Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 30, 2023 | |
Document And Entity Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | AMRN | |
Entity Registrant Name | AMARIN CORP PLC\UK | |
Entity Central Index Key | 0000897448 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity File Number | 000-21392 | |
Entity Incorporation, State or Country Code | X0 | |
Entity Address, Address Line One | Iconic Offices, The Greenway | |
Entity Address, Address Line Two | Block C Ardilaun Court | |
Entity Address, Address Line Three | 112 – 114 St Stephens Green | |
Entity Address, City or Town | Dublin | |
Entity Address, Postal Zip Code | 2 | |
Entity Address, Country | IE | |
City Area Code | 353 (0) 1 | |
Local Phone Number | 6699 020 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of each class | American Depositary Shares (ADS(s)), each ADSrepresenting the right to receive one (1) Ordinary Share ofAmarin Corporation plc | |
Name of each exchange on which registered | NASDAQ | |
Entity Tax Identification Number | 00-0000000 | |
American Depositary Shares | ||
Document And Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 387,307,491 | |
Ordinary Shares | ||
Document And Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 20,379,985 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 191,412 | $ 217,666 |
Restricted cash | 523 | 523 |
Short-term investments | 112,959 | 91,695 |
Accounts receivable, net | 133,236 | 130,990 |
Inventory | 225,813 | 228,732 |
Prepaid and other current assets | 19,878 | 19,492 |
Total current assets | 683,821 | 689,098 |
Property, plant and equipment, net | 187 | 874 |
Long-term investments | 544 | 1,275 |
Long-term inventory | 143,730 | 163,620 |
Operating lease right-of-use asset | 9,190 | 9,074 |
Other long-term assets | 1,638 | 458 |
Intangible asset, net | 21,078 | 21,780 |
TOTAL ASSETS | 860,188 | 886,179 |
Current Liabilities: | ||
Accounts payable | 58,779 | 64,602 |
Accrued expenses and other current liabilities | 183,264 | 192,678 |
Current deferred revenue | 2,199 | 2,199 |
Total current liabilities | 244,242 | 259,479 |
Long-Term Liabilities: | ||
Long-term deferred revenue | 12,702 | 13,147 |
Long-term operating lease liability | 9,841 | 10,015 |
Other long-term liabilities | 8,610 | 8,205 |
Total liabilities | 275,395 | 290,846 |
Commitments and contingencies (Note 5) | ||
Stockholders’ Equity: | ||
Common stock, GBP 0.50 par, unlimited authorized; 416,080,298 shares issued, 407,265,944 shares outstanding as of March 31, 2023 ; 412,333,087 shares issued, 404,346,256 shares outstanding as of December 31, 2022 | 301,285 | 299,002 |
Additional paid-in capital | 1,890,496 | 1,885,352 |
Treasury stock; 8,814,354 shares as of March 31, 2023; 7,986,831 shares as of December 31, 2022 | (63,277) | (61,770) |
Accumulated deficit | (1,543,711) | (1,527,251) |
Total stockholders’ equity | 584,793 | 595,333 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 860,188 | $ 886,179 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - £ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Statement of Financial Position [Abstract] | ||
Common stock, par value | £ 0.50 | £ 0.50 |
Common stock, shares authorized, unlimited | Unlimited | Unlimited |
Common stock, issued | 416,080,298 | 412,333,087 |
Common stock, outstanding | 407,265,944 | 404,346,256 |
Treasury stock, shares | 8,814,354 | 7,986,831 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total revenue, net | $ 85,975 | $ 94,630 |
Less: Cost of goods sold | 25,794 | 22,239 |
Less: Cost of goods sold - restructuring inventory | 12,254 | |
Gross margin | 47,927 | 72,391 |
Operating expenses: | ||
Selling, general and administrative | 59,587 | 90,647 |
Research and development | 5,681 | 10,051 |
Total operating expenses | 65,268 | 100,698 |
Operating loss | (17,341) | (28,307) |
Interest income, net | 2,221 | 203 |
Other income (expense), net | 624 | (246) |
Loss from operations before taxes | (14,496) | (28,350) |
Income tax provision | (1,964) | (3,213) |
Net loss | $ (16,460) | $ (31,563) |
Loss per share: | ||
Basic | $ (0.04) | $ (0.08) |
Diluted | $ (0.04) | $ (0.08) |
Weighted average shares: | ||
Basic | 406,177 | 397,805 |
Diluted | 406,177 | 397,805 |
Product Revenue, Net | ||
Total revenue, net | $ 84,654 | $ 93,986 |
Licensing and Royalty Revenue | ||
Total revenue, net | $ 1,321 | $ 644 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Shares | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 667,099 | $ 294,027 | $ (60,726) | $ 1,855,246 | $ (1,421,448) |
Balance (in shares) at Dec. 31, 2021 | 404,084,775 | ||||
Balance, Treasury Shares (in shares) at Dec. 31, 2021 | (7,486,767) | ||||
Exercise of stock options | $ 30 | $ 6 | 24 | ||
Exercise of stock options (in shares) | 10,602 | 10,602 | |||
Vesting of restricted stock units | $ (535) | $ 331 | $ (535) | (331) | |
Vesting of restricted stock units (in shares) | 493,381 | (161,083) | |||
Stock-based compensation | 6,078 | 6,078 | |||
Loss for the period | (31,563) | (31,563) | |||
Balance at Mar. 31, 2022 | 641,109 | $ 294,364 | $ (61,261) | 1,861,017 | (1,453,011) |
Balance (in shares) at Mar. 31, 2022 | 404,588,758 | ||||
Balance, Treasury Shares (in shares) at Mar. 31, 2022 | (7,647,850) | ||||
Balance at Dec. 31, 2022 | $ 595,333 | $ 299,002 | $ (61,770) | 1,885,352 | (1,527,251) |
Balance (in shares) at Dec. 31, 2022 | 412,333,087 | ||||
Balance, Treasury Shares (in shares) at Dec. 31, 2022 | 7,986,831 | (7,986,831) | |||
Exercise of stock options | $ 1,871 | $ 744 | 1,127 | ||
Exercise of stock options (in shares) | 1,232,263 | 1,232,263 | |||
Vesting of restricted stock units | $ (1,507) | $ 1,539 | $ (1,507) | (1,539) | |
Vesting of restricted stock units (in shares) | 2,514,948 | (827,523) | |||
Stock-based compensation | 5,556 | 5,556 | |||
Loss for the period | (16,460) | (16,460) | |||
Balance at Mar. 31, 2023 | $ 584,793 | $ 301,285 | $ (63,277) | $ 1,890,496 | $ (1,543,711) |
Balance (in shares) at Mar. 31, 2023 | 416,080,298 | ||||
Balance, Treasury Shares (in shares) at Mar. 31, 2023 | 8,814,354 | (8,814,354) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (16,460) | $ (31,563) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation and amortization | 63 | 144 |
(Accretion) amortization of investments | (907) | 374 |
Stock-based compensation | 5,556 | 6,078 |
Amortization of intangible asset | 702 | 636 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (2,246) | 53,419 |
Inventory | 22,809 | (52,940) |
Prepaid and other current assets | (386) | (5,740) |
Other long-term assets | (556) | |
Interest receivable | (16) | 140 |
Deferred revenue | (445) | (372) |
Accounts payable and other current liabilities | (15,237) | (69,658) |
Other long-term liabilities | 115 | 635 |
Net cash used in operating activities | (7,008) | (98,847) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Maturities of securities | 32,913 | 113,220 |
Purchases of securities | (52,523) | (14,171) |
Net cash (used in) provided by investing activities | (19,610) | 99,049 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of stock options, net of transaction costs | 1,871 | 30 |
Taxes paid related to stock-based awards | (1,507) | (535) |
Net cash provided by (used in) financing activities | 364 | (505) |
NET DECREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (26,254) | (303) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 218,189 | 223,372 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | 191,935 | 223,069 |
Cash (paid) received during the year for: | ||
Income taxes | (38) | 51 |
Supplemental disclosure of non-cash transactions: | ||
Initial recognition of operating lease right-of-use asset | 446 | $ 1,036 |
Initial recognition of furniture, fixtures and equipment lease | $ 624 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Nature of Business and Basis of Presentation | (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. Most of the Company’s historical revenue and sales, marketing and administrative activities and costs have been associated with commercial operations in the United States, or U.S. The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and continues pre-launch commercial activities throughout the rest of Europe. The Company’s operations outside of the U.S. and Europe are in early stages of development with reliance on third-party commercial partners in select geographies, including China where regulatory approval for the Company’s lead product is being actively sought. The Company’s lead product, VASCEPA ® (icosapent ethyl), 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. 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. 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 first U.S. FDA-approved use of its drug, for use to reduce severely high triglyceride levels, which is known as the MARINE indication. The Company sought appeals of the Nevada Court judgment up to the United States Supreme Court, but the Company was unsuccessful. On June 18, 2021, the Company was notified that its petition for writ of certiorari to the United States Supreme Court was denied. As a result, the following generic versions of VASCEPA 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 Launch Date Hikma Pharmaceuticals USA Inc. May 2020 November 2020 (1) Dr. Reddy’s Laboratories, Inc. August 2020 June 2021 Teva Pharmaceuticals USA, Inc. September 2020 September 2022 (2) Apotex, Inc. June 2021 January 2022 Zydus Lifesciences April 2023 N/A (1) Hikma launched a 1-gram capsule in November 2020 and a 0.5-gram capsule in March 2023. (2) Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023. On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk. Collectively, CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities. In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China. On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong had commenced. The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA based on the results from the Phase 3 clinical trial and the results from the Company’s prior studies of VASCEPA. On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication. The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States. Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States and Europe, as well as in Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product. The Company operates in one business segment. Basis of Presentation The condensed consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information in the footnote disclosures of the financial statements has been condensed or omitted where it substantially duplicates information provided in the Company’s latest audited consolidated financial statements, in accordance with the rules and regulations of the SEC. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, or the Form 10-K, filed with the SEC. The balance sheet amounts in this report were derived from the Company’s audited consolidated financial statements included in the Form 10-K. The condensed 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 condensed consolidated financial statements in conformity with 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 three months ended March 31, 2023 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 condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying condensed 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 March 31, 2023, the Company had total assets of $ 860.2 million, of which $ 304.9 million consisted of cash and liquid short-term and long-term investments. More specifically, the Company had current assets of $ 683.8 million, including cash and cash equivalents of $ 191.4 million, short-term investments of $ 113.0 million, accounts receivable, net, of $ 133.2 million and current inventory of $ 225.8 million. In addition, as of March 31, 2023, the Company had long-term investments of $ 0.5 million and long-term inventory of $ 143.7 million. As of March 31, 2023 , the Company had no debt outstanding. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | (2) Significant Accounting Policies 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 7—Revenue Recognition. 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 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 as of March 31, 2023 and December 31, 2022: In thousands March 31, 2023 December 31, 2022 Gross trade accounts receivable $ 164,010 $ 187,418 Trade allowances ( 18,920 ) ( 44,626 ) Chargebacks ( 11,854 ) ( 11,802 ) Accounts receivable, net $ 133,236 $ 130,990 Inventory The Company states inventories 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 operating cycle. The Company classifies finished goods expected to be consumed within a normal operating cycle 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. 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 condensed 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 condensed 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 states tax authorities. The Company is currently under audit by the IRS for its 2018 and 2019 U.S. income tax returns. The audit by the New Jersey Department of Treasury for the years 2012 to 2015 was closed in April 2023. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its condensed 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 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 three months ended March 31, 2023 and 2022 are as follows: For the Three Months Ended March 31, In thousands 2023 2022 Net loss—basic and diluted $ ( 16,460 ) $ ( 31,563 ) Weighted average shares outstanding—basic and diluted 406,177 397,805 Net loss per share—basic and diluted $ ( 0.04 ) $ ( 0.08 ) For the three months ended March 31, 2023 and 2022, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures: For the Three Months Ended March 31, In thousands 2023 2022 Stock options 19,639 19,639 Restricted stock and restricted stock units 18,568 15,369 Laxdale milestone shares — 1,984 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. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term and long-term investments, and accounts receivable. The Company maintains substantially all of its cash and cash equivalents and short-term and long-term investments in financial institutions believed to be of high credit quality. 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 29 % , 38 % , and 27 % , respectively, of gross product sales for the three months ended March 31, 2023, and represented 36 % , 40 % , and 20 % , respectively, of the gross accounts receivable balance as of March 31, 2023. Customers A, B, and C accounted for 21 % , 39 % , and 31 % , respectively, of gross product sales for the three months ended March 31, 2022 and represented 29 % , 37 % , and 28 % , respectively, of the gross accounts receivable balance as of March 31, 2022 . 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. 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, etc.) 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 March 31, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: March 31, 2023 In thousands Total Level 1 Level 2 Level 3 Asset: Agency Securities $ 3,999 $ 3,999 $ — $ — Money Market Fund 80,105 80,105 — — U.S. Treasury Securities 3,153 3,153 — — Corporate Bonds 16,035 — 16,035 — Commercial Paper 79,440 — 79,440 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 546 — 546 — Certificate of Deposit 8,490 — 8,490 — Non-US Government Securities 1,399 — 1,399 — Total $ 196,417 $ 87,257 $ 109,160 $ - December 31, 2022 In thousands Total Level 1 Level 2 Level 3 Asset: Money Market Fund $ 81,870 $ 81,870 $ — $ — U.S. Treasury Securities 3,117 3,117 — — Agency Securities 1,554 1,554 — — Corporate Bonds 28,416 — 28,416 — Commercial Paper 62,347 — 62,347 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 1,260 — 1,260 — Certificate of Deposit 9,100 — 9,100 — Non-US Government Securities 1,393 — 1,393 — Total $ 192,307 $ 86,541 $ 105,766 $ — 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 condensed consolidated balance sheet. Those with remaining maturities in excess of 12 months are included in long-term investments on its condensed 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 three months ended March 31, 2023 and 2022 were losses of $ 0.2 million and $ 0.9 million, respectively. Interest on investments is reported in interest income. The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature. Segment and Geographical Information Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company currently operates in one business segment, which is the development and commercialization of VASCEPA. A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. Restructuring On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes an organizational restructuring plan to address current 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 three months ended March 31, 2023 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 resulting in charges of $ 12.3 million recognized within cost of goods sold - restructuring inventory on the condensed consolidated statement of operations. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company. On 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, t he Company recognized approximately $ 4.2 million within restructuring expense on the condensed consolidated statement of operations, substantially all of which were cash expenditures. 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, 2022 $ 192 Costs incurred 12,254 Payments ( 10,323 ) Balance at March 31, 2023 $ 2,123 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. The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. |
Intangible Asset
Intangible Asset | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Asset | (3) Intangible Asset Intangible asset consists of 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 March 31, 2023, the intangible asset has an estimated weighted-average remaining life of 7.8 years. The carrying value as of March 31, 2023 and December 31, 2022 is as follows: In thousands March 31, 2023 December 31, 2022 Technology rights $ 32,859 $ 32,859 Accumulated amortization ( 11,781 ) ( 11,079 ) Intangible asset, net $ 21,078 $ 21,780 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | (4) Inventory The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by regulatory authorities. Inventories as of March 31, 2023 and December 31, 2022 consist of the following: In thousands March 31, 2023 December 31, 2022 Raw materials $ 127,025 $ 126,391 Work in process 7,085 52,297 Finished goods 235,433 213,664 Total inventory (1) $ 369,543 $ 392,352 (1) Total inventory consists of both current inventory and long-term inventory. During the three months ended March 31, 2023, approximately $ 2.3 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory. As of March 31, 2023 and December 31, 2022, the Company had $ 143.7 million and $ 163.6 million of long-term inventory, respectively, as consumption is expected beyond the Company's operating cycle. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (5) 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. Amarin intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of the se lawsuits described below, those lawsuits described in the Company's Form 10-K for the year ended December 31, 2022 or any subsequently filed lawsuits. Litigation Updates In April 2021, Dr. Reddy’s filed a complaint against the Company in the United States District Court for the District of New Jersey, Civil action No.21-cv-10309, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. The complaint also includes a related state law tortious interference claim. Damages sought include recovery for alleged economic harm to Dr. Reddy’s, payors and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s. In addition, in February 2023, Hikma filed a complaint against us in the United States District Court District of New Jersey (case no. 3:23-cv-01016) with consistent allegations as the Dr. Reddy's complaint. 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 also named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey. Amarin is a defendant in a class action lawsuit filed by Uniformed Fire Officers Association Family Protection Plan Local 854 and the Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12061, alleging Amarin and its co-defendant suppliers violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by The International Union of Operating Engineers Locals 137, 137A, 137B, 137C, 137R, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12416, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by KPH Healthcare Services, Inc., on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12747, alleging Amarin and its co-defendant suppliers violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund, on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-13009. Amarin is a defendant in a class action lawsuit filed by Teamsters Health & Welfare Fund of Philadelphia and Vicinity, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-13406, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Such antitrust litigation, and antitrust investigations, can be lengthy, costly and could materially affect and disrupt the Company’s business. The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business. If a government determines that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties. On October 21, 2021, a purported investor in the Company's publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and the former chief financial officer in the U.S. 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 ANDA litigation described above and the risk that certain of the Company's patents related to the MARINE indication would be invalidated. Based on these allegations, plaintiff alleges that he purchased securities at an inflated share price and brings claims under the Securities and Exchange Act of 1934 seeking unspecified monetary damages and attorneys' fees and costs. 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. 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. 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 alleges that the defendants failed to exercise appropriate diligence and due care in their conduct of the ANDA litigation. Based on those allegations, the complaint alleges that the defendants committed legal malpractice and seeks monetary damages and attorneys’ fees and costs. On April 8, 2023, the plaintiffs voluntarily dismissed this case without prejudice. 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 Employment Agreement, Executive Severance and Change of Control Plan, and the implied covenant of good faith and fair dealing. On April 3, 2023, the case moved to the United States District Court for the District of New Jersey (Civ. No. 3:23-cv-01856). 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 its lead product. 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. On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes a comprehensive cost and organizational restructuring plan to address current shifts within the Company’s U.S. business as a result of the generic competition. As part of this plan, the Company has reviewed its contractual supplier purchase obligations and has entered into agreements with suppliers to amend supplier agreements to align supply arrangements with current and future market demand. 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. As of March 31, 2023, the Company has a total of approximately $ 81.7 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers. In addition, the Company has total obligations of $ 39.8 million contingent on either certain suppliers obtaining regulatory approval in Europe or pricing reimbursement in certain European countries not occurring by June 30, 2024. Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £ 5 million (approximately $ 5.5 million as of March 31, 2023) 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 March 31, 2023 . |
Equity
Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Equity | (6) Equity Common Stock There was no common stock activity during the three months ended March 31, 2023 and 2022 except as described in Incentive Equity Awards below. Incentive Equity Awards The following table summarizes the aggregate number of stock options and restricted stock units, or RSUs, outstanding under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, as of March 31, 2023: March 31, 2023 Outstanding stock options 19,638,850 % of outstanding shares on a fully-diluted basis 4 % Outstanding RSUs 18,203,692 % of outstanding shares on a fully-diluted basis 4 % The following table represents equity awards activity during the three months ended March 31, 2023 and 2022: Three months ended March 31, 2023 2022 Common shares issued for stock option exercises 1,232,263 10,602 Gross and net proceeds from stock option exercises $ 1,871,758 $ 30,000 Common shares issued in settlement of vested RSUs 2,270,674 493,381 Shares retained for settlement of employee tax obligations ─ RSUs 716,438 161,083 Common shares issued in settlement of vested Performance-based RSUs (1) 244,274 — Shares retained for settlement of employee tax obligations ─ Performance-based RSUs 111,085 — (1) Performance-based RSUs vested in connection with the achievement of certain sales performance conditions on February 21, 2023. These performance-based RSUs will vest over a three-year period based on continuous service from the grant date. In February 2023, the Company granted a total of 7,775,850 RSUs and 4,297,500 stock options to employees under the 2020 Plan. The RSUs vest annually over a three-year period and the stock options vest quarterly over a four-year period with a one-year cliff vesting. Also in February 2023, the Company granted a total of 1,368,800 RSUs to employees under the 2020 Plan that vest upon the achievement of specified sales and operational performance conditions. In February 2022, the Company granted a total of 5,987,500 RSUs and 1,976,600 stock options to employees under the 2020 Plan. The RSUs vest annually over a three-year period and the stock options vest quarterly over a four-year period with a one-year cliff vesting. Also in February 2022, the Company granted a total of 1,089,500 RSUs to employees under the 2020 Plan that vest upon the achievement of specified sales and operational performance conditions. In January 2022, the Company granted a total of 81,082 RSUs and 103,569 stock options to newly appointed members of the Company’s Board of Directors under the 2020 Plan and in accordance with the Company's non-employee Director compensation policy. The RSUs vest in equal installments over a three-year period upon the anniversary of the grant date, and are subject to deferred settlement upon the Director’s separation of service with the Company. The stock options vested in full upon the one-year anniversary of the grant date. Upon termination of service to the Company or upon a change of control as defined in the 2020 Plan, 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. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | (7) Revenue Recognition The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States and Europe, or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. 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. Payments from distributors are generally received 30 - 60 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 condensed 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. 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 and three 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 condensed 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 condensed 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 the three months ended March 31, 2023 and 2022: In thousands Trade Rebates, Product Other Total Balance as of December 31, 2022 $ 44,626 $ 136,093 $ 8,746 $ 2,056 $ 191,521 Provision related to current period sales 22,313 162,858 532 5,008 190,711 Provision related to prior period sales — ( 5,589 ) — 107 ( 5,482 ) Credits/payments made for current period sales ( 11,534 ) ( 105,542 ) — ( 3,925 ) ( 121,001 ) Credits/payments made for prior period sales ( 36,485 ) ( 51,460 ) ( 577 ) ( 839 ) ( 89,361 ) Balance as of March 31, 2023 $ 18,920 $ 136,360 $ 8,701 $ 2,407 $ 166,388 In thousands Trade Rebates, Product Other Total Balance as of December 31, 2021 $ 86,636 $ 184,756 $ 8,089 $ 2,745 $ 282,226 Provision related to current period sales 22,697 148,203 549 8,325 179,774 Provision related to prior period sales — ( 301 ) — — ( 301 ) Credits/payments made for current period sales ( 2,753 ) ( 67,700 ) — ( 6,379 ) ( 76,832 ) Credits/payments made for prior period sales ( 13,536 ) ( 123,099 ) ( 350 ) ( 2,630 ) ( 139,615 ) Balance as of March 31, 2022 $ 93,044 $ 141,859 $ 8,288 $ 2,061 $ 245,252 Such net product revenue allowances and reserves are included within accrued expenses and other current liabilities within the condensed 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. 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 re-evaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. 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. Up-front 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. |
Development, Commercialization
Development, Commercialization and Supply Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Development, Commercialization and Supply Agreements | (8) 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 United States 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 United States 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 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 condensed 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 Eddingpharm (Asia) Macao Commercial Offshore Limited, or 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 right to sublicense to develop and commercialize 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 and Edding agreed to form a joint development committee to oversee regulatory and development activities for VASCEPA in the China Territory in accordance with a negotiated development plan and formed a separate joint commercialization committee in advance of expected approval in the China Territory to oversee VASCEPA planning and pre-launch commercialization activities in the China Territory. Development costs are paid by Edding to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Edding. Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at Edding’s cost with the Company’s assistance. The DCS Agreement also contains customary provisions regarding indemnification, supply, record keeping, audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type. The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by a valid claim under a licensed patent in the China Territory, or (ii) the 12th anniversary of the first commercial sale of such product in Mainland China. The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods. In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Edding has the right to terminate the DCS Agreement for convenience with 12 months’ prior notice. Neither party may assign or transfer the DCS Agreement without the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction. Upon closing of the DCS Agreement, the Company received a non-refundable $ 15.0 million up-front payment. In March 2016, Edding submitted its clinical trial application, or CTA, with respect to the MARINE indication for VASCEPA to the Chinese regulatory authority. Following the CTA submission, the Company received a non-refundable $ 1.0 million milestone payment. In March 2017, the CTA was approved by the Chinese regulatory authority and, in December 2017, Edding commenced a pivotal clinical trial aimed to support the regulatory approval of the first indication of VASCEPA in a patient population with severe hypertriglyceridemia in Mainland China. In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which is being used to seek regulatory approval in Mainland China. The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022. In addition to the non-refundable, up-front and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $ 153.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The regulatory milestone events relate to the submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application. The amounts to be received upon achievement of the regulatory milestone events relate to the submission and approval for three indications, and range from $ 2.0 million to $ 15.0 million for a total of $ 33.0 million. The sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $ 5.0 million to $ 50.0 million for a total of $ 120.0 million. Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments. The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. 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 includes the $ 15.0 million up-front consideration received and the $ 1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication. None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. During the three months ended March 31, 2023 and 2022, the Company recognized $ 0.3 million and $ 0.2 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the Edding agreement. From contract inception through March 31, 2023 and December 31, 2022, the Company recognized $ 8.0 million and $ 7.7 million, respectively, as licensing revenue under the DCS Agreement 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. The remaining transaction price of $ 9.0 million and $ 9.3 million is recorded in deferred revenue as of March 31, 2023 and December 31, 2022 , respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 11 years . 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 up-front payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory. 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 — Bahrain April 2021 April 2022 — Kuwait December 2021 March 2023 — Saudi Arabia March 2022 — — The Company recognized net product revenue of $ 0.3 million and nil for the three months ended March 31, 2023 and 2022, 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 will be responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities. Upon closing of the agreement, the Company received one-half of a non-refundable $ 5.0 million up-front payment, and received the remaining half on the six-month anniversary of the closing. Following achievement of the REDUCE-IT trial primary endpoint, which was announced in September 2018, the Company received a non-refundable $ 2.5 million milestone payment. Following approval from Health Canada in December 2019, the Company received a non-refundable milestone payment of $ 2.5 million in February 2020. In addition, in January 2020, HLS obtained regulatory exclusivity from the Office of Patented Medicines and Liaison, or OPML, as a result the Company received a non-refundable $ 3.8 million milestone payment. In addition to the non-refundable, up-front and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $ 50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada. The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. 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 includes the $ 5.0 million up-front consideration, the $ 2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $ 2.5 million milestone related to obtaining approval from Health Canada and $ 3.8 million milestone related to obtaining regulatory exclusivity from the OPML. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. During the three months ended March 31, 2023 and 2022, the Company recognized $ 0.1 million and $ 0.1 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement. From the contract’s inception through March 31, 2023 and December 31, 2022, the Company has recognized $ 8.3 million and $ 8.2 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by Amarin to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation. The remaining transaction price of $ 5.4 million and $ 5.6 million is recorded in deferred revenue as of March 31, 2023 and December 31, 2022 , respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 7 years . The Company recognized net product revenue of $ 1.6 million and nil for the three months ended March 31, 2023 and 2022, 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 addition to the upfront payment the Company will be eligible to receive event-related milestone payments of approximately $ 8.0 million and additional product-related milestone payments of approximately $ 4.0 million. 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. 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 re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. During the three months ended March 31, 2023 , the Company recognized $ 0.5 million as licensing revenue related to the upfront payment received in connection with the CSL agreement ( none in 2022). The following table presents changes in the balances of the Company’s contract assets and liabilities during the three months ended March 31, 2023 and 2022: In thousands Balance at Additions Deductions Balance at Three months ended March 31, 2023: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 15,346 $ — $ ( 445 ) $ 14,901 Three months ended March 31, 2022: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 16,709 $ — $ ( 372 ) $ 16,337 During the three months ended March 31, 2023 and 2022, 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 Three months ended March 31, Revenue recognized in the period from: 2023 2022 Amounts included in contract liability at the beginning of the period $ 445 $ 372 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | (9) 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 condensed consolidated financial statements. On February 5, 2019, the Company entered into a lease agreement for office space in Bridgewater, New Jersey, or the New Jersey Lease. The New Jersey Lease commenced on August 15, 2019 , or the New Jersey Commencement Date, for an 11-year period, with two five-year renewal options. Subject to the terms of the New Jersey Lease, the Company will have a one-time option to terminate the agreement effective on the first day of the 97 th month after the New Jersey Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the New Jersey Lease, the Company paid monthly rent of approximately $ 0.1 million for the first year following the New Jersey Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the New Jersey Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the New Jersey 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 a 5-year period, with one 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 a 2-year period. Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.4 million during the duration of the lease term. In addition to the real estate leases, the Company leases various vehicles with terms ranging from month to month up to 36 months . As of March 31, 2023 and December 31, 2022, the total operating lease liability is $ 11.7 million and $ 11.6 million, respectively, and the total operating lease right-of-use asset is $ 9.2 million and $ 9.1 million, respectively. The lease expense for the three months ended March 31, 2023 is approximately $ 0.9 million. The lease expense for the three months ended March 31, 2022 is approximately $ 0.6 million. 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 March 31, 2023: Undiscounted Remainder of 2023 $ 2,284 2024 2,827 2025 2,136 2026 2,135 2027 1,962 2028 and thereafter 5,251 Total undiscounted payments $ 16,595 Discount Adjustments $ ( 4,945 ) Current operating lease liability $ 1,809 Long-term operating lease liability $ 9,841 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 Three Months Ended March 31, 2023 Interest income from sales-type leases $ 11 Operating lease income 166 Loss recognized at commencement date of sales type lease ( 61 ) Total $ 116 Future minimum sales type lease and operating lease receivables as of March 31, 2023 are as follows: Sales-Type Leases Operating Leases Remainder of 2023 $ 48 $ 411 2024 117 1,006 2025 119 1,029 2026 122 1,051 2027 125 1,073 2028 and thereafter 345 2,974 Total $ 876 $ 7,544 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Revenue Recognition | 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 7—Revenue Recognition. |
Cash and Cash Equivalents and Restricted Cash | 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 Accounts receivable, net, comprised of trade receivables, are generally due within 45 days and are stated at amounts due from customers. The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable losses net of any recoveries. The 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 as of March 31, 2023 and December 31, 2022: In thousands March 31, 2023 December 31, 2022 Gross trade accounts receivable $ 164,010 $ 187,418 Trade allowances ( 18,920 ) ( 44,626 ) Chargebacks ( 11,854 ) ( 11,802 ) Accounts receivable, net $ 133,236 $ 130,990 |
Inventory | Inventory The Company states inventories 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 operating cycle. The Company classifies finished goods expected to be consumed within a normal operating cycle 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. |
Income Taxes | 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 condensed 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 condensed 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 states tax authorities. The Company is currently under audit by the IRS for its 2018 and 2019 U.S. income tax returns. The audit by the New Jersey Department of Treasury for the years 2012 to 2015 was closed in April 2023. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its condensed consolidated financial position or results of operations. |
Loss per Share | 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 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 three months ended March 31, 2023 and 2022 are as follows: For the Three Months Ended March 31, In thousands 2023 2022 Net loss—basic and diluted $ ( 16,460 ) $ ( 31,563 ) Weighted average shares outstanding—basic and diluted 406,177 397,805 Net loss per share—basic and diluted $ ( 0.04 ) $ ( 0.08 ) For the three months ended March 31, 2023 and 2022, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures: For the Three Months Ended March 31, In thousands 2023 2022 Stock options 19,639 19,639 Restricted stock and restricted stock units 18,568 15,369 Laxdale milestone shares — 1,984 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. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term and long-term investments, and accounts receivable. The Company maintains substantially all of its cash and cash equivalents and short-term and long-term investments in financial institutions believed to be of high credit quality. 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 29 % , 38 % , and 27 % , respectively, of gross product sales for the three months ended March 31, 2023, and represented 36 % , 40 % , and 20 % , respectively, of the gross accounts receivable balance as of March 31, 2023. Customers A, B, and C accounted for 21 % , 39 % , and 31 % , respectively, of gross product sales for the three months ended March 31, 2022 and represented 29 % , 37 % , and 28 % , respectively, of the gross accounts receivable balance as of March 31, 2022 . 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 | 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. |
Fair Value of Financial Instruments | 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, etc.) 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 March 31, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: March 31, 2023 In thousands Total Level 1 Level 2 Level 3 Asset: Agency Securities $ 3,999 $ 3,999 $ — $ — Money Market Fund 80,105 80,105 — — U.S. Treasury Securities 3,153 3,153 — — Corporate Bonds 16,035 — 16,035 — Commercial Paper 79,440 — 79,440 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 546 — 546 — Certificate of Deposit 8,490 — 8,490 — Non-US Government Securities 1,399 — 1,399 — Total $ 196,417 $ 87,257 $ 109,160 $ - December 31, 2022 In thousands Total Level 1 Level 2 Level 3 Asset: Money Market Fund $ 81,870 $ 81,870 $ — $ — U.S. Treasury Securities 3,117 3,117 — — Agency Securities 1,554 1,554 — — Corporate Bonds 28,416 — 28,416 — Commercial Paper 62,347 — 62,347 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 1,260 — 1,260 — Certificate of Deposit 9,100 — 9,100 — Non-US Government Securities 1,393 — 1,393 — Total $ 192,307 $ 86,541 $ 105,766 $ — 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 condensed consolidated balance sheet. Those with remaining maturities in excess of 12 months are included in long-term investments on its condensed 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 three months ended March 31, 2023 and 2022 were losses of $ 0.2 million and $ 0.9 million, respectively. Interest on investments is reported in interest income. The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature. |
Segment and Geographical Information | Segment and Geographical Information Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company currently operates in one business segment, which is the development and commercialization of VASCEPA. A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. |
Restructuring | Restructuring On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes an organizational restructuring plan to address current 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 three months ended March 31, 2023 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 resulting in charges of $ 12.3 million recognized within cost of goods sold - restructuring inventory on the condensed consolidated statement of operations. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company. On 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, t he Company recognized approximately $ 4.2 million within restructuring expense on the condensed consolidated statement of operations, substantially all of which were cash expenditures. 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, 2022 $ 192 Costs incurred 12,254 Payments ( 10,323 ) Balance at March 31, 2023 $ 2,123 |
Recent Accounting Pronouncements | 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. The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable Balances | The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of March 31, 2023 and December 31, 2022: In thousands March 31, 2023 December 31, 2022 Gross trade accounts receivable $ 164,010 $ 187,418 Trade allowances ( 18,920 ) ( 44,626 ) Chargebacks ( 11,854 ) ( 11,802 ) Accounts receivable, net $ 133,236 $ 130,990 |
Calculation of Net Loss and Number of Shares Used to Compute Basic and Diluted Net Loss per Share | The calculation of net loss and the number of shares used to compute basic and diluted net loss per share for the three months ended March 31, 2023 and 2022 are as follows: For the Three Months Ended March 31, In thousands 2023 2022 Net loss—basic and diluted $ ( 16,460 ) $ ( 31,563 ) Weighted average shares outstanding—basic and diluted 406,177 397,805 Net loss per share—basic and diluted $ ( 0.04 ) $ ( 0.08 ) |
Anti-Dilutive Securities Not Included in the Computation of Net Loss per Share | For the three months ended March 31, 2023 and 2022, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures: For the Three Months Ended March 31, In thousands 2023 2022 Stock options 19,639 19,639 Restricted stock and restricted stock units 18,568 15,369 Laxdale milestone shares — 1,984 |
Estimated Fair Value of Assets and Liability | The following tables present information about the estimated fair value of the Company’s assets and liabilities as of March 31, 2023 and December 31, 2022 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: March 31, 2023 In thousands Total Level 1 Level 2 Level 3 Asset: Agency Securities $ 3,999 $ 3,999 $ — $ — Money Market Fund 80,105 80,105 — — U.S. Treasury Securities 3,153 3,153 — — Corporate Bonds 16,035 — 16,035 — Commercial Paper 79,440 — 79,440 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 546 — 546 — Certificate of Deposit 8,490 — 8,490 — Non-US Government Securities 1,399 — 1,399 — Total $ 196,417 $ 87,257 $ 109,160 $ - December 31, 2022 In thousands Total Level 1 Level 2 Level 3 Asset: Money Market Fund $ 81,870 $ 81,870 $ — $ — U.S. Treasury Securities 3,117 3,117 — — Agency Securities 1,554 1,554 — — Corporate Bonds 28,416 — 28,416 — Commercial Paper 62,347 — 62,347 — Repo Securities 3,250 — 3,250 — Asset-Backed Securities 1,260 — 1,260 — Certificate of Deposit 9,100 — 9,100 — Non-US Government Securities 1,393 — 1,393 — Total $ 192,307 $ 86,541 $ 105,766 $ — |
Change in Restructuring Liability Associated with the Plan | 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, 2022 $ 192 Costs incurred 12,254 Payments ( 10,323 ) Balance at March 31, 2023 $ 2,123 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Carrying Value of Intangible Asset | The carrying value as of March 31, 2023 and December 31, 2022 is as follows: In thousands March 31, 2023 December 31, 2022 Technology rights $ 32,859 $ 32,859 Accumulated amortization ( 11,781 ) ( 11,079 ) Intangible asset, net $ 21,078 $ 21,780 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by regulatory authorities. Inventories as of March 31, 2023 and December 31, 2022 consist of the following: In thousands March 31, 2023 December 31, 2022 Raw materials $ 127,025 $ 126,391 Work in process 7,085 52,297 Finished goods 235,433 213,664 Total inventory (1) $ 369,543 $ 392,352 (1) Total inventory consists of both current inventory and long-term inventory. During the three months ended March 31, 2023, approximately $ 2.3 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory. |
Equity (Tables)
Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summarizes the Aggregate Number of Stock Options And Restricted Stock Unit | The following table summarizes the aggregate number of stock options and restricted stock units, or RSUs, outstanding under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, as of March 31, 2023: March 31, 2023 Outstanding stock options 19,638,850 % of outstanding shares on a fully-diluted basis 4 % Outstanding RSUs 18,203,692 % of outstanding shares on a fully-diluted basis 4 % |
Summary of Equity Awards Activity | The following table represents equity awards activity during the three months ended March 31, 2023 and 2022: Three months ended March 31, 2023 2022 Common shares issued for stock option exercises 1,232,263 10,602 Gross and net proceeds from stock option exercises $ 1,871,758 $ 30,000 Common shares issued in settlement of vested RSUs 2,270,674 493,381 Shares retained for settlement of employee tax obligations ─ RSUs 716,438 161,083 Common shares issued in settlement of vested Performance-based RSUs (1) 244,274 — Shares retained for settlement of employee tax obligations ─ Performance-based RSUs 111,085 — Performance-based RSUs vested in connection with the achievement of certain sales performance conditions on February 21, 2023. These performance-based RSUs will vest over a three-year period based on continuous service from the grant date. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summarize Activity of the Net Product Revenue Allowance and Reserve Categories | The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the three months ended March 31, 2023 and 2022: In thousands Trade Rebates, Product Other Total Balance as of December 31, 2022 $ 44,626 $ 136,093 $ 8,746 $ 2,056 $ 191,521 Provision related to current period sales 22,313 162,858 532 5,008 190,711 Provision related to prior period sales — ( 5,589 ) — 107 ( 5,482 ) Credits/payments made for current period sales ( 11,534 ) ( 105,542 ) — ( 3,925 ) ( 121,001 ) Credits/payments made for prior period sales ( 36,485 ) ( 51,460 ) ( 577 ) ( 839 ) ( 89,361 ) Balance as of March 31, 2023 $ 18,920 $ 136,360 $ 8,701 $ 2,407 $ 166,388 In thousands Trade Rebates, Product Other Total Balance as of December 31, 2021 $ 86,636 $ 184,756 $ 8,089 $ 2,745 $ 282,226 Provision related to current period sales 22,697 148,203 549 8,325 179,774 Provision related to prior period sales — ( 301 ) — — ( 301 ) Credits/payments made for current period sales ( 2,753 ) ( 67,700 ) — ( 6,379 ) ( 76,832 ) Credits/payments made for prior period sales ( 13,536 ) ( 123,099 ) ( 350 ) ( 2,630 ) ( 139,615 ) Balance as of March 31, 2022 $ 93,044 $ 141,859 $ 8,288 $ 2,061 $ 245,252 |
Development, Commercializatio_2
Development, Commercialization and Supply Agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Product Approval | 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 — Bahrain April 2021 April 2022 — Kuwait December 2021 March 2023 — Saudi Arabia March 2022 — — |
Changes in Balances of Contract Assets and Liabilities and Revenues Recognized | The following table presents changes in the balances of the Company’s contract assets and liabilities during the three months ended March 31, 2023 and 2022: In thousands Balance at Additions Deductions Balance at Three months ended March 31, 2023: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 15,346 $ — $ ( 445 ) $ 14,901 Three months ended March 31, 2022: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 16,709 $ — $ ( 372 ) $ 16,337 During the three months ended March 31, 2023 and 2022, 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 Three months ended March 31, Revenue recognized in the period from: 2023 2022 Amounts included in contract liability at the beginning of the period $ 445 $ 372 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Maturity Analysis of Undiscounted Payments for Operating Lease Liabilities and Reconciliation with Carrying Amount of Lease Liability | 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 March 31, 2023: Undiscounted Remainder of 2023 $ 2,284 2024 2,827 2025 2,136 2026 2,135 2027 1,962 2028 and thereafter 5,251 Total undiscounted payments $ 16,595 Discount Adjustments $ ( 4,945 ) Current operating lease liability $ 1,809 Long-term operating lease liability $ 9,841 |
Summary of Components of Lease Income | The components of lease income are as follows: For the Three Months Ended March 31, 2023 Interest income from sales-type leases $ 11 Operating lease income 166 Loss recognized at commencement date of sales type lease ( 61 ) Total $ 116 |
Summary of Future Minimum Sales Type Lease and Operating Lease Receivables | Future minimum sales type lease and operating lease receivables as of March 31, 2023 are as follows: Sales-Type Leases Operating Leases Remainder of 2023 $ 48 $ 411 2024 117 1,006 2025 119 1,029 2026 122 1,051 2027 125 1,073 2028 and thereafter 345 2,974 Total $ 876 $ 7,544 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of operating segments | Segment | 1 | |
Total assets | $ 860,188,000 | $ 886,179,000 |
Cash and liquid short-term and long-term investments | 304,900,000 | |
Total current assets | 683,821,000 | 689,098,000 |
Cash and cash equivalents | 191,412,000 | 217,666,000 |
Short-term investments | 112,959,000 | 91,695,000 |
Accounts receivable, net | 133,236,000 | 130,990,000 |
Inventory | 225,813,000 | 228,732,000 |
Long-term investments | 544,000 | 1,275,000 |
Long-term inventory | 143,730,000 | $ 163,620,000 |
Debt outstanding | $ 0 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 USD ($) Customer Segment | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Jun. 06, 2022 Sales | Sep. 22, 2021 Sales | |
Significant Accounting Policies [Line Items] | |||||
Trade receivables, credit period | 45 days | ||||
Maturities period | 24 months | ||||
Unrealized gain (loss) on held-to-maturity securities | $ 200 | $ 900 | |||
Number of operating segments | Segment | 1 | ||||
Number of sales representatives | Sales | 75 | 300 | |||
Cash expenditures | $ 2,123 | $ 192 | |||
Charges of recognized within Cost of goods sold restructuring inventory | 12,254 | ||||
Comprehensive Cost Reduction Plan [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Charges of recognized within Cost of goods sold restructuring inventory | $ 12,300 | ||||
Food and Drug Administration | Discontinued of Business Operations | Germany | |||||
Significant Accounting Policies [Line Items] | |||||
Restructuring and transformation initiative expense | $ 4,200 | ||||
Short Term Investments | |||||
Significant Accounting Policies [Line Items] | |||||
Maturities period | 12 months | ||||
Long Term Investments | |||||
Significant Accounting Policies [Line Items] | |||||
Maturities period | 12 months | ||||
Money Market Instruments | |||||
Significant Accounting Policies [Line Items] | |||||
Maturities period | 90 days | ||||
Gross Product Sales | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Number of customers | Customer | 3 | ||||
Customer A | Gross Product Sales | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 29% | 21% | |||
Customer A | Accounts Receivable | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 36% | 29% | |||
Customer B | Gross Product Sales | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 38% | 39% | |||
Customer B | Accounts Receivable | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 40% | 37% | |||
Customer C | Gross Product Sales | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 27% | 31% | |||
Customer C | Accounts Receivable | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk percentage | 20% | 28% | |||
Earliest Tax Year | Internal Revenue Service (IRS) | |||||
Significant Accounting Policies [Line Items] | |||||
Open tax year | 2018 | ||||
Earliest Tax Year | New Jersey Department of Treasury | |||||
Significant Accounting Policies [Line Items] | |||||
Open tax year | 2012 | ||||
Latest Tax Year | Internal Revenue Service (IRS) | |||||
Significant Accounting Policies [Line Items] | |||||
Open tax year | 2019 | ||||
Latest Tax Year | New Jersey Department of Treasury | |||||
Significant Accounting Policies [Line Items] | |||||
Open tax year | 2015 |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable Balances (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Gross trade accounts receivable | $ 164,010 | $ 187,418 |
Accounts receivable, net | 133,236 | 130,990 |
Trade Allowances | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Valuation allowances and reserves | (18,920) | (44,626) |
Chargebacks | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Valuation allowances and reserves | $ (11,854) | $ (11,802) |
Significant Accounting Polici_6
Significant Accounting Policies - Calculation of Net Loss and Number of Shares Used to Compute Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Loss Earnings Per Share [Line Items] | ||
Net loss-basic and diluted | $ (16,460) | $ (31,563) |
Weighted average shares outstanding-basic | 406,177 | 397,805 |
Weighted average shares outstanding-diluted | 406,177 | 397,805 |
Net loss per share-basic | $ (0.04) | $ (0.08) |
Net loss per share-diluted | $ (0.04) | $ (0.08) |
Significant Accounting Polici_7
Significant Accounting Policies - Anti-Dilutive Securities Not Included in the Computation of Net Loss per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 19,639 | 19,639 |
Restricted Stock and Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 18,568 | 15,369 |
Laxdale Milestone Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,984 |
Significant Accounting Polici_8
Significant Accounting Policies - Estimated Fair Value of Assets and Liability (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Asset: | ||
Asset, fair value | $ 196,417 | $ 192,307 |
Agency Securities | ||
Asset: | ||
Asset, fair value | 3,999 | 1,554 |
Money Market Fund | ||
Asset: | ||
Asset, fair value | 80,105 | 81,870 |
U.S. Treasury Securities | ||
Asset: | ||
Asset, fair value | 3,153 | 3,117 |
Corporate Bonds | ||
Asset: | ||
Asset, fair value | 16,035 | 28,416 |
Commercial Paper | ||
Asset: | ||
Asset, fair value | 79,440 | 62,347 |
Repo Securities | ||
Asset: | ||
Asset, fair value | 3,250 | 3,250 |
Asset Backed Securities | ||
Asset: | ||
Asset, fair value | 546 | 1,260 |
Certificates of Deposit | ||
Asset: | ||
Asset, fair value | 8,490 | 9,100 |
Non-US Government | ||
Asset: | ||
Asset, fair value | 1,399 | 1,393 |
Level 1 | ||
Asset: | ||
Asset, fair value | 87,257 | 86,541 |
Level 1 | Agency Securities | ||
Asset: | ||
Asset, fair value | 3,999 | 1,554 |
Level 1 | Money Market Fund | ||
Asset: | ||
Asset, fair value | 80,105 | 81,870 |
Level 1 | U.S. Treasury Securities | ||
Asset: | ||
Asset, fair value | 3,153 | 3,117 |
Level 2 | ||
Asset: | ||
Asset, fair value | 109,160 | 105,766 |
Level 2 | Corporate Bonds | ||
Asset: | ||
Asset, fair value | 16,035 | 28,416 |
Level 2 | Commercial Paper | ||
Asset: | ||
Asset, fair value | 79,440 | 62,347 |
Level 2 | Repo Securities | ||
Asset: | ||
Asset, fair value | 3,250 | 3,250 |
Level 2 | Asset Backed Securities | ||
Asset: | ||
Asset, fair value | 546 | 1,260 |
Level 2 | Certificates of Deposit | ||
Asset: | ||
Asset, fair value | 8,490 | 9,100 |
Level 2 | Non-US Government | ||
Asset: | ||
Asset, fair value | $ 1,399 | $ 1,393 |
Significant Accounting Polici_9
Significant Accounting Policies - Change in Restructuring Liability Associated with the Plan (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Restructuring Reserve [Roll Forward] | |
Balance at December 31, 2022 | $ 192 |
Costs incurred | 12,254 |
Payments | (10,323) |
Balance at March 31, 2023 | $ 2,123 |
Intangible Asset - Additional I
Intangible Asset - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible asset estimated weighted- average remaining life | 7 years 9 months 18 days |
Intangible Asset - Schedule of
Intangible Asset - Schedule of Carrying Value of Intangible Asset (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Technology rights | $ 32,859 | $ 32,859 |
Accumulated amortization | (11,781) | (11,079) |
Intangible asset, net | $ 21,078 | $ 21,780 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 127,025 | $ 126,391 | |
Work in process | 7,085 | 52,297 | |
Finished goods | 235,433 | 213,664 | |
Total inventory | [1] | $ 369,543 | $ 392,352 |
[1] During the three months ended March 31, 2023, approximately $ 2.3 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventory (Parenthetical) (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Inventory Disclosure [Abstract] | |
Inventory deemed not saleable | $ 2.3 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Long-term inventory | $ 143,730 | $ 163,620 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - Mar. 31, 2023 $ in Millions | USD ($) | GBP (£) |
Commitments And Contingencies Disclosure [Line Items] | ||
Future contractual purchase obligations without consideration | $ 81.7 | |
Regulatory Approval in Europe | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Additional future contractual purchase obligations without consideration | 39.8 | |
Further Indication for AMR101 | Potential Marketing Approval 1 | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Aggregate stock or cash payment upon potential market approval | 5.5 | £ 5,000,000 |
Further Indication for AMR101 | Potential Marketing Approval 2 | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Aggregate stock or cash payment upon potential market approval | $ 5.5 | £ 5,000,000 |
Equity - Common Stock - Additio
Equity - Common Stock - Additional Information (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Common Shares | ||
Stockholders Equity Note [Line Items] | ||
Common stock activity during period | 0 | 0 |
Equity - Incentive Equity Award
Equity - Incentive Equity Awards - Summarizes the Aggregate Number of Stock Options And Restricted Stock Unit (Details) - Stock Incentive Plan 2020 | Mar. 31, 2023 shares |
Stock Options | |
Stockholders Equity Note [Line Items] | |
Outstanding Stock Options | 19,638,850 |
% of Outstanding Shares | 4% |
Restricted Stock Units (RSUs) | |
Stockholders Equity Note [Line Items] | |
% of Outstanding Shares | 4% |
Outstanding RSUs | 18,203,692 |
Equity - Incentive Equity Awa_2
Equity - Incentive Equity Awards - Summary of Equity Awards Activity (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Stockholders Equity Note [Line Items] | |||
Stock Options Issued | 1,232,263 | 10,602 | |
Gross Proceeds | $ 1,871,758 | $ 30,000 | |
Restricted Stock Units (RSUs) | |||
Stockholders Equity Note [Line Items] | |||
Common Shares Issued in settlement of RSUs and Performance based RSUs Vested | 2,270,674 | 493,381 | |
Shares retained for settlement of employee tax obligations | 716,438 | 161,083 | |
Performance-Based RSUs | |||
Stockholders Equity Note [Line Items] | |||
Common Shares Issued in settlement of RSUs and Performance based RSUs Vested | [1] | 244,274 | |
Shares retained for settlement of employee tax obligations | 111,085 | ||
[1] Performance-based RSUs vested in connection with the achievement of certain sales performance conditions on February 21, 2023. These performance-based RSUs will vest over a three-year period based on continuous service from the grant date. |
Equity - Incentive Equity Awa_3
Equity - Incentive Equity Awards - Additional Information (Detail) - Stock Incentive Plan 2020 - shares | 1 Months Ended | ||
Feb. 28, 2023 | Feb. 28, 2022 | Jan. 31, 2022 | |
Restricted Stock Units (RSUs) | |||
Stockholders Equity Note [Line Items] | |||
Stock units, Granted | 81,082 | ||
Stock units, Vesting Period | 3 years | ||
Restricted Stock Units (RSUs) | Employees | |||
Stockholders Equity Note [Line Items] | |||
Stock units, Granted | 7,775,850 | 5,987,500 | |
Stock units, Vesting Period | 3 years | 3 years | |
Stock Options | |||
Stockholders Equity Note [Line Items] | |||
Stock options, Granted | 103,569 | ||
Stock units, Vesting Period | 1 year | ||
Stock Options | Employees | |||
Stockholders Equity Note [Line Items] | |||
Stock options, Granted | 4,297,500 | 1,976,600 | |
Stock units, Vesting Period | 4 years | 4 years | |
Stock units, Cliff Vesting Period | 1 year | 1 year | |
Performance-Based RSUs | Employees | |||
Stockholders Equity Note [Line Items] | |||
Stock units, Granted | 1,368,800 | 1,089,500 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 | |
Disaggregation Of Revenue [Line Items] | |
Payment period from distributors received from date of sale | 45 days |
Effect of significant financing component when transfer and customer payment of good or service occurs within one year or less | true |
VASCEPA 1-Gram | |
Disaggregation Of Revenue [Line Items] | |
Product expiration date after being converted into capsule form | 4 years |
VASCEPA 0.5-Gram | |
Disaggregation Of Revenue [Line Items] | |
Product expiration date after being converted into capsule form | 3 years |
Minimum | |
Disaggregation Of Revenue [Line Items] | |
Payment period from distributors received from date of sale | 30 days |
Sales discount percentage | 2% |
Maximum | |
Disaggregation Of Revenue [Line Items] | |
Payment period from distributors received from date of sale | 60 days |
Sales discount percentage | 3% |
Revenue Recognition - Summarize
Revenue Recognition - Summarize Activity of the Net Product Revenue Allowance and Reserve Categories (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ 191,521 | $ 282,226 |
Provision related to current period sales | 190,711 | 179,774 |
Provision related to prior period sales | (5,482) | (301) |
Credits/payments made for current period sales | (121,001) | (76,832) |
Credits/payments made for prior period sales | (89,361) | (139,615) |
Ending balance | 166,388 | 245,252 |
Trade Allowances | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 44,626 | 86,636 |
Provision related to current period sales | 22,313 | 22,697 |
Credits/payments made for current period sales | (11,534) | (2,753) |
Credits/payments made for prior period sales | (36,485) | (13,536) |
Ending balance | 18,920 | 93,044 |
Rebates, Chargebacks and Discounts | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 136,093 | 184,756 |
Provision related to current period sales | 162,858 | 148,203 |
Provision related to prior period sales | (5,589) | (301) |
Credits/payments made for current period sales | (105,542) | (67,700) |
Credits/payments made for prior period sales | (51,460) | (123,099) |
Ending balance | 136,360 | 141,859 |
Product Returns | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 8,746 | 8,089 |
Provision related to current period sales | 532 | 549 |
Credits/payments made for prior period sales | (577) | (350) |
Ending balance | 8,701 | 8,288 |
Other Incentives | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 2,056 | 2,745 |
Provision related to current period sales | 5,008 | 8,325 |
Provision related to prior period sales | 107 | |
Credits/payments made for current period sales | (3,925) | (6,379) |
Credits/payments made for prior period sales | (839) | (2,630) |
Ending balance | $ 2,407 | $ 2,061 |
Development, Commercializatio_3
Development, Commercialization and Supply Agreement - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||
Feb. 28, 2023 USD ($) | Jan. 31, 2023 USD ($) | Jan. 31, 2022 USD ($) | Feb. 29, 2020 USD ($) | Jan. 31, 2020 USD ($) | Sep. 30, 2018 USD ($) | Sep. 30, 2017 USD ($) | Mar. 31, 2016 USD ($) | Feb. 28, 2015 USD ($) | Mar. 31, 2023 USD ($) Item | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2018 USD ($) | Dec. 31, 2021 USD ($) | |
License And Collaboration Agreements [Line Items] | ||||||||||||||
Revenue recognized related to upfront and milestone payments | $ 445,000 | $ 372,000 | ||||||||||||
Licenses revenue | 85,975,000 | 94,630,000 | ||||||||||||
Deferred revenue | 14,901,000 | 16,337,000 | $ 15,346,000 | $ 16,709,000 | ||||||||||
Product Revenue, Net | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 84,654,000 | 93,986,000 | ||||||||||||
CSL Seqirus | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable up-front received | $ 500,000 | |||||||||||||
Licenses revenue | $ 500,000 | 0 | ||||||||||||
Upfront payment receivable | 500,000 | |||||||||||||
Event-related milestone payments receivable | 8,000,000 | |||||||||||||
Additional product-related milestone payments receivable | $ 4,000,000 | |||||||||||||
Mochida | In-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Milestones payment | $ 1,000,000 | $ 1,000,000 | ||||||||||||
Mochida | In-licenses | Research and Development Expense | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Upfront payment | $ 2,700,000 | |||||||||||||
Edding | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable up-front received | $ 15,000,000 | |||||||||||||
Number of indications of the regulatory milestone events relating to the submission and approval | Item | 3 | |||||||||||||
Amounts to be received upon achievement of the regulatory milestone events | $ 33,000,000 | |||||||||||||
Sales-based milestone event payment | 120,000,000 | |||||||||||||
Revenue recognized related to upfront and milestone payments | 300,000 | 200,000 | ||||||||||||
Deferred revenue | 9,000,000 | 9,300,000 | ||||||||||||
Edding | Out-licenses | Licensing Revenue | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 8,000,000 | 7,700,000 | ||||||||||||
Edding | Out-licenses | Maximum | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Additional upfront payment eligible to receive based on development, regulatory and sales Milestone | 153,000,000 | |||||||||||||
Amounts to be received upon achievement of the regulatory milestone events | 15,000,000 | |||||||||||||
Sales-based milestone event payment | 50,000,000 | |||||||||||||
Edding | Out-licenses | Minimum | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Amounts to be received upon achievement of the regulatory milestone events | 2,000,000 | |||||||||||||
Sales-based milestone event payment | 5,000,000 | |||||||||||||
Edding | Out-licenses | Clinical Trial Application | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable milestone payment received | $ 1,000,000 | |||||||||||||
Biologix FZCo | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Revenue recognition period of non-refundable up-front payment | 10 years | |||||||||||||
Biologix FZCo | Out-licenses | Product Revenue, Net | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 300,000 | 0 | ||||||||||||
HLS | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable up-front received | $ 5,000,000 | |||||||||||||
Non-refundable milestone payment received | $ 2,500,000 | $ 3,800,000 | $ 2,500,000 | |||||||||||
Revenue recognized related to upfront and milestone payments | 100,000 | 100,000 | ||||||||||||
Deferred revenue | 5,400,000 | 5,600,000 | ||||||||||||
Non-refundable up-front received period | 6 months | |||||||||||||
Non-refundable milestone payment received | $ 3,800,000 | |||||||||||||
HLS | Out-licenses | Health Canada | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable milestone payment received | 2,500,000 | |||||||||||||
HLS | Out-licenses | Licensing Revenue | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 8,300,000 | $ 8,200,000 | ||||||||||||
HLS | Out-licenses | Product Revenue, Net | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | $ 1,600,000 | $ 0 | ||||||||||||
HLS | Out-licenses | Maximum | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Additional upfront payment eligible to receive based on development, regulatory and sales Milestone | 50,000,000 | |||||||||||||
HLS | Out-licenses | Achievement of REDUCE-IT Trial | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable milestone payment received | $ 2,500,000 |
Development, Commercializatio_4
Development, Commercialization and Supply Agreement - Additional Information (Detail 1) - Out-licenses - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2023-04-01 | Mar. 31, 2023 |
Edding | |
License And Collaboration Agreements [Line Items] | |
Revenue recognized over remaining period | 11 years |
HLS | |
License And Collaboration Agreements [Line Items] | |
Revenue recognized over remaining period | 7 years |
Development, Commercializatio_5
Development, Commercialization and Supply Agreements - Summary of Product Approval (Details) - Out-licenses - Biologix [Member] - VASCEPA [Member] | 3 Months Ended |
Mar. 31, 2023 | |
Lebanon | |
License And Collaboration Agreements [Line Items] | |
Launch Date | 2018-06 |
United Arab Emirates | |
License And Collaboration Agreements [Line Items] | |
Launch Date | 2019-02 |
Marine [Member] | Lebanon | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2018-03 |
Marine [Member] | United Arab Emirates | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2018-07 |
Marine [Member] | Qatar | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2019-12 |
Marine [Member] | Bahrain | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2021-04 |
Marine [Member] | Kuwait | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2021-12 |
Marine [Member] | Saudi Arabia | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2022-03 |
Reduce IT [Member] | Lebanon | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2021-08 |
Reduce IT [Member] | United Arab Emirates | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2021-10 |
Reduce IT [Member] | Qatar | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2021-04 |
Reduce IT [Member] | Bahrain | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2022-04 |
Reduce IT [Member] | Kuwait | |
License And Collaboration Agreements [Line Items] | |
Approval Date | 2023-03 |
Development, Commercializatio_6
Development, Commercialization and Supply Agreement - Changes in Balances of Contract Assets and Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Contract liabilities: | ||
Deferred revenue, Balance at Beginning of Period | $ 15,346 | $ 16,709 |
Deferred revenue, Deductions | (445) | (372) |
Deferred revenue, Balance at End of Period | $ 14,901 | $ 16,337 |
Development, Commercializatio_7
Development, Commercialization and Supply Agreement - Recognized Revenues Changes in Contract Asset and Contract Liability Balances (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue recognized in the period from: | ||
Amounts included in contract liability at the beginning of the period | $ 445 | $ 372 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | |||||||
Feb. 01, 2023 USD ($) | Oct. 01, 2022 USD ($) | Feb. 01, 2022 USD ($) RenewalOption | Aug. 15, 2019 USD ($) RenewalOption | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Jan. 20, 2023 ft² | Dec. 31, 2022 USD ($) | |
Lessee Lease Description [Line Items] | ||||||||
Incremental borrowing rate for purposes of calculation of lease liabilities | 11.50% | |||||||
Change in incremental borrowing rate | 1% | |||||||
Rent payment | $ 16,595 | |||||||
Operating lease liability | 11,700 | $ 11,600 | ||||||
Operating lease right-of-use asset | 9,190 | $ 9,074 | ||||||
Operating lease expense | 900 | $ 600 | ||||||
Receive rent payment | $ 7,544 | |||||||
Bridgewater | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease commencement date | Aug. 15, 2019 | |||||||
Lease agreement term | 7 years 6 months | 11 years | ||||||
Number of renewal options | RenewalOption | 2 | |||||||
Lease renewal term | 5 years | |||||||
Description of lease agreement | Company will have a one-time option to terminate the agreement effective on the first day of the 97th month after the New Jersey Commencement Date upon advance written notice and a termination payment specified in the Lease. | |||||||
Lease termination description | one-time option to terminate the agreement effective on the first day of the 97th month after the New Jersey Commencement Date | |||||||
Lease termination existence of option to extend | true | |||||||
Rent payment | $ 100 | |||||||
Lease agreement area | ft² | 67,747 | |||||||
Area under sub-lease agreement | ft² | 50,000 | |||||||
Sublease commencement date | Feb. 01, 2023 | |||||||
Receive rent payment | $ 100 | |||||||
Zug Switzerland | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease commencement date | Feb. 01, 2022 | |||||||
Lease agreement term | 5 years | |||||||
Number of renewal options | RenewalOption | 1 | |||||||
Lease renewal term | 5 years | |||||||
Rent payment | $ 200 | |||||||
Dublin | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease commencement date | Oct. 01, 2022 | |||||||
Lease agreement term | 2 years | |||||||
Rent payment | $ 400 | |||||||
Maximum | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Short term lease period | 12 months | |||||||
Maximum | Vehicles | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement term | 36 months |
Leases - Maturity Analysis of U
Leases - Maturity Analysis of Undiscounted Payments for Operating Lease Liabilities and Reconciliation with Carrying Amount of Lease Liability (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Undiscounted lease payments | ||
Remainder of 2023 | $ 2,284 | |
2024 | 2,827 | |
2025 | 2,136 | |
2026 | 2,135 | |
2027 | 1,962 | |
2028 and thereafter | 5,251 | |
Total undiscounted payments | 16,595 | |
Discount Adjustments | (4,945) | |
Current operating lease liability | $ 1,809 | |
Operating lease, liability, current, statement of financial position [Extensible List] | Accrued expenses and other current liabilities | |
Long-term operating lease liability | $ 9,841 | $ 10,015 |
Leases - Summary of Components
Leases - Summary of Components of Lease Income (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Lessor, Lease, Description [Line Items] | |
Interest income from sales type leases | $ 11 |
Operating lease income | 166 |
Loss recognized at commencement date of sales type lease | (61) |
Lease income | $ 116 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Sales Type Lease and Operating Lease Receivables (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Lessor, Lease, Description [Line Items] | |
Sales-Type Leases, Remainder of 2023 | $ 48 |
Sales-Type Leases, 2024 | 117 |
Sales-Type Leases, 2025 | 119 |
Sales-Type Leases, 2026 | 122 |
Sales-Type Leases, 2027 | 125 |
Sales-Type Leases, 2028 and thereafter | 345 |
Sales-Type Leases, Total | 876 |
Operating Leases. Remainder of 2023 | 411 |
Operating Leases, 2024 | 1,006 |
Operating Leases, 2025 | 1,029 |
Operating Leases, 2026 | 1,051 |
Operating Leases, 2027 | 1,073 |
Operating Leases, 2028 and thereafter | 2,974 |
Operating Leases, Total | $ 7,544 |