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What changed in AMARIN CORP PLCUK's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of AMARIN CORP PLCUK's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+508 added−545 removedSource: 10-K (2026-03-02) vs 10-K (2025-03-12)

Top changes in AMARIN CORP PLCUK's 2025 10-K

508 paragraphs added · 545 removed · 387 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

108 edited+37 added−55 removed224 unchanged
Biggest changeBiologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially in the following countries: Country MARINE REDUCE-IT Launch Date 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 VASCEPA is under registration in additional countries in the MENA region.
Biggest changeWe 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 – (1) - VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.
The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. In addition, VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 productions as nutritional supplements. In Europe, such products are classified as food, not as prescription drugs or as over-the-counter drugs.
The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. In addition, VASCEPA faces competition from dietary supplement manufacturers marketing omega-3 productions as nutritional supplements. In Europe, such products are classified as food, not as prescription drugs or as over-the-counter drugs.
Also, if governmental parties or our competitors view our claims as misleading or false, we could also be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any of such negative circumstances could adversely affect our ability to operate our business and our results of operations.
Also, if governmental parties or our competitors view our claims as misleading or false, we could also be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any of such negative circumstances could adversely affect our ability to operate our business and our results of operations.
While certain key patents related to our product based on the MARINE clinical study were determined to be invalid as obvious by a district court in the U.S., it remains the case that our ability to successfully implement our business plan and to protect our products with our intellectual property will depend in large part on our ability to: • obtain, defend and maintain patent protection and market exclusivity for our current and future products; • preserve any trade secrets relating to our current and future products; • acquire patented or patentable products and technologies; and • operate without infringing the proprietary rights of third parties.
While certain key U.S. patents related to our product based on the MARINE clinical study were determined to be invalid as obvious by a district court in the U.S., it remains the case that our ability to successfully implement our business plan and to protect our products with our intellectual property will depend in large part on our ability to: • obtain, defend and maintain patent protection and market exclusivity for our current and future products; • preserve any trade secrets relating to our current and future products; • acquire patented or patentable products and technologies; and • operate without infringing the proprietary rights of third parties.
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, including the Final Omnibus Rule published in January 2013, collectively 18 referred to herein as HIPAA, among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payor and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, including the Final Omnibus Rule published in January 2013, collectively referred to herein as HIPAA, among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payor and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
If our promotional activities or other operations are found to be in violation of any of the laws described above or any other governmental regulations or guidance that apply to us through existing or new interpretations, we may be subject to prolonged litigation, penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.
If our promotional activities or other operations are found to be in violation of any of the laws described above or any other governmental regulations or guidance that apply to us through existing or new interpretations, we may be subject to prolonged 20 litigation, penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.
Recently, real world administrative database analyses have reported an increased CVD risk as well as direct healthcare costs associated with HTG despite statin therapy and controlled LDL-C compared to those with TG 12 Regulatory Matters Government Regulation and Regulatory Matters Any product development activities related to VASCEPA or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the U.S.
Recently, real world administrative database analyses have reported an increased CVD risk as well as direct healthcare costs associated with HTG despite statin therapy and controlled LDL-C compared to those with TG Regulatory Matters Government Regulation and Regulatory Matters Any product development activities related to VASCEPA or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the U.S.
These rules can impose post-authorization studies and additional monitoring obligations. • The manufacturing of authorized medicinal products, for which a separate manufacturer's license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive (EU) 2017/1572, Regulation (EC) No 726/2004 and the European Commission Guidelines Manufacturing Practice.
These rules can impose post-authorization studies and additional monitoring obligations. • The manufacturing of authorized medicinal products, for which a separate manufacturer's license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, 17 Directive (EU) 2017/1572, Regulation (EC) No 726/2004 and the European Commission Guidelines Manufacturing Practice.
However, this greater 3 concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S. 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.
However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S. 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.
Phase 3 trials generally involve large numbers of patients at multiple sites, in multiple countries and are designed to provide the pivotal data necessary to demonstrate the effectiveness of the product for its intended use and its safety in use, provide an adequate basis for physician labeling and may include comparisons with placebo and/or other comparator treatments.
Phase 3 trials generally involve large numbers of patients at multiple sites, in multiple countries and are designed to provide the pivotal data necessary to demonstrate the effectiveness of the product for its intended use and its safety in use, provide an adequate basis for physician labeling and may 13 include comparisons with placebo and/or other comparator treatments.
FDA and IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical trial development may proceed. Similarly, clinical trials conducted in countries such as Australia, Canada, and New Zealand, require review and approval of clinical trial proposals by an ethics committee, which 15 provides a combined ethical and scientific review process.
FDA and IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical trial development may proceed. Similarly, clinical trials conducted in countries such as Australia, Canada, and New Zealand, require review and approval of clinical trial proposals by an ethics committee, which provides a combined ethical and scientific review process.
Multiple generic versions of Tricor, Trilipix and Niaspan are also available in the U.S. We compete with 11 these drugs, and in particular, multiple low-cost generic versions of these drugs, in our U.S. FDA-approved indicated uses, even though such products do not have U.S. FDA approval to reduce CV risk on top of statin therapy.
Multiple generic versions of Tricor, Trilipix and Niaspan are also available in the U.S. We compete with these drugs, and in particular, multiple low-cost generic versions of these drugs, in our U.S. FDA-approved indicated uses, even though such products do not have U.S. FDA approval to reduce CV risk on top of statin therapy.
Accordingly, we expect to receive three-year exclusivity in connection with any future regulatory approvals of VASCEPA. We received such three-year regulatory exclusivity in connection with the approval based on the REDUCE-IT outcomes study results. Such three-year exclusivity protection precludes the U.S. FDA from approving a marketing application for an ANDA, a product candidate that the U.S.
Accordingly, we expect to receive 15 three-year exclusivity in connection with any future regulatory approvals of VASCEPA. We received such three-year regulatory exclusivity in connection with the approval based on the REDUCE-IT outcomes study results. Such three-year exclusivity protection precludes the U.S. FDA from approving a marketing application for an ANDA, a product candidate that the U.S.
The duration of treatment is often extended to mimic the actual use of a product during marketing. United States Drug Development and Approval In the U.S., the process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources.
The duration of treatment is often extended to mimic the actual use of a product during marketing. United States Drug Development and Approval In the U.S., the process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations require the expenditure of substantial time and financial resources.
Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.
Compliance with the GDPR is and will remain rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.
While we acknowledge and support the benefits of diversity and seek ways to continually improve in this area, individual hiring, promotion, compensation, retention and other employment decisions are made irrespective of personal characteristics such as race, disability, gender, sexual orientation, religion, or age.
While we acknowledge and support the benefits of diversity and seek ways to continually improve in this area, individual hiring, promotion, compensation, retention and other 24 employment decisions are made irrespective of personal characteristics such as race, disability, gender, sexual orientation, religion, or age.
An independent IRB may also suspend or terminate a study once initiated. 13 U.S. FDA Review Process The results of nonclinical studies and clinical trials, together with other information, including manufacturing information and information on the composition of the drug and proposed labeling, are submitted to the U.S.
An independent IRB may also suspend or terminate a study once initiated. U.S. FDA Review Process The results of nonclinical studies and clinical trials, together with other information, including manufacturing information and information on the composition of the drug and proposed labeling, are submitted to the U.S.
Department of Defense, Public Health Service and U.S. Coast Guard - that is no higher than the statutory Federal Ceiling Price, or FCP. The FCP is based on the non-federal average manufacturer price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis.
Department of Defense, Public Health Service and U.S. Coast Guard - that is no higher than the 22 statutory Federal Ceiling Price, or FCP. The FCP is based on the non-federal average manufacturer price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis.
Attracting, developing and retaining key scientific, technical, research, marketing, sales and other personnel is critical to our ability to implement and execute our business plan and is key to our success. Our ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development, career opportunities and work environment.
Attracting, developing and retaining key scientific, technical, research, marketing and other personnel is critical to our ability to implement and execute our business plan and is key to our success. Our ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development, career opportunities and work environment.
Once the EC's legislative proposals have been initially voted on by the European Parliament and the European Council and, 17 following initial review, been negotiated and discussed among those bodies, final approved texts (with or without amendment), they will be adopted into EU law.
Once the EC's legislative proposals have been initially voted on by the European Parliament and the European Council and, following initial review, been negotiated and discussed among those bodies, final approved texts (with or without amendment), they will be adopted into EU law.
Changes in regulations or statutes or the interpretation of existing regulations could impact our business in the future by requiring, the following: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements.
Changes in regulations or statutes or the interpretation of existing regulations could impact our business in the future by requiring, the following: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the 23 recall or discontinuation of our products; or (iv) additional record-keeping requirements.
Sales, marketing and scientific/educational programs must comply with the Food, Drug, and Cosmetic Act, the 22 Anti-Kickback Statute, and the False Claims Act and similar state laws. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990.
Sales, marketing and scientific/educational programs must comply with the Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, and the False Claims Act and similar state laws. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990.
Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the EC, who makes the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA's recommendation.
Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the EC, who makes the final decision to grant a 16 marketing authorization, which is issued within 67 days of receipt of the EMA's recommendation.
Prescription Drug Marketing Act, or the PDMA, a part of the FDCA. 14 In the U.S., once a product is approved, its manufacture is subject to comprehensive and continuing regulation by the U.S. FDA. U.S.
Prescription Drug Marketing Act, or the PDMA, a part of the FDCA. In the U.S., once a product is approved, its manufacture is subject to comprehensive and continuing regulation by the U.S. FDA. U.S.
Europe and Rest of World Cardiovascular diseases remain the leading cause of disease burden in the world. There are more than 500 million people reportedly living with cardiovascular diseases globally, with 290 million in China.
Europe and Rest of World Cardiovascular diseases remain the leading cause of disease burden in the world. Globally, there are more than 500 million people reportedly living with cardiovascular diseases, with 290 million in China alone.
For example, the EU provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.
The EU provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.
As of the date of this Annual Report on Form 10-K, we had more than 100 patent applications in the U.S. that have been either issued or allowed, most of which are listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations also known as the FDA Orange Book.
As of the date of this Annual Report on Form 10-K, we had more than 100 patent applications in the U.S. that have been either issued or allowed, many of which are listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations also known as the FDA Orange Book.
Currently-issued U.S. patents will expire between 2027 and 2033 and contain claims directed to the methods of using icosapent ethyl to treat hypertriglyceridemia, severe hypertriglyceridemia and cardiovascular risk reduction. Our VASCEPA patent portfolio also includes many granted patents in foreign jurisdictions including pending foreign and Patent Cooperation Treaty, or PCT patent applications.
Currently-issued U.S. patents for VASECPA will expire between 2027 and 2033 and contain claims directed to the methods of using icosapent ethyl to treat hypertriglyceridemia, severe hypertriglyceridemia and cardiovascular risk reduction. Our VASCEPA patent portfolio also includes many granted patents in foreign jurisdictions including pending foreign and Patent Cooperation Treaty, or PCT patent applications.
Operating activity being conducted by the European subsidiaries were in support of Amarin Pharmaceuticals Ireland Limited. Ester Neurosciences Limited had no operating activities.
Operating activity being conducted 25 by the European subsidiaries were in support of Amarin Pharmaceuticals Ireland Limited. Ester Neurosciences Limited had no operating activities.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.
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.
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 active arm of the study was comprised of patients on optimized statin therapy plus VASCEPA. All subjects enrolled in the study had elevated triglyceride levels and either established coronary heart disease or risk factors for coronary heart disease.
The control arm of the study was comprised of patients on optimized statin therapy plus placebo. The active arm of the study was comprised of patients on optimized statin therapy plus VASCEPA. All subjects enrolled in the study had elevated triglyceride levels and either established coronary heart disease or risk factors for coronary heart disease.
We are not, however, including the information contained on our website, or information that may be accessed through links on our website, as part of, or incorporating such information by reference into, this Annual Report on Form 10-K. 25
We are not, however, including the information contained on our website, or information that may be accessed through links on our website, as part of, or incorporating such information by reference into, this Annual Report on Form 10-K. 26
Studies in the scientific literature explore potentially beneficial effects of EPA on multiple atherosclerosis processes, including endothelial function, oxidative stress, foam cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture.
Studies in the scientific literature report potentially beneficial effects of EPA on multiple atherosclerosis processes, including endothelial function, oxidative stress, foam cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture.
For Europe, various suppliers have been inspected and approved by European regulatory authorities and we do not anticipate supply availability limiting our continued launch in Europe. The API material that constitutes ethyl-EPA is a chemical modification of a naturally occurring substance that is derived from specific fish sourced from qualified producers.
For Europe, various suppliers have been inspected and approved by European regulatory authorities and we do not anticipate supply availability limiting our partner's continued commercialization in Europe. The API material that constitutes ethyl-EPA is a chemical modification of a naturally occurring substance that is derived from specific fish sourced from qualified producers.
As from January 1, 2025, the marketing of medicines in the UK, including Northern Ireland, will be governed either by UK applicable marketing authorizations or by separate marketing authorizations applicable only in Great Britain or Northern Ireland, in each case 16 granted by the UK MHRA.
As of January 1, 2025, the marketing of medicines in the UK, including Northern Ireland, will be governed either by UK applicable marketing authorizations or by separate marketing authorizations applicable only in Great Britain or Northern Ireland, in each case granted by the UK MHRA.
Since VASCEPA was made commercially available in 2013, approximately 27 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.
Since VASCEPA was made commercially available in 2013, approximately 30 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful 2 appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr.
According to the Heart Disease and Stroke Statistics—2024 Update from the AHA, CVD is the underlying cause of death in approximately one out of every three deaths – one death approximately every 34 seconds.
According to the Heart Disease and Stroke Statistics—2025 Update from the AHA, CVD is the underlying cause of death in approximately one out of every three deaths – one death approximately every 34 seconds.
Periods of Authorization and Renewals A marketing authorization in the EU is valid for five years, in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by the EMA for a centrally authorized product, or by the competent authority of the authorizing Member State for a nationally authorized product.
Periods of Authorization and Renewals A marketing authorization in the EU is valid for five years, in principle, and it may be renewed after five years on the basis of a reevaluation of the risk benefit balance by the EMA for a centrally authorized product, or by the competent authority of the authorizing Member State for a nationally authorized product.
Other states or localities may have laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; relate to insurance fraud in the case of claims involving private insurers; and/or require identification or licensing of sales representatives.
Other states or localities may have laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; relate to insurance fraud in the case of claims involving private insurers; and/or require identification or licensing of sales representatives. 19 Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring manufacturers to report information related to payments to physicians and other healthcare providers, marketing expenditures, and drug pricing information.
Pending applications covering VASCEPA/VAZKEPA may, if granted, provide exclusivity for the drug until 2039. Patents and applications described above are either owned by Amarin or exclusively licensed from others. We have pending patent applications worldwide related to potential new uses of icosapent ethyl or other derivatives of EPA and potential new formulations thereof.
Pending applications covering VASCEPA/VAZKEPA may, if granted, provide additional patent exclusivity for the drug until 2039, where filed. Patents and applications described above are either owned by us or exclusively licensed from others. We have pending patent applications worldwide related to potential new uses of icosapent ethyl or other derivatives of EPA and potential new formulations thereof.
If the product has not received a national marketing authorization in any EU Member State at the time of application, it can be approved simultaneously in various Member States through the decentralized procedure. Now that the UK, which comprises Great Britain and Northern Ireland, has left the EU, Great Britain is no longer covered by EU centralized marketing authorizations.
If the product has not received a national marketing authorization in any EU Member State at the time of application, it can be approved simultaneously in various Member States through the decentralized procedure. The UK, which comprises Great Britain and Northern Ireland is not covered by EU centralized marketing authorizations.
State and foreign laws, including for example the California Consumer Privacy Act, or CCPA, and the European Union General Data Protection Regulation, or EU GDPR, and the UK equivalent of the same, or the UK GDPR, also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
State and foreign laws, including for example the California Consumer Privacy Act, or CCPA, and the European Union General Data Protection Regulation, or EU GDPR, and the UK's version of the EU GDPR, or the UK GDPR, also govern the privacy and security of health information in some circumstances, which may differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Overall adverse event rates in REDUCE-IT were similar across treatment groups and VASCEPA was well-tolerated. VASCEPA was associated with an increase (3% vs 2%) in the reported rate of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
Overall adverse event rates in REDUCE-IT were similar across treatment groups and VASCEPA was well-tolerated. VASCEPA was associated with an increase (3% vs 2%) in the reported rate of atrial fibrillation or atrial flutter requiring hospitalization in REDUCE-IT. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
As summarized from the primary results of REDUCE-IT in The New England Journal of Medicine, potential VASCEPA mechanisms of action at work in REDUCE-IT may include TG reduction, anti-thrombotic effects, antiplatelet or anticoagulant effects, membrane-stabilizing effects, effects on stabilization and/or regression of coronary plaque and inflammation reduction, each as supported by earlier stage mechanistic studies. 6 On December 13, 2019, the U.S.
As summarized from the primary results of REDUCE-IT in The New England Journal of Medicine, potential VASCEPA mechanisms of action at work in REDUCE-IT may include TG reduction, anti-thrombotic effects, antiplatelet or anticoagulant effects, membrane-stabilizing effects, effects on stabilization and/or regression of coronary plaque and inflammation reduction, each as supported by earlier stage mechanistic studies.
As part of the Windsor Framework, the MHRA has revised the market access regulations for medicines in the UK. As from January 1, 2025, among others, EU centralized marketing authorizations will no longer be effective in Northern Ireland.
As part of the Windsor Framework, the MHRA has revised the market access regulations for medicines in the UK. Effective January 1, 2025, among others, EU centralized marketing authorizations were no longer effective in Northern Ireland.
However, recent case law has called into question the extent to which government in the U.S., including the U.S. FDA, can, and is willing to seek to, prevent truthful and non-misleading speech related to off-label uses of U.S. FDA-approved products such as VASCEPA.
However, recent case law has called into question the extent to which government in the U.S., including the U.S. FDA, can, and is willing to seek to, prevent truthful and non-misleading speech related to off-label uses of U.S.
Woodward Pharma Services LLC currently sells Lovaza ® , which it acquired from GlaxoSmithKline plc in the third quarter of 2021. Lovaza, a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia was approved by the U.S. FDA in 2004 and has been on the market in the U.S. since 2005.
Vitruvias Therapeutics August 2025 January 2026 – Yes Woodward Pharma Services LLC currently sells Lovaza ® , which it acquired from GlaxoSmithKline plc in the third quarter of 2021. Lovaza, a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia was approved by the U.S. FDA in 2004 and has been on the market in the U.S. since 2005.
If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations.
FDA-approved products such as VASCEPA. 14 If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations.
With respect to Europe, the EU GDPR and UK GDPR (collectively referred to as the GDPR in this Annual Report on Form 10-K), as well as other national data protection legislation in force in relevant EU and European Economic Area, or EEA member states and the UK (including the UK Data Protection Act 2018 in the UK) govern the collection, use, storage, disclosure, transfer, or other processing of personal data that is (i) carried out in the context of the activities of our establishment in any EU and EEA member state or the UK or (ii) collected in the course of offering services to or involving behavior-monitoring of individuals located in the EU/UK.
The EU GDPR and UK GDPR, collectively referred to as the GDPR, as well as other national data protection legislation in force in relevant EU and European Economic Area, or EEA, member states and the UK (including the UK Data Protection Act 2018 in the UK) govern the collection, use, storage, disclosure, transfer, or other processing of personal data that is (i) carried out in the context of the activities of our establishment in any EU and EEA member state or the UK or (ii) collected in the course of offering or targeting services to or involving behavior-monitoring of individuals located in the EU or UK.
As of December 31, 2024, we had inventory of $230.8 million, of which approximately 60% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Competition General The biotechnology and pharmaceutical industries are highly competitive.
As of December 31, 2025, we had inventory of $195.9 million, of which approximately 50% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Competition General The biotechnology and pharmaceutical industries are highly competitive.
This ensures that data flows between the UK and the EEA remain unaffected. The EU GDPR and UK GDPR remain largely aligned. Currently, the most impactful point of divergence between the GDPR and the UK GDPR relates to these transfer mechanisms as explained above. There may be further divergence in the future, including with regard to administrative burdens.
The EU GDPR and UK GDPR remain largely aligned. Currently, the most impactful point of divergence between the EU GDPR and the UK GDPR relates to these transfer mechanisms as explained above. There may be further divergence in the future, including with regard to administrative burdens.
FDA approved a new indication and label expansion for VASCEPA capsules. VASCEPA is the first and only drug approved by the U.S.
On December 13, 2019, the U.S. FDA approved a new indication and label expansion for VASCEPA capsules. VASCEPA is the first and only drug approved by the U.S.
For example, in order to transfer data outside of the EEA or the UK to a non-adequate country, the GDPR requires us to enter into an appropriate transfer mechanism, and may require us to take additional steps to ensure an essentially equivalent level of data protection, including carrying out transfer impact assessments.
In order to transfer personal data outside of the EEA or the UK to a third country not deemed to provide adequate protection to personal data, the GDPR requires us to enter into an appropriate transfer mechanism, and may require us to take additional steps to ensure an essentially equivalent level of data protection, including carrying out transfer impact assessments.
In Canada, VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that 23 could extend into 2039. We are pursuing additional regulatory approvals for VASCEPA in Europe, Asia and the Middle East.
In Canada, VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection that could extend into 2039. We are pursuing additional regulatory approvals and subsequent commercialization for VASCEPA in Europe, Asia and the Middle East with our commercial partners.
As from January 1, 2025, the marketing of medicines in the UK, including Northern Ireland, will be governed either by UK wide applicable marketing authorizations or by separate marketing authorizations applicable only in Great Britain or Northern Ireland, in each case granted by the UK MHRA.
Effective January 1, 2025, the marketing of medicines in the UK, including Northern Ireland, are governed either by UK wide applicable marketing authorizations or by separate marketing authorizations applicable only in Great Britain or Northern Ireland, in each case granted by the UK MHRA.
The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, legal basis for processing personal data which may include obtaining consent of the individuals to whom the personal data relates, providing detailed information to individuals regarding data processing activities, implementing safeguards to protect the security and 19 confidentiality of personal data, providing notification of data breaches, ensuring certain accountability measures are in place and taking certain measures when engaging third-party processors.
The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to: processing health and other sensitive data; legal bases for processing personal data, which may include obtaining consent of the individuals to whom the personal data relates; providing detailed information to individuals regarding data processing activities; implementing appropriate technical and organizational safeguards to protect the security and confidentiality of personal data; providing notification of data breaches to the relevant supervisory authorities and affected individuals; and ensuring certain contractual measures are in place when engaging third-party processors.
Third-party payors are increasingly challenging the prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. In the U.S., the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within the HHS.
Third-party payors decide which drugs they will pay for and establish reimbursement and copayment levels. Third-party payors are increasingly challenging the prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. In the U.S., the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within the HHS.
The federal civil and criminal false claim laws, including the civil monetary penalty laws and the civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making or using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing, or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money or transmit properly to the federal government.
We continue to evaluate what effect, if any, these rules will have on our business. 18 The federal civil and criminal false claim laws, including the civil monetary penalty laws and the civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making or using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing, or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money or transmit properly to the federal government.
An additional seven secondary endpoints were achieved below the key secondary endpoint, in order of sequential statistical testing within the prespecified hierarchy: • Cardiovascular death or nonfatal heart attack: 25% RRR (p • Fatal or nonfatal heart attack: 31% RRR (p • Urgent or emergent revascularization: 35% RRR (p • Cardiovascular death: 20% RRR (p=0.03) • Hospitalization for unstable angina: 32% RRR (p=0.002) • Fatal or nonfatal stroke: 28% RRR (p=0.01) • Total mortality, nonfatal heart attack or nonfatal stroke: 23% RRR (p The next prespecified secondary endpoint in the hierarchy was the only such endpoint that did not achieve statistical significance although it trended positively: • Total mortality, which includes mortality from non-cardiovascular and cardiovascular events: 13% RRR (p=0.09) Positive REDUCE-IT results were consistent across various patient subgroups, including female/male, diabetic/non-diabetic and secondary/primary prevention.
NNT is a statistical concept intended to provide a measurement of the impact of a medicine or therapy by estimating the number of patients that need to be treated in order to have an impact on one person. 5 An additional seven secondary endpoints were achieved below the key secondary endpoint, in order of sequential statistical testing within the prespecified hierarchy: • Cardiovascular death or nonfatal heart attack: 25% RRR (p • Fatal or nonfatal heart attack: 31% RRR (p • Urgent or emergent revascularization: 35% RRR (p • Cardiovascular death: 20% RRR (p=0.03) • Hospitalization for unstable angina: 32% RRR (p=0.002) • Fatal or nonfatal stroke: 28% RRR (p=0.01) • Total mortality, nonfatal heart attack or nonfatal stroke: 23% RRR (p The next prespecified secondary endpoint in the hierarchy was the only such endpoint that did not achieve statistical significance although it trended positively: • Total mortality, which includes mortality from non-cardiovascular and cardiovascular events: 13% RRR (p=0.09) Positive REDUCE-IT results were consistent across various patient subgroups, including female/male, diabetic/non-diabetic and secondary/primary prevention.
Our ability to successfully commercialize our product therefore depends significantly on the availability of adequate financial coverage and reimbursement from third-party payors, including, in the U.S., governmental payors such as Medicare and Medicaid, as well as managed care organizations, private health insurers and other organizations. Third-party payors decide which drugs they will pay for and establish reimbursement and copayment levels.
Our ability to successfully commercialize our product therefore depends significantly on the availability of adequate financial coverage and 21 reimbursement from third-party payors, including, in the U.S., governmental payors such as Medicare and Medicaid, as well as managed care organizations, private health insurers and other organizations.
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.
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.
The CCPA creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.
The CCPA, as amended by the California Privacy Rights Act, or CPRA, establishes individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of such consumers or households.
REDUCE-IT met its primary endpoint demonstrating a 25% RRR, to a high degree of statistical significance (p VASCEPA in the REDUCE-IT study demonstrated a number needed to treat, or NNT, of 21 for the first occurrence of Major Adverse Cardiovascular Event, or MACE, in the five-point primary composite endpoint.
REDUCE-IT met its primary endpoint demonstrating a 25% relative risk reduction, or RRR, to a high degree of statistical significance (p VASCEPA in the REDUCE-IT study demonstrated a number needed to treat, or NNT, of 21 associated with the observed 25% relative risk reduction in the first occurrence of MACE of the five-point MACE primary composite endpoint.
In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing.
In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic.
As of December 31, 2024, we had approximately 275 full-time employees located in 15 countries, of which 25% are located in the U.S. and 75% are located throughout Europe. For the 25% of our total employees located in the U.S., our workforce diversity representation for gender and race is 38% and 32%, respectively.
As of December 31, 2025, we had approximately 80 full-time employees located in six countries, of which 60% are located in the U.S. and 40% are located throughout Europe. For the 60% of our total employees located in the U.S., our workforce diversity representation for gender and race is 38% and 29%, respectively.
Our personnel remained blinded to the efficacy and safety data from the REDUCE-IT study until after the study was completed and the database was locked in 2018. 5 On November 10, 2018, we announced primary results from our REDUCE-IT study as late-breaking clinical results at the 2018 Scientific Sessions of the American Heart Association, or AHA, and the results were concurrently published in The New England Journal of Medicine .
On November 10, 2018, we announced primary results from our REDUCE-IT study as late-breaking clinical results at the 2018 Scientific Sessions of the American Heart Association, or AHA, and the results were concurrently published in The New England Journal of Medicine .
While originally under the Northern Ireland Protocol, EU centralized marketing authorizations continued to be recognized in Northern Ireland, the UK has revised its system for marketing authorizations applicable as from January 1, 2025. Among others, EU centralized marketing authorizations will no longer be effective in Northern Ireland.
The UK has revised its system for marketing authorizations as of January 1, 2025. Among others, EU centralized marketing authorizations will no longer be effective in Northern Ireland.
The Company will be responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the U.S. and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.
(4) - VASCEPA is under registration in additional countries in the ASEAN region with Lotus. The Company will be 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.
There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our products profitably. We anticipate that the U.S. Congress, state legislatures and the private sector will continue to consider and may adopt healthcare policies intended to curb rising healthcare costs.
There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our products profitably. We anticipate that the U.S.
CMS surveys and publishes retail community pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost files to provide state Medicaid agencies with a basis of comparison for their own 21 reimbursement and pricing methodologies and rates.
CMS surveys and publishes retail community pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost files to provide state Medicaid agencies with a basis of comparison for their own reimbursement and pricing methodologies and rates. It is difficult to project the impact of these evolving reimbursement mechanics on the willingness of payors to cover our products.
Currently-granted European patents directed to the same subject matter as above will expire between 2027 and 2039, and may be subject to a potential further extension of a patent right. Granted patents in other foreign jurisdictions will expire between 2030 and 2039 and may be subject to a potential further patent term extension, depending on the country.
European patents directed to the same subject matter as above will expire between 2027 and 2039 subject potentially to supplementary protection certificates permissible under European and member state regulations for medical products. Granted patents in other foreign jurisdictions will expire between 2030 and 2039 and may be subject to a potential further patent term extension, depending on the country.
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.
The time required to secure reimbursement varies from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe.
The CCPA will require covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information.
For instance, the CCPA requires covered businesses to provide certain disclosures to consumers about their data collection, use and sharing practices, and to provide California consumers with ways to opt-out of certain sales or transfers of personal information, and to limit the processing of certain personal information.
FDA approval with labeling consistent with the MARINE indication of VASCEPA, have entered the U.S. market and represent our main competitors: Company FDA MARINE Indication Approval 1-gram Launch Date 0.5-gram Launch Date Hikma Pharmaceuticals USA Inc. May 2020 November 2020 March 2023 Dr. Reddy’s Laboratories, Inc. August 2020 June 2021 June 2023 Teva Pharmaceuticals USA, Inc.
FDA approval with labeling consistent with the MARINE indication of VASCEPA, have entered the U.S. market and represent our main competitors: 11 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.
REDUCE-IT was a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of VASCEPA, as an add-on to statin therapy, in reducing first major cardiovascular events in an at-risk patient population compared to statin therapy alone. The control arm of the study was comprised of patients on optimized statin therapy plus placebo.
FDA approved indication and label expansion in December 2019; basis for EU EC approved indication and label in March 2021) The REDUCE-IT study was a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of VASCEPA, as an add-on to statin therapy, in reducing first major cardiovascular events in an at-risk patient population compared to statin therapy alone.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. VASCEPA was associated with an increase (12% vs 10%) in the reported rate of bleeding in a double-blind, placebo-controlled trial.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. VASCEPA was associated with an increase (12% vs 10%) in the reported rate of bleeding in REDUCE-IT. The reported incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
The reported incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo) were musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo) were musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Europe In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland. Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 19 dossiers to gain market access in European countries, including in all of the largest countries in Europe.
Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 20 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching.
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 are often making purchasing decisions for supply more than a year in advance of anticipated product sales. 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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non-prescription competition and consumer substitution; • our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs; • our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments; • we have limited experience commercializing VASCEPA outside the U.S., and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the U.S..
Biggest changeAny changes in reimbursement procedures by governments and other third-party payors may limit our and our partners’ ability to market and sell our products; • we are required to comply with a multitude of regulatory frameworks in the development, manufacture, distribution and marketing of our products, any changes to the relevant regulations, changes in healthcare laws, or operation of the relevant government agencies or departments may adversely impact our business; • our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs; • our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments; • we are currently, and may continue to be, substantially dependent on third parties for our international efforts, and we may not be successful in negotiating or establishing relationships with business partners to support and maintain control over our international activities; • we are dependent on patents, proprietary rights and confidentiality obligations of our employees, agents, business partners and third parties to protect the commercial value and potential of VASCEPA.
We are subject to potential product liability. We are subject to the potential risk of product liability claims relating to the manufacturing and marketing of VASCEPA. Any person who is injured as a result of using VASCEPA may have a product liability claim against us without having to prove that we were at fault.
We are subject to the potential risk of product liability claims relating to the manufacturing and marketing of VASCEPA. Any person who is injured as a result of using VASCEPA may have a product liability claim against us without having to prove that we were at fault.
The degree of market acceptance of VASCEPA will depend on a number of factors, including: • the impact of and outcome of adjudicated, settled and pending patent litigation; • the commercialization and pricing of any current or potential generic versions of icosapent ethyl; • the perceived efficacy and safety of VASCEPA by prescribing healthcare professionals and patients, as compared to no treatment and as compared to alternative treatments in various at-risk patient populations; • the prevalence and severity of any side effects and warnings in VASCEPA's approved labeling internationally; • peer review of different elements of data supporting our REDUCE-IT indication over time; • continued review and analysis of the results of our clinical data supporting our REDUCE-IT indication by regulatory authorities internationally; • our ability to offer VASCEPA for sale at competitive prices; • convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try our therapies and of physicians to prescribe these therapies; • the scope, effectiveness and strength of product education, marketing and distribution support, including our sales and marketing teams; • publicity concerning VASCEPA or competing products; 30 • our ability to continually promote VASCEPA in the U.S. consistent with U.S.
The degree of market acceptance of VASCEPA will depend on a number of factors, including: • the impact of and outcome of adjudicated, settled and pending patent litigation; • the commercialization and pricing of any current or potential generic versions of icosapent ethyl; • the perceived efficacy and safety of VASCEPA by prescribing healthcare professionals and patients, as compared to no treatment and as compared to alternative treatments in various at-risk patient populations; • the prevalence and severity of any side effects and warnings in VASCEPA's approved labeling internationally; • peer review of different elements of data supporting our REDUCE-IT indication over time; • continued review and analysis of the results of our clinical data supporting our REDUCE-IT indication by regulatory authorities internationally; • our ability to offer VASCEPA for sale at competitive prices; • convenience and ease of administration compared to alternative treatments; • the willingness of the target patient population to try our therapies and of physicians to prescribe these therapies; • the scope, effectiveness and strength of product education, marketing and distribution support, including our sales and marketing teams; • publicity concerning VASCEPA or competing products; • our ability to continually promote VASCEPA in the U.S. consistent with U.S.
The commencement and rate of completion of clinical trials and the timing of obtaining marketing approval from regulatory authorities may be delayed by many factors, including, among others: • the lack of efficacy during clinical trials; • the inability to manufacture sufficient quantities of qualified materials under cGMPs for use in clinical trials; • slower than expected rates of patient recruitment; • the inability to observe patients adequately after treatment; • changes in regulatory requirements for clinical trials or preclinical studies; • the emergence of unforeseen safety issues in clinical trials or preclinical studies; • delay, suspension, or termination of a trial by the institutional review board responsible for overseeing the study at a particular study site; • unanticipated changes to the requirements imposed by regulatory authorities on the extent, nature or timing of studies to be conducted on quality, safety and efficacy; • compliance with laws and regulations related to patient data privacy; • government or regulatory delays or “clinical holds” requiring suspension or termination of a trial; and • political instability or other social or government protocols affecting our clinical trial sites.
The commencement and 42 rate of completion of clinical trials and the timing of obtaining marketing approval from regulatory authorities may be delayed by many factors, including, among others: • the lack of efficacy during clinical trials; • the inability to manufacture sufficient quantities of qualified materials under cGMPs for use in clinical trials; • slower than expected rates of patient recruitment; • the inability to observe patients adequately after treatment; • changes in regulatory requirements for clinical trials or preclinical studies; • the emergence of unforeseen safety issues in clinical trials or preclinical studies; • delay, suspension, or termination of a trial by the institutional review board responsible for overseeing the study at a particular study site; • unanticipated changes to the requirements imposed by regulatory authorities on the extent, nature or timing of studies to be conducted on quality, safety and efficacy; • compliance with laws and regulations related to patient data privacy; • government or regulatory delays or “clinical holds” requiring suspension or termination of a trial; and • political instability or other social or government protocols affecting our clinical trial sites.
FDA-approved labeling and the related perception thereof; • sufficient third-party coverage or reimbursement for VASCEPA and its prescribed uses, on-label and off-label; • natural disasters, pandemics, international conflicts and political unrest, all of which could negatively impact our supply chain or inhibit our ability to promote VASCEPA regionally and which could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions; • new policies or laws affecting VASCEPA sales, such as state and federal efforts to affect drug pricing and provide or remove healthcare coverage that includes reimbursement for prescription drugs; and • the actual and perceived efficacy of the product and the prevalence and severity of any side effects and warnings in VASCEPA’s approved labeling internationally.
FDA-approved labeling and the related perception thereof; • sufficient third-party coverage or reimbursement for VASCEPA and its prescribed uses, on-label and off-label; • natural disasters, pandemics, international conflicts and political unrest, all of which could negatively impact our supply chain or inhibit our ability to promote VASCEPA regionally and which could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions; 32 • new policies or laws affecting VASCEPA sales, such as state and federal efforts to affect drug pricing and provide or remove healthcare coverage that includes reimbursement for prescription drugs; and • the actual and perceived efficacy of the product and the prevalence and severity of any side effects and warnings in VASCEPA’s approved labeling internationally.
The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect: • the demand for any of our product candidates, if approved; • the ability to set a price that we believe is fair for any of our product candidates, if approved; • our ability to generate revenues and achieve or maintain profitability; 38 • the level of taxes that we are required to pay; and • the availability of capital.
The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect: • the demand for any of our product candidates, if approved; • the ability to set a price that we believe is fair for any of our product candidates, if approved; • our ability to generate revenues and achieve or maintain profitability; • the level of taxes that we are required to pay; and • the availability of capital.
FDA were to change this position, it could potentially have a negative impact on us by making it easier for other products to achieve a CV risk reduction indication without the need in advance to conduct a long and expensive CV outcomes study. VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements.
FDA were to change this position, it could potentially 35 have a negative impact on us by making it easier for other products to achieve a CV risk reduction indication without the need in advance to conduct a long and expensive CV outcomes study. VASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements.
Although we are cooperating with the government and completed document production in mid-2023, we cannot predict when these Investigations will be resolved, the outcome of the Investigations or their potential impact on our business. In addition, we may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement.
Although we are cooperating with the government and completed document production in mid-2023, we cannot predict when these Investigations will be resolved, the outcome of the Investigations or their potential impact on our business. 34 In addition, we may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement.
If any such changes were to be imposed, they could adversely affect the operation of our business. Refer to Item 1. Business - Current and Future Legislation and Item 1. Business - United States Healthcare Reform and Legislation. There has been increasing legislative and enforcement interest in the U.S. with respect to drug pricing practices.
If any such changes were to be imposed, they could adversely affect the 40 operation of our business. Refer to Item 1. Business - Current and Future Legislation and Item 1. Business - United States Healthcare Reform and Legislation. There has been increasing legislative and enforcement interest in the U.S. with respect to drug pricing practices.
Given our inexperience with marketing and commercializing products outside the U.S., in certain territories we may need to rely on third parties, such as our partners in Canada, China and the Middle East, to assist us in dealing with any such issues and we will have limited or no control over such partners.
Given our inexperience with marketing and commercializing products outside the U.S., in certain territories we may need to rely on third parties, such as our partners in Canada, China, Europe and the Middle East, to assist us in dealing with any such issues and we will have limited or no control over such partners.
If Edding, Biologix, HLS, CSL, Lotus, Neopharm or Vianex, or other third parties who we rely on for development and commercialization of VASCEPA, do not successfully carry out their contractual obligations or meet expected deadlines, our recourse and remedies against these parties is limited.
If Recordati, Edding, Biologix, HLS, CSL, Lotus, Neopharm or Vianex, or other third parties who we rely on for development and commercialization of VASCEPA, do not successfully carry out their contractual obligations or meet expected deadlines, our recourse and remedies against these parties is limited.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business, including the Investigations referenced above. Such investigations can be lengthy, costly and could materially affect and disrupt our business.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and 47 resource-consuming and can divert a company’s attention from the business, including the Investigations referenced above. Such investigations can be lengthy, costly and could materially affect and disrupt our business.
In addition, all of the above factors may also apply to any regulatory approval for VASCEPA obtained in territories outside the U.S.. In Europe, for example, restrictions regarding off-label promotion are in some ways more stringent than in the U.S., including restrictions covering certain communications with shareholders.
In addition, all of the above factors may also apply to any regulatory approval for VASCEPA obtained in territories outside the U.S. In Europe, restrictions regarding off-label promotion are in some ways more stringent than in the U.S., including restrictions covering certain communications with shareholders.
Our ability to commercialize VASCEPA or any future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payors.
Our ability to successfully commercialize VASCEPA, or any future products, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for any such products will be available from government and health administration authorities, private health insurers and other third-party payors.
There are a limited number of manufacturers that operate under these cGMPs as well as the International 43 Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, regulations and guidelines, that are both capable of manufacturing VASCEPA and willing to do so.
There are a limited number of manufacturers that operate under these cGMPs as well as the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, regulations and guidelines, that are both capable of manufacturing VASCEPA and willing to do so.
We are required to list our covered products on a Tricare Agreement in order for these products to be eligible for DOD formulary inclusion. If we overcharge the government in connection with our FSS contract or 37 Tricare Agreement, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government.
We are required to list our covered products on a Tricare Agreement in order for these products to be eligible for DOD formulary inclusion. If we overcharge the government in connection with our FSS contract or Tricare Agreement, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government.
Our success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how, and to operate without infringing the proprietary rights of others. Refer to “ Item 1. Business - Patents, Proprietary Technology, Trade Secrets for further details.
Our success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how, and to operate without infringing the proprietary rights of others. Refer to Item 1. Business - Patents, Proprietary Technology, Trade Secrets for further details.
FDA did not change based on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the 33 REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of VASCEPA are unique to VASCEPA and extend beyond triglyceride reduction. If the U.S.
FDA did not change based on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of VASCEPA are unique to VASCEPA and extend beyond triglyceride reduction. If the U.S.
As we continue to scale our infrastructure for commercializing VASCEPA based on market dynamics for VASCEPA in the United States and commercial initiatives and plans for VAZKEPA in Europe and other parts of the world, we may encounter difficulties in managing the size and adaptability of our operations successfully.
As we continue to scale our infrastructure for commercializing VASCEPA based on market dynamics for VASCEPA in the United States and commercial initiatives and plans for VAZKEPA in other parts of the world, we may encounter difficulties in managing the size and adaptability of our operations successfully.
We will be operating with streamlined teams in Europe and elsewhere outside the U.S.; however, we will anticipate the need to expand internally and expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties as we progress in Europe and elsewhere outside the U.S..
We will be operating with streamlined teams in Europe and elsewhere outside the U.S.; however, we will anticipate the need to expand internally and expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties as our partners progress in Europe and elsewhere outside the U.S.
Our aggregate capacity to produce API is dependent upon the continued qualification of our API suppliers and, depending on the ability of existing suppliers to meet our supply demands, the ability to qualify any new suppliers. If no additional API supplier is approved by the U.S.
Our aggregate capacity to produce API is dependent upon the continued qualification of our API suppliers and, depending on the ability of existing suppliers to meet our supply demands, the ability to qualify any new suppliers. If no 44 additional API supplier is approved by the U.S.
Further, with regard to any indications for which we may gain approval in territories outside the U.S., the number of actual patients with the condition included in such approved indication may be smaller than we anticipate.
Further, with regard to any indications for which VASCEPA may gain approval in territories outside the U.S., the number of actual patients with the condition included in such approved indication may be smaller than we anticipate.
The success of our research and development efforts is dependent in part upon our ability, and the ability of our partners or potential partners, to meet regulatory requirements in the jurisdictions where we or our partners or potential partners ultimately intend 40 to sell such products once approved.
The success of our research and development efforts is dependent in part upon our ability, and the ability of our partners or potential partners, to meet regulatory requirements in the jurisdictions where we or our partners or potential partners ultimately intend to sell such products once approved.
Results from this study were presented during the 2022 American Heart Association Scientific Sessions in November 2022 and published online in the journal Circulation in June 2024 and were consistent with the evidence from the REDUCE-IT study.
Results from this study were presented during the 2022 American 33 Heart Association Scientific Sessions in November 2022 and published online in the journal Circulation in June 2024 and were consistent with the evidence from the REDUCE-IT study.
We, or our partners, may choose to not proceed with marketing VASCEPA in a market, even after obtaining all necessary regulatory approval, due to negative commercial dynamics.
We, or our partners, may choose to not proceed with marketing VASCEPA in a particular market, even after obtaining all necessary regulatory approval, due to negative commercial dynamics.
Although we have withdrawn from the Medicaid Drug Rebate program and the 340B drug pricing program effective October 1, 2024, during the year ended December 31, 2024, we participated in such programs.
Although we have withdrawn from the Medicaid Drug Rebate program and the 340B drug pricing program effective October 1, 2024, during the year ended December 31, 2024, we previously participated in such programs.
While an authorized generic could be profitable, the market opportunity for growth from an authorized generic is likely less than from promotion of a branded drug, and as such we have not launched an authorized generic version of icosapent ethyl to date, but may elect to do so in the future. 34 The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture.
While an authorized generic could be profitable, the market opportunity for growth from an authorized generic is likely less than from promotion of a branded drug, and as such we have not launched an authorized generic version of icosapent ethyl to date, but may elect to do so in the future. 36 The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture.
If reimbursement of VASCEPA is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to successfully commercialize VASCEPA outside of the U.S. may be harmed, which could have a material and negative impact on our overall business.
If reimbursement of VASCEPA is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our and our partners’ ability to successfully commercialize VASCEPA outside of the U.S. may be harmed, which could have a material and negative impact on our overall business and prospects.
We cannot be certain what commercial value any granted patent in our patent estate will provide to us. 47 Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets.
We cannot be certain what commercial value any granted patent in our patent estate will provide to us. 49 Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets.
Application holders must also submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials. 35 With respect to sales and marketing activities, advertising and promotional materials must comply with U.S. FDA rules in addition to other applicable federal and local laws in the U.S. and in other countries.
Application holders must also submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials. 37 With respect to sales and marketing activities, advertising and promotional materials must comply with U.S. FDA rules in addition to other applicable federal and local laws in the U.S. and in other countries.
We are also committed to providing supply to our commercial partners and distributors in Australia and New Zealand, Canada, China, the Middle East and North Africa, South Korea, Southeast Asia, Greece and Israel, and we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries.
We are also committed to providing supply to our commercial partners and distributors in Australia and New Zealand, Canada, China, Europe, the Middle East and North Africa, South Korea, Southeast Asia and Israel, and we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries.
Enforcing our patent rights is challenging 26 and costly and, even if we are able to successfully enforce our patent rights, our issued patents may not prevent competitors from competing with VASCEPA; • we have pending patent applications relating to VASCEPA and its use.
Enforcing our patent rights is challenging and costly and, even if we are able to successfully enforce our patent rights, our issued patents may not prevent competitors from competing with VASCEPA; 27 • we have pending patent applications relating to VASCEPA and its use.
In addition, generic market entry, whether limited to its approved indication or not, can create market disruption which leads to an overall slowing of market growth regardless of whether the net price of the generic entry is higher or lower than the net price of the branded drug.
In addition, generic market entry, whether limited to its approved indication or not, can create market disruption that leads to an overall slowing of market growth regardless of whether the net price of the generic entry is higher or lower than the net price of the branded drug.
Any proceeding in which we are or may become involved could result in substantial costs, penalties and files as well as a diversion of management's attention and resources, which could harm our business. Please refer to
Any proceeding in which we are or may become involved could result in substantial costs, penalties and fines as well as a diversion of management's attention and resources, which could harm our business. Please refer to
Our and our partners use of smart products, Internet of Things and artificial intelligence subjects us to increased cyber and technology risks. The secure operation of these information technology systems and networks is critical to our business operations and strategy.
Our and our partners' use of smart products, Internet of Things and artificial intelligence subjects us to increased cyber and technology risks. The secure operation of these information technology systems and networks is critical to our business operations and strategy.
Government and commercial payor actions outside of the United States have affected and will continue to affect access to and sales of our products. Outside of the U.S., we expect countries will continue to take actions to reduce their drug expenditures.
Government and commercial payor actions outside of the U.S. have affected and will continue to affect access to and sales of our products. Outside of the U.S., we expect countries will continue to take actions to reduce their drug expenditures.
Risks Related to the Commercialization and Development of VASCEPA We are substantially dependent upon VASCEPA (icosapent ethyl), its commercialization in the United States and its development, launch and commercialization in Europe and other major markets. We currently derive substantially all of our revenue from sales of VASCEPA. We may be substantially dependent on sales of VASCEPA for many years.
Risks Related to the Commercialization and Development of VASCEPA We are substantially dependent upon VASCEPA (icosapent ethyl), its commercialization in the United States and its development and commercialization in Europe and other major markets. We currently derive the majority of our revenue from sales of VASCEPA. We may be substantially dependent on sales of VASCEPA for many years.
The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. As generic competitors seek to compete with VASCEPA in the United States and elsewhere, we could face additional challenges to our patents and additional patent litigation. We could face patent litigation related to the patents filed related to the REDUCE-IT study.
The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit. As generic competitors seek to compete with VASCEPA in the U.S. and elsewhere, we could face additional challenges to our patents and additional patent litigation. We could face patent litigation related to the patents filed related to the REDUCE-IT study.
We may incur significant costs or divert significant internal resources as a result of any regulatory actions or private litigation. Any of the foregoing consequences may adversely affect our business and financial condition.
We may incur significant costs or be required to divert significant internal resources as a result of any regulatory actions or private litigation. Any of the foregoing consequences may adversely affect our business and financial condition.
Litigation, investigations or threats thereof, regardless of merit or outcome, are costly and can require significant time and resources from our management and employees; • historically, we have incurred operating losses and we may not be able to generate significant revenue to achieve steady profitability.
Litigation, investigations or threats thereof, regardless of merit or outcome, are costly and can require significant time and resources from our management and employees; • we are subject to potential product liability; • historically, we have incurred operating losses and we may not be able to generate significant revenue to achieve steady profitability.
FDA or similar foreign regulatory bodies. We have limited experience commercializing VASCEPA outside the United States, and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the United States.
FDA or similar foreign regulatory bodies. We have limited experience commercializing VASCEPA outside the U.S., and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the U.S.
Because of the inherent nature of estimates, including during the uncertainty of our European launch and the impact from U.S. generic competition, we have suspended providing net revenue guidance, as there could be significant differences between our estimates and the actual amount of product demand.
Because of the inherent nature of estimates, including the impact from U.S. generic competition, we have suspended providing net revenue guidance, as there could be significant differences between our estimates and the actual amount of product demand.
As a result of our ORP, we 41 do not have a sales team to promote VASCEPA to physicians and other healthcare professionals in the U.S., and will rely on only our managed care and trade organization to support sales of VASCEPA in the U.S..
We do not have a sales team to promote VASCEPA to physicians and other healthcare professionals in the U.S., and will rely on only our managed care and trade organization to support sales of VASCEPA in the U.S.
We are seeking relevant pricing approvals in various countries; however, we may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we may not be successful in commercializing VAZKEPA in major markets outside the United States.
We are seeking relevant pricing approvals in various countries through our partners; however, these efforts may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we and our partners may not be successful in commercializing VAZKEPA in major markets outside the United States.
These risks include, but are not limited to, the following: • we are substantially dependent upon VASCEPA® (icosapent ethyl), its commercialization in the U.S. and its development, launch and commercialization in Europe and other major markets; • in the U.S., we compete with and may face increasing competition from generic drug companies and our revenues and results could continue to be materially and adversely affected; • we are seeking relevant pricing approvals in various countries; however, we may not be successful in obtaining such approvals in a timely manner, or at all and, even if successfully obtained, we may not be successful in commercializing VAZKEPA in major markets outside the U.S.; • the commercial value of VASCEPA outside the U.S. may be smaller than we anticipate, particularly if we are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.
These risks include, but are not limited to, the following: • we are substantially dependent upon VASCEPA® (icosapent ethyl), its commercialization in the U.S. and its development and commercialization in Europe and other major markets; • in the U.S., we compete with and may face increasing competition from generic drug companies, non-prescription competition omega-3 fatty acids and consumer substitution, and our revenues and results of operations could continue to be materially and adversely affected; • we are seeking relevant pricing approvals in various countries through our partners; however, these efforts may not be successful in obtaining such approvals in a timely manner, or at all and, even if successfully obtained, we and our partners may not be successful in commercializing VAZKEPA in major markets outside the U.S.; • the commercial value of VASCEPA outside the U.S. may be smaller than we anticipate, particularly if we or our partners are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.
Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.
Compliance with data protection laws and regulations in the U.S. and other jurisdictions in which we collect data could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.
Factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success.
Factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve sustained commercial success in the U.S. and major markets outside of the U.S.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or products candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and our research and development program could be delayed.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications or third party data or applications on which we rely, relating to our technology or products candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and our research and development program could be delayed.
In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices.
In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation related to our data collection and use practices or alleged violations of data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices.
Following the ANDA litigation rulings against the Company, generic versions of icosapent ethyl began launching in the U.S. in November 2020, and several generic versions are currently available, including for both the 0.5-gram and 1-gram capsules, and we expect that VASCEPA could face more competition from generic companies in the U.S.
Following the ANDA litigation rulings against the Company, several generic versions of icosapent ethyl have been available in the U.S. since November 2020, including for both the 0.5-gram and 1-gram capsules, and we expect that VASCEPA could face more competition from generic companies in the U.S.
These dynamics can restrict our ability to respond rapidly to adverse business conditions for VASCEPA. If development of, or demand for, VASCEPA does not meet expectations, we may not have the ability to effectively shift our resources to the development of alternative products, or do so in a timely manner, without suffering material adverse effects on our business.
If development of, or demand for, VASCEPA does not meet expectations, we may not have the ability to effectively shift our resources to the development of alternative products, or do so in a timely manner, without suffering material adverse effects on our business.
For example, the Inflation Reduction Act, or IRA, enacted in the U.S. in an effort to manage certain drug prices, includes provisions such as a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, the imposition of new manufacturer financial liability on most drugs in Medicare Part D, permitting the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, requiring companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay until January 1, 2032 the implementation of the HHS rebate rule that would have limited the fees that Pharmacy Benefit Managers, or PBMs, can charge.
The Inflation Reduction Act, or IRA, enacted in the U.S. in an effort to manage certain drug prices, includes provisions such as a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, the imposition of new manufacturer financial liability on most drugs in Medicare Part D, permitting the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, requiring companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay until January 1, 2032 the implementation of the U.S.
If we fail to realize or if we change or update any element of our publicly disclosed financial guidance as we have done in the past or other expectations about our business and initiative change, our stock price could decline in value.
If we fail to realize or if we change or update any element of our publicly disclosed financial guidance as we have done in the past or other expectations about our business and initiative change, our stock price could decline in value. The loss of key personnel could have an adverse effect on our business.
As part of the settlement, given, as expressed in the court’s opinion, that the dynamic nature of science and medicine is that knowledge is ever-advancing and that a statement that is fair and balanced one day may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired, we agreed that we bear the responsibility to ensure that our communications regarding off-label use of VASCEPA remain truthful and non-misleading, consistent with the federal court ruling. 32 While we believe we are now permitted under applicable law to more broadly promote VASCEPA, the U.S.
As part of the settlement, given, as expressed in the court’s opinion, that the dynamic nature of science and medicine is that knowledge is ever-advancing and that a statement that is fair and balanced one day may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired, we agreed that we bear the responsibility to ensure that our communications regarding off-label use of VASCEPA remain truthful and non-misleading, consistent with the federal court ruling.
We have expanded our VASCEPA commercialization activities outside of the U.S. through several contractual arrangements in territories including Australia and New Zealand, Canada, China, the Middle East and North Africa, South Korea, Southeast Asia, Greece and Israel.
We have expanded our VASCEPA commercialization activities outside of the U.S. through several contractual arrangements in territories including Australia and New Zealand, Canada, China, Europe, the Middle East and North Africa, South Korea, Southeast Asia and Israel. We continue to assess other opportunities to develop VASCEPA commercialization outside of the U.S. through similar arrangements.
If this occurs our revenue and business could suffer and our stock price could significantly decline. Our ORP and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S. business and establishing a more significant international footprint.
If this occurs our revenue and business could suffer and our stock price could significantly decline. Our reduction in force related to our Recordati Licensing Agreement with Recordati, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our business and establishing a more significant international footprint.
Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the U.S., including issues expressed between the countries regarding trade practices, tariffs and honoring intellectual property rights.
In June 2024, Edding received approval for the REDUCE-IT indication in Mainland China. Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the U.S., including issues expressed between the countries regarding trade practices, tariffs and honoring intellectual property rights.
We have limited prior experience as a company operating a commercial-stage pharmaceutical business in Europe. Given the amount of time and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted.
Given the amount of time and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted.
If a material breach of our information technology systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.
The number and complexity of these threats continue to increase over time. If a material breach of our information technology systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.
The commercial value of VASCEPA outside the United States may be smaller than we anticipate, particularly if we are unable to secure favorable product pricing and reimbursement levels, which vary from country to country. If we are unable to realize product reimbursement rates at reasonable price levels, or at all, patient access to VASCEPA may be limited.
The commercial value of VASCEPA outside the United States may be smaller than we anticipate, particularly if we or our partners are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.
In these instances our revenue and business could suffer and our stock price could significantly decline. 31 Any new clinical data or analysis of existing data from clinical trials involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could adversely impact public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA.
Any new clinical data or analysis of existing data from clinical trials involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could adversely impact public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA.
In addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non-prescription competition and consumer substitution. The biotechnology and pharmaceutical industries are highly competitive.
We may not be able to compete effectively against our competitors’ pharmaceutical products, including generic products. In addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non-prescription competition and consumer substitution. The biotechnology and pharmaceutical industries are highly competitive.
Other drug companies may challenge the validity, enforceability, or both of our patents and seek to design its products around our issued patent claims and gain marketing approval for generic versions of icosapent ethyl or branded competitive products based on new clinical studies.
Even if we are successful in enforcing this patent, the process could take years to reach conclusion. Other drug companies may challenge the validity, enforceability, or both of our patents and seek to design its products around our issued patent claims and gain marketing approval for generic versions of icosapent ethyl or branded competitive products based on new clinical studies.
Factors that could inhibit our efforts to successfully commercialize VASCEPA include: • the impact of the expiration of regulatory exclusivities and entry into the market of additional generic versions of icosapent ethyl; • our inability to attract and retain adequate numbers of effective sales and marketing personnel and senior management, particularly in light of our recent reductions in force, including our ORP, and turnover on the management team; • our inability to adequately train our sales and marketing personnel and our inability to adequately monitor compliance with applicable regulatory and other legal requirements; • the inability to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA; • overestimating the addressable market for VASCEPA; • regulators may impose restrictions on VASCEPA’s conditions for use, distribution or marketing, and may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials, which may be costly or result in label or other use restrictions; • complexities and challenges in connection with pricing and reimbursement, including our ability to secure adequate reimbursement coverage, which in Europe is almost exclusively covered through public national funding, and not individual private insurance companies; • the lack of complementary products to be offered may put us at a competitive disadvantage relative to companies with more extensive product lines; • an inability by us or our partners to obtain regulatory and marketing approval or establish marketing channels in foreign jurisdictions; and • unforeseen costs and expenses associated with operating a new independent sales and marketing organization outside of the U.S..
Factors that could inhibit our efforts to successfully commercialize VASCEPA include: • the impact of the expiration of regulatory exclusivities and entry into the market of additional generic versions of icosapent ethyl; • our, or our partners', inability to attract and retain adequate numbers of effective sales and marketing personnel and senior management, particularly in light of our recent reductions in force, including our Global Restructuring Plan, and turnover on the management team; • our, or our partners', inability to adequately train our sales and marketing personnel and our inability to adequately monitor compliance with applicable regulatory and other legal requirements; • the inability to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA; • overestimating the addressable market for VASCEPA; • regulators may impose restrictions on VASCEPA’s conditions for use, distribution or marketing, and may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials, which may be costly or result in label or other use restrictions; • complexities and challenges in connection with pricing and reimbursement, including our and our partner's ability to secure adequate reimbursement coverage; • the lack of complementary products to be offered may put us at a competitive disadvantage relative to companies with more extensive product lines; and • an inability by us or our partners to obtain regulatory and marketing approval or establish marketing channels in foreign jurisdictions. 31 If we experience one or more of the setbacks described above, we may not be able to pursue international regulatory and commercial efforts in a cost effective manner, or at all, which could cause our stock price to decline.
Likewise, if additional data or analyses released from time to time do not meet expectations, the perception of REDUCE-IT results and the perceived and actual value of VASCEPA may suffer.
Likewise, if additional data or analyses released from time to time do not meet expectations, the perception of REDUCE-IT results and the perceived and actual value of VASCEPA may suffer. In these instances, our revenue and business could suffer and our stock price could significantly decline.
We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks and to repair reputational costs.
We could be required to expend significant amounts of money and other resources to repair or replace information 50 systems or networks and to repair our reputation in the market.
Third-party payors decide which products and services they will cover and the conditions for such coverage. For example, a large national PBM notified the Company that, effective July 1, 2024, the PBM would no longer cover VASCEPA as the exclusive icosapent ethyl product for its commercial national formularies and would be transitioning VASCEPA to not covered status.
Third-party payors decide which products and services they will cover and the conditions for such coverage. For example, from July 1, 2024 through June 30, 2025, a large national PBM did not cover VASCEPA as the exclusive icosapent ethyl product for its commercial national formularies and transitioned VASCEPA to not covered status.
On June 25, 2024, the Federal Circuit issued a decision reversing the district court's ruling, finding that our allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents. Hikma filed a petition for rehearing en banc on August 22, 2024. which was denied on October 17, 2024.
On June 25, 2024, the Federal Circuit issued a decision reversing the district court's ruling, finding that our allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents.
If we are unable to realize product reimbursement rates at reasonable price levels, or at all, patient access to VASCEPA may be limited and our revenues and results could be adversely affected; • factors outside of our control make it more difficult for VASCEPA to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success; • our Organizational Restructuring Program, or ORP, effected in July 2023, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S. business and establishing a more significant international footprint; • the manufacture, supply and commercialization, including promotional activities, of VASCEPA and VAZKEPA are subject to regulatory oversight and scrutiny in each of the markets in which we are active; • we are required to comply with a multitude of regulatory frameworks in the development, manufacture, distribution and marketing of our products, any changes to the relevant regulations, changes in healthcare laws, or operation of the relevant government agencies or departments may adversely impact our business; • we may not be able to compete effectively against our competitors’ pharmaceutical products, including generic products.
If we or our partners are unable to realize product reimbursement rates at reasonable price levels, or at all, patient access to VASCEPA may be limited and our revenues and results could be adversely affected; • factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve sustained commercial success in the U.S. and major markets outside of the U.S.; • our Global Restructuring Plan effected in June 2025, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S. business and establishing a more significant international footprint; • the manufacture, supply and commercialization, including promotional activities, pricing controls and reimbursement limitations, of VASCEPA and VAZKEPA are subject to regulatory oversight and scrutiny in each of the markets in which we are active.
In this regard, many countries have health technology assessment organizations that use formal economic metrics such as cost effectiveness to determine prices, coverage and reimbursement of new therapies; and these organizations are expanding in established and emerging markets.
In this regard, many countries have health technology assessment organizations that use formal economic metrics such as cost effectiveness to determine prices, coverage and reimbursement of new therapies; and these organizations are expanding in established and emerging markets. Many countries also limit coverage to populations narrower than the regulatory agency approved product label or impose volume caps to limit utilization.
Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S.
Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in recent administrative policy efforts, such as Trump RX and MFN pricing, several U.S.
We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and other elements necessary for the sale of VASCEPA.
We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and other elements necessary for the sale of VASCEPA. We continue to take steps to negotiate our contract supply agreements to align supply arrangements with current and future global market demand.
Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs.
The failure to recruit key scientific, technical and management personnel would be detrimental to our ability to implement our business plan. Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs.
In addition, manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying U.S.
In addition, manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying U.S. FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the U.S.
We may not be able to obtain financing or additional resources on favorable terms, or at all; • our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, may not be implemented in a timely manner or at all, or may not have the expected results; and • if we are unable to meet the listing requirements of the NASDAQ Stock Market, or NASDAQ, our stock may be delisted.
We may not be able to obtain financing or additional resources on favorable terms, or at all; • our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, may not be implemented in a timely manner or at all, or may not have the expected results; • changes in tax laws could have a material adverse effect on our business, financial condition and results of operations.
For example, we were recently the subject of two civil investigative demands, or CIDs, from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General, or the Investigations.
Promotional activities in the biotechnology and pharmaceutical industries generally are subject to considerable regulatory scrutiny. We were recently the subject of two civil investigative demands, or CIDs, from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General, or the Investigations.
Future growth and streamlining efforts will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate the right number of employees.
Future growth and streamlining efforts will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate the right number of employees. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time.
The risk of cybersecurity attacks may increase as artificial intelligence capabilities improve and are increasingly used to identify vulnerabilities and construct increasingly sophisticated cybersecurity attacks, with the possibility of additional vulnerabilities being introduced through our own use of artificial intelligence and its use by our stakeholders, including vendors. 48 In addition, outside parties may attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems.
The risk of cybersecurity attacks may increase as artificial intelligence capabilities improve and are increasingly used to identify vulnerabilities and construct increasingly sophisticated cybersecurity attacks, with the possibility of additional vulnerabilities being introduced through our own use of artificial intelligence and its use by our stakeholders, including vendors.
We are launching VAZKEPA on our own in the most commercially significant markets in Europe, and have redesigned our commercial infrastructure in Europe. The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage and may be impacted by decisions by and interactions with local regulators.
The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage and may be impacted by decisions by and interactions with local regulators.
We continue to take steps to negotiate our contract supply agreements to align supply arrangements with current and future global market demand. 42 Expanding manufacturing capacity and qualifying such capacity is complex and subject to numerous regulations and other operational challenges. We require supply capacity to support our direct and indirect commercialization of VASCEPA.
Expanding manufacturing capacity and qualifying such capacity is complex and subject to numerous regulations and other operational challenges. We require supply capacity to support our direct and indirect commercialization of VASCEPA.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe Board and management have made cybersecurity education and training a part of our overall corporate objectives, setting the tone for the organization about the importance of cybersecurity. Management’s Role in Assessing and Managing Material Risks from Cybersecurity Threats Our Information Technology and Security team is responsible for the management, maintenance, monitoring and response of our critical internal digital assets.
Biggest changeThe Audit Committee keeps the remaining Board of Directors apprised of material risks from cybersecurity threats. The Board and management have made cybersecurity education and training a part of our overall corporate objectives, setting the tone for the organization about the importance of cybersecurity.
Risk Factors - Risks Related to Our Business - Our internal computer systems, or those of our third party 58 clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs .
Risk Factors - Risks Related to Our Business - Our internal computer systems, or those of our third party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs .
This team is led by our Senior Director of Global Information Technology and Security, who has 25 years of cyber and Enterprise IT management experience. This position monitors current cyber risk trends, engages with third party cyber security experts, and meets with the Infrastructure and Security team regularly to stay apprised of internal cyber risks.
Our Information Technology and Security team is led by our Executive Director of Global Information Technology and Security, who has 25 years of cyber and Enterprise IT management experience. This position monitors current cyber risk trends, engages with third party cyber security experts, and meets with the Infrastructure and Security team regularly to stay apprised of internal cyber risks.
The management team provides quarterly reports to the Audit Committee which cover cybersecurity and other information technology-related risks, based on our ERM framework . These quarterly updates keep the Audit Committee apprised of our ongoing cybersecurity enhancements and any emerging global threats. The Audit Committee keeps the remaining Board of Directors apprised of material risks from cybersecurity threats.
Governance Our Board of Directors has delegated to the Audit Committee oversight of risks from cybersecurity threats. The management team provides quarterly reports to the Audit Committee which cover cybersecurity and other information technology-related risks, based on our ERM framework . These quarterly updates keep the Audit Committee apprised of our ongoing cybersecurity enhancements and any emerging global threats.
These organizations provide services such as penetration testing, security assessments, as well as 24 hours per day monitoring, alerting and response, including incident responses, all of which adhere to our overall ERM framework. Our partners evaluate and rank our cybersecurity maturity and coverage as part of their services and keep us informed of emerging global threats.
These organizations provide services such as penetration testing, security assessments, as well as 24 hours per day monitoring, alerting and response, including incident responses, all of which adhere to our overall ERM framework. Among other things, these service providers evaluate and rank our cybersecurity maturity and coverage, and keep us informed of emerging global threats.
Our internal cybersecurity testing and reporting processes allow us to rank our overall risk on a periodic basis so as to enable us to identify and respond to internal risk trends. Further, we follow escalation procedures to support the communication of cyber-related events.
Our internal cybersecurity testing and reporting processes allow us to rank our overall risk on a periodic basis so as to enable us to identify and respond to internal risk trends. Further, we follow escalation procedures to support the communication of cyber-related events to necessary stakeholders, including the Audit Committee of the Board, as appropriate.
Within our ERM framework, we adhere to our Global Information Technology Policy, or IT Policy, among a host of other policies and procedures aimed at providing guidelines and standards to ensure the security, integrity, reliability and recoverability of our systems and infrastructure. We employ and manage various third-party partnerships to help protect us from cybersecurity threats.
Within our ERM framework, we adhere to our Global Information Technology Policy, or IT Policy, among a host of other policies and procedures aimed at providing guidelines and standards to ensure the security, integrity, reliability and recoverability of our systems and infrastructure.
Item 1C. Cybersecurity We recognize the importance of safeguarding the security of our computer systems, software, networks, and other technology assets. Our security efforts are aimed at preserving the confidentiality, integrity, and continued availability of information under our ownership or care with the aim to continually improve security features in order to keep pace with the evolving cybersecurity threat landscape.
Our security efforts are aimed at preserving the confidentiality, integrity, and continued availability of information under our control or in our possession with the aim to continually improve security features in order to keep pace with the evolving cybersecurity threat landscape.
As of the date of this report, we do not believe that cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to affect the Company, including our business strategy, results of operations or financial condition for the reporting period covered by this report.
Our digital infrastructure undergoes both internal and external audits as part of our Sarbanes-Oxley audit process and is designed to address the requirements of applicable information security standards and an evolving cyber landscape. 60 As of the date of this report, no cybersecurity threat, including as a result of any previous cybersecurity incidents, has materially affected or are reasonably likely to affect the Company, including our business strategy, results of operations or financial condition for the reporting period covered by this report.
We utilize the vetted processes and procedures of these partners and ensure proper cybersecurity and risk mitigation strategies are in place and functioning, which is accessed through our Vendor Risk Assessment process prior to engaging with our partners. Our cybersecurity risk identification, assessment and management response process is a critical part of our overall enterprise risk management, or ERM, program.
Risk Management and Strategy Our cybersecurity risk identification, assessment and management response process is a critical part of our overall enterprise risk management, or ERM, program.
Overview of Cybersecurity Risk Management and Strategy Based on our business model, we rely on the outsourcing of certain key business functions, including laboratory work, clinical research, and the manufacturing and distribution of our product.
Our Information Technology and Security team is responsible for the management, maintenance, and monitoring of our critical internal digital assets, as well as response to any security incidents. W e rely on the outsourcing of certain key business functions, including laboratory work, clinical research, and the manufacturing and distribution of our product.
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Our digital infrastructure undergoes both internal and external audits as part of our Sarbanes-Oxley audit process and is designed to address the requirements of applicable information security standards and an evolving cyber landscape. Board Oversight of Risks from Cybersecurity Threats Our Board of Directors has delegated to the Audit Committee oversight of risks from cybersecurity threats.
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Item 1C. Cybersecurity We recognize the importance of safeguarding the security of our computer systems, software, networks, and other technology assets.
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Prior to engagement, w e vet these third party partners using our established Vendor Risk Assessment policies and procedures to ensure that proper cybersecurity and risk mitigation strategies are in place and functioning. We employ and manage various third-party partnerships to help protect us from cybersecurity threats.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeP roperties The following table lists the location, use and ownership interest of our principal properties as of March 12, 2025: Location Use Ownership Size (sq. ft.) Dublin, Ireland Offices Leased 1,861 Bridgewater, New Jersey, USA Offices Leased 67,747 Zug, Switzerland Offices Leased 4,511 On April 26, 2024, we entered into a license agreement for office space in Dublin, Ireland, effective September 1, 2024 which terminates on August 31, 2026, and can be extended automatically for successive one-month periods.
Biggest changeP roperties The following table lists the location, use and ownership interest of our principal properties as of March 2, 2026: Location Use Ownership Size (sq. ft.) Dublin, Ireland Offices Leased 3,745 Bridgewater, New Jersey, USA Offices Leased 67,747 On February 11, 2025, we entered into a license agreement for office space in Dublin, Ireland, effective March 1, 2025 which terminates on February 28, 2027, and can be extended automatically for successive one-month periods.
Item 4. Mine Safe ty Disclosures Not applicable. 59 PART II
Item 4. Mine Safe ty Disclosures Not applicable. 61 PART II
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On October 10, 2021, we entered into a lease agreement for approximately 4,511 square feet of office space in Zug, Switzerland. The lease commenced on February 1, 2022 for a five-year period, with one five-year renewal option.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe extent and duration of these market disruptions, whether as a result of the military conflicts, including those between Russia and Ukraine and the current armed conflict in Israel and the Gaza Strip, geopolitical tensions, inflation, market volatility or otherwise, are impossible to predict, but could be substantial.
Biggest changeThe extent and duration of these market disruptions, whether as a result of the military conflicts, geopolitical tensions, inflation, market volatility or otherwise, are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this report. Our business may be adversely affected by tariffs, trade sanctions or similar government actions.
Our future capital requirements will depend on many factors, including: • the timing, amount and consistency of revenue generated from the commercial sale of VASCEPA; • the costs associated with commercializing VASCEPA in the U.S., and for commercializing VAZKEPA in Europe, including hiring experienced professionals, and for additional regulatory approvals internationally, if any, the cost and timing of securing commercial supply of VASCEPA and the timing of entering into any new strategic collaboration with others relating to the commercialization of VASCEPA, if at all, and the terms of any such collaboration; • continued costs associated with litigation and other legal proceedings and governmental inquiries; • the time and costs involved in obtaining additional regulatory approvals for VASCEPA based on REDUCE-IT results internationally; • the extent to which we continue to develop internally, acquire or in-license new products, technologies or businesses; and 51 • the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
Our future capital requirements will depend on many factors, including: • the timing, amount and consistency of revenue generated from the commercial sale of VASCEPA; • the costs associated with commercializing VASCEPA in the U.S., and for commercializing VAZKEPA in Europe, including hiring experienced professionals, and for additional regulatory approvals internationally, if any, the cost and timing of securing commercial supply of VASCEPA and the timing of entering into any new strategic collaboration with others relating to the commercialization of VASCEPA, if at all, and the terms of any such collaboration; • continued costs associated with litigation and other legal proceedings and governmental inquiries; • the time and costs involved in obtaining additional regulatory approvals for VASCEPA based on REDUCE-IT results internationally; • the extent to which we continue to develop internally, acquire or in-license new products, technologies or businesses; and • the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
Further, if an offeror or any person acting in concert with it acquires any interest in shares for cash during the offer period, the offer for that class of shares must be in cash or accompanied by a cash alternative at a price at not less than the highest price paid by the offeror or any person acting in concert with it for shares of that class acquired during the offer period. • If after an announcement of a firm intention to make an offer is made and before the offer closes for acceptance, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the then current value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired. • The offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company. • Special or favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the independent adviser to the offeree. • All shareholders must be given the same information. • Each document published in connection with an offer by or on behalf of the offeror or offeree must state that the directors of the offeror or the offeree, as the case may be, accept responsibility for the information contained therein and that, to the best of their knowledge and belief (having taken all reasonable care to ensure that such is the case) the information contained therein is in accordance with the facts and does not omit anything likely to affect the import of such information. 55 • Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers. • Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately. • Actions during the course of an offer (or even before if the board of the offeree company is aware that an offer is imminent) by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans (or the bidder consents to the proposed course of action).
Further, if an offeror or any person acting in concert with it acquires any interest in shares for cash during the offer period, the offer for that class of shares must be in cash or accompanied by a cash alternative at a price at not less than the highest price paid by the offeror or any person acting in concert with it for shares of that class acquired during the offer period. • If after an announcement of a firm intention to make an offer is made and before the offer closes for acceptance, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the then current value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired. • The offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company. • Special or favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the independent adviser to the offeree. • All shareholders must be given the same information. • Each document published in connection with an offer by or on behalf of the offeror or offeree must state that the directors of the offeror or the offeree, as the case may be, accept responsibility for the information contained therein and that, to the best of their knowledge and belief (having taken all reasonable care to ensure that such is the case) the information contained therein is in accordance with the facts and does not omit anything likely to affect the import of such information. 57 • Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers. • Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately. • Actions during the course of an offer (or even before if the board of the offeree company is aware that an offer is imminent) by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans (or the bidder consents to the proposed course of action).
If we require additional funds and adequate funds are not available to us in amounts or on terms acceptable to us or on a timely basis, or at all, our commercialization efforts for VASCEPA, and our business generally, may suffer materially. Changes in tax laws could have a material adverse effect on our business, financial condition and results of operations.
If we require additional funds and adequate funds are not available to us in amounts or on terms acceptable to us or on a timely basis, or at all, our commercialization efforts for VASCEPA, and our business generally, may suffer materially. 53 Changes in tax laws could have a material adverse effect on our business, financial condition and results of operations.
Any termination of or delay in entering into such collaborations, licenses and other strategic transactions could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations.
Any termination of or delay in entering into such collaborations, licenses and other strategic 59 transactions could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations.
Under the modified Ireland-UK DTA, from January 1, 2020, we would be solely tax resident in Ireland and not tax resident in 49 the UK if we continued to be centrally managed and controlled in Ireland and if it were mutually agreed between the Irish and UK tax authorities under the MLI “tie-breaker rule” that we are solely tax resident in Ireland.
Under the modified Ireland-UK DTA, from January 1, 2020, we would be solely tax resident in Ireland and not tax resident in the UK if we continued to be centrally managed and controlled in Ireland and if it were mutually agreed between the Irish and UK tax authorities under the MLI “tie-breaker rule” that we are solely tax resident in Ireland.
Further, the share repurchase program and other efforts to return capital to shareholders may not have the anticipated effect or increase shareholder value in the long term. If we are unable to meet the listing requirements of the NASDAQ Stock Market, our stock may be delisted.
Further, the share repurchase program and other efforts to return capital to shareholders may not have the anticipated effect or increase shareholder value in the long term. If we are unable to meet the listing requirements of the Nasdaq Stock Market, our ADS may be delisted.
If we are unable to obtain additional funding when needed, we may be required to curtail or terminate some or all of our research or development programs or our commercialization strategies. 56 Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.
If we are unable to obtain additional funding when needed, we may be required to curtail or terminate some or all of our research or development programs or our commercialization strategies. Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.
There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our securities. Our ADSs have historically had limited trading volume, which may also result in volatility.
There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our ADSs. Our ADSs have historically had limited trading volume, which may also result in volatility.
The market price of our ADSs and common shares may also be affected by factors such as: • developments or disputes concerning ongoing patent prosecution efforts and any future patent or proprietary rights; • litigation and regulatory developments in the U.S. affecting our VASCEPA promotional rights, and regulatory developments in other countries; • actual or potential medical results relating to our products or our competitors’ products; • interim failures or setbacks in product development; • innovation by us or our competitors; • currency exchange rate fluctuations; • amendment to the Deposit Agreement or changes to the ADS to ordinary share ratio; and • period-to-period variations in our results of operations.
The market price of our ADSs may also be affected by factors such as: • developments or disputes concerning ongoing patent prosecution efforts and any future patent or proprietary rights; • litigation and regulatory developments in the U.S. affecting our VASCEPA promotional rights, and regulatory developments in other countries; • actual or potential medical results relating to our products or our competitors’ products; • interim failures or setbacks in product development; • innovation by us or our competitors; • currency exchange rate fluctuations; • amendment to the Deposit Agreement or changes to the ADS to ordinary share ratio; and • period-to-period variations in our results of operations.
If acceptances are not received for 90% or more of the ordinary shares/ADSs (and 90% of the voting rights carried by those ordinary shares/ADSs) under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain 100% control of us.
If acceptances are not received for 90% or more of the ordinary shares (and 90% of the voting rights carried by those ordinary shares) under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain 100% control of us.
If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline. 50 Our operating results are difficult to predict and will likely fluctuate from quarter-to-quarter and year-to-year, and VASCEPA prescription figures will likely fluctuate from month to month.
If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline. Our operating results are difficult to predict and will likely fluctuate from quarter-to-quarter and year-to-year, and VASCEPA prescription figures will likely fluctuate from month to month.
Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends must be approved by our board of directors and, in some cases, our shareholders, and may only be paid from our distributable profits available for the purpose, determined on an unconsolidated basis. 53 The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends must be approved by our board of directors and, in some cases, our shareholders, and may only be paid from our distributable profits available for the purpose, determined on an unconsolidated basis. 55 The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
Under English law, a bidder seeking to acquire us by means of a takeover offer would need to make an offer for all of our outstanding ordinary shares/ADSs.
Under English law, a bidder seeking to acquire us by means of a takeover offer would need to make an offer for all of our outstanding ordinary shares.
Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2024 and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.
Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2025 and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.
The NASDAQ Stock Market, or NASDAQ, on which our ADSs are listed and traded, has listing requirements that include a $1.00 minimum closing bid price requirement, or the Minimum Bid Requirement. NASDAQ will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 business consecutive days.
Our ADSs are listed and traded on Nasdaq, which has listing requirements that include a $1.00 minimum closing bid price requirement, or the Minimum Bid Requirement. Nasdaq will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 business consecutive days.
Risks Related to Ownership of our ADSs and Common Shares Our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, may not be implemented in a timely manner or at all, or may not have the expected results.
Risks Related to Ownership of our ADSs and Ordinary Shares Our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, may not be implemented in a timely manner or at all, or may not have the expected results.
We believe that our quarterly and annual results of operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following: • the recent and future potential launches of additional generic versions of icosapent ethyl; • the timing and ability of efforts outside the U.S. , to develop, register and commercialize VASCEPA, including obtaining necessary regulatory approvals, favorable pricing and establishing marketing channels; • the continuing evolution of the medical community’s and the public’s perception of the REDUCE-IT study results; • the level of demand for VASCEPA, due to changes in prescriber sentiment, quarterly changes in distributor purchases, and other factors; • the extent to which coverage and reimbursement for VASCEPA is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors and the timing and extent to which such coverage and reimbursement changes; • the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales, and our cost and reorganization efforts, including our ORP announced in July 2023, and the resulting effectiveness of those efforts; • disruptions or delays in our or our partners’ commercial or development activities, including as a result of political instability, civil unrest, terrorism, pandemics or other natural disasters, such as the coronavirus pandemic; • additional developments regarding our intellectual property portfolio and regulatory exclusivity protections, if any; • outcomes of litigation and other legal proceedings; and • our ongoing regulatory dialogue.
We believe that our quarterly and annual results of operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following: 52 • the recent and future potential launches of additional generic versions of icosapent ethyl; • the timing and ability of efforts outside the U.S., to develop, register and commercialize VASCEPA, including obtaining necessary regulatory approvals, favorable pricing and establishing marketing channels; • the continuing evolution of the medical community’s and the public’s perception of the REDUCE-IT study results; • the level of demand for VASCEPA, due to changes in prescriber sentiment, quarterly changes in distributor purchases, and other factors; • the extent to which coverage and reimbursement for VASCEPA is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors and the timing and extent to which such coverage and reimbursement changes; • the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales, and our cost and reorganization efforts, including our Global Restructuring Plan announced in June 2025, and the resulting effectiveness of those efforts; • disruptions or delays in our or our partners’ commercial or development activities, including as a result of political instability, civil unrest, terrorism, pandemics or other natural disasters, such as the coronavirus pandemic; • additional developments regarding our intellectual property portfolio and regulatory exclusivity protections, if any; • outcomes of litigation and other legal proceedings; and • our ongoing regulatory dialogue.
Accordingly, we believe that we are not currently subject to 54 the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids.
Accordingly, we believe that we are not currently subject to 56 the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids.
The price of our ADSs and common shares may be volatile. The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies.
The price of our ADSs may be volatile. The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, including in Europe.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability.
Our planned share repurchase program, would, if implemented, reduce the number of shares outstanding and could result in reduced trading volumes.
Our planned share repurchase program, would, if implemented, reduce the number of ADSs outstanding and could result in reduced trading volumes.
U.S. holders of the ADSs or ordinary shares may be subject to U.S. federal income taxation at ordinary income tax rates on undistributed earnings and profits. There is a risk that we will be classified as a controlled foreign corporation, or CFC, for U.S. federal income tax purposes.
U.S. holders of ordinary shares, including ordinary shares held in the form of ADSs, may be subject to U.S. federal income taxation at ordinary income tax rates on undistributed earnings and profits. There is a risk that we will be classified as a controlled foreign corporation, or CFC, for U.S. federal income tax purposes.
We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days and to date continue to trade below $1.00. On November 22, 2024, we received notice NASDAQ granted the Company an additional 180 calendar days, or until May 19, 2025, to regain compliance with the 52 Minimum Bid Requirement.
We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days. On November 22, 2024, we received notice Nasdaq granted the Company an additional 180 calendar days, or until May 19, 2025, to regain compliance with the Minimum Bid Requirement.
For the fiscal years ended December 31, 2024, 2023 and 2022, we reported net losses of approximately $82.2 million, $59.1 million and $105.8 million, respectively. We had an accumulated deficit as of December 31, 2024 of $1.7 billion.
For the fiscal years ended December 31, 2025, 2024 and 2023, we reported net losses of approximately $38.8 million, $82.2 million and $59.1 million, respectively. We had an accumulated deficit as of December 31, 2025 of $1.7 billion.
If we are classified as a CFC, any ADS holder or shareholder that is a U.S. person that owns directly, indirectly or by attribution, 10% or more of the voting power of our outstanding shares may be subject to U.S. income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart F income.” Such 10% holder may also be taxable at ordinary income tax rates on any gain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares.
If we are classified as a CFC, any ADS holder or shareholder that is a U.S. person that owns directly, indirectly or by attribution, 10% or more of the voting power or value of our outstanding ordinary shares may be subject to U.S. income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart F income” and net CFC tested income.
We believe that our cash and cash equivalents balance of $121.0 million and short-term investment balance of $173.2 million as of December 31, 2024, aggregating $294.2 million, will be sufficient to fund our projected operations for at least 12 months from the issuance date of consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
We believe that our cash and cash equivalents balance of $134.7 million and short-term investment balance of $167.9 million as of December 31, 2025, aggregating $302.6 million, will be sufficient to fund our projected operations for at least 12 months from the issuance date of consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Having made the relevant submission under the amended provisions, we received confirmation effective January 1, 2020 of the mutual agreement of Irish and UK tax authorities that we are solely tax resident in Ireland for the purposes of the modified DTA.
Having made the relevant submission under the amended provisions, we received confirmation effective January 1, 2020 of the mutual agreement of Irish and UK tax authorities that we are solely tax resident in Ireland for the purposes of the modified DTA. 51 We cannot assure you, however, that we are or will continue to be solely resident in Ireland for tax purposes.
Even though VASCEPA has been approved by the U.S. FDA for marketing in the U.S. for two important indications, received marketing authorization in Europe and is approved in smaller jurisdictions, it may not gain enough market acceptance to support consistent profitability. We anticipate continuing to incur significant costs associated with expanding the commercialization of VASCEPA.
Even though VASCEPA has been approved by the U.S. FDA for marketing in the U.S. for two important indications, received marketing authorization in Europe and is approved in smaller jurisdictions, it may not gain enough market acceptance to support consistent profitability.
Customers A, B, and C accounted for 32%, 27%, and 30%, respectively, of gross product sales for the year ended December 31, 2024 and represented 25%, 13%, and 45%, respectively, of the gross accounts receivable balance as of December 31, 2024.
Customers A, B, and C accounted for 32%, 27%, and 30%, respectively, of gross product sales for the year ended December 31, 2024 and represented 25%, 13%, and 45%, respectively, of the gross accounts receivable balance as of December 31, 2024. We expect that we may have customer concentration risk as we enter additional countries.
Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms. While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all.
While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all.
Economic uncertainty in various global markets, including the U.S., Europe and the Middle East, caused by political instability and conflict, such as Russia's invasion of Ukraine and current armed conflict in Israel and the Gaza Strip, changes in the majority party 57 governing countries around the world, including the U.S., and economic challenges caused by pandemics or other health crises, such as the recent COVID-19 pandemic, have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally.
Economic uncertainty in various global markets, including the U.S., Europe, South America and the Middle East, caused by political instability and conflict, including Ukraine, Israel and the Gaza Strip, and Venezuela, changes in the majority party governing countries around the world, including the U.S., and economic challenges have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions.
While we are monitoring the bid price for our ADS and considering available options to resolve the deficiency, we may not be able to regain compliance with the Minimum Bid Requirement within the required time frame. Should such a delisting occur, it would adversely impact the liquidity and price of our ADSs and would impede our ability to raise capital.
While we have regained compliance with the Minimum Bid Requirement, there is no guarantee that we will be able to maintain such compliance, and we may receive additional deficiency letters in the future. 54 Should such a delisting occur, it would adversely impact the liquidity and price of our ADSs and would impede our ability to raise capital.
Customers A, B, and C accounted for 36%, 28%, and 29%, respectively, of gross product sales for the year ended December 31, 2023 and represented 36%, 18%, and 38%, respectively, of the gross accounts receivable balance as of December 31, 2023. We expect that we may have customer concentration risk as we enter additional countries.
Customers A, B, and C accounted for 28%, 27%, and 31%, respectively, of gross product sales for the year ended December 31, 2025 and represented 23%, 17%, and 43%, respectively, of the gross accounts receivable balance as of December 31, 2025.
As of February 28, 2025, we had 414,186,296 common shares outstanding including 405,383,488 shares held as ADSs and 8,802,808 held as ordinary shares (which are not held in the form of ADSs).
As of February 20, 2026, we had 416,079,145 ordinary shares outstanding including 20,364,324 shares held as ADSs and 8,792,657 held as ordinary shares (which are not held in the form of ADSs).
Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular health. We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately be developed by us.
Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular health.
Removed
We cannot assure you, however, that we are or will continue to be solely resident in Ireland for tax purposes.
Added
Effective as of April 11, 2025, we implemented an adjustment of the ratio of our ADSs to Ordinary Shares from one ADS representing one Ordinary Share to one ADS representing 20 Ordinary Shares, or the ADS Ratio Change.
Removed
We may not achieve profitability on a sustained basis in the near term due to high costs associated with, for example, our commercialization efforts in the U.S. and Europe.
Added
The ADS Ratio Change resulted in a 1-for-20 reverse split of issued and outstanding ADSs, and it had no effect on the Ordinary Shares. On April 29, 2025, we received written confirmation from Nasdaq that we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days.
Removed
Any such disruptions may also magnify the impact of other risks described in this report. Item 1B. Unresolve d Staff Comments None.
Added
Holders of ADSs may not have the same voting rights as holders of ordinary shares and may not receive voting materials in time to be able to exercise their right to vote. Holders of ADSs are not able to exercise voting rights attaching to ordinary shares underlying our ADSs on an individual basis.
Added
Each holder of ADSs has appointed the depositary or its nominee as the holder’s representative to exercise, pursuant to the instructions of the holder, the voting rights attaching to our ordinary shares underlying our ADSs.
Added
Holders of ADSs may not receive voting materials in time to instruct the depositary to vote, and it is possible that they, or persons who hold their ADSs through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote.
Added
Such 10% holder may also be taxable at ordinary income tax rates on any gain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares.
Added
We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately be developed by us. 58 Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms.
Added
The imposition and ongoing discussions regarding certain trade restrictions, sanctions and tariffs on goods exported from the U.S. or imported into the U.S., as well as retaliatory measures enacted in response to such actions and related market volatility, could have a material adverse impact on our business, financial condition, results of operations and cash flows.
Added
In light of these events, there continues to exist significant uncertainty about the future relationship between the U.S. and other countries with respect to such trade policies.
Added
These developments have had, and may in the future have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the U.S.
Added
Any of these factors could depress economic activity, lower product demand and restrict our access to potential partners, suppliers or other third parties we seek to do business with and, in turn, have a material adverse effect on the business and financial condition of such third parties, which in turn would negatively impact us.
Added
While we believe we have sufficient supply in the U.S. to address demand in the near-term, there can be no assurance that any changes to trade policies would not have a material adverse impact on our operations and financial results. Item 1B. Unresolve d Staff Comments None.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

25 edited+3 added−2 removed84 unchanged
Biggest changeInternal Revenue Code of 1986, as amended, which is referred to herein as the Code, regulations promulgated under the Code and administrative rulings and judicial decisions as in effect on the date of this Annual Report on Form 10-K, all of which are subject to change and to differing interpretations, possibly with retroactive effect, which could result in U.S. federal income tax considerations different from those summarized below. 61 This summary is general in nature and does not address the effects of any state or local taxes, the tax consequences in jurisdictions other than the U.S. or any U.S. federal taxes other than income tax (such as estate or gift tax).
Biggest changeInternal Revenue Code of 1986, as amended, which is referred to herein as the Code, regulations promulgated under the Code and administrative rulings and judicial decisions as in effect on the date of this Annual 63 Report on Form 10-K, all of which are subject to change and to differing interpretations, possibly with retroactive effect, which could result in U.S. federal income tax considerations different from those summarized below.
Subject to the discussion under “—Passive Foreign Investment Company,” below, as long as our ordinary shares or ADSs (as applicable) are treated as publicly traded on an established securities market, or we are eligible for the benefits of the U.S.-Irish Tax Treaty, any distributions treated as dividends will generally be qualified dividend income in the hands of non-corporate U.S.
Subject to the discussion under “—Passive Foreign Investment Company,” below, as long as our ordinary shares or ADSs (as applicable) are treated as publicly traded on an established securities market, or we are eligible for the benefits of the U.S.-Irish Tax 64 Treaty, any distributions treated as dividends will generally be qualified dividend income in the hands of non-corporate U.S.
In general terms, we will be a PFIC for any taxable year in which either (i) 75% or more of its our gross income is passive income, or the income test, or (ii) the average percentage, by fair market value, of our assets that produce or are held for the production of passive income is 50% or more, or the asset test.
In general terms, we will be a PFIC for any taxable year in which either (i) 75% or more of its our gross income is passive income, or the income test, or (ii) the average percentage, by fair market value, of our assets that produce or are held for the 65 production of passive income is 50% or more, or the asset test.
Tax Considerations The following is a summary of certain U.S. federal income tax considerations with respect to the ownership and disposition of ordinary shares or ADSs by a U.S. Holder (as defined below). This summary applies to you only if you hold ordinary shares or ADSs as a capital asset. This summary is based upon the U.S.
Certain Material U.S. Tax Considerations The following is a summary of certain U.S. federal income tax considerations with respect to the ownership and disposition of ordinary shares or ADSs by a U.S. Holder (as defined below). This summary applies to you only if you hold ordinary shares or ADSs as a capital asset. This summary is based upon the U.S.
Holders, provided that certain significant holding period and other requirements are met. Any dividends that are qualified dividend income will 62 generally be taxed at preferential rates to a non-corporate U.S. Holder. Any dividends paid to a corporate holder will not be eligible for the dividends received deduction. U.S.
Holders, provided that certain significant holding period and other requirements are met. Any dividends that are qualified dividend income will generally be taxed at preferential rates to a non-corporate U.S. Holder. Any dividends paid to a corporate holder will not be eligible for the dividends received deduction. U.S.
If an entity treated as a partnership for U.S. federal income tax purposes holds ordinary shares or ADSs, the tax treatment of a partner will generally depend upon the status of the partner and upon the activities of the partnership.
If an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds ordinary shares or ADSs, the tax treatment of a partner will generally depend upon the status of the partner and upon the activities of the partnership.
Each shareholder should however seek individual tax advice as specific rules may apply in certain circumstances. 65 Capital gains If you are not resident in the United Kingdom, or UK, for UK tax purposes, you will not be liable for UK tax on capital gains realized or accrued on the sale or other disposition of ordinary shares or ADSs unless the ordinary shares or ADSs are held in connection with your trade carried on in the UK through a branch or agency and the ordinary shares or ADSs are or have been used, held or acquired for the purposes of such trade or such branch or agency.
Each shareholder should however seek individual tax advice as specific rules may apply in certain circumstances. 67 Capital gains If you are not resident in the United Kingdom, or UK, for UK tax purposes, you will not be liable for UK tax on capital gains realized or accrued on the sale or other disposition of ordinary shares or ADSs unless the ordinary shares or ADSs are held in connection with your trade carried on in the UK through a branch or agency and the ordinary shares or ADSs are or have been used, held or acquired for the purposes of such trade or such branch or agency.
Double Taxation Convention, or the Treaty, (iii) in the case of an individual holder, is not also resident or ordinarily resident in Ireland for Irish tax purposes, (iv) in the case of a corporate holder, is not a resident in Ireland for Irish tax purposes and is not ultimately controlled by persons resident in Ireland, and (v) is not engaged in any trade or business and does not perform 66 independent personal services through a permanent establishment or fixed base in Ireland, and (vi) is a qualified person as defined in Article 23 of the Treaty.
Double Taxation Convention, or the Treaty, (iii) in the case of an individual holder, is not also resident or ordinarily resident in Ireland for Irish tax purposes, (iv) in the case of a corporate holder, is not a resident in Ireland for Irish tax purposes and is not ultimately controlled by persons resident in Ireland, and (v) is not engaged in any trade or business and does not perform 68 independent personal services through a permanent establishment or fixed base in Ireland, and (vi) is a qualified person as defined in Article 23 of the Treaty.
Holders are urged to consult their own tax advisers regarding the potential tax consequences of Amarin being classified as a PFIC. Medicare tax Certain U.S.
Holders are urged to consult their tax advisers regarding the potential tax consequences of Amarin being classified as a PFIC. Medicare tax Certain U.S.
Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2024, and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.
Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2025, and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.
Rules for Lower-Tier PFIC Subsidiaries. Special adverse rules apply to U.S. Holders of ordinary shares or ADSs for any year in which we are a PFIC and have a non-U.S. subsidiary that is also a PFIC, or a lower-tier PFIC. If we are or become a PFIC and a 64 U.S.
Special adverse rules apply to U.S. Holders of ordinary shares or ADSs for any year in which we are a PFIC and have a non-U.S. subsidiary that is also a PFIC, or a lower-tier PFIC. If we are or become a PFIC and a U.S.
Taxation The following summary contains a description of material U.S., UK and Irish federal income tax consequences of the ownership and disposition of our ordinary shares or ADSs. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to beneficial owners of ordinary shares or ADSs. Certain Material U.S.
Taxation The following summary contains a description of material U.S., UK and Irish federal income tax consequences of the ownership and disposition of our Ordinary Shares or ADSs representing such Ordinary Shares. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to beneficial owners of ordinary shares or ADSs.
Holder should consult its own tax advisors regarding the foreign tax credit rules. The amount of a distribution paid to a U.S. Holder of ordinary shares or ADSs in foreign currency generally will be equal to the U.S. dollar value of such distribution based on the exchange rate applicable on the date of receipt. A U.S.
Holder should consult its tax advisor regarding the foreign tax credit rules. The amount of a distribution paid to a U.S. Holder of ordinary shares or ADSs in foreign currency generally will be equal to the U.S. dollar value of such distribution based on the exchange rate applicable on the date of receipt. A U.S.
Share Repurchase Program 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. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively.
Share Repurchase Program 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 ADSs. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively.
The NASDAQ Biotechnology Index has been selected because it is an index of U.S. quoted biotechnology and pharmaceutical companies. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our ADSs and in each of the indices on December 31, 2019, and its relative performance is tracked through December 31, 2024.
The Nasdaq Biotechnology Index has been selected because it is an index of U.S. quoted biotechnology and pharmaceutical companies. An investment of $100 (with reinvestment of all dividends) is assumed to have been made in our ADSs and in each of the indices on December 31, 2020, and its relative performance is tracked through December 31, 2025.
Whether or not the mark-to-market election is available will depend on whether the ordinary shares or ADSs are regularly traded on a qualifying exchange and we cannot provide assurance that the ordinary shares or ADSs will be considered regularly traded (which determination is based on the volume of trading of the ordinary shares or ADSs) for all years in which we may be a PFIC.
Whether or not the mark-to-market election is available will depend on whether the ordinary shares or ADSs are regularly traded on a qualifying exchange and we cannot provide assurance that the ordinary shares or ADSs will be considered regularly traded (which determination is based on the volume of trading of the ordinary shares or ADSs) for all years in which we may be a PFIC. 66 Rules for Lower-Tier PFIC Subsidiaries.
Holder’s gross income as a dividend to the extent such payment is made out of our earnings and profits (as described above).
Holder’s gross income as a dividend to the extent such payment is made out of our current or accumulated earnings and profits (as described above).
The person who receives the gift or inheritance is generally accountable for any CAT due. 67 Irish stamp duty No Irish stamp duty should arise on the issue or transfer for cash of shares or ADSs on the basis that such a transfer does not relate to stocks or marketable securities of an Irish registered company.
The person who receives the gift or inheritance is generally accountable for any CAT due. 69 Irish stamp duty No Irish stamp duty should arise on the issue or transfer for cash of shares or ADSs on the basis that such a transfer does not relate to stocks or marketable securities of an Irish registered company. Item 6. [Reserved] 70
Item 5. Market for Registrant’s Common Equity, Related Stoc kholder Matters and Issuer Purchases of Equity Securities Market Information Our ADSs are listed on The NASDAQ Global Market under the symbol “AMRN”. Each ADS represents one ordinary share.
Item 5. Market for Registrant’s Common Equity, Related Stoc kholder Matters and Issuer Purchases of Equity Securities Market Information Our ADSs are listed on The Nasdaq Capital Market under the symbol “AMRN”. Each ADS represents twenty (20) Ordinary Shares.
“Passive income” includes, for example, dividends, interest, certain rents and royalties, certain gains from the sale of stock and securities, and certain gains from commodities transactions. 63 If we are a PFIC for any year, subject to the discussion of QEF (as defined herein) and mark-to-market elections below, a U.S. taxpayer who disposes or is deemed to dispose of an ordinary share or ADS at a gain or who receives a distribution treated as an “excess distribution” on an ordinary share or ADS generally would be required to allocate such gain and distribution ratably to each day in the U.S. taxpayer’s holding period for the ordinary share or ADS in question.
If we are a PFIC for any year, subject to the discussion of QEF (as defined herein) and mark-to-market elections below, a U.S. taxpayer who disposes or is deemed to dispose of an ordinary share or ADS at a gain or who receives a distribution treated as an “excess distribution” on an ordinary share or ADS generally would be required to allocate such gain and distribution ratably to each day in the U.S. taxpayer’s holding period for the ordinary share or ADS in question.
Dividends We have never paid dividends on our ordinary shares and do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future.
Our depositary, JPMorgan Chase Bank, N.A., constitutes a single record holder of our ordinary shares. Dividends We have never paid dividends on our Ordinary Shares and do not anticipate paying any cash dividends on our Ordinary Shares in the foreseeable future.
Issuer Purchases of Equity Securities Shares purchased in the fourth quarter of 2024 are as follows: Period Total Number of Shares Purchased (1) Average Price Paid per Share October 1 – 31, 2023 19,777 $ 0.61 November 1 – 30, 2023 9,016 0.58 December 1 – 31, 2023 15,690 0.64 Total 44,483 $ 0.61 (1) Represents shares withheld to satisfy tax withholding amounts due from employees related to the exercise or vesting of equity awards.
Issuer Purchases of Equity Securities ADSs purchased in the fourth quarter of 2025 are as follows: Period Total Number of Shares Purchased (1) Average Price Paid per Share October 1 – 31, 2025 4,373 $ 16.43 November 1 – 30, 2025 274 16.29 December 1 – 31, 2025 739 14.00 Total 5,386 $ 16.09 (1) Represents ADSs withheld to satisfy tax withholding amounts due from employees related to the exercise or vesting of equity awards.
A partner of a partnership that owns or disposes of ADSs should consult the partner’s tax advisor regarding the specific tax consequences of the ownership and disposition of ordinary shares or ADSs. YOU SHOULD CONSULT YOUR OWN ADVISOR REGARDING THE TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ORDINARY SHARES AND ADSS IN LIGHT OF YOUR PARTICULAR CIRCUMSTANCES.
YOU SHOULD CONSULT YOUR ADVISOR REGARDING THE TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ORDINARY SHARES AND ADSS IN LIGHT OF YOUR PARTICULAR CIRCUMSTANCES. U.S. Holders For purposes of this discussion, a U.S.
The following table sets forth the high and low prices for our ADSs in each of the quarters over the past two fiscal years, as quoted on The NASDAQ Global Market under the symbol “AMRN.” Common Stock Price Fiscal 2024 Fiscal 2023 High Low High Low First Quarter $ 1.37 $ 0.80 $ 2.23 $ 1.15 Second Quarter $ 1.11 $ 0.63 $ 1.50 $ 1.10 Third Quarter $ 0.82 $ 0.57 $ 1.49 $ 0.84 Fourth Quarter $ 0.66 $ 0.43 $ 0.93 $ 0.65 Shareholders As of January 31, 2025, there were approximately 350 holders of record of our ordinary shares.
The following table sets forth the high and low prices for our ADSs in each of the quarters over the past two fiscal years, as quoted on The Nasdaq Capital Market under the symbol “AMRN.” ADS Stock Price Fiscal 2025 Fiscal 2024 High Low High Low First Quarter $ 13.40 $ 7.00 $ 27.40 $ 16.00 Second Quarter $ 17.18 $ 7.60 $ 22.20 $ 12.60 Third Quarter $ 17.49 $ 14.05 $ 16.40 $ 11.20 Fourth Quarter $ 20.90 $ 13.41 $ 13.20 $ 8.60 Shareholders As of January 31, 2026, there were approximately 275 holders of record of our Ordinary Shares.
Included in this five-year period is the substantial negative impact on the price of Amarin’s ADSs in 2020 following the loss of the Company’s MARINE indication patents. 60 Company/Market/Peer Company 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 Amarin Corporation PLC $ 23.91 $ 16.09 $ 5.78 $ 4.15 $ 2.32 NASDAQ Composite Index $ 141.95 $ 173.43 $ 116.03 $ 166.41 $ 214.07 NASDAQ Biotechnology Index $ 131.94 $ 127.28 $ 113.40 $ 117.64 $ 116.02 Information about Our Equity Compensation Plans Information regarding our equity compensation plans is incorporated by reference in Item 12 of Part III of this Annual Report on Form 10-K.
Included in this five-year period is the substantial negative impact on the price of Amarin’s ADSs in 2020 following the loss of the Company’s MARINE indication patents. 62 Company/Market/Peer Company 12/31/2021 12/31/2022 12/31/2023 12/31/2024 12/31/2025 Amarin Corporation PLC $ 68.92 $ 24.74 $ 17.79 $ 9.16 $ 14.27 NASDAQ Composite Index $ 121.39 $ 81.21 $ 116.47 $ 153.02 $ 180.33 NASDAQ Biotechnology Index $ 99.37 $ 88.53 $ 91.84 $ 91.53 $ 119.92 Information about Our Equity Compensation Plans Information regarding our equity compensation plans is incorporated by reference in Item 12 of Part III of this Annual Report on Form 10-K.
Removed
Because many ordinary shares are held by broker nominees, we are unable to estimate the total number of shareholders represented by these record holders. Our depositary, Citibank, N.A., constitutes a single record holder of our ordinary shares.
Added
This summary is general in nature and does not address the effects of any state or local taxes, the tax consequences in jurisdictions other than the U.S. or any U.S. federal taxes other than income tax (such as estate or gift tax).
Removed
U.S. holders For purposes of this discussion, a U.S.
Added
A partner of an entity or arrangement treated as a partnership for U.S. federal income tax purposes that owns or disposes of ADSs should consult the partner’s tax advisor regarding the specific tax consequences of the ownership and disposition of ordinary shares or ADSs.
Added
“Passive income” includes, for example, dividends, interest, certain rents and royalties, certain gains from the sale of stock and securities, and certain gains from commodities transactions.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

91 edited+30 added−56 removed54 unchanged
Biggest changeBiologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially in the following countries: Country MARINE REDUCE-IT Launch Date 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 VASCEPA is under registration in additional countries in the MENA region.
Biggest changeWe 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 – (1) - VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.
The evidence considered included the (i) historical taxable profitability of our U.S. operations, (ii) historical pre-tax book loss position, (iii) sources of future taxable income, giving weight to 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.
The evidence considered included the (i) historical taxable profitability of our U.S. operations, (ii) historical pre-tax book loss position, (iii) sources of future taxable income, giving weight to 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 79 development of VASCEPA.
The 75 preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions. Actual results may differ from these estimates under different assumptions or conditions.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions. Actual results may differ from these estimates under different assumptions or conditions.
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 74 timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period.
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.
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.
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. 77 Restructuring expense.
Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida. (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.
Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida. (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. Restructuring expense .
The transaction price is then allocated to each performance obligation on a relative stand-alone selling price 76 basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.
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.
(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.
(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.
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.
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 78 arrangement.
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.
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 disclaim any intent to update or announce revisions to any forward-looking statements to reflect actual events or developments, except as required by law. Except as otherwise indicated herein, all dates referred to in this Annual Report on Form 10-K represent periods or dates fixed with reference to our fiscal year ended December 31, 2024.
We disclaim any intent to update or announce revisions to any forward-looking statements to reflect actual events or developments, except as required by law. Except as otherwise indicated herein, all dates referred to in this Annual Report on Form 10-K represent periods or dates fixed with reference to our fiscal year ended December 31, 2025.
In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for the year-ended December 31, 2024 and 2023, are not more likely than not to be realized.
In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for the year-ended December 31, 2025 and 2024, are not more likely than not to be realized.
Since VASCEPA was made commercially available in 2013, approximately 27 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.
Since VASCEPA was made commercially available in 2013, approximately 30 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr.
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., 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.
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.
The API included in the calculation of the average cost of goods sold during the years ended December 31, 2024 and 2023 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors.
The API included in the calculation of the average cost of goods sold during the years ended December 31, 2025 and 2024 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors.
Effects of Inflation We believe the impact of inflation on operations has been minimal during the past three years. Results of Operations The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2024 and 2023.
Effects of Inflation We believe the impact of inflation on operations has been minimal during the past three years. Results of Operations The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2025 and 2024.
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.
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.
When making our assessment about the realization of our deferred tax assets as of December 31, 2024, we considered all available evidence, placing particular weight on evidence that could be objectively verified.
When making our assessment about the realization of our deferred tax assets as of December 31, 2025, we considered all available evidence, placing particular weight on evidence that could be objectively verified.
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, 2024 and 2023.
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.
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. Selling, general and administrative expense.
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.
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.
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.
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 years ended December 31, 2024 and 2023 was 28% and 50%, respectively.
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 years ended December 31, 2025 and 2024 was 49% and 28%, respectively.
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. and pricing and reimbursement of VAZKEPA in Europe.
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. and the efforts of our licensee of VAZKEPA in Europe.
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.
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.
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.
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.
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.
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.
These actions reduced operating costs by $50.0 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. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively.
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. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively.
Our share of the icosapent ethyl market has decreased to approximately 53% in the year ended December 31, 2024 from approximately 57% in the year ended December 31, 2023. Additionally, based on prescription levels reported by Symphony Health, VASCEPA branded prescriptions decreased by 9% in the year ended December 31, 2024 as compared to the year ended December 31, 2023.
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. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 10% in the year ended December 31, 2025 as compared to the year ended December 31, 2024.
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.
The Company operates in one business segment. 71 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.
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.
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.
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.
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.
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 .
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 .
As of December 31, 2024, we had inventory of $230.8 million, of which approximately 60% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Financial Operations Overview Product revenue, net.
As of December 31, 2025, we had inventory of $195.9 million, of which approximately 50% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. Financial Operations Overview Product revenue, net.
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 as earned based on revenue recognized by our current partners. Cost of goods sold.
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.
(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. and Europe as well as regulatory expansion in the rest of the world.
(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. and globally as well as supporting our partners' regulatory filings throughout the rest of the world.
Our cash flows from operating, investing and financing activities, as reflected in the consolidated statements of cash flows, are summarized in the following table: Year Ended December 31, In millions 2024 2023 2022 Cash (used in) provided by: Operating activities $ (31.0 ) $ 6.9 $ (180.1 ) Investing activities (46.0 ) (25.5 ) 175.3 Financing activities (1.4 ) 0.2 (0.4 ) (Decrease) increase in cash and cash equivalents and restricted cash $ (78.4 ) $ (18.4 ) $ (5.2 ) 80 Net cash used in operating activities decreased during 2024 as compared to net cash provided by operating activities during the same period in 2023.
Our cash flows from operating, investing and financing activities, as reflected in the consolidated statements of cash flows, are summarized in the following table: Year Ended December 31, In millions 2025 2024 2023 Cash provided by (used in): Operating activities $ 6.7 $ (31.0 ) $ 6.9 Investing activities 8.8 (46.0 ) (25.5 ) Financing activities (2.0 ) (1.4 ) 0.2 Increase (decrease) in cash and cash equivalents and restricted cash $ 13.5 $ (78.4 ) $ (18.4 ) Net cash provided by operating activities increased during 2025 as compared to net cash used in operating activities during the same period in 2024.
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. On December 13, 2019, the U.S.
FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication. On December 13, 2019, 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.
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 76 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.
We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under Part II, Item IA, “Risk Factors” , and we could use our capital resources sooner than we expect or fail to achieve positive cash flow. We do not have any special purpose entities or other off-balance sheet arrangements.
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.
Research and development expenses for the years ended December 31, 2024 and 2023 are summarized in the table below: Year Ended December 31, In thousands 2024 2023 REDUCE-IT study and presentations (1) $ 1,202 $ 1,439 Fixed-dose combination (2) 44 1,064 Regulatory filing fees and expenses (3) 2,533 2,342 Non-clinical research activities (4) 2,534 1,248 Internal staffing, overhead and other (5) 11,017 11,939 Research and development expense, excluding non-cash expense 17,330 18,032 Non-cash stock-based compensation expense (6) 3,539 4,187 Total research and development expense $ 20,869 $ 22,219 79 (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.
Research and development expenses for the years ended December 31, 2025 and 2024 are summarized in the table below: Year Ended December 31, In thousands 2025 2024 REDUCE-IT study and presentations (1) $ 1,044 $ 1,202 Fixed-dose combination (2) — 44 Regulatory filing fees and expenses (3) 2,030 2,533 Non-clinical research activities (4) 1,000 2,534 Internal staffing, overhead and other (5) 13,271 11,017 Research and development expense, excluding non-cash expense 17,345 17,330 Non-cash stock-based compensation expense (6) 2,461 3,539 Total research and development expense $ 19,806 $ 20,869 (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.
During 2024, approximately $8.0 78 million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory. During 2023, approximately $5.1 million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory.
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.
Other income (expense), 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 . Provision for income taxes for the year ended December 31, 2024 and 2023 was $5.0 million and $5.4 million, respectively.
Other income, net . Other income, net, for the year ended December 31, 2025 and 2024 was $3.3 million and $1.2 million, respectively. 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 .
Amounts are recorded as accounts receivable when our right to consideration is unconditional. We do not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
We do not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
This average cost reflects the actual purchase price of VASCEPA API. 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.
This average cost reflects the actual purchase price of VASCEPA API. 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.
In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing.
In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic.
The decrease in the provision for income taxes is due to a change in geographic mix of pre-tax income. Liquidity and Capital Resources As of December 31, 2024, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $121.3 million and short-term investments of $173.2 million, aggregating $294.5 million. We have no indebtedness.
The decrease in the provision for income taxes is due to a change in geographic mix of pre-tax income. 82 Liquidity and Capital Resources As of December 31, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $134.9 million and short-term investments of $167.9 million, aggregating $302.8 million. We have no indebtedness.
Comparison of Fiscal Years Ended December 31, 2024 and December 31, 2023 Total revenue, net. We recorded total revenue, net, of $228.6 million and $306.9 million during the years ended December 31, 2024 and 2023, respectively, a decrease of $78.3 million, or 26%. Total revenue, net consists primarily of revenue from the sale of VASCEPA in the U.S..
Comparison of Fiscal Years Ended December 31, 2025 and December 31, 2024 Total revenue, net. We recorded total revenue, net, of $213.6 million and $228.6 million during the years ended December 31, 2025 and 2024, respectively, a decrease of $15.0 million, or 7%. Total revenue, net consists primarily of revenue from the sale of VASCEPA in the U.S.
We recognized total revenue, net of $228.6 million and $306.9 million during the years ended December 31, 2024 and 2023, respectively, of which $204.6 million and $285.3 million, respectively, was based on product revenue sales.
We recognized total revenue, net of $213.6 million and $228.6 million during the years ended December 31, 2025 and 2024, respectively, of which $182.8 million and $204.6 million, respectively, was based on product revenue sales.
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.
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.
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. Interest income, net and other income (expense), net.
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. Interest income, net and other income, net.
We recorded product revenue, net, of $204.6 million and $285.3 million during the years ended December 31, 2024 and 2023, respectively, a decrease of $80.7 million, or 28%. This decrease was due primarily to a 39% decrease in VASCEPA sales in the U.S..
We recorded product revenue, net, of $182.8 million and $204.6 million during the years ended December 31, 2025 and 2024, respectively, a decrease of $21.8 million, or 11%. This decrease was due primarily to a 8% decrease in VASCEPA sales in the U.S.
The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions. As of December 31, 2024, we had cash and cash equivalents of $121.0 million and short-term investments of $173.2 million, aggregating $294.2 million.
The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions. As of December 31, 2025, we had cash and cash equivalents of $134.7 million and short-term investments of $167.9 million, aggregating $302.6 million.
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.
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.
Licensing and royalty revenue during the years ended December 31, 2024 and 2023 was $24.0 million and $21.6 million, respectively, an increase of $2.4 million, or 11%.
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%.
Research and development expense for the years ended December 31, 2024 and 2023 was $20.9 million and $22.2 million, respectively, a decrease of $1.4 million, or 6%.
Research and development expense for the years ended December 31, 2025 and 2024 was $19.8 million and $20.9 million, respectively, a decrease of $1.1 million, or 5%.
(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%. 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.
(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. 81 Research and development expense.
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.
The time required to secure reimbursement varies from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe.
The Company will be responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the U.S. and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.
(4) - VASCEPA is under registration in additional countries in the ASEAN region with Lotus. 74 We will be 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.
Selling, general and administrative expenses for the years ended December 31, 2024 and 2023 are summarized in the table below: Year Ended December 31, In thousands 2024 2023 Selling expense (1) $ 79,587 $ 111,326 General and administrative expenses (2) 58,557 76,119 Non-cash stock-based compensation expense (3) 14,166 12,493 Total selling, general and administrative expense $ 152,310 $ 199,938 (1) Selling expense for the years ended December 31, 2024 and 2023 was $79.6 million and $111.3 million, respectively, a decrease of $31.7 million, or 29%.
Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 are summarized in the table below: Year Ended December 31, In thousands 2025 2024 Selling expense (1) $ 40,592 $ 79,587 General and administrative expenses (2) 65,167 58,557 Non-cash stock-based compensation expense (3) 9,244 14,166 Total selling, general and administrative expense $ 115,003 $ 152,310 (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%.
We receive payments from our customers based on billing schedules established in each contract. Upfront payments and fees are either recognized as licensing revenue or recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements.
Upfront payments and fees are either recognized as licensing revenue or recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements. Amounts are recorded as accounts receivable when our right to consideration is unconditional.
The increase is primarily due to the continued expansion within Europe and other countries throughout the world. (4) Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
(4) Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
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. and EMA regulatory approval authority, including in Mainland China, Switzerland, Australia, New Zealand and Israel, under the REDUCE-IT indication.
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. and EMA regulatory approval authority.
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%.
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%.
Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists rather than by general practitioners. Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies than in the U.S..
Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies than in the U.S. However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S.
Europe In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland. 70 Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 19 dossiers to gain market access in European countries, including in all of the largest countries in Europe.
Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date, we have filed 20 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching.
FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market: 69 Company FDA MARINE Indication Approval 1-gram Launch Date 0.5-gram Launch Date Hikma Pharmaceuticals USA Inc. May 2020 November 2020 March 2023 Dr. Reddy’s Laboratories, Inc. August 2020 June 2021 June 2023 Teva Pharmaceuticals USA, Inc. September 2020 January 2023 September 2022 Apotex, Inc.
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.
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. 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, 2024.
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.
As further 77 discussed below, the aforementioned decrease consists of a $107.2 million decrease in U.S. net product revenue, offset by increases of $26.5 million in net product revenue from sales of VASCEPA outside of the U.S. and $2.4 million in licensing and royalty revenue. Product revenue, net.
As further discussed below, the decrease consists of reductions of $12.6 million in U.S. 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.
Cost of goods sold. 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%.
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%.
FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S.
FDA 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. 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.
We are responsible for the supply of VASCEPA to all markets in which the branded product is sold, either to and through our collaborations with third-party companies or by us. We are not responsible for providing any generic company with drug product.
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.
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. as well as the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE.
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. We also continue to study the potential mechanisms of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE.
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: • 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.
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: • In November 2025, the American Heart Association, or AHA, released a Scientific Statement on Nonobstructive Coronary Artery Disease in Patients with Chest Pain.
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.
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. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
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.
Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S. 72 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).
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.
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.
On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA ® , hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels.
On 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.
Excluding the restructuring inventory and inventory write-off charges, gross margin was 50% and 66% for the years ended December 31, 2024 and 2023, respectively. The remaining decrease in gross margin is primarily as a result of a decrease in net selling price. Selling, general and administrative expense.
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. Selling, general and administrative expense. Selling, general and administrative expense for the years ended December 31, 2025 and 2024 was $115.0 million and $152.3 million, respectively, a decrease of $37.3 million, or 24%.
Country Individual Reimbursement National Reimbursement Product Availability Launch Date Sweden N/A March 2022 March 2022 March 2022 Finland N/A October 2022 December 2022 December 2022 England/Wales N/A July 2022 October 2022 October 2022 Spain N/A July 2023 September 2023 September 2023 Netherlands N/A August 2023 September 2023 September 2023 Scotland N/A August 2023 August 2023 September 2023 Greece (1) N/A May 2024 June 2024 June 2024 Portugal N/A August 2024 August 2024 September 2024 Italy N/A December 2024 December 2024 N/A Austria September 2022 February 2025 September 2022 N/A Denmark June 2022 N/A June 2022 N/A (1) Vianex S.A will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
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. 73 Country Individual Reimbursement National Reimbursement Product Availability Launch Date Sweden – March 2022 March 2022 March 2022 Finland – October 2022 December 2022 December 2022 England/Wales/Northern Ireland – July 2022 October 2022 October 2022 Spain – July 2023 September 2023 September 2023 Netherlands – August 2023 September 2023 September 2023 Scotland – August 2023 August 2023 September 2023 Greece (1) – May 2024 June 2024 June 2024 Portugal – August 2024 August 2024 September 2024 Italy – December 2024 December 2024 January 2025 Slovenia (2) – September 2025 October 2025 October 2025 Austria September 2022 February 2025 September 2022 – Denmark June 2022 – June 2022 – (1) - Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
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.
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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeOur portfolio of investments as of December 31, 2024 was 81 composed primarily of U.S. Treasury securities and other government-related securities. At December 31, 2024 and 2023, we had short-term investments of $173.2 million and $121.4 million, respectively. We invest funds to have a continuous inflow of cash from diversified short-term and long-term investments, consisting primarily of investment grade securities.
Biggest changeOur portfolio of investments as of December 31, 2025 was composed primarily of U.S. Treasury securities and other government-related securities. At December 31, 2025 and 2024, we had short-term investments of $167.9 million and $173.2 million, respectively. We invest funds to have a continuous inflow of cash from diversified short-term and long-term investments, consisting primarily of investment grade securities.

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