Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 01, 2019 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
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 | 77 Sir John Rogerson’s Quay | |
Entity Address, Address Line Two | Block C | |
Entity Address, Address Line Three | Grand Canal Docklands | |
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 of Amarin Corporation plc | |
Name of each exchange on which registered | NASDAQ | |
American Depositary Shares | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 358,703,359 | |
Ordinary Shares | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 203,528 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 673,207 | $ 249,227 |
Restricted cash | 3,904 | 1,500 |
Accounts receivable, net | 103,583 | 66,523 |
Inventory | 54,557 | 57,802 |
Prepaid and other current assets | 12,859 | 2,945 |
Total current assets | 848,110 | 377,997 |
Property, plant and equipment, net | 2,124 | 63 |
Operating lease right-of-use asset | 8,633 | |
Other long-term assets | 1,074 | 174 |
Intangible asset, net | 6,996 | 7,480 |
TOTAL ASSETS | 866,937 | 385,714 |
Current Liabilities: | ||
Accounts payable | 42,042 | 37,632 |
Accrued expenses and other current liabilities | 134,542 | 84,171 |
Current portion of long-term debt from royalty-bearing instrument | 51,166 | 34,240 |
Deferred revenue, current | 1,962 | 1,220 |
Total current liabilities | 229,712 | 157,263 |
Long-Term Liabilities: | ||
Long-term debt from royalty-bearing instrument | 8,878 | 46,108 |
Deferred revenue, long-term | 17,617 | 19,490 |
Long-term operating lease liability | 9,432 | |
Other long-term liabilities | 5,402 | 10,523 |
Total liabilities | 271,041 | 233,384 |
Commitments and contingencies (Note 6) | ||
Stockholders’ Equity: | ||
Series A Convertible Preferred Stock, £0.05 par, unlimited authorized; 289,317,460 shares issued and outstanding as of September 30, 2019 and December 31, 2018 (equivalent to 28,931,746 ordinary shares upon future consolidation and redesignation at a 10:1 ratio) | 21,850 | 21,850 |
Common stock, £0.50 par, unlimited authorized; 361,368,945 issued, 357,527,330 outstanding as of September 30, 2019; 329,110,863 issued, 325,850,013 outstanding as of December 31, 2018 | 266,878 | 246,663 |
Additional paid-in capital | 1,745,946 | 1,282,762 |
Treasury stock; 3,841,615 shares as of September 30, 2019; 3,260,850 shares as of December 31, 2018 | (20,533) | (10,413) |
Accumulated deficit | (1,418,245) | (1,388,532) |
Total stockholders’ equity | 595,896 | 152,330 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 866,937 | $ 385,714 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - £ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | £ 0.05 | £ 0.05 |
Preferred stock, shares authorized, unlimited | Unlimited | Unlimited |
Preferred stock, issued | 289,317,460 | 289,317,460 |
Preferred stock, shares outstanding | 289,317,460 | 289,317,460 |
Preferred stock, equivalent ordinary shares upon future consolidation outstanding | 28,931,746 | 28,931,746 |
Common stock, par value | £ 0.50 | £ 0.50 |
Common stock, shares authorized, unlimited | Unlimited | Unlimited |
Common stock, issued | 361,368,945 | 329,110,863 |
Common stock, outstanding | 357,527,330 | 325,850,013 |
Treasury stock, shares | 3,841,615 | 3,260,850 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Total revenue, net | $ 112,408 | $ 55,323 | $ 286,478 | $ 151,884 |
Less: Cost of goods sold | 25,444 | 13,541 | 65,354 | 37,035 |
Gross margin | 86,964 | 41,782 | 221,124 | 114,849 |
Operating expenses: | ||||
Selling, general and administrative | 82,559 | 49,960 | 227,598 | 147,310 |
Research and development | 8,923 | 14,072 | 23,295 | 43,993 |
Total operating expenses | 91,482 | 64,032 | 250,893 | 191,303 |
Operating loss | (4,518) | (22,250) | (29,769) | (76,454) |
Interest income (expense), net | 1,146 | (2,163) | 238 | (6,188) |
Other expense, net | (90) | (58) | (182) | (134) |
Loss from operations before taxes | (3,462) | (24,471) | (29,713) | (82,776) |
Net loss | $ (3,462) | $ (24,471) | $ (29,713) | $ (82,776) |
Loss per share: | ||||
Basic | $ (0.01) | $ (0.08) | $ (0.09) | $ (0.28) |
Diluted | $ (0.01) | $ (0.08) | $ (0.09) | $ (0.28) |
Weighted average shares: | ||||
Basic | 350,994 | 295,595 | 336,938 | 291,526 |
Diluted | 350,994 | 295,595 | 336,938 | 291,526 |
Product Revenue, Net | ||||
Total revenue, net | $ 112,250 | $ 54,973 | $ 285,347 | $ 151,286 |
Licensing Revenue | ||||
Total revenue, net | $ 158 | $ 350 | $ 1,131 | $ 598 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Preferred Shares | Common Shares | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2017 | $ (65,100) | $ 24,364 | $ 208,768 | $ (4,229) | $ 977,866 | $ (1,271,869) |
Balance (in shares) at Dec. 31, 2017 | 328,184,640 | 272,719,044 | (1,697,033) | |||
Balance (Cumulative-effect adjustment) | Accounting Standards Update 2014-09 | (218) | (218) | ||||
Balance at Jan. 01, 2018 | (65,318) | $ 24,364 | $ 208,768 | $ (4,229) | 977,866 | (1,272,087) |
Balance (in shares) at Jan. 01, 2018 | 328,184,640 | 272,719,044 | (1,697,033) | |||
Balance at Dec. 31, 2017 | (65,100) | $ 24,364 | $ 208,768 | $ (4,229) | 977,866 | (1,271,869) |
Balance (in shares) at Dec. 31, 2017 | 328,184,640 | 272,719,044 | (1,697,033) | |||
Issuance of common stock, net of transaction costs | 70,007 | $ 14,635 | 55,372 | |||
Issuance of common stock, net of transaction costs (shares) | 20,616,438 | |||||
Exercise of stock options | 1,548 | $ 541 | 1,007 | |||
Exercise of stock options (in shares) | 782,553 | |||||
Vesting of restricted stock units | (2,553) | $ 1,302 | $ (2,553) | (1,302) | ||
Vesting of restricted stock units (in shares) | 1,838,380 | (675,242) | ||||
Stock-based compensation | 3,754 | 3,754 | ||||
Loss for the period | (24,095) | (24,095) | ||||
Balance at Mar. 31, 2018 | (16,657) | $ 24,364 | $ 225,246 | $ (6,782) | 1,036,697 | (1,296,182) |
Balance (in shares) at Mar. 31, 2018 | 328,184,640 | 295,956,415 | (2,372,275) | |||
Balance at Dec. 31, 2017 | $ (65,100) | $ 24,364 | $ 208,768 | $ (4,229) | 977,866 | (1,271,869) |
Balance (in shares) at Dec. 31, 2017 | 328,184,640 | 272,719,044 | (1,697,033) | |||
Exercise of stock options (in shares) | 5,439,239 | |||||
Loss for the period | $ (82,776) | |||||
Balance at Sep. 30, 2018 | (52,826) | $ 21,850 | $ 232,646 | $ (9,867) | 1,057,408 | (1,354,863) |
Balance (in shares) at Sep. 30, 2018 | 289,317,460 | 307,309,316 | (3,219,598) | |||
Balance at Dec. 31, 2017 | (65,100) | $ 24,364 | $ 208,768 | $ (4,229) | 977,866 | (1,271,869) |
Balance (in shares) at Dec. 31, 2017 | 328,184,640 | 272,719,044 | (1,697,033) | |||
Balance at Dec. 31, 2018 | 152,330 | $ 21,850 | $ 246,663 | $ (10,413) | 1,282,762 | (1,388,532) |
Balance (in shares) at Dec. 31, 2018 | 289,317,460 | 329,110,863 | (3,260,850) | |||
Balance at Mar. 31, 2018 | (16,657) | $ 24,364 | $ 225,246 | $ (6,782) | 1,036,697 | (1,296,182) |
Balance (in shares) at Mar. 31, 2018 | 328,184,640 | 295,956,415 | (2,372,275) | |||
Issuance of common stock under employee stock purchase plan | 423 | $ 85 | 338 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 127,872 | |||||
Exercise of stock options | 278 | $ 116 | 162 | |||
Exercise of stock options (in shares) | 173,679 | |||||
Vesting of restricted stock units | (127) | $ 60 | $ (127) | (60) | ||
Vesting of restricted stock units (in shares) | 90,937 | (41,252) | ||||
Stock-based compensation | 3,606 | 3,606 | ||||
Loss for the period | (34,210) | (34,210) | ||||
Balance at Jun. 30, 2018 | (46,687) | $ 24,364 | $ 225,507 | $ (6,909) | 1,040,743 | (1,330,392) |
Balance (in shares) at Jun. 30, 2018 | 328,184,640 | 296,348,903 | (2,413,527) | |||
Conversion of Series A Convertible Preferred Stock, net | (39) | $ (2,514) | $ 2,514 | (39) | ||
Conversion of Series A Convertible Preferred Stock, net (in shares) | (38,867,180) | 3,886,718 | ||||
Exercise of stock options | 14,668 | $ 2,932 | 11,736 | |||
Exercise of stock options (in shares) | 4,483,007 | |||||
Vesting of restricted stock units | (2,958) | $ 1,693 | $ (2,958) | (1,693) | ||
Vesting of restricted stock units (in shares) | 2,590,688 | (806,071) | ||||
Stock-based compensation | 6,661 | 6,661 | ||||
Loss for the period | (24,471) | (24,471) | ||||
Balance at Sep. 30, 2018 | (52,826) | $ 21,850 | $ 232,646 | $ (9,867) | 1,057,408 | (1,354,863) |
Balance (in shares) at Sep. 30, 2018 | 289,317,460 | 307,309,316 | (3,219,598) | |||
Balance at Dec. 31, 2018 | 152,330 | $ 21,850 | $ 246,663 | $ (10,413) | 1,282,762 | (1,388,532) |
Balance (in shares) at Dec. 31, 2018 | 289,317,460 | 329,110,863 | (3,260,850) | |||
Exercise of stock options | 15,456 | $ 2,496 | 12,960 | |||
Exercise of stock options (in shares) | 3,838,739 | |||||
Vesting of restricted stock units | (9,080) | $ 929 | $ (9,080) | (929) | ||
Vesting of restricted stock units (in shares) | 1,416,124 | (526,708) | ||||
Stock-based compensation | 6,596 | 6,596 | ||||
Loss for the period | (24,431) | (24,431) | ||||
Balance at Mar. 31, 2019 | 140,871 | $ 21,850 | $ 250,088 | $ (19,493) | 1,301,389 | (1,412,963) |
Balance (in shares) at Mar. 31, 2019 | 289,317,460 | 334,365,726 | (3,787,558) | |||
Balance at Dec. 31, 2018 | $ 152,330 | $ 21,850 | $ 246,663 | $ (10,413) | 1,282,762 | (1,388,532) |
Balance (in shares) at Dec. 31, 2018 | 289,317,460 | 329,110,863 | (3,260,850) | |||
Exercise of stock options (in shares) | 5,122,107 | |||||
Loss for the period | $ (29,713) | |||||
Balance at Sep. 30, 2019 | 595,896 | $ 21,850 | $ 266,878 | $ (20,533) | 1,745,946 | (1,418,245) |
Balance (in shares) at Sep. 30, 2019 | 289,317,460 | 361,368,945 | (3,841,615) | |||
Balance at Mar. 31, 2019 | 140,871 | $ 21,850 | $ 250,088 | $ (19,493) | 1,301,389 | (1,412,963) |
Balance (in shares) at Mar. 31, 2019 | 289,317,460 | 334,365,726 | (3,787,558) | |||
Issuance of common stock under employee stock purchase plan | 837 | $ 30 | 807 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 47,358 | |||||
Exercise of stock options | 1,888 | $ 396 | 1,492 | |||
Exercise of stock options (in shares) | 619,404 | |||||
Vesting of restricted stock units | (1,040) | $ 74 | $ (1,040) | (74) | ||
Vesting of restricted stock units (in shares) | 116,937 | (54,057) | ||||
Stock-based compensation | 8,351 | 8,351 | ||||
Loss for the period | (1,820) | (1,820) | ||||
Balance at Jun. 30, 2019 | 149,087 | $ 21,850 | $ 250,588 | $ (20,533) | 1,311,965 | (1,414,783) |
Balance (in shares) at Jun. 30, 2019 | 289,317,460 | 335,149,425 | (3,841,615) | |||
Issuance of common stock, net of transaction costs | 440,108 | $ 15,879 | 424,229 | |||
Issuance of common stock, net of transaction costs (shares) | 25,555,556 | |||||
Exercise of stock options | 2,200 | $ 411 | 1,789 | |||
Exercise of stock options (in shares) | 663,964 | |||||
Stock-based compensation | 7,963 | 7,963 | ||||
Loss for the period | (3,462) | (3,462) | ||||
Balance at Sep. 30, 2019 | $ 595,896 | $ 21,850 | $ 266,878 | $ (20,533) | $ 1,745,946 | $ (1,418,245) |
Balance (in shares) at Sep. 30, 2019 | 289,317,460 | 361,368,945 | (3,841,615) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (29,713) | $ (82,776) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation and amortization | 53 | 12 |
Stock-based compensation | 22,729 | 14,032 |
Amortization of debt discount and debt issuance costs | 1,282 | 1,687 |
Amortization of intangible asset | 484 | 484 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (37,060) | (2,330) |
Other receivables | (25,654) | |
Inventory | 3,245 | (13,413) |
Prepaid and other current assets | (9,914) | 520 |
Other long-term assets | (900) | |
Accrued interest payable | (145) | (371) |
Deferred revenue | (1,131) | 1,902 |
Accounts payable and other current liabilities | 54,962 | 36,005 |
Other long-term liabilities | (4,322) | 7,502 |
Net cash used in operating activities | (430) | (62,400) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of furniture, fixtures and equipment | (2,114) | (53) |
Net cash used in investing activities | (2,114) | (53) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of transaction costs for conversion of preferred stock | (39) | |
Proceeds from issuance of common stock under employee stock purchase plan | 423 | |
Proceeds from issuance of common stock, net of transaction costs | 440,945 | 70,007 |
Proceeds from exercise of stock options, net of transaction costs | 19,544 | 16,494 |
Payment on long-term debt from royalty-bearing instrument | (21,441) | (10,539) |
Taxes paid related to stock-based awards | (10,120) | (5,638) |
Net cash provided by financing activities | 428,928 | 70,708 |
NET INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 426,384 | 8,255 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 250,727 | 74,237 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | 677,111 | 82,492 |
Cash paid during the year for: | ||
Interest | 3,577 | 16,030 |
Income taxes | 87 | $ 825 |
Supplemental disclosure of non-cash transactions: | ||
Initial recognition of operating lease right-of-use asset | $ 8,995 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Nature of Business and Basis of Presentation | (1) Nature of Business and Basis of Presentation Nature of Business Amarin Corporation plc (“Amarin” or the “Company”) is a pharmaceutical company with expertise in omega-3 fatty acids and lipid science focused on the commercialization and development of therapeutics to improve cardiovascular health and reduce cardiovascular risk. Since its inception, the Company has devoted substantial resources to research and development. The Company’s lead product, Vascepa ® > > The Company also developed Vascepa for FDA approval of potential additional indications for use. In particular, the Company conducted a cardiovascular outcomes study of Vascepa, titled REDUCE-IT ® The New England Journal Medicine th Journal of the American College of Cardiology. In the United States, the Company sells Vascepa principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, its Distributors or its customers, that in turn resell Vascepa to retail pharmacies for subsequent resale to patients and healthcare providers. The Company markets Vascepa in the United States through its direct sales force, which prior to the REDUCE-IT results topline announcement in September 2018 consisted of approximately 170 sales professionals, including sales representatives and their managers. In early 2019, the Company increased its sales team to approximately 440 sales professionals, including approximately 400 sales representatives. The Company is working to expand its direct sales force to approximately 800 sales professionals for the assumed launch of Vascepa in early 2020 for the cardiovascular risk reduction indication being sought through the sNDA. Hiring, training and deploying approximately 400 new sales representatives is a multi-stage process which commenced in July 2019 and is expected to be completed in early 2020. Most of the expanded sales management team needed to support this sales force expansion was hired, or internally promoted, and trained prior to September 30, 2019. In years prior to 2019, the Company engaged a co-promotion partner to help promote Vascepa in the United States which co-promotion by mutual agreement was not extended beyond December 31, 2018. Outside of the United States, the Company has entered into agreements with third party companies in select geographies for purposes of pursuing regulatory approval and commercialization of Vascepa. The Company operates in one business segment. Basis of Presentation The condensed consolidated financial statements included herein have been prepared by the Company, without audit, in accordance with accounting principles generally accepted in the United States and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. 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, 2018 , or the 2018 Form 10-K, filed with the SEC. The balance sheet amounts at December 31, 2018 in this report were derived from the Company’s audited 2018 consolidated financial statements included in the 2018 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 U.S. Generally Accepted Accounting Principles (“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 and nine months ended September 30, 2019 and 2018 are not necessarily indicative of the results for the entire fiscal year or 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. As of September 30, 2019, the Company had current assets of $848.1 million, including cash and cash equivalents of $673.2 million, accounts receivable, net, of $103.6 million and inventory of $54.6 million. The Company’s condensed consolidated balance sheets also include long-term debt from royalty-bearing instrument which is anticipated to be repaid quarterly calculated as a percentage of Vascepa net revenues until fully satisfied. As of September 30, 2019, the Company had no other debt outstanding. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | (2) Significant Accounting Policies 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 remaining 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 30 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. The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of September 30, 2019 and December 31, 2018: In thousands September 30, 2019 December 31, 2018 Gross trade accounts receivable $ 133,531 $ 86,133 Trade allowances (27,947 ) (19,495 ) Chargebacks (2,001 ) (115 ) Accounts receivable, net $ 103,583 $ 66,523 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. 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 active pharmaceutical ingredient, or 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 share-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 (IRS) and states. The Company completed the audit by the IRS for the years 2013 to 2014 in the prior year with no material changes to the filed income tax returns. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its consolidated financial position or results of operations. Loss per Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period. Diluted net loss 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 common stock options calculated using the treasury stock method and convertible notes using the “if-converted” method. In periods with reported net operating losses, all common stock options are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. The Company’s preferred stock is entitled to receive dividends on an as-if-converted basis in the same form as dividends actually paid on common shares. Accordingly, the preferred stock is considered a participating security and the Company is required to apply the two-class method to consider the impact of the preferred stock on the calculation of basic and diluted earnings per share. The Company is currently in a net loss position and is therefore not required to present the two-class method, however, in the event the Company is in a net income position, the two-class method must be applied by allocating all earnings during the period to common shares and preferred stock based on their contractual entitlements assuming all earnings were distributed. The calculation of net loss and the number of shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2019 and 2018 are as follows: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Net loss—basic and diluted $ (3,462 ) $ (24,471 ) $ (29,713 ) $ (82,776 ) Weighted average shares outstanding—basic and diluted 350,994 295,595 336,938 291,526 Net loss per share—basic and diluted $ (0.01 ) $ (0.08 ) $ (0.09 ) $ (0.28 ) For the three and nine months ended September 30, 2019 and 2018, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Stock options 16,259 21,037 16,259 21,037 Restricted stock and restricted stock units 9,359 9,634 9,359 9,634 Exchangeable senior notes (if converted) — 7,716 — 7,716 Preferred stock (if converted) 28,932 28,932 28,932 28,932 Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company maintains substantially all of its cash and cash equivalents 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 25%, 36%, and 29%, respectively, of gross product sales for the nine months ended September 30, 2019, and represented 42%, 23%, and 28%, respectively, of the gross accounts receivable balance as of September 30, 2019. Customers A, B, and C accounted for 26%, 31%, and 31%, respectively, of gross product sales for the nine months ended September 30, 2018 and represented 37%, 33%, and 17%, respectively, of the gross accounts receivable balance as of September 30, 2018. The Company has not experienced any significant write-offs of its accounts receivable. 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 termination of the Company’s current supply chain or its 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 FDA-approved API manufacturers and several independent FDA-approved API encapsulators and packagers for Vascepa manufacturing. Each of these companies has qualified and validated its manufacturing processes and is capable of manufacturing Vascepa. 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 anticipated 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 Company’s assets and liabilities as of September 30, 2019 and December 31, 2018 that are measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: September 30, 2019 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 10,041 $ 10,041 $ — $ — December 31, 2018 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 9,880 $ 9,880 $ — $ — The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. The carrying amounts and the estimated fair values of debt instruments as of September 30, 2019 and December 31, 2018 are as follows: September 30, 2019 December 31, 2018 In thousands Carrying Value Estimated Fair Value Carrying Value Estimated Fair Value Current portion of long-term debt from royalty-bearing instrument, net of accrued interest $ 50,672 $ 33,602 Long-term debt from royalty-bearing instrument 8,878 46,108 Total long-term debt from royalty-bearing instrument $ 59,550 $ 60,000 $ 79,710 $ 78,600 The estimated fair value of the long-term debt from royalty-bearing instrument is calculated utilizing the same Level 3 inputs utilized in valuing the related derivative liability (see Derivative Liabilities below). The carrying value of the long-term debt from royalty-bearing instrument as of both September 30, 2019 and December 31, 2018 did not include a debt discount as it had been fully amortized. Derivative Liabilities Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the condensed consolidated statement of operations at each period end while such instruments are outstanding. If the Company issues shares to discharge the liability, the derivative financial liability is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. Long-Term Debt Redemption Feature The Company’s December 2012 royalty-bearing instrument financing arrangement (discussed in Note 5—Debt) contains a redemption feature whereby, upon a change of control, the Company would be required to repay $150.0 million, less any previously repaid amount. The Company determined this redemption feature to be an embedded derivative, which is carried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of the embedded derivative was calculated using a probability-weighted model incorporating management estimates of future revenues and for a potential change in control, and by determining the fair value of the debt with and without the change in control provision included. The difference between the two was determined to be the fair value of the embedded derivative. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the condensed consolidated statement of operations. As of September 30, 2019, the fair value of the derivative was determined to be nil, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 0.8 and 7.6 years, (ii) coupon rates of between 6.4% and 11.5% and (iii) market yields of between 5.4% and 18.2%. As of December 31, 2018, the fair value of the derivative was determined to be nil based on underlying assumptions, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 1.3 and 4.0 years, (ii) coupon rates of between 5.4% and 10.8% and (iii) market yields of between 6.7% and 15.8%. As such, the Company recognized no gain or loss on change in fair value of derivative liability for the nine months ended September 30, 2019. The Company recognized no gain or loss on change in fair value of derivative liability for the nine months ended September 30, 2018. Certain changes in the assumptions used to value the derivative liability, including the probability of a change in control, could potentially result in a material change to the carrying value of such liability. 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. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are early adopted by the Company or adopted as of the specified effective date. In February 2016, the FASB issued Accounting Standard Update (“ASU”) 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires lessees to recognize a lease liability and a right-of-use asset for virtually all of their leases (other than leases that meet the definition of a short-term lease). Lessor accounting remains largely unchanged except for changes in the definition and classification of leases. ASU 2016-02 requires a modified retrospective approach for all leases existing at, or entered into after the date of initial adoption, with an option to elect to use certain transition relief. The FASB also proposed a transition method to allow entities to not apply the new leases standard in the comparative periods they present in their financial statements in the year of adoption. On January 1, 2019, the Company adopted ASC 842 using the modified retrospective method for all leases that existed at or commenced after January 1, 2019. The adoption of ASC 842 did not have a material impact on the Company’s condensed consolidated financial statements as of the effective date. See Note 11 – Leases for further details. The Company elected to apply the practical expedients in ASC 842-10-65-1 (f) and therefore: 1) Did not reassess expired contracts for the presence of lease components therein and if it was already concluded that such contracts had lease components then the classification of the respective lease components therein was not re-assessed. 2) Did not re-assess initial direct costs for any existing leases. 3) Will not separate the lease and non-lease components. In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting The Company also considered the following recent accounting pronouncements which were not yet adopted as of September 30, 2019: In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. |
Intangible Asset
Intangible Asset | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Asset | (3) Intangible Asset Intangible asset consists of the historical acquisition cost of certain technology rights for Vascepa and has an estimated weighted-average remaining useful life of 10.8 years. The carrying value as of September 30, 2019 and December 31, 2018 is as follows: In thousands September 30, 2019 December 31, 2018 Technology rights $ 11,624 $ 11,624 Accumulated amortization (4,628 ) (4,144 ) Intangible assets, net $ 6,996 $ 7,480 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | (4) Inventory The Company capitalizes its purchases of saleable inventory of Vascepa from suppliers that have been qualified by the FDA. Inventories as of September 30, 2019 and December 31, 2018 consist of the following: In thousands September 30, 2019 December 31, 2018 Raw materials $ 14,772 $ 14,142 Work in process 11,909 8,590 Finished goods 28,034 35,357 Total inventory, gross 54,715 58,089 Inventory cost adjustment (158 ) (287 ) Inventory $ 54,557 $ 57,802 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Debt | (5) Debt Long-Term Debt from Royalty-Bearing Instrument—December 2012 Financing On December 6, 2012, the Company entered into a Purchase and Sale Agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma. Under this agreement, the Company granted to BioPharma a security interest in future receivables associated with the Vascepa patent rights, in exchange for $100.0 million received at the closing of the agreement which occurred in December 2012. Under these terms, the Company continues to own all Vascepa intellectual property rights, however, such rights, as described below, could be used as collateral for repayment of the remaining unpaid balance under this agreement if the Company defaults on making required payments. In the agreement, the Company agreed to repay BioPharma up to $150.0 million with such repayment based on a portion of net revenues and receivables generated from Vascepa. On December 20, 2017, BioPharma assigned all rights under this agreement to CPPIB Credit Europe S.à r.l., or CPPIB. As of September 30, 2019, the remaining amount to be repaid to CPPIB is $63.6 million. During the three and nine months ended September 30, 2019, the Company made repayments under the agreement of $10.0 million and $25.0 million, respectively, to CPPIB and an additional $11.2 million is scheduled to be paid in November 2019 for the third quarter of 2019. These payments, as well as additional quarterly repayments scheduled in the future, are calculated as 10% of Vascepa net revenues. All such payments reduce the remainder of the $150.0 million in aggregate payments to CPPIB. Except upon a change of control in Amarin, the agreement does not expire until $150.0 million in aggregate has been repaid. The Company can prepay the net remaining amount at any time. The Company determined the redemption feature upon a change of control to be an embedded derivative requiring bifurcation. The fair value of the embedded derivative was calculated by determining the fair value of the debt with the change in control provision included and also without the change in control provision. The difference between the two fair values of the debt was determined to be the fair value of the embedded derivative, and upon closing the Company recorded a derivative liability of $14.6 million as a reduction to the note payable. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the condensed consolidated statement of operations and any changes in the assumptions used in measuring the fair value of the derivative liability could result in a material increase or decrease in its carrying value. Based on current assumptions underlying the valuation, the Company recognized no gain or loss on change in fair value of derivative liability during the nine months ended September 30, 2019 and 2018. As of September 30, 2019 and December 31, 2018, the carrying value of the royalty-bearing instrument, net of the unamortized debt discount and issuance costs, was $59.5 million and $79.7 million, respectively. During the nine months ended September 30, 2019, the Company recorded cash and non-cash interest expense of $3.4 million and $1.3 million, respectively, in connection with the royalty-bearing instrument. During the nine months ended September 30, 2018, the Company recorded $4.3 million and $1.5 million of cash and non-cash interest expense, respectively, in connection with the royalty-bearing instrument. The Company will periodically evaluate the remaining term of the agreement and the effective interest rate is recalculated each period based on the Company’s most current estimate of repayment. To secure the obligations under the agreement, the Company granted BioPharma, which it subsequently assigned to CPPIB, a security interest in the Company’s patents, trademarks, trade names, domain names, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoing and all proceeds of the foregoing, referred to collectively as the collateral. If the Company (i) fails to deliver a payment when due and does not remedy that failure within a specific notice period, (ii) fails to maintain a first-priority perfected security interest in the collateral in the United States and does not remedy that failure after receiving notice of such failure or (iii) becomes subject to an event of bankruptcy, then CPPIB may attempt to collect the maximum amount payable by the Company under this agreement (after deducting any payments the Company has already made). Under the agreement, the Company is restricted from paying dividends on its common shares, unless it has cash and cash equivalents in excess of a specified amount after such payment. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (6) Commitments and Contingencies Litigation 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. There have been no material changes to such matters as of the date of this filing. Milestone and Supply Purchase Obligations The Company entered into long-term supply agreements with multiple FDA-approved API suppliers and encapsulators. 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 FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers. Pursuant to supply agreements, there is a total of approximately $90.0 million that is potentially payable over the term of such agreements based on minimum purchase obligations. The Company continues to meet its contractual purchase obligations. Under the 2004 share repurchase agreement with Laxdale Limited (“Laxdale”), upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing Amarin Neuroscience Limited intellectual property acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £7.5 million (approximately $9.2 million as of September 30, 2019). Also under the Laxdale agreement, upon receipt of a marketing approval in the United States or Europe for a further indication of Vascepa (or further indication of any other product using Amarin Neuroscience Limited intellectual property), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $6.1 The Company has no provision for any of the obligations above since the amounts are either not probable or able to be estimated as of September 30, 2019. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Equity | (7) Equity Preferred Stock On March 5, 2015, the Company entered into a subscription agreement with four institutional investors (the “Purchasers”), including both existing and new investors, for the private placement of 352,150,790 restricted American Depositary Shares, each representing one (1) share of Amarin’s Series A Convertible Preference Shares, par value £0.05 per share, in the capital of the Company (“Series A Preference Shares”), resulting in gross proceeds to the Company of $52.8 million. The closing of the private placement occurred on March 30, 2015. For each restricted American Depositary Share, the Purchasers paid a negotiated price of $0.15 (equating to $1.50 on an as-if-converted-to-ordinary-shares basis), resulting in $52.8 million in aggregate gross proceeds to the Company, before deducting estimated offering expenses of approximately $0.7 million. The net proceeds are reflected as preferred stock in the accompanying condensed consolidated balance sheets. Each ten (10) Series A Preference Shares may be consolidated and redesignated as one (1) ordinary share, par value £0.50 per share, in the capital of the Company, each ordinary share to be represented by American Depositary Shares (“ADSs”), provided that consolidation will be prohibited if, as a result, the holder of such Series A Preference Shares and its affiliates would beneficially own more than 4.99% of the total number of Amarin ordinary shares or ADSs outstanding following such redesignation (the “Beneficial Ownership Limitation”). By written notice to the Company, a holder may from time to time increase or decrease the Beneficial Ownership Limitation to any other percentage not in excess of 19.9% specified in such notice; provided that any such increase will not be effective until the sixty-first (61st) day after such notice is delivered to the Company. This consolidation and redesignation may be effected by a holder of Series A Preference Shares following the first to occur of the resale of the ADSs representing the ordinary shares being registered for resale under the Securities Act pursuant to an effective registration statement, following any sale of the ADSs representing the ordinary shares pursuant to Rule 144 under the Securities Act, or if such ADSs representing the ordinary shares are eligible for sale under Rule 144, following the expiration of the one year holding requirement under Rule 144. During the year ended December 31, 2015, at the request of the holders, a portion of the Series A Preference Shares were consolidated and redesignated, resulting in the issuance of 6,283,333 ADSs. Except as otherwise provided in the Series A Preference Share Terms or as required by applicable law, the Series A Preference Shares have no voting rights. However, as long as any Series A Preference Shares are outstanding, the Company cannot, without the approval of the holders of seventy-five percent (75%) of the then outstanding Series A Preference Shares, alter or change adversely the powers, preferences or rights attaching to the Series A Preference Shares or enter into any agreement with respect to the foregoing. Holders of the Series A Preference Shares are entitled to receive, and the Company is required to pay, dividends (other than dividends in the form of ordinary shares) on the Series A Preference Shares equal (on an as-if-converted-to-ordinary-shares basis) to and in the same form as dividends (other than dividends in the form of ordinary shares) actually paid on ordinary shares when, as and if such dividends (other than dividends in the form of ordinary shares) are paid on the ordinary shares. The restricted American Depositary Shares and Series A Preference Shares were sold in a transaction exempt from the registration requirements under the Securities Act of 1933, as amended (the “Securities Act”). The Company filed a registration statement with the SEC covering the resale of the restricted American Depositary Shares and the ADSs representing ordinary shares created by the consolidation and redesignation of the Series A Preference Shares (the “Registrable Securities”) on April 9, 2015, which was declared effective by the SEC on May 1, 2015. In addition, the Company agreed to use its commercially reasonable best efforts to keep the registration, and any qualification, exemption or compliance under state securities laws which the Company determines to obtain, continuously effective, and to keep the Registration Statement free of any material misstatements or omissions, until the earlier of (a) March 11, 2017 or (b) the date on which all Registrable Securities held by Purchasers may be sold or transferred in compliance with Rule 144 under the Securities Act, without any volume or manner of sale restrictions. The Series A Preference Shares contain a contingent beneficial conversion feature (“BCF”) because they contain a conversion feature at a fixed rate that was in-the-money when issued. The BCF was recorded in the three months ended June 30, 2015 as a result of the related Form S-3 Registration Statement being declared effective, which represents the resolution of the contingency to convert the Series A Preference Shares. The BCF was recognized in stockholders’ deficit and was measured by allocating a portion of the proceeds equal to the intrinsic value of that feature to additional paid-in capital. The effective purchase price of the ordinary shares into which the preferred shares are convertible was $1.50, which was used to compute the intrinsic value. The intrinsic value was calculated as the difference between the effective purchase price of the ordinary shares and the market value ($2.39 per share) on the date the preferred shares were issued, multiplied by the number of shares into which the preferred shares are convertible. The BCF resulting from the issuance of the Series A Preference Shares was determined to be $31.3 million. The BCF was recorded as a non-cash dividend to preferred shareholders through accumulated deficit, and was therefore reflected as an adjustment to net loss applicable to common shareholders for earnings per common share purposes in accordance with GAAP for the year ended December 31, 2015. During the year ended December 31, 2018, the Company issued 3,886,718 ADSs upon consolidation and redesignation of Series A Preference Shares at the request of the holder, such that a maximum of 28,931,746 ordinary shares remain issuable upon future consolidation and redesignation of the remaining Series A Preference Shares as of September 30, 2019, subject to certain adjustments for dilutive events. Common Stock On July 18, 2019, the Company completed a public offering of 22,222,223 ADSs with each ADS representing one ordinary share of the Company, at a price of $18.00 per ADS after commission. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 3,333,333 ADSs at a price of $18.00 per ADS. On July 29, 2019, the underwriters exercised the full option. This public offering, including the exercised option, resulted in gross proceeds of approximately $ 460.0 million and, after deducting customary commissions and offering expenses, net proceeds to the Company of approximately $ 440.1 million . On November 29, 2018, the Company completed a public offering of 11,111,112 ADSs, with each ADS representing one ordinary share of the Company. The underwriters purchased the ADSs from the Company at a price of $17.575 per ADS after commission, resulting in net proceeds to the Company of approximately $194.8 million, after deducting customary commissions and offering expenses. On February 1, 2018, the Company completed a public offering of 19,178,082 ADSs, with each ADS representing one ordinary share of the Company. The Company also granted the underwriters a 30-day option to purchase an additional 2,876,712 ADSs, which was partially exercised on March 5, 2018 for issuance of 1,438,356 ADSs. The underwriters purchased the ADSs from the Company at a price of $3.41 per ADS after commission, resulting in net proceeds to the Company of approximately $70.0 million, after deducting customary commissions and offering expenses. Incentive Equity Awards As of September 30, 2019, there were an aggregate of 16,259,328 stock options and 9,358,721 restricted stock units (“RSUs”) outstanding, representing approximately 4% and 2%, respectively, of outstanding shares (including common and preferred shares) on a fully diluted basis. During the nine months ended September 30, 2019 and 2018, the Company issued 5,122,107 and 5,439,239 shares, respectively, as a result of the exercise of stock options, resulting in gross and net proceeds of $19.5 million during the nine months ended September 30, 2019 and $16.5 million during the nine months ended September 30, 2018. In October 2019, in connection with achievement of a predetermined performance-based formula tied to company cash flow, the Company issued 2,436,750 shares upon vesting of performance-based RSUs granted in 2015, of which 1,069,377 shares were retained as treasury shares as settlement of employee tax obligations. On May 20, 2019, the Company granted a total of 45,163 RSUs and 58,721 stock options to members of the Company’s Board of Directors under the Amarin Corporation plc Stock Incentive Plan (the “2011 Plan”). The RSUs vest in equal installments over a three year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. The stock options vest in full upon the earlier of the one year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. Upon termination of service to the Company or upon a change of control, each Director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares. Also on May 20, 2019, the Company granted an additional 20,000 RSUs to employees under the 2011 Plan that vest upon the achievement of a specified sales performance condition. On February 1, 2019, the Company granted a total of 757,800 RSUs and 1,193,400 stock options to employees under the 2011 Plan. The RSUs vest annually over a three year period and the stock options vest quarterly over a four year period. Also on February 1, 2019, the Company granted a total of 580,000 RSUs to employees under the 2011 Plan that vest upon the achievement of a specified sales performance condition. In September 2018, in connection with positive REDUCE-IT results, the Company issued 2,499,750 shares upon vesting of performance-based RSUs granted in 2015, of which 764,819 shares were retained as treasury shares as settlement of employee tax obligations. On May 14, 2018, the Company granted a total of 190,034 RSUs and 286,536 stock options to members of the Company’s Board of Directors under the 2011 Plan. The RSUs vest in equal installments over a three year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. The stock options vest in full upon the earlier of the one year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. Upon termination of service to the Company or upon a change of control, each Director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares. On March 12, 2018 and November 1, 2018, the Company granted a total of 970,000 RSUs and 90,000 RSUs, respectively, to employees under the 2011 Plan that vest over three years commencing after REDUCE-IT results upon the achievement of certain regulatory and sales performance conditions associated with the REDUCE-IT clinical trial and subsequent revenue growth. On February 1, 2018, the Company granted a total of 1,305,575 RSUs and 2,205,075 stock options to employees under the 2011 Plan. The RSUs vest annually over a three year period and the stock options vest monthly over a four year period. During the nine months ended September 30, 2019, the Company issued 387,715 common shares related to the vesting of these RSUs, of which 139,928 shares were retained as treasury shares as settlement of employee tax obligations. |
Co-Promotion Agreement
Co-Promotion Agreement | 9 Months Ended |
Sep. 30, 2019 | |
Co Promotion Agreement [Abstract] | |
Co-Promotion Agreement | (8) Co-Promotion Agreement On March 31, 2014, the Company entered into a Co-Promotion Agreement (the “Agreement”) with Kowa Pharmaceuticals America, Inc. related to the commercialization of Vascepa capsules in the United States. Under the terms of the Agreement, Amarin granted to Kowa Pharmaceuticals America, Inc. the right to be the sole co-promoter, together with the Company, of Vascepa in the United States during the term. The Agreement was amended on July 25, 2017 to reflect evolving promotional needs, including refinement of target lists. Amarin and Kowa Pharmaceuticals America, Inc. intentionally designed the co-promotion to naturally end as of December 31, 2018 and mutually agreed not to renew the agreement. During 2018, which was the last year of the Agreement, as amended, the Company incurred expense for co-promotion tail payments which are calculated as a percentage of the 2018 co-promotion fee, which was eighteen and a half percent (18.5%) of Vascepa gross margin. The accrued tail payments are paid over three years with declining amounts each year. Kowa Pharmaceuticals America, Inc. is eligible to receive $17.8 million in co-promotion tail payments, the present value of which, $16.6 million, was fully accrued as of December 31, 2018. There were $4.8 million in tail payments made as of September 30, 2019. As of September 30, 2019, of the $12.3 million the Company accrued for in tail payments under the Agreement, $7.6 million was classified as current on the condensed consolidated balance sheet. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue Recognition | (9) 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, or collectively, its Distributors or its Customers, that 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 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 . 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 generally include a 2% 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 twelve 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 nine months ended September 30, 2019 and 2018: In thousands Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of December 31, 2018 $ 19,495 $ 41,634 $ 2,948 $ 1,167 $ 65,244 Provision related to current period sales 62,177 274,439 1,635 30,882 369,133 Provision related to prior period sales — (204 ) — — (204 ) Credits/payments made for current period sales (34,400 ) (184,801 ) 5 (30,404 ) (249,600 ) Credits/payments made for prior period sales (19,325 ) (41,363 ) (653 ) (1,199 ) (62,540 ) Balance as of September 30, 2019 $ 27,947 $ 89,705 $ 3,935 $ 446 $ 122,033 In thousands Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of December 31, 2017 $ 12,035 $ 32,064 $ 1,887 $ 2,107 $ 48,093 Provision related to current period sales 30,814 128,905 812 14,636 175,167 Provision related to prior period sales (660 ) (836 ) — (69 ) (1,565 ) Credits/payments made for current period sales (15,908 ) (76,015 ) — (15,038 ) (106,961 ) Credits/payments made for prior period sales (11,657 ) (29,594 ) (69 ) (2,297 ) (43,617 ) Balance as of September 30, 2018 $ 14,624 $ 54,524 $ 2,630 $ (661 ) $ 71,117 Such net product revenue allowances and reserves are included within accrued expenses and other current liabilities within the consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within accounts receivable, net as discussed below. Licensing Revenue The Company enters into licensing agreements which are within the scope of Topic 606 , Revenue from Contracts with Customers 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 | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Development, Commercialization and Supply Agreements | (10) 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. (“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 (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, which was recorded in research and development expense in the condensed consolidated statement of operations for the year ended December 31, 2018. 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. Out-licenses Eddingpharm (Asia) Macao Commercial Offshore Limited In February 2015, the Company entered into a Development, Commercialization and Supply Agreement (the “DCS Agreement”) with Eddingpharm (Asia) Macao Commercial Offshore Limited (“Eddingpharm”) related to the development and commercialization of Vascepa in Mainland China, Hong Kong, Macau and Taiwan, or the “China Territory”. Under the terms of the DCS Agreement, the Company granted to Eddingpharm 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, Eddingpharm 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. Eddingpharm 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 Eddingpharm 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 to form a separate joint commercialization committee to oversee Vascepa commercialization activities in the China Territory. Development costs are paid by Eddingpharm to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Eddingpharm. Eddingpharm is responsible for preparing and filing regulatory applications in all countries of the China Territory at Eddingpharm’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 twelfth (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, Eddingpharm has the right to terminate the DCS Agreement for convenience with twelve 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, Eddingpharm submitted its clinical trial application (“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, Eddingpharm 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 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, Eddingpharm, 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, (3) ongoing development and regulatory assistance, and (4) manufacture and supply of commercial product. 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 have been included in the transaction price, as all milestone amounts were 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 as they were determined to relate predominantly to the license granted to Eddingpharm 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 nine months ended September 30, 2019 and 2018, the Company recognized $0.2 million and $0.1 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the Eddingpharm agreement. From contract inception through September 30, 2019 and December 31, 2018, the Company recognized $3.0 million and $2.8 million, respectively, as licensing revenue under the DCS Agreement concurrent with the support provided by Amarin to Eddingpharm in achieving the combined performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the performance obligation. The remaining transaction price of $13.0 million and $13.2 million is recorded in deferred revenue as of September 30, 2019 and December 31, 2018, respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 15 years. Biologix FZCo In March 2016, the Company entered into an agreement with Biologix FZCo (“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. In March 2018 and July 2018, the Company received approval for Vascepa as a prescription medication for use in Lebanon and United Arab Emirates, respectively, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. HLS Therapeutics, Inc. In September 2017, the Company entered into an agreement with HLS Therapeutics Inc. (“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. In addition to the non-refundable, up-front and regulatory milestone payments just described, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $57.5 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, (3) participate in various steering committees, and (4) manufacture and provide finished form of product. 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 and the $2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint. None of the other regulatory milestones have been included in the transaction price, as all of the remaining regulatory milestone amounts were 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 the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to HLS 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 nine months ended September 30, 2019 and 2018, the Company recognized $0.9 million and $0.5 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement. From contract inception through September 30, 2019 and December 31, 2018, the Company recognized $1.8 million and $0.9 million, respectively, as licensing revenue is recognized under the agreement concurrent with the support provided by Amarin to HLS in achieving the performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined performance obligation. The remaining transaction price of $5.7 million and $6.6 million is recorded in deferred revenue as of September 30, 2019 and December 31, 2018, respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 11 years. The following table presents changes in the balances of the Company’s contract assets and liabilities during the nine months ended September 30, 2019 and 2018: In thousands Balance at Beginning of Period Additions Deductions Balance at End of Period Nine months ended September 30, 2019: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 20,710 $ — $ (1,131 ) $ 19,579 Nine months ended September 30, 2018: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 19,054 $ 2,500 $ (598 ) $ 20,956 During the nine months ended September 30, 2019 and 2018 date, 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 Nine Months Ended September 30, Revenue recognized in the period from: 2019 2018 Amounts included in contract liability at the beginning of the period $ 1,131 $ 405 Performance obligations satisfied in previous periods $ — $ 193 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | (11) Leases 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 September 30, 2011, the Company entered into an agreement for office space in Dublin, Ireland which terminated on May 1, 2019. On April 12, 2019 and July 4, 2019, the Company entered into Office Centre Sharing Agreements effective May 1, 2019 and October 1, 2019, respectively, to replace the office space with new office space in Dublin, Ireland which terminates on April 30, 2020 and September 30, 2020, respectively, and can be extended automatically for successive one year periods. On July 1, 2011, the Company leased office space in Bedminster, New Jersey. The lease, as amended, terminated on September 15, 2019. On January 26, 2019, the Company leased additional space in another building in Bedminster, New Jersey, effective February 1, 2019 which also terminated on September 15, 2019. These leases have been determined to be short-term leases and the Company is committed to making nominal payments On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey (the “Lease”). The Lease commenced on August 15, 2019 (the “Commencement Date”) for an 11 year period, with two five year renewal options. Subject to the terms of the Lease, Amarin will have a one-time option to terminate the agreement effective on the first day of the ninety-seventh month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company pays monthly rent of approximately $0.1 million for the first year following the Commencement Date, and such rent will increase by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease. The operating lease liability is $9.6 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 September 30, 2019: Undiscounted lease payments ($000s) 2020 $ 124 2021 1,344 2022 1,743 2023 1,801 2024 1,835 2025 and thereafter 11,376 Total undiscounted payments $ 18,223 Discount Adjustments $ (8,667 ) Operating lease liability $ 9,556 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
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 remaining 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 30 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. The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of September 30, 2019 and December 31, 2018: In thousands September 30, 2019 December 31, 2018 Gross trade accounts receivable $ 133,531 $ 86,133 Trade allowances (27,947 ) (19,495 ) Chargebacks (2,001 ) (115 ) Accounts receivable, net $ 103,583 $ 66,523 |
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. 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 active pharmaceutical ingredient, or 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 share-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 (IRS) and states. The Company completed the audit by the IRS for the years 2013 to 2014 in the prior year with no material changes to the filed income tax returns. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its consolidated financial position or results of operations. |
Loss per Share | 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 common stock options calculated using the treasury stock method and convertible notes using the “if-converted” method. In periods with reported net operating losses, all common stock options are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. The Company’s preferred stock is entitled to receive dividends on an as-if-converted basis in the same form as dividends actually paid on common shares. Accordingly, the preferred stock is considered a participating security and the Company is required to apply the two-class method to consider the impact of the preferred stock on the calculation of basic and diluted earnings per share. The Company is currently in a net loss position and is therefore not required to present the two-class method, however, in the event the Company is in a net income position, the two-class method must be applied by allocating all earnings during the period to common shares and preferred stock based on their contractual entitlements assuming all earnings were distributed. The calculation of net loss and the number of shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2019 and 2018 are as follows: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Net loss—basic and diluted $ (3,462 ) $ (24,471 ) $ (29,713 ) $ (82,776 ) Weighted average shares outstanding—basic and diluted 350,994 295,595 336,938 291,526 Net loss per share—basic and diluted $ (0.01 ) $ (0.08 ) $ (0.09 ) $ (0.28 ) For the three and nine months ended September 30, 2019 and 2018, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Stock options 16,259 21,037 16,259 21,037 Restricted stock and restricted stock units 9,359 9,634 9,359 9,634 Exchangeable senior notes (if converted) — 7,716 — 7,716 Preferred stock (if converted) 28,932 28,932 28,932 28,932 |
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 and accounts receivable. The Company maintains substantially all of its cash and cash equivalents 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 25%, 36%, and 29%, respectively, of gross product sales for the nine months ended September 30, 2019, and represented 42%, 23%, and 28%, respectively, of the gross accounts receivable balance as of September 30, 2019. Customers A, B, and C accounted for 26%, 31%, and 31%, respectively, of gross product sales for the nine months ended September 30, 2018 and represented 37%, 33%, and 17%, respectively, of the gross accounts receivable balance as of September 30, 2018. The Company has not experienced any significant write-offs of its accounts receivable. |
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 termination of the Company’s current supply chain or its 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 FDA-approved API manufacturers and several independent FDA-approved API encapsulators and packagers for Vascepa manufacturing. Each of these companies has qualified and validated its manufacturing processes and is capable of manufacturing Vascepa. 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 anticipated 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 Company’s assets and liabilities as of September 30, 2019 and December 31, 2018 that are measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: September 30, 2019 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 10,041 $ 10,041 $ — $ — December 31, 2018 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 9,880 $ 9,880 $ — $ — The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. The carrying amounts and the estimated fair values of debt instruments as of September 30, 2019 and December 31, 2018 are as follows: September 30, 2019 December 31, 2018 In thousands Carrying Value Estimated Fair Value Carrying Value Estimated Fair Value Current portion of long-term debt from royalty-bearing instrument, net of accrued interest $ 50,672 $ 33,602 Long-term debt from royalty-bearing instrument 8,878 46,108 Total long-term debt from royalty-bearing instrument $ 59,550 $ 60,000 $ 79,710 $ 78,600 The estimated fair value of the long-term debt from royalty-bearing instrument is calculated utilizing the same Level 3 inputs utilized in valuing the related derivative liability (see Derivative Liabilities below). The carrying value of the long-term debt from royalty-bearing instrument as of both September 30, 2019 and December 31, 2018 did not include a debt discount as it had been fully amortized. |
Derivative Liabilities | Derivative Liabilities Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the condensed consolidated statement of operations at each period end while such instruments are outstanding. If the Company issues shares to discharge the liability, the derivative financial liability is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. Long-Term Debt Redemption Feature The Company’s December 2012 royalty-bearing instrument financing arrangement (discussed in Note 5—Debt) contains a redemption feature whereby, upon a change of control, the Company would be required to repay $150.0 million, less any previously repaid amount. The Company determined this redemption feature to be an embedded derivative, which is carried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of the embedded derivative was calculated using a probability-weighted model incorporating management estimates of future revenues and for a potential change in control, and by determining the fair value of the debt with and without the change in control provision included. The difference between the two was determined to be the fair value of the embedded derivative. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the condensed consolidated statement of operations. As of September 30, 2019, the fair value of the derivative was determined to be nil, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 0.8 and 7.6 years, (ii) coupon rates of between 6.4% and 11.5% and (iii) market yields of between 5.4% and 18.2%. As of December 31, 2018, the fair value of the derivative was determined to be nil based on underlying assumptions, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 1.3 and 4.0 years, (ii) coupon rates of between 5.4% and 10.8% and (iii) market yields of between 6.7% and 15.8%. As such, the Company recognized no gain or loss on change in fair value of derivative liability for the nine months ended September 30, 2019. The Company recognized no gain or loss on change in fair value of derivative liability for the nine months ended September 30, 2018. Certain changes in the assumptions used to value the derivative liability, including the probability of a change in control, could potentially result in a material change to the carrying value of such liability. |
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. |
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. In February 2016, the FASB issued Accounting Standard Update (“ASU”) 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires lessees to recognize a lease liability and a right-of-use asset for virtually all of their leases (other than leases that meet the definition of a short-term lease). Lessor accounting remains largely unchanged except for changes in the definition and classification of leases. ASU 2016-02 requires a modified retrospective approach for all leases existing at, or entered into after the date of initial adoption, with an option to elect to use certain transition relief. The FASB also proposed a transition method to allow entities to not apply the new leases standard in the comparative periods they present in their financial statements in the year of adoption. On January 1, 2019, the Company adopted ASC 842 using the modified retrospective method for all leases that existed at or commenced after January 1, 2019. The adoption of ASC 842 did not have a material impact on the Company’s condensed consolidated financial statements as of the effective date. See Note 11 – Leases for further details. The Company elected to apply the practical expedients in ASC 842-10-65-1 (f) and therefore: 1) Did not reassess expired contracts for the presence of lease components therein and if it was already concluded that such contracts had lease components then the classification of the respective lease components therein was not re-assessed. 2) Did not re-assess initial direct costs for any existing leases. 3) Will not separate the lease and non-lease components. In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting The Company also considered the following recent accounting pronouncements which were not yet adopted as of September 30, 2019: In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019 and December 31, 2018: In thousands September 30, 2019 December 31, 2018 Gross trade accounts receivable $ 133,531 $ 86,133 Trade allowances (27,947 ) (19,495 ) Chargebacks (2,001 ) (115 ) Accounts receivable, net $ 103,583 $ 66,523 |
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 and nine months ended September 30, 2019 and 2018 are as follows: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Net loss—basic and diluted $ (3,462 ) $ (24,471 ) $ (29,713 ) $ (82,776 ) Weighted average shares outstanding—basic and diluted 350,994 295,595 336,938 291,526 Net loss per share—basic and diluted $ (0.01 ) $ (0.08 ) $ (0.09 ) $ (0.28 ) |
Anti-Dilutive Securities Not Included in the Computation of Net Loss or Earnings per Share | For the three and nine months ended September 30, 2019 and 2018, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: Three months ended September 30, Nine months ended September 30, In thousands 2019 2018 2019 2018 Stock options 16,259 21,037 16,259 21,037 Restricted stock and restricted stock units 9,359 9,634 9,359 9,634 Exchangeable senior notes (if converted) — 7,716 — 7,716 Preferred stock (if converted) 28,932 28,932 28,932 28,932 |
Assets and Liability Measured at Fair Value on a Recurring Basis | The following tables present information about the Company’s assets and liabilities as of September 30, 2019 and December 31, 2018 that are measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: September 30, 2019 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 10,041 $ 10,041 $ — $ — December 31, 2018 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 9,880 $ 9,880 $ — $ — |
Carrying Amounts and Estimated Fair Values of Debt Instruments | The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. The carrying amounts and the estimated fair values of debt instruments as of September 30, 2019 and December 31, 2018 are as follows: September 30, 2019 December 31, 2018 In thousands Carrying Value Estimated Fair Value Carrying Value Estimated Fair Value Current portion of long-term debt from royalty-bearing instrument, net of accrued interest $ 50,672 $ 33,602 Long-term debt from royalty-bearing instrument 8,878 46,108 Total long-term debt from royalty-bearing instrument $ 59,550 $ 60,000 $ 79,710 $ 78,600 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Carrying Value of Intangible Asset | The carrying value as of September 30, 2019 and December 31, 2018 is as follows: In thousands September 30, 2019 December 31, 2018 Technology rights $ 11,624 $ 11,624 Accumulated amortization (4,628 ) (4,144 ) Intangible assets, net $ 6,996 $ 7,480 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories as of September 30, 2019 and December 31, 2018 consist of the following: In thousands September 30, 2019 December 31, 2018 Raw materials $ 14,772 $ 14,142 Work in process 11,909 8,590 Finished goods 28,034 35,357 Total inventory, gross 54,715 58,089 Inventory cost adjustment (158 ) (287 ) Inventory $ 54,557 $ 57,802 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 nine months ended September 30, 2019 and 2018: In thousands Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of December 31, 2018 $ 19,495 $ 41,634 $ 2,948 $ 1,167 $ 65,244 Provision related to current period sales 62,177 274,439 1,635 30,882 369,133 Provision related to prior period sales — (204 ) — — (204 ) Credits/payments made for current period sales (34,400 ) (184,801 ) 5 (30,404 ) (249,600 ) Credits/payments made for prior period sales (19,325 ) (41,363 ) (653 ) (1,199 ) (62,540 ) Balance as of September 30, 2019 $ 27,947 $ 89,705 $ 3,935 $ 446 $ 122,033 In thousands Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of December 31, 2017 $ 12,035 $ 32,064 $ 1,887 $ 2,107 $ 48,093 Provision related to current period sales 30,814 128,905 812 14,636 175,167 Provision related to prior period sales (660 ) (836 ) — (69 ) (1,565 ) Credits/payments made for current period sales (15,908 ) (76,015 ) — (15,038 ) (106,961 ) Credits/payments made for prior period sales (11,657 ) (29,594 ) (69 ) (2,297 ) (43,617 ) Balance as of September 30, 2018 $ 14,624 $ 54,524 $ 2,630 $ (661 ) $ 71,117 |
Development, Commercializatio_2
Development, Commercialization and Supply Agreements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
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 nine months ended September 30, 2019 and 2018: In thousands Balance at Beginning of Period Additions Deductions Balance at End of Period Nine months ended September 30, 2019: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 20,710 $ — $ (1,131 ) $ 19,579 Nine months ended September 30, 2018: Contract assets $ — $ — $ — $ — Contract liabilities: Deferred revenue $ 19,054 $ 2,500 $ (598 ) $ 20,956 During the nine months ended September 30, 2019 and 2018 date, 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 Nine Months Ended September 30, Revenue recognized in the period from: 2019 2018 Amounts included in contract liability at the beginning of the period $ 1,131 $ 405 Performance obligations satisfied in previous periods $ — $ 193 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019: Undiscounted lease payments ($000s) 2020 $ 124 2021 1,344 2022 1,743 2023 1,801 2024 1,835 2025 and thereafter 11,376 Total undiscounted payments $ 18,223 Discount Adjustments $ (8,667 ) Operating lease liability $ 9,556 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | |
Sep. 30, 2018Employee | Sep. 30, 2019USD ($)PatientEmployeeSegment | Dec. 31, 2018USD ($) | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||
REDUCE-IT study, number of patients enrolled and randomized | Patient | 8,179 | ||
Number of sales professionals | Employee | 400 | ||
Number of operating segments | Segment | 1 | ||
Total current assets | $ 848,110,000 | $ 377,997,000 | |
Cash and cash equivalents | 673,207,000 | 249,227,000 | |
Accounts receivable, net | 103,583,000 | 66,523,000 | |
Inventory | 54,557,000 | $ 57,802,000 | |
Other debt outstanding | $ 0 | ||
Sales Representatives and Managers | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||
Number of sales professionals | Employee | 170 | 440 | |
Sales Representatives | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||
Number of sales professionals | Employee | 400 | ||
Direct Sales Force | |||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||
Number of sales professionals | Employee | 800 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019USD ($)SegmentCustomer | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2012USD ($) | |
Significant Accounting Policies [Line Items] | ||||
Trade receivables, credit period | 30 days | |||
Number of operating segments | Segment | 1 | |||
Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Trade receivables, credit period | 30 days | |||
Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Trade receivables, credit period | 60 days | |||
Embedded Derivative Financial Instruments | BioPharma Debt | ||||
Significant Accounting Policies [Line Items] | ||||
Maximum repayment of future revenue and receivables | $ 150,000,000 | |||
Fair value of embedded derivative liability | $ 0 | $ 0 | ||
Gain (loss) on change in fair value of derivative liabilities | $ 0 | $ 0 | ||
Embedded Derivative Financial Instruments | BioPharma Debt | Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Derivative liability fair value assumption, coupon rate | 6.40% | 5.40% | ||
Derivative liability fair value assumptions, market yields | 5.40% | 6.70% | ||
Embedded Derivative Financial Instruments | BioPharma Debt | Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Derivative liability fair value assumption, coupon rate | 11.50% | 10.80% | ||
Derivative liability fair value assumptions, market yields | 18.20% | 15.80% | ||
Embedded Derivative Financial Instruments | BioPharma Debt | Measurement Input, Expected Term | Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Derivative liability fair value assumptions, term | 9 months 18 days | 1 year 3 months 18 days | ||
Embedded Derivative Financial Instruments | BioPharma Debt | Measurement Input, Expected Term | Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Derivative liability fair value assumptions, term | 7 years 7 months 6 days | 4 years | ||
Long-term debt from royalty-bearing instrument | ||||
Significant Accounting Policies [Line Items] | ||||
Long-term debt, discount | $ 0 | $ 0 | ||
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 | 25.00% | 26.00% | ||
Customer A | Accounts Receivable | Customer Concentration Risk | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 42.00% | 37.00% | ||
Customer B | Gross Product Sales | Customer Concentration Risk | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 36.00% | 31.00% | ||
Customer B | Accounts Receivable | Customer Concentration Risk | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 23.00% | 33.00% | ||
Customer C | Gross Product Sales | Customer Concentration Risk | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 29.00% | 31.00% | ||
Customer C | Accounts Receivable | Customer Concentration Risk | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk percentage | 28.00% | 17.00% |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable Balances (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Gross trade accounts receivable | $ 133,531 | $ 86,133 |
Accounts receivable, net | 103,583 | 66,523 |
Trade Allowances | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Valuation allowances and reserves | (27,947) | (19,495) |
Chargebacks | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Valuation allowances and reserves | $ (2,001) | $ (115) |
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 | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share [Abstract] | ||||
Net loss—basic and diluted | $ (3,462) | $ (24,471) | $ (29,713) | $ (82,776) |
Weighted average shares outstanding—basic and diluted | 350,994 | 295,595 | 336,938 | 291,526 |
Net loss per share—basic and diluted | $ (0.01) | $ (0.08) | $ (0.09) | $ (0.28) |
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 | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Preferred Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 28,932 | 28,932 | 28,932 | 28,932 |
Stock Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 16,259 | 21,037 | 16,259 | 21,037 |
Restricted Stock Units (RSUs) | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 9,359 | 9,634 | 9,359 | 9,634 |
Exchangeable Senior Notes | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,716 | 7,716 |
Significant Accounting Polici_8
Significant Accounting Policies - Assets and Liability Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Asset: | ||
Cash equivalents—money markets | $ 10,041 | $ 9,880 |
Level 1 | ||
Asset: | ||
Cash equivalents—money markets | $ 10,041 | $ 9,880 |
Significant Accounting Polici_9
Significant Accounting Policies - Carrying Amounts and Estimated Fair Values of Debt Instruments (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Current portion of long-term debt from royalty-bearing instrument, net of accrued interest, carrying value | $ 50,672 | $ 33,602 |
Long-term debt from royalty-bearing instrument, carrying value | 8,878 | 46,108 |
Total long-term debt from royalty-bearing instrument, carrying value | 59,550 | 79,710 |
Long-term debt from royalty-bearing instrument | ||
Debt Instrument [Line Items] | ||
Total long-term debt from royalty-bearing instrument, estimated fair value | $ 60,000 | $ 78,600 |
Intangible Asset - Additional I
Intangible Asset - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible asset estimated weighted- average remaining useful life | 10 years 9 months 18 days |
Intangible Asset - Schedule of
Intangible Asset - Schedule of Carrying Value of Intangible Asset (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Technology rights | $ 11,624 | $ 11,624 |
Accumulated amortization | (4,628) | (4,144) |
Intangible assets, net | $ 6,996 | $ 7,480 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 14,772 | $ 14,142 |
Work in process | 11,909 | 8,590 |
Finished goods | 28,034 | 35,357 |
Total inventory, gross | 54,715 | 58,089 |
Inventory cost adjustment | (158) | (287) |
Inventory | $ 54,557 | $ 57,802 |
Debt - Long-Term Debt from Roya
Debt - Long-Term Debt from Royalty-Bearing Instrument-December 2012 Financing - Additional Information (Detail) - USD ($) | Dec. 06, 2012 | Nov. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Debt Disclosure [Line Items] | ||||||
Long-term debt from royalty-bearing instrument, carrying amount net of unamortized discount | $ 59,550,000 | $ 59,550,000 | $ 79,710,000 | |||
Interest expense, non-cash | 1,282,000 | $ 1,687,000 | ||||
CPPIB | ||||||
Debt Disclosure [Line Items] | ||||||
Maximum repayment of future revenue and receivables | 63,600,000 | 63,600,000 | ||||
Repayment under agreement | 10,000,000 | $ 25,000,000 | ||||
CPPIB | Scenario Forecast | ||||||
Debt Disclosure [Line Items] | ||||||
Repayment under agreement | $ 11,200,000 | |||||
CPPIB | Vascepa | ||||||
Debt Disclosure [Line Items] | ||||||
Debt and future repayments percentage of net revenues | 10.00% | |||||
BioPharma Debt | ||||||
Debt Disclosure [Line Items] | ||||||
Amount received at the closing of the agreement | $ 100,000,000 | |||||
Maximum repayment of future revenue and receivables | 150,000,000 | |||||
Royalty-Bearing Debt | ||||||
Debt Disclosure [Line Items] | ||||||
Fair value of embedded derivative liability | $ 14,600,000 | |||||
Gain (loss) on change in fair value of derivative liabilities | $ 0 | 0 | ||||
Long-term debt from royalty-bearing instrument, carrying amount net of unamortized discount | $ 59,500,000 | 59,500,000 | $ 79,700,000 | |||
Royalty-Bearing Debt | Cash | ||||||
Debt Disclosure [Line Items] | ||||||
Interest expense, contractual coupon interest | 3,400,000 | 4,300,000 | ||||
Royalty-Bearing Debt | Non Cash | ||||||
Debt Disclosure [Line Items] | ||||||
Interest expense, non-cash | $ 1,300,000 | $ 1,500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - Sep. 30, 2019 $ in Millions | USD ($) | GBP (£) |
Commitments And Contingencies Disclosure [Line Items] | ||
Potential payable amount over the agreement terms based on minimum purchase obligation | $ 90 | |
Further Indication for AMR101 | Marketing Approval In Europe | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Potential aggregate stock or cash payment | 9.2 | £ 7,500,000 |
Further Indication for AMR101 | Potential Marketing Approval 1 | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Potential aggregate stock or cash payment | 6.1 | 5,000,000 |
Further Indication for AMR101 | Potential Marketing Approval 2 | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Potential aggregate stock or cash payment | 6.1 | 5,000,000 |
Further Indication for AMR101 | Maximum | ||
Commitments And Contingencies Disclosure [Line Items] | ||
Potential aggregate stock or cash payment | $ 12.3 | £ 10,000,000 |
Equity - Preferred Stock - Addi
Equity - Preferred Stock - Additional Information (Detail) | Jul. 18, 2019shares | Nov. 29, 2018shares | Feb. 01, 2018shares | Mar. 05, 2015USD ($)shares | Sep. 30, 2019USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Sep. 30, 2019£ / sharesshares | Dec. 31, 2018£ / sharesshares | Dec. 31, 2015shares | Sep. 30, 2019$ / sharesshares | Mar. 05, 2015£ / sharesshares | Mar. 05, 2015$ / sharesshares |
Stockholders Equity Note [Line Items] | ||||||||||||||
Preferred stock, par value | £ / shares | £ 0.05 | £ 0.05 | £ 0.05 | |||||||||||
Private placement, closing date | Mar. 30, 2015 | |||||||||||||
Stock issued under private placement, value | $ | $ 440,108,000 | $ 70,007,000 | ||||||||||||
Aggregate gross proceeds | $ | $ 52,800,000 | |||||||||||||
Estimated offering expense | $ | $ 700,000 | |||||||||||||
Common stock, par value | £ / shares | £ 0.50 | £ 0.50 | £ 0.50 | |||||||||||
Number of shares issued for each preference shares | 0.1 | 0.1 | ||||||||||||
Market value, per share | $ / shares | $ 2.39 | |||||||||||||
BCF resulting from issuance of Series A Preference Shares | $ | $ 31,300,000 | |||||||||||||
Preferred stock, equivalent ordinary shares upon future consolidation outstanding | 28,931,746 | 28,931,746 | 28,931,746 | |||||||||||
Series A Preferred Stock | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
American depositary shares conversion rate to preference shares | American Depositary Shares, each representing one (1) share of Amarin’s Series A Convertible Preference Shares | |||||||||||||
Series A Preferred Stock | Minimum | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Beneficial ownership limitation | 4.99% | |||||||||||||
Series A Preferred Stock | Maximum | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Beneficial ownership limitation | 19.90% | |||||||||||||
Ordinary Shares | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Convertible senior notes, total ADS into which the debt is exchangeable | 3,886,718 | 6,283,333 | ||||||||||||
Preferred stock, equivalent ordinary shares upon future consolidation outstanding | 28,931,746 | |||||||||||||
American Depositary Shares | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Issuance of stock (shares) | 22,222,223 | 11,111,112 | 19,178,082 | |||||||||||
American Depositary Shares | Series A Preferred Stock | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Issuance of stock (shares) | 352,150,790 | |||||||||||||
Stock issued under private placement, value | $ | $ 52,800,000 | |||||||||||||
Preferred Shares Basis | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Share conversion price | $ / shares | 0.15 | |||||||||||||
Ordinary Shares Basis | ||||||||||||||
Stockholders Equity Note [Line Items] | ||||||||||||||
Share conversion price | $ / shares | $ 1.50 | $ 1.50 |
Equity - Common Stock - Additio
Equity - Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 29, 2019 | Jul. 18, 2019 | Nov. 29, 2018 | Mar. 05, 2018 | Feb. 01, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Stockholders Equity Note [Line Items] | |||||||
Net proceeds from public offering | $ 440,945 | $ 70,007 | |||||
American Depositary Shares | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of stock (shares) | 22,222,223 | 11,111,112 | 19,178,082 | ||||
Over allotment option, exercisable period | 30 days | 30 days | |||||
Sale of stock price per share | $ 18 | $ 17.575 | $ 3.41 | ||||
Net proceeds from public offering | $ 194,800 | $ 70,000 | |||||
American Depositary Shares | Over-Allotment Option | |||||||
Stockholders Equity Note [Line Items] | |||||||
Issuance of stock (shares) | 3,333,333 | 2,876,712 | |||||
Issuance of stock (shares), exercised | 1,438,356 | ||||||
Sale of stock price per share | $ 18 | ||||||
Gross proceeds from public offering including exercised option | $ 460,000 | ||||||
Net proceeds from public offering including exercised option | $ 440,100 |
Equity - Incentive Equity Award
Equity - Incentive Equity Awards - Additional Information (Detail) - USD ($) $ in Thousands | May 20, 2019 | Feb. 01, 2019 | Nov. 01, 2018 | May 14, 2018 | Mar. 12, 2018 | Feb. 01, 2018 | Oct. 31, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Stockholders Equity Note [Line Items] | ||||||||||
Stock options, outstanding | 16,259,328 | |||||||||
Shares issued, exercise of stock options | 5,122,107 | 5,439,239 | ||||||||
Proceeds from exercise of stock options, net of transaction costs | $ 19,544 | $ 16,494 | ||||||||
Restricted Stock Units (RSUs) | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Restricted stock units, outstanding | 9,358,721 | |||||||||
Percentage of outstanding shares on a fully diluted basis | 2.00% | |||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Stock units, Granted | 45,163 | 757,800 | 190,034 | 1,305,575 | ||||||
Stock units, Vesting Period | 3 years | 3 years | 3 years | 3 years | ||||||
Stock units, additional granted | 20,000 | |||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Vesting Period | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Stock units, Granted | 90,000 | 970,000 | ||||||||
Stock units, Vesting Period | 3 years | |||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Vest over a three year period | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Shares issued, related to the vesting of RSUs | 387,715 | |||||||||
Treasury shares for settlement of employee tax obligations | 139,928 | |||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Employees | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Stock units, Granted | 580,000 | |||||||||
Stock Options | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Percentage of outstanding shares on a fully diluted basis | 4.00% | |||||||||
Stock Options | Stock Incentive Plan 2011 | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Stock options, Granted | 58,721 | 1,193,400 | 286,536 | 2,205,075 | ||||||
Stock units, Vesting Period | 4 years | 4 years | ||||||||
Performance-Based RSUs | ||||||||||
Stockholders Equity Note [Line Items] | ||||||||||
Shares issued, related to the vesting of RSUs | 2,436,750 | 2,499,750 | ||||||||
Treasury shares for settlement of employee tax obligations | 1,069,377 | 764,819 |
Co-Promotion Agreement - Additi
Co-Promotion Agreement - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Co Promotion Agreement [Line Items] | ||
Accrued expenses and other current liabilities | $ 134,542 | $ 84,171 |
Co-Promotion Agreement | Kowa Pharmaceuticals America, Inc. | ||
Co Promotion Agreement [Line Items] | ||
Agreement amended date | Jul. 25, 2017 | |
Promotion fee as a percentage of gross margin | 18.50% | |
Maximum co-promotion tail payments receive period | 3 years | |
Co-promotion tail payments receivable | $ 17,800 | |
Tail payments during the period | $ 4,800 | |
Accrued co- promotion tail payments | 12,300 | $ 16,600 |
Accrued expenses and other current liabilities | $ 7,600 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | |
Payment period from distributors received from date of sale | 30 days |
Sales discount percentage | 2.00% |
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 |
Maximum | |
Disaggregation Of Revenue [Line Items] | |
Payment period from distributors received from date of sale | 60 days |
Revenue Recognition - Summarize
Revenue Recognition - Summarize Activity of the Net Product Revenue Allowance and Reserve Categories (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ 65,244 | $ 48,093 |
Provision related to current period sales | 369,133 | 175,167 |
Provision related to prior period sales | (204) | (1,565) |
Credits/payments made for current period sales | (249,600) | (106,961) |
Credits/payments made for prior period sales | (62,540) | (43,617) |
Ending balance | 122,033 | 71,117 |
Trade Allowances | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 19,495 | 12,035 |
Provision related to current period sales | 62,177 | 30,814 |
Provision related to prior period sales | (660) | |
Credits/payments made for current period sales | (34,400) | (15,908) |
Credits/payments made for prior period sales | (19,325) | (11,657) |
Ending balance | 27,947 | 14,624 |
Rebates, Chargebacks and Discounts | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 41,634 | 32,064 |
Provision related to current period sales | 274,439 | 128,905 |
Provision related to prior period sales | (204) | (836) |
Credits/payments made for current period sales | (184,801) | (76,015) |
Credits/payments made for prior period sales | (41,363) | (29,594) |
Ending balance | 89,705 | 54,524 |
Product Returns | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 2,948 | 1,887 |
Provision related to current period sales | 1,635 | 812 |
Credits/payments made for current period sales | 5 | |
Credits/payments made for prior period sales | (653) | (69) |
Ending balance | 3,935 | 2,630 |
Other Incentives | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 1,167 | 2,107 |
Provision related to current period sales | 30,882 | 14,636 |
Provision related to prior period sales | (69) | |
Credits/payments made for current period sales | (30,404) | (15,038) |
Credits/payments made for prior period sales | (1,199) | (2,297) |
Ending balance | $ 446 | $ (661) |
Development, Commercializatio_3
Development, Commercialization and Supply Agreement - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 16 Months Ended | 25 Months Ended | 47 Months Ended | 56 Months Ended | ||||||
Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Mar. 31, 2016USD ($) | Feb. 28, 2015USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)Item | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2017USD ($) | |
License And Collaboration Agreements [Line Items] | ||||||||||||||
Revenue recognized related to upfront and milestone payments | $ 1,131,000 | $ 598,000 | ||||||||||||
Licenses revenue | $ 112,408,000 | $ 55,323,000 | 286,478,000 | 151,884,000 | ||||||||||
Deferred revenue | $ 20,956,000 | 19,579,000 | 20,956,000 | 19,579,000 | 20,956,000 | $ 20,710,000 | $ 20,710,000 | $ 19,579,000 | $ 20,710,000 | $ 19,579,000 | $ 19,054,000 | |||
Licensing Revenue | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 158,000 | $ 350,000 | $ 1,131,000 | 598,000 | ||||||||||
Mochida | In-licenses | Research and Development Expense | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Upfront payment | 2,700,000 | |||||||||||||
Eddingpharm | 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 | 200,000 | 100,000 | ||||||||||||
Deferred revenue | 13,000,000 | 13,000,000 | 13,200,000 | 13,200,000 | 13,000,000 | 13,200,000 | 13,000,000 | |||||||
Eddingpharm | Out-licenses | Licensing Revenue | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | 2,800,000 | 3,000,000 | ||||||||||||
Eddingpharm | 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 | |||||||||||||
Eddingpharm | 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 | |||||||||||||
Eddingpharm | Out-licenses | Clinical Trial Application | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable milestone payment | $ 1,000,000 | |||||||||||||
Biologix FZCo | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Revenue recognition period of non-refundable up-front payment | 10 years | |||||||||||||
HLS | Out-licenses | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Non-refundable up-front received | $ 5,000,000 | |||||||||||||
Non-refundable milestone payment | $ 2,500,000 | $ 2,500,000 | ||||||||||||
Revenue recognized related to upfront and milestone payments | 900,000 | $ 500,000 | ||||||||||||
Deferred revenue | $ 5,700,000 | $ 5,700,000 | $ 6,600,000 | 6,600,000 | 5,700,000 | $ 6,600,000 | $ 5,700,000 | |||||||
Non-refundable up-front received period | 6 months | |||||||||||||
HLS | Out-licenses | Licensing Revenue | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Licenses revenue | $ 900,000 | $ 1,800,000 | ||||||||||||
HLS | Out-licenses | Maximum | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Additional upfront payment eligible to receive based on development, regulatory and sales Milestone | $ 57,500,000 |
Development, Commercializatio_4
Development, Commercialization and Supply Agreement - Additional Information (Detail 1) - Out-licenses - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2019-07-01 | Sep. 30, 2019 |
Eddingpharm | |
License And Collaboration Agreements [Line Items] | |
Revenue recognized over remaining period | 15 years |
HLS | |
License And Collaboration Agreements [Line Items] | |
Revenue recognized over remaining period | 11 years |
Development, Commercializatio_5
Development, Commercialization and Supply Agreement - Changes in Balances of Contract Assets and Liabilities (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Contract liabilities: | ||
Deferred revenue, Balance at Beginning of Period | $ 20,710 | $ 19,054 |
Deferred revenue, Additions | 2,500 | |
Deferred revenue, Deductions | (1,131) | (598) |
Deferred revenue, Balance at End of Period | $ 19,579 | $ 20,956 |
Development, Commercializatio_6
Development, Commercialization and Supply Agreement - Recognized Revenues Changes in Contract Asset and Contract Liability Balances (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue recognized in the period from: | ||
Amounts included in contract liability at the beginning of the period | $ 1,131 | $ 405 |
Performance obligations satisfied in previous periods | $ 193 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | Aug. 15, 2019USD ($)RenewalOption | Jul. 04, 2019 | Apr. 12, 2019 | Jan. 26, 2019 | Jul. 01, 2011 | Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) |
Lessee Lease Description [Line Items] | |||||||
Incremental borrowing rate for purposes of calculation of lease liabilities | 11.50% | 11.50% | |||||
Change in incremental borrwing rate | 1.00% | ||||||
Monthly rent payment | $ 18,223 | $ 18,223 | |||||
Operating lease liability | 9,556 | 9,556 | |||||
Operating lease right-of-use asset | 8,633 | 8,633 | |||||
Operating lease expense | $ 400 | $ 1,100 | |||||
Dublin | Office Centre Sharing Agreements | |||||||
Lessee Lease Description [Line Items] | |||||||
Description of lease agreement | On April 12, 2019 and July 4, 2019, the Company entered into Office Centre Sharing Agreements effective May 1, 2019 and October 1, 2019, respectively, to replace the office space with new office space in Dublin, Ireland which terminates on April 30, 2020 and September 30, 2020, respectively, and can be extended automatically for successive one year periods. | ||||||
Lease termination existence of option to extend | true | ||||||
Lease renewal term | 1 year | 1 year | |||||
Operating lease, option to extend | can be extended automatically for successive one year periods. | ||||||
Operating lease, existence of option to extend [true false] | true | ||||||
Dublin | Office Centre Sharing Agreements Effective May 1, 2019 | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease, expiration date | Apr. 30, 2020 | ||||||
Dublin | Office Centre Sharing Agreements Effective October 1, 2019 | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease, expiration date | Sep. 30, 2020 | ||||||
Bedminster | |||||||
Lessee Lease Description [Line Items] | |||||||
Operating lease, expiration date | Sep. 15, 2019 | Sep. 15, 2019 | |||||
Bridgewater | |||||||
Lessee Lease Description [Line Items] | |||||||
Description of lease agreement | Amarin will have a one-time option to terminate the agreement effective on the first day of the ninety-seventh month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. | ||||||
Lease termination existence of option to extend | true | ||||||
Lease renewal term | 5 years | ||||||
Lease commencement date | Aug. 15, 2019 | ||||||
Lease agreement term | 11 years | ||||||
Number of renewal options | RenewalOption | 2 | ||||||
Lease termination description | one-time option to terminate the agreement effective on the first day of the ninety-seventh month after the Commencement Date | ||||||
Monthly rent payment | $ 100 | ||||||
Maximum | |||||||
Lessee Lease Description [Line Items] | |||||||
Short term lease period | 12 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) $ in Thousands | Sep. 30, 2019USD ($) |
Undiscounted lease payments | |
2020 | $ 124 |
2021 | 1,344 |
2022 | 1,743 |
2023 | 1,801 |
2024 | 1,835 |
2025 and thereafter | 11,376 |
Total undiscounted payments | 18,223 |
Discount Adjustments | (8,667) |
Operating lease liability | $ 9,556 |