Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 20, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | AMRN | ||
Entity Registrant Name | AMARIN CORP PLC\UK | ||
Entity Central Index Key | 897,448 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 433,300,000 | ||
Ordinary Shares | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 1,936,818 | ||
American Depository Shares | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 183,074,916 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and cash equivalents | $ 106,961 | $ 119,539 |
Restricted cash | 600 | 600 |
Accounts receivable, net | 13,826 | 7,842 |
Inventory | 18,985 | 13,733 |
Deferred tax assets, current | 934 | |
Prepaid and other current assets | 3,152 | 2,633 |
Total current assets | 143,524 | 145,281 |
Property, plant and equipment, net | 243 | 381 |
Deferred tax assets, long-term | 18,233 | 12,556 |
Other long-term assets | 2,045 | 2,826 |
Intangible asset, net | 9,417 | 10,063 |
TOTAL ASSETS | 173,462 | 171,107 |
Current Liabilities: | ||
Accounts payable | 10,832 | 8,525 |
Current portion of long-term debt | 14,742 | 15,394 |
Deferred revenue, current | 923 | |
Accrued expenses and other current liabilities | 24,226 | 16,387 |
Total current liabilities | 50,723 | 40,306 |
Long-Term Liabilities: | ||
Exchangeable senior notes, net of discount | 138,605 | 121,846 |
Long-term debt | 91,512 | 89,617 |
Long-term debt derivative liabilities | 8,170 | 7,400 |
Deferred revenue, long-term | 13,308 | |
Other long-term liabilities | 335 | 386 |
Total liabilities | $ 302,653 | $ 259,555 |
Commitments and contingencies (Note 9) | ||
Stockholders' Deficit: | ||
Series A Convertible Preferred Stock, £0.05 par, unlimited authorized; 328,184,640 issued and outstanding as of December 31, 2015 (equivalent to 32,818,464 ordinary shares upon future consolidation and redesignation at a 10:1 ratio); zero shares issued and outstanding as of December 31, 2014 | $ 24,364 | |
Common stock, £0.50 par value, unlimited authorized; 183,577,765 issued, 183,403,263 outstanding as of December 31, 2015; 174,610,451 issued, 174,590,372 outstanding as of December 31, 2014 | 149,978 | $ 143,113 |
Additional paid-in capital | 816,171 | 738,890 |
Treasury stock; 174,502 shares as of December 31, 2015; 20,079 shares as of December 31, 2014 | (411) | (217) |
Accumulated deficit | (1,119,293) | (970,234) |
Total stockholders' deficit | (129,191) | (88,448) |
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ 173,462 | $ 171,107 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - £ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Preferred stock, par value | £ 0.05 | |
Preferred stock, issued | 328,184,640 | 0 |
Preferred stock, shares outstanding | 328,184,640 | 0 |
Preferred stock, equivalent ordinary shares upon future consolidation | 32,818,464 | 0 |
Common stock, par value | £ 0.50 | £ 0.50 |
Common stock, issued | 183,577,765 | 174,610,451 |
Common stock, outstanding | 183,403,263 | 174,590,372 |
Treasury stock, shares | 174,502 | 20,079 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Product revenue, net | $ 80,987 | $ 54,202 | $ 26,351 |
Licensing revenue | 769 | ||
Total revenue, net | 81,756 | 54,202 | 26,351 |
Less: Cost of goods sold | 27,875 | 20,485 | 11,912 |
Gross margin | 53,881 | 33,717 | 14,439 |
Operating expenses: | |||
Selling, general and administrative | 101,041 | 79,346 | 123,795 |
Research and development | 51,062 | 50,326 | 72,750 |
Total operating expenses | 152,103 | 129,672 | 196,545 |
Operating loss | (98,222) | (95,955) | (182,106) |
(Loss) gain on change in fair value of derivative liabilities | (1,106) | 13,472 | 47,710 |
Gain on extinguishment of debt | 1,314 | 38,034 | |
Interest expense | (20,180) | (18,575) | (34,179) |
Interest income | 132 | 96 | 343 |
Other (expense) income, net | (228) | 3,727 | (1,189) |
Loss from operations before taxes | (118,290) | (59,201) | (169,421) |
Benefit from income taxes | 3,086 | 2,837 | 3,194 |
Net loss | (115,204) | (56,364) | (166,227) |
Preferred stock purchase option | (868) | ||
Preferred stock beneficial conversion features | (32,987) | ||
Net loss applicable to common shareholders | $ (149,059) | $ (56,364) | $ (166,227) |
Loss per share: | |||
Basic | $ (0.83) | $ (0.32) | $ (1.03) |
Diluted | $ (0.83) | $ (0.36) | $ (1.28) |
Weighted average shares: | |||
Basic | 180,654 | 173,719 | 161,022 |
Diluted | 180,654 | 173,824 | 167,070 |
Consolidated Statements Of Stoc
Consolidated Statements Of Stockholders' Deficit - USD ($) $ in Thousands | Total | Series A Preferred Stock | Preferred Shares | Preferred SharesSeries A Preferred Stock | Common Shares | Treasury Stock | Additional Paid-in Capital | Additional Paid-in CapitalSeries A Preferred Stock | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2012 | 150,360,933 | (20,079) | |||||||
Beginning Balance at Dec. 31, 2012 | $ (3,997) | $ 124,597 | $ (217) | $ 619,266 | $ (747,643) | ||||
Exercise of warrants (in shares) | 147,050 | ||||||||
Exercise of warrants | 160 | $ 113 | 47 | ||||||
Exercise of stock options (in shares) | 386,000 | ||||||||
Exercise of stock options | 627 | $ 292 | 335 | ||||||
Issuance of shares (in shares) | 21,700,000 | ||||||||
Issuance of shares | 121,206 | $ 16,401 | 104,805 | ||||||
Vesting of restricted stock units (in shares) | 93,048 | ||||||||
Vesting of restricted stock units | $ 71 | (71) | |||||||
Tax provision on stock-based compensation | (361) | (361) | |||||||
Transfer of fair value of warrants exercised from liabilities to equity | 24 | 24 | |||||||
Share issuances for services (in shares) | 4,032 | ||||||||
Share issuances for services | 27 | $ 3 | 24 | ||||||
Stock-based compensation | 14,685 | 14,685 | |||||||
Net loss | (166,227) | (166,227) | |||||||
Ending Balance (in shares) at Dec. 31, 2013 | 172,691,063 | (20,079) | |||||||
Ending Balance at Dec. 31, 2013 | $ (33,856) | $ 141,477 | $ (217) | 738,754 | (913,870) | ||||
Exercise of warrants (in shares) | 1,684,888 | 1,684,888 | |||||||
Exercise of warrants | $ 1,651 | $ 1,443 | 208 | ||||||
Exercise of stock options (in shares) | 234,500 | 234,500 | |||||||
Exercise of stock options | $ 307 | $ 193 | 114 | ||||||
Reacquisition of conversion option in convertible notes | (10,100) | (10,100) | |||||||
Tax provision on stock-based compensation | (2,299) | (2,299) | |||||||
Stock-based compensation | 9,022 | 9,022 | |||||||
Refund of equity issuance costs | 3,191 | 3,191 | |||||||
Net loss | (56,364) | (56,364) | |||||||
Ending Balance (in shares) at Dec. 31, 2014 | 174,610,451 | (20,079) | |||||||
Ending Balance at Dec. 31, 2014 | (88,448) | $ 143,113 | $ (217) | 738,890 | (970,234) | ||||
Conversion of Series A Convertible Preferred Stock, net (in shares) | (62,833,330) | 6,283,333 | |||||||
Conversion of Series A Convertible Preferred Stock, net | (187) | $ (4,804) | $ 4,804 | (187) | |||||
Preferred stock purchase option | $ 946 | 1,814 | (868) | ||||||
Preferred stock beneficial conversion features | 32,987 | (32,987) | |||||||
Exercise of warrants (in shares) | 1,844,585 | 1,844,585 | |||||||
Exercise of warrants | $ 2,713 | $ 1,429 | 1,284 | ||||||
Exercise of stock options (in shares) | 18,020 | 18,020 | |||||||
Exercise of stock options | $ 31 | $ 13 | 18 | ||||||
Issuance of shares (in shares) | 391,017,970 | ||||||||
Issuance of shares | $ 57,853 | $ 29,168 | $ 28,685 | ||||||
Vesting of restricted stock units (in shares) | 821,376 | (154,423) | |||||||
Vesting of restricted stock units | (194) | $ 619 | $ (194) | (619) | |||||
Reacquisition of conversion option in convertible notes | (1,300) | (1,300) | |||||||
Tax benefits realized from stock-based compensation | 727 | 727 | |||||||
Stock-based compensation | 13,872 | 13,872 | |||||||
Net loss | (115,204) | (115,204) | |||||||
Ending Balance (in shares) at Dec. 31, 2015 | 328,184,640 | 183,577,765 | (174,502) | ||||||
Ending Balance at Dec. 31, 2015 | $ (129,191) | $ 24,364 | $ 149,978 | $ (411) | $ 816,171 | $ (1,119,293) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (115,204) | $ (56,364) | $ (166,227) |
Adjustments to reconcile loss to net cash used in operating activities: | |||
Depreciation and amortization | 166 | 198 | 246 |
Stock-based compensation | 13,889 | 9,022 | 14,685 |
Excess tax (benefit from) provision on stock-based awards | (727) | 2,299 | 361 |
Amortization of debt discount and debt issuance costs | 8,258 | 5,863 | 17,631 |
Amortization of intangible asset | 646 | 646 | 646 |
Loss (gain) on changes in fair value of derivative liabilities | 1,106 | (13,472) | (47,710) |
Gain on extinguishment of debt | (1,314) | (38,034) | |
Deferred income taxes | (4,252) | (3,614) | (3,434) |
Change in lease liability | 6 | ||
Shares issued for services | 27 | ||
Changes in assets and liabilities: | |||
Restricted cash | 400 | (1,000) | |
Accounts receivable | (5,984) | (4,197) | (3,645) |
Inventories | (5,252) | 12,958 | (5,429) |
Prepaid and other current assets | (519) | (1,053) | 1,690 |
Other non-current assets | 431 | 4,014 | 591 |
Accrued interest payable | (652) | 2,420 | 10,454 |
Deferred revenue | 14,231 | (1,703) | 1,703 |
Accounts payable and other current liabilities | 10,489 | 8,811 | (7,228) |
Other non-current liabilities | (51) | ||
Net cash used in operating activities | (84,748) | (72,309) | (190,336) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of equipment | (28) | (14) | |
Net cash used in investing activities | (28) | (14) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of preferred stock, net of transaction costs | 57,666 | ||
Proceeds from issuance of common stock, net of transaction costs | 121,206 | ||
Proceeds from issuance of convertible debt, net of transaction costs | 27,514 | ||
Proceeds from exercise of warrants, net of transaction costs | 2,713 | 1,651 | 160 |
Proceeds from exercise of stock options, net of transaction costs | 31 | 307 | 627 |
Refund of equity issuance costs | 3,191 | ||
Debt issuance costs | (109) | (2,480) | |
Repurchase of convertible notes, including transaction costs | (16,145) | ||
Excess tax benefit from (provision on) stock-based awards | 727 | (2,299) | (361) |
Acquisition of treasury stock | (194) | ||
Payments under capital leases | (5) | (36) | (10) |
Net cash provided by financing activities | 72,198 | 334 | 121,622 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (12,578) | (71,975) | (68,728) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 119,539 | 191,514 | 260,242 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 106,961 | 119,539 | 191,514 |
Cash paid during the year for: | |||
Interest | 12,559 | 10,033 | 6,090 |
Income taxes | 711 | 781 | 1,395 |
Supplemental disclosure of non-cash items: | |||
Transfer of preferred stock purchase option derivative liability to equity | 868 | ||
Accretion of preferred stock beneficial conversion features | 32,987 | ||
Conversion of Series A Convertible Preferred Stock into common stock | 4,804 | ||
Reacquisition of conversion option in convertible notes | 1,300 | 10,100 | |
Reclassification of warrant liability to additional paid-in capital | 24 | ||
Warrant | |||
Adjustments to reconcile loss to net cash used in operating activities: | |||
Stock-based compensation | $ (9) | $ (503) | $ (3,703) |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2015 | |
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 biopharmaceutical company with expertise in lipid science focused on the commercialization and development of therapeutics to improve cardiovascular health. The Company’s lead product, Vascepa ® > > The Company is also developing Vascepa for FDA approval of potential additional indications for use. In particular, the Company is conducting a cardiovascular outcomes study of Vascepa, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial). The REDUCE-IT study is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in a high-risk patient population on statin therapy. Basis of Presentation The consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (the “U.S.” or the “United States”) and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. The consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated. The preparation of the Company’s consolidated financial statements in conformity with U.S. Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The results of operations for the years ended December 31, 2015, 2014 and 2013 are not necessarily indicative of the results for any future period. Certain prior year balances have been reclassified to conform to current year presentation. The accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. At December 31, 2015, the Company had cash and cash equivalents of $107.0 million. The Company’s consolidated balance sheets also include derivative liabilities as well as long-term debt and exchangeable senior notes. The January 2012 exchangeable senior notes, or the 2012 Notes, may be redeemed on or after January 19, 2017. The May 2014 exchangeable senior notes, or the 2014 Notes and the November 2015 exchangeable senior notes, or the 2015 Notes, may be redeemed on or after January 19, 2019 at the option of the holders and is not puttable by the holders prior to this date except upon the occurrence of certain contingent events. The 2012 Notes are exchangeable under certain circumstances into cash, American Depository Shares, or ADSs, or a combination of cash and ADSs, at the Company’s election. The 2014 Notes and 2015 Notes are exchangeable under certain circumstances into ADSs. Accordingly, the long-term debt and exchangeable senior notes do not represent a short-term claim on the liquid assets of the Company. The Company believes its cash and cash equivalents will be sufficient to fund its projected operations for at least the next twelve months. Depending on the level of cash generated from operations, additional capital may be required to sustain operations. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Significant Accounting Policies | (2) Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances. Estimates are used in determining such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances; depreciable/amortizable lives; asset impairments; valuation allowance on deferred taxes; probabilities of achievement of performance conditions for certain equity awards; amounts recorded for licensing revenue; contingencies and accruals; and valuations of derivative and long-term debt instruments. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness. Use of Forecasted Financial Information in Accounting Estimates The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of derivatives, debt instruments and intangible assets, and evaluating the need for valuation allowances for deferred tax assets. Such forecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results. Management believes that its financial forecasts are reasonable and appropriate based upon current facts and circumstances. Because of the inherent nature of forecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts the carrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates. Revenue Recognition 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, 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 accordance with GAAP, the Company’s revenue recognition policy requires that: (i) there is persuasive evidence that an arrangement exists between the Company and the Distributor, (ii) delivery has occurred, (iii) collectability is reasonably assured and (iv) the price is fixed or determinable. The Company commenced its commercial launch in the United States in January 2013. Prior to 2013, the Company recognized no revenue from Vascepa sales. In accordance with GAAP, until the Company had the ability to reliably estimate returns of Vascepa from its Distributors, revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions, and not based on sales from the Company to such Distributors. During the three months ended March 31, 2014, the Company concluded that it had developed sufficient history such that it can reliably estimate returns and as a result, began to recognize revenue based on sales to its Distributors. The change in revenue recognition methodology resulted in the recognition of previously deferred revenue. As of December 31, 2013, the Company had deferred approximately $1.7 million in amounts billed to Distributors that was not recognized as revenue. This change in revenue recognition methodology resulted in the recognition of such deferred revenues in the three months ended March 31, 2014. The Company has contracts with its primary Distributors and delivery occurs when a Distributor receives Vascepa. 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 or when the product is utilized. In order to conclude that the price is fixed or determinable, the Company must be able to (i) calculate its gross product revenues from the sales to Distributors and (ii) reasonably estimate its net product revenues. The Company calculates gross product revenues based on the wholesale acquisition cost that the Company charges its Distributors for Vascepa. The Company estimates its net product revenues by deducting from its gross product revenues (a) trade allowances, such as invoice discounts for prompt payment and distributor fees, (b) estimated government and private payor rebates, chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives offered to certain indirect customers, including patients. Trade Allowances: Rebates, Chargebacks and Discounts: Product Returns: Other Incentives: The following table summarizes activity in each of the net product revenue allowance and reserve categories described above for the years ended December 31, 2015 and 2014 (in thousands): Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of January 1, 2014 $ 1,071 $ 1,137 $ 72 $ 189 $ 2,469 Provision related to current period sales 8,157 12,753 397 11,153 32,460 Provision related to prior period sales (29 ) (80 ) 12 (31 ) (128 ) Credits/payments made for current period sales (5,950 ) (9,143 ) — (10,338 ) (25,431 ) Credits/payments made for prior period sales (1,042 ) (1,057 ) — (181 ) (2,280 ) Balance as of December 31, 2014 $ 2,207 $ 3,610 $ 481 $ 792 $ 7,090 Provision related to current period sales 14,986 32,591 342 8,310 56,229 Provision related to prior period sales (174 ) (70 ) (205 ) — (449 ) Credits/payments made for current period sales (10,690 ) (22,710 ) — (7,226 ) (40,626 ) Credits/payments made for prior period sales (2,033 ) (3,540 ) (83 ) (792 ) (6,448 ) Balance as of December 31, 2015 $ 4,296 $ 9,881 $ 535 $ 1,084 $ 15,796 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. Multiple-Element Arrangements and Licensing Revenue When evaluating multiple-element arrangements, the Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on whether the delivered element has stand-alone value to the customer or if the arrangement includes a general right of return for delivered items. The consideration received is allocated between each of the separable elements in the arrangement using the relative selling price method. The selling price used for each separable element will be based on vendor specific objective evidence (“VSOE”) if available, third-party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third-party evidence is available. Revenue is then recognized as each of the separable elements to which the revenue has been allocated is delivered. The Company may receive up-front, non-refundable payments when licensing its intellectual property in conjunction with research, development and commercialization agreements. In determining the units of accounting, management evaluates whether the license has stand-alone value from the undelivered elements to the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this 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. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributable to the license over the Company’s contractual or estimated performance period. Any unrecognized portion of license revenue is classified within deferred revenue in the accompanying consolidated balance sheets. When management believes the license to its intellectual property has stand-alone value, the Company recognizes revenue attributed to the license upon delivery. The periods over which revenue is recognized is subject to estimates by management and may change over the course of the agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Milestones Contingent consideration from activities that is earned upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. At the inception of each arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive. This evaluation includes an assessment of whether: (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. See Note 17—Development, Commercialization and Supply Agreement for further information regarding licensing revenue and milestones related to the Company’s multiple-element arrangement with Eddingpharm (Asia) Macao Commercial Offshore Limited. Distribution Costs The Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distribution services, in cost of goods sold. Cash and Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with 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 does not currently maintain an allowance for doubtful accounts and has not historically experienced any credit losses. The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of December 31, 2015 and 2014 (in thousands): December 31, 2015 December 31, 2014 Gross trade accounts receivable $ 18,270 $ 10,215 Trade allowances (4,296 ) (2,207 ) Chargebacks (148 ) (166 ) Accounts receivable, net $ 13,826 $ 7,842 Inventory The Company states inventories at the lower of cost or market value. Cost is determined based on actual cost using the average cost method. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected market value due to obsolescence, damage or quantities in excess of expected demand, the Company will reduce the carrying value of such inventory to market value. The Company received FDA approval for Vascepa on July 26, 2012 and after that date began capitalizing inventory purchases of saleable product from approved suppliers. Until an active pharmaceutical ingredient, or API, supplier is approved, all Vascepa API purchased from such supplier is included as a component of research and development expense. Upon sNDA approval of each additional supplier, the Company capitalizes subsequent Vascepa API purchases from such supplier as inventory. Purchases of Vascepa API received and expensed before such regulatory approvals is not subsequently capitalized, and all such purchases are quarantined and not used for commercial supply until such time as the sNDA for the supplier that produced the API is approved. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of Vascepa API. Property, Plant and Equipment The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life. The estimated useful lives, by asset classification, are as follows: Asset Classification Useful Lives Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Leasehold improvements Lesser of useful life or lease term Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the balance sheet and any resulting gain or loss is credited or expensed to operations. Repairs and maintenance costs are expensed as incurred. Long-Lived Asset Impairment The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets. Intangible Asset, net Intangible asset, net consists of a milestone payment paid to the former shareholders of Laxdale Limited related to the 2004 acquisition of the rights to Vascepa, which is the result of Vascepa receiving marketing approval for the first indication and is amortized over its estimated useful life on a straight-line basis. See Note 9—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale Limited. Beneficial Conversion Features The Company issued Series A preference shares in a private placement transaction executed in two tranches that each contain a conversion feature whereby such shares are convertible into ordinary shares at a fixed rate. The conversion price on the date of issuance was less than the market price of the Company’s ordinary shares. It was determined that these discounts represent contingent beneficial conversion features, which were valued based on the difference between the conversion price and the market price of the ordinary shares on the date of issuance, which is the commitment date. These features are analogous to preference dividends and were each recorded as a non-cash return to preferred shareholders through accumulated deficit upon the earliest possible date of conversion, which occurred in the three months ended June 30, 2015 upon effectiveness of the related resale Registration Statement on Form S-3 and in the three months ended September 30, 2015 upon shareholder approval received at the Company’s Annual General Meeting of Shareholders. See Note 10—Equity for further discussion. Costs for Patent Litigation and Legal Proceedings Costs for patent litigation or other legal proceedings are expensed as incurred and included in selling, general and administrative expenses. Research and Development Costs The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including: salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense. In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier. Selling, General and Administrative Costs The Company charges selling, general and administrative costs to operations as incurred. Selling, general and administrative costs include costs of salaries, programs and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of Vascepa in the United States as well as co-promotion fees payable to Kowa Pharmaceuticals America, Inc. 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 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. The Company provides reserves for potential payments of tax to various tax authorities or 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. The Company regularly assesses the realizability of deferred tax assets. Changes in historical earnings performance and future earnings projections, 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. Derivative Instruments Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the 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. Warrants are valued using a Black-Scholes option pricing model. The long-term debt redemption features are valued using probability-weighted models incorporating management estimates for potential change in control, and by determining the fair value of the debt with and without the change in control provision included. If the terms of warrants that initially require the warrant to be classified as a derivative financial liability lapse, the derivative financial liability is reclassified out of financial liabilities into equity at its fair value on that date. The cash proceeds received from exercises of warrants are recorded in common stock and additional paid-in capital. 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 and warrants 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 and warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, for diluted net loss per share purposes, the impact of such gains is reversed and the treasury stock method is used to determine diluted net loss per share. 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 years ended December 31, 2015, 2014 and 2013 are as follows: In thousands 2015 2014 2013 Net loss $ (115,204 ) $ (56,364 ) $ (166,227 ) Preferred stock purchase option (see Note 10) (868 ) — — Preferred stock beneficial conversion features (see Note 10) (32,987 ) — — Net loss applicable to common shareholders—basic (149,059 ) (56,364 ) (166,227 ) Gain on warrant derivative liability — (6,775 ) (47,936 ) Net loss—diluted (149,059 ) (63,139 ) (214,163 ) Net loss per share—basic $ (0.83 ) $ (0.32 ) $ (1.03 ) Weighted average shares outstanding—basic 180,654 173,719 161,022 Effect of dilutive warrants — 105 6,048 Weighted average shares outstanding—diluted 180,654 173,824 167,070 Net loss per share—diluted $ (0.83 ) $ (0.36 ) $ (1.28 ) For the years ended December 31, 2015, 2014 and 2013, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: In thousands 2015 2014 2013 Stock options 17,818 10,670 9,330 Restricted stock and restricted stock units 10,887 2,256 196 Warrants — — 1,702 Exchangeable senior notes (if converted) 59,407 49,215 17,021 Preferred stock (if converted) 32,818 — — Debt Instruments Debt instruments are initially recorded at fair value, with coupon interest and amortization of debt issuance discounts recognized in the statement of operations as interest expense each period in which such instruments are outstanding. If the Company issues shares to discharge the liability, the debt obligation is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. The conversion features in the 2012 Notes, the 2014 Notes and the 2015 Notes qualify for the exception from derivative accounting in accordance with ASC 815-40. The 2012 Notes may be settled, at the Company’s discretion, in any combination of ADSs or cash upon conversion and have been accounted for in accordance with ASC 470-20. Under ASC 470-20, the fair value of the liability component of the 2012 Notes was determined and deducted from the initial proceeds to determine the proceeds allocated to the conversion option, which has been recorded in equity. The difference between the initial fair value of the liability component and the amount repayable is amortized over the expected term of the instrument. The conversion features in the 2014 Notes and 2015 Notes may only be settled in ADSs upon conversion and have been accounted for as part of the debt host. The conversion options in the 2012 Notes, 2014 Notes and 2015 Notes continue to be evaluated on a quarterly basis to determine if they still receive an exception from derivative accounting in accordance with ASC 815-40. The 2014 Notes were recognized initially at fair value as part of an extinguishment of a portion of the 2012 Notes. As a result, the 2014 Notes were initially recognized at a discount of $27.9 million. The 2015 Notes were recognized initially at fair value as part of the issuance of new debt in November 2015. As a result, the 2015 Notes were initially recognized at a discount of $3.8 million. These discounts are being amortized through interest expense over the expected terms of the 2014 Notes and 2015 Notes, which is through January 2019 for each. See Note 8—Debt for further discussion. Stock-Based Compensation Stock-based compensation cost is generally measured at the grant date, based on the fair value of the award, and is recognized as compensation expense over the requisite service period. For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the fair value of the award over the estimated service period. The Company reassesses the probability of achievement of the performance conditions for such awards each reporting period. 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. The Company’s top three customers accounted for 95% of gross product sales for each of the years ending December 31, 2015 and 2014, and represented 95% and 96% of the gross accounts receivable balance as of December 31, 2015 and 2014, respectively. The Company has not experienced any write-offs of its accounts receivable. Concentration of Suppliers The Company has contractual freedom to source the API for Vascepa 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 key suppliers, in particular three suppliers of API for Vascepa. The Company cannot provide assurance that its efforts to procure uninterrupted supply of Vascepa API to meet market demand will continue to be successful or that it will be able to renew current API supply agreements on favorable terms or at all. Significant alteration to or termination of the Company’s current API supply chain or its failure to enter into new and similar agreements, 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 three FDA-approved commercial API encapsulators for Vascepa manufacturing. Each of these companies has qualified 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 encapsulate API will continue to be qualified to manufacture the product to its specifications or that these and any future suppliers will have the manufacturing capacity to meet anticipated demand for Vascepa. Foreign Currency All subsidiaries use the U.S. dollar as the functional currency. Monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at period-end exchange rates. Gains and losses from the remeasurement are included in other (expense) income, net in the consolidated statements of operations. For transactions settled during the applicable period, gains and losses are included in other (expense) income, net in the consolidated statements of operations. Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S. dollar. Debt Issuance Costs Debt issuance costs are initially recorded as a deferred cost and amortized to interest expense using the effective interest method over the expected term of the related debt. Unamortized debt issuance costs related to the extinguishment of debt are expensed at the time the debt is extinguished and recorded in other (expense) income, net in the consolidated statements of operations. Fair Value of Financial Instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, 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 December 31, 2015 and 2014 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: December 31, 2015 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 14,184 $ 14,184 $ — $ — Liabilities: Long-term debt derivative liabilities $ 8,170 $ — $ — $ 8,170 December 31, 2014 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 65,156 $ 65,156 $ — $ — Liabilities: Warrant derivative liability $ 119 $ — $ — $ 119 Long-term debt derivative liabilities $ 7,400 $ — $ — $ 7,400 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 December 31, 2015 and 2014 are as follows: December 31, 2015 December 31, 2014 In thousands Carrying Estimated Carrying Estimated Long-term debt—December 2012 financing $ 91,512 $ 87,700 $ 89,617 $ 81,000 2012 Notes 15,107 13,637 31,266 25,689 2014 Notes 96,364 108,034 90,580 75,533 2015 Notes 27,134 28,448 — — The estimated fair value of the long-term debt pursuant to the December 2012 financing is calculated utilizing the same Level 3 inputs utilized in valuing the related derivative liability (see Long-Term Debt Redemption Features below). The estimated fair value of the 2012 Notes and 2014 Notes is calculated based on Level 1 quoted bond prices, while the estimated fair value of the 2015 Notes is calculated based on Level 2 quoted bond prices for the 2014 Notes. The carrying value of the 2012 Notes as of December 31, 2015 and 2014 does not include a debt discount, as it had been fully amortized as non-cash interest expense over the expected term of the 2012 Notes. The carrying value of the 2014 Notes as of December 31, 2015 and 2014 includes a debt discount of $22.4 million and $28.2 million, respectively, which is being amortized as non-cash interest expense over the expected term of the 2014 Notes, through January 2019. The carrying value of the 2015 Notes as of December 31, 2015 includes a debt discount of $4.1 million, which is being amortized as non-cash interest expense over the expected term of the 2015 Notes, through January 2019. The change in the estimated fair values of these liabilities from Decembe |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2015 | |
Intangible Assets | (3) Intangible Assets Intangible assets consist of the historical acquisition cost of certain technology rights for Vascepa. The carrying value as of December 31, 2015 is as follows (in thousands): Gross Accumulated Amortization Net Weighted Average Remaining Useful Life (in years) Technology rights $ 11,624 $ (2,207 ) $ 9,417 14.6 Amortization expense for each of the years ended December 31, 2015 and 2014 was $0.6 million and is included in research and development expense. Estimated future amortization expense, based upon the Company’s intangible assets as of December 31, 2015 is as follows: Year Ending December 31, Amount 2016 $ 646 2017 646 2018 646 2019 646 2020 646 Thereafter 6,187 Total $ 9,417 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2015 | |
Inventory | (4) Inventory After approval of Vascepa on July 26, 2012 by the FDA, the Company began capitalizing its purchases of saleable inventory of Vascepa from suppliers that have been qualified by the FDA. Inventories as of December 31, 2015 and 2014 consist of the following (in thousands): December 31, 2015 December 31, 2014 Raw materials $ 9,096 $ 5,225 Work in process 1,640 4,757 Finished goods 8,249 3,751 Total inventory $ 18,985 $ 13,733 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment | (5) Property, Plant and Equipment Property, plant and equipment as of December 31, 2015 and 2014 consist of the following (in thousands): December 31, 2015 December 31, 2014 Leasehold improvements $ 135 $ 107 Computer equipment 63 63 Furniture and fixtures 240 240 Software 559 559 997 969 Accumulated depreciation and amortization (754 ) (588 ) Total property, plant and equipment $ 243 $ 381 Depreciation expense for each of the years ended December 31, 2015, 2014, and 2013 was $0.2 million. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses and Other Current Liabilities | (6) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following as of December 31, 2015 and 2014 (in thousands): 2015 2014 Payroll and payroll-related expenses $ 5,241 $ 3,525 Research and development expenses 828 4,391 Sales and marketing accruals 3,141 1,509 Accrued revenue allowances 10,732 4,717 All other 4,284 2,245 Total accrued expenses and other current liabilities $ 24,226 $ 16,387 |
Warrants and Warrant Derivative
Warrants and Warrant Derivative Liability | 12 Months Ended |
Dec. 31, 2015 | |
Warrant | |
Warrants and Warrant Derivative Liability | (7) Warrants and Warrant Derivative Liability October 2009 Warrants Derivative Liability On October 16, 2009, the Company completed a $70.0 million private placement with both existing and new investors resulting in $62.3 million in net proceeds and an additional $3.6 million from bridge notes converted in conjunction with the private placement. In consideration for the $62.3 million in net cash proceeds Amarin issued 66.4 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $1.00 and (ii) a warrant with a five year term to purchase 0.5 (one half) of an ADS at an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6 million of convertible bridge notes, Amarin issued 4.0 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $0.90 and (ii) a warrant with a five year term to purchase 0.5 (one half) of an ADS at an exercise price of $1.50 per ADS. The total number of warrants issued in conjunction with the financing was 35.2 million. In conjunction with the October 2009 financing, the Company issued an additional 0.9 million warrants to three former officers. The warrants issued in connection with the October 2009 financing contained a pricing variability feature which provided for an increase to the exercise price if the exchange rate between the U.S. dollar and British pound adjusts such that the warrants could be exercised at a price less than the £0.5 par value of the common stock—that is, if the exchange rate exceeded U.S. $3.00 per £1.0 sterling. Due to the potential variable nature of the exercise price, the warrants were not considered to be indexed to the Company’s common stock. Accordingly, the warrants did not qualify for the exception to classify the warrants within equity and were classified as a derivative liability. The fair value of this warrant derivative liability was remeasured at each reporting period, with changes in fair value recognized in the statement of operations. Upon exercise, the fair value of the warrants exercised was remeasured and reclassified from warrant derivative liability to additional paid-in-capital. Although the warrants contained a pricing variability feature, the number of warrants issuable remained fixed. Therefore, the maximum number of common shares issuable as a result of the October 2009 private placement was 36.1 million. The change in fair value of the warrant derivative liability is discussed in Note 2. In October 2014, the Company and the holders of the remaining October 2009 warrants mutually agreed to extend the expiration date of such warrants from October 16, 2014 to February 27, 2015. Of the 8,087,388 warrants outstanding as of December 31, 2014, 1,844,585 warrants were exercised, resulting in net proceeds to the Company of $2.7 million, and the remaining 6,242,803 warrants expired on February 27, 2015. As such, no warrants were outstanding as of December 31, 2015. July 2009 Warrants The Company issued several warrants in July 2009. As of December 31, 2015 and 2014, there were no July 2009 warrants outstanding. During the year ended December 31, 2014, 1,684,888 of the July 2009 warrants were exercised, resulting in proceeds to the Company of $1.7 million. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt | (8) Debt Long-Term Debt—December 2012 Financing On December 6, 2012, the Company entered into an 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 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 by BioPharma 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 million with such repayment based on a portion of revenues and receivables generated from Vascepa. As of December 31, 2015, the remaining amount to be repaid to BioPharma is $137.3 million. During the year ended December 31, 2015, the Company made repayments under the agreement of $7.1 million to BioPharma and an additional $2.6 million is scheduled to be paid in February 2016 for the fourth quarter of 2015. These payments were calculated based on the threshold limitation, as described below, as opposed to the scheduled quarterly repayments. Additional quarterly repayments, subject to the threshold limitation, are scheduled to be paid. The maximum quarterly amounts which could be due for payment, except upon a change of control and subject each quarter to the threshold limitation, are in accordance with the following schedule: $15.0 million in the second quarter of 2016 and in each of the next three quarters, and a payment of $13.0 million scheduled for payment in May 2017. All such payments reduce the remainder of the $150 million in aggregate payments to BioPharma. These quarterly payments are subject to a quarterly threshold amount whereby, if a calculated threshold, based on quarterly Vascepa revenues, is not achieved, the quarterly payment payable in that quarter can at the Company’s election be reduced, with the reduction carried forward without interest for payment in a future period. The payment of any carried forward amount is subject to similarly calculated threshold repayment amounts based on Vascepa revenue levels. Except upon a change of control in Amarin, the agreement does not expire until $150 million in aggregate has been repaid. Except in the event of the Company’s default, there is no compounding of interest and no scheduled cliff payment due under this agreement. Rather, payment will be made, subject to the threshold limitation, until $150 million in aggregate has been repaid, including payments made previously. The Company can prepay an amount equal to $150 million less any previously repaid amount. The Company currently estimates that its Vascepa revenue levels will not be high enough in each quarter to support repayment to BioPharma in accordance with the maximum quarterly amounts in the repayment schedule. For each quarterly period since the inception of the debt, revenues were below the contractual threshold amount such that cash payments were calculated for each period reflecting the optional reduction amount as opposed to the contractual threshold payment due for each quarterly period. In accordance with the agreement with BioPharma, quarterly differences between the calculated optional reduction amounts and the repayment schedule amounts are rescheduled for payment beginning in the second quarter of 2017. Any such deferred repayments will remain subject to continued application of the quarterly ceiling in amounts due established by the calculated threshold limitation based on quarterly Vascepa revenues. No additional interest expense or liability is incurred as a result of such deferred repayments. These estimates will be reevaluated each reporting period by the Company and adjusted if necessary, prospectively. 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 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. The Company recognized a loss on change in fair value of derivative liability of $0.7 million and a gain on change in fair value of derivative liability of $6.3 million during the years ended December 31, 2015 and 2014, respectively. During the year ended December 31, 2015, the Company recorded $6.6 million and $1.9 million of cash and non-cash interest expense, respectively, in connection with the BioPharma debt. During the year ended December 31, 2014, the Company recorded $7.2 million and $1.9 million of cash and non-cash interest expense, respectively. 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 with BioPharma, the Company granted BioPharma 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 BioPharma 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 Purchase and Sale Agreement with BioPharma, 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. January 2012 Exchangeable Senior Notes In January 2012, the Company issued $150.0 million in principal amount of 3.5% exchangeable senior notes due 2032, a portion of which were subsequently exchanged and a portion of which was extinguished (see discussion of May 2014 and November 2015 Exchangeable Senior Notes below). The 2012 Notes were issued by Corsicanto Limited, an Irish limited company acquired by Amarin in January 2012. Corsicanto Limited is a wholly-owned subsidiary of Amarin. The general, unsecured, senior obligations are fully and unconditionally guaranteed by Amarin but not by any of the Company’s other subsidiaries. Corsicanto Limited has no assets, operations, revenues or cash flows other than those related to the issuance, administration and repayment of the 2012 Notes and 2014 Notes. There are no significant restrictions on the ability of Amarin to obtain funds from Corsicanto Limited in the form of cash dividends, loans, or advances. Net proceeds to the Company, after payment of underwriting fees and expenses, were approximately $144.3 million. The 2012 Notes have a stated interest rate of 3.5% per year, payable semiannually in arrears on January 15 and July 15 of each year beginning on July 15, 2012, and ending upon the 2012 Notes’ maturity on January 15, 2032. The 2012 Notes are subject to repurchase by the Company at the option of the holders on each of January 19, 2017, January 19, 2022, and January 19, 2027, at a price equal to 100% of the principal amount of the 2012 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date. The 2012 Notes are exchangeable under certain circumstances into cash, ADSs, or a combination of cash and ADSs, at the Company’s election, with an initial exchange rate of 113.4752 ADSs per $1,000 principal amount of 2012 Notes (equivalent to an initial exchange price of approximately $8.8125 per ADS), subject to adjustment in certain circumstances, including adjustment if the Company pays cash dividends. If the Company elected physical settlement, the net remaining outstanding portion of the 2012 Notes would be exchangeable into 1,714,270. Based on the closing price of the Company’s stock as of December 31, 2015, the principal amount of the 2012 Notes would exceed the value of the shares if converted on that date by $11.9 million. Additional covenants include: (i) limitations on future indebtedness under certain circumstances, (ii) the timely filing of documents and reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 with both the SEC and the Trustee and (iii) maintaining the tradability of the 2012 Notes. The Company is required to use commercially reasonable efforts to procure and maintain the listing of the 2012 Notes on the Global Exchange Market operated under the supervision of the Irish Stock Exchange (or other recognized stock exchange as defined in the Note Indenture) prior to July 15, 2012. If the 2012 Notes are not freely tradable, as a result of restrictions pursuant to U.S. securities law or the terms of the Indenture or the 2012 Notes, the Company shall pay additional interest on the 2012 Notes at the rate of 0.50% per annum of the principal amount of 2012 Notes outstanding for each day during such period for which the Company’s failure to file has occurred and is continuing or for which the 2012 Notes are not freely tradable. The Company may not redeem the 2012 Notes prior to January 19, 2017, other than in connection with certain changes in the tax law of a relevant taxing jurisdiction that results in additional amounts becoming due with respect to payments and/or deliveries on the 2012 Notes. On or after January 19, 2017 and prior to the maturity date, the Company may redeem for cash all or part of the 2012 Notes at a redemption price equal to 100% of the principal amount of the 2012 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. There is no prepayment penalty or sinking fund provided for the 2012 Notes. If the Company undergoes a change in control, holders may require the Company to repurchase for cash all or part of their 2012 Notes at a repurchase price equal to 100% of the principal amount of the 2012 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the change in control repurchase date. The 2012 Notes are the Company’s senior unsecured obligations and rank senior in right of payment to the Company’s future indebtedness that is expressly subordinated in right of payment to the 2012 Notes and equal in right of payment to the Company’s future unsecured indebtedness that is not so subordinated. The 2012 Notes are effectively junior in right of payment to future secured indebtedness to the extent of the value of the assets securing such indebtedness. The 2012 Notes are exchangeable under certain circumstances. At the time of issuance, the Company calculated the fair value of the liability component of the outstanding 2012 Notes to be $126.2 million, and the excess of the principal amount of the debt over the liability component of $23.8 million was allocated to the conversion option resulting in a discount on the debt and corresponding increase in equity as a result of the cash settlement feature. The discount created from allocating proceeds to the conversion option was amortized to interest expense using the effective interest method over the 2012 Notes’ estimated remaining life, which was calculated to be a period of twenty-four months. As of December 31, 2015 and 2014, the discount created from the allocation of the proceeds to the conversion option was fully amortized and the carrying amount of the conversion option was $11.5 million and $12.8 million, respectively. The conversion option will not be subsequently remeasured as long as it continues to meet the criteria for equity classification. The Company also recorded a debt discount to reflect the value of the underwriter’s discounts and offering costs. A portion of the debt discount from underwriter’s discounts and offering costs was allocated to the equity and liability components of the 2012 Notes in proportion to the proceeds allocated to each component. The portion of the debt discount from underwriter’s discounts and offering costs allocated to the liability component was amortized as interest expense over the estimated life of the 2012 Notes of twenty-four months. As of December 31, 2015 and 2014, the debt discount was fully amortized and the carrying value of the 2012 Notes was $15.1 million and $31.3 million, respectively, after an exchange and repayment of a portion of the 2012 Notes (see below for further discussion of the May 2014 Notes and November 2015 Notes). May 2014 Exchangeable Senior Notes In May 2014, the Company entered into separate, privately negotiated exchange agreements with certain holders of the 2012 Notes pursuant to which Corsicanto exchanged $118.7 million in aggregate principal amount of the existing 2012 Notes for $118.7 million in aggregate principal amount of new 3.5% May 2014 Exchangeable Senior Notes due 2032, following which $31.3 million in aggregate principal amount of the 2012 Notes remained outstanding with terms unchanged (the 2012 Notes and 2014 Notes are referred to collectively as the “Notes”). The 2014 Notes have a stated interest rate of 3.5% per year, payable semiannually in arrears on January 15 and July 15 of each year beginning on July 15, 2014, and ending upon the 2014 Notes’ maturity on January 15, 2032, unless earlier repurchased or redeemed by Corsicanto or exchanged by the holders. At any time after the issuance of the 2014 Notes and prior to the close of business on the second business day immediately preceding January 15, 2032, holders may exchange the 2014 Notes at their option. If prior to January 15, 2018, a make-whole fundamental change (as defined in the Indenture) occurs or the Company elects to redeem the 2014 Notes in connection with certain changes in tax law, in each case as described in the Indenture, and a holder elects to exchange its 2014 Notes in connection with such make-whole fundamental change or election, as the case may be, such holder may be entitled to an increase in the exchange rate as described in the Indenture. In the event of physical settlement, the 2014 Notes would be exchangeable into 45,666,925 ADSs. The initial exchange rate is 384.6154 ADSs per $1,000 principal amount of the 2014 Notes (equivalent to an initial exchange price of approximately $2.60 per ADS, or the Exchange Price), subject to adjustment in certain circumstances. The exchange rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the payment of cash dividends. Based on the closing price of the Company’s stock as of December 31, 2015, the principal amount of the 2014 Notes would exceed the value of the shares if converted on that date by $32.4 million. Prior to January 19, 2018, the Company may not redeem the 2014 Notes at its option other than in connection with certain changes in the tax law of a relevant taxing jurisdiction that results in additional amounts (as defined in the Indenture) becoming due with respect to payments and/or deliveries on the 2014 Notes. On or after January 19, 2018, the Company may redeem for cash all or a portion of the 2014 Notes at a redemption price of 100% of the aggregate principal amount of the 2014 Notes to be redeemed, plus accrued and unpaid interest to, but not including, the redemption date. If a fundamental change (as defined in the Indenture) occurs, holders may require the Company to repurchase all or part of their 2014 Notes for cash at a fundamental change repurchase price equal to 100% of the aggregate principal amount of the 2014 Notes to be repurchased, plus accrued and unpaid interest to, but not including, the fundamental change repurchase date. In addition, holders of the 2014 Notes may require the Company to repurchase all or any portion of the 2014 Notes on each of January 19, 2019, January 19, 2024 and January 19, 2029 for cash at a price equal to 100% of the aggregate principal amount of the 2014 Notes to be repurchased, plus accrued and unpaid interest to, but not including, the repurchase date. The Company may elect at its option to cause all or any portion of the 2014 Notes to be mandatorily exchanged in whole or in part at any time prior to the close of business on the business day preceding January 15, 2032 if the Daily VWAP (as defined in the Indenture) equals or exceeds 110% of the Exchange Price then in effect for at least 20 VWAP Trading Days (as defined in the Indenture) in any 30 VWAP Trading Day period. The Company may only exercise its optional exchange rights upon satisfaction of specified equity conditions, including that the ADSs issuable upon exchange of the 2014 Notes be eligible for resale without registration by non-affiliates and listed on The NASDAQ Global Market, its related exchanges or the New York Stock Exchange. If Corsicanto elects to exercise its optional exchange rights on or prior to January 15, 2018, each holder whose 2014 Notes are exchanged will upon exchange receive a specified number of additional ADSs as set forth in the Indenture. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Corsicanto, 100% of the principal of and accrued and unpaid interest, if any, on all of the 2014 Notes will become due and payable automatically. Notwithstanding the foregoing, the Indenture will provide that, to the extent Corsicanto elects and for up to 360 days, the sole remedy for an event of default relating to certain failures by Corsicanto or the Company, as the case may be, to comply with certain reporting covenants in the Indenture consists exclusively of the right to receive additional interest on the 2014 Notes. Additional covenants pertaining to the 2012 Notes (as described above for the January 2012 Exchangeable Senior Notes) are also applicable to the May 2014 Notes. As a result of the note exchange (as described above), the Company assessed both quantitative and qualitative aspects of the features of the 2014 Notes as compared to the 2012 Notes. Such assessment resulted in the conclusion that the features of the 2014 Notes represent a substantive modification from the 2012 Notes as the terms of the exchange resulted in a substantive modification to the embedded conversion feature within the 2012 Notes, and as such should be accounted for as an extinguishment of debt. In accordance with ASC 470-20, the Company extinguished the 2012 Notes by recording a gain on extinguishment of the liability component of $38.0 million and repurchase of the conversion option in equity through a reduction to additional paid-in capital of $10.1 million. The 2014 Notes were recorded at fair value of $90.8 million representing a $27.9 million discount to par. In addition the Company recognized $2.5 million in underwriter’s fees and offering costs and recognized those costs as deferred assets. The Company further allocated $3.5 million of the $90.8 million fair value of the 2014 Notes to the derivative liability related to the fundamental change redemption feature (as described above), which will be measured at fair value on an ongoing basis. During the years ended December 31, 2015 and 2014, the Company recognized a gain on the change in fair value of the redemption feature of $0.5 million and $0.9 million, respectively. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the 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. Because the conversion option in the 2014 Notes receives an exception from derivative accounting and only requires gross physical settlement in shares, the embedded option does not require separate accounting and is therefore accounted for as part of the debt host at amortized cost. The debt discount is being amortized as interest expense over the estimated life of the 2014 Notes and recognized in the statement of operations as interest expense. As of December 31, 2015 and 2014, the carrying value of the 2014 Notes, net of the unamortized debt discount, was $96.4 million and $90.6 million, respectively. During the year ended December 31, 2015, the Company recognized aggregate interest expense of $11.4 million related to the Notes, of which $6.2 million represents non-cash interest and $5.2 million represents contractual coupon interest. During the year ended December 31, 2014, the Company recognized aggregate interest expense of $9.5 million related to the Notes, of which $4.2 million represents non-cash interest and $5.3 million represents contractual coupon interest. November 2015 Exchangeable Senior Notes In November 2015, the Company entered into a privately negotiated subscription agreement with one of its existing investors (the “Investor”), pursuant to which the Investor agreed to purchase approximately $31.3 million in aggregate principal amount of new 3.5% November 2015 Exchangeable Senior Notes due 2032 (the “2015 Notes”) for approximately $27.5 million. Approximately $15.9 million of such proceeds were used to finance the repayment of a portion of the 2012 Notes and the remainder will be used for working capital and general corporate purposes. The 2015 Notes have substantially identical terms to the 2014 Notes, except that the 2015 Notes were issued by Amarin Corporation plc and are not guaranteed by any entity. In the event of physical settlement, the 2015 Notes would be exchangeable into 12,025,385 ADSs. The initial exchange rate is 384.6154 ADSs per $1,000 principal amount of 2015 Notes (equivalent to an initial exchange price of approximately $2.60 per ADS), provided that exchanges will be prohibited if, as a result, the holder of such 2015 Notes and its affiliates would beneficially own more than 4.99% of the total number of the Company’s ordinary shares or ADSs outstanding following such exchange (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% (the “Beneficial Ownership Cap”) 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. The exchange rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the payment of cash dividends. Based on the closing price of the Company’s stock as of December 31, 2015, the principal amount of the 2015 Notes would exceed the value of the shares if converted on that date by $8.5 million. The 2015 Notes are the senior unsecured obligations of the Company. The 2015 Notes bear interest at a rate of 3.5% per annum from, and including, November 24, 2015, payable semi-annually in arrears on January 15 and July 15 of each year, beginning on January 15, 2016. The 2015 Notes mature on January 15, 2032, unless earlier repurchased or redeemed by the Company or exchanged by the holders. The 2015 Notes were recorded at fair value of $27.5 million representing a $3.8 million discount to par. In addition, the Company recognized $0.1 million in offering costs and recognized those costs as deferred assets. The Company further allocated $0.5 million of the $27.5 million fair value of the 2015 Notes to the derivative liability related to the fundamental change redemption feature (as described under the 2014 Notes above), which will be measured at fair value on an ongoing basis. During the year ended December 31, 2015, the Company recognized a loss on the change in fair value of the redemption feature of $0.1 million. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the 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. Because the conversion option in the 2015 Notes receives an exception from derivative accounting and only requires gross physical settlement in shares, the embedded option does not require separate accounting and is therefore accounted for as part of the debt host at amortized cost. The debt discount is being amortized as interest expense over the estimated life of the 2015 Notes and recognized in the statement of operations as interest expense. As of December 31, 2015, the carrying value of the 2015 Notes, net of the unamortized debt discount, was $27.1 million. During the year ended December 31, 2015, the Company recognized aggregate interest expense of $0.2 million related to the Notes, of which $0.1 million represents non-cash interest and $0.1 million represents contractual coupon interest. Concurrent with the issuance of the 2015 Notes, Corsicanto Limited and the Company entered into separate, privately negotiated purchase agreements with certain holders of the 2012 Notes pursuant to which the Company purchased (the “2012 Notes Purchase”) approximately $16.2 million in aggregate principal amount of the 2012 Notes for $15.9 million, which includes accrued but unpaid interest on such 2012 Notes. The 2012 Notes Purchase was funded by the issuance of the 2015 Notes. Following the closing of the 2012 Notes Purchase, Corsicanto had approximately $15.1 million in aggregate principal amount of 2012 Notes outstanding. The 2012 Notes Purchase was accounted for as an extinguishment of debt and the Company recorded a gain of $1.3 million upon extinguishment, which represents the reacquisition of the conversion option at fair value and a negotiated discount on the purchase of the notes partially offset by legal and transaction advisory costs incurred. As of December 31, 2015, the Company had total accrued interest on the Notes and the November 2015 Notes of $2.3 million, which is included in other current liabilities. As of December 31, 2014, the Company had total accrued interest on the Notes of $2.4 million. The Company made the contractual interest payments due on the Notes during the years ended December 31, 2015 and 2014. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies | (9) Commitments and Contingencies Litigation On May 7, 2015, the Company and a group of independent physicians filed a federal lawsuit to permit the Company to share truthful and non-misleading information, including, but not limited to, the ANCHOR trial clinical data, with healthcare professionals in the United States about certain uses of Vascepa not included with approved FDA labeling of Vascepa and thus not permitted under the FDA’s interpretation of applicable law. The lawsuit, captioned Amarin Pharma, Inc., et al. v. Food & Drug Administration, et al. Amarin Pharmaceuticals Ireland Ltd. v. Food & Drug Administration, et al. In March, April, and May 2014, the Company received paragraph IV certification notices from six companies contending to varying degrees that certain of its patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of Vascepa as described in those companies’ abbreviated new drug applications, or ANDAs. The Company commenced patent infringement lawsuits against each of these ANDA applicants. In each of the lawsuits, Amarin sought, among other remedies, an order enjoining the defendants from marketing generic versions of Vascepa before the last to expire of the asserted patents expires in 2030. A summary of the lawsuits is below: • In April 2014, Amarin filed lawsuits against Apotex, Inc. and Apotex Corporation, or collectively, Apotex, in the U.S. District Court for the District of New Jersey and the U.S. District Court for the Northern District of Illinois. The cases against Apotex are captioned Amarin Pharma, Inc. et al. v. Apotex, Inc. et al Amarin Pharma, Inc. et al. v. Apotex, Inc. et al • In April 2014, Amarin filed lawsuits against Roxane Laboratories, Inc., or Roxane, in the U.S. District Court for the District of New Jersey and the U.S. District Court for the Northern District of Ohio. The cases against Roxane are captioned Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc. Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc • In April 2014, Amarin also filed a lawsuit against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., or collectively, Dr. Reddy’s, in the U.S. District Court for the District of New Jersey. The case against Dr. Reddy’s is captioned Amarin Pharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al • In May 2014, Amarin also filed a lawsuit against Watson Laboratories, Inc. and Actavis, Inc., or Watson, in the U.S. District Court for the District of New Jersey. One of the Company’s directors, Patrick J. O’Sullivan, is also a director of Actavis, Inc. The case against Watson is captioned Amarin Pharma, Inc. et al. v. Watson Laboratories, Inc • In June 2014, Amarin also filed a case against Teva Pharmaceuticals USA, Inc., or Teva, in the U.S. District Court for the District of New Jersey. The case against Teva is captioned Amarin Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc • In June 2014, Amarin also filed a lawsuit against Andrx Labs, LLC, Andrx Corporation, and Actavis plc, or collectively, Andrx, in the U.S. District Court for the District of New Jersey. The case against Andrx is captioned Amarin Pharma, Inc. et al v. Andrx Labs, LLC et. al As a result of the 30-month stay associated with the filing of these lawsuits under the Hatch-Waxman Act, the FDA cannot grant final approval to any ANDA before September 2016, unless there is an earlier court decision holding that the subject patents are not infringed and/or are invalid. Based on the May 28, 2015 U.S. District Court for the District of Columbia order granting the Company’s motion for summary judgment in the NCE litigation, on June 26, 2015, the parties to the related ANDA litigation identified above agreed to a full stay of proceedings. FDA subsequently notified the ANDA filers that FDA had changed the status of their ANDAs to submitted, but no longer accepted. In rescinding acceptance of the ANDAs, the Company believed the statutory basis for the ANDA-related patent litigation (accepted ANDAs) no longer existed. Thus, on July 24, 2015, the Company moved to dismiss the pending patent infringement lawsuits against each of the Vascepa ANDA applicants in the U.S. District Court for the District of New Jersey. On January 22, 2016, the U.S. District Court for the District of New Jersey granted Amarin’s motion to dismiss all patent infringement litigation related to the 2014 acceptance by the FDA of ANDAs to Vascepa. With this dismissal, there is no pending patent litigation related to Vascepa. A notice of appeal of the court’s dismissal was filed by one ANDA filer in this case and the Company intends to continue to litigate vigorously in support of the court’s dismissal. The Company cannot predict the outcome of this litigation. A new exclusivity determination by FDA has been pending since the May 28, 2015 District of Columbia court order setting aside FDA’s denial of NCE exclusivity for Vascepa. The Company believes Vascepa is entitled to NCE exclusivity, but cannot predict the outcome of FDA’s determination. The legal process can also be costly and time-consuming. The Company plans to defend the exclusivity of Vascepa through patent litigation after notification that FDA has accepted an ANDA application related to Vascepa. Assuming an NCE exclusivity determination from the FDA or no exclusivity determination, the Company expects notification of new ANDA submissions no sooner than in late July 2016, after the expiration of four years from the 2012 approval of Vascepa. In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Leases The Company leases office space under operating leases. Future minimum lease payments under these leases, net of sublease rental income, as of December 31, 2015 are as follows (in thousands): Year Ending December 31, Operating 2016 $ 523 2017 505 2018 127 2019-2020 — Total $ 1,155 On September 30, 2011, the Company entered into an agreement for 320 square feet of office space at 2 Pembroke House, Upper Pembroke Street 28-32 in Dublin, Ireland. The office space was subsequently reduced to 270 square feet, effective November 1, 2013. The agreement began November 1, 2011 and terminates on October 31, 2016 and can be extended automatically for successive one year periods. Monthly rent is approximately €2,900 (approximately $3,200). The agreement can be terminated by either party with three months prior written notice. On July 1, 2011, the Company leased 9,747 square feet of office space in Bedminster, New Jersey. The lease, as amended, terminates on March 31, 2018, and may also be terminated with six months prior notice. On December 6, 2011 the Company leased an additional 2,142 square feet of space in the same location. On December 15, 2012 and May 8, 2013, the Company leased an additional 2,601 and 10,883 square feet of space, respectively, in the same location. In January 2014 and April 2014, the Company entered into separate transactions with the landlord of this property to vacate approximately 2,142 and 2,000 square feet of space in exchange for discounts on contractual future rent payments. In January 2015, the Company executed an agreement to sublease approximately 4,700 square feet of this property to a third party, effective April 1, 2015. Additionally, in June 2015, the Company executed an agreement to sublease approximately 2,500 square feet of this property to a separate third party, effective June 16, 2015. Total rent expense during the years ended 2015, 2014 and 2013 was approximately $0.8 million, $1.0 million, and $1.0 million, respectively. 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, as detailed below. The Company entered into its initial Vascepa API supply agreement with Nisshin Pharma, Inc., or Nisshin, in 2010. In 2011, the Company entered into agreements with two additional suppliers, Chemport, Inc., or Chemport, and BASF (formerly Equateq Limited) for the supply of API. In 2012, the Company agreed to terms with a fourth API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc. (Slanmhor). The API supply agreement with BASF terminated in February 2014. In July 2014, the Company terminated the supply agreement with Slanmhor and subsequently, in July 2015, entered into a new supply agreement with Finorga SAS (Novasep), a French company. These agreements included 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 as described below. Nisshin, Chemport and Novasep are currently the three manufacturers from which the Company purchases API. As of December 31, 2015, the Company has no royalty, milestone or minimum purchase commitments with Nisshin. Chemport was approved by the FDA to manufacture API for commercial sale in April 2013 and the Company began purchasing commercial supply from Chemport in 2013. The agreement with Chemport contains a provision requiring the Company to pay Chemport in cash for any shortfall in the minimum purchase obligations. The Company began purchasing commercial supply from Novasep in 2015. API manufactured by Novasep was previously approved by the FDA in July 2014. The 2015 supply agreement with Novasep includes commitments for the Company to fund API purchases and contains a provision requiring the Company to pay Novasep a cash remedy for any shortfall in the minimum purchase obligations. Pursuant to the supply agreements, there is a total of $44.7 million that is potentially payable over the term of such agreements based on minimum purchase obligations. The Company continues to meet its contractual volume obligations. Under the 2004 share repurchase agreement with Laxdale Limited, or Laxdale, upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing Amarin Neurosciences 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 $11.1 million as of December 31, 2015). 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 Neurosciences 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 $7.4 million as of December 31, 2015) for each of the two potential market approvals (i.e., £10 million maximum, or approximately $14.8 million as of December 31, 2015). 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 December 31, 2015. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2015 | |
Equity | (10) Equity Warrants During the year ended December 31, 2015, the Company issued 1,844,585 shares upon the exercise of warrants, resulting in gross and net proceeds of $2.8 million and $2.7 million, respectively. During the year ended December 31, 2014, the Company issued 1,684,888 shares upon the exercise of warrants, resulting in gross and net proceeds of $1.7 million. No warrants remained outstanding as of December 31, 2015. Incentive Equity Awards As of December 31, 2015, there were an aggregate of 17,818,053 stock options and 10,886,523 restricted stock units (“RSUs”) outstanding, representing approximately 7% and 4%, respectively, of outstanding shares (including common and preferred shares) on a fully diluted basis. During the years ended December 31, 2015 and 2014, the Company issued 18,020 and 234,500 shares, respectively, as a result of the exercise of stock options, resulting in gross and net proceeds of $31 thousand during the year ended December 31, 2015 and $0.3 million during the year ended December 31, 2014. On July 6, 2015, the Company granted a total of 1,455,000 RSUs and 5,470,000 stock options to employees under the Amarin Corporation plc Stock Incentive Plan (the “2011 Plan”). The RSUs granted vest over a four year period. Of the total stock options granted, 3,670,000 stock options vest over a four year period while the remaining 1,800,000 stock options vest upon the achievement of certain performance conditions. During the year ended December 31, 2015, the Company issued 181,876 common shares related to the vesting of these RSUs, of which 40,165 shares were retained as treasury shares as settlement of employee tax obligations. Also on July 6, 2015, the Company granted a total of 413,500 RSUs and 288,657 stock options to members of the Company’s Board of Directors under the 2011 Plan. Of the total awards granted, 283,500 RSUs and 121,506 stock options vest in equal installments over a three year period 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, while the remaining 130,000 RSUs and 167,151 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, which is required to be made in shares. On January 29, 2015, the Company granted a total of 2,564,251 RSUs and 1,622,500 stock options to employees under the 2011 Plan. The RSUs vest annually over a three year period and the stock options vest over a four year period. Also on January 29, 2015, the Company granted 5,455,500 RSUs to employees under the 2011 Plan that vest upon the achievement of certain performance conditions. The issuance of these performance RSUs was contingent upon shareholder approval to increase the aggregate number of shares authorized for issuance under the 2011 Plan, which was obtained at the Company’s Annual General Meeting of Shareholders held on July 6, 2015. On March 11, 2014, the Company granted a total of 173,348 RSUs and 205,890 stock options to members of the Company’s Board of Directors under the 2011 Plan. 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, which is required to be made in shares. 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 anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. On January 8, 2014, the Company granted a total of 2,082,000 RSUs and 2,605,500 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 year ended December 31, 2015, the Company issued 639,500 common shares related to the vesting of these RSUs, of which 114,258 shares were retained as treasury shares as settlement of employee tax obligations. See Note 12—Stock Incentive Plans and Stock Based Compensation for further information regarding the Company’s incentive equity awards. Tax Refund During the year ended December 31, 2014, the Company received a refund of $3.2 million for UK stamp duty taxes paid in prior periods related to the issuance of common stock. Such proceeds were recorded as an increase to additional paid-in capital. 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 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 such that a maximum of 32,818,464 ordinary shares remain issuable upon future consolidation and redesignation of the remaining Series A Preference Shares, inclusive of the shares issued in July 2015 as discussed below, subject to certain adjustments for dilutive events. 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 have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from registration requirements. 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. In addition, the Company agreed to use its commercially reasonable best efforts to effect and 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 is therefore reflected as an adjustment to net loss applicable to common shareholders for earnings per common share purposes in accordance with GAAP. On March 30, 2015, in connection with the closing of the private placement, and pursuant to a pre-existing contractual right to participate in certain private placement transactions effected by the Company, the Company entered into a separate subscription agreement with an existing investor, Sofinnova Venture Partners VII L.P. (Sofinnova), for the purchase of an additional $5.8 million of restricted American Depositary Shares, each representing one (1) share of the Company’s Series A Preference Shares, at the same price per share and otherwise on substantially the same terms as the initial private placement (the “Second Private Placement”). In accordance with applicable marketplace rules of the NASDAQ Stock Market, the consummation of the Second Private Placement was conditioned upon approval by the Company’s shareholders at a future meeting of the Company’s shareholders. Such approval was received at the Company’s Annual General Meeting of Shareholders on July 6, 2015 and as a result, the closing of the Second Private Placement occurred on July 10, 2015. The Company issued 38,867,180 restricted ADSs, each representing one Series A Preference Share, which may be consolidated and redesignated from time to time up to a maximum of 3,886,718 ordinary shares, each ordinary share to be represented by one ADS. For each restricted ADS, Sofinnova paid a negotiated price of $0.15 (equating to $1.50 on an as-if-converted-to-ordinary-shares basis) resulting in gross proceeds to the Company of $5.8 million. Dr. James Healy, a member of the Company’s Board, is a managing member of Sofinnova Management VII, L.L.C. and a general partner of Sofinnova. The existence of this preferred stock purchase option was determined to be a derivative liability effective March 5, 2015, the date on which the private placement was initially subscribed. The fair value of this liability was calculated using a Black-Scholes model and was determined to be $0.9 million at inception and was charged to accumulated deficit as a deemed non-cash dividend to Sofinnova. The liability was then marked to fair value as of March 30, 2015, the date on which the Company executed a subscription agreement with Sofinnova, resulting in a charge of $0.9 million through (loss) gain on change in fair value of derivatives. The liability of $1.8 million was reclassified to permanent equity (additional paid-in capital) on such date. Subsequent to approval of the Second Private Placement, the Company recorded the remaining value of the BCF related to this share issuance as a non-cash dividend to preferred shareholders through accumulated deficit. The value of the BCF was determined on the same basis as the first private placement and amounted to $3.4 million less $1.8 million previously recorded for the preferred stock purchase option for a net non-cash charge of $1.6 million. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | (11) Income Taxes Interest and penalties related to any uncertain tax positions have historically been insignificant. The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes. The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is $1.4 million as of December 31, 2015 and December 31, 2014. The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Beginning uncertain tax benefits $ 2,487 $ 1,674 $ 1,243 Prior year—increases 120 — — Prior year—decreases (762 ) — — Current year—increases 144 1,067 687 Current year—decreases for lapses in statutes of limitations (439 ) (254 ) (256 ) Ending uncertain tax benefits $ 1,550 $ 2,487 $ 1,674 The Company files income tax returns in the United States, Ireland and United Kingdom, or UK. The Company remains subject to tax examinations in the following jurisdictions as of December 31, 2015: Jurisdiction Tax Years United States (Federal and State) 2012-2015 Ireland 2010-2015 United Kingdom 2014-2015 The Company expects gross liabilities of $579,000 to expire in 2016 based on statutory lapses. The components of loss from operations before taxes were as follows for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 United States $ (10,137 ) $ (7,331 ) $ (9,234 ) Ireland and United Kingdom (108,153 ) (51,870 ) (160,187 ) $ (118,290 ) $ (59,201 ) $ (169,421 ) The benefit from income taxes shown in the accompanying consolidated statements of operations consists of the following for fiscal 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Current: Federal-U.S. $ 1,053 $ 660 $ 122 State-U.S. 113 117 118 Total current $ 1,166 $ 777 $ 240 Deferred: Federal-U.S. (3,343 ) (3,689 ) (4,065 ) State-U.S. (605 ) (226 ) 631 Ireland and United Kingdom (9,023 ) 3,335 (33,106 ) Change in valuation allowance 8,719 (3,034 ) 33,106 Total deferred $ (4,252 ) $ (3,614 ) $ (3,434 ) Benefit from income taxes $ (3,086 ) $ (2,837 ) $ (3,194 ) The benefit from income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for fiscal 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Benefits from taxes at statutory rate $ (29,572 ) $ (14,786 ) $ (42,355 ) Rate differential 8,572 9,493 18,494 Change in valuation reserves 8,719 (3,034 ) 33,106 Derivative liabilities 187 (2,706 ) (11,984 ) Gain on extinguishment of debt (328 ) (9,509 ) — Research and development credits (1,284 ) (1,455 ) (2,008 ) Tax return to provision adjustments 2,248 10,026 125 Cumulative translation adjustment 7,811 8,061 (280 ) Permanent and other 561 1,073 1,708 Benefit from income taxes $ (3,086 ) $ (2,837 ) $ (3,194 ) During 2015, the Company recorded adjustments to its deferred tax accounts related to the impact of foreign exchange rate changes and to reconcile the financial statement accounts to the amounts reported on its filed 2014 foreign tax returns, primarily for the impact of US GAAP to local statutory adjustments. These adjustments were fully offset with valuation allowances based on the Company’s position with respect to the realizability of its recorded deferred tax assets for non-U.S. entities. The Company is subject to corporate tax rate in Ireland of 25% for non-trading activities and 12.5% for trading activities. For the years ended December 31, 2015, 2014 and 2013, the Company applied the statutory corporate tax rate of 25% for Amarin Corporation plc, reflecting the non-trading tax rate in Ireland. However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5% Irish trading tax rate. The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2015 and 2014 is as follows (in thousands): 2015 2014 Deferred tax assets: Net operating losses $ 88,996 $ 80,096 Stock based compensation 17,975 15,600 Depreciation 74 (90 ) Tax credits 3,076 2,141 Other reserves and accrued liabilities 2,796 1,708 Gross deferred tax assets 112,917 99,455 Less: valuation allowance (94,684 ) (85,965 ) Total deferred tax assets $ 18,233 $ 13,490 The Company assesses whether it is more-likely-than-not that the Company will realize its deferred tax assets. The Company determined that it was more-likely-than-not that the Irish, UK, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods. As of December 31, 2015, deferred tax assets of approximately $3.0 million relate to certain tax credit carryforwards resulting from excess tax benefits of stock-based compensation using the with-and-without approach, the tax benefit of which, when recognized, will be accounted for as a credit to additional paid-in capital rather than a reduction to the income tax provision. Such amount has been netted with the tax credits line in the table above. In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes The following table reflects the activity in the valuation allowance for the years ended December 31, 2015 and 2014 (in thousands): 2015 2014 Beginning valuation allowance $ 85,965 $ 88,999 Increase as reflected in income tax expense 16,291 5,081 Cumulative translation adjustment (7,572 ) (8,115 ) Ending valuation allowance $ 94,684 $ 85,965 The Company has combined Irish, UK, and Israeli net operating loss carryforwards of $565.7 million, which do not expire. The total net operating loss carryforwards increased by approximately $52.4 million from the prior year primarily as a result of current year losses generated by the Company’s Irish subsidiaries, partially offset by the impact of foreign exchange rate changes and adjustments to reconcile the financial statement accounts to the amounts reported on the filed 2014 foreign tax returns. In addition, the Company has available U.S. federal tax credit carryforwards of $5.8 million and state tax credit carryforwards of $1.6 million. These amounts exclude the impact of any unrecognized tax benefits. These carryforwards, which will expire starting between 2022 and 2035, may be used to offset future taxable income, if any. The Company recognized a tax benefit related to the extension of the research and development credits retroactively enacted during the fourth quarter of 2015 and recorded a benefit of approximately $1.3 million for the credit generated during the year. As of December 31, 2015, earnings of $20.6 million have been retained indefinitely for reinvestment by foreign subsidiary or there is an expectation that any reinvestment can be recovered tax-free without significant cost, and the entity expects to ultimately use that means of recovery for domestic subsidiary companies; therefore, no provision has been made for income taxes that would be payable upon the distribution of such earnings and it would not be practicable to determine the amount of the related unrecognized deferred income tax liability. |
Stock Incentive Plans and Stock
Stock Incentive Plans and Stock Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Stock Incentive Plans and Stock Based Compensation | (12) Stock Incentive Plans and Stock Based Compensation On April 29, 2011 the Board, upon the recommendation of the Remuneration Committee, adopted the 2011 Stock Incentive Plan (“2011 Plan”), which was approved by the Company’s shareholders on July 12, 2011. The 2011 Plan replaced the Company’s 2002 Stock Option Plan (“2002 Plan”), which expired on January 1, 2012. The maximum number of the Company’s Ordinary Shares of £0.50 each or any ADS’s, as to be issued under the 2011 Plan shall not exceed the sum of (i) 31.5 million newly authorized Shares available for award and (ii) the number of Shares that remained available for grants under the Company’s 2002 Plan and (iii) the number of Shares underlying then outstanding awards under the 2002 Plan that could be subsequently forfeited, cancelled, expire or are otherwise terminated. The award of stock options (both incentive and non-qualified options) and restricted stock units, and awards of unrestricted Shares to Directors are permitted. The 2011 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 12, 2021. In addition to the grants under the 2011 Plan, the Company grants non-qualified stock options to employees to purchase the Company’s ordinary shares. These grants are made pursuant to employment agreements on terms consistent with the 2011 Plan. Under the terms of the 2011 Plan, and grants made pursuant to employment agreements, options typically vest over a four year period, expire after a ten-year term and are granted at an exercise price equal to the closing price of the Company’s American Depository Shares on the grant date. The following table summarizes all stock option activity for the year ended December 31, 2015 (in thousands, except for per share amounts): Number of Weighted Weighted Aggregate Outstanding January 1, 2015 10,670 $ 4.95 Granted 7,976 2.16 Cancelled/Expired (810 ) 3.75 Exercised (18 ) 1.76 Outstanding, December 31, 2015 17,818 3.76 8.0 years $ 1,949 Exercisable, December 31, 2015 9,406 5.02 6.9 years $ 833 Vested and Expected to Vest, December 31, 2015 2,756 4.04 8.1 years $ 520 Available for future grant as of December 31, 2015 8,960 The weighted average fair value of the stock options granted during the years ended December 31, 2015, 2014 and 2013 was $2.16, $1.58 and $6.18, respectively. During the years ended December 31, 2015 and 2014, the Company received cash of $31 thousand and $0.3 million from the exercise of options. The intrinsic value of options exercised during 2015 was $6 thousand and $0.2 million during 2014. As of December 31, 2015 and 2014, there was $14.1 million and $9.4 million of unrecognized stock-based compensation expense related to unvested stock option share-based compensation arrangements granted under the Company’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately 3.0 years. There was a benefit of $0.7 million and a provision of $2.3 million for the years ended December 31, 2015 and 2014, respectively, reflected within the consolidated statement of cash flows related to excess tax provision on the U.S. federal level that have been realized as an increase in taxes payable. The Company recognizes compensation expense for the fair values of those awards which have graded vesting on a straight line basis. The fair value of options on the date of grant was estimated using the Black-Scholes option pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs. Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option. The expected life was determined based on the short-cut method based on the term and vesting period. The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity term approximating the expected life of the option at the date of grant. No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future. Estimated forfeitures are based on the Company’s historical forfeiture activity. Employee stock options granted prior to June 30, 2009 generally vested over a three-year service period. Employee stock options granted after June 30, 2009 generally vest over a four-year service period and all stock options are settled by the issuance of new shares. Compensation expense recognized for all option grants is net of estimated forfeitures and is recognized over the awards’ respective requisite service periods. The vesting of certain stock options is contingent upon the attainment of performance criteria. The probability that such criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable. The Company recorded compensation expense in relation to stock options of $7.9 million, $7.7 million and $14.3 million for the years ended December 31, 2015, 2014 and 2013, respectively. For 2015, 2014 and 2013, the Company used the following assumptions to estimate the fair value of share-based payment awards: 2015 2014 2013 Risk free interest rate 1.37% - 1.68% 1.37% - 1.68% 0.91% - 2.07% Expected dividend yield 0.00% 0.00% 0.00% Expected option life (years) 6.25 6.25 6.25 Expected volatility 86% - 97% 97% - 109% 91% - 110% Restricted Stock Units The 2011 Plan also allows for granting of restricted stock unit awards under the terms of the Plan. The restricted stock units vest based upon a time-based service condition, a performance condition, or both. The probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable. Restricted stock units are recorded as compensation expense based on fair value, representing the market value of the Company’s common stock on the date of grant. The fair value of restricted stock units is amortized on a straight-line basis through the statement of operations over the service period until the shares have vested. The following table presents the restricted stock unit activity for the years ended December 31, 2015 and 2014 (in thousands, except for weighted average amounts): Shares Weighted Average Outstanding—as of January 1, 2014 196 $ 6.96 Granted 2,255 2.03 Vested — — Forfeited (195 ) 3.17 Outstanding—as of December 31, 2014 2,256 2.03 Granted 9,888 2.12 Vested (821 ) 2.14 Forfeited (436 ) 1.45 Outstanding—as of December 31, 2015 10,887 2.12 The Company recorded compensation expense in relation to restricted stock units of $6.0 million, $1.4 million and $0.4 million for the years ended December 31, 2015, 2014 and 2013 respectively. The following table presents the stock-based compensation expense related to stock based awards for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Research and development $ 3,280 $ 2,701 $ 2,837 Selling, general and administrative 10,609 6,321 11,848 Stock-based compensation expense $ 13,889 $ 9,022 $ 14,685 |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2015 | |
Defined Contribution Plan | (13) Defined Contribution Plan The Company makes available a 401(k) plan for its U.S. employees to which it made contributions in prior years. The Company did not make any contributions in 2015, 2014 or 2013. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions | (14) Related Party Transactions October 2009 Private Placement Several of Amarin’s current and former directors and funds connected with them purchased approximately 36.0 million of its ADSs (in the form of common stock) in the October 2009 private placement, including: (i) 17 million ADSs purchased by funds managed by Abingworth LLP, where Dr. Joseph Anderson, a former Director of Amarin, is a partner; (ii) 7 million ADSs purchased by Orbimed Advisors LLC, where Dr. Carl L. Gordon, a former Director of Amarin, is a General Partner; (iii) 7 million ADSs purchased by Sofinnova Venture Partners VII, L.P., where Dr. James I. Healy, a Director of Amarin, is a Managing General Partner; and (iv) 5 million ADSs purchased by Fountain Healthcare Partners Fund 1, L.P. Fountain Healthcare Partners Ltd. is the sole General Partner of Fountain Healthcare Partners Fund 1, L.P. Dr. Manus Rogan is a Managing Partner of Fountain Healthcare Partners Ltd. and until December 2011 was a non-executive director of Amarin. In addition, for every ADS purchased, the investor received warrants to purchase 0.5 (one half) of an ADS. No warrants remained outstanding as of December 31, 2015. Therefore, the fair value of the warrants held by the current and former directors of the Company and their related investment funds amounted to zero. March 2015 Private Placement On March 30, 2015, in connection with the closing of the initial private placement described in Note 10, and pursuant to a pre-existing contractual right to participate in certain private placement transactions effected by the Company, the Company entered into a separate subscription agreement with an existing investor, Sofinnova. The Company issued 38,867,180 restricted ADSs, each representing one Series A Preference Share, which may be consolidated and redesignated from time to time up to a maximum of 3,886,718 ordinary shares, each ordinary share to be represented by one ADS. For each restricted ADS, Sofinnova paid a negotiated price of $0.15 (equating to $1.50 on an as-if-converted-to-ordinary-shares basis) resulting in gross proceeds to the Company of $5.8 million. The shares are owned directly by Sofinnova. Dr. James Healy (“Healy”), a member of the Company’s Board and a managing member of Sofinnova Management VII, L.L.C., is a general partner of Sofinnova and may be deemed to have shared voting and dispositive power over the shares owned by Sofinnova. Healy disclaims beneficial ownership over the shares owned by Sofinnova except to the extent of any pecuniary interest therein. |
Quarterly Summarized Financial
Quarterly Summarized Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Summarized Financial Information (Unaudited) | (15) Quarterly Summarized Financial Information (Unaudited) Fiscal years ended December 31, 2015 and 2014 1st 2nd 3rd 4th 2015 2014 2015 2014 2015 2014 2015 2014 (In thousands, except per share amounts) Total revenue, net $ 15,933 $ 10,967 $ 17,707 $ 12,606 $ 21,483 $ 14,149 $ 26,633 $ 16,480 Net (loss) income applicable to common shareholders (31,994 ) (25,980 ) (62,853 ) 15,323 (32,321 ) (26,050 ) (21,891 ) (19,657 ) (Loss) earnings per share: Basic $ (0.18 ) $ (0.15 ) $ (0.35 ) $ 0.09 $ (0.18 ) $ (0.15 ) $ (0.12 ) $ (0.11 ) Diluted $ (0.18 ) $ (0.15 ) $ (0.35 ) $ 0.08 $ (0.18 ) $ (0.17 ) $ (0.12 ) $ (0.11 ) |
Co-Promotion Agreement
Co-Promotion Agreement | 12 Months Ended |
Dec. 31, 2015 | |
Co-Promotion Agreement | (16) 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 ® (icosapent ethyl) 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 initial term of the Agreement extends through 2018. During the term, Kowa Pharmaceuticals America, Inc. and Amarin have agreed to use commercially reasonable efforts to promote, detail and optimize sales of Vascepa in the United States. The performance requirements include a negotiated minimum number of details to be delivered by each party in the first and second position, and the use of a negotiated number of minimum sales representatives from each party, including no less than 250 Kowa Pharmaceuticals America, Inc. sales representatives. Kowa Pharmaceuticals America, Inc. has agreed to continue to bear the costs incurred for its sales force associated with the commercialization of Vascepa and to pay for certain incremental costs associated with the use of its sales force, such as sample costs and costs for promotional and marketing materials. Amarin will continue to recognize all revenue from sales of Vascepa and will use commercially reasonable efforts to maintain a minimum amount of inventory of Vascepa for use in the United States. In exchange for Kowa Pharmaceuticals America, Inc.’s co-promotional services, Kowa Pharmaceuticals America, Inc. is entitled to a quarterly co-promotion fee based on a percentage of Vascepa gross margin that increases during the Agreement’s term, from the high single digits in 2014 to the low twenty percent level in 2018. The co-promotion fee also varies based on sales levels and whether the FDA has approved an ANCHOR indication labeling expansion for Vascepa or has permitted the use of data generated to support obtaining FDA approval of the ANCHOR indication in the promotion of Vascepa, in which case the co-promotion fee would be decreased if specified requirements are met. In certain circumstances, upon the earlier of the expiration or termination of the Agreement in accordance with its terms, Kowa Pharmaceuticals America, Inc. may be eligible for a co-promotion tail fee equal to declining fractions of the co-promotion fee in effect prior to such expiration or termination for periods ranging from one to three years following such expiration or termination. As of December 31, 2015 and 2014, the Company had a net payable of $2.5 million and a net receivable of $0.6 million, respectively, from Kowa Pharmaceuticals America, Inc. representing co-promotion fees payable to Kowa Pharmaceuticals America, Inc. net of reimbursable amounts incurred for samples and other marketing expenses. |
Development, Commercialization
Development, Commercialization and Supply Agreement | 12 Months Ended |
Dec. 31, 2015 | |
Development, Commercialization and Supply Agreement | (17) Development, Commercialization and Supply Agreement On February 26, 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 ongoing REDUCE-IT clinical trials of Vascepa. Under the DCS Agreement, Eddingpharm will be solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company will provide development assistance and be responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company will retain all Vascepa manufacturing rights. Eddingpharm has agreed to certain restrictions regarding the commercialization of competitive products globally and the Company has 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 will be paid by Eddingpharm to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Eddingpharm. Eddingpharm will be 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, packaging, 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, which it will recognize as revenue over the estimated period in which the Company is required to provide initial and on-going regulatory and development support and clinical supply for obtaining regulatory approvals in the China Territory and through the estimated period in which the Company is required to provide commercial supply, which is currently estimated to be a period of approximately 16 years. Consequently, the Company recognized $0.8 million of the up-front payment as licensing revenue during the year ended December 31, 2015 and recorded $14.2 million as deferred revenue as of December 31, 2015. In addition to the non-refundable, up-front payment, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $154.0 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 sales-based milestone events occur when annual aggregate net sales of Vascepa in the territory equals or exceeds certain specified thresholds. 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 recognizes contingent consideration from activities that is earned upon the achievement of a substantive milestone in the period in which the milestone is achieved. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events | (18) Subsequent Events The Company has evaluated subsequent events from December 31, 2015 through the date of the issuance of these consolidated financial statements. |
Significant Accounting Polici25
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances. Estimates are used in determining such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances; depreciable/amortizable lives; asset impairments; valuation allowance on deferred taxes; probabilities of achievement of performance conditions for certain equity awards; amounts recorded for licensing revenue; contingencies and accruals; and valuations of derivative and long-term debt instruments. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness. |
Use of Forecasted Financial Information in Accounting Estimates | Use of Forecasted Financial Information in Accounting Estimates The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of derivatives, debt instruments and intangible assets, and evaluating the need for valuation allowances for deferred tax assets. Such forecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results. Management believes that its financial forecasts are reasonable and appropriate based upon current facts and circumstances. Because of the inherent nature of forecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts the carrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates. |
Revenue Recognition | Revenue Recognition 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, 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 accordance with GAAP, the Company’s revenue recognition policy requires that: (i) there is persuasive evidence that an arrangement exists between the Company and the Distributor, (ii) delivery has occurred, (iii) collectability is reasonably assured and (iv) the price is fixed or determinable. The Company commenced its commercial launch in the United States in January 2013. Prior to 2013, the Company recognized no revenue from Vascepa sales. In accordance with GAAP, until the Company had the ability to reliably estimate returns of Vascepa from its Distributors, revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions, and not based on sales from the Company to such Distributors. During the three months ended March 31, 2014, the Company concluded that it had developed sufficient history such that it can reliably estimate returns and as a result, began to recognize revenue based on sales to its Distributors. The change in revenue recognition methodology resulted in the recognition of previously deferred revenue. As of December 31, 2013, the Company had deferred approximately $1.7 million in amounts billed to Distributors that was not recognized as revenue. This change in revenue recognition methodology resulted in the recognition of such deferred revenues in the three months ended March 31, 2014. The Company has contracts with its primary Distributors and delivery occurs when a Distributor receives Vascepa. 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 or when the product is utilized. In order to conclude that the price is fixed or determinable, the Company must be able to (i) calculate its gross product revenues from the sales to Distributors and (ii) reasonably estimate its net product revenues. The Company calculates gross product revenues based on the wholesale acquisition cost that the Company charges its Distributors for Vascepa. The Company estimates its net product revenues by deducting from its gross product revenues (a) trade allowances, such as invoice discounts for prompt payment and distributor fees, (b) estimated government and private payor rebates, chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives offered to certain indirect customers, including patients. Trade Allowances: Rebates, Chargebacks and Discounts: Product Returns: Other Incentives: The following table summarizes activity in each of the net product revenue allowance and reserve categories described above for the years ended December 31, 2015 and 2014 (in thousands): Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of January 1, 2014 $ 1,071 $ 1,137 $ 72 $ 189 $ 2,469 Provision related to current period sales 8,157 12,753 397 11,153 32,460 Provision related to prior period sales (29 ) (80 ) 12 (31 ) (128 ) Credits/payments made for current period sales (5,950 ) (9,143 ) — (10,338 ) (25,431 ) Credits/payments made for prior period sales (1,042 ) (1,057 ) — (181 ) (2,280 ) Balance as of December 31, 2014 $ 2,207 $ 3,610 $ 481 $ 792 $ 7,090 Provision related to current period sales 14,986 32,591 342 8,310 56,229 Provision related to prior period sales (174 ) (70 ) (205 ) — (449 ) Credits/payments made for current period sales (10,690 ) (22,710 ) — (7,226 ) (40,626 ) Credits/payments made for prior period sales (2,033 ) (3,540 ) (83 ) (792 ) (6,448 ) Balance as of December 31, 2015 $ 4,296 $ 9,881 $ 535 $ 1,084 $ 15,796 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. Multiple-Element Arrangements and Licensing Revenue When evaluating multiple-element arrangements, the Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on whether the delivered element has stand-alone value to the customer or if the arrangement includes a general right of return for delivered items. The consideration received is allocated between each of the separable elements in the arrangement using the relative selling price method. The selling price used for each separable element will be based on vendor specific objective evidence (“VSOE”) if available, third-party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third-party evidence is available. Revenue is then recognized as each of the separable elements to which the revenue has been allocated is delivered. The Company may receive up-front, non-refundable payments when licensing its intellectual property in conjunction with research, development and commercialization agreements. In determining the units of accounting, management evaluates whether the license has stand-alone value from the undelivered elements to the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this 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. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributable to the license over the Company’s contractual or estimated performance period. Any unrecognized portion of license revenue is classified within deferred revenue in the accompanying consolidated balance sheets. When management believes the license to its intellectual property has stand-alone value, the Company recognizes revenue attributed to the license upon delivery. The periods over which revenue is recognized is subject to estimates by management and may change over the course of the agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Milestones Contingent consideration from activities that is earned upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. At the inception of each arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive. This evaluation includes an assessment of whether: (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. See Note 17—Development, Commercialization and Supply Agreement for further information regarding licensing revenue and milestones related to the Company’s multiple-element arrangement with Eddingpharm (Asia) Macao Commercial Offshore Limited. |
Distribution Costs | Distribution Costs The Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distribution services, in cost of goods sold. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents 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 does not currently maintain an allowance for doubtful accounts and has not historically experienced any credit losses. The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of December 31, 2015 and 2014 (in thousands): December 31, 2015 December 31, 2014 Gross trade accounts receivable $ 18,270 $ 10,215 Trade allowances (4,296 ) (2,207 ) Chargebacks (148 ) (166 ) Accounts receivable, net $ 13,826 $ 7,842 |
Inventory | Inventory The Company states inventories at the lower of cost or market value. Cost is determined based on actual cost using the average cost method. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected market value due to obsolescence, damage or quantities in excess of expected demand, the Company will reduce the carrying value of such inventory to market value. The Company received FDA approval for Vascepa on July 26, 2012 and after that date began capitalizing inventory purchases of saleable product from approved suppliers. Until an active pharmaceutical ingredient, or API, supplier is approved, all Vascepa API purchased from such supplier is included as a component of research and development expense. Upon sNDA approval of each additional supplier, the Company capitalizes subsequent Vascepa API purchases from such supplier as inventory. Purchases of Vascepa API received and expensed before such regulatory approvals is not subsequently capitalized, and all such purchases are quarantined and not used for commercial supply until such time as the sNDA for the supplier that produced the API is approved. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of Vascepa API. |
Property, Plant and Equipment | Property, Plant and Equipment The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life. The estimated useful lives, by asset classification, are as follows: Asset Classification Useful Lives Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Leasehold improvements Lesser of useful life or lease term Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the balance sheet and any resulting gain or loss is credited or expensed to operations. Repairs and maintenance costs are expensed as incurred. |
Long-Lived Asset Impairment | Long-Lived Asset Impairment The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets. |
Intangible Asset, net | Intangible Asset, net Intangible asset, net consists of a milestone payment paid to the former shareholders of Laxdale Limited related to the 2004 acquisition of the rights to Vascepa, which is the result of Vascepa receiving marketing approval for the first indication and is amortized over its estimated useful life on a straight-line basis. See Note 9—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale Limited. |
Beneficial Conversion Features | Beneficial Conversion Features The Company issued Series A preference shares in a private placement transaction executed in two tranches that each contain a conversion feature whereby such shares are convertible into ordinary shares at a fixed rate. The conversion price on the date of issuance was less than the market price of the Company’s ordinary shares. It was determined that these discounts represent contingent beneficial conversion features, which were valued based on the difference between the conversion price and the market price of the ordinary shares on the date of issuance, which is the commitment date. These features are analogous to preference dividends and were each recorded as a non-cash return to preferred shareholders through accumulated deficit upon the earliest possible date of conversion, which occurred in the three months ended June 30, 2015 upon effectiveness of the related resale Registration Statement on Form S-3 and in the three months ended September 30, 2015 upon shareholder approval received at the Company’s Annual General Meeting of Shareholders. See Note 10—Equity for further discussion. |
Costs for Patent Litigation and Legal Proceedings | Costs for Patent Litigation and Legal Proceedings Costs for patent litigation or other legal proceedings are expensed as incurred and included in selling, general and administrative expenses. |
Research and Development Costs | Research and Development Costs The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including: salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense. In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier. |
Selling, General and Administrative Costs | Selling, General and Administrative Costs The Company charges selling, general and administrative costs to operations as incurred. Selling, general and administrative costs include costs of salaries, programs and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of Vascepa in the United States as well as co-promotion fees payable to Kowa Pharmaceuticals America, Inc. |
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 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. The Company provides reserves for potential payments of tax to various tax authorities or 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. The Company regularly assesses the realizability of deferred tax assets. Changes in historical earnings performance and future earnings projections, 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. |
Derivative Instruments | Derivative Instruments Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the 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. Warrants are valued using a Black-Scholes option pricing model. The long-term debt redemption features are valued using probability-weighted models incorporating management estimates for potential change in control, and by determining the fair value of the debt with and without the change in control provision included. If the terms of warrants that initially require the warrant to be classified as a derivative financial liability lapse, the derivative financial liability is reclassified out of financial liabilities into equity at its fair value on that date. The cash proceeds received from exercises of warrants are recorded in common stock and additional paid-in capital. |
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 and warrants 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 and warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, for diluted net loss per share purposes, the impact of such gains is reversed and the treasury stock method is used to determine diluted net loss per share. 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 years ended December 31, 2015, 2014 and 2013 are as follows: In thousands 2015 2014 2013 Net loss $ (115,204 ) $ (56,364 ) $ (166,227 ) Preferred stock purchase option (see Note 10) (868 ) — — Preferred stock beneficial conversion features (see Note 10) (32,987 ) — — Net loss applicable to common shareholders—basic (149,059 ) (56,364 ) (166,227 ) Gain on warrant derivative liability — (6,775 ) (47,936 ) Net loss—diluted (149,059 ) (63,139 ) (214,163 ) Net loss per share—basic $ (0.83 ) $ (0.32 ) $ (1.03 ) Weighted average shares outstanding—basic 180,654 173,719 161,022 Effect of dilutive warrants — 105 6,048 Weighted average shares outstanding—diluted 180,654 173,824 167,070 Net loss per share—diluted $ (0.83 ) $ (0.36 ) $ (1.28 ) For the years ended December 31, 2015, 2014 and 2013, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: In thousands 2015 2014 2013 Stock options 17,818 10,670 9,330 Restricted stock and restricted stock units 10,887 2,256 196 Warrants — — 1,702 Exchangeable senior notes (if converted) 59,407 49,215 17,021 Preferred stock (if converted) 32,818 — — |
Debt Instruments | Debt Instruments Debt instruments are initially recorded at fair value, with coupon interest and amortization of debt issuance discounts recognized in the statement of operations as interest expense each period in which such instruments are outstanding. If the Company issues shares to discharge the liability, the debt obligation is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. The conversion features in the 2012 Notes, the 2014 Notes and the 2015 Notes qualify for the exception from derivative accounting in accordance with ASC 815-40. The 2012 Notes may be settled, at the Company’s discretion, in any combination of ADSs or cash upon conversion and have been accounted for in accordance with ASC 470-20. Under ASC 470-20, the fair value of the liability component of the 2012 Notes was determined and deducted from the initial proceeds to determine the proceeds allocated to the conversion option, which has been recorded in equity. The difference between the initial fair value of the liability component and the amount repayable is amortized over the expected term of the instrument. The conversion features in the 2014 Notes and 2015 Notes may only be settled in ADSs upon conversion and have been accounted for as part of the debt host. The conversion options in the 2012 Notes, 2014 Notes and 2015 Notes continue to be evaluated on a quarterly basis to determine if they still receive an exception from derivative accounting in accordance with ASC 815-40. The 2014 Notes were recognized initially at fair value as part of an extinguishment of a portion of the 2012 Notes. As a result, the 2014 Notes were initially recognized at a discount of $27.9 million. The 2015 Notes were recognized initially at fair value as part of the issuance of new debt in November 2015. As a result, the 2015 Notes were initially recognized at a discount of $3.8 million. These discounts are being amortized through interest expense over the expected terms of the 2014 Notes and 2015 Notes, which is through January 2019 for each. See Note 8—Debt for further discussion. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation cost is generally measured at the grant date, based on the fair value of the award, and is recognized as compensation expense over the requisite service period. For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the fair value of the award over the estimated service period. The Company reassesses the probability of achievement of the performance conditions for such awards each reporting period. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents 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. The Company’s top three customers accounted for 95% of gross product sales for each of the years ending December 31, 2015 and 2014, and represented 95% and 96% of the gross accounts receivable balance as of December 31, 2015 and 2014, respectively. The Company has not experienced any write-offs of its accounts receivable. |
Concentration of Suppliers | Concentration of Suppliers The Company has contractual freedom to source the API for Vascepa 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 key suppliers, in particular three suppliers of API for Vascepa. The Company cannot provide assurance that its efforts to procure uninterrupted supply of Vascepa API to meet market demand will continue to be successful or that it will be able to renew current API supply agreements on favorable terms or at all. Significant alteration to or termination of the Company’s current API supply chain or its failure to enter into new and similar agreements, 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 three FDA-approved commercial API encapsulators for Vascepa manufacturing. Each of these companies has qualified 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 encapsulate API will continue to be qualified to manufacture the product to its specifications or that these and any future suppliers will have the manufacturing capacity to meet anticipated demand for Vascepa. |
Foreign Currency | Foreign Currency All subsidiaries use the U.S. dollar as the functional currency. Monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at period-end exchange rates. Gains and losses from the remeasurement are included in other (expense) income, net in the consolidated statements of operations. For transactions settled during the applicable period, gains and losses are included in other (expense) income, net in the consolidated statements of operations. Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S. dollar. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs are initially recorded as a deferred cost and amortized to interest expense using the effective interest method over the expected term of the related debt. Unamortized debt issuance costs related to the extinguishment of debt are expensed at the time the debt is extinguished and recorded in other (expense) income, net in the consolidated statements of operations. |
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 December 31, 2015 and 2014 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: December 31, 2015 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 14,184 $ 14,184 $ — $ — Liabilities: Long-term debt derivative liabilities $ 8,170 $ — $ — $ 8,170 December 31, 2014 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 65,156 $ 65,156 $ — $ — Liabilities: Warrant derivative liability $ 119 $ — $ — $ 119 Long-term debt derivative liabilities $ 7,400 $ — $ — $ 7,400 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 December 31, 2015 and 2014 are as follows: December 31, 2015 December 31, 2014 In thousands Carrying Estimated Carrying Estimated Long-term debt—December 2012 financing $ 91,512 $ 87,700 $ 89,617 $ 81,000 2012 Notes 15,107 13,637 31,266 25,689 2014 Notes 96,364 108,034 90,580 75,533 2015 Notes 27,134 28,448 — — The estimated fair value of the long-term debt pursuant to the December 2012 financing is calculated utilizing the same Level 3 inputs utilized in valuing the related derivative liability (see Long-Term Debt Redemption Features below). The estimated fair value of the 2012 Notes and 2014 Notes is calculated based on Level 1 quoted bond prices, while the estimated fair value of the 2015 Notes is calculated based on Level 2 quoted bond prices for the 2014 Notes. The carrying value of the 2012 Notes as of December 31, 2015 and 2014 does not include a debt discount, as it had been fully amortized as non-cash interest expense over the expected term of the 2012 Notes. The carrying value of the 2014 Notes as of December 31, 2015 and 2014 includes a debt discount of $22.4 million and $28.2 million, respectively, which is being amortized as non-cash interest expense over the expected term of the 2014 Notes, through January 2019. The carrying value of the 2015 Notes as of December 31, 2015 includes a debt discount of $4.1 million, which is being amortized as non-cash interest expense over the expected term of the 2015 Notes, through January 2019. The change in the estimated fair values of these liabilities from December 31, 2014 to December 31, 2015 is largely related to changes in the quoted bond prices. |
Derivative Liabilities | Derivative Liabilities Warrant Derivative Liability The Company’s warrant derivative liability is carried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. Effective October 16, 2014, the Company entered into a series of warrant amendment agreements in order to extend the expiration date of certain outstanding warrants from its previously scheduled expiration date of October 16, 2014 to the close of business on February 27, 2015. Of the 8,087,388 warrants outstanding as of December 31, 2014, 1,844,585 warrants were exercised and the remaining 6,242,803 warrants expired on February 27, 2015. As such, no warrants were outstanding as of December 31, 2015 and the related derivative liability was extinguished. As of December 31, 2014, the fair value of the warrant derivative liability was determined to be $0.1 million using the Black-Scholes option valuation model applying the following assumptions: (i) risk-free rate of 0.04%, (ii) remaining term of 0.16 years, (iii) no dividend yield, (iv) volatility of 79%, and (v) the stock price on the date of measurement. As there were no warrants outstanding as of December 31, 2015, the warrant derivative liability was extinguished. The $0.1 million decrease in the fair value of the warrants during 2015 was recognized as: a $0.1 million gain on change in fair value of derivative liability. Long-Term Debt Redemption Features The Company’s December 2012 financing agreement with BioPharma Secured Debt Fund II Holdings Cayman LP (discussed in Note 8 below) contains a redemption feature whereby, upon a change of control, the Company would be required to repay $150 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. As of December 31, 2015, the fair value of the derivative was determined to be $5.5 million, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 2.0 and 7.3 years, (ii) coupon rates of between 6.6% and 12.5% and (iii) market yields of between 13.0% and 30.7%. The Company recognized a $0.7 million loss on change in fair value of derivative liability for the year ended December 31, 2015. As of December 31, 2014, the fair value of the derivative was determined to be $4.8 million, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 2.3 and 3.6 years, (ii) coupon rates of between 9.8% and 10.8% and (iii) market yields of between 10.0% and 16.8%. The Company recognized a $6.3 million gain on change in fair value of derivative liability for the year ended December 31, 2014. The Company’s 2014 Notes and 2015 Notes both contain a redemption feature whereby, upon occurrence of a change in control, the Company would be required to repurchase the notes. The Company determined these redemption features to be embedded derivatives, requiring bifurcation in accordance with ASC 815. The derivatives are carried at fair value and are classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of each embedded derivative was calculated using a probability-weighted model incorporating management estimates of the probability of a change in control occurring, 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. As of December 31, 2015, the fair value of the derivatives related to the 2014 Notes and 2015 Notes was determined to be $2.1 million and $0.6 million, respectively, and the debt was valued by using (i) the estimated remaining term of the notes, (ii) a bond yield of 25.6%, (iii) a risk-free interest rate of 2.9% and (iv) volatility of 89.0%. The Company recognized a $0.5 million gain and $0.1 million loss on change in fair value of derivative liability for the 2014 Notes and 2015 Notes, respectively, for the year ended December 31, 2015. As of December 31, 2014, the fair value of the derivative related to the 2014 Notes was determined to be $2.6 million, and the debt was valued by using (i) the estimated remaining term of the notes, (ii) a bond yield of 24.8%, (iii) a risk-free interest rate of 2.7% and (iv) volatility of 82.0%. The Company recognized a $0.9 million gain on change in fair value of derivative liability for the 2014 Notes for the year ended December 31, 2014. Preferred Stock Purchase Option Derivative Liability Pursuant to a pre-existing contractual right to participate in certain private placement transactions effected by the Company in connection with the subscription agreement executed on March 5, 2015, the Company determined that such right represented a derivative liability (see Note 10). This preferred stock purchase option derivative liability was carried at fair value and classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of this liability was calculated using a Black-Scholes model and was determined to be $0.9 million at inception. On March 30, 2015, this right was exercised and the liability was marked to fair value through such date. The liability was then reclassified to permanent equity on such date. Any changes in the assumptions used to value the derivative liabilities, including the probability of a change in control, could result in a material change to the carrying value of such liabilities. The change in the fair value of derivative liabilities for the years ended December 31, 2015 and 2014 is as follows (in thousands): October Warrants Long-Term Debt Derivative Liabilities Preferred Stock Purchase Option Total Balance as of January 1, 2014 $ 6,894 $ 11,100 $ — $ 17,994 Record initial fair value of derivative liability on 2014 Notes — 3,500 — 3,500 Gain on change in fair value of derivative liabilities (6,272 ) (7,200 ) — (13,472 ) Compensation income for change in fair value of warrants issued to former employees (503 ) — — (503 ) Balance as of December 31, 2014 $ 119 $ 7,400 $ — $ 7,519 Record initial fair value of derivative liability — 500 868 1,368 (Gain) loss on change in fair value of derivative liabilities (110 ) 270 946 1,106 Compensation income for change in fair value of warrants issued to former employees (9 ) — — (9 ) Transfer derivative liability to equity — — (1,814 ) (1,814 ) Balance as of December 31, 2015 $ — $ 8,170 $ — $ 8,170 |
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 adopted by the Company as of the specified effective date. The Company considered the following recent accounting pronouncements which were not yet adopted as of December 31, 2015: In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) In June 2014, the FASB issued guidance for accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The standard states that a performance target in a share-based payment that affects vesting and that could be achieved after the requisite service period should be accounted for as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. The Company is required to adopt this standard in the first quarter of fiscal 2016 and early adoption is permitted. This standard is not expected to have an impact on the Company’s consolidated financial statements. In August 2014, the FASB issued ASU No. 2014-15 , Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities in the instrument-specific credit risk (also referred to as “own credit”) when the organization has elected to measure the liability at fair value in accordance with the fair value option for financial instruments, among others. The new guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The new guidance permits early adoption of the own credit provision. The Company is currently evaluating the accounting, transition and disclosure requirements of the standard and cannot currently estimate the financial statement impact of adoption. The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations. |
Significant Accounting Polici26
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summarize Activity of the Net Product Revenue Allowance and Reserve Categories | The following table summarizes activity in each of the net product revenue allowance and reserve categories described above for the years ended December 31, 2015 and 2014 (in thousands): Trade Allowances Rebates, Chargebacks and Discounts Product Returns Other Incentives Total Balance as of January 1, 2014 $ 1,071 $ 1,137 $ 72 $ 189 $ 2,469 Provision related to current period sales 8,157 12,753 397 11,153 32,460 Provision related to prior period sales (29 ) (80 ) 12 (31 ) (128 ) Credits/payments made for current period sales (5,950 ) (9,143 ) — (10,338 ) (25,431 ) Credits/payments made for prior period sales (1,042 ) (1,057 ) — (181 ) (2,280 ) Balance as of December 31, 2014 $ 2,207 $ 3,610 $ 481 $ 792 $ 7,090 Provision related to current period sales 14,986 32,591 342 8,310 56,229 Provision related to prior period sales (174 ) (70 ) (205 ) — (449 ) Credits/payments made for current period sales (10,690 ) (22,710 ) — (7,226 ) (40,626 ) Credits/payments made for prior period sales (2,033 ) (3,540 ) (83 ) (792 ) (6,448 ) Balance as of December 31, 2015 $ 4,296 $ 9,881 $ 535 $ 1,084 $ 15,796 |
Summarizes the Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable | The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of December 31, 2015 and 2014 (in thousands): December 31, 2015 December 31, 2014 Gross trade accounts receivable $ 18,270 $ 10,215 Trade allowances (4,296 ) (2,207 ) Chargebacks (148 ) (166 ) Accounts receivable, net $ 13,826 $ 7,842 |
Estimated Useful Lives | The estimated useful lives, by asset classification, are as follows: Asset Classification Useful Lives Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Leasehold improvements Lesser of useful life or lease term |
Net Loss and the 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 years ended December 31, 2015, 2014 and 2013 are as follows: In thousands 2015 2014 2013 Net loss $ (115,204 ) $ (56,364 ) $ (166,227 ) Preferred stock purchase option (see Note 10) (868 ) — — Preferred stock beneficial conversion features (see Note 10) (32,987 ) — — Net loss applicable to common shareholders—basic (149,059 ) (56,364 ) (166,227 ) Gain on warrant derivative liability — (6,775 ) (47,936 ) Net loss—diluted (149,059 ) (63,139 ) (214,163 ) Net loss per share—basic $ (0.83 ) $ (0.32 ) $ (1.03 ) Weighted average shares outstanding—basic 180,654 173,719 161,022 Effect of dilutive warrants — 105 6,048 Weighted average shares outstanding—diluted 180,654 173,824 167,070 Net loss per share—diluted $ (0.83 ) $ (0.36 ) $ (1.28 ) |
Anti-Dilutive Securities Not Included in the Computation of Net Loss or Earnings per Share | For the years ended December 31, 2015, 2014 and 2013, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive: In thousands 2015 2014 2013 Stock options 17,818 10,670 9,330 Restricted stock and restricted stock units 10,887 2,256 196 Warrants — — 1,702 Exchangeable senior notes (if converted) 59,407 49,215 17,021 Preferred stock (if converted) 32,818 — — |
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 December 31, 2015 and 2014 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: December 31, 2015 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 14,184 $ 14,184 $ — $ — Liabilities: Long-term debt derivative liabilities $ 8,170 $ — $ — $ 8,170 December 31, 2014 In thousands Total Level 1 Level 2 Level 3 Asset: Cash equivalents—money markets $ 65,156 $ 65,156 $ — $ — Liabilities: Warrant derivative liability $ 119 $ — $ — $ 119 Long-term debt derivative liabilities $ 7,400 $ — $ — $ 7,400 |
Carrying Amounts and Estimated Fair Values of Debt Instruments | The carrying amounts and the estimated fair values of debt instruments as of December 31, 2015 and 2014 are as follows: December 31, 2015 December 31, 2014 In thousands Carrying Estimated Carrying Estimated Long-term debt—December 2012 financing $ 91,512 $ 87,700 $ 89,617 $ 81,000 2012 Notes 15,107 13,637 31,266 25,689 2014 Notes 96,364 108,034 90,580 75,533 2015 Notes 27,134 28,448 — — |
Change in Fair Value of Derivative Liabilities | The change in the fair value of derivative liabilities for the years ended December 31, 2015 and 2014 is as follows (in thousands): October Warrants Long-Term Debt Derivative Liabilities Preferred Stock Purchase Option Total Balance as of January 1, 2014 $ 6,894 $ 11,100 $ — $ 17,994 Record initial fair value of derivative liability on 2014 Notes — 3,500 — 3,500 Gain on change in fair value of derivative liabilities (6,272 ) (7,200 ) — (13,472 ) Compensation income for change in fair value of warrants issued to former employees (503 ) — — (503 ) Balance as of December 31, 2014 $ 119 $ 7,400 $ — $ 7,519 Record initial fair value of derivative liability — 500 868 1,368 (Gain) loss on change in fair value of derivative liabilities (110 ) 270 946 1,106 Compensation income for change in fair value of warrants issued to former employees (9 ) — — (9 ) Transfer derivative liability to equity — — (1,814 ) (1,814 ) Balance as of December 31, 2015 $ — $ 8,170 $ — $ 8,170 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Schedule of Carrying Value of Intangible Asset | The carrying value as of December 31, 2015 is as follows (in thousands): Gross Accumulated Amortization Net Weighted Average Remaining Useful Life (in years) Technology rights $ 11,624 $ (2,207 ) $ 9,417 14.6 |
Intangible Assets Estimated Amortization Expense | Estimated future amortization expense, based upon the Company’s intangible assets as of December 31, 2015 is as follows: Year Ending December 31, Amount 2016 $ 646 2017 646 2018 646 2019 646 2020 646 Thereafter 6,187 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Schedule of Inventory | Inventories as of December 31, 2015 and 2014 consist of the following (in thousands): December 31, 2015 December 31, 2014 Raw materials $ 9,096 $ 5,225 Work in process 1,640 4,757 Finished goods 8,249 3,751 Total inventory $ 18,985 $ 13,733 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant & Equipment | Property, plant and equipment as of December 31, 2015 and 2014 consist of the following (in thousands): December 31, 2015 December 31, 2014 Leasehold improvements $ 135 $ 107 Computer equipment 63 63 Furniture and fixtures 240 240 Software 559 559 997 969 Accumulated depreciation and amortization (754 ) (588 ) Total property, plant and equipment $ 243 $ 381 |
Accrued Expenses and Other Cu30
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses | Accrued expenses and other current liabilities consist of the following as of December 31, 2015 and 2014 (in thousands): 2015 2014 Payroll and payroll-related expenses $ 5,241 $ 3,525 Research and development expenses 828 4,391 Sales and marketing accruals 3,141 1,509 Accrued revenue allowances 10,732 4,717 All other 4,284 2,245 Total accrued expenses and other current liabilities $ 24,226 $ 16,387 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Future Minimum Lease Payments Net of Sublease Rental Income | Future minimum lease payments under these leases, net of sublease rental income, as of December 31, 2015 are as follows (in thousands): Year Ending December 31, Operating 2016 $ 523 2017 505 2018 127 2019-2020 — Total $ 1,155 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Reconciliation of Total Amounts of Unrecognized Tax Benefits | The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Beginning uncertain tax benefits $ 2,487 $ 1,674 $ 1,243 Prior year—increases 120 — — Prior year—decreases (762 ) — — Current year—increases 144 1,067 687 Current year—decreases for lapses in statutes of limitations (439 ) (254 ) (256 ) Ending uncertain tax benefits $ 1,550 $ 2,487 $ 1,674 |
Jurisdictions the Company Remains Subject to Tax Examinations | The Company remains subject to tax examinations in the following jurisdictions as of December 31, 2015: Jurisdiction Tax Years United States (Federal and State) 2012-2015 Ireland 2010-2015 United Kingdom 2014-2015 |
Components of Loss from Operations Before Taxes | The components of loss from operations before taxes were as follows for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 United States $ (10,137 ) $ (7,331 ) $ (9,234 ) Ireland and United Kingdom (108,153 ) (51,870 ) (160,187 ) $ (118,290 ) $ (59,201 ) $ (169,421 ) |
Benefit from Income Taxes | The benefit from income taxes shown in the accompanying consolidated statements of operations consists of the following for fiscal 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Current: Federal-U.S. $ 1,053 $ 660 $ 122 State-U.S. 113 117 118 Total current $ 1,166 $ 777 $ 240 Deferred: Federal-U.S. (3,343 ) (3,689 ) (4,065 ) State-U.S. (605 ) (226 ) 631 Ireland and United Kingdom (9,023 ) 3,335 (33,106 ) Change in valuation allowance 8,719 (3,034 ) 33,106 Total deferred $ (4,252 ) $ (3,614 ) $ (3,434 ) Benefit from income taxes $ (3,086 ) $ (2,837 ) $ (3,194 ) |
Difference between Benefit from Income Taxes and Amount Computed by Applying Statutory Income Tax Rate to Income Before Taxes | The benefit from income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for fiscal 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Benefits from taxes at statutory rate $ (29,572 ) $ (14,786 ) $ (42,355 ) Rate differential 8,572 9,493 18,494 Change in valuation reserves 8,719 (3,034 ) 33,106 Derivative liabilities 187 (2,706 ) (11,984 ) Gain on extinguishment of debt (328 ) (9,509 ) — Research and development credits (1,284 ) (1,455 ) (2,008 ) Tax return to provision adjustments 2,248 10,026 125 Cumulative translation adjustment 7,811 8,061 (280 ) Permanent and other 561 1,073 1,708 Benefit from income taxes $ (3,086 ) $ (2,837 ) $ (3,194 ) |
Income Tax Effect of Each Type of Temporary Difference Comprising Net Deferred Tax Asset | The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2015 and 2014 is as follows (in thousands): 2015 2014 Deferred tax assets: Net operating losses $ 88,996 $ 80,096 Stock based compensation 17,975 15,600 Depreciation 74 (90 ) Tax credits 3,076 2,141 Other reserves and accrued liabilities 2,796 1,708 Gross deferred tax assets 112,917 99,455 Less: valuation allowance (94,684 ) (85,965 ) Total deferred tax assets $ 18,233 $ 13,490 |
Valuation Allowance | The following table reflects the activity in the valuation allowance for the years ended December 31, 2015 and 2014 (in thousands): 2015 2014 Beginning valuation allowance $ 85,965 $ 88,999 Increase as reflected in income tax expense 16,291 5,081 Cumulative translation adjustment (7,572 ) (8,115 ) Ending valuation allowance $ 94,684 $ 85,965 |
Stock Incentive Plans and Sto33
Stock Incentive Plans and Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stock Option Activity | The following table summarizes all stock option activity for the year ended December 31, 2015 (in thousands, except for per share amounts): Number of Weighted Weighted Aggregate Outstanding January 1, 2015 10,670 $ 4.95 Granted 7,976 2.16 Cancelled/Expired (810 ) 3.75 Exercised (18 ) 1.76 Outstanding, December 31, 2015 17,818 3.76 8.0 years $ 1,949 Exercisable, December 31, 2015 9,406 5.02 6.9 years $ 833 Vested and Expected to Vest, December 31, 2015 2,756 4.04 8.1 years $ 520 Available for future grant as of December 31, 2015 8,960 |
Assumptions Used to Estimate Fair Value of Share-Based Payment Awards | For 2015, 2014 and 2013, the Company used the following assumptions to estimate the fair value of share-based payment awards: 2015 2014 2013 Risk free interest rate 1.37% - 1.68% 1.37% - 1.68% 0.91% - 2.07% Expected dividend yield 0.00% 0.00% 0.00% Expected option life (years) 6.25 6.25 6.25 Expected volatility 86% - 97% 97% - 109% 91% - 110% |
Restricted Stock Unit Activity | The following table presents the restricted stock unit activity for the years ended December 31, 2015 and 2014 (in thousands, except for weighted average amounts): Shares Weighted Average Outstanding—as of January 1, 2014 196 $ 6.96 Granted 2,255 2.03 Vested — — Forfeited (195 ) 3.17 Outstanding—as of December 31, 2014 2,256 2.03 Granted 9,888 2.12 Vested (821 ) 2.14 Forfeited (436 ) 1.45 Outstanding—as of December 31, 2015 10,887 2.12 |
Stock-Based Compensation Expense Related to Option Awards | The following table presents the stock-based compensation expense related to stock based awards for the years ended December 31, 2015, 2014 and 2013 (in thousands): 2015 2014 2013 Research and development $ 3,280 $ 2,701 $ 2,837 Selling, general and administrative 10,609 6,321 11,848 Stock-based compensation expense $ 13,889 $ 9,022 $ 14,685 |
Quarterly Summarized Financia34
Quarterly Summarized Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Summarized Financial Information (Unaudited) | Fiscal years ended December 31, 2015 and 2014 1st 2nd 3rd 4th 2015 2014 2015 2014 2015 2014 2015 2014 (In thousands, except per share amounts) Total revenue, net $ 15,933 $ 10,967 $ 17,707 $ 12,606 $ 21,483 $ 14,149 $ 26,633 $ 16,480 Net (loss) income applicable to common shareholders (31,994 ) (25,980 ) (62,853 ) 15,323 (32,321 ) (26,050 ) (21,891 ) (19,657 ) (Loss) earnings per share: Basic $ (0.18 ) $ (0.15 ) $ (0.35 ) $ 0.09 $ (0.18 ) $ (0.15 ) $ (0.12 ) $ (0.11 ) Diluted $ (0.18 ) $ (0.15 ) $ (0.35 ) $ 0.08 $ (0.18 ) $ (0.17 ) $ (0.12 ) $ (0.11 ) |
Nature of Business and Basis 35
Nature of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||
Cash and cash equivalents | $ 106,961 | $ 119,539 | $ 191,514 | $ 260,242 |
Convertible Debt | 2012 Notes | ||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||
Convertible senior notes, earliest redemption date | Jan. 19, 2017 | |||
Convertible Debt | 2014 Notes | ||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||
Convertible senior notes, earliest redemption date | Jan. 19, 2019 | |||
Convertible Debt | 2015 Notes | ||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||
Convertible senior notes, earliest redemption date | Jan. 19, 2019 |
Significant Accounting Polici36
Significant Accounting Policies - Additional Information (Detail) | Feb. 27, 2015shares | Oct. 16, 2009 | Dec. 31, 2015USD ($)TrancheSegmentshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | Nov. 30, 2015USD ($) | Mar. 05, 2015USD ($) | May. 31, 2014USD ($) | Dec. 31, 2012USD ($) | Dec. 06, 2012USD ($) |
Significant Accounting Policies [Line Items] | ||||||||||
Deferred revenue, current | $ 923,000 | $ 1,700,000 | ||||||||
Sales discount percentage | 2.00% | |||||||||
Sales discount term | 30 days | |||||||||
Trade receivables, credit period | 30 days | |||||||||
Number of tranches for private placement transaction | Tranche | 2 | |||||||||
Accounts receivable written off | $ 0 | |||||||||
Warrants outstanding | shares | 0 | |||||||||
Gain (Loss) on change in fair value of derivative liability | $ (1,106,000) | $ 13,472,000 | $ 47,710,000 | |||||||
Number of operating segments | Segment | 1 | |||||||||
Biopharma Debt | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Gain (Loss) on change in fair value of derivative liability | $ (700,000) | 6,300,000 | ||||||||
Maximum repayment of future revenue and receivables | 137,300,000 | $ 150,000,000 | ||||||||
Fair value of embedded derivative liability | $ 14,600,000 | |||||||||
Embedded Derivative Financial Instruments | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Gain (Loss) on change in fair value of derivative liability | (270,000) | 7,200,000 | ||||||||
Embedded Derivative Financial Instruments | Biopharma Debt | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Gain (Loss) on change in fair value of derivative liability | (700,000) | 6,300,000 | ||||||||
Maximum repayment of future revenue and receivables | $ 150,000,000 | |||||||||
Fair value of embedded derivative liability | 5,500,000 | $ 4,800,000 | ||||||||
Preferred Stock Purchase Option | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Gain (Loss) on change in fair value of derivative liability | $ (946,000) | |||||||||
Derivative liability at fair value | $ 900,000 | |||||||||
Top Three Customers | Gross Product Sales | Customer Concentration Risk | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Concentration risk percentage | 95.00% | 95.00% | ||||||||
Top Three Customers | Accounts Receivable | Customer Concentration Risk | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Concentration risk percentage | 95.00% | 96.00% | ||||||||
Convertible Debt | 2014 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Convertible senior notes, discount | $ 27,900,000 | |||||||||
Derivative liability fair value assumptions, risk-free rate | 2.70% | |||||||||
Derivative liability fair value assumptions, dividend yield | 24.80% | |||||||||
Derivative liability fair value assumptions, volatility rate | 82.00% | |||||||||
Gain (Loss) on change in fair value of derivative liability | $ 500,000 | $ 900,000 | ||||||||
Fair value of embedded derivative liability | 2,100,000 | $ 2,600,000 | ||||||||
Derivative liability at fair value | $ 3,500,000 | |||||||||
Convertible Debt | 2015 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Convertible senior notes, discount | $ 3,800,000 | |||||||||
Gain (Loss) on change in fair value of derivative liability | (100,000) | |||||||||
Fair value of embedded derivative liability | $ 600,000 | |||||||||
Derivative liability at fair value | $ 500,000 | |||||||||
Convertible Debt | 2014 Notes and 2015 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Derivative liability fair value assumptions, risk-free rate | 2.90% | 2.70% | ||||||||
Derivative liability fair value assumptions, dividend yield | 25.60% | 24.80% | ||||||||
Derivative liability fair value assumptions, volatility rate | 89.00% | 82.00% | ||||||||
Convertible Debt | 2012 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Convertible senior notes, discount | $ 0 | $ 0 | ||||||||
Convertible Debt | Non Cash | 2014 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Convertible senior notes, discount | 22,400,000 | $ 28,200,000 | ||||||||
Convertible Debt | Non Cash | 2015 Notes | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Convertible senior notes, discount | $ 4,100,000 | |||||||||
Warrants Issued October 2009 | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Warrants expiration date | Feb. 27, 2015 | |||||||||
Warrants outstanding | shares | 0 | 8,087,388 | ||||||||
Warrants exercised | shares | 1,844,585 | |||||||||
Warrants expired | shares | 6,242,803 | |||||||||
Warrant derivative liability | $ 100,000 | |||||||||
Derivative liability fair value assumptions, risk-free rate | 0.04% | |||||||||
Derivative liability fair value assumptions, term | 1 month 28 days | |||||||||
Derivative liability fair value assumptions, dividend yield | 0.00% | |||||||||
Derivative liability fair value assumptions, volatility rate | 79.00% | |||||||||
Gain (Loss) on change in fair value of derivative liability | $ 110,000 | |||||||||
Decrease in fair value of warrants | $ 100,000 | |||||||||
Warrants Issued October 2009 | Prior To Agreement | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Warrants expiration date | Oct. 16, 2014 | |||||||||
Maximum | Embedded Derivative Financial Instruments | Biopharma Debt | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Derivative liability fair value assumptions, term | 7 years 3 months 18 days | 3 years 7 months 6 days | ||||||||
Derivative liability fair value assumption, coupon rate | 12.50% | 10.80% | ||||||||
Derivative liability fair value assumptions, market yields | 30.70% | 16.80% | ||||||||
Minimum | Embedded Derivative Financial Instruments | Biopharma Debt | ||||||||||
Significant Accounting Policies [Line Items] | ||||||||||
Derivative liability fair value assumptions, term | 2 years | 2 years 3 months 18 days | ||||||||
Derivative liability fair value assumption, coupon rate | 6.60% | 9.80% | ||||||||
Derivative liability fair value assumptions, market yields | 13.00% | 10.00% |
Summarizes Activity of the Net
Summarizes Activity of the Net Product Revenue Allowance and Reserve Categories (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ 7,090 | $ 2,469 |
Provision related to current period and deferred sales | 56,229 | 32,460 |
Provision related to prior period sales | (449) | (128) |
Credits/payments made for current period and deferred sales | (40,626) | (25,431) |
Credits/payments made for prior period sales | (6,448) | (2,280) |
Ending balance | 15,796 | 7,090 |
Trade Receivables | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 2,207 | 1,071 |
Provision related to current period and deferred sales | 14,986 | 8,157 |
Provision related to prior period sales | (174) | (29) |
Credits/payments made for current period and deferred sales | (10,690) | (5,950) |
Credits/payments made for prior period sales | (2,033) | (1,042) |
Ending balance | 4,296 | 2,207 |
Rebates Chargebacks And Discounts | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 3,610 | 1,137 |
Provision related to current period and deferred sales | 32,591 | 12,753 |
Provision related to prior period sales | (70) | (80) |
Credits/payments made for current period and deferred sales | (22,710) | (9,143) |
Credits/payments made for prior period sales | (3,540) | (1,057) |
Ending balance | 9,881 | 3,610 |
Allowance for Sales Returns | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 481 | 72 |
Provision related to current period and deferred sales | 342 | 397 |
Provision related to prior period sales | (205) | 12 |
Credits/payments made for prior period sales | (83) | |
Ending balance | 535 | 481 |
Other Incentive Programs | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | 792 | 189 |
Provision related to current period and deferred sales | 8,310 | 11,153 |
Provision related to prior period sales | (31) | |
Credits/payments made for current period and deferred sales | (7,226) | (10,338) |
Credits/payments made for prior period sales | (792) | (181) |
Ending balance | $ 1,084 | $ 792 |
Summarizes the Impact of Accoun
Summarizes the Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Gross trade accounts receivable | $ 18,270 | $ 10,215 | |
Valuation allowances and reserves | (15,796) | (7,090) | $ (2,469) |
Accounts receivable, net | 13,826 | 7,842 | |
Trade Receivables | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Valuation allowances and reserves | (4,296) | (2,207) | $ (1,071) |
Chargebacks | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Valuation allowances and reserves | $ (148) | $ (166) |
Estimated Useful Lives (Detail)
Estimated Useful Lives (Detail) | 12 Months Ended |
Dec. 31, 2015 | |
Computer equipment and software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property Plant and Equipment Useful Life | 3 years |
Computer equipment and software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property Plant and Equipment Useful Life | 5 years |
Furniture and Fixtures | |
Property, Plant and Equipment [Line Items] | |
Property Plant and Equipment Useful Life | 5 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property Plant and Equipment Useful Life | Lesser of useful life or lease term |
Net Loss and the Number of Shar
Net Loss and the Number of Shares Used to Compute Basic and Diluted Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Earnings Loss Per Share [Line Items] | |||||||||||
Net loss | $ (21,891) | $ (32,321) | $ (62,853) | $ (31,994) | $ (19,657) | $ (26,050) | $ 15,323 | $ (25,980) | $ (115,204) | $ (56,364) | $ (166,227) |
Preferred stock purchase option (see Note 10) | (868) | ||||||||||
Preferred stock beneficial conversion features (see Note 10) | (32,987) | ||||||||||
Net loss applicable to common shareholders-basic | (149,059) | (56,364) | (166,227) | ||||||||
Gain on warrant derivative liability | (6,775) | (47,936) | |||||||||
Net loss-diluted | $ (149,059) | $ (63,139) | $ (214,163) | ||||||||
Net loss per share-basic | $ (0.12) | $ (0.18) | $ (0.35) | $ (0.18) | $ (0.11) | $ (0.15) | $ 0.09 | $ (0.15) | $ (0.83) | $ (0.32) | $ (1.03) |
Weighted average shares outstanding-basic | 180,654 | 173,719 | 161,022 | ||||||||
Effect of dilutive warrants | 105 | 6,048 | |||||||||
Weighted average shares outstanding-diluted | 180,654 | 173,824 | 167,070 | ||||||||
Net loss per share-diluted | $ (0.12) | $ (0.18) | $ (0.35) | $ (0.18) | $ (0.11) | $ (0.17) | $ 0.08 | $ (0.15) | $ (0.83) | $ (0.36) | $ (1.28) |
Anti-Dilutive Securities Not In
Anti-Dilutive Securities Not Included in the Computation of Net Loss per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Preferred Stock | |||
Earnings Loss Per Share [Line Items] | |||
Anti-dilutive securities | 32,818 | ||
Convertible Debt | |||
Earnings Loss Per Share [Line Items] | |||
Anti-dilutive securities | 59,407 | 49,215 | 17,021 |
Stock options | |||
Earnings Loss Per Share [Line Items] | |||
Anti-dilutive securities | 17,818 | 10,670 | 9,330 |
Restricted Stock Units (RSUs) | |||
Earnings Loss Per Share [Line Items] | |||
Anti-dilutive securities | 10,887 | 2,256 | 196 |
Warrant | |||
Earnings Loss Per Share [Line Items] | |||
Anti-dilutive securities | 1,702 |
Assets and Liability Measured a
Assets and Liability Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Liabilities: | |||
Derivative liability | $ 8,170 | $ 7,519 | $ 17,994 |
Long-term debt derivative liabilities | 8,170 | 7,400 | |
Fair Value, Measurements, Recurring | |||
Asset: | |||
Cash equivalents-money markets | 14,184 | 65,156 | |
Liabilities: | |||
Long-term debt derivative liabilities | 8,170 | 7,400 | |
Fair Value, Measurements, Recurring | Warrant | |||
Liabilities: | |||
Derivative liability | 119 | ||
Fair Value, Measurements, Recurring | Level 1 | |||
Asset: | |||
Cash equivalents-money markets | 14,184 | 65,156 | |
Fair Value, Measurements, Recurring | Level 3 | |||
Liabilities: | |||
Long-term debt derivative liabilities | $ 8,170 | 7,400 | |
Fair Value, Measurements, Recurring | Level 3 | Warrant | |||
Liabilities: | |||
Derivative liability | $ 119 |
Carrying Amounts and Estimated
Carrying Amounts and Estimated Fair Values of Debt Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Nov. 30, 2015 | Dec. 31, 2014 | May. 31, 2014 |
Debt Instrument [Line Items] | ||||
Long term debt-December 2012 financing, carrying value | $ 91,512 | $ 89,617 | ||
Long term debt-December 2012 financing, estimated fair value | 87,700 | 81,000 | ||
Convertible Debt | 2012 Notes | ||||
Debt Instrument [Line Items] | ||||
Exchangeable senior notes, carrying value | 15,107 | 31,266 | ||
Exchangeable senior notes, estimated fair value | 13,637 | 25,689 | ||
Convertible Debt | 2014 Notes | ||||
Debt Instrument [Line Items] | ||||
Exchangeable senior notes, carrying value | 96,364 | 90,580 | ||
Exchangeable senior notes, estimated fair value | 108,034 | $ 75,533 | $ 90,800 | |
Convertible Debt | 2015 Notes | ||||
Debt Instrument [Line Items] | ||||
Exchangeable senior notes, carrying value | 27,134 | |||
Exchangeable senior notes, estimated fair value | $ 28,448 | $ 27,500 |
Change in Fair Value of Derivat
Change in Fair Value of Derivative Liabilities (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Derivatives, Fair Value [Line Items] | |||
Beginning Balance | $ 7,519 | $ 17,994 | |
Record initial fair value of derivative liability | 1,368 | ||
(Gain) loss on change in fair value of derivative liabilities | 1,106 | (13,472) | $ (47,710) |
Transfer derivative liability to equity | (1,814) | ||
Ending Balance | 8,170 | 7,519 | 17,994 |
2014 Notes | |||
Derivatives, Fair Value [Line Items] | |||
Record initial fair value of derivative liability | 3,500 | ||
Warrant | |||
Derivatives, Fair Value [Line Items] | |||
Compensation income for change in fair value of warrants issued to former employees | (9) | (503) | (3,703) |
Warrants Issued October 2009 | |||
Derivatives, Fair Value [Line Items] | |||
Beginning Balance | 119 | 6,894 | |
(Gain) loss on change in fair value of derivative liabilities | (110) | (6,272) | |
Ending Balance | 119 | 6,894 | |
Warrants Issued October 2009 | Warrant | |||
Derivatives, Fair Value [Line Items] | |||
Compensation income for change in fair value of warrants issued to former employees | (9) | (503) | |
Embedded Derivative Financial Instruments | |||
Derivatives, Fair Value [Line Items] | |||
Beginning Balance | 7,400 | 11,100 | |
(Gain) loss on change in fair value of derivative liabilities | 270 | (7,200) | |
Ending Balance | 8,170 | 7,400 | $ 11,100 |
Embedded Derivative Financial Instruments | 2014 Notes | |||
Derivatives, Fair Value [Line Items] | |||
Record initial fair value of derivative liability | $ 3,500 | ||
Embedded Derivative Financial Instruments | 2015 Notes | |||
Derivatives, Fair Value [Line Items] | |||
Record initial fair value of derivative liability | 500 | ||
Preferred Stock Purchase Option | |||
Derivatives, Fair Value [Line Items] | |||
Record initial fair value of derivative liability | 868 | ||
(Gain) loss on change in fair value of derivative liabilities | 946 | ||
Transfer derivative liability to equity | $ (1,814) |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross | $ 11,624 | |
Accumulated Amortization | (2,207) | |
Net | $ 9,417 | $ 10,063 |
Weighted Average Remaining Useful Life (in years) | 14 years 7 months 6 days |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Intangible Assets Disclosure [Line Items] | |||
Amortization of intangible asset | $ 646 | $ 646 | $ 646 |
Intangible Assets Estimated Amo
Intangible Assets Estimated Amortization Expense (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Finite-Lived Intangible Assets [Line Items] | ||
2,016 | $ 646 | |
2,017 | 646 | |
2,018 | 646 | |
2,019 | 646 | |
2,020 | 646 | |
Thereafter | 6,187 | |
Net | $ 9,417 | $ 10,063 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Inventory [Line Items] | ||
Raw materials | $ 9,096 | $ 5,225 |
Work in process | 1,640 | 4,757 |
Finished goods | 8,249 | 3,751 |
Total inventory | $ 18,985 | $ 13,733 |
Property Plant and Equipment (D
Property Plant and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 997 | $ 969 |
Accumulated depreciation and amortization | (754) | (588) |
Total property, plant and equipment | 243 | 381 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 135 | 107 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 63 | 63 |
Furniture and Fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 240 | 240 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 559 | $ 559 |
Property Plant and Equipment -
Property Plant and Equipment - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation expense | $ 0.2 | $ 0.2 | $ 0.2 |
Accrued Expenses and Other Cu51
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Payroll and payroll-related expenses | $ 5,241 | $ 3,525 |
Research and development expenses | 828 | 4,391 |
Sales and marketing accruals | 3,141 | 1,509 |
Accrued revenue allowances | 10,732 | 4,717 |
All other | 4,284 | 2,245 |
Total accrued expenses and other current liabilities | $ 24,226 | $ 16,387 |
Warrants and Warrant Derivati52
Warrants and Warrant Derivative Liability - Additional Information (Detail) $ / shares in Units, $ in Thousands | Feb. 27, 2015shares | Oct. 16, 2009USD ($)$ / sharesshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) |
Derivative [Line Items] | |||||
Common stock issued under private placement, value | $ | $ 121,206 | ||||
Common stock issued under private placement, net proceeds | $ | $ 52,800 | ||||
Warrants outstanding | 0 | ||||
Proceeds from exercise of warrants | $ | $ 2,713 | $ 1,651 | $ 160 | ||
Warrants Issued October 2009 | |||||
Derivative [Line Items] | |||||
Warrants outstanding | 0 | 8,087,388 | |||
Warrants expiration date | Feb. 27, 2015 | ||||
Warrants exercised | 1,844,585 | ||||
Proceeds from exercise of warrants | $ | $ 2,700 | ||||
Warrants expired | 6,242,803 | ||||
Warrants Issued October 2009 | Prior To Agreement | |||||
Derivative [Line Items] | |||||
Warrants expiration date | Oct. 16, 2014 | ||||
Warrants Issued July 2009 | |||||
Derivative [Line Items] | |||||
Warrants outstanding | 0 | 0 | |||
Warrants exercised | 1,684,888 | ||||
Proceeds from exercise of warrants | $ | $ 1,700 | ||||
October 2009 Private Placement | |||||
Derivative [Line Items] | |||||
Common stock issued under private placement, value | $ | $ 70,000 | ||||
Common stock issued under private placement, net proceeds | $ | $ 62,300 | ||||
Common stock issued under private placement, shares | 66,400,000 | ||||
Number of shares that each ADS represents | 1 | ||||
Common stock issued under private placement, price per share | $ / shares | $ 1 | ||||
October 2009 Private Placement | Warrants issued to three former officers | |||||
Derivative [Line Items] | |||||
Number of warrants issued | 900,000 | ||||
October 2009 Private Placement | Bridge Loan | |||||
Derivative [Line Items] | |||||
Bridge notes converted in conjunction with the private placement, amount | $ | $ 3,600 | ||||
Common stock issued under private placement, shares | 4,000,000 | ||||
Number of shares that each ADS represents | 1 | ||||
Bridge notes converted in conjunction with the private placement, price per share | $ / shares | $ 0.90 | ||||
October 2009 Private Placement | Warrants Issued October 2009 | |||||
Derivative [Line Items] | |||||
Number of warrants issued | 35,200,000 | ||||
Description of pricing variability feature and classification of warrants | The warrants issued in connection with the October 2009 financing contained a pricing variability feature which provided for an increase to the exercise price if the exchange rate between the U.S. dollar and British pound adjusts such that the warrants could be exercised at a price less than the £0.5 par value of the common stock - that is, if the exchange rate exceeded U.S. $3.00 per £1.0 sterling. Due to the potential variable nature of the exercise price, the warrants are not considered to be indexed to the Company’s common stock. Accordingly, the warrants do not qualify for the exception to classify the warrants within equity and are classified as a derivative liability. | ||||
October 2009 Private Placement | Warrants Issued October 2009 | Maximum | |||||
Derivative [Line Items] | |||||
Warrants issued, number of shares called by the warrant | 36,100,000 | ||||
October 2009 Private Placement | Warrants Issued October 2009 | American Depositary Share | |||||
Derivative [Line Items] | |||||
Warrant term | 5 years | ||||
Warrants issued, number of shares called by a warrant | 0.5 | ||||
Exercise price of the warrants | $ / shares | $ 1.50 | ||||
October 2009 Private Placement | Warrants Issued October 2009 | Bridge Loan | American Depositary Share | |||||
Derivative [Line Items] | |||||
Warrant term | 5 years | ||||
Warrants issued, number of shares called by a warrant | 0.5 | ||||
Exercise price of the warrants | $ / shares | $ 1.50 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Dec. 06, 2012USD ($) | Nov. 30, 2015USD ($)shares$ / shares | May. 31, 2014USD ($)sharesd$ / shares | Jan. 31, 2012USD ($)shares$ / shares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Debt Disclosure [Line Items] | |||||||
Gain (Loss) on change in fair value of derivative liability | $ (1,106,000) | $ 13,472,000 | $ 47,710,000 | ||||
Interest expense | 20,180,000 | 18,575,000 | $ 34,179,000 | ||||
Proceeds from issuance of convertible debt, net of transaction costs | 27,514,000 | ||||||
Carrying amount of debt conversion option over the liability component | 11,500,000 | 12,800,000 | |||||
Decrease to additional paid-in capital for repurchase of conversion option in convertible notes | 1,300,000 | 10,100,000 | |||||
Gain on extinguishment of debt | 1,314,000 | 38,034,000 | |||||
Convertible senior notes, repayment | 16,145,000 | ||||||
Convertible Debt | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible notes, interest expense | 11,400,000 | 9,500,000 | |||||
Non-cash interest expense | 6,200,000 | 4,200,000 | |||||
Interest expense, contractual coupon interest accrual | 5,200,000 | 5,300,000 | |||||
Accrued interest on convertible note | 2,300,000 | 2,400,000 | |||||
Convertible Debt | 2012 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, principal amount | $ 15,100,000 | $ 31,300,000 | $ 150,000,000 | ||||
Convertible senior notes, stated interest rate | 3.50% | ||||||
Convertible senior notes, due date | 2,032 | ||||||
Proceeds from issuance of convertible debt, net of transaction costs | $ 144,300,000 | ||||||
Convertible senior notes, payment start date | Jul. 15, 2012 | ||||||
Convertible senior notes, maturity date | Jan. 15, 2032 | ||||||
Value of shares in excess of principal amount of Notes based on closing price | 11,900,000 | ||||||
Additional interest rate on notes per annum | 0.50% | ||||||
Convertible senior notes, repurchase price at option of the issuer | 100.00% | ||||||
Carrying amount of debt conversion option over the liability component | $ 23,800,000 | ||||||
Convertible senior notes, fair value | 13,637,000 | 25,689,000 | |||||
Note, estimated remaining life | 24 months | ||||||
Debt discount amortization period | 24 months | ||||||
Convertible notes, carrying amount net of unamortized discount | 15,100,000 | 31,300,000 | |||||
Decrease to additional paid-in capital for repurchase of conversion option in convertible notes | 10,100,000 | ||||||
Convertible senior notes, discount | 0 | 0 | |||||
Gain on extinguishment of debt | 1,300,000 | 38,000,000 | |||||
Convertible senior notes, repayment | 15,900,000 | ||||||
Convertible senior notes, principal amount purchase | 16,200,000 | ||||||
Convertible senior notes, purchase amount | 15,900,000 | ||||||
Convertible Debt | 2012 Notes | American Depository Shares | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, exchange rate of ADS per $1,000 principal amount of notes | 113.4752 | ||||||
Convertible senior notes, total ADS into which the debt is exchangeable | shares | 1,714,270 | ||||||
Convertible senior notes, initial exchange price | $ / shares | $ 8.8125 | ||||||
Convertible Debt | 2012 Notes | Exchanged Debt | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, principal amount | 118,700,000 | ||||||
Convertible Debt | 2014 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Fair value of embedded derivative liability | 2,100,000 | 2,600,000 | |||||
Gain (Loss) on change in fair value of derivative liability | 500,000 | 900,000 | |||||
Convertible senior notes, principal amount | $ 118,700,000 | ||||||
Convertible senior notes, stated interest rate | 3.50% | ||||||
Convertible senior notes, due date | 2,032 | ||||||
Convertible senior notes, payment start date | Jul. 15, 2014 | ||||||
Convertible senior notes, maturity date | Jan. 15, 2032 | ||||||
Value of shares in excess of principal amount of Notes based on closing price | 32,400,000 | ||||||
Convertible senior notes, repurchase price at option of the issuer | 100.00% | ||||||
Convertible senior notes, fair value | $ 90,800,000 | 108,034,000 | 75,533,000 | ||||
Convertible notes, carrying amount net of unamortized discount | 96,400,000 | 90,600,000 | |||||
Convertible senior notes redemption, end date | Jan. 15, 2032 | ||||||
Convertible senior notes, mandatory exchange in whole or in part if daily VWAP equals or exceeds percentage of exchange price, in any number of VWAP Trading days | d | 30 | ||||||
Convertible senior notes, discount | $ 27,900,000 | ||||||
Offering costs | 2,500,000 | ||||||
Derivative liability at fair value | $ 3,500,000 | ||||||
Convertible Debt | 2014 Notes | American Depository Shares | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, exchange rate of ADS per $1,000 principal amount of notes | 384.6154 | ||||||
Convertible senior notes, total ADS into which the debt is exchangeable | shares | 45,666,925 | ||||||
Convertible senior notes, initial exchange price | $ / shares | $ 2.60 | ||||||
Convertible Debt | 2014 Notes | Minimum | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, mandatory exchange in whole or in part if daily VWAP equals or exceeds percentage of exchange price | 110.00% | ||||||
Convertible senior notes, mandatory exchange in whole or in part if daily VWAP equals or exceeds percentage of exchange price, at least number of VWAP Trading days | 20 days | ||||||
Convertible Debt | 2015 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Fair value of embedded derivative liability | 600,000 | ||||||
Gain (Loss) on change in fair value of derivative liability | (100,000) | ||||||
Convertible senior notes, principal amount | $ 31,300,000 | ||||||
Convertible senior notes, stated interest rate | 3.50% | ||||||
Convertible senior notes, due date | 2,032 | ||||||
Proceeds from issuance of convertible debt, net of transaction costs | $ 27,500,000 | ||||||
Convertible senior notes, payment start date | Jan. 15, 2016 | ||||||
Convertible senior notes, maturity date | Jan. 15, 2032 | ||||||
Value of shares in excess of principal amount of Notes based on closing price | 8,500,000 | ||||||
Convertible senior notes, fair value | $ 27,500,000 | 28,448,000 | |||||
Convertible notes, carrying amount net of unamortized discount | 27,100,000 | ||||||
Convertible senior notes, discount | 3,800,000 | ||||||
Offering costs | 100,000 | ||||||
Derivative liability at fair value | $ 500,000 | ||||||
Convertible notes, interest expense | 200,000 | ||||||
Non-cash interest expense | 100,000 | ||||||
Interest expense, contractual coupon interest accrual | 100,000 | ||||||
Convertible Debt | 2015 Notes | American Depository Shares | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, exchange rate of ADS per $1,000 principal amount of notes | 384.6154 | ||||||
Convertible senior notes, total ADS into which the debt is exchangeable | shares | 12,025,385 | ||||||
Convertible senior notes, initial exchange price | $ / shares | $ 2.60 | ||||||
Convertible Debt | 2015 Notes | Minimum | |||||||
Debt Disclosure [Line Items] | |||||||
Beneficial ownership limitation | 4.99% | ||||||
Convertible Debt | 2015 Notes | Maximum | |||||||
Debt Disclosure [Line Items] | |||||||
Beneficial ownership limitation | 19.90% | ||||||
Convertible Debt | Other debt outstanding | 2012 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, fair value | $ 126,200,000 | ||||||
Convertible Debt | Non Cash | 2014 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, discount | 22,400,000 | 28,200,000 | |||||
Convertible Debt | Non Cash | 2015 Notes | |||||||
Debt Disclosure [Line Items] | |||||||
Convertible senior notes, discount | 4,100,000 | ||||||
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 | 137,300,000 | |||||
Repayment under agreement | 7,100,000 | ||||||
Fair value of embedded derivative liability | $ 14,600,000 | ||||||
Gain (Loss) on change in fair value of derivative liability | (700,000) | 6,300,000 | |||||
Biopharma Debt | February 2016 | |||||||
Debt Disclosure [Line Items] | |||||||
Future minimum repayment under agreement | 2,600,000 | ||||||
Biopharma Debt | Second quarter of 2016 and in each of the next three quarters | |||||||
Debt Disclosure [Line Items] | |||||||
Future minimum repayment under agreement | 15,000,000 | ||||||
Biopharma Debt | May 2017 | |||||||
Debt Disclosure [Line Items] | |||||||
Future minimum repayment under agreement | 13,000,000 | ||||||
Biopharma Debt | Cash | |||||||
Debt Disclosure [Line Items] | |||||||
Interest expense | 6,600,000 | 7,200,000 | |||||
Biopharma Debt | Non Cash | |||||||
Debt Disclosure [Line Items] | |||||||
Interest expense | $ 1,900,000 | $ 1,900,000 |
Future Minimum Lease Payments N
Future Minimum Lease Payments Net of Sublease Rental Income (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Operating | |
2,016 | $ 523 |
2,017 | 505 |
2,018 | 127 |
2019-2020 | 0 |
Total | $ 1,155 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Jun. 30, 2015ft² | Jan. 31, 2015ft² | Apr. 30, 2014ft² | Jan. 31, 2014ft² | May. 08, 2013ft² | Dec. 15, 2012ft² | Dec. 06, 2011ft² | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2015GBP (£) | Nov. 01, 2013USD ($)ft² | Nov. 01, 2013EUR (€)ft² | Sep. 30, 2011ft² | Jul. 01, 2011ft² |
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Operating lease, rental expense | $ | $ 800,000 | $ 1,000,000 | $ 1,000,000 | ||||||||||||
Potential payable amount over the agreement terms based on minimum purchase obligation | $ | $ 44,700,000 | ||||||||||||||
Dublin | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Office space leased (in square feet) | 270 | 270 | 320 | ||||||||||||
Operating lease, expiration date | Oct. 31, 2016 | ||||||||||||||
Operating lease, renewal option | 1 year | ||||||||||||||
Operating lease, monthly rent | $ 3,200 | € 2,900 | |||||||||||||
Bedminster | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Office space leased (in square feet) | 9,747 | ||||||||||||||
Operating lease, expiration date | Mar. 31, 2018 | ||||||||||||||
Additional office space leased (in square feet) | 10,883 | 2,601 | 2,142 | ||||||||||||
Square feet vacated in exchange for reduction on future rent payments | 2,000 | 2,142 | |||||||||||||
Sublease | Bedminster | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Additional office space leased under sublease (in square feet) | 2,500 | 4,700 | |||||||||||||
Further Indication for AMR101 | Laxdale Limited | Potential Marketing Approval 1 | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Potential aggregate stock or cash payment | $ 7,400,000 | £ 5,000,000 | |||||||||||||
Further Indication for AMR101 | Laxdale Limited | Potential Marketing Approval 2 | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Potential aggregate stock or cash payment | 7,400,000 | 5,000,000 | |||||||||||||
Further Indication for AMR101 | Laxdale Limited | Marketing Approval In Europe | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Potential aggregate stock or cash payment | 11,100,000 | 7,500,000 | |||||||||||||
Further Indication for AMR101 | Laxdale Limited | Maximum | |||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | |||||||||||||||
Potential aggregate stock or cash payment | $ 14,800,000 | £ 10,000,000 |
Equity - Additional Information
Equity - Additional Information (Detail) $ / shares in Units, $ in Thousands | Jul. 10, 2015USD ($)$ / sharesshares | Jul. 06, 2015shares | Mar. 05, 2015USD ($)$ / sharesshares | Jan. 29, 2015shares | Mar. 11, 2014shares | Jan. 08, 2014shares | Nov. 30, 2015USD ($) | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($)shares | Dec. 31, 2015£ / shares | Mar. 05, 2015£ / shares | Dec. 31, 2014£ / sharesshares |
Stockholders Equity Note [Line Items] | |||||||||||||
Shares issued, exercise of warrants | 1,844,585 | 1,684,888 | |||||||||||
Proceeds from exercise of warrants, gross of transaction costs | $ | $ 2,800 | $ 1,700 | |||||||||||
Proceeds from exercise of warrants, net of transaction costs | $ | $ 2,713 | $ 1,651 | $ 160 | ||||||||||
Warrants outstanding | 0 | ||||||||||||
Stock options, outstanding | 17,818,053 | 10,670,000 | |||||||||||
Restricted stock units, outstanding | 10,886,523 | ||||||||||||
Shares issued, exercise of stock options | 18,020 | 234,500 | |||||||||||
Proceeds from exercise of stock options, net of transaction costs | $ | $ 31 | $ 307 | 627 | ||||||||||
Refund of equity issuance costs | $ | $ 3,191 | ||||||||||||
Preferred stock, par value | £ / shares | £ 0.05 | ||||||||||||
Private placement, closing date | Mar. 30, 2015 | ||||||||||||
Stock issued under private placement, value | $ | $ 121,206 | ||||||||||||
Aggregate gross proceeds | $ | 52,800 | ||||||||||||
Estimated offering expense | $ | $ 700 | ||||||||||||
Common stock, par value | £ / shares | £ 0.50 | £ 0.50 | |||||||||||
Number of shares issued for each preference shares | 0.1 | ||||||||||||
Preferred stock, equivalent ordinary shares upon future consolidation | 32,818,464 | 0 | |||||||||||
Market value, per share | $ / shares | $ 2.39 | ||||||||||||
BCF resulting from issuance of Series A Preference Shares | $ | $ 32,987 | ||||||||||||
Transfer derivative liability to equity | $ | 1,814 | ||||||||||||
Preferred Stock Purchase Option | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Derivative liability at fair value | $ | $ 900 | ||||||||||||
Transfer derivative liability to equity | $ | $ 1,814 | ||||||||||||
Stock Incentive Plan 2011 | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Shares issued, related to the vesting of RSUs | 639,500 | ||||||||||||
Treasury shares for settlement of employee tax obligations | 114,258 | ||||||||||||
Convertible Debt | 2015 Notes | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Derivative liability at fair value | $ | $ 500 | ||||||||||||
Convertible Debt | 2015 Notes | Minimum | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Beneficial ownership limitation | 4.99% | ||||||||||||
Convertible Debt | 2015 Notes | Maximum | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Beneficial ownership limitation | 19.90% | ||||||||||||
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 | ||||||||||||
Preferred stock, par value | £ / shares | £ 0.05 | ||||||||||||
Stock issued under private placement, value | $ | $ 57,853 | ||||||||||||
Ordinary Shares | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Shares issued | 6,283,333 | ||||||||||||
Preferred stock, equivalent ordinary shares upon future consolidation | 32,818,464 | ||||||||||||
Second Private Placement | Preferred Stock Purchase Option | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
BCF resulting from issuance of Series A Preference Shares | $ | $ 3,400 | ||||||||||||
Derivative liability at fair value | $ | 1,800 | ||||||||||||
Gain (loss) on change in fair value of derivatives | $ | (1,600) | ||||||||||||
Second Private Placement | Series A Preferred Stock | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Preferred stock, equivalent ordinary shares upon future consolidation | 3,886,718 | ||||||||||||
Subscription agreement to purchase Additional shares | $ | $ 5,800 | ||||||||||||
First Private Placement | Preferred Stock Purchase Option | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Derivative liability at fair value | $ | $ 900 | ||||||||||||
Gain (loss) on change in fair value of derivatives | $ | (900) | ||||||||||||
Transfer derivative liability to equity | $ | $ 1,814 | ||||||||||||
American Depository Shares | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock issued under private placement, value | $ | $ 52,800 | ||||||||||||
American Depository Shares | Series A Preferred Stock | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock issued under private placement, shares | 352,150,790 | ||||||||||||
American Depository Shares | Second Private Placement | Series A Preferred Stock | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock issued under private placement, shares | 38,867,180 | ||||||||||||
Ordinary Shares Basis | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Share conversion price | $ / shares | $ 1.50 | ||||||||||||
Ordinary Shares Basis | Second Private Placement | Series A Preferred Stock | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Share conversion price | $ / shares | $ 1.50 | ||||||||||||
Preferred Shares Basis | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Share conversion price | $ / shares | $ 0.15 | ||||||||||||
Preferred Shares Basis | Second Private Placement | Series A Preferred Stock | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Share conversion price | $ / shares | $ 0.15 | ||||||||||||
Restricted Stock Units (RSUs) | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Percentage of outstanding shares on a fully diluted basis | 7.00% | ||||||||||||
Stock units, Granted | 9,888,000 | 2,255,000 | |||||||||||
Stock units, expected to vest | 10,887,000 | 196,000 | 2,256,000 | ||||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, Granted | 1,455,000 | 2,564,251 | 173,348 | 2,082,000 | |||||||||
Stock units, Vesting Period | 4 years | 3 years | 3 years | 3 years | |||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Director | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, Granted | 413,500 | ||||||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Director | Vest in equal installments over a three year period | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, Vesting Period | 3 years | ||||||||||||
Stock units, expected to vest | 283,500 | ||||||||||||
Restricted Stock Units (RSUs) | Stock Incentive Plan 2011 | Director | Vest in full | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, expected to vest | 130,000 | ||||||||||||
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] | |||||||||||||
Granted options | 5,470,000 | 1,622,500 | 205,890 | 2,605,500 | |||||||||
Stock units, Vesting Period | 4 years | 4 years | 4 years | 4 years | |||||||||
Stock options, expected to vest | 3,670,000 | ||||||||||||
Stock Options | Stock Incentive Plan 2011 | Director | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Granted options | 288,657 | ||||||||||||
Stock Options | Stock Incentive Plan 2011 | Director | Vest in equal installments over a three year period | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, Vesting Period | 3 years | ||||||||||||
Stock options, expected to vest | 121,506 | ||||||||||||
Stock Options | Stock Incentive Plan 2011 | Director | Vest in full | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock options, expected to vest | 167,151 | ||||||||||||
Performance Based Options | Stock Incentive Plan 2011 | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock options, expected to vest | 1,800,000 | ||||||||||||
Shares issued, related to the vesting of RSUs | 181,876 | ||||||||||||
Treasury shares for settlement of employee tax obligations | 40,165 | ||||||||||||
Performance Based Restricted Stock Unit | Stock Incentive Plan 2011 | |||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||
Stock units, Granted | 5,455,500 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | |||
Total amount of unrecognized tax benefits that would affect the tax rate if recognized | $ 1,400,000 | $ 1,400,000 | |
Gross liabilities to expire in 2016 | 579,000 | ||
Deferred tax asset credit tax carryforward resulting from excess tax benefits of share based compensation | 3,000,000 | ||
Deferred tax assets, current | 934,000 | ||
Deferred tax assets, long-term | 18,233,000 | 12,556,000 | |
Decrease in net operating loss carryforwards from prior years | 52,400,000 | ||
Tax credit carryforwards | 3,076,000 | $ 2,141,000 | |
Tax benefit related to extension of research and development credits | (1,300,000) | ||
Undistributed earning retained indefinitely for reinvestment by foreign subsidiary | 20,600,000 | ||
Accounting Standards Update 2015-17 | Restatement Adjustment | |||
Income Taxes [Line Items] | |||
Deferred tax assets, current | (900,000) | ||
Deferred tax assets, long-term | $ 900,000 | ||
Ireland | |||
Income Taxes [Line Items] | |||
Corporate tax rate | 25.00% | 25.00% | 25.00% |
Ireland | Amarin Pharmaceuticals Ireland Limited | |||
Income Taxes [Line Items] | |||
Corporate tax rate | 12.50% | 12.50% | 12.50% |
Ireland | Non-Trading Activity | |||
Income Taxes [Line Items] | |||
Corporate tax rate | 25.00% | ||
Ireland | Trading Activity | |||
Income Taxes [Line Items] | |||
Corporate tax rate | 12.50% | ||
Republic of Ireland, United Kingdom and Israel | |||
Income Taxes [Line Items] | |||
Foreign net operating loss carryforwards | $ 565,700,000 | ||
U.S. Federal | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 5,800,000 | ||
U.S. Federal | Minimum | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards, expiration date | 2,022 | ||
U.S. Federal | Maximum | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards, expiration date | 2,035 | ||
State | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 1,600,000 | ||
State | Minimum | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards, expiration date | 2,022 | ||
State | Maximum | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards, expiration date | 2,035 |
Reconciliation of Total Amounts
Reconciliation of Total Amounts of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | |||
Beginning uncertain tax benefits | $ 2,487 | $ 1,674 | $ 1,243 |
Prior year-increases | 120 | ||
Prior year-decreases | (762) | ||
Current year-increases | 144 | 1,067 | 687 |
Current year-decreases for lapses in statutes of limitations | (439) | (254) | (256) |
Ending uncertain tax benefits | $ 1,550 | $ 2,487 | $ 1,674 |
Jurisdictions the Company Remai
Jurisdictions the Company Remains Subject to Tax Examinations (Detail) | 12 Months Ended |
Dec. 31, 2015 | |
Earliest Tax Year | United States - Federal and State | |
Income Taxes [Line Items] | |
Tax Years | 2,012 |
Earliest Tax Year | Ireland | |
Income Taxes [Line Items] | |
Tax Years | 2,010 |
Earliest Tax Year | United Kingdom | |
Income Taxes [Line Items] | |
Tax Years | 2,014 |
Latest Tax Year | United States - Federal and State | |
Income Taxes [Line Items] | |
Tax Years | 2,015 |
Latest Tax Year | Ireland | |
Income Taxes [Line Items] | |
Tax Years | 2,015 |
Latest Tax Year | United Kingdom | |
Income Taxes [Line Items] | |
Tax Years | 2,015 |
Components of Loss from Operati
Components of Loss from Operations Before Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | |||
United States | $ (10,137) | $ (7,331) | $ (9,234) |
Loss from operations before taxes | (118,290) | (59,201) | (169,421) |
Republic of Ireland and the United Kingdom | |||
Income Taxes [Line Items] | |||
Ireland and United Kingdom | $ (108,153) | $ (51,870) | $ (160,187) |
Benefit from Income Taxes (Deta
Benefit from Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current: | |||
Federal-U.S. | $ 1,053 | $ 660 | $ 122 |
State-U.S. | 113 | 117 | 118 |
Total current | 1,166 | 777 | 240 |
Deferred: | |||
Federal-U.S. | (3,343) | (3,689) | (4,065) |
State-U.S. | (605) | (226) | 631 |
Ireland and United Kingdom | (9,023) | 3,335 | (33,106) |
Change in valuation allowance | 8,719 | (3,034) | 33,106 |
Total deferred | (4,252) | (3,614) | (3,434) |
Benefit from income taxes | $ (3,086) | $ (2,837) | $ (3,194) |
Difference between Benefit from
Difference between Benefit from Income Taxes and Amount Computed by Applying Statutory Income Tax Rate to Income Before Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | |||
Benefits from taxes at statutory rate | $ (29,572) | $ (14,786) | $ (42,355) |
Rate differential | 8,572 | 9,493 | 18,494 |
Change in valuation reserves | 8,719 | (3,034) | 33,106 |
Derivative liabilities | 187 | (2,706) | (11,984) |
Gain on extinguishment of debt | (328) | (9,509) | |
Research and development credits | (1,284) | (1,455) | (2,008) |
Tax return to provision adjustments | 2,248 | 10,026 | 125 |
Cumulative translation adjustment | 7,811 | 8,061 | (280) |
Permanent and other | 561 | 1,073 | 1,708 |
Benefit from income taxes | $ (3,086) | $ (2,837) | $ (3,194) |
Income Taxes Effect of Each Typ
Income Taxes Effect of Each Type of Temporary Difference Comprising Net Differed Tax Asset (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Deferred tax assets: | |||
Net operating losses | $ 88,996 | $ 80,096 | |
Stock based compensation | 17,975 | 15,600 | |
Depreciation | 74 | (90) | |
Tax credits | 3,076 | 2,141 | |
Other reserves and accrued liabilities | 2,796 | 1,708 | |
Gross deferred tax assets | 112,917 | 99,455 | |
Less: valuation allowance | (94,684) | (85,965) | $ (88,999) |
Total deferred tax assets | $ 18,233 | $ 13,490 |
Valuation Allowance (Detail)
Valuation Allowance (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation Allowance [Line Items] | ||
Beginning valuation allowance | $ 85,965 | $ 88,999 |
Increase as reflected in income tax expense | 16,291 | 5,081 |
Cumulative translation adjustment | (7,572) | (8,115) |
Ending valuation allowance | $ 94,684 | $ 85,965 |
Stock Incentive Plans and Sto65
Stock Incentive Plans and Stock Based Compensation - Additional Information (Detail) | Jul. 06, 2015 | Jan. 29, 2015 | Jan. 08, 2014 | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / shares | Dec. 31, 2013USD ($)$ / shares | Dec. 31, 2015£ / shares | Dec. 31, 2014£ / shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, par value | £ / shares | £ 0.50 | £ 0.50 | ||||||
Weighted average fair value of the stock options granted | $ / shares | $ 2.16 | $ 1.58 | $ 6.18 | |||||
Cash received from the exercise of options | $ 31,000 | $ 307,000 | $ 627,000 | |||||
Intrinsic value of options exercised | 6,000 | 200,000 | ||||||
Unrecognized stock-based compensation expense related to unvested stock option | $ 14,100,000 | 9,400,000 | ||||||
Unrecognized stock-based compensation expense related to unvested stock option, recognition period | 3 years | |||||||
Excess tax (benefit from) provision on from stock-based awards | $ (727,000) | 2,299,000 | 361,000 | |||||
Compensation expense related to stock option | 7,900,000 | 7,700,000 | 14,300,000 | |||||
Compensation expense in relation to restricted stock units | $ 6,000,000 | $ 1,400,000 | $ 400,000 | |||||
Stock Options Granted Prior to June 30, 2009 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options, Vesting Period | 3 years | |||||||
Stock Options Granted after June 30, 2009 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options, Vesting Period | 4 years | |||||||
Stock Incentive Plan 2011 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Newly authorized Shares available for award | shares | 31,500,000 | |||||||
Stock Incentive Plan 2011 | Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options, Vesting Period | 4 years | 4 years | 4 years | 4 years | ||||
Expire period | 10 years |
Stock Option Activity (Detail)
Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Number of Shares | ||
Outstanding January 1, 2015 | 10,670,000 | |
Granted | 7,976,000 | |
Cancelled/Expired | (810,000) | |
Exercised | (18,020) | (234,500) |
Outstanding, December 31, 2015 | 17,818,053 | 10,670,000 |
Exercisable, December 31, 2015 | 9,406,000 | |
Vested and Expected to Vest, December 31, 2015 | 2,756,000 | |
Available for future grant as of December 31, 2015 | 8,960,000 | |
Weighted Average Exercise Price | ||
Outstanding January 1, 2015 | $ 4.95 | |
Granted | 2.16 | |
Cancelled/Expired | 3.75 | |
Exercised | 1.76 | |
Outstanding, December 31, 2015 | 3.76 | $ 4.95 |
Exercisable, December 31, 2015 | 5.02 | |
Vested and Expected to Vest, December 31, 2015 | $ 4.04 | |
Weighted Average Remaining Contractual Term | ||
Outstanding, December 31, 2015 | 8 years | |
Exercisable, December 31, 2015 | 6 years 10 months 24 days | |
Vested and Expected to Vest, December 31, 2015 | 8 years 1 month 6 days | |
Aggregate Intrinsic Value | ||
Outstanding, December 31, 2015 | $ 1,949 | |
Exercisable, December 31, 2015 | 833 | |
Vested and Expected to Vest, December 31, 2015 | $ 520 |
Assumptions Used to Estimate Fa
Assumptions Used to Estimate Fair Value of Share-Based Payment Awards (Detail) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk free interest rate, minimum | 1.37% | 1.37% | 0.91% |
Risk free interest rate, maximum | 1.68% | 1.68% | 2.07% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected option life (years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Expected volatility, minimum | 86.00% | 97.00% | 91.00% |
Expected volatility, maximum | 97.00% | 109.00% | 110.00% |
Restricted Stock Unit Activity
Restricted Stock Unit Activity (Detail) - Restricted Stock Units (RSUs) - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Shares | ||
Beginning Balance | 2,256 | 196 |
Granted | 9,888 | 2,255 |
Vested | (821) | |
Forfeited | (436) | (195) |
Ending Balance | 10,887 | 2,256 |
Weighted Average Grant-Date Fair Value | ||
Beginning Balance | $ 2.03 | $ 6.96 |
Granted | 2.12 | 2.03 |
Vested | 2.14 | |
Forfeited | 1.45 | 3.17 |
Ending Balance | $ 2.12 | $ 2.03 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense Related to Option Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 13,889 | $ 9,022 | $ 14,685 |
Research and Development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 3,280 | 2,701 | 2,837 |
Selling, general and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 10,609 | $ 6,321 | $ 11,848 |
Defined Contribution Plans - Ad
Defined Contribution Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Contributions made under defined contribution plan | $ 0 | $ 0 | $ 0 |
Related Party Transaction - Add
Related Party Transaction - Additional Information (Detail) | Jul. 10, 2015USD ($)$ / sharesshares | Mar. 05, 2015shares | Oct. 16, 2009shares | Oct. 31, 2009Pointshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) |
Related Party Transaction [Line Items] | |||||||
Derivative liability | $ | $ 8,170,000 | $ 7,519,000 | $ 17,994,000 | ||||
Preferred stock, equivalent ordinary shares upon future consolidation | 32,818,464 | 0 | |||||
American Depository Shares | Series A Preferred Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 352,150,790 | ||||||
Preferred Shares Basis | |||||||
Related Party Transaction [Line Items] | |||||||
Share conversion price | $ / shares | $ 0.15 | ||||||
Ordinary Shares Basis | |||||||
Related Party Transaction [Line Items] | |||||||
Share conversion price | $ / shares | $ 1.50 | ||||||
October 2009 Private Placement | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 66,400,000 | ||||||
October 2009 Private Placement | Warrant | |||||||
Related Party Transaction [Line Items] | |||||||
Derivative liability | $ | $ 0 | ||||||
Derivative liability at fair value | $ | $ 0 | ||||||
October 2009 Private Placement | American Depository Shares | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 36,000,000 | ||||||
Number of ADS that can be purchased for each warrant received | Point | 0.5 | ||||||
October 2009 Private Placement | American Depository Shares | Abingworth LLP | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 17,000,000 | ||||||
October 2009 Private Placement | American Depository Shares | Orbimed Advisors LLC | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 7,000,000 | ||||||
October 2009 Private Placement | American Depository Shares | Sofinnova Venture Partners VII, LP | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 7,000,000 | ||||||
October 2009 Private Placement | American Depository Shares | Fountain Healthcare Partners Fund 1, LP | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 5,000,000 | ||||||
Second Private Placement | Series A Preferred Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Preferred stock, equivalent ordinary shares upon future consolidation | 3,886,718 | ||||||
Subscription agreement to purchase Additional shares | $ | $ 5,800,000 | ||||||
Second Private Placement | American Depository Shares | Series A Preferred Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase of ADSs (in the form of common stock) by directors in private placement | 38,867,180 | ||||||
Second Private Placement | Preferred Shares Basis | Series A Preferred Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Share conversion price | $ / shares | $ 0.15 | ||||||
Second Private Placement | Ordinary Shares Basis | Series A Preferred Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Share conversion price | $ / shares | $ 1.50 |
Quarterly Summarized Financia72
Quarterly Summarized Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information [Line Items] | |||||||||||
Total revenue, net | $ 26,633 | $ 21,483 | $ 17,707 | $ 15,933 | $ 16,480 | $ 14,149 | $ 12,606 | $ 10,967 | $ 81,756 | $ 54,202 | $ 26,351 |
Net (loss) income applicable to common shareholders | $ (21,891) | $ (32,321) | $ (62,853) | $ (31,994) | $ (19,657) | $ (26,050) | $ 15,323 | $ (25,980) | $ (115,204) | $ (56,364) | $ (166,227) |
(Loss) earnings per share: | |||||||||||
Basic | $ (0.12) | $ (0.18) | $ (0.35) | $ (0.18) | $ (0.11) | $ (0.15) | $ 0.09 | $ (0.15) | $ (0.83) | $ (0.32) | $ (1.03) |
Diluted | $ (0.12) | $ (0.18) | $ (0.35) | $ (0.18) | $ (0.11) | $ (0.17) | $ 0.08 | $ (0.15) | $ (0.83) | $ (0.36) | $ (1.28) |
Co-Promotion Agreement - Additi
Co-Promotion Agreement - Additional Information (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015USD ($)Employee | Dec. 31, 2014USD ($) | |
Co-Promotion Agreement [Line Items] | ||
Prepaid and other current assets | $ 3,152 | $ 2,633 |
Accrued expenses and other current liabilities | $ 24,226 | 16,387 |
Co-Promotion Agreement (the Agreement) | ||
Co-Promotion Agreement [Line Items] | ||
Promotion fee as a percentage gross margin | From the high single digits in 2014 to the low twenty percent level in 2018. | |
Co-Promotion Agreement (the Agreement) | Kowa Pharmaceuticals America | ||
Co-Promotion Agreement [Line Items] | ||
Prepaid and other current assets | $ 600 | |
Accrued expenses and other current liabilities | $ 2,500 | |
Co-Promotion Agreement (the Agreement) | Kowa Pharmaceuticals America | Minimum | ||
Co-Promotion Agreement [Line Items] | ||
Number of sales representatives | Employee | 250 |
Development, Commercializatio74
Development, Commercialization and Supply Agreement - Additional Information (Detail) - USD ($) | Feb. 26, 2015 | Dec. 31, 2015 |
License And Collaboration Agreements [Line Items] | ||
Licensing revenue | $ 769,000 | |
Eddingpharm | ||
License And Collaboration Agreements [Line Items] | ||
Non-refundable up-front received | $ 15,000,000 | |
Deferred revenue | $ 14,200,000 | |
Licensing agreement term | 16 years | |
Eddingpharm | Maximum | ||
License And Collaboration Agreements [Line Items] | ||
Additional upfront payment eligible to receive based on development, regulatory and sales Milestone | $ 154,000,000 | |
Eddingpharm | Up-front Payment | ||
License And Collaboration Agreements [Line Items] | ||
Licensing revenue | $ 800,000 |