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AMARIN CORP PLC\UK

For the period ended Mar 31, 2026. Filed Apr 29, 2026.

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About 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.

Mar 31, 2026 · Filed Apr 29, 2026

AMRN$11.61+0.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-10-29.

0001193125-25-254621

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-04-29.

0001193125-26-188940

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 139 previous paragraphs and 101 current paragraphs.

49 unchanged; 41 reworded; 11 added; 34 removed; 15 previous and 0 current paragraphs rearranged.

Tables are not compared: 9 previous and 7 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 (11)

Current report

(6) Refer to table below for listing of European countries with VAZKEPA currently available.

Current report

In January 2026, the American Diabetes Association, or ADA, released guidelines on Cardiovascular Disease and Risk Management in Standards of Care in Diabetes that stated that in individuals with Atherosclerotic Cardiovascular Disease, or ASCVD, or other CV risk factors on a statin with managed LDL-C but elevated TG (150–499 mg/dL [1.7–5.6 mmol/L]), the addition of IPE can be considered to reduce CV risk.

Current report

In January 2026, the Egyptian Heart Journal published the 2025 Egyptian guidelines for the management of dyslipidemia stating that LDL-C-lowering therapies reduce ASCVD risk regardless of TG level and in statin-treated patients with TG 135–499 mg/dL, IPE (2 g twice daily) is recommended.

Current report

In March 2026, the American College of Cardiology/American Heart Association/Multi-society Dyslipidemia Guidelines were released. These guidelines recognize that elevated TG levels contribute meaningfully to CV disease burden and ongoing CV events even in patients achieving LDL-C targets, underscoring the need for complementary therapeutic approaches beyond statin monotherapy to further reduce risk in high and very high-risk populations. IPE is the only primary TG-lowering medication that reduces ASCVD event risk in combination with statin therapy.

Current report

In March 2026, the ESC Council on Basic Cardiovascular Science, or CBCS, and associated working groups, released a scientific statement on novel CV metabolic risk factor mechanisms and therapeutic opportunities, in the European Heart Journal. The statement noted that not only does IPE cause substantial declines in TG levels, but also reduced CV events compared to placebo. The beneficial CV effects of IPE eicosapentaenoic acid ethyl ester or EPA-E, extended beyond TG level reduction, suggesting additional CV benefits of this class. IPE also promotes plaque stabilization in patients with documented coronary atherosclerosis likely by modulating inflammation, oxidative stress, and endothelial function.

Current report

In March 2026, the Polish Diabetes Association released, Clinical Recommendations on the Management of Individuals with Diabetes – 2026 Position Statement of Diabetes Poland, in Current Topics of Diabetes, the Official Journal of the Diabetes Poland. The recommendations stated that for individuals with HTG (TG: 135–499 mg/dl; 1.52–5.6 mmol/l), the use of high-dose EPA (2 g twice daily) in combination with a statin may be considered.

Current report

In January 2026, at the LS2 Cardiovascular Research meeting in Bern, Switzerland, we provided support to global collaborators for a poster presentation from within the REDUCE-IT dataset as well as fromin vitro data highlighting the potential anti-coagulant effects of IPE through suppression of tissue factor.

Current report

In March 2026, at the American College of Cardiology, or ACC, meeting in New Orleans, LA, USA, we provided support to global collaborators for two presentations, one poster and one oral. The poster presentation reported the inhibitory actions of EPA on the rate of Lipoprotein(a), or Lp(a), oxidation. The oral presentation looked at a secondary analysis of the REDUCE-IT dataset highlighting the efficacy of IPE among patients at extreme CV risk.

Current report

U.S. product revenue, net, remained consistent at $35.6 million during the three months ended March 31, 2026, compared to $35.7 million for the during the three months ended March 31, 2025.

Current report

Net cash provided by operating activities increased during the three months ended March 31, 2026 as compared to the net cash used in operating activities during the same period in 2025. This is primarily driven by the Global Restructuring Plan and the resulting cost savings, including the elimination of commercial roles in our European operations.
Removed paragraphs (34)

Previous report

(1) Strides Pharma licensed its rights to the generic version of icosapent ethyl to Amneal Pharmaceuticals.

Previous report

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc. and XL Care Pharmaceuticals, Inc.

Previous report

Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 19 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement varies from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Quarterly Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

Previous report

Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists, rather than by general practitioners. Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies than in the U.S. However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S. In Europe, VAZKEPA has the benefit of 10 years of market protection, and in April 2024 we were issued a patent that extended our exclusivity to 2039.

Previous report

In August 2025, the European Society of Cardiology and the European Atherosclerosis Society, or ESC and EAS, respectively, issued a focused update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. The following information was included regarding IPE:

Previous report

High-dose IPE (2 × 2 g/day) should be considered in combination with a statin in high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135–499 mg/dL or 1.52–5.63 mmol/L) to reduce the risk of cardiovascular events (Class IIa recommendation; Level B evidence).

Previous report

Proposed mechanisms of action of how eicosapentaenoic acid, or EPA, specifically reduces cardiovascular risk are the distinct effects on lipid oxidation, inflammation, membrane structure/organization, cholesterol domain formation, and endothelial function. In view of the newer evidence from the STRENGTH trial, this Focused Update revised the respective recommendation for polyunsaturated fatty acids, or PUFAs, by explicitly stating that high-dose IPE (as in the REDUCE-IT trial) should be considered for high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135-499 mg/dL [1.52-5.63 mmol/L]) despite statin therapy to lower cardiovascular disease, or CVD, events.

Previous report

In September 2025, a consensus statement by the American Association of Clinical Endocrinologists, or AACE, on the

Previous report

Algorithm for Management of Adults with Dyslipidemia 2025 Update, was released. A multidisciplinary task force with representatives from AACE and several international co-sponsoring organizations (Canadian Cardiovascular Society, European Association for the Study of Diabetes, and the Latin American Academy for the Study of Lipids and Cardiometabolic Risk) were appointed to determine the scope and breadth of the algorithm and the areas in need of updated guidance. The specific update regarding IPE in the new guidance includes the following:

Previous report

For those with mild to moderate hypertriglyceridemia (TG 150-499 mg/dL; 1.75.6 mmol/L), the primary concern is excess atherosclerotic cardiovascular disease, or ASCVD, risk, and the primary target must be Low-Density Lipoprotein Cholesterol, or LDL-C. This may also expand to individuals with TG in the 500 to 884 mg/dL (5.6-9.9 mmol/L) range in whom the presence of atherogenic lipoproteins predisposes them to ASCVD.

Previous report

If ASCVD risk is high or intermediate, medications with proven cardiovascular benefit, such as statins, ezetimibe, and EPA monotherapy (IPE) are preferred.

Previous report

In July 2025, at the Heart UK meeting in Coventry, England, we provided, along with our collaborators, support for a REDUCE-IT poster presentation analyzing the efficacy of IPE by burden of standard modifiable CV risk factors. This same data analysis was later presented in August of 2025 as an ENCORE poster presentation at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand, or CSANZ, with support from our partners in Australia, CSL.

Previous report

In August 2025, at the Australasian Diabetes Congress, or ADC, in Queensland, Australia, we along with CSL and our collaborators supported an ENCORE poster presentation analyzing the reduction in ischemic events with IPE in patients with diabetes and prior coronary artery bypass graft, or CABG.

Previous report

At the European Society of Cardiology, or ESC, scientific session which occurred from August 29 to Sept. 1, 2025, in Madrid, Spain, we supported along with out and global collaborators five separate presentations ranging from the effect of IPE on risk and duration of hospitalizations and death in REDUCE-IT to mechanistic data looking at the antioxidant effects of EPA on Lp(a).

Previous report

In September 2025, at the European Association for the Study of Diabetes, or EASD, congress in Vienna, Austria, we supported, along with our global collaborators an oral presentation analyzing the efficacy of IPE across the spectrum of baseline triglyceride to glucose index.

Previous report

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 report

Comparison of Nine Months Ended September 30, 2025 and September 30, 2024

Previous report

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 report

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 report

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 report

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 report

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 report

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 report

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 report

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.

Previous report

Research and development expense. Research and development expense for the nine months ended September 30, 2025 and 2024 was $14.4 million and $14.9 million, respectively, a decrease of $0.4 million, or 3%. Research and development expenses for the nine months ended September 30, 2025 and 2024 are summarized in the table below:

Previous report

Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 but was subsequently deprioritized during 2023.

Previous report

Net cash used in operating activities decreased during the nine months ended September 30, 2025 as compared to the same period in 2024. This is primarily as a result of timing and payment of invoices and accruals in 2024.
Reworded paragraphs (41)

Previous wording

Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of our long-term cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients, or the REDUCE-IT indication.

Current wording

Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or HTG, or the MARINE indication. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of our long-term CV outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in select high risk-patients, or the REDUCE-IT indication.

Previous wording

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA®, hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk statin-treated adult patients who have elevated triglycerides (>150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

Current wording

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA®, hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of CV events in high-risk statin-treated adult patients who have elevated TGs (>150 mg/dL) and either established CV disease or diabetes and at least one additional CV risk event. On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce CV risk. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

Previous wording

(1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) will be transitioned to Recordati.

Current wording

(1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) has been transitioned to Recordati.

Previous wording

VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 27 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:

Current wording

VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 30 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:

Previous 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:

Current 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 initiated or are in the process of initiating commercial launches in various territories where our partners have access. We and our partners continue to seek additional regulatory approvals in the countries in which our partners operate. We have agreements in place with the following partners within the respective territories:

Previous wording

(3) - VASCEPA is under registration in additional countries in the Israel territory with Neopharm. Revenue earned from sales of VASECPA within the Israel territory are recorded within European revenue.

Current wording

(3) VASCEPA is under registration in additional countries in the Israel territory with Neopharm.

Previous 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.

Current wording

(5) VASCEPA is under registration in 59 countries focused in Europe with Recordati.

Previous wording

In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland.

Current wording

In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland with 10 years of market protection, and in April 2024, we were issued a patent that extended our exclusivity to 2039.

Previous 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.

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, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory. Recordati may sell VAZKEPA pursuant to the product reimbursements we have already obtained in Europe, as shown below, and the agreements with existing partners in the Recordati Territory being transitioned to Recordati. In addition, Recordati will use commercially reasonable efforts to pursue future product reimbursements and approvals in the Recordati Territory.

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 with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.

Current wording

We are responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.

Previous wording

Since its inception in 2011, the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development as well as the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S. and continue to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study.

Current wording

Since its inception in 2011, the REDUCE-IT CV outcomes study of VASCEPA has been the centerpiece of our research and development. We also continue to study the potential mechanisms of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S. and continue to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study.

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 as well as guidelines which were newly received during the third 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 70 clinical treatment guidelines, consensus statements or scientific statements from global medical or scientific societies or within peer reviewed journals have recognized the use of 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 first quarter of 2026 as listed below:

Previous wording

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

Current wording

During the three months ended March 31, 2026, we and global medical and scientific collaborators supported a total of 6 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 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.

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. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. As of March 31, 2026, we had inventory of $183.6 million, of which 35% is inventory approved for use in North America.

Previous wording

Outside of the U.S., currently the majority of our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly. We also derive product revenue from sales of our product to a limited number of wholesalers in Europe, most of whom in turn resell the product to pharmacies for purposes of their reselling the product to fill patient prescriptions.

Current wording

Outside of the U.S., our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly.

Previous wording

Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our sales, marketing, executive, business development, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

Current wording

Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our marketing, executive, business development, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

Previous wording

Interest income, net and other income (expense), net. Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term and long-term investments. Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income.

Current wording

Interest income, net and other income (expense), net. Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term investments. Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income.

Previous 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.

Current wording

Total revenue, net. We recorded total revenue, net, of $45.1 million and $42.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $3.1 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 three months ending March 31, 2026, we also sold VASCEPA by prescription in certain countries outside of the U.S. through collaborations with third-party companies. As further discussed below, the aforementioned increase is due primarily to a $2.3 million increase in net product revenue outside of the U.S and a $0.8 million increase in licensing and royalty revenue.

Previous 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.

Current wording

Product revenue, net. We recorded product revenue, net, of $43.3 million and $41.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $2.3 million, or 6%. This increase was due primarily to an increase in VASCEPA sales outside the U.S.

Previous 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.

Current wording

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased by 3% for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. Our share of the icosapent ethyl market has increased to approximately 48% in the three months ended March 31, 2026 compared to approximately 42% in the three months ended March 31, 2025. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 17% in the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Previous wording

In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended September 30, 2025, we recorded Europe product revenue, net, of $4.1 million compared to $4.3 million during the three months ended September 30, 2024.

Current wording

In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended March 31, 2026, we recorded Europe product revenue, net, of $4.9 million compared to $5.4 million during the three months ended March 31, 2025, primarily due to the change in business structure within Europe.

Previous wording

For the three months ended September 30, 2025, we recorded RoW product revenue, net, of $3.6 million from our six collaboration partners, comprising multiple distinct geographies, compared to $6.9 million during the three months ended September 30, 2024.

Current wording

For the three months ended March 31, 2026, we recorded RoW product revenue, net, of $2.8 million from our six other collaboration partners, comprising multiple distinct geographies, compared to a nominal amount during the three months ended March 31, 2025. The increase reflects normal variability across the multiple geographies encompassing this early stage of a developing ex-U.S. market.

Previous wording

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended September 30, 2025 and 2024 was $1.1 million and $0.4 million, respectively, an increase of $0.7 million, or 149%. This increase was primarily due to higher royalties as a result of increased partner sales within their respective territories.

Current wording

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended March 31, 2026 and 2025 was $1.8 million and $1.0 million, respectively, an increase of $0.8 million, or 84%. This increase was primarily due to higher royalties as a result of moving to a partnering model in Europe as of June 2025 and an increase in partner sales within their respective territories.

Previous 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.

Current wording

Cost of goods sold. Cost of goods sold during the three months ended March 31, 2026 and 2025 was $27.4 million and $16.9 million, respectively, an increase of $10.5 million, or 62%. 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 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.

Current wording

Our overall gross margin on product sales for the three months ended March 31, 2026 and 2025 was 37% and 59%, respectively. The decrease 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 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:

Current wording

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended March 31, 2026 and 2025 was $21.1 million and $36.6 million, respectively, a decrease of $15.5 million, or 42%. Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below:

Previous 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.

Current wording

Selling expense for the three months ended March 31, 2026 and 2025 was $3.9 million and $16.9 million, respectively, a decrease of $13.0 million, or 77%. This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan.

Previous wording

General and administrative expense for the three months ended September 30, 2025 and 2024 was $12.6 million and $14.3 million, respectively, a decrease of $1.7 million, or 12%. This decrease is primarily due to decrease in employee-related costs as a result of the reduction in force from the Global Restructuring Plan.

Current wording

General and administrative expense for the three months ended March 31, 2026 and 2025 was $15.5 million and $16.1 million, respectively, a decrease of $0.6 million, or 4%. This decrease is primarily due to previous fees incurred related to the ADS Ratio Change incurred in the prior year as well as a decrease in employee-related costs due to the reduction in force from the Global Restructuring Plan offset by costs associated with a litigation settlement in the current year.

Previous 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.

Current wording

Non-cash stock-based compensation expense for the three months ended March 31, 2026 and 2025 was $1.7 million and $3.5 million, respectively, a decrease of $1.8 million, or 51%. 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. The decrease is as a result of the Global Restructuring Plan.

Previous wording

Subsequent to the Recordati Licensing Agreement, we will continue to manage our spending commitments to support our partners advancing commercialization and pricing and reimbursement efforts, as well as maintaining market leadership in the U.S.

Current wording

We will continue to manage our spending commitments to support our partners advancing commercialization and pricing and reimbursement efforts, as well as maintaining market leadership in the U.S.

Previous 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:

Current wording

Research and development expense. Research and development expense for the three months ended March 31, 2026 and 2025 was $4.7 million and $5.3 million, respectively, a decrease of $0.6 million, or 12%. Research and development expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below:

Previous 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.

Current wording

Restructuring expense. Restructuring expense for the three months ended March 31, 2026 and 2025 was $3.3 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 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.

Current wording

Interest income, net. Interest income, net, for the three months ended March 31, 2026 and 2025 was $2.4 million and $2.9 million, respectively, a decrease of $0.4 million, or 16%. 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 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.

Current wording

Other income, net. Other income, net, for the three months ended March 31, 2026 and 2025 was $0.2 million and $0.3 million, respectively, a decrease of $0.1 million, or 26%. 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

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.

Current wording

Provision for income taxes. Income tax provision for the three months ended March 31, 2026 and 2025 was $1.8 million and $2.1 million, respectively. The provision for the three months ended March 31, 2026 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full-year estimated U.S. and foreign income tax liability.

Previous wording

As of September 30, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $123.1 million and short-term investments of $163.8 million, aggregating $286.6 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 March 31, 2026, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $131.3 million and short-term investments of $176.8 million, aggregating $307.8 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 provided by investing activities during the nine months ended September 30, 2025 decreased due primarily to proceeds from the maturity of $162.3 million in investment grade interest-bearing instruments offset by the purchases of $150.0 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 $185.8 million, partially offset by $208.9 million in purchases of investment-grade interest bearing instruments.

Current wording

Net cash used in investing activities during the three months ended March 31, 2026 decreased due primarily to the purchases of $50.8 million of investment grade interest-bearing instruments offset by proceeds from the maturity of $42.5 million in investment grade interest-bearing instruments as compared to the same period in 2025 where proceeds from the maturity of investment grade interest-bearing instruments were $55.0 million, partially offset by $42.9 million in purchases of investment-grade interest bearing instruments.

Previous wording

Net cash used in financing activities during the nine months ended September 30, 2025 as compared to the same period in 2024 was primarily as a result of taxes paid on stock-based awards.

Current wording

Net cash used in financing activities increased during the three months ended March 31, 2026 as compared to the same period in 2025 was as a result of taxes paid on stock-based awards.

Previous wording

As of September 30, 2025, we had net accounts receivable of $127.3 million, current inventory of $184.7 million and long-term inventory of $9.1 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of September 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.

Current wording

As of March 31, 2026, we had net accounts receivable of $108.1 million and inventory of $183.6 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 March 31, 2026.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $122.8 million and short-term investments of $163.8 million, aggregating $286.6 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

Current wording

As of March 31, 2026, we had cash and cash equivalents of $131.1 million and short-term investments of $176.8 million, aggregating $307.8 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 if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

Showing the first 40 of 41 pairs. Open the source sections for the rest.

Rearranged previous paragraphs (15)

Previous report — wording carried elsewhere

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 report — wording carried elsewhere

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 report — wording carried elsewhere

For the nine months ended September 30, 2025, we recorded RoW product revenue, net, of $7.1 million from our six collaboration partners, comprising multiple distinct geographies, compared to $12.3 million during the nine months ended September 30, 2024.

Previous report — wording carried elsewhere

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 report — wording carried elsewhere

The API included in the calculation of the average cost of goods sold during the nine months ended September 30, 2025 and 2024 was sourced from multiple API suppliers.

Previous report — wording carried elsewhere

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 report — wording carried 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.

Previous report — wording carried 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.

Previous report — wording carried elsewhere

Non-clinical research activities are primarily related to ongoing experiments and analyses further exploring the potential biological activities of IPE.

Previous report — wording carried 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.

Previous report — wording carried 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.

Previous report — wording carried elsewhere

Restructuring expense. Restructuring expense for the nine months ended September 30, 2025 and 2024 was $32.2 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 report — wording carried elsewhere

Interest income, net. Interest income, net, for the nine months ended September 30, 2025 and 2024 was $8.3 million and $10.0 million, respectively, a decrease of $1.8 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.

Previous report — wording carried elsewhere

Other income, net. Other income, net, for the nine months ended September 30, 2025 and 2024 was $0.4 million and $2.0 million, respectively, a decrease of $1.6 million, or 81%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Previous report — wording carried elsewhere

Benefit from (provision for) income taxes. Income tax benefit from (provision for) for the nine months ended September 30, 2025 and 2024 were provisions of $2.4 million and $6.3 million, respectively. The provision for income taxes for the nine months ended September 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.