AMARIN CORP PLC\UK

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 50 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.

Previous wording

We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to determine the actual number of total prescriptions for products like VASCEPA during such periods. The vendor's estimate utilizes a proprietary projection methodology and is based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable. Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions.

Current wording

We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to determine the actual number of total prescriptions for products like VASCEPA during such periods. The vendor's estimate utilizes a proprietary projection methodology and is based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable. Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S.

Previous wording

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 wording

In June 2025, we entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe, or the Recordati Territory. As a result of the Recordati Licensing Agreement, we implemented a global restructuring plan, or the 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 our European operations.

Previous wording

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 wording

As a result of the Recordati Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory. Recordati may sell VAZKEPA pursuant to the product reimbursements we have already obtained in Europe and will use commercially reasonable efforts to pursue future approvals in the Recordati Territory.

Previous wording

(1) Vianex S.A will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.

Current wording

(1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.

Previous wording

In addition, we received regulatory approval in Switzerland by the Swiss Agency for Therapeutic Products, or Swissmedic. VAZKEPA has been made available under individual reimbursement since January 2023.

Current wording

In addition, we received regulatory approval in Switzerland by the Swiss Agency for Therapeutic Products, or Swissmedic. VAZKEPA has been made available in Switzerland under individual reimbursement since January 2023.

Previous wording

One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets. We and our partners have obtained varying levels of indication approvals and commercial launches in the respective territories. Through the date of this Quarterly 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. We have agreements in place with the following partners within the respective territories:

Current wording

One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets, outside the Recordati Territory. We and our RoW partners have obtained varying levels of indication approvals and initiated or are in the process of initiating commercial launches in various territories where our partners have access. Through the date of this Quarterly 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. We have agreements in place with the following partners within the respective territories:

Previous 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:

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 as well as guidelines which were newly received during the third quarter of 2025 as listed below:

Previous wording

In the second quarter of 2025, we and global medical and scientific collaborators supported thirteen publications inclusive of accepted abstracts, posters, and manuscripts.

Current wording

In the third quarter of 2025, we and global medical and scientific collaborators supported sixteen 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 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.

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 in the U.S. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. 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 September 30, 2025, we had inventory of $193.8 million, of which 49% 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

Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized as earned based on revenue recognized by our current partners.

Current wording

Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized when the uncertainty related to the consideration is resolved.

Previous wording

Provision for income taxes. Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the U.S. and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2025 and 2024 are not more likely than not to be realized.

Current wording

Benefit from (provision for) income taxes. Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the U.S. and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2025 and 2024 are not more likely than not to be realized.

Previous 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.

Current wording

Total revenue, net. We recorded total revenue, net, of $49.7 million and $42.3 million during the three months ended September 30, 2025 and 2024, respectively, an increase of $7.4 million, or 17%. 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 September 30, 2025, we also sold VASCEPA by prescription in certain countries outside of the U.S., through collaborations with third-party companies. As further discussed below, the aforementioned increase is due primarily to a $10.3 million increase in U.S. net product revenue and a $0.7 million increase in licensing and royalty revenue, offset by a $3.6 million decrease in net product revenue outside of the U.S.

Previous wording

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 wording

Product revenue, net. We recorded product revenue, net, of $48.6 million and $41.9 million during the three months ended September 30, 2025 and 2024, respectively, an increase of $6.7 million, or 16%. This increase was due primarily to an increase in VASCEPA sales within the U.S., offset by a decrease in VASCEPA sales outside the U.S.

Previous 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.

Current wording

We recorded U.S. product revenue, net, of $40.9 million and $30.6 million during the three months ended September 30, 2025 and 2024, respectively. This increase was due to increased net selling price as a result of our exit from the Medicaid and 340B programs on October 1, 2024, as well as an increase in volume primarily related to regaining a large national pharmacy benefit manager, or PBM, which transitioned from no longer covering VASCEPA to being exclusive.

Previous 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.

Current wording

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased by 2% for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. Our share of the icosapent ethyl market has increased to approximately 51% in the three months ended September 30, 2025 compared to approximately 50% in the three months ended September 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 3% in the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Previous 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.

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. Royalty payments are recognized based on revenue reported by our partners. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.

Previous wording

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 wording

Cost of goods sold. Cost of goods sold during the three months ended September 30, 2025 and 2024 was $27.5 million and $26.0 million, respectively, an increase of $1.4 million, or 6%. This increase in cost of goods sold is due to increased product volumes. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.

Previous 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.

Current wording

Our overall gross margin on product sales for the three months ended September 30, 2025 and 2024 was 43% and 38%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.

Previous 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:

Current wording

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended September 30, 2025 and 2024 was $19.7 million and $36.9 million, respectively, a decrease of $17.2 million, or 47%. Selling, general and administrative expenses for the three months ended September 30, 2025 and 2024 are summarized in the table below:

Previous wording

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 wording

Selling expense for the three months ended September 30, 2025 and 2024 was $5.4 million and $18.8 million, respectively, a decrease of $13.4 million, or 71%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan.

Previous 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.

Current wording

Non-cash stock-based compensation expense for the three months ended September 30, 2025 and 2024 was $1.8 million and $3.8 million, respectively, a decrease of $2.1 million, or 54%. 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 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:

Current wording

Research and development expense. Research and development expense for the three months ended September 30, 2025 and 2024 was $4.2 million and $4.5 million, respectively, a decrease of $0.3 million, or 7%. Research and development expenses for the three months ended September 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 the world.

Current wording

We continuously evaluate all of our research and development investment commitments and priorities and are prepared to adjust such investment levels based on various factors, including the impact of U.S. generic competition, as well as timing of pricing reimbursements throughout the world.

Previous wording

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 wording

Restructuring expense. Restructuring expense for the three months ended September 30, 2025 and 2024 was $9.4 million and nil, respectively. The charge in the current year is due to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.

Previous 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.

Current wording

Interest income, net. Interest income, net, for the three months ended September 30, 2025 and 2024 was $2.8 million and $3.4 million, respectively, a decrease of $0.6 million, or 18%. 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

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 wording

Other income, net. Other income, net, for the three months ended September 30, 2025 and 2024 was $0.2 million and $0.3 million, respectively, a decrease of $0.1 million, or 23%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Previous 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.

Current wording

Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the three months ended September 30, 2025 and 2024 was a benefit of $0.4 million and a provision of $3.6 million, respectively. The benefit for the three months ended September 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

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 wording

Total revenue, net. We recorded total revenue, net, of $164.4 million and $166.3 million during the nine months ended September 30, 2025 and 2024, respectively, a decrease of $1.9 million, or 1%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the nine months ended September 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 is due primarily to a $9.4 million decrease in U.S. net product revenue, offset in part by a $1.1 million increase in net product revenue outside of the U.S. and a $6.4 million increase in licensing and royalty revenue.

Previous 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..

Current wording

Product revenue, net. We recorded product revenue, net, of $136.2 million and $144.5 million during the nine months ended September 30, 2025 and 2024, respectively, a decrease of $8.3 million, or 6%. This decrease was due primarily to a 8% decrease in VASCEPA sales in the U.S..

Previous wording

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 wording

We recorded U.S. product revenue, net, of $113.0 million and $122.5 million during the nine months ended September 30, 2025 and 2024, respectively. This decrease was due to a decrease in volume primarily related to a large national PBM not covering VASCEPA during the first half of the year.

Previous wording

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 wording

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the nine months ended September 30, 2025 by 2% as compared to the nine months ended September 30, 2024. Our share of the icosapent ethyl market has decreased to approximately 45% in the nine months ended September 30, 2025 compared to approximately 55% in the nine months ended September 30, 2024. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 17% in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

Previous 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.

Current wording

In Europe, we recorded product revenue, net, of $16.1 million and $9.7 million during the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

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 wording

Licensing and royalty revenue. Licensing and royalty revenue during the nine months ended September 30, 2025 and 2024 was $28.2 million and $21.8 million, respectively, an increase of $6.4 million, or 30%. This increase was primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement and higher royalties as a result of an increase in partner sales within their respective territories. During the nine months ended September 30, 2024, we 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.

Previous 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.

Current wording

Cost of goods sold. Cost of goods sold during the nine months ended September 30, 2025 and 2024 was $66.7 million and $75.4 million, respectively, a decrease of $8.6 million, or 11%. 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 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 wording

Our overall gross margin on product sales for the nine months ended September 30, 2025 and 2024 was 51% and 48%, respectively. The increase in gross margin is primarily as a result of a change in customer mix.

Previous wording

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 wording

Selling, general and administrative expense. Selling, general and administrative expense for the nine months ended September 30, 2025 and 2024 was $94.9 million and $115.3 million, respectively, a decrease of $20.4 million, or 18%. Selling, general and administrative expenses for the nine months ended September 30, 2025 and 2024 are summarized in the table below:

Previous 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.

Current wording

Selling expense for the nine months ended September 30, 2025 and 2024 was $36.9 million and $59.7 million, respectively, a decrease of $22.8 million, or 38%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan, as well as decreased promotional and marketing initiatives and other cost optimization initiatives.

Previous 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

Current wording

General and administrative expense for the nine months ended September 30, 2025 and 2024 was $49.9 million and $44.1 million, respectively, an increase of $5.8 million, or 13%. This increase is primarily due to fees associated with the ADS Ratio Change and Recordati Licensing Agreement. This increase is offset by a decrease in branded pharma fees as a result of lower sales and the reduction of costs associated with the Global Restructuring Plan.

Previous wording

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 wording

Non-cash stock-based compensation expense for the nine months ended September 30, 2025 and 2024 was $8.2 million and $11.6 million, respectively, a decrease of $3.4 million, or 29%. 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.