Amarin Corporation
Annual Report 2022

Plain-text annual report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 0-21392 Amarin Corporation plc (Exact name of registrant as specified in its charter) England and Wales (State or other jurisdiction of incorporation or organization) Not applicable (I.R.S. Employer Identification No.) Iconic Offices, The Greenway, Block C Ardilaun Court, 112-114 St Stephens Green, 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: Trading Symbol Name of each exchange on which registered Title of each class American Depositary Shares (ADS(s)), each ADS representing the right to receive one (1) Ordinary Share of Amarin Corporation plc Securities registered pursuant to section 12(g) of the Act: None. AMRN NASDAQ Stock Market LLC Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☑ NO ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ☐ NO ☑ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☑ NO ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☑ NO ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer Non-accelerated filer Emerging growth company ☑ Accelerated filer ☐ Smaller reporting company ☐ ☐ ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☑ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☑ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2022 was approximately $721.2 million, based upon the closing price on the NASDAQ Global Market reported for such date. 406,115,721 shares were outstanding as of February 24, 2023, including 385,785,809 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share, and 20,329,912 Ordinary Shares. Certain information required to be disclosed in Part III of this Annual Report on Form 10-K is incorporated by reference from the registrant’s definitive proxy statement to be filed not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K. DOCUMENTS INCORPORATED BY REFERENCE Table of Contents PART I Business Risk Factors Unresolved Staff Comments Properties Legal Proceedings Mine Safety Disclosures PART II Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Management’s Discussion and Analysis of Financial Condition and Results of Operations Quantitative and Qualitative Disclosures about Market Risk Financial Statements and Supplementary Data Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Controls and Procedures Other Information Disclosure Regarding Foreign Jurisdictions that Prevent Inspections PART III Directors, Executive Officers and Corporate Governance Executive Compensation Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Certain Relationships and Related Transactions, and Director Independence Principal Accountant Fees and Services Item 1. Item 1A. Item 1B. Item 2. Item 3. Item 4. Item 5. Item 7. Item 7A. Item 8. Item 9. Item 9A. Item 9B. Item 9C. Item 10. Item 11. Item 12. Item 13. Item 14. Item 15. Item 16. Exhibits and Financial Statement Schedules Form 10-K Summary SIGNATURES PART IV Page 2 29 63 64 64 64 65 74 86 86 86 86 89 89 90 90 90 90 90 91 95 96 PART I SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements, including statements regarding the progress and timing of our clinical programs, regulatory filings and commercialization activities, and the potential clinical benefits, safety and market potential of our product candidates, as well as more general statements regarding our expectations for future financial and operational performance, regulatory environment, and market trends. In some cases, you can identify forward-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 limited to statements regarding the commercial success of and benefits and market opportunity for VASCEPA (brand name VAZKEPA in Europe but predominately referenced in this document by its brand name in the United States and other countries where it is approved, VASCEPA or icosapent ethyl) and factors that can affect such success; plans to obtain regulatory approvals and favorable market access and pricing in several jurisdictions, to expand promotion of VASCEPA and statements regarding cost and pricing of VASCEPA and other treatments; interpretation of court decisions; plans with respect to litigation; expectation on determinations and policy positions of the United States Food and Drug Administration, or U.S. FDA; the safety and efficacy of our product and product candidates; expectation regarding the potential for VASCEPA to be partnered, developed and commercialized outside of the United States; expectation on the scope and strength of our intellectual property protection and the likelihood of securing additional patent protection; estimates of the potential markets for our product candidates; estimates of the capacity of manufacturing and other facilities to support our products; our operating and growth strategies; our industry; our projected cash needs, liquidity and capital resources; and our expected future revenues, operations and expenditures. Forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our 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 this Annual 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 that may benefit from these product candidates and the potential commercial opportunity for our product candidates, is based on information from independent industry 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 data from 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 believe that 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, including those 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 and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. 1 Item 1. Business References in this Annual Report on Form 10-K to “Amarin,” the “Company,” “we,” “our” and “us” refer to Amarin Corporation plc and its subsidiaries, on a consolidated basis, 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 is a public limited company incorporated under the laws of England and Wales. Amarin Corporation plc was originally incorporated in England as a private limited company on March 1, 1989 under the Companies Act 1985, and re-registered in England as a public limited company on March 19, 1993. Our principal office is located at Iconic Offices, The Greenway, Block C Ardilaun Court, 112-114 St Stephens Green, Dublin 2 Ireland. Our registered office is located at One New Change, London EC4M 9AF, England. Our primary office for our European market access team is located at Überbauung Metalli, Gotthardstrasse 2, Zug CH-6300, Switzerland. Our primary office in the United States is located at 440 Route 22, Bridgewater, NJ 08807, USA. Our telephone number 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.” Overview We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication, and commercially launched in 2013. On December 13, 2019, the U.S. FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication. On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA®, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels. On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk. VASCEPA is currently available by prescription in the U.S. and certain other countries throughout the world, as described below. We are responsible for the supply of VASCEPA to all markets in which the branded product is sold, either directly by us or to and through our collaborations with third-party companies. We are not responsible for providing any generic company with drug product. Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to the U.S. patent litigation and judgment described below and no similar litigation is pending outside of the United States. United States VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Since VASCEPA was made commercially available in 2013, more than twenty million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market with a 1-gram capsule: Company Hikma Pharmaceuticals USA Inc. Dr. Reddy’s Laboratories, Inc. Teva Pharmaceuticals USA, Inc. Apotex, Inc. FDA MARINE Indication Approval May 2020 August 2020 September 2020 June 2021 Launch Date November 2020 June 2021 September 2022 January 2022 (1) (1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023. 2 In June 2022, to address shifts within our U.S. business due to these generic competitors, we announced a comprehensive cost and organizational restructuring plan which is expected to result in savings of $100.0 million over the subsequent twelve months compared to 2021 operating expenses. Our U.S. cost reduction plan included: • • U.S. workforce reduction: The reduction of our U.S. field force and corporate positions. Our U.S. field force was reduced from approximately 300 sales representatives to approximately 75 sales representatives. Streamlined operational expenditures: Includes reductions and reallocations in overall selling, general and administrative expenses as well as savings related to refining our research and development strategy to a more focused, stepwise approach for our fixed-dose combination, or FDC, program. In alignment with our U.S. cost reduction plan, our focus is primarily on engaging with our top VASCEPA brand prescribers, maintaining our exclusive formulary coverage with specific payers, and implementing targeted promotional initiatives amid the continued pressure from generic competitors. Europe In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland. Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed thirteen dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national, general organization reimbursement. In countries where individual price reimbursement allowed prior to national reimbursement, product can be made available on a patient by patient basis, while national reimbursement negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Annual Report on Form 10-K, we have received and made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively. Country Sweden Finland United Kingdom Austria Denmark Individual Reimbursement NA NA NA September 2022 June 2022 National Reimbursement March 2022 October 2022 July 2022 NA NA Product Availability March 2022 December 2022 October 2022 September 2022 June 2022 Launch Date March 2022 December 2022 October 2022 NA NA In order to launch impactfully throughout Europe, we are building a core team of experienced professionals and highly capable local commercial teams involved with pre-launch planning and other commercial preparation activities and we are leveraging third-party relationships for various support activities. We are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approach, which will be utilized throughout Europe as launches are rolled out. Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists rather than by general practitioners. Privacy laws and other factors impact the availability of data to inform European commercial operations at individual physician level. Generally, less data is available and at reduced frequencies than in the United States. However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion in Europe than in the United States. In Europe, VAZKEPA has the benefit of ten years of market protection, and we have been issued a patent that expires in 2033 with additional pending applications that could extend exclusivity into 2039. In September 2021, as part of the German reimbursement process, VAZKEPA was made available in Germany with temporary reimbursement while negotiations for final reimbursement were ongoing and VAZKEPA was included in the country's electronic prescribing system as of October 1, 2021. On August 19, 2022, reimbursement negotiations were concluded without agreement. As a result, we discontinued our German business operations as of September 1, 2022. Following the local reimbursement process and initiated by G-KV, we moved to the Arbitration Board. In November 2022, the Arbitration Board process was concluded without reaching a deal. German legislation allows re-submission of a pricing and reimbursement dossier with new data and we plan to resubmit once we have a new dossier ready. 3 Rest of World China In February 2015, we entered into an exclusive agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, to develop and commercialize VASCEPA in what we refer to as the China Territory, consisting of the territories of Mainland China, Hong Kong, Macau and Taiwan. On February 23, 2022 the Hong Kong Department of Health completed their evaluation of the clinical trial conducted in China and approved the use of VASCEPA under the REDUCE-IT indication. In China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final National Medical Products Administration, or NMPA, review of the VASCEPA NDA was initiated with Edding expecting approval by the end of 2022. Due to delays at the Center for Drug Evaluation, or CDE, as a result of the resurgence of COVID-19 in the Beijing area at the end of 2022, Edding has communicated that an approval in Mainland China could be achieved by mid-year of 2023. Middle East and North Africa (MENA) In March 2016, we entered into an agreement with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Biologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially in the following countries: Country Lebanon United Arab Emirates Qatar Bahrain Kuwait Saudi Arabia MARINE March 2018 July 2018 December 2019 April 2021 December 2021 March 2022 REDUCE-IT August 2021 October 2021 April 2021 April 2022 — — Launch Date June 2018 February 2019 — — — — VASCEPA is under registration in additional countries in the MENA region. Canada In September 2017, we entered into an agreement with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada. In March 2019, HLS received formal confirmation from Health Canada that Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission, which was filed in April 2019. In December 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority granted approval for VASCEPA to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. In January 2020, HLS obtained regulatory exclusivity designation and launched commercially in February 2020. In July 2020, the Canadian Agency for Drugs and Technologies in Health recommended that VASCEPA be reimbursed by participating public drug plans for statin-treated patients with established cardiovascular diseases and elevated triglycerides. In April 2022, HLS completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance for the terms and conditions under which VASCEPA would qualify for public market reimbursement in Canada. Following these negotiations, HLS signed a Letter of Intent which allows HLS to work with all participating provincial jurisdictions to secure coverage from publicly funded drug plans across Canada, and for VASCEPA to potentially be added to their respective plans. HLS also received notification by the Patented Medical Prices Review Board that, further to its review, VASCEPA’s price did not trigger the investigation criteria for excessive pricing. As of December 31, 2022, reimbursement coverage is approximately 70% of publicly covered lives and 95% for private coverage. Public reimbursement is now available in Ontario, Quebec, Saskatchewan, New Brunswick Northwest Territories and for the Non-Insured Health Benefits program for the First Nations and Inuit people. Coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada. VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that could extend into 2039. Other We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the United States and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval. We have completed the first of a three year plan to submit and obtain regulatory approval in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA. Through the date of this Annual Report on Form 10-K, we have filed for regulatory review in 10 countries and have received approval in seven countries outside of European Medicines Agency, or EMA, regulatory approval authority, including in Switzerland, Australia and New Zealand, under the 4 REDUCE-IT indication. In February 2023, we entered into an agreement with CSL Seqirus to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. Clinical Trials The REDUCE-IT Study (basis for expanded U.S. FDA approved indication and label expansion in December 2019) The REDUCE-IT study was designed to evaluate the efficacy of VASCEPA in reducing major cardiovascular events in an at-risk patient population also receiving statin therapy. REDUCE-IT was a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of VASCEPA, as an add-on to statin therapy, in reducing first major cardiovascular events in an at-risk patient population compared to statin therapy alone. The control arm of the study was comprised of patients on optimized statin therapy plus placebo. The active arm of the study was comprised of patients on optimized statin therapy plus VASCEPA. All subjects enrolled in the study had elevated triglyceride levels and either established coronary heart disease or risk factors for coronary heart disease. In August 2011, we reached agreement with the U.S. FDA on a special protocol assessment, or SPA, agreement for the design of the REDUCE-IT cardiovascular outcomes study. An SPA is an evaluation by the U.S. FDA of a protocol with the goal of reaching an agreement that the Phase 3 trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval. The U.S. FDA agreed that, based on the information we submitted to the agency, the design and planned analysis of the REDUCE-IT study adequately addressed the objectives necessary to support a regulatory submission. An SPA is generally binding upon the U.S. FDA unless a substantial scientific issue essential to determining safety or efficacy of the drug is identified after the testing begins. It is believed that the effects of the omega-3 acid eicosapentaenoic acid, or EPA, are not due to a single mode of action, such as triglyceride lowering, but rather to multiple mechanisms working together. Studies in the scientific literature explore potentially beneficial effects of EPA on multiple atherosclerosis processes, including endothelial function, oxidative stress, foam cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture. With respect to triglyceride levels, our scientific rationale for the REDUCE-IT study was supported by (i) epidemiological data that suggests elevated triglyceride levels correlate with increased cardiovascular disease risk, (ii) genetic data that suggest triglyceride and/or triglyceride-rich lipoproteins (as well as LDL-C, known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data that suggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. The REDUCE-IT study was designed to determine the clinical benefit, if any, of stable EPA therapy in statin-treated patients with elevated triglyceride levels. In September 2011, we engaged a clinical research organization, or CRO, and began initial trial and clinical site preparation for REDUCE-IT. In December 2011, we announced that the first patient was dosed in the study. In 2016, we completed patient enrollment and randomization of 8,179 individual patients into the REDUCE-IT study. Our personnel remained blinded to the efficacy and safety data from the REDUCE-IT study until after the study was completed and the database was locked in 2018. On November 10, 2018, we announced primary results from our REDUCE-IT study as late-breaking clinical results at the 2018 Scientific Sessions of the AHA and the results were concurrently published in The New England Journal of Medicine. REDUCE-IT met its primary endpoint demonstrating a 25% RRR, to a high degree of statistical significance (p<0.001), in first occurrence of MACE in the intent-to-treat patient population with use of VASCEPA 4 grams/day as compared to placebo. Patients qualified to enroll in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various cardiovascular risk factors including persistent elevated TG between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or age 50 or more with diabetes mellitus and at least one other CV risk factor (primary prevention cohort). Approximately 59% of the patients had diabetes at baseline, approximately 71% of the patients had established cardiovascular disease at time of enrollment and approximately 29% were primary prevention subjects at high risk for cardiovascular disease. REDUCE-IT also showed a 26% RRR in its key secondary composite endpoint of cardiovascular death, heart attacks and stroke (p<0.001). We expended more than $300.0 million to fund completion of the REDUCE-IT study. VASCEPA in the REDUCE-IT study demonstrated a number needed to treat, or NNT, of 21 for the first occurrence of MACE in the 5-point primary composite endpoint. NNT is a statistical concept intended to provide a measurement of the impact of a medicine or therapy by estimating the number of patients that need to be treated in order to have an impact on one person. An additional seven secondary endpoints were achieved below the key secondary endpoint, in order of sequential statistical testing within the prespecified hierarchy: • • • Cardiovascular death or nonfatal heart attack: 25% RRR (p<0.001) Fatal or nonfatal heart attack: 31% RRR (p<0.001) Urgent or emergent revascularization: 35% RRR (p<0.001) 5 • • • • Cardiovascular death: 20% RRR (p=0.03) Hospitalization for unstable angina: 32% RRR (p=0.002) Fatal or nonfatal stroke: 28% RRR (p=0.01) Total mortality, nonfatal heart attack or nonfatal stroke: 23% RRR (p<0.001) The next prespecified secondary endpoint in the hierarchy was the only such endpoint that did not achieve statistical significance although it trended positively: • Total mortality, which includes mortality from non-cardiovascular and cardiovascular events: 13% RRR (p=0.09) Positive REDUCE-IT results were consistent across various patient subgroups, including female/male, diabetic/non-diabetic and secondary/primary prevention. Overall adverse event rates in REDUCE-IT were similar across treatment groups and VASCEPA was well tolerated. VASCEPA was associated with an increase (3% vs 2%) in the reported rate of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. VASCEPA was associated with an increase (12% vs 10%) in the reported rate of bleeding in a double-blind, placebo-controlled trial. The reported incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo) were: musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo) were: arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents for bleeding are to be monitored. In the REDUCE-IT trial, cardiovascular benefits appeared not to be influenced significantly by TG levels at baseline (above or below 150 mg/dL baseline range) or as achieved at one year, potentially suggesting mechanisms at work with use of VASCEPA that are independent of baseline TG levels or therapy-driven reduction in TG levels. Determining the mechanisms responsible for the benefit shown in REDUCE-IT was not the focus of REDUCE-IT. As summarized from the primary results of REDUCE-IT in The New England Journal of Medicine, potential VASCEPA mechanisms of action at work in REDUCE-IT may include TG reduction, anti-thrombotic effects, antiplatelet or anticoagulant effects, membrane-stabilizing effects, effects on stabilization and/or regression of coronary plaque and inflammation reduction, each as supported by earlier stage mechanistic studies. The U.S. FDA granted Priority Review designation to our March 2019 supplemental new drug application, or sNDA, seeking an expanded indication for VASCEPA in the United States based on the positive results of the REDUCE-IT study. The U.S. FDA grants Priority Review designation to applications for drugs that, if approved, have the potential to offer significant improvements in the effectiveness and safety of the treatment of serious conditions when compared to standard applications. In November 2019, the U.S. FDA held an Endocrinologic and Metabolic Drugs Advisory Committee, or EMDAC, meeting to review the REDUCE-IT sNDA. The EMDAC voted unanimously (16-0) to recommend approval of an indication and label expansion for VASCEPA to reduce cardiovascular events in high-risk patients based on the REDUCE-IT results. On December 13, 2019, the U.S. FDA approved a new indication and label expansion for VASCEPA capsules. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG levels (≥150 mg/dL) and either established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. Based on REDUCE-IT results, as of the date of the filing of this Annual Report on Form 10-K, 30 clinical treatment guidelines, consensus statements or scientific statements from medical societies or journals have been updated recommending the use of icosapent ethyl in appropriate at-risk patients, including those statements which we were informed of by our global partners in Canada, China and the Middle East as well as guidelines which were newly received during the fourth quarter of 2022 as listed below: • • In November 2022, the American Society of Preventive Cardiology published a clinical practice statement delineating key attributes that define the field of preventive cardiology, including that REDUCE-IT established that icosapent ethyl, or IPE, reduced CV events among patients fasting TG 135 to 499 mg/dL and that results from REDUCE-IT have not been replicated in trials using mixed omega-3 fatty acids suggesting that the CV benefit is attributed to EPA. In November 2022, NICE released its guidelines on lipid management, which included that IPE is recommended for patients with established CVD and elevated fasting TG and who are taking statins with LDL-C levels between 1.04 and 2.60 mmol/L, as per the REDUCE-IT results. 6 • • In December 2022, the Finnish Medical Association and the Finnish Association of Internists published updated guidelines on dyslipidemia treatment, including that IPE is indicated for patients on statin therapy who have elevated TG levels and are at particularly high risk for arterial disease. In December 2022, the National Society of Cardiometabolic Medicine in China released its consensus statement on the role of omega-3 fatty acids in the prevention and treatment of CVD in Chinese patients. The consensus statement reviewed current knowledge about omega-3 fatty acids and their use in managing CVD in the Chinese population. The following key recommendations were included on use of IPE: o o o High-dose IPE can confer CV benefits in patients with high TG levels at high risk for ASCVD and who have additional CV risk factors. EPA levels may be the driving force behind CV benefit reported with IPE, a concept supported by JELIS and REDUCE-IT trials in which serum EPA levels were inversely associated with CV risk in a dose-response relationship as well as in a sub-analysis of REDUCE-IT, which showed that the CV reduction reported with IPE was attributed to changes in EPA levels rather than lipid biomarkers. IPE is the only omega-3 fatty acid approved by the FDA, Health Canada and the European Medicines Agency, or EMA, for CV risk reduction in patients with CVD or diabetes with other ASCVD risk factors. During 2022, we announced the following data which added to our growing body of knowledge on VASCEPA as a result of our continued analysis of the REDUCE-IT trial results: • • • • In March 2022, a post hoc sub-analysis of REDUCE-IT, published in the Journal of the American Heart Association, or JAHA, found VASCEPA reduced the risk of cardiovascular death, strokes, heart attacks, coronary revascularization and unstable angina by 34% in patients with a history of percutaneous coronary intervention, or PCI, noting 8.5% and 5.4% absolute risk reductions, respectively, for the primary and secondary composite endpoints. In May 2022, a post hoc sub-analysis of REDUCE-IT, published in the Journal of the American College of Cardiology found VASCEPA significantly reduced the total ischemic event risk of cardiovascular death, stroke, myocardial infarction, coronary revascularization, or hospitalization for unstable angina by 35% in patients who had a prior heart attack. In May 2022, we presented data at the 2022 European Society of Cardiology Congress that VASCEPA significantly reduced ST-segment elevation myocardial infarction by 40% and non-ST segment elevated myocardial by 27%. In August 2022, a post hoc exploratory analysis of REDUCE-IT found VASCEPA significantly reduced the risk of cardiovascular death, strokes, heart attacks, coronary revascularization and unstable angina in current/former smokers by 23% and former smokers by 29%. The MARINE Trial (first U.S. FDA-approved label for VASCEPA approved in July 2012) The MARINE trial was a Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week study for patients with very high triglycerides which was completed in 2010. In November 2010, we reported topline data for the MARINE trial. In the trial, VASCEPA met its primary endpoint at doses of 4 grams and 2 grams per day 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 to placebo 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 grams of VASCEPA and 2 grams of VASCEPA, respectively. VASCEPA was well tolerated in the MARINE trial, with a safety profile comparable to placebo and there were no treatment-related serious adverse events observed. Observed Clinical Safety of VASCEPA in MARINE, ANCHOR and Early Development In the MARINE and ANCHOR trials, patients dosed with VASCEPA demonstrated a safety profile similar to placebo. There were no treatment- related serious adverse events 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 adverse reaction > 3% and greater than placebo. Prior to commencing the REDUCE-IT, MARINE and ANCHOR trials, we conducted a pre-clinical program for VASCEPA, including toxicology and pharmacology studies. In addition, we previously investigated VASCEPA in central nervous system disorders in several double-blind, placebo- controlled studies, including Phase 3 trials in Huntington’s disease. Over 1,000 patients 7 were dosed with VASCEPA in these studies, with over 100 receiving continuous treatment for a year or more. In all studies performed to date, VASCEPA has shown a favorable safety and tolerability profile. In addition to the REDUCE-IT, MARINE and ANCHOR trials, we completed a 28-day pharmacokinetic study in healthy volunteers, a 26-week study to evaluate the toxicity of VASCEPA in transgenic mice and multiple pharmacokinetic drug-drug interaction studies in healthy subjects in which we evaluated the effect of VASCEPA on certain common prescription drugs. All findings from these studies were consistent with our expectations and confirmed the overall safety profile of VASCEPA. Clinical Study in China Edding completed a Phase 3 study of VASCEPA in China, the study design of which was similar to, but larger than, our MARINE study. In November 2020, along with Edding, we announced statistically significant topline positive results. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo. There were no treatment-related serious adverse events in this study. On February 23, 2022, the Hong Kong Department of Health completed their evaluation and approved the use of VASCEPA under the REDUCE-IT indication. Edding has communicated that an approval in Mainland China could be achieved by mid-year of 2023. Collaboration with Mochida In Japan, ethyl-EPA is marketed under the product name of Epadel by Mochida Pharmaceutical Co., Ltd., or Mochida, and is indicated for hyperlipidemia and peripheral vascular disease. In an outcomes study called the Japan EPA Lipid Intervention Study, or JELIS study, which consisted of more than 18,000 patients followed over multiple years, Epadel, when used in conjunction with statins, was shown to reduce cardiovascular events by 19% compared to the use of statins alone. In this study, cardiovascular events decreased by approximately 53% compared to statins alone in the subset of primary prevention patients with triglyceride levels of (cid:0)150 mg/dL (median of 272 mg/dL at entry) and HDL-C <40 mg/dL. In June 2018, we entered into a multi-faceted collaboration with Mochida related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA. Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories. In addition, the parties will collaborate to research and develop new products and indications based on EPA for our commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development. Upon closing of the collaboration agreement, we made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for milestone payments from us upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any. In November 2022, the data related to RESPECT-EPA was presented at the American Heart Association, or AHA, 2022 Scientific Sessions, A Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid and PROMINENT, Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes Study. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation and is the third study to show CV benefit consistent with REDUCE-IT and JELIS. The study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk and achieved a statistically significant 26.6% reduction in the secondary composite endpoint. Fixed-Dose Combination On January 10, 2022, we announced that we have initiated development of a fixed-dose combination product that has both icosapent ethyl and a statin. Potential Benefits and Market Opportunity for VASCEPA VASCEPA, encapsulated in 1-gram capsules, is 1-gram of icosapent ethyl, or ethyl-EPA, and contains no docosahexaenoic acid, or DHA. Icosapent ethyl is the only active ingredient. We believe that icosapent ethyl, in the stable form as it is presented in VASCEPA, is more effective than if combined with other omega-3 molecules. In particular, based on clinical evidence, we believe that the removal of DHA mitigates against the LDL-C raising effect observed in omega-3 compositions that include DHA. Based on the results of the REDUCE-IT trial, VASCEPA was the first omega-3 based product, or any type of product, to demonstrate a statistically significant reduction in cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment. Prior to REDUCE-IT, based on the MARINE trial, VASCEPA was the first omega-3 based product to demonstrate statistically significant triglyceride reduction without a statistically significant increase in LDL-C in this very high triglyceride population. 8 Guidelines for the management of very high triglyceride levels ((cid:0)500 mg/dL) suggest that reducing triglyceride levels is the primary treatment goal in these patients to reduce the risk of acute pancreatitis. Treating LDL-C remains an important secondary goal. Other important parameters to consider in patients with very high triglycerides include levels of apolipoprotein B, or apo B, non-HDL-C, and very low-density lipoprotein cholesterol, or VLDL-C. The effect of VASCEPA on the risk for pancreatitis in patients with hypertriglyceridemia has not been determined. We believe that the results of the REDUCE-IT, ANCHOR and MARINE clinical trials of VASCEPA and VASCEPA’s EPA only/DHA-free composition position VASCEPA to achieve a global “best-in-class” prescription therapy in studied patient populations. Potential mechanisms of action at work in the reduction of cardiovascular events seen in REDUCE-IT as discussed in The New England Journal of Medicine publication of REDUCE-IT primary results include TG reduction, anti-thrombotic effects, antiplatelet or anticoagulant effects, membrane-stabilizing effects, effects on stabilization and/or regression of coronary plaque and inflammation reduction. Mechanisms responsible for the benefit shown in REDUCE-IT were not studied in REDUCE-IT as that was not the purpose of an outcomes study. While the mechanisms of action of VASCEPA have been broadly studied and continue to be studied, similar to other drugs with multifactorial mechanisms of action, such as aspirin, statins and metformin, we may never fully determine to what extent, if any, each of these effects or others may be responsible for the CV risk reduction benefit demonstrated in REDUCE-IT. United States Heart 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—2022 Update from the AHA, CVD is the underlying cause of death in approximately one out of every three deaths – one death approximately every 36 seconds. Approximately 127 million adults in the United States live with one or more types of cardiovascular disease with an estimated 1 million new or recurrent coronary events and 795,000 new or recurrent strokes occurring each year. An estimated 28 million adults (cid:0)20 years of age have high total serum cholesterol levels ((cid:0)240 mg/dL), and an estimated 70 million adults (cid:0)20 years of age have borderline high or high low-density lipoprotein (“bad”) cholesterol, or LDL-C, levels ((cid:0)130 mg/dL). According to the Cardiovascular Disease: A Costly Burden for America Projections Through 2035 from the AHA, 45% of the United States population is projected to have some form of CVD by 2035 and total costs of CVD are expected to reach $1.1 trillion in 2035, with direct medical costs projected to reach $749.0 billion and indirect costs estimated to reach $368.0 billion. It is estimated that more than 50 million adults in the United States have elevated triglyceride levels ≥150 mg/dL. Additionally, approximately 2 to 3 million adults in the United States have very high triglyceride levels ((cid:0)500 mg/dL), the condition for which VASCEPA received its initial drug approval from the U.S. FDA in 2012 based on the MARINE clinical trial. There are approximately 5 to 15 million people in the United States that meet the specific REDUCE-IT inclusion criteria. Additionally, the U.S. FDA-approved label for VASCEPA mentions maximally tolerated statin therapy in the indication statement. Since 1976, mean triglyceride levels have increased, along with the growing epidemic of obesity, insulin resistance, and type 2 diabetes mellitus. In contrast, mean LDL-C levels have decreased. Multiple primary and secondary prevention trials have shown a significant RRR of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual CV risk despite the achievement of target LDL-C levels. Europe and Rest of World Cardiovascular diseases remain the leading cause of disease burden in the world. There are more than 500 million people reportedly living with cardiovascular diseases globally, with 290 million in China. In the European Union, there are approximately 60 million people reportedly living with cardiovascular disease, including approximately 38 million diagnosed with ischemic heart disease, stroke or peripheral heart disease. The proportion of patients dying from cardiovascular disease is reportedly higher in Europe than in the United States and there are more patients on statin therapy in Europe in aggregate compared to the United States. Caring for cardiovascular disease in Europe is expensive with annual spending estimated to currently exceed €200 billion annually. Manufacturing and Supply for VASCEPA We manage the manufacturing and supply of VASCEPA and have done so since we began clinical development of VASCEPA prior to the drug’s marketing approval by the U.S. FDA in 2012. We rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include API, manufacturing, encapsulation of the active pharmaceutical ingredient, or API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for 9 qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The U.S. FDA has approved several international large-scale API manufacturers, global encapsulation leaders and multiple U.S.-based packagers for use in the manufacturing of VASCEPA. All of our manufacturing facilities were approved by the U.S. FDA following successful preapproval inspections and they remain active manufacturers of VASCEPA under U.S. FDA authority. The European Regulatory Authorities has approved an additional European-based packager for use in the manufacturing of VAZKEPA for the European markets. The API material that constitutes ethyl-EPA is a chemical modification of a naturally occurring substance that is derived from specific fish sourced from qualified producers. The fishing from which the raw material for VASCEPA is derived is regulated by local government agencies under policies designed to ensure sustainability of the marine life supply. A limited number of other manufacturers have the ability, scale, know-how, sufficient supply chain capability and suitable, industrial-scale facilities to produce ethyl-EPA to the required level of purity. We have worked with our suppliers to build required scale, quality and cost-efficiency needed to meet our current and anticipated future market requirements. Among the conditions for U.S. FDA approval of a pharmaceutical product is the requirement that the manufacturer’s quality control and manufacturing procedures are validated and conform to pharmaceutical current Good Manufacturing Practice, or cGMP, which, under applicable regulations, must be followed at all times. The U.S. FDA typically inspects manufacturing facilities before regulatory approval of a product candidate, such as VASCEPA, and on a periodic basis after the initial approval. Consistent with cGMP regulations, pharmaceutical manufacturers must expend resources and time to ensure compliance with product specifications as well as production, record keeping, quality control, reporting, and other regulatory requirements. Similar to the U.S. FDA, regulators in other countries in which we, or our partners, sell or seek to sell VASCEPA, regulate manufacturer’s quality control and manufacturing procedures. For Europe, various suppliers have been inspected and approved by European regulatory authorities and we do not anticipate supply availability limiting our launch in Europe. Production of VASCEPA, from sourcing of starting materials through stocking of finished goods inventory requires significant coordination between companies and considerable lead-times. We are often making purchasing decisions for supply more than a year in advance of anticipated product sales. Planning for capacity expansion also requires significant lead-times as, for example, creation of new manufacturing facilities for API can require multiple years to construct, equip and qualify. In 2022, we reviewed our contractual supplier purchase obligations and have taken steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of December 31, 2022, we had inventory of $392.4 million, of which approximately 90% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Competition General 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 product. It is probable that the number of companies seeking to develop products and therapies similar to our product will increase. Many of these and other existing or potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products. These companies may develop and introduce products and processes competitive with, more efficient than or superior to ours. In addition, other technologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, which might render our technology and products noncompetitive or obsolete. United States Our competitors include large, well-established pharmaceutical and generic companies, specialty and generic pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy's, and Hikma, and certain of their affiliates, or collectively, the Defendants, several of the Company's patents covering the MARINE indication were declared invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA, have entered the U.S. market and represent our main competitors: 10 Company Hikma Pharmaceuticals USA Inc. Dr. Reddy’s Laboratories, Inc. Teva Pharmaceuticals USA, Inc. Apotex, Inc. FDA MARINE Indication Approval May 2020 August 2020 September 2020 June 2021 Launch Date November 2020 June 2021 September 2022 January 2022 (1) (1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023. Woodward Pharma Services LLC currently sells Lovaza®, which it acquired from GlaxoSmithKline plc in the third quarter of 2021. Lovaza, a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia was approved by the U.S. FDA in 2004 and has been on the market in the United States since 2005. Multiple generic versions of Lovaza are available in the United States. Other large companies with competitive products include AbbVie, Inc., which currently sells Tricor® and Trilipix® for the treatment of severe hypertriglyceridemia and Niaspan®, which is primarily used to raise high-density lipoprotein cholesterol, or HDL-C, but is also used to lower triglycerides. Multiple generic versions of Tricor, Trilipix and Niaspan are also available in the United States. We compete with these drugs, and in particular, multiple low-cost generic versions of these drugs, in our U.S. FDA-approved indicated uses, even though such products do not have U.S. FDA approval to reduce CV risk on top of statin therapy. AstraZeneca conducted a long-term outcomes study to assess Statin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia, or STRENGTH. The study was a randomized, double-blind, placebo-controlled (corn oil), parallel group design that is believed to have enrolled approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for cardiovascular disease randomized 1:1 to either corn oil plus statin or Epanova plus statin, once daily. On January 13, 2020, following the recommendation of an independent Data Monitoring Committee, AstraZeneca decided to close the STRENGTH trial due to its low likelihood of demonstrating benefit to patients with mixed dyslipidemia who are at increased risk of cardiovascular disease. Full data from the STRENGTH trial was presented at the AHA’s Scientific Sessions in November 2020 confirming that Epanova failed to meet the primary endpoint of CV risk reduction, and published in Journal of the American Medical Association, or JAMA, in December 2020. In addition, in March 2017, Kowa Research Institute (a subsidiary of the Japanese company Kowa Co., Ltd) initiated a Phase 3 cardiovascular outcomes trial titled PROMINENT examining the effect of pemafibrate (experimental name K-877) in reducing cardiovascular events in Type II diabetic patients with hypertriglyceridemia. In April 2022, Kowa Research Institute announced the decision to not continue the PROMINENT study as the primary endpoint was unlikely to be met. Results of the PROMINENT trial were presented at the 2022 AHA Scientific Session in November 2022, confirming that pemafibrate did not lower the incidence of cardiovascular events among the studied population. We are also aware of other pharmaceutical companies that are developing products that, if successfully developed, approved and marketed, would compete with VASCEPA. It is not fully clear at this time what the impact of COVID-19 will be on each of these programs. Based on prior communications from the U.S. FDA, including communications in connection with its review of the ANCHOR indication for VASCEPA, it is our understanding that the U.S. FDA is not prepared to approve any therapy for treatment of cardiovascular risk based on biomarker modification without cardiovascular outcomes study data, with the potential exception of therapies which lower LDL-cholesterol, depending on the circumstances. In particular, it is our understanding that the U.S. FDA is not prepared to approve any therapy based primarily on data demonstrating lowering of triglyceride levels. In our view, this position from the U.S. FDA did not change based on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of VASCEPA are unique to VASCEPA and extend beyond triglyceride reduction. If the U.S. FDA were to change this position, it could potentially have a negative impact on us by making it easier for other products to achieve a cardiovascular risk reduction indication without the need in advance to conduct a long and expensive cardiovascular outcomes study. VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements. Such products are classified as food, not as prescription drugs or as over-the-counter drugs, by the U.S. FDA in the United States. Most regulatory regimes outside the United States are similar in this regard. Some of the promoters of such products have greater resources than us and are not restricted to the same standards as are prescription drugs with respect to promotional claims or manufacturing quality, consistency and subsequent product stability. We have taken successful legal action against supplement manufacturers attempting to use the REDUCE-IT results to promote their products. Still, we cannot be sure physicians and pharmacists will view the U.S. FDA-approved, prescription-only status, and EPA-only purity and stability of VASCEPA or the U.S. FDA’s stringent regulatory oversight, as significant advantages versus omega-3 dietary supplements regardless of clinical study results and other scientific data. 11 Europe and Rest of World On March 26, 2021, the EC granted approval of the marketing authorization application in the EU for VAZKEPA as an approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels, which is based on the REDUCE-IT indication. There is currently no other drug that is approved for cardiovascular risk reduction in at-risk patients in Europe. In addition, there is currently no other direct competition for Canada and the Middle East. However, consistent with the U.S., our competitors include large, well-established pharmaceutical companies, specialty and generic pharmaceutical companies, marketing companies, and specialized cardiovascular treatment companies. Recent CV outcomes trials and meta-analyses with low and high dose omega-3 fatty acid mixtures containing DHA have not shown substantial benefit in patients receiving contemporary medical therapy, including statins. Due to failed low dose omega-3 CV outcomes trials, the European regulatory authorities have concluded that omega-3 fatty acid medicines (specifically Lovaza®/Omacor®) at a dose of 1-gram per day are not effective in preventing further events for patients who have had a heart attack. The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. In addition, VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 productions as nutritional supplements. In Europe, such products are classified as food, not as prescription drugs or as over-the-counter drugs. Limitations of Current Therapies HTG is a prevalent lipid disorder in approximately 25% of the U.S. adult population. Both epidemiological and genetic data have shown associations between HTG and coronary heart disease. Many of those patients are taking statin therapy directed at lowering the risk of CVD by lowering their LDL-C levels, primarily. Recently, real world administrative database analyses have reported an increased CVD risk as well as direct healthcare costs associated with HTG despite statin therapy and controlled LDL-C compared to those with TG<150 mg/dL. Regulatory Matters Government Regulation and Regulatory Matters Any product development activities related to VASCEPA or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the U.S. FDA and comparable regulatory authorities in other countries, which regulate the design, research, clinical and nonclinical development, testing, manufacturing, storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products. Generally, before a new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. The data are generated in two distinct development stages: preclinical and clinical. Drugs must be approved by regulatory authorities before they are first marketed for example, by the U.S. FDA through the new drug application, or NDA, process in the United States or the marketing authorization application, or MAA, process under the EMA in the EU. For new chemical entities, the preclinical development stage generally involves synthesizing the active component, developing the formulation, determining the manufacturing process and controls, 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 of healthy volunteers are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these studies is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug. Phase 2 trials typically involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected. Phase 3 trials generally involve large numbers of patients at multiple sites, in multiple countries and are designed to provide the pivotal data necessary to demonstrate the effectiveness of the product for its intended use and its safety in use, provide an adequate basis for physician labeling and may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing. United States Drug Development and Approval In the United States, the process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at 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 U.S. FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. 12 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 the U.S. FDA’s Good Laboratory Practices regulations, or GLP, and an IND is filed with the U.S. FDA. Similar filings are required in other countries; however, data requirements and other information needed for a complete submission may differ in other countries. The amount of data that must 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 be submitted to the U.S. FDA prior to commencement of a clinical trial. If the U.S. FDA has concerns about the clinical plan or the safety of the proposed studies, it may suspend or terminate the study at any time. Studies must be conducted in accordance with Good Clinical Practice, or GCP, including the requirement that subjects provide their informed consent, and regular reporting of study progress and any adverse experiences is required. Studies are also subject to review by independent institutional review boards, or IRBs, responsible for overseeing studies at particular sites and protecting human research study subjects. An independent IRB may also suspend or terminate a study once initiated. U.S. FDA Review Process The results of nonclinical studies and clinical trials, together with other information, including manufacturing information and information on the composition of the drug and proposed labeling, are submitted to the U.S. FDA in an NDA requesting approval to market the drug for one or more specified indications. Each NDA is typically accompanied by a user fee and there is also an annual prescription drug product program fee for human drugs. The U.S. FDA reviews an NDA to determine, among other things, whether a drug is safe and effective for its intended use and whether the product is being manufactured in accordance with cGMP requirements to assure and preserve the product’s identity, strength, quality and purity. The U.S. FDA will conduct a pre-approval inspection of the manufacturing facilities for the new drug and may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the U.S. FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The U.S. FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. After the U.S. FDA evaluates an NDA, it will issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A complete response letter indicates that the review cycle of the application is complete and the application will not be approved in its present form, and usually describes all the specific deficiencies in the NDA identified by the U.S. FDA. The complete response letter may require additional clinical data and/or additional clinical trial(s), and/or other information. If a complete response letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, withdraw the application, or request a hearing. Even if such data and information is submitted, the U.S. FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Following the approval process of any drug product, the U.S. FDA may require post-marketing testing and surveillance to monitor the effects of approved products or it may place conditions on approvals including 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 requirements or if problems occur following initial marketing. Off-label Promotion in the United States The Federal Food, Drug, and Cosmetic Act, or FDCA, has been interpreted by the U.S. FDA and the U.S. government to make it illegal for pharmaceutical companies to promote their U.S. FDA-approved products for uses that have not been approved by the U.S. FDA. Companies that market drugs for off-label uses or indications have been subject to related costly litigation, criminal penalties and civil liability under the FDCA and the False Claims Act. However, recent case law has called into question the extent to which government in the United States, including the U.S. FDA, can, and is willing to seek to, prevent truthful and non-misleading speech related to off-label uses of U.S. FDA-approved products such as VASCEPA. If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Also, if governmental parties or our competitors view our claims as misleading or false, we could also be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any of such negative circumstances could adversely affect our ability to operate our business and our results of operations. Post-Marketing Requirements in the United States Following approval of a new product, a pharmaceutical company generally must engage in numerous specific monitoring and recordkeeping activities, such as routine safety surveillance, and must continue to submit periodic and other reports to the applicable regulatory agencies, including any cases of adverse events and appropriate quality control records. Such reports submitted to the U.S. FDA may result in changes to the label and/or other post-marketing requirements or actions, including product withdrawal. Additionally, under the Food and Drug Omnibus Reform Act of 2022, or FDORA, sponsors of approved drugs must provide six months’ notice to the FDA of any changes in marketing status, such as the withdrawal of a drug, and failure to do so could result in the 13 FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed.These are viable risks once a product is on the market. Additionally, modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval of the U.S. FDA and other 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 U.S. FDA regulates prescription drug promotion, including direct-to-consumer advertising. Prescription drug promotional materials must be submitted to the U.S. FDA in conjunction with their first use. Any distribution of prescription drug products and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act, or the PDMA, a part of the FDCA. In the United States, once a product is approved, its manufacture is subject to comprehensive and continuing regulation by the U.S. FDA. U.S. FDA regulations require that products be manufactured in specific approved facilities and in accordance with pharmaceutical cGMPs, and NDA holders must list their products and register their manufacturing establishments with the U.S. FDA and certain state agencies. Third-party manufacturers and other entities involved in the manufacture and distribution of approved drugs, and those supplying products, ingredients, and components of them, are also required to register their establishments with the U.S. FDA and certain state agencies. 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 U.S. FDA at any time, and the discovery of violative conditions, including failure to conform to cGMPs, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them. In addition, manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the U.S. FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. U.S. FDA Marketing Exclusivity and Generic Competition The FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or the Hatch-Waxman Amendments, provides for market exclusivity provisions that can help protect the exclusivity of new drugs by delaying the acceptance and final approval of certain competitive drug applications. New chemical entity, or NCE, marketing exclusivity precludes approval during the five-year exclusivity period of certain 505(b)(2) applications and ANDAs submitted by another company for another version of the drug. The timelines and conditions under the ANDA process that permit the start of patent litigation and allow the U.S. FDA to approve generic versions of brand name drugs like VASCEPA differ based on whether a drug receives three-year, or five-year, NCE marketing exclusivity. NCE marketing exclusivity precludes approval during the five-year exclusivity period of certain 505(b)(2) applications and ANDAs submitted by another company for another version of the drug. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. In such case, the pioneer drug company is afforded the benefit of a 30-month stay against the launch of such a competitive product that extends from the end of the five-year exclusivity period. A pioneer company could also be afforded extensions to the stay under applicable regulations, including a six-month pediatric exclusivity extension or a judicial extension if applicable requirements are met. In May 2016, after litigation, the U.S. FDA determined that VASCEPA was entitled to NCE marketing exclusivity. The related 30-month stay expired on January 26, 2020, seven-and-a-half years after U.S. FDA approval of VASCEPA. A three-year period of exclusivity under the Hatch-Waxman Amendments is generally granted for a drug product that contains an active moiety that has been previously approved, when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by the sponsor that were essential to approval of the application. Accordingly, we expect to receive three-year exclusivity in connection with any future regulatory approvals of VASCEPA. For example, we received such three-year regulatory exclusivity in connection with the approval based on the REDUCE-IT outcomes study results. Such three-year exclusivity protection precludes the U.S. FDA from approving a marketing application for an ANDA, a product candidate that the U.S. FDA views 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 submitted to the U.S. FDA with VASCEPA as the reference product, for a period of three years from the date of U.S. FDA approval. The U.S. FDA may accept and commence review of such applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of patents at any time, subject to any prior four-year period pending from a grant of five-year exclusivity. This three-year form of exclusivity may also not prevent the U.S. FDA from approving an NDA that relies only on its own data to support the change or innovation. Regulatory exclusivity is in addition to exclusivity afforded by issued patents related to VASCEPA. 14 European Union Drug Development and Approval The below EU rules relating to drug development, approval and post-approval are generally applicable in the European Economic Area, or EEA, which consists of the EU Member States, Norway, Liechtenstein and Iceland. Clinical Trials Regulation In April 2014, the EU adopted Clinical Trials Regulation (EU) No 536/2014, which replaced the Clinical Trials Directive 2001/20/EC on January 31, 2022 and overhauled the system of approvals for clinical trials. Specifically, the new Regulation, which is directly applicable in all EU Member States, such that no national implementing legislation in each EU Member State is required, aims to simplify and streamline the approval of clinical trials in the EU. For example, the new Regulation provides for a streamlined application procedure through a single entry point and strictly defined deadlines for the assessment of clinical trial applications. Drug Review and Approval Medicinal products can only be commercialized after obtaining a marketing authorization. To obtain regulatory approval of a medicinal product in the EU, a company must submit a marketing authorization application, or MAA. Centralized marketing authorizations are issued by the EC through the centralized procedure based on the opinion of the CHMP of the EMA and are valid throughout the EU as well as Iceland, Norway and Lichtenstein. The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicinal products such as gene-therapy, somatic cell-therapy or tissue-engineered medicines, and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions, and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. Under the centralized procedure, the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP. Clock stops may extend the timeframe of evaluation of an MAA considerably beyond 210 days. Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the EC, who makes the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA's recommendation. Accelerated assessments may be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is 150 days, excluding clock stops, but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate to conduct an accelerated assessment. National marketing authorizations, which are issued by the competent authorities of the Member States of the EU and only cover their respective territory, are available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been authorized for marketing in a Member State of the EU, this national marketing authorization can be recognized in other EU Member States through the mutual recognition procedure. If the product has not received a national marketing authorization in any EU Member State at the time of application, it can be approved simultaneously in various Member States through the decentralized procedure. Now that the United Kingdom, which comprises Great Britain and Northern Ireland, has left the EU, Great Britain is no longer covered by centralized marketing authorizations, while under the Northern Ireland Protocol centralized marketing authorizations continue to be recognized in Northern Ireland. All medicinal products with a centralized marketing authorization were automatically converted to Great Britain marketing authorizations on January 1, 2021. For a period of three years from January 1, 2021, the MHRA may rely on a decision taken by the EC on the approval of a new marketing authorization in the centralized procedure, in order to quickly grant a Great Britain marketing authorization despite a separate application being required. On January 24, 2023, the MHRA announced that a new international recognition framework will be put in place from January 1, 2024. Under this new framework, the MHRA will have regard to decisions on the approval of a marketing authorization made by the EMA and certain other regulators when considering whether to grant a UK marketing authorization. The MHRA also has the power to have regard to marketing authorizations approved in EU Member States through decentralized or mutual recognition procedures with a view to more quickly granting a marketing authorization in the UK or Great Britain. Periods of Authorization and Renewals A marketing authorization in the EU is valid for five years, in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by the EMA for a centrally authorized product, or by the competent authority of the authorizing Member State for a nationally authorized product. Once renewed, the marketing authorization is valid for an unlimited period, unless the EC or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization that is not followed by the placement of the product on the EU market, in the 15 case of the centralized procedure, or on the market of the authorizing Member State for a nationally authorized product, within three years after authorization, or if the product is removed from the market for three consecutive years, ceases to be valid. Data and Market Exclusivity In the EU, upon receiving marketing authorization, innovative medicinal products generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents generic or biosimilar applicants from referencing the innovator's pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing authorization in the EU, during a period of eight years from the date on which the reference product was first authorized in the EU. During the additional two year period of market exclusivity, a generic or biosimilar marketing authorization application can be submitted, and the innovator's data may be referenced, but no generic or biosimilar product can be marketed until the expiration of the market exclusivity. The overall ten year period will be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit in comparison to the existing therapies. There is no guarantee that a product will be considered by the EMA to be an innovative medicinal product and products may not qualify for data exclusivity. Even if a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company obtained a marketing authorization based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials. Regulatory Requirements after obtaining Marketing Authorization Where a marketing authorization for a medicinal product in the EU is obtained, the holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. These include: • • • Compliance with the EU's stringent pharmacovigilance or safety reporting rules must be ensured. These rules can impose post-authorization studies and additional monitoring obligations. The manufacturing of authorized medicinal products, for which a separate manufacturer's license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU. The marketing and promotion of authorized medical products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of medical products and/or the general public, are strictly regulated in the EU. Direct-to-consumer advertising of prescription medicines is prohibited across the EU. Foreign Regulation of New Drug Compounds In addition to regulations in the United States, we may be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products. Whether or not we obtain U.S. FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in all or most foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical trial application, or CTA, much like the IND prior to the commencement of human clinical trials. In Europe, for example, a CTA must be submitted to each country’s national health authority and an independent ethics committee, much like the U.S. FDA and IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical trial development may proceed. Similarly, clinical trials conducted in countries such as Australia, Canada, and New Zealand, require review and approval of clinical trial proposals by an ethics committee, which provides a combined ethical and scientific review process. Most countries in which clinical studies are conducted require the approval of the clinical trial proposals by both the national regulatory body and an ethics committee. The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, the clinical trials must be conducted in accordance with GCP, which have their origin in the World Medical Association’s Declaration of Helsinki, the applicable regulatory requirements, and guidelines developed by the International Conference on Harmonization, or ICH, for GCP practices in clinical trials. 16 Fraud and Abuse Laws and Data Regulation In addition to U.S. FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws restrict certain marketing practices in the biopharmaceutical industry. These laws include Anti-Kickback Statutes and false claims statutes. The federal Anti-Kickback Statute prohibits, among other things, any person or entity knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly, in cash or in kind, to induce 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 arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. Liability may be established without a person or entity having actual knowledge of the federal anti-kickback statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti- Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, there are no safe harbors for many common practices, such as educational and research grants or patient or product support programs. On November 20, 2020, the United States Department of Health and Human Services, or HHS, Office of Inspector General, or OIG, finalized further modifications to the federal Anti- Kickback Statute. Under the final rules, OIG added safe harbor protections under the Anti-Kickback Statute for certain coordinated care and value-based arrangements among clinicians, providers, and others. These rules, with exceptions, became effective January 19, 2021. We continue to evaluate what effect, if any, these rules will have on our business. The federal civil and criminal false claim laws, including the civil monetary penalty laws and the civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making or using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing, or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money or transmit properly to the federal government. Manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the statute and to share in any monetary recovery. Recently, several pharmaceutical and other healthcare companies have been investigated or faced enforcement actions under the federal civil False Claims Act for a variety of alleged improper marketing activities, including allegations that they caused false claims to be submitted because of the company’s marketing of the product for unapproved, and thus allegedly non-reimbursable, uses. Federal enforcement agencies also have showed increased interest in pharmaceutical companies’ product and patient assistance programs, including reimbursement and co-pay support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements. Pharmaceutical and other healthcare companies also are subject to other federal false claims laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, including the Final Omnibus Rule published in January 2013, collectively referred to herein as HIPAA, among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payor and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. In addition, HITECH imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. It requires certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. The federal Physician Payment Sunshine Act, implemented as the Open Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare and Medicaid Services, or CMS, information related to direct or indirect payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held in the company by physicians and their immediate family members. Effective January 1, 2022, applicable manufacturers are also required to report information regarding 17 payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives. The federal government price reporting laws require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs. Additionally, federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers. Many foreign countries and the majority of states also have statutes or regulations similar to the federal Anti-Kickback Statute and False Claims Act, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Other states or localities may have laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; relate to insurance fraud in the case of claims involving private insurers; and/or require identification or licensing of sales representatives. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring manufacturers to report information related to payments to physicians and other healthcare providers, marketing expenditures, and drug pricing information. Certain state and local laws require the registration of pharmaceutical sales representatives. State and foreign laws, including for example the California Consumer Privacy Act, or CCPA, and the European Union General Data Protection Regulation, or GDPR, also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. The CCPA creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA will require covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information. The CCPA went into effect on January 1, 2020, and the California Attorney General has commenced enforcement against violators as of July 1, 2020. While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities. The REDUCE-IT cardiovascular outcomes trial was conducted in part through clinical sites in the EEA. As a result, we are subject to additional privacy restrictions pursuant to European data protection laws, such as the GDPR. We may decide to conduct clinical trials or continue to enroll subjects in our ongoing or future clinical trials, which may result in us becoming subject to additional privacy restrictions. The collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the EEA including personal health data, is subject to the GDPR. The GDPR is wide- ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, ensuring certain accountability measures are in place and taking certain measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities. Further, since the UK's exit of the EU, often referred to as Brexit, companies have to now comply with the GDPR and also the United Kingdom GDPR, or UK GDPR, which, together with the amended UK Data Protection Act of 2018, retains the GDPR in UK national law. The UK GDPR follows fines up to the greater of £17.5 million or 4% of global turnover. The GDPR and UK GDPR, and other applicable data protection laws, impose restrictions in relation to the international transfer of personal data. For example, in order to transfer data outside of the EEA or the UK to a non-adequate country, the GDPR and UK GDPR (as applicable) requires us to enter into an appropriate transfer mechanism, and may require us to take additional steps to ensure an essentially equivalent level of data protection. These transfer mechanisms are subject to change, and implementing new or revised transfer mechanisms or ensuring an essentially equivalent protection may involve additional expense and potentially increased compliance risk. In the event a legislator, government, regulator or court imposes additional restrictions on international transfers, there may be operational interruption in the performance of services for customers and internal processing of employee information. Such restrictions may also increase our obligations in relation to carrying out international transfers of personal data, and incur additional expense and increased regulatory liabilities. On June 28, 18 2021, the EC adopted an adequacy decision in respect of transfers of personal data to the UK for a four year period until June 27, 2025. Similarly, the UK has determined that it considers all of the EEA to be adequate for the purposes of data protection. This ensures that data flows between the UK and the EEA remain unaffected. Despite Brexit, the GDPR and UK GDPR remain largely aligned. Currently, the most impactful point of divergence between the GDPR and the UK GDPR relates to these transfer mechanisms as explained above. There may be further divergence in the future, including with regard to administrative burdens. The UK has announced plans to reform the country’s data protection legal framework in its Data Reform Bill, which will introduce significant changes from the GDPR. This may lead to additional compliance costs and could increase our overall risk exposure as we may no longer be able to take a unified approach across the EEA and the UK, and we will need to amend our processes and procedures to align with the new framework. Because of the breadth of these laws and the narrowness of the exceptions or safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Such a challenge could have a material adverse effect on our business, financial condition and results of operations. These laws may impact, among other things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. If our promotional activities or other operations are found to be in violation of any of the laws described above or any other governmental regulations or guidance that apply to us through existing or new interpretations, we may be subject to prolonged litigation, penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Also, if governmental parties or our competitors view our claims as misleading or false, we could also be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any of such negative circumstances could adversely affect our ability to operate our business and our results of operations. In the U.S., to help patients afford our approved product, we may utilize programs to assist them, including patient assistance programs, or PAPs and co-pay coupon programs for eligible patients. PAPs are regulated by and subject to guidance from HHS OIG. In addition, at least one insurer has directed its network pharmacies to no longer accept co-pay coupons for certain specialty drugs identified by the insurer. Our co-pay coupon programs could become the target of similar insurer actions. In addition, in November 2013, the CMS issued guidance to the issuers of qualified health plans sold through the ACA's, as defined herein, marketplaces encouraging such plans to reject patient cost-sharing support from third parties and indicating that the CMS intends to monitor the provision of such support and may take regulatory action to limit it in the future. The CMS subsequently issued a rule requiring individual market qualified health plans to accept third-party premium and cost-sharing payments from certain government-related entities. In September 2014, the OIG of the HHS issued a Special Advisory Bulletin warning manufacturers that they may be subject to sanctions under the federal anti-kickback statute and/or civil monetary penalty laws if they do not take appropriate steps to exclude Part D beneficiaries from using co-pay coupons. Accordingly, companies exclude these Part D beneficiaries from using co-pay coupons. On December 2, 2020, the HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, or PBMs, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between PBMs and manufacturers. Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026. This deadline was delayed to January 1, 2027 by the Bipartisan Safer Communities Act. The Inflation Reduction Act of 2022 further delayed implementation of this rule to January 1, 2032. Further, on December 31, 2020, CMS published a new rule, effective January 1, 2023, requiring manufacturers to ensure the full value of co-pay assistance is passed on to the patient or these dollars will count toward the Average Manufacturer Price and Best Price calculation of the drug. On May 21, 2021, PhRMA sued the HHS in the U.S. District Court for the District of Columbia, to stop the implementation of the rule claiming that the rule contradicts federal law surrounding Medicaid rebates. On May 17, 2022, the U.S. District Court for the District of Columbia granted PhRMA’s motion for summary judgement invalidating the Medicaid Accumulator Rule. We cannot predict how the implementation of and any further changes to this rule will affect our business. We cannot predict how the implementation of and any further changes to this rule will affect our business. United States Healthcare Reform and Legislation In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our 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 seek to reduce healthcare costs. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposed new requirements for the distribution and pricing of prescription drugs for 19 Medicare beneficiaries. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities which will provide coverage of outpatient prescription drugs. Part D plans include both stand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Part A and B, Part D coverage is not standardized. Part D prescription 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 identifies which drugs it will cover and at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class 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 be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand for our products for which we receive marketing approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payers. In addition, there has been renewed interest in amending the Social Security Act to allow Medicare to negotiate prices for prescription drugs covered under Medicare Part B. If this were to be enacted by Congress and signed by the President, the prices we obtain for our products covered under Part B could be lower than the prices we might otherwise obtain, and it could exert a similar lowering pressure on payments from non-governmental payers. The Agency for Healthcare Research and Quality, or AHRQ, established by the MMA and provided additional funding by the American Recovery and Reinvestment Act of 2009, conducts comparative effectiveness research on different treatments for the same illness. Although the results of the comparative effectiveness studies are not intended to mandate coverage policies for public or private payers, it is possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of our product candidates. If third-party payers do not consider our products to be cost-effective compared to other available therapies, they may not cover our products 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. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, was enacted, which has substantially changed the way healthcare is financed by both governmental and private insurers and has significantly impacted the pharmaceutical industry. Among the provisions of the ACA 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, apportioned among these entities according to their market share in certain government healthcare programs, that began in 2011; expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability; expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; expanded the types of entities eligible for the 340B drug discount program; established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount, which was increased to 70% by the Bipartisan Budget Act of 2018 (as of January 1, 2019), off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organization; establishes annual fees and taxes on manufacturers of certain branded prescription drugs; 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; and 20 • establishment of a Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began on January 1, 2011. Certain provisions of the ACA have yet to be implemented and others have been subject to judicial challenges, as well as efforts to repeal or replace them or to alter their interpretation or implementation. Prior to the Biden administration, on October 13, 2017, former President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA. The former Trump administration concluded that cost-sharing reduction, or CSR, payments to insurance companies required under the ACA have not received necessary appropriations from Congress and announced that it will discontinue these payments immediately until those appropriations are made. Several state Attorney Generals filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017. On August 14, 2020, the U.S. Court of Appeals for the Federal Circuit ruled in two separate cases that the federal government is liable for the full amount of unpaid CSRs for the years preceding and including 2017. For CSR claims made by health insurance companies for the years 2018 and later, further litigation will be required to determine to amounts due, if any. Further, on June 14, 2018, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12.0 billion in ACA risk corridor payments to third-party payors who argued the payments were owed to them. On April 27, 2020, the U.S. Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit's decision and remanded the case to the U.S. Court of Federal Claims, concluding that the government has an obligation to pay these risk corridor payments under the relevant formula. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as the Tax Cuts and Jobs Act enacted on December 22, 2017, or the Tax Act, which included a provision that decreased the tax-based shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the “individual mandate,” to $0, effective January 1, 2019. On December 14, 2018, a federal district court in Texas ruled the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well. On December 18, 2019, the Fifth Circuit U.S. Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to reconsider its earlier invalidation of the full ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court's decision, President Biden issued an Executive Order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The Executive Order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, re-examining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results. We continue to evaluate the effect that the ACA and its possible repeal and replacement could have on our business. Further, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. The Bipartisan Budget Act of 2018 among other things, amended the Medicare statute, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” On December 20, 2019, President Trump signed into law the Further Consolidated Appropriations Act (H.R. 1865), which repeals the “Cadillac” tax on certain high-cost employer-sponsored insurance plans, the health insurance provider tax based on market share, and the medical device excise tax on non-exempt medical devices. It is impossible to determine whether similar taxes could be instated in the future. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. It is unclear how the ACA and its implementation, as well as efforts to repeal, replace, or invalidate, the ACA or its implementing regulations, or portions thereof, and other legislative changes adopted since, will affect our business. It is possible that the ACA will continue to exert pressure on pharmaceutical pricing, especially under the Medicare and Medicaid programs, and may also increase our regulatory burdens and operating costs. Additional legislative changes, regulatory changes, and judicial challenges related to the ACA remain possible. We will continue to evaluate the effect that the ACA as well as its possible repeal, replacement, or invalidation, in whole or in part, has on our business. Pharmaceutical Pricing and Reimbursement In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Our ability to successfully commercialize our product therefore depends significantly on the availability of adequate financial coverage and reimbursement from third-party payors, including, in the United States, governmental payors such as Medicare and Medicaid, as 21 well as managed care organizations, private health insurers and other organizations. Third-party payors decide which drugs they will pay for and establish reimbursement and copayment levels. Third-party payors are increasingly challenging the prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost effectiveness of our products. Even with studies, our products may be considered less safe, less effective or less cost effective than other products, and third-party payors may not provide coverage and reimbursement for our product candidates, in whole or in part. Reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the U.S. FDA or comparable foreign regulatory authorities. Product candidates may not be considered medically necessary or cost effective. In the United States, the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within the HHS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Outside the United States, ensuring coverage and adequate payment for a product also involves challenges. Pricing of prescription pharmaceuticals is subject to government control in many countries. Pricing negotiations with government authorities can extend well beyond the receipt of regulatory approval for a product and may require a clinical trial that compares the cost-effectiveness of a product to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in commercialization. In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies. A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates. Historically, products launched in the European Union do not follow price structures of the U.S. and generally prices, particularly when for the same product and the same indication as in the U.S., tend to be significantly lower. Price negotiations are conducted in each EU (and UK) country for new medicines between the manufacturer and the national government pricing committee, or the parties. In many cases, there is no specific timeline for negotiation conclusion and the dynamics depends on the discussions between both parties. Analyzing a benchmark of innovative cardiovascular and metabolic products in recent years, the average time to price negotiation from marketing authorization ranged from 12 months in England to 52 months in countries like France. Recent macro-economic context has put additional pressure on EU authorities in their ability to allocate large budgets for innovative medicines. After this negotiation phase concludes between the parties, a confidential agreement is signed for usually 3 to 5 years with a specific public budget allocation and a price is published, or the list price. For retail products like VAZKEPA in the UK, Sweden or Finland there are no confidential deals with authorities impacting net prices. A decision by a third-party payor not to cover a product could reduce physician utilization once the product is approved and have a material adverse effect on sales, results of operations and financial condition. Additionally, a third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for the product, and the level of coverage and reimbursement can differ significantly from payor to payor. In the United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors. Coverage and reimbursement for drug products can differ significantly from payor to payor. The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved. The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit a company’s revenue generated from the sale of any approved products. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. 22 In August 2022, the Inflation Reduction Act of 2022, or IRA was signed into law. The IRA includes several provisions that will impact our business to varying degrees, including provisions that reduce the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025; impose new manufacturer financial liability on certain drugs in Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one rare disease designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it will not qualify for the orphan drug exemption. Political, economic and regulatory influences are subjecting the healthcare industry in the United States to fundamental changes. There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our products profitably. We anticipate that the United States Congress, state legislatures and the private sector will continue to consider and may adopt healthcare policies intended to curb rising healthcare costs. These cost containment measures include: controls on government funded reimbursement for drugs; new or increased requirements to pay prescription drug rebates to government healthcare programs; controls on healthcare providers; challenges to the pricing of drugs or limits or prohibitions on reimbursement for specific products through other means; requirements to try less expensive products or generics before a more expensive branded product; changes in drug importation laws; expansion of use of managed care systems in which healthcare providers contract to provide comprehensive healthcare for a fixed cost per person; and public funding for cost effectiveness research, which may be used by government and private third-party payors to make coverage and payment decisions. Further, federal budgetary concerns could result in the implementation of significant federal spending cuts, including cuts in Medicare and other health related spending in the near term. For example, on August 2, 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic. Following the temporary suspension, a 1% payment reduction was effective beginning April 1, 2022 through June 30, 2022, and the 2% payment reduction resumed on July 1, 2022. Payors also are increasingly considering new metrics as the basis for reimbursement rates, such as average sales price, average manufacturer price and actual acquisition cost. CMS surveys and publishes retail community pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost files to provide state Medicaid agencies with a basis of comparison for their own reimbursement and pricing methodologies and rates. It is difficult to project the impact of these evolving reimbursement mechanics on the willingness of payors to cover our products. We participate in the Medicaid Drug Rebate program, the 340B drug pricing program, and the U.S. Department of Veterans Affairs, or VA, Federal Supply Schedule, or FSS, pricing program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Part B of the Medicare program. 23 Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program. There have been several changes to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities. On December 27, 2018, the District Court for the District of Columbia invalidated a reimbursement formula change under the 340B drug pricing program, and CMS subsequently altered the FY’s 2019 and 2018 reimbursement formula on specified covered outpatient drugs, or SCODs. The court ruled this change was not an “adjustment” which was within the Secretary’s discretion to make but was instead a fundamental change in the reimbursement calculation. However, most recently, on July 31, 2020, the U.S. Court of Appeals for the District of Columbia Circuit overturned the district court’s decision and found that the changes were within the Secretary’s authority. On September 14, 2020, the plaintiffs- appellees filed a Petition for Rehearing En Banc, i.e., before the full court, but was denied on October 16, 2020. Plaintiffs-appellees filed a petition for a writ of certiorari at the U.S. Supreme Court on February 10, 2021. On Friday July 2, 2021, the Supreme Court granted the petition. On June 15, 2022, the Supreme Court unanimously reversed the Court of Appeals’ decision, holding that HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful. We continue to review developments impacting the 340B program. It is unclear how these developments could affect covered hospitals who might purchase our future products and affect the rates we may charge such facilities for our approved products in the future, if any. In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we participate in the VA/FSS pricing program. Under this program, we are obligated to make our products available for procurement on an FSS contract and charge a price to four federal agencies - the VA, U.S. Department of Defense, Public Health Service and U.S. Coast Guard - that is no higher than the statutory Federal Ceiling Price, or FCP. The FCP is based on the non-federal average manufacturer price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis. We also participate in the Tricare Retail Pharmacy program, under which we pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non-FAMP and FCP. The Medicaid Drug Rebate program, 340B program, and VA/FSS pricing program, and the risks relating to price reporting and other obligations under these programs, are further discussed under the heading “If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects” in Part I, Item 1A of this Annual Report on Form 10-K. Recently, there have been several U.S. Congressional inquiries and proposed and adopted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, President Biden signed an Executive Order on July 9, 2021 affirming the administration's policy to (i) support legislative reforms that would lower the prices of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, imposing inflation caps and supporting the development and market entry of lower-cost generic drugs and biosimilars; and (ii) support the enactment of a public health insurance option. Among other things, the Executive Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, to enhance the domestic drug supply chain, to reduce the price that the Federal government pays for drugs, and to address price gouging in the industry; and directs the U.S. FDA to work with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the U.S. FDA's implementing regulations. The U.S. FDA released such implementing regulations on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, CMS issued an Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates will be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. On December 29, 2021, CMS rescinded the Most Favored Nations rule. Further, authorities in Canada have passed rules designed to safeguard the Canadian drug supply from shortages. If implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our products. Additionally, on December 2, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Pursuant to the court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026. This deadline was delayed to January 1, 2027 by the Bipartisan Safer Communities 24 Act. The Inflation Reduction Act of 2022 further delayed implementation of this rule to January 1, 2032. Further, on December 31, 2020, CMS published a new rule, effective January 1, 2023, requiring manufacturers to ensure the full value of co-pay assistance is passed on to the patient or these dollars will count toward the Average Manufacturer Price and Best Price calculation of the drug. On May 21, 2021, PhRMA sued the HHS in the U.S. District Court for the District of Columbia, to stop the implementation of the rule claiming that the rule contradicts federal law surrounding Medicaid rebates. On May 17, 2022, the U.S. District Court for the District of Columbia granted PhRMA’s motion for summary judgement invalidating the Medicaid Accumulator Rule. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that it will continue to seek new legislative measures to control drug costs. In addition, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for U.S. FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining U.S. FDA permission under the U.S. FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act. Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, the State of California enacted legislation that requires notice for exceeding specified limits on annual drug price increases and other legislation that seeks to limit the use of co-pay cards in certain situations. Other Regulatory Matters Manufacturing, sales, promotion, importation, and other activities related to approved products are also subject to regulation by numerous regulatory authorities, including, in the United States, the U.S. FDA, the Centers for Medicare & Medicaid Services, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments. Sales, marketing and scientific/educational programs must comply with the Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, and the False Claims Act and similar state laws. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. 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 to meet applicable regulatory 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 product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. In addition, even if a firm complies with U.S. FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the U.S. FDA to modify or withdraw a product approval. Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect our business 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. Patents, Proprietary Technology, Trade Secrets 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. While certain key patents related to our product based on the MARINE clinical study were determined to be invalid as obvious by a district court in the United States, it remains the case that our ability to successfully implement our business plan and to protect our products with our intellectual 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; 25 • • acquire patented or patentable products and technologies; and operate without infringing the proprietary rights of third parties. We have prosecuted, and are currently prosecuting, multiple patent applications to protect the intellectual property developed during the VASCEPA development program. As of the date of this Annual Report on Form 10-K, we had more than 100 patent applications in the United States that have been either issued or allowed, most of which are listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations also known as the FDA Orange Book. There are more than 30 additional patent applications pending in the United States. Currently-issued U.S. patents will expire between 2027 and 2033 and contain claims directed to the methods of using icosapent ethyl to treat hypertriglyceridemia, severe hypertriglyceridemia and cardiovascular risk reduction. Our VASCEPA patent portfolio also includes many granted patents in foreign jurisdictions including pending foreign and Patent Cooperation Treaty, or PCT patent applications. Currently-granted European patents directed to the same subject matter as above will expire between 2027 and 2033, and may be subject to a potential further extension of a patent right. Granted patents in other foreign jurisdictions will expire between 2030 and 2033 and may be subject to a potential further patent term extension, depending on the country. Pending applications covering VASCEPA/VAZKEPA may, if granted, provide exclusivity for the drug until 2039. Patents and applications described above are either owned by Amarin or exclusively licensed from others. We have pending patent applications worldwide related to potential new uses of icosapent ethyl or other derivatives of EPA and potential new formulations thereof. Patents maturing from such pending applications would expire between 2030 and 2043. A Notice of Allowance is issued after the U.S. Patent and Trademark Office, or USPTO, makes a determination that a patent can be granted from an application. A Notice of Allowance does not afford patent protection until the underlying patent is issued by the USPTO. No assurance can be given that applications with issued notices of allowance will 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 patents will prevent competitors from competing with VASCEPA. For example, we may choose to not assert all issued patents in patent litigation and patents or claims within patents may be determined to be invalid. Geographies outside the United States in which VASCEPA is sold or under regulatory review are not subject to the U.S. patent litigation and judgment. No litigation involving potential generic versions of VASCEPA is pending outside the United States. Outside the United States, VASCEPA is currently available by prescription in certain European countries, Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that could extend into 2039. We are pursuing additional regulatory approvals for VASCEPA in Europe, China and the Middle East. In China and the Middle East, we are pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners. The EC approval provides ten years of market protection in the EU. Furthermore, patent protection in Europe includes: one allowed patent related to the use of a pharmaceutical composition comprised of 4g of 96% EPA ethyl ester to treat the REDUCE-IT population expiring 2033. In addition, pending patent applications in Europe, if granted, may have the potential to extend exclusivity into 2039. We may be dependent in some cases upon third-party licensors to pursue filing, prosecution and maintenance of patent rights or applications owned or controlled by those parties, including, for example, under our collaboration with Mochida. It is possible that third parties will obtain patents or other proprietary rights that might be necessary or useful to us. In cases 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 went into 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 such technology 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 proprietary technology we acquire or develop does not infringe the rights of other parties, we may not be able to ascertain the existence of all potentially conflicting claims. Therefore, there is a risk that third parties may make claims of infringement against our current or future products or technologies. In addition, third parties 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 or royalties 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 legal proceedings against a third party to stop such an infringement, such proceedings could be costly and time consuming, regardless of the outcome. No assurances 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, unenforceable or both. Although we intend to protect our trade secrets and proprietary know-how through confidentiality agreements with our manufacturers, employees and consultants, we may not be able to prevent parties subject to such confidentiality agreements from breaching these agreements or third parties from independently developing or learning of our trade secrets. 26 We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patented technologies for regulatory approvals. Competitors may seek to oppose our patent 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. For example, one of our patents was revoked in an opposition proceeding in Europe due to a determination of improper claim amendments under a provision of law not applicable in the United States. Such proceedings are generally highly technical, expensive, and time consuming, and there can be no assurance that such a challenge would not result in the narrowing or complete revocation of any patent of ours that was so challenged. Human Capital Management As of December 31, 2022, we had approximately 365 full-time employees located in fifteen countries. Attracting, developing and retaining key scientific, technical, research, marketing, sales and other personnel is critical to our ability to implement and execute our business plan and is key to the success of the business. Our ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development, career opportunities and work environment. Diversity and Inclusion We believe that a diverse and inclusive workforce helps us better connect our work with the needs of our patients, physicians, partners and other stakeholders. In our hiring and recruiting of prospective candidates, we give priority to attitude, intelligence, competency for the position and assessment of what they can contribute to our company. We promote employees based on merit with emphasis on accomplishments over effort while supporting the benefits of diversity. In our hiring, promotion, compensation, retention and other employment practices, we regularly evaluate whether women and minority populations are being treated equally. We seek ways to continually improve in this area. While we acknowledge and support the benefits of diversity, individual hiring and promotion decisions are made irrespective of personal characteristics such as race, disability, gender, sexual orientation, religion, or age. Executive Leadership Management Sales Professionals and Other Associates 2022 Workforce Diversity Representation (U.S. Only) Gender 20% 42% 58% Race 16% 36% 29% In the above table, executive leadership is defined as positions of vice president and above. Management is defined as positions of director, manager or equivalent roles. Employee Development & Engagement We believe in a direct management-employee engagement model by which managers and employees maintain a regular dialogue about working conditions, compensation, compliance, safety and advancement opportunities. We communicate frequently and transparently with our employees through a variety of communication methods, including written communications and quarterly town hall meetings. We believe these engagement efforts keep our employees informed about our strategy, purpose and priorities, which is consistent with our core values of integrity, operational excellence, collaboration and commitment to quality and we believe this engagement motivates our employees to do their best work. Our core values promote an empowering, supportive atmosphere where we work together to put patients first and improve patient care through our actions and products. We encourage employees to share ideas and learn from each other, while expecting high standards of quality and continuous improvement. Compensation and Benefits We are committed to rewarding, supporting, and developing our employees who make it possible to deliver on our strategy. To that end, we offer a comprehensive rewards program aimed at the varying health and financial needs of our employees. Our program includes market-competitive salaries and wages, bonuses and broad-based stock grants, healthcare benefits, retirement plans with employer matching provisions, paid time off and family leave and a strong commitment to corporate wellness. In addition, we have implemented a hybrid workplace model for our offices throughout the world. We utilize independent consultants to help us ensure that 27 our compensation and benefits are competitive with market practices and compliant with laws and regulations in the various geographies in which we operate. Organizational Structure At March 1, 2023, we had the following subsidiaries: Subsidiary Name Amarin Pharmaceuticals Ireland Limited Amarin Pharma, Inc. Ester Neurosciences Limited Amarin Switzerland GmbH Amarin Germany GmbH Amarin France SAS Amarin UK Limited Amarin Italy S.r.l. Amarin Switzerland GmbH Sucursal Espana Amarin Switzerland GmbH Austrian branch Amarin Belgium, branch of Amarin Switzerland GmbH Amarin Denmark, filial af Amarin Switzerland GmbH Amarin Switzerland GmbH, Suomen sivuliike Amarin Switzerland GmbH Greek branch Amarin Switzerland GmbH Dutch branch Amarin Switzerland GmbH Norwegian branch Amarin Switzerland GmbH, Sucursal em Portugal Amarin Switzerland GmbH Sweden filial Country of Incorporation or Registration Proportion of Ownership Interest and Voting Power Held Ireland United States Israel Switzerland Germany France United Kingdom Italy Spain Austria Belgium Denmark Finland Greece Netherlands Norway Portugal Sweden 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% As of the date of this Annual Report on Form 10-K, our principal operating activities were being conducted by Amarin Corporation plc, together with Amarin Pharmaceuticals Ireland Limited and Amarin Pharma, Inc. Operating activity being conducted by the European subsidiaries were in support of Amarin Pharmaceuticals Ireland Limited. Ester Neurosciences Limited had no operating activities. Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K (including exhibits), and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are made available free of charge on or through our website at www.amarincorp.com as soon as reasonably practicable after such reports are filed with, or furnished to, the Securities and Exchange Commission, or SEC. The SEC also maintains a website, www.sec.gov, that contains reports and other information regarding issuers that file electronically with the SEC. We are not, however, including the information contained on our website, or information that may be accessed through links on our website, as part of, or incorporating such information by reference into, this Annual Report on Form 10-K. Financial Information The financial information required under this Item 1 is incorporated herein by reference to Item 8 of this Annual Report on Form 10-K. 28 Item 1A. Risk Factors This Annual Report on Form 10-K contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA and VAZKEPA, collectively referred to as VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties, effects of tax reform, and other risks set forth below. Summary Risk Factors Our business is subject to numerous risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited to, the following: • • • • • • • • • • • We are substantially dependent upon VASCEPA (icosapent ethyl), its commercialization in the United States and its development, launch and commercialization in Europe and other major markets. In the United States, we face increasing competition from generic drug companies in the near term and our revenues and results of operations could continue to be materially and adversely affected. In Europe, we are seeking relevant pricing approvals in various countries; however, we may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we may not be successful in commercializing VAZKEPA in Europe. Factors outside of our control make it more difficult for VASCEPA to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success. Our recent cost reduction and organizational restructuring plans, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our Company's U.S. business and establishing a more significant international footprint. The manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny. We may not be able to compete effectively against our competitors’ pharmaceutical product, including generic products. In addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non- prescription competition and consumer substitution. The commercial value of VASCEPA outside the United States may be smaller than we anticipate, including if we are unable to secure favorable product reimbursement levels, which can vary from country to country. If we are unable to realize product reimbursement rates at reasonable levels, or at all, patient access to VASCEPA may be limited. Our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs. Our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments. We have limited experience commercializing VASCEPA outside the United States, and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the United States. We are currently, and may continue to be, substantially dependent on third parties for our international 29 efforts, and we may not be successful in negotiating or establishing relationships with business partners to support and maintain control over our international activities. We are dependent on patents, proprietary rights and confidentiality obligations of our employees, agents, business partners and third parties to protect the commercial value and potential of VASCEPA. Enforcing our patent rights is challenging and costly and, even if we are able to successfully enforce our patent rights, our issued patents may not prevent competitors from competing with VASCEPA. We have pending patent applications relating to VASCEPA and its use. There can be no assurance that any of these applications will issue patents, and even if patent protection is obtained, it may be insufficient to minimize competition or support our commercialization efforts. • • • The summary risk factors described above should be read together with the text of the full risk factors below and in the other information set forth in this Annual Report on Form 10-K, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. If any such risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations. Risks Related to the Commercialization and Development of VASCEPA We are substantially dependent upon VASCEPA (icosapent ethyl), its commercialization in the United States and its development, launch and commercialization in Europe and other major markets. We currently derive substantially all of our revenue from sales of VASCEPA. We may be substantially dependent on sales of VASCEPA for many years. Our financial condition and the success of our company will be materially adversely affected, we may have to further restructure our current operations, and our business prospects will be limited if we experience any negative developments relating to VASCEPA. For example, in the first quarter of 2020, the U.S. District Court for the District of Nevada issued a ruling in favor of two generic drug companies, Dr. Reddy's Laboratories, Inc., or Dr. Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, that declared as invalid several patents of ours protecting the first U.S. FDA-approved use of our drug, to reduce severely high triglyceride levels, or the MARINE indication. We were unsuccessful in our appeals and our stock price was adversely and materially impacted by the ruling, the results of the appeals process and the introduction of generic competition. If other proprietary rights protecting VASCEPA or its use are challenged, our stock price could further decline, particularly if such challenges, which are costly to defend, are successful. Although we are exploring ways to broaden our development and commercial pipeline, such efforts are likely to be time consuming, costly and may utilize resources that could otherwise be focused on commercializing VASCEPA. For example, it took over a decade of preceding product development before we received marketing approval for VAZKEPA in March 2021 from the European Commission, or the EC. Likewise, if we seek to diversify our development programs or product offerings through licensing or acquisitions, such transactions are also time- consuming, may be dilutive to existing shareholdings, and may be initially disruptive to operations. These transactions may not be available on favorable terms, or at all. These dynamics can restrict our ability to respond rapidly to adverse business conditions for VASCEPA. If development of, or demand for, VASCEPA does not meet expectations, we may not have the ability to effectively shift our resources to the development of alternative products, or do so in a timely manner, without suffering material adverse effects on our business. As a result, the lack of alternative markets and products we develop could constrain our ability to generate revenues and achieve profitability. In the United States, we face increasing competition from generic drug companies in the near term and our revenues and results of operations could continue to be materially and adversely affected. Following the patent litigation rulings against us, generic versions of VASCEPA began launching in the United States in November 2020, and several generic versions are currently available including for both the 0.5-gram and 1-gram capsules, and we expect that VASCEPA could face more competition from generic companies in the United States. Increasing sales of generic versions of VASCEPA could continue to have a material and adverse impact on our revenues and results of operations in the United States. Generally, once a generic version of a drug is available in the market, the generic version is typically used in many U.S. states to fill a prescription for any use of the drug, subject to state substitution laws. Although, we intend to vigorously defend our intellectual property rights related to VASCEPA, there can be no assurance that we will be successful in preventing use of generic versions of VASCEPA in indications for which they have not been approved by U.S. FDA, even if such use is determined to infringe certain of our patent claims. 30 Given the changing dynamic in the U.S. market, we initiated cost and organizational restructuring plans which reduced our U.S. commercial team from approximately 300 sales representatives to approximately 75 sales representatives by the end of 2022. Although this streamlining has resulted in an improved expense structure, such efforts could impact employee morale and make hiring and retaining talented personnel more challenging, may not result in all of the cost-savings or other benefits we anticipate and are costly to implement. In Europe, we are seeking relevant pricing approvals in various countries; however, we may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we may not be successful in commercializing VAZKEPA in Europe. We continue our development efforts to support commercialization of VASCEPA in major markets outside the United States, particularly in light of the level of competition, including from generic products, in the United States. This process is conducted on a country-by-country basis and is time- consuming and complex, and, even though the EC approved the marketing authorization for VAZKEPA in March 2021, and we have received positive national pricing and reimbursement decisions in England and Wales, Sweden and Finland, there is no guarantee that we will be able to negotiate and obtain further reimbursement and pricing terms on favorable terms, or at all, in the countries where we are pursuing commercialization. Further, successful progress or pricing terms in one country may not be indicative of our outcomes in other jurisdictions. For example, although the UK’s National Institute for Health and Care Excellence, or NICE, announced final guidance for reimbursement for VAZKEPA® and use across the National Health Service, or NHS, in England and Wales, we decided to discontinue business operations in Germany following the conclusion of negotiations with the National Association of Statutory Health Insurance Funds during which a viable agreement on the reimbursement price of VAZKEPA could not be reached. The Arbitration Board process concluded without an agreement in November 2022 and although we plan to resubmit a pricing and reimbursement dossier with new data in Germany once we have a new dossier ready, we may be unable to resume commercial operations in Germany. We may not be successful in obtaining additional approvals in a timely manner with acceptable terms, or in additional countries and if we are unable to do so, and continue to face increased competition in the United States, our financial position could be materially and adversely impacted. We have been developing VAZKEPA on our own in Europe, where we have limited experience. We are exploring possible strategic collaborations in smaller markets within Europe and in other major markets, which will increase our reliance on third parties, over whom we have limited control. We currently have multiple partners for the development and commercialization of VASCEPA in select geographies and are assessing potential partners to commercialize VASCEPA in other parts of the world. For example, we have strategic collaborations for the development and commercialization of VASCEPA in Canada, the Middle East and Greater China. However, we cannot make any guarantees as to the success of these efforts or that our beliefs about the value potential are accurate, or that we will be able to rely upon these third parties; if commercialization plans for VASCEPA do not meet expectations in major markets such as the United States and Europe, our business and prospects could be materially and adversely affected. The commercial value of VASCEPA outside the United States may be smaller than we anticipate, including if we are unable to secure favorable product reimbursement levels, which can vary from country to country. If we are unable to realize product reimbursement rates at reasonable levels, or at all, patient access to VASCEPA may be limited. There can be no assurance as to the market for VASCEPA outside the United States. For example, despite having received EC approval to commercialize VAZKEPA in Europe and through our partner, Edding, marketing approval for VASCEPA in Hong Kong as well as we expect to obtain through Edding, marketing approval for VASCEPA in Mainland China, Macau and Taiwan, applicable regulatory agencies may impose restrictions on the product’s conditions for use, distribution or marketing and in some cases may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials. Further, securing adequate reimbursement is critical for commercial success of any therapeutic and pricing and reimbursement levels of medications in markets outside the United States can be unpredictable and vary considerably on a country-by-country basis. In some foreign countries, including major markets in Europe, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with individual governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product, and is not always successful. For example, after the conclusion of negotiations with the National Association of Statutory Health Insurance Funds, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached. As a result of the negotiation outcome, we discontinued our German operations as of September 1, 2022. In November 2022 the Arbitration Board process concluded without an agreement. Further, in certain European countries, securing product reimbursement is a requisite to commercial launch. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a pharmacoeconomic study that compares the cost-effectiveness of VASCEPA to other available therapies. Such pharmacoeconomic studies can be costly and the results uncertain. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time. Our business could be harmed if reimbursement of our products is unavailable, delayed or limited in scope or amount or if pricing is set at unsatisfactory levels. If the pricing and reimbursement levels of VASCEPA are lower than we anticipate, then affordability of, and market access to, VASCEPA may be adversely affected and thus market potential in these territories would suffer. 31 We or our partners may even choose to not proceed with marketing VASCEPA in a market, even after obtaining all necessary regulatory approval, due to negative commercial dynamics. Further, with regard to any indications for which we may gain approval in territories outside the United States, the number of actual patients with the condition included in such approved indication may be smaller than we anticipate. In addition, we could face competition from products similar or deemed equivalent to VASCEPA in various jurisdictions through regulatory pathways that are more lenient than in the United States or in jurisdictions in which we do not have exclusivity from regulations or intellectual property. If any of these market dynamics exist, the commercial potential in these territories for our product would suffer. We have limited experience as a company in commercializing VASCEPA outside of the United States and may be unsuccessful in developing sales internationally. We may be unsuccessful in expanding our global footprint. For example, we are launching VAZKEPA on our own in the most commercially significant markets in Europe. The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage and be impacted by decisions by and interactions with local regulators, and we have no prior experience as a company operating a commercial- stage pharmaceutical business in Europe. For example, and as noted above, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached with German regulators and we have discontinued our Germany business operations. Given the amount of time and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted. Factors that could inhibit our efforts to successfully commercialize VASCEPA include: • • • • • • • • • • • the impact of the expiration of regulatory exclusivities and entry into the market of additional generic versions of VASCEPA; our inability to attract and retain adequate numbers of effective sales and marketing personnel, particularly in light of our recent reductions in force; our inability to adequately train our sales and marketing personnel and our inability to adequately monitor compliance with applicable regulatory and other legal requirements; if we have overestimated the addressable market; the inability of our sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA; regulators may impose restrictions on VASCEPA’s conditions for use, distribution or marketing, and may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials, which may be costly or result in label or other use restrictions; complexities and challenges in connection with pricing and reimbursement, including our ability to secure adequate reimbursement coverage, which in Europe is almost exclusively covered through public national funding, and not individual private insurance companies; the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; an inability by us or our partners to obtain regulatory and marketing approval or establish marketing channels in foreign jurisdictions; unforeseen costs and expenses associated with operating a new independent sales and marketing organization; and the continued or resumed impact from COVID-19 on healthcare providers, patients and personnel which may vary considerably from jurisdiction to jurisdiction, as well as on local restrictions and practices, including the complexities of having to understand and navigate multiple and evolving sets of protocols and the accessibility and rates of vaccinations in various geographies. If we experience one or more of the setbacks described above, we may not be able to pursue international regulatory and commercial efforts in a cost effective manner, or at all, which could cause our stock price to decline. Our ability to generate meaningful revenues outside of the United States may be limited, including due to the strict price controls and reimbursement limitations imposed by payors outside of the United States. Our ability to generate meaningful revenues of VASCEPA outside of the United States is dependent on the availability and extent of coverage and reimbursement from third-party payors. In many markets around the world, these payors, including 32 government health systems, private health insurers and other organizations, remain focused on reducing the cost of healthcare, and their efforts have intensified as a result of rising healthcare costs and economic challenges. Drugs remain heavily scrutinized for cost containment. As a result, payors are becoming more restrictive regarding the use of biopharmaceutical products and scrutinizing the prices of these products while requiring a higher level of clinical evidence to support the benefits such products bring to patients and the broader healthcare system. These pressures are intensified where our products are subject to competition, including from biosimilars. In many countries outside the United States, government-sponsored healthcare systems are the primary payors for drugs. With increasing budgetary constraints and differing views on or challenges in valuing medicines, governments and payors in many countries are applying a variety of measures to exert downward price pressure. These measures can include mandatory price controls, price referencing, therapeutic-reference pricing, increases in mandates, incentives for generic substitution and biosimilar usage and government-mandated price cuts. In this regard, many countries have health technology assessment organizations that use formal economic metrics such as cost-effectiveness to determine prices, coverage and reimbursement of new therapies; and these organizations are expanding in established and emerging markets. Many countries also limit coverage to populations narrower than the regulatory agency approved product label or impose volume caps to limit utilization. We expect that countries will continue to take aggressive actions to seek to reduce expenditures on drugs. Similarly, fiscal constraints may also affect the extent to which countries are willing to approve new and innovative therapies and/or allow access to new technologies. The dynamics and developments discussed above serve to create pressure on the pricing and potential usage of our products and the industry. Given the diverse interests in play among payors, biopharmaceutical manufacturers, policy makers, healthcare providers and independent organizations, if and whether the parties involved can achieve alignment on the matters discussed above remains unclear and the outcome of any such alignment is difficult to predict. If reimbursement of VASCEPA is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to successfully commercialize VASCEPA outside of the United States may be harmed, which could have a material and negative impact on our overall business. Government and commercial payor actions outside of the United States have affected and will continue to affect access to and sales of our products Outside of the United States, we expect countries will continue to take actions to reduce their drug expenditures. International reference pricing, or IRP, has been widely used by many countries outside of the United States to control costs based on an external benchmark of a product’s price in other countries. IRP policies can change quickly and frequently and may not reflect differences in the burden of disease, indications, market structures, or affordability differences across countries or regions. In addition, countries may refuse to reimburse or may restrict the reimbursed population for a product when their national health technology assessments do not consider a medicine to demonstrate sufficient clinical benefit beyond existing therapies or to meet certain cost effectiveness thresholds. Some countries also allow additional rebates or discounts to be negotiated. The outcome of such negotiations can be uncertain and could become publicly disclosed in the future. Some countries decide on reimbursement between potentially competing products through national or regional tenders that often result in one product receiving most or all of the sales in that country or region. Thus, there can be no certainty that we will negotiate satisfactory reimbursement or pricing rates in markets outside of the United States in a timely manner, or at all, or even if we are successful in obtaining satisfactory coverage and reimbursement, we may be unsuccessful in sustaining such coverage and reimbursement, or could face challenges as to the timeliness or certainty of payment by payors to physicians and other providers, which would have a material and adverse impact on our commercialization efforts outside of the United States. We as an organization have limited experience in navigating the pricing and reimbursement regimes, outside of the United States, which foreign regimes are varied and complex, which might hinder our effectiveness in establishing satisfactory pricing, coverage and reimbursement levels in a timely manner or at all. Factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success. In January 2013, we launched VASCEPA based on the U.S. FDA approval of our MARINE indication, for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (TG >500 mg/dL) hypertriglyceridemia. Guidelines for the management of very high triglyceride levels suggest that the primary goal of reducing triglyceride levels in this patient population is reduction in the risk of acute pancreatitis. A secondary goal for this patient population is to reduce cardiovascular risk. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined and our U.S. FDA-approved labeling and promotional efforts state this fact. In December 2019, the U.S. FDA approved another indication and label expansion for VASCEPA as an adjunct to statin therapy to reduce the risk of MACE events in adult patients with elevated TG levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease, or our REDUCE-IT indication. Despite U.S. FDA approval for this indication and expanded label for VASCEPA, we may not meet expectations for market acceptance by physicians, patients, healthcare payors and others in the medical community for this approved use, especially in light of 33 generic competition. If VASCEPA does not achieve an adequate level of acceptance, we may not generate product revenues sufficient to become profitable, or, even if we do achieve profitability, we may not be able to generate consistent profitability. The degree of market acceptance of VASCEPA for its approved indications and uses or otherwise will depend on a number of factors, including: • • • • • • • • • • • • • • • • the impact of and outcome of adjudicated, settled and pending patent litigation; the commercialization and pricing of any current or potential generic versions of VASCEPA; the perceived efficacy and safety of VASCEPA by prescribing healthcare professionals and patients, as compared to no treatment and as compared to alternative treatments in various at-risk patient populations; the prevalence and severity of any side effects and warnings in VASCEPA's approved labeling internationally; peer review of different elements of data supporting our REDUCE-IT indication over time; continued review and analysis of the results of our clinical data supporting our REDUCE-IT indication by regulatory authorities internationally; 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 teams; publicity concerning VASCEPA or competing products; our ability to continually promote VASCEPA in the United States consistent with and outside of U.S. FDA-approved labeling and the related perception thereof; sufficient third-party coverage or reimbursement for VASCEPA and its prescribed uses, on-label and off-label; natural disasters, including pandemics such as the COVID-19 pandemic, international conflicts, and political unrest which could inhibit our ability to promote VASCEPA regionally and which could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions; new policies or laws affecting VASCEPA sales, such as state and federal efforts to affect drug pricing and provide or remove healthcare coverage that includes reimbursement for prescription drugs; and the actual and perceived efficacy of the product and the prevalence and severity of any side effects and warnings in VASCEPA’s approved labeling internationally. Any one or more of the above factors could have a negative impact on our ability to successfully commercialize VASCEPA, which would in turn have a negative impact on our financial condition. Additional data or related interpretations that are generated or arise over time related to REDUCE-IT might not meet expectations, and the perception of REDUCE-IT results and VASCEPA revenue potential may suffer and our stock price may decline. While the U.S. FDA approved the expanded label for VASCEPA for the REDUCE-IT indication in 2019, additional data assessment by international regulatory authorities or otherwise could yield additional information to inform greater understanding of study outcome, which information could impact the perception of VASCEPA. Such data or interpretations may not be favorable for us. Generally, trial data assessment sufficient to convey a complete picture of trial outcome can take years to complete and publish. When new data are assessed and released or presented it could exceed, match or may not meet investor expectations. In addition, the same set of data can sometimes be interpreted to reach different conclusions, as when Health Canada approved an indication based on our REDUCE-IT trial data that was different in certain respects than that approved by U.S. FDA and by the EC in Europe. It is possible the scope of subsequent regulatory approvals, if any, could likewise differ based on the same data. Conflicting interpretations of data, or new data, could impact public and medical community perception of the totality of the efficacy and safety data from REDUCE-IT. 34 Regulatory authorities and medical guideline committees outside of the United States and Europe may consider the following additional factors, which could lead to evaluations of the totality of the efficacy and safety data from REDUCE-IT that differ from those of the U.S. FDA or the EC: • • • • • • • • the magnitude of the treatment benefit and related risks on the primary composite endpoint, its components, secondary endpoints and the primary and secondary risk prevention cohorts; consideration of which components of the composite or secondary endpoints have the most clinical significance; the consistency of the primary and secondary outcomes; the consistency of findings across cohorts and important subgroups; safety considerations and risk/benefit considerations (such as those related to adverse events, including bleeding and atrial fibrillation generally and in different sub-populations); consideration of REDUCE-IT results in the context of other clinical studies; consideration of the cumulative effect of VASCEPA in studied patients; and study conduct and data quality, integrity and consistency, including aspects such as analyses regarding the placebo used in REDUCE-IT and other studies of VASCEPA and its impact, if any, on the reliability of clinical data. If regulatory authorities and medical guideline committees outside of the United States and Europe draw conclusions that differ from those of the U.S. FDA or the EC, the U.S. FDA or the EC could reevaluate its conclusions as to the safety and efficacy of VASCEPA. Likewise, if additional data or analyses released from time to time do not meet expectations, the perception of REDUCE-IT results and the perceived and actual value of VASCEPA may suffer. In these instances our revenue and business could suffer and our stock price could significantly decline. Ongoing clinical trials or new clinical data involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could adversely impact public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA. Ongoing trials of moderate-to-high doses of VASCEPA and icosapent ethyl, or a similar eicosapentaenoic acid product could render new or adverse information on the effects of VASCEPA and its commercial and regulatory prospects. For example, the Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and EPA (RESPECT-EPA; UMIN Clinical Trials Registry number, UMIN000012069) is a study examining Japanese patients with chronic coronary artery disease receiving LDL-C lowering treatment by statin therapy. Results from this study were presented during the 2022 American Heart Association Scientific Sessions in November 2022 and were consistent with the evidence from the REDUCE-IT study. In November 2020, we announced statistically significant topline results from a Phase 3 clinical trial of VASCEPA, conducted by our partner in China, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, which investigated VASCEPA as a treatment for patients with very high triglycerides. Even though such results from these trials were positive, additional clinical development efforts may be necessary in these markets to demonstrate the effectiveness of VASCEPA, which may be costly to pursue, or may not produce the desired or expected results. If the outcomes of any study involving VASCEPA and icosapent ethyl is unfavorable, the perception of existing clinical results of VASCEPA, such as MARINE or REDUCE-IT, or the perceived clinical profile and commercial value of VASCEPA and its regulatory status, or perceptions about the potential for VASCEPA, including as a treatment for broader indications, may suffer. If this occurs our revenue and business could suffer and our stock price could significantly decline. Our recent cost reduction and organizational restructuring plans, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our Company's U.S. business and establishing a more significant international footprint. If we are not successful in our efforts to continue to market and sell VASCEPA in the United States, including following the implementation of our cost reduction and organizational restructuring plan, our anticipated revenues or our expenses could be materially and negatively affected, and we may not maintain profitability in the United States or obtain profitability internationally, may need to cut back on research and development activities or we may need to implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business. 35 Our promotional initiatives have had to adjust over the last several years, given the impact of COVID-19 and international instability, which efforts have been costly and require considerable resources. Shifts from traditional face-to-face interactions to mostly virtual outreach, specifically, access to healthcare professionals through digital or other channels, were not as productive as in-person interactions in promoting use of VASCEPA and we have been pursuing increased face-to-face interactions with targeted health care professionals as protocols have eased and travel has resumed to more stable levels. Such efforts are costly and there can be no assurance that they will result in an increase in VASCEPA prescriptions and sales in the near future, or at all. The manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny. The Federal Food, Drug, and Cosmetic Act, or FDCA, has been interpreted by the U.S. FDA and the U.S. government to make it illegal for pharmaceutical companies to promote their U.S. FDA-approved products for uses that have not been approved by the U.S. FDA. Companies that market drugs for off-label uses or indications have been subject to related costly litigation, criminal penalties and civil liability under the FDCA and the FCA. However, case law over the last several years has called into question the extent to which the U.S. government, including the U.S. FDA, can, and is willing to seek to, prevent truthful and non-misleading speech related to off-label uses of U.S. FDA-approved products such as VASCEPA. As a result of a lawsuit that we and a group of independent physicians filed against the U.S. FDA in 2015, we were granted preliminary relief through the court’s declaratory judgment that confirmed we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA to healthcare professionals, i.e., to treat patients with persistently high triglycerides, and that such speech may not form the basis of a misbranding action under the FDCA. The U.S. FDA did not appeal the court’s ruling and ultimately settled this litigation under terms by which the U.S. FDA and the U.S. government agreed to be bound by the conclusions from the federal court order that we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA and that certain statements and disclosures that we proposed to make to healthcare professionals were truthful and non- misleading. As part of the settlement, given, as expressed in the court’s opinion, that the dynamic nature of science and medicine is that knowledge is ever- advancing and that a statement that is fair and balanced one day may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired, we agreed that we bear the responsibility to ensure that our communications regarding off-label use of VASCEPA remain truthful and non-misleading, consistent with the federal court ruling. While we believe we are now permitted under applicable law to more broadly promote VASCEPA, the U.S. FDA-approved labeling for VASCEPA did not change as a result of this litigation and settlement, and neither government nor other third-party coverage or reimbursement to pay for the off-label use of VASCEPA promoted under the court declaration was required. Promotional activities in the biotechnology and pharmaceutical industries generally are subject to considerable regulatory scrutiny and, may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement. For example, under the settlement, we remain responsible for ensuring our speech is truthful and non-misleading, which is subject to a considerable amount of judgment. We, the U.S. FDA, the U.S. government, our competitors and other interested parties may not agree on the truthfulness and non-misleading nature of our promotional materials. Federal and state governments or agencies may also seek to find other means to prevent our promotion of unapproved truthful and non-misleading information about VASCEPA. In June 2020, we received a civil investigative demand, or CID, from the U.S. Department of Justice, or the DOJ, informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. Civil False Claims Act, or the FCA, in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa Pharmaceuticals America, Inc., or Kowa America. Similarly, in March 2021, the United States Federal Trade Commission, or the FTC, issued a CID to us in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA. The New York State attorney general similarly issued a subpoena to us regarding the same subject matter on which the FTC CID is focused. The inquiries require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods. Although we are cooperating with the government, we cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the U.S. Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties. If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Also, if governmental parties or our competitors view our claims as misleading or false, we could be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any allegations that our promotional activities are not truthful or misleading, even allegations without merit, could cause reputational harm and adversely affect our ability to operate our business and our results of operations. 36 We may not be able to compete effectively against our competitors’ pharmaceutical product, including generic products. In addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non-prescription competition and consumer substitution. 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 product. We expect that the number of companies seeking to develop products and therapies similar to VASCEPA will increase. Many of these and other existing or potential competitors may have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products. These companies may develop and introduce products and processes competitive with, more efficient than or superior to ours. In addition, other technologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, which might render our technology and products noncompetitive or obsolete. Our competitors include large, well-established pharmaceutical and generic companies, specialty and generic pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies. With generic versions of VASCEPA launched in the U.S. by companies such as Hikma, Dr. Reddy's, Apotex and Teva, who have greater resources than us, and with the potential for further generic versions being launched, it may not be viable for us to continue to invest in market education to grow the market and our ability to maintain current promotional efforts and attract favorable commercial terms in several aspects of our business will likely be adversely affected as we face increased generic competition, or if we launch our own generic version of VASCEPA. We also face considerable competition in the United States from branded products and generic versions of competing branded products and formulations, including Lovaza®, Tricor,® Trilipix® and Niaspan®, all of which have multiple generic competing versions. We compete with these drugs, in our U.S. FDA-approved indicated uses, even though such products do not have U.S. FDA approval to reduce CV risk on top of statin therapy. For a more detailed discussion of our competitors, and potential competing drugs in development, in the United States and the rest of the world, see our discussion above in Item 1. Business - Competition. Further, drugs in development that are expected to compete with VASCEPA if they are ultimately approved and commercialized, and the perceived safety and efficacy of such commercialized drugs or drug products, could have a negative impact on the perceived safety and efficacy of VASCEPA. Based on prior communications from the U.S. FDA, including communications in connection with its review of the ANCHOR indication for VASCEPA, it is our understanding that the U.S. FDA is not prepared to approve any therapy for treatment of cardiovascular risk based on biomarker modification without cardiovascular outcomes study data, with the potential exception of therapies which lower LDL-cholesterol, depending on the circumstances. In particular, it is our understanding that the U.S. FDA is not prepared to approve any therapy based primarily on data demonstrating lowering of triglyceride levels. In our view, this position from the U.S. FDA did not change based on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of VASCEPA are unique to VASCEPA and extend beyond triglyceride reduction. If the U.S. FDA were to change this position, it could potentially have a negative impact on us by making it easier for other products to achieve a cardiovascular risk reduction indication without the need in advance to conduct a long and expensive cardiovascular outcomes study. VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements. Such products are classified as food, not as prescription drugs or over-the-counter drugs, by the U.S. FDA in the United States with similar regulatory regimes in Europe and elsewhere. Some of the promoters of such products have greater resources than us and are not restricted to the same standards as are prescription drugs with respect to promotional claims or manufacturing quality, consistency and subsequent product stability. Although we have taken successful legal action against supplement manufacturers attempting to use the REDUCE-IT results to promote their products, we cannot be sure physicians and pharmacists will view the U.S. FDA-approved, prescription-only status, and EPA-only purity and stability of VASCEPA or U.S. FDA’s stringent regulatory oversight, as significant advantages versus omega-3 dietary supplements regardless of clinical study results and other scientific data. Consistent with the U.S., our competitors include large, well-established and experienced pharmaceutical companies, specialty and generic pharmaceutical companies, marketing companies, and specialized cardiovascular treatment companies and we have no experience as a company self- commercializing a product outside of the United States. Recent CV outcomes trials and meta-analyses with low and high dose omega-3 fatty acid mixtures containing DHA have not shown substantial benefit in patients receiving contemporary medical therapy, including statins. Due to failed low dose omega-3 CV outcomes trials, the European regulatory authorities have concluded that omega-3 fatty acid medicines (specifically Lovaza®/Omacor®) at a dose of 1-gram per day are not effective in preventing further events for patients who have had a heart attack. The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. 37 As generic company competitors seek to compete with copies of VASCEPA in the United States and elsewhere we could face additional challenges to our patents and additional patent litigation. The FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or the Hatch-Waxman Amendments, permits the U.S. FDA to approve ANDAs for generic versions of brand name drugs like VASCEPA. We refer to the process of generic drug applications as the “ANDA process.” The ANDA process permits competitor companies to obtain marketing approval 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 clinical studies, an ANDA applicant needs to submit data demonstrating that its product is bioequivalent to the brand name product, usually based on pharmacokinetic studies. As an alternate path to U.S. FDA approval for modifications of products previously approved by the U.S. FDA, an applicant may submit a new drug application, or NDA, under Section 505(b)(2) of the FDCA (enacted as part of the Hatch-Waxman Amendments). This statutory provision permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference from the owner of the data. The Hatch-Waxman Amendments permit the applicant to rely upon the U.S. FDA findings of safety and effectiveness of a drug that has obtained U.S. FDA approval based on preclinical or clinical studies conducted by others. In addition to relying on U.S. FDA prior findings of safety and effectiveness for a referenced drug product, the U.S. FDA may require companies to perform additional preclinical or clinical studies to support approval of the modification to the referenced product. If an application for a generic version of a branded product or a Section 505(b)(2) application relies on a prior U.S. FDA finding of safety and effectiveness of a previously-approved product including an alternative strength thereof, the applicant is required to certify to the U.S. FDA concerning any patents listed for the referenced product in the U.S. FDA publication called “Approved Drug Products with Therapeutic Equivalence Evaluations,” otherwise known as the “Orange Book.” Specifically, the applicant must certify in the application that: • • • • there is no patent information listed for the reference drug; the listed patent has expired for the reference drug; the listed patent for the reference drug has not expired, but will expire on a particular date and approval is sought after patent expiration; or the listed patent for the reference drug is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the product for which the ANDA or 505(b)(2) NDA is submitted. The Hatch-Waxman Amendments require an applicant for a drug product that relies, in whole or in part, on the U.S. FDA’s prior approval of VASCEPA, to notify 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 both claim VASCEPA and are listed in the Orange Book. A bona fide paragraph IV notice may not be given under the Hatch-Waxman Amendments until after the generic company receives from the U.S. FDA an acknowledgement 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 proposed product does not infringe our patents, that the relevant patents are invalid, or both. After receipt of a valid notice, the branded product manufacturer has the option of bringing a patent infringement 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, the Hatch-Waxman Amendments provide for a 30-month stay on U.S. FDA’s ability to give final approval to the proposed generic product, which period begins on the date the paragraph IV notice is received. Generally, during a period of time in which generic applications may be submitted for a branded product based on a product’s regulatory exclusivity status, if no patents are listed in the Orange Book before the date on which a complete ANDA application for a product (excluding an amendment or supplement to the application) is submitted, an ANDA application could be approved by U.S. FDA without regard to a stay. For products entitled to five-year exclusivity status, the Hatch-Waxman Amendments provide that an ANDA application may be submitted after four years following U.S. FDA approval of the branded product if it contains a certification of patent invalidity or non-infringement to a patent listed in the Orange Book. In such a case, the 30-month stay runs from the end of the five-year exclusivity period. Statutory stays may be shortened or lengthened if either party fails 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 the ANDA applicant before the expiration of the 30-month period, the stay will be immediately lifted and the U.S. FDA’s review of the application may be completed. Such litigation 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 to infringe such patents. In addition to the ANDA patent litigation described above, we could face patent litigation related to the patents filed in the Orange Book related to the REDUCE-IT study. A three-year period of exclusivity under the Hatch-Waxman Amendments is generally granted for a drug product that contains an active moiety that has been previously approved, such as when the application contains 38 reports of new clinical investigations (other than bioavailability studies) conducted by the sponsor that were essential to approval of the application. Accordingly, we received three-year exclusivity in connection with the approval of our sNDA for REDUCE-IT study results. Such three-year exclusivity protection precludes, unless otherwise agreed, the U.S. FDA from approving a marketing application for an ANDA, a product candidate that the U.S. FDA views 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 submitted to the U.S. FDA with VASCEPA as the reference product until December 13, 2022, three years from the date of U.S. FDA approval of the REDUCE-IT sNDA. While this three-year exclusivity would generally prevent such an approval based on our REDUCE-IT indication during such time, it does not preclude tentative or final approval of an ANDA based on our MARINE indication. The U.S. FDA may accept and commence review of such REDUCE-IT-related applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of REDUCE-IT patents during such period. This three-year form of exclusivity may also not prevent the U.S. FDA from approving an NDA that relies only on its own data to support the change or innovation. Regulatory exclusivity is in addition to exclusivity afforded by issued patents related to VASCEPA. We may also face challenges to the validity of our patents through a procedure known as inter partes review. Inter partes review is a trial proceeding conducted through the Patent Trial and Appeal Board, of the USPTO. Such a proceeding could be introduced against us within the statutory one-year window triggered by service of a complaint for infringement related to an ANDA filing or at any time by an entity not served with a complaint. Such proceedings may review the patentability of one or more claims in a patent on specified substantive grounds such as allegations that a claim is obvious on the basis of certain prior art. We cannot predict the outcome of the pending lawsuits, any appeals, or any subsequently filed lawsuits or inter partes review. Generally, if an ANDA filer meets the approval requirements for a generic version of VASCEPA to the satisfaction of the U.S. FDA under its ANDA, U.S. FDA may grant tentative approval to the ANDA during a Hatch-Waxman 30-month stay period and during the Hatch-Waxman 36-month regulatory exclusivity period. A tentative approval is issued to an ANDA applicant when its application is approvable prior to the expiration of any exclusivities applicable to the branded, reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final ANDA approval until applicable exclusivity protections have expired. Generic versions of VASCEPA made available in the market, even if based on a MARINE indication, are often used to fill a prescription for any intended use of the drug. If any approved ANDA filers are able to supply the product in significant commercial quantities, generic companies could introduce generic versions of VASCEPA in the market, as Hikma, Dr. Reddy's, Apotex and Teva have done. Although any such introduction of a generic version of VASCEPA would also be subject to any litigation settlement terms and patent infringement claims (including any new claims and those that may then be subject to an appeal), pursuing such litigation may be prohibitively costly or could put a substantial constraint on our resources. On July 9, 2021, President Biden issued an executive order directing the U.S. FDA to, among other things, continue to clarify and improve the approval framework for generic drugs and identify and address any efforts to impede generic drug competition. Any significant degree of generic market entry would limit our U.S. sales, which would have a significant adverse impact on our business and results of operations. In addition, even if a competitor’s effort to introduce a generic product is ultimately unsuccessful, the perception that such development is in progress and/or news related to such progress or news related to litigation outcomes could materially affect the reputation of VASCEPA or the perceived value of our company and our stock price. In addition, generic market entry, whether limited to its approved indication or not, can create market disruption which leads to an overall slowing of market growth regardless of whether the net price of the generic entry is higher or lower than the net price of the branded drug. Such disruption includes potential stock shortages of the generic market entry at retail pharmacies and wholesalers which can cause filling of prescriptions for patients to be delayed or abandoned. Sponsors of generic entries typically do not fund market education initiatives to help healthcare professionals and at-risk patients learn about a new drug, which, particularly for a recently launched drug, can potentially limit overall growth. And certain States impose restrictions on the promotion of branded drugs, particularly if the generic market entry is less expensive than the branded drug. While some companies with generic competition elect to launch an authorized generic form of the drug to counter the perception, real or imagined, that generics are less expensive, if launched, an authorized generic is typically aligned with reduction or elimination of promotion of the associated branded drug, thus limiting the extent of market growth and potentially contracting the overall size of the realized market penetration. While an authorized generic could be profitable the market opportunity for growth from an authorized generic is likely less than from promotion of a branded drug, and as such we have not launched an authorized generic version of VASCEPA to date, but may elect to do so in the future. The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitments to ensure sufficient capacity is available when needed. One of our generic competitors has filed a lawsuit against us claiming we have engaged in anticompetitive practices related to our building of adequate supply for our needs, and government agencies are investigating our business as it relates to the supply of the 39 active pharmaceutical ingredient in VASCEPA. Consumer lawsuits with similar allegations have also been filed. This dynamic and resulting regulatory scrutiny could be costly for us and could negatively and materially interfere with our business plans. The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and necessitates long-term financial commitments to ensure sufficient capacity is available when needed. We have invested over a decade of resources and expenses to develop with our third-party, active pharmaceutical ingredient, or API, supply chain the technical knowhow, manufacturing processes and obtained related regulatory approvals that have helped enable our suppliers to supply our clinical and commercial needs globally. Despite such efforts, the stability of the supply chain is largely out of our control and is subject to market and supply volatility and the actions of third parties. Any disruption to the supply chain, including the manufacturing processes and availability of API, would be disruptive to our business and would have a negative impact on our results of operations. In April 2021, Dr. Reddy’s filed a complaint against us in the United States District Court District of New Jersey (case no. 2:21-cv-10309) alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. Damages sought include recovery for alleged economic harm to Dr. Reddy’s, payors, and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s. Consumer group lawsuits followed claiming similar violations and alleging, for example, that such alleged violations resulted in higher prices to consumers. In addition, in February 2023, Hikma filed a complaint against us in the United States District Court District of New Jersey (case no. 3:23-cv-01016) with consistent allegations as the Dr. Reddy's complaint. Such litigation can be lengthy, costly and could materially affect and disrupt our business. In addition, as noted above, we have also received a CID from the U.S. FTC and a subpoena from the New York Attorney General with respect to practices relating to our supply of the active pharmaceutical ingredient in VASCEPA. The government inquiries require us to produce documents and answer related questions relevant to specified time periods. We are cooperating with the agencies. Such investigations can be lengthy, costly and could materially affect and disrupt our business. We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business. If a government determines that we have violated antitrust law, we could be subject to significant civil fines and penalties. VASCEPA is a prescription-only omega-3 fatty acid product. Omega-3 fatty acids are also marketed by other companies as non-prescription dietary supplements. As a result, in the U.S., VASCEPA is subject to non-prescription competition and consumer substitution. Our only product, VASCEPA, is a prescription-only form of EPA, an omega-3 fatty acid in ethyl ester form. Mixtures of omega-3 fatty acids in triglyceride form are naturally occurring substances contained in various foods, including fatty fish. Omega-3 fatty acids are marketed by others in a number of chemical forms as non-prescription dietary supplements. We cannot be sure physicians and other providers will view the U.S. FDA approval, pharmaceutical grade purity and proven efficacy and safety of VASCEPA as having a superior therapeutic profile to unproven and loosely regulated omega- 3 fatty acid dietary supplements. In addition, the U.S. FDA has not yet enforced to the full extent of its regulatory authority what we view as illegal claims made by certain omega-3 fatty acid product manufacturers to the extent we believe appropriate under applicable law and regulations, for example, claims that certain of such chemically altered products are dietary supplements and that certain of such products reduce triglyceride levels or could reduce cardiovascular risk. Also, for over a decade, subject to certain limitations, the U.S. FDA has expressly permitted dietary supplement manufacturers that sell supplements containing the omega-3 fatty acids EPA and/or DHA to make the following qualified health claim directly to consumers: Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Such companies are not, however, permitted, based on U.S. FDA enforcement activity, to make claims that suggest or imply treatment of cardiovascular disease. These factors enable dietary supplements to compete with VASCEPA. We may not be successful in such efforts, or such efforts may prove too costly to be effective. In addition, the net price of VASCEPA to patients even after insurance reimbursement and offered discounts could be significantly higher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements (through the lack of coverage by insurers or otherwise), physicians and pharmacists may recommend these retail alternatives instead of writing or filling prescriptions for VASCEPA or patients may elect on their own to take commercially available omega-3 fatty acids. Also, insurance plans may increasingly impose policies that directly or indirectly favor supplement use over VASCEPA. VASCEPA pricing might not be sufficient for healthcare providers or patients to elect VASCEPA over alternative treatments that may be perceived as less expense or more convenient to access. If healthcare providers or patients favor dietary supplements over prescribing VASCEPA, we may be constrained in how we price our product or VASCEPA’s market acceptance may be less than expected, which would have a negative impact on our revenues and results of operations. 40 Our products and marketing efforts are subject to extensive post-approval government regulation. Once a product candidate receives U.S. FDA marketing approval, numerous post-approval requirements apply. Among other things, the holder of an approved NDA is subject to periodic and other monitoring and reporting obligations enforced by the U.S. FDA and other regulatory bodies, including obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the approved application. Application holders must also submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials. With respect to sales and marketing activities, advertising and promotional materials must comply with U.S. FDA rules in addition to other applicable federal and local laws in the United States and in other countries. The result of our litigation and settlement with the U.S. FDA, as discussed above, may cause the government to scrutinize our promotional efforts or otherwise monitor our business more closely. Industry-sponsored scientific and educational activities also must comply with U.S. FDA and other requirements. In the United States, the distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Manufacturing facilities remain subject to U.S. FDA inspection and must continue to adhere to the U.S. FDA’s pharmaceutical current good manufacturing practice requirements, or cGMPs. Application holders must obtain U.S. FDA approval for product and manufacturing changes, depending on the nature of the change. In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are subject to periodic unannounced inspections by the U.S. FDA and state agencies for compliance with cGMP requirements. We participate in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule, or FSS, of the U.S. Department of Veterans Affairs, or the VA, and other government drug programs, and, accordingly, are subject to complex laws and regulations regarding reporting and payment obligations. We must also comply with requirements to collect and report adverse events and product complaints associated with our products. Our activities are also subject to U.S. federal and state consumer protection and unfair competition laws, non-compliance with which could subject us to significant liability. Similar requirements exist in many of these areas in other countries. Depending on the circumstances, failure to meet 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 to allow us to enter into supply contracts, including government contracts. We may also be held responsible for the non-compliance of our partners, such as our former co-promotion partner Kowa America. As discussed above, in June 2020, we received a CID from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver programs during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. FCA in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America. The New York State attorney general similarly issued a subpoena to us regarding the same subject matter on which the FTC CID is focused. The inquiries require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods. We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business. If the government determines that we have violated the U.S. Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties, and our reputation may be harmed. In addition, even if we comply with U.S. FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the U.S. FDA to modify or withdraw a product approval. Newly discovered or developed safety or effectiveness data may require changes to a drug’s approved labeling and marketing, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures. Adverse regulatory action, whether pre- or post-approval, can potentially lead to product liability claims and increase our product liability exposure. We must also compete against other products in qualifying for coverage and reimbursement under applicable third-party payment and insurance programs. In addition, all of the above factors may also apply to any regulatory approval for VASCEPA obtained in territories outside the United States. In Europe, for example, restrictions regarding off-label promotion are in some ways more stringent than in the United States, including restrictions covering certain communications with shareholders. Given our inexperience with marketing and commercializing products outside the United States, in certain territories we may need to rely on third parties, such as our partners in Canada, China and the Middle East, to assist us in dealing with any such issues and we will have limited or no control over such partners. Legislative or regulatory reform of the healthcare system in the United States and foreign jurisdictions may affect our ability to profitably sell VASCEPA. Our ability to commercialize VASCEPA or any future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payors. The continuing efforts of the U.S. and foreign governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce healthcare costs 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 maintain 41 profitability. Refer to Item 1. Business - United States Healthcare Reform and Legislation and Item 1. Business - Pharmaceutical Pricing and Reimbursement for further details. In addition, it is time-consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare and private payors. Our products may not be considered cost effective, and government and third-party private health insurance coverage and reimbursement may 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 results of operations could be adversely affected by ACA and by other healthcare reforms that may be enacted or adopted in the future. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. For example, proposals are being considered to expand the use of dietary supplements in addition to or in place of drugs in government and private payor plans. In addition, cost control initiatives could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our profitability. These and similar regulatory dynamics, including the entry of generic versions of VASCEPA into the market, and the potential for additional generic versions in the near term, can affect our ability to commercialize VASCEPA on commercially reasonable terms and limit the commercial value of VASCEPA. If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects. We participate in the Medicaid Drug Rebate program, the 340B drug pricing program, and the VA’s FSS pricing program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare Part B. Those rebates are based on pricing data reported by us on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate program. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug which, in general, represents the lowest price available from the manufacturer to any commercial entity in the U.S. in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions. Our failure to comply with these price reporting and rebate payment obligations could negatively impact our financial results. The ACA made significant changes to the Medicaid Drug Rebate program. CMS issued a final regulation, which became effective in 2016, to implement the changes to the Medicaid Drug Rebate program under the ACA. The issuance of the final regulation has increased and will continue to increase our costs and the complexity of compliance, has been and will continue to be time-consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS challenges the approach we take in our implementation of the final regulation. Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program, and in general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement. Any additional future changes to the definition of average manufacturer price and the Medicaid rebate amount under the ACA, other legislation, or in regulation could affect our 340B ceiling price calculations and negatively impact our results of operations. The Health Resources and Services Administration, or HRSA, which administers the 340B program, issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019. We also are required to report our 340B ceiling prices to HRSA on a quarterly basis. Implementation of the civil monetary penalties regulation and the issuance of any other final regulations and guidance could affect our obligations under the 340B program in ways we cannot anticipate. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in the inpatient setting. Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by us, governmental or regulatory agencies and the courts. In the case of our Medicaid pricing data, if we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due. Such restatements and recalculations increase our costs for 42 complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B program or could require us to issue refunds to 340B covered entities. Significant civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing information to CMS, or if we fail to submit the required price data on a timely basis. Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs. Significant civil monetary penalties also can be applied if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price. We cannot assure you that our submissions will not be found by CMS or HRSA to be incomplete or incorrect. In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, as noted above, we participate in the VA’s FSS pricing program. As part of this program, we are obligated to make our products available for procurement on an FSS contract under which we must comply with standard government terms and conditions and charge a price that is no higher than the statutory Federal Ceiling Price, or FCP, to four federal agencies (the VA, U.S. Department of Defense, or DOD, Public Health Service, and the U.S. Coast Guard). The FCP is based on the Non-Federal Average Manufacturer Price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis. Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer to significant penalties for each item of false information. These obligations also contain extensive disclosure and certification requirements. We also participate in the Tricare Retail Pharmacy program, under which we pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non- FAMP and FCP. We are required to list our covered products on a Tricare Agreement in order for these products to be eligible for DOD formulary inclusion. If we overcharge the government in connection with our FSS contract or Tricare Agreement, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the FCA and other laws and regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. Changes in reimbursement procedures by government and other third-party payors may limit our ability to market and sell our approved drugs. These changes could have a material adverse effect on our business and financial condition. In the U.S., Europe and other regions globally, sales of pharmaceutical drugs are dependent, in part, on the availability of reimbursement to the consumer from third-party payors, such as government and private insurance plans. Third-party payors decide which products and services they will cover and the conditions for such coverage. Third party payors also establish reimbursement rates for those products and services. Increasingly, third-party payors are challenging the prices charged for medical products and services. Some third-party payor benefit packages restrict reimbursement, charge copayments to patients, or do not provide coverage for specific drugs or drug classes. In addition, certain U.S. based healthcare providers are moving toward a managed care system in which such providers contract to provide comprehensive healthcare services, including prescription drugs, for a fixed cost per person. We are unable to predict the reimbursement policies employed by third-party healthcare payors may not be favorable to us. We expect to experience pricing and reimbursement pressures in connection with the sale of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative and executive proposals, as well as the availability of generic versions of VASCEPA. In addition, we may confront limitations in, or exclusions from, insurance coverage for our products, particularly as generic competition intensifies. If we fail to successfully secure and maintain reimbursement coverage for our approved drugs or are significantly delayed in doing so, we may have difficulty achieving market acceptance of our approved drugs and investigational drug candidates for which we obtain approval, and our business may be harmed. Congress has enacted healthcare reform and may enact further reform, which could adversely affect the pharmaceutical industry as a whole, and therefore could have a material adverse effect on our business. Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations. In the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any products for which we obtain marketing approval. 43 Changes in regulations, 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. Refer to Item 1. Business - Current and Future Legislation and Item 1. Business - United States Healthcare Reform and Legislation. There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The enactment and implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates. Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA. Although we are not directly subject to HIPAA – other than with respect to providing certain employee benefits – we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our operating results and business. European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information. The REDUCE-IT cardiovascular outcomes trial was conducted in part through clinical sites in the EEA. As a result, we are subject to additional privacy restrictions. The collection and use of personal health data in the EU is governed by the provisions of the GDPR. The GDPR imposes several requirements relating to the legal basis for processing personal data which may include the consent of the individuals to whom the personal data relates, the information provided to the individuals and the security and confidentiality of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EEA to third countries, including the United States. A decision by the Court of Justice of the European Union, or CJEU, in 2020 invalidated the EU-U.S. Privacy Shield Framework, which was one of the primary mechanisms used by U.S. companies to import personal information from Europe in compliance with the GDPR's cross-border data transfer restrictions, and raised questions about whether the EC's Standard Contractual Clauses, or SCCs, one of the primary alternatives to the Privacy Shield, can lawfully be used for personal information transfers from Europe to the United States or most other countries. Furthermore, on June 4, 2021, the EC issued new forms of standard contractual clauses for data transfers from controllers or processors in the EEA, or otherwise subject to the GDPR, to controllers or processors established outside the EEA, and not subject to the GDPR. The new forms of standard contractual clauses have replaced the standard contractual clauses that were adopted previously under the Data Protection Directive. They require a case-by-case assessment of the law in the recipient country to ensure it provides “essentially equivalent” protections to safeguard the transferred personal data as the EEA, and require businesses to adopt supplementary measures if such standard is not met The new SCCs do not apply to the UK, but the UK Information Commissioner’s Office has published its own transfer mechanism, the International Data Transfer Agreement, or UK IDTA, which entered into force on March 21, 2022, and enables data transfers originating from the UK. It requires a similar assessment of the data protection provided in the importer’s country. We will be required to transition to the new forms of transfer mechanisms and doing so will require significant effort and cost. The new transfer 44 mechanisms may also impact our business as companies based in Europe may be reluctant to utilize the new clauses to legitimize transfers of personal information to third countries given the burdensome requirements of transfer impact assessments and the substantial obligations that the new standard contractual clauses impose upon exporters. Failure to comply with the requirements of the GDPR or the UK GDPR, and the related national data protection laws of the EEA Member States or the UK may result in substantial fines. The GDPR may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules. This may be costly, onerous and adversely affect our business, financial condition, prospects and results of operations. The U.S. FDA, other regulatory agencies and industry organizations strictly regulate the promotional claims that may be made about prescription products and promotional efforts such as speaker programs. If we or our partners are found to have improperly promoted uses, efficacy or safety of VASCEPA or otherwise are found to have violated the law or applicable regulations, we may become subject to significant fines and other liability. The government may seek to find means to prevent our promotion of truthful and non-misleading information beyond the current court ruling and litigation settlement or seek to find violations of other laws or regulations in connection with the promotional efforts we undertake on our own or through third parties. The U.S. FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, in general, the U.S. government’s position has been that a product may not be promoted for uses that are not approved by the U.S. FDA as reflected in the product’s approved labeling. The Federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The U.S. FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Even though we received U.S. FDA marketing approval for VASCEPA for the MARINE indication and for the REDUCE-IT indication, and our settlement with the U.S. FDA affords us a degree of protection for other promotional efforts, physicians may still prescribe VASCEPA to their patients for use in the treatment of conditions that are not included as part of the indication statement in our U.S. FDA-approved VASCEPA label or our settlement. If we are found to have promoted VASCEPA outside the terms of the litigation settlement or in violation of what federal or state government may determine to be acceptable, we may become subject to significant government fines and other related liability, such as under the FDCA, the FCA, or other theories of liability. Government may also seek to hold us responsible for the non-compliance of our former co-promotion partner, Kowa America, or our commercialization partners outside the United States or other third-parties that we retain to help us implement our business plan. In addition, incentives exist under applicable laws that encourage competitors, employees and physicians to report violations of rules governing promotional activities for pharmaceutical products. These incentives could lead to so-called “whistleblower lawsuits” as part of which such persons seek to collect 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 the marketplace and we 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. For example, the June 2020, CIDs from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program violated the U.S. Anti-Kickback Statute and from the FCA relating to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America, as well as the March 2021, CID from the FTC in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods. As does the subpoena from the New York State attorney general regarding the same subject matter on which the FTC CID is focused. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the U.S. Anti-Kickback Statute, the FCA or antitrust regulations we could be subject to significant civil and criminal fines and penalties. We may not be successful in developing and receiving regulatory approval for VASCEPA in other jurisdictions or marketing future products if we cannot meet the extensive regulatory requirements of regulatory agencies, such as for quality, safety, efficacy and data privacy. 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 meet regulatory requirements in the jurisdictions where we or our partners or potential partners ultimately intend to sell such products once approved. The development, manufacture and marketing of pharmaceutical products are subject to extensive regulation by governmental authorities in the United States and elsewhere. In the United States, the U.S. FDA generally requires preclinical testing and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before its introduction into the market. Regulatory authorities in other jurisdictions impose similar requirements. The process of obtaining regulatory approvals is lengthy and expensive and the issuance of such approvals is uncertain. 45 The commencement and rate of completion of clinical trials and the timing of obtaining marketing approval from regulatory authorities may be delayed by many factors, including, among others: • • • • • • • • • • • 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 trials or preclinical studies; the emergence of unforeseen safety issues in clinical trials 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 on quality, safety and efficacy; compliance with laws and regulations related to patient data privacy; government or regulatory delays or “clinical holds” requiring suspension or termination of a trial; and political instability or other social or government protocols affecting our clinical trial sites. Even if we obtain positive results from our efforts to seek regulatory approvals, from early stage preclinical studies or clinical trials, we may not achieve the same success in future efforts. Clinical trials that we or potential partners conduct may not provide sufficient safety and efficacy data to obtain the requisite regulatory approvals for product candidates. The failure of clinical trials to demonstrate safety and efficacy for our desired indications could harm the development of that product candidate as well as other product candidates, and our business and results of operations would suffer. For example, in connection with U.S. FDA’s review of REDUCE-IT data and sNDA in 2019, the agency determined that an interaction between mineral oil and statins leading to decreased absorption of statins cannot be excluded when the two are co-administered as could have been the case in some patients in REDUCE-IT and that, in the agency’s view, indirect evidence suggested the presence of a potential inhibitory effect on statin absorption by mineral oil. However, U.S. FDA’s exploratory analysis indicated that the effect of LDL cholesterol values on the time to the primary endpoint was numerically small and unlikely to change the overall conclusion of treatment benefit. U.S. FDA then relied on this assessment and all data available to it to approve a new indication statement and labeling based on REDUCE-IT results. This matter illustrates that concerns such as this may arise in the future that could affect our product development, regulatory reviews or the public perception of our products and our future prospects, including REDUCE-IT results. Any approvals that are obtained may be limited in scope, may require additional post-approval studies or may require the addition of labeling statements, including boxed warnings, focusing on product safety that could affect the commercial potential for our product candidates. Any of these or similar circumstances could adversely affect our ability to gain approval for new indications and affect revenues from the sale of our products. Even in circumstances where products are approved by a regulatory body for commercialization, the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead to the withdrawal of a product from the market or similar use restrictions. The discovery of previously unknown problems with a clinical trial or product, or in connection with the manufacturer of products, may result in regulatory issues that prevent proposed future approvals of a product and/or restrictions on that product or manufacturer, including withdrawal of an indication or the product from the market, which would have a negative impact on our potential revenue stream. As we continue to scale our infrastructure for commercializing VASCEPA based on market dynamics for VASCEPA in the United States and commercial initiatives and plans for VAZKEPA in Europe and other parts of the world, we may encounter difficulties in managing the size and adaptability of our operations successfully. The process of establishing, maintaining, expanding and streamlining a commercial infrastructure is difficult, expensive and time-consuming, particularly when such efforts need to adapt to changing market and business dynamics. We implemented cost and organizational restructuring plans, which included a reduction to our U.S. commercial team to approximately 75 sales representatives by the end of 2022. Our sales team promotes VASCEPA to a targeted group of physicians and other healthcare professionals in select geographies in the United States who recognize the potential benefit to patients, and this team is not large enough to call upon a sufficient number of physicians. 46 In addition to sales force reductions in the United States, we continue to work on our own and with our international partners to support regulatory efforts outside the United States based on REDUCE-IT results. If we are successful in obtaining sufficient approvals and adequate pricing and reimbursement levels in major markets in Europe and elsewhere, we will need to ensure that our operations are adequate to support a commercial launch and continued promotion. Although we are preparing for growth in Europe and elsewhere by expanding our infrastructure, we are operating with streamlined teams and will need to expand internally and we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties. Future growth and streamlining efforts will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate the right number of employees. For example, in Europe we have built out our team subsequent to EC approval of the marketing authorization acceptance in 2021, with plans to continue to expand our European staff as deemed appropriate on a country by country basis. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations could have a significant impact on our ability to hire and retain personnel and realize the commercial opportunity of VAZKEPA in Europe. Our future financial performance and our ability to commercialize VASCEPA and to compete effectively will depend, in part, on our ability to manage our future growth effectively, and such efforts may be disrupted by ongoing or reinstated COVID-19 protocols. To that end, we must be able to manage our development efforts effectively, and hire, train, integrate and retain an appropriate level of management, administrative and sales and marketing personnel and have limited experience managing a commercial organization. We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company. Our life-cycle management, in large part, currently depends on our ability to develop, obtain regulatory approval and commercialize a fixed- dose combination of VASCEPA and yet to be disclosed statins. Our life-cycle management is substantially dependent on our ability to develop, obtain regulatory approval and commercialize a fixed-dose combination of VASCEPA and yet to be disclosed statins. Due to the risks and uncertainties involved in progressing through development and bioequivalence or even potential additional trials (as may be required by specific regulatory agencies), and the time and cost involved in obtaining regulatory approvals, we cannot reasonably estimate the timing, completion dates and costs, or range of costs, of our drug development program, or of the successful development of any particular fixed-dose combination. The potential success of any fixed-dose combination will depend on a number of factors, including the following: • • • • • Our ability to successfully manufacture a combination of VASCEPA and a statin; Our ability to maintain a supply of necessary statin for use in the fixed-dose combination; Our ability to obtain regulatory approvals for any and all markets in which we intend to commercialize a fixed-dose combination of VASCEPA and a statin; Our ability to obtain payor acceptance and market access for a fixed-dose combination product of VASCEPA and a statin; and Our ability to achieve market acceptance of a fixed-dose combination of VASCEPA and a statin. The continued scale, scope and duration of business interruptions caused by the COVID-19 pandemic and related recovery efforts remain uncertain. Despite recent improvements, the ongoing presence of COVID-19 has created significant volatility, uncertainty and disruption in healthcare, social, supply and economic infrastructures. The extent to which the coronavirus pandemic will continue to impact our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict or plan around, including: • • • • • • the duration, volatility and scope of the pandemic, including resurgences, and the efficacy of recovery efforts; governmental, business and individuals’ actions that have been and continue to be taken in response to the pandemic; the impact of the pandemic on economic and political activity and actions taken in response; the effect on patients, healthcare providers and business partners, including patients’ ability to access supplies of VASCEPA and the willingness of patients to visit doctors for non-urgent medical examination or to visit labs for blood tests to assess biomarkers such as lipid levels; our ability to commercialize VASCEPA, including if travel restrictions, social distancing and other containment measures are resumed or intensified; the enrollment or monitoring of patients in clinical trials, particularly at clinical trial sites located in highly impacted jurisdictions and jurisdictions where vaccination rates are low; 47 • • • • • the ability to access, secure and otherwise obtain and deliver sufficient and timely commercial or clinical supplies of VASCEPA at reasonable prices and sufficient to meet demand if the production capabilities of suppliers is disrupted; disruptions in regulatory oversight and actions if regulators and industry professionals continue to expend significant and unexpected resources addressing COVID-19; the availability of coverage and reimbursement from government and health administration authorities, private health insurers and other third-party payors if the system continues to be overly strained; the ability of regulators to complete inspections and reviews of operations and applications, respectively, in a timely manner; and any further, prolonged or reinstated closures of our and our partners’ offices, operations and facilities impeding our ability to work together as a company and with our business and healthcare partners. Even as the impacts of the pandemic appear to subside, additional variants may emerge and as vaccine usage and protocols evolve, face-to-face interactions may continue to be challenging for us to predict. The circumstances surrounding COVID-19 vary geographically and vary over time, with continued risk of potential resurgences in COVID-19 cases, and the possibility of reinstitution of protocols, in various geographies as the efficacy of the vaccine on various strains remains uncertain. While we have supplemented our face-to-face interactions with virtual outreach, these efforts may not be as impactful as traditional, in-person interactions. Specifically, access to healthcare professionals through the internet or other channels, may not be as productive as in-person interactions. The disruptions associated with the coronavirus pandemic could delay the potential timing of subsequent steps for the launch of commercialization of VAZKEPA in Europe. Additionally, COVID-19 has already and could continue to limit our ability to have access with healthcare professionals to help educate them regarding VAZKEPA so that they are more likely to prescribe it to their at-risk patients. And, similar to our experience in the United States, the effects of COVID-19 and related preventative measures may reduce the frequency at which at-risk patients seek non-urgent preventative medical care. Risks Related to Our Reliance on Third Parties Our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs. We have no in-house manufacturing capacity and rely entirely on contract manufacturers for our clinical and commercial product supply. We cannot provide assurance that we will successfully manufacture any product we may develop, either independently or under manufacturing arrangements, if any, with our third-party manufacturers. Moreover, if our manufacturers should cease doing business with us or experience delays, shortages of supply or excessive demands on their capacity, or if they insist on burdensome terms, such as excessive minimum supply commitments, we may not be able to obtain adequate quantities of product in a timely manner, at cost efficient levels or at all. If we are not able to continue to operate our business relationships in a manner that is sufficiently profitable for us and our suppliers, certain members of our supply chain could compete with us through supply to competitors, such as generic drug companies, through breach of our agreements or otherwise. Any manufacturing problem, natural or manmade disaster affecting manufacturing facilities, government action, or the loss of a contract manufacturer could potentially be disruptive to our operations and result in lost sales. Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment of products, increase our cost of goods sold and/or result in lost sales. If our suppliers were unable to supply us with adequate volumes of active pharmaceutical ingredient, or API, (drug substance) or encapsulated bulk product (drug product), it would have a material adverse effect on our ability to continue to commercialize VASCEPA. We have contractual freedom to source the API for VASCEPA and to procure other services supporting our supply chain. We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and other elements necessary for the sale of VASCEPA. We continue to take steps to negotiate our contract supply agreements to align supply arrangements with current and future global market demand. Expanding manufacturing capacity and qualifying such capacity is complex and subject to numerous regulations and other operational challenges. We require supply capacity to support our direct and indirect commercialization of VASCEPA. We are also committed to providing supply to our commercial partners and distributors in Canada, China, the Middle East and North Africa, and we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries. The resources of our suppliers vary and are limited; costs associated with projected expansion and qualification can be significant, and lead-times for supply purchases and capacity expansion are long requiring certain supply related decisions and commitment to be made in advance of 48 commercial launch, including in China and various European countries. Our aggregate capacity to produce API is dependent upon the continued qualification of our API suppliers and, depending on the ability of existing suppliers to meet our supply demands, and the ability to qualify any new suppliers. If no additional API supplier is approved by the U.S. FDA as part of an sNDA, our API supply will be limited to the API we purchase from previously approved suppliers. For example, the EMA has not yet approved use of each of our suppliers used for VASCEPA in the United States for supply of VAZKEPA in the EU. Further, there can be no guarantee that current suppliers and future suppliers with which we have contracted to encapsulate API will be continually qualified to manufacture the product to our specifications or that current and any future suppliers will have the manufacturing capacity to meet anticipated demand for VASCEPA. If our third-party manufacturing capacity is not appropriately qualified and/or compliant with applicable regulatory requirements, we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand. We cannot guarantee that we can contract with any future manufacturer on acceptable terms or that any such alternative supplier will not require capital investment from us in order for them to meet our requirements. Alternatively, our purchase of supply, or any minimum purchase requirements, may exceed actual demand for VASCEPA. For example, certain of our agreements with our suppliers include minimum purchase obligations and limited exclusivity provisions. These purchases are generally made on the basis of rolling 12-month forecasts which in part are binding on us and the balance of which are subject to adjustment by us subject to certain limitations. Certain of our agreements also include contractual minimum purchase commitments regardless of the rolling 12-month forecasts. We may not purchase sufficient quantities of VASCEPA to meet actual demand or we may be required to purchase more supply than needed to meet actual demand. If our minimum purchase commitments exceed our supply needs for VASCEPA, we may have to renegotiate with partners in our supply chain who may not be incentivized to renegotiate terms that are favorable to us, or at all. If we are unable to secure adequate levels of supply to meet demand, our financial condition could be negatively and materially impacted. Our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments. We sell VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and mail order pharmacy providers, or collectively, our distributors or our customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. These parties exercise a substantial amount of bargaining power over us given their control over large segments of the market for VASCEPA. This bargaining power has led us to bear increasingly higher discounts in the sale of VASCEPA. In addition, payors have broad latitude to change individual products’ formulary position or to implement other barriers that inhibit patients from receiving therapies prescribed by their healthcare professionals. These payor barriers include requirements that patients try another drug before VASCEPA, known as step edits, and the requirement that prior authorization be obtained by a healthcare provider after a prescription is written before a patient will be reimbursed by their health plan for the cost of a VASCEPA prescription. Further, pharmacy benefit managers implement plans that act as disincentives for VASCEPA use, such as increasingly higher deductibles. One practical impact of higher deductibles is that they may cause patients to delay filling prescriptions for asymptomatic, chronic care medications such as hypertriglyceridemia earlier in the year, until patients meet their deductible and the cost of VASCEPA is then borne more by their insurance carrier. Collectively, these dynamics negatively affect our profitability for the sale of VASCEPA and could increase over time further impacting our operating results. Consolidation among these industry participants could increase the pressure on us from these market dynamics. The manufacture, packaging and distribution of pharmaceutical products such as VASCEPA are subject to U.S. FDA regulations and those of similar foreign regulatory bodies. If we or our third-party manufacturers fail to satisfy these requirements, our product development and commercialization efforts may be materially harmed. The manufacture, packaging and distribution of pharmaceutical products, such as VASCEPA, are regulated by the U.S. FDA and similar foreign regulatory bodies and must be conducted in accordance with the U.S. FDA’s cGMPs and comparable requirements of foreign regulatory bodies. There are a limited number of manufacturers that operate under these cGMPs as well as the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, regulations and guidelines, that are both capable of manufacturing VASCEPA and willing to do so. Failure by us or our third-party manufacturers to comply with applicable regulations, requirements, or guidelines could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or voluntary recalls of product, operating restrictions and criminal prosecutions and penalties, any of which could significantly and adversely affect our business. If we are not able to manufacture VASCEPA to required specifications through our current and potential API suppliers, we may be delayed in successfully supplying the product to meet anticipated demand and our anticipated future revenues and financial results may be materially adversely affected. 49 Changes in the manufacturing process or procedure, including a change in the location where the product is manufactured or a change of a third- party manufacturer, may require prior U.S. FDA review and pre-approval of the manufacturing process and procedures in accordance with the U.S. FDA’s cGMPs. Any new facility may be subject to a pre-approval inspection by the U.S. FDA and would again require us to demonstrate product comparability to the U.S. FDA. If any third-party manufacturer with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different third-party manufacturer, which we may not be able to do on reasonable terms, if at all. In either scenario, our clinical trials or commercial distribution could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or product candidates may be unique or proprietary to the original third-party manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change third-party manufacturer for any reason, we will be required to verify that the new third-party manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product according to the specifications previously submitted to or approved by the U.S. FDA or another regulatory authority. The delays associated with the verification of a new third-party manufacturer could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. Furthermore, a third-party manufacturer may possess technology related to the manufacture of our product candidate that such third-party manufacturer owns independently. This would increase our reliance on such third-party manufacturer or require us to obtain a license from such third-party manufacturer in order to have another third-party manufacturer manufacture our products or product candidates. In addition, in the case of the third-party manufacturers that supply any future product candidates, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials. There are comparable foreign requirements under ICH guidelines. In addition, certain past COVID-19 restrictions have affected Regulatory Agencies' ability to conduct facility inspections and may affect the timing of further approvals. This review may be costly and time consuming and could delay or prevent the launch of a product. Furthermore, the U.S. FDA and foreign regulatory agencies require that we be able to consistently produce the API and the finished product in commercial quantities and of specified quality on a repeated basis, including demonstrated product stability, and document our ability to do so. This requirement is referred to as process validation. Process validation includes stability testing, measurement of impurities and testing of other product specifications by validated test methods. If the U.S. FDA 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 may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand. On March 27, 2020, former President Trump signed into law the CARES Act in response to the COVID-19 pandemic. Throughout the COVID-19 pandemic, there has been public concern over the availability and accessibility of critical medical products, and the CARES Act enhances U.S. FDA’s existing authority with respect to drug shortage measures. Under the CARES Act, we must have in place a risk management plan that identifies and evaluates the risks to the supply of approved drugs for certain serious diseases or conditions for each establishment where the drug or API is manufactured. The risk management plan will be subject to U.S. FDA review during an inspection. If we experience shortages in the supply of our marketed products, our results could be materially impacted. The U.S. FDA and similar foreign regulatory bodies may also implement new requirements, or change their interpretation and enforcement of existing requirements, for manufacture, packaging or testing of products at any time. If we or our approved suppliers are unable to comply, we may be subject to regulatory, civil actions or penalties, or we may be prevented from manufacturing or selling VASCEPA, all of which could significantly and adversely affect our business. Furthermore, reductions in government operations due to pandemic mitigation efforts, or other factors, may delay timely regulatory review by U.S. FDA or similar foreign regulatory bodies. For example, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the U.S. FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the U.S. FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the U.S. FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed. During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities. We have limited experience commercializing VASCEPA outside the United States, and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the United States. We are currently, and may continue to be, substantially dependent on third parties for our international efforts, and we may not be 50 successful in negotiating or establishing relationships with business partners to support and maintain control over our international activities. We have expanded our VASCEPA commercialization activities outside of the United States through several contractual arrangements in territories including China, the Middle East, North Africa and Canada. We continue to assess other opportunities to develop VASCEPA commercialization outside of the United States through similar arrangements. For example, Edding is responsible for development and commercialization activities in the China Territory and associated expenses under our development, commercialization and supply agreement with them. Additionally, Edding is required to conduct clinical trials in the China Territory to secure regulatory approval in certain territories. Although Edding has successfully undertaken clinical trials and approval initiatives under our arrangement with them, including the announcement of statistically significant positive topline results from Edding’s Phase 3 clinical trial of VASCEPA and has obtained approval for VASCEPA under the REDUCE-IT indication in Hong Kong, with anticipated approval in Mainland China expected by mid-year of 2023, Edding may be required to undertake clinical development efforts in these markets, or Edding may face challenges or be unsuccessful in pursuing commercial launch. Further, any development and regulatory efforts in the China Territory may be negatively impacted if the coronavirus pandemic worsens, continues or spreads, and if resources by regulators and industry professionals continue to be diverted to address the prolonged coronavirus pandemic. Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the United States, including in connection with COVID-19 and other issues expressed between the countries regarding trade practices, tariffs and honoring intellectual property rights. If Edding is not able to effectively develop and commercialize VASCEPA in the China Territory, we may not be able to generate revenue from the DCS Agreement resulting from the sale of VASCEPA in the China Territory. We are party to arrangements with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries and with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada. Although Biologix is currently actively commercializing VASCEPA in the United Arab Emirates and Lebanon, and HLS is currently commercializing VASCEPA in Canada, we are completely reliant on these third parties to secure approval and successfully commercialize the product in those markets, which markets can be complex and challenging. Further, development and commercialization across the Middle East and North Africa is subject to similar risks as in the China Territory, and has been negatively impacted by COVID-19 and the destabilized local economies in the region. If Edding, Biologix or HLS, or other third parties who we rely on for development and commercialization of VASCEPA, do not successfully carry out their contractual obligations or meet expected deadlines, our recourse and remedies against these parties is limited Our efforts to launch and support commercialization of VAZKEPA on our own in Europe is a complex undertaking for a company that, other than our launch of VAZKEPA in Germany in September 2021 (where operations were subsequently discontinued) and the launch of VAZKEPA in certain countries in the fourth quarter of 2022, including the UK in October 2022, has not launched or otherwise commercialized a product in Europe and could be subject to significant risks of execution to our successful development and revenue generation of VAZKEPA in Europe. We have limited experience working with partners outside the United States to develop and market our products in non-U.S. jurisdictions. In order for our partners to market and sell VASCEPA in any country outside of the United States for any indication, it will be necessary to obtain regulatory approval from the appropriate regulatory authorities. The requirements and timing for regulatory approval, which may include conducting clinical trials, vary widely from country to country and may in some cases be different than or more rigorous than requirements in the United States. Any failure by us or our partners to obtain approval for VASCEPA in non-U.S. jurisdictions in a timely manner may limit the commercial success of VASCEPA and our ability to grow our revenues. Our relationships with healthcare providers and physicians and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the promotion, sales and marketing of healthcare items and services, as well as a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the 51 improper use of information obtained in the course of patient recruitment for clinical trials. Refer to “Item 1. Business - Government Regulation - Fraud and Abuse Laws and Data Regulation" for further details. 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. In addition, manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying U.S. FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies continue to give regular and close scrutiny to interactions between healthcare companies and healthcare providers, and such scrutiny often leads to investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business. For example, the June 2020 CIDs from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program violated the U.S. Anti-Kickback Statute, and from the FCA relating to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America as well as the March 2021 CID from the FTC in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods. As does the subpoena from the New York State attorney general regarding the same subject matter on which the FTC CID is focused. As noted, we are cooperating with the government, but we cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the U.S. Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties. The failure to comply with any of these laws or regulatory requirements subjects entities to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs (such as Medicare and Medicaid), contractual damages and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Third party patient assistance programs that receive financial support from companies have become the subject of enhanced government and regulatory scrutiny. Government enforcement agencies have shown increased interest in pharmaceutical companies' product and patient assistance programs, including reimbursement support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements. The U.S. government has established guidelines that suggest that it is lawful for pharmaceutical manufacturers to make donations to charitable organizations who provide co-pay assistance to Medicare patients, provided that such organizations, among other things, are bona fide charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come basis according to consistent financial criteria and do not link aid to use of a donor's product. However, donations to patient assistance programs have received some negative publicity and have been the subject of multiple government enforcement actions, related to allegations regarding their use to promote branded pharmaceutical products over other less costly alternatives. Specifically, in recent years there have been multiple settlements resulting out of government claims challenging the legality of their patient assistance programs under a variety of federal and state laws. It is possible that we may make grants to independent charitable foundations that help financially needy patients with their premium, co-pay, and co-insurance obligations. If we choose to do so, and if we or our vendors or donation recipients are deemed to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we could be subject to damages, fines, penalties, or other criminal, civil, or administrative sanctions or enforcement actions. We cannot ensure that our compliance controls, policies, and procedures will be sufficient to protect against acts of our employees, business partners, or vendors that may violate the laws or regulations of the jurisdictions in which we operate. Regardless of whether we have complied with the law, a government investigation could impact our business practices, harm our reputation, divert the attention of management, increase our expenses, and reduce the availability of foundation support for our patients who need assistance. Further, it is possible that changes in 52 insurer policies regarding co-pay coupons and/or the introduction and enactment of new legislation or regulatory measures impacting patients using affected products could have a material adverse effect on our sales, business and financial condition. For example, on December 31, 2020, CMS published a new rule, effective January 1, 2023, requiring manufacturers to ensure the full value of co-pay assistance is passed on to the patient or these dollars will count toward the Average Manufacturer Price and Best Price calculation of the drug. On May 17, 2022, the U.S. District Court for the District of Columbia granted the Pharmaceutical Research and Manufacturers of America's, or PhRMA, motion for summary judgment invalidating the accumulator adjustment rule. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the current U.S. presidential administration may reverse or otherwise change these measures, both the current U.S. presidential administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs. We cannot predict how the implementation of and any further changes to this rule will affect our business. In addition, with the approval and commercialization of any of our products outside the United States, we will also likely be subject to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines 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 are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trials. Moreover, the U.S. FDA requires us to comply with requirements, commonly referred to as good clinical practices, for conducting, recording, and reporting the results of clinical trials to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed in obtaining regulatory approvals for our product candidates and may be delayed in our efforts to successfully commercialize our product candidates for targeted diseases. Risks Related to Our Intellectual Property We are dependent on patents, proprietary rights and confidentiality obligations of our employees, agents, business partners and third parties to protect the commercial value and 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. Refer to “Item 1.Business - Patents, Proprietary Technology, Trade Secrets for further details. Enforcing our patent rights is challenging and costly and, even if we are able to successfully enforce our patent rights, our issued patents may not prevent competitors from competing with VASCEPA. We plan to vigorously defend our rights under issued patents, however such defense activities can be costly to pursue and may not have the desired results. For example, on November 30, 2020 we filed a patent infringement lawsuit against Hikma for making, selling, offering to sell and importing generic icosapent ethyl capsules in and into the United States in a manner that we allege has induced the infringement of patents covering the use of VASCEPA to reduce specified cardiovascular risk. On January 25, 2021, we expanded the scope of this patent infringement lawsuit to include a health care insurance provider, Health Net, LLC. On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss. On October 13, 2022, the district court granted final judgement and we have appealed this decision but cannot predict the outcome or the impact on our business. We entered into a settlement agreement with Health Net, LLC on December 26, 2022. We likewise plan to engage in similar patent litigation should other competitors arise with products that infringe our intellectual property rights. Patent litigation is a time-consuming and costly process. There can be no assurance that we will be successful in enforcing this patent or that it will not be successfully challenged and invalidated. Even if we are successful in enforcing this patent, the process 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 claims and gain marketing approval for generic versions of VASCEPA or branded competitive products based on new clinical studies. The pharmaceutical industry is highly 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 these proceedings, which could have a material adverse effect on us. Patent litigation is costly and time consuming, and we may not have sufficient resources to bring these actions to a successful conclusion. 53 We have pending patent applications relating to VASCEPA and its use. There can be no assurance that any of these applications will issue patents, and even if patent protection is obtained, it may be insufficient to minimize competition or support our commercialization efforts. We have filed and are prosecuting numerous families of patent applications in the United States and internationally with claims designed to protect the proprietary position of VASCEPA. For certain of these patent families, we have filed multiple patent applications. Collectively the patent applications include numerous independent claims and dependent claims. Several of our patent applications contain claims that are based upon what we believe are unexpected and favorable findings from our clinical trials. However, our pending patent applications may not be granted or, if they grant, that they will prevent competitors from competing with VASCEPA. Securing patent protection for a product is a complex process involving many legal and factual questions. The patent applications we have filed in the United States and internationally are at varying stages of examination, the timing of which is outside our control. The process to getting a patent granted can be lengthy and claims initially submitted are often modified in order to satisfy the requirements of the patent office. This process includes written and public communication with the patent office. The process can also include direct discussions with the patent examiner. There can be no assurance that the patent office will accept our arguments with respect to any patent application or with respect to any claim therein. 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 the patent office during examination of our patent applications. Providing such additional evidence and publications could prolong the patent office’s review of our applications and result in us incurring additional costs. We cannot be certain what commercial value any granted patent in our patent estate will provide to us. Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets. In addition to our patent portfolio and strategy, 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 cases when we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require certain of our academic collaborators, contractors and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information. Risks Related to Our Business If the estimates we make, or the assumptions on which we rely, in preparing our projected guidance prove inaccurate, our actual results may vary from those reflected in our projections and accruals. In January 2023, we disclosed our 2023 financial outlook. Such outlook and estimates are based on estimates, assumptions and the judgment of management. Because of the inherent nature of estimates, including during the uncertainty of our European launch and the impact from U.S. generic competition, we have suspended providing net revenue guidance, as there could be significant differences between our estimates and the actual amount of product demand. If we fail to realize or if we change or update any element of our publicly disclosed financial guidance as we have done in the past or other expectations about our business and initiative change, our stock price could decline in value. The loss of key personnel could have an adverse effect on our business, particularly in light of our announcement of management succession plan. 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 have a material adverse effect on us. Given our rapidly expanding enterprise coupled with a streamlined management structure and sales force, the departure of any key person could have a significant impact and would be potentially disruptive to our business until such time as a suitable replacement is hired. Furthermore, because of the specialized nature of our business, as our business plan progresses, we will be highly dependent upon our ability to attract and retain qualified scientific, technical and key management personnel. As we continue to expand our commercialization efforts, particularly on a global scale, we may experience continued or increased turnover among members of our senior management team. We may have difficulty identifying, attracting and integrating new executives to replace any such losses. As we expand commercialization efforts in Europe, we need to rapidly hire employees and ensure that they are well trained and working cohesively with core values which are consistent with our existing operations and which, we believe, help improve our position for success. In the United States, employees are increasingly being recruited by other companies. While our business remains focused on continued promotion of VASCEPA in the United States, and expansion in Europe, the current and potential threat of generic competition and our recent reductions in force can create employee uncertainty which could lead to increased employee turnover. There is intense competition for qualified personnel in the areas of our activities. In this environment, we may not be able to attract or retain the personnel necessary for the development of our business, particularly if we do not achieve profitability. The failure to recruit key scientific, technical and management personnel would be detrimental to our ability to implement our business plan. 54 Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs. Despite the implementation of security measures, our internal computer systems and those of our third‑party clinical research organizations and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. Any such incident could cause interruptions in our operations or a material disruption of our programs. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or products candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and our research and development program could be delayed. We could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information systems and networks of our company and our vendors, including personal information of our employees and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems. We may experience threats to our data and systems, including malicious codes and viruses, phishing and other cyber-attacks. The number and complexity of these threats continue to increase over time. For example, in June 2019, a report published by security researchers claimed that a database belonging to one of our vendors containing information about individuals who use or have expressed interest in VASCEPA was accessible to unauthorized users. Although we were informed that such breach did not include social security numbers or credit card information, a more material breach could occur in the future. If a material breach of our information technology systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged. We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks and to repair reputational costs. In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. We may incur significant costs or divert significant internal resources as a result of any regulatory actions or private litigation. Any of the foregoing consequences may adversely affect our business and financial condition. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely. As we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems. In addition, there can be no assurance that our internal information technology systems or those of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm. We are subject to potential product liability. We are subject to the potential risk of product liability claims relating to the manufacturing and marketing 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 we were 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 development stage products. A successful claim brought against us could have a material adverse effect on our business. We cannot guarantee that a product liability claim will not be asserted against us in the future. A change in our tax residence and/or tax laws could have a negative effect on our future profitability. We expect that our tax jurisdiction will remain in Ireland. Under current UK legislation, a company incorporated in England and Wales, or which is centrally managed and controlled in the UK, is regarded as resident in the UK for taxation purposes. Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrally managed and controlled in Ireland, or, in certain circumstances, if it is incorporated in Ireland. Up to December 31, 2019, where a company was treated as tax resident under the domestic laws of both the UK and Ireland, then the provisions of article 4(3) of the Double Tax Agreement, or DTA, between the UK and Ireland provided that such enterprise would be treated as resident only in the jurisdiction in which its place of effective management is situated. We had at all times sought to conduct our affairs in such a way so as to be solely resident in Ireland for tax purposes by virtue of having our place of effective management situated in Ireland. 55 These rules regarding determination of tax residence changed effective January 1, 2020, when a modified Ireland-UK DTA came into effect pursuant to the OECD’s Multilateral Instrument, or MLI. Under the modified Ireland-UK DTA, from January 1, 2020, we would be solely tax resident in Ireland and not tax resident in the UK if we continued to be centrally managed and controlled in Ireland and if it were mutually agreed between the Irish and UK tax authorities under the MLI “tie-breaker rule” that we are solely tax resident in Ireland. Having made the relevant submission under the amended provisions, we received confirmation effective January 1, 2020 of the mutual agreement of Irish and UK tax authorities that we are solely tax resident in Ireland for the purposes of the modified DTA. However, we cannot assure you that we are or will continue to be solely resident in Ireland for tax purposes. It is possible that in the future, whether as a result 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 be regarded 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 Irish capital gains tax on our assets and the basis on which our income is taxed may also change. Similarly, if the tax residency of our Irish or UK subsidiaries were to change from their current jurisdiction, they may be subject to a charge to local capital gains tax on their assets and the basis on which their income is taxed may also change. Our and our subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or the IRS, and states. For example, the IRS began an examination of our 2018 U.S. income tax return in the first quarter of 2020. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, we do not believe the outcome of any ongoing or future audits will have a material adverse effect on our consolidated financial position or results of operations. 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. Three customers individually accounted for 10% or more of our U.S. gross product sales. Customers A, B, and C accounted for 35%, 31%, and 27%, respectively, of gross product sales for the year ended December 31, 2022 and represented 35%, 21%, and 39%, respectively, of the gross accounts receivable balance as of December 31, 2022. Customers A, B, and C accounted for 37%, 28%, and 27%, respectively, of gross product sales for the year ended December 31, 2021 and represented 39%, 22%, and 35%, respectively, of the gross accounts receivable balance as of December 31, 2021. We expect that we may have customer concentration risk as we enter additional countries. There can be no guarantee that we will be able to sustain our accounts receivable or gross sales levels from our key 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 through our distributor relationships, our financial condition and results of operations could be negatively affected. Risks Related to Our Financial Position and Capital Requirements We have a history of operating losses and anticipate that we will incur continued losses for an indefinite period of time. We have not yet reached sustained profitability. For the fiscal year ended December 31, 2022 and 2020, we reported net losses of approximately $105.8 million and $18.0 million, respectively. For the fiscal year ended December 31, 2021, we reported net income of approximately $7.7 million. We had an accumulated deficit as of December 31, 2022 of $1.5 billion. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs, from general and administrative costs associated with our operations, and costs related to the commercialization of VASCEPA. Additionally, as a result of our significant expenses relating to commercialization and research and development, we expect to continue to incur significant operating losses for an indefinite period. Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products, we are unable to predict the magnitude of these future losses. Our historic losses, combined with expected future losses, have had and will continue to have an adverse effect on our cash resources, shareholders’ deficit and working capital. We may never generate sufficient revenue to achieve a steady state of profitability. Our ability to become profitable on a sustained basis depends upon our ability to generate revenue. We have been generating product revenue from sales of VASCEPA since January 2013, but we may not be able to generate sufficient revenue to achieve a steady state of profitability. Our ability to generate profits on sales of VASCEPA is subject to the market acceptance and commercial success of VASCEPA and our ability to manufacture commercial quantities of VASCEPA through third parties at acceptable cost levels, and may also depend upon our ability to effectively market and sell VASCEPA through our strategic collaborations. Even though VASCEPA has been approved by the U.S. FDA for marketing in the United States for two important indications, received marketing authorization in Europe, and is approved in smaller jurisdictions, it may not gain enough market acceptance to support consistent profitability. We anticipate continuing to incur significant costs associated with expanding the commercialization of VASCEPA. We may not achieve profitability on a sustained basis in the near term due to high costs associated with, for example, our expanded commercialization efforts in the United States and our expected commercialization efforts in Europe. If we are unable to 56 consistently generate robust product revenues, we will not become profitable on a sustained basis in the near term, if ever, and may be unable to continue operations without continued funding. Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading 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 will likely fluctuate from month to month. VASCEPA sales are difficult to predict 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 of VASCEPA may be below the expectation of securities analysts or investors in the future. We believe that our quarterly and annual results of operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following: • • • • • • • • • • • the recent and future potential launches of additional generic versions of VASCEPA; continued and prolonged disruption to our business, or delays in resuming normal business activities, or reinstating restrictions after protocols have been lifted, from the COVID-19 pandemic; the continuing evolution of the medical community’s and the public’s perception of the REDUCE-IT study results; the level of demand for VASCEPA, due to changes in prescriber sentiment, quarterly changes in distributor purchases, and other factors; the extent to which coverage and reimbursement for VASCEPA is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors and the timing and extent to which such coverage and reimbursement changes; the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales, and our cost and reorganization efforts, including our recent cost reduction plan, and the resulting effectiveness of those efforts; disruptions or delays in our or our partners’ commercial or development activities, including as a result of political instability, civil unrest, terrorism, pandemics or other natural disasters, such as the coronavirus pandemic; the timing and ability of efforts outside the United States, to develop, register and commercialize VASCEPA in Europe, the China Territory, several Middle Eastern and North African countries, and Canada, for example, including obtaining necessary regulatory approvals, favorable pricing and establishing marketing channels; additional developments regarding our intellectual property portfolio and regulatory exclusivity protections, if any; outcomes of litigation and other legal proceedings; and our ongoing regulatory dialogue. We may require substantial additional resources to fund our operations. If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business. We currently operate with limited resources. We believe that our cash and cash equivalents balance of $217.7 million and short-term investment balance of $91.7 million as of December 31, 2022, will be sufficient to fund our projected operations for at least 12 months from the issuance date of consolidated financial statements included elsewhere in this Annual Report on Form 10-K. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect or fail to achieve positive cash flow. Depending on the level of cash generated from operations, and depending in part on the rate of prescription growth for VASCEPA, additional capital may be required to support planned VASCEPA promotion and potential VASCEPA promotion beyond which we are currently executing and for commercialization of VAZKEPA in Europe. If additional capital is required and we are unable to obtain additional capital on satisfactory terms, or at all, we may be forced to delay, limit or eliminate certain promotional activities. We anticipate that quarterly net cash outflows in future periods will be variable as a result of the timing of certain items, including our purchases of API and VASCEPA promotional and educational activities, including launch activities in Europe, on our operations and those of our customers and any current or potential generic competition. In order to fully realize the market potential of VASCEPA, we may need to enter into a new strategic collaboration or raise additional capital. Our future capital requirements will depend on many factors, including: • the timing, amount and consistency of revenue generated from the commercial sale of VASCEPA; 57 • • • • • the costs associated with commercializing VASCEPA in the United States and sales force sizing, and for commercializing VAZKEPA in Europe, including hiring experienced professionals, and for additional regulatory approvals internationally, if any, the cost and timing of securing commercial supply of VASCEPA and the timing of entering into any new strategic collaboration with others relating to the commercialization of VASCEPA, if at all, and the terms of any such collaboration; continued costs associated with litigation and other legal proceedings and governmental inquiries; the time and costs involved in obtaining additional regulatory approvals for VASCEPA based on REDUCE-IT results internationally; 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, our commercialization efforts for VASCEPA, and our business generally, may suffer materially. Changes in tax laws could have a material adverse effect on our business, financial condition and results of operations. Tax law and policies in the United States and Ireland are unsettled and may be subject to significant change, including based on adjustments in political perspectives and administration shifts. In the United States and internationally, how to tax entities with international operations, like us, has been subject to significant re-evaluation. We believe we developed VASCEPA in and from Ireland based on understanding of applicable requirements. In recent years, particularly since 2013 when commercial sale of VASCEPA commenced in the United States, the majority of our consolidated operations have been in the United States. Ownership of VASCEPA continues to reside with our wholly-owned Ireland-based subsidiary, Amarin Pharmaceuticals Ireland Ltd., and oversight and operations of that entity are structured to be maintained in Ireland. In order to effectively utilize our accumulated net operating loss carryforwards for tax purposes in Ireland, our operations, particularly for this subsidiary, need to be active in Ireland under applicable requirements. In addition, utilization of these accumulated net operating loss carryforwards assumes that tax treaties between Ireland and other countries, particularly the United States, do not change in a manner that limit our future ability to offset earnings with these operating loss carryforwards for tax purposes. Similarly, a change in our Irish tax residence could materially affect our ability to obtain and maintain profitability, if otherwise achievable. Changes in tax law and tax rates, particularly in the United States and Ireland, could also impact our assessment of deferred taxes. Any change in our assessment of the realizability or the timing for realizing deferred taxes could have a negative impact our future profitability. Changes in tax laws (including in response to the COVID-19 pandemic) or tax rulings, or changes in interpretations of existing laws, could cause us to be subject to additional income-based taxes and non-income taxes (such as payroll, sales, use, value-added, digital tax, net worth, property, and goods and services taxes), which in turn could materially affect our financial position and results of operations. In particular, there have been a number of significant changes to the U.S. federal income tax rules in recent years and additional tax reform proposed by the Biden administration may be enacted. The effect of any such tax reform is uncertain. As we continue to expand internationally, we will be subject to varied and complex tax regimes, and the tax laws of one jurisdiction may impact our expansion to or operations in other jurisdictions. Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our partners’ and our compliance, operating and other costs, as well as the costs of our products. As we expand the scale of our business activities, any changes in the taxation of such activities may increase our effective tax rate and harm our business, financial condition, and results of operations. The IRA was enacted into law on August 16, 2022. Included in the IRA was a provision to implement a 15% corporate alternative minimum tax on corporations whose average annual adjusted financial statement income during the most recently completed three-year period exceeds $1.0 billion. This provision is effective for tax years beginning after December 31, 2022. We are in the process of evaluating the provisions of the IRA. Risks Related to Ownership of our ADSs and Common Shares The 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 of particular companies. In addition, the market prices of the securities of many pharmaceutical and medical technology companies have been especially volatile in the past, and this trend is expected to continue in the future. As of February 24, 2023, we had 406,115,721 common shares outstanding including 385,785,809 shares held as ADSs and 20,329,912 held as ordinary shares (which are not held in the form of ADSs). There is a risk that there may not be sufficient liquidity 58 in the market to accommodate significant increases in selling activity or the sale of 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 seek to sell substantial amounts of our ADSs, particularly if these sales are in a rapid or disorderly 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; litigation and regulatory developments in the United States affecting our VASCEPA promotional rights, and regulatory developments in 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. Further, the effects of Brexit are uncertain and may have a negative effect on global economic conditions, financial markets and our business, which could reduce the price of our ADSs and common shares. In particular, Brexit could lead to a period of considerable uncertainty in relation to the UK financial and banking markets, as well as on the regulatory process in Europe, which could cause the broader global financial markets to experience significant volatility. Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility due to the ongoing uncertainty. Lack of clarity about future UK laws and regulations as the United Kingdom determines which EU rules and regulations to replace or replicate could decrease foreign direct investment in the UK, increase costs, disrupt our business, depress economic activity and restrict our access to capital, any of which could negatively impact the price of our ADSs and common shares. Actual or potential sales of our common shares by our employees, including members of our senior management team, pursuant to pre- arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors. In accordance with the guidelines specified under Rule 10b5-1 under the Exchange Act and our policies regarding stock transactions, 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 that they beneficially own. Generally, sales under such plans by members of our senior management team and directors 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 increasing for numerous reasons. For example, a substantial amount of our ADSs becoming available (or being perceived to become available) for sale in the public market 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 viewed negatively by other investors. If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S. investors. A non-U.S. corporation will be classified as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for any taxable year, if either (i) 75% or more of its gross income for such year consists of certain types of “passive” income or (ii) 50% or more of the value of its assets (determined on the basis of a quarterly average) during such year produce or are held for the production of passive income. Passive income generally includes dividends, interest, royalties, rents, annuities, net gains from the sale or exchange of property producing such income and net foreign currency gains. In addition, a non-U.S. corporation will be treated as owning its proportionate share of the assets and earning its proportionate share of the income of any other corporation in which it owns, directly or indirectly, no more than 25% (by value) of the stock. Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2022, and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future. However, because PFIC status is based on our income, assets and activities for the entire taxable year, which we expect may vary substantially over time, it is not possible to determine whether we will be characterized as a PFIC for any taxable year until after the close of the taxable year. Moreover, we must determine our PFIC status annually based on tests that are factual in nature, and our status in future years will depend on our income, assets and activities in each of those years. There can be no assurance that we will not be considered a PFIC for any taxable year. 59 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 must be 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 by English law, including the provisions of the Companies Act 2006, and by our Articles of Association. These rights differ in certain respects from the rights of shareholders 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 on a 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 all meetings. 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 a proportionate 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. Under English law and our Articles of Association, certain matters require the approval of 75% of the shareholders who vote (in person or by proxy) on the relevant resolution (or on a poll of shareholders representing 75% of the ordinary shares voting (in person or by proxy)), including amendments to the Articles of Association. This may make it more difficult for us to complete corporate transactions deemed advisable by our board of directors. Under U.S. law, generally only majority shareholder approval is required to amend the certificate of incorporation or to approve 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 to acquire us by means of a takeover offer would need to make an offer for all of our outstanding ordinary shares/ADSs. If acceptances are not received for 90% or more of the ordinary shares/ADSs under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain 100% control of us. Accordingly, acceptances of 90% of our outstanding ordinary shares/ADSs will likely be a condition in any takeover offer to acquire us, not 50% as is more common in tender offers for corporations organized under Delaware law. By contrast, a scheme of arrangement, the successful completion of which would result in a bidder obtaining 100% control of us, requires the approval of a majority of shareholders voting at 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, or have been, interested in our shares may be required to disclose information regarding their interests in our shares upon our request, and the failure to provide the required information could result in the loss or restriction of rights attaching to the shares, including prohibitions on certain transfers 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 by proxy or, in the case of a shareholder which is a corporation, represented by a duly authorized officer (although the marketplace rules of the Nasdaq Stock Market require that shareholders holding at least one-third of our outstanding shares of voting stock are present at the meeting or by proxy). Under U.S. law, a majority of the shares eligible to vote must generally be present (in person or by proxy) at a shareholders’ meeting in order to constitute a quorum. The minimum number of shares required for a quorum can be reduced pursuant to a provision in a company’s certificate of incorporation or bylaws, but typically not below one-third of the shares entitled to vote at the meeting. Shareholder protections found in provisions under the UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us. The Takeover Code provides a framework within which takeovers of certain companies organized in the United Kingdom are regulated and conducted. However, because our place of central management and control is currently outside of the United Kingdom, we are not subject to the Takeover Code. As a result, our shareholders are not entitled to the benefit of certain takeover offer 60 protections provided under the Takeover Code. The following is a brief summary of some of the most important rules of the Takeover Code which, as noted, does not apply to us: • • • • • • • • • • • • • In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the company is “the subject of rumor or speculation” or there is an “untoward movement” in the company’s share price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the company to make a public announcement about the potential offer. When a person or group of persons who are treated as “acting in concert” with each other (a) acquires interests in shares carrying 30% or more of the voting rights of a company (which percentage is treated by the Takeover Code as the level at which effective control is obtained) or (b) increases the aggregate percentage interest they have when they are already interested in not less than 30% and not more than 50%, they must make a cash offer to all other shareholders at the highest price paid by them in the 12 months before the offer was announced. When interests in shares of any class representing 10% of shares of that class have been acquired for cash by an offeror (i.e., a bidder) during the offer period (i.e., broadly speaking, the period after the potential offer has been made public) and within 12 months prior to commencement of the offer period, the offer must be in cash or be accompanied by a cash alternative for all shareholders of that class at the highest price paid by the offeror in that period. Further, if an offeror acquires any interest in shares for cash during the offer period, the offer for the shares must be in cash or accompanied by a cash alternative at a price at least equal to the price paid for such shares during the offer period. If after an announcement is made, the offeror acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased accordingly. The offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company. Favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the financial adviser to the offeree. All shareholders must be given the same information. The directors of those parties issuing takeover circulars must include statements taking responsibility for the contents thereof. Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers. Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately. Actions during the course of an offer (or even before if the board of the offeree company is aware that an offer is imminent) by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans (or the bidder consents to the proposed course of action). Frustrating actions would include, for example, issuing new shares, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group. Stringent requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities. Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer. In addition, the offeree company’s employee representatives and pension scheme trustees have the right to have a separate opinion on the effects of the offer on employment and pension schemes appended to the offeree board of directors’ circular or published on a website. 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 foreign jurisdictions. 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 the assets 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 United States upon such persons or to enforce against them judgments obtained in U.S. courts predicated upon the civil liability provisions of the federal securities laws 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 in actions for 61 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 and profits. 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 shares may 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 F income.” Such 10% holder may also be taxable at ordinary income tax rates on any gain 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 rules are 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 to them in their particular circumstances. General Risk Factors Potential technological changes in our field of business create considerable uncertainty. The pharmaceutical industry in which we operate is characterized by extensive research efforts and rapid technological progress. New developments in research are expected to continue at a rapid pace in both industry and academia. We cannot assure you that research and discoveries by others will not render some or all of our programs or product candidates uncompetitive or obsolete. Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular health. We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately be developed by us. Legal, political and economic uncertainty surrounding the exit of the UK from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the UK and pose additional risks to our business, revenue, financial condition, and results of operations. The continued uncertainty concerning the UK’s legal, political and economic relationship with the EU after Brexit may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements whether economic, tax, fiscal, legal, regulatory or otherwise. These developments, or the perception that any of them could occur, may have a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and limit the ability of key market participants to operate in certain financial markets. In particular, it could also lead to a period of considerable uncertainty in relation to the UK financial and banking markets, as well as on the regulatory process in Europe. Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility. If the UK and the EU are unable to implement acceptable agreements or if other EU member states pursue withdrawal, barrier-free access between the UK and other EU member states or among the European Economic Area, or EEA, overall could be diminished or eliminated. The long-term effects of Brexit will depend on any agreements (or lack thereof) between the UK and the EU. Such a withdrawal from the EU is unprecedented, and it is unclear how the UK’s access to the European single market for goods, capital, services and labor within the EU, or single market, and the wider commercial, legal and regulatory environment, will impact our current and future operations (including business activities conducted by third parties and contract manufacturers on our behalf) and clinical activities in the UK. In addition to the foregoing, our UK operations support our current and future operations and clinical activities in other countries in the EU and EEA and these operations and clinical activities could be disrupted by the ongoing effects of Brexit. We may also face new regulatory costs and challenges that could have an adverse effect on our operations. The impact of the terms of the recent trade deal between the UK and EU are uncertain. Since the regulatory framework in the UK covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime with respect to the commercialization of our products in the UK. Any delay in commercializing our products in the UK and/or the EU could restrict our ability to generate revenue and achieve and sustain profitability. The uncertainty around the UK’s future relationship with the EU continues to cause economic uncertainty which could adversely impact customer confidence resulting in customers reducing their spending budgets on our solutions, which could adversely affect our business, revenue, financial condition, results of operations and could adversely affect the market price of our ADSs. Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms. 62 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 markets in order to finance our current operations or expand development programs for VASCEPA, or that there will not be deterioration in financial markets and confidence in economies, particularly in light of the continued volatility attributed to COVID-19 and other global instability. We may also have to scale back or further restructure our operations. If we are unable to obtain additional funding when needed, 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. We may seek additional capital through a combination of private and public equity offerings, debt financings and collaboration, strategic and licensing arrangements. 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. Debt financing, if available, may involve agreements that include burdensome covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, VASCEPA or product candidates beyond the rights we have already 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 of VASCEPA or other strategic transactions or collaborations with third parties. The consummation and performance of any such future transactions 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 to our shareholders. If we are unsuccessful in consummating any such transaction or collaboration, we may be required to reevaluate our business only after we have incurred substantial expenses and devoted significant management time and resources. We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, including in Europe, and record inflation. Our business, financial condition and results of operations could be materially and adversely affected by any negative impact on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Economic uncertainty in various global markets, including the U.S. and Europe, caused by political instability and conflict, such as Russia's invasion of Ukraine, and economic challenges caused by the COVID-19 pandemic, have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally. Although, to date, our business has not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such instability could impact our business and results of operations. The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, geopolitical tensions, record inflation or otherwise, are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this report. Item 1B. Unresolved Staff Comments None. 63 Item 2. Properties The following table lists the location, use and ownership interest of our principal properties as of March 1, 2023: Location Dublin, Ireland Bridgewater, New Jersey, USA Zug, Switzerland Use Offices Offices Offices Ownership Leased Leased Leased Size (sq. ft.) 1,302 67,747 4,511 On September 13, 2022, we entered into a License Agreement for office space in Dublin, Ireland effective October 1, 2022 which terminates on September 30, 2024 and can be extended automatically for successive two year periods. Effective February 5, 2019, we entered into a lease agreement for approximately 67,747 square feet of office space in Bridgewater, New Jersey. The lease commenced on August 15, 2019, for an 11-year period, with two five-year renewal options. On January 20, 2023, we entered into a sublease agreement to sublease 50,000 square feet of the leased 67,747 square feet of office space in Bridgewater, New Jersey. The sublease commences on February 1, 2023 and terminates as of the date of the head lease. On October 10, 2021, we entered into a lease agreement for approximately 4,511 square feet of office space in Zug, Switzerland. The lease commenced on February 1, 2022 for a 5-year period, with one five-year renewal option. We believe that our facilities are adequate for our current and anticipated near-term needs and that suitable additional or substitute space would be available if needed. Item 3. Legal Proceedings In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Refer to Note—7 Commitments and Contingencies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for further details on our legal proceedings. Item 4. Mine Safety Disclosures Not applicable. 64 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our ADSs are listed on The NASDAQ Global Market under the symbol “AMRN”. Each ADS represents one ordinary share. The 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 NASDAQ Global Market under the symbol “AMRN.” First Quarter Second Quarter Third Quarter Fourth Quarter Shareholders Common Stock Price Fiscal 2022 Fiscal 2021 High Low High Low $ $ $ $ 3.82 3.74 1.71 1.38 $ $ $ $ 2.76 1.11 1.04 1.06 $ $ $ $ 9.25 6.58 5.97 5.24 $ $ $ $ 4.80 4.16 3.84 3.11 As of January 31, 2023, there were approximately 375 holders of record of our ordinary shares. Because many ordinary shares are held by broker nominees, we are unable to estimate the total number of shareholders represented by these record holders. Our depositary, Citibank, N.A., constitutes a single record holder of our ordinary shares. Dividends We have never paid dividends on our ordinary shares and do not anticipate paying any cash dividends on our 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 must be 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. Performance Graph—5 Year The following performance graph and related information shall not be deemed “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act of 1933 or Securities Exchange 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 shareholders of our ADSs relative to the cumulative total returns of the NASDAQ Composite Index and the NASDAQ Biotechnology Index. We believe these indices are the most appropriate indices against which the total shareholder return of Amarin should be measured. The NASDAQ Biotechnology Index has been selected because it is an index of U.S. quoted biotechnology and pharmaceutical companies. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our ADSs and in each of the indices on December 31, 2017, and its relative performance is tracked through December 31, 2022. Included in this 5-year time period is the substantial positive impact on the price of Amarin’s ADSs in 2018 following presentation and publication of positive REDUCE-IT results and, in late 2019, following approval by the FDA of a new indication and 65 label expansion for VASCEPA to reduce cardiovascular risk. Also included during this 5-year period is the substantial negative impact on the price of Amarin’s ADSs in 2020 following the loss of the Company’s patent litigation and subsequent appeal. Company/Market/Peer Company Amarin Corporation PLC NASDAQ Composite Index NASDAQ Biotechnology Index 12/31/2018 330.17 95.38 88.94 $ $ $ 12/31/2019 537.41 130.47 113.68 $ $ $ 12/31/2020 124.94 185.48 146.04 $ $ $ 12/31/2021 84.04 226.63 140.88 $ $ $ 12/31/2022 30.17 151.61 125.52 $ $ $ Information about Our Equity Compensation Plans Information regarding our equity compensation plans is incorporated by reference in Item 12 of Part III of this Annual Report on Form 10-K. Recent Sales of Unregistered Securities None Issuer Purchases of Equity Securities Shares purchased in the fourth quarter of 2022 are as follows: Period October 1 – 31, 2022 November 1 – 30, 2022 December 1 – 31, 2022 Total Total Number of Shares Purchased (1) Average Price Paid per Share 14,067 $ 9,794 131,885 155,746 $ 1.09 1.17 1.20 1.19 (1) Represents shares withheld to satisfy tax withholding amounts due from employees related to the exercise or vesting of equity awards. Taxation The following summary contains a description of material U.S., UK and Irish federal income tax consequences of the ownership and disposition of our ordinary shares or ADSs. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to beneficial owners of ordinary shares or ADSs. Certain Material U.S. Tax Considerations The following is a summary of certain U.S. federal income tax considerations with respect to the ownership and disposition of ordinary shares or ADSs by a U.S. Holder (as defined below). This summary applies to you only if you hold ordinary shares or ADSs 66 as a capital asset. This summary is based upon the U.S. Internal Revenue Code of 1986, as amended, which is referred to herein as the Code, regulations promulgated under the Code and administrative rulings and judicial decisions as in effect on the date of this Annual Report on Form 10-K, all of which are subject to change and to differing interpretations, possibly with retroactive effect, which could result in U.S. federal income tax considerations different from those summarized below. This summary is general in nature and does not address the effects of any state or local taxes, the tax consequences in jurisdictions other than the United States or any U.S. federal taxes other than income tax (such as estate or gift tax). In addition, it does not address U.S. federal income tax consequences that may be relevant to you in your particular circumstances, including alternative minimum tax consequences, nor does it apply to you if you are a holder with a special status, such as: • • • • • • • • • • • a person that owns, or is treated as owning under certain ownership attribution rules, 10% or more of the voting power or value of the stock of Amarin; a broker, dealer or trader in securities or currencies; a bank, mutual fund, life insurance company or other financial institution; a tax-exempt entity; a qualified retirement plan or individual retirement account; a person that holds ordinary shares or ADSs as part of a straddle, hedge, constructive sale or other integrated transaction for tax purposes; a partnership, S corporation or other pass-through entity; an investor in a partnership, S corporation or other pass-through entity; a person that is required to report income with respect to ordinary shares or ADSs no later than such income is reported on an “applicable financial statement;” a person who received ordinary shares or ADSs in connection with the performance of services; and a person whose functional currency for U.S. federal income tax purposes is not the U.S. dollar. If an entity treated as a partnership for U.S. federal income tax purposes holds ordinary shares or ADSs, the tax treatment of a partner will generally depend upon the status of the partner and upon the activities of the partnership. A partner of a partnership that owns or disposes of ADSs should consult the partner’s tax advisor regarding the specific tax consequences of the ownership and disposition of ordinary shares or ADSs. YOU SHOULD CONSULT YOUR OWN ADVISOR REGARDING THE TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ORDINARY SHARES AND ADSS IN LIGHT OF YOUR PARTICULAR CIRCUMSTANCES. U.S. holders For purposes of this discussion, a U.S. Holder is any beneficial owner of an ordinary share or ADS that is, for U.S. federal income tax purposes: • • • • an individual who is a citizen or resident of the United States, any state thereof or the District of Columbia; a corporation created or organized under the laws of the United States, any state thereof or the District of Columbia; an estate the income of which is subject to U.S. federal income taxation regardless of its source; or, a trust (i) that validly elects to be treated as a U.S. person for U.S. federal income tax purposes, or (ii) the administration over which a U.S. court can exercise primary supervision and all of the substantial decisions of which one or more U.S. persons have the authority to control. Distributions Subject to the discussion under “—Passive Foreign Investment Company,” below, the gross amount of distributions, if any, payable on ordinary shares and ADSs generally would be treated as dividend income to the extent paid out of current or accumulated earnings and profits (as determined for U.S. federal income tax purposes). A U.S. Holder would be required to include the amount of such distribution in gross income as a dividend (without reduction for any income tax withheld from such distribution). Because we do not maintain calculations of our earnings and profits in accordance with U.S. federal income tax principles, U.S. Holders should assume that any distribution by us with respect to the ordinary shares and ADSs will constitute ordinary dividend income. 67 Subject to the discussion under “—Passive Foreign Investment Company,” below, as long as our ordinary shares or ADSs (as applicable) are treated as publicly traded on an established securities market, or we are eligible for the benefits of the U.S.-Irish Tax Treaty, any distributions treated as dividends will generally be qualified dividend income in the hands of non-corporate U.S. Holders, provided that certain significant holding period and other requirements are met. Any dividends that are qualified dividend income will generally be taxed at preferential rates to a non-corporate U.S. Holder. Any dividends paid to a corporate holder will not be eligible for the dividends received deduction. U.S. Holders generally may claim the amount of Irish withholding tax withheld either as a deduction from gross income or as a credit against U.S. federal income tax liability. However, the foreign tax credit is subject to numerous complex limitations that must be determined and applied on an individual basis. Generally, the credit cannot exceed the proportionate share of a U.S. Holder’s U.S. federal income tax liability that such U.S. Holder’s foreign source taxable income bears to such U.S. Holder’s worldwide taxable income. In applying this limitation, a U.S. Holder’s various items of income and deduction must be classified, under complex rules, as either foreign source or U.S. source. In addition, this limitation is calculated separately with respect to specific categories of income. The amount of a distribution with respect to the ordinary shares or ADSs that is treated as a dividend may be lower for U.S. federal income tax purposes than it is for Irish income tax purposes, potentially resulting in a reduced foreign tax credit for the U.S. Holder. Each U.S. Holder should consult its own tax advisors regarding the foreign tax credit rules. The amount of a distribution paid to a U.S. Holder of ordinary shares or ADSs in foreign currency generally will be equal to the U.S. dollar value of such distribution based on the exchange rate applicable on the date of receipt. A U.S. Holder that does not convert foreign currency received as a distribution into U.S. dollars on the date of receipt generally will have a tax basis in such foreign currency equal to the U.S. dollar value of such foreign currency on the date of receipt. Such a U.S. Holder generally will recognize ordinary income or loss on the subsequent sale or other taxable disposition of such foreign currency (including an exchange for U.S. dollars). Sale or other disposition of ordinary shares or ADSs Subject to the discussion under “—Passive Foreign Investment Company,” below, in general, if you sell or otherwise dispose of ordinary shares or ADSs in a taxable disposition: • • • you will recognize gain or loss equal to the difference (if any) between the U.S. dollar value of the amount realized on such sale or other taxable disposition and your adjusted tax basis in such ordinary shares or ADSs; any gain or loss will be capital gain or loss and will be long-term capital gain or loss if your holding period for the ordinary shares or ADSs sold or otherwise disposed of is more than one year at the time of such sale or other taxable disposition; and, any gain or loss will generally be treated as U.S.-source income for U.S. foreign tax credit purposes, although special rules apply to U.S. Holders who have a fixed place of business outside the United States to which this gain is attributable. Under current law, long-term capital gains of non-corporate U.S. Holders are taxed at reduced rates. The deductibility of capital losses is subject to limitations. In certain circumstances, amounts received by a U.S. Holder upon the redemption of ordinary shares or ADSs may be treated as a dividend with respect to such ordinary shares or ADSs, rather than as a payment in exchange for such ordinary shares or ADSs that results in the recognition of capital gain or loss. In these circumstances, the redemption payment would be included in a U.S. Holder’s gross income as a dividend to the extent such payment is made out of our earnings and profits (as described above). The determination of whether redemption of ordinary shares or ADSs will be treated as a dividend, rather than as a payment in exchange for such ordinary shares or ADSs, will depend, in part, on whether and to what extent the redemption reduces the U.S. Holder’s ownership in us (including as a result of certain constructive ownership attribution rules). The rules applicable to redemptions are complex, and each U.S. Holder should consult its own tax adviser to determine the consequences of any redemption. Passive foreign investment company PFIC Rules Generally. U.S. Holders of ordinary shares and ADSs should be aware that each of Amarin and certain of its subsidiaries could constitute a PFIC for U.S. federal income tax purposes. The tests for determining PFIC status for a taxable year depend upon the relative values of certain categories of assets and the relative amounts of certain kinds of income. The application of these factors depends upon our financial results for the year, which are beyond our ability to predict or control, and the application of the relevant rules is subject to legal and factual uncertainties. Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a 68 PFIC for the taxable year ended December 31, 2022, and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future. However, there can be no assurance that we will not be classified as a PFIC for any taxable year. In general terms, we will be a PFIC for any taxable year in which either (i) 75% or more of its our gross income is passive income, or the income test, or (ii) the average percentage, by fair market value, of our assets that produce or are held for the production of passive income is 50% or more, or the asset test. “Passive income” includes, for example, dividends, interest, certain rents and royalties, certain gains from the sale of stock and securities, and certain gains from commodities transactions. If we are a PFIC for any year, subject to the discussion of QEF (as defined herein) and mark-to-market elections below, a U.S. taxpayer who disposes or is deemed to dispose of an ordinary share or ADS at a gain or who receives a distribution treated as an “excess distribution” on an ordinary share or ADS generally would be required to allocate such gain and distribution ratably to each day in the U.S. taxpayer’s holding period for the ordinary share or ADS in question. The portion of any excess distributions including gains, which are treated for all purposes as excess distributions, allocated to the current taxable year or to a year prior to the first year in which we were a PFIC would be includible as ordinary income in the current taxable year. In contrast, the portion of any excess distributions allocated to the first year in the U.S. Holder’s holding period in which we were a PFIC and any subsequent year or years (excluding the current year) would be taxed at the highest marginal rate applicable to ordinary income for each year (regardless of the U.S. Holder’s actual marginal rate for that year and without reduction by any losses or loss carryforwards) and would be subject to interest charges to reflect the value of the U.S. federal income tax deferral. In accordance with the rules above, if we are or were a PFIC at any time during the U.S. Holder’s holding period, none of the gain recognized on the sale or other disposition of an ordinary share or ADS would be eligible for the preferential long-term capital gains rate. In addition, dividends generally will not be qualified dividend income if in the year of payment or the preceding year we are a PFIC. Certain elections may sometimes be used to reduce the adverse impact of the PFIC rules on U.S. Holders qualifying electing fund, or QEF, and mark-to-market elections, but these elections may accelerate the recognition of taxable income and may result in the recognition of ordinary income. QEF Election. The rules described above for excess distributions would not apply to a U.S. Holder if the U.S. Holder makes a timely QEF election for the first taxable year of the U.S. Holder’s holding period for ordinary shares or ADSs during which we are a PFIC and we comply with specified reporting requirements. A timely QEF election for a taxable year generally must be made on or before the due date (as may be extended) for filing the taxpayer’s U.S. federal income tax return for the year. A U.S. Holder who makes a QEF election generally must report and include in income on a current basis a pro rata share of our ordinary earnings and net capital gain for any taxable year in which we are a PFIC, whether or not those earnings or gains are distributed. A U.S. Holder who makes a QEF election must file a Form 8621 with its annual income tax return. For U.S. Holders who seek to make a QEF election, with respect to our ordinary shares or ADSs, we will make available an information statement that will contain the necessary information required for making a QEF election and permit such U.S. Holders access to certain information in the event of an audit by the U.S. tax authorities. If a U.S. Holder does not make a QEF election for the first taxable year of the U.S. Holder’s holding period for ordinary shares or ADSs during which we are a PFIC, the QEF election will not be treated as timely and the adverse tax regime described above would apply to dispositions of or excess distributions on the ordinary shares or ADSs. In such case, a U.S. Holder may make a deemed sale election whereby the U.S. Holder would be treated as if the U.S. Holder had sold the ordinary shares or ADSs in a fully taxable sale at fair market value on the first day of such taxable year in which the QEF election takes effect. Such U.S. Holder would be required to recognize any gain on the deemed sale as an excess distribution and pay any tax and interest due on the excess distribution when making the deemed sale election. The effect of such further election would be to restart the U.S. Holder’s holding period in the ordinary shares or ADSs, subject to the QEF regime, and to purge the PFIC status of such ordinary shares or ADSs going forward. Mark-to-Market Election. If we are or become a PFIC, a U.S. Holder of ordinary shares or ADSs may elect to recognize any gain or loss on ordinary shares or ADSs on a mark-to-market basis at the end of each taxable year, so long as the ordinary shares and ADSs, respectively, are regularly traded on a qualifying exchange. The mark-to-market election under the PFIC rules is an alternative to the QEF election. A U.S. Holder who makes a mark- to-market election generally must recognize as ordinary income all appreciation inherent in the U.S. Holder’s investment in ordinary shares or ADSs on a mark-to-market basis and may recognize losses inherent in such ordinary shares or ADSs only to the extent of prior mark-to-market gain recognition. The income and deductions entailed by the mark-to-market regime will increase and decrease the U.S. Holder’s adjusted basis in its ordinary shares or ADSs. Upon a sale or other disposition of ordinary shares or ADSs that have been marked-to-market, any gain recognized will be treated as ordinary income. The mark-to-market election must be made by the due date (as may be extended) for filing the U.S. Holder’s federal income tax return for the first year in which the election is to take effect. If a mark-to-market election is made after the first taxable year of a U.S. Holder’s holding period, any gain recognized in the year of the election will be treated like an excess distribution (as 69 described above). Whether or not the mark-to-market election is available will depend on whether the ordinary shares or ADSs are regularly traded on a qualifying exchange and we cannot provide assurance that the ordinary shares or ADSs will be considered regularly traded (which determination is based on the volume of trading of the ordinary shares or ADSs) for all years in which we may be a PFIC. Rules for Lower-Tier PFIC Subsidiaries. Special adverse rules apply to U.S. Holders of ordinary shares or ADSs for any year in which we are a PFIC and have a non-U.S. subsidiary that is also a PFIC, or a lower-tier PFIC. If we are or become a PFIC and a U.S. Holder does not make a QEF election (as described above) in respect of any lower-tier PFIC, the U.S. Holder could incur liability for the deferred tax and interest charge described above if (i) we receive a distribution from, or disposes of all or part of our interest in, the lower-tier PFIC or (ii) the U.S. Holder disposes of all or part of its ordinary shares or ADSs. A QEF election that is made for ordinary shares or ADSs will not apply to a lower tier PFIC, although a separate QEF election may be made with respect to a lower-tier PFIC. For U.S. Holders who seek to make a QEF election, with respect to our ordinary shares or ADSs, we will make available an information statement that will contain the necessary information required for making a QEF election with respect to any lower-tier PFIC and permit such U.S. Holders access to certain information in the event of an audit by the U.S. tax authorities. For U.S. Holders that make a mark-to-market election for Amarin, if available, no such election may be made with respect to the stock of a lower-tier PFIC that a U.S. Holder is treated as owning if such stock is not marketable. Hence, the mark-to-market election will not be effective to eliminate a U.S. Holder’s liability for the deferred tax and interest charge described above with respect to deemed dispositions of lower-tier PFIC stock or distributions from a lower-tier PFIC. Taxpayer Reporting Obligations. A U.S. Holder’s ownership of ordinary shares or ADSs in a PFIC generally must be reported by filing Form 8621 with the U.S. Holder’s annual U.S. federal income tax return. Every U.S. Holder who is a shareholder in a PFIC must file an annual report containing the information required by the IRS. The PFIC rules are extremely complex, and U.S. Holders are urged to consult their own tax advisers regarding the potential tax consequences of Amarin being classified as a PFIC. Medicare tax Certain U.S. Holders that are individuals, estates or trusts are required to pay up to an additional 3.8% tax on the lesser of (i) the U.S. person’s net investment income (or undistributed net investment income in the case of an estate or trust) for the relevant taxable year and (ii) the excess of the U.S. person’s modified adjusted gross income (or adjusted gross income, in the case of an estate or trust) for the taxable year over a certain threshold (which in the case of individuals will be between $125,000 and $250,000, depending on the individual’s circumstances). A U.S. Holder’s net investment income will include dividends and capital gains on the U.S. Holder’s ordinary shares and ADSs. U.S. Holders should consult their own tax advisors regarding the effect, if any, of the Medicare tax on the ownership and disposition of ordinary shares or ADSs. Taxpayer reporting obligations Certain U.S. Holders that hold certain foreign financial assets are required to report information relating to such assets to the IRS, subject to certain exceptions. U.S. Holders may also be required to make other tax filings with respect to their investments in our ordinary shares and ADSs, including IRS Form 926 (Return by a U.S. Transferor of Property to a Foreign Corporation). Failure to provide such information could result in significant additional taxes and penalties. U.S. Holders should consult their own tax advisors regarding potential reporting obligations. U.S. Information reporting and backup withholding U.S. Holders of ordinary shares and ADSs may be subject to information reporting and may be subject to backup withholding on distributions on ordinary shares and ADSs or on the proceeds from a sale or other disposition of ordinary shares and ADSs paid within the United States. Payments of distributions on, or the proceeds from the sale or other disposition of ordinary shares and ADSs to or through a foreign office of a broker generally will not be subject to backup withholding, although information reporting may apply to those payments in certain circumstances. Backup withholding will generally not apply, however, to a U.S. Holder who: • • furnishes a correct taxpayer identification number and certifies that the U.S. Holder is not subject to backup withholding on IRS Form W-9, Request for Taxpayer Identification Number and Certification (or substitute form); or is otherwise exempt from backup withholding. Backup withholding is not an additional tax. Any amounts withheld from a payment to a holder under the backup withholding rules may be credited against the holder’s U.S. federal income tax liability, and a holder may obtain a refund of any excess amounts withheld by filing the appropriate claim for refund with the IRS in a timely manner. U.S. Holders should consult their own tax advisors regarding information reporting and potential back up withholdings. 70 Certain Material UK Tax Considerations The following discussion is limited to an overview of the tax consequences of ownership and disposition of ordinary shares, or such shares represented by ADSs (those ordinary shares or ADSs deriving over 75% of their value otherwise than from United Kingdom land). Each shareholder should however seek individual tax advice as specific rules may apply in certain circumstances. Capital gains If you are not resident in the United Kingdom, or UK, for UK tax purposes, you will not be liable for UK tax on capital gains realized or accrued on the sale or other disposition of ordinary shares or ADSs unless the ordinary shares or ADSs are held in connection with your trade carried on in the UK through a branch or agency and the ordinary shares or ADSs are or have been used, held or acquired for the purposes of such trade or such branch or agency. An individual holder of ordinary shares or ADSs who ceases to be resident in the UK for UK tax purposes for a period of less than five years and who disposes of ordinary shares or ADSs during that period may also be liable on returning to the UK for UK capital gains tax despite the fact that the individual may not be resident in the UK at the time of the disposal. Inheritance tax If 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 1978 between the United States and the UK, any ordinary shares or ADS beneficially owned by you will not generally be subject to UK inheritance tax on your death 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 the ordinary share or ADS is part of the business property of your UK permanent establishment. Where the ordinary 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 not a national of the UK, the ordinary shares or ADSs will not generally be subject to UK inheritance tax. Stamp duty and stamp duty reserve tax Transfer of ADSs and ADRs representing ADSs No UK stamp duty or stamp duty reserve tax will be payable on an instrument transferring an ADS or an American Depositary Receipt, or ADR, representing an ADS or on a written agreement to transfer an ADS or an ADR representing an ADS whether made in or outside the UK. Issue and transfer of ordinary shares The issue of ordinary shares by Amarin will not give rise to a charge to UK stamp duty or stamp duty reserve tax. Transfers of ordinary shares, as opposed to ADSs or ADRs representing ADSs, will generally attract ad valorem stamp duty at the rate of 0.5% of the amount or value of the consideration (or in some circumstances, the open market value of those ordinary shares, if higher). A charge to stamp duty reserve tax, at the rate of 0.5% of the amount or value of the consideration (or in some circumstances, the open market value of the ordinary shares, if higher), will generally arise on an agreement to transfer ordinary shares. The stamp 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 is executed 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 been paid ceases to be payable. Taxation of dividends Under UK law, there is no withholding tax on dividends paid on the ordinary shares or ADSs. Certain Material Irish Tax Considerations The summary only applies to U.S. Holders that legally and beneficially hold their ordinary shares, or such shares represented by ADSs evidenced by ADRs as capital assets (i.e. investments) and does not address special classes of holders including, but not limited to, dealers in securities, insurance companies, pension schemes, employee share ownership trusts, collective investment undertakings, charities, tax-exempt organizations, financial institutions and close companies, each of which may be subject to special rules not discussed below. Solely for the purposes of this summary of Irish Tax Considerations, a U.S. Holder means a holder of shares or ADSs evidenced by ADRs that (i) beneficially owns the shares or ADSs registered in their name; (ii) is resident in the United States for the purposes of the Ireland-United States Double Taxation Convention, or the Treaty; (iii) in the case of an individual holder, is not also resident or ordinarily resident in Ireland for Irish tax purposes; (iv) in the case of a corporate holder, is not a resident in Ireland for Irish tax purposes and is not ultimately controlled by persons resident in Ireland; and (v) is not engaged in any trade or business and does not 71 perform independent personal services through a permanent establishment or fixed base in Ireland; and (vi) is a qualified person as defined in Article 23 of the Treaty. For Irish taxation purposes, and for the purposes of the Treaty, U.S. Holders of ADSs will be treated as the owners of the shares represented by such ADSs. The following discussion is limited to the tax consequences of ownership and disposition of shares or ADSs. Tax considerations applicable to other types of securities will be described in the related prospectus supplement. Taxation of dividends We do not expect to pay dividends in the foreseeable future. Should we begin paying dividends, such dividends will generally be subject to dividend withholding tax, or DWT, in Ireland at a rate of 25%. Where DWT applies, we will be responsible for withholding such tax at source. Dividends paid by us to U.S. Holders of shares or ADSs evidenced by ADRs will be exempt from DWT if, prior to the payment of such dividends, the recipient U.S. Holder delivers to us a declaration in the form prescribed by the Irish Revenue Commissioners. In addition, a certificate of residency in the form prescribed by the Irish Revenue Commissioners, will also be required if the U.S. holder is an individual. Where DWT is withheld from dividend payments to U.S. Holders of shares or ADSs evidenced by ADRs, such U.S. Holders can apply to the Irish Revenue Commissioners claiming a full refund of DWT paid by filing a declaration in the form prescribed by the Irish Revenue Commissioners. As above, a certificate of residency in the form prescribed by the Irish Revenue Commissioners, will also be required if the U.S. holder is an individual. The DWT rate applicable to U.S. Holders may be reduced under the terms of the Treaty, however, in the first instance, an exemption should be in place under Irish domestic legislation. Irish source income U.S. Holders will not be liable to Irish income tax on dividends paid by us. Capital gains on disposals of shares or ADSs U.S. Holders will not be subject to Irish capital gains tax, or CGT, on the disposal of shares or ADSs provided that such shares or ADSs are quoted on a stock exchange at the time of disposition such as Nasdaq. While it is our intention to continue the listing of ADSs on Nasdaq, no assurances can be given in this regard. If, for any reason, our ADSs cease to be listed on Nasdaq, U.S. Holders will not be subject to CGT on the disposal of their shares or ADSs provided that the shares or ADSs do not, at the time of the disposal, derive the greater part of their value from land, buildings, minerals, or mineral rights or exploration rights in Ireland. Irish Capital Acquisitions Tax (CAT) CAT comprises principally gift and inheritance tax. A gift or inheritance of shares or ADSs will come within the charge to CAT if either: (i) the disponer or the donee/successor in relation to the gift or inheritance is resident or ordinarily resident in Ireland (please note that special rules with regard to residence apply where an individual is not domiciled in Ireland); or (ii) the ordinary shares or ADSs are regarded as property situated in Ireland (e.g. shares would be regarded as Irish property if the share register is maintained in Ireland. ADSs, if registered, will be regarded as Irish property if the register is maintained in Ireland, or, if in bearer form, if the instrument of ownership is located in Ireland). On the basis that the shares or ADSs (assuming they are registered) should not be regarded as property situated in Ireland (given that the registers are not maintained in Ireland), a gift or inheritance of the shares or ADSs should only come within the charge to Irish CAT if either the disponer or donee/successor is resident or ordinarily resident in Ireland at the date of the gift or inheritance. The rate of CAT is currently 33% and is payable if the taxable value of the gift or inheritance exceeds certain tax-free thresholds. The appropriate tax-free threshold depends on the relationship between the disponer and the donee/successor. A gift or inheritance received from a spouse is exempt from CAT. The person who receives the gift or inheritance is generally accountable for any CAT due. 72 Irish stamp duty No Irish stamp duty should arise on the issue or transfer for cash of shares or ADSs on the basis that such a transfer does not relate to stocks or marketable securities of an Irish registered company. Item 6. [Reserved] 73 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations This Annual Report on Form 10-K contains forward-looking statements concerning future events and our performance. When used in this Annual Report on Form 10-K, 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. These statements include but are not limited to statements regarding the commercial success of VASCEPA and factors that can affect such success; interpretation of court decisions; plans with respect to litigation; expectation on determinations and policy positions of the United States Food and Drug Administration, or U.S. FDA; the safety and efficacy of our product and product candidates; expectation regarding the potential for VASCEPA to be partnered, developed and commercialized outside of the United States; expectation on the scope and strength of our intellectual property protection and the likelihood of securing additional patent protection; estimates of the potential markets for our product candidates; estimates of the capacity of manufacturing and other facilities to support our products; our operating and growth strategies; our industry; our projected cash needs, liquidity and capital resources; and our expected future revenues, operations and expenditures. These forward-looking statements are based on our current expectations and assumptions and many factors could cause our actual results to differ materially from those indicated in these forward-looking statements. You should review carefully the factors identified in this Annual Report on Form 10-K in Item 1A, “Risk Factors”. We disclaim any intent to update or announce revisions to any forward-looking statements to reflect actual events or developments, except as required by law. Except as otherwise indicated herein, all dates referred to in this Annual Report on Form 10-K represent periods or dates fixed with reference to our fiscal year ended December 31, 2022. Overview We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication and commercially launched in 2013. On December 13, 2019, the U.S. FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication. On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA®, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels. On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk. VASCEPA is currently available by prescription in the U.S. and certain other countries throughout the world, as described below. We are responsible for the supply of VASCEPA to all markets in which the branded product is sold, either to and through our collaborations with third-party companies or by us. We are not responsible for providing any generic company with drug product. Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to the U.S. patent litigation and judgment described below and no similar litigation is pending outside of the United States. United States VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Since VASCEPA was made commercially available in 2013, more than twenty million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared as invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market with a 1-gram capsule: Company Hikma Pharmaceuticals USA Inc. Dr. Reddy’s Laboratories, Inc. Teva Pharmaceuticals USA, Inc. Apotex, Inc. FDA MARINE Indication Approval May 2020 August 2020 September 2020 June 2021 Launch Date November 2020 June 2021 September 2022 January 2022 (1) (1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023. 74 In June 2022, to address shifts within our U.S. business due to these generic competitors, we announced a comprehensive cost and organizational restructuring plan which is expected to result in savings of $100.0 million over the subsequent twelve months compared to 2021 operating expenses. Our U.S. cost reduction plan included: • • U.S. workforce reduction: The reduction of our U.S. field force and corporate positions. Our U.S. field force was reduced from approximately 300 sales representatives to approximately 75 sales representatives. Streamlined operational expenditures: Includes reductions and reallocations in overall selling, general and administrative expenses as well as savings related to refining our research and development strategy to a more focused, stepwise approach for our fixed-dose combination, or FDC, program. In alignment with our U.S. cost reduction plan, our focus is primarily on engaging with our top VASCEPA brand prescribers, maintaining our exclusive formulary coverage with specific payers, and implementing targeted promotional initiatives amid the continued pressure from generic competitors. We obtain data from a third party, Symphony Health, who collects and reports estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to determine the actual number of total prescriptions for products like VASCEPA during such periods. The vendor's estimate utilizes a proprietary projection methodology and are based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable. Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions over the year ended December 31, 2022. Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients, calculated on a normalized basis (i.e., one month’s supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams). Inventory levels at wholesalers tend to fluctuate based on seasonal factors, prescription trends and other factors. The previous calculations of prescription levels by this vendor can change between periods and can be significantly affected by lags in data reporting from various sources or by changes in pharmacies and other distributors providing data. Such methods can from time to time result in significant inaccuracies in information when ultimately compared with actual results. These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use. Further, data for a single and limited period may not be representative of a trend or otherwise predictive of future results. We are not responsible for the accuracy of this vendor's information and we do not receive prescription data directly from retail pharmacies. Europe In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland. Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed thirteen dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national, general organization reimbursement. In countries where 75 individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient by patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Annual Report on Form 10-K, we have received and made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively. Country Sweden Finland United Kingdom Austria Denmark Individual Reimbursement NA NA NA September 2022 June 2022 National Reimbursement March 2022 October 2022 July 2022 NA NA Product Availability March 2022 December 2022 October 2022 September 2022 June 2022 Launch Date March 2022 December 2022 October 2022 NA NA In order to launch impactfully in targeted major markets in Europe we are building a core team of experienced professionals and highly capable local commercial teams involved with pre-launch planning and commercial launch activities and we are leveraging third-party relationships for various support activities. We are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approach for more impact and cost efficiency, which is or will be utilized throughout Europe as launches are rolled out. Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists rather than by general practitioners. Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies than in the United States. However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the United States. In Europe, VAZKEPA has the benefit of ten years of market protection, and we have been issued a patent that expires in 2033 with additional pending applications that could extend exclusivity into 2039. In September 2021, as part of the German reimbursement process, VAZKEPA was made available in Germany with temporary reimbursement while negotiations for final reimbursement were ongoing and VAZKEPA was included in the country's electronic prescribing system as of October 1, 2021. On August 19, 2022, reimbursement negotiations were concluded without agreement. As a result, we discontinued our German business operations as of September 1, 2022. Following the local reimbursement process and initiated by G-KV, we moved to the Arbitration Board. In November 2022, the Arbitration Board process was concluded without reaching a deal. German legislation allows re-submission of a pricing and reimbursement dossier with new data and we plan to resubmit once we have a new dossier ready. Rest of World China In February 2015, we entered into an exclusive agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, to develop and commercialize VASCEPA capsules in what we refer to as the China Territory, consisting of the territories of Mainland China, Hong Kong, Macau and Taiwan. Edding, with our support, conducted a clinical trial of VASCEPA in China, which evaluated the effect of VASCEPA on patients with very high triglyceride levels (≥500 mg/dL). In November 2020, we announced statistically significant topline positive results from this Phase 3 clinical trial of VASCEPA conducted by Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo. There were no treatment-related serious adverse events in this study. On February 9, 2021, we announced that the regulatory review processes in Mainland China and Hong Kong have commenced. The National Medical Products Administration, or NMPA, accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA. On February 23, 2022 the Hong Kong Department of Health completed their evaluation of the clinical trial conducted in China and approved the use of VASCEPA under the REDUCE-IT indication. In China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final NMPA review of the VASCEPA NDA was initiated with Edding expecting approval by the end of 2022. Due to delays at CDE as a result of the resurgence of COVID-19 in the Beijing area at the end of 2022, Edding has communicated that an approval in Mainland China could be achieved by mid-year of 2023. 76 Middle East and North Africa (MENA) In March 2016, we entered into an agreement with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Biologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially, in the following countries: Country Lebanon United Arab Emirates Qatar Bahrain Kuwait Saudi Arabia MARINE March 2018 July 2018 December 2019 April 2021 December 2021 March 2022 REDUCE-IT August 2021 October 2021 April 2021 April 2022 — — Launch Date June 2018 February 2019 — — — — VASCEPA is under registration in additional countries in the MENA region. Canada In September 2017, we entered into an agreement with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada. In March 2019, HLS received formal confirmation from Health Canada that Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission, which was filed in April 2019. In December 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority granted approval for VASCEPA to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. In January 2020, HLS obtained regulatory exclusivity designation and launched commercially in February 2020. In July 2020, the Canadian Agency for Drugs and Technologies in Health recommended that VASCEPA be reimbursed by participating public drug plans for statin-treated patients with established cardiovascular diseases and elevated triglycerides. In April 2022, HLS completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance for the terms and conditions under which VASCEPA would qualify for public market reimbursement in Canada. Following these negotiations, HLS signed a Letter of Intent which allows HLS to work with all participating provincial jurisdictions to secure coverage from publicly funded drug plans across Canada, and for VASCEPA to potentially be added to their respective plans. HLS also received notification by the Patented Medical Prices Review Board that, further to its review, VASCEPA’s price did not trigger the investigation criteria for excessive pricing. As of December 31, 2022, reimbursement coverage is approximately 70% of publicly covered lives and 95% for private coverage. Public reimbursement is now available in Ontario, Quebec, Saskatchewan, New Brunswick Northwest Territories and for the Non-Insured Health Benefits program for the First Nations and Inuit people. Coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada. VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that could extend into 2039. Other We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the United States and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval. We have completed the first year of a three year plan to submit and obtain regulatory approval in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA. Through the date of this Annual Report on Form 10-K, we have filed for regulatory review in 10 countries and have received approval in seven countries outside of the United States and European Medicines Agency, or EMA, regulatory approval authority, including in Switzerland, Australia and New Zealand, under the REDUCE-IT indication. In February 2023, we entered into an agreement with CSL Seqirus to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. Research and Development Since its inception in 2011, conduct of the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development. Most of our other research and development during this period also pertained to VASCEPA, including study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the United States and continue to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study. Based on REDUCE-IT results, as of the date of the filing of this Annual Report on Form 10-K, 30 clinical treatment guidelines, consensus statements or scientific statements from medical societies or journals have been updated recommending the use of icosapent 77 ethyl in appropriate at-risk patients, including those statements which we were informed of by our global partners in Canada, China and the Middle East as well as guidelines which were newly received during the fourth quarter of 2022 as listed below: • • • • In November 2022, the American Society of Preventive Cardiology published a clinical practice statement delineating key attributes that define the field of preventive cardiology, including that REDUCE-IT established that IPE reduced CV events among patients fasting TG 135 to 499 mg/dL and that results from REDUCE-IT have not been replicated in trials using mixed omega-3 fatty acids suggesting that the CV benefit is attributed to EPA. In November 2022, NICE released its guidelines on lipid management, which included that IPE is recommended for patients with established CVD and elevated fasting TG and who are taking statins with LDL-C levels between 1.04 and 2.60 mmol/L, as per the REDUCE-IT results. In December 2022, the Finnish Medical Association and the Finnish Association of Internists published updated guidelines on dyslipidemia treatment, including that IPE is indicated for patients on statin therapy who have elevated TG levels and are at particularly high risk for arterial disease. In December 2022, the National Society of Cardiometabolic Medicine in China released its consensus statement on the role of omega-3 fatty acids in the prevention and treatment of CVD in Chinese patients. The consensus statement reviewed current knowledge about omega-3 fatty acids and their use in managing CVD in the Chinese population. The following key recommendations were included on use of IPE: o o o High-dose IPE can confer CV benefits in patients with high TG levels at high risk for ASCVD and who have additional CV risk factors. EPA levels may be the driving force behind CV benefit reported with IPE, a concept supported by JELIS and REDUCE-IT trials in which serum EPA levels were inversely associated with CV risk in a dose-response relationship as well as in a sub- analysis of REDUCE-IT, which showed that the CV reduction reported with IPE was attributed to changes in EPA levels rather than lipid biomarkers. IPE is the only omega-3 fatty acid approved by the FDA, Health Canada and the EMA for CV risk reduction in patients with CVD or diabetes with other ASCVD risk factors. During 2022, we announced the following data which added to our growing body of knowledge on VASCEPA as a result of our continued analysis of the REDUCE-IT trial results: • • • • In March 2022, a post hoc sub-analysis of REDUCE-IT, published in the Journal of the American Heart Association, or JAHA, found VASCEPA reduced the risk of cardiovascular death, strokes, heart attacks, coronary revascularization and unstable angina by 34% in patients with a history of percutaneous coronary intervention, or PCI, noting 8.5% and 5.4% absolute risk reductions, respectively, for the primary and secondary composite endpoints. In May 2022, a post hoc sub-analysis of REDUCE-IT, published in the Journal of the American College of Cardiology found VASCEPA significantly reduced the total ischemic event risk of cardiovascular death, stroke, myocardial infarction, coronary revascularization, or hospitalization for unstable angina by 35% in patients who had a prior heart attack. In May 2022, we presented data at the 2022 European Society of Cardiology Congress that VASCEPA significantly reduced ST-segment elevation myocardial infarction by 40% and non-ST segment elevated myocardial by 27%. In August 2022, a post hoc exploratory analysis of REDUCE-IT found VASCEPA significantly reduced the risk of cardiovascular death, strokes, heart attacks, coronary revascularization and unstable angina in current/former smokers by 23% and former smokers by 29%. In addition, in November 2022, we presented at the American Heart Association, or AHA, 2022 Scientific Sessions data related to RESPECT-EPA, A Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid and PROMINENT, Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes Study. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation and is the third study to show CV benefit consistent with REDUCE-IT and JELIS. The study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk and achieved a statistically significant 26.6% reduction in the secondary composite endpoint. On January 10, 2022, we announced that we have initiated development of a fixed-dose combination product that has both icosapent ethyl and a statin. 78 Commercial and Clinical Supply We manage the manufacturing and supply of VASCEPA internally and have done so since we began clinical development of VASCEPA prior to the drug’s marketing approval by U.S. FDA in 2012. We rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA- approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the United States. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. In 2022, we reviewed our contractual supplier purchase obligations and have taken steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of December 31, 2022, we had inventory $392.4 million, of which 90% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Financial Operations Overview Product revenue, net. All of our product revenue is derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. In the United States, VASCEPA is sold to three major wholesalers, as well as several regional wholesalers along with mail order pharmacy providers, or collectively, our distributors or our customers. Most of these customers resell VASCEPA to retail pharmacies for purposes of dispensing VASCEPA to patients. Revenues from VASCEPA sales are recognized upon delivery to the distributor or customer. Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period. During the years ended December 31, 2022 and 2021, our Product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the United States. Such support is intended to offset a portion of the out- of-pocket expense that patients are required to pay for VASCEPA based upon the benefit design of their prescription drug coverage. Our cost for these co- payment support payments in both years ended December 31, 2022 and 2021 was up to $150 per 30-day prescription filled and up to $450 per 90-day prescription filled. Outside of the United States, currently the majority of our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product upon delivery to the commercial partner. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly. We also derive product revenue from sales of our product to a limited number of wholesalers in Europe, most of whom in turn resell the product to pharmacies for purposes of their reselling the product to fill patient prescriptions. Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of up-front, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the United States. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. 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 the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in Cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country. In the year ended December 31, 2022, we incurred costs of $18.1 million in Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand. Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our sales, marketing, executive, business development, 79 finance and information technology functions. 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 in conjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid to independent 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 facilities costs. In addition, Research and development expenses include the cost to support current development efforts, costs of product supply received from suppliers when such receipt by us is prior to regulatory approval of the supplier, as well as license fees related to our strategic collaboration with Mochida. We expense research and development costs as incurred. Restructuring expense. Restructuring expense consists of restructuring costs incurred under our June 2022 cost reduction plan, the discontinuation of German operations and our September 2021 Go-to-Market strategy implementation, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation expense and other contract related costs. Interest and other (expense) income, net. Interest expense primarily consists of interest incurred under our December 2012 royalty-bearing instrument financing arrangement, which was calculated based on an estimated repayment schedule and was paid in full in 2020. Interest income consists of interest earned on our cash and cash equivalents, as well as our short term and long-term investments. Other (expense) income, net, consists primarily of foreign exchange losses and gains. Income tax provision. Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the United States and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for the year-ended December 31, 2022 and 2021, are not more likely than not to be realized. On March 27, 2020, the CARES Act was enacted in the United States. Among other provisions, the CARES Act allows businesses to carry back net operating losses arising in years 2018 to 2020 to the five prior tax years. Critical Accounting Policies and Significant Judgments and Estimates Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies, significant judgments and estimates is presented in Note 2—Significant Accounting Policies to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements. Revenue Recognition—In accordance with GAAP, under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, which we adopted on a modified retrospective basis effective January 1, 2018, revenue is recognized when product has been delivered to the wholesaler, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Topic 606, we perform the following five steps: (i) identify the contract(s) with a Distributor; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We apply the five-step model to contracts only when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the Distributor. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract, determine those that are performance obligations and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. We recognized Total revenue, net of $369.2 million and $583.2 million during the years ended December 31, 2022 and 2021, respectively, of which $366.5 million and $580.3 million, respectively, was based on VASCEPA sales. For a complete discussion of our accounting for net product revenue, licensing and royalty revenues, which make up Total revenue, net, see Note 2—Significant Accounting Policies. We have written contracts with our distributors, and transfer of control typically occurs upon delivery of our product to the Distributor. We evaluate the creditworthiness of each of our 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. We calculate gross product revenues based on the wholesale acquisition cost charged to our distributors for VASCEPA. We estimate 80 our Product revenue, net by deducting from our gross product revenues (a) trade allowances, such as invoice discounts for prompt payment and distributor fees, (b) estimated government and private payor rebates, chargebacks and healthcare discounts, such as Medicaid reimbursements, (c) expected product returns and (d) estimated costs of incentives offered to certain indirect customers, including patients. The gross to net deductions are estimated based on available actual prescription data, historical industry trends, and levels of inventory in the distribution channel. We rely on resale data provided by our distributors as well as prescription data provided by Symphony Health and IQVIA in estimating the level of inventory held in the distribution channel. A hypothetical 5% change in estimated aggregate bottles of channel inventory would result in a change of less than 1% in net product revenues reported during each of the three and twelve months ended December 31, 2022 and 2021. When evaluating licensing arrangements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. In determining performance obligations, we evaluate whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of us. If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the Distributor and the Distributor is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. At the inception of each arrangement that includes development, regulatory and commercial milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our control or the control of the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. We evaluate factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment. We receive payments from our customers based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We do not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Income Taxes—Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases 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 other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by us in our tax filings or positions is more 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 and penalties 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 taxable income during the periods in which the tax benefits are deductible or creditable. When making our assessment about the realization of our deferred tax assets as of December 31, 2022, we considered all available evidence, placing particular weight on evidence that could be objectively verified. The evidence considered included the (i) historical taxable profitability of our U.S. operations, (ii) historical pre-tax book loss position, (iii) sources of future taxable income, giving weight to 81 sources according to the extent to which they can be objectively verified, (iv) the provisions of the Tax Cuts and Jobs Act enacted in 2017 and their impact on our future taxable income, and (v) the risks to our business related to the commercialization and development of VASCEPA. Based on our assessment, we concluded that all of our net deferred tax assets are not more likely than not to be realizable as of both December 31, 2022 and 2021. Changes in historical earnings performance, future earnings projections, and changes in tax laws and tax rates, among other factors, may cause us to adjust our valuation allowance on deferred tax assets in the future, which would impact our income tax expense in the period in which we determine that these factors have changed. We intend to maintain the valuation allowance until sufficient positive evidence exists to conclude that it is more likely than not that our deferred tax benefits will be realized. We will continue to monitor the need for valuation allowances in each jurisdiction and may adjust our positions in the future. Excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments are recognized as an income tax benefit and expense, respectively, in the consolidated statement of operations. Recent Accounting Pronouncements For a discussion of recent accounting pronouncements, see Note 2—Significant Accounting Policies in the accompanying Notes to Consolidated Financial Statements in this Annual Report on Form 10-K. Effects of Inflation We believe the impact of inflation on operations has been minimal during the past three years. Results of Operations The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2022 and 2021. For a comparison of our results of operations and financial condition for fiscal years 2021 and 2020, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2021 Annual Report on Form 10-K, filed with the SEC on March 1, 2022. Comparison of Fiscal Years Ended December 31, 2022 and December 31, 2021 Total revenue, net. We recorded total revenue, net, of $369.2 million and $583.2 million during the years ended December 31, 2022 and 2021, respectively, a decrease of $214.0 million, or 37%. Total revenue, net consists primarily of revenue from the sale of VASCEPA in the United States. In addition to the United States, we also sell VASCEPA by prescription in certain countries in Europe and is available by prescription in Canada, Lebanon and the United Arab Emirates through collaborations with third-party companies. As further discussed below, this decrease consists of a $218.0 million decrease in U.S. product revenue, $0.2 million decrease in licensing and royalty revenue, offset by an increase of $4.3 million in net product revenue from sales of VASCEPA outside of the United States. Product revenue, net. We recorded product revenue, net, of $366.5 million and $580.3 million during the years ended December 31, 2022 and 2021, respectively, a decrease of $213.8 million, or 37%. This decrease was driven primarily by a 38% decrease in VASCEPA sales to our customers in the United States. This decrease was driven by a decline in volume and net selling price as a result of the impact from generic competition in the market. During the year ended December 31, 2022 there were three generics in the market for the majority of the year, with a fourth generic entering in the fourth quarter for the 0.5-gram capsule. During the majority of the year ended December 31, 2021 there was only one generic in the market, with the second generic entering the market in the third quarter of 2021. The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, increased for the year ended December 31, 2022 by 7% as compared to the year ended December 31, 2021. Our share of the icosapent ethyl market has decreased to approximately 60% in the year ended December 31, 2022 compared to approximately 85% in the year ended December 31, 2021. Additionally, based on prescription levels reported by Symphony Health, VASCEPA branded prescriptions decreased by 19% in the year ended December 31, 2022 as compared to the year ended December 31, 2021. In Europe, our commercial launch and growth of the market has been slower than expected due to government health care spending pressure, the resurgence of COVID-19 earlier this year, political unrest in eastern Europe and the Company's decision to cease commercial operations in Germany resulting in product revenue, net of $2.6 million and $0.7 million as of December 31, 2022 and 2021, respectively. The initial launch of VAZKEPA in Europe occurred at the end of the third quarter of 2021. For the year ended December 31, 2022 we recorded $4.1 million of product revenue, net, to our collaboration partners compared to $1.7 million during the year ended December 31, 2021. 82 Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. During 2022 and through the date of this Annual Report on Form 10-K, we launched commercial operations in five countries throughout Europe, while also receiving regulatory approval in seven countries outside of EMA regulatory approval authority. In 2023, we will continue to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets as well as progressing international regulatory filings and supporting approval processes in up to nine countries. Licensing and royalty revenue. Licensing and royalty revenue during the years ended December 31, 2022 and 2021 was $2.7 million and $2.9 million, respectively, a decrease of 0.2 million, or 6%. Licensing and royalty revenue relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements: • • Edding – a $15.0 million up-front payment received in February 2015 and a $1.0 million milestone payment achieved in March 2016. HLS – a $5.0 million up-front payment which was received upon closing of the agreement in September 2017, a $2.5 million milestone payment that was received following achievement of the REDUCE-IT trial primary endpoint in September 2018, a $2.5 million milestone payment that was received following U.S. FDA approval of another indication and label expansion in December 2019, and a $3.8 million milestone payment that was received as a result of obtaining a regulatory exclusivity designation in January 2020. The up-front and milestone payments are being recognized over the estimated period in which we are required to provide regulatory and development support pursuant to the agreements. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required. As part of our licensing agreements with certain territories outside of the United States, we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized as earned based on revenue recognized by our current partners. Cost of goods sold. Cost of goods sold during the years ended December 31, 2022 and 2021 was $126.7 million and $121.3 million, respectively, an increase of $5.4 million, or 4%. Cost of goods sold includes the cost of API for VASCEPA as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance, which revenue was recognized during the period. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API. During 2022, as part of our cost reduction plan, we have taken steps to amend supplier agreements to align supply arrangements with current and future demand resulting in a $18.1 million charge, which was recorded as Cost of goods sold - restructuring inventory. In addition, during 2022, we recorded an approximately $9.6 million inventory write-off due to unsellable inventory unrelated to product dating. The API included in the calculation of the average cost of goods sold during the years ended December 31, 2022 and 2021 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. We currently anticipate API average cost in 2023 to be similar to or modestly lower than 2022. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier. Our gross margin on product sales for the years ended December 31, 2022 and 2021 was 65% and 79%, respectively. Excluding the restructuring inventory and inventory write-off, gross margin was 73% for the year ended December 31, 2022. The remaining decrease in gross margin is primarily as a result of a decrease in net selling price. Selling, General and Administrative Expense. Selling, general and administrative expense for the years ended December 31, 2022 and 2021 was $304.4 million and $408.3 million, respectively, a decrease of $103.9 million, or 25%. Selling, general and administrative expenses for the years ended December 31, 2022 and 2021 are summarized in the table below: In thousands Selling expense (1) General and administrative expenses (2) Non-cash stock-based compensation expense (3) Total selling, general and administrative expense Year Ended December 31, 2022 2021 $ $ 185,614 $ 96,462 22,340 304,416 $ 266,474 109,555 32,305 408,334 (1) Selling expense for the years ended December 31, 2022 and 2021 was $185.6 million and $266.5 million, respectively, a decrease of $80.9 million, or 30%. This decrease is primarily related to the reduction in our U.S. sales force from approximately 600 sales representatives at the beginning of 2021 to 300 sales representatives in September 2021, with a further reduction in 83 force to 75 sales representatives in June 2022. In addition, there has been a related decrease in promotional initiatives in the United States during 2022. (2) (3) General and administrative expense for the years ended December 31, 2022 and 2021 was $96.5 million and $109.6 million, respectively, a decrease of $13.1 million, or 12%. This decrease is primarily due to a decrease in employee related costs as a result of the reduction in force from the September 2021 and the June 2022 restructuring activities. The decrease was further impacted by a decrease in branded pharma fees as a result of lower sales due to additional generic entrants in the market as well as higher legal fees related to the patent infringement litigation during the year ended December 31, 2021. Non-cash stock-based compensation expense for the years ended December 31, 2022 and 2021 was $22.3 million and $32.3 million, respectively, a decrease of $10.0 million, or 31%. Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions. The decrease is primarily due to the decrease in U.S. field force as well as the reversal of expense associated with certain performance-based awards as it was no longer deemed probable that the performance criteria for vesting would be achieved within the required timeframe. We are investing in building an appropriate foundation for the successful launch of VAZKEPA throughout Europe, advancing regulatory filings internationally and navigating the dynamic U.S. environment. As a result, we will continue to evaluate all of our spending commitments and priorities as well as adjust our level of education and promotional activities based on various factors, including the impact of U.S. generic competition as well as timing of pricing reimbursements throughout Europe. Research and Development Expense. Research and development expense for the years ended December 31, 2022 and 2021 was $30.4 million and $29.3 million, respectively, an increase of $1.1 million, or 4%. Research and development expenses for the years ended December 31, 2022 and 2021 are summarized in the table below: In thousands REDUCE-IT study (1) Fixed-dose combination (2) Regulatory filing fees and expenses (3) Internal staffing, overhead and other (4) Research and development expense, excluding non-cash expense Non-cash stock-based compensation expense (5) Total research and development expense Year Ended December 31, 2022 2021 $ $ 1,724 $ 5,777 1,959 16,486 25,946 4,465 30,411 $ 3,607 — 1,441 19,932 24,980 4,327 29,307 (1) (2) (3) (4) The decrease in expenses for the REDUCE-IT study is primarily driven by the decrease in the number of analyses performed beyond the original REDUCE-IT cardiovascular outcomes trial. Fixed-dose combination expenses relate to the cost associated with the development of the fixed-dose combination of VASCEPA and a statin, which began in 2022. The regulatory filing fees in each of the years ended December 31, 2022 and 2021 included annual U.S. FDA fees for maintaining manufacturing sites. Such fees primarily represent fees for qualification of new suppliers, including increasing capacity capabilities, and fees to support international regulatory review of VASCEPA, particularly in Europe, sites used for the manufacture of product used in the REDUCE-IT clinical outcomes study. 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 to specific projects, including costs associated with securing regulatory approvals for VAZKEPA in Europe as achieved in 2021 as well as further regulatory expansion in other countries throughout 2022. Also included are costs related to qualifying suppliers and costs associated with various other investigations, including other costs in collaboration with Mochida and pilot studies regarding VASCEPA. (5) Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to personnel supporting our research and development and regulatory functions. We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S. generic competition as well as timing of pricing reimbursements throughout Europe. Restructuring expense. Restructuring expense for the years ended December 31, 2022 and 2021 was $13.5 million and $13.7, respectively, a decrease of $0.2 million or 1%. The charge in the current year is due to the implementation of the Comprehensive Cost Reduction Plan announced on June 6, 2022 as well as the discontinuation of the German operations announced on August 19, 2022. 84 These two plans were related to the reduction of our U.S. field force from approximately 300 sales representatives to approximately 75 sales representatives and the closure of our German operations due to a viable agreement on the reimbursement price of VAZKEPA in Germany not being reached, respectively. The prior year charge was the result of a September 2021 restructuring that reduced the U.S. sales force from approximately 600 sales representatives to approximately 300 sales representatives at that time. Refer to Note 2 Significant Accounting Policies for additional information. Interest Income, net. Net interest income for the years ended December 31, 2022 and 2021 was $2.8 million and $1.1 million, respectively, an increase of $1.7 million, or 157%. The increase is primarily due to higher interest rates in the current year compared to the prior year. Other (expense) income, net. Other (expense) income, net, for the year ended December 31, 2022 and 2021 was expense of $0.7 million and $0.3 million, respectively. Other (expense) income, net, in the years ended December 31, 2022 and 2021 primarily consists of gains and losses on foreign exchange transactions. Provision for income taxes. Provision for income taxes for the year ended December 31, 2022 and 2021 was $2.0 million and $3.6 million, respectively. The decrease in the provision for income taxes is due to a change in geographic mix of pre-tax income. Liquidity and Capital Resources Our aggregate sources of liquidity as of December 31, 2022 are approximately $311.2 million, with no debt. Our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $218.2 million, short-term investments of $91.7 million and long-term investments of $1.3 million. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities less than 90 days. Our short-term investments consist of held-to-maturity securities that will be due in one year or less. Our long-term investments consist of held-to-maturity securities that will be due in more than one year. We invest cash in excess of our immediate requirements, in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation. 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 Cash (used in) provided by: Operating activities Investing activities Financing activities Increase (decrease) in cash and cash equivalents and restricted cash 2022 Year Ended December 31, 2021 2020 $ $ (180.1 ) 175.3 (0.4 ) (5.2 ) $ $ (66.5 ) $ 104.1 (5.1 ) 32.5 $ (21.7 ) (377.0 ) (58.9 ) (457.6 ) Net cash used in operating activities during 2022 compared to 2021 increased primarily as a result of a decrease in U.S. product revenue, costs associated with commercial and pre-launch operations in Europe as well as an increase in inventory purchases in the first half of 2022. Net cash provided by investing activities during the year ended December 31, 2022 is primarily due to the proceeds from the maturity of $257.5 million in investment-grade interest bearing instruments, partially offset by $81.6 million in purchases of investment-grade interest bearing instruments as compared to the same period in 2021 where proceeds from the maturity of investment-grade interest bearing instruments was $394.3 million, partially offset by $290.2 million in purchases of investment-grade interest bearing instruments. Net cash used in financing activities during the years ended December 31, 2022 and 2021 are primarily as a result of costs associated with our stock compensation plan. As of December 31, 2022, we had net accounts receivable of $131.0 million, current inventory of $228.7 million and long-term inventory of $163.6 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.5 billion as of December 31, 2022. We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API, the generic competition in the United States and commercialization of VAZKEPA in Europe. VAZKEPA is available in certain countries throughout Europe, including the UK, and we commenced pre-launch planning and other commercial preparation activities, and continue to grow our European staff by hiring Market access and Medical affairs teams, among others, across Europe as deemed appropriate on a country by country basis. 85 As of December 31, 2022, we had cash and cash equivalents of $217.7 million and short-term investments of $91.7 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date of the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations for at least twelve months from the issuance date of our audited consolidated financial statements included elsewhere within this Annual Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under Part II, Item IA, “Risk Factors”, and we could use our capital resources sooner than we expect or fail to achieve positive cash flow. We do not have any special purpose entities or other off-balance sheet arrangements. Item 7A. Quantitative and Qualitative Disclosures about Market Risk We are exposed to market risks, which include changes in interest rates. We do not use derivative financial instruments in our investment portfolio, and we do not enter into foreign exchange contracts. Our investments meet high credit quality and diversification standards, as specified in our investment policy. Foreign Currency Exchange Risk. Our results of operations and cash flows are subject to fluctuations due to changes in the Euro, Sterling, Swiss Franc and Yen. The majority of cash and cash equivalents, investments, and the majority of our vendor relationships are denominated in U.S. dollars. We therefore believe that the risk of a significant impact on our operating income from foreign currency fluctuations is not substantial. All of our investments are held in U.S. dollars. We maintain a small amount of our cash and cash equivalents in Euro and from time to time, maintain a small amount of our cash and cash equivalents in other currencies. We purchase a portion of our supply based on a U.S. dollar to Euro exchange rate and, as such, remain subject to currency fluctuation risk for such purchases. Based on the size of our international operations and the amount of our expenses denominated in foreign currencies, currency fluctuation would not have a material effect on our financial position or results of operations. We believe the impact of inflation on operations has been minimal during the past three years. 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 bearing liabilities and assets. Our portfolio of held-to-maturity investments as of December 31, 2022 was composed of U.S. Treasury securities, commercial paper, corporate, CD and asset-backed securities and other government-related securities. At December 31, 2022 and 2021, we had short-term investments and long-term investments of $93.0 million and $269.7 million, respectively. We invest funds to have a continuous inflow of cash from diversified short-term and long-term investments, consisting primarily of investment grade securities. A hypothetical 10 percent change in interest rates would not result in a material decrease or increase in the fair value of our securities due to the balance and diversified investment portfolio. Credit Risk. We monitor our investments with our investment managers with the objective of minimizing concentrations of credit risks. Our short- term investments consist of held-to-maturity securities that will be due in one year or less. Our long-term investments consist of held-to-maturity securities that will be due in more than one year. We invest cash in excess of our immediate requirements, in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation. Additionally, our investment policy is to invest only in institutions that meet high credit quality and diversification standards and established limits on the amount and time to maturity of investments. Item 8. Financial Statements and Supplementary Data Our consolidated financial statements are annexed to this Annual Report on Form 10-K beginning on page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. As of December 31, 2022, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide 86 only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of December 31, 2022, our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting for our company. Internal control over financial reporting is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process designed by, or under the supervision of, our principal executive officer and principal financial officer and effected by our board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally 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 with generally accepted accounting principles; provide reasonable assurance that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements. Because of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions or that the degree of compliance with 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 our internal control over financial reporting as of December 31, 2022. In conducting this evaluation, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013). Based upon this evaluation and those criteria, management has concluded that, as of December 31, 2022, our internal control over financial reporting was effective. Ernst & Young LLP (PCAOB ID 42), our independent registered public accounting firm, has audited our consolidated financial statements and the effectiveness of our internal control over financial reporting as of December 31, 2022. This report appears below. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting during the fourth quarter of 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 87 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and the Board of Directors of Amarin Corporation plc Opinion on Internal Control over Financial Reporting We have audited Amarin Corporation plc’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Amarin Corporation plc (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes and our report dated March 1, 2023 expressed an unqualified opinion thereon. Basis for Opinion The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. Definition and Limitations of Internal Control Over Financial Reporting A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal 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 as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP Iselin, New Jersey March 1, 2023 88 Item 9B. Other Information Entry into Rule 10b5-1 Trading Plans Our policy governing transactions in our securities by our directors, officers and employees permits our officers, directors and certain other persons to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. Consistent with such regulation, our policy permits such plans to be entered into only when that person confirms they are not in possession of material non-public information. Our policy also requires a waiting period after a trading plan is created before shares can be traded under the plan. Our open trading windows are established in consultation with legal counsel. We have been from time to time advised that a number of our directors and employees, including members of our senior management team, and investment funds associated with such persons, have entered into trading plans in accordance with Rule 10b5-1 and our policy governing transactions in our securities. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections Not applicable. 89 Item 10. Directors, Executive Officers and Corporate Governance PART III The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. Code of Ethics Our board of directors has adopted a code of business conduct and ethical responsibility that applies to our directors, officers and employees. There have been no material modifications to, or waivers from, the provisions of such code. This code is available on the corporate governance section of our website (which is a subsection of the investor relations section of our website) at the following address: www.amarincorp.com. You may also request a printed copy of the code, without charge, by writing to us at Amarin Pharma, Inc., 440 Route 22, Bridgewater, NJ 08807, Attention: Investor Relations. In addition, should any changes be made to our code of business conduct and ethical responsibility, we intend to disclose within four business days on our website (or in any other medium required by law or the NASDAQ): (a) the date and nature of any amendment to our code of business conduct and ethical responsibility that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (b) the nature of any waiver, including an implicit waiver, from a provision of our code of business conduct and ethical responsibility that is granted to one of these specified officers, the name of such person is granted the waiver, and the date of the waiver. Item 11. Executive Compensation The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 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 Matters The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders to be filed within 120 days after the fiscal year ended December 31, 2022 ("Definitive Proxy Statement"). Such information is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence The information required by this item will be contained in our Definitive Proxy Statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. Item 14. Principal Accountant Fees and Services The information required by this item will be contained in our Definitive Proxy Statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference. 90 Item 15. Exhibits and Financial Statement Schedules PART IV (a)(1) For a list of the financial statements included herein, see Index to Consolidated Financial Statements on page F-1 of this Annual Report on Form 10-K. (2) Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated financial statements or the notes thereto. (3) Exhibits The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report on Form 10-K are listed in the Exhibit Index below. The exhibits listed in the Exhibit Index are incorporated by reference herein. (b) Exhibit Index 91 Exhibit Number Description Incorporated by Reference Herein Form Date 3.1 4.1 4.2 4.3 4.4 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.9 Articles of Association of the Company Quarterly Report on Form 10-Q for the quarterly August 8, 2013 Form of Amended and Restated Deposit Agreement, dated as of November 4, 2011, among the Company, Citibank, N.A., as Depositary, and all holders from time to time of American Depositary Receipts issued thereunder period ended June 30, 2013, as Exhibit 3.1 Annual Report on Form 10-K for the year ended February 29, 2012 December 31, 2011, as Exhibit 4.1 Form of Ordinary Share certificate Annual Report on Form 20-F for the year ended April 24, 2003 December 31, 2002, as Exhibit 2.4 Form of American Depositary Receipt evidencing Annual Report on Form 10-K for the year ended February 29, 2012 ADSs December 31, 2011, as Exhibit 4.4 Description of Registrant’s Securities Annual Report on Form 10-K for the year ended February 25, 2020 December 31, 2019, as Exhibit 4.7 The Company 2002 Stock Option Plan* Annual Report on Form 20-F for the year ended March 5, 2007 December 31, 2006, as Exhibit 4.17 The Company 2011 Stock Option Plan* Quarterly Report on Form 10-Q for the quarterly August 9, 2011 period ended June 30, 2011, as Exhibit 10.4 Amendment No. 1 to 2011 Stock Option Incentive Quarterly Report on Form 10-Q for the quarterly August 8, 2012 Plan* period ended June 30, 2012, as Exhibit 10.1 Amendment No. 2 to 2011 Stock Option Incentive Quarterly Report on Form 10-Q for the quarterly August 8, 2012 Plan* period ended June 30, 2012, as Exhibit 10.2 Amendment No. 3 to 2011 Stock Option and Annual Report on Form 10-K for the year ended February 28, 2013 Incentive Plan* December 31, 2012, as Exhibit 10.5 Amendment No. 4 to 2011 Stock Option and Quarterly Report on Form 10-Q for the quarterly August 6, 2015 Incentive Plan* period ended June 30, 2015, as Exhibit 4.1 Amendment No. 5 to 2011 Stock Option and Quarterly Report on Form 10-Q for the quarterly August 6, 2015 Incentive Plan* period ended June 30, 2015, as Exhibit 4.2 Amendment No.6 to 2011 Stock Incentive Plan* Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 4.1 August 2, 2017 Amarin Corporation plc Management Incentive Annual Report on Form 10-K for the year ended March 16, 2011 Compensation Plan* December 31, 2010, as Exhibit 10.44 10.10 Form of Incentive Stock Option Award Agreement* Annual Report on Form 10-K for the year ended February 29, 2012 December 31, 2011, as Exhibit 10.3 10.11 Form of Non-Qualified Stock Option Award Annual Report on Form 10-K for the year ended February 29, 2012 Agreement* December 31, 2011, as Exhibit 10.4 10.12 Form of Restricted Stock Unit Award Agreement* Annual Report on Form 10-K for the year ended February 29, 2012 December 31, 2011, as Exhibit 10.5 10.13 2017 Employee Stock Purchase Plan* Annual Report on Form 10-K for the year ended February 27, 2018 December 31, 2017, as Exhibit 10.64 10.14 2020 Stock Incentive Plan* Current Report on Form 8-K dated July 13, 2020, as July 14, 2020 Exhibit 10.1 92 10.15 10.16 Amendment No. 1 to 2020 Stock Incentive Plan* Current Report on Form 8-K dated June 27, 2022, as Exhibit 10.2 June 30, 2022 Form of Incentive Stock Option Award Agreement* Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.2 November 5, 2020 10.17 Form of Non-Qualified Stock Option Award Agreements* Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.3 November 5, 2020 10.18 Form of Restricted Stock Unit Award Agreement* Quarterly Report on Form 10-Q for the quarterly August 3, 2022 period ended June 30, 2022, as Exhibit 10.3 10.19 Form of Non-Qualified Stock Option for Non- Employee Director Award Agreement* Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.5 November 5, 2020 10.20 Form of Deferred Restricted Stock Unit Award Quarterly Report on Form 10-Q for the quarterly August 3, 2022 Agreement* period ended June 30, 2022, as Exhibit 10.2 10.21 Amarin Corporation plc Executive Severance and Current Report on Form 8-K dated January 28, 2021, January 29, 2021 Change of Control Plan* as Exhibit 10.1 10.22 Contract of Employment between Karim Mikhail and Amarin Switzerland GmbH, Grafenauweg 8, 6300 Zug, dated April 12, 2021* Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.4 April 29, 2021 10.23 Employment Agreement between Jason Marks and Amarin Corporation plc, dated July 19, 2021* Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, as Exhibit 10.1 November 3, 2021 10.24 Letter Agreement with Steve Ketchum, dated Registration Statement on Form F-1, as Exhibit 10.1 February 28, 2012 February 8, 2012* 10.25 Amendment, dated July 6, 2015, to Letter Agreement Quarterly Report on Form 10-Q for the quarterly August 6, 2015 with Steven Ketchum, dated February 8, 2012* period ended June 30, 2015, as Exhibit 10.2 10.26 2012 Long Term Incentive Award with Steven Registration Statement on Form S-8, as Exhibit 4.2 March 16, 2012 Ketchum dated March 1, 2012* 10.27 Letter Agreement, dated May 9, 2016, by and Current Report on Form 8-K dated June 30, 2016, as June 30, 2016 between Amarin Corporation plc and Michael Kalb* Exhibit 10.1 10.28 10.29 10.30 10.31 Employment Agreement, dated April 20, 2018, by and between Amarin Corporation plc and Aaron Berg* Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as Exhibit 10.1 May 1, 2019 Offer Letter with Thomas Reilly, dated May 26, 2022* Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.4 August 3, 2022 Transition and Separation Agreement between Michael W. Kalb and Amarin Corporation plc, dated June 6, 2022* Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3 August 3, 2022 Transition Agreement between Jason M. Marks and Amarin Corporation plc, dated December 6, 2022* Filed herewith 93 10.32 10.33 API Commercial Supply Agreement, dated May 25, 2011, between Amarin Pharmaceuticals Ireland Ltd. and Chemport Inc. ** Amendment to API Commercial Supply Agreement by and between Amarin Pharmaceuticals Ireland Ltd and Chemport Inc., dated April 4, 2012 ** Annual Report on Form 10-K for the year ended March 1, 2022 December 31, 2021, as Exhibit 10.35 Annual Report on Form 10-K for the year ended March 1, 2022 December 31, 2021, as Exhibit 10.36 10.34 Second Amendment to API Commercial Supply Annual Report on Form 10-K for the year ended March 1, 2022 10.35 Agreement by and between Amarin Pharmaceuticals Ireland Ltd. and Chemport Inc., dated July 19, 2012 ** Purchase and Sale Agreement, dated December 6, 2012, by and between Amarin Corporation plc, Amarin Pharmaceuticals Ireland Limited and BioPharma Secured Debt Fund II Holdings Cayman LP ** December 31, 2021, as Exhibit 10.37 Annual Report on Form 10-K for the year ended March 1, 2022 December 31, 2021, as Exhibit 10.38 10.36 Consent and Waiver, dated December 20, 2017, by Annual Report on Form 10-K for the year ended February 27, 2018 10.37 10.38 and among Amarin Pharmaceuticals Ireland Limited, Amarin Corporation PLC, BioPharma Secured Debt Fund II Holdings Cayman LP and Pharmakon Advisors LP Co-Promotion Agreement dated March 31, 2014, by and among the Company and Kowa Pharmaceuticals America, Inc. †† First Amendment to the Co-Promotion Agreement of March 31, 2014 dated July 25, 2017, by and among Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc., and Kowa Pharmaceuticals America, Inc. †† 10.39 Development, Commercialization and Supply Agreement dated February 26, 2015, by and between Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc. and Eddingpharm (Asia) Macao Commercial Offshore Limited†† December 31, 2017, as Exhibit 10.66 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014, as Exhibit 10.1 May 9, 2014 Quarterly Report on Form 10-Q for the quarterly August 2, 2017 period ended June 30, 2017, as Exhibit 10.1 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015, as Exhibit 10.1 May 8, 2015 10.40 Distribution Agreement, dated March 8, 2016, by and Annual Report on Form 10-K for the year ended February 27, 2018 among Biologix FZCo, Amarin Pharmaceuticals Ireland Limited and Amarin Pharma, Inc. †† December 31, 2017, as Exhibit 10.67 10.41 Development, Commercialization and Supply Annual Report on Form 10-K for the year ended February 27, 2018 Agreement, dated September 25, 2017, by and among Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc. and HLS Therapeutics Inc. †† December 31, 2017, as Exhibit 10.68 10.42 Lease Agreement, dated February 5, 2019, by and Annual Report on Form 10-K for the year ended February 27, 2019 between 440 Route 22 LLC and Amarin Pharma, Inc. December 31, 2018, as Exhibit 10.69 10.43 English Summary of German Language Commercial Lease Agreement dated October 10, 2021, by and between Amarin Switzerland GmbH and Zug Estates AG Annual Report on Form 10-K for the year ended March 1, 2022 December 31, 2021, as Exhibit 10.54 94 10.44 Consent of Landlord to Sublease dated as of January 20, 2023, among Amarin Pharma, Inc. ST Shared Services LLC and Liberty Denver Wood LLC Filed herewith 10.45 Guaranty dated January 20, 2023, issued by MEH, Filed herewith Inc. 10.46 Sublease Agreement dated January 20, 2023, by and Filed herewith between Amarin Pharma, Inc. and ST Shared Services LLC 10.47 License Agreement dated September 13, 2022, Filed herewith 21.1 23.1 24.1 31.1 between Amarin Pharmaceuticals Ireland Ltd and Weston Office Solutions Ltd List of Subsidiaries Filed herewith Consent of Independent Registered Public Filed herewith Accounting Firm Power of Attorney Included on the signature page(s) hereto Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 Filed herewith 31.2 Certification of Senior Vice President and Chief Filed herewith Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 32.1 Certification of President and Chief Executive Officer Furnished herewith (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002 101.INS Inline XBRL Instance Document 101.SCH Inline XBRL Taxonomy Extension Schema Filed herewith Filed herewith Document 101. CAL Inline XBRL Taxonomy Extension Calculation Filed herewith Linkbase Document 101. DEF Inline XBRL Taxonomy Extension Definition Filed herewith Linkbase Document 101. LAB Inline XBRL Taxonomy Extension Label Linkbase Filed herewith Document 101. PRE Inline XBRL Taxonomy Extension Presentation Filed herewith Linkbase Document 104 Cover Page Interactive Data File (formatted as inline Filed herewith XBRL with applicable taxonomy extension information contained in Exhibit 101.) †† Confidential treatment has been granted with respect to portions of this exhibit pursuant to an application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. A complete copy of this exhibit, including the redacted terms, has been separately filed with the Securities and Exchange Commission. ** Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. * Management contract or compensatory plan or arrangement. Item 16. Form 10-K Summary Not applicable. 95 Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. SIGNATURES AMARIN CORPORATION PLC By: /s/ Karim Mikhail Karim Mikhail President and Chief Executive Officer (Principal Executive Officer) Date: March 1, 2023 We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Karim Mikhail and Tom Reilly, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated. Signature Title Date /s/ Karim Mikhail Karim Mikhail /s/ Tom Reilly Tom Reilly /s/ Adam Berger Adam Berger /s/ Erin Enright Erin Enright /s/ Jan van Heek Jan van Heek /s/ Geraldine Murphy Geraldine Murphy /s/ Kristine Peterson Kristine Peterson /s/ Murray Stewart D.M., F.R.C.P. Murray Stewart D.M., F.R.C.P. /s/ Alfonso Zulueta Alfonso Zulueta 96 Director, President and Chief Executive Officer (Principal Executive Officer) Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) Director Director Director Director Director Director March 1, 2023 March 1, 2023 March 1, 2023 March 1, 2023 March 1, 2023 March 1, 2023 March 1, 2023 March 1, 2023 Director March 1, 2023 AMARIN CORPORATION PLC INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm Financial Statements: Consolidated Balance Sheets as of December 31, 2022 and 2021 Consolidated Statements of Operations for the years ended December 31, 2022, 2021 and 2020 Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2022, 2021 and 2020 Consolidated Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020 Notes to Consolidated Financial Statements Financial Statement Schedules: Page F-2 F-4 F-5 F-6 F-7 F-8 Financial statement schedules have been omitted for the reason that the required information is presented in the consolidated financial statements or notes thereto, the amounts involved are not significant or the schedules are not applicable. F-1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and the Board of Directors of Amarin Corporation plc Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Amarin Corporation plc (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, 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) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 1, 2023 expressed an unqualified opinion thereon. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates. Product Return Reserve Estimate Description of the Matter At December 31, 2022, the Company recorded a liability for product returns totaling $8.7 million. As discussed in Note 13 of the financial statements, the Company sells its product to distributors that in turn resell the product to retail pharmacies for subsequent sale to patients and healthcare providers. The Company estimates variable consideration resulting from product returns based on quantitative and qualitative data from various internal and external sources. Auditing management’s estimate of product returns was complex and judgmental due to the significant estimation required to determine inventory in the distribution channel that will not ultimately be sold to patients and healthcare providers and will be returned. Sales into the distribution channel could exceed market demand. F-2 How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s estimation process for product returns including inventory in the distribution channel. These procedures included controls over management’s review of the inputs used and assumptions applied in the returns reserve calculation and channel inventory analysis. To test the estimated product return reserve, we performed audit procedures that included, among others, testing management’s historical return rate calculation and testing the completeness and accuracy of sales and returns data used in the calculation. We also compared product expiration dates in the calculation to the related quality control documentation. We assessed the historical accuracy of management’s estimate and performed analytical procedures to assess the correlation of monthly sales to distributors and monthly patient prescriptions. In addition, we assessed the Company’s quarterly analysis of inventory held at various stages in the distribution channel. We confirmed prescription data directly with a third party, confirmed contract terms directly with significant customers, and tested credit memos issued subsequent to year-end for recording in the proper period. We read significant customer contracts and performed direct inquiries with management including the sales, legal, and contracting departments to identify any terms or conditions not included in customer contracts that could impact the estimate of product returns. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2014. Iselin, New Jersey March 1, 2023 F-3 AMARIN CORPORATION PLC CONSOLIDATED BALANCE SHEETS (in thousands, except share amounts) $ $ $ December 31, 2022 2021 217,666 $ 523 91,695 130,990 228,732 19,492 689,098 874 1,275 163,620 9,074 458 21,780 886,179 $ 64,602 $ 192,678 2,199 259,479 13,147 10,015 8,205 290,846 219,454 3,918 234,674 163,653 234,676 22,352 878,727 1,425 34,996 121,254 7,660 456 23,547 1,068,065 114,922 253,111 2,649 370,682 14,060 8,576 7,648 400,966 ASSETS Current Assets: Cash and cash equivalents Restricted cash Short-term investments Accounts receivable, net Inventory Prepaid and other current assets Total current assets Property, plant and equipment, net Long-term investments Long-term inventory Operating lease right-of-use asset Other long-term assets Intangible asset, net TOTAL ASSETS LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable Accrued expenses and other current liabilities Current deferred revenue Total current liabilities Long-Term Liabilities: Long-term deferred revenue Long-term operating lease liability Other long-term liabilities Total liabilities Commitments and contingencies (Note 7) Stockholders’ Equity: Common stock, £0.50 par, unlimited authorized; 412,333,087 shares issued, 404,346,256 shares outstanding at December 31, 2022; 404,084,775 shares issued, 396,598,008 shares outstanding at December 31, 2021 Additional paid-in capital Treasury stock; 7,986,831 shares at December 31, 2022; 7,486,767 shares at December 31, 2021 Accumulated deficit Total stockholders’ equity TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 299,002 1,885,352 (61,770 ) (1,527,251 ) 595,333 886,179 $ 294,027 1,855,246 (60,726 ) (1,421,448 ) 667,099 1,068,065 See the notes to the consolidated financial statements. F-4 AMARIN CORPORATION PLC CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Product revenue, net Licensing and royalty revenue Total revenue, net Less: Cost of goods sold Less: Cost of goods sold - restructuring inventory Gross margin Operating expenses: Selling, general and administrative Research and development Restructuring Total operating expenses Operating (loss) income Interest income Interest expense Other (expense) income, net (Loss) income from operations before taxes Provision for income taxes Net (loss) income (Loss) earnings per share: Basic Diluted Weighted average shares outstanding: Basic Diluted 2022 Year Ended December 31, 2021 2020 $ $ $ $ 366,511 $ 2,682 369,193 108,631 18,078 242,484 304,416 30,411 13,526 348,353 (105,869 ) 2,819 (15 ) (740 ) (103,805 ) (1,998 ) (105,803 ) $ 580,320 $ 2,867 583,187 121,327 — 461,860 408,334 29,307 13,717 451,358 10,502 1,220 (129 ) (302 ) 11,291 (3,562 ) 7,729 $ (0.26 ) (0.26 ) $ $ 0.02 $ 0.02 $ 401,155 401,155 395,992 402,480 607,025 7,035 614,060 131,444 — 482,616 463,312 38,959 — 502,271 (19,655 ) 4,901 (2,605 ) 104 (17,255 ) (745 ) (18,000 ) (0.05 ) (0.05 ) 381,759 381,759 See the notes to the consolidated financial statements. F-5 AMARIN CORPORATION PLC CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (in thousands, except share amounts) December 31, 2019 Conversion of Series A Convertible Preferred Stock, net Issuance of common stock under employee stock purchase plan Exercise of stock options Vesting of restricted stock units Stock-based compensation Loss for the period December 31, 2020 Issuance of common stock under employee stock purchase plan Exercise of stock options Vesting of restricted stock units Stock-based compensation Income for the period December 31, 2021 Issuance of common stock under employee stock purchase plan Issuance of common stock for milestone payment Exercise of stock options Vesting of restricted stock units Stock-based compensation Loss for the period December 31, 2022 Preferred Shares 289,317,460 Common Shares 365,014,893 (289,317,460 ) 28,931,746 — — — — — — — — — — — — — — — — — — — 347,153 1,623,460 2,507,748 — — 398,425,000 399,286 1,203,845 4,056,644 — — 404,084,775 456,696 5,817,942 33,303 1,940,371 — — 412,333,087 Treasury Shares (4,910,992 ) $ Preferred Stock 21,850 $ Common Stock 269,173 Additional Paid-in Capital $ 1,764,317 Treasury Stock (35,900 ) $ Accumulated Deficit (1,411,177 ) $ $ Total 608,263 — — — (975,927 ) — — (5,886,919 ) $ — — (1,599,848 ) — — (7,486,767 ) $ — — — (500,064 ) — — (7,986,831 ) $ (21,850 ) 18,020 3,326 — — — — — — — — — — — — — — — — — — - $ $ $ 225 1,062 1,635 — — 290,115 275 827 2,810 — — 294,027 283 3,461 21 1,210 — — 299,002 $ $ $ 1,732 4,096 (1,635 ) 45,813 — 1,817,649 $ 1,375 2,094 (2,810 ) 36,938 — 1,855,246 $ 322 4,742 39 (1,210 ) 26,213 — 1,885,352 $ — — — (15,182 ) — — (51,082 ) $ — — (9,644 ) — — (60,726 ) $ — — — (1,044 ) — — (61,770 ) $ — (504 ) — — — — (18,000 ) (1,429,177 ) $ — — — — 7,729 (1,421,448 ) $ — — — — — (105,803 ) (1,527,251 ) $ 1,957 5,158 (15,182 ) 45,813 (18,000 ) 627,505 1,650 2,921 (9,644 ) 36,938 7,729 667,099 605 8,203 60 (1,044 ) 26,213 (105,803 ) 595,333 See the notes to the consolidated financial statements. F-6 AMARIN CORPORATION PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) 2022 Year Ended December 31, 2021 2020 $ (105,803 ) $ 7,729 $ (18,000 ) CASH FLOWS FROM OPERATING ACTIVITIES: Net (loss) income Adjustments to reconcile net (loss) income to net cash used in operating activities: Depreciation and amortization Amortization of investments Stock-based compensation Amortization of debt discount and debt issuance costs Amortization of intangible asset Changes in assets and liabilities: Accounts receivable, net Inventory Prepaid and other current assets Other long-term assets Interest receivable Accrued interest payable Deferred revenue Accounts payable, accrued expenses and other current liabilities Other long-term liabilities Net cash used in operating activities CASH FLOWS FROM INVESTING ACTIVITIES: Sale and maturities of securities Purchases of securities Investment in website development costs Disposal (purchases) of furniture, fixtures and equipment Net cash provided by (used in) investing activities CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock under employee stock purchase plan Proceeds from exercise of stock options, net of transaction costs Payment of transaction costs for conversion of preferred stock Payment on debt from royalty-bearing instrument Taxes related to stock-based awards Net cash used in financing activities NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD Supplemental disclosure of cash flow information: Cash (paid) received during the year for: Interest Income taxes Supplemental disclosure of non-cash transactions: Laxdale milestone Shares issued in settlement of Laxdale milestone payment Initial recognition of operating lease right-of-use asset Conversion of Series A Convertible Preferred Stock into common stock $ $ $ $ $ $ $ 551 473 26,213 — 2,545 32,663 (36,422 ) 2,860 (2 ) 341 — (1,363 ) (102,729 ) 581 (180,092 ) 257,520 (81,633 ) (599 ) — 175,288 605 60 — — (1,044 ) (379 ) (5,183 ) 223,372 218,189 $ — $ (1,782 ) $ — 8,203 2,041 — $ $ $ $ 587 1,929 36,938 — 2,270 (9,079 ) (167,066 ) 8,595 (24 ) 738 — (1,923 ) 51,516 1,253 (66,537 ) 394,294 (290,195 ) — 4 104,103 1,650 2,921 — — (9,644 ) (5,073 ) 32,493 190,879 223,372 $ — 3,656 12,000 — — — $ $ $ $ $ $ 597 1,602 45,813 635 1,441 (38,144 ) (112,095 ) (17,636 ) 642 (1,329 ) (428 ) (2,214 ) 114,741 2,629 (21,746 ) 301,989 (678,700 ) — (252 ) (376,963 ) 1,957 5,158 (504 ) (50,336 ) (15,182 ) (58,907 ) (457,616 ) 648,495 190,879 (2,043 ) (207 ) — — — 18,020 See the notes to the consolidated financial statements. F-7 AMARIN CORPORATION PLC NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (1) Nature of Business and Basis of Presentation Nature of Business Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. Most of the Company’s historical revenue and sales, marketing and administrative activities and costs have been associated with commercial operations in the United States, or U.S. The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and continues pre-launch commercial activities throughout the rest of Europe. The Company’s operations outside of the U.S. and Europe are in early stages of development with reliance on third-party commercial partners in select geographies. The Company’s commercialized product, VASCEPA® (icosapent ethyl), was approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, or the MARINE indication. VASCEPA was also approved for another indication in December 2019 for use as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy's Laboratories, Inc., or Dr. Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or collectively, the Defendants, several of the Company's patents covering the MARINE indication were declared as invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market with a 1-gram capsule: Company Hikma Pharmaceuticals USA Inc. Dr. Reddy’s Laboratories, Inc. Teva Pharmaceuticals USA, Inc. Apotex, Inc. FDA MARINE Indication Approval May 2020 August 2020 September 2020 June 2021 Launch Date November 2020 June 2021 September 2022 January 2022 (1) (1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023. On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk, statin- treated adult patients who have elevated triglycerides (>150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk through MHRA’s new ‘reliance’ route. On December 7, 2022, the Company announced that Swissmedic approved VAZKEPA in Switzerland. Collectively CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities. In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China. On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong had commenced. The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA based on the results from the Phase 3 clinical trial and the results from the Company’s prior studies of VASCEPA. On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication. The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States. Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States, and certain countries throughout Europe, as well as, in Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product. The Company operates in one business segment. Basis of Presentation The consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. F-8 The consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated. The preparation of the Company’s consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The results of operations for the years ended December 31, 2022, 2021 and 2020 are not necessarily indicative of the results for any future period. Certain numbers presented throughout this document may not add precisely to the totals provided due to rounding. Absolute and percentage changes are calculated using the underlying amounts in thousands. 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. The accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business, as well as the ongoing global pandemic, COVID-19. At December 31, 2022, the Company had Total assets of $886.2 million, of which $310.6 million consisted of cash and liquid short-term and long-term investments. More specifically, the Company had Current assets of $689.1 million, including Cash and cash equivalents of $217.7 million, Short-term investments of $91.7 million, Accounts receivable, net, of $131.0 million and Inventory of $228.7 million. In addition, at December 31, 2022, the Company had Long-term investments of $1.3 million and Long-term inventory of $163.6 million. At December 31, 2022, the Company had no debt outstanding. (2) Significant Accounting Policies Principles of Consolidation 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. Use of Estimates Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances. Estimates and assumptions relied upon in preparing these consolidated financial statements relate to, but are not limited to, such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances; depreciable/amortizable lives; asset impairments; valuation allowance on deferred taxes; probabilities of achievement of performance conditions for certain equity awards; amounts recorded for licensing revenue; contingencies and accruals. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness. Use of Forecasted Financial Information in Accounting Estimates The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of intangible assets, evaluating the need for valuation allowances for deferred tax assets, and assessing the Company’s ability to continue as a going concern. Such forecasted 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 of forecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts the carrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates. Revenue Recognition In accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services committed within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the F-9 performance obligation is satisfied. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 13—Revenue Recognition. Distribution Costs The Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distribution services, in Cost of goods sold. Cash and Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees. Accounts Receivable, net Accounts receivable, net, comprised of trade receivables, are generally due within 45 days and are stated at amounts due from customers. The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable losses net of any recoveries. The allowance is based primarily on assessment of specific identifiable customer accounts considered at risk or uncollectible, as well as an analysis of current receivables aging and expected future write-offs. The expense associated with the allowance for doubtful accounts is recognized as Selling, general, and administrative expense. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected; however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’ ability to meet their financial obligations. The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances at December 31, 2022 and 2021: In thousands Gross trade accounts receivable Trade allowances Chargebacks Allowance for doubtful accounts Accounts receivable, net Inventory December 31, 2022 December 31, 2021 $ $ 187,418 $ (44,626 ) (11,802 ) — 130,990 $ 262,948 (86,636 ) (11,714 ) (945 ) 163,653 The Company states inventories at the lower of cost or net realizable value. Cost is determined based on actual cost using the average cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company classifies inventory as long-term inventory when consumption of the finished goods and work in process inventory is expected beyond the normal operating cycle. The Company classifies finished goods expected to be consumed within a normal operating cycle and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected net realizable value due to obsolescence, damage or quantities in excess of expected demand, changes in price levels or other causes, the Company will reduce the carrying value of such inventory to net realizable value and recognize the difference as a component of cost of goods sold in the period in which it occurs. The Company capitalizes inventory purchases of saleable product from approved suppliers while inventory purchases from suppliers prior to regulatory approval are included as a component of research and development expense. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of VASCEPA API. Long-Lived Asset Impairment The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets. F-10 Intangible Asset, net Intangible asset, net consists of website development costs and milestone payments to the former shareholders of Laxdale Limited, or Laxdale, related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021. These assets are amortized over its estimated useful life on a straight-line basis. See Note 7—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale. Costs for Patent Litigation and Legal Proceedings Costs for patent litigation or other legal proceedings are expensed as incurred and included in Selling, general and administrative expense. Research and Development Costs The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including: salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense. In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier, as well as license fees related to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida. Selling, General and Administrative Costs The Company charges selling, general and administrative costs to operations as incurred. Selling, general and administrative costs include salaries and benefits, stock-based compensation expense, and costs of programs and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of VASCEPA in the United States. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other tax 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. Deferred tax assets and liabilities are classified as non- current in the consolidated balance sheet. The Company provides reserves for potential payments of tax to various tax authorities and does not recognize tax benefits related to uncertain tax positions and 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 or positions 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 is to record interest and penalties in the provision for income taxes, as applicable. The Company regularly assesses its ability to realize deferred tax assets. Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed. Excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments are recognized as an income tax benefit and expense, respectively, in the consolidated statement of operations. Excess income tax benefits are classified as cash flows from operating activities and cash paid to taxing authorities arising from the withholding of shares from employees are classified as cash flows from financing activities. The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and states. The Company is currently under audit by the IRS for the Company’s 2018 U.S. income tax return and by the New Jersey Department of Treasury for the years 2012 to 2015. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its consolidated financial position or results of operations. F-11 (Loss) Earnings per Share Basic net (loss) earnings per share is determined by dividing net (loss) income by the weighted average shares of common stock outstanding during the period. Diluted net (loss) earnings per share is determined by dividing net (loss) income by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as from the exercise of stock options and vesting of restricted stock units calculated using the treasury stock method. In periods with reported net operating losses, all stock options and restricted stock units outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal. The calculation of net (loss) income and the number of shares used to compute basic and diluted net (loss) earnings per share for the years ended December 31, 2022, 2021, and 2020 are as follows: In thousands Net (loss) income —basic and diluted Weighted average shares outstanding—basic Effect of dilutive securities: Stock options Restricted stock and restricted stock units Weighted average shares outstanding—diluted Net (loss) earnings per share—basic Net (loss) earnings per share—diluted 2022 2021 2020 $ (105,803 ) 401,155 $ 7,729 $ 395,992 — — 401,155 (0.26 ) (0.26 ) $ $ 4,420 2,068 402,480 0.02 $ 0.02 $ $ $ (18,000 ) 381,759 — — 381,759 (0.05 ) (0.05 ) For the years ended December 31, 2022, 2021 and 2020, the following potentially dilutive securities were not included in the computation of net (loss) earnings per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures: In thousands Stock options Restricted stock and restricted stock units Laxdale milestone shares 2022 2021 2020 19,182 14,461 — 9,926 3,764 1,984 16,664 7,710 — Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying shares on the last day of the reporting period. Restricted stock and restricted stock units are anti-dilutive during periods of net earnings when underlying performance-based vesting requirements were not achieved as of the last day of the reporting period. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation, or ASC 718, and requires the fair value of all stock-based payments to employees and non-employees to be recognized in the consolidated statement of operations over the requisite service period. The fair value of the Company's restricted stock units is determined to be the market price on the date of the grant. The Company estimates the fair value of stock option awards on the date of the grant using the Black-Scholes Model, which requires that the Company makes certain assumptions regarding: (i) the expected volatility in the market price of its common stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise, referred to as the expected holding period. As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants. For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the grant date fair value of the award over the requisite service period. The Company reassesses the probability of achievement of the performance conditions each reporting period. The Company estimates the level of forfeitures expected to occur based on its historical data and records compensation cost only for those awards that are ultimately expected to vest. See Note 9—Stock Incentive Plans and Stock-Based Compensation for further discussion. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term and long-term investments, and accounts receivable. The Company maintains substantially all of its cash and cash equivalents and short-term and long-term investments, in financial institutions believed to be of high-credit quality. A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry. The Company monitors the creditworthiness of customers to whom 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. Three customers individually accounted for 10% or more of the Company’s F-12 gross product sales. Customers A, B, and C accounted for 35%, 31%, and 27%, respectively, of gross product sales for the year ended December 31, 2022 and represented 35%, 21%, and 39%, respectively, of the gross accounts receivable balance as of December 31, 2022. Customers A, B, and C accounted for 37%, 28% and 27%, respectively, of gross product sales for the year ended December 31, 2021 and represented 39%, 22%, and 35%, respectively, of the gross accounts receivable balance as of December 31, 2021. The Company has not experienced any significant write-offs of its accounts receivable. All customer accounts are actively managed and no losses are currently expected; however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’ ability to meet their financial obligations. Concentration of Suppliers The Company has contractual freedom to source the API for VASCEPA and to procure other services supporting its supply chain and has entered into supply agreements with multiple suppliers. The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers. The Company cannot provide assurance that its efforts to procure uninterrupted supply of VASCEPA to meet market demand will continue to be successful or that it will be able to renew current supply agreements on favorable terms or at all. Significant alteration to or disruption or termination of the Company’s current supply chain, including as a result of COVID-19, or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations. The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing. Each of these API manufacturers, encapsulators and packagers is U.S. FDA-approved and certain of these API manufacturers, encapsulators and packagers are also approved by the European Regulatory Authorities for manufacturing VAZKEPA in Europe. These suppliers are also used by the Company to source supply to meet the clinical trial and commercial demands of its partners in other countries. Each of these suppliers has qualified and validated its manufacturing processes. There can be no guarantee that these or other suppliers with which the Company may contract in the future to manufacture VASCEPA or VASCEPA API will remain qualified to do so to its specifications or that these and any future suppliers will have the manufacturing capacity to meet potential global demand for VASCEPA. Foreign Currency Monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at period-end exchange rates. Gains and losses from the remeasurement are included in Other (expense) income, net in the consolidated statements of operations. For transactions settled during the applicable period, gains and losses are included in Other (expense) income, net in the consolidated statements of operations. Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S. dollar. The Company recorded a foreign currency loss within the Other (expense) income, net on the consolidated statement of operations of $0.7 million, $0.6 million and less than $0.1 million for each of the years ended December 31, 2022, 2021, and 2020, respectively. Fair Value of Financial Instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs 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 the measurement 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 markets that 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 derived principally 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 or liability. The Company develops these inputs based on the best information available, including its own data. The following tables present information about the estimated fair value of the Company’s assets and liabilities as of December 31, 2022 and 2021 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: F-13 In thousands Asset: Money Market Fund U.S. Treasury Shares Agency Securities Corporate Bonds Commercial Paper Repo Securities Asset Backed Securities Certificate of Deposit Non-US Government Total In thousands Asset: Money Market Fund U.S. Treasury Shares Corporate Bonds Commercial Paper Repo Securities Asset Backed Securities Certificate of Deposit Non-US Government Total Total Level 1 Level 2 Level 3 December 31, 2022 $ $ $ $ 81,870 3,117 1,554 28,416 62,347 3,250 1,260 9,100 1,393 192,307 95,063 23,219 83,587 121,773 8,000 8,816 21,553 12,900 374,911 $ $ $ $ Total 81,870 3,117 1,554 — — — — — — 86,541 $ $ December 31, 2021 Level 1 Level 2 95,063 23,219 — — — — — — 118,282 $ $ — — — 28,416 62,347 3,250 1,260 9,100 1,393 105,766 — — 83,587 121,773 8,000 8,816 21,553 12,900 256,629 $ $ $ $ — — — — — — — — — — — — — — — — — — — Level 3 The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature. The cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of the purchase of 90 days or less. The Company’s held-to-maturity investments are stated at amortized cost, which approximates fair value. The Company does not intend to sell these investment securities and the contractual maturities are not greater than 24 months. Those with original maturities greater than 90 days and less than 12 months are included in short-term investments on its consolidated balance sheet. Those with remaining maturities in excess of 12 months are included in long-term investments on its consolidated balance sheet. Unrealized gains or losses on held-to-maturity securities are not recognized until maturity, except other-than-temporary unrealized losses which are recognized in earnings in the period incurred. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. The unrealized gain or loss for the year ended December 31, 2022 and December 31, 2021 were losses of $0.4 million and $0.2 million, respectively. Interest on investments is reported in interest income. The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature. Segment and Geographical Information Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company currently operates in one business segment, which is the development and commercialization of VASCEPA. A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. Restructuring On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA. As part of this strategy, the Company completed a reduction of its U.S. field force to approximately 300 sales representatives, enhanced managed care access and optimized VASCEPA prescriptions for cardiovascular risk reduction. During the year ended December 31, 2021, the Company recognized approximately $13.7 million in charges related to the reduction in force, substantially all of which were cash expenditures for one-time termination benefits and associated costs. F-14 On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which included an organizational restructuring plan to address shifts within the Company’s U.S. business. As part of the plan, the Company completed a reduction of its U.S. field force from approximately 300 sales representatives to approximately 75 sales representatives. During the year ended December 31, 2022 the Company recognized approximately $9.4 million within Restructuring expense on the consolidated statement of operations related to the Comprehensive Cost Reduction Plan, substantially all of which are cash expenditures. The Company also reviewed its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand resulting in charges of $18.1 million recognized within Cost of goods sold - restructuring inventory for the year ended December 31, 2022 on the consolidated statement of operations. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company. On August 19, 2022, the Company announced that after the conclusion of the fourth and final round of negotiations with the National Association of Statutory Health Insurance Funds, or GKV-SV, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached. As a result of the negotiation outcome with the GKV-SV, the Company discontinued its German business operations effective September 1, 2022. The Company recognized approximately $4.2 million within Restructuring expense on the consolidated statement of operations, substantially all of which are cash expenditures. The following table sets forth the components of the Company's restructuring charges for the years ended December 31, 2022 and 2021 (none in 2020): In thousands Employee restructuring separation charges Vendor contract charges Total restructuring expense Restructuring inventory Stock forfeitures Total restructuring costs incurred For the Year Ended December 31, 2022 2021 $ $ 9,310 4,216 13,526 18,078 591 32,195 $ $ The following table shows the change in restructuring liability which is included within accrued expenses and other current liabilities: In thousands Balance at December 31, 2021 Costs incurred Payments Balance at December 31, 2022 Recent Accounting Pronouncements Restructuring Liability $ $ 13,717 — 13,717 — — 13,717 1,186 32,195 (33,189 ) 192 From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are early adopted by the Company or adopted as of the specified effective date. The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. (3) Intangible Asset Intangible asset consists of website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for the first indication in 2012, the expanded label in 2019 and marketing approval in Europe in 2021. For the year ended December 31, 2022, the Company capitalized $0.8 million of costs associated with the development of a global company website. In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization. As of December 31, 2022, the intangible assets have an estimated weighted-average remaining useful life of 8.1 years. The carrying value as of December 31, 2022 and 2021 is as follows: In thousands Technology rights Accumulated amortization Intangible asset, net December 31, 2022 December 31, 2021 $ $ 32,859 $ (11,079 ) 21,780 $ 32,081 (8,534 ) 23,547 F-15 Amortization expense for the years ended December 31, 2022 and 2021 was $2.5 million and $2.3 million, respectively. Estimated future amortization expense, based upon the Company’s intangible asset, as of December 31, 2022 is as follows: In thousands Year Ending December 31, 2023 2024 2025 2026 2027 Thereafter Total (4) Inventory $ $ Amount 2,805 2,805 2,805 2,546 2,546 8,273 21,780 The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA and other global regulatory agencies. Inventories as of December 31, 2022 and 2021 consist of the following: In thousands Raw materials Work in process Finished goods Inventory December 31, 2022 December 31, 2021 $ $ 126,391 $ 52,297 213,664 392,352 $ 107,695 41,965 206,270 355,930 The Company classifies inventory as long-term when consumption of the finished goods and work in process inventory are expected beyond the normal operating cycle. As of December 31, 2022 and 2021, we had $163.6 million and $121.3 million of Long-term inventory, respectively. (5) Property, Plant and Equipment Property, plant and equipment as of December 31, 2022 and 2021 consist of the following: In thousands Furniture and fixtures Leasehold improvements Software Computer equipment Property, plant and equipment Accumulated depreciation and amortization Property, plant and equipment, net Useful Life (in years) 5 lesser of useful life or lease term 3 - 5 3 - 5 December 31, 2022 December 31, 2021 1,633 $ 869 617 227 3,346 (2,472 ) 874 $ 1,633 869 617 227 3,346 (1,921 ) 1,425 $ $ The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life. Depreciation expense for the years ended December 31, 2022, 2021, and 2020 were $0.6 million, annually. Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is credited or expensed to operations. Repairs and maintenance costs are expensed as incurred. F-16 (6) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following as of December 31, 2022 and 2021: In thousands Payroll and payroll-related expenses Sales and marketing accruals Accrued revenue allowances All other Accrued expenses and other current liabilities (7) Commitments and Contingencies Litigation – U.S. ANDAs December 31, 2022 December 31, 2021 20,302 $ 1,672 135,061 35,643 192,678 $ 19,730 3,563 184,216 45,602 253,111 $ $ On March 30, 2020, the Nevada Court, ruled in favor of two generics companies, Hikma and Dr. Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S. FDA approval for sale of generic versions of VASCEPA for the original indication of VASCEPA as an adjunct to diet to reduce TG levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. On September 3, 2020, the U.S. Court of Appeals for the Federal Circuit, or the Federal Circuit, upheld the March ruling by the Nevada Court in favor of the two generics companies. On October 2, 2020, the Company filed a combined petition for panel rehearing or rehearing en banc. On November 4, 2020, the Company’s rehearing and en banc petitions were denied. On February 11, 2021, Amarin filed a petition for a writ of certiorari with the United States Supreme Court to ask the Court to hear the Company’s appeal in this litigation, which was denied on June 18, 2021. On May 22, 2020 and August 10, 2020, Hikma and Dr. Reddy’s, respectively, received U.S. FDA approval to market its generic versions of VASCEPA. During the ANDA litigation, the Company reached agreements with Teva and Apotex, under which they received royalty-free license agreements to promote a generic version of icosapent ethyl in the U.S. under certain circumstances, one of which circumstances was achieved when the Federal Circuit upheld the ruling by the Nevada Court and Hikma launched its generic version of icosapent ethyl. On September 11, 2020, and June 30, 2021, Teva and Apotex, respectively, received U.S. FDA approval to market their respective generic versions of icosapent ethyl. In November 2020, Hikma announced the price and launched its generic version of icosapent ethyl. In June 2021, Dr. Reddy’s announced the price and launched its generic version of icosapent ethyl. In January 2022, Apotex announced the price and launched its generic version of icosapent ethyl. In September 2022, Teva announced the price and launched its generic version of icosapent ethyl for the 0.5-gram capsule and the 1.0 gram capsule in January 2023. All generic versions of icosapent ethyl as approved by the U.S. FDA pertains to the MARINE indication of VASCEPA, lowering of TG levels in patients with very high TG (>500 mg/dL). Current generic competition, together with past and on-going litigation related to such generic versions of icosapent ethyl are applicable to the U.S. only. The Company did not seek, nor is VAZKEPA approved in Europe for lowering of TG levels in patients with very high TG (>500 mg/dL). The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitment, including to manufacturing infrastructure such as dedicated facilities, to ensure sufficient capacity is available when needed. The Company has invested over a decade of resources and expenses to develop with individual members of its third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable the Company’s suppliers to supply the Company’s need for clinical and commercial supply globally. In November 2020, the Company filed a patent infringement lawsuit against Hikma in the United States District Court in Delaware. The complaint alleged that Hikma induced the infringement of VASCEPA-related CV risk reduction U.S. Patent Nos. 9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States. In January 2021, the Company expanded the scope of the VASCEPA CV risk reduction patent infringement lawsuit against Hikma to include a health care insurance provider in the United States, Health Net LLC, or Health Net. Through insurance coverage and economic incentives the Company alleged that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of the related patents. In the complaint, the Company sought remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement. On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss. On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma. The F-17 Company has appealed the decision of the district court. On December 26, 2022, the Company entered into a settlement agreement with Health Net that resolved the litigation relating to the Company and Health Net. The Company will continue to consider its legal options against parties similarly situated to Health Net and Hikma and acting in concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same. As has been a practice in the generic pharmaceutical industry, on April 27, 2021 and February 21, 2023, Dr. Reddy’s and Hikma, respectively, filed a complaint against the Company in the United States District Court for the District of New Jersey, Civil actions No.21-cv-10309 and No.3:23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. The complaints also includes a related state law tortious interference claim. Damages sought include recovery for alleged economic harm to Dr. Reddy’s and Hikma's, payors and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s and Hikma. Amarin believes it has valid defenses and will vigorously defend against the claims. In March 2021, Amarin received a civil investigative demand, or CID, from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General with respect to information on the same antitrust topic covered in the Dr. Reddy's litigation. Similarly, in June 2020, the Company received a CID from the U.S. Department of Justice, or the DOJ, informing Amarin that the DOJ is investigating whether aspects of its promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. Civil False Claims Act, in relation to the sale and marketing of VASCEPA by the Company and its previous co-marketing partner, Kowa Pharmaceuticals America, Inc. The Company believes such contact from the governments may have been prompted by a generic competitor. The inquiries require the Company to produce documents and answer written questions, or interrogatories, relevant to specified time periods. Amarin is cooperating with the government agencies and cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business. As has been a practice of class action legal counsel following governmental investigations and litigation by generics companies, Amarin is also named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey. Amarin is a defendant in a class action lawsuit filed by Uniformed Fire Officers Association Family Protection Plan Local 854 and the Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12061, alleging Amarin and its co-defendant suppliers violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by The International Union of Operating Engineers Locals 137, 137A, 137B, 137C, 137R, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12416, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund, on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-13009. Amarin is a defendant in a class action lawsuit filed by Teamsters Health & Welfare Fund of Philadelphia and Vicinity, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-13406, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by Board of Trustees of Heavy and General Laborers' Local Unions 472 and 172 of N.J. Welfare Fund, on behalf of indirect purchasers, in the District Court of New Jersey, Civil Action No. 21-14639, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. These cases have been consolidated into In re Vascepa Antitrust Litigation (Indirect Purchasers), Civil Action No. 21-12061, in the District Court for the District of New Jersey. Amarin is a defendant in a class action lawsuit filed by KPH Healthcare Services, Inc., on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12747, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. This case has been coordinated with the consolidated indirect purchaser case above as In re Vascepa Antitrust Litigation (Direct Purchasers), Civil Action No. 21-12747, in the District Court for the District of New Jersey. Such antitrust litigation and investigations can be lengthy, costly and could materially affect and disrupt the Company’s business. The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business. If a government determines that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties. The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of these lawsuits or any subsequently filed lawsuits. Litigation – Other On February 22, 2019, a purported investor in the Company’s publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and chief scientific officer in the U.S. District Court for the District of New F-18 Jersey, Debendra Sharma v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 2:19-cv-06601 (D.N.J. Feb. 22, 2019). On March 12, 2019, another purported investor filed a substantially similar lawsuit captioned Richard Borghesi v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 3:19-cv-08423 (D.N.J. March 12, 2019). On May 14, 2019 the court consolidated the cases under the caption In re Amarin Corporation PLC Securities Litigation, No. 3:19-cv-06601 and appointed two other purported shareholders, Dan Kotecki and the Gaetano Cecchini Living Trust, as Co-Lead Plaintiffs. Co-Lead Plaintiffs filed a consolidated amended complaint, or Amended Complaint, on July 22, 2019 that added as defendants the Company’s former chief medical officer and the Company’s former chief executive officer. The Amended Complaint alleged that from September 24, 2018 to November 9, 2018 the Company misled investors by releasing topline results for the REDUCE-IT study without disclosing data on biomarker increases in the placebo group as compared with baseline measurement. The Amended Complaint alleged that these data suggest that the mineral oil placebo used in the REDUCE-IT study may have interfered with statin absorption in the placebo group, which they alleged may have increased adverse outcomes in the placebo group. The Amended Complaint further alleged that these purported misrepresentations and omissions inflated the share price. Based on these allegations, the suit asserted claims under the Securities Exchange Act of 1934 and sought unspecified monetary damages and attorneys’ fees and costs. On March 29, 2021, the court granted the Company’s motion to dismiss this litigation for failure to state a valid claim. The litigation was dismissed without prejudice, giving the plaintiffs the right to file an amended complaint. Plaintiffs in this action did not file an amended complaint within the permitted filing deadline. Plaintiffs filed a notice of appeal of the motion to dismiss ruling, which has been denominated In re: Amarin Corp. PLC, case number 21-2071 (3d Cir.). On June 14, 2022, the Court of Appeals for the Third Circuit affirmed the dismissal of the matter by the trial district court. On October 21, 2021, a purported investor in the Company's publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and the former chief financial officer in the U.S. District Court for the District of New Jersey, Vincent Dang v. Amarin Corporation plc, John F. Thero and Michael W. Kalb, No. 1:21-cv-19212 (D.N.J. Oct. 21, 2021) and a subsequent case, Dorfman v. Amarin Corporation plc, et al., No. 3:21-cv-19911 (D.N.J. filed Nov. 10, 2021), was filed in November 2021. In December 2021, several Amarin shareholders moved to consolidate the cases, or the Securities Litigation, and appoint a lead plaintiff and lead counsel pursuant to the Private Securities Litigation Reform Act. The plaintiffs filed an amended complaint on January 13, 2023 that added as a defendant the Company's former general counsel. The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the ANDA litigation described above and the risk that certain of the Company's patents would be invalidated. Based on these allegations, plaintiff alleges that he purchased securities at an inflated share price and brings claims under the Securities and Exchange Act of 1934 seeking unspecified monetary damages and attorneys' fees and costs. The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome. The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims. On April 7, 2022, a purported investor in the Company's publicly traded securities filed a derivative lawsuit naming the same officer defendants from the Securities Litigation, the Officer Defendants, and also the members of the Company's board of directors, and the Company as nominal defendant in the U.S. District Court for the District of New Jersey, Gary Schader v. Amarin Corporation plc, John F. Thero, Michael W. Kalb, Lars G. Ekman, Jan Van Heek, Karim Mikhail, Patrick J. O'Sullivan, Per Wold-Olsen, Kristine Peterson, David Stack, and Joseph S. Zakrzewski, No. 3:22-cv-02017 (D.N.J. Apr. 7, 2022). The complaint alleges, like the Securities Litigation, that the defendants allegedly downplayed the risk associated with the ANDA litigation and the risk that certain of the Company's patents would be invalidated. Based on the allegations, plaintiffs allege that the directors breached their fiduciary duties and that the Officer Defendants were unjustly enriched, and plaintiffs seek contribution from the Officer Defendants for any liability they incur in the Securities Litigation and for which they are indemnified by the Company. On July 1, 2022, the plaintiff voluntarily dismissed this matter. In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Milestone and Supply Purchase Obligations The Company currently has long-term supply agreements with multiple API suppliers and encapsulators. The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls. These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers. On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes a comprehensive cost and organizational restructuring plan to address current shifts within the Company’s U.S. business as a result of the generic competition. As part of this plan, the Company has reviewed its contractual supplier purchase obligations and has entered into agreements with F-19 some suppliers to amend supplier agreements to align supply arrangements with current and future market demand. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company. As of December 31, 2022, the Company has a total of approximately $86.0 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers. On March 26, 2021, the EC approved the marketing authorization application for VAZKEPA. Under the 2004 share repurchase agreement with Laxdale upon receipt of pricing approval in Europe for the first indication for VASCEPA (or first indication of any product containing intellectual property acquired from Laxdale in 2004), the Company was obligated to make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of such former shareholders) of £7.5 million. On July 13, 2022 in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make the aggregate milestone payment of £7.5 million to Laxdale’s former shareholders (in either stock or cash at the election of each shareholder). As of December 31, 2022, the Company has settled the first European indication approval milestone through issuance of stock and cash payments based on the respective shareholder's election. Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £5.0 million (approximately $6.0 million as of December 31, 2022) for the potential market approval. The Company has no provision for any of these obligations, except as noted above, since the amounts are either not paid or payable as of December 31, 2022. (8) Equity Common Stock On July 13, 2022, in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make an aggregate milestone payment of £7.5 million to Laxdale's former shareholders (in either stock or cash at the election of each shareholder) under the 2004 purchase agreement among the Company and such former shareholders. One of the shareholders elected to receive payment in stock for its pro rata portion of the milestone payment, resulting in the issuance of 5,817,942 shares at a price of $1.41 per share in July 2022. During the years ended December 31, 2022 and 2021, other than as described elsewhere in this Annual Report on Form 10-K, including in the Notes to Consolidated Financial Statements, the Company did not engage in any transactions involving its common stock. Refer to Incentive Equity Awards below for discussion of ordinary shares issued as a result of stock option exercises and the vesting of restricted stock units. Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan. Incentive Equity Awards The Company issues incentive equity awards, including incentive and non-qualified stock options and restricted stock units, under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, which is the successor to the Amarin Corporation plc 2011 Stock Incentive Plan, as amended, or the 2011 Plan, and the Amarin Corporation plc 2002 Stock Option Plan, as amended, or the 2002 Plan, and together with the 2020 Plan and 2011 Plan, the Plans. Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for further information regarding the Company’s incentive equity plans and awards. The following table summarizes the aggregate number of stock options and restricted stock units, or RSUs, outstanding under the 2020 Plan as of December 31, 2022: Outstanding stock options % of outstanding shares on a fully diluted basis Outstanding RSUs % of outstanding shares on a fully diluted basis F-20 December 31, 2022 19,182,111 4 % 14,461,050 3 % The following table represents equity awards activity during the years ended December 31, 2022 and 2021: Common shares issued for stock option exercises Gross and net proceeds from stock option exercises Common shares issued in settlement of vested RSUs Shares retained for settlement of employee tax obligations ─ RSUs Common shares issued in settlement of vested Performance-Based RSUs Shares retained for settlement of employee tax obligations ─ Performance- Based RSUs (1) $ For the Year Ended December 31, 2022 2021 $ 33,303 59,686 1,940,371 500,064 — — 1,203,845 2,921,000 1,203,845 782,917 1,923,316 816,931 (1) Performance-based RSUs vested in connection with the achievement of certain regulatory and sales performance conditions associated with the REDUCE-IT clinical trial and subsequent revenue growth. These performance-based RSUs have fully vested as of August 2021. During the years ended December 31, 2022 and 2021, the Company granted a total of 3,065,000 and 4,535,117 stock options, respectively, and 9,069,500 and 5,497,700 RSUs, respectively, to employees under the Plans. The RSUs typically vest annually over a three- or four-year period and the stock options typically vest quarterly over a four-year period. Also during 2022 and 2021, the Company granted a total of 1,919,500 and 2,008,800 RSUs, respectively, to employees under the Plans that vest upon the achievement of specified performance conditions. In addition, during the years ended December 31, 2022 and 2021, the Company granted a total of 1,973,124 and 278,271 stock options, respectively, and 1,597,955 and 218,000 RSUs, respectively, to members of the Company’s Board of Directors under the Plans. The RSUs vest in equal installments over a three-year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. The stock options vest in full upon the earlier of the one-year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. Upon termination of service to the Company or upon a change of control, each director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares. (9) Stock Incentive Plans and Stock-Based Compensation On March 16, 2020, the Company’s Board of Directors, upon the recommendation of the Remuneration Committee, adopted, subject to shareholder approval, the 2020 Plan which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders. The 2020 Plan is the successor to the Company’s 2011 Plan, which was set to expire on July 12, 2021, and the Company’s 2002 Plan, the Plans. The 2020 Plan allows the Company to grant stock options, both incentive and non-qualified options, to employees and Directors, restricted stock units to employees and unrestricted shares to Directors. The maximum number of the Company’s Ordinary Shares of £0.50 each or any ADS’s, as to be issued under the 2020 Plan shall not exceed the sum of (i) 20,000,000 shares and (ii) the number of Shares that remained available for grants under the Company’s 2011 Plan as of July 13, 2020. If any award granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent grants under the 2020 Plan. The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030. Stock Options Under the terms of the Plans, stock options typically vest over a four-year period and expire after a ten-year term. The stock options are granted at an exercise price equal to the closing price of the Company’s American Depositary Shares on the grant date. The following table summarizes all stock option activity for the year ended December 31, 2022: F-21 In thousands (except per share amounts and years) Outstanding as of January 1, 2022 Granted Forfeited Expired Exercised Outstanding as of December 31, 2022 Exercisable as of December 31, 2022 Vested and expected to vest as of December 31, 2022 Available for future grant as of December 31, 2022 Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value 18,493 $ 5,038 (4,105 ) (211 ) (33 ) 19,182 12,888 18,867 15,383 7.32 2.56 8.39 11.65 1.79 5.80 6.80 5.83 6.2 years $ 4.9 years $ 6.2 years $ 158 86 155 The weighted average grant date fair value of stock options granted during the years ended December 31, 2022, 2021, and 2020 was $2.56, $5.12, and $14.43, respectively. The total grant date fair value of options vested during the years ended December 31, 2022, 2021, and 2020 was $16.6 million, $21.1 million, and $22.5 million, respectively. During the years ended December 31, 2022, 2021 and 2020, the Company received proceeds from the exercise of options of $0.1 million, $2.9 million, and $5.2 million, respectively. The total intrinsic value of options exercised during the years ended December 31, 2022, 2021, and 2020 was nominal, $4.9 million, and $9.0 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards. As of December 31, 2022, options have $13.5 million of unrecognized stock-based compensation expense with such expense expected to be recognized over a weighted-average period of approximately 2.1 years. The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which include: • • • • Risk free rate: The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity term approximating the expected life of the option at the date of grant. Expected dividend yield: No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future. Expected option life: The expected life was determined using the simplified method based on the term and vesting period. Expected volatility: Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option. For 2022, 2021, and 2020, the Company used the following assumptions to estimate the fair value of share-based payment awards: Risk-free interest rate Expected dividend yield Expected option life (years) Expected volatility 2022 2021 1.64% - 4.35% 0.53% - 1.36% 0.00% 6.25 96% - 101% 0.00% 6.25 96% - 99% 2020 0.33% - 1.74% 0.00% 6.25 84% - 99% Employee stock options generally require future service and vest ratably over a four-year service period and are settled by the issuance of new common shares. The grant date fair value of the stock options, net of an estimated forfeiture rate is amortized straight-line over the awards’ vesting periods or respective requisite service periods and is adjusted for actual forfeitures over such period. The Company recorded compensation expense in relation to stock options of $14.8 million, $23.0 million, and $22.4 million for the years ended December 31, 2022, 2021, and 2020, respectively. Restricted Stock Units The restricted stock units vest based upon either a time-based service condition, a performance condition, or both. The grant date fair value of the restricted stock unites, net of the estimated forfeiture rate, is amortized straight-line over the vesting periods or requisite service periods and is adjusted for actual forfeitures over such period. For any awards with a performance condition, the probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable. F-22 The following table presents the restricted stock unit activity for the year ended December 31, 2022 : In thousands (except per share amounts) Outstanding as of January 1, 2022 Granted Vested Forfeited Outstanding as of December 31, 2022 Shares Weighted Average Grant Date Fair Value 9,277 12,587 (1,940 ) (5,463 ) 14,461 $ 7.70 2.97 7.30 6.79 3.98 The Company recorded compensation expense in relation to restricted stock units of $11.4 million, $13.9 million, and $23.4 million for the years ended December 31, 2022, 2021, and 2020 respectively. As of December 31, 2022, restricted stock units have $23.7 million of unrecognized stock-based compensation expense with such expense to be recognized over a weighted-average period of approximately 2.2 years. The following table presents the stock-based compensation expense related to stock-based awards for the years ended December 31, 2022, 2021, and 2020: In thousands Research and development Selling, general and administrative Restructuring Stock-based compensation expense Employee Stock Purchase Plan $ $ 2022 2021 2020 4,465 $ 22,339 (591 ) 26,213 $ 4,327 $ 32,305 306 36,938 $ 6,568 39,245 — 45,813 On March 13, 2017, the Board adopted, subject to shareholder approval, the Amarin Corporation plc 2017 Employee Stock Purchase Plan, or the ESPP, which was approved by the Company’s shareholders on May 15, 2017. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code. The maximum fair market value of stock which can be purchased by a participant in a calendar year is $25,000. Under the ESPP, an aggregate of 3,000,000 ordinary shares (each ordinary share to be represented by one ADS) are reserved and available for issuance, which were registered with the SEC on August 2, 2017, for sale to eligible employees. Subject to certain exclusions, any employee of the Company’s U.S. subsidiary, Amarin Pharma, Inc., who works at least 20 hours per week and has been employed for at least six months as of the first day of the applicable offering period is eligible to participate in the ESPP. Eligible employees may authorize payroll deductions of up to 15 percent of their base pay to be withheld to purchase ordinary shares, subject to terms and limitations of the plan, at a price equal to 85 percent of the lower of the fair market values of the Company’s ordinary shares as of the beginning or the end of six-month offering periods. For the offering periods ended on the last business day on or before each of May 31, 2022 and November 30, 2022, the Company issued 265,214 shares and 191,482 shares, respectively, at a purchase price of $1.45 per share and $1.15 per share, respectively. For the offering periods ended on the last business day on or before each of May 31, 2021 and November 30, 2021, the Company issued 226,402 shares and 172,884 shares, respectively, at a purchase price of $3.86 per share and $3.06 per share, respectively. For the offering periods ended on the last business day on or before each of May 31, 2020 and November 30, 2020, the Company issued shares 123,608 shares and 223,545 shares, respectively, at a purchase price of $5.83 per share and $4.22 per share, respectively. As of December 31, 2022, 1,361,577 shares were reserved for future issuance under the ESPP. (10) Income Taxes The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes. The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is $8.2 million and $7.9 million as of December 31, 2022 and 2021, respectively. The Company recognized interest related to uncertain tax positions of $0.5 million and $0.9 million for the years ended December 31, 2022 and 2021, respectively. No penalties have been recognized in conjunction with these positions. F-23 The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31, 2022, 2021 and 2020: In thousands Beginning uncertain tax benefits Prior year—increases Prior year—decreases Current year—increases Ending uncertain tax benefits $ $ 2022 2021 2020 22,040 $ — (9,107 ) 5,782 18,715 $ 24,034 $ 16 (2,248 ) 238 22,040 $ 26,743 2,428 (5,391 ) 254 24,034 The Company files income tax returns in the United States, Ireland and United Kingdom, or UK. The Company remains subject to tax examinations in the following jurisdictions as of December 31, 2022: Jurisdiction United States—Federal United States—State Ireland United Kingdom Tax Years 2018-2022 2012-2022 2018-2022 2021-2022 The Company does not expect any gross liabilities to expire in 2023 based on statutory lapses or audits. The components of income (loss) from operations before taxes were as follows for the years ended December 31, 2022, 2021 and 2020: In thousands United States Ireland and United Kingdom Other Total (loss) / income before taxes 2022 2021 2020 $ $ 5,358 $ (112,527 ) 3,364 (103,805 ) $ 10,222 $ (4,368 ) 5,437 11,291 $ 14,915 (32,170 ) — (17,255 ) The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for the years ended December 31, 2022, 2021 and 2020: In thousands Current: United States—Federal United States—State Foreign Total current Deferred: United States—Federal United States—State Foreign Change in valuation allowance Total deferred Provision for income taxes 2022 2021 2020 562 $ 573 863 1,998 $ (3,721 ) 284 (1,646 ) 5,083 — $ 1,998 $ 2,690 $ 716 156 3,562 $ 5,222 (3,057 ) (1,619 ) (546 ) — $ 3,562 $ 45 700 — 745 1,972 1,956 (26,793 ) 22,865 — 745 $ $ $ $ F-24 The provision for income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for the years ended December 31, 2022, 2021 and 2020: In thousands Benefits from taxes at statutory rate Rate differential Change in valuation reserves Nondeductible employee compensation Stock option/RSU windfall (shortfall) ISO disqualifying disposition windfall Research and development credits Tax return to provision adjustments Net operating loss carryback Foreign exchange Permanent and other Uncertain tax positions Foreign-derived intangible income Loss of tax attributes Provision for income taxes 2022 2021 2020 $ $ (25,952 ) $ 9,141 5,083 2,344 3,569 — (958 ) 424 — 7,859 (1,542 ) (3,290 ) (2,935 ) 8,255 1,998 $ 2,823 $ (4,416 ) (546 ) 5,249 81 (219 ) (1,170 ) (8,372 ) — 4,109 863 5,160 — — 3,562 $ (4,314 ) 128 22,865 6,122 (3,262 ) (253 ) (6,225 ) (138 ) (2,465 ) (10,852 ) (4,283 ) 3,422 — — 745 The Company is subject to a corporate tax rate in Ireland of 25% for non-trading activities and 12.5% for trading activities. For the years ended December 31, 2022, 2021, and 2020, 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 trading tax rate. In the table above, the Company used Amarin Corporation plc’s 25% tax rate as the starting point for the reconciliation since it is the parent entity of the business. On August 16, 2022, the Inflation Reduction Act of 2022, or the Act, was signed into law by the Biden Administration, with tax provisions effective January 1, 2023 primarily focused on implementing a 15% minimum tax on global adjusted financial statement income (CAMT) and a 1% excise tax on share repurchases. While we are still evaluating the impact of the Act, we do not expect either of these provisions to have a material impact on our financial results. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, was enacted in the United States. Among other provisions, the CARES Act allows businesses to carry back net operating losses arising in years 2018 to 2020 to the five prior tax years. We recorded an income tax benefit of $2.5 million for the year ended December 31, 2020 as a result of these loss carrybacks and an income tax benefit of nil for the years ended December 31, 2022 and 2021, respectively. In April 2016, the Company adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Share-Based Payment Accounting which changes the accounting for certain aspects of share-based payments to employees. One aspect of the standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized as an income tax benefit and expense in the income statement. Previously, such amounts were recognized as an increase and decrease in additional paid-in capital. This aspect of the standard was adopted prospectively, and accordingly the provisions for income taxes for the years ended December 31, 2022, 2021 and 2020 includes $0.6 million, $0.1 million and $3.7 million of excess tax benefits, respectively, arising from share-based payments during the period. F-25 The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2022 and 2021 is as follows: In thousands Deferred tax assets: Net operating losses Stock-based compensation Tax credits Capitalized R&D Lease liability Other reserves and accrued liabilities Gross deferred tax assets Less: valuation allowance Total deferred tax assets Deferred tax liabilities: Depreciation and amortization Lease asset Other liabilities Total deferred tax liabilities Net deferred tax assets December 31, 2022 December 31, 2021 $ $ 136,862 $ 11,616 2,639 4,723 2,583 11,895 170,318 (165,378 ) 4,940 (3,337 ) (1,603 ) — (4,940 ) — $ 127,378 8,563 15,803 — 2,348 11,257 165,349 (160,295 ) 5,054 (3,404 ) (1,639 ) (11 ) (5,054 ) — 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, U.S., Germany, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods. The following table reflects the activity in the valuation allowance for the years ended December 31, 2022 and 2021: In thousands Beginning valuation allowance Increase as reflected in income tax expense Foreign exchange Ending valuation allowance 2022 2021 $ $ 160,295 $ 12,942 (7,859 ) 165,378 $ 160,841 2,899 (3,445 ) 160,295 During 2022, the Company recorded adjustments to its deferred tax accounts related to the impact of foreign exchange rate changes and to reconcile the financial statement accounts to the amounts expected to result in future income and deductions under local law, primarily as it relates to Irish net operating losses and deferred taxes for stock compensation. These adjustments were fully offset with valuation allowances based on the Company’s position with respect to the realizability of its recorded deferred tax assets. The Company has combined U.S. and Non-U.S. net operating loss carryforwards of $834.4 million, which do not expire. The total net operating loss carryforwards decreased by approximately $15.6 million from the prior year primarily as a result of current year loss generated by the Company’s U.S. and Non-U.S. subsidiaries, the impact of foreign exchange rate changes, and adjustments to reconcile the financial statement accounts to the amounts reported on the filed 2021 foreign tax returns. In addition, the Company has U.S. Federal tax credit carryforwards of $9.5 million and state tax credit carryforwards of $3.7 million. These amounts exclude the impact of any unrecognized tax benefits and valuation allowances. These carryforwards, which will expire between 2023 and 2042, may be used to offset future taxable income, if any. As of December 31, 2022, there are no earnings that have been retained indefinitely for reinvestment by foreign subsidiary; therefore, no provision has been made for income taxes that would be payable upon the distribution of such earnings or the recovery of the Company’s investment in its subsidiaries as the amount of the related unrecognized deferred income tax liability is zero. The Company's and its subsidiaries' income tax returns are periodically examined by various taxing authorities. The Company is currently under audit by the IRS for the Company’s 2018 U.S. income tax return, by the New Jersey Department of Treasury for the years 2012 to 2015 and by the New York Department of Finance for the years 2018 and 2019. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on the Company's consolidated financial position or results of operations. (11) Defined Contribution Plan The Company makes available a 401(k) plan for its U.S. employees. Under the 401(k) plan, employees may make contributions which are eligible for a discretionary percentage match, in cash, as defined in the 401(k) plan and determined by the Board of Directors. The F-26 Company recognized $1.7 million, $1.9 million and $1.7 million of related compensation expense for the years ended December 31, 2022, 2021 and 2020, respectively. (12) Co-Promotion Agreement On March 31, 2014, the Company entered into a Co-Promotion Agreement, or the Agreement, with Kowa Pharmaceuticals America, Inc. related to the commercialization of VASCEPA capsules in the United States. The Company and Kowa Pharmaceuticals America, Inc. intentionally designed the Agreement to naturally end as of December 31, 2018 and mutually agreed not to renew the Agreement. During 2018, which was the last year of the co-promotion of VASCEPA by Kowa Pharmaceuticals America, Inc., the Company incurred expense for co- promotion tail payments which are calculated as a percentage of the 2018 co-promotion fee, which was eighteen and a half percent (18.5%) of VASCEPA gross margin in 2018. The accrued tail payments are paid over three years with declining amounts each year. Kowa Pharmaceuticals America, Inc. was eligible to receive $17.8 million in co-promotion tail payments, the present value of which $16.6 million, was fully accrued as of December 31, 2018. During the first quarter of 2022, the final co-promotion tail payment was made to Kowa Pharmaceuticals America, Inc. As of December 31, 2021, the Company recognized a net payable to Kowa Pharmaceuticals America, Inc. of $0.6 million was classified as current on the consolidated balance sheets, representing the remaining accrued co-promotion tail payments. (13) Revenue Recognition The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States and Europe, or collectively, its distributors or its customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Patients are required to have a prescription in order to purchase VASCEPA. In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product. Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor or customer. Payments from distributors are generally received 30-60 days from the date of sale. The Company evaluates the creditworthiness 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. The Company calculates gross product revenues generally based on the wholesale acquisition cost or list price that the Company charges its distributors for VASCEPA. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on individual contractual amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (distributor payments or credits) or as a current liability (payable to a non-distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors in the U.S. and Germany generally include a 2-3% discount for prompt payment while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized. F-27 Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, for partial or full reimbursement from, such Third-party Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability- weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in Accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. 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 payor mix for VASCEPA. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Product Returns: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently four years and three years, respectively, after being converted into capsule form, which is the last step in the manufacturing process for VASCEPA and generally occurs within a few months before VASCEPA is delivered to distributors. The Company estimates future product returns on sales of VASCEPA based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine 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) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in Accrued expenses and other current liabilities on the consolidated balance sheets. Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program to establish its accruals for co-pay mitigation rebates. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in Accrued expenses and other current liabilities on the consolidated balance sheets. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed. The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the years ended December 31, 2022 and 2021: In thousands Balance as of January 1, 2021 Provision related to current period sales Provision related to prior period sales Credits/payments made for current period sales Credits/payments made for prior period sales Balance as of December 31, 2021 Provision related to current period sales Provision related to prior period sales Credits/payments made for current period sales Credits/payments made for prior period sales Balance as of December 31, 2022 Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives 141,200 $ 684,010 (2,034 ) (504,210 ) (134,210 ) 184,756 676,816 592 (548,783 ) (177,288 ) $ 136,093 7,798 $ 1,531 — — (1,240 ) 8,089 2,347 — — (1,690 ) $ 8,746 5,584 $ 45,501 — (42,754 ) (5,586 ) 2,745 26,612 — (24,671 ) (2,630 ) $ 2,056 $ $ 36,242 $ 121,378 — (36,473 ) (34,511 ) 86,636 96,340 — (54,952 ) (83,398 ) $ 44,626 F-28 Total 190,824 852,420 (2,034 ) (583,437 ) (175,547 ) 282,226 802,115 592 (628,406 ) (265,006 ) 191,521 Such net product revenue allowances and reserves are included within Accrued expenses and other current liabilities within the consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within Accounts receivable, net as discussed above. Licensing Revenue The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing and royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment. The Company receives payments from its customers based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. (14) Development, Commercialization and Supply Agreements In-licenses Mochida Pharmaceutical Co., Ltd. In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to F-29 certain Mochida intellectual property to advance the Company’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development. Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any. In January 2022 and 2021, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million, respectively, to Mochida, which was recorded as Research and development expense in the consolidated statement of operations. Out-licenses Eddingpharm (Asia) Macao Commercial Offshore Limited In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or the China Territory. Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with right to sublicense to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA. Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory. The Company and Edding agreed to form a joint development committee to oversee regulatory and development activities for VASCEPA in the China Territory in accordance with a negotiated development plan and formed a separate joint commercialization committee in advance of expected approval in the China Territory to oversee VASCEPA planning and pre-launch commercialization activities in the China Territory. Development costs are paid by Edding to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Edding. Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at Edding’s cost with the Company’s assistance. The DCS Agreement also contains customary provisions regarding indemnification, supply, 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 a valid claim under a licensed patent in the China Territory, or (ii) the 12th anniversary of the first commercial sale of such product in Mainland China. The DCS 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, Edding has the right to terminate the DCS Agreement for convenience with 12 months’ prior notice. Neither party may assign or transfer the DCS Agreement without the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction. Upon closing of the DCS Agreement, the Company received a non-refundable $15.0 million up-front payment. In March 2016, Edding submitted its clinical trial application, or CTA, with respect to the MARINE indication for VASCEPA to the Chinese regulatory authority. Following the CTA submission, the Company received a non-refundable $1.0 million milestone payment. In March 2017, the CTA was approved by the Chinese regulatory authority, and, in December 2017, Edding commenced a pivotal clinical trial aimed to support the regulatory approval of the first indication of VASCEPA in a patient population with severe hypertriglyceridemia in Mainland China. In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which is being used to seek regulatory approval in Mainland China. The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022. In addition to the non-refundable, up-front and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $153.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The regulatory milestone events relate to the submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application. The amounts to be received upon achievement of the regulatory milestone events relate to the submission and approval for three indications, and range from $2.0 million to $15.0 million for a total of $33.0 million. The F-30 sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $5.0 million to $50.0 million for a total of $120.0 million. Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments. The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company, (2) the obligation to participate in various steering committees, and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation. The transaction price includes the $15.0 million up-front consideration received and the $1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication. None of the other clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. During the years ended December 31, 2022 and 2021, the Company recognized $0.6 million and $1.1 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the Edding agreement. From contract inception through December 31, 2022 and 2021, the Company recognized $7.7 million and $7.1 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by the Company to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation. The remaining transaction price of $9.3 million and $9.8 million is recorded in deferred revenue as of December 31, 2022 and 2021, respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 12 years. The Company recognized net product revenue of $0.2 million and $0.3 million for the years ended December 31, 2022 and 2021, respectively, related to sales to Edding. Biologix FZCo In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, the Company granted to Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Upon closing of the agreement, the Company received a non-refundable up-front payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory. The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price. The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries: Country Lebanon United Arab Emirates Qatar Bahrain Kuwait Saudi Arabia MARINE March 2018 July 2018 December 2019 April 2021 December 2021 March 2022 REDUCE-IT August 2021 October 2021 April 2021 April 2022 — — Launch Date June 2018 February 2019 — — — — The Company recognized net product revenue of approximately $1.0 million and $1.4 million as of December 31, 2022 and 2021, respectively, related to sales to Biologix. HLS Therapeutics, Inc. In September 2017, the Company entered into an agreement with HLS Therapeutics Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS will be responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local F-31 filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities. Upon closing of the agreement, the Company received one-half of a non-refundable $5.0 million up-front payment, and received the remaining half on the six-month anniversary of the closing. Following achievement of the REDUCE-IT trial primary endpoint, which was announced in September 2018, the Company received a non-refundable $2.5 million milestone payment. Following approval from Health Canada in December 2019, the Company received a non-refundable milestone payment of $2.5 million in February 2020. In addition, in January 2020 HLS obtained regulatory exclusivity from the Office of Patented Medicines and Liaison, or OPML, as a result the Company received a non-refundable $3.8 million milestone payment. In addition to the non- refundable, up-front and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada. The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada, (2) support general development and regulatory activities, and (3) participate in various steering committees. Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation. The transaction price includes the $5.0 million up-front consideration, the $2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $2.5 million milestone related to obtaining approval from Health Canada and $3.8 million milestone related to obtaining regulatory exclusivity from the OPML. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. During the years ended December 31, 2022 and 2021, the Company recognized $0.7 million and $0.9 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement. From the contract’s inception through December 31, 2022 and 2021, the Company has recognized $8.2 million and $7.5 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by the Company to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation. The remaining transaction price of $5.6 million and $6.2 million is recorded in deferred revenue as of December 31, 2022 and 2021, respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 8 years. The Company recognized net product revenue of $2.9 million and nil for the years ended December 31, 2022 and 2021, respectively, related to sales to HLS. CSL Seqirus In February 2023, the Company entered into an agreement with CSL Seqirus to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. The Company will receive an upfront payment of $0.5 million and be eligible to receive event-related milestone payments of approximately $8.0 million and additional product-related milestone payments of approximately $4.0 million. The Company will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price. The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2022 and 2021: In thousands Year ended December 31, 2022: Contract assets Contract liabilities: Deferred revenue Year ended December 31, 2021: Contract assets Contract liabilities: Deferred revenue Balance at Beginning of Period Additions Deductions Balance at End of Period — $ — $ — $ — 16,709 $ 6 $ (1,369 ) $ 15,346 — $ — $ — $ — 18,632 $ 128 $ (2,051 ) $ 16,709 $ $ $ $ F-32 During the years ended December 31, 2022 and 2021, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods: In thousands Revenue recognized in the period from: Amounts included in contract liability at the beginning of the period Performance obligations satisfied in previous periods Twelve Months Ended December 31, 2022 2021 $ $ 1,366 2 $ $ 1,997 46 (15) Leases The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842. The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1% would not result in a material change to the Company’s consolidated financial statements. On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease. The Lease commenced on August 15, 2019, or the Commencement Date, for an 11-year period, with two five-year renewal options. Subject to the terms of the Lease, Amarin will have a one-time option to terminate the agreement effective on the first day of the 97th month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company paid monthly rent of approximately $0.1 million for the first year following the Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease. On November 17, 2021, the Company entered into a lease agreement for new office space in Zug Switzerland, or the Zug Lease. The Zug Lease commenced on February 1, 2022, or the Zug Commencement Date, for a 5-year period, with one five-year renewal option. Under the Zug Lease, the Company will pay annual rent of approximately $0.2 million for the first year following the Zug Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Zug Commencement Date. On September 13, 2022, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Dublin Lease. The Dublin Lease commenced on October 1, 2022, or the Dublin Commencement Date, for a 2-year period. Under the Dublin Lease, the Company will pay annual rent of approximately $0.4 million during the duration of the lease term. In addition to the real estate leases, the Company leases various vehicles with terms ranging from month to month up to 36 months. F-33 The operating lease liability is $11.6 million and $10.3 million and the operating lease right-of-use asset is $9.1 million and $7.7 million, as of December 31, 2022 and 2021, respectively. The lease expense for the years ended December 31, 2022, 2021 and 2020 is approximately $2.8 million, $2.2 million and $1.6 million, respectively. The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of December 31, 2022: 2023 2024 2025 2026 2027 2028 and thereafter Total undiscounted payments Discount Adjustments Current operating lease liability Long-term operating lease liability Undiscounted lease payments ($000s) 2,796 2,572 2,096 2,131 1,962 5,251 16,808 (5,227 ) 1,566 10,015 $ $ $ $ The Company entered into a sublease agreement to lease a portion of the Bridgewater, New Jersey facility. The lease commenced on February 1, 2023, or the Sublease Commencement Date, for a seven and a half year period. Under the sublease, the Company will receive monthly rent payments of approximately $0.1 million during the first year, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date. F-34 Exhibit 10.31 December 1, 2022 Jason Marks Re: Transition Agreement Dear Jason: This letter confirms that your employment with Amarin Corporation plc (together with its subsidiaries and any controlled affiliates, the "Company") will be ending. We appreciate your service and contributions and would like to make this transition as smooth as possible. This letter sets forth the terms of a Transition Agreement (the “Agreement") between you and the Company under which you would remain employed by the Company and receive your current compensation and benefits (subject to the terms of any applicable benefits plan) and vest in your outstanding, unvested equity awards between now and February 28,2023, unless your employment ends on an earlier date consistent with the terms of the Agreement. In addition, the below Agreement provides you the opportunity to receive the severance pay and benefits described in Section 4 below pursuant to the terms of the Amarin Corporation plc Executive Severance and Change of Control Plan effective as of January 28, 2021 (the "Plan"). As you know, you are an "Eligible Executive" under the Plan, and provided that you satisfy the Conditions set forth in Section 3 below, the ending of your employment will be treated as a termination by the Company without Cause for purposes of the Plan. Accordingly, if you satisfy the Conditions, you will be eligible for the Severance Benefits under Section 3 of the Plan and as described in Section 4 below. The below Agreement is the "Release" and "Separation Agreement" described in the Plan. With those understandings, the Agreement between you and the Company is as follows: 1. Transition Period (a) If you enter into and comply with this Agreement, your employment with the Company will continue, along with the compensation, benefits and vesting described in Section l(c) below, until February 28, 2023, at which time it will end, unless you sooner resign or the Company sooner ends your employment for Cause (as defined in the Plan). The actual last day of your employment is referred to herein as the "Date of Termination." The time period between the date of this letter and the Date of Termination is referred to herein as the "Transition Period." (b) At the commencement of the Transition Period, you will transition to the role of Senior Advisor. You agree to work professionally and cooperatively with the leadership team and your colleagues as requested during the 1 ACTIVE/120151144.1 Transition Period. You agree that Good Reason (as defined under the Plan) shall not apply during the Transition Period. (c) You will continue to receive your current base salary and be eligible for benefits, subject to the terms of any applicable benefits plan, during the Transition Period. You will receive your full 2022 bonus in the amount of $313,000.00 in accordance with the bonus language in Section 6 of the Employment Agreement dated July 19, 2021 (the "Employment Agreement") and subsequent April 10, 2022 promotion letter. The bonus, will be paid no later than March 15, 2023. You will also continue to vest in your outstanding, unvested equity awards during the Transition Period, subject to the terms of the applicable stock option agreement or restricted stock unit agreement and equity incentive plan(s) (collectively, the "Equity Documents"). 2. Ending of Employment (a) Your employment with the Company will end on the Date of Termination, which will be no later than February 28, 2023. Regardless of whether you enter into this Agreement, the Company will provide you with the following "Accrued Obligations" in connection with the ending of your employment: (i) your base salary through the Date of Termination, (ii) an amount equal to the value of your accrued unused paid time off days through the Date of Termination, and (iii) the amount of any business expenses properly incurred by you on behalf of the Company prior to the Date of Termination and not yet reimbursed, if any. You agree that you will submit your final documented expense reimbursement statement reflecting all unreimbursed business expenses no later than 10 calendar days after the Date of Termination. You will not be eligible for any compensation or benefits after the Date of Termination except as set forth in this Agreement. For the avoidance of doubt, the Company's insider trading policy shall continue to be in effect during and after your employment, consistent with the terms of the policy. (b) Your eligibility to participate in the Company's group health plans ceases on the last day of the month in which the Date of Termination occurs in accordance with the terms and conditions of those plans. You may elect to continue your existing health plan benefits under such plans in accordance with and subject to the law known as COBRA. You will be provided with information regarding COBRA under separate cover, and COBRA continuation coverage will be at your own cost, subject to Section 4(b) below if you satisfy the Conditions. Your eligibility to participate in the Company's other employee benefit plans and programs ceases on the Date of Termination in accordance with the terms and conditions of each of those benefit plans and programs. (c) Consistent with the Equity Documents, you will cease vesting in your outstanding, unvested equity awards on the Date of Termination, subject to Section 4(c) below if you satisfy the Conditions. Any vested stock options must be exercised within the time period set forth in the Equity Documents. 2 ACTIVE/120151144.1 (d) You will be deemed to have resigned from all officer, trustee and board member positions that you hold with the Company or any of its respective subsidiaries and affiliates as of December 7, 2022. You agree to execute any documents requested by the Company or any of its respective subsidiaries and affiliates necessary to effectuate such resignations. (e) You agree that you will promptly inform the Company of the commencement of any new employment prior to February 28, 2023 and that your employment with the Company, and the Transition Period, will end on the date immediately preceding the commencement of your new employment. However, if the CEO approves of your departure prior to February 28, 2023 to commence new employment. you will be paid through February 28, 2023 and, if you satisfy the Conditions, you will also be entitled to the Severance Benefits. 3. Conditions for Severance Benefits. To receive the Severance Benefits set forth in Section 4 below, you must (i) enter into and comply with this Agreement, (ii) not be terminated by the Company for Cause, (iii) not resign from your employment without the prior written approval of the Company's Chief Executive Officer ("CEO") and (iv) enter into and not revoke the certificate attached hereto as Exhibit A, which updates the release of claims in Section 5 of this Agreement and adds a release under the Age Discrimination in Employment Act (the "Certificate") within the timeframe set forth therein. For the avoidance of doubt, if the Company terminates your employment for Cause, or if you fail to satisfy any of the Conditions, your employment will end and you will be entitled to the Accrued Obligations but will not be entitled to the Severance Benefits set forth in Section 4 or any other post-employment compensation or benefits from the Company. 4. Severance Benefits. If you satisfy the Conditions, then: (a) the Company shall continue to pay you your current base salary for the twelve (12) month period following the Date of Termination (the "Salary Continuation Period"); and (b) if you elect and remain eligible for COBRA continuation coverage, the Company shall continue your group health plan benefits to the extent authorized by and consistent with COBRA, with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and you as in effect on the Date of Termination until the earlier of: (i) the end of the Salary Continuation Period, and (ii) the date that you become eligible for health benefits through another employer or otherwise become ineligible for COBRA; and (c) the portion of your outstanding stock options, restricted stock units or other equity incentive awards (in each case, only to the extent subject to time-based vesting) that would have vested in the six (6) months following the Date of Termination will immediately accelerate and become fully exercisable or nonforfeitable as of the later of the Date of Termination and the effective date of this Agreement. The forfeiture of 3 ACTIVE/120151144.1 5. any unvested equity that is subject to acceleration will be delayed to the extent necessary to effectuate this provision and will not occur if the acceleration pursuant to this provision occurs. The amounts payable under this Section 4 shall be paid out in substantially equal installments in accordance with the Company's payroll practice over the Salary Continuation Period commencing on the Company's first practicable payroll date following the Date of Termination; provided that the initial payment shall include a catch-up payment to cover amounts retroactive to the day immediately following the Date of Termination. Release of All Claims. You, on your own behalf and on behalf of your heirs, executors, administrators, attorneys and assigns, hereby unconditionally and irrevocably release, waive and forever discharge Amarin Corporation plc, Amarin Pharma, Inc. and each of their respective affiliates, parents, successors, and predecessors, and the subsidiaries, directors, owners, members, shareholders, officers, agents, and employees of Amarin Corporation plc, Amarin Pharma, Inc. and their respective affiliates, parents, successors, predecessors, and subsidiaries (collectively, all of the foregoing are referred to as the "Releasees"), from any and all causes of action, claims and damages, including attorneys' fees, whether known or unknown, foreseen or unforeseen, presently asserted or otherwise arising through the date on which you sign this Agreement. This release includes, but is not limited to, any claim or entitlement to salary, bonuses, any other payments, benefits or damages arising under any federal law (including, but not limited to, Title VII of the Civil Rights Act of 1964, the Employee Retirement Income Security Act of 1974, the Americans with Disabilities Act, Executive Order 11246, the Family and Medical Leave Act ("FMLA"), and the Worker Adjustment and Retraining Notification Act ("WARN"), each as amended and any other federal, state, local or foreign law relating to notice of employment termination or to severance pay, (including, without limitation, any claim under N.J. Rev. Stat 34:21-2.2a. et seq. and any other state mini-WARN laws); any claim arising under any state or local laws, ordinances or regulations (including, but not limited to, the New Jersey Law Against Discrimination, the New Jersey Family Leave Act, and any state or local laws, ordinances or regulations requiring that advance notice be given of certain workforce reductions); and any claim arising under any common law principle or public policy, including, but not limited to, all suits in tort or contract, such as wrongful termination, defamation, emotional distress, invasion of privacy or loss of consortium; provided, however, that this release shall not apply to (a) claims to enforce your rights under this Agreement; (b) claims for vested benefits pursuant to ERISA; (c) claims with respect to your vested equity rights as of the Date of Termination; (d) claims to enforce the Company's obligation to indemnify you to the extent such indemnification obligations exist; and (e) claims or administrative charges which legally may not be waived. 4 ACTIVE/120151144.1 You are waiving, however, any right to monetary recovery or individual relief should any federal, state or local agency (including the Equal Employment Opportunity Commission) pursue any claim on your behalf arising out of or related to your employment with and/or separation from employment with the Company; provided that nothing in this Agreement limits any right you may have to receive a whistleblower award or bounty for information provided to the Securities and Exchange Commission. You represent that you have not assigned any claim to any third party. 6. Return of Company Property. On or prior to the Date of Termination (and sooner if requested by the Company), you agree to return to the Company, without copying, transferring, modifying or deleting any of the Company's confidential information, all hard copy and electronic documents (and all copies thereof) and other Company property that you have had in your possession at any time, including, but not limited to, files, notes, drawings, records, business plans and forecasts, financial information, specifications, computer-recorded information (including email), tangible property (laptop computer, iPad, cell phone, PDA, etc.), credit cards, entry cards, identification badges and keys; and, any materials of any kind that contain or embody any proprietary or confidential information of the Company (and all reproductions thereof). After returning all such Company property to the Company, you must delete and finally purge any duplicates of files or documents that may contain Company information from any non-Company computer or other device that remains your property after the Date of Termination. If you discover after the Date of Termination that you have retained any Company proprietary or confidential information, you agree, immediately upon discovery, to contact the Company and make arrangements for returning the information. 7. Restrictive Covenants and Continuing Obligations. (a) Restrictive Covenants Agreement. You acknowledge your continuing obligations under your Nondisclosure, Developments and Noncompetition Agreement (the "Restrictive Covenants Agreement"), which, among other things prohibits disclosure of any confidential or proprietary information of the Company; provided, however, that that the Company will not enforce the noncompetition provision contained in the Restrictive Covenants Agreement in a way that would prevent you from practicing law. The remaining terms of the Restrictive Covenants Agreement are incorporated by reference as material terms of this Agreement (the Restrictive Covenants Agreement together with Sections 6, 7(a) through (c)(i) and 8 of this Agreement shall be referred to herein as the "Continuing Obligations"). (b) Cooperation. You agree to cooperate reasonably with the Company (including its outside counsel) in connection with (i) the contemplation, prosecution and defense of all phases of existing, past and future litigation about which the Company reasonably believes you may have knowledge or information; (ii) internal or external investigations related to matters that occurred during your employment and about which the Company reasonably believes that you have relevant information and (iii) 5 ACTIVE/120151144.1 ACTIVE/120151144.l 5 transitioning your duties (together "Cooperation Services"). You further agree to make yourself available to provide Cooperation Services at mutually convenient times. The Company shall not utilize this section to require you to make yourself available to an extent that would unreasonably interfere with full-time employment or other business responsibilities that you may have. The Company shall reimburse you for any reasonable travel expenses that you incur due to your performance of Cooperation Services, after receipt of appropriate documentation consistent with the Company's business expense reimbursement policy. (c) No Disparagement. You agree not to make, publish or communicate to any person or entity or in any public forum any disparaging or defamatory statements (whether written, oral, through social or electronic media or otherwise) concerning any of the Releasees, any of their respective products or services or any of their respective current or former officers, directors, shareholders, employees or agents. For its part, the Company agrees to instruct current members of the Board and current C- level executives not to make, publish or communicate to any person or entity or in any public forum any disparaging or defamatory statements (whether written, oral, through social or electronic media or otherwise) concerning you or your work with the Company. 8. Communications Regarding Your Departure. Promptly following the date of the public announcement regarding your transition and departure from the Company, the Company will issue a formal written internal announcement, with the content of such internal announcement to be mutually agreed upon by you and the CEO (the "Company Announcement"). Until such time as the Company Announcement is made, you agree that you will not (without the prior written approval of the CEO) communicate about your transition and departure with anyone until after the Company Announcement has been made; provided that you may communicate with your tax advisor(s), attorney(s), and spouse about your transition and departure before the Company Announcement; provided further that you first advise such persons not to reveal information about your transition and departure until the Company Announcement is made and each such person agrees. Once the Company has made the Company Announcement, you agree to limit any communications regarding your transition and departure to statements consistent with the Company Announcement. 9. Tax Treatment; Section 409A (a) The Company shall undertake to make deductions, withholdings and tax reports with respect to payments and benefits under this Agreement to the extent that it reasonably and in good faith determines that it is required to make such deductions, withholdings and tax reports. Nothing in this Agreement shall be construed to require the Company to make any 6 ACTIVE/120151144.1 payments to compensate you for any adverse tax effect associated ACTIVE/120151144.1 6 with any payments or benefits or for any deduction or withholding from any payment or benefit. (b) The parties intend that payments under this Agreement will be exempt from or comply with Section 409A of the Internal Revenue Code of 1986, as amended (the "Code"). To the extent that any provision of this Agreement is ambiguous as to its exemption from or compliance with Section 409A of the Code, the provision shall be read in such a manner so that all payments hereunder are exempt from or comply with Section 409A of the Code. The Company makes no representation or warranty and shall have no liability to you or any other person if any provisions of this Agreement are determined to constitute deferred compensation subject to Section 409A of the Code but do not satisfy an exemption from, or the conditions of, such Section. Each payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section 1, 409A 2(b)(2). Acknowledgements and Representations You acknowledge and represent that, except as expressly provided in this Agreement, you have been paid all wages, bonuses, compensation, benefits and other amounts that any of the Releasees has ever owed to you, and you understand that you will not receive any additional compensation, severance or benefits after the Date of Termination, except as set forth in this Agreement. Legally Binding; Advice of Counsel. This Agreement is a legally binding document, and your signature will commit you to its terms. The Company advises you to consult with an attorney prior to entering into this Agreement. By signing this Agreement, you acknowledge that you are knowingly and voluntarily entering into this Agreement. Time for Consideration; Effective Date. You acknowledge that you have been given an adequate amount of time to review the Agreement. To accept this Agreement, you must execute an unmodified copy of this Agreement via DocuSign no later than December 6, 2022 at 4:00 pm EST. If you breach any of the terms of this Agreement prior to execution, the offer of this Agreement is withdrawn and your execution of the Agreement will not be valid. This Agreement shall become effective on the date that it is fully executed (the "Effective Date"). 10. 11. 12. 13. Protected Disclosures. Nothing contained in this Agreement limits your ability to file a charge or complaint with any federal, state or local governmental agency or commission (a 7 ACTIVE/120151144.1 "Government Agency"). In addition, nothing contained in this Agreement limits your ability to communicate with any Government Agency or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency. If you file any charge or complaint with any Government Agency and if the Government Agency pursues any claim on your behalf, or if any other third party pursues any claim on your behalf, you would not be entitled to monetary or other individualized relief provided that nothing in this Agreement limits any right you may have to receive a whistleblower award or bounty for information provided to the Securities and Exchange Commission. Nothing in this Agreement any other agreement prevents you from discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination or any other conduct that you have reason to believe is unlawful. 14. Other Provisions (a) Absence of Reliance. In signing this Agreement, you are not relying upon any promises or representations made by anyone at or on behalf of the Company. (b) No Admission of Liability. This Agreement does not constitute an admission of liability or wrongdoing on the part of the Company, the Company does not admit there has been any wrongdoing whatsoever against you, and the Company expressly denies that any wrongdoing has occurred. (c) Entire Agreement. This Agreement, together with the Restrictive Covenants Agreement, constitutes the entire agreement between you and the Company and supersedes any previous agreements or understandings between you and the Company, including, without limitation, the Employment Agreement; provided, however, that the Equity Documents remain in full force and effect, subject to the terms of this Agreement. (d) Severability. If any portion or provision of this Agreement (including, without limitation, any portion or provision of any section of this Agreement) shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law. (e) Relief. You agree that it would be difficult to measure any harm caused to the Company that might result from any breach by you of any of the Continuing Obligations. You further agree that money damages would be an inadequate remedy for any breach of the Continuing Obligations. Accordingly, you agree that if you breach, or propose to breach, any portion of the Continuing Obligations, the Company shall be entitled, in addition to all other remedies it may have, to an injunction or other appropriate equitable relief to restrain any such breach, without showing or proving any actual damage to the Company and without the 8 ACTIVE/120151144.1 necessity of posting a bond, and to its costs of enforcement of the Continuing Obligations, including its reasonable attorney's fees and expenses. In addition, and without limiting the foregoing, in the event that you breach, or propose to breach, any portion of the Continuing Obligations, the Company shall be entitled, in addition to all other remedies it may have, to discontinue the severance pay and benefits under Section 4 and/or to seek recovery of any previously paid severance pay and benefits. (f) Governing Law; Interpretation. This Agreement shall be governed by the laws of the State of New Jersey, excluding the choice of law rules thereof. In the event of any dispute, this Agreement is intended by the parties to be construed as a whole, to be interpreted in accordance with its fair meaning, and not to be construed strictly for or against either you or the Company or the "drafter" of all or any portion of this Agreement. (g) Jurisdiction. You and the Company hereby agree that the state and federal courts in the State of New Jersey shall have the exclusive jurisdiction to consider any matters related to this Agreement, including without limitation any claim of a violation of this Agreement. With respect to any such court action, you submit to the jurisdiction of such courts and you acknowledge that venue in such courts is proper. (h) Waiver; Amendment. No waiver of any provision of this Agreement shall be effective unless made in writing and signed by the waiving party. The failure of a party to require the performance of any term or obligation of this Agreement, or the waiver by a party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach. This Agreement may not be modified or amended except in a writing signed by both you and the CEO. (i) Counterparts. This Agreement may be executed in separate counterparts. When both counterparts are signed, they shall be treated together as one and the same document. Electronic and pdf signatures shall be deemed to have the same legal effect as originals. [Signature page follows.] Please indicate your agreement to the terms of this Agreement by signing and returning this Agreement within the time period set forth above. The Company wishes you the best in your future endeavors. 9 ACTIVE/120151144.1 Very truly yours, AMARIN CORPORATION PLC By: _ Name: Title: The foregoing is agreed to and accepted by: Jason Marks Date: Exhibit A Certificate I, Jason Marks, hereby acknowledge and certify that I entered into a Transition Agreement with Amarin Corporation plc (together with its subsidiaries and any controlled affiliates, the "Company") in connection with the ending of my employment (the "Agreement"). Capitalized terms used herein and not otherwise defined have the meanings ascribed to such terms in the Agreement. Pursuant to the Agreement, and provided that I have satisfied the Conditions, I am required to execute this certificate, which updates the release of claims set forth in Section 5 of the Agreement and adds a release under the Age Discrimination in Employment Act (this "Certificate"), in order to be eligible for the Severance Benefits in Section 4 of the Agreement. I understand that I may not sign this Certificate until on or after the Date of Termination and that I must return it to the Company within twenty-one (21) days after the Date of Termination. I, therefore, agree as follows: 1. A copy of this Certificate was attached to the Agreement as Exhibit A. 2. In consideration of the benefits contained in the Agreement, including but not limited to the Severance Benefits set forth in Section 4 of the Agreement, for which I become eligible only if I sign this Certificate, I hereby extend the release of claims set forth in Section 5 of the Agreement to any and all claims that arose after the date I signed the Agreement through the date I sign this Certificate, subject to all other exclusions and terms set forth in the Agreement, and I release any claims under the Age Discrimination in Employment Act. 10 ACTIVE/120151144.1 3. 4. 5. I have carefully read and fully understand all of the provisions of this Certificate, I knowingly and voluntarily agree to all of the terms set forth in this Certificate, and I acknowledge that in entering into this Certificate, I am not relying on any representation, promise or inducement made by the Company or its representatives with the exception of those promises contained in this Certificate and the Agreement. I acknowledge that I have knowingly and voluntarily entered into this Certificate and that the Company advises me to consult with an attorney before signing this Certificate. I understand and acknowledge that I have been given the opportunity to consider this Certificate for twenty-one (21) days following the Date of Termination (the "Consideration Period"). To receive the Severance Benefits, I must return a signed, unmodified original or PDF copy of this Certificate so that it is received by Donna Pasek (donna.pasek@amarincorp.com) at or before the expiration of the Consideration Period. For the period of seven (7) days from the date when I sign this Certificate, I have the right to revoke this Certificate by written notice to Ms. Pasek. For such a revocation to be effective, it must be delivered so that it is received by Ms. Pasek at or before the expiration of the seven (7) day revocation period. This Certificate shall not become effective or enforceable during the revocation period. This Certificate shall become effective on the first business day following the expiration of the revocation period (the "Effective Date of Certificate"). I agree that this Certificate is part of the Agreement. Jason Marks Date 11 ACTIVE/120151144.1 CONSENT OF LANDLORD TO SUBLEASE Exhibit 10.44 THIS CONSENT OF LANDLORD TO SUBLEASE (this “Consent”) is made as of January 20, 2023, among AMARIN PHARMA, INC., a Delaware corporation (“Sublessor”), ST SHARED SERVICES LLC, a New Jersey limited liability company (“Sublessee”), and LIBERTY DENVER WOOD LLC, a New Jersey limited liability company (“Landlord”). WHEREAS, Sublessor is the tenant under the Lease made with Landlord (as successor-in- interest to 440 Route 22 LLC), dated February 15, 2019 (the “Lease”), regarding certain premises located at 440 US Highway 22, Bridgewater, New Jersey 08807, as more particularly described in the Lease (the “Premises”). WHEREAS, pursuant to that certain Sublease Agreement dated as of January 20, 2023, between Sublessor and Sublessee (the “Sublease”) attached hereto and made a part hereof as Exhibit A, Sublessor desires to sublease, and Sublessee desires to sublet, a portion of the Premises from Sublessor, which portion (the “Subleased Premises”) contains approximately 50,000 rentable square feet. WHEREAS, Landlord hereby consents to the act of subletting of the Subleased Premises to Sublessee (not to the terms and conditions of the Sublease) in accordance with, and subject to: (i) the terms and conditions set forth in the Sublease; (ii) compliance with the terms set forth in the Lease; and (iii) subject to the terms and conditions set forth herein. NOW THEREFORE, in consideration of the Premises and other good and valuable consideration, the sufficiency and receipt of which is hereby acknowledged, the parties hereto agree as follows: 1. The foregoing recitals are hereby incorporated in this First Amendment and made a part hereof by reference. All capitalized terms used herein but undefined shall have the meaning as defined in the Lease. 2. (a) Notwithstanding anything contained in the Sublease to the contrary, Landlord’s granting of the within consent shall not be deemed a waiver of Landlord’s rights under Article 17 of the Lease to consent to or approve (a) any further or additional subletting(s) of the Premises or of the Subleased Premises or any portions thereof by Sublessor, Sublessee or any person or entity claiming by, through or under Sublessor or Sublessee, (b) any assignment or amendment of the Lease or the Sublease, or (c) any modifications, alterations or changes to the Premises. Except in connection with a Permitted Transfer, Sublessor and Sublessee hereby agree that without Landlord’s prior written consent in each instance (which consent may not be unreasonably withheld, conditioned or delayed), Sublessee shall not assign or encumber the Sublease, or further -1- -2- sublet all or any portion of the Subleased Premises, or otherwise suffer or permit the Subleased Premises, or any part thereof, to be used or occupied by others. Any person or legal representative of Sublessor and/or Sublessee, to whom Sublessor’s and/or Sublessee’s, as the case may be, interest under the Sublease passes by operation of law, or otherwise, shall be bound by the provisions of this Consent. As used in this Paragraph the word “control,” (including the derivations of the word “control,” such as “controlling”, “controlled by” or “under common control with” or words of like import) shall mean: (i) ownership of more than 50% of the outstanding voting capital stock of a corporation or more than 50% of the beneficial interests of any other entity or (ii) the ability effectively to control or direct the business decisions of such corporation or entity; and (b) Without waiving Landlord’s right to consent to an assignment of the Sublease by Sublessee or to the further subletting by Sublessee of the Subleased Premises (or portions thereof), if the interest of Sublessee in the Sublease is assigned (as defined in the Lease), or if Sublessee further sublets the Subleased Premises or any portion thereof (as defined in the Lease), Sublessor shall pay to Landlord, as additional rent under the Lease, the amounts described in Section 17.08 of the Lease to the extent received by Sublessor from Sublessee in connection with any such assignments or sublettings contemplated under Article 17 of the Lease, within ten (10) days after Sublessor’s receipt of such amounts from time to time in accordance with and as further described in Section 17.08 of the Lease. 3. Nothing contained in this Consent or in the Sublease shall be construed to modify, waive, impair or affect any of the provisions, covenants, terms or conditions contained in the Lease, or to waive any breach thereof, or any rights of Landlord against any person, firm, association, company or corporation liable or responsible for the performance thereof, or to enlarge or increase Landlord’s obligations or liabilities under the Lease at law or in equity, or to expand or increase any of Sublessor’s rights under the Lease, and all provisions, covenants, agreements terms and conditions of the Lease are hereby declared to be in full force and effect, and by execution of this Consent, as of the effective date of said Consent, Sublessor confirms such and that to Sublessor’s knowledge that Landlord has performed its obligations thereunder without default. 4. No alterations, improvements or additions to the Subleased Premises, or any portion thereof, shall be made by or on behalf of Sublessor or Sublessee except in accordance with the provisions of the Lease, notwithstanding anything contained in the Sublease which may be deemed to the contrary. Nothing contained in this Consent or otherwise shall be deemed a waiver by Landlord of Sublessor’s removal and restoration obligations under the Lease with respect to alterations and improvements installed or otherwise made in or to the Premises or other portions of the Building by or on behalf of Sublessor (or any person or entity, including, without limitation, Sublessee, claiming by, through or under Sublessor). -3- 5. Nothing contained in this Consent or in the Sublease, nor any amendment or modification of the Sublease (whether made with or without Landlord’s consent), shall be deemed to constitute a release of Sublessor from any of its obligations as tenant under the Lease, and Sublessor shall remain fully liable for the performance of all of its obligations as tenant under the Lease, and shall be fully responsible for all the acts and omissions of Sublessee or anyone claiming by, under or through Sublessor or Sublessee that shall be a violation of, or default under, any of the obligations or liabilities of tenant under the Lease, provided that nothing stated herein shall operate to limit or negate any indemnification obligation of Sublessee to Sublessor under the Sublease. Both Sublessor and Sublessee shall be and continue to be jointly and severally liable for all unpaid bills rendered by Landlord for charges incurred or imposed for services rendered and material supplied to the Subleased Premises, during the term of the Sublease, by Landlord whether requested by Sublessor on Sublessee’s behalf and/or Sublessee. The execution of this Consent by Sublessee and any acceptance by Landlord of any base rent or additional rent under the Lease directly from Sublessee shall not be deemed to create privity of title or contract but an election of mitigation of Sublessor’s obligations as tenant and shall be deemed received on behalf of Sublessor as tenant under the Lease and shall be credited against Sublessor’s obligation as tenant to pay the full amount of such Base Rent and Additional Rent, provided, however, that nothing contained in this Consent or in the Lease or otherwise shall require Landlord to accept from Sublessee any such Base Rent and Additional Rent. 6. The Sublease shall be subject and subordinate at all times to the Lease, to all of the terms, covenants, conditions, provisions and agreements (collectively, “Provisions”) contained therein (notwithstanding anything contained in the Sublease which may be deemed to the contrary), and to all instruments, agreements and other matters to which the Lease is or shall be subject and subordinate, and to any renewals, extensions, modifications or replacements of any of the foregoing. Sublessee shall not do any act or thing which violates, or is a default under, the Lease. Any breach or violation of any Provision of the Lease by Sublessee shall be deemed to be and shall constitute a default by Sublessor in fulfilling such Provisions and, in such event, Landlord shall have all of the rights, powers and remedies provided in the Lease or at law or in equity or by state or otherwise with respect to defaults. In the event the Lease expires or terminates for any reason or in the event of re-entry or dispossess by Landlord under the Lease, then, notwithstanding anything contained in the Sublease which may be deemed to the contrary, provided that Sublessee is not then in default under the Sublease, upon the termination of Lease, the Sublease shall automatically become a direct lease between Landlord and Sublessee, and Sublessee shall attorn to Landlord pursuant to the then executory provisions of the Sublease, except that (i) the annual Fixed Rent under the Sublease shall be increased for the balance of the Term to the annual Base Rent per square foot under the Lease (by way of example, if the Sublease becomes a direct lease with Landlord during the last six months of the Term, then the Fixed Annual Rent would be increased from $25.50 per RSF to $30.50 per RSF, resulting in the Monthly Fixed Rent for such period being increased from $106,250.00 to $127,083.33), and (ii) the Landlord shall not be (except as otherwise provided below): -4- (a) liable for any previous act or omission of Sublessor under the Sublease; (b) subject to any credits, offsets, claims, counterclaims, demands or defenses which Sublessee may have against Sublessor, except for a claim or defense that Sublessee paid the Base Rent, Additional Rent, or other charges payable under the Sublease in accordance with the provisions thereof (excluding any prepayment of more than one month’s such rent, additional rent or other charges); (c) bound by any previous modification of the Sublease or by any previous prepayment of more than one month’s rent or other Additional Rent (notwithstanding anything contained in subsection (b) above to the contrary), unless such modification or prepayment shall have been expressly approved in writing by Landlord, Sublessor and Sublessee hereby agreeing that Landlord has not approved any prepayment of Rental; (d) bound by any covenant to undertake or complete any construction of the Subleased Premises or any portion thereof or to perform any other work that Sublessor is obligated to perform (except to the extent Landlord is expressly obligated to undertake or complete such construction or to perform any other work under the terms of the Lease) or to pay for or reimburse Sublessee for any costs incurred in connection with any construction or work, Sublessor and Sublessee hereby agreeing that Landlord is not in this Consent approving, nor has Landlord heretofore approved, the performance of any work on behalf of Sublessee or with respect to the Subleased Premises unless expressly contained in a fully executed agreement among Landlord, Sublessor and Sublessee; (e) required to account for any security deposit of Sublessee other than any security deposit actually received by Landlord, notwithstanding anything contained in subsection (b) above to the contrary; (f) period as Landlord holds such interest; liable for the obligations of Sublessor under the Sublease for any period of time other than such the credit of Sublessee; (g) subject to the provisions of subsection (e) above, responsible for any monies owing by Sublessor to arising prior to the date on which such takeover and attornment became effective; (h) bound by any obligation to make any payment to Sublessee or grant or be subject to any credits (i) provide or furnish under the Lease; bound by any obligation to provide any service or furnish any utility that Landlord is not obligated to -5- bound by any Base Rent and Additional Rent payable by Sublessee under the Sublease prior to acceptance of Sublessee as a direct tenant under the terms of the Sublease upon recognition of Sublessee and Sublessee’s attornment as required hereby; and (j) be liable for all restoration obligations set forth under the Lease. (k) bound by any limitations on Sublessee’s obligation to restore the Premises, but rather Sublessee shall 7. At a minimum, and in addition to Sublessor’s insurance obligations under the Lease, Sublessee shall maintain all insurance coverage in forms and manner that Sublessor is required to maintain under the Lease. In addition, all insurance maintained (or required to be maintained) by Sublessee for the benefit of Sublessor shall also be maintained for the benefit of Landlord. Landlord (and all other persons and entities designated by Landlord) shall be named as an additional insured on all insurance policies maintained by Sublessee with respect to the Subleased Premises and the Sublease, and copies of all insurance certificates evidencing such insurance shall be in form and substance reasonably acceptable to Landlord, delivered to Landlord prior to the commencement of the term of the Sublease, from time to time thereafter, within five (5) days after Landlord’s request therefor, and within ten (10) days after any of the insurance coverage maintained by or on behalf of Sublessee is renewed, extended or modified. Sublessee shall cause to be included in each of its property insurance policies (including business interruption) a waiver of the insurer’s right of subrogation against Landlord and Sublessor, and Sublessee hereby releases Landlord and Sublessor from any claim (including a claim for negligence) which Sublessee might otherwise have for loss, damage or destruction to Sublessee’s property (including business interruption) to the extent to which such loss, damage or destruction is insured by Sublessee or would have been required to be insured by Sublessee if Sublessee were the tenant under the Lease. Landlord shall cause its managing agent to include a waiver of insurer’s right of subrogation as against Sublessee. 8. (a) The term of the Sublease shall end no later than one day prior to the last day of the term of the Lease, and Sublessee shall have no right or option to renew or extend the term of the Lease; and (b) Except to the extent Sublessee is permitted to remain in occupancy of the Subleased Premises pursuant to Paragraph 5 above, Sublessee’s failure to vacate and surrender the Subleased Premises in accordance with the applicable provisions of the Lease on or before the last day of the term of the Lease shall be deemed Sublessor’s failure to vacate and surrender the entire Premises, entitling Landlord to exercise and enforce against Sublessee any and all of its rights and remedies under the Lease, at law and in equity. In addition, subject to the provisions of Section 3 of this Consent, if Sublessee fails to vacate and surrender the Subleased Premises in accordance with the applicable provisions of the Lease on or before the last day of the term of the Lease, Sublessee agrees that it will not seek, and it expressly waives any right to seek, any stay of prosecution of, -6- or the execution of any judgment awarded in, any action by Landlord to recover possession of the Premises or any part thereof and Sublessee shall indemnify, defend and hold harmless Landlord from any reasonable costs or damages resulting from the breach hereof or the enforcement by Landlord of the terms of this Consent or the Lease, including reasonable legal fees and all related court costs and experts fees. Subject to the provisions of Section 6 of this Consent, nothing contained in this Paragraph 7(b) shall be deemed to give Sublessee the right to remain in possession or occupancy of any portion of the Subleased Premises beyond the last day of the term of the Sublease. 9. Landlord’s obligations to Sublessor are governed only by the Lease and this Consent. Landlord shall be deemed not to have any obligations directly to Sublessee and shall have no obligations to Sublessee under the Lease, Sublease or this Consent and there shall be deemed to be no privity of contract or estate created between Landlord and Sublessee in fact or inferred from this Consent; provided, however that (a) Sublessee may deal directly with Landlord (and/or the manager of the Building) with respect to requesting overtime services and other services provided by or through Landlord, and (b) Landlord agrees that Sublessee shall have the right to directly enforce the rights of the Sublessor as Tenant under the Lease and the obligations of Landlord under the Lease with respect to the Subleased Premises. Notwithstanding the fact that a copy of the Sublease has been delivered to Landlord for its information and is annexed hereto, Sublessor and Sublessee acknowledge and agree that Landlord is not a party thereto and is not bound by any of its provisions and is approving the act of the subleasing and not the contents of the Sublease document or terms thereof. Nothing contained in this Consent shall be construed as a consent to, or approval or ratification by Landlord of, any of the particular provisions of the Sublease or as a representation, certification or warranty by or of Landlord. Except as expressly provided in this Consent, neither the acceptance by Landlord of any Base Rent or Additional Rent or other charges or sums under the Lease or Sublease from Sublessee, nor Sublessee’s execution of this Consent, nor anything else contained in the Sublease or in this Consent, nor any other act or deed, shall create or be deemed to have created any privity of estate or privity of contract between Landlord and Sublessee. Landlord shall be deemed to be a third-party beneficiary of Sublessee’s obligations and liabilities under this Consent. (For the purposes of illustration and not limitation, if Sublessee requests that Landlord provide any building service for which Landlord imposes a separate charge, and if such service is provided by Landlord from time to time, Sublessee and Sublessor shall remain primarily liable for payment of such charges pursuant to the terms of the Lease, provided that nothing stated herein shall operate to limit or negate any payment obligation of Sublessee to Sublessor under the Sublease). 10. The failure on the part of Sublessor or Sublessee to observe, perform or comply with any of the terms, covenants or conditions in this Consent on their respective parts to observe, perform or comply with, or any representation or warranty of Sublessor or Sublessee in this Consent being are false, incorrect or misleading, in any material respect, or any action taken by Sublessee which would constitute a default under the Lease, shall be a default by Sublessor under -7- the Lease, entitling Landlord to exercise any or all of its rights and remedies thereunder, at law and in equity. 11. Sublessor and Sublessee jointly and severally shall indemnify and hold Landlord harmless from and against all costs, expenses, commissions, fees, compensation and damages paid or incurred by Landlord (including, without limitation, all legal, litigation and courts costs, expenses and disbursements for which Landlord is liable) arising under or out of, or in connection with, or resulting from (a) any and all claims, actions or proceedings made or brought by any brokers (including, without any limitation, Jones Lang LaSalle Brokerage, Inc.), finders or consultants with whom Sublessor or Sublessee has dealt, or is claimed to have dealt, in connection with this Consent, the Sublease or the subletting of any portion of the Premises to Sublessee, and/or (b) any dispute between Sublessor and Sublessee regarding this Consent, the Lease, the Subleased Premises and/or the Sublease, only to the extent said dispute does not arise out of the gross negligence, willful misconduct or intentional or bad faith breach of a term or provision of the Lease by Landlord. 12. (a) Sublessor and Sublessee represent and warrant that: (i) no Base Rent, Additional Rent or other consideration of any kind (directly or indirectly) has been paid, is being paid or is payable to, or at the direction of, Sublessor or any person or entity which is affiliated or related to Sublessor, by, or on behalf of, or any person or entity which is affiliated or related to Sublessee, directly or indirectly in respect of the Sublease or for the right to use or occupy the Subleased Premises or for the use, sale or rental of fixtures, leasehold improvements, equipment, furniture or other personal property, except as expressly set forth in the Sublease, and (ii) the copy of the Sublease attached to this Consent is a complete, true and correct copy thereof and there are no other agreements or understandings (oral or written) relating to the subletting of the Subleased Premises by Sublessor to Sublessee, including, without limitation, any agreements or understandings relating to the payment of any rent, additional rental or other consideration of any kind (directly or indirectly) to, or at the direction of, Sublessor or any person or entity which is affiliated or related to Sublessor, by, or on behalf of, or any person or entity which is affiliated or related to Sublessee. For the purposes of illustration and not limitation, the full or partial release by Sublessee of an obligation owed by Sublessor would be deemed a payment by Sublessee to Sublessor; and (b) Neither Sublessor nor Sublessee shall change, modify, amend, cancel or terminate the Sublease or enter into any additional agreements relating to or affecting the use or occupancy of the Subleased Premises or any other portion of the Premises or the use, sale or rental of fixtures, or leasehold improvements, without first notifying Landlord in writing, and neither Sublessor nor Sublessee shall change, modify or amend the Sublease in any material manner or enter into any additional material agreements relating to or affecting the use or occupancy of the Subleased -8- Premises or any other portion of the Premises or the use, sale or rental of fixtures, or leasehold improvements, or enter into any agreement renewing or extending the term of the Sublease, without first obtaining Landlord’s prior written consent thereto, which consent shall be granted or denied in accordance with, and subject to, the applicable provisions of the Lease, as if the modification, amendment or agreement in question had been a part of the original Sublease. Notwithstanding the foregoing, Sublessor and Sublessee shall have the right, upon prior written notice to Landlord, to terminate or cancel the Sublease, without prior consent of Landlord, but any such termination or cancellation shall not release or relieve Sublessor from any of its obligations or liabilities under the Lease or this Consent, and any such termination or cancellation shall not release or relieve Sublessee from any of its obligations or liabilities under this Consent. (c) Sublessor warrants and represents to Landlord that: (i) The Lease is in full force and effect; to Sublessor’s actual knowledge no default exists on the part of Landlord under the Lease; Sublessor has neither received nor given any notice of default thereunder which continues at the date hereof; Sublessor has no actual knowledge of the existence of any condition which constitutes a default under the Lease or which, with the giving of notice or the passage of time, or both, would constitute a default under the Lease; Sublessor has no actual knowledge of any defense or counterclaim to the enforcement of the Lease; and to Sublessor’s actual knowledge, Sublessor is not entitled to any reduction, offset or abatement of the rents payable under the Lease; (ii) Sublessor is the present tenant under the Lease, has a valid and subsisting leasehold estate to the Premises under the Lease; (iii) Neither Sublessor nor any Sublessor Entity (as hereinafter defined) has introduced hazardous substances in or to the Premises in violation of the Lease other than customary and typical office cleaning products; (iv) Sublessor has not committed, permitted or suffered, and shall not commit, permit or suffer, any act or deed whereby the Premises (or any portion(s) thereof), the Lease, or the security deposited thereunder, have been, or may be, or will be, pledged, hypothecated, encumbered, assigned, conveyed or otherwise transferred, except as set forth in this Consent or in accordance with the Lease; (v) To Sublessor’s knowledge, there are no liens, security interests, chattel mortgages or other encumbrances against the Premises, the Building, Landlord, or any interest in the Premises, the Building or Landlord, created by, or otherwise directly or indirectly resulting from, the act or omission of Sublessor or of any person or entity claiming by, through and under Sublessor, including subtenants, licensees and concessionaires of any portion of the Premises, and the employees, invitees, agents and -9- contractors of Sublessor or of any such subtenants, licensees or concessionaires (any such person or entity being herein referred to as a “Sublessor Entity”); (vi) Other than Sublessor’s agreement to sublease the Premises to Sublessee, Sublessor has not sublet, underlet, assigned, pledged, encumbered or otherwise transferred any present or future possessory, use or occupancy right in or to all or any portions of the Lease or the Premises; (vii) Sublessor is not insolvent and has not filed a voluntary petition under any bankruptcy or insolvency law and no involuntary petition under any bankruptcy or insolvency law has been filed against Sublessor; and (viii) All work hereto performed by or on behalf of Sublessor and all Sublessor Entities in or to any portion of the Premises or any other portion of the Building has been paid for in full and there are no liens outstanding in respect thereof. 13. other, that: Sublessor and Sublessee each hereby separately represent and warrant to Landlord as to itself, but not the (a) it is not acting, directly or indirectly, for or on behalf of any person, group, entity, or nation named by any Executive Order or the United State Treasury Department as a terrorist, “Specially Designated National and Blocked Person,” or other banned or blocked person, entity, nation, or transaction pursuant to any law, order, rule, or regulation that is enforced or administered by the Office of Foreign Assets Control; this transaction, directly or indirectly on behalf of, any such person, group, entity, or nation; and (b) it is not engaged in this transaction, directly or indirectly on behalf of, or instigating or facilitating (c) neither Sublessor nor Sublessee nor any person, group, entity or nation who owns any direct or indirect beneficial interest in Sublessor or Sublessee or any of them is in violation of any anti-money laundering or anti- terrorism statute, including, without limitation, the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, U.S. Public Law 107-56 (commonly known as the USA PATRIOT Act) and the related regulations issued thereunder, including, without limitation, temporary regulations, all as amended from time to time. Sublessor and Sublessee each hereby agree to defend, indemnify, and hold harmless Landlord and its respective partners, lenders, shareholders, directors, officers, agents and employees from and against any and all claims, damages, losses, liabilities and expenses (including reasonable attorney’s fees and costs) arising from or related to any breach by it of its own representations contained in this Paragraph 14. -10- 14. The Subleased Premises and each part thereof shall be occupied and used by Sublessee solely for general, executive and administrative offices and for no other purpose, and such use and occupancy shall be conducted in accordance with all applicable provisions of the Lease. Neither Sublessor nor Sublessee shall use or permit the use of the Subleased Premises or any part thereof for any purpose which is inconsistent with the first-class character of the Building, and neither Sublessor nor Sublessee shall suffer or permit the Subleased Premises or any part thereof to be used in any manner, or permit anything to be done therein or suffer or permit anything to be brought into or kept in the Subleased Premises or any part thereof, which creates excessive elevator use, exceeds the floor loads for which the Building was designed, materially impairs or interferes with any of the Building operations or the proper and economic operation of the Building systems, cleaning or other servicing of the Building (other than to a de minimis extent), interferes with the use of the other areas of the Building by any other tenants, or impairs the appearance of the Building. Neither Sublessor nor Sublessee shall install or permit to be installed in the Subleased Premises or any part thereof any electrical or other similar or dissimilar equipment of any kind which, in the reasonable judgment of Landlord, might foreseeably cause any such interference or impairment. 15. Landlord’s granting of the within consent is conditioned upon (a) the delivery to Landlord of a fully executed counterpart of the Sublease between Sublessor and Sublessee, (b) the payment by Sublessor to Landlord of any amounts payable under Section 17.08 of the Lease, if applicable, and (c) the payment by Sublessor of said counsel’s reasonable legal fee and disbursements and all other reasonable costs, fees and expenses paid or incurred by Landlord in connection with this Consent and/or the Sublease review as set forth in Section 17.07 of the Lease; which amounts hereinabove reflected in (b) through (c) shall be deemed to be Additional Rent under the Lease and shall be paid to Landlord upon Sublessor’s execution of this Consent. 16. Notwithstanding anything contained in the Lease or Sublease to the contrary, as it relates to Sublessee, Section 13.01 of the Lease shall not apply. Landlord agrees, at its expense, place identification for Sublessee in the internal building directories, if any. Subject to Landlord’s prior written consent, not to be unreasonably withheld, Sublessee, at its own expense, shall have the right to install a sign identifying Sublessee at the entrance to the Subleased Premises. Sublessee shall not otherwise have the right to install any signage at the Subleased Premises or at the Building without first obtaining Landlord’s prior written consent, which may be withheld in Landlord’s sole discretion. Sublessee shall maintain all signs installed by Sublessee in good condition and in compliance with all applicable Laws and the Building’s Rules and Regulations. Sublessee shall remove its signs at the termination of the Sublease, shall repair any resulting damage, and shall restore the Property to its condition existing prior to the installation of Sublessee’s signs. Nothing herein shall affect Sublessor’s rights under Section 13.01 as Tenant and such rights shall remain in full force and effect. -11- 17. Notwithstanding anything contained in the Lease or Sublease to the contrary, as it relates to Sublessee, Section 22.04 of the Lease shall be modified to reflect that all Landlord’s reasonable out-of-pocket costs associated with providing Sublessee subordination non-disturbance and attornment agreements shall be paid by Sublessee to Landlord within fifteen (15) days after Landlord’s request. 18. (a) This Consent constitutes the entire agreement between the parties with respect to the subject matter hereof, and all understandings and agreements heretofore or simultaneously had between the parties are merged in and are contained in this Consent. (b) Sublessor and Sublessee each separately represent and warrant that it has not relied upon any representation or warranty of Landlord (or any of Landlord’s agents or employees), express or implied, in entering into this Consent. (c) This Consent shall be governed by and construed in accordance with the laws of the State of New Jersey applicable to agreements made and to be performed in that State. (d) This Consent may not be changed orally, and shall be binding upon and inure to the benefit of the parties to it, their respective successors and assigns. If any provision of this Consent, or its application to any situation, shall be invalid or unenforceable to any extent, the remainder of this Consent, or the application thereof to situations other than that as to which it is invalid or unenforceable, shall not be affected thereby, and every provision of this Consent shall be valid and enforceable to the fullest extent permitted by law. (e) This Consent shall be construed without regard to any presumption or other rule requiring construction against the party causing this Consent to be drafted. In the event of any action, suit, arbitration, dispute or proceeding affecting the terms of this Consent, no weight shall be given to any deletions or striking out of any of the terms of this Consent contained in any draft of this Consent and no such deletion or strike out shall be entered into evidence in any such action, suit, arbitration, dispute or proceeding nor given any weight therein. (f) If there shall be any conflict or inconsistency between the terms, covenants and conditions of this Consent or the Lease and the Sublease, then the terms, covenants and conditions of this Consent or the Lease shall prevail. If there shall be any conflict or inconsistency between this Consent and the Lease, this Consent will control. (g) Each right and remedy of Landlord provided for in this Consent or in the Lease shall be cumulative and shall be in addition to every other right and remedy provided for therein or now or hereafter existing at law or in equity or by statute or otherwise, and the exercise or -12- beginning of the exercise by Landlord of any one or more of the rights or remedies so provided for or existing shall not preclude the simultaneous or later exercise by Landlord of any or all other rights or remedies so provided for or so existing. (h) TO THE EXTENT THAT LANDLORD HAS ANY LIABILITY UNDER THIS CONSENT, SUCH LIABILITY SHALL BE LIMITED TO LANDLORD’S ESTATE AND PROPERTY INTEREST IN THE BUILDING ONLY, AND NO OTHER PROPERTY OR ASSETS OF LANDLORD OR ANY PARTNER, MEMBER, OFFICER OR DIRECTOR THEREOF, DISCLOSED OR UNDISCLOSED SHALL BE SUBJECT TO LEVY, EXECUTION OR OTHER ENFORCEMENT PROCEDURE FOR THE SATISFACTION OF ANY REMEDIES UNDER OR WITH RESPECT TO THIS CONSENT. LANDLORD SHALL IN NO EVENT BE LIABLE FOR ANY LOSS OF BUSINESS OR ANY INDIRECT OR CONSEQUENTIAL DAMAGES UNDER OR WITH RESPECT TO THIS CONSENT OR THE SUBLETTING OF THE SUBLEASED PREMISES. THE OBLIGATIONS, IF ANY, OF LANDLORD UNDER THIS CONSENT SHALL NOT BE BINDING UPON LANDLORD HEREIN NAMED WITH RESPECT TO ANY PERIOD SUBSEQUENT TO THE TRANSFER OF ITS INTEREST IN THE BUILDING AS OWNER OR LESSEE THEREOF AND IN EVENT OF SUCH TRANSFER SAID OBLIGATIONS SHALL THEREAFTER BE BINDING UPON EACH TRANSFEREE OF THE INTEREST OF LANDLORD HEREIN NAMED AS SUCH OWNER OR LESSEE OF THE BUILDING, BUT ONLY WITH RESPECT TO THE PERIOD ENDING WITH A SUBSEQUENT TRANSFER WITHIN THE MEANING OF THIS SUBPARAGRAPH. (i) LANDLORD, SUBLESSOR AND SUBLESSEE HEREBY WAIVE TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER AGAINST THE OTHER ON ANY MATTER WHATSOEVER ARISING OUT OF OR IN ANY WAY CONNECTED WITH THIS CONSENT. (j) All of Sublessor’s and Sublessee’s respective obligations and liabilities under and with respect to this Consent shall survive the expiration and/or termination of the Lease and the Sublease, for a period of no less than three (3) years. (k) This Consent may be executed in one or more counterparts, each of which shall be deemed an original. Said counterparts shall constitute but one and the same instrument and shall be binding upon each of the undersigned individually as fully and completely as if all had signed but one instrument. The signature of any party on a copy of this Consent forwarded by facsimile transmission or other electronic transmission (e.g., in Portable Document Format) shall be deemed to be an original signature. [THE BALANCE OF THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK] -13- IN WITNESS WHEREOF, the parties hereto have caused this Consent to be duly executed as of the effective date hereinabove stated. LANDLORD: LIBERTY DENVER WOOD LLC By: Name: Title: SUBLESSOR: AMARIN PHARMA, INC. By: Name: Title: SUBLESSEE: ST SHARED SERVICES LLC By: Name: Title: Signature Page to Consent Exhibit A to Consent EXHIBIT A. SUBLEASE (follows this cover page) GUARANTY Exhibit 10.45 MEH, INC., a corporaon organized under the laws of the state of Nevada, having an address of 675 McDonnell Blvd., Hazelwood, MO 63042, An: Jeffrey Hunter (the “Guarantor”) has requested that AMARIN PHARMA, INC., a Delaware corporaon, having an address at 440 Route 22, Suite 300, Bridgewater, New Jersey 08807 (“Sublessor”) to enter into a Sublease Agreement of even date herewith (the “Sublease”) with ST SHARED SERVICES LLC, a New Jersey limited liability company, having an address of 675 McDonnell Blvd., Hazelwood, MO 63042 (the “Sublessee”) covering certain premises located at 440 US Highway 22, Bridgewater, New Jersey, as more parcularly described in the Sublease. In order to induce Sublessor to enter into the Sublease and in consideraon of Sublessor’s entering into the Sublease, Guarantor hereby guarantees, uncondionally and absolutely, to Sublessor, its successors and assigns (without requiring any noce of non-payment, non-keeping, non- performance or non-observance or proof of noce or demand whereby to charge Guarantor all of which Guarantor hereby waives, other than such noce as required to be given to Sublessee under the Lease which noce may be delivered simultaneously to Guarantor and Sublessee and for purposes of which shall be deemed given to Guarantor if given to Sublessee so long as Guarantor remains affiliates with Sublessee) the full and faithful keeping, performance and observance of all the covenants, agreements, terms, provisions and condions provided to be kept by Sublessee under the Sublease, including, without limitaon, the payment as and when due of all Fixed Rent, Addional Rent, charges and damages payable by Sublessee under the Sublease. All capitalized terms not defined herein shall have the meanings ascribed to them in the Sublease. As a further inducement to Sublessor to enter into the Sublease and in consideraon thereof, Guarantor hereby covenants and acknowledges as follows: (1)Guarantor is the indirect owner of an equity interest in Sublessee. (2)The obligaons of Guarantor shall not be terminated or affected in any way or manner whatsoever by reason of Sublessor’s failure to resort to any summary or other proceedings, acons or remedies for the enforcement of any of Sublessor’s rights under the Sublease or by reason of any extensions of me or indulgences granted by Sublessor, or by reason of the assignment or surrender of all or any part of the Sublease or the term and estate thereby granted or all or part of the Subleased Premises. The liability of Guarantor is co(cid:0)extensive with that of Sublessee and also joint and several, and acon or suit may be brought against Guarantor and carried to final judgment and/or compleon and recovery had, either with or without making Sublessee or any other guarantor a party thereto. Insofar as the payment by Sublessee of any sums of money to Sublessor is involved, this Guaranty is a guaranty of payment and not of collecon and shall remain in full force and effect unl payment in full to Sublessor of all sums payable under this Guaranty. Guarantor waives any right to require that any acon be brought against Sublessee or to require that resort be had to any secured interest, security or to any other credit in favor of Sublessee. (3)If the Sublease be modified by agreement between Sublessor and Sublessee in any other respect, the obligaons of Guarantor shall extend and apply with respect to the full and faithful keeping, performance and observance of all of the covenants, agreements, terms, provisions and condions which under such renewal of the Sublease or extension of its terms or which under any new sublease or amendment or modificaon agreement, entered into for the purpose of express or confirming any such renewal, extension, inclusion, substuon or modificaon, are to be kept, performed and observed by Sublessee (including, without being limited to, the payment as and when due of Fixed Rent, Addional Rent, charges and damages provided for thereunder). (4)Neither Guarantor’s obligaon to make payment in accordance with the terms of this Guaranty nor any remedy for the enforcement thereof shall be impaired, modified, changed, stayed, released or limited in any manner whatsoever by any impairment, modificaon, change, release, limitaon or stay of the liability of Sublessee or its estate in bankruptcy or any remedy for the enforcement thereof, resulng from the operaon of any present or future provision of the Bankruptcy Act of the United States or other statute or from the decision of any court interpreng any of the same, and Guarantor shall be obligated under this Guaranty as if no such impairment, stay, modificaon, change, release or limitaon has occurred. (5)This Guaranty shall be binding on Guarantor and its successors and assigns and inure to the benefit of Sublessor and its successors and assigns. (6)Guarantor and Sublessor each waives the right to trial by jury in any acon or proceeding in respect of this Guaranty. (7)It is expressly understood and agreed by Guarantor and Sublessor that all maers arising out of the Sublease and this Guaranty, including the validity or any provisions hereof, are to be governed by, interpreted and construed in accordance with the laws of the State of New Jersey (without giving regard or effect to any conflicts of law rules or other choice of law rules). (8)With respect to any dispute or legal acon of any kind arising from the terms of this Guaranty that any party may have, either during the term of this Guaranty or thereaer, it is expressly agreed that such acon shall be brought either in the state courts of the State of New Jersey (or in the United States District Court for the District of New Jersey, to the extent such court has jurisdicon thereof), and that such court shall be deemed to be the court of sole and exclusive jurisdicon and venue for the bringing of such acon. The foregoing consent to jurisdicon and venue shall not constute general consent by Guarantor to jurisdicon and venue in the State of New Jersey for any purpose except as provided herein and shall not be deemed to confer rights on any other person or enty. (9)Guarantor consents that Sublessee shall hereaer have full authority and be duly empowered to accept service of process on behalf of Guarantor in connecon with the enforcement of this Guaranty, and Guarantor hereby appoints Sublessee as its agent for purposes of acceptance of service of process in connecon with the enforcement of this Guaranty. (10)Provided that Sublessor is the prevailing party in any acon brought to enforce this Sublease Guaranty, Guarantor shall pay to Sublessor all of Sublessor’s reasonable expenses, including, without limitaon, reasonable third-party out of pocket aorneys’ fees and disbursements, in enforcing this Sublease Guaranty following an event of default by Sublessee under the Sublease, beyond any applicable noce and cure periods. Dated: January 20, 2023 GUARANTOR: MEH, INC., a Nevada corporation By: __________________________________ Name: Title: SUBLEASE AGREEMENT Exhibit 10.46 THIS SUBLEASE AGREEMENT (the “Sublease”) made this 20th day of January, 2023 by and between AMARIN PHARMA, INC., a Delaware corporation, having an address at 440 Route 22, Suite 300, Bridgewater, New Jersey 08807 (the “Sublessor”), and ST SHARED SERVICES LLC, a Delaware limited liability company, having an address at 675 McDonnell Blvd. St. Louis, MO 63042 (the “Sublessee”). BACKGROUND: A. By lease dated February 5, 2019 (the “Prime Lease”), LIBERTY DENVER WOOD, LLC, a New Jersey limited liability company, having an address at 950 Airport Road, Lakewood, New Jersey 08701, as successor-in-interest to 440 ROUTE 22 LLC (the “Prime Landlord”) leased to Sublessor certain premises (the “Premises”) in an office building located at 440 U.S. Highway 22, Bridgewater, New Jersey 08807 (the “Property”). The Premises consists of approximately 67,747 rentable square feet located on the third floor of the Property and is shown on the plan attached to this Sublease as Exhibit A. B. A copy of the Prime Lease is attached to this Sublease as Exhibit B. Capitalized terms which are used but not otherwise defined in this Sublease shall have the meanings ascribed to them in the Prime Lease. C. Sublessee desires to sublease a portion of the Premises from Sublessor, which portion (the “Subleased Premises”) contains approximately 50,000 rentable square feet and is shown by hatching on Exhibit A-1. NOW, THEREFORE, for and in consideration of the covenants and agreements set forth in this Sublease, and intending to be legally bound, Sublessor and Sublessee agree as follows: 1. Demise; Term. Demise. Sublessor hereby subleases the Subleased Premises to Sublessee, and Sublessee hereby subleases the Subleased Premises from Sublessor, together with all fixtures installed in the Subleased Premises by or for the benefit of Sublessor, and also together with all appurtenances and rights ancillary to the Subleased Premises. 1.1. 1.2. Term. 1.2.1. The term of this Sublease (the “Sublease Term”) shall begin on the later of (A) February 1, 2023, or (B) the date that Sublessor receives the Prime Landlord’s Consent (as defined in Section 23.1 of this Sublease) (the “Sublease Commencement Date”). It shall be a condition of the Sublease Commencement Date that Sublessor delivers possession of the Subleased Premises to Sublessee in the condition required pursuant to this Sublease. The Sublease Term shall expire on August 30, 2030, unless sooner terminated by either party as provided in this IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 1 Sublease. The term “Lease Year” as used in this Sublease shall mean the period of twelve (12) full calendar months commencing on the Sublease Commencement Date plus any partial month following the Sublease Commencement Date if the Sublease Commencement Date is not the first day of a month and each twelve (12) month period thereafter. 1.2.2. In the event that Sublessor fails to deliver possession of the Subleased Premises in the condition required hereunder within the later of (i) thirty (30) days after Sublessor receives the Prime Landlord’s Consent; and, (ii) March 1, 2023, in each case subject to day-for-day extensions for matters outside Sublessor’s reasonable control (the “Outside Delivery Date”), for any reason or no reason, the Sublease Commencement Date shall be postponed and Sublessee shall receive an abatement of Fixed Rent (in addition to the six (6) month abatement of Fixed Rent set forth in Section 4.1 hereof) equal to one (1) day of Fixed Rent for each day of delay between the Outside Delivery Date and the Sublease Commencement Date. 2. Prime Lease. 2.1. Terms of Sublease Identical With Prime Lease. It is intended that the terms and conditions of this Sublease shall be identical to the terms and conditions of the Prime Lease as they relate to the Subleased Premises, except to the extent inconsistent with the express terms of this Sublease and except as set forth in Section 2.2 of this Sublease. Therefore, Sublessor and Sublessee agree that: 2.1.1. each and every term, condition, covenant and agreement of the Prime Lease, as it relates to the Subleased Premises, is a term, condition, covenant and agreement of this Sublease, and is incorporated in this Sublease by reference, except to the extent inconsistent with the express terms of this Sublease and except as set forth in Section 2.2 of this Sublease; 2.1.2. Sublessee shall perform all obligations and comply with all terms, conditions, covenants and agreements of Sublessor as tenant under the Prime Lease for the Sublease Term, as they relate to the Subleased Premises, except to the extent inconsistent with the express terms of this Sublease and except as set forth in Section 2.2 of this Sublease. Sublessee shall have no obligation to perform any of the obligations of Sublessor as “tenant” under the Prime Lease that accrue prior to the Sublease Commencement Date except those that relate to the Subleased Premises and that are ongoing after the Sublease Commencement Date. 2.1.3. For avoidance of doubt, Sublessor shall remain solely responsible for the obligations of the Tenant under the Prime Lease with respect to that portion of the Premises not subleased to Sublessee pursuant to this Sublease (the “Remaining Premises”), and Sublessor shall perform all obligations and comply with all terms, conditions, covenants and agreements of Sublessor as tenant under the Prime Lease for the Sublease Term, as they relate to the Remaining Premises. the term “Tenant” as set forth in the Prime Lease shall mean Sublessee in this Sublease. 2.1.4. The term “Landlord” as set forth in the Prime Lease shall mean Sublessor in this Sublease and IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 2 provisions of the Prime Lease are not incorporated in or made part of this Sublease or otherwise are amended as follows: 2.2. Terms Not Incorporated. Notwithstanding the provisions of Section 2.1 of this Sublease, the following Section 1.01. Basic Data and Definitions. Subsections (d), (e), (f), (g), (h), (i), (j), (k), (l), (m). Section 2.02. Term and Lease Year. Section 2.04. Renewal Option. Section 2.05. Right of First Offer. Section 3.01. Rental Section 4.01. Base Rent Section 7.05(c) (with respect to the NAICS Code) • • • • • • • • Article 6. Landlord’s Work. • Article 13. Signs • Article 27. Security Deposit • Article 29. Brokerage Claims • Article 31. Termination Right • Article 33. Guaranty Exhibit G. Guaranty • those set forth in the Prime Lease, the terms and conditions set forth in this Sublease shall control. 2.3. Sublease Controls. If there is a conflict between the stated terms and conditions in this Sublease and 2.4. Performance To Be Tendered To Prime Landlord. Except as otherwise provided in this Sublease, Sublessee shall tender performance of its obligations under this Sublease (other than the payment of Fixed Rent and Additional Rent for Operating Expenses and taxes) directly to Prime Landlord so that all of Sublessor’s obligations under the Prime Lease accruing during the Sublease Term with respect to the Subleased Premises (other than Sublessor’s obligation for the payment of Basic Rent and Additional Rent for Operating Expenses and taxes) shall be satisfied and discharged by Sublessee’s performance to the extent such obligation of Sublessor under the Prime Lease is an obligation of Sublessee under this Sublease. 2.5. Covenant Against Actions Causing Default Under Prime Lease. Sublessee shall not do or cause to be done or, with respect to the Subleased Premises, suffer or permit to be done, any act or thing which would constitute a default under the Prime Lease or which would cause the Prime Lease or any of Sublessor’s rights under the Prime Lease to be cancelled, terminated, forfeited or prejudiced or which would render Sublessor liable for any damages, fines, claims, penalties, costs or expenses under the Prime Lease. 2.6. Sublessor Covenants/Representations and Warranties. 2.6.1. Sublessor agrees to reasonably cooperate with Sublessee in obtaining the consent of the Prime Landlord where any such consent is required by this Sublease or the Prime Lease (at no out-of-pocket cost to Sublessor other than the cost of obtaining Prime IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 3 Landlord’s consent to this Sublease). Without limiting the generality of the foregoing, if Sublessee shall submit to Sublessor a request for Prime Landlord’s consent or approval with respect to any given matter required by this Sublease or the Prime Lease, then Sublessor shall promptly forward such request on to Prime Landlord for its consent or approval. 2.6.2. Sublessor covenants and agrees not to act or, with respect to the Subleased Premises, suffer or permit anything to be done which results in a default under the Prime Lease beyond any applicable notice and cure periods, unless prevented from doing so or otherwise caused by Sublessee’s default under this Sublease. Sublessor further covenants and agrees that it will not (i) exercise its early termination right under Section 31 of the Prime Lease, or (ii) terminate, modify or amend the Prime Lease during the Term of the Sublease if such modification or amendment would materially affect the rights of Sublessee. Without limiting the foregoing, provided that Sublessee pays all Rent and Additional Rent due hereunder as and when such amounts become due and payable hereunder, Sublessor covenants and agrees to pay Prime Landlord all Rental and other charges that may become due and payable by Sublessor pursuant to the Prime Lease, as and when such amounts become due and payable thereunder. 2.6.3. Sublessor represents and warrants to Sublessee that: (i) Exhibit B to this Sublease is a true, correct and complete copy of the Prime Lease, as may be redacted; (ii) the Prime Lease is unmodified (except for any amendments or modifications of the Prime Lease set forth on Exhibit B); (iii) the Prime Lease is in full force and effect; (iv) Sublessor has received no written notice from Prime Landlord of default by Sublessor under the Prime Lease which remains uncured; (v) to Sublessor’s knowledge, Sublessor is not now in default or breach of any of the provisions of the Prime Lease and Sublessor has no knowledge of any claim by Prime Landlord that Sublessor is in default or breach of any of the provisions of the Prime Lease; (vi) Sublessor has no knowledge that Prime Landlord is in default or breach of any provisions of the Prime Lease; (vii) Sublessor holds the entire tenant’s interest in the Subleased Premises under the Prime Lease, free and clear of any leasehold mortgages, subleases and occupancies, other than this Sublease; (viii) to Sublessor’s knowledge, Sublessor holds the entire tenant’s interest in the Subleased Premises under the Prime Lease, free and clear of any liens and claims; and (ix) Sublessor has full right, power and authority to enter into this Sublease and the person signing this Sublease on behalf of Sublessor is vested with authority to act on behalf of Sublessor with respect to this Sublease, and the execution of this Sublease has been duly executed by all appropriate corporate action(s). Sublessee shall not be responsible for any liens or claims determined to exist against the Subleased Premises to the extent arising prior to the Sublease Commencement Date, except to the extent arising from the acts or omissions of Sublessee. 2.6.4. Sublessor shall use its reasonable and diligent efforts to cause Prime Landlord to provide such services, amenities and rights that Sublessee is entitled under this Sublease, provided that the failure by the Prime Landlord to provide such services, amenities and rights shall not constitute a default by Sublessor under this Sublease, except if such failure by Prime Landlord is a result of the default by Sublandlord under the Prime Lease that is not otherwise caused by Sublessee’s default under this Sublease. Subject to the foregoing and Section 3.1 below, Sublessee shall be entitled to: (x) receive the services (including, without limitation, electricity, water, sewer, heat, air conditioning, cleaning, security and elevators) that Landlord has agreed to provide pursuant to the Prime Lease; and (y) the repairs, replacements, restorations and IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 4 maintenance or other work that Landlord has agreed to make or perform in the Prime Lease, in each case with respect to the Subleased Premises. 2.6.5. Sublessor agrees that Sublessee may deal directly with Prime Landlord (and/or the manager of the building) with respect to requesting overtime services and other services provided by or through Prime Landlord and such items may (at Prime Landlord’s option) be billed directly from Prime Landlord to Sublessee provided, however, that Sublessee shall be responsible to pay Sublessor for any such charges incurred but not billed directly from Prime Landlord to Sublessee. Any such charges shall constitute “Rent” under this Sublease. 2.6.6. Without Sublessee’s prior written consent, which consent will not be unreasonably withheld, conditioned, or delayed, Sublessor shall not amend, modify, supplement or grant waivers under the Prime Lease if such waivers would materially affect the rights of Sublessee. within three (3) business days of receiving the same. 2.6.7. Sublessor will provide to Sublessee copies of default notices received from Prime Landlord 2.7. Abatement of Rental. If Sublessor at any time during the term is entitled an abatement of Rental applicable to the Subleased Premises pursuant to the terms of the Prime Lease, then Sublessee shall be entitled to receive a proportionate share of such abated Rental under this Sublease (such proportionate share based on the Fixed Rent owed by Sublessee under this Sublease over the Base Rent due) to the extent the abated Rental is attributable to the Subleased Premises. 3. Performance. 3.1. Sublessor Not Liable For Prime Landlord’s Obligations. 3.1.1. Although the terms, conditions, covenants and agreements of the Prime Lease are incorporated as terms and agreement of this Sublease, Sublessor shall not be liable to Sublessee for performance or non-performance of obligations of Sublessor under this Sublease which are also the obligations of Prime Landlord under the Prime Lease (the “Prime Landlord’s Obligations”). It is intended that Sublessee shall look solely to and hold solely responsible Prime Landlord for the performance of the Prime Landlord’s Obligations under the Prime Lease. 3.1.2. Without limiting the generality of Section 3.1.1 of this Sublease, Sublessor shall have no obligation or responsibility for any of the following: (A) maintenance or repair of the Subleased Premises, or the common areas or mechanical systems of the Property; (B) providing heating, ventilating, air conditioning or any utility service; or (C) providing building services, such as janitorial or security services. Sublessor shall have no liability by reason of any failure by Prime Landlord to provide any of the foregoing services or to otherwise perform any of the Prime Landlord’s Obligations except to the extent such failure is due to Sublessor’s failure to comply with its obligations under this Sublease or to the extent attributable to Sublessor’s default under the Prime Lease which is not caused by Sublessee’s default under this Sublease, provided, however, that to the extent Sublessor actually receives an abatement of Rental as a result of such Prime Landlord default, Sublessee shall be entitled to a corresponding abatement of Rent to the IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 5 extent attributable to the Subleased Premises including, without limitation, as a result of a Service Interruption. 3.1.3. Notwithstanding anything to the contrary in this Sublease, Subtenant shall be entitled to exercise those self-help rights as provided in Section 11.05 of the Prime Lease for any non-performance of the obligations of Landlord under Article 11 of the Prime Lease, and shall be entitled to the benefit of the reimbursement obligations contained therein; provided, Sublessee shall indemnify, defend, and hold Sublessor harmless from any liabilities and damages, including, without limitation, reasonable attorneys’ fees resulting from any claim by Prime Landlord that the exercise of such rights was made in violation of the Prime Lease. 3.2. Assignment of Remedies. 3.2.1. In order to enable Sublessee to enforce the Prime Landlord’s Obligations as they relate to the Subleased Premises, Sublessor hereby assigns to Sublessee the rights and remedies of Sublessor under the Prime Lease for the enforcement of the Prime Landlord’s Obligations, as they relate to the Subleased Premises. Sublessee’s right to enforce the Prime Landlord’s Obligations shall be non-exclusive, and Sublessor reserves to itself also the right to exercise any rights and remedies under the Prime Lease for the enforcement of the Prime Landlord’s Obligations. In the event the foregoing assignment of remedies is not recognized or enforceable, Sublessor shall, upon the written request of Sublessee, use diligent efforts to enforce the Prime Lease and obtain the compliance of the Prime Landlord with its obligations thereunder at no out-of-pocket cost to Sublessor and provided further that Sublessor shall not be obligated to commence litigation against Prime Landlord. provided in this Sublease, Sublessee shall not have the right to: 3.2.2. Notwithstanding the provisions of Subsection 3.2.1 of this Sublease, except as expressly 3.2.2.1. terminate, alter or amend the Prime Lease; 3.2.2.2. withhold Rent or any other sum payable under this Sublease; or 3.2.2.3. set off or deduct any amount from Rent or any other sum payable under this Sublease. 4. Rent. 4.1. Fixed Rent. Sublessee shall pay rent (“Fixed Rent”) at the times and in the amounts set forth in Exhibit C. Notwithstanding anything to the contrary contained herein, in consideration of Sublessee entering into this Sublease and so long as there is no Default under this Sublease, monthly Fixed Rent shall abate for the first six (6) full calendar months of the Sublease Term (the “Rent Abatement Period”). The total amount of monthly Fixed Rent during the Rent Abatement Period shall be referred to herein as the “Abated Rent.” During the Rent Abatement Period all other costs and charges specified in this Sublease other than the Abated Rent shall remain as due and payable pursuant to the provisions of this Sublease. If a Default by Sublessee shall occur while the foregoing Rent Abatement Period is still in effect, such abatement shall be IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 6 suspended during any period in which Sublessee is in default under this Sublease beyond any applicable notice and cure periods and shall resume when such default has been cured, if Sublessor elects to accept such cure, and thereafter remain in effect until Sublessee has received the full 6 months of abated Fixed Rent. If a Default by Sublessee shall occur at any time during the Sublease Term which results in a termination of this Sublease or Sublessee’s right to possession of the Subleased Premises hereunder, the portion of the Abated Rent unamortized as of the date such Default occurs (with the Abated Rent being deemed to have been amortized in equal monthly installments together with interest thereon at the rate of eight percent (8%) per annum over the number of full calendar months in the Sublease Term following such abatement period) shall become due and payable by Sublessee to Sublessor within thirty (30) days of such termination. 4.2. Additional Rent. In addition to Fixed Rent, Sublessee shall pay as additional rent for Electricity and Operating Expenses (collectively, the “Additional Rent”) in the amounts set forth in Exhibit D, in accordance with the Prime Lease. Sublessee’s payment of Additional Rent shall be subject to the provisions of Article 9 and Article 10 of the Prime Lease as amended pursuant to Exhibit D and may be adjusted throughout the Sublease Term in accordance with the terms of the Prime Lease. Sublessor shall have the same rights and remedies for nonpayment of Additional Rent as Sublessor has for nonpayment of Fixed Rent. 4.3. Rent In General. 4.3.1. All Fixed Rent, Additional Rent, and any other amounts due from Sublessee to Sublessor under this Sublease (collectively, “Rent”) shall be paid to Sublessor at the following address, or at such other address as Sublessor may direct from time to time: Amarin Pharma, Inc., 440 Route 22 East, Suite 300, Bridgewater, New Jersey 08807 (Attn: Accounts Payable). Notwithstanding anything to the contrary contained herein, Sublessor will complete and return a W-9 form and forward its banking account information to Sublessee, and Sublessee shall have the option to make all required payments of Rent by electronic funds transfer. except as expressly provided herein or as expressly provided in the Prime Lease. 4.3.2. All Rent shall be paid without notice or demand and without any setoff or deduction whatsoever, 4.3.3. Any payment of Rent which is not paid within five (5) days of the date due shall bear interest from the date due until the date paid at the rate of five percent (5%) per annum over the rate announced by JP Morgan Chase Bank, N.A., or its successor as its prime or corporate based lending rate from time to time, but no more than the maximum rate permitted by law (the “Overdue Interest Rate”). 5. Use. Sublessee shall use and occupy the Subleased Premises for the following purposes only and for no other purpose: executive, general and administrative offices, training and any other lawfully permitted use consistent with a Class A office building, all subject to applicable laws as set forth in the Prime Lease. Sublessee shall be responsible to secure, at its sole cost and expense, any and all certificates of occupancy or permits required for Sublessee’s use and occupancy of the Subleased Premises. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 7 6. Subleased Premises Accepted “AS-IS”. The Subleased Premises are accepted by Sublessee in their present condition, “AS-IS,” without any representation or warranty by Sublessor, except as expressly provided for in this Sublease, subject to the state of title on the date of this Sublease, and also subject to all applicable legal requirements and any violation of legal requirements which may exist on the date of this Sublease. Sublessee has visually examined and approved the Subleased Premises, subject to Sublessor’s obligation to deliver the Subleased Premises in clean, vacant condition (except for the Sublessor’s Property, as hereinafter defined). Sublessor shall have no obligation to make any improvements to the Subleased Premises or provide Sublessee any allowance for so doing. Upon Prime Landlord’s consent and the full-execution of this Sublease, Sublessee shall be permitted to enter the Subleased Premises in order to commence installing its equipment, racking systems, fixtures, and furniture, subject to Sublessee obtaining, at Sublessee’s sole cost and expense, all permits required in connection with the installation thereof (if any). With respect to such early access, all provisions of this Sublease shall then be in full force and effect, including Sections 8 and 11 hereof (excluding, however, Sublessor’s obligations to pay Fixed Rent or Additional Rent, including electricity). 7. Assignment and Subletting. 7.1. Sublessor’s Consent Required. Except as expressly provided herein, Sublessee shall not assign this Sublease or sublet all or any part of the Subleased Premises, or mortgage, pledge or encumber the subleasehold interest created by this Sublease, without the prior written consent of Sublessor, which consent shall not be unreasonably withheld, conditioned or delayed, and the prior written consent of Prime Landlord, to the extent Prime Landlord’s consent is required pursuant to the Prime Lease. consent shall not be required for a Permitted Transfer (as defined in the Prime Lease). 7.2. Permitted Transfers. Notwithstanding anything set forth in this Sublease to the contrary, Sublessor’s Transfers By Legal Process or Operation of Law. For purposes of this Article 7, any transfer by levy or sale on execution, by other legal process, by operation of law, and any transfer in bankruptcy or insolvency, or under any other compulsory procedure or order of court shall be deemed to be an assignment of this Sublease. 7.3. 8. Alterations. 8.1. General Requirements. 8.1.1. Sublessee shall not make any alterations, additions or improvements to the Subleased Premises (“Alterations”) without the prior written consent of Sublessor, which consent may be withheld in Sublessor’s sole and uncontrolled discretion as to any Structural or Exterior Change (as defined in the Prime Lease), and which consent shall not be unreasonably withheld, conditioned or delayed in relation to approval for other Alterations and IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 8 the prior written consent of Prime Landlord, to the extent such consent is required pursuant to the Prime Lease. 8.1.2. All Alterations shall be made at Sublessee’s sole cost and expense, including, but not limited to, obtaining construction or building permits, in a good and workmanlike manner, in accordance with all applicable laws and in accordance with the Prime Lease. 8.1.3. The built-ins, furniture, fixtures, and all equipment presently in the Subleased Premises (“Sublessor’s Property”) will remain in the Subleased Premises during the Sublease Term for use by the Sublessee at no additional rent or other charge or consideration and shall become the property of Sublessee at the expiration or sooner termination of the Sublease Term, except in the event that such termination arises a default by Sublessee or a failure to obtain Prime Landlord’s consent, in which case Sublessor shall have the right to retain the Sublessor’s Property. If requested by Sublessee, Sublessor shall deliver a bill of sale to Sublessee for Sublessor’s Property. Except as set forth in the Prime Lease, Sublessee shall have no obligation to make any repairs or replacements to the Sublessor’s Property or insure the Sublessor’s Property and shall have the right to dispose of any item of Sublessor’s Property during the Sublease Term. An inventory of Sublessor’s Property that shall become the Property of Sublessee is set forth in Exhibit E-1 attached hereto. Sublessor makes no representation or warranty as to the condition or utility of Sublessor’s Property, provided that Sublessor represents and warrants that it is the owner of the Sublessor’s Property, and the Sublessor’s Property is not subject to any security interest or other lien. 8.1.4. Sublessee has agreed to transfer title to Sublessor certain property of Sublessee presently located at Sublessee’s Hampton facility and listed on Exhibit E-2 attached hereto (“Sublessee’s Hampton FF&E”). Sublessee shall remove and move Sublessee’s Hampton FF&E to the Remaining Premises at Sublessee’s sole cost and expense within thirty (30) days after the Sublease Commencement Date. If requested by Sublessor, Sublessee shall deliver a bill of sale to Sublessee for Sublessor’s Property. Sublessee makes no representation or warranty as to the condition or utility of Sublessee’s Hampton FF&E, provided that Sublessee represents and warrants that it is the owner of the Sublessee’s Hampton FF&E, and the Sublessee’s Hampton FF&E is not subject to any security interest or other lien. 8.2. Removal of Sublessor’s Property and Alterations. Upon the expiration or sooner termination of the Sublease Term, Sublessee shall remove all of Sublessor’s Property and any Alterations made by Sublessee which Sublessor requires that Sublessee remove, provided that Sublessor may only require that any Alteration made by Sublessee be removed upon the expiration or earlier termination of the Sublease Term if Sublessor notified Sublessee in writing that such removal would be required at the time Sublessor approved the Alteration, or if Prime Landlord requires that such Alterations be removed at the expiration or sooner termination of the Term. Sublessee will repair and restore any damage to the Subleased Premises caused by the installation or removal of its Alterations. Without limiting the generality of the foregoing, if required by Prime Landlord, all wiring and cabling installed by or for Sublessee, whether inside or outside, shall be removed by Sublessee, at Sublessee’s sole cost and expense, at the expiration or earlier termination of the Sublease Term. If Sublessee fails to perform any of its obligations under this Section 8.2, IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 9 Sublessor may perform such obligations on behalf of Sublessee, and the cost and expense thereof, together with interest at the Overdue Interest Rate from the date such costs and expenses were incurred by Sublessor, shall be paid by Sublessee to Sublessor as Additional Rent within thirty (30) days after Sublessee is billed therefor. For avoidance of doubt, Sublessee shall have no obligation to removal any Alterations, improvements or fixtures that exist in the Subleased Premises as of the Commencement Date. 9. Mechanics Liens; Other Encumbrances. 9.1. Intentionally Omitted. 9.2. Obligation to Discharge; Failure to Discharge. 9.2.1. Sublessee shall promptly pay each of Sublessee’s contractors, and shall keep the Subleased Premises, the Premises and the Property free from any liens arising out of any labor, services, materials, supplies or equipment furnished or alleged to have been furnished to Sublessee. Should any lien be made or filed in connection with the Alterations, Sublessee shall bond against or discharge the same within thirty (30) days after receiving notice thereof, regardless of the validity of the lien or claim. If Sublessee shall fail to cause such lien to be bonded against or to be dis(cid:0)charged within such period, then, in addition to any other right or remedy which Sublessor may have, Sublessor may, but shall not be obligated to, dis(cid:0)charge the same either by paying the amount claimed to be due or by procur(cid:0)ing the discharge of such lien by deposit or by bond(cid:0)ing. Any amount so paid by Sublessor and all costs and expenses incurred by Sublessor in connection therewith, together with interest at the Overdue Interest Rate from the respective dates of Sublessor’s making of the payment and incurring of the cost and expense, shall consti(cid:0)tute Addi(cid:0)tional Rent payable by Sublessee under this Sublease and shall be paid by Sublessee to Sublessor within thirty (30) days of written demand. 9.3. No Consent Implied. Nothing set forth in this Sublease shall be deemed or construed as (A) a consent or request by Prime Landlord or Sublessor, expressed or im(cid:0)plied, by inference or otherwise, to any contrac(cid:0)tor, labor(cid:0)er or materialman for the performance of any labor or the furnishing of any materials for any specific or general improvement, alteration or repair of or to the Subleased Pre(cid:0)mises, the Premises or the Property or any part thereof; or (B) giving Sublessee or any other person, firm or corporation any right to contract for or to perform any labor or furnish any services or materials that would permit or give rise to a lien against the Subleased Premises, the Premises, the Property or any part thereof. Neither this Sublease nor any other writing signed by Sublessor or Prime Landlord shall be construed as evidencing, indi(cid:0)cating, or causing an appearance that any erection, con(cid:0)struction, alteration or repair to be done, or caused to be done, by Sublessee is or was for the immediate use or benefit of Sublessor or Prime Landlord. 10. Parking. Except as otherwise set forth in this Section 10, all parking shall be subject to the Prime Lease. Sublessee shall have the right to use fourteen (14) of the nineteen (19) reserved parking spaces allocated to Sublessor pursuant to the Prime Lease for Sublessee’s exclusive use. The reserved parking spaces allocated for Sublessee’s use are shown on Exhibit F. The remaining five (5) reserved parking spaces shall remain for Sublessor’s exclusive use (“Sublessor’s Designated Parking”). In addition to the fourteen (14) reserved parking spaces, IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 10 Sublessee shall have the right to use parking in accordance with Article 30 of the Prime Lease, other than Sublessor’s Designated Parking. 11. Insurance. coverages in full force and effect during the Sublease Term: 11.1. Sublessee’s Insurance. Sublessee, at its sole cost and expense, shall maintain the following insurance 11.1.1. Commercial general liability insurance, with contractual liability endorsement, with a combined single limit per occurrence for personal injury and property damage of not less than Three Million Dollars ($3,000,000.00), with a Four Million Dollar ($4,000,000.00) aggregate limitation; that can be satisfied with any combination of primary and umbrella / excess liability policies with such commercially reasonable increases as Sublessor or Prime Landlord may request from time to time within twelve (12) months of request; law; 11.1.2. Worker’s compensation and employer’s liability insurance in form and amounts as required by 11.1.3. Special form (formerly known as “all risks”) property insurance insuring loss of or damage to all of Sublessee’s personal property located therein, including, without limitation, Sublessee’s goods, trade fixtures, and equipment, written at 100% of replacement cost (exclusive of footings, foundations and underground utilities); and 11.1.4. such other insurance in forms and amounts as may be required by the Prime Lease. 11.2. Policy Requirements. 11.2.1. Each policy of insurance required to be maintained by Sublessee shall: 11.2.1.1. 11.2.1.2. be issued by responsible insurance companies, qualified to do business in the State of New Jersey and acceptable to Prime Landlord; to the extent commercially available, provide that (A) such policy shall not be changed, canceled or expire without at least thirty (30) days prior written notice to Sublessor and Prime Landlord, and (B) no act or omission of Sublessee shall affect the obligation of the insurer to pay the full amount of any loss sustained; 11.2.1.3. comply with the requirements of the Prime Lease; and 11.2.1.4. otherwise be acceptable to Prime Landlord. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 11 11.2.2. The liability insurance maintained by Sublessee pursuant to Subsection 11.1.1 shall: 11.2.2.1. name Sublessor and Prime Landlord as additional insureds; 11.2.2.2. be primary in coverage to any similar insurance maintained by Sublessor or Prime Landlord; 11.2.2.3. intentionally omitted; and 11.2.2.4. to the extent any coverage is provided pursuant to a “blanket” policy, include an “Aggregate Per Location” endorsement, so that the full aggregate limit of liability shall be applicable to occurrences at the Subleased Premises. 11.3. Delivery of Certificates; Failure to Maintain Insurance. 11.3.1. Prior to the Sublease Commencement Date, and within ten (10) days prior to the expiration of each policy required under Section 11.1, Sublessee shall deliver to Sublessor certificates evidencing the foregoing insurance or renewal thereof, as the case may be. 11.3.2. If Sublessee shall fail, refuse or neglect to obtain or to maintain any insurance that it is required to provide or to fur(cid:0)nish Sublessor with satisfactory evidence of coverage on any such policy, Sublessor shall have the right to purchase such insurance seventy-two (72) hours after it has provided Sublessee with written notice that it intends to do so unless within such seventy-two (72) hour period, Sublessee furnishes Sublessor with evidence that Sublessee has procured such insurance. Sublessee shall reimburse Sublessor for all such payments made by Sublessor, together with interest thereon at the Overdue Interest Rate from the date paid by Sublessor, within ten (10) days after Sublessee is billed therefor. 11.4. Notwithstanding anything to the contrary in this Sublease, Sublessee shall at all times obtain and maintain the insurance coverage set forth in Article 14 of the Prime Lease applicable to the Subleased Premises in accordance with the terms and conditions therein. 12. Waiver of Subrogation. 12.1. Sublessor and Sublessee, for themselves and their respective insurers, hereby release each other of and from any and all claims, demands, actions and causes of action, (including, without limitation, subrogation claims), for loss or damage to their respective property, even if the loss or damage shall have been caused by the fault or negligence of the other party, or anyone for whom such party may be responsible. 12.2. The waiver and release provided in Section 12.1 shall be effective only with respect to loss or damage (a) covered by insurance or required to be covered by insurance pursuant to the terms of this Sublease, and (b) occurring during such time as the relevant insurance policy IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 12 contains either (i) a waiver of the insurer’s right of subrogation against the other party, or (ii) a clause or endorsement to the effect that the waiver and release provided in Section 12.1 shall not adversely affect or impair such insurance or prejudice the right of the insured to recover under the insurance policy. Each party will use its best efforts to obtain such a clause or endorsement, but if an additional premium is charged therefor, the party benefiting from such clause or endorsement, if it desires to have such waiver, will pay to the other the amount of such additional premi(cid:0)um within ten (10) days after delivery of a statement for the amount due. 12.3. With respect to the waiver of subrogation contained in Section 14.10 of the Prime Lease, such waiver shall be deemed to be modified to constitute an agreement by and among and apply to Prime Landlord, Sublessor, and Sublessee (and Prime Landlord’s consent to this Sublease shall be deemed to constitute its approval of this modification). 13. Indemnification. 13.1. Sublessee shall indemnify, defend and hold harmless Sublessor and its affiliates, and their respective officers, directors, stockholders, beneficiaries, partners, representatives, agents, contractors, invitees and employees (whether singular or plural, “Sublessor Indemnified Parties”), from and against any and all Liabilities (as defined in the Prime Lease) in connection with a third-party claim and to the extent arising from: (i) any occurrence in, upon or at the Subleased Premises following the Commencement Date, except to the extent caused by the negligence or willful misconduct of the Sublessor Indemnified Parties, (ii) the occupancy or use of the Subleased Premises or any part thereof by the Sublessee Indemnified Parties, (iii) a material breach of the provisions of this Sublease by the Sublessee Indemnified Parties, or (iv) the negligence or willful misconduct of the Sublessee Indemnified Parties, except to the extent caused by the negligence or willful misconduct of the Sublessor Indemnified Parties. 13.2. Sublessor shall indemnify, defend, and hold harmless Sublessee and its affiliates, and their respective officers, directors, stockholders, beneficiaries, partners, representatives, agents, contractors, invitees and employees (whether singular or plural, “Sublessee Indemnified Parties”) from and against any and all Liabilities in connection with a third-party claim and to the extent arising from (i) any occurrence in, upon or at the Remaining Premises, except to the extent caused by the negligence or willful misconduct of the Sublessee Indemnified Parties, (ii) any occurrence in, upon or at the Subleased Premises occurring prior to the Commencement Date, except to the extent caused by the negligence or willful misconduct of the Sublessee Indemnified Parties, (iii) a material breach of the provisions of this Sublease by the Sublessor Indemnified Parties, or (iv) resulting from the negligence or willful misconduct of the Sublessor Indemnified Parties, except to the extent caused by the negligence or willful misconduct of the Sublessee Indemnified Parties. 13.3. A party that intends to claim indemnification (“Indemnitee”) under this Section 13 shall promptly notify the indemnifying party (“Indemnitor”) in writing of any third-party claim included within the indemnification obligations described in Section 13.1 or Section 13.2 (each a “Claim”) with respect to which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense and settlement of the Claim. The Indemnitee shall have the right to participate, at its own expense, with counsel of its own choosing in the defense or settlement of the Claim. The indemnification obligations set forth in this Section IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 13 13 shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the consent of the Indemnitor. The Indemnitee, at the Indemnitor’s request and expense, shall provide full information and reasonable assistance to Indemnitor and its legal representatives with respect to Claims. An Indemnitor’s indemnification obligation shall include any fees incurred by the Indemnitee successfully enforcing the Indemnitor’s indemnification obligation. 14. Environmental Matters. Sublessee represents that its North American Industrial Classification System (“NAICS”) number, as designated in the Standard Classification Manual prepared by the Office of Management and Budget, Executive Office of the President of the United States, is 423450. 15. Surrender; Holdover. 15.1. Condition Upon Surrender. Subject to the provisions of Section 23.1, at the expiration or earlier termination of the Sublease Term, Sublessee shall promptly surrender possession of the Subleased Premises and all Alterations (subject to Article 8 of this Sublease), in the condition required by the Prime Lease provided, however, that Sublessee shall have no obligation or liability for the removal of any alterations or improvements to the Subleased Premises that existed prior to the Commencement Date of this Sublease. 15.2. Personal Property. Subject to the provisions of Section 23.1, sublessee shall remove all personal property from the Subleased Premises at the expiration or earlier termination of the Sublease Term. Any personal property which shall remain in the Subleased Premises after the expiration or earlier termination of the Sublease Term shall be deemed to have been abandoned and either may be retained by Sublessor as Sublessor’s property or may be disposed of in such manner as Sublessor may see fit. Any costs of removing and disposing of the personal property incurred by Sublessor, together with interest at the Overdue Interest Rate from the date such costs and expenses are incurred, shall be paid by Sublessee to Sublessor as Additional Rent within thirty (30) days after Sublessee is billed therefor. If such personal property is sold by Sublessor, Sublessor may receive and retain the pro(cid:0)ceeds of such sale as Sublessor’s property. 15.3. Holdover. Subject to the provisions of Section 23.1, if Sublessee retains possession of the Subleased Premises or any part thereof after the termination of this Sublease by expiration of the Sublease Term or otherwise, Sublessee shall pay Sublessor (A) an amount, calculated on a per diem basis for each day of such unlawful retention, equal to one and one- half (1½) the Fixed Rent in effect immediately prior to the expiration or earlier termination of the Sublease Term plus all Additional Rent payable hereunder, (B) any amounts due to Prime Landlord under the Prime Lease including, without limitation, holdover charges arising by reason of Sublessee’s holding over, to the extent in excess of the holdover charge under clause (A) above, and (C) if such holdover exceeds sixty (60) days all other actual and direct damages, costs and expenses sustained by Sublessor by reason of Sublessee’s holding over. All of Sublessee’s obligations with respect to the use, occupancy and maintenance of the Subleased Premises shall continue during such period of retention; however, neither the com(cid:0)pliance with such obligations nor the payment of the amounts set forth above in this Section shall create any right in Sublessee to continue in possession of the Subleased Premises or limit any rights or remedies of Sublessor resulting from such holdover. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 14 16. Default. Any of the Conditions of Limitation set forth in Article 18 of the Prime Lease shall constitute a default (“Default”) hereunder. In addition, it shall be a Default under this Sublease if: 16.1. Sublessee fails to pay any installment of Rent or other sum due under this Sublease within five (5) days after Sublessor shall have given a written notice to Sublessee specifying Sublessee’s failure to do so; Sublessor shall not be required to give such notice more than two (2) times during any calendar year, then, thereafter, any such failure to pay Rent on the date when same is due and payable shall entitle Sublessor to exercise the rights hereinafter provided in the event of Sublessee’s default without further notice; or 16.2. Sublessee fails to observe or perform any other covenant or agreement of Sublessee contained in this Sublease (including, without limitation, the covenants and agreements incorporated from the Prime Lease by reference, pursuant to Article 2 of this Sublease) and such failure continues after written notice given by or on behalf of Sublessor to Sublessee for more than twenty-five (25) days and such additional time, if any, as is reasonably necessary to cure such failure, provided Sublessee commences to cure such failure within such twenty-five day period and diligently thereafter prosecutes such cure to completion. 17. Remedies. The rights and remedies of Sublessor upon the occurrence of a Default under this Sublease shall be the same as the rights and remedies of Prime Landlord upon the occurrence of an event of Default under the Prime Lease. In the event of a Default, Sublessor shall use commercially reasonable efforts to mitigate its damages. For purposes of this Section, references to Base Rent mean Fixed Rent as used in the Prime Lease. 18. Waiver Of Jury Trial. SUBLESSEE AND SUBLESSOR EACH HEREBY WAIVES TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT ON ANY MATTER ARISING OUT OF OR IN ANY WAY CONNECTED WITH THIS SUBLEASE, THE RELATIONSHIP OF SUBLESSOR AND SUBLESSEE, SUBLESSEE’S USE OR OCCUPANCY OF THE SUBLEASED PREMISES, OR ANY CLAIM OF INJURY OR DAMAGE, OR ANY OTHER REMEDY WITH RESPECT THERETO. 19. Security Deposit. 19.1. Amount. Simultaneously with the execution of this Sublease, Sublessee shall deposit the sum of ONE HUNDRED EIGHTY THREE THOUSAND THREE HUNDRED THIRTY-THREE DOLLARS AND 33/100 ($183,333.33) with Sublessor to secure Sublessee’s performance of its obligations under this Sublease (the “Security Deposit”). Security Deposit with other moneys of Sublessor. 19.2. No Interest. Sublessee shall receive no interest on the Security Deposit. Sublessor may commingle the 19.3. Application. Upon the occurrence of a Default, Sublessor may, without prejudice to Sublessor’s other remedies, apply part or all of the Security Deposit (A) to cure the Default, in whole or in part, and (B) to any losses or damages suffered by Sublessor by reason of such Default. If Sublessor so applies part or all of the Security Deposit, Sublessee shall within ten IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 15 (10) days after written demand, pay Sublessor the amount necessary to restore the Security Deposit to its original amount. 19.4. Transfer of Sublessor’s Interest In Sublease. In the event of a sale, assignment or other transfer of Sublessor’s interest in this Sublease, Sublessor shall transfer the Security Deposit to the purchaser, assignee or transferee. Upon such transfer, Sublessee shall look only to the new sublessor for the return of the Security Deposit and Sublessor shall be released from all liability for the return of the Security Deposit. 19.5. Return of Security Deposit. Any part of the Security Deposit not used by Sublessor shall be returned to Sublessee within thirty (30) days after the later to occur of (A) the expiration of the Sublease Term; or (B) the surrender of the Subleased Premises by Sublessee in accordance with the terms of the Sublease. 20. Quiet Enjoyment. Upon payment by Sublessee of the Rent and upon the observance and performance of all of the covenants, terms and conditions on Sublessee’s part to be observed and performed under this Sublease, Sublessee shall peaceably and quietly hold and enjoy the Subleased Premises for the Term, without hindrance or interruption by Sublessor or any other person or persons lawfully or equitably claiming by, through or under Sublessor, subject, nevertheless, to the terms and conditions of this Sublease, and any mortgage, deed of trust or lease to which this Sublease is subordinate. 21. Sublease Subordinate to Prime Lease; Termination of Prime Lease. subordinate to the Prime Lease. 21.1. Sublease Subordinate. This Sublease and the rights of the parties under this Sublease are subject and 21.2. Termination of Prime Lease. Subject to the provisions of Section 23.1, if the Prime Lease is terminated for any reason, subject to the terms of the Prime Landlord’s Consent (as hereinafter defined), this Sublease shall terminate as of the date of termination of the Prime Lease and Sublessor shall have no liability to Sublessee as a result of such termination, provided, however, in the event of a voluntary termination of the Prime Lease without the prior written consent of Sublessee or in the event of a termination of the Prime Lease as a result of a default by Sublessor under the Prime Lease (and such default was not caused by a default by Sublessee under this Sublease), Sublessor shall indemnify, defend, and hold Sublessee harmless from any liabilities and damages, including, without limitation, reasonable attorneys’ fees to the extent arising from such termination. For avoidance of doubt, such damages shall include the increased Rent payable by Sublessee under the Prime Lease over the Rent payable under this Sublease pursuant to the recognition provisions of the Prime Landlord’s Consent. 21.3. Sublessee’s Consent. Sublessor’s option to terminate the Prime Lease shall be subject to Sublessee’s prior written approval. 22. Notices. Any notices required or permitted to be given under this Agreement shall be given in writing and shall be delivered by: national overnight delivery service or by United States certified IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 16 mail, return receipt requested, postage prepaid, and shall be deemed to have been given, if sent by national overnight delivery service, as of the first (1st) weekday upon which delivery is first attempted and, if sent by United States certified mail, as of the third (3rd) business day following deposit in the United States mail. Such notices shall be addressed as follows: If to Sublessor: Amarin Pharma, Inc. 440 Route 22 East Bridgewater, NJ 08807 Attn: General Counsel With a required copy to: Benjamin A. Nadell, Esq. Saul Ewing LLP 650 College Road East, Suite 4000 Princeton, NJ 08540 If to Sublessee: ST Shared Services LLC 675 McDonnell Blvd. Hazelwood, MO 63042 Jeffrey Hunter Attn: With separate copy attention to General Counsel With a required copy to: McCarter & English, LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 Attention: Martin F. Dowd or to such other address as either party may from time to time specify in writing to the other party. Any notice shall be effective only upon receipt (or refusal by the intended recipient to accept delivery). Any notice which is received on a Saturday, Sunday or a legal holiday, or after 5:00 p.m. prevailing local time at the place of receipt, shall be deemed received on the next business day. 23. Prime Landlord’s Consent. 23.1. Sublease Conditioned Upon Consent. This Sublease is subject to, and conditioned upon, Sublessor’s obtaining the written consent of Prime Landlord to this Sublease (the “Prime Landlord’s Consent”) in the form attached hereto as Exhibit H, or such other form as IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 17 approved by Sublessor and Sublessee. As set forth in Section 1.2 of this Sublease, the Sublease Term shall not commence until the Prime Landlord’s Consent is fully executed by the parties thereto. 23.2. Delivery of Information. Sublessee shall promptly deliver to Sublessor any information reasonably required by Prime Landlord (in connection with the Prime Landlord’s Consent) with respect to the nature and operation of Sublessee’s business and/or the financial condition of Sublessee. Prime Landlord, that this Sublease shall not: 23.3. Agreements for Benefit of Prime Landlord. Sublessor and Sublessee hereby agree, for the benefit of provided in Prime Landlord’s Consent; 23.3.1. create privity of contract between Prime Landlord and Sublessee, except as otherwise expressly agreed in writing to such amendment); or 23.3.2. be deemed to amend the Prime Lease in any way (unless Prime Landlord shall have expressly Lease by Sublessor or any further subletting of the Premises. 23.3.3. be construed as a waiver of Prime Landlord’s right to consent to any assignment of the Prime by Sublessor. 23.4. Fee. Any fee charged by Prime Landlord in connection with the Prime Landlord’s Consent shall be paid 23.5. Effect of Failure to Obtain Prime Landlord’s Consent. If Prime Landlord fails to consent to this Sublease within thirty (30) days after the execution and delivery of this Sublease by the parties, either Sublessor or Sublessee may terminate this Sublease by giving written notice to the other at any time thereafter, but before Prime Landlord grants such consent. Upon such termination, (A) Sublessor will return the Security Deposit to Sublessee, (B) this Sublease will become null and void, and (C) neither party will have any liability or obligation to the other under this Sublease. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 18 24. Brokers. Sublessor and Sublessee represent and warrant to each other that no broker or finder other than Jones Lang LaSalle Brokerage, Inc. (the “Broker”), was instrumental in arranging or bringing about this transaction and that there are no claims or rights for commissions, finders’ fees or other compensation (collectively, “compensation”) by any person or entity other than the Broker. Sublessor shall be solely responsible for all compensation payable to the Broker. If any broker or finder asserts a claim for compensation based upon any actual or alleged contact, dealings or communi(cid:0)ca(cid:0)tion with Sublessor or Sublessee, then the party through whom such broker or finder makes its claim shall indemnify and hold the other party (the “Indemnified Party”) harmless from and against any and all claims, damages, judgments, suits, liabilities, losses, costs and expenses (including without limitation, reasonable attorneys’ fees and court costs) suffered or incurred by or brought against the Indemnified Party in connection with such claim for compensation. 25. Patriot Act; Executive Order 13224; Anti-Money Laundering Act. 25.1. Representation and Warranty. Sublessee represents and warrants that (a) no Benefited Party is a Prohibited Person, and (b) no Benefited Party is in violation of the Executive Order, the Patriot Act, the Anti-Money Laundering Act, or any order, rule, regulation or recommendation promulgated under or in connection with the Executive Order, the Patriot Act or the Anti-Money Laundering Act. 25.2. Covenants. Sublessee covenants and agrees to ensure that throughout the Term (a) no Benefited Party will be a Prohibited Person, and (b) no Benefited Party will be in violation of the Executive Order, the Patriot Act, the Anti- Money Laundering Act, or any order, rule, regulation or recommendation promulgated under or in connection with the Executive Order, the Patriot Act or the Anti-Money Laundering Act. 25.3. Certification. On request by Landlord from time to time, Sublessee covenants and agrees promptly to deliver to Sublessor such certification or other evidence as Sublessor may request, confirming that all Benefited Parties are in compliance with the requirements of this Section. 25.4. Definitions. 25.4.1. “Benefited Party” means and includes (a) Sublessee; (b) any officer, director, shareholder, partner or member of Sublessee; (c) any direct or indirect holder of any equity interest in Sublessee; and (d) any affiliate of Sublessee. 25.4.2. “Prohibited Person” means and includes any person or entity with whom US persons or entities are prohibited or restricted from doing business pursuant to (a) the Executive Order and the Annex thereto, (b) the regulations of the Office of Foreign Asset Control of the Department of the Treasury (including the Specially Designated Nationals and Blocked Persons List, as updated from time to time, and (c) any other statute, law, executive order, rule, regulation or other governmental action. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 19 “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism.” 25.4.3. “Executive Order” means Executive Order 13224 signed on September 24, 2001 and titled Required to Intercept and Obstruct Terrorism Act of 2001. 25.4.4. “Patriot Act” means the Uniting and Strengthening America by Providing Appropriate Tools Financial Anti-Terrorism Act of 2001. 25.4.5. “Anti-Money Laundering Act” means the International Money Laundering Abatement and 26. Guaranty. Concurrent with Sublessee’s execution and delivery of this Sublease and as a material inducement to Sublessor’s execution of this Sublease, Sublessee shall deliver to Sublessor a guaranty from MEH, Inc. (the “Guarantor”) of Sublessee’s obligations under this Sublease in the form of Exhibit G attached hereto (the “Guaranty”). 27. Miscellaneous. 27.1. Interpretation of Sublease. The headings and captions in this Sublease are inserted for convenience of reference only and in no way de(cid:0)fine, describe or limit the scope or intent of this Sublease or any of its provisions. Where the context so requires, the use of the singular shall include the plural and vice versa and the use of the masculine shall include the feminine and the neuter. 27.2. Governing Law; Jurisdiction and Venue. This Sublease shall be governed by and construed in accordance with the laws of the State of New Jersey. If any provision of this Sublease or the application thereof to any person or circumstances shall, to any extent, be invalid or unenforceable, the remainder of this Sublease shall not be affected thereby and each remaining provision of the Sublease shall be valid and enforceable to the fullest extent permitted by Law. Sublessor and Sublessee hereby irrevocably submit themselves to the exclusive jurisdiction of the state courts of the State of New Jersey and the United States District Court, District of New Jersey in the event of any action or controversy concerning this Sublease or the Subleased Premises. Sublessee. 27.3. No Recording. Neither this Sublease nor any memorandum or short form thereof may be recorded by 27.4. Survival. Any covenants set forth in this Sublease which, by their nature, would reasonably be expected to be performed after the expiration or earlier termination of this Sublease, shall survive the expiration or earlier termination of this Sublease. deemed an original, but all of which taken together shall constitute one and the same instrument. 27.5. Counterparts. This Sublease may be executed in two or more counterparts, each of which shall be 27.6. Transmission of Sublease by Facsimile or PDF. The transmission of a signed counterpart of this Sublease by facsimile or by portable document file (“PDF”) shall have the same force and effect as delivery of an original signed counterpart of this Sublease, and shall constitute valid and effective delivery for all purposes. If either party delivers a signed counterpart of this IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 20 Sublease by transmission of a facsimile or PDF, it shall also send promptly thereafter by overnight courier or personal delivery a signed original counterpart of this Sublease to the other party, but failure to do so shall not render this Sublease void or voidable by either party. benefit of, the parties to this Sublease and their respective successors and assigns. 27.7. Binding Effect; Assignment. Subject to Article 7, this Sublease shall be binding upon, and inure to the 27.8. Intentionally Omitted. 27.9. Joint and Several Liability. If two or more individuals, corporations, partnerships, or other entities (or any combination of two or more thereof) sign this Sublease as sublessee, the liability of each such individual, corporation, partnership or other entity to pay Rent and perform all other obligations of Sublessee under this Sublease shall be joint and several. 27.10. Entire Agreement; Requirement for Writing. 27.10.1.This Sublease and the Exhibits attached to this Sublease contain the final and entire agreement of Sublessor and Sublessee and are intended to be an integration of all prior negotiations and understandings. Neither Sublessor nor Sublessee shall be bound by any covenants, agreements, statements, representations or warranties, oral or written, not contained in this Sublease. signed by the parties to this Sublease. 27.10.2.No change or modification to this Sublease shall be valid unless the same is in writing and and is signed by the party against which it is sought to be enforced. 27.10.3.No waiver of any of the provisions of this Sublease shall be valid unless the same is in writing 27.11. Severability. If any provision of this Sublease, or the application thereof to any person, place or circumstance, shall be held by a court of competent jurisdiction to be invalid, unenforceable or void, the remainder of this Sublease and such provisions as applied to other persons, places and circumstances shall remain in full force and effect. element. 27.12. Time of Essence. Time is of the essence of each and every provision of this Sublease of which time is an 27.13. Drafts not an Offer to Enter into a Legally Binding Contract. The submission of a draft of this Sublease by one party to another is not intended by either party to be an offer to enter into a legally binding contract. The parties shall be legally bound pursuant to the terms of this Sublease only if and when Sublessor and Sublessee have fully executed and delivered to each other a counterpart of this Sublease. IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" [Signature Page Follows] 21 IN WITNESS WHEREOF, Sublessor and Sublessee have duly executed this Sublease as of the day and year first above written. SUBLESSOR: AMARIN PHARMA, INC. By: __________________________________ Name: ________________________________ Title: _________________________________ SUBLESSEE: ST SHARED SERVICES LLC By: __________________________________ Name: ________________________________ Title: _________________________________ IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 22 Exhibit A – Premises IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 23 Exhibit A-1 – Subleased Premises IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 24 Exhibit B – Prime Lease [Attached.] 25 IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" Exhibit C – Fixed Rent Period Month 1 through Month 12 Month 13 through Month 24 Month 25 through Month 36 Month 37 through Month 48 Month 49 through Month 60 Month 61 through Month 72 Month 73 through Month 84 Month 85 through Month 91 Annual Fixed Rent $1,100,000.00 $1,125,000.00 $1,150,000.00 $1,175,000.00 $1,200,000.00 $1,225,000.00 $1,250,000.00 $1,275,000.00 Monthly Fixed Rent $91,666.67 $93,750.00 $95,833.33 $97,916.67 $100,000.00 $102,083.33 $104,166.67 $106,250.00 Fixed Rent Per RSF $22.00 $22.50 $23.00 $23.50 $24.00 $24.50 $25.00 $25.50 IF "Error! No document variable supplied." = "1" "Error! Unknown document property name." "" 26 Exhibit D – Additional Rent Article 9 – Operating Expenses Section 9.01 – Payment of Operating Expenses – In addition to Fixed Rent, Sublessee shall pay to Sublessor, as Additional Rent, Sublessee’s Proportionate Share of the amount by which the Operating Expenses in any calendar year exceed the Operating Expenses for the 2023 calendar year, subject to adjustments as set forth in Article 9 of the Prime Lease. When calculating the amounts due pursuant to Article 9 of the Prime Lease, the following provisions shall apply: 1. Sublessee’s Proportionate Share shall mean 25.1%. 2. Base Amount shall mean the Operating Expenses for calendar year 2023. 3. Upon the request of Sublessee, Sublessor shall audit Prime Landlord’s records with respect to Operating Expenses, subject to the terms of the Prime Lease. The provisions of Article 9 of the Prime Lease are hereby modified to provide that the “Operating Expenses Base Year” for purposes of this Sublease shall be “Base Year 2023.” Article 10 – Utilities and Services Section 10.01 – Electricity – In addition to Fixed Rent, Sublessee shall pay to Sublessor, for and in consideration for electrical services, as Additional Rent, the annual sum of $87,500.00 ($1.75 per rentable square foot), which shall be payable in equal monthly installments of $7,291.67, in advance on the first day of each month throughout the Sublease Term, and shall be deemed Additional Rent payable under this Sublease, provided however, that the foregoing rate shall be subject to increases as set forth in Article 10 of the Prime Lease. To the extent any provisions of Article 9 and Article 10 of the Prime Lease conflict with the provisions of this Exhibit D, the provisions of this Exhibit D shall control. To the extent any provisions of Article 9 and Article 10 of the Prime Lease are incorporated in the Sublease, any such provisions shall be amended as set forth in this Exhibit D. 40866702.2 Exhibit E-1– Sublessor’s Property Inventory Stand up desk 2 drawer lateral file cabinet 3 drawer file cabinet Desk chair Guest chairs Meeting Tables Meeting chairs Wall monitor Phones White Boards Monitors Printers Rolling Cube 148 51 49 170 136 14 27 64 102 49 136 17 164 40866702.2 Exhibit E-2– Sublessee’s Hampton FF&E Inventory 40866702.2 Exhibit F – Parking EXHIBIT G GUARANTY MEH, INC., a corporation organized under the laws of the state of Nevada, having an address of 675 McDonnell Blvd., Hazelwood, MO 63042, Attn: Jeffrey Hunter (the “Guarantor”) has requested that AMARIN PHARMA, INC., a Delaware corporation, having an address at 440 Route 22, Suite 300, Bridgewater, New Jersey 08807 (“Sublessor”) to enter into a Sublease Agreement of even date herewith (the “Sublease”) with ST SHARED SERVICES LLC, a New Jersey limited liability company, having an address of 675 McDonnell Blvd., Hazelwood, MO 63042 (the “Sublessee”) covering certain premises located at 440 US Highway 22, Bridgewater, New Jersey, as more particularly described in the Sublease. In order to induce Sublessor to enter into the Sublease and in consideration of Sublessor’s entering into the Sublease, Guarantor hereby guarantees, unconditionally and absolutely, to Sublessor, its successors and assigns (without requiring any notice of non-payment, non-keeping, non- performance or non-observance or proof of notice or demand whereby to charge Guarantor all of which Guarantor hereby waives, other than such notice as required to be given to Sublessee under the Lease which notice may be delivered simultaneously to Guarantor and Sublessee and for purposes of which shall be deemed given to Guarantor if given to Sublessee so long as Guarantor remains affiliates with Sublessee) the full and faithful keeping, performance and observance of all the covenants, agreements, terms, provisions and conditions provided to be kept by Sublessee under the Sublease, including, without limitation, the payment as and when due of all Fixed Rent, Additional Rent, charges and damages payable by Sublessee under the Sublease. All capitalized terms not defined herein shall have the meanings ascribed to them in the Sublease. As a further inducement to Sublessor to enter into the Sublease and in consideration thereof, Guarantor hereby covenants and acknowledges as follows: (1)Guarantor is the indirect owner of an equity interest in Sublessee. (2)The obligations of Guarantor shall not be terminated or affected in any way or manner whatsoever by reason of Sublessor’s failure to resort to any summary or other proceedings, actions or remedies for the enforcement of any of Sublessor’s rights under the Sublease or by reason of any extensions of time or indulgences granted by Sublessor, or by reason of the assignment or surrender of all or any part of the Sublease or the term and estate thereby granted or all or part of the Subleased Premises. The liability of Guarantor is co(cid:0)extensive with that of Sublessee and also joint and several, and action or suit may be brought against Guarantor and carried to final judgment and/or completion and recovery had, either with or without making Sublessee or any other guarantor a party thereto. Insofar as the payment by Sublessee of any sums of money to Sublessor is involved, this Guaranty is a guaranty of payment and not of collection and shall remain in full force and effect until payment in full to Sublessor of all sums payable under this Guaranty. Guarantor waives any right to require that any action be brought against Sublessee or to require that resort be had to any secured interest, security or to any other credit in favor of Sublessee. (3)If the Sublease be modified by agreement between Sublessor and Sublessee in any other respect, the obligations of Guarantor shall extend and apply with respect to the full and faithful keeping, performance and observance of all of the covenants, agreements, terms, provisions and conditions which under such renewal of the Sublease or extension of its terms or which under any new sublease or amendment or modification agreement, entered into for the purpose of express or confirming any such renewal, extension, inclusion, substitution or modification, are to be kept, performed and observed by Sublessee (including, without being limited to, the payment as and when due of Fixed Rent, Additional Rent, charges and damages provided for thereunder). (4)Neither Guarantor’s obligation to make payment in accordance with the terms of this Guaranty nor any remedy for the enforcement thereof shall be impaired, modified, changed, stayed, released or limited in any manner whatsoever by any impairment, modification, change, release, limitation or stay of the liability of Sublessee or its estate in bankruptcy or any remedy for the enforcement thereof, resulting from the operation of any present or future provision of the Bankruptcy Act of the United States or other statute or from the decision of any court interpreting any of the same, and Guarantor shall be obligated under this Guaranty as if no such impairment, stay, modification, change, release or limitation has occurred. Sublessor and its successors and assigns. (5)This Guaranty shall be binding on Guarantor and its successors and assigns and inure to the benefit of Guaranty. (6)Guarantor and Sublessor each waives the right to trial by jury in any action or proceeding in respect of this (7)It is expressly understood and agreed by Guarantor and Sublessor that all matters arising out of the Sublease and this Guaranty, including the validity or any provisions hereof, are to be governed by, interpreted and construed in accordance with the laws of the State of New Jersey (without giving regard or effect to any conflicts of law rules or other choice of law rules). (8)With respect to any dispute or legal action of any kind arising from the terms of this Guaranty that any party may have, either during the term of this Guaranty or thereafter, it is expressly agreed that such action shall be brought either in the state courts of the State of New Jersey (or in the United States District Court for the District of New Jersey, to the extent such court has jurisdiction thereof), and that such court shall be deemed to be the court of sole and exclusive jurisdiction and venue for the bringing of such action. The foregoing consent to jurisdiction and venue shall not constitute general consent by Guarantor to jurisdiction and venue in the State of New Jersey for any purpose except as provided herein and shall not be deemed to confer rights on any other person or entity. service of process on behalf of Guarantor in connection with the (9)Guarantor consents that Sublessee shall hereafter have full authority and be duly empowered to accept enforcement of this Guaranty, and Guarantor hereby appoints Sublessee as its agent for purposes of acceptance of service of process in connection with the enforcement of this Guaranty. (10)Provided that Sublessor is the prevailing party in any action brought to enforce this Sublease Guaranty, Guarantor shall pay to Sublessor all of Sublessor’s reasonable expenses, including, without limitation, reasonable third-party out of pocket attorneys’ fees and disbursements, in enforcing this Sublease Guaranty following an event of default by Sublessee under the Sublease, beyond any applicable notice and cure periods. Dated: January 20, 2023 GUARANTOR: MEH, INC., a Nevada corporation By: __________________________________ Name: Title: Exhibit H CONSENT OF LANDLORD TO SUBLEASE [Attached.] LICENCE AGREEMENT LICENSOR (‘US’, ‘WE’ OR ‘OUR’): LICENSEE (‘YOU’, OR ‘YOUR’): Weston Office Solutions Ltd T/A Iconic Offices 81 Merrion Square South Dublin 2 D02 NR12 Ireland Ireland Amarin Pharmaceuticals Ireland Ltd 77 Sir John Rogerson's Quay D02 NP08 OFFICES(S): COMPANY REGISTRATION NUMBER: Greenway 211-219 Exhibit 10.47 BILLING CONTACT DETAILS: CENTRE: The Greenway C Ardiluan Court 112-114 Stephens Green Dublin 2 D02TD28 Contact name: David Keenan Telephone: 0878541984 Email: david.keenan@amarincorp.eu ADDITIONAL CONTACTS: Contact Name Contact Email Contact Role YOUR INVOICING ADDRESS: 77 Sir John Rogerson's Quay D02 NP08 Ireland LICENCE START DATE: 01/10/2022 LICENCE END DATE: 30/09/2024 SERVICE RETAINER: €55,200.00 MONTHLY FEE: €27,600 (excl tax) LICENCE AGREEMENT By signing this agreement you confirm that you have read, understood and agree to abide by the conditions attached to the license. LICENSOR DETAILS Full Name: Liadh Grainger LICENSEE DETAILS Full Name: \Dr David Keenan Title: Sales Executive Title: \SVP Technical Operators, Director Date: Date: \d2\ Signature: Signature: \s1\ \s2\ LICENCE AGREEMENT MONTHLY LICENCE TOTAL: €27,600.00 LICENCE FEE MONTHLY PRICE SERVICES QUANTITY MONTHLY PRICE October 2022 €27,600.00 November 2022 €27,600.00 December 2022 €27,600.00 January 2023 €27,600.00 February 2023 €27,600.00 March 2023 €27,600.00 April 2023 €27,600.00 May 2023 €27,600.00 June 2023 €27,600.00 July 2023 €27,600.00 August 2023 €27,600.00 September 2023 €27,600.00 October 2023 €27,600.00 November 2023 €27,600.00 December 2023 €27,600.00 January 2024 €27,600.00 February 2024 €27,600.00 March 2024 €27,600.00 April 2024 €27,600.00 May 2024 €27,600.00 June 2024 €27,600.00 July 2024 €27,600.00 August 2024 €27,600.00 September 2024 €27,600.00 MONTHLY TOTAL: €27,600.00 MONTHLY TOTAL: €700.00 LICENCE AGREEMENT SETUP FEES QUANTITY ONE-OFF FEE Establishment Fee 21 €819.00 ONE-OFF Fee Total: €819.00 ADDITIONAL TERMS: i. ii. iii. The Licensor agrees to notify the Licensee when construction of Scotch House resumes and subsequently confirm the date for the relocation to Scotch House (“Scotch House start date”). The Licensee will have first right of refusal on suites 204, 205, 208, 209 at the agreed list price of €27,600 ex vat per month at Scotch House. Upon receipt of the confirmed completion date for Scotch House, the Licensee will have two (2) business days to provide written acceptance that they wish to relocate to Scotch House. If the Licensee accepts the relocation, an addendum will be affixed to this License agreement confirming the Licensee’s relocation to Suites 204, 205, 208 and 209 at Scotch House for the remainder of the License term ending 30th September 2024. Should the Licensee wish to remain within Suites 211-219 at The Greenway, office suite license fees for the remaining term shall be at the then prevailing market rate as notified by the Licensor to the Licensee. The uplift in fees will apply from the Scotch House start date. For the avoidance of doubt, the capacity of Suites 211-219 at The Greenway is 60 workstations and shall be charged at the prevailing market rate. If the Licensee agrees to relocate to Suites 204, 205, 208 & 209 in Scotch House, the below services and fit out works will commence: The following services and pricing have been agreed: Two (2) dedicated car parking spaces @€350 ex vat to be charged monthly. The Licensee agrees to Iconic proceeding with the following scheduled works, fees will be borne by the Licensee: Demolition of existing wall €2,100 ex vat Make bulkhead for glass partition €650 ex vat Supply and install of double-glazed partition with black frame €7,700 ex vat Supply and install of double-glazed glass door €1,200 ex vat Redecorate adjoining walls €350 ex vat Subtotal cost €12,000 ex vat The Licensee agrees to pay the below restoration charges upon notice of termination. For the avoidance of doubt this will be 3 (three) full calendar months prior to the license agreements end date. Should the Licensee wish to enact the break, the Licensee must pay the restoration fee at the end of month 9 (June 2022). All restoration works are to be completed post exit when The Licensee has vacated the office space. Restoration Removal of glass partition and glass door €1950 ex vat Reinstatement of double slabbed acoustically insulated partition €5,500 LICENCE AGREEMENT Paint new wall and adjoining walls €700 ex vat Subtotal cost €8,150 ex vat iv. v. vi. The Licensor agrees to a monthly fee of €27,600 + vat per month for the duration of this contract term. The fees on any renewal shall be at the then prevailing market rate as notified by the Licensor to the Licensee unless the monthly fees are updated due to the Licensee remaining in The Greenway as outlined in clause ii Should the Licensee wish to terminate within the fixed term, the Licensee must furnish the Licensor with three full calendar months written notice and must pay the outstanding balance on the contract net of the amount of the “service retainer” deposit. The Licensor and Licensee agree to a Break Option at the end of month 12. Should the Licensee wish to enact the break, the Licensee must furnish the Licensor with three calendar months written notice. For the avoidance of doubt the Licensee must contact the Licensor in writing by the end of Month 9 (May 2023) should they wish to Terminate the Agreement at the end on Month 12 (September 2023). vii. Car Parking TBC The following services and pricing have been agreed: Internet requirements TBC The Licensee shall be allowed to use Scotch House as their business address. The Licensor agrees to arrange for the weekly delivery of any mail to The Greenway. For the duration of the Licensees time in The Greenway, the Licensor agrees to grant the licensee complimentary use of The Greenroom once a month on a half day basis valued at €500 ex vat. The Licensee will need to provide the Licensor with 2 weeks’ notice if booking The Greenroom. Standard meeting room T’s and C’s will apply. The Licensor and Licensee understand there will be ongoing work in neighbouring building. As such, the Licensee agrees and understands that there may be some noise disturbance during this time. The Licensee agrees and understands that this disturbance is outside of the Licensor's control. The Licensor agrees to provide sit/stand desks for 24 workstations. The Licensor agrees to provide 3 TV screens to place in open plan and two smaller offices. The Licensor agrees to execute the below layout labelled ‘’Exhibit A’’ One off set up costs will also apply they are broken down as follows: Establishment Fee @ €39.00 per person x 21 (keys, fobs & security settings). Service levels will be confirmed by the Centre Manager through the Move In Questionnaire and all additional services are as per the proposal. All per person charges will be billed as and when new employees join the office. LICENCE AGREEMENT Amended terms 1.6 Anti-competitive behaviour: The Licensee shall not at any time from the date on which the License commences to the expiry of 12 (twelve) months after the end date of the License, solicit, entice away any existing Licensee from the Licensor 1.7 Confidentiality: The terms of this agreement are confidential. Neither Iconic Offices nor the Licensee must disclose them without the other’s consent unless required to do so by law or an official authority or as needed in the ordinary course of business. This obligation continues after this agreement ends. 2.3 Providing the Services: Access to the accommodation(s): Iconic Offices employees may need to enter the Licensee’s Office(s) and may do so at any time. However, unless there is an emergency or the Licensee has given notice to terminate, Iconic Offices will notify the Licensee(s) verbally or electronically in advance when Iconic needs access to carry out viewings (where the Licensee has given notice to terminate), testing, repair or works other than routine inspection, cleaning, and maintenance. Iconic Offices will also respect reasonable security procedures to protect the confidentiality of the Licensee’s business. 4.4 Ending this agreement immediately: To the maximum extent permitted by applicable law, Iconic Offices may (acting always in good faith) put an end to this agreement immediately by giving the Licensee notice and without need to follow any additional procedure if (a) the Licensee becomes insolvent, bankrupt, goes into liquidation or becomes unable to pay its debts as they fall due, or (b) the Licensee is in breach of one of its obligations which cannot be put right or which Iconic Offices have given the Licensee notice to put right and which the Licensee has failed to put right within fourteen (14) days of that notice, or (c) its conduct, and that of any party authorised and appointed and or invited by it or that of someone at the Building with its permission or invitation, is incompatible with ordinary office use If Iconic Offices puts an end to this agreement for any of these reasons it does not put an end to any outstanding obligations, including additional services used and the monthly license fee. Notwithstanding the foregoing, any outstanding obligation would be limited to the lesser of the remaining license fee at the time of termination, or 3 (Three) months of the license value (€82,800 ex vat). For the avoidance of doubt the security deposit will be returned as outlined in amended term 9.2. 8.2 The extent of Iconic Offices liability: To the maximum extent permitted by applicable law, Iconic Offices is not liable to the Licensee in respect of any loss or damage the Licensee suffers in connection with this agreement, with the services or with the Licensee’s Office(s) unless Iconic Offices has acted negligently in causing that loss or damage. Iconic Offices is not liable for any loss because of Iconic Offices’ failure to provide a service because of a mechanical breakdown. In no event shall Iconic Offices be liable for any loss or damage unless the Licensee provides Iconic Offices written notice and gives Iconic Offices a reasonable time to put it right. If Iconic Offices is liable for failing to provide the Licensee with any service under this agreement, then subject to the exclusions and limits set out immediately below Iconic Offices will pay any actual and reasonable expenses the Licensee has incurred in obtaining that service from an alternative source. If the Licensee believes Iconic Offices has failed to deliver a service consistent with these terms and conditions the Licensee shall provide Iconic Offices written notice of such failure and give Iconic Offices a reasonable period to put it right. 8.3 Exclusion of consequential losses, etc. The Licensee and Licensor will not in any circumstances have any liability to the other for consequential, incidental or indirect damages or expenses including damages for loss of business, loss of profits, loss of anticipated savings, loss of or damage to data, third party claims or any consequential loss. Iconic offices strongly advise the licencee to insure against all such potential loss, damage, expense, or liability. LICENCE AGREEMENT 9.2 Service Retainer/ Security Payment: The Licensee shall pay to Iconic Offices no later than 2 (two) business days after the License is signed, the prepayment as specified in the agreement as security against all obligations entered into by the Licensee in this agreement. The Service Retainer / Security Payment is to be returned to the Licensee provided that the Licensee has complied with its obligations under this agreement, and subject to the deduction of an amount in respect of any outstanding invoices or deductions and will be refundable 30 (thirty) days after the end day of this agreement, or receipt of bank details for the return, whichever is later. It is the Licensor’s responsibility to ensure the Service Retainer/ Security Payment is returned to the Licensee before the last day of the twelfth calendar month after the end day of this agreement. Iconic Offices is not required under regulation to hold these funds on account, but this does not negate Iconic Offices from its responsibilities to return of same. Iconic Offices also may opt to offer a rent-free period prior to the expiry of this term or any subsequent terms in lieu of part or all the Service Retainer/security payment. Licensee has the right to accept or reject such offer. Neither the giving of the Service Retainer / Security Payment nor any deduction from it by Iconic Offices shall relieve the Tenant from any of its obligations under this agreement or otherwise limit Iconic Offices’ right to recover against the Licensee for any breach of this agreement. Should the Service Retainer / Security Payment not be received by Iconic within 2 (two) working days of the signing of the agreement, Iconic Offices reserves the right to nullify this agreement. 9.6 In the event that the Licensee does not pay the total undisputed amount as stated on an invoice by the stipulated date Iconic Offices shall be entitled to: 1) On the 5th (fifth) day of the new month withdraw and stop partial or all services provided by Iconic Offices including, but not limited to internet, telephone, and electricity services. 2) On the 11th (eleventh) day of the new month enter the office and change the locks/keys without prior notice. 3) On the 14th (fourteenth) of the new month terminate the License agreement and claim all costs including legal fees associated with recovering all monies owed to Iconic Offices from the Licensee with immediate effect. 4) Subject to Data Protection Laws, the Licensor may register the Licensee with a credit rating agency if any debt of the Licensee to the Licensor remains unpaid for more than thirty (30) days. 9.7 Late payment Fee: If the Licensee has not paid their account in full of cleared funds by the due date, a late payment fee will be charged on the account. This fee will be €30.00 (thirty) Ex. VAT plus a 5% penalty on all overdue balances. If the Licensee disputes any part of an invoice the Licensee must pay the amount not in dispute by the due date or be subject to late fees. Iconic Offices also reserves the right to withhold services (including for the avoidance of doubt, denying the Licensee access to its accommodation(s) while there are any undisputed outstanding fees and/or interest or the Licensee is in breach of this agreement. 18 FORCE MAJEURE Neither Party shall be in breach of this Agreement nor liable for delay in performing, or failure to perform, any of its obligations under this Agreement if such delay or failure result from events, circumstances or causes beyond its reasonable control. In such circumstances the affected Party shall be entitled to a reasonable extension of time for performing such obligations. If the period of delay or non-performance continues for four (4) weeks, the Party not affected may terminate this agreement by giving fourteen (14) days' written notice to the affected Party. Amendments to House Rules For the avoidance of doubt Clause 4.5 , 5.1 & 5.2 below refer to undisputed charges only. 4.5. Cross Default: The Client agrees that, if they are in default under a service agreement with Iconic Offices at a different building (“Different Location Agreement”) to the one specified in this Agreement, that Iconic Offices may recover any unpaid sums due under a Different Location Agreement from the Client under this Agreement and that Iconic Offices may, in particular (but not limited to), withhold services under this Agreement or deduct sums from the retainer held under this Agreement in respect of such unpaid sums. LICENCE AGREEMENT 5.1. Standard services: The standard fee and any fixed, recurring services requested by the Client are payable in advance, by the 25th day (or such other day as Iconic Offices designates) of each month following the date the Client receives their invoice. Where a daily rate applies, the charge for any such month will be 30 times the standard fee. For a period of less than a month the standard fee will be applied on a prorated basis. Recurring services will be provided by Iconic Offices at the specified rates for the duration of your Agreement (including any renewal). Any changes to monthly reoccurring services can be made in writing to the Building/ Community Manager with 1 calendar month notice. 5.2. Pay-as-you-use and Additional Variable Services: Fees for pay-as-you-use services, plus applicable taxes, in accordance with our published rates which may change from time to time, are invoiced in arrears and payable on the 25th day (or such other day as we designate) of the month following the calendar month in which the additional services were provided. 2. USE PREVENTION CLAUSE 2.1 Subject to Special Term 2.2 below, if a Use Prevention Measure takes effect, payment of the License Fee and outgoings shall be deferred on a daily basis in respect of the period from and including the Use Prevention Date until the Use Prevention End Date. 2.2 The License Fee shall not be deferred under Special Term 2.1 above if at any time from and including the Use Prevention Date and before the Use Prevention End Date, the Licensee uses all or part of the Office or the Use Prevention Measure was imposed as a direct result of any act or omission of the Licensee. 2.3 The maximum amount of the Licensee Fee that may be deferred in any period of 12 months pursuant to this Special Term 2 shall be €27,600 Ex vat2.4 In this Special Term 2: 2.4.1 “Coronavirus” means the disease known as coronavirus disease (COVID-19) and the virus known as severe acute respiratory coronavirus 2 (SARS-CoV-2); 2.4.2 “Government” means local, regional or central government; 2.4.3 “Use Prevention Date” means the date on which a Use Prevention Measure takes effect; 2.4.4 “Use Prevention End Date” means the date on which the Use Prevention Measure ceases to take effect; 2.4.5 “Use Prevention Measure” means any requirement of the Government for the prevention or delay of the spread of Coronavirus which requires: 2.4.5.1 the Licensee to work from home unless essential for work, which is an essential health, social care or other essential service and cannot be done from home. 2.4.5.2 Iconic to prevent or restrict access to the Office or the Building for the Licensee (or its employees and customers) so that the Licensee is not able to use the office for its intended purposes By signing this agreement you confirm that you have read, understood, and agree to abide by the conditions attached to the licence. LICENCE AGREEMENT TERMS AND CONDITIONS Weston Office Solutions Ltd T/a Iconic Offices (herein referred to as Iconic or Iconic Offices) - Terms and Conditions 1. GENERAL TERMS This Agreement 1.1 Nature of this agreement: This License Agreement is personal to the Parties hereto and is strictly not assignable by the Licensee and the Licensee shall not share or part with possession of this agreement or any part thereof. Iconic and this agreement gives the Licensee no legal or equitable interest in the property, other than the right to share the facilities within the building with Iconic Offices and any other entities appointed and authorised by Iconic Offices. 1.2 (The) Licensee unreservedly confirms that it did not rely upon any warranty or representation made by Iconic Offices in entering this agreement except those that are expressly set out in this agreement. 1.3 Where the Licensee comprises of more than one individual such individuals shall be jointly and severally liable to observe and perform the licensee’s obligations under this License Agreement. 1.4 Comply with House Rules: It is a condition of the within Agreement that the Licensee is subject to full compliance and adherence to all House Rules imposed by Iconic. A copy of said House Rules has been furnished to the Licensee before entering into this Agreement. By execution hereof, the Licensee agrees to fully comply with the terms of said House Rules. Iconic reserves the right to amend said House Rules from time to time and will furnish a copy of the newly amended document to the Licensee. Licensee(s) and all authorised and appointed employees, agents, servants, and invitees must always comply with all applicable House Rules. 1.5Communication with employees and Iconic Offices: While this agreement is in force and for a period of six months after it ends, neither Iconic nor the Licensee may knowingly solicit or offer employment to any of the other’s staff employed in the Building or by Iconic. This obligation applies to any employee employed at the Building up to that employee’s termination of employment, and for three months thereafter. Nothing in this clause shall prevent either party from employing an individual who responds in good faith and independently to an advertisement, which is made to the public at large. 1.6 Anti-competitive behaviour: The Licensee shall not at any time from the date on which the License commences to the expiry of 12 (twelve) months after the end date of the License, solicit, entice away any existing Licensee from the Licensor. If the Licensee engages in any behaviour which results in an existing Licensee of the Licensor to terminate their License, the Licensee agrees to pay a sum equivalent to 6 (six) months License fees of the current License fees payable by that Licensee. 1.7 Confidentiality: The terms of this agreement are confidential. Neither Iconic Offices nor the Licensee must disclose them without the other’s consent unless required to do so by law or an official authority. This obligation continues after this agreement ends. 1.8 Applicable law: This agreement is interpreted and enforced in accordance with Irish laws. Iconic Offices and the Licensee both accept the exclusive jurisdiction of the courts of such jurisdiction. If any provision of these terms and conditions is held void or unenforceable under the applicable law, the other provisions shall remain in force. 2. SERVICES 2.1 Office Services: Iconic Offices is to provide during normal opening hours or where permitted by the Building 24 x 7 access. The complimentary services provided are, daily cleaning of common areas, daily cleaning of office where the Building is deemed “fully serviced”, lighting, heating, electricity & reasonable public liability, “Meet and greet” reception services are provided in some locations LICENCE AGREEMENT and the reception in specific locations will be manned 9am to 5.30pm Monday to Friday except for Bank and National Holidays. If Iconic decides that a request for any service is excessive, it reserves the right to charge an additional fee determined at the time of request. Licensees can only utilise the address that is reflected in their current agreement and each Licensee is responsible for the collection of mail from the communal letterbox supplied by the Building unless the location has a fully manned reception, in which instance the reception team will hold post for collection by Licensees at the front desk. 2.2 Iconic Offices IT: Iconic Offices does not make any representations as to the security of Iconic Offices’ network (or the internet) or of any information that the Licensee places on it. The Licensee should adopt all prudent security measures it believes are appropriate to its circumstances. Iconic Offices offers no guarantee whatsoever that a particular degree of availability will be attained in connection with the Licensee’s use of Iconic Offices’ network (or the internet). The Licensee’s sole and exclusive remedy shall be the remedy of such failure by Iconic Offices within a reasonable time after written notice. Iconic, via their appointed IT contractor, provide the preparation of each individual suite so that each company has: a) their own secure and private network (VLAN) b) access to both a shared building Wireless Private and Guest network c) shared Internet Connectivity with other companies in the building. If a Licensee has any requirement outside of these three items they should contact, or have their IT company contact, Iconic Offices’ appointed IT contractor to discuss the specific requirements. Additional charges may apply where specific or specialised IT work is required. 2.3 Providing the Services: Access to the accommodation(s): Iconic Offices employees may need to enter the Licensee’s Office(s) and may do so at any time. However, unless there is an emergency or the Licensee has given notice to terminate, Iconic Offices will attempt notify the Licensee(s) verbally or electronically in advance when Iconic needs access to carry out viewings (where the Licensee has given notice to terminate), testing, repair or works other than routine inspection, cleaning, and maintenance. Iconic Offices will also endeavor to respect reasonable security procedures to protect the confidentiality of the Licensee’s business. 3. ACCOMMODATION 3.1 Accommodation(s): The Licensee must not alter any part of its accommodation and must take good care of all parts of the Building, its equipment, fixtures, fittings, and furnishings which the Licensee uses. The Licensee is liable for any damage caused by its employees, contractors, agents, or other persons invited to the premises by the Licensee. 3.2 Office furniture and office customisation: The Licensee must take good care of all parts of the Iconic Offices building, its equipment, fittings, and furnishings that they use. The Licensee must not alter any part of the accommodation without prior written consent by Iconic Offices. If the Licensee has introduced customization of the Licensee’s private office space, upon exiting the premises at the point of termination, the Licensee is to reinstate the premises to the original condition it was in prior to the building works commencing. 3.3 I.T. and Telecoms equipment: The Licensee must not install any cabling, IT or telecom connections without Iconic Office’ consent in writing, which Iconic may refuse at its absolute discretion. Iconic Offices will charge a separate fee should a Licensee wish to install an internet line separate to that provided by Iconic. This fee is €35 (thirty-five Euro) + VAT per person and should be considered a concession fee. As a condition to Iconic Offices’ consent, the Licensee must permit Iconic to oversee any installations (for example IT or electrical systems) and to verify that such installations do not interfere with the use of the Office(s) by other Licensees or Iconic Offices or any landlord of the building. 3.4 If the Building is no longer available: If Iconic is permanently unable to provide the services and Office(s) at the Building stated in this agreement, then this agreement will end, and the Licensee will only have to pay monthly license fees up to the date it ends and for the additional services the Licensee has used. Iconic Offices will attempt to find suitable alternative Office(s) for the Licensee at another Iconic Buildings only. If no alternative within the Iconic Offices portfolio is deemed suitable by either party, then Licensee is released from its obligations as stated and Iconic shall have no further obligation or responsibility to Licensee. 4. RENEWAL AND ENDING YOUR MEMBERSHIP 4.1 All notices must be in writing: Notices to the Licensee will be considered served if handed personally or emailed to the legal representative or authorised representative of the business who was the signatory to this agreement. Notices to Iconic Offices will be considered served if mailed by registered mail to Iconic Offices’ registered address or by email to one of its nominated Building Managers, Community Team Leads or to a Director of Iconic Offices. 4.2 Duration: This agreement lasts for the period stated herein and then will be extended automatically for successive periods equal to the current term but no less than 3 (three) months until said Term is terminated by the Licensee or by Iconic Offices. All periods shall run to the last day of the LICENCE AGREEMENT month in which they would otherwise expire. The fees on any renewal will be at the then prevailing market rate as notified by Iconic. Automatic renewal will occur should the Licensee fail to provide Iconic Offices 3 (three) full calendar months’ written notice. The Licensor will endeavour to provide a courtesy reminder prior to the renewal notice period within this agreement. Terminating the agreement 4.3 Bringing this agreement to an end: No later than three (3) months before the end of the Term as outlined on page 1 (one) of this agreement, notice must be given in writing either by Iconic Offices or the Licensee to the other Party notifying the other Party that they intend to terminate this agreement at the end date stated in it, or at the end of any extension or renewal period. If an automatic renewal has been applied the termination will be effective at the end of the term stipulated in the automatic renewal. However, if this agreement, extension, or renewal is for three months or less and either Iconic or the Licensee wishes to terminate it, the notice period is two months or (if two months or shorter) two weeks less than the period stated in this agreement. The Licensee will be released from their obligations under this License and allowed to terminate prior to the end date of this License subject to the Licensee paying Iconic the full agreement obligation for the unexpired term, together with all other outstanding invoices. Upon settlement of these terms, the service retainer will then subsequently be refunded to the Licensee within 30 days of payment. 4.4 4.4 Ending this agreement immediately: To the maximum extent permitted by applicable law, Iconic Offices may put an end to this agreement immediately by giving the Licensee notice and without need to follow any additional procedure if (a) the Licensee becomes insolvent, bankrupt, goes into liquidation or becomes unable to pay its debts as they fall due, or (b) the Licensee is in breach of one of its obligations which cannot be put right or which Iconic Offices have given the Licensee notice to put right and which the Licensee has failed to put right within fourteen (14) days of that notice, or (c) its conduct, and that of any party authorised and appointed and or invited by it or that of someone at the Building with its permission or invitation, is incompatible with ordinary office use . If Iconic Offices puts an end to this agreement for any of these reasons it does not put an end to any outstanding obligations, including additional services used and the monthly license fee for the remainder of the period for which this agreement would have lasted if Iconic Offices had not ended it. remainder of the period for which this agreement would have lasted if Iconic Offices had not ended it. . 4.5 When this agreement terminates, the Licensee shall vacate the Office(s) immediately, leaving the Office(s) in the same condition as it was when the Licensee entered the premises. Upon the licensee’s departure or if the Licensee, at its option, chooses to relocate to different rooms/workstations within the Building, Iconic will charge an Office Restoration Service fee to cover normal cleaning procedures and to return the Office(s) to its original state. The standard restoration fee is €20 (twenty Euro) + VAT per square meter. Iconic Offices reserves the right to charge additional reasonable fees for any repairs needed above and beyond normal wear and tear. If the Licensee leaves any property in the Building Iconic may dispose of it at the Licensee’s cost in any way Iconic Offices chooses without owing the Licensee any responsibility for it or any proceeds of sale. When a Licensee vacates its Office(s) the Licensee must establish a mail redirection service with An Post for a minimum of 3 (three) months. If the Licensee continues to receive mail at the Buildings address after this agreement has ended, Iconic Offices will not be responsible for any loss, claim or liability incurred because of the Licensee’s failure to redirect their mail. All correspondence received post a Licensee moving out will be disposed of within 24 (twenty-four) hours of it being received at the Building. 4.6 Keys, access fobs and passes: On or before the expiry of this agreement the Licensee must return to Iconic all keys and other means of access to the office and the building. Whenever any key(s) or other means of access is lost the Licensee is to report such loss forthwith to Iconic Offices and incur the cost to replace such key(s) or other means of access as well as the cost of replacing any lock/keys changed by Iconic for other tenants. 5. OBLIGATIONS AND LICENSE CONDUCT 5.1 Furnished office accommodation(s): Iconic Offices is to provide the number of serviced and furnished Office(s) for which the Licensee has agreed to pay in the Building as stated in this agreement. This agreement lists the Office(s) Iconic Offices has initially allocated for the Licensee’s use. Occasionally Iconic may need to allocate different accommodation(s), but these Office(s) will be reasonably equivalent in quality and size and Iconic will notify the Licensee with respect to such different Office(s) at least 30 (thirty) days in advance. LICENCE AGREEMENT 5.1 Insurance: It is the Licensee’s responsibility to arrange insurance for its own property which it brings into the Building and for its own liability to its employees and to third parties. Iconic strongly recommends that the Licensee put such insurance in place. For the avoidance of doubt, the Licensee is advised to possess contents insurance and public liability. 5.2. Security: Where Iconic Buildings are unmanned, they rely 100% on its occupants to securely lock the premises upon exiting the Building. It is the sole responsibility of the last person exiting the Licensee’s office space to securely turn off the lights and lock all windows and doors the Licensee has access to. In the case of an incident occurring failure to comply by the terms of this may result in liability being placed on the Licensee responsible. 6 USE 6.1 The Licensee must only use the Office(s) for office purposes. Office use of a “retail” or “medical” nature, involving frequent visits by members of the public, is not permitted unless permission is given in writing by Iconic. Residing overnight in the premises is also not permitted. 6.2 The Licensee must not carry out a business that competes with Iconic Offices provision of serviced offices or its ancillary services. 6.3 The Licensee’s name and address: The Licensee may only carry out its business in its registered name stipulated in this agreement or a trading name disclosed to the Licensor in writing. 6.4 Use of the Building Address: The Licensee may use the Building address as its business address. Any other uses are prohibited without Iconic Offices prior written consent. For the avoidance of doubt, the Licensee may not register its business at an Iconic Offices Building unless agreed upon in writing by the Licensor. 7 COMPLIANCE 7.1 Comply with the law: The Licensee must comply with all relevant laws and regulations in the conduct of its business. The Licensee must do nothing illegal in connection with its use of the Building. The Licensee must not do anything that may interfere with the use of the Building by Iconic Offices or by others, cause any nuisance or annoyance, increase the insurance premiums Iconic Offices must pay, or cause loss or damage to Iconic Offices (including damage to reputation) or to the owner of any interest in the building which the Licensee is using. The Licensee acknowledges that (a) the terms of the foregoing sentence are a material inducement in Iconic Offices execution of this agreement and (b) any violation by the Licensee of the foregoing sentence shall constitute a material default by the Licensee hereunder, entitling Iconic Offices to terminate this agreement, without further notice or procedure. 7.2 The Licensee acknowledges and accepts that its personal data may be transferred or made accessible to all entities of the Iconic Offices group, wherever located, for the purposes of providing the services herein. 8 ICONIC OFFICES LIABILITY 8.1 Availability at the start of this agreement: If for any reason Iconic Offices cannot provide the Office(s) stated in this agreement by the date when this agreement is due to start it has no liability to the Licensee for any loss or damages, but the Licensee may cancel this agreement without penalty. Iconic will not charge the Licensee the monthly licence fee for Office(s) the Licensee cannot use until it becomes available. Iconic may delay the start date of this agreement provided it provides to the Licensee alternative Office(s) that shall be at least of equivalent size to the Office(s) stated in this agreement. 8.2 The extent of Iconic Offices liability: To the maximum extent permitted by applicable law, Iconic Offices is not liable to the Licensee in respect of any loss or damage the Licensee suffers in connection with this agreement, with the services or with the Licensee’s Office(s) unless Iconic Offices has acted negligently in causing that loss or damage. Iconic Offices is not liable for any loss because of Iconic Offices’ failure to provide a service because of mechanical breakdown, strike, termination of Iconic Offices.. In no event shall Iconic Offices be liable for any loss or damage unless the Licensee provides Iconic Offices written notice and gives Iconic Offices a reasonable time to put it right. If Iconic Offices is liable for failing to provide the Licensee with any service under this agreement, then subject to the exclusions and limits set out immediately below Iconic Offices will pay any actual and reasonable expenses the Licensee has incurred in obtaining that service from an alternative source. If the Licensee believes Iconic Offices has failed to deliver a service consistent with these terms and conditions the Licensee shall provide Iconic Offices written notice of such failure and give Iconic Offices a reasonable period to put it right. 8.3 Exclusion of consequential losses, etc. Iconic offices will not in any circumstances have any liability for loss of business, loss of profits, loss of anticipated savings, loss of or damage to data, third party claims or any consequential loss unless iconic offices otherwise agree in writing. Iconic offices strongly advise the licencee to insure against all such potential loss, damage, expense, or liability. LICENCE AGREEMENT 9. FEES AND CHARGES 9.1 Taxes and miscellaneous charges: The Licensee agrees to pay the VAT applicable to each invoice submitted by Iconic Offices to the Licensee. 9.2 Service Retainer/ Security Payment: The Licensee shall pay to Iconic Offices no later than 2 (two) business days after the License is signed, the prepayment as specified in the agreement as security against all obligations entered into by the Licensee in this agreement. The Service Retainer / Security Payment is to be returned to the Licensee provided that the Licensee has complied with its obligations under this agreement, and subject to the deduction of an amount in respect of any outstanding invoices or deductions and will be refundable 30 (thirty) days after the end day of this agreement, or receipt of bank details for the return, whichever is later. It is the Licensee’s responsibility to ensure the Service Retainer/ Security Payment is returned to the Licensee before the last day of the twelfth calendar month after the end day of this agreement. There is no obligation on the Licensor to return the Service Retainer/ Security Payment if not requested by the Licensee. Iconic Offices is not required under regulation to hold these funds on account, but this does not negate Iconic Offices from its responsibilities to return of same. Iconic Offices also may opt to offer a rent-free period prior to the expiry of this term or any subsequent terms in lieu of part or all the Service Retainer/security payment. Neither the giving of the Service Retainer / Security Payment nor any deduction from it by Iconic Offices shall relieve the Tenant from any of its obligations under this agreement or otherwise limit Iconic Offices’ right to recover against the Licensee for any breach of this agreement. Should the Service Retainer / Security Payment not be received by Iconic within 2 (two) working days of the signing of the agreement, Iconic Offices reserves the right to nullify this agreement. 9.3 Iconic Offices may require the Licensee to pay an increased Service Retainer/ Security Payment if outstanding fees exceed the Service Retainer/ Security Payment held and/or the Licensee frequently fails to pay Iconic Offices when due. 9.3.1. Iconic Offices may require the Licensee to pay an increase Service Retainer/ Security Payment if there has been an uplift in the monthly rental amount. 9.4The Licensee will be charged an office set up fee per occupant. Fee amounts are stated in the House Rules and within the proposal documents which can be requested at any time. 9.5 Payment: The monthly office fee and any recurring services requested by the Licensee will be payable monthly and in advance. Unless otherwise agreed in writing these recurring services will be provided by Iconic Offices at the specified rates for the duration of this agreement (including renewal). Payment will be due on the or before the 25th of each month. Pay-as-you-use services (published rates may change from time to time) plus applicable taxes are invoiced in arrears and are payable the 25th of the month following the calendar month in which the additional services were provided. The Licensor requests the Licensee sign up to Direct Debit payments, failure to do so will incur an additional 3.5% surcharge which will be applied to the Licensee’s next invoice. 9.6 In the event that the Licensee does not pay the total amount as stated on an invoice by the stipulated date Iconic Offices shall be entitled to: 1) On the 5th (fifth) day of the new month withdraw and stop partial or all services provided by Iconic Offices including, but not limited to internet, telephone, and electricity services. 2) On the 11th (eleventh) day of the new month enter the office and change the locks/keys without prior notice. 3) On the 14th (fourteenth) of the new month terminate the License agreement and claim all costs including legal fees associated with recovering all monies owed to Iconic Offices from the Licensee with immediate effect. 4) Subject to Data Protection Laws, the Licensor may register the Licensee with a credit rating agency if any debt of the Licensee to the Licensor remains unpaid for more than thirty (30) days. 9.7 Late payment Fee: If the Licensee has not paid their account in full of cleared funds by the due date, a late payment fee will be charged on the account. This fee will be €30.00 (thirty) Ex. VAT plus a 5% penalty on all overdue balances. If the Licensee disputes any part of an invoice the Licensee must pay the amount not in dispute by the due date or be subject to late fees. Iconic Offices also reserves the right to withhold services (including for the avoidance of doubt, denying the Licensee access to its accommodation(s) while there are any outstanding fees and/or interest or the Licensee is in breach of this agreement. 9.8 Insufficient Funds: The Licensee will pay a fee for any returned cheque or any other declined payments due to insufficient funds. This fee will be €30.00 (thirty) Ex. VAT. LICENCE AGREEMENT 9.9 Standard services: The monthly License fee and any recurring services requested by the Licensee are payable monthly in advance. Unless otherwise agreed in writing, these recurring services will be provided by Iconic at the specified rates for the duration of this Agreement (including any renewal). Increases or changes to service levels should be agreed in writing with the Community Manager with 1 (one) calendar months’ notice. Where a daily rate applies, the charge for any such month will be 30 (thirty) times the daily fee. For a period of less than a month the fee will be applied daily. 9.10 Pay-as-you-use and additional variable services: Fees for pay-as-you-use services, plus applicable taxes, in accordance with Iconic Offices’ published rates which may change from time to time, are invoiced in arrears and payable the month following the calendar month in which the additional services were provided. 9.11 Discounts, Promotions and Offers: If the Licensee benefited from a special discount, promotion or offer, Iconic Offices may discontinue that discount, promotion or offer without notice if the Licensee breaches these terms and conditions or becomes overdue on payment on 2 (two) or more occasions. On the renewal of an agreement these benefits will expire. 10 DATA PROTECTION 10.1 Each Party shall comply with the Data Protection Laws applicable to it in connection with this Agreement and shall not cause the other Party to breach any of its obligations under Data Protection Laws. The Parties agree that the Receiving Party will Process Personal Data as the Processor on behalf of the Disclosing Party which shall act as a Controller of such Personal Data in connection with this Agreement. 10.2.1 The Processor shall, or shall ensure that its sub-contractor shall: 10.2.2. Process the Personal Data only on behalf of the Controller, only for the purposes of performing its obligations under this Agreement, and only in accordance with instructions contained in this Agreement or instructions received in writing from the Controller from time to time. The Processor shall notify the Controller if, in its opinion, any instruction given by the Controller breaches Data Protection Laws or other applicable law. 10.2.3. Not otherwise modify, amend, or alter the contents of the Personal Data or disclose or permit the disclosure of any of the Personal Data to any third party (including without limitation the Data Subject) unless specifically authorised in writing by the Controller. 10.2.4. Only grant access to the Personal Data to persons who need to have access to it for the purposes of performing this Agreement. 10.2.5. Ensure that all persons with access to the Personal Data are subject to an obligation of confidentiality in respect of the Personal Data. 10.2.6. Considering the nature of the Processing and the information available to the Processor, assist the Controller in ensuring compliance with the Controller’s obligations under Data Protection Laws. 10.2.7. Implement and maintain appropriate technical and organisational measures to protect Personal Data against unauthorised or unlawful access; unauthorised or unlawful alteration, disclosure, destruction or damage; unauthorised or unlawful Processing and accidental loss, alteration, disclosure, destruction or damage. 10.2.8. 10.2.9. Notify any loss, damage, or destruction of Personal Data (“Security Breach”) to the Controller as soon as reasonably practicable and in any event within 24 hours of becoming aware of a Security Breach and provide all reasonable assistance to the Controller in relation to the notification of such breach to the Data Protection Commission and any other applicable Supervisory Authority and any Data Subject. not engage another processor (a "Sub-Processor") to process the Personal Data on its behalf without specific written consent of the Controller, approving a named Sub-Processor, such consent always subject to the Processor binding any Sub-Processor by written agreement, imposing on the Sub-Processor obligations in relation to the Personal Data equivalent to those set out in this Agreement. 10.2.10. Notify the Controller (within seven days) if it receives: LICENCE AGREEMENT 10.2.10.1. A request from a Data Subject to have access to that person's Personal Data or to Rectify that person's Personal Data or to restrict Processing of that person’s Personal Data or port that person’s Personal Data. 10.2.10.2. A notice from a Data Subject objecting to the Processing of that person’s Personal Data or stating that that person is not to be subject to a decision based on automated Processing. 10.2.10.3. A complaint or request relating to the Controller's obligations under Data Protection Laws; or 10.2.11. Any other communication relating directly or indirectly to the processing of any Personal Data in connection with this Agreement. 10.2.12. Not act in relation to any communication it receives under Clause 10.2.10. unless compelled by law or a regulator, without the Controller's prior approval, and shall comply with any reasonable instructions the Controller gives in relation to such communication. 10.2.13. Cooperate with all reasonable requests of the Controller concerning any complaint or request made in respect of any Personal Data (including in relation to reporting, investigation, mitigation, and remediation of any Security Breach). 10.2.14. Immediately inform the Controller if, in its opinion, compliance with any instruction of the Controller under this Agreement would breach Data Protection Laws. 10.2.15. Not transfer Personal Data outside of the European Economic Area without the prior written consent of the Controller. The provisions in this Clause shall not apply if the transfer of Personal Data is to a country outside of the-European Economic Area that the European Commission has recognised as providing an adequate level of data protection; and on termination of this Agreement and otherwise at the Controller's request, delete or return to the Controller the Personal Data, and procure that any party to whom the Processor has disclosed the Personal Data does the same. 10.2.16. The Controller shall enter the Standard Contractual Clauses as set out with the relevant Processor for the purposes of any transfers of Personal Data by the Processor to a country outside of the European Economic Area. The provisions shall not apply if the transfer of Personal Data is to a country outside of the European Economic Area that the European Commission has recognised as providing an adequate level of data protection. 11 ASSIGNMENT The Licensor may at any time assign, transfer, charge, or deal in any other manner with this Agreement or any of its rights under it including the Warranties, or sub- licence any or all its obligations under it. The Licensee shall not without the prior written consent of the Licensor assign, transfer, charge, or deal in any other manner with this Agreement or any of its rights under it or purport to do any of the same, nor sub-licence any or all its obligations under this Agreement. 12 SURVIVAL Provisions of this Agreement which are either expressed to survive its termination or from their nature or context it is contemplated that they are to survive such termination, shall remain in full force and effect notwithstanding such termination. 13 NO PARTNERSHIP OR AGENCY Nothing in this Agreement, and no action taken by the Parties pursuant to this Agreement, shall constitute, or be deemed to constitute, a partnership between the Parties, or shall constitute either Party as the agent, employee, or representative of the other. 14 VARIATION No variation of or amendment to this Agreement shall bind either Party unless made in writing and signed by both Parties. 15 NON-APPLICATION OF CONTRA PROFERENTEM If any ambiguity or question of intent or interpretation arises this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favouring or disfavouring any Party by virtue of the authorship of any of the terms of this Agreement. LICENCE AGREEMENT 16 WAIVERS A delay in exercising or a failure to exercise a right or remedy under or in connection with this Agreement shall not constitute a waiver of, or prevent or restrict the future exercise of, that or any other right or remedy, nor will the single or partial exercise of, that or any other right or remedy prevent or restrict the further exercise of that or any other right or remedy. A waiver of any right, remedy, breach, or default will only be valid if it is in writing and signed by the Party giving it and only in circumstances and for the purpose for which it was given and will not constitute a waiver of any other right, remedy, breach, or default. 17 SEVERABILITY All the terms and provisions of this Agreement are distinct and severable. If any term or provision of this Agreement is held to be unenforceable, illegal, or void, in whole or in part, under any enactment, rule of law, judgment or by any court, regulatory authority or other competent authority, that term or provision or part shall, to that extent, be deemed not to form part of this Agreement, but the enforceability, legality and validity of the remainder of this Agreement shall not be affected and will remain in full force and effect. 18 FORCE MAJEURE Neither Party shall be in breach of this Agreement nor liable for delay in performing, or failure to perform, any of its obligations under this Agreement if such delay or failure result from events, circumstances or causes beyond its reasonable control. In such circumstances the affected Party shall be entitled to a reasonable extension of time for performing such obligations. If the period of delay or non-performance continues for four (4) weeks, the Party not affected may terminate this agreement by giving fourteen (14) days' written notice to the affected Party. Notwithstanding the provisions of this Clause 18 all fees due and payable to the Licensor shall continue to accrue and be payable by the Licensee.. Iconic Offices - Terms & Conditions – V2MAY22. I acknowledge and accept the terms as set out above as a fair and true guide as to the terms and conditions of an Iconic License Agreement. I have read and understood the automatic renewal clause and accept all terms contained above on behalf of the business to which I am an authorised signatory. LICENSOR DETAILS Full Name: Liadh Grainger LICENSEE DETAILS Full Name:\ Dr David Keenan\ Title: Sales Executive Title:\SVP Technical Operators, Director LICENCE AGREEMENT Date: Signature: \s2\ Date:\d2\ Signature: Exhibit A LICENCE AGREEMENT Subsidiaries of the Registrant as of December 31, 2022 EXHIBIT 21.1 Name Amarin Pharmaceuticals Ireland Limited Amarin Pharma, Inc. Ester Neurosciences Limited Amarin Switzerland GmbH Amarin Germany GmbH Amarin France SAS Amarin UK Limited Amarin Italy S.r.l Amarin Switzerland GmbH Sucursal Espana Amarin Switzerland GmbH Austrian branch Amarin Belgium, branch of Amarin Switzerland GmbH Amarin Denmark, filial af Amarin Switzerland GmbH Amarin Switzerland GmbH, Suomen sivuliike Amarin Switzerland GmbH Greek branch Amarin Switzerland GmbH Dutch branch Amarin Switzerland GmbH Norwegian branch Amarin Switzerland GmbH, Sucursal em Portugal Amarin Switzerland GmbH Sweden filial Jurisdiction Ireland United States Israel Switzerland Germany France United Kingdom Italy Spain Austria Belgium Denmark Finland Greece Netherlands Norway Portugal Sweden We consent to the incorporation by reference in the following Registration Statements: CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (1) Registration Statement on Form F-1 No. 333-163704 of Amarin Corporation plc; and (2) Registration Statements on Form S-8 Nos. 333-146839, 333-143358, 333-132520, 333-110704, 333-101775, 333-168055, 333-168054, 333- 176877, 333-183160, 333-205863, 333-219644, 333-180180, 333-84152, 333-240321 and 333-266611 of Amarin Corporation plc of our reports dated March 1, 2023, with respect to the consolidated financial statements of Amarin Corporation plc, and the effectiveness of internal control over financial reporting of Amarin Corporation plc, included in this Annual Report (Form 10-K) of Amarin Corporation plc for the year ended December 31, 2022. EXHIBIT 23.1 /s/ Ernst & Young LLP Iselin, New Jersey March 1, 2023 EXHIBIT 31.1 I, Karim Mikhail, certify that: CERTIFICATION 1. 2. 3. 4. I have reviewed this Annual Report on Form 10-K of Amarin Corporation plc; 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the registrant and have: a. b. c. d. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; Designed such internal controls over financial reporting, or caused such internal controls over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and 5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a. b. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. Date: March 1, 2023 /s/ Karim Mikhail Karim Mikhail President and Chief Executive Officer (Principal Executive Officer) EXHIBIT 31.2 I, Tom Reilly, certify that: CERTIFICATION 1. 2. 3. 4. I have reviewed this Annual Report on Form 10-K of Amarin Corporation plc; 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the registrant and have: a. b. c. d. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and 5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a. b. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. Date: March 1, 2023 /s/ Tom Reilly Tom Reilly Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) STATEMENT PURSUANT TO 18 U.S.C. § 1350 EXHIBIT 32.1 Pursuant 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 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Karim Mikhail, President and Chief Executive Officer (Principal Executive Officer) of Amarin Corporation plc (the “Company”), and Tom Reilly, Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of the Company, each hereby certifies that, to the best of his knowledge: (1) (2) The Company’s Annual Report on Form 10-K for the period ended December 31, 2022, 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 of 1934; and The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the end of such year. Date: March 1, 2023 Date: March 1, 2023 /s/ Karim Mikhail Karim Mikhail President and Chief Executive Officer (Principal Executive Officer) /s/ Tom Reilly Tom Reilly Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting 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 incorporated by 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 the Form 10-K), irrespective of any general incorporation language contained in such filing. 

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