AMARIN CORP PLC\UK 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements reflect our plans, estimates and beliefs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or our Annual Report, and under Part II, Item IA, “Risk Factors” of this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise. The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report, and the audited consolidated financial statements and accompanying notes, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report. 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, 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 HTG, or the MARINE indication. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of our long-term CV outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in select high risk-patients, or the REDUCE-IT indication. On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA ® , hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of CV events in high-risk statin-treated adult patients who have elevated TGs ( > 150 mg/dL) and either established CV disease or diabetes and at least one additional CV risk event. On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce CV risk. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities. We and our seven commercial partners are in various stages: seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization. VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S. New Drug Application, or NDA, core dossier or the EMA core dossier. VASCEPA (U.S. NDA Core Dossier) VAZKEPA (EMA Core Dossier) Amarin (US) Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1) HLS Therapeutics Inc. "HLS" (Canada) CSL Seqirus "CSL"(Australia/New Zealand) Biologix FZCo "Biologix" (Middle East North Africa, or MENA) Lotus Pharmaceuticals, "Lotus" (Southeast Asia) Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory) Neopharm (Israel) 1996 Ltd. "Neopharm" (Israel) (1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) has been transitioned to Recordati. We are responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate us for such supply. We are not responsible for providing any generic company with drug product. The Company operates in one business segment. 27 United States VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail 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. Since VASCEPA was made commercially available in 2013, approximately 30 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 icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market: Company (ANDA Holder) Distributed / Licensee FDA MARINE Indication Approval 1-gram Launch Date 0.5-gram Launch Date Active Hikma Pharmaceuticals USA Inc. Hikma Pharmaceuticals USA Inc.; Northstar Rx; Bryant Ranch Pre-Pack May 2020 November 2020 March 2023 Yes Dr. Reddy’s Laboratories, Inc. Dr. Reddy’s Laboratories, Inc. August 2020 June 2021 June 2023 Yes Teva Pharmaceuticals USA, Inc. Teva Pharmaceuticals USA, Inc.; AvKare September 2020 January 2023 September 2022 Yes Apotex, Inc. Apotex, Inc.; American Health Packaging; Golden State Medical Supply June 2021 January 2022 – Yes Zydus Lifesciences Zydus Pharmaceuticals USA April 2023 August 2024 June 2024 Yes Onesource Specialty (Amneal Original Filer) Amneal Pharmaceuticals September 2023 April 2024 April 2024 Yes Humanwell Puracap Epic Pharma December 2023 March 2024 – Yes Ascent Pharmaceuticals, Inc. Camber Pharmaceuticals; Northstar Rx; XL Care Pharmaceuticals December 2023 April 2024 February 2024 August 2024 April 2024 – December 2024 Yes Qilu Pharmaceutical Co Ltd – November 2024 – – No PharmaObedient (Spriaso Original Filer) – December 2024 – – No Xiamen LP Pharma Co. Vitruvias Therapeutics August 2025 January 2026 – Yes We obtain data from a third party, Symphony Health, which 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 is 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 in the U.S. 28 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. Partnerships One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets. We and our partners have obtained varying levels of indication approvals and initiated or are in the process of initiating commercial launches in various territories where our partners have access. We and our partners continue to seek additional regulatory approvals in the countries in which our partners operate. We have agreements in place with the following partners within the respective territories: Partner Agreement Date Country MARINE Approval REDUCE-IT Approval Launch Date Edding (1) February 2015 Mainland China June 2023 June 2024 October 2023 Hong Kong – February 2023 May 2024 Biologix (2) March 2016 Lebanon March 2018 August 2021 June 2018 United Arab Emirates July 2018 October 2021 February 2019 Qatar December 2019 April 2021 May 2022 Bahrain April 2021 April 2022 September 2023 Kuwait December 2021 March 2023 September 2023 Saudi Arabia March 2022 June 2023 September 2023 HLS September 2017 Canada – December 2019 February 2020 CSL February 2023 Australia – November 2022 October 2024 New Zealand – January 2023 – Neopharm (3) August 2023 Israel – March 2023 May 2024 Lotus (4) August 2023 South Korea – May 2025 – Singapore – December 2025 – Recordati (5) June 2025 Europe (6) – March 2021 (6) (1) VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding. (2) VASCEPA is under registration in additional countries in the MENA region with Biologix. (3) VASCEPA is under registration in additional countries in the Israel territory with Neopharm. (4) VASCEPA is under registration in additional countries in the ASEAN region with Lotus. (5) VASCEPA is under registration in 59 countries focused in Europe with Recordati. (6) Refer to table below for listing of European countries with VAZKEPA currently available. 29 In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland with 10 years of market protection, and in April 2024, we were issued a patent that extended our exclusivity to 2039. In June 2025, we entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe, or the Recordati Territory. As a result of the Recordati Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory. Recordati may sell VAZKEPA pursuant to the product reimbursements we have already obtained in Europe, as shown below, and the agreements with existing partners in the Recordati Territory being transitioned to Recordati. In addition, Recordati will use commercially reasonable efforts to pursue future product reimbursements and approvals in the Recordati Territory. Country Individual Reimbursement National Reimbursement Product Availability Launch Date Sweden – March 2022 March 2022 March 2022 Finland – October 2022 December 2022 December 2022 England/Wales/Northern Ireland – July 2022 October 2022 October 2022 Spain – July 2023 September 2023 September 2023 Netherlands – August 2023 September 2023 September 2023 Scotland – August 2023 August 2023 September 2023 Greece (1) – May 2024 June 2024 June 2024 Portugal – August 2024 August 2024 September 2024 Italy – December 2024 December 2024 January 2025 Slovenia (2) – September 2025 October 2025 October 2025 Austria September 2022 February 2025 September 2022 – Denmark June 2022 – June 2022 – (1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA. (2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA. In addition, we received regulatory approval in Switzerland by the Swiss Agency for Therapeutic Products, or Swissmedic. VAZKEPA has been made available in Switzerland under individual reimbursement since January 2023. We are responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval. Research and Development Since its inception in 2011, the REDUCE-IT CV outcomes study of VASCEPA has been the centerpiece of our research and development. We also continue to study the potential mechanisms of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S. 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 Quarterly Report, more than 70 clinical treatment guidelines, consensus statements or scientific statements from global medical or scientific societies or within peer reviewed journals have recognized the use of icosapent ethyl, or IPE, in appropriate at-risk patients for CV risk reductions, including those statements which we were informed of by our global partners as well as guidelines which were newly received during the first quarter of 2026 as listed below: • In January 2026, the American Diabetes Association, or ADA, released guidelines on Cardiovascular Disease and Risk Management in Standards of Care in Diabetes that stated that in individuals with Atherosclerotic Cardiovascular Disease, or ASCVD, or other CV risk factors on a statin with managed LDL-C but elevated TG (150–499 mg/dL [1.7–5.6 mmol/L]), the addition of IPE can be considered to reduce CV risk. • In January 2026, the Egyptian Heart Journal published the 2025 Egyptian guidelines for the management of dyslipidemia stating that LDL-C-lowering therapies reduce ASCVD risk regardless of TG level and in statin-treated patients with TG 135–499 mg/dL, IPE (2 g twice daily) is recommended. • In March 2026, the American College of Cardiology/American Heart Association/Multi-society Dyslipidemia Guidelines were released. These guidelines recognize that elevated TG levels contribute meaningfully to CV disease burden and 30 ongoing CV events even in patients achieving LDL-C targets, underscoring the need for complementary therapeutic approaches beyond statin monotherapy to further reduce risk in high and very high-risk populations. IPE is the only primary TG-lowering medication that reduces ASCVD event risk in combination with statin therapy. • In March 2026, the ESC Council on Basic Cardiovascular Science, or CBCS, and associated working groups, released a scientific statement on novel CV metabolic risk factor mechanisms and therapeutic opportunities, in the European Heart Journal. The statement noted that not only does IPE cause substantial declines in TG levels, but also reduced CV events compared to placebo. The beneficial CV effects of IPE eicosapentaenoic acid ethyl ester or EPA-E, extended beyond TG level reduction, suggesting additional CV benefits of this class. IPE also promotes plaque stabilization in patients with documented coronary atherosclerosis likely by modulating inflammation, oxidative stress, and endothelial function. • In March 2026, the Polish Diabetes Association released, Clinical Recommendations on the Management of Individuals with Diabetes – 2026 Position Statement of Diabetes Poland, in Current Topics of Diabetes, the Official Journal of the Diabetes Poland. The recommendations stated that for individuals with HTG (TG: 135–499 mg/dl; 1.52–5.6 mmol/l), the use of high-dose EPA (2 g twice daily) in combination with a statin may be considered. In January 2026, at the LS2 Cardiovascular Research meeting in Bern, Switzerland, we provided support to global collaborators for a poster presentation from within the REDUCE-IT dataset as well as from in vitro data highlighting the potential anti-coagulant effects of IPE through suppression of tissue factor. In March 2026, at the American College of Cardiology, or ACC, meeting in New Orleans, LA, USA, we provided support to global collaborators for two presentations, one poster and one oral. The poster presentation reported the inhibitory actions of EPA on the rate of Lipoprotein(a), or Lp(a), oxidation. The oral presentation looked at a secondary analysis of the REDUCE-IT dataset highlighting the efficacy of IPE among patients at extreme CV risk. During the three months ended March 31, 2026, we and global medical and scientific collaborators supported a total of 6 publications inclusive of accepted abstracts, posters, and manuscripts. Commercial and Clinical Supply We manage the manufacturing and supply of VASCEPA and 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 in the U.S. 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 U.S. 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. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. As of March 31, 2026, we had inventory of $183.6 million, of which 35% is inventory approved for use in North America. 31 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 U.S., VASCEPA is sold to three major wholesalers, several regional wholesalers along with mail order pharmacy providers that in turn resell the product to retail pharmacies, as well as directly to select regional retail pharmacy chains, 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. Our product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the U.S. Outside of the U.S., 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. 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. Licensing and royalty revenue . Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized when the uncertainty related to the consideration is resolved. 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. 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 marketing, executive, business development, 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 2025 Global Restructuring Plan, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs. Interest income, net and other income (expense), net . Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term investments. Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income. Benefit from (provision for) income taxes. 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 U.S. and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and 32 conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2026 and 2025 are not more likely than not to be realized. Critical Accounting Policies and Estimates Our discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the U.S., or GAAP. The preparation of these condensed consolidated 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 Part II, Item 7 of our Annual Report. There have been no material changes to our critical accounting policies, significant judgments and estimates described in our Annual Report. Recent Accounting Pronouncements For a discussion of recent accounting pronouncements, see Note 2—Significant Accounting Policies in the accompanying Notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. Effects of Inflation We believe the impact of inflation on operations has been minimal during the past three years. Results of Operations Comparison of Three Months Ended March 31, 2026 and March 31, 2025 Total revenue, net. We recorded total revenue, net, of $45.1 million and $42.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $3.1 million, or 7%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the three months ending March 31, 2026, we also sold VASCEPA by prescription in certain countries outside of the U.S. through collaborations with third-party companies. As further discussed below, the aforementioned increase is due primarily to a $2.3 million increase in net product revenue outside of the U.S and a $0.8 million increase in licensing and royalty revenue. Product revenue, net . We recorded product revenue, net, of $43.3 million and $41.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $2.3 million, or 6%. This increase was due primarily to an increase in VASCEPA sales outside the U.S. U.S. product revenue, net, remained consistent at $35.6 million during the three months ended March 31, 2026, compared to $35.7 million for the during the three months ended March 31, 2025. The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased by 3% for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. Our share of the icosapent ethyl market has increased to approximately 48% in the three months ended March 31, 2026 compared to approximately 42% in the three months ended March 31, 2025. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 17% in the three months ended March 31, 2026 compared to the three months ended March 31, 2025. In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended March 31, 2026, we recorded Europe product revenue, net, of $4.9 million compared to $5.4 million during the three months ended March 31, 2025, primarily due to the change in business structure within Europe. For the three months ended March 31, 2026, we recorded RoW product revenue, net, of $2.8 million from our six other collaboration partners, comprising multiple distinct geographies, compared to a nominal amount during the three months ended March 31, 2025. The increase reflects normal variability across the multiple geographies encompassing this early stage of a developing ex-U.S. market. Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. For the remainder of 2026, we will continue to (i) competitively manage our market leadership in the U.S., and (ii) drive expanded access and increased patient uptake of VASCEPA through ongoing support of our commercialization partners and their pricing, reimbursement and licensure initiatives in non-U.S. geographies around the world. 33 Licensing and royalty revenue . Licensing and royalty revenue during the three months ended March 31, 2026 and 2025 was $1.8 million and $1.0 million, respectively, an increase of $0.8 million, or 84%. This increase was primarily due to higher royalties as a result of moving to a partnering model in Europe as of June 2025 and an increase in partner sales within their respective territories. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. Royalty payments are recognized based on revenue reported by our partners. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories. Cost of goods sold. Cost of goods sold during the three months ended March 31, 2026 and 2025 was $27.4 million and $16.9 million, respectively, an increase of $10.5 million, or 62%. This increase in cost of goods sold is due to increased product volumes. 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, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API. The API included in the calculation of the average cost of goods sold during the quarters ended March 31, 2026 and 2025 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. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier. Our overall gross margin on product sales for the three months ended March 31, 2026 and 2025 was 37% and 59%, respectively. The decrease in gross margin is primarily as a result of a change in customer mix. Selling, general and administrative expense . Selling, general and administrative expense for the three months ended March 31, 2026 and 2025 was $21.1 million and $36.6 million, respectively, a decrease of $15.5 million, or 42%. Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below: Three months ended March 31, In thousands 2026 2025 Selling expense (1) $ 3,888 $ 16,921 General and administrative expense (2) 15,497 16,124 Non-cash stock-based compensation expense (3) 1,730 3,528 Total selling, general and administrative expense $ 21,115 $ 36,573 (1) Selling expense for the three months ended March 31, 2026 and 2025 was $3.9 million and $16.9 million, respectively, a decrease of $13.0 million, or 77%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan. (2) General and administrative expense for the three months ended March 31, 2026 and 2025 was $15.5 million and $16.1 million, respectively, a decrease of $0.6 million, or 4%. This decrease is primarily due to previous fees incurred related to the ADS Ratio Change incurred in the prior year as well as a decrease in employee-related costs due to the reduction in force from the Global Restructuring Plan offset by costs associated with a litigation settlement in the current year. (3) Non-cash stock-based compensation expense for the three months ended March 31, 2026 and 2025 was $1.7 million and $3.5 million, respectively, a decrease of $1.8 million, or 51%. 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 as a result of the Global Restructuring Plan. We will continue to manage our spending commitments to support our partners advancing commercialization and pricing and reimbursement efforts, as well as maintaining market leadership in the U.S. 34 Research and development expense . Research and development expense for the three months ended March 31, 2026 and 2025 was $4.7 million and $5.3 million, respectively, a decrease of $0.6 million, or 12%. Research and development expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below: Three months ended March 31, In thousands 2026 2025 REDUCE-IT study and presentations (1) $ 199 $ 247 Regulatory filing fees and expenses (2) 552 527 Non-clinical research activities (3) 40 257 Internal staffing, overhead and other (4) 3,309 3,482 Research and development expense, excluding non-cash expense 4,100 4,513 Non-cash stock-based compensation expense (5) 565 799 Total research and development expense $ 4,665 $ 5,312 (1) REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and to provide data to be published in medical journals. (2) Regulatory and quality filing fees are primarily related to the preparation, submission and review defense of regulatory filings as well as assistance with securing and maintaining regulatory approvals for qualifying suppliers for VASCEPA in the U.S. and Europe as well as regulatory expansion in the rest of the world. (3) Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE. (4) Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research, development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated to specific projects. Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida. (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 research and development investment commitments and priorities and are prepared to adjust such investment levels based on various factors, including the impact of U.S. generic competition, as well as timing of pricing reimbursements throughout the world. Restructuring expense . Restructuring expense for the three months ended March 31, 2026 and 2025 was $3.3 million and nil, respectively. The charge in the current year is due to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information. Interest income, net . Interest income, net, for the three months ended March 31, 2026 and 2025 was $2.4 million and $2.9 million, respectively, a decrease of $0.4 million, or 16%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period. Other income, net . Other income, net, for the three months ended March 31, 2026 and 2025 was $0.2 million and $0.3 million, respectively, a decrease of $0.1 million, or 26%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility. Provision for income taxes. Income tax provision for the three months ended March 31, 2026 and 2025 was $1.8 million and $2.1 million, respectively. The provision for the three months ended March 31, 2026 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full-year estimated U.S. and foreign income tax liability. 35 Liquidity and Capital Resources As of March 31, 2026, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $131.3 million and short-term investments of $176.8 million, aggregating $307.8 million. We have no indebtedness. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities of less than 90 days. Our short-term investments consist of securities that will be due in one year or less. 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 condensed consolidated statements of cash flows, are summarized in the following table: Three months ended March 31, In millions 2026 2025 Cash provided by (used in): Operating activities $ 6.4 $ (12.5 ) Investing activities (8.3 ) 12.1 Financing activities (1.7 ) (1.1 ) Decrease in cash and cash equivalents and restricted cash $ (3.6 ) $ (1.5 ) Net cash provided by operating activities increased during the three months ended March 31, 2026 as compared to the net cash used in operating activities during the same period in 2025. This is primarily driven by the Global Restructuring Plan and the resulting cost savings, including the elimination of commercial roles in our European operations. Net cash used in investing activities during the three months ended March 31, 2026 decreased due primarily to the purchases of $50.8 million of investment grade interest-bearing instruments offset by proceeds from the maturity of $42.5 million in investment grade interest-bearing instruments as compared to the same period in 2025 where proceeds from the maturity of investment grade interest-bearing instruments were $55.0 million, partially offset by $42.9 million in purchases of investment-grade interest bearing instruments. Net cash used in financing activities increased during the three months ended March 31, 2026 as compared to the same period in 2025 was as a result of taxes paid on stock-based awards. On January 10, 2024, we announced plans to initiate a share repurchase program to purchase up to $50.0 million of the Company's Ordinary Shares held in the form of American Depository Shares, or ADS. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively. The share repurchase program has a five-year approval window and can be deployed at any point until the second quarter of 2029. The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions. As of March 31, 2026, we had net accounts receivable of $108.1 million and inventory of $183.6 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of March 31, 2026. As of March 31, 2026, we had cash and cash equivalents of $131.1 million and short-term investments of $176.8 million, aggregating $307.8 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 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, including the share repurchase program if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly 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 inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow. Contractual Obligations Except for our contractual obligations related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office space as set forth in Note 5 – Commitments and Contingencies and Note 9 – Leases, respectively, in our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes from the contractual obligations and commitments as of December 31, 2025 previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 2, 2026. We do not have any special purpose entities or other off-balance sheet arrangements. 36 Item 3. Quantitative and Qualitat ive Disclosures about Market Risk There have been no material changes with respect to the information appearing in Part II, Item 7A “Quantitative and Qualitative Disclosures about Market Risk” of our Annual Report.