What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-07-29 compared with 2026-04-29 · 165 added, 83 removed, 294 unchanged (46% of the section changed)

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Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire.

We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or our Annual Report, and under Part II, Item IA, “Risk Factors” of this Quarterly Report.

Given these uncertainties, you should not place undue reliance on these forward-looking statements.

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We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.

Our commercialized product, VASCEPA ® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S.

Our commercialized product, VASCEPA ® (icosapent ethyl, or IPE) 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.

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 CV 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.

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 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 TG ( > 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.

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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) has been transitioned to Recordati.

"Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) have 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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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.

As a result, the following generic versions of IPE have obtained U.S.

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

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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.

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

(3) Magnapharm will be the sole and exclusive distributor of VAZKEPA in the Romanian 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.

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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.

We also continue to study the potential mechanisms of action of the single active ingredient in VASCEPA, 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 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.

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 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 second quarter of 2026 as listed below:

• In April 2026, the European Federation of Internal Medicine released Assessment and Management of Cardiovascular–Kidney–Liver Metabolic-Syndrome in the Primary Care Setting:

A Multidisciplinary Consensus Statement, in the European Journal of Internal Medicine.

This stated that treatment of elevated triglycerides, or TG, can be considered in high- or very-high-risk patients, with elevated TG (1.52–5.63 mmol/L or 135–499 mg/dL).

High-dose IPE (2 g twice daily) could be added to statin therapy to reduce CV risk.

• In May 2026, the American Heart Association, or AHA, released a 2026 Scientific Statement update on the Secondary Prevention After Coronary Artery Bypass Graft Surgery, which stated that as a third line therapy if the combination of statin and ezetimibe still fails to achieve the target Low-Density Lipoprotein Cholesterol, or LDL-C, thresholds then consider either PCSK9 inhibitor or IPE if the TG level is between 135 mg/dL (1.5 mmol/L) and 500 mg/dL (5.6 mmol/L).

• In June 2026, the American College of Cardiology/AHA Joint Committee released a report;

the 2026 AHA/American College of Cardiology, or ACC/American Diabetes Association, or ADA/American Society of Nephrology, or ASN, Guideline for the Prevention, Detection, Evaluation, and Management of Cardiovascular-Kidney-Metabolic Syndrome.

This report states that for those with persistent HTG on maximally tolerated statins, or with additional CV risk factors, IPE can be considered to lower ASCVD risk.

In addition, studies using relative-risk reduction estimates from RCTs and absolute event rates from epidemiologic studies of CAC demonstrate that moderate-to-severe CAC identifies patients at high absolute CVD risk who are most likely to benefit from several preventive therapies indicated for CKM syndrome (statins, GLP-1–based therapy, aggressive BP lowering, and IPE in those with HTG).

In May 2026, at the Digestive Disease Week meeting in Chicago, IL, researchers from Harvard working on an Amarin supported investigator-initiated trial presented data at a poster session.

The poster presentation included data on the effect of IPE treatment on fecal metabolites and microbiome among patients with a history of adenoma, and results from a secondary analysis of a prospective, single-arm clinical study.

In May 2026, at the European Atherosclerosis Society meeting in Athens, Greece, global collaborators presented two Amarin supported oral E-poster presentations.

The first presentation reported data on how risk-weighted apolipoprotein B compares to traditional lipid biomarkers in predicting residual CV risk in statin-treated hypertriglyceridemic patients, post hoc analysis of the REDUCE-IT placebo arm.

The second presentation reported on residual CV risk from elevated TG in established atherosclerotic CV disease patients from the CPRD database in the UK.

In June 2026, at the European Society for Clinical Investigation meeting in Lisbon, Portugal, at an oral poster presentation, global collaborators presented a post-hoc analysis of REDUCE-IT reporting the impact of IPE on coagulation biomarkers and clinical outcomes in high-risk CV patients.

In June 2026, at the National Lipid Association meeting in Chicago, IL, researchers from the Geisinger Health System reported on designing and implementation strategies for improving best clinician practices of HTG management in patients post-ACS as a poster presentation.

During the six months ended June 30, 2026, Amarin and global medical and scientific collaborators supported a total of 12 publications inclusive of accepted abstracts, posters, and manuscripts.

Commercial and Clinical Supply

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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.

As of June 30, 2026, we had inventory of $164.1 million, of which 43% is inventory approved for use in North America.

Financial Operations Overview

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

Cost of goods sold may vary by region due to regional approval requirements.

Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country.

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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 investments.

Interest income, net, consists primarily of interest earned on our cash and cash equivalents, as well as on our short-term investments.

Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income.

Benefit from (provision for) income taxes.

Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid.

Benefit from (provision for) income taxes, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid.

We are subject to income taxes in both the U.S.

and foreign jurisdictions.

In applying guidance prescribed under ASC 740 and based on present evidence and

conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2026 and 2025 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 March 31, 2026 and March 31, 2025

Comparison of Three Months Ended June 30, 2026 and June 30, 2025

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%.

We recorded total revenue, net, of $42.2 million and $72.7 million during the three months ended June 30, 2026 and 2025, respectively, a decrease of $30.5 million, or 42%.

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.

In addition to the U.S., during the three months ending June 30, 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 decrease is due primarily to a $23.0 million decrease in licensing and royalty revenue, a $4.3 million decrease in U.S.

net product revenue and a $3.3 million decrease in net product revenue outside of the U.S.

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.

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.

We recorded product revenue, net, of $39.1 million and $46.6 million during the three months ended June 30, 2026 and 2025, respectively, a decrease of $7.5 million, or 16%.

This decrease was due primarily to decreases in VASCEPA prices within the U.S., transition of European operations to Recordati and lower sales to our partners outside Europe.

We recorded U.S.

product revenue, net, of $32.2 million and $36.5 million during the three months ended June 30, 2026 and 2025, respectively.

This decrease was primarily due to a lower net selling price associated with changes in customer mix.

The overall IPE market in the U.S., based on prescription levels reported by Symphony Health, increased by 3% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

Our share of the IPE market has increased to approximately 48% in the three months ended June 30, 2026 compared to approximately 43% in the three months ended June 30, 2025.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 17% in the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

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.

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.

For the three months ended June 30, 2026, we recorded Europe product revenue, net, of $5.4 million compared to $6.6 million during the three months ended June 30, 2025, primarily due to the change in business structure within Europe.

For the three months ended June 30, 2026, we recorded RoW product revenue, net, of $1.4 million from our six collaboration partners, comprising multiple distinct geographies, compared to $3.5 million during the three months ended June 30, 2025.

The decrease 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.

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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.

Licensing and royalty revenue during the three months ended June 30, 2026 and 2025 was $3.1 million and $26.1 million, respectively, a decrease of $23.0 million, or 88%.

This decrease was primarily due to the recognition of a

$25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement in prior year offset by higher royalties as a result of increased 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 March 31, 2026 and 2025 was $27.4 million and $16.9 million, respectively, an increase of $10.5 million, or 62%.

Cost of goods sold during the three months ended June 30, 2026 and 2025 was $27.2 million and $22.4 million, respectively, an increase of $4.8 million, or 22%.

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 March 31, 2026 and 2025 was sourced from multiple API suppliers.

The API included in the calculation of the average cost of goods sold during the quarters ended June 30, 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 March 31, 2026 and 2025 was 37% and 59%, respectively.

Our overall gross margin on product sales for the three months ended June 30, 2026 and 2025 was 30% and 52%, 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 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, general and administrative expense for the three months ended June 30, 2026 and 2025 was $22.2 million and $38.7 million, respectively, a decrease of $16.5 million, or 43%.

Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025 are summarized in the table below:

Three months ended June 30,

Selling expense (1)

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Total selling, general and administrative expense

(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%.

(1) Selling expense for the three months ended June 30, 2026 and 2025 was $2.8 million and $14.6 million, respectively, a decrease of $11.8 million, or 81%.

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 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%.

(2) General and administrative expense for the three months ended June 30, 2026 and 2025 was $17.8 million and $21.2 million, respectively, a decrease of $3.4 million, or 16%.

This decrease is primarily due to a 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 June 30, 2026 and 2025 was $1.6 million and $2.9 million, respectively, a decrease of $1.3 million, or 45%.

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.

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 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,

Research and development expense for the three months ended June 30, 2026 and 2025 was $4.8 million and $4.9 million, respectively, a decrease of $0.1 million, or 3%.

Research and development expenses for the three months ended June 30, 2026 and 2025 are summarized in the table below:

Three months ended June 30,

REDUCE-IT study and presentations (1)

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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.

Restructuring expense for the three months ended June 30, 2026 and 2025 was less than $0.1 million and $22.8 million, respectively.

The charges in both the current and prior year are 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 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, for the three months ended June 30, 2026 and 2025 was $3.1 million and $2.6 million, respectively, an increase 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.

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.

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.

Other income (expense), net .

Other income (expense), net, for the three months ended June 30, 2026 and 2025 was income of $1.1 million and expense of $0.1 million, respectively, an increase of $1.2 million, or 1384%.

Other income (expense), net, increased primarily due to the recognition of the Employee Retention Credit, or ERC, awarded as part of the Coronavirus Aid, Relief, and Economic Security, or CARES, Act.

Benefit from (provision for) income taxes.

Income tax benefit from (provision for) for the three months ended June 30, 2026 and 2025 was a benefit of $0.2 million and a provision of $0.7 million, respectively.

The benefit for the three months ended June 30, 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.

Comparison of Six Months Ended June 30, 2026 and June 30, 2025

Total revenue, net.

We recorded total revenue, net, of $87.3 million and $114.8 million during the six months ended June 30, 2026 and 2025, respectively, a decrease of $27.4 million, or 24%.

Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S.

In addition to the U.S., during the six months ended June 30, 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 decrease is due primarily to a $22.2 million decrease in licensing and royalty revenue, a $4.3 million decrease in U.S.

net product revenue and a $0.9 million decrease in net product revenue outside of the U.S.

Product revenue, net.

We recorded product revenue, net, of $82.4 million and $87.7 million during the six months ended June 30, 2026 and 2025, respectively, a decrease of $5.2 million, or 6%.

This decrease was due primarily to 6% and 13% decreases in VASCEPA sales in the U.S.

We recorded U.S.

product revenue, net, of $67.9 million and $72.2 million during the six months ended June 30, 2026 and 2025, respectively.

This decrease was primarily due to a lower net selling price associated with changes in customer mix.

The overall IPE market in the U.S., based on prescription levels reported by Symphony Health, increased for the six months ended June 30, 2026 by 3% as compared to the six months ended June 30, 2025.

Our share of the IPE market has increased to approximately 49% in the six months ended June 30, 2026 compared to approximately 42% in the six months ended June 30, 2025.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 19% in the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe.

For the six months ended June 30, 2026, we recorded Europe product revenue, net, of $10.4 million compared to $12.0 million during the six months ended June 30, 2025, primarily due to the change in business structure.

For the six months ended June 30, 2026, we recorded RoW product revenue, net, of $4.2 million from our six collaboration partners, comprising multiple distinct geographies, compared to $3.5 million during the six months ended June 30, 2025.

Licensing and royalty revenue .

Licensing and royalty revenue during the six months ended June 30, 2026 and 2025 was $4.9 million and $27.1 million, respectively, a decrease of $22.2 million, or 82%.

This decrease was primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati Licensing Agreement in the prior year offset by higher royalties as a result of an increase in partner sales within their respective territories.

Cost of goods sold.

Cost of goods sold during the six months ended June 30, 2026 and 2025 was $54.6 million and $39.3 million, respectively, an increase of $15.3 million, or 39%.

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 six months ended June 30, 2026 and 2025 was sourced from multiple API suppliers.

Our overall gross margin on product sales for the six months ended June 30, 2026 and 2025 was 34% and 55%, 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 six months ended June 30, 2026 and 2025 was $43.3 million and $75.2 million, respectively, a decrease of $31.9 million, or 42%.

Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 are summarized in the table below:

Six months ended June 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 six months ended June 30, 2026 and 2025 was $6.7 million and $31.5 million, respectively, a decrease of $24.8 million, or 79%.

This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan.

(2) General and administrative expense for the six months ended June 30, 2026 and 2025 was $33.3 million and $37.3 million, respectively, a decrease of $4.1 million, or 11%.

This decrease is primarily due to a reduction in costs associated with the Global Restructuring Plan as well as fees associated with the ADS Ratio Change and Recordati EU Licensing Agreement incurred in the prior year.

The decreases are offset by costs associated with litigation-related charges in the current year.

(3) Non-cash stock-based compensation expense for the six months ended June 30, 2026 and 2025 was $3.3 million and $6.4 million, respectively, a decrease of $3.1 million, or 48%.

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 six months ended June 30, 2026 and 2025 was $9.4 million and $10.2 million, respectively, a decrease of $0.8 million, or 8%.

Research and development expenses for the six months ended June 30, 2026 and 2025 are summarized in the table below:

Six months ended June 30,

REDUCE-IT study and presentations (1)

Regulatory filing fees and expenses (2)

Non-clinical research activities (3)

Internal staffing, overhead and other (4)

Research and development expense, excluding non-cash expense

Non-cash stock-based compensation expense (5)

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

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

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

(4) 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.

(5) 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 six months ended June 30, 2026 and 2025 was $3.4 million and $22.8 million, respectively.

The charge in both the current and prior year are 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, remained consistent at $5.5 million during the six months ended June 30, 2026, compared to $5.5 million during the six months ended June 30, 2025.

Interest income, net, represents income earned on cash and investment balances.

Other income (expense), net .

Other income (expense), net, for the six months ended June 30, 2026 and 2025 was income of $1.3 million and $0.2 million, respectively, an increase of $1.1 million, or 661%.

Other income (expense), net, increased primarily due to the recognition of the Employee Retention Credit, or ERC, awarded as part of the Coronavirus Aid, Relief, and Economic Security, or CARES, Act.

Benefit from (provision for) income taxes.

Income tax benefit from (provision for) for the six months ended June 30, 2026 and 2025 were provisions of $1.6 million and $2.8 million, respectively.

The provision for income taxes for the six months ended June 30, 2026 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.

Liquidity and Capital Resources

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.

As of June 30, 2026, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $143.8 million and short-term investments of $171.1 million, aggregating $314.9 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.

Our short-term investments consist of securities that will mature 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.

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:

Three months ended March 31,

Six months ended June 30,

Cash provided by (used in):

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Financing activities

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.

Increase in cash and cash equivalents and restricted cash

Net cash provided by operating activities increased during the six months ended June 30, 2026 as compared to 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.

Net cash (used in) provided by investing activities during the six months ended June 30, 2026 decreased due primarily to the purchases of $90.5 million in investment grade interest-bearing instruments offset by proceeds from the maturity of $88.4 million of

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 $105.3 million, partially offset by $80.8 million in purchases of investment-grade interest bearing instruments.

Net cash used in financing activities during the six months ended June 30, 2026 and the same period in 2025 was primarily 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 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.

As of June 30, 2026, we had net accounts receivable of $92.9 million, and inventory of $164.1 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 June 30, 2026.

As of June 30, 2026, we had cash and cash equivalents of $143.6 million and short-term investments of $171.1 million, aggregating $314.6 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.

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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