What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-03-12 compared with 2024-02-29 · 344 added, 312 removed, 1166 unchanged (36% of the section changed)

15 unchanged sentences

Our management, including our principal executive officer and principal financial officer, has conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024.

In conducting this evaluation, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013) .

In conducting this evaluation, we used the

criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013) .

Based upon this evaluation and those criteria, management has concluded that, as of December 31, 2024, our internal control over financial reporting was effective.

8 unchanged sentences

In our opinion, Amarin Corporation plc (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria .

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 29, 2024 expressed an unqualified opinion thereon.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and our report dated March 12, 2025 expressed an unqualified opinion thereon.

Basis for Opinion

16 unchanged sentences

Iselin, New Jersey

February 29, 2024

March 12, 2025

Othe r Information

3 unchanged sentences

Directors, Executive Of ficers and Corporate Governance

The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2024 Annual General Meeting of Shareholders.

Such information is incorporated herein by reference.

Code of Ethics

Our board of directors has adopted a code of business conduct and ethical responsibility that applies to our directors, officers and employees.

There have been no material modifications to, or waivers from, the provisions of such code.

We have adopted a code of conduct that applies to our directors, officers and employees.

This code is available on the corporate governance section of our website (which is a subsection of the investor relations section of our website) at the following address:

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Investor Relations.

In addition, should any changes be made to our code of business conduct and ethical responsibility, we intend to disclose within four business days on our website (or in any other medium required by law or the NASDAQ):

(a) the date and nature of any amendment to our code of business conduct and ethical responsibility that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (b) the nature of any waiver, including an implicit waiver, from a provision of our code of business conduct and ethical responsibility that is granted to one of these specified officers, the name of such person is granted the waiver, and the date of the waiver.

We intend to make any legally required disclosures regarding amendments to, or waivers of, provisions of this code on our website rather than by filing a Current Report on Form 8-K.

The remaining information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2025 Annual General Meeting of Shareholders.

Such information is incorporated herein by reference.

Executi ve Compensation

2 unchanged sentences

Security Ownership of Certain Beneficial Ow ners and Management and Related Stockholder Matters

The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2024 Annual General Meeting of Shareholders to be filed within 120 days after the fiscal year ended December 31, 2023 ("Definitive Proxy Statement").

The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2025 Annual General Meeting of Shareholders.

Such information is incorporated herein by reference.

13 unchanged sentences

Articles of Association of the Company

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013, as Exhibit 3.1

August 8, 2013

Current Report on Form 8-K filed with the Commission on April 22, 2024, as Exhibit 3.1

April 22, 2024

Form of Amended and Restated Deposit Agreement, dated as of November 4, 2011, among the Company, Citibank, N.A., as Depositary, and all holders from time to time of American Depositary Receipts issued thereunder

85 unchanged sentences

March 16, 2012

Employment Agreement, dated April 20, 2018, by and between Amarin Corporation plc and Aaron Berg*

Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as Exhibit 10.1

Offer Letter with Thomas Reilly, dated May 26, 2022*

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.4

August 3, 2022

API Commercial Supply Agreement, dated May 25, 2011, between Amarin Pharmaceuticals Ireland Ltd.

42 unchanged sentences

August 2, 2023

Employment Agreement between Aaron D.

Berg and Amarin Corporation, plc.

dated April 13, 2023

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as Exhibit 10.2

August 2, 2023

CEO Employment Agreement between Patrick Holt and Amarin Corporation, plc.

10 unchanged sentences

Offer Letter with Jonathan Provoost, dated October 9, 2023*

Annual Report on Form 10-K filed with the Commission for the year ended December 31, 2023, as Exhibit 10.43

February 29, 2024

Amendment No.

3 to the Amarin Corporation plc 2020 Stock Incentive Plan

Current Report on Form 8-K filed with the Commission on April 22, 2024, as Exhibit 10.2

April 22, 2024

CEO Employment Agreement, dated July 25, 2024, by and between Amarin Corporation plc and Aaron Berg.

Current Report on Form 8-K filed with the Commission on July 29, 2024, as Exhibit 10.1

July 29, 2024

Consulting Agreement, dated July 26, 2024, by and between Amarin Corporation plc and Patrick Holt

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as Exhibit 10.1

October 30, 2024

Insider Trading and Disclosure Policy

Filed herewith

Special Trading Procedures for Insiders

Filed herewith

List of Subsidiaries

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Filed herewith

Certification of Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002

Certification of Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002

Filed herewith

Certification of President and Chief Executive Officer (Principal Executive Officer) and Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002

Certification of President and Chief Executive Officer (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002

Furnished herewith

Compensation Recovery Plan

Filed herewith

Inline XBRL Instance Document

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AMARIN CORPORATION PLC

/s/ Patrick Holt

/s/ Aaron Berg

President and Chief Executive Officer

(Principal Executive Officer)

February 29, 2024

We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Patrick Holt and Tom Reilly, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

March 12, 2025

We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Aaron Berg and Peter Fishman, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.

/s/ Patrick Holt

/s/ Aaron Berg

Director, President and Chief

1 unchanged sentence

Executive Officer)

February 29, 2024

/s/ Tom Reilly

Executive Vice President and Chief

March 12, 2025

/s/ Peter Fishman

Peter Fishman

Senior Vice President and Chief

Financial Officer (Principal

Financial and Accounting Officer)

February 29, 2024

March 12, 2025

/s/ Patrice Bonfiglio

Patrice Bonfiglio

February 29, 2024

March 12, 2025

/s/ Paul Cohen, M.D.

Paul Cohen, M.D.

February 29, 2024

March 12, 2025

/s/ Mark DiPaolo

February 29, 2024

March 12, 2025

/s/ Odysseas Kostas, M.D.

February 29, 2024

March 12, 2025

Odysseas Kostas, M.D.

1 unchanged sentence

Louis Sterling III.

February 29, 2024

March 12, 2025

/s/ Oliver O'Connor

February 29, 2024

March 12, 2025

Oliver O'Connor

1 unchanged sentence

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

Report of Independent Registered Public Accounting Firm (PCAOB ID 42)

Financial Statements:

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generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 29, 2024 expressed an unqualified opinion thereon.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 12, 2025 expressed an unqualified opinion thereon.

Basis for Opinion

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Critical Audit Matter

(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.

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Description of the Matter

At December 31, 2023, the Company recorded a liability for product returns totaling $7.7 million.

As discussed in Note 12 of the financial statements, the Company sells its product to distributors that in turn resell the product to retail pharmacies for subsequent sale to patients and healthcare providers.

At December 31, 2024, the Company recorded a liability for product returns relating to U.S.

product revenue totaling $4.7 million.

As discussed in Note 12 of the financial statements, the Company sells its product to distributors in the U.S.

that in turn resell the product to retail pharmacies for subsequent sale to patients and healthcare providers.

The Company estimates variable consideration resulting from product returns based on quantitative and qualitative data from various internal and external sources.

Auditing management’s estimate of product returns was complex and judgmental due to the significant estimation required to determine inventory in the distribution channel that will not ultimately be sold to patients and healthcare providers and will be returned.

Auditing management’s estimate of U.S.

product returns was complex and judgmental due to the significant estimation required to determine inventory in the distribution channel that will not ultimately be sold to patients and healthcare providers and will be returned.

Sales into the distribution channel could exceed market demand.

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These procedures included controls over management’s review of the inputs used and assumptions applied in the returns reserve calculation and channel inventory analysis.

To test the estimated product return reserve, we performed audit procedures that included, among others, testing management’s historical return rate calculation and testing the completeness and accuracy of sales and returns data used in the calculation.

We also compared product expiration dates in the calculation to the related quality control documentation.

We assessed the historical accuracy of management’s estimate and performed analytical procedures to assess the correlation of monthly sales to distributors and monthly patient prescriptions.

In addition, we assessed the Company’s quarterly analysis of inventory held at various stages in the distribution channel.

We confirmed prescription data directly with a third party, confirmed contract terms directly with significant customers, and tested credit memos issued subsequent to year-end for recording in the proper period.

We read significant customer contracts and performed direct inquiries with management including the sales, legal, and contracting departments to identify any terms or conditions not included in customer contracts that could impact the estimate of product returns.

To test the estimated U.S.

product return reserve, we performed audit procedures that included, among others, testing management’s historical return rate calculation and testing the completeness and accuracy of sales and returns data used in the calculation.

We also compared product expiration dates in the calculation to the related supporting documentation.

We tested the Company's provision and credit activity for the current year and performed analytical procedures to assess the correlation of monthly sales to distributors and monthly patient prescriptions.

In addition, we assessed the Company’s quarterly analysis of inventory held in the distribution channel.

We confirmed prescription data directly with a third party and tested credit memos issued subsequent to year-end for recording in the proper period.

We read significant customer contracts and performed direct inquiries with management to identify any terms or conditions not included in customer contracts that could impact the estimate of U.S.

product returns.

/s/ Ernst & Young LLP

1 unchanged sentence

Iselin, New Jersey

February 29, 2024

March 12, 2025

AMARIN CORPORATION PLC

9 unchanged sentences

Property, plant and equipment, net

Long-term investments

Long-term inventory

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Total operating expenses

Operating (loss) income

Operating loss

Interest income

1 unchanged sentence

Other income (expense), net

(Loss) income from operations before taxes

Loss from operations before taxes

Provision for income taxes

Net (loss) income

(Loss) earnings per share:

Loss per share:

Weighted average shares outstanding:

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Issuance of common stock under employee stock purchase plan

Issuance of common stock for milestone payment

Exercise of stock options

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CASH FLOWS FROM OPERATING ACTIVITIES:

Net (loss) income

Adjustments to reconcile net (loss) income to net cash used in operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

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Other long-term liabilities

Net cash provided by (used in) operating activities

Net cash (used in) provided by operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

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Investment in software and website development costs

(Purchases) disposal of furniture, fixtures and equipment

Purchases of furniture, fixtures and equipment

Net cash (used in) provided by investing activities

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Taxes related to stock-based awards

Net cash provided by (used in) financing activities

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

Net cash (used in) provided by financing activities

NET DECREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD

1 unchanged sentence

Supplemental disclosure of cash flow information:

Cash (paid) received during the year for:

Cash paid during the year for:

Supplemental disclosure of non-cash transactions:

Laxdale milestone

Shares issued in settlement of Laxdale milestone payment

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Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.

The Company is commercialized in the United States, or the U.S, under the brand name VASCEPA ® (icosapent ethyl).

The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and Spain and continues pre-launch commercial activities throughout the rest of Europe.

The Company is commercialized in the United States, or the U.S, under the brand name VASCEPA ® (icosapent ethyl), or VASCEPA.

The Company is also commercialized in various European countries, including the United Kingdom, or the UK, and Spain, under the brand name VAZKEPA, hereinafter along with VASCEPA, collectively referred to as VASCEPA.

The Company’s operations outside of the U.S.

and Europe are in varying stages of development and commercialization with reliance on third-party commercial partners in select geographies, including China and Canada.

The Company’s lead product, VASCEPA, was first approved by the U.S.

and Europe are in varying stages of development and commercialization with reliance on third-party commercial partners in select geographies, including China, Australia and Canada.

VASCEPA, was first approved by the U.S.

Food and Drug Administration, or U.S.

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Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or, collectively, the Defendants, that declared as invalid several of the Company's patents covering the MARINE indication.

The Company sought appeals of the Nevada Court judgment up to the United States Supreme Court, but the Company was unsuccessful.

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

The Company sought appeals of the Nevada Court judgment up to the U.S.

Supreme Court, but the Company was unsuccessful.

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

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

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December 2023

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, hereinafter along with the U.S.

brand name VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high risk, statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event.

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.

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

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

Collectively CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China.

On June 1, 2023, the Company announced the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and launched commercially in October 2023.

On June 1, 2023, the Company announced the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and the Company's partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, launched commercially in October 2023.

On June 28, 2024, the Company's partner in China received NMPA approval for VASCEPA in Mainland China for the REDUCE-IT indication.

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

The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States and Europe.

Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States, and Europe, as well as in countries where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply.

Amarin is responsible for supplying VASCEPA to all markets in which the branded product is sold, including the U.S., and Europe, as well as in countries where the drug is promoted and sold via collaboration with third-party partners that compensate Amarin for such supply.

Amarin is not responsible for providing any generic company with drug product.

1 unchanged sentence

Basis of Presentation

The consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC.

The consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the U.S.

and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC.

The consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated.

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All intercompany accounts and transactions have been eliminated in consolidation.

Certain amounts in the consolidated financial statements of the prior year have been reclassified to conform to current year presentation.

The accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

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At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the

performance obligation is satisfied.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

For a complete discussion of accounting for net product revenue and licensing revenue, see Note 12—Revenue Recognition .

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Accounts receivable, net, comprised of trade receivables, are generally due within 45 days and are stated at amounts due from customers.

The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable losses net of any recoveries.

The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable credit losses net of any recoveries.

The allowance is based primarily on assessment of specific identifiable customer accounts considered at risk or uncollectible, as well as an analysis of current receivables aging and expected future write-offs.

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Accounts receivable, net

The Company states inventories at the lower of cost or net realizable value.

The Company states inventory at the lower of cost or net realizable value.

Cost is determined based on actual cost using the average cost method.

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for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021.

These assets are

amortized over its estimated useful life on a straight-line basis.

These assets are amortized over its estimated useful life on a straight-line basis.

See Note 7—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale.

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The Company charges selling, general and administrative costs to operations as incurred.

Selling, general and administrative costs include salaries and benefits, stock-based compensation expense, and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of VASCEPA in the United States and Europe.

Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other tax attributes using enacted rates expected to be in effect when those differences reverse.

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income tax returns.

An audit by the New Jersey Department of Treasury for the years 2012 to 2015 was closed in April 2023.

Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its consolidated financial position or results of operations.

(Loss) Earnings per Share

Basic net (loss) earnings per share is determined by dividing net (loss) income by the weighted average shares of common stock outstanding during the period.

Diluted net (loss) earnings per share is determined by dividing net (loss) income by diluted weighted average shares outstanding.

Loss per Share

Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period.

Diluted net loss earnings per share is determined by dividing net loss by diluted weighted average shares outstanding.

Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as from the exercise of stock options and vesting of restricted stock units calculated using the treasury stock method.

In periods with reported net operating losses, all stock options and restricted stock units outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.

The calculation of net (loss) income and the number of shares used to compute basic and diluted net (loss) earnings per share for the years ended December 31, 2023, 2022, and 2021 are as follows:

The calculation of net loss and the number of shares used to compute basic and diluted net loss per share for the years ended December 31, 2024, 2023, and 2022 are as follows:

Net (loss) income —basic and diluted

Weighted average shares outstanding—basic

Effect of dilutive securities:

Stock options

Restricted stock and restricted stock units

Weighted average shares outstanding—diluted

Net (loss) earnings per share—basic (1)

Net (loss) earnings per share—diluted (1)

(1) Excluding the licensing revenue change in estimate and Medicaid change in estimate, both discussed in Note 12 – Revenue Recognition, net loss per share basic and diluted for the year ended December 31, 2023 would have been $( 0.21 ).

Weighted average shares outstanding—basic and diluted

Net (loss) earnings per share—basic and diluted (1)

(1) Excluding the licensing revenue change in estimate incurred in 2024 and the licensing revenue change in estimate and Medicaid change in estimate incurred in 2023, both discussed in Note 12 – Revenue Recognition , net loss per share basic and diluted for both years ended December 31, 2024 and 2023 would have been $( 0.21 ) .

For the years ended December 31, 2024, 2023 and 2022, the following potentially dilutive securities were not included in the computation of net (loss) earnings per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:

1 unchanged sentence

Restricted stock and restricted stock units

Laxdale milestone shares

Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying shares on the last day of the reporting period.

2 unchanged sentences

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation , or ASC 718, and requires the fair value of all stock-based payments to employees and non-employees to be recognized in the consolidated statement of operations over the requisite service period.

The fair value of the Company's restricted stock units is determined to be the market price on the date of the grant.

The fair value of the Company's restricted stock units is determined to be the higher of (1) our nominal par value of 50 pence per share, for which our Plan dictates under United Kingdom law, or (2) fair market value of stock price on the NASDAQ at close of business day on the date of the grant.

The Company estimates the fair value of stock option awards on the date of the grant using the Black-Scholes Model, which requires that the Company makes certain assumptions regarding:

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Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term and long-term investments, and accounts receivable.

The Company maintains substantially all of its cash and cash equivalents and short-term and long-term investments, in financial institutions believed to be of high-credit quality.

Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term investments, and accounts receivable.

The Company maintains substantially all of its cash and cash equivalents and short-term, in financial institutions believed to be of high-credit quality.

A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry.

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Certain amounts payable are denominated in currencies other than the U.S.

The Company recorded a foreign currency loss within the Other income (expense), net on the consolidated statement of operations of $ 2.6 million, $ 0.7 million and $ 0.6 million for each of the years ended December 31, 2023, 2022, and 2021 , respectively.

During the year ended December 31, 2024 , the Company recorded a foreign currency gain of $ 0.8 million and foreign currency losses of $ 2.6 million and $ 0.7 million for the years ended December 31, 2023 and 2022 , respectively, within the Other income (expense), net on the consolidated statement of operations.

Fair Value of Financial Instruments

7 unchanged sentences

December 31, 2024

Treasury Shares

Treasury Securities

Money Market Fund

Agency Securities

Repo Securities

December 31, 2023

Treasury Securities

Money Market Fund

Commercial Paper

Corporate Bonds

Certificate of Deposit

Repo Securities

Treasury Shares

Agency Securities

Non-US Government

Asset Backed Securities

Repo Securities

The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature.

6 unchanged sentences

The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary.

The unrealized gain or loss for the years ended December 31, 2023 and December 31, 2022 was a gain of less than $ 0.1 million and a loss of $ 0.4 million, respectively.

Interest on investments is reported in interest income.

The unrealized gain or loss for the years ended December 31, 2024 and December 31, 2023 were gains of $ 0.1 million and less than $ 0.1 million, respectively.

Interest on investments is reported in interest income in our consolidated statement of operations.

Interest receivable in investment securities is reported in prepaid and other current assets in our consolidated balance sheet.

The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature.

Segment and Geographical Information

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing performance of the segment.

The Company currently operates in one business segment, which is the development and commercialization of VASCEPA.

A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business.

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or CODM, in deciding how to allocate resources to an individual segment and in assessing performance of the segment.

The Company currently operates in two business segments, U.S.

and Europe, which are aggregated into a single reportable segment, for the development and commercialization of VASCEPA.

A single management team that reports to the Company’s CODM, who is the Chief Executive Officer, comprehensively manages the business on an integrated basis for the purpose of allocating resources.

The Company’s CODM does not currently assess segment performance or allocate resources based on a measure of total assets nor is it practical for the Company to disaggregate assets based on geography.

Accordingly, a total asset measure has not been provided for segment disclosure.

Accordingly, the Company does not have separately reportable segments.

The table below is a summary of the reportable segment profit or loss, including significant reportable segment expenses:

Year Ended December 31,

US product revenue, net

Europe product revenue, net

RoW product revenue, net

Total product revenue, net

Licensing and royalty revenue

Total revenue, net

Cost of goods sold

Cost of goods sold - restructuring inventory

Operating expenses:

General and administrative

Research and development

Payroll and payroll related expense

Non-cash stock-based compensation expense

Restructuring

Total operating expenses

Operating loss

Interest income

Interest expense

Other income (expense), net

Loss from operations before taxes

Provision for income taxes

Segment & consolidated net loss

Restructuring

The Company identifies a restructuring event as a program that is planned and controlled by management, and materially changes either the scope of the Company's business or the manner in which that business is conducted.

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The Company accrues a liability for termination benefits under ASC 712 when it is probable that a liability has been incurred and the amount can be reasonably estimated and under ASC 420 when the termination benefits are communicated.

The Company continued to assess its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand.

As a result of the ongoing assessment, the Company recognized $ 36.5 million, $ 39.2 million, and $ 18.1 million during the year ended December 31, 2024, 2023, and 2022 , respectively, within cost of goods sold - restructuring inventory on the consolidated statement of operations for both cash and non-cash obligations.

During the year ended December 31, 2024, the Company entered into an amended supply agreement resulting in the return of approximately $ 36.5 million of API previously recorded within raw materials.

The API is set to be returned over an agreed upon period at predetermined volumes.

The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.

In June 2023, the Company approved and subsequently announced on July 18, 2023, an Organizational Restructuring Plan, or ORP, to right-size and strengthen the Company.

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During the year ended December 31, 2023, the Company recognized approximately $ 11.0 million within restructuring expense on the consolidated statement of operations related to the reduction in force, substantially all of which are cash expenditures.

The Company continued to assess its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand.

As a result of the ongoing assessment, the Company recognized $ 39.2 million and $ 18.1 million during the years ended December 31, 2023 and 2022, respectively, within cost of goods sold - restructuring inventory on the consolidated statement of operations.

The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.

On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan, or CRP, which included an organizational restructuring plan to address the shifts within the Company’s U.S.

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field force from approximately 300 sales representatives to approximately 75 sales representatives.

During the year ended December 31, 2022 , the Company recognized approximately $ 9.4 million within restructuring expense on the consolidated statement of operations related to the reduction in force, substantially all of which was cash expenditures.

During the year ended

December 31, 2022, the Company recognized approximately $ 9.4 million within restructuring expense on the consolidated statement of operations related to the reduction in force, substantially all of which was cash expenditures.

On August 19, 2022, the Company announced that after the conclusion of the fourth and final round of negotiations in Germany with the National Association of Statutory Health Insurance Funds, or GKV-SV, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached.

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During the year ended December 31, 2022, the Company recognized approximately $ 4.2 million within restructuring expense on the condensed consolidated statement of operations, substantially all of which was cash expenditures.

On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA.

As part of this strategy, the Company completed a reduction of its U.S.

field force to approximately 300 sales representatives, enhanced managed care access and optimized VASCEPA prescriptions for cardiovascular risk reduction.

During the year ended December 31, 2021, the Company recognized approximately $ 13.7 million in charges related to the reduction in force, substantially all of which were cash expenditures for one-time termination benefits and associated costs.

The following table sets forth the components of the Company's restructuring charges for the years ended December 31, 2023, 2022 and 2021:

The following table sets forth the cash obligations of the Company's restructuring charges for the years ended December 31, 2024, 2023 and 2022:

For the Year Ended December 31,

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From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are early adopted by the Company or adopted as of the specified effective date.

The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosu res, which improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, requirements of public entities that have a single reportable segment provide all the disclosures required by ASU No.

2023-07 and all existing segment disclosures in Topic 280, among other disclosure enhancements.

The Company adopted this standard effective January 1, 2024 and additional requirements are disclosed within the Company's consolidated financial statements.

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures , which provide more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information.

This change is effective for annual periods beginning after December 15, 2024.

The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on our consolidated financial statements and disclosures.

In November 2024, the FASB issued ASU No.

2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) , which require a public business entity to disclose specific information about certain costs and expenses in the notes to its financial statements for interim and annual reporting periods beginning after December 15, 2026.

The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on the Company’s consolidated financial statements.

The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

(3) Intangible Asset

Intangible asset consists of internal-use software, website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S.

for the first indication in 2012, the expanded label in 2019 and marketing approval in Europe in 2021.

For the year ended December 31, 2023 , the Company capitalized $ 0.3 million of costs associated with the implementation of internal-use software.

In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization.

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(1) Total inventory consists of both current inventory and long-term inventory.

During the year ended December 31, 2023 , approximately $ 5.1 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory.

During the year ended December 31, 2022 approximately $ 9.6 million of finished goods were expensed through cost of goods sold related to unsellable inventory not related to product dating.

During the year ended December 31, 2024 , approximately $ 8.0 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory and as part of our ongoing supply agreement settlements, $ 36.5 million was expensed through cost of goods sold - inventory restructuring and reserved for the future return of API.

During the year ended December 31, 2023 , $ 5.1 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory.

As of December 31, 2024 and 2023, the Company had $ 64.7 million and $ 77.6 million of long-term inventory, respectively, as consumption is expected beyond the Company's operating cycle of 12 months.

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The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life.

Depreciation expense for the year ended December 31, 2023 was $ 0.2 million and for the years ended December 31 2022, and 2021 was $ 0.6 million, respectively.

Depreciation expense for the years ended December 31, 2024, 2023,

and 2022 was $ 0.1 million, $ 0.2 million, and $ 0.6 million, respectively.

Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is credited or expensed to operations.

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If a reasonable estimate cannot be made, however, Amarin will provide disclosure to that effect.

Litigation – U.S.

On March 30, 2020, the Nevada Court, ruled in favor of two generics companies, Hikma and Dr.

Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S.

FDA approval for sale of generic versions of VASCEPA for the original indication of VASCEPA as an adjunct to diet to reduce TG levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia.

On September 3, 2020, the U.S.

Court of Appeals for the Federal Circuit, or the Federal Circuit, upheld the March ruling by the Nevada Court in favor of the two generics companies.

On October 2, 2020, the Company filed a combined petition for panel rehearing or rehearing en banc.

On November 4, 2020, the Company’s rehearing and en banc petitions were denied.

On February 11, 2021, Amarin filed a petition for a writ of certiorari with the United States Supreme Court to ask the Court to hear the Company’s appeal in this litigation, which was denied on June 18, 2021.

On May 22, 2020 and August 10, 2020, Hikma and Dr.

Reddy’s, respectively, received U.S.

FDA approval to market its generic versions of VASCEPA.

During the ANDA litigation, the Company reached agreements with Teva and Apotex, under which they received royalty-free license agreements to promote a generic version of icosapent ethyl in the U.S.

under certain circumstances, one

of which circumstances was achieved when the Federal Circuit upheld the ruling by the Nevada Court and Hikma launched its generic version of icosapent ethyl.

On September 11, 2020, and June 30, 2021, Teva and Apotex, respectively, received U.S.

FDA approval to market their respective generic versions of icosapent ethyl.

In November 2020, Hikma announced the price and launched its generic version of icosapent ethyl.

In June 2021, Dr.

Reddy’s announced the price and launched its generic version of icosapent ethyl.

In January 2022, Apotex announced the price and launched its generic version of icosapent ethyl.

In September 2022, Teva announced the price and launched its generic version of icosapent ethyl for the 0.5-gram capsule and the 1.0 gram capsule in January 2023.

All generic versions of icosapent ethyl as approved by the U.S.

FDA pertains to the MARINE indication of VASCEPA, lowering of TG levels in patients with very high TG (>500 mg/dL).

Current generic competition, together with past and on-going litigation related to such generic versions of icosapent ethyl are applicable to the U.S.

The Company did not seek, nor is VAZKEPA approved in Europe for lowering of TG levels in patients with very high TG (>500 mg/dL).

The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitment, including to manufacturing infrastructure such as dedicated facilities, to ensure sufficient capacity is available when needed.

The Company has invested over a decade of resources and expenses to develop with individual members of its third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable the Company’s suppliers to supply the Company’s need for clinical and commercial supply globally.

In November 2020, the Company filed a patent infringement lawsuit against Hikma in the United States District Court in Delaware.

The complaint alleged that Hikma induced the infringement of VASCEPA-related CV risk reduction U.S.

9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States.

In January 2021, the Company expanded the scope of the VASCEPA CV risk reduction patent infringement lawsuit against Hikma to include a health care insurance provider in the United States, Health Net LLC, or Health Net.

Through insurance coverage and economic incentives the Company alleged that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of the related patents.

In the complaint, the Company sought remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement.

On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss.

On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma.

The Company has appealed the decision of the district court.

On December 26, 2022, the Company entered into a settlement agreement with Health Net that resolved the litigation relating to the Company and Health Net.

The Company will continue to consider its legal options against parties similarly situated to Health Net and Hikma and acting in concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.

As has been a practice in the generic pharmaceutical industry, on April 27, 2021 and February 21, 2023, Dr.

Reddy’s and Hikma, respectively, filed complaints against the Company in the United States District Court for the District of New Jersey, Civil action No.

On April 27, 2021 and February 21, 2023, Dr.

Reddy’s and Hikma, respectively, filed complaints against the Company in the U.S.

District Court for the District of New Jersey, Civil action No.

21-cv-10309 and No.

23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA.

The DRL complaints also includes a related state law tortious interference claim.

Damages sought include recovery for alleged economic harm to Dr.

Reddy’s and to Hikma respectively, treble damages, other costs and fees and injunctive relief against the alleged violative activities.

DRL's complaint also includes a state law tortious interference claim related to the same alleged conduct.

On March 28, 2024, Teva Pharmaceuticals USA, Inc., or Teva, filed a complaint against the Company in the U.S.

District Court for the District of New Jersey, Civil action No.

24-cv-04341 alleging various antitrust violations analogous to those made by Dr.

Reddy’s and Hikma.

Further, on June 14, 2024, Apotex, Inc., or Apotex, filed a complaint against the Company in the U.S.

District Court for the District of New Jersey.

Civil action No.

24-cv-07041 alleging various antitrust violations analogous to those made by Dr.

Reddy’s, Hikma and Teva, as well as a breach of contract claim related to the same alleged conduct.

Apotex also seeks declaratory judgement regarding the applicability of a 2020 settlement agreement to its antitrust claims.

In October 2024, Apotex amended its complaint to add as defendants KD Pharma-Bexbach GmbH;

KD Swiss GmbH;

Marine Ingredients, LLC;

Innova Softgel, LLC;

03 Holding GmbH;

Relief sought include an unspecified amount of damages for alleged economic harm to each of Dr.

Reddy’s, Hikma, Teva and Apotex, treble damages, other costs and fees and injunctive relief against the alleged violative activities.

Amarin believes it has valid defenses and will vigorously defend against the claims.

Such litigation can be lengthy, costly and could materially affect and disrupt our business.

In March 2021, Amarin received a civil investigative demand, or CID, from the U.S.

Federal Trade Commission and a subpoena from the New York Attorney General with respect to information on the same antitrust topic covered in the Dr.

Reddy's litigation.

Similarly, in June 2020, the Company received a CID from the U.S.

Department of Justice, or the DOJ, informing Amarin that the DOJ is investigating whether aspects of its promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S.

Anti-Kickback Statute and the U.S.

Civil False Claims Act, in relation to the sale and marketing of VASCEPA by the Company and its previous co-marketing partner, Kowa Pharmaceuticals America, Inc.

Amarin is cooperating with the government agencies regarding these two investigations, or the Investigations, and concluded document production and interrogatory responses in mid-2023.

We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business.

Amarin is named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey, as displayed in the table below.

Each of the six antitrust class action lawsuits allege Amarin and its co-defendant suppliers violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

Each of the six antitrust class action lawsuits allege Amarin and its co-defendant suppliers violated federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

The Indirect Purchaser Plaintiffs also assert related state antitrust, consumer protection, and unjust enrichment claims.

The Indirect Purchaser Plaintiffs seek relief in the form of an unspecified amount of compensatory damages, treble damages, other costs and fees, restitution, and declaratory and injunctive relief against the alleged violative activities.

The Direct Purchaser plaintiffs seek treble damages and other costs and fees.

Civil Action #

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Uniformed Fire Officers Association Family Protection Plan Local 854

Indirect Purchaser

Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan

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Indirect Purchaser

Board of Trustees of Heavy and General Laborers’ Local Unions 472 and 172 of N.J.

Indirect Purchaser

Such antitrust litigation, and antitrust investigations, can be lengthy, costly and could materially affect and disrupt the Company’s business.

The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business.

If a government determines that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties.

The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of these lawsuits or any subsequently filed lawsuits.

Litigation – Other

On October 21, 2021, a purported investor in the Company's publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and the former chief financial officer in the U.S.

If it is determined that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties.

In June 2020, the Company received a civil investigative demand, or CID, from the U.S.

Anti-Kickback Statute and the U.S.

Civil False Claims Act, in relation to the sale and marketing of VASCEPA by the Company and its previous co-marketing partner, Kowa Pharmaceuticals America, Inc.

The inquiries require the Company to produce documents and answer written questions, or interrogatories, relevant to specified time periods.

Amarin is cooperating with the government agencies and cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business.

On October 21, 2021, a purported investor in the Company’s publicly-traded securities filed a putative class action lawsuit against the Company, the former chief executive officer and the former chief financial officer in the U.S.

District Court for the District of New Jersey, Vincent Dang v.

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A subsequent case, Dorfman v.

Amarin Corporation plc, et al., No.

Amarin Corporation plc, et al.

3:21-cv-19911 (D.N.J.

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In December 2021, several Amarin shareholders moved to consolidate the cases and appoint a lead plaintiff and lead counsel pursuant to the Private Securities Litigation Reform Act.

The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the Company's ANDA litigation described above and the risk that certain of the Company's patents related to the MARINE indication would be invalidated.

Based on these allegations, plaintiff alleges that he purchased securities at an inflated share price and brings claims under the Securities and Exchange Act of 1934 seeking unspecified monetary damages and attorneys' fees and costs.

The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the Company’s patent litigation related to its Abbreviated New Drug Application, or ANDA, that sought U.S.

FDA approval for the sale of generic versions of icosapent ethyl, or ANDA litigation, and the risk that certain of the Company’s patents related to the MARINE indication would be invalidated.

Based on these allegations, plaintiffs alleges that they purchased securities at an inflated share price and brought claims under the Securities and Exchange Act of 1934 seeking unspecified monetary damages and attorneys’ fees and costs.

In October 2022, the court consolidated the cases and appointed a lead plaintiff for the putative class.

On January 13, 2023, lead plaintiff filed an amended complaint that also named the former general counsel, and again alleged that the Company made false statements regarding the ANDA litigation as well as about the REDUCE-IT indication and VASCEPA’s financial prospects resulting from REDUCE-IT.

All Defendants have moved to dismiss the amended complaint and the motion remains pending.

The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome.

The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.

All defendants have moved to dismiss the amended complaint and on September 25, 2024, the New Jersey District Court granted the Company’s motion to dismiss for all counts, without prejudice, permitting the Plaintiffs 30 days to amend and refile their lawsuit.

The court subsequently granted on October 24, 2024, the Plaintiffs request for an additional 30 days to amend and refile the complaint.

On November 6, 2024, the Plaintiffs advised the court that they would not refile their complaint, closing the case.

On March 29, 2023, purported investors in the Company’s publicly traded securities filed a derivative lawsuit, naming as defendants the Company’s former general counsel, the Company’s trial counsel for the ANDA litigation, and the Company as nominal defendant, in the Superior Court of New Jersey, Law Division, Monmouth County, captioned Anne Abramson, John Lissandrello, Georgette Appiano, and Andrew Bondarowicz v.

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On April 8, 2023, the plaintiffs voluntarily dismissed this case without prejudice.

On November 30, 2020, the Company filed a patent infringement lawsuit against Hikma for making, selling, offering to sell, and importing generic icosapent ethyl capsules in and into the U.S.

in a manner that the Company alleges induced the infringement of patents covering the use of VASCEPA to reduce specified CV risk.

On January 4, 2022, the district court for the District of Delaware granted a motion to dismiss the Company’s lawsuit for failure to state a claim.

Thereafter, the Company appealed to the Court of Appeals for the Federal Circuit.

On June 25, 2024, the Federal Circuit issued a decision reversing the district court, finding that the

Company’s allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents.

Hikma filed a petition for rehearing en banc on August 22, 2024, which was denied on October 17, 2024.

The case is remanded to the district court and will proceed accordingly.

On March 31, 2023, the Company’s former chief executive officer, Karim Mikhail, filed a complaint against the Company and certain of its affiliates in the Superior Court of New Jersey, Law Division – Somerset County, captioned Mikhail v.

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The complaint seeks unspecified damages arising from claims for breaches of his employment agreement, Executive Severance and Change of Control Plan, and the implied covenant of good faith and fair dealing.

On April 3, 2023, the case moved to the United States District Court for the District of New Jersey (Civ.

On April 3, 2023, the case moved to the U.S.

District Court for the District of New Jersey (Civ.

3:23-cv-01856).

On June 30, 2023, all defendants moved to dismiss this case without prejudice.

On June 30, 2023, all defendants moved to dismiss this case without prejudice due to lack of jurisdiction.

On March 4, 2024, the District Court granted the motion in part and denied the motion in part, permitting the parties to pursue limited discovery on the issue of personal jurisdiction, and allowing defendants thereafter to refile a motion to dismiss.

The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome.

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The Company continues to negotiate with contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.

As of the date of filing this Annual Report, the Company has a total of approximately $ 37.0 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.

In addition, the Company has total obligations of $ 186.5 million contingent on either certain suppliers obtaining regulatory approval in Europe or pricing reimbursement in certain European countries not occurring by June 30, 2024.

During 2023, the Company determined that it was probable that the Company would not be able to obtain pricing reimbursement in certain countries outlined within renegotiated supply agreements by June 30, 2024.

The Company's reasonable estimate of the liability is a range between $ 8.0 million and $ 15.8 million, with no amount within that range a better estimate than any other amount;

accordingly, an $ 8.0 million provision was recognized in cost of goods sold - restructuring inventory on the consolidated statement of operations.

The ultimate resolution of the matter could result in up to an additional $ 7.8 million of the amount accrued.

On March 26, 2021, the EC approved the marketing authorization application for VAZKEPA.

Under the 2004 share repurchase agreement with Laxdale upon receipt of pricing approval in Europe for the first indication for VASCEPA (or first indication of any product containing intellectual property acquired from Laxdale in 2004), the Company was obligated to make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of such former shareholders) of £ 7.5 million.

On July 13, 2022 in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make the aggregate milestone payment of £ 7.5 million to Laxdale’s former shareholders (in either stock or cash at the election of each shareholder).

A s of December 31, 2023, the Company has settled the first European indication approval milestone through issuance of stock and cash payments based on the respective shareholder's election.

Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £ 5.0 million (approximately $ 6.4 million as of December 31, 2023) for the potential market approval.

The Company has no provision for any of these obligations, except the $ 8.0 million provision noted above, since the amounts are either not paid or payable as of December 31, 2023 .

On January 10, 2024, the Company 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.

On July 13, 2022, in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make an aggregate milestone payment of £ 7.5 million to Laxdale's former shareholders (in either stock or cash at the election of each shareholder) under the 2004 purchase agreement among the Company and such former shareholders.

One of the shareholders elected to receive payment in stock for its pro rata portion of the milestone payment, resulting in the issuance of 5,817,942 shares at a price of $ 1.41 per share in July 2022.

During the years ended December 31, 2023 and 2022, other than as described elsewhere in this Annual Report on Form 10-K, including in the Notes to Consolidated Financial Statements, the Company did not engage in any transactions involving its common stock.

As of the date of filing this Annual Report, the Company has total obligations of $ 160.8 million contingent on certain suppliers obtaining regulatory approval in Europe.

In addition, the Company has a total of approximately $ 63.6 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.

The unconditional purchase obligations for contracts with remaining terms in excess of one year are summarized below:

Years Ended December 31,

Unconditional Purchase Obligations

In addition to the above, the Company was unable to obtain pricing reimbursement in certain countries outlined within renegotiated supply agreements by June 30, 2024, triggering obligations up to $ 15.8 million.

The Company entered into an amended supply agreement, resulting in a liability amounting to $ 7.8 million, which the Company had previously recorded in cost of goods sold - restructuring inventory on the consolidated statement of operations in 2023.

Under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £ 5.0 million (approximately $ 6.3 million as of December 31, 2024) for the potential market approval.

The Company has no provision for any of these obligations, except as noted above, since the amounts are either not paid or payable as of December 31, 2024 .

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 will continue to monitor business and market conditions.

During the years ended December 31, 2024 and 2023, other than as described elsewhere in this Annual Report on Form 10-K, including in the Notes to Consolidated Financial Statements, the Company did not engage in any transactions involving its common

Refer to Incentive Equity Awards below for discussion of ordinary shares issued as a result of stock option exercises and the vesting of restricted stock units.

Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan.

On March 12, 2025, the Company announced its intent to effect a ratio change on its ADSs from one ADS representing one ordinary share, to the new ratio of one ADS representing 20 ordinary shares, or the Ratio Change.

The effective date of the Ratio Change is expected to be on or about April 11, 2025 .

Incentive Equity Awards

The Company issues incentive equity awards, including incentive and non-qualified stock options and restricted stock units, under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, which is the successor to the Amarin Corporation plc 2011 Stock Incentive Plan, as amended, or the 2011 Plan, and the Amarin Corporation plc 2002 Stock Option Plan, as amended, or the 2002

Plan, and together with the 2020 Plan and 2011 Plan, the Plans.

Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for further information regarding the Company’s incentive equity plans and awards.

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For the Year Ended December 31,

(in thousands, except share amounts)

Common shares issued for stock option exercises

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During the years ended December 31, 2024 and 2023, the Company granted a total of 2,662,000 and 5,456,800 stock options, respectively, and 7,445,700 and 8,227,800 RSUs, respectively, to employees under the Plans.

The RSUs typically vest annually over a three - or four-year period and the stock options typically vest quarterly over a four-year period.

Also during 2023 and 2022, the Company granted a total of 1,368,800 and 1,919,500 RSUs, respectively, to employees under the Plans that vest upon the achievement of specified performance conditions.

In addition to the grants noted above, in connection with the implementation of a retention program in July 2023, the Company granted a total of 3,978,300 stock options to employees under the 2020 Plan.

The options vest 50 % on both January 1, 2024 and January 1, 2025, respectively.

Also in July 2023, the Company granted 5,000,000 stock options to Patrick Holt in connection with his appointment as President and Chief Executive Officer, which will vest upon achievement of specified stock price conditions for the Company.

The RSUs typically vest annually over a three-year period and the stock options typically vest quarterly over a four-year period.

In addition to the grants noted above, in July 2024, the Company granted 5,000,000 stock options to Aaron Berg in connection with his appointment as President and Chief Executive Officer, which will vest upon achievement of specified stock price conditions for the Company.

During the years ended December 31, 2024 and 2023, the Company granted a total of 1,438,360 and 3,853,025 stock options, respectively, and 492,296 and 1,392,257 RSUs, respectively, to members of the Company’s Board of Directors under the Plans.

2 unchanged sentences

Upon termination of service to the Company or upon a change of control, each director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares.

In connection with the implementation of a retention program in July 2023, the Company granted a total of 3,978,300 stock options to employees under the 2020 Plan.

The options vest 50 % on both January 1, 2024 and January 1, 2025, respectively.

Also in July 2023, the Company granted 5,000,000 stock options to Patrick Holt in connection with his appointment as President and Chief Executive Officer, which would have vested upon achievement of specified stock price conditions for the Company, but was forfeited upon Mr.

Holt's resignation from the Company.

(9) Stock Incentive Plans and Stock-Based Compensation

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The maximum number of the Company’s Ordinary Shares of £ 0.50 each or any ADS’s, as to be issued under the 2020 Plan shall not exceed the sum of (i) 20,000,000 shares and (ii) the number of Shares that remained available for grants under the Company’s 2011 Plan as of July 13, 2020.

If any award granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent

grants under the 2020 Plan.

If any award granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent grants under the 2020 Plan.

The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.

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Included within the above table is the 5,000,000 market-based stock option award with a weighted average grant date fair value of $ 0.29 .

During the years ended December 31, 2023, 2022 and 2021, the Company received proceeds from the exercise of options of $ 1.9 million, $ 0.1 million, and $ 2.9 million, respectively.

The total intrinsic value of options exercised during the years ended December 31, 2023, 2022, and 2021 was $ 0.4 million , nominal and $ 4.9 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards.

During the years ended December 31, 2024, 2023 and 2022 , the Company received proceeds from the exercise of options of less than $ 0.1 million, $ 1.9 million, and $ 0.1 million, respectively.

The total intrinsic value of options exercised during the years ended December 31, 2024, 2023, and 2022 was less than $ 0.1 million, $ 0.4 million and less than $ 0.1 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards.

As of December 31, 2024, options have $ 6.2 million of unrecognized stock-based compensation expense with such expense expected to be recognized over a weighted-average period of approximately 3.2 years.

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101 % - 104 %

The Company used the following assumptions to estimate the fair value of share-based payment awards under the Monte Carlo model in 2023:

The Company used the following assumptions to estimate the fair value of share-based payment awards under the Monte Carlo model in 2024 and 2023:

Risk-free interest rate

3.92 % - 3.96 %

4.06 % - 4.09 %

Expected dividend yield

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51.00 % - 42.80 %

42.5 % - 43.00 %

Employee stock options generally require future service and vest ratably over a four-year service period and are settled by the issuance of new common shares.

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The restricted stock units vest based upon either a time-based service condition, a performance condition, or both.

The grant date fair value of the restricted stock unites, net of the estimated forfeiture rate, is amortized straight-line over the vesting periods or requisite service periods and is adjusted for actual forfeitures over such period.

The grant date fair value of the restricted stock units, net of the estimated forfeiture rate, is amortized straight-line over the vesting periods or requisite service periods and is adjusted for actual forfeitures over such period.

For any awards with a performance condition, the probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable.

6 unchanged sentences

The Company recorded compensation expense in relation to restricted stock units of $ 10.4 million, $ 9.8 million, and $ 11.4 million, for the years ended December 31, 2024, 2023, and 2022, respectively.

The total grant date fair value of restricted stock units vested during the years ended December 31, 2023, 2022, and 2021 was $ 16.3 million, $ 14.3 million and $ 23.8 million, respectively.

The total grant date fair value of restricted stock units vested during

the years ended December 31, 2024, 2023, and 2022 was $ 9.3 million, $ 16.3 million, and $ 14.3 million, respectively.

As of December 31, 2024, restricted stock units have $ 10.1 million of unrecognized stock-based compensation expense with such expense to be recognized over a weighted-average period of approximately 1.7 years.

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Beginning uncertain tax benefits

Prior year—increases

Prior year—decreases

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The Company does no t expect any gross liabilities to expire in 2025 based on statutory lapses or audits.

The components of (loss) income from operations before taxes were as follows for the years ended December 31, 2023, 2022 and 2021:

The components of loss from operations before taxes were as follows for the years ended December 31, 2024, 2023 and 2022:

United States

Ireland and United Kingdom

Total (loss) / income before taxes

Total loss before taxes

The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for the years ended December 31, 2024, 2023 and 2022:

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ISO disqualifying disposition windfall

Branded prescription drug fee

Research and development credits

2 unchanged sentences

Permanent and other

Stock Option/RSU Deferred Only Adjustment

Uncertain tax positions

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Previously, such amounts were recognized as an increase and decrease in additional paid-in capital.

This aspect of the standard was adopted prospectively, and accordingly the provisions for income taxes for the years ended December 31, 2023, 2022 and 2021 includes nil , $ 0.6 million and $ 0.1 million of excess tax benefits, respectively, arising from share-based payments during the period.

This aspect of the standard was adopted prospectively, and accordingly the provisions for income taxes for the years ended December 31, 2024, 2023 and 2022 includes $ 1.0 million, nil and $ 0.6 million of excess tax benefits, respectively, arising from share-based payments during the period.

The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2024 and 2023 is as follows:

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Stock-based compensation

Capitalized R&D

Lease liability

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The Company assesses whether it is more-likely-than-not that the Company will realize its deferred tax assets.

The Company determined that it was more-likely-than-not that the Irish, U.S., Germany, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods.

The following table reflects the activity in the valuation allowance for the years ended December 31, 2023 and 2022:

Beginning valuation allowance

Increase as reflected in income tax expense

Foreign exchange

Ending valuation allowance

The Company determined that it was more likely than not that the net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods.

During 2024, the Company recorded adjustments to its deferred tax accounts related to the impact of foreign exchange rate changes and to reconcile the financial statement accounts to the amounts expected to result in future income and deductions under local law, primarily as it relates to Irish net operating losses and deferred taxes for stock compensation.

1 unchanged sentence

The Company has combined U.S.

net operating loss carryforwards of $ 959.9 million, which do not expire.

net operating loss carryforwards of $ 1.0 billion , which do not expire.

The total net operating loss carryforwards increased by approximately $ 75.6 million from the prior year primarily as a result of current year loss generated by the Company’s U.S.

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Under the 401(k) plan, employees may make contributions which are eligible for a discretionary percentage match, in cash, as defined in the 401(k) plan and determined by the Board of Directors.

Company recognized $ 2.7 million, $ 1.7 million and $ 1.9 million of related compensation expense for the years ended December 31, 2023, 2022 and 2021 , respectively.

The Company recognized $ 2.2 million, $ 2.7 million and $ 1.7 million of related compensation expense for the years ended December 31, 2024, 2023 and 2022 , respectively.

(12) Revenue Recognition

The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States and Europe, or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers.

The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty retail pharmacy providers in the U.S.

and Europe, or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers.

Patients are required to have a prescription in order to purchase VASCEPA.

In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.

Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor.

Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor and in certain instances upon shipment.

Payments from distributors are generally received 45 day s from the date of sale.

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For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program.

The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA.

The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been

recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.

distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA.

For the year ended December 31, 2023, the Company recognized $ 15.1 million related to a change in estimate primarily for the Medicaid rebate provision as a result of a change in the percentage of business within the Medicaid segment, with a related reduction in net loss by $ 15.1 million in the year ended December 31, 2023.

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development, regulatory and commercial milestone payments;

payments for manufacturing supply services the Company provides through its

contract manufacturers;

payments for manufacturing supply services the Company provides through its contract manufacturers;

and royalties on net sales of licensed products.

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The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

During the three months ended June 30, 2023, the Company adjusted the measure of performance and recognized an additional $ 5.0 million and $ 5.3 million of license revenue relating to Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, and HLS Therapeutics Inc., or HLS, respectively.

During the three months ended June 30, 2024, the Company adjusted the measure of performance and recognized an additional $ 4.0 million of license revenue relating to Edding.

Excluding this change in estimate, net loss per share basic and diluted for the year ended December 31, 2024 would have been $( 0.21 ) .

Excluding this change in estimate, net loss per share basic and diluted for the yea r ended December 31, 2023 would have been $( 0.17 ).

Refer to Note 13—Development, Commercialization and Supply Agreements for further details.

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

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

At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.

Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.

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Mochida Pharmaceutical Co., Ltd.

In June 2018, the Company entered into a collaboration with Mochida related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid.

In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the

omega-3 acid, EPA, or eicosapentaenoic acid.

Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the U.S.

2 unchanged sentences

The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.

Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable up-front payment of approximately $ 2.7 million.

Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $ 2.7 million.

In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.

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Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.

The Company and Edding agreed to form a joint development committee to oversee regulatory and development activities for VASCEPA in the China Territory in accordance with a negotiated development plan and formed a separate joint commercialization committee in advance of expected approval in the China Territory to oversee VASCEPA planning and pre-launch commercialization activities in the China Territory.

Development costs are paid by Edding to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Edding.

Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at Edding’s cost with the Company’s assistance.

The DCS Agreement also contains customary provisions regarding indemnification, supply, record keeping, audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type.

The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by a valid claim under a licensed patent in the China Territory, or (ii) the 12th anniversary of the first commercial sale of such product in Mainland China.

The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods.

In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Edding has the right to terminate the DCS Agreement for convenience with 12 months’ prior notice.

Neither party may assign or transfer the DCS Agreement without the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction.

Upon closing of the DCS Agreement, the Company received a non-refundable $ 15.0 million upfront payment.

In March 2016, Edding submitted its clinical trial application, or CTA, with respect to the MARINE indication for VASCEPA to the Chinese regulatory authority.

Following the CTA submission, the Company received a non-refundable $ 1.0 million milestone payment.

In March 2017, the CTA was approved by the Chinese regulatory authority, and, in December 2017, Edding commenced a pivotal clinical trial aimed to support the regulatory approval of the first indication of VASCEPA in a patient population with severe hypertriglyceridemia in Mainland China.

In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which was used to seek regulatory approval in Mainland China.

The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022 and under the MARINE indication in Mainland China in the second quarter of 2023.

Following approval of VASCEPA in Mainland China under the MARINE indication, the Company received a non-refundable $ 5.0 million milestone payment.

In October 2023, Edding submitted its CTA with respect to the REDUCE-IT indication for VASCEPA to the Chinese regulatory authority.

Following the CTA submission, the Company recognized a non-refundable $ 3.0 million milestone.

In addition to the non-refundable, upfront and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $ 145.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens.

The regulatory milestone events relate to the submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application.

The amounts to be received upon achievement of the regulatory milestone events relate to the submission and approval for three indications, and range from $ 2.0 million to $ 15.0 million for a total of $ 25.0 million.

December 31, 2023 the Company has recognized $ 9.0 million relating to milestone achievements.

Achievement of regulatory approval for a third indication is not probable.

The achievement of sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $ 5.0 million to $ 50.0 million for a total of $ 120.0 million.

Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved.

Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer.

2 unchanged sentences

Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.

The transaction price includes the $ 15.0 million upfront consideration received, the $ 1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication, the $ 5.0 million milestone payment received related to the approval of VASCEPA under the MARINE indication and the $ 3.0 million milestone payment related to the submission of the CTA for the REDUCE-IT indication.

The transaction price is comprised of the following upfront payments and milestones:

Transaction Price Components

February 2015

Submission of the CTA for the MARINE indication

Approval of VASCEPA under the MARINE indication

Submission of the CTA for the REDUCE-IT indication

Approval of VASCEPA under the REDUCE-IT indication

Regulatory Development Support

Total Transaction Price

In addition to the non-refundable, upfront and regulatory milestone payments described above, the Company is entitled to receive tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens.

The achievement of sales-based milestone events occur when annual aggregate net sales of VASCEPA in the China Territory equals or exceeds certain specified thresholds, and range from $ 5.0 million to $ 50.0 million, for a total of $ 120.0 million.

Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved.

Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained.

1 unchanged sentence

Any consideration related to sales-based milestones including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price.

The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the second quarter of 2023, Edding received regulatory approval in China under the MARINE indication and pursuit of additional indications outside of the REDUCE-IT indication is not probable.

The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the second quarter of 2023, Edding received regulatory approval in China under the MARINE indication and pursuit of additional indications outside of the REDUCE-IT indication was not probable.

As a result, the Company reevaluated the performance period and determined that completion of the remaining performance obligations was estimated to be by the end of December 2025.

The effect of this change in estimate from the previously received upfront payment and prior year milestone payments was an increase of $ 5.0 million in licensing revenue and a related reduction in net loss by $ 5.0 million for the year ended December 31, 2023.

In addition, the Company recognized $ 3.9 million related to the milestone payment received in the second quarter for the MARINE indication approval and the remaining $ 1.1 million will be recognized over the remaining performance period through December 2025.

The change in estimate resulted in the remaining performance period decreasing from 11 years to three years for recognizing the remaining deferred revenue.

During the years ended December 31, 2023 and 2022, the Company recognized $ 12.9 million and $ 0.6 million, respectively, as licensing revenue related to the upfront and milestone payments received in connection with the Edding agreement.

From contract inception through December 31, 2023 and 2022, the Company recognized $ 20.6 million and $ 7.7 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by the Company to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

The remaining transaction price of $ 4.4 million and $ 9.3 million is recorded in deferred revenue as of December 31, 2023 and 2022, respectively, on the consolidated balance sheets and as of December 31, 2023 will be recognized as revenue over the remaining period of two years .

In addition, the Company recognized $ 3.9 million related to the milestone payment received in the second quarter of 2023 for the MARINE indication approval and the remaining $ 1.1 million would have been recognized over the remaining performance period through December 2025.

The change in estimate in 2023 resulted in the remaining performance period decreasing from 11 years to three years for recognizing the remaining deferred revenue.

During the second quarter of 2024, Edding received approval in China under the REDUCE-IT indication.

The REDUCE-IT indication approval concludes the Company's support for regulatory activities and, as noted above, pursuit of additional indications was deemed to be not probable.

As a result, the Company reevaluated the performance period and determined that all remaining performance obligations were satisfied as of June 30, 2024, resulting in a decrease of the previous performance period of two years.

The effect of this change in estimate from the previously received upfront payment and prior year milestone payments was an increase of $ 4.0 million in licensing revenue and a related reduction in net loss by $ 4.0 million for the year ended December 31, 2024.

In addition, the Company also recognized $ 15.0 million in the second quarter related to the REDUCE-IT indication approval milestone.

Licensing revenue recognized during the year ended December 31, 2024 (1)

Licensing revenue recognized during the year ended December 31, 2023 (1)

Licensing revenue recognized from contract inception through December 31, 2024

Licensing revenue recognized from contract inception through December 31, 2023

(1) Licensing revenue under the DCS Agreement is recognized concurrent with the input measure of support hours provided by Amarin to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

As of December 31, 2023, the remaining transaction price of $ 4.4 million is recorded in deferred revenue on the consolidated balance sheets.

The Company fully recognized the transaction price as of June 30, 2024.

The Company recognized net product revenue of $ 16.0 million and $ 1.8 million for the years ended December 31, 2024 and 2023, respectively, related to sales to Edding.

2 unchanged sentences

Under the terms of the distribution agreement, the Company granted to Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory.

Upon closing of the agreement, the Company received a non-refundable upfront payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory.

Upon closing of the agreement, the Company received a non-refundable upfront payment, which has been fully recognized as of June 30, 2024.

The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.

3 unchanged sentences

December 2019

September 2023

December 2021

1 unchanged sentence

September 2023

The Company recognized net product revenue of approximately $ 3.4 million and $ 1.0 million as of December 31, 2023 and 2022, respectively, related to sales to Biologix.

The Company recognized net product revenue of $ 2.7 million and $ 3.4 million as of December 31, 2024 and 2023, respectively, related to sales to Biologix.

HLS Therapeutics, Inc.

In September 2017, the Company entered into an agreement with HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada.

In September 2017, the Company entered into an agreement with HLS Therapeutics, Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada.

Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs.

The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

Upon closing of the agreement, the Company received one-half of a non-refundable $ 5.0 million upfront payment, and received the remaining half on the six-month anniversary of the closing.

Following achievement of the REDUCE-IT trial primary endpoint, which was announced in September 2018, the Company received a non-refundable $ 2.5 million milestone payment.

Following approval from Health Canada in December 2019, the Company received a non-refundable milestone payment of $ 2.5 million in February 2020.

In addition, in January 2020, HLS obtained regulatory exclusivity from the Office of Patented Medicines and Liaison, or OPML, as a result the Company received a non-refundable $ 3.8 million milestone payment.

In addition to the non-refundable, upfront and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $ 50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer.

4 unchanged sentences

Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.

The transaction price includes the $ 5.0 million upfront consideration, the $ 2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $ 2.5 million milestone related to obtaining approval from Health Canada and $ 3.8 million milestone related to obtaining regulatory exclusivity from the OPML.

The transaction price is comprised of the following upfront payments and milestones:

Transaction Price Components

September 2017

Achievement of the REDUCE-IT trial primary endpoint

September 2018

Approval from Health Canada

December 2019

Regulatory exclusivity from the Office of Patented Medicines and Liaison

Total Transaction Price

None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained.

As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.

Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price.

The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the second quarter of 2023, the Company concluded support for regulatory activities and pursuit of additional indications was deemed to be not probable.

As a result, the Company reevaluated the performance period and determined that all remaining performance obligations were satisfied as of June 30, 2023, resulting in a decrease of the previous performance period of eight years .

The effect of this change in estimate was the remaining transaction price of $ 5.3 million being recognized in licensing revenue and a related reduction in net loss by $ 5.3 million during the year ended December 31, 2023 from the previously received upfront payment and prior year milestone payments.

During the years ended December 31, 2023 and 2022, the Company recognized $ 5.6 million and $ 0.7 million, respectively, as licensing revenue related to upfront and milestone payments received in connection with the HLS agreement.

From the contract’s inception through December 31, 2023 and 2022, the Company has recognized $ 13.7 million and $ 8.2 million, respectively.

Licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by Amarin to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation.

As of December 31, 2022 the remaining transaction price of $ 5.6 million is recorded in deferred revenue on the consolidated balance sheets.

The Company fully recognized the transaction price as of December 31, 2023.

The effect of this change in estimate was the remaining transaction price of $ 5.3 million being recognized in licensing revenue and a related reduction in net loss by $ 5.3 million in the year ended December 31, 2023 from the previously received upfront payment and prior year milestone payments.

During the December 31, 2023, the Company recognized $ 5.6 million as licensing revenue related to upfront and milestone payments received in connection with the HLS agreement.

The Company fully recognized the transaction price as of June 30, 2023.

The Company recognized net product revenue of $ 4.7 million and $ 3.1 million for the years ended December 31, 2024 and 2023, respectively, related to sales to HLS.

1 unchanged sentence

The Company received an upfront payment of $ 0.5 million which was fully recognized during the first quarter of 2023.

In addition to the upfront payment, the Company will be eligible to receive event-related milestone payments of approximately $ 8.0 million and additional product-related milestone payments of approximately $ 4.0 million.

In October 2024, CSL obtained listing of VAZKEPA on the Pharmaceutical Benefits Scheme, or PBS, in Australia, as a result the Company received a non-refundable $ 1.2 million milestone payment.

In addition to the upfront and milestone payment, the Company will be eligible to receive event-related milestone payments of approximately $ 6.0 million and additional product-related milestone payments of approximately $ 4.0 million.

The Company will be responsible for supplying finished product to CSL Seqirus at a price that is the greater of (i) a fixed transfer price, or (ii) a fixed percentage of the net selling price, as defined in the CSL agreement.

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The Company identified the following distinct performance obligations at the inception of the contract:

an exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.

The transaction price includes the $ 0.5 million upfront consideration.

an exclusive license

to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.

The transaction price includes the $ 0.5 million upfront consideration as well as the $ 1.2 million milestone payment received related to the listing of VAZKEPA on the PBS in Australia.

Any consideration related to event-based or product-based milestones will be recognized when the related milestone events occur and therefore have also been excluded from the transaction price.

The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the year ended December 31, 2023 , the Company recognized $ 0.5 million as licensing revenue related to the upfront payment received in connection with the CSL agreement (none in 2022).

During the year ended December 31, 2024 , the Company recognized $ 1.2 million as licensing revenue related to the listing of VAZKEPA on the PBS in Australia.

During the year ended December 31, 2023 , the Company recognized $ 0.5 million as licensing revenue related to the upfront payment received in connection with the CSL agreement.

The Company recognized net product revenue of $ 0.8 million for the year ended December 31, 2024 related to sales to CSL ( no ne in 2023).

Lotus Pharmaceuticals

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

The Company received an up-front payment of $ 0.3 million and is eligible to receive event-related and product-related milestone payments.

The Company received an upfront payment of $ 0.3 million and is eligible to receive event-related and product-related milestone payments.

The Company will be responsible for supplying finished product to Lotus at a pre-defined supply price.

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The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the year ended December 31, 2023 , the Company recognized $ 0.3 million as licensing revenue related to the upfront payment received in connection with the Lotus agreement (none in 2022).

During the year ended December 31, 2023, the Company recognized $ 0.3 million as licensing revenue related to the upfront payment received in connection with the Lotus agreement ( no ne in 2024).

The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2024 and 2023:

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Deferred revenue (2)

(1) The approximately $ 4.9 million reduction consists primarily of recognition of $ 4.0 million relating to the change in estimate for Edding during the three months ended June 30, 2024.

(2) The approximately $ 18.5 million reduction consists of recognition of $ 5.0 million and $ 5.3 million relating to the change in estimate for Edding and HLS, respectively, as well as recognizing, based on the revised timeline, $ 3.9 million for the MARINE indication approval in China achieved during the three months ended June 30, 2023 and $ 2.5 million for the CTA submission with respect to the REDUCE-IT indication in China during the three months ended December 31, 2023.

During the years ended December 31, 2024 and 2023, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods:

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Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.4 million during the duration of the lease term.

On April 26, 2024, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Subsequent Dublin Lease.

The Subsequent Dublin Lease commenced on September 1, 2024 , or the Subsequent Dublin Commencement Date, for a two-year period.

Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.5 million during the duration of the lease term.

In addition to the real estate leases, the Company continually enters into leases agreements for various vehicles with terms ranging from month-to-month up to 36 months .

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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 9A. Controls and Procedures