21 unchanged sentences
Our commercialized product, VASCEPA ® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S.
−Removed: FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication and we commercially launched in 2013.
+Added: FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication.
On December 13, 2019, the U.S.
−Removed: FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial.
−Removed: VASCEPA is the first and only drug approved by the U.S.
+Added: FDA approved another indication and label expansion for VASCEPA based on the results of our long-term cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial.
+Added: VASCEPA is approved by the U.S.
FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication.
−Removed: On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA ® , hereinafter along with the U.S.
−Removed: brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels.
−Removed: On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk.
−Removed: On June 1, 2023, we announced that regulatory approval from the National Medical Products Administration, or NMPA, for VASCEPA in Mainland China was received by our partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, for the MARINE indication and on June 28, 2024 for the REDUCE-IT indication.
−Removed: Through the date of this Annual Report we have received regulatory approval for VASCEPA under the REDUCE-IT indication in 49 countries, including the U.S.
−Removed: and 27 EU Member States.
−Removed: VASCEPA is currently available by prescription in the U.S.
−Removed: and certain other countries throughout the world, as described below.
−Removed: We are responsible for the supply of VASCEPA to all markets in which the branded product is sold, either to and through our collaborations with third-party companies or by us.
+Added: 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 cardiovascular events in high-risk statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event.
+Added: 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 cardiovascular risk.
+Added: Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
+Added: We and our seven commercial partners are in various stages;
+Added: seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization.
+Added: VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S.
+Added: New Drug Application, or NDA, core dossier or the EMA core dossier.
+Added: VASCEPA (U.S.
+Added: NDA Core Dossier)
+Added: VAZKEPA (EMA Core Dossier)
+Added: Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1)
+Added: HLS Therapeutics Inc.
+Added: "HLS" (Canada)
+Added: CSL Seqirus "CSL"(Australia/New Zealand)
+Added: Biologix FZCo "Biologix" (Middle East North Africa, or MENA)
+Added: Lotus Pharmaceuticals, "Lotus" (Southeast Asia)
+Added: Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory)
+Added: Neopharm (Israel) 1996 Ltd.
+Added: "Neopharm" (Israel)
+Added: (1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L.
+Added: "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) will be transitioned to Recordati.
+Added: 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.
−Removed: Geographies outside the U.S.
−Removed: in which VASCEPA is sold and under regulatory review are not subject to the U.S.
−Removed: patent litigation and judgment described below and no similar litigation is pending outside of the U.S..
+Added: The Company operates in one business segment.
United States
6 unchanged sentences
FDA approval with labeling consistent with the MARINE indication and have entered the U.S.
+Added: Company (ANDA Holder)
+Added: Distributed / Licensee
FDA MARINE Indication Approval
2 unchanged sentences
Hikma Pharmaceuticals USA Inc.
+Added: Hikma Pharmaceuticals USA Inc.;
+Added: Northstar Rx;
+Added: Bryant Ranch Pre-Pack
November 2020
Reddy’s Laboratories, Inc.
+Added: Reddy’s Laboratories, Inc.
Teva Pharmaceuticals USA, Inc.
+Added: Teva Pharmaceuticals USA, Inc.;
September 2020
September 2022
+Added: Apotex, Inc.;
+Added: American Health Packaging;
+Added: Golden State Medical Supply
Zydus Lifesciences
−Removed: Strides Pharma (1)
+Added: Zydus Pharmaceuticals USA
+Added: Onesource Specialty (Amneal Original Filer)
+Added: Amneal Pharmaceuticals
September 2023
+Added: Humanwell Puracap
December 2023
Ascent Pharmaceuticals, Inc.
+Added: Camber Pharmaceuticals;
+Added: Northstar Rx;
+Added: XL Care Pharmaceuticals
December 2023
+Added: February 2024
+Added: December 2024
Qilu Pharmaceutical Co Ltd
November 2024
+Added: PharmaObedient (Spriaso Original Filer)
December 2024
−Removed: (1) Strides Pharma licensed its rights to the generic version of icosapent ethyl to Amneal Pharmaceuticals.
−Removed: (2) Ascent Pharmaceuticals, Inc.
−Removed: licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc.
−Removed: and XL Care Pharmaceuticals, Inc.
+Added: Xiamen LP Pharma Co.
+Added: Vitruvias Therapeutics
We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information.
1 unchanged sentence
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.
−Removed: Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions.
+Added: Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S.
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).
5 unchanged sentences
In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland.
+Added: 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.
+Added: As a result of the Recordati Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory.
+Added: 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.
+Added: In addition, Recordati will use commercially reasonable efforts to pursue future product reimbursements and approvals in the Recordati Territory.
Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis.
6 unchanged sentences
While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe.
−Removed: Through the date of this Annual Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.
+Added: Through the date of this Annual Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations, which has since been licensed to Recordati, in the following countries, respectively.
Individual Reimbursement
3 unchanged sentences
December 2022
−Removed: England/Wales
+Added: England/Wales/Northern Ireland
September 2023
7 unchanged sentences
September 2025
+Added: September 2022
February 2025
September 2022
−Removed: (1) Vianex S.A will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
−Removed: We continue to advance our pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed.
−Removed: We are leveraging third-party relationships for various support activities and are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approaches to drive greater impact and improved cost efficiency, which is or will be utilized throughout Europe as launches are rolled out.
+Added: (1) - Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
+Added: (2) - Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.
Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists rather than by general practitioners.
3 unchanged sentences
In Europe, VAZKEPA has the benefit of 10 years of market protection, and in April 2024 we were issued a patent that extended our exclusivity to 2039.
−Removed: Rest of World
−Removed: One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets, including Canada, Middle East North Africa, or MENA, China, Australia and New Zealand and Association of Southeast Asian Nations, or ASEAN, and South Korea and we will continue to explore additional partnerships in other countries throughout the world.
−Removed: In February 2015, we entered into an exclusive agreement with Edding to develop and commercialize VASCEPA in what we refer to as the China Territory, consisting of the territories of Mainland China, Hong Kong, Macau and Taiwan.
−Removed: Edding, with our support, conducted a clinical trial of VASCEPA in China, which evaluated the effect of VASCEPA on patients with very high triglyceride levels (≥500 mg/dL).
−Removed: On February 23, 2022, the Hong Kong Department of Health completed their regulatory evaluation and approved the use of VASCEPA under the REDUCE-IT indication.
−Removed: In Mainland China, the NMPA accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA.
−Removed: In Mainland China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final NMPA review of the VASCEPA New Drug Application, or NDA, was initiated.
−Removed: The Company announced on June 1, 2023 that Edding received approval from the NMPA for VASCEPA in Mainland China under the MARINE indication and launched commercially in October 2023.
−Removed: In October 2023, Edding's submission of a regulatory
−Removed: filing to the NMPA for VASCEPA under the REDUCE-IT indication was accepted.
−Removed: On June 28, 2024, Edding received approval from the NMPA for VASCEPA in Mainland China under the REDUCE-IT indication.
−Removed: In March 2016, we entered into an agreement with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries.
−Removed: Biologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially in the following countries:
+Added: Rest of World (RoW)
+Added: One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets, outside the Recordati Territory.
+Added: We and our RoW 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.
+Added: Through the date of this Annual Report, we have filed for regulatory review in 22 countries and regions and have received approval in 17 countries and regions outside of the U.S.
+Added: and EMA regulatory approval authority.
+Added: We have agreements in place with the following partners within the respective territories:
+Added: Agreement Date
+Added: MARINE Approval
+Added: REDUCE-IT Approval
+Added: February 2015
+Added: Mainland China
+Added: February 2023
United Arab Emirates
5 unchanged sentences
September 2023
−Removed: VASCEPA is under registration in additional countries in the MENA region.
−Removed: In September 2017, we entered into an agreement with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada.
−Removed: In December 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority granted approval for VASCEPA to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high-risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.
−Removed: In January 2020, HLS obtained regulatory exclusivity designation and launched commercially in February 2020.
−Removed: In April 2022, HLS completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance for the terms and conditions under which VASCEPA would qualify for public market reimbursement in Canada.
−Removed: HLS has obtained reimbursement from all major private and public payors gaining access to a majority of eligible patients in Canada.
−Removed: Coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada.
−Removed: VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that could extend into 2039.
−Removed: We completed the final year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries and regions in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA.
−Removed: Through the date of this Annual Report, we have filed for regulatory review in 22 countries and regions and have received approval in 15 countries and regions outside of the U.S.
−Removed: and EMA regulatory approval authority, including in Mainland China, Switzerland, Australia, New Zealand and Israel, under the REDUCE-IT indication.
−Removed: In addition, VAZKEPA has been made available under individual pricing reimbursement in Switzerland.
−Removed: In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand.
−Removed: In October 2024, CSL obtained pricing approval and subsequently launched VAZKEPA in Australia.
−Removed: In July 2023, the Company entered into an agreement with Lotus Pharmaceuticals to commercialize and distribute VAZKEPA in South Korea and nine countries in Southeast Asia.
−Removed: In August 2023, the Company entered into an agreement with Neopharm (Israel) 1996 Ltd., or Neopharm, to distribute VAZKEPA in Israel, Gaza, West Bank, and the territories of the Palestinian Authority.
−Removed: The Company will be responsible for supplying finished product to these partners.
−Removed: We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the U.S.
−Removed: and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.
−Removed: Management Updates
−Removed: As announced and effective on June 3, 2024, Patrick Holt voluntarily resigned as President and Chief Executive Officer and as a member of the Board of Directors.
−Removed: Effective June 4, 2024, the Board of Directors appointed Aaron Berg, previously our Executive Vice President, President U.S., to succeed Mr.
−Removed: Holt as our President and Chief Executive Officer, and as a member of the Board of Directors.
−Removed: As announced on October 7, 2024, Tom Reilly voluntarily resigned as Executive Vice President, Chief Financial Officer, effective October 23, 2024.
−Removed: Effective December 13, 2024, our Vice President, Global Controller and principal financial and accounting officer of the Company, Peter Fishman, has been appointed as Senior Vice President, Chief Financial Officer.
−Removed: Organizational Restructuring Program
−Removed: On July 18, 2023, we announced that we were implementing a new Organizational Restructuring Program, or ORP, resulting in the elimination of our entire U.S.
−Removed: sales force and elimination and consolidation of certain other roles across our organization, both in the U.S.
−Removed: and abroad and representing a reduction of our total employee base by approximately 30%.
−Removed: The ORP was implemented following a review of our business and to better position the organization for a new strategic focus.
−Removed: The ORP resulted in an operating cost reduction of $50.0 million annually.
+Added: September 2017
+Added: December 2019
+Added: February 2020
+Added: February 2023
+Added: November 2022
+Added: December 2025
+Added: (1) - VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.
+Added: (2) - VASCEPA is under registration in additional countries in the MENA region with Biologix.
+Added: (3) - VASCEPA is under registration in additional countries in the Israel territory with Neopharm.
+Added: Revenue earned from sales of VASECPA within the Israel territory are recorded within European revenue.
+Added: (4) - VASCEPA is under registration in additional countries in the ASEAN region with Lotus.
+Added: We will be responsible for supplying finished product to these partners.
+Added: 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.
+Added: Global Restructuring Program
+Added: On June 24, 2025, we announced a global restructuring plan, the Global Restructuring Plan, in connection with the execution of an exclusive long-term license and supply agreement with Recordati, with the vast majority of estimated cost savings to come from the elimination of commercial roles in our European operations.
+Added: We expect these actions will reduce operating costs by approximately $70 million annually.
Research and Development
Since its inception in 2011, the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development.
−Removed: as well as the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE.
+Added: 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.
1 unchanged sentence
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.
−Removed: Based on REDUCE-IT results, as of the date of the filing of this Annual Report, more than 50 clinical treatment guidelines, consensus statements, or scientific statements from global medical societies or 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 in Canada, China, Southeast Asia, Australia, and the Middle East as well as guidelines which were newly received during the fourth quarter of 2024 as listed below:
−Removed: • In September 2024, the European Society of Cardiology, or ESC, updated their guidelines on the management of peripheral arterial and aortic disease to recommend IPE 2g BID in high-risk patients with comorbid hypertriglyceridemia (>1.5 mmol/L) despite lifestyle changes and statin therapy.
−Removed: This update is a Class IIb recommendation supported by Level B evidence.
−Removed: • In November 2024, the Taiwan Society of Cardiology updated their guidelines on the prevention of Atherosclerotic Cardiovascular Disease, or ASCVD, to recommend IPE 2-4g QD to patients receiving statin therapy with TG levels ≥150 mg/dL.
−Removed: Patients with very high TG levels ≥500 mg/dL with pancreatic risk may also benefit from IPE or EPA.
−Removed: • In December 2024, the Royal College of Physicians of Thailand, or RCPT, updated their guidelines on the management of dyslipidemia for ASCVD prevention to recommend IPE for risk reduction in patients age >40 years with type 2 diabetes, two or more risk factors for ASCVD, and persistently elevated TG levels even after achieving target LDL-C levels with statin therapy.
−Removed: During 2024, we announced the following data which added to our growing body of knowledge on VASCEPA as a result of our continued analysis of the REDUCE-IT trial results:
−Removed: • In February 2024, we supported our commercialization partners in Australia with an encore research presentation at the 4 Corners of Cardiology Meeting in Melbourne, Australia.
−Removed: This encore presentation included the REDUCE-IT mediation analysis report of the contribution of IPE and other biomarkers to major adverse cardiovascular events reduction.
−Removed: • In April 2024, we highlighted four data presentations showcasing the mechanistic activity of EPA and one REUDCE-IT subgroup analysis presentation reporting the effect of VASCEPA in patients with elevated TG and high or low Lipoprotein(a) concentrations at the American College of Cardiology scientific session.
−Removed: These presentations advanced the understanding of how EPA and VASCEPA work to reduce CV events in at-risk patients.
−Removed: • In May 2024, we supported two data presentations showcasing the mechanistic activity of EPA at the European Atherosclerosis Society, or EAS, scientific session in Lyon, France.
−Removed: These presentations may advance the understanding of how EPA and VASCEPA work to reduce CV events in at-risk patients.
−Removed: • In June 2024, we supported a poster with real world, observational, safety data of IPE from a U.S.
−Removed: database at the National Lipid Association, or NLA, scientific session in Las Vegas, Nevada.
−Removed: This presentation may advance the understanding of the safety profile of IPE in the real world and how it compares to the safety listed in the approved labeling and those from the large REDUCE-IT CV outcomes trial.
−Removed: • In June 2024, we supported an economic analysis of the budget impact of IPE in the prevention of cardiovascular events in Italy at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Italy meeting in Bologna, Italy.
−Removed: • In July 2024, we supported data presentations showcasing the mechanistic activity of EPA as well as encore data reporting on real world safety of IPE at the Heart UK scientific conference in Coventry, England.
−Removed: • In August 2024, we provided support to our commercial partner in Australia to present sub-analyses from the REDUCE-IT study in endpoints such at ST-elevation myocardial infarction as well as analyses in patients with established cardiovascular disease and diabetes mellitus.
−Removed: These data presentations occurred at the Cardiac Society of Australia and New Zealand, or CSANZ, and at the Australian Diabetes Congress, or ADC.
−Removed: • In August and September 2024, we supported data presentations at both the ESC in London, UK, and the European Association for the Study of Diabetes, or EASD in Madrid, Spain.
−Removed: These presentations included sub-analyses from the REDUCE-IT trial, EPA mechanistic data, and data from Spanish hospitals reporting on the residual cardiovascular risk of elevated TG levels in patients with acute coronary syndrome, or ACS, as well as the eligibility of IPE in patients with ACS.
−Removed: • In October 2024, we supported our Canadian partner, HLS, with an encore REDUCE-IT subgroup analysis presentation reporting the effect of VASCEPA/VAZKEPA in patients with elevated triglycerides and high or low Lipoprotein(a) concentrations at the Canadian Cardiovascular Congress, or CCC, in Vancouver, BC.
−Removed: • In November 2024, we supported three data presentation at the AHA Scientific Sessions in Chicago, IL.
−Removed: One data presentation was a subgroup analysis from REDUCE-IT in patients with prior CV events regardless of coronary artery disease history, and the other two data presentations showed the mechanistic activity of EPA.
−Removed: • In November 2024, we supported two health economics and outcomes research, or HEOR, presentations in Barcelona, Spain, at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Europe meeting.
−Removed: These data presentations highlighted the value add and cost-effectiveness of VASCEPA/VAZKEPA in patients with recent acute coronary syndrome in the Catalonia region of Spain.
−Removed: • In December 2024, we recognized support from our partner in the Middle East, Biologix, for a data presentation at the 20th International Symposium on Atherosclerosis, or ISA, in Muscat, Oman.
−Removed: The presentation reported on the effectiveness of VASCEPA/VAZKEPA in middle eastern patients with dyslipidemia within cardiology and endocrinology clinics.
−Removed: In total, Amarin and global medical and scientific collaborators supported close to 45 publications inclusive of accepted abstracts, posters, and manuscripts for the year 2024.
+Added: Based on REDUCE-IT results, as of the date of the filing of this Annual Report, more than 70 global medical societies or journals have recognized the use of IPE in appropriate at-risk patients for CV risk reductions in clinical treatment guidelines, consensus statements, or scientific statements, including those statements which we were informed of by our global partners in Canada, China, Southeast Asia, Australia, and the Middle East as well as guidelines which were newly received during the fourth quarter of 2025 as listed below:
+Added: • In November 2025, the American Heart Association, or AHA, released a Scientific Statement on Nonobstructive Coronary Artery Disease in Patients with Chest Pain.
+Added: The following information was included on IPE:
+Added: o Despite reduction in LDL-C levels, residual risk remains up to 30% at 10 years, representing a needed target for pharmacologic interventions.
+Added: Among medications with proven Randomized Controlled Trials, or RCT, data improving outcomes from residual risk, IPE has the most supporting data.
+Added: In the landmark REDUCE-IT, IPE 4 g/day added to statin therapy reduced the composite of cardiovascular death, Myocardial Infarction, or MI, stroke, coronary revascularization, or unstable angina by 25% among patients with established atherosclerotic disease or diabetes and ≥1 additional cardiovascular risk factor and triglyceride levels between 135 and 499 mg/dL (HR, 0.75 [95% CI, 0.68–0.83];
+Added: In addition, imaging studies, such as EVAPORATE, or Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy, have shown that treatment with icosapent ethyl can lead to plaque regression.
+Added: • In November 2025, the French Society of Endocrinology, the Francophone Society of Diabetes, the New Francophone Society of Atherosclerosis, and the French Society of Cardiology released a consensus statement on the management of dyslipidemias in adults.
+Added: The following recommendations and information was included on IPE:
+Added: o Only the REDUCE-IT study with high-dose IPE (4 g/day) was associated with a significant reduction in major CV events (CV death, non-fatal MI and stroke, unstable angina, and coronary revascularization) by 25% compared to placebo (paraffin oil) in people with Hypertriglyceridemia, or HTG, in secondary prevention or living with Type 2 Diabetes on statins.
+Added: o Based on the REDUCE-IT clinical trial, which showed a 26% reduction in CV events despite a moderate decrease in TG concentrations, IPE at 4 g/day is indicated, in addition to a statin, in patients with high or very high CV risk with HTG between 1.35 and 4.99 g/L (1.5 and 5.6 mmol/L).
+Added: In individuals with high or very high CV risk and moderate HTG (1.5-5 g/L), IPE (2 g twice daily) should be considered in addition to a statin.
+Added: • In November 2025, the European Association of Preventive Cardiology, the European Association of Cardiovascular Imaging, of the European Society of Cardiology, or ESC, the ESC Working Group on Atherosclerosis and Vascular Biology, and the ESC Working Group on Cardiovascular Pharmacotherapy, released a scientific statement on therapies leading to coronary atherosclerosis plaque regression.
+Added: The following information was included on IPE:
+Added: o An Intravascular Ultrasound randomized controlled trial, CHERRY, assessed whether coronary plaque regression is reinforced by the addition of EPA to high-dose pitavastatin.
+Added: The study showed greater regression of atheroma volumes over 6 months with the administration of EPA 1800 mg/day compared with pitavastatin alone.
+Added: o In the EVAPORATE trial, 80 subjects were randomized to EPA vs.
+Added: optimal medical treatment with more advanced low attenuation and fibrofatty plaque regression on Coronary Computed Tomography Angiography observed in the EPA group.
+Added: During 2025, we announced and supported the following data which added to our growing body of knowledge on VASCEPA as a result of our continued analysis of the REDUCE-IT trial results:
+Added: • In March 2025, at the American College of Cardiology, or ACC, Scientific Sessions, we supported two posters, one looking at the antioxidant and anti-inflammatory effects of EPA in combination with a Glucagon-like peptide-1, or GLP-1, agonist on endothelial cells, and another looking at the antioxidant effects of EPA on Lipoprotein little a, or Lp(a), as compared to small, dense, LDL and TG rich lipoprotein.
+Added: • In April 2025, at the European Society of Cardiology Preventive Cardiology, or ESC-PC, congress in Milan, Italy, we provided grant support for two poster presentations, one evaluating eligibility for and barriers to IPE utilization in a medical clinic, and another reporting on a project aimed to improve lipid lowering for secondary prevention in a primary healthcare facility.
+Added: • In May 2025, at the EAS Congress in Glasgow, UK, we provided grant support for two poster presentations, both reporting on the potential additive effects of eicosapentaenoic acid and a GLP-1 agonist on changes in protein expression associated with antioxidant and/or anti-inflammatory effects in response to inflammatory stimuli.
+Added: • In June 2025, at the National Lipid Association scientific sessions in Miami, Florida, we provided grant support for a poster reporting on a pilot implementation strategy to improve post-acute coronary syndrome management of patients with hypertriglyceridemia.
+Added: • In July 2025, at the Heart UK meeting in Coventry, England, we along with our collaborators provided support for a REDUCE-IT poster presentation analyzing the efficacy of IPE by burden of standard modifiable CV risk factors.
+Added: This same data analysis was later presented in August of 2025 as an ENCORE poster presentation at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand with support from our partners in Australia, CSL.
+Added: • In August 2025, at the Australasian Diabetes Congress in Queensland, Australia, we along with CSL and our collaborators supported an ENCORE poster presentation analyzing the reduction in ischemic events with IPE in patients with diabetes and prior coronary artery bypass graft.
+Added: • At the European Society of Cardiology, or ESC, scientific session which occurred from August 29 to September 1, 2025, in Madrid, Spain, we along with our global collaborators supported five separate presentations ranging from the effect of IPE on risk and duration of hospitalizations and death in REDUCE-IT to mechanistic data looking at the antioxidant effects of EPA on Lp(a).
+Added: • In September 2025, at the European Association for the Study of Diabetes Congress in Vienna, Austria, we along with our global collaborators supported an oral presentation analyzing the efficacy of IPE across the spectrum of baseline triglyceride to glucose index.
+Added: • In October 2025, at the Canadian Cardiovascular Congress in Quebec, Canada, we along with our global collaborators supported two encore presentations from REDUCE-IT on the effects of IPE in secondary prevention patients with cardiovascular-kidney-metabolic syndrome, and on the effects of IPE on the risk and duration of hospitalizations and death.
+Added: • In November 2025, at the AHA Scientific Sessions meeting in New Orleans, Louisiana, we along with our global collaborators supported four separate presentations ranging from the efficacy of IPE on CV risk reduction by aspirin use in REDUCE-IT to mechanistic data evaluating the effects of EPA on Lp(a) oxidation, and the effect of the combination of EPA and a GLP-1 agonist on protein expression in endothelial cells during inflammation.
+Added: In total, Amarin and global medical and scientific collaborators supported 45 publications inclusive of accepted abstracts, posters, and manuscripts for the year 2025.
Commercial and Clinical Supply
3 unchanged sentences
We have multiple U.S.
−Removed: FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise.
−Removed: 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..
+Added: FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise in the U.S.
+Added: We also have multiple international API
+Added: 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.
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Revenues from VASCEPA sales are recognized upon delivery to the distributor or customer.
−Removed: Timing of shipments to wholesalers, as used for revenue recognition, and
−Removed: timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period.
+Added: 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.
−Removed: Outside of the U.S., currently the majority of our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners.
+Added: 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.
2 unchanged sentences
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.
−Removed: We also derive product revenue from sales of our product to a limited number of wholesalers in Europe, most of whom in turn resell the product to pharmacies for purposes of their reselling the product to fill patient prescriptions.
Licensing and royalty revenue.
2 unchanged sentences
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.
−Removed: The royalty payments are being recognized as earned based on revenue recognized by our current partners.
+Added: The royalty payments are being recognized when the uncertainty related to the consideration is resolved.
Cost of goods sold.
3 unchanged sentences
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.
−Removed: In the years ended December 31, 2024 and 2023, we incurred costs within Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand.
+Added: In the year ended December 31, 2024, we incurred costs within Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand.
Selling, general and administrative expense.
6 unchanged sentences
Restructuring expense.
−Removed: Restructuring expense consists of restructuring costs incurred under our July 2023 ORP, June 2022 Cost Reduction Plan, or CRP, and August 2022 discontinuation of German operations, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation expense and other contract related costs.
−Removed: Interest income, net and other income (expense), net.
+Added: Restructuring expense consists of restructuring costs incurred under our June 2025 Global Restructuring Plan and July 2023 ORP, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs.
+Added: Interest income, net and other income, net.
Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term and long-term investments.
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Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the U.S., or GAAP.
−Removed: preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses.
+Added: The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses.
On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions.
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We rely on resale data provided by our distributors as well as prescription data provided by Symphony Health and IQVIA in estimating the level of inventory held in the distribution channel.
−Removed: A hypothetical 5% change in estimated aggregate bottles of channel inventory would result in a change of less than 1% in net product revenues reported during the years ended December 31, 2024 and 2023.
+Added: A hypothetical 5% change in estimated aggregate bottles of channel inventory would result in a change of approximately 1% in net product revenues reported during the years ended December 31, 2025 and 2024.
When evaluating licensing arrangements, we perform the following steps:
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and (v) recognition of revenue when (or as) we satisfy each performance obligation.
−Removed: In determining performance obligations, we evaluate whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement.
+Added: In determining performance obligations, we evaluate whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each
Factors considered include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of us.
−Removed: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up front fees allocated to the license when the license is transferred to the distributor and the distributor is able to use and benefit from the license.
−Removed: For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees.
+Added: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the distributor and the distributor is able to use and benefit from the license.
+Added: For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees.
We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
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We evaluate factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required.
−Removed: The transaction price is then allocated to each performance obligation on a relative stand-alone selling price
−Removed: basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.
+Added: The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.
At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price.
Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.
+Added: At the inception of each arrangement that includes royalty-based payments, the Company evaluates whether the royalties relate to the license of intellectual property, in which case they are accounted for under the royalty constraint within ASC 606 and recognized when the later of the subsequent sale or usage occurs or when the performance obligations have been satisfied.
+Added: If the royalties do not relate to the licensing of intellectual property, the royalties are accounted for under the variable consideration constraint within ASC 606 and are recognized in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue will not occur when the uncertainty around the variable consideration is subsequently resolved.
+Added: Royalty payments that fall within the variable consideration constraint take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.
+Added: The royalties that are considered variable consideration are recognized when the uncertainty related to the variable consideration is subsequently resolved.
+Added: At the end of each subsequent reporting period, the Company reevaluates the circumstances and recognizes royalties that are no longer constrained.
We receive payments from our customers based on billing schedules established in each contract.
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The evidence considered included the (i) historical taxable profitability of our U.S.
−Removed: operations, (ii) historical pre-tax book loss position, (iii) sources of future taxable income, giving weight to sources according to the extent to which they can be objectively verified, (iv) the provisions of the Tax Cuts and Jobs Act enacted in 2017 and their impact on our future taxable income, and (v) the risks to our business related to the commercialization and development of VASCEPA.
+Added: operations, (ii) historical pre-tax book loss position, (iii) sources of future taxable income, giving weight to sources according to the extent to which they can be objectively verified, (iv) the provisions of the Tax Cuts and Jobs Act enacted in 2017 and their impact on our future taxable income, and (v) the risks to our business related to the commercialization and
+Added: development of VASCEPA.
Based on our assessment, we concluded that all of our net deferred tax assets are not more likely than not to be realizable as of both December 31, 2025 and 2024.
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The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2025 and 2024.
−Removed: For a comparison of our results of operations and financial condition for fiscal years 2023 and 2022, see “ Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations ” of our 2023 Annual Report on Form 10-K, filed with the SEC on February 29, 2024 .
+Added: For a comparison of our results of operations and financial condition for fiscal years 2024 and 2023, see “ Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations ” of our 2024 Annual Report on Form 10-K, filed with the SEC on March 12, 2025 .
Comparison of Fiscal Years Ended December 31, 2025 and December 31, 2024
2 unchanged sentences
Total revenue, net consists primarily of revenue from the sale of VASCEPA in the U.S.
−Removed: In addition to the U.S., we also sell VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the U.S.
−Removed: and Europe, such as China and Canada, through collaborations with third-party companies.
−Removed: discussed below, the aforementioned decrease consists of a $107.2 million decrease in U.S.
−Removed: net product revenue, offset by increases of $26.5 million in net product revenue from sales of VASCEPA outside of the U.S.
−Removed: and $2.4 million in licensing and royalty revenue.
+Added: As further discussed below, the decrease consists of reductions of $12.6 million in U.S.
+Added: net product revenue and $9.3 million in net product revenue from sales of VASCEPA to our partners located outside of the U.S., offset by increases of $6.9 million in licensing and royalty revenue.
Product revenue, net.
3 unchanged sentences
product revenue, net, of $154.1 million and $166.7 million for the years ended December 31, 2025 and 2024, respectively.
−Removed: This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market, a decrease in volume primarily related to the loss of a large national Pharmacy Benefit Managers, or PBM, going from exclusive to no longer covering VASCEPA, as well as a change in estimate adjustment made in 2023 primarily related to Medicaid rebates of $15.1 million.
−Removed: The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, decreased for the year ended December 31, 2024 by 2% as compared to the year ended December 31, 2023.
+Added: This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market.
+Added: The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the year ended December 31, 2025 by 2% as compared to the year ended December 31, 2024.
Our share of the icosapent ethyl market has decreased to approximately 47% in the year ended December 31, 2025 from approximately 53% in the year ended December 31, 2024.
1 unchanged sentence
In Europe, we recorded product revenue, net, of $18.4 million and $13.7 million as of December 31, 2025 and 2024, respectively, primarily from the UK and Spain.
−Removed: For the year ended December 31, 2024, we recorded $24.2 million of product revenue, net, to our collaboration partners compared to $8.1 million during the year ended December 31, 2023.
−Removed: Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high.
−Removed: In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to advance our pricing and reimbursement and licensing activities to drive access in remaining geographies as well as being the market leader in the U.S.
+Added: For the year ended December 31, 2025, we recorded RoW product revenue, net, of $10.2 million from our six collaboration partners, comprising multiple distinct geographies, compared to $24.2 million during the year ended December 31, 2024.
+Added: The decline reflects normal variability across the multiple geographies encompassing this early stage of a developing ex-U.S.
Licensing and royalty revenue.
Licensing and royalty revenue during the years ended December 31, 2025 and 2024 was $30.9 million and $24.0 million, respectively, an increase of $6.9 million, or 29%.
−Removed: The current year licensing and royalty revenue is comprised primarily of the following:
−Removed: • $15.0 million milestone payment following NMPA approval in China of VASCEPA under the REDUCE-IT indication,
−Removed: • $4.0 million recognition of previously deferred revenue arising from a change in estimate,
−Removed: • $1.2 million milestone arising from the Pharmaceutical Benefits Scheme, or PBS, listing of VAZKEPA in Australia, and
−Removed: • royalties from sales of VASCEPA in select territories.
−Removed: The prior year licensing and royalty revenue is comprised of the following:
−Removed: • partial recognition of a $5.0 million milestone following NMPA approval in China of VASCEPA under the MARINE indication,
−Removed: • partial recognition of a $3.0 million milestone following regulatory submission in China of VASCEPA under the REDUCE-IT indication,
−Removed: • $10.3 million recognition of previously deferred revenue arising from a change in estimate, and
−Removed: • royalties from sales of VASCEPA in select territories.
−Removed: Refer to Note 13 Development, Commercialization and Supply Agreements for further details on our licensing agreements.
−Removed: 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.
−Removed: The royalty payments are being recognized as earned based on revenue recognized by our current partners.
+Added: This increase was primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement and higher royalties as a result of an increase in partner sales within their respective territories.
+Added: During the year ended December 31, 2024, we recognized a $15.0
+Added: million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.
Cost of goods sold.
−Removed: Cost of goods sold during the years ended December 31, 2024 and 2023 was $147.2 million and $141.4 million, respectively, an increase of $5.9 million, or 4%.
+Added: Cost of goods sold during the years ended December 31, 2025 and 2024 was $92.8 million and $147.2 million, respectively, a decrease of $54.5 million, or 37%.
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.
1 unchanged sentence
This average cost reflects the actual purchase price of VASCEPA API.
−Removed: During 2024 and 2023, we have taken steps to amend supplier agreements to align supply arrangements with current and future demand resulting in charges of $36.5 million and $39.2 million, respectively, which were recorded as cost of goods sold - restructuring inventory.
−Removed: During 2024, approximately $8.0
−Removed: million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory.
+Added: During 2024, we took steps to amend supplier agreements to align supply arrangements with current and future demand resulting in a $36.5 million charge recorded as cost of goods sold - restructuring inventory.
+Added: During 2025, approximately $0.4 million of inventory was expensed through cost of goods sold due to product dating.
During 2024, approximately $8.0 million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory.
5 unchanged sentences
Excluding the restructuring inventory and inventory write-off charges, gross margin was 49% and 50% for the years ended December 31, 2025 and 2024, respectively.
−Removed: The remaining decrease in gross margin is primarily as a result of a decrease in net selling price.
Selling, general and administrative expense.
7 unchanged sentences
(1) Selling expense for the years ended December 31, 2025 and 2024 was $40.6 million and $79.6 million, respectively, a decrease of $39.0 million, or 49%.
−Removed: This decrease is primarily due to a reduction in costs associated with our ORP and cost reduction plans resulting in decreased promotional initiatives, reduced travel and elimination of our U.S.
−Removed: (2) General and administrative expense for the years ended December 31, 2024 and 2023 was $58.6 million and $76.1 million, respectively, a decrease of $17.6 million, or 23%.
−Removed: This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the ORP and cost reduction plans and decreased advisory fees related to the shareholder's special meeting in 2023.
−Removed: (3) Non-cash stock-based compensation expense for the years ended December 31, 2024 and 2023 was $14.2 million and $12.5 million, respectively, an increase of $1.7 million, or 13%.
+Added: This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan, as well as other cost optimization initiatives.
+Added: (2) General and administrative expense for the years ended December 31, 2025 and 2024 was $65.2 million and $58.6 million, respectively, an increase of $6.6 million, or 11%.
+Added: This increase is primarily due to fees associated with the ADS Ratio Change and Recordati Licensing Agreement.
+Added: This increase is offset by a decrease in branded pharma fees as a result of lower sales and the reduction of costs associated with the Global Restructuring Plan.
+Added: (3) Non-cash stock-based compensation expense for the years ended December 31, 2025 and 2024 was $9.2 million and $14.2 million, respectively, a decrease of $4.9 million, or 35%.
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.
−Removed: The increase is due to prior years reversal of expense associated with our former CEO's resignation, as well as certain performance-based awards as it was no longer deemed probable that the performance criteria for vesting would be achieved within the required timeframe.
−Removed: We are focused on getting VASCEPA to as many patients as possible by continuing to advance our pricing and reimbursement and licensing activities to drive access in remaining geographies, as well as advancing regulatory filings internationally.
−Removed: We will continue to evaluate all of our spending commitments and priorities based on this focus.
Research and development expense.
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(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.
−Removed: (2) Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 but was subsequently deprioritized during 2023.
+Added: (2) Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 but was subsequently deprioritized in 2023.
(3) 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.
−Removed: and Europe as well as regulatory expansion in the rest of the world.
−Removed: The increase is primarily due to the continued expansion within Europe and other countries throughout the world.
+Added: and globally as well as supporting our partners' regulatory filings throughout the rest of the world.
(4) Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
2 unchanged sentences
(6) 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.
−Removed: We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S.
−Removed: generic competition as well as timing of pricing reimbursements throughout Europe.
Restructuring expense .
−Removed: Restructuring expense for the years ended December 31, 2024 and 2023 was nil and $11.0 million, respectively, a decrease of $11.0 million, or 100%.
−Removed: The charge in the prior year is due to the implementation of the ORP which was approved in the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S.
−Removed: sales field force, with our managed care and trade organization continuing to support our U.S.
−Removed: commercial efforts, as well as a reduction of approximately 30% of non-sales positions.
+Added: Restructuring expense for the years ended December 31, 2025 and 2024 was $36.2 million and nil, respectively, an increase of $36.2 million, or 100%.
+Added: 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.
−Removed: Interest income, net, for the years ended December 31, 2024 and 2023 was $13.4 million and $11.9 million, respectively, an increase of $1.5 million, or 13%.
+Added: Interest income, net, for the years ended December 31, 2025 and 2024 was $10.8 million and $13.4 million, respectively, a decrease of $2.6 million, or 19%.
Interest income, net, represents income earned on cash and investment balances.
−Removed: The increase is primarily due to higher interest rates in the current year period compared to the prior year period.
−Removed: Other income (expense), net .
−Removed: Other income (expense), net, for the year ended December 31, 2024 and 2023 was income of $1.2 million and $2.1 million, respectively.
−Removed: Other income (expense), net, primarily consists of the gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, NJ facility.
+Added: The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.
+Added: Other income, net .
+Added: Other income, net, for the year ended December 31, 2025 and 2024 was $3.3 million and $1.2 million, respectively.
+Added: Other income, net, primarily consists of the gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, NJ facility.
Provision for income taxes .
9 unchanged sentences
Year Ended December 31,
−Removed: Cash (used in) provided by:
+Added: Cash provided by (used in):
Operating activities
1 unchanged sentence
Financing activities
−Removed: (Decrease) increase in cash and cash equivalents and restricted cash
−Removed: Net cash used in operating activities decreased during 2024 as compared to net cash provided by operating activities during the same period in 2023.
−Removed: This is primarily as a result of timing and payment of invoices and accruals in 2024 as well as a decrease in U.S.
−Removed: product revenue in 2024.
−Removed: Net cash used in investing activities decreased during the year ended December 31, 2024 compared to the same period in 2023.
−Removed: This is primarily due to the purchase of investment grade interest-bearing instruments of $278.8 million partially offset by $232.8 million from proceeds from the maturity of investment grade interest-bearing instruments, as compared to the same period in 2023 where proceeds from the maturity of investment grade interest-bearing instruments was $215.1 million, partially offset by $190.1 million in purchases of investment grade interest-bearing instruments.
−Removed: Net cash used in financing activities decreased during the years ended December 31, 2024 compared to net cash provided by financing activities during the same period in 2023, primarily as a result of a decrease in proceeds related to stock option exercises.
−Removed: As of December 31, 2024, we had net accounts receivable of $122.3 million, current inventory of $166.0 million and long-term inventory of $64.7 million.
+Added: Increase (decrease) in cash and cash equivalents and restricted cash
+Added: Net cash provided by operating activities increased during 2025 as compared to net cash used in operating activities during the same period in 2024.
+Added: This is primarily driven by the Global Restructuring Plan and the resulting cost savings, including from the elimination of commercial roles in our European operations.
+Added: Net cash provided by investing activities increased during the year ended December 31, 2025 compared to net cash used in investing activities during the same period in 2024.
+Added: This is primarily due to the proceeds from the maturity of investment grade interest-bearing instruments of $209.3 million partially offset by $200.5 million from the purchase of investment grade interest-bearing instruments, as compared to the same period in 2024, where purchases of investment grade interest-bearing instruments of $278.8 million were partially offset by $232.8 million from proceeds from the maturity of investment grade interest-bearing instruments.
+Added: Net cash used in financing activities increased during the years ended December 31, 2025 compared to the same period in 2024, was primarily as a result of taxes paid on stock-based awards.
+Added: As of December 31, 2025, we had net accounts receivable of $126.8 million and current inventory of $195.9 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 December 31, 2025.
We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API, the generic competition in the U.S.
−Removed: and pricing and reimbursement of VAZKEPA in Europe.
−Removed: In July 2023, we announced that we were implementing the ORP resulting in the elimination and consolidation of certain roles across the organization, both in the U.S.
−Removed: and abroad, representing a reduction of our total employee base by approximately 30%.
−Removed: In the U.S., all sales force positions were eliminated, with the managed care and trade organization continuing to support U.S.
−Removed: commercial efforts, and 30% of non-sales positions were eliminated, while in Europe we have redesigned our commercial infrastructure to better align with pricing and reimbursement status, commercial progress to date, as well as streamlining certain cross-geographic functions and better leveraging learnings across countries.
−Removed: These actions reduced operating costs by $50.0 million annually.
+Added: and the efforts of our licensee of VAZKEPA in Europe.
+Added: In June 2025, we announced a Global Restructuring Plan, in connection with the execution of an exclusive long-term license and supply agreement with Recordati, with the vast majority of estimated cost savings to come from the elimination of commercial roles in the Company’s European operations.
+Added: We expect these actions will reduce operating costs by approximately $70.0 million annually.
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.
3 unchanged sentences
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.
−Removed: 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, for at least one year from the issuance date of our audited consolidated financial statements included elsewhere in this Annual Report and is adequate to support continued operations based on our current plans.
+Added: We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including, if commenced, the share repurchase program, for at least one year from the issuance date of our audited consolidated financial statements included elsewhere in this Annual Report and is adequate to support continued operations based on our current plans.
We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under Part II, Item IA, “Risk Factors” , and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.
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Interest rate risk mainly arises through interest bearing liabilities and assets.
−Removed: Our portfolio of investments as of December 31, 2024 was
−Removed: composed primarily of U.S.
+Added: Our portfolio of investments as of December 31, 2025 was composed primarily of U.S.
Treasury securities and other government-related securities.
10 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.