What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-07-30 compared with 2025-05-07 · 173 added, 72 removed, 283 unchanged (46% of the section changed)

73 unchanged sentences

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.

Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis.

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In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic.

The time required to secure reimbursement varies from country to country and cannot be reliably

The time required to secure reimbursement varies from country to country and cannot be reliably predicted.

While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe.

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VAZKEPA has been made available under individual reimbursement since January 2023.

We continue to advance our pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed.

We are leveraging third-party relationships for various support activities and are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approaches to drive greater impact and improved cost efficiency, which is or will be utilized throughout Europe as commercial operations launch.

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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"Neopharm" (3)

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

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

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Revenue earned from sales of VASECPA within the Israel territory are recorded within European revenue.

In addition to the above partnerships, the Company partnered with Lotus Pharmaceuticals, or Lotus, in July 2023 to commercialize and distribute VAZKEPA in South Korea and nine other countries in Southeast Asia, or collectively ASEAN.

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

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

We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the U.S.

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

We continue to assess other potential partnership opportunities for VASCEPA with companies with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.

Research and Development

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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 50 clinical treatment guidelines, consensus statements or scientific statements from global medical societies or 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 first quarter of 2025 as listed below:

• In January 2025, the American Diabetes Association, or ADA, updated their recommendations for risk management in patients with cardiovascular disease in their Standards of Care in Diabetes.

The following information was included regarding IPE:

o In individuals with ASCVD or other cardiovascular risk factors on a statin with managed LDL cholesterol but elevated triglycerides (150–499 mg/dL [1.7–5.6 mmol/L]), the addition of icosapent ethyl can be considered to reduce cardiovascular risk

• In February 2025, the American Association of Clinical Endocrinology, or AACE, issued a focused update of the 2017 AACE Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease and provided evidence-based recommendations for the pharmacologic management of adults with dyslipidemia by clinicians and their care teams.

The following recommendations were included for patients with CVD or at increased risk for ASCVD:

o In adults with hypertriglyceridemia (150-499 mg/dL) who have cardiovascular disease or who are at increased risk for ASCVD, AACE suggests for the use of EPA (IPE) in addition to statins.

o In adults with hypertriglyceridemia (150-499 mg/dL) who have cardiovascular disease or are at increased risk for cardiovascular disease, AACE suggests against the use of EPA plus DHA in addition to statin therapy.

o In adults with hypertriglyceridemia (150-499 mg/dL) who have ASCVD or are at increased risk for ASCVD, AACE recommends against the use of niacin in addition to usual care.

• In April of 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.

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:

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

In March 2025, at the American College of Cardiology, or ACC, Scientific Sessions, we supported two posters, one looking at the antioxidant and anti-inflammatory effects of EPA in combination with a GLP-1 agonist on endothelial cells, and another looking at the antioxidant effects of EPA on Lp(a) as compared to small, dense, LDL and TG rich lipoprotein.

In the first three months of 2025, we and global medical and scientific collaborators supported seven publications inclusive of accepted abstracts, posters, and manuscripts.

• 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.

Commercial and Clinical Supply

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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 March 31, 2025, we had inventory of $216.9 million, of which 52% is inventory approved for use in North America.

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

We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand.

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We expense research and development costs as incurred.

Restructuring expense .

Restructuring expense consists of restructuring costs incurred under our June 2025 global restructuring plan, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs.

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

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Results of Operations

Comparison of Three Months Ended March 31, 2025 and March 31, 2024

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

Total revenue, net.

We recorded total revenue, net, of $42.0 million and $56.5 million during the three months ended March 31, 2025 and 2024, respectively, a decrease of $14.5 million, or 26%.

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

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

In addition to the U.S., during the three months ending March 31, 2025, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the U.S.

and Europe, such as China and Canada, through collaborations with third-party companies.

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.

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 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.

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.

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.

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.

Cost of goods sold.

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

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

The cost of the API included in cost of goods sold reflects the average cost of API included in inventory.

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

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.

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

The increase in gross margin is primarily as a result of a change in customer mix.

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 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 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%.

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 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,

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.

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

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

Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net .

Interest income, net, for the three months ended June 30, 2025 and 2024 was $2.6 million and $3.3 million, respectively, a decrease of $0.7 million, or 20%.

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

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

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.

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

Total revenue, net.

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

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

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

and Europe, through collaborations with third-party companies.

As further discussed below, the aforementioned decrease consists of a $19.7 million decrease in U.S.

net product revenue and a $1.7 million decrease in net product revenue outside of the U.S., as well as a $0.4 million decrease in licensing and royalty revenue.

net product revenue offset in part by a $4.7 million increase in net product revenue outside of the U.S.

and a $5.8 million increase in licensing and royalty revenue.

Product revenue, net.

We recorded product revenue, net, of $41.0 million and $55.2 million during the three months ended March 31, 2025 and 2024, respectively, a decrease of $14.1 million, or 26%.

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

This decrease was due primarily to a 21% decrease in VASCEPA sales in the U.S..

We recorded U.S.

product revenue, net, of $35.7 million and $48.1 million during the three months ended March 31, 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 effective July 1, 2024.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased for the three months ended March 31, 2025 by 3% as compared to the three months ended March 31, 2024.

Our share of the icosapent ethyl market has decreased to approximately 42% in the three months ended March 31, 2025 compared to approximately 56% in the three months ended March 31, 2024.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 24% in the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

In Europe, we recorded product revenue, net, of $5.4 million and $1.9 million during the three months ended March 31, 2025 and 2024, respectively.

For the three months ended March 31, 2025, we recorded nominal product revenue, net, from our collaboration partners compared to $5.2 million during the three months ended March 31, 2024.

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.

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

Licensing and royalty revenue .

Licensing and royalty revenue during the three months ended March 31, 2025 and 2024 was $1.0 million and $1.4 million, respectively, a decrease of $0.4 million, or 28%.

Licensing and royalty revenue has decreased primarily due to recognition of previously achieved milestone payments from Edding in the prior year.

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.

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.

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 March 31, 2025 and 2024 was $16.9 million and $24.6 million, respectively, a decrease of $7.7 million, or 31%.

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

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

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

The cost of the API included in cost of goods sold reflects the average cost of API included in inventory.

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

The API included in the calculation of the average cost of goods sold during the quarters ended March 31, 2025 and 2024 was sourced from multiple API suppliers.

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.

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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, 2025 and 2024 was 59% and 55%, respectively.

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

The increase in gross margin is primarily as a result of a change in customer mix.

Selling, general and administrative expense .

Selling, general and administrative expense for the three months ended March 31, 2025 and 2024 was $36.6 million and $39.9 million, respectively, a decrease of $3.3 million, or 8%.

Selling, general and administrative expenses for the three months ended March 31, 2025 and 2024 are summarized in the table below:

Three months ended March 31,

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 expense (1)

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Total selling, general and administrative expense

(1) Selling expense for the three months ended March 31, 2025 and 2024 was $16.9 million and $20.4 million, respectively, a decrease of $3.5 million, or 17%.

(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 three months ended March 31, 2025 and 2024 was $16.1 million and $15.3 million, respectively, an increase of $0.8 million, or 6%.

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

(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%.

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.

We are focused on getting VASCEPA to as many patients as possible by continuing to advance our pricing and reimbursement and licensing activities to drive access in remaining geographies, as well as advancing regulatory filings internationally.

We will continue to evaluate all of our spending commitments and priorities based on this focus.

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 three months ended March 31, 2025 and 2024 was $5.3 million and $5.6 million, respectively, a decrease of $0.3 million, or 5%.

Research and development expenses for the three months ended March 31, 2025 and 2024 are summarized in the table below:

Three months ended March 31,

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,

REDUCE-IT study and presentations (1)

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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 Europe.

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%.

Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net .

Interest income, net, for the three months ended March 31, 2025 and 2024 was $2.9 million and $3.4 million, respectively, a decrease of $0.5 million, or 15%.

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, 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, 2025 and 2024 was $0.3 million and $1.5 million, respectively, a decrease of $1.3 million, or 84%.

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

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 three months ended March 31, 2025 and 2024 was $2.1 million and $1.3 million, respectively.

The provision for the three months ended March 31, 2025 is the result of changes in income generated by our U.S.

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.

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 March 31, 2025, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $119.8 million and short-term investments of $162.3 million, aggregating $282.1 million.

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.

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:

Three months ended March 31,

Cash (used in) provided by:

Six months ended June 30,

Cash provided by (used in):

Operating activities

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Financing activities

(Decrease) increase in cash and cash equivalents and restricted cash

Net cash used in operating activities remained consistent during the three months ended March 31, 2025 as compared to the same period in 2024.

Net cash provided by investing activities during the three months ended March 31, 2025 decreased due primarily to the proceeds from the maturity of $55.0 million in investment grade interest-bearing instruments offset by purchases of $42.9 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 $62.0 million, partially offset by $33.3 million in purchases of investment-grade interest bearing instruments.

Net cash used in financing activities during the three months ended March 31, 2025 as compared to net cash provided by financing activities during the same period in 2024 was primarily as a result of a decrease in taxes paid on stock based-awards.

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.

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.

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, 2025, we had net accounts receivable of $106.7 million, current inventory of $159.5 million and long-term inventory of $57.4 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, 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, the generic competition in the U.S.

and pricing and reimbursement of VAZKEPA in Europe.

As of March 31, 2025, we had cash and cash equivalents of $119.5 million and short-term investments of $162.3 million, aggregating $281.8 million.

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.

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.

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 2024 Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

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.

Contractual Obligations

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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