercialization of Vascepa for the MARINE indication, the continued funding of the REDUCE-IT cardiovascular outcomes study, working capital andother general corporate activities. Our cash flows from operating, investing and financing activities, as reflected in the consolidated statements of cash flows,are summarized in the following table (in millions): Years Ended December 31, 2014 2013 2012 Cash (used in) provided by: Operating activities $(72.3) $(190.3) $(122.3) Investing activities — — (14.3) Financing activities 0.3 121.6 280.2 (Decrease) increase in cash and cash equivalents $(72.0) $(68.7) $143.6 On December 6, 2012 we entered into a financing agreement with BioPharma. Under this agreement, we granted to BioPharma a security interest infuture receivables and all related rights to Vascepa, in exchange for $100 million received at the closing of the agreement which closing occurred inDecember 2012. We have agreed to repay BioPharma up to $150 million of future revenue and receivables. As of December 31, 2014, the net remainingamount to be repaid to BioPharma is $144.4 million. To date, our revenues have been below the contractual threshold amount such that each payment madehas reflected the calculated optional reduction amount as opposed to the contractual threshold payments for each quarterly period. The maximum amountpayable under the contractual threshold for 2015 is $31.6 million. The quarterly repayments through December 31, 2014 represented interest only. Inaccordance with the agreement with BioPharma, quarterly differences between the calculated optional reduction amounts and the repayment scheduleamounts are rescheduled for payment beginning in the second quarter of 2017. Any such deferred payments will remain subject to continued application ofthe quarterly ceiling in amounts due established by the calculated threshold based on quarterly Vascepa revenues. No additional interest expense or liabilityis incurred as a result of such deferred repayments. The agreement does not expire until $150 million in aggregate has been repaid. We can prepay an amountequal to $150 million less any previously repaid amount. We currently estimate that Vascepa revenue levels will not be high enough in each quarter tosupport repayment to BioPharma in accordance with threshold amounts in the repayment schedule.On January 9, 2012, Amarin, through our wholly-owned subsidiary Corsicanto Limited, or Corsicanto, a private limited company incorporated underthe laws of Ireland, completed a private placement of $150.0 million in aggregate principal amount of its 3.5% exchangeable senior notes due 2032, or the2012 Notes. The proceeds we received from the January 2012 debt offering were approximately $144.3 million, net of fees and transaction costs. On May 20,2014, we entered into separate, privately negotiated exchange agreements with certain holders of the 2012 Notes pursuant to which Corsicanto exchanged$118.7 million in aggregate principal amount of the 2012 Notes for $118.7 million in aggregate principal amount of new 3.50% May 2014 ExchangeableSenior Notes due 2032, or the 2014 Notes, following which $31.3 million in aggregate principal amount of the 2012 Notes remain outstanding with termsunchanged.The 2012 Notes were issued pursuant to an indenture dated as of January 9, 2012, by and among Corsicanto, us as guarantor, and Wells Fargo Bank,National Association, as trustee. The notes are the senior unsecured obligations of Corsicanto and are guaranteed by us. The 2012 Notes bear interest at a rateof 3.5% per annum, 81Table of Contentspayable semi-annually in arrears on January 15 and July 15 of each year, beginning on July 15, 2012. The notes mature on January 15, 2032, unless earlierrepurchased, redeemed or exchanged. On or after January 19, 2017, we may elect to redeem for cash all or a portion of the notes for the principal amount ofthe notes plus accrued and unpaid interest. On each of January 19, 2017, January 19, 2022 and January 19, 2027, the holders of the notes may require that werepurchase in cash the principal amount of the notes plus accrued and unpaid interest. At any time prior to January 15, 2032, upon certain circumstances,which circumstances include our issuing a notice of redemption to the note holders, the price of our shares trading above 130% of the exchange price, orcertain other events defined in the note agreement, the holders of the notes may elect to convert the notes. The exchange rate for conversion is 113.4752ADSs per $1,000 principal amount of the notes (equivalent to an initial exchange price of approximately $8.8125 per ADS), subject to adjustment in certaincircumstances, including adjustment if we pay cash dividends. Upon exchange, the notes may be settled, at our election, subject to certain conditions, incash, ADSs or a combination of cash and ADSs.The 2014 Notes were issued pursuant to an indenture dated May 20, 2014 by and among Corsicanto, us as grantor, and Wells Fargo Bank, NationalAssociation, as trustee. The notes are senior unsecured obligations of Corsicanto and are guaranteed by us. The 2014 Notes have a stated interest rate of3.5% per year, payable semiannually in arrears on January 15 and July 15 of each year beginning on July 15, 2014, and ending upon the Notes’ maturity onJanuary 15, 2032, unless earlier repurchased or redeemed by Corsicanto or exchanged by the holders. At any time after the issuance of the 2014 Notes andprior to the close of business on the second business day immediately preceding January 15, 2032, holders may exchange their 2014 Notes at their option. Ifprior to January 15, 2018, a make-whole fundamental change (as defined in the Indenture) occurs or we elect to redeem the 2014 Notes in connection withcertain changes in tax law, in each case as described in the Indenture, and a holder elects to exchange its 2014 Notes in connection with such make-wholefundamental change or election, as the case may be, such holder may be entitled to an increase in the exchange rate as described in the Indenture. The initialexchange rate is 384.6154 ADSs per $1,000 principal amount of the 2014 Notes (equivalent to an initial exchange price of approximately $2.60 per ADS, orthe Exchange Price), subject to adjustment in certain circumstances. The exchange rate is subject to adjustment from time to time upon the occurrence ofcertain events, including, but not limited to, the payment of cash dividends.As of December 31, 2014, we had cash and cash equivalents of $119.5 million, a decrease of $72.0 million from December 31, 2013. The decrease isprimarily due to net cash used in operating activities in support of the continued commercialization of Vascepa and the continued funding of REDUCE-ITless accounts receivable collections. Cash flows from financing activities in the year ended December 31, 2014 include a refund of $3.2 million for UK stampduty taxes paid in prior periods related to the issuance of common stock. We have incurred annual operating losses since our inception and, as a result, wehad an accumulated deficit of $970.2 million as of December 31, 2014. We believe that our cash and cash equivalents balance of $119.5 million atDecember 31, 2014 will be sufficient to fund our projected operations for at least the next twelve months. We anticipate that quarterly net cash outflows infuture periods will be variable and that net cash outflows in the first quarter of 2015 will be higher than the fourth quarter of 2014 as a result of the timing ofcertain items, including interest payments and supply purchases. 82Table of ContentsContractual ObligationsThe following table summarizes our contractual obligations at December 31, 2014 and the effects such obligations are expected to have on ourliquidity and cash flows in future periods (in millions):Payments Due by Period Total 2015 2016to 2017 2018to 2019 After 2019 Contractual Obligations: Purchase obligations (1) $55.5 $15.4 $27.3 $12.8 $— Operating lease obligations (2) 2.0 0.6 1.2 0.2 — Interest payment obligations—exchangeable debt (3) 21.5 5.3 10.0 6.2 — Total contractual cash obligations $79.0 $21.3 $38.5 $19.2 $— (1)We have agreements with API suppliers which include minimum purchase levels to enable us to maintain certain exclusivity with each respectivesupplier and certain agreements require any shortfall in such purchase levels to be paid in cash. The amounts in the table above reflect amountspotentially payable to our suppliers based on our minimum purchase obligations assuming such suppliers are qualified. Each supplier is required tomeet certain performance obligations and the agreements may be terminated by us in the event of non-performance.(2)Represents operating lease costs, primarily consisting of leases for facilities in Dublin, Ireland and Bedminster, NJ.(3)Represents scheduled interest payments due under the terms of the 2012 Notes and 2014 Notes, assuming that the 2012 Notes remain outstandingthrough January 19, 2017 and that the 2014 Notes remain outstanding through January 19, 2019 and they have not been exchanged for ADSs. Theabove table does not reflect the repayment of the $150.0 million notes as they may be exchanged for ADSs.On December 6, 2012, we entered into an agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma. Under this agreement,we granted to BioPharma a security interest in future receivables associated with the Vascepa patent rights, in exchange for $100 million received at theclosing of the agreement which occurred in December 2012. We agreed to repay BioPharma up to $150 million of future revenue and receivables. As ofDecember 31, 2014, the net remaining amount to be repaid to BioPharma is $144.4 million. To date, each payment made has reflected the calculated optionalreduction amount as opposed to the contractual threshold payments for each quarterly period. These quarterly payments are subject to a quarterly thresholdamount whereby, if a calculated threshold, based on quarterly Vascepa revenues, is not achieved, the quarterly payment payable in that quarter can at ourelection be reduced and with the reduction carried forward without interest for payment in a future period. There is no compounding of interest as part of thisagreement and, except in conjunction with a change of control, insolvency or default, no cliff payment is scheduled or otherwise due. Quarterly repayments,subject to the contractual threshold limitation, are scheduled to be paid in accordance with the following schedule: $10.0 million in the second quarter of2015 and in each of the next three quarters, $15.0 million per quarter in each of the next four quarters, and a final payment of $13.0 million scheduled forpayment in May 2017.We do not enter into financial instruments for trading or speculative purposes. At December 31, 2014, we had no outstanding forward exchangecontracts.In April 2013, we announced the approval by the FDA of the sNDAs covering two of our API suppliers, Chemport, Inc. and BASF (formerly EquateqLimited). In April 2014, we reached a settlement agreement with BASF under which we received a refund for material purchases of $3.0 million. TheChemport supply agreement provides access to additional API supply that is incremental to supply from Nisshin, our other existing FDA-approved APIsupplier. The Chemport agreement includes minimum annual purchase levels enabling us to maintain supply exclusivity. The Chemport agreement alsoincludes a provision that any shortfall in the 83Table of Contentsminimum purchase commitments is payable in cash, and the maximum amounts payable pursuant to this provision are reflected in the table above. The APIsupply agreement with BASF terminated in February 2014.The 2011 supply agreement with Chemport includes commitments for us to fund (i) certain development fees (ii) material purchases for initial rawmaterials, which amount will be credited against future API purchases and (iii) a raw material purchase commitment. During the year ended December 31,2014, we made payments of $6.7 million to Chemport. We have paid $3.1 million to BASF related to development and supply commitments throughDecember 31, 2014. We have paid $6.2 million to the Slanmhor consortium related to development and supply provisions through December 31, 2014 andduring the years ended December 31, 2014 and 2013, we made payments of $0.4 million and $6.1 million, respectively, related to stability and technicalbatches and advances on anticipated future API purchases.Concurrent with our supply agreement with Chemport entered into in 2011 for the supply of API materials for Vascepa, we agreed to make a non-controlling minority share equity investment in the supplier of up to $3.3 million. We invested $1.7 million under this agreement in July 2011 and theremaining $1.6 million during 2012. In September 2013, we entered into an equity sale and purchase agreement between this supplier and a third party inwhich we agreed to sell approximately $1.3 million of our investment in the supplier to the third party at cost. This transaction closed in the first quarter of2014. In August 2014, we entered into a second equity sale and purchase agreement between this supplier and another third party in which we agreed to sellapproximately $1.0 million of our remaining investment. This transaction closed in the fourth quarter of 2014. The remaining carrying amount of $0.2million and $3.3 million as of December 31, 2014 and 2013, respectively, is included in other long term assets and is accounted for under the cost method.Under the 2004 share repurchase agreement with Laxdale Limited, or Laxdale, upon approval of Vascepa by the FDA on July 26, 2012, we wererequired to make a milestone payment to Laxdale of £7.5 million. We made this payment in 2012 and capitalized this Laxdale milestone payment of $11.6million as a component of other long term assets. This long-term asset is being amortized over the estimated useful life of the intellectual property weacquired from Laxdale and we recognized amortization expense of $0.6 million during each of the years ended December 31, 2014 and 2013. Also under theLaxdale agreement, upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing AmarinNeuroscience intellectual property acquired from Laxdale in 2004), we must make an aggregate stock or cash payment to the former shareholders of Laxdale(at the sole option of each of the sellers) of £7.5 million (approximately $11.7 million at December 31, 2014). Additionally, upon receipt of a marketingapproval in the U.S. or Europe for a further indication of Vascepa (or further indication of any other product using Amarin Neuroscience intellectualproperty), we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $7.8 million atDecember 31, 2014) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $15.5 million at December 31, 2014).In addition to the obligations in the table above, we have recorded a liability of $0.4 million for uncertain tax positions that have been recorded inlong-term liabilities at December 31, 2014. We are not able to reasonably estimate in which future periods these amounts will ultimately be settled.Off-Balance Sheet ArrangementsWe do not have any special purpose entities or other off-balance sheet arrangements.Shelf Registration StatementOn March 29, 2014, the universal shelf registration statement on Form S-3 (Registration No. 333-173132) that we had filed with the SEC on March 29,2011, expired. On August 7, 2014, we filed with the SEC a new universal shelf registration statement on Form S-3, which provides for the offer, from time totime, of up to $300,000,000 of: ordinary shares, which may be represented by American Depositary Shares; preference shares, 84Table of Contentswhich may be represented by American Depositary Shares; senior or subordinated debt securities; warrants to purchase any of these securities; and anycombination of these securities, individually or as units. The addition of any newly issued equity securities into the market may be dilutive to existingstockholders and new issuances by us or sales by our selling security holders could have an adverse effect on the price of our securities. Item 7A.Quantitative and Qualitative Disclosures about Market RiskWe are exposed to market risks, which include changes in interest rates. We do not use derivative financial instruments in our investment portfolio, andprior to 2013 we entered into no foreign exchange contracts. Our investments meet high credit quality and diversification standards, as specified in ourinvestment policy. At December 31, 2014, we recorded as a liability the fair value of warrants to purchase 8.1 million shares of our common stock issued toinvestors. The fair value of this warrant derivative liability is determined using the Black-Scholes option valuation model and is therefore sensitive tochanges in the market price and volatility of our common stock among other factors. In the event of a hypothetical 10% increase in the market price of ourcommon shares ($1.08 based on the $0.98 market price of our stock at December 31, 2014) on which the December 31, 2014 valuation was based, the valueof the derivative liability would have increased by $0.1 million. Such increase would have been reflected as a loss on change in fair value of derivativeliability and increase in warrant compensation expense in our statement of operations.Foreign Currency Exchange Risk. Our results of operations and cash flows are subject to fluctuations due to changes in the Euro, Sterling and Yen. Themajority of cash and cash equivalents and the majority of our vendor relationships are denominated in U.S. dollars. We therefore believe that the risk of asignificant impact on our operating income from foreign currency fluctuations is not substantial. From time to time, we maintain a small amount of our cashand cash equivalents in Euro and Pound Sterling. We purchase supply from Nisshin in Japanese Yen. As our level of supply purchases from Nisshin increasedin 2013, we entered into short-term forward currency pricing contracts to lock-in the exchange rate on a portion of our anticipated purchases denominated inJapanese Yen. All such contracts were settled as of December 31, 2013 and there were no forward currency contracts executed in 2014.Interest Rate Risk. We believe that we are not exposed to significant interest rate risk through market value fluctuations of balance sheet items (i.e.,price risk) or through changes in interest income or expenses (i.e., re-financing or re-investment risk). Interest rate risk mainly arises through interest bearingliabilities and assets. We invest funds not needed for near-term operating expenses in diversified short-term investments, consisting primarily of investmentgrade securities. As of December 31, 2014, the fair value of our cash and cash equivalents maturing in one year or less was $119.5 million and represented100% of our cash, cash equivalents and investment portfolio. A hypothetical 50 basis point change in interest rates would not result in a material decrease orincrease in the fair value of our securities due to the general short-term nature of our investment portfolio. Item 8.Financial Statements and Supplementary DataOur consolidated financial statements are annexed to this report beginning on page F-1. Item 9.Changes in and Disagreements with Accountants on Accounting and Financial DisclosureNone. Item 9A.Controls and ProceduresEvaluation of Disclosure Controls and ProceduresWe maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file orsubmit under the Securities Exchange Act of 1934, as amended (the 85Table of Contents“Exchange Act”), is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated andcommunicated to our management, including our Principal Executive Officer and Principal Financial Officer, to allow timely decisions regarding requireddisclosure.As of December 31, 2014 (the “Evaluation Date”), our management, with the participation of our Principal Executive Officer and Principal FinancialOfficer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Ourmanagement recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achievingtheir objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. OurPrincipal Executive Officer and Principal Financial Officer have concluded based upon the evaluation described above that, as of the Evaluation Date, ourdisclosure controls and procedures were effective at the reasonable assurance level.Management’s Report on Internal Control over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting for our company. Internal controlover financial reporting is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act as a process designed by, or under the supervisionof, our Principal Executive Officer and Principal Financial Officer and effected by our board of directors, management, and other personnel to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance withgenerally accepted accounting principles and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of our assets; • provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance withgenerally accepted accounting principles; • provide reasonable assurance that our receipts and expenditures are being made only in accordance with authorization of our management anddirectors; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that couldhave a material effect on the financial statements.Because of inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation ofeffectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions or that the degree of compliancewith the policies or procedures may deteriorate.Our management, including our Principal Executive Officer and Principal Financial Officer, has conducted an evaluation of the effectiveness of ourinternal control over financial reporting as of December 31, 2014. In conducting this evaluation, we used the criteria set forth by the Committee ofSponsoring Organizations of the Treadway Commission (COSO), in Internal Control-Integrated Framework (2013).Based upon this evaluation and those criteria, management believes that, as of December 31, 2014, our internal controls over financial reporting wereeffective.Ernst & Young LLP, our independent registered public accounting firm, has audited our consolidated financial statements and the effectiveness of ourinternal control over financial reporting as of December 31, 2014. This report appears below.Changes in Internal Control over Financial ReportingThere were no changes in our internal control over financial reporting during the fourth quarter of 2014 that have materially affected, or are reasonablylikely to materially affect, our internal control over financial reporting. 86Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMThe Board of Directors and Shareholders ofAmarin Corporation plcWe have audited Amarin Corporation plc’s internal control over financial reporting as of December 31, 2014, based on criteria established in InternalControl—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).Amarin Corporation plc’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of theeffectiveness of internal control over financial reporting included in the accompanying Report of Management on Internal Controls Over FinancialReporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards requirethat we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in allmaterial respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weaknessexists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures aswe considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.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 (1) pertain to the maintenance of records that, in reasonable detail,accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded asnecessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of thecompany are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assuranceregarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on thefinancial 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 the degreeof compliance with the policies or procedures may deteriorate.In our opinion, Amarin maintained, in all material respects, effective internal control over financial reporting as of December 31, 2014, based on theCOSO criteria.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balancesheet of Amarin Corporation plc as of December 31, 2014, and the related consolidated statements of statement of operations, stockholders’ deficit and cashflow for the year ended December 31, 2014 of Amarin Corporation plc and our report dated March 3, 2015 expressed an unqualified opinion thereon./s/ Ernst & Young LLPMetroPark, New JerseyMarch 3, 2015 87Table of ContentsItem 9B.Other InformationEntry into Rule 10b5-1 Trading PlansOur policy governing transactions in our securities by our directors, officers and employees permits our officers, directors and certain other persons toenter into trading plans complying with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended. We have been advised that a number of ourdirectors and employees, including members of our senior management team, and investment funds associated with such persons, have entered into tradingplans in accordance with Rule 10b5-1 and our policy governing transactions in our securities. We undertake no obligation to update or revise theinformation provided herein, including for revision or termination of an established trading plan.Entry into Material AgreementOn February 26, 2015, we entered into a Development, Commercialization and Supply Agreement (the “DCS Agreement”) with Eddingpharm (Asia)Macao Commercial Offshore Limited (“Eddingpharm”) related to the development and commercialization of Vascepa in Mainland China, Hong Kong,Macau and Taiwan (the “Territory”). Under the terms of the DCS Agreement, we granted to Eddingpharm an exclusive (including as to Amarin) license withright to sublicense to develop and commercialize Vascepa in the Territory for uses that are currently commercialized and under development by us based onour MARINE, ANCHOR and ongoing REDUCE-IT clinical trials of Vascepa.Under the DCS Agreement, Eddingpharm will be solely responsible for development and commercialization activities in the Territory and associatedexpenses. We will provide development assistance and be responsible for supplying finished, and later bulk, drug product at defined prices under negotiatedsupply terms. We will retain all Vascepa manufacturing rights. We received a non-refundable $15.0 million up-front payment and are eligible to receivedevelopment, regulatory and sales-based milestone payments of up to an additional $154.0 million. In addition, Eddingpharm will pay us tiered double-digitpercentage royalties on net sales of Vascepa in the Territory escalating to the high teens. Eddingpharm has agreed to certain restrictions regarding thecommercialization of competitive products globally and we have agreed to certain restrictions regarding the commercialization of competitive products inthe Territory.We and Eddingpharm agreed to form a joint development committee to oversee regulatory and development activities for Vascepa in the Territory inaccordance with a negotiated development plan and to form a separate joint commercialization committee to oversee Vascepa commercialization activities inthe Territory. Development costs will be paid by Eddingpharm to the extent such costs are incurred in connection with the negotiated development plan orotherwise incurred by Eddingpharm. Eddingpharm will be responsible for preparing and filing regulatory applications in all countries of the Territory atEddingpharm’s cost with our assistance. The DCS Agreement also contains customary provisions regarding indemnification, packaging, record keeping,audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type.The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by avalid claim under a licensed patent in the Territory, or (ii) the twelfth (12th) anniversary of the first commercial sale of such product in Mainland China. TheDCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods.In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Eddingpharm has the right to terminatethe DCS Agreement for convenience with twelve months’ prior notice. Neither party may assign or transfer the DCS Agreement without the prior consent ofthe other party, provided that we may assign the DCS Agreement in the event of a change of control transaction.The DCS Agreement will be filed as an exhibit to our Quarterly Report on Form 10-Q for the three months ending March 31, 2015. 88Table of ContentsPART III Item 10.Directors, Executive Officers and Corporate GovernanceThe information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our2015 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.Code of EthicsOur Board of Directors has adopted a code of business conduct and ethics that applies to our directors, officers and employees. There have been nomaterial modifications to, or waivers from, the provisions of such code. This code is available on the corporate governance section of our website (which is asubsection of the investor relations section of our website) at the following address: www.amarincorp.com. Any waivers from or amendments to the code willbe filed with the SEC on Form 8-K. You may also request a printed copy of the code, without charge, by writing to us at Amarin Pharma, Inc., 1430 Route206, Bedminster, NJ 07921, Attention: Investor Relations. Item 11.Executive CompensationThe information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our2015 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersThe information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our2015 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. Item 13.Certain Relationships and Related Transactions, and Director IndependenceThe information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our2015 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. Item 14.Principal Accountant Fees and ServicesThe information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our2015 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. 89Table of ContentsPART IV Item 15.Exhibits and Financial Statement Schedules ExhibitNumber Description Incorporated by Reference Herein Form Date 3.1 Articles of Association of the Company Quarterly Report on Form 10-Q, File No. 0-21392, asExhibit 3.1 August 8, 2013 4.1 Form of Amended and Restated Deposit Agreement,dated as of November 4, 2011, among the Company,Citibank, N.A., as Depositary, and all holders fromtime to time of American Depositary Receipts issuedthereunder Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit 4.1 February 29, 2012 4.2 Indenture, dated as of January 9, 2012, by and amongCorsicanto Limited, the Company and Wells FargoBank, National Association, as trustee Current Report on Form 8-K dated January 9, 2012,File No. 0-21392, as Exhibit 4.1 January 10, 2012 4.3 Indenture, dated as of May 20, 2014, by and amongCorsicanto Limited, the Company and WilmingtonTrust, National Association, as trustee Current Report on Form 8-K dated May 15, 2014,File No. 000-21392, as Exhibit 4.1 May 21, 2014 4.4 Form of Ordinary Share certificate Annual Report on Form 20-F for the year endedDecember 31, 2002, File No. 0-21392, as Exhibit 2.4 April 24, 2003 4.5 Form of American Depositary Receipt evidencingADSs Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit 4.4 February 29, 201210.1 The Company 2002 Stock Option Plan* Annual Report on Form 20-F for the year endedDecember 31, 2006, File No. 0-21392, asExhibit 4.17 March 5, 200710.2 The Company 2011 Stock Option Plan* Quarterly Report on Form 10-Q for the period endedJune 30, 2011, File No. 0-21392, as Exhibit 10.4 August 9, 201110.3 Amendment No. 1 to 2011 Stock Option IncentivePlan* Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, asExhibit 10.1 August 8, 200810.4 Amendment No. 2 to 2011 Stock Option IncentivePlan* Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, asExhibit 10.2 August 8, 200810.5 Amendment No. 3 to 2011 Stock Option andIncentive Plan* Annual Report on Form 10-K for the year endedDecember 31, 2012, File No. 0-21392, asExhibit 10.5 February 28, 201210.6 Amarin Corporation plc Management IncentiveCompensation Plan* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.44 March 16, 2011 90Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.7 Form of Incentive Stock Option Award Agreement Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit 10.3 February 29, 201210.8 Form of Non-Qualified Stock Option Award Agreement Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit 10.4 February 29, 201210.9 Form of Restricted Stock Unit Award Agreement Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit 10.5 February 29, 201210.10 Letter Agreement dated August 1, 2008 with PareshSoni* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.20 March 16, 201110.11 Letter Agreement dated October 12, 2009 with Dr.Declan Doogan* Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.101 December 14, 200910.12 Letter Agreement dated October 12, 2009 with Joseph S.Zakrzewski* Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.102 December 14, 200910.13 Letter Agreement dated October 16, 2009 with ThomasG. Lynch* Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.103 December 14, 200910.14 Letter Agreement, dated December 2, 2009, among theCompany, Sunninghill Limited, Michael Walsh andSimon Kukes Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.35 March 16, 201110.15 Letter Agreement dated December 9, 2009 with ThomasG. Lynch, Alan Cooke and Tom Maher* Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.106 December 14, 200910.16 Letter Agreement, dated August 16, 2010, between theCompany and Colin Stewart* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.39 March 16, 201110.17 Letter Agreement, dated November 15, 2010, betweenthe Company and John F. Thero* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.42 March 16, 201110.18 Letter Agreement dated March 1, 2010 with FrederickW. Ahlholm* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.46 March 16, 201110.19 Letter Agreement dated January 28, 2011 with PaulHuff* Quarterly Report on Form 10-Q for the period endedMarch 31, 2011, File No. 0-21392, as Exhibit 10.1 May 10, 201110.20 Letter Agreement with Joseph Kennedy, datedDecember 13, 2011* Current Report on Form 8-K dated December 23, 2011,File No. 0-21392, as Exhibit 10.5 December 23, 2011 91Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.21 Letter Agreement with Stuart Sedlack, dated December23, 2011* Current Report on Form 8-K dated December 23, 2011,File No. 0-21392, as Exhibit 10.3 December 23, 201110.22 Letter Agreement with John Thero, dated December 23,2011* Current Report on Form 8-K dated December 23, 2011,File No. 0-21392, as Exhibit 10.1 December 23, 201110.23 Letter Agreement with Paul Huff, dated December 23,2011* Current Report on Form 8-K dated December 23, 2011,File No. 0-21392, as Exhibit 10.2 December 23, 201110.24 Letter Agreement with Paresh Soni, dated December 23,2011* Current Report on Form 8-K dated December 23, 2011,File No. 0-21392, as Exhibit 10.4 December 23, 201110.25 Letter Agreement with Steve Ketchum, dated February8, 2012* Current Report on Form 8-K dated February 16, 2012,File No. 0-21392, as Exhibit 10.1 February 16, 201210.26 2011 Long Term Incentive Award with Joseph Kennedydated December 16, 2011* Form S-8, File No. 333-180180, as Exhibit 4.1 March 16, 201210.27 2012 Long Term Incentive Award with Steven Ketchumdated March 1, 2012* Form S-8, File No. 333-180180, as Exhibit 4.2 March 16, 201210.28 Compromise Agreement, dated October 16, 2009,between the Company and Alan Cooke Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.95 October 22, 200910.29 Warrant Agreement, dated October 16, 2009, betweenthe Company and Thomas G. Lynch* Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.96 October 22, 200910.30 Employment Agreement dated November 5, 2009 withJohn F. Thero* Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.104 December 14, 200910.31 Compromise Agreement dated December 10, 2009 withTom Maher* Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, as Exhibit 99.3 December 14, 200910.32 Transitional Employment Agreement, dated August 16,2010, between the Company and Declan Doogan* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.38 March 16, 201110.33 Resignation and Release Agreement, dated November 9,2010, between the Company and Colin Stewart* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.41 March 16, 201110.34 Employment Agreement, effective December 31, 2010,between the Company and Joseph S. Zakrzewski* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.43 March 16, 2011 92Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.35 Consulting Agreement, dated November 10, 2010,between the Company and Joseph S. Zakrzewski* Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, asExhibit 10.45 March 16, 201110.36 Amended and Restated Employment Agreement withJoe Zakrzewski, dated October 20, 2011* Current Report on Form 8-K dated October 20, 2011,File No. 0-21392, as Exhibit 10.1 October 20, 201110.37 Stuart Sedlack offer letter, dated August 1, 2007* Quarterly Report on Form 10-Q for the period endedSeptember 30, 2011, File No. 0-21392, as Exhibit 10.1 November 8, 201110.38 Sale and Purchase Agreement, dated March 14, 2003,between F. Hoffmann-La Roche Limited, Hoffmann-LaRoche Inc., and the Company Annual Report on Form 20-F for the year endedDecember 31, 2002, File No. 0-21392, as Exhibit 4.22 April 24, 200310.39 Share Purchase Agreement, dated October 8, 2004between the Company, Vida Capital Partners Limitedand the Vendors named therein Registration Statement on Form F-3, File No. 333-121431, as Exhibit 4.24 December 20, 200410.40 Agreement, dated January 18, 2007, between NeurostatPharmaceuticals Inc., Amarin Pharmaceuticals IrelandLimited, the Company and Mr. Tim Lynch Annual Report on Form 20-F for the year endedDecember 31, 2007, File No. 0-21392, as Exhibit 4.62 May 19, 200810.41 Development and License Agreement dated March 6,2007 between Amarin Pharmaceuticals Ireland Limitedand Elan Pharma International Limited †† Annual Report on Form 20-F for the year endedDecember 31, 2007, File No. 0-21392, as Exhibit 4.67 May 19, 200810.42 Termination and Assignment Agreement, dated July 21,2009 between Elan Pharma International Limited andAmarin Pharmaceuticals Ireland Limited †† Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.90 October 22, 200910.43 Form of Purchase Agreement, dated June 1, 2007,between the Company and the Purchasers named therein Annual Report on Form 20-F for the year endedDecember 31, 2007,File No. 0-21392, as Exhibit 4.69 May 19, 200810.44 Form of Equity Securities Purchase Agreement for U.S.Purchasers, dated December 4, 2007, between theCompany and the Purchasers named therein Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, asExhibit 99.5 December 17, 200710.45 Form of Equity Securities Purchase Agreement for Non-U.S. Purchasers, dated December 4, 2007, between theCompany and the Purchasers named therein Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, asExhibit 99.6 December 17, 2007 93Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.46 Form of Debt Securities Purchase Agreement, datedDecember 4, 2007, between the Company and thePurchasers named therein Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, asExhibit 99.7 December 17, 200710.47 Stock Purchase Agreement, dated December 5, 2007,between the Company, the selling shareholders of EsterNeurosciences Limited, Ester Neurosciences Limitedand Medica II Management L.P. †† Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, asExhibit 99.1 January 28, 200810.48 Letter Agreement, dated December 6, 2007, between theCompany and the Sellers’ Representative of the sellingshareholders of Ester Neurosciences Limited Report of Foreign Private Issuer filed on Form 6-K, FileNo. 0-21392, asExhibit 99.1 February 1, 200810.49 Amendment No. 1 to Stock Purchase Agreement, datedApril 7, 2008, between the Company and Medica IIManagement L.P. Annual Report on Form 20-F for the year endedDecember 31, 2007,File No. 0-21392, as Exhibit 4.79 May 19, 200810.50 Securities Purchase Agreement, dated May 12, 2008,among the Company and the Purchasers named therein Annual Report on Form 20-F for the year endedDecember 31, 2008,File No. 0-21392, as Exhibit 4.80 October 22, 200910.51 Form of Securities Purchase Agreement, dated May 13,2008, between the Company and the Purchasers namedtherein †† Annual Report on Form 20-F for the year endedDecember 31, 2007,File No. 0-21392, as Exhibit 4.81 May 19, 200810.52 Amendment and Waiver Agreement, dated May 25,2009, between Ester Neurosciences Limited, Medica IIManagement L.P. and the Company†† Annual Report on Form 20-F/A for the year endedDecember 31, 2008,File No. 0-21392, as Exhibit 4.88 December 4, 200910.53 Bridge Loan Agreement, dated July 31, 2009 betweenthe Company and the Lenders identified therein Annual Report on Form 20-F for the year endedDecember 31, 2008,File No. 0-21392, as Exhibit 4.93 October 22, 200910.54 Amendment No. 1 to Bridge Loan Agreement, datedSeptember 30, 2009, between the Company and theLenders identified therein Annual Report on Form 10-K for the year endedDecember 31, 2010,File No. 0-21392, as Exhibit 10.21 March 16, 201110.55 Form of Securities Purchase Agreement datedOctober 12, 2009 between the Company and thePurchasers named therein Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.94 October 22, 200910.56 Amendment No. 1, dated December 2, 2009, toSecurities Purchase Agreement dated October 12, 2009between the Company and the Purchasers named therein Registration Statement on Form F-1, File No. 333-163704, as Exhibit 4.105 December 14, 2009 94Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.57 Master Services Agreement, dated September 29, 2009,between Medpace Inc. and Amarin Pharma, Inc. andAmarin Pharmaceuticals Ireland Limited Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.92 October 22, 200910.58 Amendment Agreement dated October 12, 2009, to theForm of Equity Securities Purchase Agreement datedMay 13, 2008 between the Company and the Purchasersnamed therein Annual Report on Form 20-F for the year endedDecember 31, 2008, File No. 0-21392, as Exhibit 4.97 October 22, 200910.59 Management Rights Deed of Agreement dated October16, 2009 by and among the Company and Purchasersnamed therein Annual Report on Form 20-F for the year endedDecember 31, 2009, File No. 0-21392, as Exhibit4.100 June 25, 201010.60 Supply Agreement, dated November 1, 2010, betweenNisshin Pharma Inc. and Amarin Pharmaceuticals IrelandLimited †† Annual Report on Form 10-K for the year endedDecember 31, 2010, File No. 0-21392, as Exhibit10.40 March 16, 201110.61 API Commercial Supply Agreement, dated May 25,2011, between Amarin Pharmaceuticals Ireland Ltd. andChemport Inc. †† Quarterly Report on Form 10-Q for the period endedJune 30, 2011, File No. 0-21392, as Exhibit 10.2 August 9, 201110.62 Amendment to API Commercial Supply Agreement byand between Amarin Pharmaceuticals Ireland Ltd andChemport Inc., dated April 4, 2012 †† Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, as Exhibit10.6 August 8, 200810.63 Second Amendment to API Commercial SupplyAgreement by and between Amarin PharmaceuticalsIreland Ltd. and Chemport Inc., dated July 19, 2012 †† Quarterly Report on Form 10-Q for quarterly periodended September 30, 2012, File No. 0-21392, asExhibit 10.1 November 8, 201210.64 API Commercial Supply Agreement, dated May 25,2011, between Amarin Pharmaceuticals Ireland Ltd. andEquateq Limited†† Quarterly Report on Form 10-Q for the period endedJune 30, 2011, File No. 0-21392, as Exhibit 10.1 August 9, 201110.65 Amendment to API Commercial Supply Agreement,dated October 19, 2011, between AmarinPharmaceuticals Ireland Ltd. and Equateq Limited†† Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit10.51 February 29, 201210.66 Second Amendment to API Supply Agreement by andbetween Amarin Pharmaceuticals Ireland Ltd. andEquateq Limited dated January 9, 2012 †† Quarterly Report on Form 10-Q for quarterly periodended March 31, 2012, File No. 0-21392, asExhibit 10.1 May 5, 2012 95Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.67 Third Amendment to API Supply Agreement by andbetween Amarin Pharmaceuticals Ireland Ltd. andEquateq Limited dated May 7, 2012 †† Quarterly Report on Form 10-Q for quarterly periodended March 31, 2012, File No. 0-21392, asExhibit 10.2 May 5, 201210.68 Irrevocable License Agreement dated as of April 11,2011, as amended by the First Amendment toIrrevocable License Agreement dated as of May 9, 2011,each by Amarin Pharmaceuticals Ireland Ltd. andBedminster 2 Funding, LLC Quarterly Report on Form 10-Q for the period endedJune 30, 2011, File No. 0-21392, as Exhibit 10.3 August 9, 201110.69 Second Amendment to Irrevocable License Agreement,by and between Bedminster 2 Funding, LLC andAmarin Pharmaceuticals Ireland Ltd., dated April 25,2012 Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, as Exhibit10.4 August 8, 200810.70 Third Amendment to Irrevocable License Agreement byand between Bedminster 2 Funding, LLC and AmarinPharmaceuticals Ireland Ltd., dated July 17, 2012 Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, as Exhibit10.5 August 8, 200810.71 Fourth Amendment to Irrevocable License Agreementby and between Bedminster 2 Funding, LLC andAmarin Pharmaceuticals Ireland Ltd., dated December15, 2012 Annual Report on Form 10-K for the year endedDecember 31, 2012, File No. 0-21392, as Exhibit10.71 February 28, 201210.72 Online Office Agreement dated as of September 30,2011 by Amarin Corporation plc and Regus CMEIreland Ltd. Quarterly Report on Form 10-Q for the period endedSeptember 30, 2011, File No. 0-21392, as Exhibit 10.2 November 8, 201110.73 Lease Agreement, dated January 22, 2007, between theCompany, Amarin Pharmaceuticals Ireland Limited andMr. David Colgan, Mr. Philip Monaghan, Mr. FinianMcDonnell and Mr. Patrick Ryan Annual Report on Form 20-F for the year endedDecember 31, 2006, File No. 0-21392, as Exhibit 4.71 March 5, 200710.74 Lease Agreement dated May 8, 2013, by and betweenAmarin Pharma, Inc. and Bedminster 2 Funding, LLC. Quarterly Report on Form 10-Q for the period endedMarch 31, 2013, File No. 0-21392, as Exhibit 10.1 May 9, 201310.75 Lease Agreement dated November 28, 2011, by theCompany, 534 East Middle Turnpike, LLC, Peter JayAlter, as Trustee of the Leon C. Lech Irrevocable Trustunder Declaration of Trust dated October 14, 1980 andFerndale Realty, LLC Annual Report on Form 10-K for the year endedDecember 31, 2011, File No. 0-21392, as Exhibit10.61 February 29, 2012 96Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date10.76 Sublease Agreement by and among Advance RealtyManagement, Inc., Bedminster 2 Funding, LLC andAmarin Pharma Inc., dated April 25, 2012 Quarterly Report on Form 10-Q for quarterly periodended June 30, 2012, File No. 0-21392, as Exhibit10.3 August 8, 200810.77 Purchase and Sale Agreement, dated December 6, 2012,by and between Amarin Corporation plc, AmarinPharmaceuticals Ireland Limited and BioPharmaSecured Debt Fund II Holdings Cayman LP†† Annual Report on Form 10-K for the year endedDecember 31, 2012, File No. 0-21392, as Exhibit10.76 February 28, 201210.78 Co-Promotion Agreement dated March 31, 2014, by andamong the Company and Kowa PharmaceuticalsAmerica, Inc. †† Quarterly Report on Form 10-Q for quarterly periodended March 31, 2014, File No. 0-21392, asExhibit 10.1 May 9, 201410.79 Form of Amendment to October 2009 Form of Warrant Current Report on Form 8-K dated October 16, 2014,File No. 0-21392, as Exhibit 10.1 October 16, 201410.80 Second Amendment to Lease Agreement by andbetween Amarin Pharma, Inc. and Bedminster 2Funding, LLC, dated January 23, 2014 Filed herewith 10.81 Third Amendment to Lease Agreement dated May 8,2013, by and between Amarin Pharma, Inc. andBedminster 2 Funding, LLC, dated April 3, 2014 Filed herewith 14.1 Code of Ethics Registration Statement on Form F-3, File No. 333-170505, as Exhibit 99.1 November 10, 201016.1 Letter of Deloitte & Touche LLP to the Securities andExchange Commission dated March 6, 2014 Current Report on Form 8-K, File No. 0-21392, asExhibit 16.1 March 6, 201421.1 List of Subsidiaries Filed herewith 23.1 Consent of Independent Registered Public AccountingFirm Filed herewith 23.2 Consent of Independent Registered Public AccountingFirm Filed herewith 31.1 Certification of President and Chief Executive Officer(Principal Executive Officer) pursuant to Section 302 ofSarbanes-Oxley Act of 2002 Filed herewith 97Table of ContentsExhibitNumber Description Incorporated by Reference Herein Form Date31.2 Certification of Vice President, Finance (PrincipalFinancial Officer) pursuant to Section 302 ofSarbanes-Oxley Act of 2002 Filed herewith 32.1 Certification of President and Chief Executive Officer(Principal Executive Officer) and Vice President,Finance (Principal Financial Officer) pursuant toSection 906 of Sarbanes-Oxley Act of 2002 Filed herewith 101 INS XBRL Instance Document 101 SCH XBRL Taxonomy Extension Schema Document 101 CAL XBRL Taxonomy Calculation LinkbaseDocument 101 DEF XBRL Taxonomy Extension DefinitionLinkbase Document 101 LAB XBRL Taxonomy Label Linkbase Document 101 PRE XBRL Taxonomy Presentation LinkbaseDocument ††Confidential treatment has been granted with respect to portions of this exhibit pursuant to an application requesting confidential treatment underRule 24b-2 of the Securities Exchange Act of 1934. A complete copy of this exhibit, including the redacted terms, has been separately filed with theSecurities and Exchange Commission.*Management contract or compensatory plan or arrangement. 98Table of ContentsSIGNATURESPursuant 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 signed onits behalf by the undersigned, thereunto duly authorized. AMARIN CORPORATION PLCBy: /s/ John F. Thero John F. Thero President and Chief Executive Officer(Principal Executive Officer)Date: March 3, 2015Pursuant 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 date indicated. Signature Title Date/s/ John F. TheroJohn F. Thero President and Chief Executive Officer (PrincipalExecutive Officer) March 3, 2015/s/ Michael J. FarrellMichael J. Farrell Vice President, Finance(Principal Financial and Accounting Officer) March 3, 2015/s/ Lars Ekman, M.D., Ph.D.Lars Ekman Director March 3, 2015/s/ James Healy, M.D., Ph.D.James Healy, M.D., Ph.D. Director March 3, 2015/s/ Patrick O’SullivanPatrick O’Sullivan Director March 3, 2015/s/ Kristine PetersonKristine Peterson Director March 3, 2015/s/ David StackDavid Stack Director March 3, 2015/s/ Jan van HeekJan van Heek Director March 3, 2015/s/ Joseph ZakrzewskiJoseph Zakrzewski Director March 3, 2015 99Table of ContentsAMARIN CORPORATION PLCINDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm F-2 Financial Statements: Consolidated Balance Sheets F-4 Consolidated Statements of Operations F-5 Consolidated Statements of Stockholders’ Deficit F-6 Consolidated Statements of Cash Flows F-7 Notes to Consolidated Financial Statements F-8 Financial Statement Schedules: Financial statement schedules have been omitted for the reason that the required information is presented in the consolidated financial statements or notesthereto, the amounts involved are not significant or the schedules are not applicable. F-1Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMThe Board of Directors and Shareholders ofAmarin Corporation plcWe have audited the accompanying consolidated balance sheet of Amarin Corporation plc as of December 31, 2014, and the related consolidated statementsof statement of operations, stockholders’ deficit and cash flow for the year ended December 31, 2014. These financial statements are the responsibility of theCompany’s management. Our responsibility is to express an opinion on these financial statements based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includesexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accountingprinciples used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our auditprovide a reasonable basis for our opinion.In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Amarin Corporation plcat December 31, 2014, and the consolidated results of its operations and its cash flows for the year ended December 31, 2014, in conformity with U.S.generally accepted accounting principles.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Amarin Corporation plc’sinternal control over financial reporting as of December 31, 2014, based on criteria established in Internal Control-Integrated Framework issued by theCommittee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated March 3, 2015 expressed an unqualifiedopinion thereon./s/ Ernst & Young LLPMetroPark, New JerseyMarch 3, 2015 F-2Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and Stockholders ofAmarin Corporation plcDublin, IrelandWe have audited the accompanying consolidated balance sheet of Amarin Corporation plc and subsidiaries (the “Company”) as of December 31, 2013, andthe related consolidated statements of operations, stockholders’ deficit, and cash flows for each of the two years in the period ended December 31, 2013.These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the consolidatedfinancial statements based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includesexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accountingprinciples used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our auditprovides a reasonable basis for our opinion.In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of Amarin Corporation plc andsubsidiaries as of December 31, 2013, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2013,in conformity with accounting principles generally accepted in the United States of America./s/ DELOITTE & TOUCHE LLPParsippany, New JerseyFebruary 27, 2014 F-3Table of ContentsAMARIN CORPORATION PLCCONSOLIDATED BALANCE SHEETS(in thousands, except share amounts) As ofDecember 31, 2014 2013 ASSETS Current Assets: Cash and cash equivalents $119,539 $191,514 Restricted cash 600 1,000 Accounts receivable, net 7,842 3,645 Inventory, current 13,733 21,209 Deferred tax assets 934 471 Other current assets 2,633 1,563 Total current assets 145,281 219,402 Property, plant and equipment, net 381 579 Inventory, long-term — 5,482 Deferred tax assets 12,556 11,944 Other non-current assets 2,826 4,360 Intangible asset, net 10,063 10,709 TOTAL ASSETS $171,107 $252,476 LIABILITIES AND STOCKHOLDERS’ DEFICIT Current Liabilities: Accounts payable $8,525 $6,375 Current portion of long-term debt 15,394 12,974 Warrant derivative liability 119 6,894 Deferred revenue — 1,703 Accrued expenses and other current liabilities 16,268 9,594 Total current liabilities 40,306 37,540 Long-Term Liabilities: Exchangeable senior notes, net of discount 121,846 149,317 Long-term debt 89,617 87,717 Long-term debt derivative liabilities 7,400 11,100 Other long-term liabilities 386 658 Total liabilities 259,555 286,332 Commitments and contingencies (Note 9) Stockholders’ Deficit: Common stock, £0.50 par value, unlimited authorized; 174,610,451 issued, 174,590,372 outstanding at December 31,2014; 172,691,063 issued, 172,670,984 outstanding at December 31, 2013 143,113 141,477 Additional paid-in capital 738,890 738,754 Treasury stock; 20,079 shares at December 31, 2014 and 2013 (217) (217) Accumulated deficit (970,234) (913,870) Total stockholders’ deficit (88,448) (33,856) TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $171,107 $252,476 See the notes to the consolidated financial statements. F-4Table of ContentsAMARIN CORPORATION PLCCONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts) Years Ended December 31, 2014 2013 2012 Product revenues, net $54,202 $26,351 $— Less: Cost of goods sold 20,485 11,912 — Gross margin 33,717 14,439 — Operating expenses: Selling, general and administrative 79,346 123,795 57,794 Research and development 50,326 72,750 58,956 Total operating expenses 129,672 196,545 116,750 Operating loss (95,955) (182,106) (116,750) Gain (loss) on change in fair value of derivative liabilities 13,472 47,710 (35,344) Gain on extinguishment of debt 38,034 — — Interest expense (18,575) (34,179) (18,091) Interest income 96 343 544 Other income (expense), net 3,727 (1,189) (427) Loss from operations before taxes (59,201) (169,421) (170,068) Benefit from (provision for) income taxes 2,837 3,194 (9,116) Net loss $(56,364) $(166,227) $(179,184) Loss per share: Basic $(0.32) $(1.03) $(1.24) Diluted $(0.36) $(1.28) $(1.24) Weighted average shares: Basic 173,719 161,022 144,017 Diluted 173,824 167,070 144,017 See the notes to the consolidated financial statements. F-5Table of ContentsAMARIN CORPORATION PLCCONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICITYEARS ENDED DECEMBER 31, 2014, 2013 and 2012(in thousands, except share amounts) CommonShares CommonStock AdditionalPaid-inCapital TreasuryStock AccumulatedDeficit TotalStockholders’Deficit At January 1, 2012 135,832,542 $113,321 $449,393 $(217) $(568,459) $(5,962) Exercise of warrants 11,047,579 8,540 8,180 — — 16,720 Exercise of stock options 3,380,413 2,659 5,546 — — 8,205 Vesting of restricted stock units 97,398 76 (76) — — — Conversion option contained in exchangeable notes — — 22,898 — — 22,898 Tax benefits realized from stock-based compensation — — 11,334 — — 11,334 Transfer of fair value of warrants exercised from liabilities toequity — — 103,885 — — 103,885 Share issuances for services 3,001 1 31 — — 32 Stock-based compensation — — 18,075 — — 18,075 Net loss — — — — (179,184) (179,184) At December 31, 2012 150,360,933 $124,597 $619,266 $(217) $(747,643) $(3,997) Exercise of warrants 147,050 113 47 — — 160 Exercise of stock options 386,000 292 335 — — 627 Stock issued in July financing 21,700,000 16,401 104,805 121,206 Vesting of restricted stock units 93,048 71 (71) — — — Tax provision on stock-based compensation — — (361) — — (361) Transfer of fair value of warrants exercised from liabilities toequity — — 24 — — 24 Share issuances for services 4,032 3 24 — — 27 Stock-based compensation — — 14,685 — — 14,685 Net loss — — — — (166,227) (166,227) At December 31, 2013 172,691,063 $141,477 $738,754 $(217) $(913,870) $(33,856) Exercise of warrants 1,684,888 1,443 208 — — 1,651 Exercise of stock options 234,500 193 114 — — 307 Reacquisition of conversion option in convertible notes — — (10,100) — — (10,100) Tax provision on stock-based compensation — — (2,299) — — (2,299) Stock-based compensation — — 9,022 — — 9,022 Refund of equity issuance costs — — 3,191 — — 3,191 Net loss — — — — (56,364) (56,364) At December 31, 2014 174,610,451 $143,113 $738,890 $(217) $(970,234) $(88,448) See the notes to the consolidated financial statements. F-6Table of ContentsAMARIN CORPORATION PLCCONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands) Years Ended December 31, 2014 2013 2012 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(56,364) $(166,227) $(179,184) Adjustments to reconcile loss to net cash used in operating activities: Depreciation and amortization 198 246 180 Stock-based compensation 9,022 14,685 18,075 Stock-based compensation—warrants (503) (3,703) 247 Excess tax provision (benefit) from stock-based awards 2,299 361 (11,334) Amortization of debt discount and debt issuance costs 5,863 17,631 12,856 Amortization of intangible asset 646 646 269 Foreign exchange loss on intangible asset — — 519 (Gain) loss on changes in fair value of derivative liabilities (13,472) (47,710) 35,344 Gain on extinguishment of debt (38,034) — — Deferred income taxes (3,614) (3,434) (3,714) Change in lease liability — 6 (50) Shares issued for services — 27 32 Changes in assets and liabilities: Restricted cash 400 (1,000) — Accounts receivable (4,197) (3,645) — Other current and prepaid assets (1,053) 1,690 (1,416) Inventories 12,958 (5,429) (21,262) Other non-current assets 4,014 591 (1,060) Accrued interest payable 2,420 10,454 2,520 Deferred revenue (1,703) 1,703 — Accounts payable and other current liabilities 8,811 (7,228) 25,675 Net cash used in operating activities (72,309) (190,336) (122,303) CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of equipment — (14) (549) Purchase of long-term investment — — (1,650) Purchase of intangible asset — — (12,143) Net cash used in investing activities — (14) (14,342) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock, net of transaction costs — 121,206 — Refund of equity issuance costs 3,191 — — Proceeds from exercise of stock options, net of transaction costs 307 627 8,205 Proceeds from exercise of warrants, net of transaction costs 1,651 160 16,720 Proceeds on issuance of exchangeable senior notes, net of transaction costs — — 144,316 Proceeds from long-term debt, net of transaction costs — — 99,730 Debt issuance costs (2,480) — — Excess tax (provision) benefit from stock-based awards (2,299) (361) 11,334 Payments under capital leases (36) (10) (20) Net cash provided by financing activities 334 121,622 280,285 NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (71,975) (68,728) 143,640 CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 191,514 260,242 116,602 CASH AND CASH EQUIVALENTS, END OF PERIOD $119,539 $191,514 $260,242 Supplemental disclosure of cash flow information: Cash paid during the year for: Interest $10,033 $6,090 $2,713 Income taxes $781 $1,395 $1,118 Supplemental disclosure of non-cash items: Reclass of warrant liability to additional paid-in capital $— $24 $103,885 Reacquisition of conversion option in convertible notes $10,100 $— $— See the notes to the consolidated financial statements. F-7Table of ContentsAMARIN CORPORATION PLCNOTES TO CONSOLIDATED FINANCIAL STATEMENTS(1) Nature of Business and Basis of PresentationNature of BusinessAmarin Corporation plc (“Amarin” or the “Company”) is a biopharmaceutical company with expertise in lipid science focused on the commercialization anddevelopment of therapeutics to improve cardiovascular health.The Company’s lead product, Vascepa (icosapent ethyl) capsules, is approved by the U.S. Food and Drug Administration, or FDA, for use as an adjunct todiet to reduce triglyceride levels in adult patients with severe (TG >500 mg/dL) hypertriglyceridemia. Vascepa is available in the United States byprescription only. The Company began selling and marketing Vascepa in the United States in January 2013. The Company sells Vascepa principally to alimited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, its Distributors, that in turnresell Vascepa to retail pharmacies for subsequent resale to patients and health care providers. The Company markets Vascepa through its sales force ofapproximately 150 sales professionals, including sales representatives and their managers. In March 2014, the Company entered into a co-promotionagreement with Kowa Pharmaceuticals America, Inc. under which approximately 250 Kowa Pharmaceuticals America, Inc. sales representatives began todevote a substantial portion of their time to promoting Vascepa starting in May 2014 in conjunction with the promotion of Kowa Pharmaceutical America,Inc.’s primary product, a branded statin for patients with high cholesterol. The Company operates in one business segment.The Company is also developing Vascepa for potential additional indications for use. In particular, the Company is conducting a cardiovascular outcomesstudy of Vascepa, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial). The REDUCE-IT study, the results of which arecurrently blinded to the Company, is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in a high risk patient populationon statin therapy.Basis of PresentationThe accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company willcontinue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.The Company’s business operations are focused on the commercialization and development of Vascepa, which received approval from the FDA in 2012 andfor which the Company commenced marketing and sales in 2013. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.At December 31, 2014, the Company had cash and cash equivalents of $119.5 million. The Company’s consolidated balance sheets also include derivativeliabilities as well as long term debt and exchangeable senior notes. The outstanding January 2012 exchangeable senior notes, or the 2012 Notes, and May2014 exchangeable senior notes, or the 2014 Notes, may be redeemed on or after January 19, 2017 and January 19, 2019, respectively, at the option of theholders and it is not puttable by the holders prior to these dates except upon the occurrence of certain contingent events. The 2012 Notes are exchangeableunder certain circumstances into cash, American Depository Shares, or ADSs, or a combination of cash and ADSs, at the Company’s election. The 2014 Notesare exchangeable under certain circumstances into ADSs. Accordingly, the warrant derivative liability, long term debt and exchangeable senior notes do notpresent a short term claim on the liquid assets of the Company.The Company believes its cash and cash equivalents will be sufficient to fund its projected operations for at least the next twelve months. F-8®Table of Contents(2) Significant Accounting PoliciesPrinciples of ConsolidationThe consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactionshave been eliminated in consolidation.Use of EstimatesThe consolidated financial statements reflect all adjustments that, in the opinion of management, are necessary to present fairly the Company’s financialposition, results of operations and cash flows for the periods indicated. The preparation of the Company’s consolidated financial statements in conformitywith GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assetsand liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Accounting estimatesare based on historical experience and other factors that are considered reasonable under the circumstances. Estimates are used in determining such items asprovisions for sales returns, rebates and incentives, chargebacks, and other sales allowances, depreciable/amortizable lives, asset impairments, valuationallowance on deferred taxes, amounts recorded for contingencies and accruals, and valuations of derivative and long-term debt instruments. Because of theuncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparationof the consolidated financial statements for continued reasonableness. The results of operations for the years ended December 31, 2014 and 2013,respectively, are not necessarily indicative of the results for any future period.Use of Forecasted Financial Information in Accounting EstimatesThe use of forecasted financial information is inherent in many of the Company’s accounting estimates, including but not limited to, determining theestimated fair values of derivatives, debt instruments and intangible assets, and evaluating the need for valuation allowances for deferred tax assets. Suchforecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results.Management believes that its financial forecasts are reasonable and appropriate based upon current facts and circumstances. Because of the inherent nature offorecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts thecarrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates.Revenue RecognitionThe Company sells Vascepa principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers,or collectively, its Distributors, that in turn resell Vascepa to retail pharmacies for subsequent resale to patients and health care providers. Patients arerequired to have a prescription in order to purchase Vascepa. In accordance with GAAP, the Company’s revenue recognition policy requires that: (i) there ispersuasive evidence that an arrangement exists between the Company and the Distributor, (ii) delivery has occurred, (iii) collectability is reasonably assuredand (iv) the price is fixed or determinable.The Company commenced its commercial launch in the United States in January 2013. Prior to 2013, the Company recognized no revenue from Vascepasales. In accordance with GAAP, until the Company had the ability to reliably estimate returns of Vascepa from its Distributors, revenue was recognized basedon the resale of Vascepa for the purposes of filling patient prescriptions, and not based on sales from the Company to such Distributors. Beginning in January2014, the Company concluded that it had developed sufficient history such that it can reliably estimate returns and as a result, began to recognize revenuebased on sales to its Distributors. The change in revenue recognition methodology resulted in the recognition of previously deferred revenue. At F-9Table of ContentsDecember 31, 2013, the Company had deferred approximately $1.7 million in amounts billed to Distributors that was not recognized as revenue. This changein revenue recognition methodology resulted in the recognition of such deferred revenues in the three months ended March 31, 2014.The Company has contracts with its primary Distributors and delivery occurs when a Distributor receives Vascepa. The Company evaluates thecreditworthiness of each of its Distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements,or whether recognition is required to be delayed until receipt of payment or when the product is utilized. In order to conclude that the price is fixed ordeterminable, the Company must be able to (i) calculate its gross product revenues from the sales to Distributors and (ii) reasonably estimate its net productrevenues. The Company calculates gross product revenues based on the wholesale acquisition cost that the Company charges its Distributors for Vascepa.The Company estimates its net product revenues by deducting from its gross product revenues (a) trade allowances, such as invoice discounts for promptpayment and distributor fees, (b) estimated government and private payor rebates, chargebacks and discounts, such as Medicaid reimbursements, (c) reservesfor expected product returns and (d) estimated costs of incentives offered to certain indirect customers, including patients.Trade Allowances: The Company generally provides invoice discounts on Vascepa sales to its Distributors for prompt payment and pays fees fordistribution services, such as fees for certain data that Distributors provide to the Company. The payment terms for sales to Distributors generallyinclude a 2% discount for payment within 30 days while the fees for distribution services are based on contractual rates agreed with the respectiveDistributors. Based on the Company’s judgment and experience, the Company expects its Distributors to earn these discounts and fees, and deducts thefull amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, other government agencies and various private organizations, orcollectively, Third-party Payors, so that Vascepa will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors. TheCompany estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its grossproduct revenues at the time the revenues are recognized. The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s Distributors and (iv) information obtained from other third parties regarding the payormix for Vascepa.Product Returns: The Company’s Distributors have the right to return unopened unprescribed Vascepa during the 18-month period beginningsix months prior to the labeled expiration date and ending twelve months after the labeled expiration date. The expiration date for Vascepa is threeyears after it has been converted into capsule form, which is the last step in the manufacturing process for Vascepa and generally occurs within a fewmonths before Vascepa is delivered to Distributors. As of December 31, 2014, the Company had experienced a de minimis quantity of product returns.The Company estimates future product returns on sales of Vascepa based on: (i) data provided to the Company by its Distributors (including weeklyreporting of Distributors’ sales and inventory held by Distributors that provided the Company with visibility into the distribution channel in order todetermine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies,(iii) data provided to the Company by a third party data provider which collects and publishes prescription data, and other third parties, (iv) historicalindustry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of Vascepa previously shippedand currently being shipped to Distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’sDistributors.Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company tocommercially insured patients who have coverage for Vascepa and who reside in states that permit co-pay mitigation programs. The Company’s co-paymitigation program is intended to reduce each participating patient’s portion of the financial responsibility for F-10Table of ContentsVascepa’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similarspecialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects toparticipate in the program in order to establish its accruals for co-pay mitigation rebates and deducts these estimated amounts from its gross productrevenues at the time the revenues are recognized. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activityand estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed. In addition, as is customary prior to thelaunch of new drugs, the Company provided certain of its Distributors with financial incentives to begin stocking Vascepa prior to the Company’scommercial launch of Vascepa in order to ensure that Vascepa was readily available to fill patient prescriptions upon launch. Such incentives wereonly offered on purchases of initial launch quantities of Vascepa stocked by Distributors in January 2013. The amount of these financial incentives wasrecorded by the Company as a reduction to revenues on a pro-rata basis for each of the bottles subject to such financial incentives. The Companyestimates that all of these initial launch quantities stocked by its primary Distributors in January 2013 were resold by such Distributors prior toDecember 31, 2013.The following table summarizes activity in each of the net product revenue allowance and reserve categories described above for the years endedDecember 31, 2014 and 2013 (in thousands): TradeAllowances Rebates,Chargebacksand Discounts ProductReturns OtherIncentives Total Balance at January 1, 2014 $1,071 $1,137 $72 $189 $2,469 Provision related to current period sales 8,157 12,753 397 11,153 32,460 Provision related to prior period sales (29) (80) 12 (31) (128) Credits/payments made for current period sales (5,950) (9,143) — (10,338) (25,431) Credits/payments made for prior period sales (1,042) (1,057) — (181) (2,280) Balance at December 31, 2014 $2,207 $3,610 $481 $792 $7,090 TradeAllowances Rebates,Chargebacksand Discounts ProductReturns OtherIncentives Total Balance at January 1, 2013 $— $— $— $— $— Provision related to current period and deferred sales 4,178 4,282 72 3,114 11,646 Credits/payments made for current period and deferred sales (3,107) (3,145) — (2,925) (9,177) Balance at December 31, 2013 $1,071 $1,137 $72 $189 $2,469 The following table summarizes product revenue recognized and deferred during the years ended December 31, 2014 and 2013 (in thousands): December 31, 2014 December 31, 2013 Product revenue recognized, net $54,202 $26,351 Deferred product revenue — 1,703 $54,202 $28,054 F-11Table of ContentsIn conjunction with the Company’s recognition and deferral of product revenues, the Company expensed and capitalized the associated cost of goods, asfollows, during the years ended December 31, 2014 and 2013 (in thousands): December 31, 2014 December 31, 2013 Cost of goods sold expensed $20,485 $11,912 Finished goods inventory held by others — 627 $20,485 $12,539 Distribution CostsThe Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distributionservices, in cost of goods sold.Cash and Cash EquivalentsCash and cash equivalents consist of cash, deposits with banks and short term highly liquid money market instruments with remaining maturities at the dateof purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may beincurred for business travel under corporate credit cards held by employees.Accounts Receivable, netAccounts receivable, net, comprised of trade receivables, are generally due within 30 days and are stated at amounts due from customers. The Company doesnot currently maintain an allowance for doubtful accounts and has not historically experienced any credit losses.The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of December 31, 2014 and2013 (in thousands): December 31, 2014 December 31, 2013 Gross trade accounts receivable $10,215 $4,812 Trade allowances (2,207) (1,143) Chargebacks (166) (24) Accounts receivable, net $7,842 $3,645 InventoryThe Company states inventories at the lower of cost or market value. Cost is determined based on actual cost using the average cost method. An allowance isestablished when management determines that certain inventories may not be saleable. If inventory cost exceeds expected market value due to obsolescence,damage or quantities in excess of expected demand, the Company will reduce the carrying value of such inventory to market value. The Company receivedFDA approval for Vascepa on July 26, 2012 and after that date began capitalizing inventory purchases of saleable product from approved suppliers. Until anAPI supplier is approved, all Vascepa API purchased from such supplier is included as a component of research and development expense. Upon sNDAapproval of each additional supplier, the Company capitalizes subsequent Vascepa API purchases from such supplier as inventory. Purchases of Vascepa APIreceived and expensed before such regulatory approvals is not subsequently capitalized, and all such purchases are quarantined and not used for commercialsupply until such time as the sNDA for the supplier that produced the API is approved. The Company expenses inventory identified for use as marketingsamples when they are packaged. The average cost reflects the actual purchase price of Vascepa API, as well as a portion of API carried at zero cost formaterial which was purchased prior to FDA approval of Vascepa or was purchased prior to the sNDA approval of the Company’s suppliers. F-12Table of ContentsProperty, Plant and EquipmentThe Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of thefixed asset over its estimated useful life. The estimated useful lives, by asset classification, are as follows: Asset Classification Useful LivesComputer equipment and software 3 - 5 yearsFurniture and fixtures 5 yearsLeasehold Improvements Lesser of useful life or lease termUpon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the balance sheet and anyresulting gain or loss is credited or expensed to operations. Repairs and maintenance costs are expensed as incurred.Long-Lived Asset ImpairmentThe Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets maynot be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assetsrelate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecastedcash flows or appraised values, depending on the nature of the assets.Intangible Asset, netIntangible assets consist of a milestone payment paid to the former shareholders of Laxdale Limited related to the 2004 acquisition of the rights to Vascepa,which is the result of Vascepa receiving marketing approval for the first indication and is amortized over its estimated useful life on a straight-line basis. SeeNote 9—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale Limited.Costs for Patent Litigation and Legal ProceedingsCosts for patent litigation or other legal proceedings are expensed as incurred and included in selling, general and administrative expenses.Deferred RevenueAs of December 31, 2013, deferred revenue represents product shipments to Distributors for which the Company has invoiced the Distributors but notrecognized as revenue because the product was not reported to the Company as having been resold for the purpose of filling prescriptions. Commencing onJanuary 1, 2014, the Company recognizes revenue based on product shipments to its Distributors and as a result, no deferred revenue was recorded as ofDecember 31, 2014.Research and Development CostsThe Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by theCompany in performing research and development activities, including salary and benefits; stock-based compensation expense; laboratory supplies andother direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drugcandidates; and infrastructure costs, including facilities costs and depreciation expense. In addition, research and development costs include the costs ofproduct supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier. F-13Table of ContentsSelling, General and Administrative CostsThe Company charges selling, general and administrative costs to operations as incurred. Selling, general and administrative costs include costs of salaries,programs and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization ofVascepa in the United States for the MARINE indication as well as co-promotion fees payable to Kowa Pharmaceuticals America, Inc. Also included as part ofselling, general and administrative costs is warrant related income from non-cash changes in fair value of the derivative liability associated with warrantsissued in October 2009 to former officers of Amarin which is recorded as compensation income.Income TaxesDeferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets andliabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuationallowances are provided against deferred tax assets that are not more likely than not to be realized.The Company provides reserves for potential payments of tax to various tax authorities or does not recognize tax benefits related to uncertain tax positionsand other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings orpositions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy isto record interest and penalties in the provision for income taxes.The Company regularly assesses the realizability of deferred tax assets. Changes in historical earnings performance and future earnings projections, amongother factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in theperiod in which it is determined that these factors have changed.Derivative InstrumentsDerivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the statement of operations ateach period end while such instruments are outstanding. If the Company issues shares to discharge the liability, the derivative financial liability isderecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. The warrants are valued using a Black-Scholesoption pricing model due to the nature of instrument. The long term debt redemption feature is valued using a probability-weighted model incorporatingmanagement estimates for potential change in control, and by determining the fair value of the debt with and without the change in control provisionincluded.If the terms of warrants that initially require the warrant to be classified as a derivative financial liability lapse, the derivative financial liability is reclassifiedout of financial liabilities into equity at its fair value on that date. The cash proceeds received from exercises of warrants are recorded in common stock andadditional paid-in capital.Loss per ShareBasic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period. Diluted net lossper share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, ifany, of potentially dilutive common shares, such as common stock options and warrants calculated using the treasury stock method and convertible notesusing the “if-converted” method. In periods with reported net operating losses, all common stock options and warrants are deemed anti-dilutive such thatbasic net loss per share and diluted net loss per share are equal. However, in certain periods in which there is a gain recorded pursuant to the change in fairvalue of the warrant derivative liability, for diluted earnings per share purposes, the impact of such gains is reversed and the treasury stock method is used todetermine diluted earnings per share. F-14Table of ContentsThe calculation of net loss and the number of shares used to compute basic and diluted earnings per share for the years ended December 31, 2014, 2013 and2012 are as follows: In thousands 2014 2013 2012 Net loss—basic $(56,364) $(166,227) $(179,184) Gain on warrant derivative liability (6,775) (47,936) — Net loss—diluted (63,139) (214,163) (179,184) Net loss per share—basic $(0.32) $(1.03) $(1.24) Weighted average shares outstanding—basic 173,719 161,022 144,017 Effect of dilutive warrants 105 6,048 — Weighted average shares outstanding—diluted 173,824 167,070 144,017 Net income loss per share—diluted $(0.36) $(1.28) $(1.24) For the years ended December 31, 2014, 2013 and 2012, the following potentially dilutive securities were not included in the computation of net loss pershare because the effect would be anti-dilutive: In thousands 2014 2013 2012 Stock options 10,670 9,330 10,892 Restricted stock and restricted stock units 2,256 196 465 Warrants — 1,702 9,937 Exchangeable senior notes (if converted) 49,215 17,021 17,021 Debt InstrumentsDebt instruments are initially recorded at fair value, with coupon interest and amortization of debt issuance discounts recognized in the statement ofoperations as interest expense each period in which such instruments are outstanding. If the Company issues shares to discharge the liability, the debtobligation is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. The conversion features in boththe 2012 Notes and 2014 Notes qualify for the exception from derivative accounting in accordance with ASC 815-40. The 2012 Notes may be settled, at theCompany’s discretion, in any combination of ADSs or cash upon conversion and have been accounted for in accordance with ASC 470-20. Under ASC 470-20, the fair value of the liability component of the 2012 Notes was determined and deducted from the initial proceeds to determine the proceeds allocated tothe conversion option, which has been recorded in equity. The difference between the initial fair value of the liability component and the amount repayablewas amortized over the expected term of the instrument. The conversion feature in the 2014 Notes may only be settled in ADSs upon conversion and has beenaccounted for as part of the debt host.The conversion options in both the 2012 Notes and 2014 Notes continue to be evaluated on a quarterly basis to determine if they still receive an exceptionfrom derivative accounting in accordance with ASC 815-40. The 2014 Notes were recognized initially at fair value as part of an extinguishment of a portionof the 2012 Notes (see further discussion in Note 8). As a result, the debt was initially recognized at a discount of $27.9 million. This discount will beamortized through interest expense over the expected term of the note.Stock-Based CompensationStock-based compensation cost is generally measured at the grant date, based on the fair value of the award, and is recognized as compensation cost over therequisite service period.Concentration of Credit RiskFinancial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents and accounts receivable. TheCompany maintains substantially all of its cash and cash equivalents in financial institutions believed to be of high-credit quality. F-15Table of ContentsA significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry. The Company monitors the creditworthiness of customers towhom it grants credit terms and has not experienced any credit losses. The Company does not require collateral or any other security to support credit sales.The Company’s top three customers accounted for 95% and 96% of gross product sales for the years ending December 31, 2014 and 2013, respectively andrepresented 96% and 95% of the gross accounts receivable balance as of December 31, 2014 and 2013, respectively. The Company has not experienced anywrite-offs of its accounts receivable in the years ended December 31, 2014 and 2013.Concentration of SuppliersThe Company entered into Vascepa API supply agreements with Nisshin Pharma, Inc., or Nisshin, in 2010. In 2011, the Company entered into agreementswith two additional suppliers, Chemport, Inc., or Chemport, and BASF (formerly Equateq Limited) for the supply of API. In 2012, the Company agreed toterms with a fourth API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc. (Slanmhor). The Company terminated its agreement withBASF in February 2014. While the Company has contractual freedom to source the API for Vascepa and has entered into supply agreements with multiplesuppliers who also rely on other third party suppliers of the key raw material to manufacture the API for Vascepa, Nisshin and Chemport currently supply allof the Company’s API for Vascepa. The Company cannot provide assurance that the efforts of its contractual suppliers will continue to be successful, that itwill be able to renew such agreements or that it will be able to enter into new agreements in the future. Any alteration to or termination of the Company’scurrent API supply, manufacturing, and distribution agreements, its failure to enter into new and similar agreements, or the interruption of the supply of itsproducts under such agreements, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations. Forthe year ended December 31, 2014, all of the Company’s net product sales were generated from API purchased from Nisshin Pharma, Inc. and Chemport, Inc.The Company currently relies on Patheon (formerly Banner Pharmacaps) for the encapsulation of Vascepa. The Company has encapsulation agreements withtwo other commercial API encapsulators. These companies have qualified their manufacturing processes and are capable of manufacturing Vascepa. Therecan be no guarantee that other suppliers with which the Company has contracted to encapsulate API will be qualified to manufacture the product to itsspecifications or that these and any future suppliers will have the manufacturing capacity to meeting anticipated demand for Vascepa.Foreign CurrencyAll subsidiaries use the United States dollar as the functional currency. Monetary assets and liabilities denominated in a foreign currency are remeasured intoUnited States dollars at period-end exchange rates. Gains and losses from the remeasurement are included in other income (expense), net in the consolidatedstatements of operations. For transactions settled during the applicable period, gains and losses are included in other income (expense), net in theconsolidated statements of operations. The Company periodically uses foreign exchange forward contracts to hedge against changes in exchange rates forinventory purchases denominated in foreign currency. As of December 31, 2014, there were no outstanding foreign exchange contracts.Debt Issuance CostsDebt issuance costs are initially capitalized as a deferred cost and amortized to interest expense using the effective interest method over the expected term ofthe related debt. Unamortized debt issuance costs related to extinguishment of debt are expensed at the time the debt is extinguished and recorded in otherincome (expense), net in the consolidated statements of operations.Fair Value of Financial InstrumentsThe Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon saleof an asset or paid to transfer a liability in an orderly transaction F-16Table of Contentsbetween market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with theinputs to fair valuation of these assets and liabilities using the following three levels:Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at themeasurement date.Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in marketsthat are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derivedprincipally from or corroborated by observable market data by correlation or other means (market corroborated inputs).Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset orliability. The Company develops these inputs based on the best information available, including its own data.The following table presents information about the Company’s assets and liabilities as of December 31, 2014 and 2013 that are measured at fair value on arecurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2014 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $65,156 $65,156 $— $— Liabilities: Warrant derivative liability $119 $— $— $119 Long-term debt derivative liabilities $7,400 $— $— $7,400 December 31, 2013 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $113,474 $113,474 $— $— Liabilities: Warrant derivative liability $6,894 $— $— $6,894 Long-term debt derivative liability $11,100 $— $— $11,100 The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. Thecarrying amounts and the estimated fair values of debt instruments as of December 31, 2014 and 2013 are as follows: December 31, 2014 December 31, 2013 In thousands CarryingValue EstimatedFair Value CarryingValue EstimatedFair Value Long-term debt—December 2012 financing $89,617 $81,000 $87,717 $75,700 2012 Notes 31,266 25,689 149,317 106,600 2014 Notes 90,580 75,533 — — The estimated fair value of the long-term debt pursuant to the December 2012 financing is calculated utilizing the same Level 3 inputs utilized in valuing therelated derivative liability (see Long-Term Debt Derivative Liabilities below). The estimated fair value of the 2012 Notes and 2014 Notes is calculated basedon Level 1 F-17Table of Contentsquoted bond prices. The carrying value of the 2012 Notes at December 31, 2014 and 2013 includes a debt discount of zero and $0.7 million, respectively,which is being amortized as non-cash interest expense over the expected term of the 2012 Notes. The carrying value of the 2014 Notes at December 31, 2014includes a debt discount of $28.2 million which is being amortized as non-cash interest expense over the expected term of the 2014 Notes. The change in theestimated fair values of these liabilities from December 31, 2013 to December 31, 2014 is largely related to the issuance of the 2014 Notes and the quotedbond prices.Warrant Derivative LiabilityThe Company’s warrant derivative liability is carried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significantunobservable inputs. The initial fair value of the warrant derivative liability at the date of issuance in October 2009 was determined to be $48.3 million usingthe Black-Scholes option valuation model applying the following assumptions: (i) risk-free rate of 2.37%, (ii) remaining term of 5 years, (iii) no dividendyield, (iv) volatility of 119%, and (v) the stock price on the date of measurement. Effective October 16, 2014, the Company entered into a series of warrantamendment agreements (collectively, the “Warrant Amendments”) in order to extend the expiration date of certain outstanding warrants (collectively, the“Warrants”) from its previously scheduled expiration date of October 16, 2014 to the close of business on February 27, 2015.At December 31, 2013, the fair value of the warrant derivative liability was determined to be $6.9 million using the Black-Scholes option valuation modelapplying the following assumptions: (i) risk-free rate of 0.12%, (ii) remaining term of 0.8 years, (iii) no dividend yield (iv) volatility of 99%, and (v) the stockprice on the date of measurement. For the year ended December 31, 2013, the $47.9 million decrease in the fair value of the warrants, net of exercises, wasrecognized as: (i) a $44.2 million gain on change in fair value of the remaining derivative liability and (ii) $3.7 million in compensation income for changein fair value of warrants issued to former employees. Both amounts are included within the consolidated statement of operations for the year endedDecember 31, 2013. As of December 31, 2014, the fair value of the warrant derivative liability was determined to be $0.1 million using the Black-Scholesoption valuation applying the following assumptions: (i) risk-free rate of 0.04%, (ii) remaining term of 0.16 years, (iii) no dividend yield (iv) volatility of79%, and (v) the stock price on the date of measurement. The $6.8 million decrease in the fair value of the warrants during the year was recognized as: (i) a$6.3 million gain on change in fair value of the remaining derivative liability and (ii) $0.5 million in compensation income for change in fair value ofwarrants issued to former employees. Both amounts are included within the consolidated statement of operations for the year ended December 31, 2014.The fair value of this warrant liability is determined using the Black-Scholes option valuation method and is therefore sensitive to changes in the marketprice and volatility of the Company’s common stock, among other factors. In the event of a hypothetical 10% increase in the market price of the Company’scommon shares ($1.08 based on the $0.98 market price of the Company’s stock at December 31, 2014) on which the December 31, 2014 valuation was based,the value of the derivative liability would have increased by $0.1 million. Such increase would have been reflected as a loss on change in fair value ofderivative liabilities and as an increase in warrant compensation expense within the statement of operations. Significant increases (decreases) in this input inisolation would result in a significantly higher (lower) fair value asset measurement.Long-Term Debt Derivative LiabilitiesThe Company’s December 2012 financing agreement with BioPharma Secured Debt Fund II Holdings Cayman LP (discussed in Note 8 below) contains aredemption feature whereby, upon a change of control, the Company would have been required to pay $140 million, less any previously repaid amount, if thechange of control occurred on or before December 31, 2013, or required to repay $150 million, less any previously repaid amount, if the change of controlevent occurs after December 31, 2013. The Company determined this redemption feature to be an embedded derivative, which is carried at fair value and isclassified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of the embedded derivative was calculatedusing F-18Table of Contentsa probability-weighted model incorporating management estimates for potential change in control, and by determining the fair value of the debt with andwithout the change in control provision included. The difference between the two was determined to be the fair value of the embedded derivative. AtDecember 31, 2014, the fair value of the derivative was determined to be $4.8 million, and the debt was valued by comparing debt issues of similarcompanies with (i) remaining terms of between 2.3 and 3.6 years, (ii) coupon rates of between 9.8% and 10.8% and (iii) market yields of between 10.0% and16.8%. The Company recognized a $6.3 million gain on change in fair value of derivative liability for the year ended December 31, 2014. At December 31,2013, the fair value of the derivative was determined to be $11.1 million, and the debt was valued by comparing debt issues of similar companies with(i) remaining terms of between 3.3 and 6.6 years, (ii) coupon rates of between 9.9% and 12.5% and (iii) market yields of between 9.0% and 29.4%. TheCompany recognized a $3.5 million gain on change in fair value of derivative liability for the year ended December 31, 2013.The Company’s 2014 Notes contain a redemption feature whereby, upon occurrence of a change in control, the Company would be required to repurchase thenotes. The Company determined this redemption feature to be an embedded derivative, requiring bifurcation in accordance with ASC 815. The derivative iscarried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of the embeddedderivative was calculated using a probability-weighted model incorporating management estimates of the probability of a change in control occurring, andby determining the fair value of the debt with and without the change in control provision included. The difference between the two was determined to be thefair value of the embedded derivative. At December 31, 2014, the fair value of the derivative was determined to be $2.6 million, and the debt was valued byusing (i) the estimated remaining term of the notes, (ii) a bond yield of 24.8%, (iii) a risk-free interest rate of 2.7% and (iv) volatility of 82.0%. The Companyrecognized a $0.9 million gain on change in fair value of derivative liability for the year ended December 31, 2014.Any changes in the assumptions used to value the derivative liabilities, including the probability of a change in control, could result in a material change tothe carrying value of such liabilities.The change in the fair value of derivative liabilities is as follows (in thousands): October2009Warrants Long-TermDebt DerivativeLiabilities Totals Balance at December 31, 2012 $54,854 $14,577 $69,431 Gain on change in fair value of derivative liabilities (44,233) (3,477) (47,710) Compensation income for change in fair value of warrants issued to former employees (3,703) — (3,703) Transfers to equity (24) — (24) Balance at December 31, 2013 $6,894 $11,100 $17,994 Record initial fair value of derivative liability on 2014 senior notes — 3,500 3,500 Gain on change in fair value of derivative liabilities (6,272) (7,200) (13,472) Compensation income for change in fair value of warrants issued to former employees (503) — (503) Balance at December 31, 2014 $119 $7,400 $7,519 Segment and Geographical InformationOperating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis bythe chief operating decision-maker, or decision making group, in deciding how to allocate resources to an individual segment and in assessing performanceof the segment. The Company currently operates in one business segment, which is the development and commercialization of F-19Table of ContentsVascepa. A single management team that reports to the Company’s chief decision maker, who is the Chief Executive Officer, comprehensively manages thebusiness. Accordingly, the Company does not have separately reportable segments.Recent Accounting PronouncementsFrom time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted by the Company asof the specified effective date. The Company considered the following recent accounting pronouncements which were not yet adopted as of September 30,2014:In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” This amendment provides principles forrecognizing revenue for the transfer of promised goods or services to customers with the consideration to which the entity expects to be entitled in exchangefor those goods or services. This amendment will be effective for the Company’s fiscal year beginning January 1, 2017. Early adoption is not permitted. TheCompany is currently evaluating the accounting, transition and disclosure requirements of the standard and cannot currently estimate the financial statementimpact of adoption.In June 2014, the FASB issued guidance for accounting for share-based payments when the terms of an award provide that a performance target could beachieved after the requisite service period. The standard states that a performance target in a share-based payment that affects vesting and that could beachieved after the requisite service period should be accounted for as a performance condition. As such, the performance target should not be reflected inestimating the grant-date fair value of the award. The Company is required to adopt this standard in the first quarter of fiscal 2016 and early adoption ispermitted. This standard is not expected to have an impact on the Company’s consolidated financial statements.In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern, Disclosure of Uncertainties about an Entity’sAbility to Continue as a Going Concern (Subtopic 205-40). ASU 2014-15 requires management to assess an entity’s ability to continue as a going concern byincorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the ASU (i) provides a definition of the termsubstantial doubt, (ii) requires an evaluation every reporting period including interim periods, (iii) provides principles for considering the mitigating effect ofmanagement’s plans, (iv) requires certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (v) requires anexpress statement and other disclosures when substantial doubt is not alleviated and (vi) requires an assessment for a period of one year after the date that thefinancial statements are issued (or available to be issued). This standard is effective for the fiscal years ending after December 15, 2016, and for annualperiods and interim periods thereafter. Early application is permitted. The Company is currently evaluating the accounting, transition and disclosurerequirements of the standard and cannot currently estimate the financial statement impact of adoption.The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact onconsolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.(3) Intangible AssetsIntangible assets as of December 31, 2014 are as follows: Gross AccumulatedAmortization Net Weighted AverageRemaining UsefulLife (years) Technology rights $11,624 $(1,561) $10,063 15.6 F-20Table of ContentsAmortization expense for each of the years ended December 31, 2014 and 2013 was $0.6 million and is included in research and development expense.Estimated future amortization expense, based upon the Company’s intangible assets as of December 31, 2014 is as follows: Year Ending December 31, Amount 2015 $646 2016 646 2017 646 2018 646 2019 646 Thereafter 6,833 Total $10,063 (4) InventoryAfter approval of Vascepa on July 26, 2012 by the FDA, the Company began capitalizing its purchases of saleable inventory of Vascepa from suppliers thathave been qualified by the FDA. Inventories consist of the following (in thousands): December 31, 2014 December 31, 2013 Raw materials, current $5,225 $4,246 Work in process 4,757 11,310 Finished goods 3,751 5,026 Finished goods inventory held by others — 627 Total inventory, current 13,733 21,209 Raw materials, long-term — 5,482 Total inventory $13,733 $26,691 During the years ended December 31, 2014 and 2013, the Company wrote off zero and $1.8 million, respectively, of inventories deemed to be unrecoverable.In addition, as of December 31, 2014 and 2013, zero and $5.5 million, respectively, of raw material inventory was reclassified to long-term inventory, as itwas not anticipated to be sold within the next twelve months based on current estimates.(5) Property, Plant and EquipmentProperty, plant and equipment consist of the following (in thousands): December 31,2014 December 31,2013 Leasehold improvements $107 $107 Computer equipment 63 63 Furniture and fixtures 240 240 Software 559 559 969 969 Accumulated depreciation and amortization (588) (390) Construction in progress — — $381 $579 Depreciation expense for each of the years ended December 31, 2014, 2013, and 2012 was $0.2 million. F-21Table of Contents(6) Accrued Expenses and Other Current LiabilitiesAccrued expenses and other current liabilities consist of the following at December 31, 2014 and 2013 (in thousands): 2014 2013 Payroll and payroll-related expenses $3,525 $2,112 Research and development expenses (1) 4,391 — Sales and marketing accruals 1,509 2,922 Accrued revenue allowances 4,717 1,216 All other 2,126 3,344 $16,268 $9,594 (1)Research and development accruals are based on the timing of clinical trial activities and related progress payments. As of December 31, 2013, theCompany was in a prepaid position related to such expenses.(7) Warrants and Warrant Derivative LiabilityThe Company had 8,087,388 warrants to purchase common shares outstanding at December 31, 2014 at a weighted-average exercise price of $1.50, asdescribed below.October 2009 Warrants Derivative LiabilityOn October 16, 2009, the Company completed a $70.0 million private placement with both existing and new investors resulting in $62.3 million in netproceeds and an additional $3.6 million from bridge notes converted in conjunction with the private placement. In consideration for the $62.3 million in netcash proceeds Amarin issued 66.4 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $1.00 and (ii) awarrant with a five year term to purchase 0.5 of an ADS at an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6 million ofconvertible bridge notes, Amarin issued 4.0 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $0.90and (ii) a warrant with a five year term to purchase 0.5 of an ADS at an exercise price of $1.50 per ADS. The total number of warrants issued in conjunctionwith the financing was 35.2 million.In conjunction with the October 2009 financing, the Company issued an additional 0.9 million warrants to three former officers. The warrants issued inconnection with the October 2009 financing contained a pricing variability feature which provided for an increase to the exercise price if the exchange ratebetween the U.S. dollar and British pound adjusts such that the warrants could be exercised at a price less than the £0.5 par value of the common stock—thatis, if the exchange rate exceeded U.S. $3.00 per £1.0 sterling. Due to the potential variable nature of the exercise price, the warrants are not considered to beindexed to the Company’s common stock. Accordingly, the warrants do not qualify for the exception to classify the warrants within equity and are classifiedas a derivative liability.The fair value of this warrant derivative liability is remeasured at each reporting period, with changes in fair value recognized in the statement of operations.Upon exercise, the fair value of the warrants exercised is remeasured and reclassified from warrant derivative liability to additional paid-in-capital. Althoughthe warrants contain a pricing variability feature, the number of warrants issuable remains fixed. Therefore, the maximum number of common shares issuableas a result of the October 2009 private placement is 36.1 million. The change in fair value of the warrant derivative liability is discussed in Note 2.As of December 31, 2014, October 2009 warrants remained outstanding to purchase up to an aggregate of 8,087,388 of the ordinary shares of the Company at$1.50 per share. In October 2014, the Company and the holders of the remaining October 2009 warrants mutually agreed to extend the expiration date of suchwarrants from October 16, 2014 to February 27, 2015. F-22Table of ContentsJuly 2009 WarrantsThe Company issued several warrants in July 2009. As of December 31, 2014, there are no July 2009 warrants outstanding, while at December 31, 2013 thesewarrants were classified as equity instruments and included in the Company’s consolidated balance sheet within additional paid-in-capital. During the yearended December 31, 2014, 1,684,888 of the July 2009 warrants were exercised, resulting in proceeds to the Company of $1.7 million. During the year endedDecember 31, 2013, 120,000 of the July 2009 warrants were exercised, resulting in proceeds to the Company of $0.1 million.(8) DebtLong-Term Debt—December 2012 FinancingOn December 6, 2012, the Company entered into an agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma. Under thisagreement, the Company granted to BioPharma a security interest in future receivables associated with the Vascepa patent rights, in exchange for $100million received at the closing of the agreement which occurred in December 2012. The Company has agreed to repay BioPharma up to $150 million offuture revenue and receivables. As of December 31, 2014, the remaining amount to be repaid to BioPharma is $144.4 million. During the year endedDecember 31, 2014, the Company made repayments under the agreement of $4.8 million to BioPharma and an additional $1.6 million is scheduled to be paidin February 2015 for the fourth quarter of 2014. These payments were calculated based on the threshold limitation, as described below, as opposed to thescheduled quarterly repayments. Additional quarterly repayments, subject to the threshold limitation, are scheduled to be paid thereafter in accordance withthe following schedule: $10.0 million in the second quarter of 2015 and in each of the next three quarters, $15.0 million per quarter in each of the next fourquarters, and a final payment of $13.0 million scheduled for payment in May 2017. All such payments reduce the remainder of the $150 million in aggregatepayments to BioPharma. These quarterly payments are subject to a quarterly threshold amount whereby, if a calculated threshold, based on quarterly Vasceparevenues, is not achieved, the quarterly payment payable in that quarter can at the Company’s election be reduced and with the reduction carried forwardwithout interest for payment in a future period. The payment of any carried forward amount is subject to similarly calculated threshold repayment amountsbased on Vascepa revenue levels. Except upon a change of control in Amarin, the agreement does not expire until $150 million in aggregate has been repaid.The Company can prepay an amount equal to $150 million less any previously repaid amount.The Company currently estimates that its Vascepa revenue levels will not be high enough in each quarter to support repayment to BioPharma in accordancewith the amounts in the repayment schedule. For each quarterly period since the inception of the debt, revenues were below the contractual threshold amountsuch that cash payments were calculated for each period reflecting the optional reduction amount as opposed to the contractual threshold payment due foreach quarterly period. In accordance with the agreement with BioPharma, quarterly differences between the calculated optional reduction amounts and therepayment schedule amounts are rescheduled for payment beginning in the second quarter of 2017. Any such deferred repayments will remain subject tocontinued application of the quarterly ceiling in amounts due established by the calculated threshold limitation based on quarterly Vascepa revenues. Noadditional interest expense or liability is incurred as a result of such deferred repayments. These estimates will be reevaluated each reporting period by theCompany and adjusted if necessary, prospectively.The Company determined the redemption feature upon a change of control to be an embedded derivative requiring bifurcation. The fair value of theembedded derivative was calculated by determining the fair value of the debt with the change in control provision included and also without the change incontrol provision. The difference between the two fair values of the debt was determined to be the fair value of the embedded derivative, and upon closingthe Company recorded a derivative liability of $14.6 million as a reduction to the note payable. The fair value of this derivative liability is remeasured ateach reporting period, with changes in fair value recognized in the statement of operations and any changes in the assumptions used in measuring the F-23Table of Contentsfair value of the derivative liability could result in a material increase or decrease in its carrying value. The Company recognized a gain on change in fairvalue of derivative liability of $6.3 million and $3.5 million during the years ended December 31, 2014 and 2013, respectively.During the year ended December 31, 2014, the Company recorded $7.2 million and $1.9 million of cash and non-cash interest expense, respectively, on theBioPharma debt. During the year ended December 31, 2013, the Company recorded $11.3 million and $2.6 million of cash and non-cash interest expense,respectively. The Company will periodically evaluate the remaining term of the agreement and the effective interest will be recalculated each period basedon the Company’s most current estimate of repayment.To secure the obligations under the agreement with BioPharma, the Company granted BioPharma a security interest in the Company’s patents, trademarks,trade names, domain names, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoingand all proceeds of the foregoing, referred to collectively as the collateral. If the Company (i) fails to deliver a payment when due and does not remedy thatfailure within a specific notice period, (ii) fails to maintain a first-priority perfected security interest in the collateral in the United States and does not remedythat failure after receiving notice of such failure or (iii) becomes subject to an event of bankruptcy, then BioPharma may attempt to collect the maximumamount payable by the Company under this agreement (after deducting any payments the Company has already made).January 2012 Exchangeable Senior NotesIn January 2012, the Company issued $150.0 million in principal amount of 3.5% exchangeable senior notes due 2032, a portion of which were subsequentlyexchanged (see discussion of May 2014 Exchangeable Senior Notes below). The 2012 Notes were issued by Corsicanto Limited, an Irish limited companyacquired by Amarin in January 2012. Corsicanto Limited is a wholly-owned subsidiary of Amarin. The general, unsecured, senior obligations are fully andunconditionally guaranteed by Amarin but not by any of the Company’s other subsidiaries. Corsicanto Limited has no assets, operations, revenues or cashflows other than those related to the issuance, administration and repayment of the 2012 Notes and 2014 Notes. There are no significant restrictions on theability of Amarin to obtain funds from Corsicanto Limited in the form of cash dividends, loans, or advances. Net proceeds to the Company, after payment ofunderwriting fees and expenses, were approximately $144.3 million.The 2012 Notes have a stated interest rate of 3.5% per year, payable semiannually in arrears on January 15 and July 15 of each year beginning on July 15,2012, and ending upon the 2012 Notes’ maturity on January 15, 2032. The 2012 Notes are subject to repurchase by the Company at the option of the holderson each of January 19, 2017, January 19, 2022, and January 19, 2027, at a price equal to 100% of the principal amount of the 2012 Notes to be repurchased,plus accrued and unpaid interest to, but excluding, the repurchase date. The 2012 Notes are exchangeable under certain circumstances into cash, ADSs, or acombination of cash and ADSs, at the Company’s election, with an initial exchange rate of 113.4752 ADSs per $1,000 principal amount of 2012 Notes. If theCompany elected physical settlement, the net remaining outstanding portion of the 2012 Notes would be exchangeable into 3,547,916 ADSs after the May2014 exchange of a portion of the 2012 Notes (see below for further discussion of the May 2014 exchange). Based on the closing price of the Company’sstock at December 31, 2014, the principal amount of the 2012 Notes would exceed the value of the shares if converted on that date by $27.8 million.Additional covenants include: (i) limitations on future indebtedness under certain circumstances, (ii) the timely filing of documents and reports pursuant toSection 13 or 15(d) of the Exchange Act with both the SEC and the Trustee and (iii) maintaining the tradability of the 2012 Notes. The Company is requiredto use commercially reasonable efforts to procure and maintain the listing of the 2012 Notes on the Global Exchange Market operated under the supervisionof the Irish Stock Exchange (or other recognized stock exchange as defined in the Note Indenture) prior to July 15, 2012. If the 2012 Notes are not freelytradable, as a result of restrictions pursuant to U.S. securities law or the terms of the Indenture or the 2012 Notes, the Company shall pay additional interest on F-24Table of Contentsthe 2012 Notes at the rate of 0.50% per annum of the principal amount of 2012 Notes outstanding for each day during such period for which the Company’sfailure to file has occurred and is continuing or for which the 2012 Notes are not freely tradable.The Company may not redeem the 2012 Notes prior to January 19, 2017, other than in connection with certain changes in the tax law of a relevant taxingjurisdiction that results in additional amounts becoming due with respect to payments and/or deliveries on the 2012 Notes. On or after January 19, 2017 andprior to the maturity date, the Company may redeem for cash all or part of the 2012 Notes at a redemption price equal to 100% of the principal amount of the2012 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. There is no prepayment penalty or sinking fundprovided for the 2012 Notes. If the Company undergoes a change in control, holders may require the Company to repurchase for cash all or part of their 2012Notes at a repurchase price equal to 100% of the principal amount of the 2012 Notes to be repurchased, plus accrued and unpaid interest to, but excluding,the change in control repurchase date. The 2012 Notes are the Company’s senior unsecured obligations and rank senior in right of payment to the Company’sfuture indebtedness that is expressly subordinated in right of payment to the 2012 Notes and equal in right of payment to the Company’s future unsecuredindebtedness that is not so subordinated. The 2012 Notes are effectively junior in right of payment to future secured indebtedness to the extent of the valueof the assets securing such indebtedness.The 2012 Notes are exchangeable under certain circumstances. At the time of issuance, the Company calculated the fair value of the liability component ofthe outstanding 2012 Notes to be $126.2 million, and the excess of the principal amount of the debt over the liability component of $23.8 million wasallocated to the conversion option resulting in a discount on the debt and corresponding increase in equity as a result of the cash settlement feature. Thediscount created from allocating proceeds to the conversion option is being amortized to interest expense using the effective interest method over the 2012Notes’ estimated remaining life, which was calculated to be a period of twenty-four months. As of December 31, 2014, the discount created from theallocation of the proceeds to the conversion option was fully amortized. The conversion option will not be subsequently remeasured as long as it continuesto meet the criteria for equity classification.The Company also recorded a debt discount to reflect the value of the underwriter’s discounts and offering costs. A portion of the debt discount fromunderwriter’s discounts and offering costs was allocated to the equity and liability components of the 2012 Notes in proportion to the proceeds allocated toeach component. The portion of the debt discount from underwriter’s discounts and offering costs allocated to the liability component was amortized asinterest expense over the estimated life of the 2012 Notes of twenty-four months. As of December 31, 2014, the debt discount was fully amortized and thecarrying value of the 2012 Notes was $31.3 million after an exchange of a portion of the 2012 Notes (see below for further discussion of the May 2014exchange).May 2014 Exchangeable Senior NotesIn May 2014, the Company entered into separate, privately negotiated exchange agreements with certain holders of the 2012 Notes pursuant to whichCorsicanto exchanged $118.7 million in aggregate principal amount of the existing 2012 Notes for $118.7 million in aggregate principal amount of new3.50% May 2014 Exchangeable Senior Notes due 2032, following which $31.3 million in aggregate principal amount of the 2012 Notes remainedoutstanding with terms unchanged (the 2012 Notes and 2014 Notes are referred to collectively as the “Notes”).The 2014 Notes have a stated interest rate of 3.5% per year, payable semiannually in arrears on January 15 and July 15 of each year beginning on July 15,2014, and ending upon the 2014 Notes’ maturity on January 15, 2032, unless earlier repurchased or redeemed by Corsicanto or exchanged by the holders. Atany time after the issuance of the 2014 Notes and prior to the close of business on the second business day immediately preceding January 15, 2032, holdersmay exchange the 2014 Notes at their option. If prior to January 15, 2018, a make-whole fundamental change (as defined in the Indenture) occurs or theCompany elects to redeem the 2014 Notes F-25Table of Contentsin connection with certain changes in tax law, in each case as described in the Indenture, and a holder elects to exchange its 2014 Notes in connection withsuch make-whole fundamental change or election, as the case may be, such holder may be entitled to an increase in the exchange rate as described in theIndenture. In the event of physical settlement, the 2014 Notes would be exchangeable into 45,666,925 ADSs. The initial exchange rate is 384.6154 ADSs per$1,000 principal amount of the 2014 Notes (equivalent to an initial exchange price of approximately $2.60 per ADS, or the Exchange Price), subject toadjustment in certain circumstances. The exchange rate is subject to adjustment from time to time upon the occurrence of certain events, including, but notlimited to, the payment of cash dividends. Based on the closing price of the Company’s stock at December 31, 2014, the principal amount of the 2014 Noteswould exceed the value of the shares if converted on that date by $74.0 million.Prior to January 19, 2018, the Company may not redeem the 2014 Notes at its option other than in connection with certain changes in the tax law of arelevant taxing jurisdiction that results in additional amounts (as defined in the Indenture) becoming due with respect to payments and/or deliveries on the2014 Notes. On or after January 19, 2018, the Company may redeem for cash all or a portion of the 2014 Notes at a redemption price of 100% of theaggregate principal amount of the 2014 Notes to be redeemed, plus accrued and unpaid interest to, but not including, the redemption date. If a fundamentalchange (as defined in the Indenture) occurs, holders may require the Company to repurchase all or part of their 2014 Notes for cash at a fundamental changerepurchase price equal to 100% of the aggregate principal amount of the 2014 Notes to be repurchased, plus accrued and unpaid interest to, but notincluding, the fundamental change repurchase date. In addition, holders of the 2014 Notes may require the Company to repurchase all or any portion of the2014 Notes on each of January 19, 2019, January 19, 2024 and January 19, 2029 for cash at a price equal to 100% of the aggregate principal amount of the2014 Notes to be repurchased, plus accrued and unpaid interest to, but not including, the repurchase date.The Company may elect at its option to cause all or any portion of the 2014 Notes to be mandatorily exchanged in whole or in part at any time prior to theclose of business on the business day preceding January 15, 2032 if the Daily VWAP (as defined in the Indenture) equals or exceeds 110% of the ExchangePrice then in effect for at least 20 VWAP Trading Days (as defined in the Indenture) in any 30 VWAP Trading Day period. The Company may only exerciseits optional exchange rights upon satisfaction of specified equity conditions, including that the ADSs issuable upon exchange of the 2014 Notes be eligiblefor resale without registration by non-affiliates and listed on The NASDAQ Global Market, its related exchanges or the New York Stock Exchange. IfCorsicanto elects to exercise its optional exchange rights on or prior to January 15, 2018, each holder whose 2014 Notes are exchanged will upon exchangereceive a specified number of additional ADSs as set forth in the Indenture. Upon such a declaration of acceleration, such principal and accrued and unpaidinterest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involvingCorsicanto, 100% of the principal of and accrued and unpaid interest, if any, on all of the 2014 Notes will become due and payable automatically.Notwithstanding the foregoing, the Indenture will provide that, to the extent Corsicanto elects and for up to 360 days, the sole remedy for an event of defaultrelating to certain failures by Corsicanto or the Company, as the case may be, to comply with certain reporting covenants in the Indenture consistsexclusively of the right to receive additional interest on the 2014 Notes. Additional covenants pertaining to the 2012 Notes (as described above for theJanuary 2012 Exchangeable Senior Notes) are also applicable to the May 2014 Notes.As a result of the note exchange (as described above), the Company assessed both quantitative and qualitative aspects of the features of the 2014 Notes ascompared to the 2012 Notes. Such assessment resulted in the conclusion that the features of the 2014 Notes represent a substantive modification from the2012 Notes as the terms of the exchange resulted in a substantive modification to the embedded conversion feature within the 2012 Notes, and as suchshould be accounted for as an extinguishment of debt. In accordance with ASC 470-20, the Company extinguished the 2012 Notes by recording a gain onextinguishment of the liability component of $38.0 million and repurchase of the conversion option in equity through a reduction to additional paid-incapital of $10.1 million. The 2014 Notes were recorded at fair value of $90.8 million representing a $27.9 million discount to par. In addition the Companyrecognized $2.5 million in underwriter’s fees and offering costs and recognized F-26Table of Contentsthose costs as deferred assets. The Company further allocated $3.5 million of the $90.8 million fair value of the 2014 Notes to the derivative liability relatedto the fundamental change redemption feature (as described above), which will be measured at fair value on an ongoing basis. During the year endedDecember 31, 2014, the Company recognized a $0.9 million gain on the change in fair value of the redemption feature. The fair value of this derivativeliability is remeasured at each reporting period, with changes in fair value recognized in the statement of operations and any changes in the assumptions usedin measuring the fair value of the derivative liability could result in a material increase or decrease in its carrying value.Because the conversion option in the 2014 Notes receives an exception from derivative accounting and only requires gross physical settlement in shares, theembedded option does not require separate accounting and is therefore accounted for as part of the debt host at amortized cost. The debt discount is beingamortized as interest expense over the estimated life of the 2014 Notes and recognized in the statement of operations as interest expense. As of December 31,2014, the carrying value of the 2014 Notes was $90.6 million. During the year ended December 31, 2014, the Company recognized aggregate interestexpense of $9.5 million related to the Notes, of which $4.2 million represents non-cash interest and $5.3 million, represents contractual coupon interest. AtDecember 31, 2014 and 2013, the Company had accrued interest on the Notes of $2.4 million in each year, which is included in other current liabilities. TheCompany made the contractual interest payments due on the Notes during the years ended December 31, 2014 and 2013 of $5.3 million.(9) Commitments and ContingenciesLitigationOn November 1, 2013, a purported investor of Amarin filed a putative class action lawsuit captioned Steven Sklar v. Amarin Corporation plc et al., No. 13-cv-6954 (D.N.J. Nov. 1, 2013) in the U.S. District Court for the District of New Jersey. Substantially similar lawsuits, captioned Bove v. Amarin Corporationplc, Civ. No. 13-07882 (AT) (S.D.N.Y. Nov. 5, 2013), Bentley v. Amarin Corporation plc, Civ. No. 13-08283 (AT) (S.D.N.Y. Nov. 20, 2013) and Siegel v.Amarin Corporation plc, No. 3:13-cv-07210 (D.N.J. Nov. 27, 2013), were subsequently filed in the U.S. District Court for the District of New Jersey and U.S.District Court for the Southern District of New York. On December 9, 2013, the cases filed in the Southern District of New York were transferred to the Districtof New Jersey and all such cases are now consolidated as In re Amarin Corporation plc, Securities Litigation, No. 3:13-cv-06663 (D.N.J. Nov. 1, 2013). Theplaintiffs assert claims under the Securities Exchange Act of 1934 and allege that Amarin and certain of its current and former officers and directors mademisstatements and omissions regarding the FDA’s willingness to approve Vascepa’s ANCHOR indication and related contributing factors and the potentialrelevance of data from the ongoing REDUCE-IT trial to that approval. The lawsuit seeks unspecified monetary damages and attorneys’ fees and costs. TheCompany believes that it has valid defenses and will vigorously defend against this class action suit, but cannot predict the outcome. The Company is unableto reasonably estimate the loss exposure, if any, associated with the claims. The Company has insurance coverage that is anticipated to cover any significantloss exposure that may arise from this action after payment by the Company of the associated deductible obligation under such insurance coverage.On February 27, 2014, the Company commenced a lawsuit against the FDA that challenges FDA’s denial of the Company’s request for five-year NCEexclusivity for Vascepa based on its reading of the relevant statute, the Company’s view of FDA’s inconsistency with past actions in this area and theretroactive effect of what the Company believes is a new policy at FDA as it relates to Vascepa situation. The Company’s complaint requests that the courtvacate FDA’s decision, declare that Vascepa is entitled to the benefits of five-year statutory exclusivity, bar the FDA from accepting any ANDA or similarapplication for which Vascepa is the reference-listed drug until after the statutory exclusivity period and set aside what the Company contends are—due tothe denial of five-year exclusivity to Vascepa—prematurely accepted pending ANDA applications.In March, April, and May 2014, the Company received paragraph IV certification notices from six companies contending to varying degrees that certain of itspatents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of Vascepa as described in thosecompanies’ F-27Table of Contentsabbreviated new drug applications, or ANDAs. The Company has commenced patent infringement lawsuits against each of these ANDA applicants. In each ofthe lawsuits, Amarin is seeking, among other remedies, an order enjoining the defendants from marketing generic versions of Vascepa before the last to expireof the asserted patents expires in 2030. In April 2014, Amarin filed lawsuits against Apotex, Inc. and Apotex Corporation, or collectively, Apotex, in the U.S.District Court for the District of New Jersey and the U.S. District Court for the Northern District of Illinois. The cases against Apotex are captioned AmarinPharma, Inc. et al. v. Apotex, Inc. et al., Civ. A. No. 14-2550 (D.N.J) and Amarin Pharma, Inc. et al. v. Apotex, Inc. et al., Civ. A. No. 14-2958 (N.D. Ill.). InApril 2014, Amarin also filed lawsuits against Roxane Laboratories, Inc., or Roxane, in the U.S. District Court for the District of New Jersey and the U.S.District Court for the Northern District of Ohio. The cases against Roxane are captioned Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc., Civ. A.No. 14-2551 (D.N.J) and Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc., Civ. A. No. 14-901 (N.D. Ohio). Amarin voluntarily dismissed the NorthernDistrict of Ohio case against Roxane on May 7, 2014. In April 2014, Amarin also filed a lawsuit against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’sLaboratories, Ltd., or collectively, Dr. Reddy’s, in the U.S. District Court for the District of New Jersey. The case against Dr. Reddy’s is captioned AmarinPharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civ. A. No. 14-2760 (D.N.J.). In May 2014, Amarin also filed a lawsuit against WatsonLaboratories, Inc. and Actavis plc, or Watson, in the U.S. District Court for the District of New Jersey. One of the Company’s directors, Patrick J. O’Sullivan, isalso a director of Actavis plc. The case against Watson is captioned Amarin Pharma, Inc. et al. v. Watson Laboratories, Inc. et al., Civ. A. No. 14-3259(D.N.J). On July 17, 2014, Amarin agreed to dismiss Actavis plc but the lawsuit against Watson remains pending. In June 2014, Amarin also filed a caseagainst Teva Pharmaceuticals USA, Inc., or Teva, in the U.S. District Court for the District of New Jersey. The case against Teva is captioned Amarin Pharma,Inc. et al. v. Teva Pharmaceuticals USA, Inc., Civ. A. No. 14-3558 (D.N.J.). In June 2014, Amarin also filed a lawsuit against Andrx Labs, LLC, AndrxCorporation, and Actavis plc, or collectively, Andrx, in the U.S. District Court for the District of New Jersey. The case against Andrx is captioned AmarinPharma, Inc. et al v. Andrx Labs, LLC et. al., Civ. A. No. 14-3924 (D.N.J.). As a result of the 30-month stay associated with the filing of these lawsuits underthe Hatch-Waxman Act, the FDA cannot grant final approval to any ANDA before September 2016, unless there is an earlier court decision holding that thesubject patents are not infringed and/or are invalid. The Company intends to vigorously enforce its intellectual property rights relating to Vascepa, butcannot predict the outcome of these lawsuits.In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, andthreats of litigation relating to intellectual property, commercial arrangements and other matters. While the outcome of these proceedings and claims cannotbe predicted with certainty, as of December 31, 2014, the Company was not party to any legal or arbitration proceedings that may have, or have had in therecent past, significant effects on the Company’s financial position or profitability. No governmental proceedings are pending or, to its knowledge,contemplated against the Company. The Company is not a party to any material proceedings in which any director, member of senior management or affiliateis either a party adverse to the Company or its subsidiaries or has a material interest adverse to the Company or its subsidiaries.LeasesThe Company leases office space and office equipment under operating and capital leases. Future minimum lease payments under these leases as ofDecember 31, 2014 are as follows (in thousands): Year Ending December 31, Operating 2015 $636 2016 617 2017 628 2018 158 2019 — Total $2,039 F-28Table of ContentsOn September 30, 2011, the Company entered into an agreement for 320 square feet of office space at 2 Pembroke House, Upper Pembroke Street 28-32 inDublin, Ireland. The office space was subsequently reduced to 270 square feet, effective November 1, 2013. The agreement began November 1, 2011 andterminates on October 31, 2015 and can be extended automatically for successive one year periods. Monthly rent is approximately €2,800 (approximately$3,400). The agreement can be terminated by either party with three months prior written notice.On July 1, 2011, the Company leased 9,747 square feet of office space in Bedminster, New Jersey. The lease, as amended, terminates on March 31,2018, and may also be terminated with six months prior notice. On December 6, 2011 the Company leased an additional 2,142 square feet of space in thesame location. On December 15, 2012 and May 8, 2013, the Company leased an additional 2,601 and 10,883 square feet of space, respectively, in the samelocation. In January 2014 and April 2014, the Company entered into separate transactions with the landlord of this property to vacate approximately 2,142and 2,000 square feet of space in exchange for discounts on contractual future rent payments. Additionally, in January 2015, the Company executed anagreement to sublease approximately 4,700 square feet of this property to a third party, effective April 1, 2015.Total rent expense during the years ended 2014, 2013 and 2012 was approximately $1.0 million, $1.0 million, and $0.6 million, respectively.Milestone and Supply Purchase ObligationsThe Company entered into several product development agreements with, subject to performance obligations, certain milestone and supply purchaseobligations, as detailed below: • The Company entered into its initial Vascepa API supply agreement with Nisshin Pharma, Inc., or Nisshin, in 2010. In 2011, the Companyentered into agreements with two additional suppliers, Chemport, Inc., or Chemport, and BASF (formerly Equateq Limited) for the supply of API.In 2012, the Company agreed to terms with a fourth API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc. (Slanmhor).These agreements included requirements for the suppliers to meet certain product specifications and qualify their materials and facilities withapplicable regulatory authorities including the FDA. The Company has incurred certain costs associated with the qualification of productproduced by these suppliers as described below.Chemport was approved by the FDA to manufacture API for commercial sale in April 2013. The Company began purchasing commercial supplyfrom Chemport in 2013. The agreement with Chemport contains a provision requiring the Company to pay Chemport in cash for any shortfall inthe minimum purchase obligations. The 2011 supply agreement with Chemport includes commitments for the Company to fund (i) certaindevelopment fees, (ii) material purchases for initial raw materials, which amount will be credited against future API purchases and (iii) a rawmaterial purchase commitment. During the year ended December 31, 2014, the Company made payments of $6.7 million to Chemport.Chemport together with Nisshin are currently the two manufacturers from which the Company purchases API. The Company has no royalty,milestone or minimum purchase commitments with Nisshin.The API supply agreement with BASF terminated in February 2014. In April 2014, the Company reached a settlement agreement with BASFunder which it received a refund for material purchases of $3.0 million, included as other income in the statement of operations. The Companymade payments of $3.1 million to BASF related to development and supply commitments through December 31, 2014.The Company made payments of $6.2 million to the Slanmhor consortium related to development fees and other provisions throughDecember 31, 2014 and during the year ended December 31, 2014 and 2013, made payments of $0.4 million and $6.1 million, respectively, tothe Slanmhor consortium related to stability and technical batches and advances on anticipated future API purchases. F-29Table of ContentsPursuant to the agreements with the Company’s suppliers, there is a total of $55.5 million that is potentially payable over the term of suchagreements based on minimum purchase obligations. • Concurrent with its entry into one of its API supply agreements, the Company agreed to make a non-controlling minority share equityinvestment in the supplier of $3.3 million. The Company invested $1.7 million under this agreement in July 2011 and the remaining $1.6million during 2012. In September 2013, the Company entered into an equity sale and purchase agreement between this supplier and a thirdparty in which the Company agreed to sell approximately $1.3 million of its investment in the supplier to the third party at cost. This transactionclosed in the first quarter of 2014. In August 2014, the Company entered into a second equity sale and purchase agreement between this supplierand another third party in which the Company agreed to sell approximately $1.0 million of the remaining investment. This transaction closed inthe fourth quarter of 2014. The carrying amount of the investment of $0.2 million and $3.3 million as of December 31, 2014 and 2013,respectively, is included in other long term assets and is accounted for under the cost method. • Under the 2004 share repurchase agreement with Laxdale Limited, or Laxdale, upon receipt of marketing approval in Europe for the firstindication for Vascepa (or first indication of any product containing Amarin Neuroscience intellectual property acquired from Laxdale in 2004),the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of£7.5 million (approximately $11.7 million at December 31, 2014). Also under the Laxdale agreement, upon receipt of a marketing approval inthe U.S. or Europe for a further indication of Vascepa (or further indication of any other product using Amarin Neuroscience intellectualproperty), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately$7.8 million at December 31, 2014) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $15.5 million atDecember 31, 2014).The Company has no provision for any of the obligations above since the amounts are either not probable or able to be estimated atDecember 31, 2014.(10) EquityDuring the year ended December 31, 2014, the Company received a refund of $3.2 million for UK stamp duty taxes paid in prior periods related to theissuance of common stock. Such proceeds were recorded as an increase to additional paid-in capital.During the years ended December 31, 2014 and 2013, the Company issued 234,500 and 386,000 shares, respectively, as a result of the exercise of stockoptions, resulting in gross and net proceeds of $0.3 million during the year ended December 31, 2014 and $0.6 million during the year ended December 31,2013. In addition, during the year ended December 31, 2014 and 2013, the Company issued 1,684,888 and 147,050 shares, respectively, as a result of theexercise of warrants, resulting in gross and net proceeds of $1.7 million during the year ended December 31, 2014 and $0.2 million during the year endedDecember 31, 2013.On March 11, 2014, the Company granted a total of 173,348 restricted stock units, or RSUs, and 205,890 stock options to members of the Company’s Boardof Directors under the Amarin Corporation plc 2011 Stock Incentive Plan, or the 2011 Plan. The RSUs vest in equal installments over a three year periodcommencing with each installment vesting each year upon the earlier of the anniversary of the grant date or the Company’s annual general meeting ofshareholders in such anniversary year. The RSUs will become fully vested upon a change of control of the Company. Upon termination of service to theCompany, each Director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock, which is required to be made inshares. The stock options vest in full upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in suchanniversary year. The stock options will become fully vested upon a change of control of the Company. F-30Table of ContentsOn January 8, 2014, the Company granted a total of 2,082,000 RSUs and 2,605,500 stock options to employees under the 2011 Plan. The RSU’s vestannually over a three year period and the stock options vest monthly over a four year period, with both becoming fully vested upon a change of control of theCompany.In January 2013, the Company granted 454,875 RSUs to several employees under the 2011 Plan. The terms of these RSUs provided for vesting upon theachievement of certain operational milestones. In the year ended December 31, 2013, as a result of the operational milestones not being achieved, all of theseRSU’s were forfeited and no shares were issued as a result of vesting.(11) Income TaxesAs of December 31, 2014 and 2013, interest and penalties related to any uncertain tax positions have been insignificant. The Company recognizes interestand penalties related to uncertain tax positions within the provision for income taxes. The total amount of unrecognized tax benefits that would affect theCompany’s effective tax rate if recognized is $1.4 million as of December 31, 2014, as compared to $1.7 million as of December 31, 2013.The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31, 2014, 2013 and 2012 (in thousands): 2014 2013 2012 Beginning uncertain tax benefits $1,674 $1,243 $997 Current year—increases 1,067 687 294 Current year—decreases for lapses in statutes of limitations (254) (256) (48) Ending uncertain tax benefits $2,487 $1,674 $1,243 The Company files income tax returns in the U.S., Ireland and United Kingdom. The Company remains subject to tax examinations in the followingjurisdictions as of December 31, 2014: Jurisdiction Tax Years United States (Federal and State) 2011-2014 Ireland 2009-2014 United Kingdom 2013-2014 The Company expects gross liabilities of $439,000 to expire in 2015 based on statutory lapses.The components of loss from operations before taxes were as follows at December 31, 2014, 2013 and 2012 (in thousands): 2014 2013 2012 United States $(7,331) $(9,234) $1,874 Ireland and United Kingdom (51,870) (160,187) (171,942) $(59,201) $(169,421) $(170,068) F-31Table of ContentsThe (benefit) expense from income taxes shown in the accompanying consolidated statements of operations consists of the following for fiscal 2014, 2013and 2012 (in thousands): 2014 2013 2012 Current: Federal-U.S. $660 $122 $10,265 State-U.S. 117 118 2,565 Total Current $777 $240 $12,830 Deferred: Federal-U.S. (3,689) (4,065) (2,803) State-U.S. (226) 631 (911) Ireland and United Kingdom 3,335 (33,106) (22,515) Change in valuation allowance (3,034) 33,106 22,515 Total Deferred $(3,614) $(3,434) $(3,714) $(2,837) $(3,194) $9,116 The (benefit) expense from income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to thefollowing for fiscal 2014, 2013 and 2012 (in thousands): 2014 2013 2012 Benefits from taxes at statutory rate $(14,786) $(42,355) $(42,517) Rate differential 9,493 18,494 13,249 Change in valuation reserves (3,034) 33,106 22,515 Warrant derivative liabilities (2,706) (11,984) 8,904 Gain on extinguishment of debt (9,509) — — Research and development credits (1,455) (2,008) (48) Tax return to provision adjustments 10,026 125 375 Cumulative translation adjustment 8,061 (280) — Permanent and other 1,073 1,708 6,638 $(2,837) $(3,194) $9,116 During 2014, the Company recorded adjustments to its deferred tax accounts related to the impact of foreign exchange rate changes and to reconcile thefinancial statement accounts to the amounts reported on its filed 2013 foreign tax returns, primarily for the impact of US GAAP to local statutory adjustments.These adjustments were fully offset with valuation allowances based on the Company’s position with respect to the realizability of its recorded deferred taxassets for non-US entities.The Company is subject to corporate tax rate in Ireland of 25% for non-trading activities and 12.5% for trading activities. For the years ended December 31,2014, 2013 and 2012, the Company applied the statutory corporate tax rate of 25% for Amarin Corporation plc, reflecting the non-trading tax rate in Ireland.However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5% Irish tradingtax rate. F-32Table of ContentsThe income tax effect of each type of temporary difference comprising the net deferred tax asset at December 31, 2014 and 2013 is as follows (in thousands): 2014 2013 Deferred tax assets: Net operating losses $80,096 $85,724 Stock based compensation 15,600 11,660 Depreciation (90) (126) Tax credits 2,141 1,256 Other reserves and accrued liabilities 1,708 2,900 Gross deferred tax asset 99,455 101,414 Less: valuation allowance (85,965) (88,999) $13,490 $12,415 The Company assesses whether it is more-likely-than-not that the Company will realize its deferred tax assets. The Company determined that it was more-likely-than-not that the Irish, UK, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a fullvaluation allowance has been provided for all periods.The following table reflects the activity in the valuation allowance for the years ended December 31, 2014 and 2013 (in thousands): 2014 2013 Beginning valuation allowance $88,999 $55,894 Increase as reflected in income tax expense 5,081 32,999 Cumulative translation adjustment (8,115) 106 Ending valuation allowance $ 85,965 $ 88,999 The Company has combined Irish, UK, and Israeli net operating loss carryforwards of $513.3 million, which do not expire. The total net operating losscarryforwards decreased by approximately $14.9 million from the prior year primarily as a result of the impact of foreign exchange rate changes andadjustments to reconcile the financial statement accounts to the amounts reported on the filed 2013 foreign tax returns, which were in excess of current yeartaxable losses generated in these countries. In addition, the Company has available U.S. Federal tax credit carryforwards of $6.2 million and state tax creditcarryforwards of $1.4 million. These amounts exclude the impact of any unrecognized tax benefits. These carryforwards, which will expire starting between2020 and 2034 may be used to offset future taxable income, if any.The Company recognized a tax benefit related to the extension of the research and development credits retroactively enacted during the fourth quarter of2014 and recorded a benefit of approximately $1.4 million for the credit generated during the year.(12) Stock Incentive Plans and Stock Based CompensationOn April 29, 2011 the Board, upon the recommendation of the Remuneration Committee, adopted the 2011 Stock Incentive Plan (“2011 Plan”), which wasapproved by the Company’s shareholders on July 12, 2011. The 2011 Plan replaced the Company’s 2002 Stock Option Plan (“2002 Plan”), which expired onJanuary 1, 2012. The maximum number of the Company’s Ordinary Shares of £0.50 each or any ADS’s, as to be issued under the 2011 Plan shall not exceedthe sum of (i) 3.5 million newly authorized Shares available for award and (ii) the number of Shares that remained available for grants under the Company’s2002 Plan and (iii) the number of F-33Table of ContentsShares underlying then outstanding awards under the 2002 Plan that could be subsequently forfeited, cancelled, expire or are otherwise terminated. Theaward of stock options (both incentive and non-qualified options) and restricted stock units, and awards of unrestricted Shares to Directors are permitted. The2011 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 12, 2021.In addition to the grants under the 2011 Plan, the Company grants nonqualified stock options to employees to purchase the Company’s ordinary shares.These grants are made pursuant to employment agreements on terms consistent with the 2011 Plan.Under the terms of the 2011 Plan, and grants made pursuant to employment agreements, options typically vest over a four year period, expire after a 10 yearterm and are granted at an exercise price equal to the closing price of the Company’s American Depository Shares on the grant date. The following tablesummarizes all stock option activity for the year ended December 31, 2014 (in thousands, except for per share amounts): Number ofShares WeightedAverageExercisePrice WeightedAverageRemainingContractualTerm AggregateIntrinsicValue Outstanding January 1, 2014 9,330 $6.64 Granted 3,271 1.99 Cancelled/Expired (1,696) 9.02 Exercised (235) 1.31 Outstanding, December 31, 2014 10,670 4.95 7.7 years $— Exercisable, December 31, 2014 7,263 5.33 7.3 years $— Vested and Expected to Vest, December 31, 2014 1,630 6.03 8.2 years $— Available for future grant at December 31, 2014 5,578 The weighted average fair value of the stock options granted during the years ended December 31, 2014, 2013 and 2012 was $1.58, $6.18 and $8.79,respectively.During the years ended December 31, 2014 and 2013, the Company received cash of $0.3 million and $0.6 million from the exercise of options. The intrinsicvalue of options exercised during 2014 was $0.2 million and $2.4 million during 2013. As of December 31, 2014 and 2013, there was $9.4 million and $15.7million of unrecognized stock-based compensation expense related to unvested stock option share-based compensation arrangements granted under theCompany’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately 2.4 years. There was a provisionof $2.3 million and a provision of $0.4 million for the years ended December 31, 2014 and 2013, respectively, reflected within the consolidated statement ofcash flows related to excess tax provision on the U.S. federal level that have been realized as an increase in taxes payable. The Company recognizescompensation expense for the fair values of those awards which have graded vesting on a straight line basis.The fair value of options on the date of grant was estimated using the Black-Scholes option pricing model. Use of a valuation model requires management tomake certain assumptions with respect to selected model inputs. Expected stock price volatility was calculated based on the historical volatility of theCompany’s common stock over the expected life of the option. The expected life was determined based on the short-cut method based on the term andvesting period. The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity term approximating the expected life of the optionat the date of grant. No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipatedoing so in the foreseeable future. Estimated forfeitures are based on the Company’s historical forfeiture activity. F-34Table of ContentsEmployee stock options granted prior to June 30, 2009 generally vested over a three-year service period. Employee stock options granted after June 30, 2009generally vest over a four-year service period and all stock options are settled by the issuance of new shares. Compensation expense recognized for all optiongrants is net of estimated forfeitures and is recognized over the awards’ respective requisite service periods. The Company recorded compensation expense inrelation to stock options of $7.7 million, $14.3 million and $16.7 million for the years ended December 31, 2014, 2013 and 2012, respectively.For 2014, 2013 and 2012, the Company used the following assumptions to estimate the fair value of share-based payment awards: 2014 2013 2012Risk free interest rate 1.37% - 1.68% 0.91% - 2.07% 0.81% - 1.39%Expected dividend yield 0.00% 0.00% 0.00%Expected option life (years) 6.25 6.25 6.25Expected volatility 97% - 109% 91% - 110% 109% - 111%Restricted Stock UnitsThe 2011 Plan also allows for granting of restricted stock unit awards under the terms of the Plan. The majority of the restricted stock units vest based upon atime-based service condition. For restricted stock units with a performance condition, no compensation expense is recorded until it becomes probable that theperformance condition will be achieved. Restricted stock units are recorded as compensation expense based on fair value, representing the market value ofthe Company’s common stock on the date of grant. The fair value of restricted stock units is amortized on a straight-line basis through the statement ofoperations over the service period until the shares have vested. The following table presents the restricted stock unit activity for the years endedDecember 31, 2014 and 2013 (in thousands, except for weighted average amounts): Shares Weighted AverageGrant Date FairValue Outstanding—as of January 1, 2013 465 8.86 Granted 553 7.75 Vested (93) 8.86 Forfeited (729) 8.21 Outstanding—as of December 31, 2013 196 6.96 Granted 2,255 2.03 Vested — — Forfeited (195) 3.17 Outstanding—as of December 31, 2014 2,256 2.03 The Company recorded compensation expense in relation to restricted stock units of $1.4 million, $0.4 million and $1.4 million for the years endedDecember 31, 2014, 2013 and 2012 respectively.The following table presents the stock-based compensation expense related to stock based awards for the period ended December 31, 2014, 2013 and 2012(in thousands): 2014 2013 2012 Research and development $2,701 $2,837 $3,700 Selling, general and administrative 6,321 11,848 14,375 Stock-based compensation expense $9,022 $14,685 $18,075 F-35Table of Contents(13) Defined Contribution PlanThe Company makes available a 401(k) plan for its U.S. employees to which it made contributions in prior years. The Company did not make anycontributions in 2014, 2013 or 2012.(14) Related Party TransactionOctober 2009 Private PlacementSeveral of Amarin’s current and former directors and funds connected with them purchased approximately 36.0 million of its ADSs (in the form of commonstock) in the October 2009 private placement, including: (i) 17 million ADSs purchased by funds managed by Abingworth LLP, where Dr. Joseph Anderson, aformer Director of Amarin, is a partner; (ii) 7 million ADSs purchased by Orbimed Advisors LLC, where Dr. Carl L. Gordon, a former Director of Amarin, is aGeneral Partner; (iii) 7 million ADSs purchased by Sofinnova Venture Partners VII, L.P., where Dr. James I. Healy, a Director of Amarin, is a Managing GeneralPartner; and (iv) 5 million ADSs purchased by Fountain Healthcare Partners Fund 1, L.P. Fountain Healthcare Partners Ltd. is the sole General Partner ofFountain Healthcare Partners Fund 1, L.P. Dr. Manus Rogan is a Managing Partner of Fountain Healthcare Partners Ltd. and until December 2011 was a non-executive director of Amarin. In addition, for every ADS purchased, the investor received warrants to purchase 0.5 of an ADS. Of the $0.1 million warrantderivative liability at December 31, 2014, the fair value of the warrants held by the current and former directors of the Company and their related investmentfunds amounted to $65 thousand.(15) RestructuringAs part of a program to reduce costs and increase operational efficiencies, in October 2013, the Company announced a plan to streamline operations to betteralign its cost structure with current market conditions by reducing its global workforce by approximately 50%. In connection with this program, theCompany recorded $2.8 million in charges for severance and related benefits to reduce the Company’s workforce during the quarter ended December 31,2013, of which $0.2 million is reflected in research and development expense and $2.6 million is reflected in selling, general and administrative expense inthe accompanying consolidated statement of operations. The Company made all remaining payments in the first half of 2014.The restructuring charges, which are included in accrued expenses and other current liabilities in the accompanying consolidated balance sheet as ofDecember 31, 2013, are summarized as follows: Employee Severanceand Benefits Balance as of January 1, 2013 $— Restructuring charges 2,781 Cash payments (2,646) Balance as of December 31, 2013 135 Restructuring charges — Cash payments (135) Balance as of December 31, 2014 $— F-36Table of Contents(16) Quarterly Summarized Financial Information (Unaudited) Fiscal years ended December 31, 2014 and 2013 1stQuarter 2ndQuarter 3rdQuarter 4thQuarter 2014 2013 2014 2013 2014 2013 2014 2013 (In thousands, except per share amounts) Revenue $10,967 $2,342 $12,606 $5,500 $14,149 $8,403 $16,480 $10,106 Net (loss) income (25,980) (62,158) 15,323 (39,774) (26,050) (48,884) (19,657) (15,411) Net (loss) income per share: Basic $(0.15) $(0.41) $0.09 $(0.26) $(0.15) $(0.29) $(0.11) $(0.09) Diluted $(0.15) $(0.43) $0.08 $(0.34) $(0.17) $(0.29) $(0.11) $(0.27) (17) Co-Promotion AgreementOn March 31, 2014, the Company entered into a Co-Promotion Agreement (the Agreement) with Kowa Pharmaceuticals America, Inc. related to thecommercialization of Vascepa (icosapent ethyl) capsules in the United States. Under the terms of the Agreement, Amarin granted to Kowa PharmaceuticalsAmerica, Inc. the right to be the sole co-promoter, together with the Company, of Vascepa in the United States during the term. The initial term of theAgreement extends through 2018.During the term, Kowa Pharmaceuticals America, Inc. and Amarin have agreed to use commercially reasonable efforts to promote, detail and optimize sales ofVascepa in the United States The performance requirements include a negotiated minimum number of details to be delivered by each party in the first andsecond position, and the use of a negotiated number of minimum sales representatives from each party, including no less than 250 Kowa PharmaceuticalsAmerica, Inc. sales representatives. Kowa Pharmaceuticals America, Inc. has agreed to continue to bear the costs incurred for its sales force associated with thecommercialization of Vascepa and to pay for certain incremental costs associated with the use of its sales force, such as sample costs and costs forpromotional and marketing materials. Amarin will continue to recognize all revenue from sales of Vascepa and will use commercially reasonable efforts tomaintain a minimum amount of inventory of Vascepa for use in the United States.In exchange for Kowa Pharmaceuticals America, Inc.’s co-promotional services, Kowa Pharmaceuticals America, Inc. is entitled to a quarterly co-promotionfee based on a percentage of Vascepa gross margins that increases during the Agreement’s term, from the high single digits in 2014 to the low twenty percentlevels in 2018. The co-promotion fee also varies based on sales levels and whether the FDA has approved an ANCHOR indication labeling expansion forVascepa or has permitted the use of data generated to support obtaining FDA approval of the ANCHOR indication in the promotion of Vascepa, in which casethe co-promotion fee would be decreased if specified requirements are met. In certain circumstances, upon the earlier of the expiration or termination of theAgreement in accordance with its terms, Kowa Pharmaceuticals America, Inc. may be eligible for a co-promotion tail fee equal to declining fractions of theco-promote fee in effect prior to such expiration or termination for periods ranging from one to three years following such expiration or termination.As of December 31, 2014, the Company had a net receivable of $0.6 million from Kowa Pharmaceuticals America, Inc. representing reimbursable amountsincurred for samples and other marketing expenses less the co-promotion fees payable to Kowa Pharmaceuticals America, Inc. F-37®Table of Contents(18) Subsequent EventsThe Company has evaluated subsequent events from December 31, 2014 through the date of the issuance of these consolidated financial statements.On January 29, 2015, the Company granted a total of 2,564,251 RSUs and 1,622,500 stock options to employees under the 2011 Plan. The RSUs vestannually over a three year period and the stock options vest monthly over a four year period.On February 26, 2015, Amarin entered into a Development, Commercialization and Supply Agreement (the “DCS Agreement”) with Eddingpharm (Asia)Macao Commercial Offshore Limited (“Eddingpharm”) related to the development and commercialization of Vascepa in Mainland China, Hong Kong,Macau and Taiwan (the “Territory”). Under the terms of the DCS Agreement, Amarin granted to Eddingpharm an exclusive (including as to Amarin) licensewith right to sublicense to develop and commercialize Vascepa in the Territory for uses that are currently commercialized and under development by Amarinbased on Amarin’s MARINE, ANCHOR and ongoing REDUCE-IT clinical trials of Vascepa.Under the DCS Agreement, Eddingpharm will be solely responsible for development and commercialization activities in the Territory and associatedexpenses. Amarin will provide development assistance and be responsible for supplying finished, and later bulk drug product at defined prices undernegotiated supply terms. Amarin will retain all Vascepa manufacturing rights. Amarin received a non-refundable $15.0 million up-front payment and iseligible to receive development, regulatory and sales-based milestone payments of up to an additional $154.0 million. In addition, Eddingpharm will payAmarin tiered double-digit percentage royalties on net sales of Vascepa in the Territory escalating to the high teens. Eddingpharm has agreed to certainrestrictions regarding the commercialization of competitive products globally and Amarin has agreed to certain restrictions regarding the commercializationof competitive products in the Territory.Amarin and Eddingpharm agreed to form a joint development committee to oversee regulatory and development activities for Vascepa in the Territory inaccordance with a negotiated development plan and to form a separate joint commercialization committee to oversee Vascepa commercialization activities inthe Territory. Development costs will be paid by Eddingpharm to the extent such costs are incurred in connection with the negotiated development plan orotherwise incurred by Eddingpharm. Eddingpharm will be responsible for preparing and filing regulatory applications in all countries of the Territory atEddingpharm’s cost with Amarin’s assistance. The DCS Agreement also contains customary provisions regarding indemnification, packaging, recordkeeping, audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type.The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by a validclaim under a licensed patent in the Territory, or (ii) the twelfth (12th) anniversary of the first commercial sale of such product in Mainland China. The DCSAgreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods. Inaddition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Eddingpharm has the right to terminate theDCS Agreement for convenience with twelve months’ prior notice. Neither party may assign or transfer the DCS Agreement without the prior consent of theother party, provided that Amarin may assign the DCS Agreement in the event of a change of control transaction. F-38Exhibit 10.80SECOND AMENDMENT TO LEASEAND PARTIAL SURRENDER AND EARLY TERMINATION AGREEMENTTHIS SECOND AMENDMENT TO LEASE AND SURRENDER AND PARTIAL EARLY TERMINATION AGREEMENT (this “Agreement”) is madeand entered into as of the 23rd day of January 2014, by and between BEDMINSTER 2 FUNDING LLC, (“Landlord”), and AMARIN PHARMACEUTICALSIRELAND LTD., (“Tenant”).RECITALS:A. Landlord and Tenant are parties to that certain Office Lease Agreement dated as of April 1, 2013, License Agreement dated April 11, 2011; 1st Amendmentto License dated May 11 2011; 2nd Amendment to License dated April 25, 2012; 3rd Amendment to License dated July 17, 2012; 4th Amendment to Licensedated December 15, 2012 and 5th Amendment to License dated February 27, 2013 (the “Lease”), pursuant to which Tenant currently leases approximately25,373 square feet of rentable area (the “Premises”) on the 1st and 2nd floors of the building known as 1430 Route 206, Bedminster, New JerseyB. Landlord and Tenant desire to surrender approximately 2,142 square feet in Suite #220, (“Surrendered Premises”) on the terms and conditions set forthherein.NOW, THEREFORE, in consideration of the mutual undertakings and covenants set forth herein, and other good and valuable consideration, thereceipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows:1. Landlord and Tenant hereby agree that the Effective Date of the Surrender shall be as of 11:59 p.m. on December 31, 2013 (the “Surrender Date”), subjectto:(a) Tenant covenants and agrees to surrender the Premises to Landlord on or before the Surrender Date, vacant, clean and free of debris, and in goodorder and repair as well as otherwise in accordance with the applicable provisions of the Lease.2. Tenant’s obligations to pay any Base Rent, additional rent or other amounts due in accordance with the Lease which accrue through the Surrender Dateshall survive the termination of the term of the Lease and shall remain an obligation of Tenant until fully satisfied.3. If Tenant fails to surrender the Surrender Premises on or before the Surrender Date in accordance with the terms of this Agreement, then, from and after theday after the Amended Early Termination Date, Tenant shall be obligated to pay holdover rent for the Surrendered Premises in accordance with the Lease.4. Effective January 1, 2014, Minimum Base Rent for the Demised Premises (as reduced) shall be as follows: Square Feet Period Per Square Foot $ Monthly Base Rent23,231 1/1/2014 4/30/2014 $26.50 $51,301.79 23,231 5/1/2014 4/30/2015 $27.00 $52,269.75 23,231 5/1/2015 4/30/2016 $27.50 $53,237.71 23,231 5/1/2016 4/30/2017 $28.00 $54,205.67 23,231 5/1/2017 4/30/2018 $28.50 $55,173.63 14. Tenant shall pay an Early Termination Fee for the Surrendered Premises, which shall be considered Additional Rent, on a monthly basis and is calculatedas follows: Square Feet Period Existing PerSquare Foot $ Per SquareFoot $ MonthlyBase Rent Number ofMonths Total 2,142 1/1/2014 4/30/2014 $26.50 $11.93 $2,128.61 4 $8,514.45 2,142 5/1/2014 4/30/2015 $27.00 $12.15 $2,168.78 12 $26,025.30 2,142 5/1/2015 4/30/2016 $27.50 $12.38 $2,208.94 12 $26,507.25 2,142 5/1/2016 4/30/2017 $28.00 $12.60 $2,249.10 12 $26,989.20 2,142 5/1/2017 4/30/2018 $28.50 $12.83 $2,289.26 12 $27,471.15 Total 45% $115,507.35 Annualized Per Month$2,221.30 $2,221.30 Per Month Additional Rent effective January 1, 2014, any amounts previously paid in excess of the aforementioned will be issued as a credit onTenants billing statement.5. The parties hereto represent and warrant to each other that each has full right and authority to enter into this Agreement and that the person signing thisAgreement on behalf of Landlord and Tenant respectively has the requisite authority for such act.6. Except as expressly provided herein, all other terms, conditions, covenants, conditions and agreements as set forth in the Lease remain unchanged and infull force and effect.IN WITNESS WHEREOF, the parties have executed this Amendment as of the date first above written. AGREED TO:LANDLORD:BEDMINSTER 2 FUNDING, LLC,A New Jersey limited liability companyBy:/s/ Kurt R. PadavanoName:Kurt R. PadavanoTitle:Authorized RepresentativeTENANT:AMARIN PHARMACEUTICALS IRELAND LTDBy:/s/ John F. TheroName:John F. TheroTitle:Director 2Exhibit 10.81THIRD AMENDMENT TO LEASEAND PARTIAL SURRENDER AND EARLY TERMINATION AGREEMENTTHIS THIRD AMENDMENT TO LEASE AND SURRENDER AND PARTIAL EARLY TERMINATION AGREEMENT (this “Agreement”) is made andentered into as of the 3rd day of April 2014, by and between BEDMINSTER 2 FUNDING LLC, (“Landlord”), and AMARIN PHARMACEUTICALSIRELAND LTD., (“Tenant”).RECITALS:A. Landlord and Tenant are parties to that certain Office Lease Agreement dated as of April 1, 2013, 2nd Amendment to Lease and Partial Surrender and EarlyTermination Agreement dated January 23, 2014; License Agreement dated April 11, 2011; 1st Amendment to License dated May 11 2011; 2nd Amendmentto License dated April 25, 2012; 3rd Amendment to License dated July 17, 2012; 4th Amendment to License dated December 15, 2012, and 5th Amendmentto License dated February 27, 2013 (the “Lease”), pursuant to which Tenant currently leases approximately 23,231 square feet of rentable area (the“Premises”) on the 1st and 2nd floors of the building known as 1430 Route 206, Bedminster, New JerseyB. Landlord and Tenant desire to surrender approximately 2,000 square feet from Suite #200, (“Surrendered Premises”) on the terms and conditions set forthherein.NOW, THEREFORE, in consideration of the mutual undertakings and covenants set forth herein, and other good and valuable consideration, thereceipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows:1. Landlord and Tenant hereby agree that the Effective Date of the Surrender shall be as of 11:59 p.m. on April 30, 2014 (the “Surrender Date”), subject to:(a) Tenant covenants and agrees to surrender the Premises to Landlord on or before the Surrender Date, vacant, clean and free of debris, and in goodorder and repair as well as otherwise in accordance with the applicable provisions of the Lease.Landlord shall have early access to the Surrender Premises commencing April 1, 2014 in order to perform the work necessary to demise the space2. Tenant’s obligations to pay any Base Rent, additional rent or other amounts due in accordance with the Lease which accrue through the Surrender Dateshall survive the termination of the term of the Lease and shall remain an obligation of Tenant until fully satisfied.3. If Tenant fails to surrender the Surrender Premises on or before the Surrender Date in accordance with the terms of this Agreement, then, from and after theday after the Amended Early Termination Date, Tenant shall be obligated to pay holdover rent for the Surrendered Premises in accordance with the Lease.4. Effective May 1, 2014, Minimum Base Rent for the Demised Premises (as reduced) shall be as follows: Square Feet Period Per Square Foot $ Monthly Base Rent 21,231 5/1/2014 4/30/2015 $27.00 $47,769.75 21,231 5/1/2015 4/30/2016 $27.50 $48,654.38 21,231 5/1/2016 4/30/2017 $28.00 $49,539.00 21,231 5/1/2017 4/30/2018 $28.50 $50,423.63 15. Tenant shall pay an Early Termination Fee for the Surrendered Premises, which shall be considered Additional Rent, on a monthly basis and is calculatedas follows: Square Feet Period Existing PerSquare Foot $ Per SquareFoot $ Monthly BaseRent Number ofMonths Total 2,000 5/1/2014 4/30/2015 $27.00 $12.15 $2,025.00 12 $24,300.00 2,000 5/1/2015 4/30/2016 $27.50 $12.38 $2,062.50 12 $24,750.00 2,000 5/1/2016 4/30/2017 $28.00 $12.60 $2,100.00 12 $25,200.00 2,000 5/1/2017 4/30/2018 $28.50 $12.83 $2,137.50 12 $25,650.00 Total 45% 48 $99,900.00 Annualized Per Month $2,081.25 $2,081.25 Per Month Additional Rent effective May 1, 2014, any amounts previously paid in excess of the aforementioned will be issued as a credit onTenants billing statement.6. The parties hereto represent and warrant to each other that each has full right and authority to enter into this Agreement and that the person signing thisAgreement on behalf of Landlord and Tenant respectively has the requisite authority for such act.7. Except as expressly provided herein, all other terms, conditions, covenants, conditions and agreements as set forth in the Lease remain unchanged and infull force and effect.IN WITNESS WHEREOF, the parties have executed this Amendment as of the date first above written. AGREED TO:LANDLORD:BEDMINSTER 2 FUNDING, LLC,A New Jersey limited liability companyBy:/s/ Kurt R. PadavanoName:Kurt R. PadavanoTitle:Authorized RepresentativeTENANT:AMARIN PHARMACEUTICALS IRELAND LTDBy:/s/ John F. TheroName:John F. TheroTitle:President & CEO 2EXHIBIT 21.1Subsidiaries of the Registrant as of December 31, 2014 Name JurisdictionAmarin Pharmaceuticals Ireland Limited IrelandAmarin Pharma, Inc. DelawareAmarin Neuroscience Limited ScotlandCorsicanto Ltd. IrelandEster Neurosciences Limited IsraelEXHIBIT 23.1CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMWe consent to the incorporation by reference in the following Registration Statements: (1)Registration Statement (Form F-1 No. 333-163704) of Amarin Corporation plc, (2)Registration Statement (Form F-3 No. 333-170505) of Amarin Corporation plc, (3)Registration Statement (Form S-3 No. 333-197936) of Amarin Corporation plc, (4)Registration Statement (Form S-8 Nos. 333-146839, 333-143358, 333-132520, 333-110704, 333-101775, and 333-168055) pertaining to the 2002Stock Option Plan of Amarin Corporation plc, (5)Registration Statement (Form S-8 No. 333-168054) pertaining to the 2008 Long Term Incentive Award dated May 20, 2008 issued to Mr. Tom Maher,Mr. Alan Cooke, and Dr. Declan Doogan of Amarin Corporation plc, (6)Registration Statement (Form S-8 Nos. 333-176877 and 333-183160) pertaining to the 2011 Stock Incentive Plan of Amarin Corporation plc, (7)Registration Statement (Form S-8 No. 333-180180) ) pertaining to the Employment Inducement Award of Amarin Corporation plc, and (8)Registration Statement (Form S-8 No. 333-84152);of our reports dated March 3, 2015, with respect to the consolidated financial statements of Amarin Corporation plc and the effectiveness of internal controlover financial reporting of Amarin Corporation plc included in this Annual Report (Form 10-K) of Amarin Corporation plc for the year ended December 31,2014./s/ Ernst & Young LLPMetroPark, New JerseyMarch 3, 2015EXHIBIT 23.2CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMWe consent to the incorporation by reference in Registration Statement Nos. 333-163704 and 333-170505 on Form F-3, Registration Statement No. 333-173132 on Form S-3 and Registration Statement Nos. 333-146839, 333-143358, 333-132520, 333-110704, 333-101775, 333-84152, 333-168054, 333-176877, 333-168055, 333-180180 and 333-183160 on Form S-8 of our report dated February 27, 2014, relating to the consolidated financial statements as ofDecember 31, 2013 and for each of the two years in the period ended December 31, 2013 of Amarin Corporation plc and subsidiaries, appearing in thisAnnual Report on Form 10-K of Amarin Corporation plc for the year ended December 31, 2014./s/ DELOITTE & TOUCHE LLPParsippany, New JerseyMarch 3, 2015EXHIBIT 31.1CERTIFICATIONI, John F. Thero, certify that: 1.I have reviewed this Annual Report on Form 10-K of Amarin Corporation plc; 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-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 our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared; b.Designed such internal controls over financial reporting, or caused such internal controls 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 most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’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 are reasonablylikely 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 internal controlover financial reporting. Date: March 3, 2015 /s/ John F. Thero John F. Thero President and Chief Executive Officer(Principal Executive Officer)Exhibit 31.2CERTIFICATIONI, Michael J. Farrell, certify that: 1.I have reviewed this Annual Report on Form 10-K of Amarin Corporation plc; 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-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 our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, 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 most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’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 are reasonablylikely 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 internal controlover financial reporting. Date: March 3, 2015 /s/ Michael J. Farrell Michael J. Farrell Vice President, Finance (Principal Financial Officer)EXHIBIT 32.1STATEMENT PURSUANT TO 18 U.S.C. § 1350Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 ofChapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), John F. Thero, President and Chief Executive Officer (Principal Executive Officer) ofAmarin Corporation plc (the “Company”) and Michael J. Farrell, Vice President, Finance (Principal Financial Officer) of the Company, each hereby certifiesthat, to the best of his knowledge: (1)The Company’s Annual Report on Form 10-K for the period ended December 31, 2014, to which this Certification is attached as Exhibit 32.1 (the“Annual Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act; and (2)The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of theCompany at the end of such year. /s/ John F. TheroDate: March 3, 2015 John F. Thero President and Chief Executive Officer (Principal Executive Officer) /s/ Michael J. FarrellDate: March 3, 2015 Michael J. Farrell Vice President, Finance (Principal Financial Officer)This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not incorporatedby reference into any filing of Amarin Corporation plc under the Securities Exchange Act of 1934, as amended (whether made before or after the date of theForm 10-K), irrespective of any general incorporation language contained in such filing.

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