AMARIN CORP PLC\UK
For the period ended Jun 30, 2025. Filed Jul 30, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Jul 30, 2025
AMRN$11.61+0.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-07.
0000950170-25-064981
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-30.
0000950170-25-099879
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 106 previous paragraphs and 130 current paragraphs.
59 unchanged; 30 reworded; 24 added; 16 removed; 1 previous and 17 current paragraphs rearranged.
Tables are not compared: 7 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
In June 2025, the Company entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati EU Licensing Agreement, with Recordati, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe. As a result of the Recordati EU Licensing Agreement we implemented a global restructuring plan which we estimate will result in annual cost savings of approximately $70.0 million primarily from the elimination of commercial roles in the Company’s European operations.
Current report
As a result of the Recordati EU Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the EU Territory. Recordati may sell VAZKEPA pursuant to the product reimbursement’s we have already obtained in Europe and will use commercially reasonable efforts to pursue future approvals in the EU Territory.
Current report
(4) - VASCEPA is under registration in additional countries in the ASEAN region with Lotus.
Current report
In May 2025, the European Athrosclerosis Society, or EAS, issued a consensus statement to the guide management of metabolic disorders and their sequelae, in the European Heart Journal stating that high-dose IPE (2-4 g/day) is the only agent documented to lower cardiovascular risk in statin-treated individuals with elevated triglycerides.
Current report
In April 2025, at the European Society of Cardiology Preventive Cardiology, or ESC-PC, congress in Milan, Italy, we provided grant support for two poster presentations, one evaluating eligibility for and barriers to IPE utilization in a medical clinic, and another reporting on a project aimed to improve lipid lowering for secondary prevention in a primary healthcare facility.
Current report
In May 2025, at the EAS congress in Glasgow, UK, we provided grant support for two poster presentations, both reporting on the potential additive effects of eicosapentaenoic acid and a GLP-1 agonist on changes in protein expression associated with antioxidant and/or anti-inflammatory effects in response to inflammatory stimuli.
Current report
In June 2025, at the National Lipid Association scientific sessions in Miami, Florida, we provided grant support for a poster reporting on a pilot implementation strategy to improve post-acute coronary syndrome management of patients with hypertriglyceridemia.
Current report
Restructuring expense. Restructuring expense consists of restructuring costs incurred under our June 2025 global restructuring plan, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs.
Current report
Product revenue, net. We recorded product revenue, net, of $46.6 million and $47.5 million during the three months ended June 30, 2025 and 2024, respectively, a decrease of $0.9 million, or 2%. This decrease was due primarily to a decrease in VASCEPA sales within the U.S. offset by increase in VASCEPA sales outside the U.S.
Current report
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to support our partners advancing commercialization activities in markets with access and pricing and reimbursement activities to drive access in remaining geographies as well as being the market leader in the U.S.
Current report
Licensing and royalty revenue. Licensing and royalty revenue during the three months ended June 30, 2025 and 2024 was $26.1 million and $20.0 million, respectively, an increase of $6.1 million, or 31%. Licensing and royalty revenue has increased primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati EU Licensing Agreement. We previously recognized a $15.0 million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.
Current report
Selling, general and administrative expense. Selling, general and administrative expense for the three months ended June 30, 2025 and 2024 was $38.7 million and $38.5 million, respectively, an increase of $0.1 million. Selling, general and administrative expenses for the three months ended June 30, 2025 and 2024 are summarized in the table below:
Current report
General and administrative expense for the three months ended June 30, 2025 and 2024 was $21.2 million and $14.5 million, respectively, an increase of $6.7 million, or 46%. This increase is primarily due to fees incurred in association with Recordati EU Licensing Agreement offset by a decrease in costs as a result of cost optimization efforts.
Current report
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to support our partners advancing commercialization activities in markets with access and pricing and reimbursement activities to drive access in remaining geographies as well as being the market leader in the U.S.
Current report
Restructuring expense. Restructuring expense for the three months ended June 30, 2025 and 2024 was $22.8 million and nil, respectively, an increase of $22.8 million, or 100%. The charge in the current year is due to the implementation of a global restructuring plan associated with the execution of the Recordati EU Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.
Current report
Comparison of Six Months Ended June 30, 2025 and June 30, 2024
Current report
In Europe, we recorded product revenue, net, of $12.0 million and $5.4 million during the six months ended June 30, 2025 and 2024, respectively.
Current report
For the six months ended June 30, 2025, we recorded $3.5 million of product revenue, net, from our collaboration partners compared to $5.4 million during the six months ended June 30, 2024.
Current report
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to support our partners advancing commercialization activities in markets with access and pricing and reimbursement activities to drive access in remaining geographies as well as being the market leader in the U.S.
Current report
Licensing and royalty revenue. Licensing and royalty revenue during the six months ended June 30, 2025 and 2024 was $27.1 million and $21.3 million, respectively, an increase of $5.8 million, or 27%. Licensing and royalty revenue has increased primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati EU Licensing Agreement. We previously recognized a $15.0 million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.
Current report
Non-cash stock-based compensation expense for the six months ended June 30, 2025 and 2024 was $6.4 million and $7.7 million, respectively, a decrease of $1.3 million, or 17%. 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.
Current report
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to support our partners advancing commercialization activities in markets with access and pricing and reimbursement activities to drive access in remaining geographies as well as being the market leader in the U.S.
Current report
Research and development expense. Research and development expense for the six months ended June 30, 2025 and 2024 was $10.2 million and $10.3 million, respectively, a decrease of $0.1 million, or 1%. Research and development expenses for the six months ended June 30, 2025 and 2024 are summarized in the table below:
Current report
Restructuring expense. Restructuring expense for the six months ended June 30, 2025 and 2024 was $22.8 million and nil, respectively, an increase of $22.8 million, or 100%. The charge in the current year is due to the implementation of a global restructuring plan associated with the execution of the Recordati EU Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.
Removed paragraphs (16)
Previous report
We continue to advance our pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed. We are leveraging third-party relationships for various support activities and are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approaches to drive greater impact and improved cost efficiency, which is or will be utilized throughout Europe as commercial operations launch.
Previous report
In addition to the above partnerships, the Company partnered with Lotus Pharmaceuticals, or Lotus, in July 2023 to commercialize and distribute VAZKEPA in South Korea and nine other countries in Southeast Asia, or collectively ASEAN.
Previous report
In January 2025, the American Diabetes Association, or ADA, updated their recommendations for risk management in patients with cardiovascular disease in their Standards of Care in Diabetes. The following information was included regarding IPE:
Previous report
In individuals with ASCVD or other cardiovascular risk factors on a statin with managed LDL cholesterol but elevated triglycerides (150–499 mg/dL [1.7–5.6 mmol/L]), the addition of icosapent ethyl can be considered to reduce cardiovascular risk
Previous report
In February 2025, the American Association of Clinical Endocrinology, or AACE, issued a focused update of the 2017 AACE Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease and provided evidence-based recommendations for the pharmacologic management of adults with dyslipidemia by clinicians and their care teams. The following recommendations were included for patients with CVD or at increased risk for ASCVD:
Previous report
o
Previous report
In adults with hypertriglyceridemia (150-499 mg/dL) who have cardiovascular disease or who are at increased risk for ASCVD, AACE suggests for the use of EPA (IPE) in addition to statins.
Previous report
o
Previous report
In adults with hypertriglyceridemia (150-499 mg/dL) who have cardiovascular disease or are at increased risk for cardiovascular disease, AACE suggests against the use of EPA plus DHA in addition to statin therapy.
Previous report
o
Previous report
In adults with hypertriglyceridemia (150-499 mg/dL) who have ASCVD or are at increased risk for ASCVD, AACE recommends against the use of niacin in addition to usual care.
Previous report
o
Previous report
In March 2025, at the American College of Cardiology, or ACC, Scientific Sessions, we supported two posters, one looking at the antioxidant and anti-inflammatory effects of EPA in combination with a GLP-1 agonist on endothelial cells, and another looking at the antioxidant effects of EPA on Lp(a) as compared to small, dense, LDL and TG rich lipoprotein.
Previous report
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to advance our pricing and reimbursement and licensing activities to drive access in remaining geographies as well as being the market leader in the U.S.
Previous report
Licensing and royalty revenue. Licensing and royalty revenue during the three months ended March 31, 2025 and 2024 was $1.0 million and $1.4 million, respectively, a decrease of $0.4 million, or 28%. Licensing and royalty revenue has decreased primarily due to recognition of previously achieved milestone payments from Edding in the prior year.
Previous report
We are focused on getting VASCEPA to as many patients as possible by continuing to advance our pricing and reimbursement and licensing activities to drive access in remaining geographies, as well as advancing regulatory filings internationally. We will continue to evaluate all of our spending commitments and priorities based on this focus.
Reworded paragraphs (30)
Previous wording
We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication and we commercially launched in 2013. On December 13, 2019, the U.S. FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication. On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA®, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels. On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk. On June 1, 2023, we announced that regulatory approval from the National Medical Products Administration, or NMPA, for VASCEPA in Mainland China was received by our partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, for the MARINE indication and on June 28, 2024 for the REDUCE-IT indication. Through the date of this Quarterly Report, we have received regulatory approval for VASCEPA under the REDUCE-IT indication in 49 countries, including the U.S. and 27 EU Member States.
Current wording
We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication and we commercially launched in 2013. On December 13, 2019, the U.S. FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication. On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA®, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels. On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk. On June 1, 2023, we announced that regulatory approval from the National Medical Products Administration, or NMPA, for VASCEPA in Mainland China was received by our partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, for the MARINE indication and on June 28, 2024 for the REDUCE-IT indication. Through the date of this Quarterly Report, we have received regulatory approval for VASCEPA under the REDUCE-IT indication in 50 countries, including the U.S. and 27 EU Member States.
Previous wording
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.
Current wording
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.
Previous wording
Based on REDUCE-IT results, as of the date of the filing of this Quarterly 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 first quarter of 2025 as listed below:
Current wording
Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 55 clinical treatment guidelines, consensus statements or scientific statements from global medical or scientific societies or within peer reviewed journals have recognized the use of icosapent ethyl, or IPE, in appropriate at-risk patients for CV risk reductions, including those statements which we were informed of by our global partners in Canada, China, Southeast Asia, Australia, and the Middle East as well as guidelines which were newly received during the second quarter of 2025 as listed below:
Previous wording
In April of 2025, the National Heart Foundation of Australia & Cardiac Society of Australia and New Zealand issued a clinical guideline for diagnosing and managing acute coronary syndromes, or ACS. The following information was included regarding IPE as a practice point within the Post-ACS Pharmacotherapy section under lipid modifying therapies:
Current wording
In April 2025, the National Heart Foundation of Australia & Cardiac Society of Australia and New Zealand issued a clinical guideline for diagnosing and managing acute coronary syndromes, or ACS. The following information was included regarding IPE as a practice point within the Post-ACS Pharmacotherapy section under lipid modifying therapies:
Previous wording
In the first three months of 2025, we and global medical and scientific collaborators supported seven publications inclusive of accepted abstracts, posters, and manuscripts.
Current wording
In the second quarter of 2025, we and global medical and scientific collaborators supported thirteen publications inclusive of accepted abstracts, posters, and manuscripts.
Previous wording
We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of March 31, 2025, we had inventory of $216.9 million, of which 52% 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.
Current wording
We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of June 30, 2025, we had inventory of $210.8 million, of which 47% 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.
Previous wording
Total revenue, net. We recorded total revenue, net, of $42.0 million and $56.5 million during the three months ended March 31, 2025 and 2024, respectively, a decrease of $14.5 million, or 26%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S.. In addition to the U.S., during the three months ending March 31, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the U.S. and Europe, such as China and Canada, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists of a $12.5 million decrease in U.S. net product revenue and a $1.7 million decrease in net product revenue outside of the U.S., as well as a $0.4 million decrease in licensing and royalty revenue.
Current wording
Total revenue, net. We recorded total revenue, net, of $72.7 million and $67.5 million during the three months ended June 30, 2025 and 2024, respectively, an increase of $5.3 million, or 8%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the three months ending June 30, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as in certain countries outside of the U.S. and Europe, through collaborations with third-party companies. As further discussed below, the aforementioned increase consists in part of a $6.4 million increase in net product revenue outside of the U.S. and a $6.1 million increase in licensing and royalty revenue, offset by a $7.3 million decrease in U.S. net product revenue.
Previous wording
We recorded U.S. product revenue, net, of $35.7 million and $48.1 million during the three months ended March 31, 2025 and 2024, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national pharmacy benefit manager, or PBM, going from exclusive to no longer covering VASCEPA effective July 1, 2024.
Current wording
We recorded U.S. product revenue, net, of $36.5 million and $43.8 million during the three months ended June 30, 2025 and 2024, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national pharmacy benefit manager, or PBM, going from exclusive to no longer covering VASCEPA.
Previous wording
The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the three months ended March 31, 2025 by 3% as compared to the three months ended March 31, 2024. Our share of the icosapent ethyl market has decreased to approximately 42% in the three months ended March 31, 2025 compared to approximately 56% in the three months ended March 31, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 24% in the three months ended March 31, 2025 compared to the three months ended March 31, 2024.
Current wording
The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, remained consistent for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. Our share of the icosapent ethyl market has decreased to approximately 43% in the three months ended June 30, 2025 compared to approximately 59% in the three months ended June 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 28% in the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Previous wording
In Europe, we recorded product revenue, net, of $5.4 million and $1.9 million during the three months ended March 31, 2025 and 2024, respectively.
Current wording
In Europe, we recorded product revenue, net, of $6.6 million and $3.5 million during the three months ended June 30, 2025 and 2024, respectively.
Previous wording
For the three months ended March 31, 2025, we recorded nominal product revenue, net, from our collaboration partners compared to $5.2 million during the three months ended March 31, 2024.
Current wording
For the three months ended June 30, 2025, we recorded $3.5 million of product revenue, net, from our collaboration partners compared to $0.2 million during the three months ended June 30, 2024.
Previous wording
Licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.
Current wording
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. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.
Previous wording
Cost of goods sold. Cost of goods sold during the three months ended March 31, 2025 and 2024 was $16.9 million and $24.6 million, respectively, a decrease of $7.7 million, or 31%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.
Current wording
Cost of goods sold. Cost of goods sold during the three months ended June 30, 2025 and 2024 was $22.4 million and $24.7 million, respectively, a decrease of $2.3 million, or 9%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.
Previous wording
Our overall gross margin on product sales for the three months ended March 31, 2025 and 2024 was 59% and 55%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.
Current wording
Our overall gross margin on product sales for the three months ended June 30, 2025 and 2024 was 52% and 48%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.
Previous wording
Selling expense for the three months ended March 31, 2025 and 2024 was $16.9 million and $20.4 million, respectively, a decrease of $3.5 million, or 17%. This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.
Current wording
Selling expense for the three months ended June 30, 2025 and 2024 was $14.6 million and $20.5 million, respectively, a decrease of $5.9 million, or 29%. This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.
Previous wording
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.
Current wording
Non-cash stock-based compensation expense for the three months ended June 30, 2025 and 2024 was $2.9 million and $3.5 million, respectively, a decrease of $0.7 million, or 19%. 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.
Previous wording
Research and development expense. Research and development expense for the three months ended March 31, 2025 and 2024 was $5.3 million and $5.6 million, respectively, a decrease of $0.3 million, or 5%. Research and development expenses for the three months ended March 31, 2025 and 2024 are summarized in the table below:
Current wording
Research and development expense. Research and development expense for the three months ended June 30, 2025 and 2024 was $4.9 million and $4.7 million, respectively, an increase of $0.2 million, or 4%. Research and development expenses for the three months ended June 30, 2025 and 2024 are summarized in the table below:
Previous wording
We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S. generic competition as well as timing of pricing reimbursements throughout Europe.
Current wording
We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S. generic competition as well as timing of pricing reimbursements throughout the world.
Previous wording
Interest income, net. Interest income, net, for the three months ended March 31, 2025 and 2024 was $2.9 million and $3.4 million, respectively, a decrease of $0.5 million, or 15%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.
Current wording
Interest income, net. Interest income, net, for the three months ended June 30, 2025 and 2024 was $2.6 million and $3.3 million, respectively, a decrease of $0.7 million, or 20%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.
Previous wording
Provision for income taxes. Income tax provision for the three months ended March 31, 2025 and 2024 was $2.1 million and $1.3 million, respectively. The provision for the three months ended March 31, 2025 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full year estimated U.S. and foreign income tax liability.
Current wording
Provision for income taxes. Income tax provision for the three months ended June 30, 2025 and 2024 was $0.7 million and $1.4 million, respectively. The provision for the three months ended June 30, 2025 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full year estimated U.S. and foreign income tax liability.
Previous wording
Product revenue, net. We recorded product revenue, net, of $41.0 million and $55.2 million during the three months ended March 31, 2025 and 2024, respectively, a decrease of $14.1 million, or 26%. This decrease was due primarily to a 26% decrease in VASCEPA sales in the U.S..
Current wording
Product revenue, net. We recorded product revenue, net, of $87.7 million and $102.7 million during the six months ended June 30, 2025 and 2024, respectively, a decrease of $15.0 million, or 15%. This decrease was due primarily to a 21% decrease in VASCEPA sales in the U.S..
Previous wording
Selling, general and administrative expense. Selling, general and administrative expense for the three months ended March 31, 2025 and 2024 was $36.6 million and $39.9 million, respectively, a decrease of $3.3 million, or 8%. Selling, general and administrative expenses for the three months ended March 31, 2025 and 2024 are summarized in the table below:
Current wording
Selling, general and administrative expense. Selling, general and administrative expense for the six months ended June 30, 2025 and 2024 was $75.2 million and $78.4 million, respectively, a decrease of $3.2 million, or 4%. Selling, general and administrative expenses for the six months ended June 30, 2025 and 2024 are summarized in the table below:
Previous wording
General and administrative expense for the three months ended March 31, 2025 and 2024 was $16.1 million and $15.3 million, respectively, an increase of $0.8 million, or 6%. This increase is primarily due to fees associated with the ADS Ratio Change offset by a decrease in in branded pharma fees as a result of lower sales.
Current wording
General and administrative expense for the six months ended June 30, 2025 and 2024 was $37.3 million and $29.8 million, respectively, an increase of $7.5 million, or 25%. This increase is primarily due to fees associated with the ADS Ratio Change and Recordati EU Licensing Agreement offset by a decrease in branded pharma fees as a result of lower sales
Previous wording
Other income, net. Other income, net, for the three months ended March 31, 2025 and 2024 was $0.3 million and $1.5 million, respectively, a decrease of $1.3 million, or 84%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.
Current wording
Other (expense) income, net. Other (expense) income, net, for the six months ended June 30, 2025 and 2024 was income of $0.2 million and $1.7 million, respectively, a decrease of $1.5 million, or 90%. Other (expense) income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.
Previous wording
As of March 31, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $119.8 million and short-term investments of $162.3 million, aggregating $282.1 million. We have no indebtedness. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities of less than 90 days. Our short-term investments consist of securities that will be due in one year or less. We invest cash in excess of our immediate requirements, in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.
Current wording
As of June 30, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $148.2 million and short-term investments of $150.8 million, aggregating $298.7 million. We have no indebtedness. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities of less than 90 days. Our short-term investments consist of securities that will be due in one year or less. We invest cash in excess of our immediate requirements in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.
Previous wording
Net cash used in operating activities remained consistent during the three months ended March 31, 2025 as compared to the same period in 2024.
Current wording
Net cash provided by operating activities increased during the six months ended June 30, 2025 as compared to the net cash used in operating activities during the same period in 2024. This is primarily as a result of timing and payment of invoices and accruals in 2024.
Previous wording
Net cash provided by investing activities during the three months ended March 31, 2025 decreased due primarily to the proceeds from the maturity of $55.0 million in investment grade interest-bearing instruments offset by purchases of $42.9 million of investment grade interest-bearing instruments as compared to the same period in 2024 where proceeds from the maturity of investment grade interest-bearing instruments were $62.0 million, partially offset by $33.3 million in purchases of investment-grade interest bearing instruments.
Current wording
Net cash provided by investing activities during the six months ended June 30, 2025 decreased due primarily to proceeds from the maturity of $105.3 million in investment grade interest-bearing instruments offset by the purchases of $80.8 million of investment grade interest-bearing instruments as compared to the same period in 2024 where proceeds from the maturity of investment grade interest-bearing instruments were $133.0 million, partially offset by $99.6 million in purchases of investment-grade interest bearing instruments.
Previous wording
Net cash used in financing activities during the three months ended March 31, 2025 as compared to net cash provided by financing activities during the same period in 2024 was primarily as a result of a decrease in taxes paid on stock based-awards.
Current wording
Net cash used in financing activities during the six months ended June 30, 2025 as compared to net cash used in financing activities during the same period in 2024 was primarily as a result of a decrease in proceeds related to stock option exercises.
Previous wording
As of March 31, 2025, we had net accounts receivable of $106.7 million, current inventory of $159.5 million and long-term inventory of $57.4 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of March 31, 2025. We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API, the generic competition in the U.S. and pricing and reimbursement of VAZKEPA in Europe.
Current wording
As of June 30, 2025, we had net accounts receivable of $119.1 million, current inventory of $171.2 million and long-term inventory of $39.6 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of June 30, 2025. We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API and the generic competition in the U.S. and the efforts of our licensee of VAZKEPA in Europe.
Previous wording
As of March 31, 2025, we had cash and cash equivalents of $119.5 million and short-term investments of $162.3 million, aggregating $281.8 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and 2024 Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.
Current wording
As of June 30, 2025, we had cash and cash equivalents of $147.9 million and short-term investments of $150.8 million, aggregating $298.7 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the 2024 Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.
Rearranged current paragraphs (17)
Current report — wording carried from elsewhere
Other (expense) income, net. Other (expense) income, net, for the three months ended June 30, 2025 and 2024 was expense of $0.1 million and income of $0.1 million, respectively, a decrease of $0.2 million, or 159%. Other (expense) income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.
Current report — wording carried from elsewhere
Total revenue, net. We recorded total revenue, net, of $114.8 million and $124.0 million during the six months ended June 30, 2025 and 2024, respectively, a decrease of $9.3 million, or 7%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the six months ended June 30, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as in certain countries outside of the U.S. and Europe, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists of a $19.7 million decrease in U.S. net product revenue offset in part by a $4.7 million increase in net product revenue outside of the U.S. and a $5.8 million increase in licensing and royalty revenue.
Current report — wording carried from elsewhere
We recorded U.S. product revenue, net, of $72.2 million and $91.9 million during the six months ended June 30, 2025 and 2024, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national PBM, going from exclusive to no longer covering VASCEPA.
Current report — wording carried from elsewhere
The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the six months ended June 30, 2025 by 2% as compared to the six months ended June 30, 2024. Our share of the icosapent ethyl market has decreased to approximately 42% in the six months ended June 30, 2025 compared to approximately 57% in the six months ended June 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 26% in the six months ended June 30, 2025 compared to the six months ended June 30, 2024.
Current report — wording carried from elsewhere
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. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.
Current report — wording carried from elsewhere
Cost of goods sold. Cost of goods sold during the six months ended June 30, 2025 and 2024 was $39.3 million and $49.3 million, respectively, a decrease of $10.1 million, or 20%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.
Current report — wording carried from elsewhere
The API included in the calculation of the average cost of goods sold during the six months ended June 30, 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. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.
Current report — wording carried from elsewhere
Our overall gross margin on product sales for the six months ended June 30, 2025 and 2024 was 55% and 52%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.
Current report — wording carried from elsewhere
Selling expense for the six months ended June 30, 2025 and 2024 was $31.5 million and $40.9 million, respectively, a decrease of $9.4 million, or 23%. This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.
Current report — wording carried from elsewhere
Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research, development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated to specific projects. Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S. generic competition as well as timing of pricing reimbursements throughout the world.
Current report — wording carried from elsewhere
Interest income, net. Interest income, net, for the six months ended June 30, 2025 and 2024 was $5.5 million and $6.7 million, respectively, a decrease of $1.2 million, or 17%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.
Current report — wording carried from elsewhere
Provision for income taxes. Income tax provision for the six months ended June 30, 2025 and 2024 was $2.8 million and $2.7 million, respectively. The provision for income taxes for the six months ended June 30, 2025 is the result of income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full year estimated U.S. and foreign income tax liability.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.