What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-07 compared with 2024-10-30 · 138 added, 277 removed, 217 unchanged (66% of the section changed)

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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 for the MARINE indication and on June 28, 2024 our partner received NMPA approval for VASCEPA in Mainland China for the REDUCE-IT indication.

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 49 countries, including the U.S.

and 27 EU Member States.

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

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

Geographies outside the United States 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 United States.

Management Succession Plan

As announced and effective on June 3, 2024, Patrick Holt voluntarily resigned as President and Chief Executive Officer and as a member of the Board of Directors.

Effective June 4, 2024, the Board of Directors appointed Aaron Berg, previously our Executive Vice President, President U.S., to succeed Mr.

Holt as our President and Chief Executive Officer, and as a member of the Board of Directors.

As announced on October 7, 2024, Tom Reilly voluntarily resigned as Executive Vice President, Chief Financial Officer, effective October 23, 2024.

In the interim, our Vice President, Global Controller, Peter Fishman, will assume the duties as principal financial and accounting officer of the Company.

Organizational Restructuring Program

On July 18, 2023, we announced that we were implementing a new Organizational Restructuring Program, or the ORP, resulting in the elimination of our entire U.S.

sales force and elimination and consolidation of certain other roles across our organization, both

and abroad and representing a reduction of our total employee base by approximately 30%.

The ORP was implemented following a review of our business and to better position the organization for a new strategic focus.

The ORP resulted in an operating cost reduction of $50.0 million annually.

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.

United States

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December 2023

Qilu Pharmaceutical Co Ltd

November 2024

December 2024

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

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These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use.

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

We are not responsible for the accuracy of this vendor's information and we do not receive prescription data directly from retail pharmacies.

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

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

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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 predicted.

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

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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September 2024

December 2024

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.

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.

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 launches are rolled out.

Patients at high risk for cardiovascular disease tend to be treated more often by specialists, such as cardiologists, rather than by general practitioners.

Privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level.

Generally, less data is available and at reduced frequencies than in the United States.

However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the United States.

Generally, less data is available and at reduced frequencies than in the U.S.

However, this greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion than in the U.S.

In Europe, VAZKEPA has the benefit of 10 years of market protection, and in April 2024 we were issued a patent that extended our exclusivity to 2039.

Rest of World

One of the core areas of focus from our ORP is continuing to work on generating revenue from our partnerships in key international markets, including Canada, MENA, China, Australia and New Zealand and ASEAN and South Korea and we will continue to explore additional partnerships.

In February 2015, we entered into an exclusive agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, to develop and commercialize VASCEPA capsules in what we refer to as the China Territory, consisting of the territories of Mainland China, Hong Kong, Macau and Taiwan.

Edding, with our support, conducted a clinical trial of VASCEPA in China, which evaluated the effect of VASCEPA on patients with very high triglyceride levels (≥500 mg/dL).

In November 2020, we announced statistically significant topline positive results from this Phase 3 clinical trial of VASCEPA conducted by Edding.

The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo.

There were no treatment-related serious adverse events in this study.

On February 9, 2021, we announced that the regulatory review processes in Mainland China and Hong

Kong had commenced.

On February 23, 2022, the Hong Kong Department of Health completed their regulatory evaluation and approved the use of VASCEPA under the REDUCE-IT indication.

In Mainland China, the NMPA accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA.

In Mainland China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final NMPA review of the VASCEPA NDA was initiated.

The Company announced on June 1, 2023 that Edding received approval from the NMPA for VASCEPA in Mainland China under the MARINE indication and launched commercially in October 2023.

In October 2023, Edding's submission of a regulatory filing to the NMPA for VASCEPA under the REDUCE-IT indication was accepted.

On June 28, 2024, Edding received approval from the NMPA for VASCEPA in Mainland China under the REDUCE-IT indication.

In March 2016, we entered into an agreement with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries.

Biologix obtained approval of VASCEPA under the MARINE and REDUCE-IT indications, and subsequently launched commercially, in the following countries:

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.

and EMA regulatory approval authority.

We have agreements in place with the following partners within the respective territories:

Agreement Date

MARINE Approval

REDUCE-IT Approval

"China Territory"

February 2015

Mainland China

February 2023

Biologix FZCo "Biologix" (2)

United Arab Emirates

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December 2019

September 2023

December 2021

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September 2023

VASCEPA is under registration in additional countries in the MENA region.

In September 2017, we entered into an agreement with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada.

In December 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority granted approval for VASCEPA to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.

In January 2020, HLS obtained regulatory exclusivity designation and launched commercially in February 2020.

In April 2022, HLS completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance for the terms and conditions under which VASCEPA would qualify for public market reimbursement in Canada.

HLS has obtained reimbursement from all major private and public payors gaining access to a majority of eligible patients in Canada.

Coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada.

VASCEPA has the benefit of data protection afforded through Health Canada until the end of 2027, in addition to separate patent protection with expiration dates that could extend into 2039.

We are in the final year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries and regions in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA.

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 United States and EMA regulatory approval authority, including in Mainland China, Switzerland, Australia, New Zealand and Israel, under the REDUCE-IT indication.

In addition, VAZKEPA has been made available under individual pricing reimbursement in Switzerland.

In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand.

In October 2024, CSL obtained pricing approval for VAZKEPA in Australia.

In July 2023, the Company entered into an agreement with Lotus Pharmaceuticals to commercialize and distribute VAZKEPA in South Korea and nine countries in Southeast Asia.

In August 2023, the Company entered into an agreement with Neopharm (Israel) 1996 Ltd., or Neopharm, to distribute VAZKEPA in Israel, Gaza, West Bank, and the territories of the Palestinian Authority.

In May 2024, the Company entered into an agreement with Vianex S.A.

to import, register, distribute and commercialize VAZKEPA in Greece.

HLS Therapeutics Inc.

September 2017

December 2019

February 2020

February 2023

Neopharm (Israel) 1996 Ltd.

"Neopharm" (3)

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

(2) - VASCEPA is under registration in additional countries in the MENA region with Biologix.

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

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

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.

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 United States 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 outside of the U.S.

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

Research and Development

Since its inception in 2011, the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development.

Most of our other research and development during this period also pertained to VASCEPA, including the study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE.

Based on the final positive

results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the United States and continue to pursue approval for VASCEPA around the world.

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

Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S.

and continue to pursue approval for VASCEPA around the world.

We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study.

Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 40 clinical treatment guidelines, consensus statements or scientific statements from global medical societies or journals have been updated recommending the use of icosapent ethyl in appropriate at-risk patients, including those statements which we were informed of by our global partners in Australia, Canada, China and the Middle East as well as guidelines or statements which were newly received during the third quarter of 2024 as listed below:

• In June 2024, nine Spanish scientific societies published consensus recommendations for lipid-lowering treatments after a chronic vascular event in patients with very high or extreme vascular risk.

Included within these scientific societies are statements that although fibrates have classically been used to reduce hypertriglyceridemia, they have only shown to reduce vascular events in patients without treatment with statins;

given that patients with good LDL-C control still have non-negligible residual risk, drugs such as IPE can help reduce vascular events.

• In July 2024, the Joint Association of British Clinical Diabetologist and UK Kidney Association published clinical practice guidelines for management of lipids in adults with diabetic kidney disease and stated that IPE should be given consideration for secondary prevention in people with elevated fasted TG.

• In July 2024, the International Atherosclerosis Society published a consensus statement on the assessment and management of cardiovascular risk due to elevated TGs.

The statement states that if TG levels remain elevated after lifestyle changes and the patient is at high CV risk, then IPE can be considered.

In July 2024, we supported data presentations showcasing the mechanistic activity of eicosapentaenoic acid, or EPA, as well as encore data reporting on real world safety of IPE at the Heart UK scientific conference in Coventry, England.

In August 2024, we provided support to our commercial partner in Australia to present sub-analyses from the REDUCE-IT study in endpoints such at ST-elevation myocardial infarction as well as analyses in patients with established cardiovascular disease and diabetes mellitus.

These data presentations occurred at the Cardiac Society of Australia and New Zealand and at the Australian Diabetes Congress.

In August and September of 2024, we supported data presentations at both the European Society of Cardiology in London, UK, and the European Association for the Study of Diabetes in Madrid, Spain.

These presentations included sub-analyses from the REDUCE-IT trial, EPA mechanistic data, and data from Spanish hospitals reporting on the residual cardiovascular risk of elevated TG levels in patients with acute coronary syndrome, or ACS, as well as the eligibility of IPE in patients with ACS.

In the first nine months of 2024, we and global medical and scientific collaborators supported over 25 publications inclusive of accepted abstracts, posters, and accepted journal manuscripts.

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.

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 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.

Commercial and Clinical Supply

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

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 United States.

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

Not all of our suppliers approved by the U.S.

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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 September 30, 2024, we had inventory of $298.0 million, of which 70% is inventory approved for use in North America.

As of March 31, 2025, we had inventory of $216.9 million, of which 52% 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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All of our product revenue is derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns.

In the United States, VASCEPA is sold to three major wholesalers, as well as several regional wholesalers along with mail order pharmacy providers, or collectively, our distributors or our customers.

In the U.S., VASCEPA is sold to three major wholesalers, several regional wholesalers along with mail order pharmacy providers that in turn resell the product to retail pharmacies, as well as directly to select regional retail pharmacy chains, or collectively, our distributors or our customers.

Most of these customers resell VASCEPA to retail pharmacies for purposes of dispensing VASCEPA to patients.

1 unchanged sentence

Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period.

During the quarters ended September 30, 2024 and 2023, our product revenue, net, included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the United States.

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

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

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

These commercial partners then resell the product in their agreed commercial territory.

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Licensing and royalty revenue .

Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the United States.

We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements.

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.

Cost of goods sold .

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

In the three and nine months ended September 30, 2023, we incurred costs within Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand.

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.

finance and information technology functions.

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

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We expense research and development costs as incurred.

Restructuring expense .

Restructuring expense consists of restructuring costs incurred under our July 2023 ORP, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation expense and other contract related costs.

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

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

Other income (expense), net, consists of the Employee Retention Credit, or ERC, awarded as part of the Coronavirus Aid, Relief and Economic Stabilization Act, or CARES Act, and foreign exchange losses and gains as well as sublease income.

(Provision for) benefit from income taxes.

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

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 United States and foreign jurisdictions.

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

and foreign jurisdictions.

In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2025 and 2024 are not more likely than not to be realized.

Critical Accounting Policies and Significant Judgments and Estimates

Our discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.

Critical Accounting Policies and Estimates

The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses.

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Results of Operations

Comparison of Three Months Ended September 30, 2024 and September 30, 2023

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

Total revenue, net.

We recorded total revenue, net, of $42.3 million and $66.1 million during the three months ended September 30, 2024 and 2023, respectively, a decrease of $23.8 million, or 36%.

Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States.

In addition to the United States, during the three months ending September 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies.

As further discussed below, the aforementioned decrease consists in part of a $31.8 million decrease in U.S.

net product revenue and a $0.7 million decrease in licensing and royalty revenue offset by a $8.6 million increase in net product revenue outside of the United States.

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%.

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.

As further discussed below, the aforementioned decrease consists of a $12.5 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.

Product revenue, net .

We recorded product revenue, net, of $41.9 million and $64.9 million during the three months ended September 30, 2024 and 2023, respectively, a decrease of $23.1 million, or 36%.

This decrease was due primarily to a 51% decrease in VASCEPA sales in the United States.

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%.

This decrease was due primarily to a 26% decrease in VASCEPA sales in the U.S..

We recorded U.S.

product revenue, net, of $30.6 million and $62.4 million during the three months ended September 30, 2024 and 2023, 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 United States, based on prescription levels reported by Symphony Health, decreased for the three months ended September 30, 2024 by 1% as compared to the three months ended September 30, 2023.

Our share of the icosapent ethyl market has decreased to approximately 50% in the three months ended September 30, 2024 compared to approximately 58% in the three months ended September 30, 2023.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 13% in the three months ended September 30, 2024 compared to the three months ended September 30, 2023.

In Europe, we recorded product revenue, net, of $4.3 million and $0.8 million during the three months ended September 30, 2024 and 2023, respectively.

For the three months ended September 30, 2024, we recorded $6.9 million of product revenue, net, from our collaboration partners compared to $1.8 million during the three months ended September 30, 2023.

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.

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

In 2024, we will continue to focus on extending the lifecycle of VASCEPA in the U.S., obtaining pricing reimbursement and launching commercial operations in all remaining European markets as well as supporting our partners to advance access and growing commercial operations throughout the rest of the world.

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 September 30, 2024 and 2023 was $0.4 million and $1.2 million, respectively, a decrease of $0.7 million, or 61%.

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 recognized in the prior period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

• Edding – a $15.0 million upfront payment received in February 2015, a $1.0 million milestone payment achieved in March 2016 following submission of the clinical trial application to the Chinese regulatory authority, a $5.0 million milestone payment achieved in June 2023 following NMPA approval of VASCEPA under the MARINE indication, a $3.0 million milestone payment achieved in October 2023 following a regulatory submission to the NMPA for VASCEPA under the REDUCE-IT indication and a $15.0 million milestone payment achieved in June 2024 following regulatory approval of VASCEPA under the REDUCE-IT indication.

As of June 30, 2024, these payments have been fully recognized.

• Lotus – a $0.3 million upfront payment which was received upon closing of the agreement in August 2023.

The upfront and milestone payments from Edding were being recognized over the estimated period in which we were required to provide regulatory and development support pursuant to the respective agreements which were satisfied in June 2024.

The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

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

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.

Cost of goods sold.

Cost of goods sold, inclusive of restructuring charges, during the three months ended September 30, 2024 and 2023 was $26.0 million and $36.2 million, respectively, a decrease of $10.2 million, or 28%.

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 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.

During the three months ended September 30, 2023, we recorded as cost of goods sold - restructuring inventory $12.7 million as a result of amendments to our supplier agreements.

The API included in the calculation of the average cost of goods sold during the quarters ended September 30, 2024 and 2023 was sourced from multiple API suppliers.

The API included in the calculation of the average cost of goods sold during the quarters ended March 31, 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 September 30, 2024 and 2023 was 38% and 44%, respectively.

Excluding the restructuring inventory charge, gross margin was 38% and 64% for the three months ended September 30, 2024 and 2023, respectively.

The decrease in gross margin is primarily as a result of a decrease in net selling prices.

Our overall gross margin on product sales for the three months ended March 31, 2025 and 2024 was 59% and 55%, 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 September 30, 2024 and 2023 was $36.9 million and $45.5 million, respectively, a decrease of $8.6 million, or 19%.

Selling, general and administrative expenses for the three months ended September 30, 2024 and 2023 are summarized in the table below:

Three months ended September 30,

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 expense (1)

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Total selling, general and administrative expense

(1) Selling expense for the three months ended September 30, 2024 and 2023 was $18.8 million and $24.1 million, respectively, a decrease of $5.3 million, or 22%.

(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%.

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 September 30, 2024 and 2023 was $14.3 million and $17.8 million, respectively, a decrease of $3.5 million, or 19%.

This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the 2023 ORP and cost reduction plans.

(3) Non-cash stock-based compensation expense for the three months ended September 30, 2024 and 2023 was $3.8 million and $3.7 million, respectively, an increase of $0.2 million, or 5%.

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.

As part of our ORP announced in July 2023, we have redesigned our commercial infrastructure in Europe and in the U.S.

as well as focusing on maximizing U.S.

cash flow through a streamlined model, which has resulted in $50.0 million in operating cost reductions annually.

We will continue to evaluate all of our spending commitments and priorities based on our refocused strategic priorities and restructuring plan.

Research and development expense .

Research and development expense for the three months ended September 30, 2024 and 2023 was $4.5 million and $5.1 million, respectively, a decrease of $0.6 million, or 11%.

Research and development expenses for the three months ended September 30, 2024 and 2023 are summarized in the table below:

Three months ended September 30,

REDUCE-IT study and presentations (1)

Fixed-dose combination (2)

Regulatory filing fees and expenses (3)

Non-clinical research activities (4)

Internal staffing, overhead and other (5)

Research and development expense, excluding non-cash expense

Non-cash stock-based compensation expense (6)

Total research and development expense

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

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

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

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

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

(5) Internal staffing, overhead and other research and development expenses primarily relate to the costs of our personnel employed to manage research, development and regulatory affairs activities and related overhead costs including consulting and other professional fees that are not allocated to specific projects.

Also included are costs related to qualifying suppliers and costs associated with various other activities, including other costs in collaboration with Mochida.

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

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.

Restructuring expense .

Restructuring expense for the three months ended September 30, 2024 and 2023 was nil and $0.7 million, respectively, a decrease of $0.7 million, or 100%.

The charge in the prior year is due to the implementation of the ORP which was approved during the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S.

sales field force, with our managed care and trade organization continuing to support our U.S.

commercial efforts, as well as a reduction of approximately 30% of non-sales positions.

Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net .

Interest income, net, for the three months ended September 30, 2024 and 2023 was $3.4 million and $3.2 million, respectively, an increase of $0.2 million, or 5%.

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

The increase is primarily due to higher investment balances in the current year period compared to the prior year period.

Other income (expense), net .

Other income (expense), net, for the three months ended September 30, 2024 and 2023 was income of $0.3 million and expense of $0.6 million, respectively, an increase of $0.8 million, or 146%.

Other income (expense), 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 September 30, 2024 and 2023 was $3.6 million and $0.5 million, respectively.

The provision for the three months ended September 30, 2024 is the result of changes in income generated by our U.S.

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

and foreign income tax liability.

Comparison of Nine Months Ended September 30, 2024 and September 30, 2023

Total revenue, net.

We recorded total revenue, net, of $166.3 million and $232.2 million during the nine months ended September 30, 2024 and 2023, respectively, a decrease of $65.9 million, or 28%.

Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States.

In addition to the United States, during the nine months ended September 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies.

As further discussed below, the aforementioned decrease consists of a $86.5 million decrease in U.S.

net product revenue offset in part by a $16.2 million increase in net product revenue outside of the United States and a $4.3 million increase in licensing and royalty revenue.

Product revenue, net.

We recorded product revenue, net, of $144.5 million and $214.7 million during the nine months ended September 30, 2024 and 2023, respectively, a decrease of $70.2 million, or 33%.

This decrease was due primarily to a 41% decrease in VASCEPA sales in the United States.

We recorded U.S.

product revenue, net, of $122.5 million and $209.0 million during the nine months ended September 30, 2024 and 2023, 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 United States, based on prescription levels reported by Symphony Health, decreased for the nine months ended September 30, 2024 by 2% as compared to the nine months ended September 30, 2023.

Our share of the icosapent ethyl market has decreased to approximately 55% in the nine months ended September 30, 2024 compared to approximately 57% in the nine months ended September 30, 2023.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 5% in the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

In Europe, we recorded product revenue, net, of $9.7 million and $1.9 million during the nine months ended September 30, 2024 and 2023, respectively.

For the nine months ended September 30, 2024, we recorded $12.3 million of product revenue, net, from our collaboration partners compared to $3.9 million during the nine months ended September 30, 2023.

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

In 2024, we continue to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets as well as supporting our partners to advance access and growing commercial operations throughout the rest of the world.

Licensing and royalty revenue .

Licensing and royalty revenue during the nine months ended September 30, 2024 and 2023 was $21.8 million and $17.5 million, respectively, an increase of $4.3 million, or 25%.

Licensing and royalty revenue increased primarily due to recognition of the REDUCE-IT indication milestone in China, offset by the recognition of CSL and Lotus upfront payments and recognition of previously achieved milestone payments from HLS in the prior year.

Licensing and royalty revenue recognized in the current period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

As of June 30, 2024, these payments have been fully recognized.

Licensing and royalty revenue recognized in the prior period relates to the partial recognition of the above upfront and previously achieved milestones, excluding the REDUCE-IT indication approval, as well as below amounts received in connection with the following VASCEPA licensing agreements:

• HLS – a $5.0 million upfront payment which was received upon closing of the agreement in September 2017, a $2.5 million milestone payment that was received following achievement of the REDUCE-IT trial primary endpoint in September 2018, a $2.5 million milestone payment that was received following U.S.

FDA approval of a new indication and label expansion in December 2019, and a $3.8 million milestone payment that was received as a result of obtaining a regulatory exclusivity designation in January 2020.

As of June 30, 2023, these payments have been fully recognized.

• CSL – a $0.5 million upfront payment which was received upon closing of the agreement in January 2023.

• Lotus – a $0.3 million upfront payment which was received upon closing of the agreement in August 2023.

The upfront and milestone payments from Edding and HLS were being recognized over the estimated period in which we were required to provide regulatory and development support pursuant to the respective agreements which were satisfied in 2024 and 2023, respectively.

The upfront payment from CSL and Lotus was recognized in January 2023 and August 2023, respectively, upon closing of the agreement as no regulatory and development support is required pursuant to the agreement.

The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

As part of our licensing agreements with certain territories outside of the United States, 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.

Cost of goods sold.

Cost of goods, inclusive of restructuring charges, sold during the nine months ended September 30, 2024 and 2023 was $75.4 million and $111.8 million, respectively, a decrease of $36.4 million, or 33%.

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.

During the nine months ended September 30, 2023, we have taken steps to amend supplier agreements to align supply arrangements with current and future demand resulting in charges of $39.2 million which were recorded as cost of goods sold - restructuring inventory.

The API included in the calculation of the average cost of goods sold during the nine months ended September 30, 2024 and 2023 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 both of the nine months ended September 30, 2024 and 2023 was 48%.

Excluding the restructuring inventory gross margin was 48% and 66% for the nine months ended September 30, 2024 and 2023, respectively.

The decrease in gross margin is primarily as a result of a decrease in net selling price.

Selling, general and administrative expense .

Selling, general and administrative expense for the nine months ended September 30, 2024 and 2023 was $115.3 million and $156.0 million, respectively, a decrease of $40.7 million, or 26%.

Selling, general and administrative expenses for the nine months ended September 30, 2024 and 2023 are summarized in the table below:

Nine months ended September 30,

Selling expense (1)

General and administrative expense (2)

Non-cash stock-based compensation expense (3)

Total selling, general and administrative expense

(1) Selling expense for the nine months ended September 30, 2024 and 2023 was $59.7 million and $88.5 million, respectively, a decrease of $28.9 million, or 33%.

This decrease is primarily due to a reduction in costs associated with our ORP and cost reduction plans resulting in decreased promotional initiatives, reduced travel and elimination of our U.S.

(2) General and administrative expense for the nine months ended September 30, 2024 and 2023 was $44.1 million and $58.5 million, respectively, a decrease of $14.4 million, or 25%.

This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the ORP and cost reduction plans, a decrease in branded pharma fees as a result of lower sales due to additional generic entrants in the market and decreased advisory fees related to the shareholder's special meeting in the prior year.

(3) Non-cash stock-based compensation expense for the nine months ended September 30, 2024 and 2023 was $11.6 million and $8.9 million, respectively, an increase of $2.6 million, or 29%.

(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.

(3) Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions.

The increase is due to prior years reversal of expense associated with our former CEO's resignation, as well as certain performance-based awards as it was no longer deemed probable that the performance criteria for vesting would be achieved within the required timeframe.

As part of our ORP announced in July 2023, we have redesigned our commercial infrastructure in Europe and in the U.S.

as well as focusing on maximizing U.S.

cash flow through a streamlined model, which has resulted in $50.0 million in operating cost reductions annually.

We will continue to evaluate all of our spending commitments and priorities based on our refocused strategic priorities and restructuring plan.

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.

Research and development expense .

Research and development expense for the nine months ended September 30, 2024 and 2023 was $14.9 million and $16.4 million, respectively, a decrease of $1.5 million, or 9%.

Research and development expenses for the nine months ended September 30, 2024 and 2023 are summarized in the table below:

Nine months ended September 30,

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,

REDUCE-IT study and presentations (1)

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The increase is as a result of additional conferences and publications in the U.S.

and Europe to support the expansion and growth in the European markets.

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

The increase is primarily due to the continued expansion within Europe and other countries throughout the world.

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

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generic competition as well as timing of pricing reimbursements throughout Europe.

Restructuring expense .

Restructuring expense for the nine months ended September 30, 2024 and 2023 was nil and $10.7 million, respectively, a decrease of $10.7 million, or 100%.

The charge in the prior year is due to the implementation of the ORP which was approved in the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S.

sales field force, with our managed care and trade organization continuing to support our U.S.

commercial efforts, as well as a reduction of approximately 30% of non-sales positions.

Refer to Note 2 Significant Accounting Policies for additional information.

Interest income, net .

Interest income, net, for the nine months ended September 30, 2024 and 2023 was $10.0 million and $8.4 million, respectively, an increase of $1.6 million, or 19%.

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, represents income earned on cash and investment balances.

The increase is primarily due to higher investment balances in the current year period compared to the prior year period.

Other income (expense), net .

Other income (expense), net, for the nine months ended September 30, 2024 and 2023 was income of $2.0 million and $3.1 million, respectively, a decrease of $1.1 million, or 37%.

Other income (expense), net, primarily consists of the ERC awarded as part of the CARES Act, gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.

The decrease in other income, net, is primarily due to receiving formal notice in the prior year from the IRS that we are entitled to the ERC funds and that receipt of a $3.9 million credit is probable.

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.

Provision for income taxes.

Income tax provision for the nine months ended September 30, 2024 and 2023 was $6.3 million and $2.1 million, respectively.

The provision for income taxes for the nine months ended September 30, 2024 is the result of income

generated by our U.S.

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.

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

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Liquidity and Capital Resources

As of September 30, 2024, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $157.5 million and short-term investments of $148.8 million.

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.

We have no indebtedness.

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

Nine months ended September 30,

Three months ended March 31,

Cash (used in) provided by:

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

Net cash used in operating activities increased during the nine months ended September 30, 2024 as compared to net cash provided by operating activities during the same period in 2023.

This is primarily as a result of timing and payment of invoices and accruals in 2024.

Net cash used in investing activities during the nine months ended September 30, 2024 decreased due primarily to the purchases of $208.9 million of investment grade interest-bearing instruments offset by proceeds from the maturity of $185.8 million in investment grade interest-bearing instruments as compared to the same period in 2023 where proceeds from the maturity of investment grade interest-bearing instruments was $161.0 million, partially offset by $115.5 million in purchases of investment-grade interest bearing instruments.

Net cash used in financing activities during the nine months ended September 30, 2024 as compared to net cash provided by financing activities during the same period in 2023 was primarily as a result of a decrease in proceeds related to stock option exercises.

As of September 30, 2024, we had net accounts receivable of $112.6 million, current inventory of $224.0 million and long-term inventory of $74.0 million.

We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.6 billion as of September 30, 2024.

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 United States and pricing and reimbursement of VAZKEPA in Europe.

In July 2023, we announced that we were implementing the ORP resulting in the elimination and consolidation of certain roles across the organization, both in the United States and abroad, representing a reduction of our total employee base by approximately 30%.

In the U.S., all sales force positions were eliminated, with the managed care and trade organization continuing to support U.S.

commercial efforts, and 30% of non-sales positions were eliminated, while in Europe we have redesigned our commercial infrastructure to better align with pricing and reimbursement status, commercial progress to date, as well as streamlining certain cross-geographic functions and better leveraging learnings across countries.

These actions reduced operating costs by $50.0 million annually.

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.

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.

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.

We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively.

The share repurchase program has a five-year approval window and can be deployed at any point until the second quarter of 2029.

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

As of September 30, 2024, we had cash and cash equivalents of $156.9 million and short-term investments of $148.8 million.

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.

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.

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 for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and are 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 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, 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.

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