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 1A, “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, or IPE) 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 CV 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 TG ( > 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) have 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 31 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 IPE 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. 29 (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. 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 have been 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 Romania (3) – April 2026 May 2026 May 2026 Austria September 2022 February 2025 September 2022 January 2026 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. (3) Magnapharm will be the sole and exclusive distributor of VAZKEPA in the Romanian 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, 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 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 second quarter of 2026 as listed below: • In April 2026, the European Federation of Internal Medicine released Assessment and Management of Cardiovascular–Kidney–Liver Metabolic-Syndrome in the Primary Care Setting: A Multidisciplinary Consensus Statement, in the European Journal of Internal Medicine. This stated that treatment of elevated triglycerides, or TG, can be considered in high- or very-high-risk patients, with elevated TG (1.52–5.63 mmol/L or 135–499 mg/dL). High-dose IPE (2 g twice daily) could be added to statin therapy to reduce CV risk. 30 • In May 2026, the American Heart Association, or AHA, released a 2026 Scientific Statement update on the Secondary Prevention After Coronary Artery Bypass Graft Surgery, which stated that as a third line therapy if the combination of statin and ezetimibe still fails to achieve the target Low-Density Lipoprotein Cholesterol, or LDL-C, thresholds then consider either PCSK9 inhibitor or IPE if the TG level is between 135 mg/dL (1.5 mmol/L) and 500 mg/dL (5.6 mmol/L). • In June 2026, the American College of Cardiology/AHA Joint Committee released a report; the 2026 AHA/American College of Cardiology, or ACC/American Diabetes Association, or ADA/American Society of Nephrology, or ASN, Guideline for the Prevention, Detection, Evaluation, and Management of Cardiovascular-Kidney-Metabolic Syndrome. This report states that for those with persistent HTG on maximally tolerated statins, or with additional CV risk factors, IPE can be considered to lower ASCVD risk. In addition, studies using relative-risk reduction estimates from RCTs and absolute event rates from epidemiologic studies of CAC demonstrate that moderate-to-severe CAC identifies patients at high absolute CVD risk who are most likely to benefit from several preventive therapies indicated for CKM syndrome (statins, GLP-1–based therapy, aggressive BP lowering, and IPE in those with HTG). In May 2026, at the Digestive Disease Week meeting in Chicago, IL, researchers from Harvard working on an Amarin supported investigator-initiated trial presented data at a poster session. The poster presentation included data on the effect of IPE treatment on fecal metabolites and microbiome among patients with a history of adenoma, and results from a secondary analysis of a prospective, single-arm clinical study. In May 2026, at the European Atherosclerosis Society meeting in Athens, Greece, global collaborators presented two Amarin supported oral E-poster presentations. The first presentation reported data on how risk-weighted apolipoprotein B compares to traditional lipid biomarkers in predicting residual CV risk in statin-treated hypertriglyceridemic patients, post hoc analysis of the REDUCE-IT placebo arm. The second presentation reported on residual CV risk from elevated TG in established atherosclerotic CV disease patients from the CPRD database in the UK. In June 2026, at the European Society for Clinical Investigation meeting in Lisbon, Portugal, at an oral poster presentation, global collaborators presented a post-hoc analysis of REDUCE-IT reporting the impact of IPE on coagulation biomarkers and clinical outcomes in high-risk CV patients. In June 2026, at the National Lipid Association meeting in Chicago, IL, researchers from the Geisinger Health System reported on designing and implementation strategies for improving best clinician practices of HTG management in patients post-ACS as a poster presentation. During the six months ended June 30, 2026, Amarin and global medical and scientific collaborators supported a total of 12 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 June 30, 2026, we had inventory of $164.1 million, of which 43% 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. Cost of goods sold may vary by region due to regional approval requirements. 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 on 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. Benefit from (provision for) income taxes, 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 32 evidence and 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 June 30, 2026 and June 30, 2025 Total revenue, net. We recorded total revenue, net, of $42.2 million and $72.7 million during the three months ended June 30, 2026 and 2025, respectively, a decrease of $30.5 million, or 42%. 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 June 30, 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 decrease is due primarily to a $23.0 million decrease in licensing and royalty revenue, a $4.3 million decrease in U.S. net product revenue and a $3.3 million decrease in net product revenue outside of the U.S. Product revenue, net . We recorded product revenue, net, of $39.1 million and $46.6 million during the three months ended June 30, 2026 and 2025, respectively, a decrease of $7.5 million, or 16%. This decrease was due primarily to decreases in VASCEPA prices within the U.S., transition of European operations to Recordati and lower sales to our partners outside Europe. We recorded U.S. product revenue, net, of $32.2 million and $36.5 million during the three months ended June 30, 2026 and 2025, respectively. This decrease was primarily due to a lower net selling price associated with changes in customer mix. The overall IPE market in the U.S., based on prescription levels reported by Symphony Health, increased by 3% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. Our share of the IPE market has increased to approximately 48% in the three months ended June 30, 2026 compared to approximately 43% in the three months ended June 30, 2025. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 17% in the three months ended June 30, 2026 compared to the three months ended June 30, 2025. In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended June 30, 2026, we recorded Europe product revenue, net, of $5.4 million compared to $6.6 million during the three months ended June 30, 2025, primarily due to the change in business structure within Europe. For the three months ended June 30, 2026, we recorded RoW product revenue, net, of $1.4 million from our six collaboration partners, comprising multiple distinct geographies, compared to $3.5 million during the three months ended June 30, 2025. The decrease 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. Licensing and royalty revenue . Licensing and royalty revenue during the three months ended June 30, 2026 and 2025 was $3.1 million and $26.1 million, respectively, a decrease of $23.0 million, or 88%. This decrease was primarily due to the recognition of a 33 $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement in prior year offset by higher royalties as a result of increased 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 June 30, 2026 and 2025 was $27.2 million and $22.4 million, respectively, an increase of $4.8 million, or 22%. 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 June 30, 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 June 30, 2026 and 2025 was 30% and 52%, 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 June 30, 2026 and 2025 was $22.2 million and $38.7 million, respectively, a decrease of $16.5 million, or 43%. Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025 are summarized in the table below: Three months ended June 30, In thousands 2026 2025 Selling expense (1) $ 2,828 $ 14,587 General and administrative expense (2) 17,770 21,215 Non-cash stock-based compensation expense (3) 1,588 2,871 Total selling, general and administrative expense $ 22,186 $ 38,673 (1) Selling expense for the three months ended June 30, 2026 and 2025 was $2.8 million and $14.6 million, respectively, a decrease of $11.8 million, or 81%. 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 June 30, 2026 and 2025 was $17.8 million and $21.2 million, respectively, a decrease of $3.4 million, or 16%. This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the Global Restructuring Plan. (3) Non-cash stock-based compensation expense for the three months ended June 30, 2026 and 2025 was $1.6 million and $2.9 million, respectively, a decrease of $1.3 million, or 45%. 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. 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. Research and development expense . Research and development expense for the three months ended June 30, 2026 and 2025 was $4.8 million and $4.9 million, respectively, a decrease of $0.1 million, or 3%. Research and development expenses for the three months ended June 30, 2026 and 2025 are summarized in the table below: Three months ended June 30, In thousands 2026 2025 REDUCE-IT study and presentations (1) $ 254 $ 263 Regulatory filing fees and expenses (2) 471 741 Non-clinical research activities (3) 52 79 Internal staffing, overhead and other (4) 3,483 3,238 Research and development expense, excluding non-cash expense 4,260 4,321 Non-cash stock-based compensation expense (5) 513 594 Total research and development expense $ 4,773 $ 4,915 34 (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 June 30, 2026 and 2025 was less than $0.1 million and $22.8 million, respectively. The charges in both the current and prior year are 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 June 30, 2026 and 2025 was $3.1 million and $2.6 million, respectively, an increase of $0.4 million, or 16%. Interest income, net, represents income earned on cash and investment balances. Other income (expense), net . Other income (expense), net, for the three months ended June 30, 2026 and 2025 was income of $1.1 million and expense of $0.1 million, respectively, an increase of $1.2 million, or 1384%. Other income (expense), net, increased primarily due to the recognition of the Employee Retention Credit, or ERC, awarded as part of the Coronavirus Aid, Relief, and Economic Security, or CARES, Act. Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the three months ended June 30, 2026 and 2025 was a benefit of $0.2 million and a provision of $0.7 million, respectively. The benefit for the three months ended June 30, 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. Comparison of Six Months Ended June 30, 2026 and June 30, 2025 Total revenue, net. We recorded total revenue, net, of $87.3 million and $114.8 million during the six months ended June 30, 2026 and 2025, respectively, a decrease of $27.4 million, or 24%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the six months ended June 30, 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 decrease is due primarily to a $22.2 million decrease in licensing and royalty revenue, a $4.3 million decrease in U.S. net product revenue and a $0.9 million decrease in net product revenue outside of the U.S. Product revenue, net. We recorded product revenue, net, of $82.4 million and $87.7 million during the six months ended June 30, 2026 and 2025, respectively, a decrease of $5.2 million, or 6%. This decrease was due primarily to 6% and 13% decreases in VASCEPA sales in the U.S. and Europe. We recorded U.S. product revenue, net, of $67.9 million and $72.2 million during the six months ended June 30, 2026 and 2025, respectively. This decrease was primarily due to a lower net selling price associated with changes in customer mix. The overall IPE market in the U.S., based on prescription levels reported by Symphony Health, increased for the six months ended June 30, 2026 by 3% as compared to the six months ended June 30, 2025. Our share of the IPE market has increased to approximately 49% in the six months ended June 30, 2026 compared to approximately 42% in the six months ended June 30, 2025. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 19% in the six months ended June 30, 2026 compared to the six months ended June 30, 2025. 35 In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the six months ended June 30, 2026, we recorded Europe product revenue, net, of $10.4 million compared to $12.0 million during the six months ended June 30, 2025, primarily due to the change in business structure. For the six months ended June 30, 2026, we recorded RoW product revenue, net, of $4.2 million from our six collaboration partners, comprising multiple distinct geographies, compared to $3.5 million during the six months ended June 30, 2025. Licensing and royalty revenue . Licensing and royalty revenue during the six months ended June 30, 2026 and 2025 was $4.9 million and $27.1 million, respectively, a decrease of $22.2 million, or 82%. This decrease was primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement in the prior year offset by higher royalties as a result of an increase in partner sales within their respective territories. Cost of goods sold. Cost of goods sold during the six months ended June 30, 2026 and 2025 was $54.6 million and $39.3 million, respectively, an increase of $15.3 million, or 39%. 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 six months ended June 30, 2026 and 2025 was sourced from multiple API suppliers. Our overall gross margin on product sales for the six months ended June 30, 2026 and 2025 was 34% and 55%, 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 six months ended June 30, 2026 and 2025 was $43.3 million and $75.2 million, respectively, a decrease of $31.9 million, or 42%. Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 are summarized in the table below: Six months ended June 30, In thousands 2026 2025 Selling expense (1) $ 6,717 $ 31,508 General and administrative expense (2) 33,267 37,340 Non-cash stock-based compensation expense (3) 3,318 6,399 Total selling, general and administrative expense $ 43,302 $ 75,247 (1) Selling expense for the six months ended June 30, 2026 and 2025 was $6.7 million and $31.5 million, respectively, a decrease of $24.8 million, or 79%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan. (2) General and administrative expense for the six months ended June 30, 2026 and 2025 was $33.3 million and $37.3 million, respectively, a decrease of $4.1 million, or 11%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan as well as fees associated with the ADS Ratio Change and Recordati EU Licensing Agreement incurred in the prior year. The decreases are offset by costs associated with litigation-related charges in the current year. (3) Non-cash stock-based compensation expense for the six months ended June 30, 2026 and 2025 was $3.3 million and $6.4 million, respectively, a decrease of $3.1 million, or 48%. 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. Research and development expense . Research and development expense for the six months ended June 30, 2026 and 2025 was $9.4 million and $10.2 million, respectively, a decrease of $0.8 million, or 8%. Research and development expenses for the six months ended June 30, 2026 and 2025 are summarized in the table below: Six months ended June 30, In thousands 2026 2025 REDUCE-IT study and presentations (1) $ 453 $ 509 Regulatory filing fees and expenses (2) 1,023 1,269 Non-clinical research activities (3) 92 336 Internal staffing, overhead and other (4) 6,792 6,721 Research and development expense, excluding non-cash expense 8,360 8,835 Non-cash stock-based compensation expense (5) 1,078 1,392 Total research and development expense $ 9,438 $ 10,227 36 (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. Restructuring expense . Restructuring expense for the six months ended June 30, 2026 and 2025 was $3.4 million and $22.8 million, respectively. The charge in both the current and prior year are 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, remained consistent at $5.5 million during the six months ended June 30, 2026, compared to $5.5 million during the six months ended June 30, 2025. Interest income, net, represents income earned on cash and investment balances. Interest income, net, represents income earned on cash and investment balances. Other income (expense), net . Other income (expense), net, for the six months ended June 30, 2026 and 2025 was income of $1.3 million and $0.2 million, respectively, an increase of $1.1 million, or 661%. Other income (expense), net, increased primarily due to the recognition of the Employee Retention Credit, or ERC, awarded as part of the Coronavirus Aid, Relief, and Economic Security, or CARES, Act. Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the six months ended June 30, 2026 and 2025 were provisions of $1.6 million and $2.8 million, respectively. The provision for income taxes for the six months ended June 30, 2026 is the result of 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. Liquidity and Capital Resources As of June 30, 2026, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $143.8 million and short-term investments of $171.1 million, aggregating $314.9 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 mature 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: Six months ended June 30, In millions 2026 2025 Cash provided by (used in): Operating activities $ 13.0 $ 4.1 Investing activities (2.2 ) 24.5 Financing activities (1.9 ) (1.8 ) Increase in cash and cash equivalents and restricted cash $ 8.9 $ 26.8 Net cash provided by operating activities increased during the six months ended June 30, 2026 as compared to 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) provided by investing activities during the six months ended June 30, 2026 decreased due primarily to the purchases of $90.5 million in investment grade interest-bearing instruments offset by proceeds from the maturity of $88.4 million of 37 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 $105.3 million, partially offset by $80.8 million in purchases of investment-grade interest bearing instruments. Net cash used in financing activities during the six months ended June 30, 2026 and the same period in 2025 was primarily 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 June 30, 2026, we had net accounts receivable of $92.9 million, and inventory of $164.1 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 June 30, 2026. As of June 30, 2026, we had cash and cash equivalents of $143.6 million and short-term investments of $171.1 million, aggregating $314.6 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. 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.