Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 04, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Alkermes plc. | ||
Entity Central Index Key | 1,520,262 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ALKS | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 6,322,607,110 | ||
Entity Common Stock, Shares Outstanding | 156,039,212 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 266,762 | $ 191,296 |
Investments—short-term | 272,533 | 242,208 |
Receivables, net | 292,223 | 233,590 |
Contract assets | 8,230 | 0 |
Inventory | 90,196 | 93,275 |
Prepaid expenses and other current assets | 53,308 | 48,475 |
Total current assets | 983,252 | 808,844 |
PROPERTY, PLANT AND EQUIPMENT, NET | 309,987 | 284,736 |
INTANGIBLE ASSETS, NET | 191,001 | 256,168 |
INVESTMENTS—LONG-TERM | 80,744 | 157,212 |
GOODWILL | 92,873 | 92,873 |
CONTINGENT CONSIDERATION | 65,200 | 84,800 |
DEFERRED TAX ASSETS | 85,807 | 98,560 |
OTHER ASSETS | 16,143 | 14,034 |
TOTAL ASSETS | 1,825,007 | 1,797,227 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 333,762 | 286,166 |
Contract liabilities—short-term | 3,169 | 1,956 |
Long-term debt—short-term | 2,843 | 3,000 |
Total current liabilities | 339,774 | 291,122 |
LONG-TERM DEBT | 276,465 | 278,436 |
OTHER LONG-TERM LIABILITIES | 27,958 | 19,204 |
CONTRACT LIABILITIES—LONG-TERM | 9,525 | 5,657 |
Total liabilities | 653,722 | 594,419 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 16) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at December 31, 2018 and 2017, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 158,180,833 and 156,057,632 shares issued; 155,757,344 and 154,009,456 shares outstanding at December 31, 2018 and 2017, respectively | 1,579 | 1,557 |
Treasury shares, at cost (2,423,489 and 2,048,176 shares at December 31, 2018 and 2017, respectively) | (108,969) | (89,347) |
Additional paid-in capital | 2,467,323 | 2,338,755 |
Accumulated other comprehensive loss | (3,280) | (3,792) |
Accumulated deficit | (1,185,368) | (1,044,365) |
Total shareholders’ equity | 1,171,285 | 1,202,808 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,825,007 | $ 1,797,227 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock shares, authorized | 50,000,000 | 50,000,000 |
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 450,000,000 | 450,000,000 |
Ordinary shares, shares issued | 158,180,833 | 156,057,632 |
Ordinary shares, shares outstanding | 155,757,344 | 154,009,456 |
Treasury shares | 2,423,489 | 2,048,176 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
REVENUES: | |||
Total revenues | $ 1,094,274 | $ 903,374 | $ 745,694 |
EXPENSES: | |||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 176,420 | 154,748 | 132,122 |
Research and development | 425,406 | 412,889 | 387,148 |
Selling, general and administrative | 526,408 | 421,578 | 374,130 |
Amortization of acquired intangible assets | 65,168 | 62,059 | 60,959 |
Total expenses | 1,193,402 | 1,051,274 | 954,359 |
OPERATING LOSS | (99,128) | (147,900) | (208,665) |
OTHER (EXPENSE) INCOME, NET: | |||
Interest income | 9,238 | 4,649 | 3,752 |
Interest expense | (15,437) | (12,008) | (14,889) |
Change in the fair value of contingent consideration | (19,600) | 21,600 | 7,900 |
Other expense, net | (2,040) | (9,615) | (2,485) |
Total other (expense) income, net | (27,839) | 4,626 | (5,722) |
LOSS BEFORE INCOME TAXES | (126,967) | (143,274) | (214,387) |
INCOME TAX PROVISION (BENEFIT) | 12,344 | 14,671 | (5,943) |
NET LOSS | $ (139,311) | $ (157,945) | $ (208,444) |
LOSS PER ORDINARY SHARE: | |||
Basic and diluted (in dollars loss per ordinary share) | $ (0.90) | $ (1.03) | $ (1.38) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | |||
Basic and diluted (in shares) | 155,112 | 153,415 | 151,484 |
COMPREHENSIVE LOSS: | |||
Net loss | $ (139,311) | $ (157,945) | $ (208,444) |
Holding gain, net of a tax provision (benefit) of $159, $(295) and $237, respectively | 512 | (518) | 522 |
COMPREHENSIVE LOSS | (138,799) | (158,463) | (207,922) |
Manufacturing and royalty revenues | |||
REVENUES: | |||
Total revenues | 526,675 | 505,308 | 487,247 |
Product sales, net | |||
REVENUES: | |||
Total revenues | 450,334 | 362,834 | 256,146 |
Research and development revenue | |||
REVENUES: | |||
Total revenues | 68,895 | 7,232 | $ 2,301 |
License revenue | |||
REVENUES: | |||
Total revenues | $ 48,370 | $ 28,000 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | |||
Tax (benefit) provision | $ 159 | $ (295) | $ 237 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Treasury Stock |
BALANCE at Dec. 31, 2015 | $ 1,314,275 | $ 1,518 | $ 2,114,711 | $ (3,795) | $ (739,498) | $ (58,661) |
BALANCE (in shares) at Dec. 31, 2015 | 152,128,941 | (1,427,952) | ||||
Increase (Decrease) in Shareholders' Equity | ||||||
Issuance of ordinary shares under employee stock plans | 20,308 | $ 20 | 20,288 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 2,027,571 | |||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards | (13,467) | $ 1 | 510 | $ (13,978) | ||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 34,769 | (332,815) | ||||
Share-based compensation expense | 94,458 | 94,458 | ||||
Excess tax benefit from share-based compensation | 1,830 | 1,830 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) $159, $(295), and $237 for the years ended December 31, 2018, 2017 and 2016, respectively | 521 | 521 | ||||
Net loss | (208,444) | (208,444) | ||||
BALANCE at Dec. 31, 2016 | 1,209,481 | $ 1,539 | 2,231,797 | (3,274) | (947,942) | $ (72,639) |
BALANCE (in shares) at Dec. 31, 2016 | 154,191,281 | (1,760,767) | ||||
Increase (Decrease) in Shareholders' Equity | ||||||
Issuance of ordinary shares under employee stock plans | 23,517 | $ 16 | 23,501 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,850,084 | |||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards | (16,433) | $ 2 | 273 | $ (16,708) | ||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 16,267 | (287,409) | ||||
Share-based compensation expense | 83,184 | 83,184 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) $159, $(295), and $237 for the years ended December 31, 2018, 2017 and 2016, respectively | (518) | (518) | ||||
Cumulative effect adjustment related to change in accounting for excess tax benefits | 61,522 | 61,522 | ||||
Net loss | (157,945) | (157,945) | ||||
BALANCE at Dec. 31, 2017 | 1,202,808 | $ 1,557 | 2,338,755 | (3,792) | (1,044,365) | $ (89,347) |
BALANCE (in shares) at Dec. 31, 2017 | 156,057,632 | (2,048,176) | ||||
Increase (Decrease) in Shareholders' Equity | ||||||
Issuance of ordinary shares under employee stock plans | 20,877 | $ 11 | 20,866 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,087,815 | |||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards | (19,622) | $ 11 | (11) | $ (19,622) | ||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 1,035,386 | (375,313) | ||||
Share-based compensation expense | 107,713 | 107,713 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) $159, $(295), and $237 for the years ended December 31, 2018, 2017 and 2016, respectively | 512 | 512 | ||||
Cumulative effect adjustment related to the adoption of new accounting standards | (1,692) | (1,692) | ||||
Net loss | (139,311) | (139,311) | ||||
BALANCE at Dec. 31, 2018 | $ 1,171,285 | $ 1,579 | $ 2,467,323 | $ (3,280) | $ (1,185,368) | $ (108,969) |
BALANCE (in shares) at Dec. 31, 2018 | 158,180,833 | (2,423,489) |
CONSOLIDATED STATEMENTS OF SH_2
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Stockholders Equity [Abstract] | |||
Tax (benefit) provision | $ 159 | $ (295) | $ 237 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (139,311) | $ (157,945) | $ (208,444) |
Adjustments to reconcile net loss to cash flows from operating activities: | |||
Depreciation and amortization | 103,660 | 98,523 | 94,256 |
Share-based compensation expense | 105,357 | 83,917 | 94,396 |
Deferred income taxes | 10,623 | 7,234 | (9,689) |
Change in the fair value of contingent consideration | 19,600 | (21,600) | (7,900) |
Impairment of property, plant and equipment | 5,746 | ||
Loss on debt refinancing | 2,298 | 2,075 | |
Payment made for debt refinancing | (2,251) | ||
Impairment of investment in Synchronicity Pharma, Inc. | 10,471 | ||
Excess tax benefit from share-based compensation | (4,229) | ||
Other non-cash charges | 979 | 3,471 | 2,936 |
Changes in assets and liabilities: | |||
Receivables | (58,632) | (42,489) | (35,616) |
Contract assets | 880 | ||
Inventory | (2,665) | (30,191) | (26,381) |
Prepaid expenses and other assets | (5,990) | (9,506) | (15,014) |
Accounts payable and accrued expenses | 46,739 | 72,658 | 45,870 |
Contract liabilities | 3,252 | (1,447) | (649) |
Other long-term liabilities | 8,996 | 6,094 | 4,587 |
Cash flows provided by (used in) operating activities | 99,281 | 19,190 | (63,802) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Additions of property, plant and equipment | (69,431) | (51,300) | (43,657) |
Proceeds from the sale of equipment | 507 | 162 | 194 |
Purchases of investments | (397,727) | (431,712) | (375,099) |
Sales and maturities of investments | 444,456 | 464,494 | 560,805 |
Investment in Synchronicity Pharma, Inc. | (15,000) | ||
Cash flows (used in) provided by investing activities | (22,195) | (18,356) | 127,243 |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 20,877 | 23,517 | 20,308 |
Employee taxes paid related to net share settlement of equity awards | (19,622) | (16,433) | (13,467) |
Payment made for debt refinancing | (743) | (65,813) | |
Excess tax benefit from share-based compensation | 4,229 | ||
Principal payments of long-term debt | (2,132) | (3,000) | (3,429) |
Cash flows (used in) provided by financing activities | (1,620) | 4,084 | (58,172) |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 75,466 | 4,918 | 5,269 |
CASH AND CASH EQUIVALENTS—Beginning of period | 191,296 | 186,378 | 181,109 |
CASH AND CASH EQUIVALENTS—End of period | 266,762 | 191,296 | 186,378 |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | |||
Cash paid for interest | 12,526 | 11,143 | 12,458 |
Cash paid for taxes | 754 | 2,992 | 5,531 |
Non-cash investing and financing activities: | |||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 11,720 | $ 11,151 | $ 5,766 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION Alkermes plc (the “Company”) is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. The Company has a diversified portfolio of commercial drug products and a clinical pipeline of product candidates focused on central nervous system (“CNS”) disorders such as schizophrenia, depression, addiction and multiple sclerosis (“MS”), and oncology. Headquartered in Dublin, Ireland, the Company has a research and development (“R&D”) center in Waltham, Massachusetts; R&D and manufacturing facilities in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries: Alkermes Ireland Holdings Limited; Daravita Pharma Ireland Limited; Daravita Limited; Alkermes Science Four Limited; Alkermes Science Five Limited; Alkermes Science Six Limited; Alkermes Pharma Ireland Limited; Alkermes U.S. Holdings, Inc.; Alkermes, Inc.; Alkermes Controlled Therapeutics, Inc.; Alkermes Europe, Ltd.; Alkermes Finance Ireland Limited; Alkermes Finance Ireland (No. 2) Limited; Alkermes Finance Ireland (No. 3) Limited; and Alkermes Finance S.à r.l. Intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of the Company’s consolidated financial statements in accordance with accounting principles generally accepted in the United States (“U.S.”) (“GAAP”) requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on‑going basis, the Company evaluates its estimates and judgments and methodologies, including those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long‑lived assets, share‑based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Cash and Cash Equivalents The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates their market value. The Company considers only those investments which are highly liquid, readily convertible into cash and so near their maturity, generally three months from the date of purchase, that they present insignificant risk of change in value because of interest rate changes to be cash equivalents. Investments The Company has investments in various types of securities, consisting primarily of U.S. government and agency obligations, corporate debt securities and debt securities issued by foreign agencies and backed by foreign governments. The Company generally holds its interest-bearing investments with major financial institutions and in accordance with documented investment policies. The Company limits the amount of credit exposure to any one financial institution or corporate issuer. At December 31, 2018, substantially all these investments were classified as available for sale and were recorded at fair value. Holding gains and losses on available-for-sale investments are considered “unrealized” and are reported within “Accumulated other comprehensive loss,” a component of shareholders’ equity. The Company uses the specific identification method for reclassifying unrealized gains and losses into earnings when investments are sold. The Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment and its application to certain investments, as required by GAAP. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses on available-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded in “Accumulated other comprehensive loss.” For securities with unrealized losses, the Company performs an analysis to assess whether it intends to sell or whether it would more likely than not be required to sell the security before the expected recovery of its amortized cost basis. If the Company intends to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded within earnings as an impairment loss. Regardless of the Company’s intent to sell a security, the Company performs additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. The Company's held-to-maturity investments are restricted investments held as collateral under letters of credit related to certain of the Company's agreements and are included in “Investments—long-term,” in the accompanying consolidated balance sheets. Fair Value of Financial Instruments The Company’s financial assets and liabilities are recorded at fair value and are classified as Level 1, 2 or 3 within the fair value hierarchy, as described in the accounting standards for fair value measurement. The Company’s financial assets and liabilities consist of cash equivalents, investments, contingent consideration and warrants to purchase the common stock of a publicly traded company and are classified within the fair value hierarchy as follows: • Level 1 –these valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 1 inputs at December 31, 2018 included U.S. treasury securities, marketable securities classified as cash equivalents and a fixed term deposit account; • Level 2 –these valuations are based on a market approach using quoted prices obtained from brokers or dealers for similar securities or for securities for which the Company has limited visibility into their trading volumes. Valuations of these financial instruments do not require a significant degree of judgment. Assets and liabilities utilizing Level 2 inputs at December 31, 2018 included U.S. government agency debt securities, debt securities issued by foreign agencies and backed by foreign governments and investments in corporate debt securities that are trading in the credit markets; and • Level 3 –these valuations are based on an income approach using certain inputs that are unobservable and are significant to the overall fair value measurement. Valuations of these products require a significant degree of judgment. At December 31, 2018, assets utilizing Level 3 inputs included contingent consideration, warrants to purchase the common stock of Recro Pharma, Inc. (“Recro”) and an investment in a corporate debt security. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued expenses approximate fair value due to their short‑term nature. Inventory Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Included in inventory are raw materials used in production of pre-clinical and clinical products, which have alternative future use and are charged to R&D expense when consumed. The cost elements included within inventory include three primary categories for commercial products: cost of raw materials; direct labor; and overhead. Overhead is based on the normal capacity of the Company’s production facilities and does not include costs from abnormally low production or idle capacity, which are expensed directly to the consolidated statement of operations and comprehensive loss. Property, Plant and Equipment Property, plant and equipment are recorded at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Expenditures for repairs and maintenance are charged to expense as incurred and major renewals and improvements are capitalized. Depreciation is calculated using the straight‑line method over the following estimated useful lives of the assets: Asset group Term Buildings and improvements 15 - 40 years Furniture, fixtures and equipment 3 - 10 years Leasehold improvements Shorter of useful life or lease term Contingent Consideration The Company records contingent consideration it is entitled to receive at fair value on the acquisition date. The Company estimates the fair value of contingent consideration through valuation models that incorporate probability-adjusted assumptions related to the achievement of milestones and thus likelihood of receiving related payments. The Company revalues its contingent consideration each reporting period, with changes in the fair value of contingent consideration recognized within the consolidated statements of operations and comprehensive loss. Changes in the fair value of contingent consideration can result from changes to one or multiple inputs, including adjustments to discount rates, changes in the amount or timing of cash flows, changes in the assumed achievement or timing of any development or sales-based milestones and changes in the assumed probability associated with regulatory approval. The period over which the Company discounts its contingent consideration is based on the current development stage of the product candidate, the specific development plan for that product candidate, adjusted for the probability of completing the development steps, and when contingent payments would be triggered. In estimating the probability of success, the Company utilizes data regarding similar milestone events from several sources, including industry studies and the Company’s own experience. These fair value measurements are based on significant inputs not observable in the market. Significant judgment was employed in determining the appropriateness of these assumptions at the acquisition date and for each subsequent period. Accordingly, changes in assumptions described above could have a material impact on the increase or decrease in the fair value of contingent consideration recorded in any given period. Goodwill and Intangible Assets Goodwill represents the excess cost of the Company's investment in the net assets of acquired companies over the fair value of the underlying identifiable net assets at the date of acquisition. The Company’s goodwill consists solely of goodwill created as a result of the Company’s acquisition of Elan Drug Technologies (“EDT”) from Elan Corporation, plc (the “Business Combination”) in September 2011 and has been assigned to one reporting unit. A reporting unit is an operating segment or one level below an operating segment or a component to which goodwill is assigned when initially recorded. Goodwill is not amortized but is reviewed for impairment on an annual basis, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of the goodwill might not be recoverable. The Company has the option to first assess qualitative factors to determine whether it is necessary to perform the quantitative impairment test. If the Company elects this option and believes, as a result of the qualitative assessment, that it is more-likely-than-not that the fair value of its reporting unit is less than its carrying amount, the quantitative impairment test is required; otherwise, no further testing is required. Alternatively, the Company may elect to not first assess qualitative factors and immediately perform the quantitative impairment test. In the quantitative impairment test, the Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of its reporting unit, then the Company would record an impairment loss equal to the difference. The Company's finite-lived intangible assets, consisting of core developed technology and collaboration agreements acquired as part of the acquisition of EDT, were recorded at fair value at the time of their acquisition and are stated within the Company’s consolidated balance sheets net of accumulated amortization and impairments. The finite-lived intangible assets are amortized over their estimated useful lives using the economic use method, which reflects the pattern that the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. The useful lives of the Company's intangible assets are primarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the potential extension or renewal of the contract or patent. Impairment of Long‑Lived Assets The Company reviews long‑lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written‑down to their estimated fair values. Long‑lived assets to be disposed of are carried at fair value less costs to sell them. Revenue from Contracts with Customers Effective January 1, 2018, the Company adopted the requirements of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (In thousands) Topic 606 Adjustment Contract assets $ 9,110 Inventory (8,209 ) Deferred tax asset 109 Contract liabilities—short-term (1,104 ) Contract liabilities—long-term (724 ) Accumulated deficit 818 $ — When entering into arrangements with customers, the Company identifies whether its performance obligations under the arrangement represent a distinct good or service or a series of distinct goods or services. If a contract contains more than one performance obligation, the Company allocates the total transaction price to each performance obligation in an amount based on the estimated relative standalone selling prices of the promised goods or services underlying each performance obligation. The fair value of performance obligations under the arrangement may be derived using an estimate of selling price if the Company does not sell the goods or services separately. The Company recognizes revenue when or as it satisfies a performance obligation by transferring an asset or providing a service to a customer. Management judgment is required in determining the consideration to be earned under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. The Company adopted Topic 606 using the modified retrospective method. As such, the Company recognized the cumulative effect of initially applying Topic 606 as an adjustment to the opening balance of shareholders’ equity at January 1, 2018. Therefore, the comparative information has not been adjusted and continues to be reported under the old revenue recognition guidance (“Topic 605”). The quantitative impacts of the changes are set out below for each of the condensed consolidated balance sheet and the condensed consolidated statement of operations and comprehensive loss for the current reporting period. ADJUSTED CONDENSED CONSOLIDATED BALANCE SHEET December 31, 2018 (In thousands) As Reported Adjustment Balances Without Adoption of Topic 606 ASSETS Contract assets $ 8,230 $ (8,230 ) (1) $ — Inventory 90,196 8,847 (2) 99,043 Deferred tax asset 85,807 (133 ) (3) 85,674 LIABILITIES Contract liabilities—short-term $ 3,169 $ (3,169 ) (4) $ — Deferred revenue—short-term — 1,224 (4) 1,224 Contract liabilities—long-term 9,525 (9,525 ) (4) — Deferred revenue—long-term — 8,852 (4) 8,852 SHAREHOLDERS' EQUITY Accumulated deficit $ (1,185,368 ) $ 2,156 (5) $ (1,183,212 ) The adjustments are a result of the following: (1) Adjustment to contract assets to reverse revenue recognized over time under Topic 606. (2) Adjustment to inventory to add back the cost of goods manufactured related to the revenue transactions summarized in item (1), above. (3) Adjustment to deferred tax asset to apply the tax impact of the revenue transactions summarized in item (1), above. (4) Adjustments to contract liabilities—short-term and contract liabilities—long-term is to reclassify amounts previously classified as deferred revenue—short-term and deferred revenue—long-term under Topic 605. (5) Adjustment to accumulated deficit for the net impact of the transactions noted in items (1) through (4) above. ADJUSTED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Year Ended December 31, 2018 (In thousands, except per share amounts) As Reported Adjustment Balances Without Adoption of Topic 606 REVENUES: Manufacturing and royalty revenues $ 526,675 $ 1,911 (1) $ 528,586 Product sales, net 450,334 — 450,334 Research and development revenue 68,895 48,473 (2) 117,368 License revenue 48,370 (48,370 ) (3) — Total revenues 1,094,274 2,014 1,096,288 EXPENSES: Cost of goods manufactured and sold 176,420 (640 ) (4) 175,780 Research and development 425,406 — 425,406 Selling, general and administrative 526,408 — 526,408 Amortization of acquired intangible assets 65,168 — 65,168 Total expenses 1,193,402 (640 ) 1,192,762 Operating loss (99,128 ) 2,654 (96,474 ) Other (expense) income, net (27,839 ) — (27,839 ) Loss before income taxes (126,967 ) 2,654 (124,313 ) Income tax provision (benefit) 12,344 24 12,368 Net loss $ (139,311 ) $ 2,630 $ (136,681 ) Loss per ordinary share — basic and diluted $ (0.90 ) $ 0.02 $ (0.88 ) WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: Basic and diluted 155,112 155,112 155,112 The adjustments are a result of the following: (1) Adjustments to manufacturing and royalty revenues to recognize revenue under Topic 605 in the year ended December 31, 2018 that was recognized under Topic 606. (2) Adjustments to research and development revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (3) Adjustments to license revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (4) Adjustments to cost of goods manufactured and sold to recognize the cost from the transactions noted in item (1) above. The Company’s changes in assets and liabilities within its condensed consolidated statement of cash flows changed as a result of the differences in the condensed consolidated balance sheet and changes in net loss in the condensed consolidated statement of operations, but the overall cash flows used in operating activities did not change. Collaborative Arrangements The Company has entered into collaboration agreements with pharmaceutical companies including Janssen Pharmaceutica Inc. (“Janssen, Inc.”), Janssen Pharmaceutica International, a division of Cilag International AG (“Janssen International”), and Janssen Pharmaceutica N.V. (together with Janssen, Inc., Janssen International and their affiliates “Janssen”) for INVEGA SUSTENNA ® ® ® ® ® ® ® Manufacturing Revenue The Company recognizes manufacturing revenues from the sale of products it manufactures for resale by its licensees. Manufacturing revenues Prior to the adoption of Topic 606, the Company recorded manufacturing revenue from the sale of products it manufactures for resale by its partners after the Company had shipped such products and risk of loss had passed to the Company’s partner, assuming persuasive evidence of an arrangement existed, the sales price was fixed or determinable and collectability was reasonably assured. The Company is the exclusive manufacturer of RISPERDAL CONSTA for commercial sale under its manufacturing and supply agreement with Janssen. The Company determined that it is appropriate to record revenue under this agreement at the point in time when control of the product passes to Janssen, which is determined to be when the product has been fully manufactured, since Janssen does not control the product during the manufacturing process and, in the event Janssen terminates the manufacturing and supply agreement, it is uncertain whether, and at what amount, the Company would be reimbursed for performance completed to date for product not yet fully manufactured. The manufacturing process is considered fully complete once the finished goods have been approved for shipment by both the Company and Janssen. The sales price for certain of the Company’s manufacturing revenues is based on the end-market sales price earned by its licensees. As end-market sales generally occur after the Company has recorded manufacturing revenue, the Company estimates the sales price for such products based on information supplied to it by the Company’s licensees, its historical transaction experience and other third-party data. Differences between actual manufacturing revenues and estimated manufacturing revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The difference between the Company’s actual and estimated manufacturing revenues has not been material to date. Royalty Revenue The Company recognizes royalty revenues related to the sale of products by its licensees that incorporate the Company's technologies. Royalties, with the exception of those earned on sales of AMPYRA as set forth below, qualify for the sales-and-usage exemption under Topic 606 as (i) royalties are based strictly on the sales-and-usage by the licensee; and (ii) a license of intellectual property (“IP”) is the sole or predominant item to which such royalties relate. Based on this exemption, these royalties are earned in the period the products are sold by the Company's partner and the Company has a present right to payment. Royalties on AMPYRA manufactured under our license and supply agreements with Acorda are incorporated into the standard cost-based model described in the manufacturing revenues section, above, as the terms of such agreements entitle the Company to royalty revenue as the product is being manufactured, which represents a faithful depiction of the transfer of goods, and not based on the actual end-market sales of the licensee. Certain of the Company's royalty revenues are recognized by the Company based on information supplied to the Company by its licensees and require estimates to be made. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The difference between the Company’s actual and estimated royalty revenues has not been material to date. Research and Development Revenue R&D revenue consists of funding that compensates the Company for formulation, pre‑clinical and clinical testing under R&D arrangements with its partners. The Company generally bills its partners under R&D arrangements using a full‑time equivalent (“FTE”) or hourly rate, plus direct external costs, if any. Revenue is recognized as the obligations under the R&D arrangements are performed. License Revenue The Company recognizes revenue from the grant of distinct, right-to-use licenses of intellectual property (“IP”) when control of the license is transferred to the customer, which is the point in time the customer is able to direct the use of and obtain substantially all of the benefits from the license. Product Sales, Net The Company’s product sales, net consist of sales of VIVITROL ® ® in the U.S. primarily to wholesalers, specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer. Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, health care providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances: • Medicaid Rebates — the Company records accruals for rebates to states under the Medicaid Drug Rebate Program as a reduction of sales when the product is shipped into the distribution channel using the expected value method. The Company rebates individual states for all eligible units purchased under the Medicaid program based on a rebate per unit calculation, which is based on the Company’s average manufacturer prices. The Company estimates expected unit sales and rebates per unit under the Medicaid program and adjusts its rebate based on actual unit sales and rebates per unit. To date, actual Medicaid rebates have not differed materially from the Company’s estimates; • Chargebacks — discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Company the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer. The allowance for chargebacks is made using the expected value method and is based on actual and expected utilization of these programs. Chargebacks could exceed historical experience and the Company’s estimates of future participation in these programs. To date, actual chargebacks have not differed materially from the Company’s estimates; • Product Discounts — cash consideration, including sales incentives, given by the Company under agreements with a number of wholesaler, distributor, pharmacy, and treatment provider customers that provide them with a discount on the purchase price of products. The reserve is made using the expected value method and to date, actual product discounts have not differed materially from the Company’s estimates; and • Product Returns — the Company records an estimate for product returns at the time its customers take control of the Company’s product. The Company estimates this liability using the expected value method based on its historical return levels and specifically identified anticipated returns due to known business conditions and product expiry dates. Return amounts are recorded as a deduction to arrive at product sales, net. Once product is returned, it is destroyed. • Medicare Part D — the Company records accruals for Medicare Part D liabilities under the Medicare Coverage Gap Discount Program (“CGDP”) as a reduction of sales. Under the CGDP, patients reaching the annual coverage gap threshold are eligible for reimbursement coverage for out-of-pocket costs for covered prescription drugs. Under an agreement with the Center for Medicare and Medicaid, manufacturers are responsible to reimburse prescription plan sponsors for the portion of out-of-pocket expenses not covered under their Medicare plans. Receivables, net Receivables, net, include amounts billed and currently unconditionally due from customers. The amounts due are stated at their net estimated realizable value. The Company maintains an allowance for doubtful accounts to provide for the estimated amounts of receivables that will not be collected. The allowance is based upon an assessment of customer creditworthiness, historical payment experience, the age of outstanding receivables and collateral to the extent applicable. The Company’s allowance for doubtful accounts was $0.2 million at December 31, 2018 and 2017. Contract Assets Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time. The products included in the contract assets table below complete the manufacturing process in ten days to eight weeks. Contract assets are classified as current. Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2018 $ 9,110 Additions 57,617 Transferred to receivables, net (58,497 ) Contract assets at December 31, 2018 $ 8,230 Contract Liabilities The Company’s contract liabilities consist of contractual obligations related to deferred revenue. Contract liabilities consisted of the following: (In thousands) Contract Liabilities Contract liabilities at January 1, 2018 $ 9,442 Additions 6,381 Amounts recognized into revenue (3,129 ) Contract liabilities at December 31, 2018 $ 12,694 Foreign Currency The Company's functional and reporting currency is the U.S. dollar. Transactions in foreign currencies are recorded at the exchange rate prevailing on the date of the transaction. The resulting monetary assets and liabilities are translated into U.S. dollars at exchange rates prevailing on the subsequent balance sheet date. Gains and losses as a result of translation adjustments are recorded within “Other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive loss. During the years ended December 31, 2018, 2017 and 2016 the Company recorded a (loss) gain on foreign currency translation of $(2.3) million, $3.7 million and $0.1 million, respectively. Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk are receivables and marketable securities. Billings to large pharmaceutical companies account for the majority of the Company's receivables, and collateral is generally not required from these customers. To mitigate credit risk, the Company monitors the financial performance and credit worthiness of its customers. The following represents revenue and receivables from the Company's customers exceeding 10% of the total in each category as of, and for the years ended, December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 27 % 29 % 31 % 33 % 33 % 36 % Acorda 15 % 10 % 14 % 13 % 17 % 15 % Cardinal Health * 13 % * * * * Biogen * 10 % * * * * * Indicates the revenues or receivables for the customer did not exceed 10% of the Company’s total in each category as of or for the years ended December 31, 2018, 2017 and 2016, as noted. The Company holds its interest‑bearing investments with major financial institutions and, in accordance with documented investment policies, the Company limits the amount of credit exposure to any one financial institution or corporate issuer. The Company’s investment objectives are, first, to assure liquidity and conservation of capital and, second, to obtain investment income. Geographic Information Company revenues by geographic location, as determined by the location of the customer, and the location of its assets, are as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Revenue by region: U.S. $ 884,600 $ 700,090 $ 557,312 Ireland 4,915 9,706 4,407 Rest of world 204,759 193,578 183,975 Assets by region: Current assets: U.S. $ 546,533 $ 402,481 $ 382,168 Ireland 433,837 403,167 407,761 Rest of world 2,882 3,196 |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS During the years ended December 31, 2018, 2017 and 2016, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 241,423 $ 241,423 AMPYRA/FAMPYRA 53,044 54,009 107,053 RISPERDAL CONSTA 52,770 18,352 71,122 Other 27,214 79,863 107,077 $ 133,028 $ 393,647 $ 526,675 Year Ended December 31, 2017 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 214,931 $ 214,931 AMPYRA/FAMPYRA 55,373 61,646 117,019 RISPERDAL CONSTA 64,793 20,129 84,922 Other 32,655 55,781 88,436 $ 152,821 $ 352,487 $ 505,308 Year Ended December 31, 2016 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 184,233 $ 184,233 AMPYRA/FAMPYRA 53,406 60,787 114,193 RISPERDAL CONSTA 64,914 22,316 87,230 Other 33,641 67,950 101,591 $ 151,961 $ 335,286 $ 487,247 During the years ended December 31, 2018, 2017 and 2016, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2018 2017 2016 VIVITROL $ 302,609 $ 269,321 $ 208,982 ARISTADA 147,725 93,513 47,164 Total product sales, net $ 450,334 $ 362,834 $ 256,146 Research and Development Revenue and License Revenue The research and development revenue and license revenue recorded during the years ended December 31, 2018 and 2017 primarily related to revenue earned under the Company’s license and collaboration agreement with Biogen for BIIB098. In November 2017, the Company granted Biogen, under a license and collaboration agreement, a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize BIIB098 and other products covered by patents licensed to Biogen under the agreement. Upon entering into the agreement in November 2017, the Company received an up-front cash payment of $28.0 million. In June 2018, the Company received an additional cash payment of $50.0 million following Biogen’s review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098. The Company is also eligible to receive an additional payment of $150.0 million upon an approval by the FDA on or before December 31, 2021 of a 505(b)(2) new drug application (“NDA”) (or, in certain circumstances, a 505(b)(1) NDA) for BIIB098. The Company is also eligible to receive additional payments upon achievement of developmental milestones with respect to the first two products, other than BIIB098, covered by patents licensed to Biogen under the agreement. In addition, the Company will receive a mid-teens percentage royalty on worldwide net sales of BIIB098, subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of BIIB098. The Company will also receive royalties on net sales of products, other than BIIB098, covered by patents licensed to Biogen under the agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double-digits. All royalties are payable on a product-by-product and country-by-country basis until the later of (i) the last-to-expire patent right covering the applicable product in the applicable country and (ii) a specified period of time from the first commercial sale of the applicable product in the applicable country. Royalties for all such products and the minimum annual payments for BIIB098 are subject to reductions as set forth in the agreement. Biogen paid a portion of the BIIB098 development costs the Company incurred in 2017 and, since January 1, 2018, Biogen is responsible for all BIIB098 development costs the Company incurs, subject to annual budget limitations. The Company has retained the right to manufacture clinical supplies and commercial supplies of BIIB098 and all other products covered by patents licensed to Biogen under the agreement, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer and subject to good faith agreement by the parties on the terms of such manufacturing arrangements. The Company evaluated the agreement under Topic 606 and determined that it had four deliverables: (i) the grant of a distinct, right-to-use license of IP to Biogen; (ii) future development services; (iii) clinical supply; and (iv) participation on a joint steering committee with Biogen. The Company’s participation on the joint steering committee was considered to be perfunctory and thus not recognized as a performance obligation. The deliverables, aside from the participation in the joint steering committee which was considered to be perfunctory, were determined to be separate performance obligations as the license is separately identifiable from the development services and clinical supply, and the development services are not expected to significantly modify or customize the IP. The Company allocated the arrangement consideration to each performance obligation using the standalone selling prices based on its estimate of selling price for the license and other deliverables. The Company used a discounted cash flow model to estimate the standalone selling price of the license in order to allocate the consideration to the performance obligations. To estimate the standalone selling price of the license, the Company assessed the likelihood of the FDA’s approval of BIIB098 and estimated the expected future cash flows assuming FDA approval and maintenance of the IP protecting BIIB098. The Company then discounted these cash flows using a discount rate of 8.0%, which it believes captures a market participant’s view of the risk associated with the expected cash flows. The estimate of selling price of the development services and clinical supply were determined through third-party evidence. The Company believes that a change in the assumptions used to determine its estimate of selling price for the license most likely would not have a significant effect on the allocation of consideration transferred. As the license was delivered to Biogen in November 2017, under Topic 606, the Company allocated the $28.0 million upfront payment as follows: $27.0 million to the delivery of the license; $0.9 million to future development services; and $0.1 million to clinical supply. The Company allocated the $50.0 million payment received in 2018 following Biogen’s review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098 as follows: $48.3 million to the delivery of the license; $1.5 million to future development services; and $0.2 million to clinical supply. The amounts allocated to the license were recognized upon receipt of the payments as delivery of the license occurred upon entry into the agreement in 2017. The amounts allocated to the development services and clinical supply will be recognized over the course of the development work and as clinical supply is delivered to Biogen, which is expected to continue through 2019. The Company determined that the future milestones it is entitled to receive, including the $150.0 million payment upon approval by the FDA on or before December 31, 2021 of a 505(b)(2) NDA (or, in certain circumstances, a 505(b)(1) NDA) for BIIB098, and sales-based royalties, are variable consideration. The Company is using the most likely amount method for estimating the variable consideration to be received related to the milestones under this arrangement. Given the challenges inherent in developing and obtaining approval for pharmaceutical and biologic products, there was substantial uncertainty as to whether these milestones would be achieved at the time the license and collaboration agreement was entered into. Accordingly, the Company has not included these milestones in the transaction price as it is not probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The royalties are subject to the sales-based exception and will be recorded when the corresponding sale occurs. The Company expects to earn an additional $60.4 million in research and development revenue under this agreement with Biogen through 2021. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENTS Investments consist of the following: Gross Unrealized Losses Amortized Less than Greater than Estimated December 31, 2018 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 120,197 $ 57 $ (62 ) $ (274 ) $ 119,918 U.S. government and agency debt securities 80,055 115 (11 ) (87 ) 80,072 International government agency debt securities 72,091 85 (8 ) (117 ) 72,051 272,343 257 (81 ) (478 ) 272,041 Held-to-maturity securities: Corporate debt securities 492 — — — 492 Total short-term investments 272,835 257 (81 ) (478 ) 272,533 Long-term investments: Available-for-sale securities: Corporate debt securities 53,505 — (185 ) (93 ) 53,227 U.S. government and agency debt securities 18,474 — (21 ) (12 ) 18,441 International government agency debt securities 5,457 — (4 ) — 5,453 77,436 — (210 ) (105 ) 77,121 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 136 — — 1,803 3,487 136 — — 3,623 Total long-term investments 80,923 136 (210 ) (105 ) 80,744 Total investments $ 353,758 $ 393 $ (291 ) $ (583 ) $ 353,277 December 31, 2017 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 150,673 $ 1 $ (130 ) $ (233 ) $ 150,311 Corporate debt securities 56,552 3 (48 ) (10 ) 56,497 International government agency debt securities 35,478 1 (54 ) (25 ) 35,400 Total short-term investments 242,703 5 (232 ) (268 ) 242,208 Long-term investments: Available-for-sale securities: Corporate debt securities 83,924 — (300 ) (34 ) 83,590 U.S. government and agency debt securities 48,948 — (270 ) (71 ) 48,607 International government agency debt securities 21,453 — (118 ) — 21,335 154,325 — (688 ) (105 ) 153,532 Held-to-maturity securities: Fixed term deposit account 1,667 222 — — 1,889 Certificates of deposit 1,791 — — — 1,791 3,458 222 — — 3,680 Total long-term investments 157,783 222 (688 ) (105 ) 157,212 Total investments $ 400,486 $ 227 $ (920 ) $ (373 ) $ 399,420 Realized gains and losses on the sales and maturities of marketable securities, which were identified using the specific identification method, were as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Proceeds from the sales and maturities of marketable securities $ 444,456 $ 464,494 $ 560,805 Realized gains $ 4 $ 9 $ 206 Realized losses $ 268 $ 3 $ 28 The Company’s available‑for‑sale and held‑to‑maturity securities at December 31, 2018 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 184,841 $ 184,304 $ 2,312 $ 2,312 After 1 year through 5 years 164,938 164,858 1,667 1,803 Total $ 349,779 $ 349,162 $ 3,979 $ 4,115 At December 31, 2018, the Company believed that the unrealized losses on its available-for-sale investments were temporary. The investments with unrealized losses consisted of U.S. government and agency debt securities, corporate debt securities and international government agency debt securities. The unrealized losses are a result of market conditions related to increasing interest rates. In making the determination that the decline in fair value of these securities was temporary, the Company considered various factors, including, but not limited to: the length of time each security was in an unrealized loss position; the extent to which fair value was less than cost; financial condition and near-term prospects of the issuers; and the Company’s intent not to sell these securities and the assessment that it is more likely than not that the Company would not be required to sell these securities before the recovery of their amortized cost basis. In February 2016, the Company entered into a collaboration and license option agreement with Synchronicity Pharma, Inc. (“Synchronicity”) formerly Reset Therapeutics, Inc. (“Reset”), a related party. The Company made an upfront, non-refundable payment of $10.0 million in partial consideration of the grant to the Company of the rights and licenses included in such agreement, which was included in R&D expense in the three months ended March 31, 2016, and simultaneously made a $15.0 million investment in exchange for shares of Synchronicity’s Series B Preferred Stock. The Company was accounting for its investment in Synchronicity under the equity method based on its percentage of ownership, its seat on the board of directors and its belief that it could exert significant influence over the operating and financial policies of Synchronicity. In September 2017, the Company recorded an other-than-temporary impairment charge of $10.5 million within “Other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive loss, which represented the Company’s remaining investment in Synchronicity, as the Company believed that Synchronicity was unable to generate future earnings that justify the carrying amount of the investment. In November 2017, the collaboration and license option agreement with Synchronicity was terminated. During the year ended December 31, 2017, the Company recorded a reduction in its investment in Synchronicity of $2.8 million, which represented the Company’s proportional share of Synchronicity’s net loss for the period. In May 2014, the Company entered into an agreement whereby it is committed to provide up to €7.4 million to a partnership, Fountain Healthcare Partners II, L.P. of Ireland (“Fountain”), which was created to carry on the business of investing exclusively in companies and businesses engaged in the healthcare, pharmaceutical and life sciences sectors. As of December 31, 2018, the Company’s total contribution in Fountain was equal to €5 million, |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 5. FAIR VALUE The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques the Company utilized to determine such fair value: December 31, (In thousands) 2018 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 54,590 $ 54,590 $ — $ — U.S. government and agency debt securities 98,513 60,107 38,406 — Corporate debt securities 173,637 — 173,145 492 International government agency debt securities 77,504 — 77,504 — Contingent consideration 65,200 — — 65,200 Common stock warrants 1,205 — — 1,205 Total $ 470,649 $ 114,697 $ 289,055 $ 66,897 December 31, 2017 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,889 $ 1,889 $ — $ — U.S. government and agency debt securities 198,918 124,958 73,960 — Corporate debt securities 140,087 — 140,087 — International government agency debt securities 56,735 — 56,735 — Contingent consideration 84,800 — — 84,800 Common stock warrants 1,395 — — 1,395 Total $ 483,824 $ 126,847 $ 270,782 $ 86,195 The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were no transfers of any securities from Level 1 to Level 2 or from Level 2 to Level 1 during the year ended December 31, 2018. The following table is a rollforward of the fair value of the Company’s investments whose fair value was determined using Level 3 inputs at December 31, 2018: (In thousands) Fair Value Balance, January 1, 2018 $ 86,195 Purchase of corporate debt security 492 Change in the fair value of contingent consideration (19,600 ) Decrease in the fair value of warrants (190 ) Balance, December 31, 2018 $ 66,897 The Company’s investments in U.S. government and agency debt securities, international government agency debt securities and corporate debt securities classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. On December 20, 2018, the Company entered into a Second Amendment to the Purchase and Sale Agreement (“Purchase and Sale Agreement Amendment”) dated March 7, 2015 with Recro and Recro Gainesville LLC and a Second Amendment to the Asset Transfer and License Agreement dated April 10, 2015 with Recro Gainesville LLC (the “License Agreement Amendment” and, together with the Purchase and Sale Agreement Amendment, the “Amendments”). Under the terms of the Amendments, the milestone payment of $45.0 million previously due to the Company upon approval of an NDA for IV/IM and parenteral forms of Meloxicam or any other product with the same active ingredient as Meloxicam IV/IM that is discovered or identified using certain of the Company’s IP to which Recro was provided a right of use, through license or transfer (the “Meloxicam Product(s)”) was amended and replaced with (i) a $5.0 million payment due within 30 days of signing of the Amendments; (ii) a $5.0 million payment due by April 23, 2019; (iii) a $5.0 million payment due within 180 days following approval of an NDA for injectable Meloxicam; and (iv) an additional $45.0 million following approval of an NDA for Meloxicam Product(s), payable in seven equal annual payments of approximately $6.4 million beginning on the first anniversary of such approval. At December 31, 2018, the Company determined the value of the contingent consideration receivable using the following valuation approaches: • Based upon the terms of the Amendments, the fair value of the regulatory milestone was estimated based on the likelihood of achieving this regulatory milestone and applying a discount rate from the expected time the milestone occurs to the balance sheet date. The Company received the first $5.0 million milestone payment in January 2019 and expects to receive the second $5.0 million in April 2019. Additionally, the Company expects the regulatory milestone event to occur in the first quarter of 2019 and to receive milestone payments on the subsequent seven anniversary years thereafter. A discount rate of 15.8% was utilized in this analysis; • The Company is entitled to receive future royalties on net sales of Meloxicam Products. To estimate the fair value of the future royalties, the Company assessed the likelihood of a Meloxicam Product being approved for sale and estimated the expected future sales of such Meloxicam Product assuming approval and IP protection. The Company then discounted these expected payments using a discount rate of 16.0%, which it believes captures a market participant’s view of the risk associated with the expected payments; and • The Company is entitled to receive payments of up to $80.0 million upon achieving certain sales milestones on future sales of the Meloxicam Products. The fair value of the sales milestones were determined through the use of a real options approach, where net sales are simulated in a risk-neutral world. To employ this methodology, the Company used a risk-adjusted expected growth rate based on its assessments of expected growth in net sales of the approved Meloxicam Product, adjusted by an appropriate factor capturing their respective correlation with the market. A resulting expected (probability-weighted) milestone payment was then discounted at a cost of debt, which was 15.8%. At December 31, 2018 and 2017, the Company determined that the value of the contingent consideration was $65.2 million and $84.8 million, respectively. The Company recorded a decrease of $19.6 million and increases of $21.6 million and $7.9 million during the years ended December 31, 2018, 2017 and 2016, respectively, within “Change in the fair value of contingent consideration” in the accompanying consolidated statements of operations and comprehensive loss. In addition to the signing of the Amendments, as described above, on December 20, 2018, the Company and Recro entered into a First Amendment to the Warrant to Purchase Stock (the “Warrant Amendment”), pursuant to which the exercise price of the warrant to purchase 350,000 shares of Recro’s common stock, was decreased to a per share exercise price of $8.26 from $19.46, subject to adjustment as set forth therein. The Company used a Black-Scholes model with the following assumptions to determine the fair value of these warrants at December 31, 2018: Closing stock price at December 31, 2018 $ 7.10 Warrant strike price $ 8.26 Expected term (years) 3.27 Risk-free rate 2.46 % Volatility 75.0 % The decrease of $0.2 million, the increase of less than $0.1 million and the decrease of $0.4 million in the fair value of the warrants during the years ended December 31, 2018, 2017 and 2016, respectively, was recorded within “Other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive loss. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term nature. In March 2018, the Company amended and refinanced its existing term loan, referred to as Term Loan B-1 (as so amended and refinanced, the “2023 Term Loans”), in order to, among other things, extend the due date of the loan from September 25, 2021 to March 26, 2023, reduce the interest payable from LIBOR plus 2.75% with a LIBOR floor of 0.75% to LIBOR plus 2.25% with a 0% LIBOR floor and increase covenant flexibility (the “Refinancing”). The estimated fair value of the 2023 Term Loans, which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $274.7 million and $285.7 million at December 31, 2018 and 2017, respectively. Please refer to Note 10, Long-Term Debt |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. INVENTORY Inventory consists of the following: December 31, December 31, (In thousands) 2018 2017 Raw materials $ 31,824 $ 29,883 Work in process 38,019 38,964 Finished goods ( 1) 20,353 24,428 Total inventory $ 90,196 $ 93,275 (1) At December 31, 2018 and 2017, the Company had $11.0 million and $8.7 million, respectively, of finished goods inventory located at its third‑party warehouse and shipping service provider. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | 7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consist of the following: December 31, December 31, (In thousands) 2018 2017 Land $ 6,486 $ 6,293 Building and improvements 157,053 155,198 Furniture, fixtures and equipment 314,831 289,455 Leasehold improvements 20,105 19,578 Construction in progress 88,983 54,270 Subtotal 587,458 524,794 Less: accumulated depreciation (277,471 ) (240,058 ) Total property, plant and equipment, net $ 309,987 $ 284,736 Depreciation expense was $38.5 million, $36.5 million and $33.3 million for the years ended December 31, 2018, 2017 and 2016, respectively. Also, during the years ended December 31, 2018, 2017 and 2016, the Company wrote off furniture, fixtures and equipment that had a carrying value of $0.5 million, $0.1 million and $0.9 million, respectively, at the time of disposition. Amounts included as construction in progress in the consolidated balance sheets primarily include capital expenditures at the Company’s manufacturing facility in Wilmington, Ohio. The Company continues to evaluate its manufacturing capacity based on expectations of demand for its products and will continue to record such amounts within construction in progress until such time as the underlying assets are placed into service. The Company continues to periodically evaluate whether facts and circumstances indicate that the carrying value of its long‑lived assets to be held and used may not be recoverable. In 2016, the Company began an expansion of its Wilmington, Ohio manufacturing facility to meet forecasted manufacturing demand for VIVITROL. The original expansion project included constructing a separate facility adjacent to the existing Wilmington, Ohio facility. In December 2018, the Company determined that it could expand its existing facility rather than build a separate facility and wrote-off to SG&A expense $5.7 million of design and other miscellaneous costs that had been capitalized but it was determined had no future value. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consist of the following: December 31, 2018 December 31, 2017 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (319,311 ) $ 146,279 $ 465,590 $ (269,392 ) $ 196,198 NanoCrystal technology 13 74,600 (38,942 ) 35,658 74,600 (31,283 ) 43,317 OCR technologies 12 42,560 (33,496 ) 9,064 42,560 (25,907 ) 16,653 Total $ 582,750 $ (391,749 ) $ 191,001 $ 582,750 $ (326,582 ) $ 256,168 The Company’s finite‑lived intangible assets consist of collaborative agreements and the NanoCrystal and OCR technologies acquired as part of the EDT acquisition. The Company recorded $65.2 million, $62.1 million and $61.0 million of amortization expense related to its finite‑lived intangible assets during the years ended December 31, 2018, 2017 and 2016, respectively. Based on the Company’s most recent analysis, amortization of intangible assets included within its consolidated balance sheets at December 31, 2018 is expected to be approximately $40.0 million, $40.0 million, $40.0 million, $35.0 million and $35.0 million in the years ending December 31, 2019 through 2023, respectively. Although the Company believes such available information and assumptions are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the change in revenues. The Company performed its annual goodwill impairment test as of October 31, 2018. The Company elected to perform a quantitative impairment test and determined that the fair value of the reporting unit exceeded its carrying value. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consist of the following: December 31, December 31, (In thousands) 2018 2017 Accounts payable $ 39,767 $ 55,526 Accrued compensation 67,613 54,568 Accrued sales discounts, allowances and reserves 152,911 111,137 Accrued other 73,471 64,935 Total accounts payable and accrued expenses $ 333,762 $ 286,166 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 10. LONG‑TERM DEBT Long‑term debt consists of the following: December 31, December 31, (In thousands) 2018 2017 2023 Term Loans, due March 26, 2023 $ 279,308 $ 281,436 Less: current portion (2,843 ) (3,000 ) Long-term debt $ 276,465 $ 278,436 2023 Term Loans The Refinancing involved multiple lenders who were considered members of a loan syndicate. In determining whether the Refinancing was to be accounted for as a debt extinguishment or a debt modification, the Company considered whether creditors remained the same or changed and whether the changes in debt terms were substantial. A change in the debt terms was considered to be substantial if the present value of the remaining cash flows under the new terms of the 2023 Term Loans was at least 10% different from the present value of the remaining cash flows under the former Term Loan B-1 (commonly referred to as the “10% Test”). The Company performed a separate 10% Test for each individual creditor participating in the loan syndication. With the exception of one lender, who owned 1% of the total outstanding principal amount of Term Loan B-1 at the date of the Refinancing and was accounted for as a debt extinguishment, the Refinancing was accounted for as a debt modification. The Refinancing resulted in a $2.3 million charge in the three months ended March 31, 2018, which was included in “Interest expense” in the accompanying consolidated statement of operations and comprehensive loss. Scheduled maturities with respect to the 2023 Term Loans are as follows (in thousands): Year Ending December 31: 2019 $ 2,843 2020 2,843 2021 2,843 2022 2,843 2023 270,746 Total $ 282,118 Beginning on January 1, 2014, the Company became subject to mandatory prepayments of principal if certain excess cash flow thresholds, as defined in the 2023 Term Loans, were met. The 2023 Term Loans have an incremental facility capacity in an amount of $175.0 million, plus additional amounts as long as the Company meets certain conditions, including a specified leverage ratio. The 2023 Term Loans include a number of restrictive covenants that, among other things and subject to certain exceptions and baskets, impose operating and financial restrictions on the Company and certain of its subsidiaries. The 2023 Term Loans also contain customary affirmative covenants and events of default. The Company was in compliance with its debt covenants at December 31, 2018. At December 31, 2018, the Company’s balance of unamortized deferred financing costs and unamortized original issue discount costs were $0.8 million and $2.0 million, respectively. These costs are being amortized to interest expense over the estimated repayment period of the 2023 Term Loans using the effective interest method. During the years ended December 31, 2018, 2017 and 2016, the Company had amortization expense of $0.7 million, $0.8 million and $0.9 million, respectively, related to deferred financing costs and original issue discount. |
Loss Per Share
Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Loss Per Share | 11. LOSS PER SHARE Basic loss per ordinary share is calculated based upon net loss available to holders of ordinary shares divided by the weighted average number of shares outstanding. For the years ended December 31, 2018, 2017 and 2016, as the Company was in a net loss position, the diluted loss per share did not assume conversion or exercise of stock options and awards as they would have an anti-dilutive effect on loss per share. The following potential ordinary equivalent shares were not included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Year Ended December 31, (In thousands) 2018 2017 2016 Stock options 11,331 9,540 10,166 Restricted stock units 2,592 2,119 1,320 Total 13,923 11,659 11,486 |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Shareholders' Equity | 12. SHAREHOLDERS’ EQUITY Share Repurchase Program On September 16, 2011, the board of directors authorized the continuation of the Alkermes, Inc. share repurchase program to repurchase up to $215.0 million of the Company’s ordinary shares at the discretion of management from time to time in the open market or through privately negotiated transactions. At December 31, 2018, approximately $101.0 million was available to repurchase ordinary shares pursuant to the repurchase program. All shares repurchased are recorded as treasury stock. The repurchase program has no set expiration date and may be suspended or discontinued at any time. During the years ended December 31, 2018 and 2017, the Company did not acquire any ordinary shares under the repurchase program. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | 13. SHARE‑BASED COMPENSATION Share‑based Compensation Expense The following table presents share‑based compensation expense included in the Company’s consolidated statements of operations and comprehensive loss: Year Ended December 31, (In thousands) 2018 2017 2016 Cost of goods manufactured and sold $ 9,174 $ 7,596 $ 8,633 Research and development 32,943 22,635 24,023 Selling, general and administrative 63,240 53,686 61,740 Total share-based compensation expense $ 105,357 $ 83,917 $ 94,396 During the years ended December 31, 2018, 2017 and 2016, $2.7 million, $0.4 million and $1.1 million, respectively, of share‑based compensation expense was capitalized and recorded as “Inventory” in the accompanying consolidated balance sheets. Share‑Based Compensation Plans The Company has one share-based compensation plan pursuant to which awards are currently being made: the 2011 Stock Option and Incentive Plan (the “2011 Plan”). The Company has one share-based compensation plan pursuant to which awards are eligible to be made, but from which no awards have been made to date: the 2018 Stock Option and Incentive Plan (the “2018 Plan”). The Company has one share‑based compensation plan pursuant to which outstanding awards have been made, but from which no further awards can or will be made: the 2008 Stock Option and Incentive Plan. The 2018 Plan and the 2011 Plan provide for the issuance of non-qualified and incentive stock options, restricted stock, restricted stock units, cash-based awards and performance shares to employees, officers and directors of, and consultants to, the Company in such amounts and with such terms and conditions as may be determined by the compensation committee of the Company's board of directors, subject to provisions of the 2018 Plan and the 2011 Plan. At December 31, 2018, there were 11.1 million ordinary shares authorized for issuance under the Company’s stock plans. The 2018 Plan and the 2011 Plan provide that awards other than stock options will be counted against the total number of shares available under the plan in a 1.8-to‑1 ratio. Stock Options A summary of stock option activity is presented in the following table: Number of Weighted Average Shares Exercise Price Outstanding, January 1, 2018 14,773,412 $ 36.64 Granted 2,269,830 $ 61.45 Exercised (1,087,815 ) $ 19.19 Forfeited (924,343 ) $ 51.88 Expired (178,627 ) $ 59.83 Outstanding, December 31, 2018 14,852,457 $ 40.48 Exercisable, December 31, 2018 10,506,897 $ 34.26 The weighted average grant date fair value of stock options granted during the years ended December 31, 2018, 2017 and 2016 was $30.47, $25.81 and $17.11, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2018, 2017 and 2016 was $35.5 million, $40.4 million and $35.0 million, respectively. At December 31, 2018, there were 4.2 million stock options expected to vest with a weighted average exercise price of $55.46 per share, a weighted average contractual remaining life of 8.3 years with no aggregate intrinsic value. At December 31, 2018, the aggregate intrinsic value of stock options exercisable was $64.8 million with a weighted average remaining contractual term of 4.5 years. The number of stock options expected to vest was determined by applying the pre‑vesting forfeiture rate to the total outstanding options. The intrinsic value of a stock option is the amount by which the market value of the underlying stock exceeds the exercise price of the stock option. At December 31, 2018, there was $51.4 million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted average period of 2.0 years. Cash received from option exercises under the Company’s award plans during the years ended December 31, 2018, 2017 and 2016 was $20.9 million, $23.5 million and $20.3 million, respectively. Time‑Vested Restricted Stock Units A summary of time‑vested RSU activity is presented in the following table: Weighted Average Number of Shares Grant Date Fair Value Unvested, January 1, 2018 1,936,808 $ 46.72 Granted 1,367,710 $ 63.01 Vested (723,473 ) $ 47.72 Forfeited (314,759 ) $ 53.09 Unvested, December 31, 2018 2,266,286 $ 55.32 The weighted average grant date fair value of time‑vested RSUs granted during the years ended December 31, 2018, 2017 and 2016 were $63.01, $54.85 and $32.27, respectively. The total fair value of time‑vested RSUs that vested during the years ended December 31, 2018, 2017 and 2016, was $34.5 million, $31.5 million and $26.0 million, respectively. At December 31, 2018, there was $57.5 million of total unrecognized compensation cost related to unvested time‑vested RSUs, which will be recognized over a weighted average remaining contractual term of 2.0 years. Performance-Based Restricted Stock Units In February 2017, the compensation committee of the Company’s board of directors approved awards of RSUs to all employees employed by the Company during 2017, in each case subject to vesting on the achievement of the following performance criteria: (i) FDA approval of the NDA for ALKS 5461, (ii) the achievement of the pre-specified primary efficacy endpoints in each of two phase 3 studies of ALKS 3831, and (iii) revenues equal to or greater than a pre-specified amount for the year ending December 31, 2019. These performance criteria are being assessed over a performance period of three years from the date of the grant. In December 2018, the Company achieved the pre-specified primary efficacy endpoints on its second of the two phase 3 studies of ALKS 3831, resulting in the vesting of a portion of the granted performance-based RSUs and the recognition of $17.1 million in share-based compensation expense related to these awards. The Company recognized $2.1 million, $6.7 million and $8.3 million of this expense in cost of goods manufactured and sold; R&D expense; and SG&A expense, respectively. A summary of performance-based RSU activity is presented in the following table: Weighted Average Number of Shares Grant Date Fair Value Unvested, January 1, 2018 1,108,653 $ 54.72 Granted 6,065 $ 55.89 Forfeited (176,637 ) $ 54.64 Vested (311,913 ) $ 54.74 Unvested, December 31, 2018 626,168 $ 54.75 The grant date fair value of the performance-based RSUs was equal to the market value of the Company’s stock on the date of grant. At December 31, 2018, the Company does not consider it probable that the performance criteria will be met on the remaining two performance obligations and has not recognized any additional share-based compensation expense related to these performance-based RSUs. At December 31, 2018, there was $34.3 million of unrecognized compensation cost related to the remaining unvested portion of the performance-based RSUs, which would be recognized in accordance with the terms of the award when the Company deems it probable that the performance criteria will be met. The unvested awards will expire if the performance conditions have not been met on or before the three-year anniversary of the grant date. |
Collaborative Arrangements
Collaborative Arrangements | 12 Months Ended |
Dec. 31, 2018 | |
Collaborative Arrangements Disclosure [Abstract] | |
Collaborative Arrangements | 14. COLLABORATIVE ARRANGEMENTS The Company has entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to access technologies, financial, marketing, manufacturing and other resources. Refer to the “Patents and Proprietary Rights” section in “Part I, Item 1— Business” of this Annual Report for information with respect to intellectual property protection for these products. The collaboration revenue the Company has earned in the years ended December 31, 2018, 2017 and 2016 is summarized in Note 3, Revenue from Contracts with Customers The Company’s significant collaborative arrangements are described below: Janssen INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA Under its license agreement with Janssen Pharmaceutica N.V., the Company granted Janssen a worldwide exclusive license under its NanoCrystal technology to develop, commercialize and manufacture INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA and related products. Under this license agreement, the Company received milestone payments upon the achievement of certain development goals from Janssen; there are no further milestones to be earned under this agreement. The Company receives tiered royalty payments between 5% and 9% of INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA end-market net sales in each country where the license is in effect, with the exact royalty percentage determined based on aggregate worldwide net sales. The tiered royalty payments consist of a patent royalty and a know‑how royalty, both of which are determined on a country‑by‑country basis. The patent royalty, which equals 1.5% of net sales, is payable in each country until the expiration of the last of the patents claiming the product in such country. The know‑how royalty is a tiered royalty of 3.5%, 5.5% and 7.5% on aggregate worldwide net sales of below $250 million, between $250 million and $500 million, and greater than $500 million, respectively. The know‑how royalty is payable for the later of 15 years from first commercial sale of a product in each individual country or March 31, 2019, subject in each case to the expiry of the license agreement. These royalty payments may be reduced in any country based on patent litigation or on competing products achieving certain minimum sales thresholds. The license agreement expires upon the later of (i) March 31, 2019 or (ii) the expiration of the last of the patents subject to the agreement. After expiration, Janssen retains a non‑exclusive, royalty‑free license to develop, manufacture and commercialize the products. Janssen may terminate the license agreement in whole or in part upon three months’ notice to the Company. The Company and Janssen have the right to terminate the agreement upon a material breach of the other party, which is not cured within a certain time period, or upon the other party’s bankruptcy or insolvency. RISPERDAL CONSTA Under a product development agreement, the Company collaborated with Janssen on the development of RISPERDAL CONSTA. Under the development agreement, Janssen provided funding to the Company for the development of RISPERDAL CONSTA and Janssen is responsible for securing all necessary regulatory approvals for the product. Under two license agreements, the Company granted Janssen and an affiliate of Janssen exclusive worldwide licenses to use and sell RISPERDAL CONSTA. Under its license agreements with Janssen, the Company receives royalty payments equal to 2.5% of Janssen’s end-market net sales of RISPERDAL CONSTA in each country where the license is in effect based on the quarter when the product is sold by Janssen. This royalty may be reduced in any country based on lack of patent coverage and significant competition from generic versions of the product. Janssen can terminate the license agreements upon 30 days’ prior written notice to the Company. Either party may terminate the license agreements by written notice following a breach which continues for 90 days after the delivery of written notice thereof or upon the other party’s insolvency. The licenses granted to Janssen expire on a country‑by‑country basis upon the later of: (i) the expiration of the last patent claiming the product in such country; or (ii) 15 years after the date of the first commercial sale of the product in such country, provided that in no event will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of the product in each such country, with the exception of Canada, France, Germany, Italy, Japan, Spain and the United Kingdom, in each case where the fifteen‑year minimum shall pertain regardless. After expiration, Janssen retains a non‑exclusive, royalty‑free license to manufacture, use and sell RISPERDAL CONSTA. The Company exclusively manufactures RISPERDAL CONSTA for commercial sale. Under its manufacturing and supply agreement with Janssen, the Company records manufacturing revenues when product fully manufactured and approved for shipment, based on a percentage of Janssen’s net unit sales price for RISPERDAL CONSTA for the applicable calendar year. This percentage is determined based on Janssen’s unit demand for such calendar year and varies based on the volume of units shipped, with a minimum manufacturing fee of 7.5%. Either party may terminate the manufacturing and supply agreement upon a material breach by the other party, which is not resolved within 60 days after receipt of a written notice specifying the material breach or upon written notice in the event of the other party’s insolvency or bankruptcy. Janssen may terminate the agreement upon six months’ written notice to the Company. In the event that Janssen terminates the manufacturing and supply agreement without terminating the license agreements, the royalty rate payable to the Company on Janssen’s net sales of RISPERDAL CONSTA would increase from 2.5% to 5.0%. Acorda Under an amended and restated license agreement, the Company granted Acorda an exclusive worldwide license to use and sell and, solely in accordance with its supply agreement, to make or have made AMPYRA/FAMPYRA. The Company receives certain commercial and development milestone payments, license revenues and a royalty of approximately 10% based on net sales of AMPYRA (including the authorized generic version of AMPYRA)/FAMPYRA by Acorda and its sub‑licensee, Biogen. This royalty payment may be reduced in any country based on lack of patent coverage, competing products achieving certain minimum sales thresholds and whether Alkermes manufactures the product. In June 2009, the Company entered into an amendment of the amended and restated license agreement and the supply agreement with Acorda and, pursuant to such amendment, consented to the sublicense by Acorda to Biogen of Acorda’s rights to use and sell FAMPYRA in certain territories outside of the U.S. (to the extent that such rights were to be sublicensed to Biogen pursuant to its separate collaboration and license agreement with Acorda). Under this amendment, the Company agreed to modify certain terms and conditions of the amended and restated license agreement and the supply agreement with Acorda to reflect the sublicense by Acorda to Biogen. Acorda has the right to terminate the amended and restated license agreement upon 90 days’ written notice. The Company has the right to terminate the amended and restated license agreement for countries in which Acorda fails to launch a product within a specified time after obtaining the necessary regulatory approval or fails to file regulatory approvals within a commercially reasonable time after completion of and receipt of positive data from all pre-clinical and clinical studies required for filing a marketing authorization application. Either party has the right to terminate the amended and restated license agreement by written notice following a material breach of the other party, which is not cured within a certain time period, or upon the other party’s entry into bankruptcy or dissolution proceedings. If the Company terminates Acorda's license in any country, the Company is entitled to a license from Acorda of its patent rights and know-how relating to the product as well as the related data, information and regulatory files, and to market the product in the applicable country, subject to an initial payment equal to Acorda's cost of developing such data, information and regulatory files and to ongoing royalty payments to Acorda. Subject to the termination of the amended and restated license agreement, licenses granted under the license agreement terminate on a country-by-country basis upon the expiration of the last to expire of our patents or the existence of a threshold level of competition in the marketplace. Under its commercial manufacturing supply agreement with Acorda, the Company manufactures and supplies AMPYRA/FAMPYRA for Acorda (and its sub‑licensee, Biogen). Under the terms of the agreement, Acorda may obtain up to 25% of its total annual requirements of product from a second‑source manufacturer. The Company receives manufacturing royalties equal to 8% of net selling price for all product manufactured by it and a compensating payment for product manufactured and supplied by a third party. The Company may terminate the commercial manufacturing supply agreement upon 12 months’ prior written notice to Acorda and either party may terminate the commercial manufacturing supply agreement following a material and uncured breach of the commercial manufacturing supply agreement or amended and restated license agreement or the entry into bankruptcy or dissolution proceedings by the other party. In addition, subject to early termination of the commercial manufacturing supply agreement noted above, the commercial manufacturing supply agreement terminates upon the expiry or termination of the amended and restated license agreement. The Company is entitled to receive the following milestone payments under its amended and restated license agreement with Acorda for each of the third and fourth new indications of the product developed thereunder: • initiation of a phase 3 clinical trial: $1.0 million; • acceptance of a New Drug Application (“NDA”) by the FDA: $1.0 million; • approval of the NDA by the FDA: $1.5 million; and • the first commercial sale: $1.5 million. Biogen Under a license and collaboration agreement, the Company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize BIIB098 and other products covered by patents licensed to Biogen under the agreement. Upon entering into this agreement in November 2017, the Company received an up-front cash payment of $28.0 million. The Company also received a $50.0 million option payment upon Biogen’s decision to continue the collaboration after having reviewed certain data from our long-term safety clinical trial and part A of the head-to-head phase 3 gastrointestinal tolerability clinical trial comparing BIIB098 to TECFIDERA in 2018. The Company is also eligible to receive a $150.0 million payment upon an approval by the FDA on or before December 31, 2021 of a 505(b)(2) NDA (or, in certain circumstances, a 505(b)(1) NDA) for BIIB098. The Company is also eligible to receive additional payments upon achievement of milestones with respect to the first two products, other than BIIB098, covered by patents licensed to Biogen under the agreement. In addition, the Company will receive a mid-teens percentage royalty on worldwide net sales of BIIB098, subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of BIIB098. The Company will also receive royalties on net sales of products, other than BIIB098, covered by patents licensed to Biogen under the agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double digits. All royalties are payable on a product-by-product and country-by-country basis until the later of (i) the last-to-expire patent right covering the applicable product in the applicable country and (ii) a specified period of time from the first commercial sale of the applicable product in the applicable country. Royalties for all products and the minimum annual payments for BIIB098 are subject to customary reductions. Except in certain limited circumstances, until FDA approval of an NDA for BIIB098, the Company is responsible for the development of BIIB098 for the treatment of MS. Biogen paid a portion of the BIIB098 development costs the Company incurred in 2017 and, since January 1, 2018, Biogen is responsible for all BIIB098 development costs the Company incurs, subject to annual budget limitations. After the date of FDA approval of an NDA for BIIB098 for the treatment of MS, Biogen will be responsible for all development and commercialization activities, as well as the costs of all such activities, for BIIB098 and all other products covered by patents licensed to Biogen under the agreement. The Company has retained the right to manufacture clinical supplies and commercial supplies of BIIB098 and all other products covered by patents licensed to Biogen under the agreement, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer and subject to good faith agreement by the parties on the terms of such manufacturing arrangements. If BIIB098 discontinuations due to gastrointestinal adverse events in BIIB098’s long-term safety clinical trial exceed a certain pre-defined threshold, or, if in part B of the head-to-head phase 3 gastrointestinal tolerability clinical trial, BIIB098 demonstrates a greater rate of discontinuations as compared to TECFIDERA and TECFIDERA demonstrates statistical superiority to BIIB098 on the primary endpoint, then “GI Inferiority” shall be deemed to exist, and (i) Biogen shall have the right to recapture from the Company its $50.0 million option payment through certain temporary reductions in royalty rates, (ii) the minimum annual payments Biogen owes to the Company shall terminate, and (iii) there shall be no reversion of BIIB098 to the Company in the event that Biogen terminates the agreement and does not commercialize BIIB098. Unless earlier terminated, the agreement will remain in effect until the expiry of all royalty obligations. Biogen has the right to terminate the agreement at will, on a product-by-product basis or in its entirety. Either party has the right to terminate the agreement following any governmental prohibition of the transactions effected by the agreement, or in connection with an insolvency event involving the other party. Upon termination of the agreement by either party, if, prior to such termination (i) GI Inferiority was not deemed to exist or (ii) GI Inferiority was deemed to exist but Biogen commercialized BIIB098, then, at the Company’s request, the BIIB098 program will revert to the Company. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. INCOME TAXES The Company’s provision (benefit) for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2018 2017 2016 Current income tax provision: U.S. federal $ (53 ) $ 6,964 $ 3,163 U.S. state 1,774 350 480 Rest of world — 123 103 Deferred income tax provision (benefit): U.S. federal 10,624 8,188 (9,278 ) U.S. state 62 (933 ) (269 ) Ireland (63 ) (21 ) (142 ) Total tax provision (benefit) $ 12,344 $ 14,671 $ (5,943 ) The income tax provision in 2018 and 2017 and the income tax benefit in 2016 was primarily due to U.S. federal and state taxes. The favorable change in income taxes in 2018, as compared to 2017, was due to the one-off nature of a $21.5 million tax expense in 2017 from the enactment of the Tax Cuts and Jobs Act (The “Act” or “Tax Reform”), partially offset by increased taxes on income earned in the U.S. The unfavorable change in income taxes in 2017, as compared to 2016, was primarily due to the enactment of Tax Reform and an increase in income earned in the U.S., partially offset by the recognition of excess tax benefits related to share-based compensation. A $4.2 million benefit was recorded to additional paid-in capital in the year ended December 31, 2016 with a corresponding reduction to current taxes payable. This was primarily due to the utilization of current year tax benefits and NOL carryforwards derived from the exercise of employee stock options and vesting of restricted stock units. No provision for income tax has been provided on undistributed earnings of the Company's foreign subsidiaries because such earnings are indefinitely reinvested in the foreign operations or may be repatriated to Ireland without incurring any tax liability. Cumulative unremitted earnings of overseas subsidiaries totaled approximately $327.1 million at December 31, 2018. In the event of a repatriation of those earnings in the form of dividends or otherwise, the Company may be liable for income taxes, subject to adjustment, if any, for foreign tax credits and foreign withholding taxes payable to foreign tax authorities. The Company estimates that approximately $8.3 million of income taxes would be payable on the repatriation of the unremitted earnings to Ireland. The distribution of the Company’s loss before the provision (benefit) for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2018 2017 2016 Ireland $ (180,195 ) $ (172,363 ) $ (212,198 ) U.S. 53,287 2,414 (18,935 ) Rest of world (59 ) 26,675 16,746 Loss before provision (benefit) for income taxes $ (126,967 ) $ (143,274 ) $ (214,387 ) The components of the Company’s net deferred tax assets (liabilities) were as follows: December 31, December 31, (In thousands) 2018 2017 Deferred tax assets: Irish NOL carryforwards $ 198,633 $ 177,435 Tax credits 52,395 71,366 Share-based compensation 44,873 40,048 Other 24,561 13,239 Less: valuation allowance (219,093 ) (172,797 ) Total deferred tax assets 101,369 129,291 Deferred tax liabilities: Intangible assets — (18,184 ) Property, plant and equipment (14,533 ) (12,040 ) Other (1,274 ) (818 ) Total deferred tax liabilities (15,807 ) (31,042 ) Net deferred tax assets $ 85,562 $ 98,249 As of December 31, 2017, a deferred tax asset of $13.3 million was recorded as a provisional amount in respect of performance-based compensation provided to covered employees prior to November 2, 2017. The Company has since completed its review of the Act and has determined he Company concluded that it had met the requirements for recognition of the tax benefit, and no longer considers this item a provisional amount in the financial statements under Staff Accounting Bulletin 118 (“SAB 118”). In March 2016, the FASB issued guidance as part of its simplification initiative that involves several aspects of the accounting for share-based payment transactions including the requirement that all future excess tax benefits and tax deficiencies be recognized as income tax expense or benefit in the income statement. On January 1, 2017, the Company adopted this standard on a modified retrospective basis, which resulted in a $57.8 million increase to its deferred tax assets, a $3.7 million decrease in liabilities and a $61.5 million favorable cumulative-effect adjustment to accumulated deficit due to the change in the accounting treatment of excess tax benefits. The activity in the valuation allowance associated with deferred taxes consisted of the following: (In thousands) Balance at Beginning of Period Additions (1) Balance at End of Period Deferred tax asset valuation allowance for the year ended December 31, 2016 $ (106,746 ) $ (35,113 ) $ (141,859 ) Deferred tax asset valuation allowance for the year ended December 31, 2017 $ (141,859 ) $ (30,938 ) $ (172,797 ) Deferred tax asset valuation allowance for the year ended December 31, 2018 $ (172,797 ) $ (46,296 ) $ (219,093 ) (1) The additions in each of the periods presented relate primarily to Irish NOL’s. At December 31, 2018, the Company maintained a valuation allowance of $11.7 million against certain U.S. state deferred tax assets and $207.4 million against certain Irish deferred tax assets as the Company has determined that it is more-likely-than-not that these net deferred tax assets will not be realized. If the Company demonstrates consistent profitability in the future, the evaluation of the recoverability of these deferred tax assets could change and the remaining valuation allowances could be released in part or in whole. If the Company incurs losses in the U.S. in the future, or experiences significant excess tax benefits arising from the future exercise of stock options and/or the vesting of RSUs, the evaluation of the recoverability of the U.S. deferred tax assets could change and a valuation allowance against the U.S. deferred tax assets may be required in part or in whole. As of December 31, 2018, the Company had $1.4 billion of Irish NOL carryforwards, $2.5 million of state NOL carryforwards, $44.8 million of federal R&D credits, $2.0 million of alternative minimum tax (“AMT”) credits and $14.8 million of state tax credits which will either expire on various dates through 2038 or can be carried forward indefinitely. These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax and, in the case of the AMT credits, may be refundable. These loss and credit carryforwards are subject to review and possible adjustment by the appropriate taxing authorities. These loss and credit carryforwards, which may be utilized in a future period, may be subject to limitations based upon changes in the ownership of the Company's ordinary shares. In addition to deferred tax assets and liabilities, the Company recorded deferred charges related to certain intercompany asset transfers. Deferred charges are included in the following accounts: December 31, December 31, (In thousands) 2018 2017 Prepaid expenses and other current assets $ — $ 188 Other assets — long-term — 686 Total deferred charges $ — $ 874 The Company adopted ASU 2016-16 effective January 1, 2018 requiring an unfavorable cumulative-effect adjustment of $0.9 million recorded to accumulated deficit to write-off the unamortized deferred tax charge at December 31, 2017. In addition, the Company recorded a $17.8 million deferred tax asset to take account of certain basis differences on intangible assets, with a corresponding adjustment to valuation allowance. A reconciliation of the Company’s statutory tax rate to its effective tax rate is as follows: Year Ended December 31, (In thousands, except percentage amounts) 2018 2017 2016 Statutory tax rate 12.5 % 12.5 % 12.5 % Income tax provision at statutory rate $ (15,871 ) $ (17,909 ) $ (26,798 ) Change in valuation allowance 28,371 26,771 35,290 Federal tax law change ( 1) — 21,453 — Impairment on equity method investment — 1,662 — Foreign rate differential ( 2) 5,405 (682 ) 2,723 Share-based compensation 1,163 (1,205 ) 2,072 U.S. state income taxes, net of U.S. federal benefit 1,732 (558 ) (2 ) Intercompany amounts ( 3) (751 ) (5,041 ) (5,209 ) Irish rate differential ( 4) (2,350 ) (2,675 ) (5,231 ) R&D credit (7,698 ) (9,326 ) (10,572 ) Other permanent items ( 5) 2,343 2,181 1,784 Income tax provision (benefit) $ 12,344 $ 14,671 $ (5,943 ) Effective tax rate (9.7 ) % (10.2 ) % 2.8 % (1) Represents a $21.5 million deferred tax expense recorded as a discrete item during the three months ended December 31, 2017, as a result of the reduction in the U.S. federal tax rate from 35% to 21%. (2) Represents income or losses of non-Irish subsidiaries, including U.S. subsidiaries, subject to tax at a rate other than the Irish statutory rate. (3) Intercompany amounts include cross-territory eliminations, the pre-tax effect of which has been eliminated in arriving at the Company's consolidated loss before taxes. (4) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. (5) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses, non-deductible lobbying expenses and non-deductible compensation of senior officers of the Company. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Unrecognized (In thousands) Tax Benefits Balance, December 31, 2015 $ 3,778 Reductions based on tax positions related to prior periods (7 ) Additions based on tax positions related to the current period 917 Balance, December 31, 2016 $ 4,688 Reductions based on tax positions related to prior periods (47 ) Additions based on tax positions related to the current period 877 Balance, December 31, 2017 $ 5,518 Additions based on tax positions related to prior periods 4 Additions based on tax positions related to the current period 559 Balance, December 31, 2018 $ 6,081 The unrecognized tax benefits at December 31, 2018, if recognized, would affect the Company's effective tax rate. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly increase or decrease within the next 12 months. The Company has elected to include interest and penalties related to uncertain tax positions as a component of its provision for taxes. For the years ended December 31, 2018, 2017 and 2016, the Company's accrued interest and penalties related to uncertain tax positions were not material. The Company’s major taxing jurisdictions include Ireland and the U.S. (federal and state). These jurisdictions have varying statutes of limitations. In the U.S., the 2015 through 2018 fiscal years remain subject to examination by the respective tax authorities. In Ireland, the years 2014 to 2018 remain subject to examination by the Irish tax authorities. Additionally, because of the Company’s Irish and U.S. loss carryforwards and credit carryforwards, certain tax returns from fiscal years 1999 onward may also be examined. These years generally remain open for three to four years after the loss carryforwards and credit carryforwards have been utilized. The years ended December 31, 2015 and 2014 for Alkermes U.S. Holdings, Inc. are currently under examination by the State of Illinois. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 16. COMMITMENTS AND CONTINGENT LIABILITIES Lease Commitments The Company leases certain of its offices, research laboratories and manufacturing facilities under operating leases that expire through the year 2029. Certain of the leases contain provisions for extensions of up to ten years. These lease commitments are primarily related to the Company’s corporate headquarters in Ireland and its corporate office and R&D facility in Massachusetts. As of December 31, 2018, the total future annual minimum lease payments under the Company’s non‑cancelable operating leases are as follows: Payment (In thousands) Amount Years Ending December 31, 2019 $ 9,394 2020 10,717 2021 4,706 2022 2,455 2023 2,389 Thereafter 23,940 $ 53,601 Rent expense related to operating leases charged to operations was $10.8 million, $9.4 million and $8.1 million for the years ended December 31, 2018, 2017 and 2016, respectively. In addition to its lease commitments, the Company had open purchase orders totaling $530.3 million at December 31, 2018. Litigation From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates based on available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At December 31, 2018, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. INVEGA SUSTENNA ANDA Litigation In January 2018, Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Teva Pharmaceuticals USA, Inc. (“Teva”), who filed an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. Requested judicial remedies included recovery of litigation costs and injunctive relief. The Company is not a party to these proceedings. For information about risks relating to the INVEGA SUSTENNA Paragraph IV litigation, see “Part I, Item 1A—Risk Factors” of this Annual Report and specifically the section entitled “—We or our licensees may face claims against intellectual property rights covering our products and competition from generic drug manufacturers.” AMPYRA ANDA Litigation Eleven separate Paragraph IV Certification Notices have been received by the Company and/or its partner Acorda from: Accord Healthcare, Inc. (“Accord”); Actavis Laboratories FL, Inc. (“Actavis”); Alkem Laboratories Ltd. (“Alkem”); Apotex Corporation and Apotex, Inc. (collectively, “Apotex”); Aurobindo Pharma Ltd. (“Aurobindo”); MicroLabs Limited (“MicroLabs”); Mylan Pharmaceuticals, Inc. (“Mylan”); Par Pharmaceutical, Inc. (“Par”); Roxane Laboratories, Inc. (“Roxane”); Sun Pharmaceutical Industries Limited and Sun Pharmaceuticals Industries Inc. (collectively, “Sun”); and Teva (collectively with Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Mylan, Par, Roxane and Sun, the “ANDA Filers”) advising that each of the ANDA Filers had submitted an ANDA to the FDA seeking marketing approval for generic versions of AMPYRA (dalfampridine) Extended-Release Tablets, 10 mg. The ANDA Filers challenged the validity of one or more of the Orange Book-listed patents for AMPYRA, and they also asserted that their generic versions do not infringe certain claims of these patents. In response, the Company and/or Acorda filed lawsuits against the ANDA Filers asserting infringement of one or more of the Orange Book-listed patents for AMPYRA. Requested judicial remedies included recovery of litigation costs and injunctive relief. All lawsuits were filed within 45 days from the date of receipt of each of the Paragraph IV Certification Notices from the ANDA Filers. As a result, a 30-month statutory stay of approval period applied to each of the ANDA Filers’ ANDAs under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). The first 30-month stay restricted the FDA from approving the ANDA Filers’ ANDAs until July 2017 at the earliest, unless a Federal district court issued a decision adverse to all of the asserted Orange Book-listed patents prior to that date. Lawsuits with eight of the ANDA Filers have been consolidated into a single case. The Company and/or Acorda entered into a settlement agreement with each of Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Par and Sun to resolve the patent litigation that the Company and/or Acorda brought against these settling ANDA Filers. The settlements with these settling ANDA Filers did not impact the patent litigation that the Company and Acorda brought against the remaining ANDA Filers, including as described below. In March 2017, after a bench trial, the U.S. District Court for the District of Delaware (the “Delaware Court”) issued an opinion (the “Delaware Court Decision”), which, among other things, invalidated U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. The Delaware Court also upheld the validity of the U.S. Patent No. 5,540,938, which pertains to the formulation of AMPYRA, but that patent expired on July 30, 2018. In May 2017, Acorda filed an appeal with the Federal Circuit of the Delaware Court Decision with respect to the findings on U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. On July 27, 2018, Acorda and the Company entered into a settlement agreement with Mylan, pursuant to which, among other things, Mylan was permitted to market an authorized generic version of AMPYRA in the U.S. in the event of an affirmance by the Federal Circuit of the Delaware Court Decision. On September 10, 2018, the Federal Circuit affirmed the Delaware Court Decision, which invalidated U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. On October 24, 2018, Acorda filed a petition for rehearing and rehearing en banc of the Federal Circuit’s decision. On January 4, 2019, the Federal Circuit denied Acorda’s petition. Acorda has until April 4, 2019 to file a petition for writ of certiorari to the Supreme Court of the United States. For information about risks relating to the AMPYRA Paragraph IV litigations and other proceedings see “Part I, Item 1A—Risk Factors” of this Annual Report and specifically the section entitled “—We or our licensees may face claims against intellectual property rights covering our products and competition from generic drug manufacturers.” VIVITROL IPR Proceeding inter partes RISPERDAL CONSTA European Opposition Proceedings In December 2016, Nanjing Luye Pharmaceutical Co Ltd, Pharmathen SA, Teva Pharmaceutical Industries Ltd and Dehns Ltd (a law firm representing an unidentified opponent) filed notices of opposition with the European Patent Office (the “EPO”) in respect of EP 2 269 577 B (the “EP ’577” Patent), which is a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter on January 23, 2019, the Opposition Division (the “OD”) of the EPO verbally advised the parties of its interlocutory decision to revoke the EP ‘577 Patent. The Company expects a written decision to be issued within a few months of the hearing date, following which the Company will have two months to appeal the decision to the EPO’s Technical Boards of Appeal. The Company will vigorously defend the EP ’577 Patent in the opposition proceedings. For information about risks relating to the EP ’577 Patent opposition proceedings see “Part I, Item 1A—Risk Factors” in this Annual Report and specifically the sections entitled “— Patent protection for our products is important and uncertain” and “— Uncertainty over intellectual property in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or commercialization of our products, and could adversely affect our business.” Government Matters On June 22, 2017 and January 17, 2019, the Company received a subpoena and a civil investigative demand, respectively, each from an Office of the U.S. Attorney for documents related to VIVITROL. The Company is cooperating with the government. Securities Litigation On November 22, 2017, a purported stockholder of the Company filed a putative class action against the Company and certain of its officers (collectively, the “Defendants”) in the United States District Court for the Southern District of New York captioned Gagnon v. Alkermes plc, et al On December 27, 2018, a purported stockholder of the Company filed a putative class action against the Company and certain of its officers in the United States District Court for the Eastern District of New York captioned Karimian v. Alkermes plc, et al. McDermott v. Alkermes plc, et al. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries: Alkermes Ireland Holdings Limited; Daravita Pharma Ireland Limited; Daravita Limited; Alkermes Science Four Limited; Alkermes Science Five Limited; Alkermes Science Six Limited; Alkermes Pharma Ireland Limited; Alkermes U.S. Holdings, Inc.; Alkermes, Inc.; Alkermes Controlled Therapeutics, Inc.; Alkermes Europe, Ltd.; Alkermes Finance Ireland Limited; Alkermes Finance Ireland (No. 2) Limited; Alkermes Finance Ireland (No. 3) Limited; and Alkermes Finance S.à r.l. Intercompany accounts and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in accordance with accounting principles generally accepted in the United States (“U.S.”) (“GAAP”) requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on‑going basis, the Company evaluates its estimates and judgments and methodologies, including those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long‑lived assets, share‑based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company values its cash and cash equivalents at cost plus accrued interest, which the Company believes approximates their market value. The Company considers only those investments which are highly liquid, readily convertible into cash and so near their maturity, generally three months from the date of purchase, that they present insignificant risk of change in value because of interest rate changes to be cash equivalents. |
Investments | Investments The Company has investments in various types of securities, consisting primarily of U.S. government and agency obligations, corporate debt securities and debt securities issued by foreign agencies and backed by foreign governments. The Company generally holds its interest-bearing investments with major financial institutions and in accordance with documented investment policies. The Company limits the amount of credit exposure to any one financial institution or corporate issuer. At December 31, 2018, substantially all these investments were classified as available for sale and were recorded at fair value. Holding gains and losses on available-for-sale investments are considered “unrealized” and are reported within “Accumulated other comprehensive loss,” a component of shareholders’ equity. The Company uses the specific identification method for reclassifying unrealized gains and losses into earnings when investments are sold. The Company conducts periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment and its application to certain investments, as required by GAAP. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses on available-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded in “Accumulated other comprehensive loss.” For securities with unrealized losses, the Company performs an analysis to assess whether it intends to sell or whether it would more likely than not be required to sell the security before the expected recovery of its amortized cost basis. If the Company intends to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded within earnings as an impairment loss. Regardless of the Company’s intent to sell a security, the Company performs additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. The Company's held-to-maturity investments are restricted investments held as collateral under letters of credit related to certain of the Company's agreements and are included in “Investments—long-term,” in the accompanying consolidated balance sheets. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial assets and liabilities are recorded at fair value and are classified as Level 1, 2 or 3 within the fair value hierarchy, as described in the accounting standards for fair value measurement. The Company’s financial assets and liabilities consist of cash equivalents, investments, contingent consideration and warrants to purchase the common stock of a publicly traded company and are classified within the fair value hierarchy as follows: • Level 1 –these valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 1 inputs at December 31, 2018 included U.S. treasury securities, marketable securities classified as cash equivalents and a fixed term deposit account; • Level 2 –these valuations are based on a market approach using quoted prices obtained from brokers or dealers for similar securities or for securities for which the Company has limited visibility into their trading volumes. Valuations of these financial instruments do not require a significant degree of judgment. Assets and liabilities utilizing Level 2 inputs at December 31, 2018 included U.S. government agency debt securities, debt securities issued by foreign agencies and backed by foreign governments and investments in corporate debt securities that are trading in the credit markets; and • Level 3 –these valuations are based on an income approach using certain inputs that are unobservable and are significant to the overall fair value measurement. Valuations of these products require a significant degree of judgment. At December 31, 2018, assets utilizing Level 3 inputs included contingent consideration, warrants to purchase the common stock of Recro Pharma, Inc. (“Recro”) and an investment in a corporate debt security. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued expenses approximate fair value due to their short‑term nature. |
Inventory | Inventory Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Included in inventory are raw materials used in production of pre-clinical and clinical products, which have alternative future use and are charged to R&D expense when consumed. The cost elements included within inventory include three primary categories for commercial products: cost of raw materials; direct labor; and overhead. Overhead is based on the normal capacity of the Company’s production facilities and does not include costs from abnormally low production or idle capacity, which are expensed directly to the consolidated statement of operations and comprehensive loss. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are recorded at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Expenditures for repairs and maintenance are charged to expense as incurred and major renewals and improvements are capitalized. Depreciation is calculated using the straight‑line method over the following estimated useful lives of the assets: Asset group Term Buildings and improvements 15 - 40 years Furniture, fixtures and equipment 3 - 10 years Leasehold improvements Shorter of useful life or lease term |
Contingent Consideration | Contingent Consideration The Company records contingent consideration it is entitled to receive at fair value on the acquisition date. The Company estimates the fair value of contingent consideration through valuation models that incorporate probability-adjusted assumptions related to the achievement of milestones and thus likelihood of receiving related payments. The Company revalues its contingent consideration each reporting period, with changes in the fair value of contingent consideration recognized within the consolidated statements of operations and comprehensive loss. Changes in the fair value of contingent consideration can result from changes to one or multiple inputs, including adjustments to discount rates, changes in the amount or timing of cash flows, changes in the assumed achievement or timing of any development or sales-based milestones and changes in the assumed probability associated with regulatory approval. The period over which the Company discounts its contingent consideration is based on the current development stage of the product candidate, the specific development plan for that product candidate, adjusted for the probability of completing the development steps, and when contingent payments would be triggered. In estimating the probability of success, the Company utilizes data regarding similar milestone events from several sources, including industry studies and the Company’s own experience. These fair value measurements are based on significant inputs not observable in the market. Significant judgment was employed in determining the appropriateness of these assumptions at the acquisition date and for each subsequent period. Accordingly, changes in assumptions described above could have a material impact on the increase or decrease in the fair value of contingent consideration recorded in any given period. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill represents the excess cost of the Company's investment in the net assets of acquired companies over the fair value of the underlying identifiable net assets at the date of acquisition. The Company’s goodwill consists solely of goodwill created as a result of the Company’s acquisition of Elan Drug Technologies (“EDT”) from Elan Corporation, plc (the “Business Combination”) in September 2011 and has been assigned to one reporting unit. A reporting unit is an operating segment or one level below an operating segment or a component to which goodwill is assigned when initially recorded. Goodwill is not amortized but is reviewed for impairment on an annual basis, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of the goodwill might not be recoverable. The Company has the option to first assess qualitative factors to determine whether it is necessary to perform the quantitative impairment test. If the Company elects this option and believes, as a result of the qualitative assessment, that it is more-likely-than-not that the fair value of its reporting unit is less than its carrying amount, the quantitative impairment test is required; otherwise, no further testing is required. Alternatively, the Company may elect to not first assess qualitative factors and immediately perform the quantitative impairment test. In the quantitative impairment test, the Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of its reporting unit, then the Company would record an impairment loss equal to the difference. The Company's finite-lived intangible assets, consisting of core developed technology and collaboration agreements acquired as part of the acquisition of EDT, were recorded at fair value at the time of their acquisition and are stated within the Company’s consolidated balance sheets net of accumulated amortization and impairments. The finite-lived intangible assets are amortized over their estimated useful lives using the economic use method, which reflects the pattern that the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. The useful lives of the Company's intangible assets are primarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the potential extension or renewal of the contract or patent. |
Impairment of Long-Lived Assets | Impairment of Long‑Lived Assets The Company reviews long‑lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written‑down to their estimated fair values. Long‑lived assets to be disposed of are carried at fair value less costs to sell them. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers Effective January 1, 2018, the Company adopted the requirements of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (In thousands) Topic 606 Adjustment Contract assets $ 9,110 Inventory (8,209 ) Deferred tax asset 109 Contract liabilities—short-term (1,104 ) Contract liabilities—long-term (724 ) Accumulated deficit 818 $ — When entering into arrangements with customers, the Company identifies whether its performance obligations under the arrangement represent a distinct good or service or a series of distinct goods or services. If a contract contains more than one performance obligation, the Company allocates the total transaction price to each performance obligation in an amount based on the estimated relative standalone selling prices of the promised goods or services underlying each performance obligation. The fair value of performance obligations under the arrangement may be derived using an estimate of selling price if the Company does not sell the goods or services separately. The Company recognizes revenue when or as it satisfies a performance obligation by transferring an asset or providing a service to a customer. Management judgment is required in determining the consideration to be earned under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. The Company adopted Topic 606 using the modified retrospective method. As such, the Company recognized the cumulative effect of initially applying Topic 606 as an adjustment to the opening balance of shareholders’ equity at January 1, 2018. Therefore, the comparative information has not been adjusted and continues to be reported under the old revenue recognition guidance (“Topic 605”). The quantitative impacts of the changes are set out below for each of the condensed consolidated balance sheet and the condensed consolidated statement of operations and comprehensive loss for the current reporting period. ADJUSTED CONDENSED CONSOLIDATED BALANCE SHEET December 31, 2018 (In thousands) As Reported Adjustment Balances Without Adoption of Topic 606 ASSETS Contract assets $ 8,230 $ (8,230 ) (1) $ — Inventory 90,196 8,847 (2) 99,043 Deferred tax asset 85,807 (133 ) (3) 85,674 LIABILITIES Contract liabilities—short-term $ 3,169 $ (3,169 ) (4) $ — Deferred revenue—short-term — 1,224 (4) 1,224 Contract liabilities—long-term 9,525 (9,525 ) (4) — Deferred revenue—long-term — 8,852 (4) 8,852 SHAREHOLDERS' EQUITY Accumulated deficit $ (1,185,368 ) $ 2,156 (5) $ (1,183,212 ) The adjustments are a result of the following: (1) Adjustment to contract assets to reverse revenue recognized over time under Topic 606. (2) Adjustment to inventory to add back the cost of goods manufactured related to the revenue transactions summarized in item (1), above. (3) Adjustment to deferred tax asset to apply the tax impact of the revenue transactions summarized in item (1), above. (4) Adjustments to contract liabilities—short-term and contract liabilities—long-term is to reclassify amounts previously classified as deferred revenue—short-term and deferred revenue—long-term under Topic 605. (5) Adjustment to accumulated deficit for the net impact of the transactions noted in items (1) through (4) above. ADJUSTED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Year Ended December 31, 2018 (In thousands, except per share amounts) As Reported Adjustment Balances Without Adoption of Topic 606 REVENUES: Manufacturing and royalty revenues $ 526,675 $ 1,911 (1) $ 528,586 Product sales, net 450,334 — 450,334 Research and development revenue 68,895 48,473 (2) 117,368 License revenue 48,370 (48,370 ) (3) — Total revenues 1,094,274 2,014 1,096,288 EXPENSES: Cost of goods manufactured and sold 176,420 (640 ) (4) 175,780 Research and development 425,406 — 425,406 Selling, general and administrative 526,408 — 526,408 Amortization of acquired intangible assets 65,168 — 65,168 Total expenses 1,193,402 (640 ) 1,192,762 Operating loss (99,128 ) 2,654 (96,474 ) Other (expense) income, net (27,839 ) — (27,839 ) Loss before income taxes (126,967 ) 2,654 (124,313 ) Income tax provision (benefit) 12,344 24 12,368 Net loss $ (139,311 ) $ 2,630 $ (136,681 ) Loss per ordinary share — basic and diluted $ (0.90 ) $ 0.02 $ (0.88 ) WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: Basic and diluted 155,112 155,112 155,112 The adjustments are a result of the following: (1) Adjustments to manufacturing and royalty revenues to recognize revenue under Topic 605 in the year ended December 31, 2018 that was recognized under Topic 606. (2) Adjustments to research and development revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (3) Adjustments to license revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (4) Adjustments to cost of goods manufactured and sold to recognize the cost from the transactions noted in item (1) above. The Company’s changes in assets and liabilities within its condensed consolidated statement of cash flows changed as a result of the differences in the condensed consolidated balance sheet and changes in net loss in the condensed consolidated statement of operations, but the overall cash flows used in operating activities did not change. Collaborative Arrangements The Company has entered into collaboration agreements with pharmaceutical companies including Janssen Pharmaceutica Inc. (“Janssen, Inc.”), Janssen Pharmaceutica International, a division of Cilag International AG (“Janssen International”), and Janssen Pharmaceutica N.V. (together with Janssen, Inc., Janssen International and their affiliates “Janssen”) for INVEGA SUSTENNA ® ® ® ® ® ® ® Manufacturing Revenue The Company recognizes manufacturing revenues from the sale of products it manufactures for resale by its licensees. Manufacturing revenues Prior to the adoption of Topic 606, the Company recorded manufacturing revenue from the sale of products it manufactures for resale by its partners after the Company had shipped such products and risk of loss had passed to the Company’s partner, assuming persuasive evidence of an arrangement existed, the sales price was fixed or determinable and collectability was reasonably assured. The Company is the exclusive manufacturer of RISPERDAL CONSTA for commercial sale under its manufacturing and supply agreement with Janssen. The Company determined that it is appropriate to record revenue under this agreement at the point in time when control of the product passes to Janssen, which is determined to be when the product has been fully manufactured, since Janssen does not control the product during the manufacturing process and, in the event Janssen terminates the manufacturing and supply agreement, it is uncertain whether, and at what amount, the Company would be reimbursed for performance completed to date for product not yet fully manufactured. The manufacturing process is considered fully complete once the finished goods have been approved for shipment by both the Company and Janssen. The sales price for certain of the Company’s manufacturing revenues is based on the end-market sales price earned by its licensees. As end-market sales generally occur after the Company has recorded manufacturing revenue, the Company estimates the sales price for such products based on information supplied to it by the Company’s licensees, its historical transaction experience and other third-party data. Differences between actual manufacturing revenues and estimated manufacturing revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The difference between the Company’s actual and estimated manufacturing revenues has not been material to date. Royalty Revenue The Company recognizes royalty revenues related to the sale of products by its licensees that incorporate the Company's technologies. Royalties, with the exception of those earned on sales of AMPYRA as set forth below, qualify for the sales-and-usage exemption under Topic 606 as (i) royalties are based strictly on the sales-and-usage by the licensee; and (ii) a license of intellectual property (“IP”) is the sole or predominant item to which such royalties relate. Based on this exemption, these royalties are earned in the period the products are sold by the Company's partner and the Company has a present right to payment. Royalties on AMPYRA manufactured under our license and supply agreements with Acorda are incorporated into the standard cost-based model described in the manufacturing revenues section, above, as the terms of such agreements entitle the Company to royalty revenue as the product is being manufactured, which represents a faithful depiction of the transfer of goods, and not based on the actual end-market sales of the licensee. Certain of the Company's royalty revenues are recognized by the Company based on information supplied to the Company by its licensees and require estimates to be made. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, which is generally within the same quarter. The difference between the Company’s actual and estimated royalty revenues has not been material to date. Research and Development Revenue R&D revenue consists of funding that compensates the Company for formulation, pre‑clinical and clinical testing under R&D arrangements with its partners. The Company generally bills its partners under R&D arrangements using a full‑time equivalent (“FTE”) or hourly rate, plus direct external costs, if any. Revenue is recognized as the obligations under the R&D arrangements are performed. License Revenue The Company recognizes revenue from the grant of distinct, right-to-use licenses of intellectual property (“IP”) when control of the license is transferred to the customer, which is the point in time the customer is able to direct the use of and obtain substantially all of the benefits from the license. Product Sales, Net The Company’s product sales, net consist of sales of VIVITROL ® ® in the U.S. primarily to wholesalers, specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer. Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, health care providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances: • Medicaid Rebates — the Company records accruals for rebates to states under the Medicaid Drug Rebate Program as a reduction of sales when the product is shipped into the distribution channel using the expected value method. The Company rebates individual states for all eligible units purchased under the Medicaid program based on a rebate per unit calculation, which is based on the Company’s average manufacturer prices. The Company estimates expected unit sales and rebates per unit under the Medicaid program and adjusts its rebate based on actual unit sales and rebates per unit. To date, actual Medicaid rebates have not differed materially from the Company’s estimates; • Chargebacks — discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Company the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer. The allowance for chargebacks is made using the expected value method and is based on actual and expected utilization of these programs. Chargebacks could exceed historical experience and the Company’s estimates of future participation in these programs. To date, actual chargebacks have not differed materially from the Company’s estimates; • Product Discounts — cash consideration, including sales incentives, given by the Company under agreements with a number of wholesaler, distributor, pharmacy, and treatment provider customers that provide them with a discount on the purchase price of products. The reserve is made using the expected value method and to date, actual product discounts have not differed materially from the Company’s estimates; and • Product Returns — the Company records an estimate for product returns at the time its customers take control of the Company’s product. The Company estimates this liability using the expected value method based on its historical return levels and specifically identified anticipated returns due to known business conditions and product expiry dates. Return amounts are recorded as a deduction to arrive at product sales, net. Once product is returned, it is destroyed. • Medicare Part D — the Company records accruals for Medicare Part D liabilities under the Medicare Coverage Gap Discount Program (“CGDP”) as a reduction of sales. Under the CGDP, patients reaching the annual coverage gap threshold are eligible for reimbursement coverage for out-of-pocket costs for covered prescription drugs. Under an agreement with the Center for Medicare and Medicaid, manufacturers are responsible to reimburse prescription plan sponsors for the portion of out-of-pocket expenses not covered under their Medicare plans. |
Receivables, net | Receivables, net Receivables, net, include amounts billed and currently unconditionally due from customers. The amounts due are stated at their net estimated realizable value. The Company maintains an allowance for doubtful accounts to provide for the estimated amounts of receivables that will not be collected. The allowance is based upon an assessment of customer creditworthiness, historical payment experience, the age of outstanding receivables and collateral to the extent applicable. The Company’s allowance for doubtful accounts was $0.2 million at December 31, 2018 and 2017. |
Contract Assets | Contract Assets Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time. The products included in the contract assets table below complete the manufacturing process in ten days to eight weeks. Contract assets are classified as current. Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2018 $ 9,110 Additions 57,617 Transferred to receivables, net (58,497 ) Contract assets at December 31, 2018 $ 8,230 |
Contract Liabilities | Contract Liabilities The Company’s contract liabilities consist of contractual obligations related to deferred revenue. Contract liabilities consisted of the following: (In thousands) Contract Liabilities Contract liabilities at January 1, 2018 $ 9,442 Additions 6,381 Amounts recognized into revenue (3,129 ) Contract liabilities at December 31, 2018 $ 12,694 |
Foreign Currency | Foreign Currency The Company's functional and reporting currency is the U.S. dollar. Transactions in foreign currencies are recorded at the exchange rate prevailing on the date of the transaction. The resulting monetary assets and liabilities are translated into U.S. dollars at exchange rates prevailing on the subsequent balance sheet date. Gains and losses as a result of translation adjustments are recorded within “Other (expense) income, net” in the accompanying consolidated statements of operations and comprehensive loss. During the years ended December 31, 2018, 2017 and 2016 the Company recorded a (loss) gain on foreign currency translation of $(2.3) million, $3.7 million and $0.1 million, respectively. |
Concentrations | Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk are receivables and marketable securities. Billings to large pharmaceutical companies account for the majority of the Company's receivables, and collateral is generally not required from these customers. To mitigate credit risk, the Company monitors the financial performance and credit worthiness of its customers. The following represents revenue and receivables from the Company's customers exceeding 10% of the total in each category as of, and for the years ended, December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 27 % 29 % 31 % 33 % 33 % 36 % Acorda 15 % 10 % 14 % 13 % 17 % 15 % Cardinal Health * 13 % * * * * Biogen * 10 % * * * * * Indicates the revenues or receivables for the customer did not exceed 10% of the Company’s total in each category as of or for the years ended December 31, 2018, 2017 and 2016, as noted. The Company holds its interest‑bearing investments with major financial institutions and, in accordance with documented investment policies, the Company limits the amount of credit exposure to any one financial institution or corporate issuer. The Company’s investment objectives are, first, to assure liquidity and conservation of capital and, second, to obtain investment income. |
Geographic Information | Geographic Information Company revenues by geographic location, as determined by the location of the customer, and the location of its assets, are as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Revenue by region: U.S. $ 884,600 $ 700,090 $ 557,312 Ireland 4,915 9,706 4,407 Rest of world 204,759 193,578 183,975 Assets by region: Current assets: U.S. $ 546,533 $ 402,481 $ 382,168 Ireland 433,837 403,167 407,761 Rest of world 2,882 3,196 749 Long-term assets: U.S.: Other $ 312,243 $ 360,641 $ 236,175 Ireland: Intangible assets $ 191,001 $ 256,168 $ 318,227 Goodwill 92,873 92,873 92,873 Other 245,638 278,701 288,470 |
Research and Development Expenses | Research and Development Expenses For each of its R&D programs, the Company incurs both external and internal expenses. External R&D expenses include costs related to clinical and non‑clinical activities performed by contract research organizations, consulting fees, laboratory services, purchases of drug product materials and third‑party manufacturing development costs. Internal R&D expenses include employee‑related expenses, occupancy costs, depreciation and general overhead. The Company tracks external R&D expenses for each of its development programs, however, internal R&D expenses, with the exception of those expenses related to BIIB098, are not tracked by individual program as they benefit multiple programs or its technologies in general. |
Selling, General and Administrative Expenses | Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses are primarily comprised of employee-related expenses associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. Advertising costs are expensed as incurred. During the years ended December 31, 2018, 2017 and 2016, advertising costs totaled $54.7 million, $34.4 million and $24.0 million, respectively. |
Share-Based Compensation | Share‑Based Compensation The Company’s share‑based compensation programs grant awards which include stock options and restricted stock units (“RSUs”), which vest with the passage of time and, to a limited extent, vest based on the achievement of certain performance criteria. The Company issues new shares upon stock option exercise or the vesting of RSUs. Certain of the Company’s employees are retirement eligible under the terms of the Company’s stock option plans (the “Plans”), and stock option awards to these employees generally vest in full upon retirement. Since there are no effective future service requirements for these employees, the fair value of these awards is expensed in full on the grant date or upon meeting the retirement eligibility criteria, whichever is later. Stock Options Stock option grants to employees expire ten years from the grant date and generally vest one‑fourth per year over four years from the anniversary of the date of grant, provided the employee remains continuously employed with the Company, except as otherwise provided in the plan. Stock option grants to directors are for ten‑year terms and generally vest over a one‑year period provided the director continues to serve on the Company’s board of directors through the vesting date, except as otherwise provided in the plan. The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period. Share‑based compensation expense is based on awards ultimately expected to vest. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The fair value of stock option grants is based on estimates as of the date of grant using a Black‑Scholes option valuation model. The Company uses historical data as the basis for estimating option terms and forfeitures. Separate groups of employees that have similar historical stock option exercise and forfeiture behavior are considered separately for valuation purposes. The ranges of expected terms disclosed below reflect different expected behavior among certain groups of employees. Expected stock volatility factors are based on a weighted average of implied volatilities from traded options on the Company’s ordinary shares and historical share price volatility of the Company’s ordinary shares, which is determined based on a review of the weighted average of historical daily price changes of the Company’s ordinary shares. The risk‑free interest rate for periods commensurate with the expected term of the share option is based on the U.S. treasury yield curve in effect at the time of grant. The dividend yield on the Company’s ordinary shares is estimated to be zero as the Company has not paid and does not expect to pay dividends. The exercise price of options granted is equal to the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Stock Market on the date of grant. The fair value of each stock option grant was estimated on the grant date with the following weighted‑average assumptions: Year Ended December 31, 2018 2017 2016 Expected option term 5 - 8 years 5 - 8 years 5 - 7 years Expected stock volatility 44 % - 49 % 43 % - 47 % 39 % - 53 % Risk-free interest rate 2.25 % - 3.10 % 1.69 % - 2.38 % 0.95 % - 2.14 % Expected annual dividend yield — — — Time‑Vested Restricted Stock Units Time‑vested RSUs awarded to employees generally vest one‑fourth per year over four years from the anniversary of the date of grant, provided the employee remains continuously employed with the Company. Shares of the Company’s ordinary shares are delivered to the employee upon vesting, subject to payment of applicable withholding taxes. The fair value of time‑vested RSUs is equal to the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. Performance-Based Restricted Stock Units Performance-based RSUs awarded to employees vest upon the achievement of certain performance criteria. The estimated fair value of these RSUs is based on the market value of the Company’s ordinary shares on the date of grant. Compensation expense for performance-based RSUs is recognized from the moment the Company determines the performance criteria probable to the date the Company deems the event is likely to occur. Cumulative adjustments are recorded quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date results are determined. |
Income Taxes | Income Taxes The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In evaluating the Company’s ability to recover its deferred tax assets, the Company considers all available positive and negative evidence including its past operating results, the existence of cumulative income in the most recent fiscal years, changes in the business in which the Company operates and its forecast of future taxable income. In determining future taxable income, the Company is responsible for assumptions utilized including the amount of Irish, U.S. and other foreign pre‑tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying businesses. The Company accounts for uncertain tax positions using a more‑likely‑than‑not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company evaluates its tax position on a quarterly basis. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in income tax expense. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss consists of net loss and other comprehensive loss. Other comprehensive loss includes changes in equity that are excluded from net loss, such as unrealized holding gains and losses on available‑for‑sale marketable securities. |
Loss Per Share | Loss Per Share Basic loss per share is calculated based upon net loss available to holders of ordinary shares divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings per share, the Company uses the weighted average number of ordinary shares outstanding, as adjusted for the effect of potential dilutive securities, including stock options and RSUs. |
Segment Information | Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to yield better therapeutic outcomes and improve the lives of patients with serious diseases. The Company’s chief decision maker, the Chairman and Chief Executive Officer, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. |
Employee Benefit Plans | Employee Benefit Plans 401(k) Plan The Company maintains a 401(k) retirement savings plan (the “401(k) Plan”), which covers substantially all of its U.S.‑based employees. Eligible employees may contribute up to 100% of their eligible compensation, subject to certain Internal Revenue Service (“IRS”) limitations. The Company matches 100% of employee contributions up to the first 5% of employee pay, up to IRS limits. Employee and Company contributions are fully vested when made. During the years ended December 31, 2018, 2017 and 2016, the Company contributed $12.1 million, $9.8 million and $8.1 million, respectively, to match employee deferrals under the 401(k) Plan. Defined Contribution Plan The Company maintains a defined contribution plan for its Ireland‑based employees (the “Defined Contribution Plan”). The Defined Contribution Plan provides for eligible employees to contribute up to the maximum of 40%, depending upon their age, of their total taxable earnings subject to an earnings cap of €115,000. The Company provides a match of up to 18% of taxable earnings depending upon an individual’s contribution level. During the years ended December 31, 2018, 2017 and 2016, the Company contributed $4.0 million, $3.7 million and $3.2 million, respectively, in contributions to the Defined Contribution Plan. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard‑setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU 2016-02, Leases In April 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-14, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In November 2018, the FASB issued ASU 2018-18, Clarifying the Interaction Between Topic 808 and Topic 606 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Estimated Useful Life of Property, Plant and Equipment | Asset group Term Buildings and improvements 15 - 40 years Furniture, fixtures and equipment 3 - 10 years Leasehold improvements Shorter of useful life or lease term |
Schedule of Adjusted Condensed Consolidated Statement of Balance Sheet, Statement of Operations and Comprehensive Loss | The following balance sheet accounts were impacted: (In thousands) Topic 606 Adjustment Contract assets $ 9,110 Inventory (8,209 ) Deferred tax asset 109 Contract liabilities—short-term (1,104 ) Contract liabilities—long-term (724 ) Accumulated deficit 818 $ — |
Schedule of Contract Assets and Contract Liabilities | Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2018 $ 9,110 Additions 57,617 Transferred to receivables, net (58,497 ) Contract assets at December 31, 2018 $ 8,230 Contract liabilities consisted of the following: (In thousands) Contract Liabilities Contract liabilities at January 1, 2018 $ 9,442 Additions 6,381 Amounts recognized into revenue (3,129 ) Contract liabilities at December 31, 2018 $ 12,694 |
Schedule of Revenue and Receivables From Customers Exceeding 10% of Total in Each Category | The following represents revenue and receivables from the Company's customers exceeding 10% of the total in each category as of, and for the years ended, December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 27 % 29 % 31 % 33 % 33 % 36 % Acorda 15 % 10 % 14 % 13 % 17 % 15 % Cardinal Health * 13 % * * * * Biogen * 10 % * * * * |
Schedule of Revenues by Geographic Location, as Determined by the Location of the Customer, and the Location of its Long-term Assets | Company revenues by geographic location, as determined by the location of the customer, and the location of its assets, are as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Revenue by region: U.S. $ 884,600 $ 700,090 $ 557,312 Ireland 4,915 9,706 4,407 Rest of world 204,759 193,578 183,975 Assets by region: Current assets: U.S. $ 546,533 $ 402,481 $ 382,168 Ireland 433,837 403,167 407,761 Rest of world 2,882 3,196 749 Long-term assets: U.S.: Other $ 312,243 $ 360,641 $ 236,175 Ireland: Intangible assets $ 191,001 $ 256,168 $ 318,227 Goodwill 92,873 92,873 92,873 Other 245,638 278,701 288,470 |
Schedule of Fair Value of Each Stock Option Grant Estimated on The Grant Date Using Weighted-average Assumptions | The fair value of each stock option grant was estimated on the grant date with the following weighted‑average assumptions: Year Ended December 31, 2018 2017 2016 Expected option term 5 - 8 years 5 - 8 years 5 - 7 years Expected stock volatility 44 % - 49 % 43 % - 47 % 39 % - 53 % Risk-free interest rate 2.25 % - 3.10 % 1.69 % - 2.38 % 0.95 % - 2.14 % Expected annual dividend yield — — — |
ASU 2014-09 | |
Schedule of Adjusted Condensed Consolidated Statement of Balance Sheet, Statement of Operations and Comprehensive Loss | The quantitative impacts of the changes are set out below for each of the condensed consolidated balance sheet and the condensed consolidated statement of operations and comprehensive loss for the current reporting period. ADJUSTED CONDENSED CONSOLIDATED BALANCE SHEET December 31, 2018 (In thousands) As Reported Adjustment Balances Without Adoption of Topic 606 ASSETS Contract assets $ 8,230 $ (8,230 ) (1) $ — Inventory 90,196 8,847 (2) 99,043 Deferred tax asset 85,807 (133 ) (3) 85,674 LIABILITIES Contract liabilities—short-term $ 3,169 $ (3,169 ) (4) $ — Deferred revenue—short-term — 1,224 (4) 1,224 Contract liabilities—long-term 9,525 (9,525 ) (4) — Deferred revenue—long-term — 8,852 (4) 8,852 SHAREHOLDERS' EQUITY Accumulated deficit $ (1,185,368 ) $ 2,156 (5) $ (1,183,212 ) The adjustments are a result of the following: (1) Adjustment to contract assets to reverse revenue recognized over time under Topic 606. (2) Adjustment to inventory to add back the cost of goods manufactured related to the revenue transactions summarized in item (1), above. (3) Adjustment to deferred tax asset to apply the tax impact of the revenue transactions summarized in item (1), above. (4) Adjustments to contract liabilities—short-term and contract liabilities—long-term is to reclassify amounts previously classified as deferred revenue—short-term and deferred revenue—long-term under Topic 605. (5) Adjustment to accumulated deficit for the net impact of the transactions noted in items (1) through (4) above. ADJUSTED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Year Ended December 31, 2018 (In thousands, except per share amounts) As Reported Adjustment Balances Without Adoption of Topic 606 REVENUES: Manufacturing and royalty revenues $ 526,675 $ 1,911 (1) $ 528,586 Product sales, net 450,334 — 450,334 Research and development revenue 68,895 48,473 (2) 117,368 License revenue 48,370 (48,370 ) (3) — Total revenues 1,094,274 2,014 1,096,288 EXPENSES: Cost of goods manufactured and sold 176,420 (640 ) (4) 175,780 Research and development 425,406 — 425,406 Selling, general and administrative 526,408 — 526,408 Amortization of acquired intangible assets 65,168 — 65,168 Total expenses 1,193,402 (640 ) 1,192,762 Operating loss (99,128 ) 2,654 (96,474 ) Other (expense) income, net (27,839 ) — (27,839 ) Loss before income taxes (126,967 ) 2,654 (124,313 ) Income tax provision (benefit) 12,344 24 12,368 Net loss $ (139,311 ) $ 2,630 $ (136,681 ) Loss per ordinary share — basic and diluted $ (0.90 ) $ 0.02 $ (0.88 ) WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: Basic and diluted 155,112 155,112 155,112 The adjustments are a result of the following: (1) Adjustments to manufacturing and royalty revenues to recognize revenue under Topic 605 in the year ended December 31, 2018 that was recognized under Topic 606. (2) Adjustments to research and development revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (3) Adjustments to license revenue during the year ended December 31, 2018 to recognize revenue under Topic 605 that was recognized under Topic 606. (4) Adjustments to cost of goods manufactured and sold to recognize the cost from the transactions noted in item (1) above. |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Collaborative Aggregate Arrangements | During the years ended December 31, 2018, 2017 and 2016, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 241,423 $ 241,423 AMPYRA/FAMPYRA 53,044 54,009 107,053 RISPERDAL CONSTA 52,770 18,352 71,122 Other 27,214 79,863 107,077 $ 133,028 $ 393,647 $ 526,675 Year Ended December 31, 2017 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 214,931 $ 214,931 AMPYRA/FAMPYRA 55,373 61,646 117,019 RISPERDAL CONSTA 64,793 20,129 84,922 Other 32,655 55,781 88,436 $ 152,821 $ 352,487 $ 505,308 Year Ended December 31, 2016 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 184,233 $ 184,233 AMPYRA/FAMPYRA 53,406 60,787 114,193 RISPERDAL CONSTA 64,914 22,316 87,230 Other 33,641 67,950 101,591 $ 151,961 $ 335,286 $ 487,247 |
Product sales, net | |
Schedule of Disaggregation of Revenue | During the years ended December 31, 2018, 2017 and 2016, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2018 2017 2016 VIVITROL $ 302,609 $ 269,321 $ 208,982 ARISTADA 147,725 93,513 47,164 Total product sales, net $ 450,334 $ 362,834 $ 256,146 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Investments | Investments consist of the following: Gross Unrealized Losses Amortized Less than Greater than Estimated December 31, 2018 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 120,197 $ 57 $ (62 ) $ (274 ) $ 119,918 U.S. government and agency debt securities 80,055 115 (11 ) (87 ) 80,072 International government agency debt securities 72,091 85 (8 ) (117 ) 72,051 272,343 257 (81 ) (478 ) 272,041 Held-to-maturity securities: Corporate debt securities 492 — — — 492 Total short-term investments 272,835 257 (81 ) (478 ) 272,533 Long-term investments: Available-for-sale securities: Corporate debt securities 53,505 — (185 ) (93 ) 53,227 U.S. government and agency debt securities 18,474 — (21 ) (12 ) 18,441 International government agency debt securities 5,457 — (4 ) — 5,453 77,436 — (210 ) (105 ) 77,121 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 136 — — 1,803 3,487 136 — — 3,623 Total long-term investments 80,923 136 (210 ) (105 ) 80,744 Total investments $ 353,758 $ 393 $ (291 ) $ (583 ) $ 353,277 December 31, 2017 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 150,673 $ 1 $ (130 ) $ (233 ) $ 150,311 Corporate debt securities 56,552 3 (48 ) (10 ) 56,497 International government agency debt securities 35,478 1 (54 ) (25 ) 35,400 Total short-term investments 242,703 5 (232 ) (268 ) 242,208 Long-term investments: Available-for-sale securities: Corporate debt securities 83,924 — (300 ) (34 ) 83,590 U.S. government and agency debt securities 48,948 — (270 ) (71 ) 48,607 International government agency debt securities 21,453 — (118 ) — 21,335 154,325 — (688 ) (105 ) 153,532 Held-to-maturity securities: Fixed term deposit account 1,667 222 — — 1,889 Certificates of deposit 1,791 — — — 1,791 3,458 222 — — 3,680 Total long-term investments 157,783 222 (688 ) (105 ) 157,212 Total investments $ 400,486 $ 227 $ (920 ) $ (373 ) $ 399,420 |
Schedule of Proceeds From Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses | Realized gains and losses on the sales and maturities of marketable securities, which were identified using the specific identification method, were as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Proceeds from the sales and maturities of marketable securities $ 444,456 $ 464,494 $ 560,805 Realized gains $ 4 $ 9 $ 206 Realized losses $ 268 $ 3 $ 28 |
Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities | The Company’s available‑for‑sale and held‑to‑maturity securities at December 31, 2018 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 184,841 $ 184,304 $ 2,312 $ 2,312 After 1 year through 5 years 164,938 164,858 1,667 1,803 Total $ 349,779 $ 349,162 $ 3,979 $ 4,115 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques the Company utilized to determine such fair value: December 31, (In thousands) 2018 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 54,590 $ 54,590 $ — $ — U.S. government and agency debt securities 98,513 60,107 38,406 — Corporate debt securities 173,637 — 173,145 492 International government agency debt securities 77,504 — 77,504 — Contingent consideration 65,200 — — 65,200 Common stock warrants 1,205 — — 1,205 Total $ 470,649 $ 114,697 $ 289,055 $ 66,897 December 31, 2017 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,889 $ 1,889 $ — $ — U.S. government and agency debt securities 198,918 124,958 73,960 — Corporate debt securities 140,087 — 140,087 — International government agency debt securities 56,735 — 56,735 — Contingent consideration 84,800 — — 84,800 Common stock warrants 1,395 — — 1,395 Total $ 483,824 $ 126,847 $ 270,782 $ 86,195 |
Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs | The following table is a rollforward of the fair value of the Company’s investments whose fair value was determined using Level 3 inputs at December 31, 2018: (In thousands) Fair Value Balance, January 1, 2018 $ 86,195 Purchase of corporate debt security 492 Change in the fair value of contingent consideration (19,600 ) Decrease in the fair value of warrants (190 ) Balance, December 31, 2018 $ 66,897 |
Schedule of Assumptions Used to Determine the Fair Value of the Warrants | The Company used a Black-Scholes model with the following assumptions to determine the fair value of these warrants at December 31, 2018: Closing stock price at December 31, 2018 $ 7.10 Warrant strike price $ 8.26 Expected term (years) 3.27 Risk-free rate 2.46 % Volatility 75.0 % |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory consists of the following: December 31, December 31, (In thousands) 2018 2017 Raw materials $ 31,824 $ 29,883 Work in process 38,019 38,964 Finished goods ( 1) 20,353 24,428 Total inventory $ 90,196 $ 93,275 (1) At December 31, 2018 and 2017, the Company had $11.0 million and $8.7 million, respectively, of finished goods inventory located at its third‑party warehouse and shipping service provider. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consist of the following: December 31, December 31, (In thousands) 2018 2017 Land $ 6,486 $ 6,293 Building and improvements 157,053 155,198 Furniture, fixtures and equipment 314,831 289,455 Leasehold improvements 20,105 19,578 Construction in progress 88,983 54,270 Subtotal 587,458 524,794 Less: accumulated depreciation (277,471 ) (240,058 ) Total property, plant and equipment, net $ 309,987 $ 284,736 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consist of the following: December 31, 2018 December 31, 2017 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (319,311 ) $ 146,279 $ 465,590 $ (269,392 ) $ 196,198 NanoCrystal technology 13 74,600 (38,942 ) 35,658 74,600 (31,283 ) 43,317 OCR technologies 12 42,560 (33,496 ) 9,064 42,560 (25,907 ) 16,653 Total $ 582,750 $ (391,749 ) $ 191,001 $ 582,750 $ (326,582 ) $ 256,168 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following: December 31, December 31, (In thousands) 2018 2017 Accounts payable $ 39,767 $ 55,526 Accrued compensation 67,613 54,568 Accrued sales discounts, allowances and reserves 152,911 111,137 Accrued other 73,471 64,935 Total accounts payable and accrued expenses $ 333,762 $ 286,166 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long‑term debt consists of the following: December 31, December 31, (In thousands) 2018 2017 2023 Term Loans, due March 26, 2023 $ 279,308 $ 281,436 Less: current portion (2,843 ) (3,000 ) Long-term debt $ 276,465 $ 278,436 |
Scheduled Maturities of Term Loan Facility | Scheduled maturities with respect to the 2023 Term Loans are as follows (in thousands): Year Ending December 31: 2019 $ 2,843 2020 2,843 2021 2,843 2022 2,843 2023 270,746 Total $ 282,118 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Equivalent Shares Excluded from Calculation of Net (Loss) Income Per Share | The following potential ordinary equivalent shares were not included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Year Ended December 31, (In thousands) 2018 2017 2016 Stock options 11,331 9,540 10,166 Restricted stock units 2,592 2,119 1,320 Total 13,923 11,659 11,486 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Share-based Compensation Expense | The following table presents share‑based compensation expense included in the Company’s consolidated statements of operations and comprehensive loss: Year Ended December 31, (In thousands) 2018 2017 2016 Cost of goods manufactured and sold $ 9,174 $ 7,596 $ 8,633 Research and development 32,943 22,635 24,023 Selling, general and administrative 63,240 53,686 61,740 Total share-based compensation expense $ 105,357 $ 83,917 $ 94,396 |
Schedule of Stock Option Activity | A summary of stock option activity is presented in the following table: Number of Weighted Average Shares Exercise Price Outstanding, January 1, 2018 14,773,412 $ 36.64 Granted 2,269,830 $ 61.45 Exercised (1,087,815 ) $ 19.19 Forfeited (924,343 ) $ 51.88 Expired (178,627 ) $ 59.83 Outstanding, December 31, 2018 14,852,457 $ 40.48 Exercisable, December 31, 2018 10,506,897 $ 34.26 |
Time-vested RSUs | |
Summary of RSU Activity | A summary of time‑vested RSU activity is presented in the following table: Weighted Average Number of Shares Grant Date Fair Value Unvested, January 1, 2018 1,936,808 $ 46.72 Granted 1,367,710 $ 63.01 Vested (723,473 ) $ 47.72 Forfeited (314,759 ) $ 53.09 Unvested, December 31, 2018 2,266,286 $ 55.32 |
Performance-based RSUs | |
Summary of RSU Activity | A summary of performance-based RSU activity is presented in the following table: Weighted Average Number of Shares Grant Date Fair Value Unvested, January 1, 2018 1,108,653 $ 54.72 Granted 6,065 $ 55.89 Forfeited (176,637 ) $ 54.64 Vested (311,913 ) $ 54.74 Unvested, December 31, 2018 626,168 $ 54.75 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision (Benefit) for Income Taxes | The Company’s provision (benefit) for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2018 2017 2016 Current income tax provision: U.S. federal $ (53 ) $ 6,964 $ 3,163 U.S. state 1,774 350 480 Rest of world — 123 103 Deferred income tax provision (benefit): U.S. federal 10,624 8,188 (9,278 ) U.S. state 62 (933 ) (269 ) Ireland (63 ) (21 ) (142 ) Total tax provision (benefit) $ 12,344 $ 14,671 $ (5,943 ) |
Schedule of (Loss) Income Before Provision for Income Taxes by Geographical Area | The distribution of the Company’s loss before the provision (benefit) for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2018 2017 2016 Ireland $ (180,195 ) $ (172,363 ) $ (212,198 ) U.S. 53,287 2,414 (18,935 ) Rest of world (59 ) 26,675 16,746 Loss before provision (benefit) for income taxes $ (126,967 ) $ (143,274 ) $ (214,387 ) |
Schedule of Components of Net Deferred Tax Assets (Liabilities) | The components of the Company’s net deferred tax assets (liabilities) were as follows: December 31, December 31, (In thousands) 2018 2017 Deferred tax assets: Irish NOL carryforwards $ 198,633 $ 177,435 Tax credits 52,395 71,366 Share-based compensation 44,873 40,048 Other 24,561 13,239 Less: valuation allowance (219,093 ) (172,797 ) Total deferred tax assets 101,369 129,291 Deferred tax liabilities: Intangible assets — (18,184 ) Property, plant and equipment (14,533 ) (12,040 ) Other (1,274 ) (818 ) Total deferred tax liabilities (15,807 ) (31,042 ) Net deferred tax assets $ 85,562 $ 98,249 |
Schedule of Activity in Valuation Allowance Associated with Deferred taxes | The activity in the valuation allowance associated with deferred taxes consisted of the following: (In thousands) Balance at Beginning of Period Additions (1) Balance at End of Period Deferred tax asset valuation allowance for the year ended December 31, 2016 $ (106,746 ) $ (35,113 ) $ (141,859 ) Deferred tax asset valuation allowance for the year ended December 31, 2017 $ (141,859 ) $ (30,938 ) $ (172,797 ) Deferred tax asset valuation allowance for the year ended December 31, 2018 $ (172,797 ) $ (46,296 ) $ (219,093 ) (1) The additions in each of the periods presented relate primarily to Irish NOL’s. |
Schedule of Deferred Tax Assets and Liabilities Related to Intercompany Assets of Intellectual Property | Deferred charges are included in the following accounts: December 31, December 31, (In thousands) 2018 2017 Prepaid expenses and other current assets $ — $ 188 Other assets — long-term — 686 Total deferred charges $ — $ 874 |
Schedule of Reconciliation of Federal Statutory Tax Rate to its Effective Tax Rate | A reconciliation of the Company’s statutory tax rate to its effective tax rate is as follows: Year Ended December 31, (In thousands, except percentage amounts) 2018 2017 2016 Statutory tax rate 12.5 % 12.5 % 12.5 % Income tax provision at statutory rate $ (15,871 ) $ (17,909 ) $ (26,798 ) Change in valuation allowance 28,371 26,771 35,290 Federal tax law change ( 1) — 21,453 — Impairment on equity method investment — 1,662 — Foreign rate differential ( 2) 5,405 (682 ) 2,723 Share-based compensation 1,163 (1,205 ) 2,072 U.S. state income taxes, net of U.S. federal benefit 1,732 (558 ) (2 ) Intercompany amounts ( 3) (751 ) (5,041 ) (5,209 ) Irish rate differential ( 4) (2,350 ) (2,675 ) (5,231 ) R&D credit (7,698 ) (9,326 ) (10,572 ) Other permanent items ( 5) 2,343 2,181 1,784 Income tax provision (benefit) $ 12,344 $ 14,671 $ (5,943 ) Effective tax rate (9.7 ) % (10.2 ) % 2.8 % (1) Represents a $21.5 million deferred tax expense recorded as a discrete item during the three months ended December 31, 2017, as a result of the reduction in the U.S. federal tax rate from 35% to 21%. (2) Represents income or losses of non-Irish subsidiaries, including U.S. subsidiaries, subject to tax at a rate other than the Irish statutory rate. (3) Intercompany amounts include cross-territory eliminations, the pre-tax effect of which has been eliminated in arriving at the Company's consolidated loss before taxes. (4) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. (5) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses, non-deductible lobbying expenses and non-deductible compensation of senior officers of the Company. |
Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Unrecognized (In thousands) Tax Benefits Balance, December 31, 2015 $ 3,778 Reductions based on tax positions related to prior periods (7 ) Additions based on tax positions related to the current period 917 Balance, December 31, 2016 $ 4,688 Reductions based on tax positions related to prior periods (47 ) Additions based on tax positions related to the current period 877 Balance, December 31, 2017 $ 5,518 Additions based on tax positions related to prior periods 4 Additions based on tax positions related to the current period 559 Balance, December 31, 2018 $ 6,081 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments under Non cancelable Operating Leases | As of December 31, 2018, the total future annual minimum lease payments under the Company’s non‑cancelable operating leases are as follows: Payment (In thousands) Amount Years Ending December 31, 2019 $ 9,394 2020 10,717 2021 4,706 2022 2,455 2023 2,389 Thereafter 23,940 $ 53,601 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Buildings and improvements | Minimum | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 15 years |
Buildings and improvements | Maximum | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 40 years |
Furniture, fixtures and equipment | Minimum | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 3 years |
Furniture, fixtures and equipment | Maximum | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | 10 years |
Leasehold improvements | |
Property Plant And Equipment [Line Items] | |
Estimated useful life | Shorter of useful life or lease term |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | Jan. 01, 2017USD ($) | Dec. 31, 2018USD ($)ft²segmentleaselocation | Dec. 31, 2018EUR (€)segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Mar. 31, 2018ft² | Jan. 01, 2018USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ (1,185,368) | $ (1,044,365) | $ 900 | ||||
Allowance for doubtful accounts | 200 | 200 | |||||
(Loss) gain on foreign currency translation | $ (2,300) | $ 3,700 | $ 100 | ||||
Threshold percentage for disclosure of revenue and receivables | 10.00% | 10.00% | 10.00% | 10.00% | |||
Advertising Expense | $ 54,700 | $ 34,400 | $ 24,000 | ||||
Number of business segments | segment | 1 | 1 | |||||
Number of operating leases | lease | 2 | ||||||
Corporate office and administrative space expire in 2020 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Area of real estate property | ft² | 67,000 | ||||||
Corporate office and administrative space expire in 2021 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Area of real estate property | ft² | 175,000 | ||||||
MASSACHUSETTS | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Number of separate locations | location | 2 | ||||||
MASSACHUSETTS | Corporate office and administrative space begin in 2020 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Area of real estate property | ft² | 220,000 | ||||||
Ireland | Corporate office and administrative space expire in 2022 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Area of real estate property | ft² | 14,600 | ||||||
401 (K) Plan | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Employee contribution limit as a percentage of their eligible compensation | 100.00% | 100.00% | |||||
Percentage of employer contribution matched of the first employee pay | 100.00% | 100.00% | |||||
Maximum employee contribution limit as a percentage of their total taxable earnings | 5.00% | 5.00% | |||||
Employer contribution | $ 12,100 | 9,800 | 8,100 | ||||
Defined Contribution Plan | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Maximum employee contribution limit as a percentage of their total taxable earnings | 40.00% | 40.00% | |||||
Employer contribution | $ 4,000 | $ 3,700 | $ 3,200 | ||||
Per employee contribution limit | € | € 115,000 | ||||||
Maximum percentage of employer contribution matched of employee's | 18.00% | 18.00% | |||||
Stock options | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Expiration period | 10 years | 10 years | |||||
Vesting rights per year (as a percent) | 25.00% | 25.00% | |||||
Vesting period | 4 years | 4 years | |||||
Stock options | Directors | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Expiration period | 10 years | 10 years | |||||
Vesting period | 1 year | 1 year | |||||
Time-vested RSUs | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Vesting rights per year (as a percent) | 25.00% | 25.00% | |||||
Vesting period | 4 years | 4 years | |||||
Minimum | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Manufacturing Process period | 10 days | 10 days | |||||
Maximum | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Manufacturing Process period | 56 days | 56 days | |||||
Manufacturing and royalty revenues | Minimum | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Payment terms in number of days | 30 days | 30 days | |||||
Manufacturing and royalty revenues | Maximum | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Payment terms in number of days | 90 days | 90 days | |||||
ASU 2014-09 | Adjustment | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ 2,156 | $ 818 | |||||
Cumulative Effect Adjustment To Retained Earnings | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Adjustment to retained earnings to record net deferred tax asset | $ 61,500 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Adjusted Condensed Consolidated Statement of Balance Sheet, Statement of Operations and Comprehensive Loss (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Contract assets | $ 8,230 | $ 0 | $ 9,110 | |
Inventory | 90,196 | 93,275 | ||
Deferred tax asset | 85,807 | 98,560 | ||
Contract liabilities—short-term | 3,169 | 1,956 | ||
Contract liabilities—long-term | 9,525 | 5,657 | ||
Accumulated deficit | (1,185,368) | (1,044,365) | 900 | |
REVENUES: | ||||
Total revenues | 1,094,274 | 903,374 | $ 745,694 | |
EXPENSES: | ||||
Cost of goods manufactured and sold | $ 176,420 | 154,748 | 132,122 | |
Type of cost of goods and manufactured and sold | alks:PharmaceuticalMember | |||
Research and development | $ 425,406 | 412,889 | 387,148 | |
Selling, general and administrative | 526,408 | 421,578 | 374,130 | |
Amortization of acquired intangible assets | 65,168 | 62,059 | 60,959 | |
Total expenses | 1,193,402 | 1,051,274 | 954,359 | |
OPERATING LOSS | (99,128) | (147,900) | (208,665) | |
Other (expense) income, net | (27,839) | 4,626 | (5,722) | |
LOSS BEFORE INCOME TAXES | (126,967) | (143,274) | (214,387) | |
Income tax provision (benefit) | 12,344 | $ 14,671 | $ (5,943) | |
Net loss | $ (139,311) | |||
Loss per ordinary share — basic and diluted | $ (0.90) | $ (1.03) | $ (1.38) | |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic and diluted (in shares) | 155,112 | 153,415 | 151,484 | |
Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | $ 526,675 | $ 505,308 | $ 487,247 | |
Product sales, net | ||||
REVENUES: | ||||
Total revenues | 450,334 | 362,834 | 256,146 | |
Research and development revenue | ||||
REVENUES: | ||||
Total revenues | 68,895 | 7,232 | $ 2,301 | |
License revenue | ||||
REVENUES: | ||||
Total revenues | 48,370 | $ 28,000 | ||
ASU 2014-09 | Adjustment | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Contract assets | (8,230) | 9,110 | ||
Inventory | 8,847 | (8,209) | ||
Deferred tax asset | (133) | 109 | ||
Contract liabilities—short-term | (3,169) | (1,104) | ||
Contract liabilities—long-term | (9,525) | (724) | ||
Accumulated deficit | 2,156 | $ 818 | ||
Deferred revenue—short-term | 1,224 | |||
Deferred revenue—long-term | 8,852 | |||
REVENUES: | ||||
Total revenues | 2,014 | |||
EXPENSES: | ||||
Cost of goods manufactured and sold | (640) | |||
Total expenses | (640) | |||
OPERATING LOSS | 2,654 | |||
LOSS BEFORE INCOME TAXES | 2,654 | |||
Income tax provision (benefit) | 24 | |||
Net loss | $ 2,630 | |||
Loss per ordinary share — basic and diluted | $ 0.02 | |||
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic and diluted (in shares) | 155,112 | |||
ASU 2014-09 | Adjustment | Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | $ 1,911 | |||
ASU 2014-09 | Adjustment | Research and development revenue | ||||
REVENUES: | ||||
Total revenues | 48,473 | |||
ASU 2014-09 | Adjustment | License revenue | ||||
REVENUES: | ||||
Total revenues | (48,370) | |||
ASU 2014-09 | Balances Without Adoption of Topic 606 | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Inventory | 99,043 | |||
Deferred tax asset | 85,674 | |||
Accumulated deficit | (1,183,212) | |||
Deferred revenue—short-term | 1,224 | |||
Deferred revenue—long-term | 8,852 | |||
REVENUES: | ||||
Total revenues | 1,096,288 | |||
EXPENSES: | ||||
Cost of goods manufactured and sold | 175,780 | |||
Research and development | 425,406 | |||
Selling, general and administrative | 526,408 | |||
Amortization of acquired intangible assets | 65,168 | |||
Total expenses | 1,192,762 | |||
OPERATING LOSS | (96,474) | |||
Other (expense) income, net | (27,839) | |||
LOSS BEFORE INCOME TAXES | (124,313) | |||
Income tax provision (benefit) | 12,368 | |||
Net loss | $ (136,681) | |||
Loss per ordinary share — basic and diluted | $ (0.88) | |||
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic and diluted (in shares) | 155,112 | |||
ASU 2014-09 | Balances Without Adoption of Topic 606 | Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | $ 528,586 | |||
ASU 2014-09 | Balances Without Adoption of Topic 606 | Product sales, net | ||||
REVENUES: | ||||
Total revenues | 450,334 | |||
ASU 2014-09 | Balances Without Adoption of Topic 606 | Research and development revenue | ||||
REVENUES: | ||||
Total revenues | $ 117,368 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Contract Assets and Contract Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | |
Contract Asset [Abstract] | |||
Contract assets | $ 8,230 | $ 9,110 | $ 0 |
Additions | 57,617 | ||
Transferred to receivables, net | (58,497) | ||
Contract Liabilities [Abstract] | |||
Contract liabilities at beginning of the period | 9,442 | ||
Additions | 6,381 | ||
Amounts recognized into revenue | (3,129) | ||
Contract liabilities at end of the period | $ 12,694 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Concentration (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Janssen | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 27.00% | 31.00% | 33.00% |
Janssen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 29.00% | 33.00% | 36.00% |
Acorda | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 15.00% | 14.00% | 17.00% |
Acorda | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | 13.00% | 15.00% |
Cardinal Health | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 13.00% | ||
Biogen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Concentration Parenthetical (Details) - Customer Concentration Risk - Minimum | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues Net | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | 10.00% | 10.00% |
Accounts Receivable | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | 10.00% | 10.00% |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Schedule of Revenues by Geographic Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Geographic Information | |||
Revenue by region: | $ 1,094,274 | $ 903,374 | $ 745,694 |
Current assets: | 983,252 | 808,844 | |
Long-term assets: | |||
OTHER ASSETS | 16,143 | 14,034 | |
GOODWILL | 92,873 | 92,873 | |
U.S. | |||
Geographic Information | |||
Revenue by region: | 884,600 | 700,090 | 557,312 |
Current assets: | 546,533 | 402,481 | 382,168 |
Long-term assets: | |||
OTHER ASSETS | 312,243 | 360,641 | 236,175 |
Ireland | |||
Geographic Information | |||
Revenue by region: | 4,915 | 9,706 | 4,407 |
Current assets: | 433,837 | 403,167 | 407,761 |
Long-term assets: | |||
OTHER ASSETS | 245,638 | 278,701 | 288,470 |
Intangible assets | 191,001 | 256,168 | 318,227 |
GOODWILL | 92,873 | 92,873 | 92,873 |
Rest of world | |||
Geographic Information | |||
Revenue by region: | 204,759 | 193,578 | 183,975 |
Current assets: | $ 2,882 | $ 3,196 | $ 749 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Summary of Estimated Fair Value of Stock Option Grant on Weighted Average Assumptions (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Weighted-average assumptions | |||
Expected stock volatility, minimum (as a percent) | 44.00% | 43.00% | 39.00% |
Expected stock volatility, maximum (as a percent) | 49.00% | 47.00% | 53.00% |
Risk-free interest rate, minimum (as a percent) | 2.25% | 1.69% | 0.95% |
Risk-free interest rate, maximum (as a percent) | 3.10% | 2.38% | 2.14% |
Minimum | |||
Weighted-average assumptions | |||
Expected option term | 5 years | 5 years | 5 years |
Maximum | |||
Weighted-average assumptions | |||
Expected option term | 8 years | 8 years | 7 years |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Aggregate Collaborative Arrangements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 1,094,274 | $ 903,374 | $ 745,694 |
Manufacturing Revenue | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 133,028 | 152,821 | 151,961 |
Manufacturing Revenue | AMPYRA/FAMPYRA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 53,044 | 55,373 | 53,406 |
Manufacturing Revenue | RISPERDAL CONSTA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 52,770 | 64,793 | 64,914 |
Manufacturing Revenue | Other | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 27,214 | 32,655 | 33,641 |
Royalty Revenue | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 393,647 | 352,487 | 335,286 |
Royalty Revenue | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 241,423 | 214,931 | 184,233 |
Royalty Revenue | AMPYRA/FAMPYRA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 54,009 | 61,646 | 60,787 |
Royalty Revenue | RISPERDAL CONSTA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 18,352 | 20,129 | 22,316 |
Royalty Revenue | Other | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 79,863 | 55,781 | 67,950 |
Manufacturing and royalty revenues | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 526,675 | 505,308 | 487,247 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 241,423 | 214,931 | 184,233 |
Manufacturing and royalty revenues | AMPYRA/FAMPYRA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 107,053 | 117,019 | 114,193 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | 71,122 | 84,922 | 87,230 |
Manufacturing and royalty revenues | Other | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Total revenues | $ 107,077 | $ 88,436 | $ 101,591 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 1,094,274 | $ 903,374 | $ 745,694 |
VIVITROL | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 302,609 | 269,321 | 208,982 |
ARISTADA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 147,725 | 93,513 | 47,164 |
Product sales, net | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 450,334 | $ 362,834 | $ 256,146 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2018USD ($) | Nov. 30, 2017USD ($)item | Dec. 31, 2021USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | $ 1,094,274 | $ 903,374 | $ 745,694 | |||
License revenue | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | 48,370 | 28,000 | ||||
Research and development revenue | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | 68,895 | $ 7,232 | $ 2,301 | |||
Biogen | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Up-front payment received | $ 28,000 | |||||
Additional cash payment received | 50,000 | $ 50,000 | ||||
Milestone payment entitled to be received upon the approval of NDA by the FDA | $ 150,000 | |||||
Number of initial performance obligations | item | 4 | |||||
Discount Rate (As a percent) | 8.00% | |||||
Biogen | License revenue | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | $ 48,300 | $ 27,000 | ||||
Biogen | Research and development revenue | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | 1,500 | 900 | ||||
Biogen | Research and development revenue | Forecast | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Additional cash payment received | $ 60,400 | |||||
Biogen | Clinical Supply | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Total revenues | $ 200 | $ 100 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Available-for-sale securities: | ||
Amortized Cost | $ 349,779 | |
Estimated Fair Value | 349,162 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 4,115 | |
Long-term Investments | ||
Total long-term investments | 80,744 | $ 157,212 |
Total investments | ||
Amortized Cost | 353,758 | 400,486 |
Gross Unrealized Gains | 393 | 227 |
Gross Unrealized Losses, Less than One Year | (291) | (920) |
Gross Unrealized Losses, Greater than One Year | (583) | (373) |
Estimated Fair Value | 353,277 | 399,420 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 272,343 | 242,703 |
Gross Unrealized Gains | 257 | 5 |
Gross Unrealized Losses, Less than One Year | (81) | (232) |
Gross Unrealized Losses, Greater than One Year | (478) | (268) |
Estimated Fair Value | 272,041 | 242,208 |
Held-to-maturity securities: | ||
Amortized Cost | 272,835 | |
Gross Unrealized Gains | 257 | |
Gross Unrealized Losses, Less than One Year | (81) | |
Gross Unrealized Losses, Greater than One Year | (478) | |
Estimated Fair Value | 272,533 | |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 80,055 | 150,673 |
Gross Unrealized Gains | 115 | 1 |
Gross Unrealized Losses, Less than One Year | (11) | (130) |
Gross Unrealized Losses, Greater than One Year | (87) | (233) |
Estimated Fair Value | 80,072 | 150,311 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 120,197 | 56,552 |
Gross Unrealized Gains | 57 | 3 |
Gross Unrealized Losses, Less than One Year | (62) | (48) |
Gross Unrealized Losses, Greater than One Year | (274) | (10) |
Estimated Fair Value | 119,918 | 56,497 |
Held-to-maturity securities: | ||
Amortized Cost | 492 | |
Estimated Fair Value | 492 | |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 72,091 | 35,478 |
Gross Unrealized Gains | 85 | 1 |
Gross Unrealized Losses, Less than One Year | (8) | (54) |
Gross Unrealized Losses, Greater than One Year | (117) | (25) |
Estimated Fair Value | 72,051 | 35,400 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 77,436 | 154,325 |
Gross Unrealized Losses, Less than One Year | (210) | (688) |
Gross Unrealized Losses, Greater than One Year | (105) | (105) |
Estimated Fair Value | 77,121 | 153,532 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | 3,458 |
Gross Unrealized Gains | 136 | 222 |
Estimated Fair Value | 3,623 | 3,680 |
Long-term Investments | ||
Amortized Cost | 80,923 | 157,783 |
Gross Unrealized Gains | 136 | 222 |
Gross Unrealized Losses, Less than One Year | (210) | (688) |
Gross Unrealized Losses, Greater than One Year | (105) | (105) |
Total long-term investments | 80,744 | 157,212 |
Long-term investments | Certificates of deposit | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,820 | 1,791 |
Estimated Fair Value | 1,820 | 1,791 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 18,474 | 48,948 |
Gross Unrealized Losses, Less than One Year | (21) | (270) |
Gross Unrealized Losses, Greater than One Year | (12) | (71) |
Estimated Fair Value | 18,441 | 48,607 |
Long-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 53,505 | 83,924 |
Gross Unrealized Losses, Less than One Year | (185) | (300) |
Gross Unrealized Losses, Greater than One Year | (93) | (34) |
Estimated Fair Value | 53,227 | 83,590 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 5,457 | 21,453 |
Gross Unrealized Losses, Less than One Year | (4) | (118) |
Estimated Fair Value | 5,453 | 21,335 |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | 1,667 |
Gross Unrealized Gains | 136 | 222 |
Estimated Fair Value | $ 1,803 | $ 1,889 |
Investments - Schedule of Proce
Investments - Schedule of Proceeds From Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Investments Debt And Equity Securities [Abstract] | |||
Proceeds from the sales and maturities of marketable securities | $ 444,456 | $ 464,494 | $ 560,805 |
Realized gains | 4 | 9 | 206 |
Realized losses | $ 268 | $ 3 | $ 28 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 184,841 |
After 1 year through 5 years | 164,938 |
Amortized Cost | 349,779 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 184,304 |
After 1 year through 5 years | 164,858 |
Total | 349,162 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 2,312 |
After 1 year through 5 years | 1,667 |
Total | 3,979 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 2,312 |
After 1 year through 5 years | 1,803 |
Total | $ 4,115 |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | |||||
Sep. 30, 2017USD ($) | Feb. 29, 2016USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2018EUR (€) | May 31, 2014EUR (€) | |
Equity method investment | |||||||
Other-than-temporary impairment charge | $ 10,471 | ||||||
Synchronicity Pharma Inc | |||||||
Equity method investment | |||||||
Cost Of License | $ 10,000 | ||||||
Carrying value of equity investment | $ 15,000 | ||||||
Increase (decrease) in carrying value of investment of the entity, which represents the Company's share of investee's net gains (losses) | 2,800 | ||||||
Synchronicity Pharma Inc | Investee | |||||||
Equity method investment | |||||||
Other-than-temporary impairment charge | $ 10,500 | ||||||
Fountain Healthcare Partners II, LP of Ireland | |||||||
Equity method investment | |||||||
Increase (decrease) in carrying value of investment of the entity, which represents the Company's share of investee's net gains (losses) | $ 500 | (100) | $ (400) | ||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | |||||
Fountain Healthcare Partners II, LP of Ireland | Maximum | |||||||
Equity method investment | |||||||
Maximum commitment on equity method investment | € | € 7.4 | ||||||
Fountain Healthcare Partners II, LP of Ireland | Other Assets | |||||||
Equity method investment | |||||||
Carrying value of equity investment | $ 5,500 | $ 3,700 | |||||
Total equity method commitment | € | € 5.2 |
Fair Value - Summary of the Com
Fair Value - Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair value | ||
Debt securities | $ 349,162 | |
Contingent consideration | 65,200 | $ 84,800 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 54,590 | 1,889 |
Contingent consideration | 65,200 | 84,800 |
Common stock warrants | 1,205 | 1,395 |
Assets, Total | 470,649 | 483,824 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 54,590 | 1,889 |
Assets, Total | 114,697 | 126,847 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 289,055 | 270,782 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 65,200 | 84,800 |
Common stock warrants | 1,205 | 1,395 |
Assets, Total | 66,897 | 86,195 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 98,513 | 198,918 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 60,107 | 124,958 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 38,406 | 73,960 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 173,637 | 140,087 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 173,145 | 140,087 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 492 | |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 77,504 | 56,735 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 77,504 | $ 56,735 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | Dec. 20, 2018USD ($)Milestone | Oct. 12, 2016 | Apr. 30, 2019USD ($) | Jan. 31, 2019USD ($) | Mar. 26, 2018 | Dec. 31, 2018USD ($)item$ / shares | Dec. 31, 2018USD ($)item$ / shares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Apr. 23, 2019USD ($) | Mar. 31, 2019item | Dec. 19, 2018USD ($) | Apr. 10, 2015shares | Apr. 09, 2015$ / shares |
Fair Value | ||||||||||||||
Number of investments transferred from level 1 to level 2 | item | 0 | |||||||||||||
Number of investments transferred from level 2 to level 1 | item | 0 | |||||||||||||
Milestone payment due upon approval of NDA | $ 45,000,000 | |||||||||||||
Milestone payment due within 30 days | $ 5,000,000 | |||||||||||||
Milestone payment due within 180 days | 5,000,000 | |||||||||||||
Milestone additional payment approval of NDA | $ 45,000,000 | |||||||||||||
Number of milestone payment upon approval of NDA | Milestone | 7 | |||||||||||||
Milestone annual payment | $ 6,400,000 | |||||||||||||
Contingent consideration | $ 65,200,000 | $ 65,200,000 | $ 84,800,000 | |||||||||||
Increase (decrease) in the fair value of contingent consideration | $ (19,600,000) | 21,600,000 | $ 7,900,000 | |||||||||||
Term Loan B-1 | ||||||||||||||
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | ||||||||||||||
Due date of loan | Sep. 25, 2021 | |||||||||||||
Variable interest rate base | LIBOR | |||||||||||||
2023 Term Loan | ||||||||||||||
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | ||||||||||||||
Due date of loan | Mar. 26, 2023 | |||||||||||||
Variable interest rate base | LIBOR | |||||||||||||
Amount to be realized in future | $ 274,700,000 | $ 274,700,000 | 285,700,000 | |||||||||||
LIBOR | Term Loan B-1 | ||||||||||||||
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | ||||||||||||||
Interest rate added to base rate (as a percent) | 2.75% | |||||||||||||
Interest rate, variable interest rate floor (as a percent) | 0.75% | |||||||||||||
LIBOR | 2023 Term Loan | ||||||||||||||
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | ||||||||||||||
Interest rate added to base rate (as a percent) | 2.25% | |||||||||||||
Interest rate, variable interest rate floor (as a percent) | 0.00% | |||||||||||||
Recro | ||||||||||||||
Fair Value | ||||||||||||||
Warrants purchase under amendments | shares | 350,000 | |||||||||||||
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | ||||||||||||||
Warrant strike price | $ / shares | $ 8.26 | $ 8.26 | $ 19.46 | |||||||||||
Maximum | ||||||||||||||
Fair Value | ||||||||||||||
Milestone payments receivable | $ 80,000,000 | |||||||||||||
Other (Expense) Income, Net | ||||||||||||||
Fair Value | ||||||||||||||
Increase (decrease) in fair value of warrants | $ (200,000) | $ (400,000) | ||||||||||||
Other (Expense) Income, Net | Maximum | ||||||||||||||
Fair Value | ||||||||||||||
Increase (decrease) in fair value of warrants | $ 100,000 | |||||||||||||
Discount Rate | Real options approach | ||||||||||||||
Fair Value | ||||||||||||||
Discount rate (as a percent) | item | 15.8 | 15.8 | ||||||||||||
Discount Rate | Future royalties | ||||||||||||||
Fair Value | ||||||||||||||
Discount rate (as a percent) | item | 16 | 16 | ||||||||||||
Subsequent Event | ||||||||||||||
Fair Value | ||||||||||||||
Milestone payments received | $ 5,000,000 | |||||||||||||
Forecast | ||||||||||||||
Fair Value | ||||||||||||||
Milestone payment due | $ 5,000,000 | |||||||||||||
Milestone payments receivable | $ 5,000,000 | |||||||||||||
Forecast | Discount Rate | ||||||||||||||
Fair Value | ||||||||||||||
Discount rate (as a percent) | item | 15.8 |
Fair Value - Rollforward of the
Fair Value - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Balance at the beginning of the period | $ 86,195 |
Balance at the end of the period | 66,897 |
Change in the fair value of contingent consideration | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value of contingent consideration | (19,600) |
Decrease in the fair value of warrants | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value of contingent consideration | (190) |
Corporate debt securities | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Purchase of corporate debt security | $ 492 |
Fair Value - Schedule of Assump
Fair Value - Schedule of Assumptions Used to Determine the Fair Value of the Warrants (Details) - Recro | Dec. 31, 2018itemyr$ / shares |
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | |
Closing stock price at December 31, 2018 | $ / shares | $ 7.10 |
Warrant strike price | $ / shares | $ 8.26 |
Expected Term (Years) | |
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | |
Expected term (years) | yr | 3.27 |
Risk Free Interest Rate | |
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | |
Risk-free rate | item | 2.46 |
Volatility | |
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract] | |
Volatility | item | 75 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 31,824 | $ 29,883 |
Work in process | 38,019 | 38,964 |
Finished goods | 20,353 | 24,428 |
Total inventory | $ 90,196 | $ 93,275 |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 11 | $ 8.7 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Subtotal | $ 587,458 | $ 524,794 |
Less: accumulated depreciation | (277,471) | (240,058) |
Total property, plant and equipment, net | 309,987 | 284,736 |
Land | ||
Property Plant And Equipment [Line Items] | ||
Subtotal | 6,486 | 6,293 |
Building and improvements | ||
Property Plant And Equipment [Line Items] | ||
Subtotal | 157,053 | 155,198 |
Furniture, fixtures and equipment | ||
Property Plant And Equipment [Line Items] | ||
Subtotal | 314,831 | 289,455 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Subtotal | 20,105 | 19,578 |
Construction in progress | ||
Property Plant And Equipment [Line Items] | ||
Subtotal | $ 88,983 | $ 54,270 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Line Items] | |||
Depreciation expense | $ 38,500 | $ 36,500 | $ 33,300 |
Impairment of property, plant and equipment | 5,746 | ||
Furniture, fixtures and equipment | |||
Property Plant And Equipment [Line Items] | |||
Carrying value at the time of disposition | $ 500 | $ 100 | $ 900 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Finite Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 92,873 | $ 92,873 |
Net Carrying Amount | 92,873 | 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 582,750 | 582,750 |
Accumulated Amortization | (391,749) | (326,582) |
Net Carrying Amount | $ 191,001 | 256,168 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | 465,590 |
Accumulated Amortization | (319,311) | (269,392) |
Net Carrying Amount | $ 146,279 | 196,198 |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | 74,600 |
Accumulated Amortization | (38,942) | (31,283) |
Net Carrying Amount | $ 35,658 | 43,317 |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | 42,560 |
Accumulated Amortization | (33,496) | (25,907) |
Net Carrying Amount | $ 9,064 | $ 16,653 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |||
Amortization of acquired intangible assets | $ 65,168 | $ 62,059 | $ 60,959 |
Expected amortization of intangible assets | |||
2,019 | 40,000 | ||
2,020 | 40,000 | ||
2,021 | 40,000 | ||
2,022 | 35,000 | ||
2,023 | $ 35,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 39,767 | $ 55,526 |
Accrued compensation | 67,613 | 54,568 |
Accrued sales discounts, allowances and reserves | 152,911 | 111,137 |
Accrued other | 73,471 | 64,935 |
Total accounts payable and accrued expenses | $ 333,762 | $ 286,166 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (3,000) |
Long-term debt | 276,465 | 278,436 |
2023 Term Loan | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | $ 279,308 | $ 281,436 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)Lender | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Long-term debt | ||||
Number of lender holding percentage of outstanding amount | Lender | 1 | |||
Percentage of outstanding principal amount held by lender | 1.00% | |||
Unamortized deferred financing costs at period end | $ 0.8 | |||
Original issue discount | 2 | |||
Amortization of offering costs and discount | 0.7 | $ 0.8 | $ 0.9 | |
2023 Term Loan | ||||
Long-term debt | ||||
Incremental capacity | $ 175 | |||
Interest Expense | ||||
Long-term debt | ||||
Refinancing charges | $ 2.3 | |||
Minimum | ||||
Long-term debt | ||||
Threshold percentage comparing present value of remaining cash flows | 10.00% |
Long-term Debt - Scheduled Matu
Long-term Debt - Scheduled Maturities of Term Loan Facility (Details) - 2023 Term Loan $ in Thousands | Dec. 31, 2018USD ($) |
Long-term debt | |
2,019 | $ 2,843 |
2,020 | 2,843 |
2,021 | 2,843 |
2,022 | 2,843 |
2,023 | 270,746 |
Total | $ 282,118 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Equivalent Shares Excluded from Calculation of Net (Loss) Income Per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 13,923 | 11,659 | 11,486 |
Stock options | |||
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 11,331 | 9,540 | 10,166 |
Restricted stock units | |||
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 2,592 | 2,119 | 1,320 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) | Dec. 31, 2018 | Sep. 16, 2011 |
Equity [Abstract] | ||
Value of shares authorized under repurchase program | $ 215,000,000 | |
Value of shares available for repurchase pursuant to repurchase program | $ 101,000,000 |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based compensation Expense | |||
Total share-based compensation expense | $ 105,357 | $ 83,917 | $ 94,396 |
Cost of goods manufactured and sold | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 9,174 | 7,596 | 8,633 |
Research and development | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 32,943 | 22,635 | 24,023 |
Selling, general and administrative | |||
Share-based compensation Expense | |||
Total share-based compensation expense | $ 63,240 | $ 53,686 | $ 61,740 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018USD ($)itemshares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Share-based compensation Expense | |||
Number of share-based compensation plan under which awards are currently made | 1 | ||
Number of share-based compensation plan under which eligible awards to be made | 1 | ||
Number of share-based compensation plan under which no further awards will be made | 1 | ||
Shares of common stock authorized for issuance | shares | 11,100,000 | ||
2011 Plan and 2018 Plan | |||
Share-based compensation Expense | |||
Ratio of awards other than stock options counted against the total number of shares available for issuance | 1.8 | ||
Inventory | |||
Share-based compensation Expense | |||
Share based compensation cost capitalized | $ | $ 2.7 | $ 0.4 | $ 1.1 |
Share-based Compensation - Sc_2
Share-based Compensation - Schedule of Stock Option Activity (Details) - Stock options | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Shares | |
Outstanding at the beginning of the period (in shares) | shares | 14,773,412 |
Granted (in shares) | shares | 2,269,830 |
Exercised (in shares) | shares | (1,087,815) |
Forfeited (in shares) | shares | (924,343) |
Expired (in shares) | shares | (178,627) |
Outstanding at the end of the period (in shares) | shares | 14,852,457 |
Exercisable at the end of the period (in shares) | shares | 10,506,897 |
Weighted Average Exercise Price | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 36.64 |
Granted (in dollars per share) | $ / shares | 61.45 |
Exercised (in dollars per share) | $ / shares | 19.19 |
Forfeited (in dollars per share) | $ / shares | 51.88 |
Expired (in dollars per share) | $ / shares | 59.83 |
Outstanding at the end of the period (in dollars per share) | $ / shares | 40.48 |
Exercisable at the end of the period (in dollars per share) | $ / shares | $ 34.26 |
Share-based Compensation - Stoc
Share-based Compensation - Stock Options - Additional Information (Details) - Stock options - USD ($) $ / shares in Units, shares in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based compensation Expense | |||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 30.47 | $ 25.81 | $ 17.11 |
Aggregate intrinsic value of stock options exercised | $ 35,500,000 | $ 40,400,000 | $ 35,000,000 |
Stock options expected to vest (in shares) | 4.2 | ||
Weighted average exercise price (in dollars per share) | $ 55.46 | ||
Weighted average contractual remaining life | 8 years 3 months 18 days | ||
Aggregate intrinsic value | $ 0 | ||
Aggregate intrinsic value of stock options exercisable | $ 64,800,000 | ||
Weighted average remaining contractual term of stock options exercisable | 4 years 6 months | ||
Unrecognized compensation cost | $ 51,400,000 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 2 years | ||
Cash received from option exercises | $ 20,900,000 | $ 23,500,000 | $ 20,300,000 |
Share-based Compensation - Summ
Share-based Compensation - Summary of RSU Activity (Details) - Time-vested RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Shares | |||
Unvested at the beginning of the period (in shares) | 1,936,808 | ||
Granted (in shares) | 1,367,710 | ||
Vested (in shares) | (723,473) | ||
Forfeited (in shares) | (314,759) | ||
Unvested at the end of the period (in shares) | 2,266,286 | 1,936,808 | |
Weighted Average Grant Date Fair Value | |||
Unvested at the beginning of the period (in dollars per share) | $ 46.72 | ||
Granted (in dollars per share) | 63.01 | $ 54.85 | $ 32.27 |
Vested (in dollars per share) | 47.72 | ||
Forfeited (in dollars per share) | 53.09 | ||
Unvested at the end of the period (in dollars per share) | $ 55.32 | $ 46.72 |
Share-based Compensation - Time
Share-based Compensation - Time Vested Restricted Stock Units - Additional Information (Details) - Time-vested RSUs - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based compensation Expense | |||
Granted (in dollars per share) | $ 63.01 | $ 54.85 | $ 32.27 |
Fair value of RSU's vested | $ 34.5 | $ 31.5 | $ 26 |
Unrecognized compensation cost | $ 57.5 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 2 years |
Share-based Compensation - Perf
Share-based Compensation - Performance-Based Restricted Stock Units - Additional Information (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018USD ($)item | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Share-based compensation Expense | |||
Total share-based compensation expense | $ 105,357 | $ 83,917 | $ 94,396 |
Cost of goods manufactured and sold | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 9,174 | 7,596 | 8,633 |
Research and development | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 32,943 | 22,635 | 24,023 |
Selling, general and administrative | |||
Share-based compensation Expense | |||
Total share-based compensation expense | $ 63,240 | $ 53,686 | $ 61,740 |
Performance-based RSUs | |||
Share-based compensation Expense | |||
Number of Phase 3 studies of ALKS 3831 | item | 2 | ||
Number of years from the date of the grant | 3 years | ||
Total share-based compensation expense | $ 17,100 | ||
Expiration period | 3 years | ||
Unrecognized compensation cost | $ 34,300 | ||
Performance-based RSUs | Cost of goods manufactured and sold | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 2,100 | ||
Performance-based RSUs | Research and development | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 6,700 | ||
Performance-based RSUs | Selling, general and administrative | |||
Share-based compensation Expense | |||
Total share-based compensation expense | $ 8,300 |
Share-based Compensation - Su_2
Share-based Compensation - Summary of PRSU Activity (Details) - Performance-based RSUs | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Shares | |
Unvested at the beginning of the period (in shares) | shares | 1,108,653 |
Granted (in shares) | shares | 6,065 |
Vested (in shares) | shares | (176,637) |
Forfeited (in shares) | shares | (311,913) |
Unvested at the end of the period (in shares) | shares | 626,168 |
Weighted Average Grant Date Fair Value | |
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 54.72 |
Granted (in dollars per share) | $ / shares | 55.89 |
Forfeited (in dollars per share) | $ / shares | 54.64 |
Vested (in dollars per share) | $ / shares | 54.74 |
Unvested at the end of the period (in dollars per share) | $ / shares | $ 54.75 |
Collaborative Arrangements - Si
Collaborative Arrangements - Significant collaborative arrangements (Details) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2017USD ($) | Dec. 31, 2018USD ($)Agreement | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenues | $ 1,094,274,000 | $ 903,374,000 | $ 745,694,000 | |
Biogen | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment entitled to be received upon the approval of NDA by the FDA | $ 150,000,000 | |||
Payment received upon the initiation of phase 3 clinical trial | 50,000,000 | |||
Payment eligible to receive upon the approval of NDA by the FDA | 150,000,000 | |||
Biogen | License | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenues | $ 28,000,000 | |||
License agreement | RISPERDAL CONSTA | Janssen | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Notice period required to be given before termination of agreement | 30 days | |||
License agreement | AMPYRA/FAMPYRA | Acorda | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Notice period required to be given before termination of agreement | 90 days | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Patent royalty rate (as a percent) | 1.50% | |||
Period after the date of the first commercial sale of the product for license expiration | 15 years | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Net sales of below $250.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Know-how royalty rate (as a percent) | 3.50% | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Net sales between $250.0 million and 500.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Know-how royalty rate (as a percent) | 5.50% | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Net sales greater than $500.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Know-how royalty rate (as a percent) | 7.50% | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Minimum | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 5.00% | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Minimum | Net sales between $250.0 million and 500.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Aggregate worldwide net sales | $ 250,000,000 | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Minimum | Net sales greater than $500.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Aggregate worldwide net sales | $ 500,000,000 | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Maximum | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 9.00% | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Maximum | Net sales of below $250.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Aggregate worldwide net sales | $ 250,000,000 | |||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | Maximum | Net sales between $250.0 million and 500.0 million | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Aggregate worldwide net sales | $ 500,000,000 | |||
License agreement | Janssen | RISPERDAL CONSTA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 2.50% | |||
Period after the date of the first commercial sale of the product for license expiration | 15 years | |||
Number of license agreements | Agreement | 2 | |||
Period for resolving default or breach after the receipt of notice for termination of agreement | 90 days | |||
License agreement | Acorda | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment entitled to be received upon the initiation of phase 3 clinical trial | $ 1,000,000 | |||
Milestone payment entitled to be received upon the acceptance of NDA by the FDA | 1,000,000 | |||
Milestone payment entitled to be received upon the approval of NDA by the FDA | 1,500,000 | |||
Milestone payment entitled to be received upon the first commercial sale | $ 1,500,000 | |||
License agreement | Acorda | AMPYRA/FAMPYRA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 10.00% | |||
Manufacturing and supply agreement | RISPERDAL CONSTA | Janssen | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Notice period required to be given before termination of agreement | 6 months | |||
Manufacturing and supply agreement | AMPYRA/FAMPYRA | Maximum | Acorda | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Percentage of total annual requirement of product that can be obtained from second source manufacturer | 25.00% | |||
Manufacturing and supply agreement | Janssen | RISPERDAL CONSTA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Period after the date of the first commercial sale of the product for license expiration | 60 days | |||
Manufacturing and supply agreement | Janssen | RISPERDAL CONSTA | Minimum | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 7.50% | |||
Royalty rate upon termination of manufacturing and supply agreement (as a percent) | 2.50% | |||
Manufacturing and supply agreement | Janssen | RISPERDAL CONSTA | Maximum | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate upon termination of manufacturing and supply agreement (as a percent) | 5.00% | |||
Manufacturing and supply agreement | Acorda | AMPYRA/FAMPYRA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Royalty rate (as a percent) | 8.00% | |||
Notice period required to be given before termination of agreement | 12 months |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision (Benefit) for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Deferred income tax provision (benefit): | |||
Deferred income tax provision (benefit) | $ 10,623 | $ 7,234 | $ (9,689) |
Total tax provision (benefit) | 12,344 | 14,671 | (5,943) |
Ireland | |||
Deferred income tax provision (benefit): | |||
Deferred income tax provision (benefit) | (63) | (21) | (142) |
U.S. federal | |||
Current income tax provision: | |||
Current income tax provision | (53) | 6,964 | 3,163 |
Deferred income tax provision (benefit): | |||
Deferred income tax provision (benefit) | 10,624 | 8,188 | (9,278) |
U.S. state | |||
Current income tax provision: | |||
Current income tax provision | 1,774 | 350 | 480 |
Deferred income tax provision (benefit): | |||
Deferred income tax provision (benefit) | $ 62 | (933) | (269) |
Rest of world | |||
Current income tax provision: | |||
Current income tax provision | $ 123 | $ 103 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | Jan. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | Dec. 31, 2015 |
Income Taxes [Line Items] | ||||||
Tax expense from enactment of Tax Cuts and Jobs Act | $ 21,453 | |||||
Income tax benefit due to utilization of NOL carryforwards | $ 4,200 | |||||
Cumulative unremitted earnings of overseas subsidiaries | $ 327,100 | |||||
Performance-based compensation deferred tax asset | 13,300 | |||||
Increase in deferred tax assets | $ 57,800 | |||||
Decrease in deferred tax liabilities | 3,700 | |||||
Decrease in accumulated deficit | $ 61,500 | |||||
Less: valuation allowance | (219,093) | (172,797) | $ (141,859) | $ (106,746) | ||
Federal research and development credits | 44,800 | |||||
Alternative minimum tax | 2,000 | |||||
State tax credits | 14,800 | |||||
Accumulated deficit to write-off unamortized deferred tax charge | $ 1,185,368 | 1,044,365 | $ (900) | |||
Minimum | ||||||
Income Taxes [Line Items] | ||||||
Period after loss carryforwards utilized that tax returns remain open to examination | 3 years | |||||
Maximum | ||||||
Income Taxes [Line Items] | ||||||
Period after loss carryforwards utilized that tax returns remain open to examination | 4 years | |||||
Accounting Standards Update 2016-16 | ||||||
Income Taxes [Line Items] | ||||||
Accumulated deficit to write-off unamortized deferred tax charge | 900 | |||||
Deferred Tax Assets, Goodwill and Intangible Assets | $ 17,800 | |||||
U.S. state | ||||||
Income Taxes [Line Items] | ||||||
Less: valuation allowance | $ (11,700) | |||||
Operating loss carryforwards | 2,500 | |||||
Ireland | ||||||
Income Taxes [Line Items] | ||||||
Income taxes payable on repatriation of unremitted earnings | 8,300 | |||||
Less: valuation allowance | (207,400) | |||||
Operating loss carryforwards | $ 1,400,000 |
Income Taxes - Schedule of (Los
Income Taxes - Schedule of (Loss) Income Before Provision for Income Taxes by Geographical Area (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | $ (126,967) | $ (143,274) | $ (214,387) |
Ireland | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | (180,195) | (172,363) | (212,198) |
U.S. | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | 53,287 | 2,414 | (18,935) |
Rest of world | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | $ (59) | $ 26,675 | $ 16,746 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Net Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||||
Irish NOL carryforwards | $ 198,633 | $ 177,435 | ||
Tax credits | 52,395 | 71,366 | ||
Share-based compensation | 44,873 | 40,048 | ||
Other | 24,561 | 13,239 | ||
Less: valuation allowance | (219,093) | (172,797) | $ (141,859) | $ (106,746) |
Total deferred tax assets | 101,369 | 129,291 | ||
Deferred tax liabilities: | ||||
Intangible assets | (18,184) | |||
Property, plant and equipment | (14,533) | (12,040) | ||
Other | (1,274) | (818) | ||
Total deferred tax liabilities | (15,807) | (31,042) | ||
Net deferred tax assets | $ 85,562 | $ 98,249 |
Income Taxes - Schedule of Acti
Income Taxes - Schedule of Activity in Valuation Allowance Associated with Deferred taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Balance at Beginning of Period | $ (172,797) | $ (141,859) | $ (106,746) |
Additions | (46,296) | (30,938) | (35,113) |
Balance at End of Period | $ (219,093) | $ (172,797) | $ (141,859) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities Related to Intercompany Assets of Intellectual Property (Details) $ in Thousands | Dec. 31, 2017USD ($) |
Deferred charges related to intercompany transfers of intellectual property | |
Prepaid expenses and other current assets | $ 188 |
Other assets — long-term | 686 |
Total deferred charges | $ 874 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Statutory Tax Rate to Effective Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of effective income tax rate | |||
Statutory tax rate (as a percent) | 12.50% | 12.50% | 12.50% |
Income tax provision at statutory rate | $ (15,871) | $ (17,909) | $ (26,798) |
Change in valuation allowance | 28,371 | 26,771 | 35,290 |
Federal tax law change | 21,453 | ||
Impairment on equity method investment | 1,662 | ||
Foreign rate differential | 5,405 | (682) | 2,723 |
Share-based compensation | 1,163 | (1,205) | 2,072 |
U.S. state income taxes, net of U.S. federal benefit | 1,732 | (558) | (2) |
Intercompany amounts | (751) | (5,041) | (5,209) |
Irish rate differential | (2,350) | (2,675) | (5,231) |
R&D credit | (7,698) | (9,326) | (10,572) |
Other permanent items | 2,343 | 2,181 | 1,784 |
Total tax provision (benefit) | $ 12,344 | $ 14,671 | $ (5,943) |
Effective tax rate (as a percent) | (9.70%) | (10.20%) | 2.80% |
Income Taxes - Schedule of Re_2
Income Taxes - Schedule of Reconciliation of Statutory Tax Rate to Effective Tax Rate (Parenthetical) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of effective income tax rate | ||||
Federal tax law change | $ 21,453 | |||
Statutory tax rate (as a percent) | 12.50% | 12.50% | 12.50% | |
U.S. federal | ||||
Reconciliation of effective income tax rate | ||||
Federal tax law change | $ 21,500 | |||
Statutory tax rate (as a percent) | 21.00% | 35.00% |
Income Taxes - Schedule of Re_3
Income Taxes - Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Balance at the beginning of the period | $ 5,518 | $ 4,688 | $ 3,778 |
Reductions based on tax positions related to prior periods | (47) | (7) | |
Additions based on tax positions related to prior periods | 4 | ||
Additions based on tax positions related to the current period | 559 | 877 | 917 |
Balance at the end of the period | $ 6,081 | $ 5,518 | $ 4,688 |
Commitments and Contingent Li_3
Commitments and Contingent Liabilities - Schedule of Future Minimum Lease Payments under Non cancelable Operating Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Future minimum lease payments under non cancelable operating leases | |
2,019 | $ 9,394 |
2,020 | 10,717 |
2,021 | 4,706 |
2,022 | 2,455 |
2,023 | 2,389 |
Thereafter | 23,940 |
Total future minimum lease payments under non cancelable operating leases | $ 53,601 |
Commitments and Contingent Li_4
Commitments and Contingent Liabilities - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2018USD ($)NoticeFiler | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |||
Rent expense | $ 10,800,000 | $ 9,400,000 | $ 8,100,000 |
Open purchase order commitments | 530,300,000 | ||
Potential losses from claims, legal proceedings probable of occurring | $ 0 | ||
Number of separate Paragraph IV notices received | Notice | 11 | ||
Maximum number of days for lawsuit | 45 days | ||
Minimum number of months before FDA can approve patent request | 30 months | ||
Number of ANDA Filers consolidated to a single case | Filer | 8 |