What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-04-29 compared with 2025-10-29 · 143 added, 228 removed, 234 unchanged (61% of the section changed)

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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.

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 cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial.

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 cardiovascular risk in select high risk-patients, or the REDUCE-IT indication.

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.

FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in select high risk-patients, or the REDUCE-IT indication.

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.

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CSL Seqirus "CSL"(Australia/New Zealand)

Biologix FZCo "Biologix" (MENA)

Biologix FZCo "Biologix" (Middle East North Africa, or MENA)

Lotus Pharmaceuticals, "Lotus" (Southeast Asia)

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(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.

"Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) has been transitioned to Recordati.

We are responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate us for such supply.

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FDA approval with labeling consistent with the MARINE indication and have entered the U.S.

Company (ANDA Holder)

Distributed / Licensee

FDA MARINE Indication Approval

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Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc.;

Northstar Rx;

Bryant Ranch Pre-Pack

November 2020

Reddy’s Laboratories, Inc.

Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc.;

September 2020

September 2022

Apotex, Inc.;

American Health Packaging;

Golden State Medical Supply

Zydus Lifesciences

Strides Pharma (1)

Zydus Pharmaceuticals USA

Onesource Specialty (Amneal Original Filer)

Amneal Pharmaceuticals

September 2023

Humanwell Puracap

December 2023

Ascent Pharmaceuticals, Inc.

Camber Pharmaceuticals;

Northstar Rx;

XL Care Pharmaceuticals

December 2023

February 2024

December 2024

Qilu Pharmaceutical Co Ltd

November 2024

PharmaObedient (Spriaso Original Filer)

December 2024

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

(2) Ascent Pharmaceuticals, Inc.

licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc.

and XL Care Pharmaceuticals, Inc.

Xiamen LP Pharma Co.

Vitruvias Therapeutics

We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information.

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Further, data for a single and limited period may not be representative of a trend or otherwise predictive of future results.

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

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.

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.

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.

Individual Reimbursement

National Reimbursement

Product Availability

December 2022

England/Wales

September 2023

September 2024

December 2024

September 2025

September 2022

February 2025

September 2022

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

(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.

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.

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.

Rest of World (RoW)

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

and EMA regulatory approval authority.

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:

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November 2022

December 2025

Recordati (5)

(1) VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.

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(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.

(4) VASCEPA is under registration in additional countries in the ASEAN region with Lotus.

The Company will be responsible for supplying finished product to these partners.

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

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

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.

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.

Individual Reimbursement

National Reimbursement

Product Availability

December 2022

England/Wales/Northern Ireland

September 2023

September 2024

December 2024

September 2025

September 2022

February 2025

September 2022

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

(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.

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.

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.

Research and Development

Since its inception in 2011, the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development as well as the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE.

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.

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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.

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:

• 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:

o 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).

o 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.

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

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:

o 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.

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

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.

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.

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).

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.

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

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:

• 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.

• 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.

• 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.

• 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.

• 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.

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 from in vitro data highlighting the potential anti-coagulant effects of IPE through suppression of tissue factor.

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.

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.

Commercial and Clinical Supply

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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.

As of March 31, 2026, we had inventory of $183.6 million, of which 35% is inventory approved for use in North America.

Financial Operations Overview

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Our product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the U.S.

Outside of the U.S., currently the majority of our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners.

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.

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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.

Licensing and royalty revenue .

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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.

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.

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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.

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.

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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.

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.

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 2026 and 2025 are not more likely than not to be realized.

Critical Accounting Policies and Estimates

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Results of Operations

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

Comparison of Three Months Ended March 31, 2026 and March 31, 2025

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%.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high.

For the remainder of 2025, we will continue to (i) competitively manage our market leadership in the U.S., and (ii) drive expanded access and

increased patient uptake of VASCEPA through ongoing support of our commercialization partners and their pricing, reimbursement and licensure initiatives in non-U.S.

For the remainder of 2026, we will continue to (i) competitively manage our market leadership in the U.S., and (ii) drive expanded access and increased patient uptake of VASCEPA through ongoing support of our commercialization partners and their pricing, reimbursement and licensure initiatives in non-U.S.

geographies around the world.

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.

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.

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.

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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%.

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.

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This average cost reflects the actual purchase price of VASCEPA API.

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

The API included in the calculation of the average cost of goods sold during the quarters ended March 31, 2026 and 2025 was sourced from multiple API suppliers.

These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors.

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The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.

Our overall gross margin on product sales for the 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.

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.

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:

Three months ended September 30,

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:

Three months ended March 31,

Selling expense (1)

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Total selling, general and administrative expense

(1) 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%.

(1) 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.

(2) 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.

(3) 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%.

(2) 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.

(3) 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.

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.

The decrease is as a result of the Global Restructuring Plan.

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.

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:

Three months ended September 30,

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:

Three months ended March 31,

REDUCE-IT study and presentations (1)

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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.

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.

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.

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.

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

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.

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..

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.

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.

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.

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.

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.

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.

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.

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.

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:

Nine months ended September 30,

Selling expense (1)

General and administrative expense (2)

Non-cash stock-based compensation expense (3)

Total selling, general and administrative expense

(1) 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.

(2) 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.

(3) 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.

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:

Nine months ended September 30,

REDUCE-IT study and presentations (1)

Fixed-dose combination (2)

Regulatory filing fees and expenses (3)

Non-clinical research activities (4)

Internal staffing, overhead and other (5)

Research and development expense, excluding non-cash expense

Non-cash stock-based compensation expense (6)

Total research and development expense

(1) REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and to provide data to be published in medical journals.

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

(3) Regulatory and quality filing fees are primarily related to the preparation, submission and review defense of regulatory filings as well as assistance with securing and maintaining regulatory approvals for qualifying suppliers for VASCEPA in the U.S.

and Europe as well as regulatory expansion in the rest of the world.

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

(5) 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.

(6) Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to personnel supporting our research and development and regulatory functions.

Restructuring expense .

Restructuring expense for the nine months ended September 30, 2025 and 2024 was $32.2 million and nil, respectively.

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

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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, 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.

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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, 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.

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.

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.

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Liquidity and Capital Resources

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.

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.

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Our cash flows from operating, investing and financing activities, as reflected in the condensed consolidated statements of cash flows, are summarized in the following table:

Nine months ended September 30,

Cash (used in) provided by:

Three months ended March 31,

Cash provided by (used in):

Operating activities

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Financing activities

Increase (decrease) in cash and cash equivalents and restricted cash

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.

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.

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.

Decrease in cash and cash equivalents and restricted cash

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.

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.

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.

On January 10, 2024, we announced plans to initiate a share repurchase program to purchase up to $50.0 million of the Company's Ordinary Shares held in the form of American Depository Shares, or ADS.

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The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions.

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.

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.

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.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis