AMARIN CORP PLCUK
For the period ended Dec 31, 2024. Filed Mar 12, 2025.
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FY2024 · Filed Mar 12, 2025
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Notes to Consolidated Financial Statements
(1)
Nature of Business and Basis of Presentation
Nature of Business
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), 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, Australia and Canada.
VASCEPA, was first approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, or the MARINE indication. In January 2013, the Company launched 1-gram size VASCEPA in the U.S. and in October 2016, introduced a 0.5-gram capsule size. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of the Company’s long-term cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.
On March 30, 2020, following conclusion of a trial in late January 2020, the U.S. District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. 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 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. market:
| Company | FDA MARINE Indication Approval | 1-gram Launch Date | 0.5-gram Launch Date |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | May 2020 | November 2020 | March 2023 |
| Dr. Reddy’s Laboratories, Inc. | August 2020 | June 2021 | June 2023 |
| Teva Pharmaceuticals USA, Inc. | September 2020 | January 2023 | September 2022 |
| Apotex, Inc. | June 2021 | January 2022 | N/A |
| Zydus Lifesciences | April 2023 | N/A | June 2024 |
| Strides Pharma (1) | September 2023 | April 2024 | April 2024 |
| Epic Pharma | December 2023 | March 2024 | N/A |
| Ascent Pharmaceuticals, Inc. (2) | December 2023 | April 2024 | April 2024 |
| Qilu Pharmaceutical Co Ltd | November 2024 | N/A | N/A |
| Spriaso LLC | December 2024 | N/A | N/A |
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.
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.
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. The Company operates inone business segment.
Basis of Presentation
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. The preparation of the Company’s consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The results of operations for the years ended December 31, 2024, 2023 and 2022 are not necessarily indicative of the results for any future period. Certain numbers presented throughout this document may not add precisely to the totals provided due to rounding. Absolute and percentage changes are calculated using the underlying amounts in thousands. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. 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.
At December 31, 2024, the Company had total assets of$685.3 million, of which$294.2 million consisted of cash and liquid short-term investments. More specifically, the Company had current assets of$595.4 million, including cash and cash equivalents of$121.0 million, short-term investments of$173.2 million, accounts receivable, net, of$122.3 million and current inventory of$166.0 million. In addition, at December 31, 2024, the Company had long-term inventory of$64.7 million. At December 31, 2024, the Company hadno debt outstanding.
(2)
Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances. Estimates and assumptions relied upon in preparing these consolidated financial statements relate to, but are not limited to, such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances; depreciable/amortizable lives; asset impairments; valuation allowance on deferred taxes; probabilities of achievement of performance conditions for certain equity awards; amounts recorded for licensing revenue; contingencies and accruals. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness.
Use of Forecasted Financial Information in Accounting Estimates
The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of intangible assets, evaluating the need for valuation allowances for deferred tax assets, and assessing the Company’s ability to continue as a going concern. Such forecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results. Management believes that its financial forecasts are reasonable and appropriate based upon current facts and circumstances. Because of the inherent nature of forecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts the carrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates.
Revenue Recognition
In accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. 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. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 12—Revenue Recognition.
Distribution Costs
The Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distribution services, in Cost of goods sold.
Cash and Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees.
Accounts Receivable, net
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 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. The expense associated with the allowance for doubtful accounts is recognized as selling, general, and administrative expense. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.
The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances at December 31, 2024 and 2023:
| In thousands | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Gross trade accounts receivable | $133,072 | $160,686 |
| Trade allowances | (9,433) | (18,834) |
| Chargebacks | (1,360) | (8,289) |
| Accounts receivable, net | $122,279 | $133,563 |
Inventory
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. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company classifies inventory as long-term inventory when consumption of the inventory is expected beyond the next 12 months. The Company classifies finished goods expected to be sold within the next 12 months and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected net realizable value due to obsolescence, damage or quantities in excess of expected demand, changes in price levels or other causes, the Company will reduce the carrying value of such inventory to net realizable value and recognize the difference as a component of cost of goods sold in the period in which it occurs. The Company capitalizes inventory purchases of saleable product from approved suppliers while inventory purchases from suppliers prior to regulatory approval are included as a component of research and development expense. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of VASCEPA API.
Long-Lived Asset Impairment
The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets.
Intangible Asset, net
Intangible asset, net consists of website development costs and milestone payments to the former shareholders of Laxdale Limited, or 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 authorization in Europe in 2021. 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.
Costs for Patent Litigation and Legal Proceedings
Costs for patent litigation or other legal proceedings are expensed as incurred and included in Selling, general and administrative expense.
Research and Development Costs
The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including: salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense. In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier, as well as license fees related to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida.
Selling, General and Administrative Costs
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 U.S. and Europe.
Income Taxes
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. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. Deferred tax assets and liabilities are classified as non-current in the consolidated balance sheet.
The Company provides reserves for potential payments of tax to various tax authorities and does not recognize tax benefits related to uncertain tax positions and other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy is to record interest and penalties in the provision for income taxes, as applicable.
The Company regularly assesses its ability to realize deferred tax assets. Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed.
Excess tax benefits and deficiencies that arise upon vesting or exercise of stock-based payments are recognized as an income tax benefit and expense, respectively, in the consolidated statement of operations. Excess income tax benefits are classified as cash flows from operating activities and cash paid to taxing authorities arising from the withholding of shares from employees are classified as cash flows from financing activities.
The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and state tax authorities. The Company is currently under audit by the IRS for its 2018 and 2019 U.S.
incometax returns. 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 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 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:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Net (loss) income —basic and diluted | $(82,183) | $(59,112) | $(105,803) |
| Weighted average shares outstanding—basic and diluted | 410,937 | 407,655 | 401,155 |
| Net (loss) earnings per share—basic and diluted (1) | $(0.20) | $(0.15) | $(0.26) |
(1)Excluding the licensing revenue change in estimate incurred in 2024 and the licensing revenue change in estimate and Medicaid change in estimate incurred in 2023, both discussed in Note 12 – Revenue Recognition, net loss per share basic and diluted for both years ended December 31, 2024 and 2023 would have been$(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:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Stock options | 27,696 | 27,956 | 19,182 |
| Restricted stock and restricted stock units | 13,865 | 11,983 | 14,461 |
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. Restricted stock and restricted stock units are anti-dilutive during periods of net earnings when underlying performance-based vesting requirements were not achieved as of the last day of the reporting period.
Stock-Based Compensation
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 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: (i) the expected volatility in the market price of its common stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise, referred to as the expected holding period. As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants.
For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the grant date fair value of the award over the requisite service period. The Company reassesses the probability of achievement of the performance conditions each reporting period. For awards with market conditions, the Company recognizes compensation expense based on the grant date fair value of the award, using the Monte Carlo Model, over the requisite service period.
The Company estimates the level of forfeitures expected to occur based on its historical data and records compensation cost only for those awards that are ultimately expected to vest. See Note 9—Stock Incentive Plans and Stock-Based Compensation for further discussion.
Concentration of Credit Risk
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. The Company monitors the creditworthiness of customers to whom it grants credit terms and has not experienced any credit losses. The Company does not require collateral or any other security to support credit sales. Three customers individually accounted for 10% or more of the Company’s gross product sales. Customers A, B, and C accounted for 32%,27%, and 30%, respectively, of gross product sales for the year ended December 31, 2024 and represented 25%,13%, and 45%, respectively, of the gross accounts receivable balance as of December 31, 2024. Customers A, B, and C accounted for 36%,28% and 29%, respectively, of gross product sales for the year ended December 31, 2023 and represented 36%,18%, and 38%, respectively, of the gross accounts receivable balance as of December 31, 2023. The Company has not experienced any significant write-offs of its accounts receivable. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.
Concentration of Suppliers
The Company has contractual freedom to source the API for VASCEPA and to procure other services supporting its supply chain and has entered into supply agreements with multiple suppliers. The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.
The Company cannot provide assurance that its efforts to procure uninterrupted supply of VASCEPA to meet market demand will continue to be successful or that it will be able to renew current supply agreements on favorable terms or at all. Significant alteration to or disruption or termination of the Company’s current supply chain, or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations.
The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing. Each of these API manufacturers, encapsulators and packagers is U.S. FDA-approved and certain of these API manufacturers, encapsulators and packagers are also approved by the European Regulatory Authorities for manufacturing VAZKEPA in Europe. These suppliers are also used by the Company to source supply to meet the clinical trial and commercial demands of its partners in other countries. Each of these suppliers has qualified and validated its manufacturing processes. There can be no guarantee that these or other suppliers with which the Company may contract in the future to manufacture VASCEPA or VASCEPA API will remain qualified to do so to its specifications or that these and any future suppliers will have the manufacturing capacity to meet potential global demand for VASCEPA.
Foreign Currency
Monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at period-end exchange rates. Gains and losses from the remeasurement are included in Other income (expense), net in the consolidated statements of operations. For transactions settled during the applicable period, gains and losses are included in Other income (expense), net in the consolidated statements of operations. Certain amounts payable are denominated in currencies other than the U.S. dollar. 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
The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:
Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
The following tables present information about the estimated fair value of the Company’s assets and liabilities as of December 31,2024 and 2023 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
| In thousands | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Asset: | ||||
| U.S. Treasury Securities | $174,722 | $174,722 | $— | $— |
| Money Market Fund | 67,456 | 67,456 | — | — |
| Repo Securities | 5,000 | — | 5,000 | — |
| Total | $247,178 | $242,178 | $5,000 | $— |
| In thousands | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Asset: | ||||
| U.S. Treasury Securities | $123,992 | $123,992 | $— | $— |
| Money Market Fund | 99,226 | 99,226 | — | — |
| Agency Securities | 8,912 | — | 8,912 | — |
| Repo Securities | 3,250 | — | 3,250 | — |
| Total | $235,380 | $223,218 | $12,162 | $— |
The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature. The cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of the purchase of 90 days or less.
The Company’s investments are stated at amortized cost, which approximates fair value. The Company does not intend to sell these investment securities and the contractual maturities are not greater than 24 months. Those with original maturities greater than 90 days and maturities less than 12 months are included in short-term investments on its consolidated balance sheet. Those with remaining maturities in excess of 12 months are included in long-term investments on its consolidated balance sheet.
Unrealized gains or losses are not recognized until maturity, except other-than-temporary unrealized losses which are recognized in earnings in the period incurred. 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, 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 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 asingle 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, | |||
|---|---|---|---|
| In thousands | 2024 | 2023 | 2022 |
| US product revenue, net | $166,701 | $273,886 | $359,856 |
| Europe product revenue, net | 13,664 | 3,284 | 2,585 |
| RoW product revenue, net | 24,225 | 8,129 | 4,070 |
| Total product revenue, net | 204,590 | 285,299 | 366,511 |
| Licensing and royalty revenue | 24,024 | 21,612 | 2,682 |
| Total revenue, net | 228,614 | 306,911 | 369,193 |
| Less: Cost of goods sold | 110,758 | 102,142 | 108,631 |
| Less: Cost of goods sold - restructuring inventory | 36,474 | 39,228 | 18,078 |
| Gross margin | 81,382 | 165,541 | 242,484 |
| Operating expenses: | |||
| Selling | 40,150 | 57,243 | 117,012 |
| General and administrative | 38,290 | 52,559 | 75,261 |
| Research and development | 8,276 | 9,270 | 17,766 |
| Payroll and payroll related expense | 68,758 | 86,405 | 97,983 |
| Non-cash stock-based compensation expense | 17,705 | 16,680 | 26,805 |
| Restructuring | — | 10,972 | 13,526 |
| Total operating expenses | 173,179 | 233,129 | 348,353 |
| Operating loss | (91,797) | (67,588) | (105,869) |
| Interest income | 13,403 | 11,863 | 2,819 |
| Interest expense | (7) | (8) | (15) |
| Other income (expense), net | 1,201 | 2,063 | (740) |
| Loss from operations before taxes | (77,200) | (53,670) | (103,805) |
| Provision for income taxes | (4,983) | (5,442) | (1,998) |
| Segment & consolidated net loss | $(82,183) | $(59,112) | $(105,803) |
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. The accounting for involuntary termination benefits that are provided pursuant to a one-time benefit arrangement are accounted for under ASC 420 – Exit or Disposal Cost Obligations whereas involuntary termination benefits that are part of an ongoing written or substantive plan are accounted for under ASC 712 – Compensation – Nonretirement Postemployment Benefits. 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. As part of the plan, the Company completed the elimination of its entire U.S. sales field force, as well as a reduction of approximately 30% of the non-sales positions. The Company maintained its managed care and trade organization to support U.S. commercial efforts. 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.
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. business. As part of the plan, the Company completed a reduction of its U.S. 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.
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. As a result, the Company discontinued its German business operations effective September 1, 2022. 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.
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, | |||
|---|---|---|---|
| In thousands | 2024 | 2023 | 2022 |
| Employee restructuring separation charges | $— | $10,383 | $9,310 |
| Vendor contract charges | — | 589 | 4,216 |
| Total restructuring expense | — | 10,972 | 13,526 |
| Restructuring inventory | — | 39,228 | 18,078 |
| Stock forfeitures | — | 1,034 | 591 |
| Total restructuring cash obligations incurred | $— | $51,234 | $32,195 |
The following table shows the change in restructuring liability which is included within accrued expenses and other current liabilities:
| In thousands | Restructuring Liability |
|---|---|
| Balance at December 31, 2023 | $13,589 |
| Restructuring cash obligations incurred | — |
| Payments | (13,589) |
| Balance at December 31, 2024 | $— |
Recent Accounting Pronouncements
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.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures, 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. 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. As of December 31, 2024, the intangible assets have an estimated weighted-average remaining useful life of 6.1 years. The carrying value as of December 31,2024 and 2023 is as follows:
| In thousands | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Technology rights | $33,188 | $33,188 |
| Accumulated amortization | (16,799) | (13,884) |
| Intangible asset, net | $16,389 | $19,304 |
Amortization expense for the years ended December 31, 2024 and 2023 was$2.9 million and$2.8 million, respectively. Estimated future amortization expense as of December 31,2024 is as follows:
| In thousands | |
|---|---|
| Year Ending December 31, | Amount |
| 2025 | $2,915 |
| 2026 | 2,655 |
| 2027 | 2,546 |
| 2028 | 2,546 |
| 2029 | 2,546 |
| Thereafter | 3,181 |
| Total | $16,389 |
(4)
Inventory
The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA and other global regulatory agencies. Inventories as of December 31,2024 and 2023 consist of the following:
| In thousands | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Raw materials | $91,421 | $155,128 |
| Work in process | 30,482 | 5,373 |
| Finished goods | 108,885 | 175,730 |
| Inventory (1) | $230,788 | $336,231 |
(1)Total inventory consists of both current inventory and long-term inventory. 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.
(5)
Property, Plant and Equipment
Property, plant and equipment as of December 31,2024 and 2023 consists of the following:
| In thousands | Useful Life (in years) | December 31, 2024 | December 31, 2023 |
|---|---|---|---|
| Furniture and fixtures | 5 | $425 | $432 |
| Leasehold improvements | lesser of useful life or lease term | 217 | 217 |
| Software | 3 - 5 | 617 | 617 |
| Computer equipment | 3 - 5 | 227 | 227 |
| Property, plant and equipment | 1,486 | 1,493 | |
| Accumulated depreciation and amortization | (1,470) | (1,379) | |
| Property, plant and equipment, net | $16 | $114 |
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 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. Repairs and maintenance costs are expensed as incurred.
(6)
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following as of December 31,2024 and 2023:
| In thousands | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Payroll and payroll-related expenses | $15,362 | $18,942 |
| Sales and marketing accruals | 2,194 | 3,587 |
| Accrued revenue allowances | 104,482 | 145,034 |
| Accrued restructuring | — | 13,589 |
| All other | 17,545 | 23,022 |
| Accrued expenses and other current liabilities | $139,583 | $204,174 |
(7)
Commitments and Contingencies
Amarin accrues a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. Amarin reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and Amarin’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in Amarin’s accrued liabilities would be recorded in the period in which such determination is made. For the matters referenced below, the amount of liability is not probable nor can the amount be reasonably estimated; therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for matters in which the likelihood of material loss is at least reasonably possible, Amarin provides disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, Amarin will provide disclosure to that effect.
Litigation
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. 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; Capiton AG. 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.
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 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.
| Lawsuits | Civil Action # | Direct/Indirect Purchasers | Date Filed |
|---|---|---|---|
| Uniformed Fire Officers Association Family Protection Plan Local 854 Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan | 21-12061 | Indirect Purchaser | 6/2/2021 |
| The International Union of Operating Engineers Locals 137, 137A, 137B, 137C, 137R | 21-12416 | Indirect Purchaser | 6/11/2021 |
| KPH Healthcare Services, Inc. | 21-12747 | Direct Purchaser | 6/18/2021 |
| Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund | 21-13009 | Indirect Purchaser | 6/25/2021 |
| Teamsters Health & Welfare Fund of Philadelphia and Vicinity | 21-13406 | Indirect Purchaser | 7/7/2021 |
| Board of Trustees of Heavy and General Laborers’ Local Unions 472 and 172 of N.J. Welfare Fund | 21-14639 | Indirect Purchaser | 8/5/2021 |
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 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. 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 going back to January 1, 2015, 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. 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. Amarin Corporation plc, John F. Thero and Michael W. Kalb, No. 1:21-cv-19212 (D.N.J. Oct. 21, 2021). A subsequent case, Dorfman v. Amarin Corporation plc, et al., No. 3:21-cv-19911 (D.N.J. filed Nov. 10, 2021), was filed in November 2021. 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 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 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. Amarin Corporation plc, Covington & Burling, LLP, Joseph T. Kennedy, and John Does A-Z, No. MON-L-000984-23 (N.J. Super. Ct. Law Div. Mar. 29, 2023). The complaint alleged that the defendants failed to exercise appropriate diligence and due care in their conduct of the ANDA litigation. Based on those allegations, the complaint alleged that the defendants committed legal malpractice and sought monetary damages and attorneys’ fees and costs. 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. Amarin Corporation, plc(Docket No. SOM-L-000366-23), concerning Mr. Mikhail’s alleged “constructive termination” from the Company. 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 U.S. District Court for the District of New Jersey (Civ. No. 3:23-cv-01856). 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. The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.
In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters.
Milestone and Supply Purchase Obligations
The Company currently has long-term supply agreements with multiple API suppliers and encapsulators. The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.
These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers.
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 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, | |||||||
|---|---|---|---|---|---|---|---|
| 2025 | 2026 | 2027 | 2028 | 2029 | Thereafter | Total | |
| Unconditional Purchase Obligations | $16,500 | $18,900 | $5,700 | $8,100 | $3,600 | $10,800 | $63,600 |
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.
(8)
Equity
Common Stock
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, or ADS. 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 stock. 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.
The following table summarizes the aggregate number of stock options and restricted stock units, or RSUs, outstanding under the 2020 Plan as of December 31, 2024:
| Outstanding stock options | 27,696,061 |
|---|---|
| % of outstanding shares on a fully diluted basis | 7% |
| Outstanding RSUs | 13,865,487 |
| % of outstanding shares on a fully diluted basis | 3% |
The following table represents equity awards activity during the years ended December 31, 2024 and 2023:
| For the Year Ended December 31, | ||
|---|---|---|
| (in thousands, except share amounts) | 2024 | 2023 |
| Common shares issued for stock option exercises | 9,500 | 1,239,763 |
| Gross and net proceeds from stock option exercises | $10 | $1,882 |
| Common shares issued in settlement of vested RSUs | 3,351,960 | 3,890,395 |
| Shares retained for settlement of employee tax obligations ─ RSUs | 1,009,154 | 1,187,251 |
| Common shares issued in settlement of vested Performance-Based RSUs (1) | 497,397 | 358,440 |
| Shares retained for settlement of employee tax obligations ─ Performance-Based RSUs | 345,693 | 143,120 |
(1)
Performance-based RSUs vested in connection with the achievement of certain performance conditions. These performance-based RSUs will primarily vest over a three-year period based on continuous service from the grant date.
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 athree-year period and the stock options typically vest quarterly over afour-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. The RSUs vest in equal installments over athree-year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. The stock options vest in full upon the earlier of theone-year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. 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
On March 16, 2020, the Company’s Board of Directors, upon the recommendation of the Remuneration Committee, adopted, subject to shareholder approval, the 2020 Plan which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders. The 2020 Plan is the successor to the Company’s 2011 Plan, which was set to expire on July 12, 2021, and the Company’s 2002 Plan, the Plans.
The 2020 Plan allows the Company to grant stock options, both incentive and non-qualified options, to employees and Directors, restricted stock units to employees and unrestricted shares to Directors. 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. The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.
Stock Options
Under the terms of the Plans, stock options typically vest over afour-year period and expire after a 10-year term. The stock options are granted at an exercise price equal to the closing price of the Company’s American Depositary Shares on the grant date. The following table summarizes all stock option activity for the year ended December 31,2024:
| In thousands (except per share amounts and years) · Number ofShares · WeightedAverageExercisePrice · WeightedAverageRemainingContractualTerm · AggregateIntrinsicValue | |||||
|---|---|---|---|---|---|
| Outstanding as of January 1, 2024 | 27,956 | $3.21 | |||
| Granted | 9,100 | 0.83 | |||
| Forfeited | (8,961) | 2.81 | |||
| Expired | (389) | 1.98 | |||
| Exercised | (10) | 1.08 | |||
| Outstanding as of December 31, 2024 | 27,696 | 2.65 | 7.3 years | $ | - |
| Exercisable as of December 31, 2024 | 13,834 | 4.33 | 5.6 years | $ | - |
| Vested and expected to vest as of December 31, 2024 | 27,005 | 2.70 | 6.5 years | $ | - |
| Available for future grant as of December 31, 2024 | 27,290 | ||||
The weighted average grant date fair value of stock options granted during the years ended December 31, 2024, 2023, and 2022 was $0.57, $1.27, and $2.56, respectively. The total grant date fair value of options vested during the years ended December 31,2024, 2023, and 2022 was $7.3 million, $8.2 million, and $16.6 million, respectively. 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, 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.
The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model except for the market-based option awards which used the Monte Carlo option pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which include:
Risk free rate: The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity term approximating the expected life of the option at the date of grant.
Expected dividend yield: No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future.
Expected option life: The expected life was determined using the simplified method based on the term and vesting period.
Expected volatility: Expected stock price volatility for the Black-Scholes model was calculated based on the historical volatility of the Company’s common stock over the expected life of the option. For the Monte Carlo model, expected stock price volatility was calculated based on the historical volatility of both the Company's common stock and comparable company's common stock over the expected life of the option.
For 2024, 2023, and 2022, the Company used the following assumptions to estimate the fair value of share-based payment awards under the Black-Scholes model:
| 2024 | 2023 | 2022 | |
|---|---|---|---|
| Risk-free interest rate | 3.84% - 4.66% | 3.59% - 4.72% | 1.64% - 4.35% |
| Expected dividend yield | 0.00% | 0.00% | 0.00% |
| Expected option life (years) | 6.25 | 6.25 | 6.25 |
| Expected volatility | 106% | 101% - 104% | 96% - 101% |
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:
| 2024 | 2023 | |
|---|---|---|
| Risk-free interest rate | 3.92% - 3.96% | 4.06% - 4.09% |
| Expected dividend yield | 0.00% | 0.00% |
| Expected option life (years) | 9 | 9 |
| Expected volatility | 51.00% - 42.80% | 42.5% - 43.00% |
Employee stock options generally require future service and vest ratably over afour-year service period and are settled by the issuance of new common shares. The grant date fair value of the stock options, net of an estimated forfeiture rate is amortized straight-line over the awards’ vesting periods or respective requisite service periods and is adjusted for actual forfeitures over such period. The Company recorded compensation expense in relation to stock options of $7.3 million, $6.8 million, and $14.8 million for the years ended December 31,2024, 2023, and 2022, respectively.
Restricted Stock Units
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 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.
The following table presents the restricted stock unit activity for the year ended December 31,2024:
| In thousands (except per share amounts) | Shares | Weighted AverageGrant Date FairValue |
|---|---|---|
| Outstanding as of January 1, 2024 | 11,983 | 1.70 |
| Granted | 7,938 | 1.16 |
| Vested | (3,852) | 2.42 |
| Forfeited | (2,204) | 2.09 |
| Outstanding as of December 31, 2024 | 13,865 | $1.15 |
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, 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.
The following table presents the stock-based compensation expense related to stock-based awards for the years ended December 31,2024, 2023, and 2022:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Research and development | $3,539 | $4,187 | $4,465 |
| Selling, general and administrative | 14,166 | 12,493 | 22,339 |
| Restructuring | — | (1,034) | (591) |
| Stock-based compensation expense | $17,705 | $15,646 | $26,213 |
Employee Stock Purchase Plan
On March 13, 2017, the Board adopted, subject to shareholder approval, the Amarin Corporation plc 2017 Employee Stock Purchase Plan, or the ESPP, which was approved by the Company’s shareholders on May 15, 2017. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code. The maximum fair market value of stock which can be purchased by a participant in a calendar year is $25,000.
Under the ESPP, an aggregate of 3,000,000 ordinary shares (each ordinary share to be represented by one ADS) are reserved and available for issuance, which were registered with the SEC on August 2, 2017, for sale to eligible employees. Subject to certain exclusions, any employee of the Company’s U.S. subsidiary, Amarin Pharma, Inc., who works at least 20 hours per week and has been employed for at least six months as of the first day of the applicable offering period is eligible to participate in the ESPP. Eligible employees may authorize payroll deductions of up to 15 percent of their base pay to be withheld to purchase ordinary shares, subject to terms and limitations of the plan, at a price equal to 85 percent of the lower of the fair market values of the Company’s ordinary shares as of the beginning or the end of six-month offering periods.
For the offering periods ended on the last business day on or before each of May 31, 2024 and November 30, 2024, the Company issued 139,982 shares and 116,766 shares, respectively, at a purchase price of $0.64 per share and $0.43 per share, respectively.
For the offering periods ended on the last business day on or before each of May 31, 2023 and November 30, 2023, the Company issued 205,861 shares and 113,749 shares, respectively, at a purchase price of $1.01 per share and $0.66 per share, respectively.
For the offering periods ended on the last business day on or before each of May 31, 2022 and November 30, 2022, the Company issued 265,214 shares and 191,482 shares, respectively, at a purchase price of $1.45 per share and $1.15 per share, respectively.
As of December 31, 2024,785,219 shares were reserved for future issuance under the ESPP.
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Income Taxes
The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes. The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is$11.7 million and$8.9 million as of December 31, 2024 and 2023, respectively. The Company recognized interest related to uncertain tax positions of$1.7 million and$0.7 million for the years ended December 31, 2024 and 2023, respectively. No penalties have been recognized in conjunction with these positions.
The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31,2024, 2023 and 2022:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Beginning uncertain tax benefits | $18,658 | $18,715 | $22,040 |
| Prior year—decreases | (1,612) | (2,261) | (9,107) |
| Current year—increases | 2,437 | 2,204 | 5,782 |
| Ending uncertain tax benefits | $19,483 | $18,658 | $18,715 |
The Company files income tax returns in the United States, Ireland and United Kingdom, or UK. The Company remains subject to tax examinations in the following jurisdictions as of December 31,2024:
| Jurisdiction | Tax Years |
|---|---|
| United States—Federal | 2018-2024 |
| United States—State | 2018-2024 |
| Ireland | 2019-2024 |
| United Kingdom | 2022-2024 |
The Company doesnot expect any gross liabilities to expire in 2025 based on statutory lapses or audits.
The components of loss from operations before taxes were as follows for the years ended December 31,2024, 2023 and 2022:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| United States | $(5,284) | $15,881 | $5,358 |
| Ireland and United Kingdom | (76,910) | (85,177) | (112,527) |
| Other | 4,994 | 15,626 | 3,364 |
| Total loss before taxes | $(77,200) | $(53,670) | $(103,805) |
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:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Current: | |||
| United States—Federal | $3,185 | $1,597 | $562 |
| United States—State | 355 | 243 | 573 |
| Foreign | 1,443 | 3,602 | 863 |
| Total current | $4,983 | $5,442 | $1,998 |
| Deferred: | |||
| United States—Federal | (2,886) | 9,927 | (3,721) |
| United States—State | (1,369) | (934) | 284 |
| Foreign | (11,514) | (15,408) | (1,646) |
| Change in valuation allowance | 15,769 | 6,415 | 5,083 |
| Total deferred | $— | $— | $— |
| Provision for income taxes | $4,983 | $5,442 | $1,998 |
The provision for income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for the years ended December 31,2024, 2023 and 2022:
| In thousands | 2024 | 2023 | 2022 |
|---|---|---|---|
| Benefits from taxes at statutory rate | $(19,300) | $(13,418) | $(25,952) |
| Rate differential | 8,896 | 8,042 | 9,141 |
| Change in valuation reserves | 15,769 | 6,415 | 5,083 |
| Nondeductible employee compensation | 1,374 | 31 | 2,344 |
| Stock option/RSU windfall | 783 | 4,500 | 3,569 |
| ISO disqualifying disposition windfall | 459 | — | — |
| Branded prescription drug fee | (280) | — | — |
| Research and development credits | (257) | (376) | (958) |
| Tax return to provision adjustments | 544 | 4,187 | 424 |
| Foreign exchange | — | (2,921) | 7,859 |
| Permanent and other | (1,048) | 141 | (1,542) |
| Stock Option/RSU Deferred Only Adjustment | (1,716) | — | — |
| Uncertain tax positions | 921 | 780 | (3,290) |
| Foreign-derived intangible income | (1,162) | (1,939) | (2,935) |
| Loss of tax attributes | — | — | 8,255 |
| Provision for income taxes | $4,983 | $5,442 | $1,998 |
The Company is subject to a corporate tax rate in Ireland of 25% for non-trading activities and 12.5% for trading activities. For the years ended December 31,2024, 2023, and 2022, the Company applied the statutory corporate tax rate of 25% for Amarin Corporation plc, reflecting the non-trading tax rate in Ireland. However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5% Irish trading tax rate. In the table above, the Company used Amarin Corporation plc’s 25% tax rate as the starting point for the reconciliation since it is the parent entity of the business.
In April 2016, the Company adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Share-Based Payment Accounting which changes the accounting for certain aspects of share-based payments to employees. One aspect of the standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized as an income tax benefit and expense in the income statement. 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, 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:
| In thousands | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Deferred tax assets: | ||
| Net operating losses | $166,405 | $154,086 |
| Stock-based compensation | 12,451 | 9,929 |
| Tax credits | 2,421 | 2,409 |
| Lease liability | 1,837 | 1,971 |
| Other reserves and accrued liabilities | 8,808 | 7,916 |
| Gross deferred tax assets | 191,922 | 176,311 |
| Less: valuation allowance | (187,562) | (171,793) |
| Total deferred tax assets | 4,360 | 4,518 |
| Deferred tax liabilities: | ||
| Depreciation and amortization | (2,985) | (3,050) |
| Lease asset | (1,375) | (1,468) |
| Total deferred tax liabilities | (4,360) | (4,518) |
| Net deferred tax assets | $— | $— |
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 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. These adjustments were fully offset with valuation allowances based on the Company’s position with respect to the realizability of its recorded deferred tax assets.
The Company has combined U.S. and non-U.S. 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. and non-U.S. subsidiaries, the impact of foreign exchange rate changes and adjustments to reconcile to the amount reported on the filed 2023 foreign tax returns. In addition, the Company has U.S. Federal tax credit carryforwards of$7.8 million and state tax credit carryforwards of$4.1 million. These amounts exclude the impact of any unrecognized tax benefits and valuation allowances. These carryforwards, which will expire between 2025 and 2044, may be used to offset future taxable income, if any.
As of December 31, 2024, there areno earnings that have been retained indefinitely for reinvestment by foreign subsidiary; therefore, no provision has been made for income taxes that would be payable upon the distribution of such earnings or the recovery of the Company’s investment in its subsidiaries as the amount of the related unrecognized deferred income tax liability iszero.
The Company's and its subsidiaries' income tax returns are periodically examined by various taxing authorities. The Company is currently under audit by the IRS for the Company’s 2018 U.S. income tax return and by the New York Department of Finance for the years 2018 and 2019. 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 the Company's consolidated financial position or results of operations.
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Defined Contribution Plan
The Company makes available a 401(k) plan for its U.S. employees. 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. 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.
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Revenue Recognition
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 and in certain instances upon shipment. Payments from distributors are generally received 45 days from the date of sale. The Company evaluates the creditworthiness of each of its distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements, or whether recognition is required to be delayed until receipt of payment. The Company calculates gross product revenues generally based on the wholesale acquisition cost or list price that the Company charges its distributors for VASCEPA.
Reserves for Variable Consideration
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the distributor) or as a current liability (if the amount is payable to a party other than a distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors in the U.S. and Europe generally include a 2-3% discount for prompt payment while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.
Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the consolidated balance sheets. 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. 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. Excluding this change in estimate, net loss per share basic and diluted for the year ended December 31, 2023 would have been $(0.18).
Product Returns: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently four years andthree years, respectively, after being converted into capsule form, which is the last step in the manufacturing process for VASCEPA and generally occurs within a few months before VASCEPA is delivered to distributors. The Company estimates future product returns on sales of VASCEPA based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in Accrued expenses and other current liabilities on the consolidated balance sheets.
Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed.
The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for theyears ended December 31, 2024 and 2023:
| In thousands | TradeAllowances | Rebates,Chargebacksand Discounts | ProductReturns | OtherIncentives | Total |
|---|---|---|---|---|---|
| Balance as of January 1, 2023 | $44,626 | $136,093 | $8,746 | $2,056 | $191,521 |
| Provision related to current period sales | 90,806 | 726,119 | 2,199 | 16,561 | 835,685 |
| Provision related to prior period sales | (897) | (16,337) | (250) | 106 | (17,378) |
| Credits/payments made for current period sales | (71,972) | (593,584) | (1,744) | (14,658) | (681,958) |
| Credits/payments made for prior period sales | (43,729) | (109,258) | (1,219) | (2,163) | (156,369) |
| Balance as of December 31, 2023 | 18,834 | 143,033 | 7,732 | 1,902 | 171,501 |
| Provision related to current period sales | 81,262 | 751,254 | 1,914 | 12,019 | 846,449 |
| Provision related to prior period sales | - | (2,111) | - | - | (2,111) |
| Credits/payments made for current period sales | (72,281) | (656,381) | (246) | (10,387) | (739,295) |
| Credits/payments made for prior period sales | (18,382) | (138,269) | (4,666) | (1,986) | (163,303) |
| Balance as of December 31, 2024 | $9,433 | $97,526 | $4,734 | $1,548 | $113,241 |
Such net product revenue allowances and reserves are included within accrued expenses and other current liabilities within the consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within accounts receivable, net as discussed above.
Licensing Revenue
The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing and royalty revenues.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company.
Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. 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, 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). 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 Edding and HLS Therapeutics Inc., or HLS, respectively. Excluding this change in estimate, net loss per share basic and diluted for the year ended December 31, 2023 would have been $(0.17). Refer to Note 13—Development, Commercialization and Supply Agreements for further details.
Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which 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 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.
The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
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Development, Commercialization and Supply Agreements
In-licenses
Mochida Pharmaceutical Co., Ltd.
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. and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the U.S. and certain other territories. 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 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.
In January 2024, 2023 and 2022, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million, in each of such periods, to Mochida, which was recorded as research and development expense in the consolidated statement of operations.
Out-licenses
Eddingpharm (Asia) Macao Commercial Offshore Limited
In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Edding related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or collectively, the China Territory. Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.
Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. 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 assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company, (2) the obligation to participate in various steering committees, and (3) ongoing development and regulatory assistance. 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 is comprised of the following upfront payments and milestones:
| In thousands | ||
|---|---|---|
| Transaction Price Components | Achieved | Amount |
| Upfront fee | February 2015 | $15,000 |
| Submission of the CTA for the MARINE indication | March 2016 | 1,000 |
| Approval of VASCEPA under the MARINE indication | March 2017 | 5,000 |
| Submission of the CTA for the REDUCE-IT indication | October 2023 | 3,000 |
| Approval of VASCEPA under the REDUCE-IT indication | June 2024 | 15,000 |
| Regulatory Development Support | Various | 1,081 |
| Total Transaction Price | $40,081 | |
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. 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 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 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 tothree 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.
| In thousands | Amount |
|---|---|
| Licensing revenue recognized during the year ended December 31, 2024 (1) | $19,426 |
| Licensing revenue recognized during the year ended December 31, 2023 (1) | 12,913 |
| Licensing revenue recognized from contract inception through December 31, 2024 | 40,081 |
| Licensing revenue recognized from contract inception through December 31, 2023 | $20,655 |
(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.
Biologix FZCo
In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. 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 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.
The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries:
| Country | MARINE | REDUCE-IT | Launch Date |
|---|---|---|---|
| Lebanon | March 2018 | August 2021 | June 2018 |
| United Arab Emirates | July 2018 | October 2021 | February 2019 |
| Qatar | December 2019 | April 2021 | May 2022 |
| Bahrain | April 2021 | April 2022 | September 2023 |
| Kuwait | December 2021 | March 2023 | September 2023 |
| Saudi Arabia | March 2022 | June 2023 | September 2023 |
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 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.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada; (2) support general development and regulatory activities; and (3) participate in various steering committees. 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 is comprised of the following upfront payments and milestones:
| In thousands | ||
|---|---|---|
| Transaction Price Components | Achieved | Amount |
| Upfront fee | September 2017 | $5,000 |
| Achievement of the REDUCE-IT trial primary endpoint | September 2018 | 2,500 |
| Approval from Health Canada | December 2019 | 2,500 |
| Regulatory exclusivity from the Office of Patented Medicines and Liaison | January 2020 | 3,800 |
| Total Transaction Price | $13,800 | |
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. 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.
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 ofeight 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 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.
CSL Seqirus
In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. The Company received an upfront payment of $0.5 million which was fully recognized during the first quarter of 2023. 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.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, CSL, is a customer. 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 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, 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 (none 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 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.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Lotus, is a customer. 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 South Korea and Southeast Asian territories.
The transaction price includes the $0.3 million upfront consideration. 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 $0.3 million as licensing revenue related to the upfront payment received in connection with the Lotus agreement (none in 2024).
The following table presents changes in the balances of the Company’s contract assets and liabilities foryears ended December 31, 2024 and 2023:
| In thousands | Balance atBeginning ofPeriod | Additions | Deductions | Balance atEnd of Period |
|---|---|---|---|---|
| Year ended December 31, 2024: | ||||
| Contract assets | $— | $— | $— | $— |
| Contract liabilities: | ||||
| Deferred revenue (1) | $4,850 | $— | $(4,850) | $— |
| Year ended December 31, 2023: | ||||
| Contract assets | $— | $— | $— | $— |
| Contract liabilities: | ||||
| Deferred revenue (2) | $15,346 | $8,090 | $(18,586) | $4,850 |
(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:
| In thousands | Twelve Months Ended December 31, | |
|---|---|---|
| Revenue recognized in the period from: | 2024 | 2023 |
| Amounts included in contract liability at the beginning of the period | $1,180 | $1,892 |
| Performance obligations satisfied in previous periods | $3,670 | $16,182 |
(14)
Leases
Lessee
The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842.
The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1% would not result in a material change to the Company’s consolidated financial statements.
On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease. The Lease commenced on August 15, 2019, or the Commencement Date, for an 11-year period, withtwo five-year renewal options. Subject to the terms of the Lease, Amarin will have aone-time option to terminate the agreement effective on the first day of the 97 th month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company paid monthly rent of approximately $0.1 million for the first year following the Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease.
On November 17, 2021, the Company entered into a lease agreement for new office space in Zug Switzerland, or the Zug Lease. The Zug Lease commenced on February 1, 2022, or the Zug Commencement Date, for afive-year period, withone five-year renewal option. Under the Zug Lease, the Company will pay annual rent of approximately $0.2 million for the first year following the Zug Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Zug Commencement Date.
On September 13, 2022, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Dublin Lease. The Dublin Lease commenced on October 1, 2022, or the Dublin Commencement Date, for atwo-year period. 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 atwo-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.
The operating lease liability is$9.7 million and$10.6 million and the operating lease right-of-use asset is$7.6 million and$8.3 million, as of December 31, 2024 and 2023, respectively.
The lease expense for the years ended December 31, 2024, 2023 and 2022 is approximately$2.9 million,$3.2 million and$2.8 million, respectively.
The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of December 31,2024:
| Undiscountedleasepayments($000s) | |
|---|---|
| 2025 | $2,942 |
| 2026 | 2,563 |
| 2027 | 1,965 |
| 2028 | 1,978 |
| 2029 | 2,011 |
| 2030 and thereafter | 1,262 |
| Total undiscounted payments | $12,721 |
| Discount Adjustments | $(3,047) |
| Current operating lease liability | 1,951 |
| Long-term operating lease liability | $7,723 |
Lessor
The Company classifies contractual lease arrangements entered as a lessor as a sales-type, direct financing or operating lease as described in ASC 842. For sales-type leases, the Company derecognizes the leased asset and recognizes the lease investment on the balance sheet.
On January 20, 2023, the Company entered into a sublease agreement for 50,000 square feet of the 67,747 square foot New Jersey Lease and included within the sublease are furniture, fixtures and equipment, collectively the Sublease. The Sublease commenced on February 1, 2023, or the Sublease Commencement Date, for a 7.5-year period. Under the Sublease, the Company will be paid monthly rent of approximately $0.1 million for the first year following the Sublease Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date. In addition, Amarin will provide certain abatements subject to the limitations in the Lease.
The components of lease income are as follows:
| For the Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Interest income from sales-type leases | $62 | $61 |
| Operating lease income | 995 | 912 |
| Loss recognized at commencement date of sales type lease | — | (61) |
| Total | $1,057 | $912 |
Future minimum sales type lease and operating lease receivables as of December 31, 2024 are as follows:
| Sales-Type Leases · Operating Leases | ||
|---|---|---|
| 2025 | $119 | $1,029 |
| 2026 | 122 | 1,051 |
| 2027 | 125 | 1,073 |
| 2028 | 127 | 1,096 |
| 2029 | 130 | 1,118 |
| 2030 and thereafter | 88 | 759 |
| Total | $711 | $6,126 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.