What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-10-29 compared with 2025-07-30 · 169 added, 163 removed, 293 unchanged (53% 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, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication and we commercially launched in 2013.

FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or the MARINE indication.

On December 13, 2019, the U.S.

FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial.

VASCEPA is the first and only drug approved by the U.S.

FDA approved another indication and label expansion for VASCEPA based on the results of our long-term cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA – Intervention Trial.

VASCEPA is approved by the U.S.

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

On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the European Union, or EU, for VAZKEPA ® , hereinafter along with the U.S.

brand name VASCEPA, collectively referred to as VASCEPA, which is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated TG levels.

On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk.

On June 1, 2023, we announced that regulatory approval from the National Medical Products Administration, or NMPA, for VASCEPA in Mainland China was received by our partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, for the MARINE indication and on June 28, 2024 for the REDUCE-IT indication.

Through the date of this Quarterly Report, we have received regulatory approval for VASCEPA under the REDUCE-IT indication in 50 countries, including the U.S.

and 27 EU Member States.

VASCEPA is currently available by prescription in the U.S.

and certain other countries throughout the world, as described below.

We are responsible for the supply of VASCEPA to all markets in which the branded product is sold, either to and through our collaborations with third-party companies or by us.

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA ® , hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event.

On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk.

Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

We and our seven commercial partners are in various stages;

seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization.

VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S.

New Drug Application, or NDA, core dossier or the EMA core dossier.

VASCEPA (U.S.

NDA Core Dossier)

VAZKEPA (EMA Core Dossier)

Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1)

HLS Therapeutics Inc.

"HLS" (Canada)

CSL Seqirus "CSL"(Australia/New Zealand)

Biologix FZCo "Biologix" (MENA)

Lotus Pharmaceuticals, "Lotus" (Southeast Asia)

Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory)

Neopharm (Israel) 1996 Ltd.

"Neopharm" (Israel)

(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.

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.

We are not responsible for providing any generic company with drug product.

Geographies outside the U.S.

in which VASCEPA is sold and under regulatory review are not subject to the U.S.

patent litigation and judgment described below and no similar litigation is pending outside of the U.S.

The Company operates in one business segment.

United States

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The vendor's estimate utilizes a proprietary projection methodology and is based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable.

Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions.

Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S.

Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients, calculated on a normalized basis (i.e., one month’s supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams).

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

In June 2025, the Company entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati EU Licensing Agreement, with Recordati, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe.

As a result of the Recordati EU Licensing Agreement we implemented a global restructuring plan which we estimate will result in annual cost savings of approximately $70.0 million primarily from the elimination of commercial roles in the Company’s European operations.

As a result of the Recordati EU Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the EU Territory.

Recordati may sell VAZKEPA pursuant to the product reimbursement’s we have already obtained in Europe and will use commercially reasonable efforts to pursue future approvals in the EU Territory.

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.

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September 2025

September 2022

February 2025

September 2022

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

(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 under individual reimbursement since January 2023.

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.

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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

One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets.

We and our partners have obtained varying levels of indication approvals and commercial launches in the respective territories.

Through the date of this Quarterly Report, we have filed for regulatory review in 22 countries and regions and have received approval in 15 countries and regions outside of the U.S.

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.

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REDUCE-IT Approval

"China Territory"

February 2015

1 unchanged sentence

February 2023

Biologix FZCo "Biologix" (2)

United Arab Emirates

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September 2023

HLS Therapeutics Inc.

September 2017

2 unchanged sentences

February 2023

Neopharm (Israel) 1996 Ltd.

"Neopharm" (3)

Lotus Pharmaceuticals, "Lotus" "ASEAN" (4)

November 2022

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

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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 in Canada, China, Southeast Asia, Australia, and the Middle East as well as guidelines which were newly received during the second quarter of 2025 as listed below:

• In April 2025, the National Heart Foundation of Australia & Cardiac Society of Australia and New Zealand issued a clinical guideline for diagnosing and managing acute coronary syndromes, or ACS.

The following information was included regarding IPE as a practice point within the Post-ACS Pharmacotherapy section under lipid modifying therapies:

o In people with ACS with triglyceride levels of 1.5–5.6 mmol/L and LDL-C 1.0–2.6 mmol/L despite statin therapy, consider adding icosapent ethyl [549].

Note that the current PBS eligibility criteria for icosapent ethyl is a triglyceride level of 1.7 mmol/L.

• In May 2025, the European Athrosclerosis Society, or EAS, issued a consensus statement to the guide management of metabolic disorders and their sequelae, in the European Heart Journal stating that high-dose IPE (2-4 g/day) is the only agent documented to lower cardiovascular risk in statin-treated individuals with elevated triglycerides.

In April 2025, at the European Society of Cardiology Preventive Cardiology, or ESC-PC, congress in Milan, Italy, we provided grant support for two poster presentations, one evaluating eligibility for and barriers to IPE utilization in a medical clinic, and another reporting on a project aimed to improve lipid lowering for secondary prevention in a primary healthcare facility.

In May 2025, at the EAS congress in Glasgow, UK, we provided grant support for two poster presentations, both reporting on the potential additive effects of eicosapentaenoic acid and a GLP-1 agonist on changes in protein expression associated with antioxidant and/or anti-inflammatory effects in response to inflammatory stimuli.

In June 2025, at the National Lipid Association scientific sessions in Miami, Florida, we provided grant support for a poster reporting on a pilot implementation strategy to improve post-acute coronary syndrome management of patients with hypertriglyceridemia.

In the second quarter of 2025, we and global medical and scientific collaborators supported thirteen 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 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.

Commercial and Clinical Supply

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We have multiple U.S.

FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise.

FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise in the U.S.

We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S.

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Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory.

As of June 30, 2025, we had inventory of $210.8 million, of which 47% is inventory approved for use in North America.

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.

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As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners.

The royalty payments are being recognized as earned based on revenue recognized by our current partners.

The royalty payments are being recognized when the uncertainty related to the consideration is resolved.

Cost of goods sold .

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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.

Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

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

Provision for income taxes.

Benefit from (provision for) income taxes.

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

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

We are subject to income taxes

in both the U.S.

and foreign jurisdictions.

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Results of Operations

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

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

Total revenue, net.

We recorded total revenue, net, of $72.7 million and $67.5 million during the three months ended June 30, 2025 and 2024, respectively, an increase of $5.3 million, or 8%.

We recorded total revenue, net, of $49.7 million and $42.3 million during the three months ended September 30, 2025 and 2024, respectively, an increase of $7.4 million, or 17%.

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

In addition to the U.S., during the three months ending June 30, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as in certain countries outside of the U.S.

and Europe, through collaborations with third-party companies.

As further discussed below, the aforementioned increase consists in part of a $6.4 million increase in net product revenue outside of the U.S.

and a $6.1 million increase in licensing and royalty revenue, offset by a $7.3 million decrease in U.S.

net product revenue.

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.

Product revenue, net .

We recorded product revenue, net, of $46.6 million and $47.5 million during the three months ended June 30, 2025 and 2024, respectively, a decrease of $0.9 million, or 2%.

This decrease was due primarily to a decrease in VASCEPA sales within the U.S.

offset by increase in VASCEPA sales outside the U.S.

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 $36.5 million and $43.8 million during the three months ended June 30, 2025 and 2024, respectively.

This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national pharmacy benefit manager, or PBM, going from exclusive to no longer covering VASCEPA.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, remained consistent for the three months ended June 30, 2025 compared to the three months ended June 30, 2024.

Our share of the icosapent ethyl market has decreased to approximately 43% in the three months ended June 30, 2025 compared to approximately 59% in the three months ended June 30, 2024.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 28% in the three months ended June 30, 2025 compared to the three months ended June 30, 2024.

In Europe, we recorded product revenue, net, of $6.6 million and $3.5 million during the three months ended June 30, 2025 and 2024, respectively.

For the three months ended June 30, 2025, we recorded $3.5 million of product revenue, net, from our collaboration partners compared to $0.2 million during the three months ended June 30, 2024.

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.

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.

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

In 2025, we will continue to focus on getting VASCEPA to as many patients as possible by continuing to support our partners advancing commercialization activities in markets with access and pricing and reimbursement activities to drive access in remaining geographies as well as being the market leader in the U.S.

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.

geographies around the world.

Licensing and royalty revenue .

Licensing and royalty revenue during the three months ended June 30, 2025 and 2024 was $26.1 million and $20.0 million, respectively, an increase of $6.1 million, or 31%.

Licensing and royalty revenue has increased primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati EU Licensing Agreement.

We previously recognized a $15.0 million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.

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.

As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners.

The royalty payments are being recognized as earned based on revenue recognized by our current partners.

Royalty payments are recognized based on revenue reported by our partners.

The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.

Cost of goods sold.

Cost of goods sold during the three months ended June 30, 2025 and 2024 was $22.4 million and $24.7 million, respectively, a decrease of $2.3 million, or 9%.

Cost of goods sold during the three months ended September 30, 2025 and 2024 was $27.5 million and $26.0 million, respectively, an increase of $1.4 million, or 6%.

This increase in cost of goods sold is due to increased product volumes.

Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance.

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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 June 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 September 30, 2025 and 2024 was sourced from multiple API suppliers.

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

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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 June 30, 2025 and 2024 was 52% and 48%, respectively.

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.

Selling, general and administrative expense .

Selling, general and administrative expense for the three months ended June 30, 2025 and 2024 was $38.7 million and $38.5 million, respectively, an increase of $0.1 million.

Selling, general and administrative expenses for the three months ended June 30, 2025 and 2024 are summarized in the table below:

Three months ended June 30,

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 expense (1)

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Total selling, general and administrative expense

(1) Selling expense for the three months ended June 30, 2025 and 2024 was $14.6 million and $20.5 million, respectively, a decrease of $5.9 million, or 29%.

This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.

(2) General and administrative expense for the three months ended June 30, 2025 and 2024 was $21.2 million and $14.5 million, respectively, an increase of $6.7 million, or 46%.

This increase is primarily due to fees incurred in association with Recordati EU Licensing Agreement offset by a decrease in costs as a result of cost optimization efforts.

(3) Non-cash stock-based compensation expense for the three months ended June 30, 2025 and 2024 was $2.9 million and $3.5 million, respectively, a decrease of $0.7 million, or 19%.

(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%.

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%.

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.

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

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.

Research and development expense .

Research and development expense for the three months ended June 30, 2025 and 2024 was $4.9 million and $4.7 million, respectively, an increase of $0.2 million, or 4%.

Research and development expenses for the three months ended June 30, 2025 and 2024 are summarized in the table below:

Three months ended June 30,

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,

REDUCE-IT study and presentations (1)

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(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.

We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S.

We continuously evaluate all of our research and development investment commitments and priorities and are prepared to adjust such investment levels based on various factors, including the impact of U.S.

generic competition, as well as timing of pricing reimbursements throughout the world.

Restructuring expense .

Restructuring expense for the three months ended June 30, 2025 and 2024 was $22.8 million and nil, respectively, an increase of $22.8 million, or 100%.

The charge in the current year is due to the implementation of a global restructuring plan associated with the execution of the Recordati EU Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations.

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 June 30, 2025 and 2024 was $2.6 million and $3.3 million, respectively, a decrease of $0.7 million, or 20%.

Interest income, net, 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 (expense) income, net .

Other (expense) income, net, for the three months ended June 30, 2025 and 2024 was expense of $0.1 million and income of $0.1 million, respectively, a decrease of $0.2 million, or 159%.

Other (expense) income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Provision for income taxes.

Income tax provision for the three months ended June 30, 2025 and 2024 was $0.7 million and $1.4 million, respectively.

The provision for the three months ended June 30, 2025 is the result of changes in income generated by our U.S.

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 Six Months Ended June 30, 2025 and June 30, 2024

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

Total revenue, net.

We recorded total revenue, net, of $114.8 million and $124.0 million during the six months ended June 30, 2025 and 2024, respectively, a decrease of $9.3 million, or 7%.

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 six months ended June 30, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as in certain countries outside of the U.S.

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 consists of a $19.7 million decrease in U.S.

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.

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Product revenue, net.

We recorded product revenue, net, of $87.7 million and $102.7 million during the six months ended June 30, 2025 and 2024, respectively, a decrease of $15.0 million, or 15%.

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 $72.2 million and $91.9 million during the six months ended June 30, 2025 and 2024, respectively.

This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national PBM, going from exclusive to no longer covering VASCEPA.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the six months ended June 30, 2025 by 2% as compared to the six months ended June 30, 2024.

Our share of the icosapent ethyl market has decreased to approximately 42% in the six months ended June 30, 2025 compared to approximately 57% in the six months ended June 30, 2024.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 26% in the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

In Europe, we recorded product revenue, net, of $12.0 million and $5.4 million during the six months ended June 30, 2025 and 2024, respectively.

For the six months ended June 30, 2025, we recorded $3.5 million of product revenue, net, from our collaboration partners compared to $5.4 million during the six months ended June 30, 2024.

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

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 six months ended June 30, 2025 and 2024 was $27.1 million and $21.3 million, respectively, an increase of $5.8 million, or 27%.

Licensing and royalty revenue has increased primarily due to the recognition of a $25.0 million upfront payment resulting from the execution of the Recordati EU Licensing Agreement.

We previously recognized a $15.0 million milestone and $4.0 million change in estimate resulting from the regulatory approval of VASCEPA under the REDUCE-IT indication in China in June 2024.

As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners.

The royalty payments are being recognized as earned based on revenue recognized by our current partners.

The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.

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 six months ended June 30, 2025 and 2024 was $39.3 million and $49.3 million, respectively, a decrease of $10.1 million, or 20%.

Cost of goods sold includes the cost of API for VASCEPA on which

revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance.

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%.

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, 2025 and 2024 was sourced from multiple API suppliers.

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

In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors.

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

Our overall gross margin on product sales for the six months ended June 30, 2025 and 2024 was 55% and 52%, respectively.

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 six months ended June 30, 2025 and 2024 was $75.2 million and $78.4 million, respectively, a decrease of $3.2 million, or 4%.

Selling, general and administrative expenses for the six months ended June 30, 2025 and 2024 are summarized in the table below:

Six months ended June 30,

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)

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Total selling, general and administrative expense

(1) Selling expense for the six months ended June 30, 2025 and 2024 was $31.5 million and $40.9 million, respectively, a decrease of $9.4 million, or 23%.

This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.

(2) General and administrative expense for the six months ended June 30, 2025 and 2024 was $37.3 million and $29.8 million, respectively, an increase of $7.5 million, or 25%.

This increase is primarily due to fees associated with the ADS Ratio Change and Recordati EU Licensing Agreement offset by a decrease in branded pharma fees as a result of lower sales

(3) Non-cash stock-based compensation expense for the six months ended June 30, 2025 and 2024 was $6.4 million and $7.7 million, respectively, a decrease of $1.3 million, or 17%.

(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.

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

Research and development expense .

Research and development expense for the six months ended June 30, 2025 and 2024 was $10.2 million and $10.3 million, respectively, a decrease of $0.1 million, or 1%.

Research and development expenses for the six months ended June 30, 2025 and 2024 are summarized in the table below:

Six months ended June 30,

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)

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(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.

We continuously evaluate all of our spending commitments and priorities and we plan to adjust our level of research and development activities based on various factors, including the impact of U.S.

generic competition as well as timing of pricing reimbursements throughout the world.

Restructuring expense .

Restructuring expense for the six months ended June 30, 2025 and 2024 was $22.8 million and nil, respectively, an increase of $22.8 million, or 100%.

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

Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net .

Interest income, net, for the six months ended June 30, 2025 and 2024 was $5.5 million and $6.7 million, respectively, a decrease of $1.2 million, or 17%.

Interest income, net, for the nine months ended September 30, 2025 and 2024 was $8.3 million and $10.0 million, respectively, a decrease of $1.8 million, or 17%.

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

The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.

Other (expense) income, net .

Other (expense) income, net, for the six months ended June 30, 2025 and 2024 was income of $0.2 million and $1.7 million, respectively, a decrease of $1.5 million, or 90%.

Other (expense) income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Provision for income taxes.

Income tax provision for the six months ended June 30, 2025 and 2024 was $2.8 million and $2.7 million, respectively.

The provision for income taxes for the six months ended June 30, 2025 is the result of income generated by our U.S.

Other income, net .

Other income, net, for the nine months ended September 30, 2025 and 2024 was $0.4 million and $2.0 million, respectively, a decrease of $1.6 million, or 81%.

Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

Benefit from (provision for) income taxes.

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

The provision for income taxes for the nine months ended September 30, 2025 is the result of income generated by our U.S.

and foreign operations for which tax expense has been recognized based on a full-year estimated U.S.

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Liquidity and Capital Resources

As of June 30, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $148.2 million and short-term investments of $150.8 million, aggregating $298.7 million.

As of September 30, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $123.1 million and short-term investments of $163.8 million, aggregating $286.6 million.

We have no indebtedness.

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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:

Six months ended June 30,

Cash provided by (used in):

Nine months ended September 30,

Cash (used in) provided by:

Operating activities

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Financing activities

Increase in cash and cash equivalents and restricted cash

Net cash provided by operating activities increased during the six months ended June 30, 2025 as compared to the net cash used in operating activities during the same period in 2024.

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 six months ended June 30, 2025 decreased due primarily to proceeds from the maturity of $105.3 million in investment grade interest-bearing instruments offset by the purchases of $80.8 million of investment

grade interest-bearing instruments as compared to the same period in 2024 where proceeds from the maturity of investment grade interest-bearing instruments were $133.0 million, partially offset by $99.6 million in purchases of investment-grade interest bearing instruments.

Net cash used in financing activities during the six months ended June 30, 2025 as compared to net cash used in financing activities during the same period in 2024 was primarily as a result of a decrease in proceeds related to stock option exercises.

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.

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 June 30, 2025, we had net accounts receivable of $119.1 million, current inventory of $171.2 million and long-term inventory of $39.6 million.

We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of June 30, 2025.

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 June 30, 2025, we had cash and cash equivalents of $147.9 million and short-term investments of $150.8 million, aggregating $298.7 million.

As of September 30, 2025, we had cash and cash equivalents of $122.8 million and short-term investments of $163.8 million, aggregating $286.6 million.

In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued.

We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans.

We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the 2024 Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans.

We have based this estimate on assumptions that may prove to be inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

Contractual Obligations

Our contractual obligations consist mainly of payments related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office space.

Except for our contractual obligations related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office space as set forth in Note 5 – Commitments and Contingencies and Note 9 – Leases, respectively, in our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes from the contractual obligations and commitments as of December 31, 2024 previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2025.

We do not have any special purpose entities or other off-balance sheet arrangements.

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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