What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-12 compared with 2024-02-29 · 174 added, 158 removed, 333 unchanged (50% 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.

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 Annual 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.

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 and consolidation of certain roles across our organization, both in the U.S.

and abroad, 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.

We expect the ORP will reduce operating costs by approximately $40.0 million annually.

Our refocused strategic priorities and restructuring plan focuses on three core areas:

• Maximizing U.S.

Cash Flow Through Streamlined Model:

We have maintained VASCEPA as a cost-competitive option to generics despite the elimination of all U.S.

sales force positions and approximately 30% of non-sales positions.

We maintained our managed care and trade organization to support these efforts.

We continue to explore innovative approaches to driving revenue to maintain our leadership position in the icosapent ethyl, or IPE, market.

• European Redesign:

We redesigned our commercial infrastructure in Europe to better align with pricing and reimbursement status, commercial progress to date, as well as streamline certain cross-geographic functions and better leverage learnings across countries.

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

• Expanding Upon International Partnerships:

We continue to work on generating revenue from our partnerships in key international markets, including Canada, MENA, China, South Korea, Australia and New Zealand and will continue to explore additional partnerships.

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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Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid.

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

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

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

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December 2023

Ascent Pharmaceuticals, Inc.

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.

(2) Ascent Pharmaceuticals, Inc.

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

and XL Care Pharmaceuticals, Inc.

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

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The previous calculations of prescription levels by this vendor can change between periods and can be significantly affected by lags in data reporting from various sources or by changes in pharmacies and other distributors providing data.

Such methods can from

time to time result in significant inaccuracies in information when ultimately compared with actual results.

Such methods can from time to time result in significant inaccuracies in information when ultimately compared with actual results.

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

Further, 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.

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 tends to vary from country to country and cannot be reliably predicted.

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

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

Through the date of this Annual Report, we have received and made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

Through the date of this Annual Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

Individual Reimbursement

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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.

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 approach for more impact and cost efficiency, which is or will be utilized throughout Europe as launches are rolled out.

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.

In Europe, VAZKEPA has the benefit of 10 years of market protection, and we have been issued a patent that expires in 2033 with additional pending applications that could extend exclusivity into 2039.

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

As discussed above, 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 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.

One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets, including Canada, Middle East North Africa, or MENA, China, Australia and New Zealand and Association of Southeast Asian Nations, or ASEAN, and South Korea and we will continue to explore additional partnerships in other countries throughout the world.

In February 2015, we entered into an exclusive agreement with Edding to develop and commercialize VASCEPA 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 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 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.

Middle East and North Africa (MENA)

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 New Drug Application, or 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.

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December 2019

September 2023

December 2021

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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 completed the second 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 Annual Report, we have filed for regulatory review in 20 countries and regions and have received approval in 13 countries and regions outside of the United States and European Medicines Agency, or EMA, regulatory approval authority, including in Switzerland, Australia, New Zealand and Israel, under the REDUCE-IT indication.

We completed 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 Annual 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, 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 and subsequently launched 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.

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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.

Management Updates

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.

Effective December 13, 2024, our Vice President, Global Controller and principal financial and accounting officer of the Company, Peter Fishman, has been appointed as Senior Vice President, Chief Financial Officer.

Organizational Restructuring Program

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

sales force and elimination and consolidation of certain other roles across our organization, both in the U.S.

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.

Research and Development

Since its inception in 2011, conduct of 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 study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl.

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 Annual Report on Form 10-K, more than 40 clinical treatment guidelines, consensus statements or scientific statements from 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 Canada, China and the Middle East as well as guidelines which were newly received during the fourth quarter of 2023 as listed below:

• In December 2023, the Hellenic Atherosclerosis Society published guidelines for the diagnosis and treatment of dyslipidemia.

The publication stated that clinical trials and meta-analyses have not shown that increasing consumption of omega-3 PUFA decreases the risk of atherosclerotic cardiovascular disease, or ASCVD, except for IPE.

Based on the findings of REDUCE-IT, IPE (at a dose of 2 g twice daily) should be added in combination with a statin (and fenofibrate if needed) for patients with type 2 diabetes and established ASCVD or with ≥1 major risk factor and TG >150 mg/dL.

• The Cardiological Society of India released clinical practice guidelines for dyslipidemia management in December 2023.

The guidelines state that in patients with mild to moderate hypertriglyceridemia (TG 150–499 mg/dL), there is no role for fibric acid derivatives.

In those with diabetes (≥40 years of age) or ASCVD, IPE may be considered if TG remains high after lifestyle changes and diabetes control have been achieved.

In addition, the guidelines not that the REDUCE-IT randomized controlled trial of highly purified IPE showed significant reduction of MACE.

Based on REDUCE-IT results, as of the date of the filing of this Annual 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 fourth quarter of 2024 as listed below:

• In September 2024, the European Society of Cardiology, or ESC, updated their guidelines on the management of peripheral arterial and aortic disease to recommend IPE 2g BID in high-risk patients with comorbid hypertriglyceridemia (>1.5 mmol/L) despite lifestyle changes and statin therapy.

This update is a Class IIb recommendation supported by Level B evidence.

• In November 2024, the Taiwan Society of Cardiology updated their guidelines on the prevention of Atherosclerotic Cardiovascular Disease, or ASCVD, to recommend IPE 2-4g QD to patients receiving statin therapy with TG levels ≥150 mg/dL.

Patients with very high TG levels ≥500 mg/dL with pancreatic risk may also benefit from IPE or EPA.

• In December 2024, the Royal College of Physicians of Thailand, or RCPT, updated their guidelines on the management of dyslipidemia for ASCVD prevention to recommend IPE for risk reduction in patients age >40 years with type 2 diabetes, two or more risk factors for ASCVD, and persistently elevated TG levels even after achieving target LDL-C levels with statin therapy.

During 2024, we announced the following data which added to our growing body of knowledge on VASCEPA as a result of our continued analysis of the REDUCE-IT trial results:

• In March 2023, a new prespecified and post hoc exploratory analysis of REDUCE-IT, presented at the American College of Cardiology scientific session, found VASCEPA significantly reduced the risk of first cardiovascular death, strokes, heart attacks, coronary revascularization or unstable angina in a subgroup of patients with recent (<12 months) acute coronary syndrome by 37% (HR 0.63;

95% CI, 0.48-0.84, p=0.002).

• In April 2023, the EVAPORATE- FFRCT study was published online in the European Heart Journal - Cardiovascular Imaging.

This subgroup analysis assessed the impact of VASCEPA on coronary physiology assessed by fractional flow reserve derived from coronary CTA data sets, or FFRCT, using imaging data from EVAPORATE.

FFRCT has been associated with various clinical outcomes, such as the safe deferral of invasive coronary angiography, cardiovascular death or myocardial infarction, and revascularization.

This study is the first assessment of FFRCT to determine drug effect, and there was significant improvement in the pre-specified primary endpoint of FFRCT value in the distal coronary segment from baseline to follow-up in the most diseased vessel per patient using VASCEPA compared with placebo.

VASCEPA improved mean distal segment FFRCT at 9- and 18-months follow-up compared with placebo (P = 0.02, P = 0.03 respectively).

The secondary endpoint, change in translesional FFRCT (change in FFRCT across the most severe (minimum 30%) diameter stenosis) coronary lesion per vessel was improved with VASCEPA treatment compared with placebo, although it was not statistically significant (P = 0.054).

• In August 2023, we supported research that was presented at the ESC Congress, both onsite and online in Amsterdam.

This new research included, along with other topics, the REDUCE-IT mediation analysis report of the contribution of IPE and other biomarkers to MACE reduction.

In total, Amarin and global medical and scientific collaborators supported close to 50 publications inclusive of accepted abstracts, posters, and manuscripts.

• In February 2024, we supported our commercialization partners in Australia with an encore research presentation at the 4 Corners of Cardiology Meeting in Melbourne, Australia.

This encore presentation included the REDUCE-IT mediation analysis report of the contribution of IPE and other biomarkers to major adverse cardiovascular events reduction.

• In April 2024, we highlighted four data presentations showcasing the mechanistic activity of EPA and one REUDCE-IT subgroup analysis presentation reporting the effect of VASCEPA in patients with elevated TG and high or low Lipoprotein(a) concentrations at the American College of Cardiology scientific session.

These presentations advanced the understanding of how EPA and VASCEPA work to reduce CV events in at-risk patients.

• In May 2024, we supported two data presentations showcasing the mechanistic activity of EPA at the European Atherosclerosis Society, or EAS, scientific session in Lyon, France.

These presentations may advance the understanding of how EPA and VASCEPA work to reduce CV events in at-risk patients.

• In June 2024, we supported a poster with real world, observational, safety data of IPE from a U.S.

database at the National Lipid Association, or NLA, scientific session in Las Vegas, Nevada.

This presentation may advance the understanding of the safety profile of IPE in the real world and how it compares to the safety listed in the approved labeling and those from the large REDUCE-IT CV outcomes trial.

• In June 2024, we supported an economic analysis of the budget impact of IPE in the prevention of cardiovascular events in Italy at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Italy meeting in Bologna, Italy.

• In July 2024, we supported data presentations showcasing the mechanistic activity of 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, or CSANZ, and at the Australian Diabetes Congress, or ADC.

• In August and September 2024, we supported data presentations at both the ESC in London, UK, and the European Association for the Study of Diabetes, or EASD 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 October 2024, we supported our Canadian partner, HLS, with an encore REDUCE-IT subgroup analysis presentation reporting the effect of VASCEPA/VAZKEPA in patients with elevated triglycerides and high or low Lipoprotein(a) concentrations at the Canadian Cardiovascular Congress, or CCC, in Vancouver, BC.

• In November 2024, we supported three data presentation at the AHA Scientific Sessions in Chicago, IL.

One data presentation was a subgroup analysis from REDUCE-IT in patients with prior CV events regardless of coronary artery disease history, and the other two data presentations showed the mechanistic activity of EPA.

• In November 2024, we supported two health economics and outcomes research, or HEOR, presentations in Barcelona, Spain, at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, Europe meeting.

These data presentations highlighted the value add and cost-effectiveness of VASCEPA/VAZKEPA in patients with recent acute coronary syndrome in the Catalonia region of Spain.

• In December 2024, we recognized support from our partner in the Middle East, Biologix, for a data presentation at the 20th International Symposium on Atherosclerosis, or ISA, in Muscat, Oman.

The presentation reported on the effectiveness of VASCEPA/VAZKEPA in middle eastern patients with dyslipidemia within cardiology and endocrinology clinics.

In total, Amarin and global medical and scientific collaborators supported close to 45 publications inclusive of accepted abstracts, posters, and manuscripts for the year 2024.

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 December 31, 2023, we had inventory of $336.2 million, of which 80% is inventory approved for use in North America.

As of December 31, 2024, we had inventory of $230.8 million, of which approximately 60% 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.

Revenues from VASCEPA sales are recognized upon delivery to the distributor or customer.

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 years ended December 31, 2023 and 2022, 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.

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.

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 up-front, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the United States.

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 U.S..

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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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.

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

Income tax provision.

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 the year-ended December 31, 2024 and 2023, 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 consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP.

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

Critical Accounting Policies and Estimates

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

On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions.

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We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements.

Revenue Recognition —In accordance with GAAP, under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , which we adopted on a modified retrospective basis effective January 1, 2018, revenue is recognized when product has been delivered to the wholesaler, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.

Revenue Recognition —In accordance with GAAP, under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers revenue is recognized when product has been delivered to the wholesaler, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.

To determine revenue recognition for arrangements that we determine are within the scope of Topic 606, we perform the following five steps:

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(iv) allocation of the transaction price to the performance obligations;

and (v) recognition of revenue when (or as) we satisfy each

performance obligation.

and (v) recognition of revenue when (or as) we satisfy each performance obligation.

In determining performance obligations, we evaluate whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement.

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We evaluate factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required.

The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.

The transaction price is then allocated to each performance obligation on a relative stand-alone selling price

basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.

At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price.

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We receive payments from our customers based on billing schedules established in each contract.

Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements.

Upfront payments and fees are either recognized as licensing revenue or recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements.

Amounts are recorded as accounts receivable when our right to consideration is unconditional.

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The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2024 and 2023.

For a comparison of our results of operations and financial condition for fiscal years 2022 and 2021, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2022 Annual Report on Form 10-K, filed with the SEC on March 1, 2023 .

For a comparison of our results of operations and financial condition for fiscal years 2023 and 2022, see “ Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations ” of our 2023 Annual Report on Form 10-K, filed with the SEC on February 29, 2024 .

Comparison of Fiscal Years Ended December 31, 2024 and December 31, 2023

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We recorded total revenue, net, of $228.6 million and $306.9 million during the years ended December 31, 2024 and 2023, respectively, a decrease of $78.3 million, or 26%.

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

In addition to the United States, we also sell 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 an $86.0 million decrease in U.S.

net product revenue, offset by increases of $18.9 million in licensing and royalty revenue and $4.7 million in net product revenue from sales of VASCEPA outside of the United States.

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

In addition to the U.S., we also sell 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.

discussed below, the aforementioned decrease consists of a $107.2 million decrease in U.S.

net product revenue, offset by increases of $26.5 million in net product revenue from sales of VASCEPA outside of the U.S.

and $2.4 million in licensing and royalty revenue.

Product revenue, net.

We recorded product revenue, net, of $204.6 million and $285.3 million during the years ended December 31, 2024 and 2023, respectively, a decrease of $80.7 million, or 28%.

This decrease was due primarily to a 24% decrease in VASCEPA sales in the United States.

This decrease was due primarily to a 39% decrease in VASCEPA sales in the U.S..

We recorded U.S.

product revenue, net, of $166.7 million and $273.9 million for the years ended December 31, 2024 and 2023, respectively.

This decrease was primarily due to a decline in net selling price as a result of the impact from an increase in generic competition in the market, offset by an adjustment primarily related to Medicaid rebates of $15.1 million.

During the year ended December 31, 2023 there were four generics in the market.

During the majority of the year ended December 31, 2022 there were three generics in the market.

The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, increased for the year ended December 31, 2023 by 4% as compared to the year ended December 31, 2022.

This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market, a decrease in volume primarily related to the loss of a large national Pharmacy Benefit Managers, or PBM, going from exclusive to no longer covering VASCEPA, as well as a change in estimate adjustment made in 2023 primarily related to Medicaid rebates of $15.1 million.

The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, decreased for the year ended December 31, 2024 by 2% as compared to the year ended December 31, 2023.

Our share of the icosapent ethyl market has decreased to approximately 53% in the year ended December 31, 2024 from approximately 57% in the year ended December 31, 2023.

Additionally, based on prescription levels reported by Symphony Health, VASCEPA branded prescriptions decreased by 9% in the year ended December 31, 2024 as compared to the year ended December 31, 2023.

In Europe, we recorded product revenue, net of $3.3 million and $2.6 million as of December 31, 2023 and 2022, respectively.

Revenue in 2023 was primarily related to sales in the U.K.

and Spain, whereas 2022 was primarily related to sales in Germany, from which we subsequently withdrew in the third quarter of 2022.

In Europe, we recorded product revenue, net, of $13.7 million and $3.3 million as of December 31, 2024 and 2023, respectively, primarily from the UK and Spain.

For the year ended December 31, 2024, we recorded $24.2 million of product revenue, net, to our collaboration partners compared to $8.1 million during the year ended December 31, 2023.

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 years ended December 31, 2024 and 2023 was $24.0 million and $21.6 million, respectively, an increase of $2.4 million, or 11%.

The increase is primarily due to the recognition of previously deferred milestone and upfront payments relating to Edding and HLS due to a change in the estimates in which we previously recognized revenue as well as recognition of regulatory milestones achieved during the year.

Licensing and royalty revenue 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,

and a $3.0 million milestone payment achieved in October 2023 following a regulatory submission to the NMPA for VASCEPA under the REDUCE-IT indication.

• 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.

• 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 are being recognized over the estimated period in which we are required to provide regulatory and development support pursuant to the agreements.

The upfront payment from CSL and Lotus are recognized upon closing 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.

During the second quarter of 2023, the performance period for Edding and HLS was reevaluated and adjusted, resulting in the Company recognizing an additional $5.0 million and $5.3 million, respectively, in license revenues related to this change in estimate for the year ended December 31, 2023.

For additional information over the change in estimate refer to Note 13 - Development, Commercialization and Supply Agreements.

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 current year licensing and royalty revenue is comprised primarily of the following:

• $15.0 million milestone payment following NMPA approval in China of VASCEPA under the REDUCE-IT indication,

• $4.0 million recognition of previously deferred revenue arising from a change in estimate,

• $1.2 million milestone arising from the Pharmaceutical Benefits Scheme, or PBS, listing of VAZKEPA in Australia, and

• royalties from sales of VASCEPA in select territories.

The prior year licensing and royalty revenue is comprised of the following:

• partial recognition of a $5.0 million milestone following NMPA approval in China of VASCEPA under the MARINE indication,

• partial recognition of a $3.0 million milestone following regulatory submission in China of VASCEPA under the REDUCE-IT indication,

• $10.3 million recognition of previously deferred revenue arising from a change in estimate, and

• royalties from sales of VASCEPA in select territories.

Refer to Note 13 Development, Commercialization and Supply Agreements for further details on our licensing 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.

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During 2024 and 2023, we have taken steps to amend supplier agreements to align supply arrangements with current and future demand resulting in charges of $36.5 million and $39.2 million, respectively, which were recorded as cost of goods sold - restructuring inventory.

During 2024, approximately $8.0

million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory.

During 2023, approximately $5.1 million of inventory was expensed through cost of goods sold due to both product dating and non-product dating unsellable inventory.

During 2022, approximately $9.6 million of inventory was expensed through cost of goods sold not due to product dating unsellable inventory.

The API included in the calculation of the average cost of goods sold during the years ended December 31, 2024 and 2023 was sourced from multiple API suppliers.

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(1) Selling expense for the years ended December 31, 2024 and 2023 was $79.6 million and $111.3 million, respectively, a decrease of $31.7 million, or 29%.

This decrease is primarily due to a reduction in costs from the elimination of our U.S.

force as part of our ORP and previous cost reduction plans which also led to a decrease in promotional initiatives and reduced travel.

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 years ended December 31, 2024 and 2023 was $58.6 million and $76.1 million, respectively, a decrease of $17.6 million, or 23%.

This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the ORP and previous cost reduction plans as well as a decrease in branded pharma fees as a result of lower sales due to additional generic entrants in the market.

The decrease in general and administrative expense was offset by advisory fees related to the 2023 shareholder's special meeting.

(3) Non-cash stock-based compensation expense for the years ended December 31, 2023 and 2022 was $12.5 million and $22.3 million, respectively, a decrease of $9.8 million, or 44%.

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 and decreased advisory fees related to the shareholder's special meeting in 2023.

(3) Non-cash stock-based compensation expense for the years ended December 31, 2024 and 2023 was $14.2 million and $12.5 million, respectively, an increase of $1.7 million, or 13%.

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

The decrease is due to the reversal of expense associated with the resignation of our former board members and our former CEO, the ORP announced in July 2023, 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 to better align with pricing and reimbursement status, commercial progress to date, as well as streamline certain cross-geographic functions.

In addition, we are continuing to advance our pricing and reimbursement activities to drive access in remaining geographies, as well as advancing regulatory filings internationally and focusing on maximizing U.S.

cash flow through a streamlined model.

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

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.

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.

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Year Ended December 31,

REDUCE-IT study (1)

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)

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Total research and development expense

(1) The decrease in expenses for the REDUCE-IT study is primarily driven by incremental efficiencies applied to ongoing analyses performed on the REDUCE-IT cardiovascular outcomes trial data, further leveraging existing internal resources compared to outsourced support.

(2) The decrease in fixed-dose combination expenses is primarily due to initial start-up and other costs beginning in 2022 associated with planning and development of the fixed-dose combination of VASCEPA and a statin.

The development of the fixed-dose combination was deprioritized during 2023 after it became clear that it would not drive short-term value.

(3) The decrease in regulatory filing fees is primarily related to higher spend in 2022 relating to the preparation, submission, and review defense of regulatory filings for several countries.

The Company has not prepared nor submitted as many regulatory filings in 2023 as in the previous year.

(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, including costs associated with securing and maintaining regulatory approvals for VAZKEPA in Europe as originally achieved in 2021, as well as regulatory expansion in other countries throughout 2023.

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

(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.

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.

(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.

The decrease is due to the reversal of expense associated with certain performance-based awards as it was no longer deemed probable that the performance criteria for vesting would be achieved within the required timeframe.

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.

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Restructuring expense .

Restructuring expense for the years ended December 31, 2023 and 2022 was $11.0 million and $13.5 million, respectively, a decrease of $2.6 million, or 19%.

The charge in the current 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.

Restructuring expense for the years ended December 31, 2024 and 2023 was nil and $11.0 million, respectively, a decrease of $11.0 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.

The prior year charge was the result of the implementation of the CRP announced on June 6, 2022, which primarily related to the reduction of our U.S.

field force from approximately 300 sales representatives to approximately 75 sales representatives, as well as the discontinuation of the German operations announced on August 19, 2022.

Refer to Note 2 Significant Accounting Policies for additional information.

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Other income (expense), net .

Other income (expense), net, for the year ended December 31, 2023 and 2022 was income of $2.1 million and expense of $0.7 million, respectively, an increase of $2.8 million or 379%.

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, NJ facility.

Other income (expense), net, for the year ended December 31, 2024 and 2023 was income of $1.2 million and $2.1 million, respectively.

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

Provision for income taxes .

Provision for income taxes for the year ended December 31, 2024 and 2023 was $5.0 million and $5.4 million, respectively.

The increase in the provision for income taxes is due to a change in geographic mix of pre-tax income.

On August 16, 2022, the Inflation Reduction Act of 2022, or the Act, was signed into law by the Biden Administration, with tax provisions effective January 1, 2023 primarily focused on implementing a 15% minimum tax on global adjusted financial statement income (CAMT) and a 1% excise tax on share repurchases.

We do not expect either of these provisions to have a material impact on our financial results, including the impact from our share repurchase program announced in January 2024.

The decrease in the provision for income taxes is due to a change in geographic mix of pre-tax income.

Liquidity and Capital Resources

As of December 31, 2023, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $199.8 million and short-term investments of $121.4 million.

As of December 31, 2024, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $121.3 million and short-term investments of $173.2 million, aggregating $294.5 million.

We have no indebtedness.

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Year Ended December 31,

Cash provided by (used in):

Cash (used in) provided by:

Operating activities

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

Net cash provided by operating activities increased during 2023 as compared to net cash used in operating activities during the same period in 2022.

This is primarily as a result of higher costs in 2022 associated with commercial and pre-launch operations in Europe as well as higher inventory purchases in the first half of 2022, offset by a decrease in U.S.

Net cash used in operating activities decreased during 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 as well as a decrease in U.S.

product revenue in 2024.

Net cash used in investing activities decreased during the year ended December 31, 2023 compared to net cash provided by investing activities during the same period in 2022.

Net cash used in investing activities decreased during the year ended December 31, 2024 compared to the same period in 2023.

This is primarily due to the purchase of investment grade interest-bearing instruments of $278.8 million partially offset by $232.8 million from proceeds from the maturity of 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 $215.1 million, partially offset by $190.1 million in purchases of investment grade interest-bearing instruments.

Net cash provided by financing activities increased during the years ended December 31, 2023 compared to net cash used in financing activities during the same period in 2022, primarily as a result of an increase in proceeds related to stock option exercises, offset by taxes paid related to stock-based awards

Net cash used in financing activities decreased during the years ended December 31, 2024 compared to net cash provided by financing activities during the same period in 2023, primarily as a result of a decrease in proceeds related to stock option exercises.

As of December 31, 2024, we had net accounts receivable of $122.3 million, current inventory of $166.0 million and long-term inventory of $64.7 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 December 31, 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 an 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%.

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 U.S.

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.

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.

We expect these actions will reduce operating costs by approximately $40.0 million annually.

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.

The implementation of the share repurchase program will require shareholder approval as well as UK High Court approval, as required under UK company law.

As of December 31, 2023, we had cash and cash equivalents of $199.3 million and short-term investments of $121.4 million.

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

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

As of December 31, 2024, we had cash and cash equivalents of $121.0 million and short-term investments of $173.2 million, aggregating $294.2 million.

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

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Interest rate risk mainly arises through interest bearing liabilities and assets.

Our portfolio of investments as of December 31, 2023 was composed primarily of U.S.

Our portfolio of investments as of December 31, 2024 was

composed primarily of U.S.

Treasury securities and other government-related securities.

At December 31, 2023 and 2022, we had short-term investments and long-term investments of $121.4 million and $93.0 million, respectively.

At December 31, 2024 and 2023, we had short-term investments of $173.2 million and $121.4 million, respectively.

We invest funds to have a continuous inflow of cash from diversified short-term and long-term investments, consisting primarily of investment grade securities.

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Our short-term investments consist of securities that mature in one year or less.

Our long-term investments consist of securities that mature in more than one year.

We invest cash in excess of our immediate requirements, in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.

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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-K

Item 7. Management’s Discussion and Analysis