Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 04, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Entity Registrant Name | Alkermes plc. | ||
Entity Central Index Key | 0001520262 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 3,507,584,798 | ||
Entity Common Stock, Shares Outstanding | 157,787,433 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ALKS | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity File Number | 001-35299 | ||
Entity Incorporation, State or Country Code | L2 | ||
Entity Tax Identification Number | 98-1007018 | ||
Entity Address, Address Line One | Connaught House | ||
Entity Address, Address Line Two | 1 Burlington Road | ||
Entity Address, City or Town | Dublin 4 | ||
Entity Address, Country | IE | ||
Entity Address, Postal Zip Code | D04 C5Y6 | ||
City Area Code | 353 | ||
Local Phone Number | 1-772-8000 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Title of 12(b) Security | Ordinary shares, $0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2020 Annual General Meeting of Shareholders are incorporated by reference into Part III of this report. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 203,771 | $ 266,762 |
Investments—short-term | 331,208 | 272,533 |
Receivables, net | 257,086 | 292,223 |
Contract assets | 8,386 | 8,230 |
Inventory | 101,803 | 90,196 |
Prepaid expenses and other current assets | 59,716 | 53,308 |
Total current assets | 961,970 | 983,252 |
PROPERTY, PLANT AND EQUIPMENT, NET | 362,168 | 309,987 |
INTANGIBLE ASSETS, NET | 150,643 | 191,001 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 96,558 | 85,807 |
INVESTMENTS—LONG-TERM | 79,391 | 80,744 |
CONTINGENT CONSIDERATION | 32,400 | 65,200 |
RIGHT-OF-USE ASSETS | 12,379 | |
OTHER ASSETS | 17,021 | 16,143 |
TOTAL ASSETS | 1,805,403 | 1,825,007 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 373,037 | 333,762 |
Operating lease liabilities—short-term | 8,466 | |
Contract liabilities—short-term | 6,766 | 3,169 |
Long-term debt—short-term | 2,843 | 2,843 |
Total current liabilities | 391,112 | 339,774 |
LONG-TERM DEBT | 274,295 | 276,465 |
CONTRACT LIABILITIES—LONG-TERM | 22,068 | 9,525 |
OPERATING LEASE LIABILITIES—LONG-TERM | 5,342 | |
OTHER LONG-TERM LIABILITIES | 27,144 | 27,958 |
Total liabilities | 719,961 | 653,722 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 19) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at December 31, 2019 and 2018, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 160,489,888 and 158,180,833 shares issued; 157,779,002 and 155,757,344 shares outstanding at December 31, 2019 and 2018, respectively | 1,602 | 1,579 |
Treasury shares, at cost (2,710,886 and 2,423,489 shares at December 31, 2019 and 2018, respectively) | (118,386) | (108,969) |
Additional paid-in capital | 2,586,030 | 2,467,323 |
Accumulated other comprehensive loss | (1,816) | (3,280) |
Accumulated deficit | (1,381,988) | (1,185,368) |
Total shareholders’ equity | 1,085,442 | 1,171,285 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,805,403 | $ 1,825,007 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 | 160,489,888 | 158,180,833 |
Ordinary shares, shares outstanding | 157,779,002 | 155,757,344 |
Treasury shares | 2,710,886 | 2,423,489 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
REVENUES: | |||
Total revenues | $ 1,170,947 | $ 1,094,274 | $ 903,374 |
EXPENSES: | |||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 180,385 | 176,420 | 154,748 |
Research and development | 512,833 | 425,406 | 412,889 |
Selling, general and administrative | 599,449 | 526,408 | 421,578 |
Amortization of acquired intangible assets | 40,358 | 65,168 | 62,059 |
Restructuring expense | 13,401 | ||
Total expenses | 1,346,426 | 1,193,402 | 1,051,274 |
OPERATING LOSS | (175,479) | (99,128) | (147,900) |
OTHER (EXPENSE) INCOME, NET: | |||
Interest income | 13,976 | 9,238 | 4,649 |
Interest expense | (13,601) | (15,437) | (12,008) |
Change in the fair value of contingent consideration | (22,800) | (19,600) | 21,600 |
Other income (expense), net | 848 | (2,040) | (9,615) |
Total other (expense) income, net | (21,577) | (27,839) | 4,626 |
LOSS BEFORE INCOME TAXES | (197,056) | (126,967) | (143,274) |
INCOME TAX (BENEFIT) PROVISION | (436) | 12,344 | 14,671 |
NET LOSS | $ (196,620) | $ (139,311) | $ (157,945) |
LOSS PER ORDINARY SHARE: | |||
Basic and diluted (in dollars loss per ordinary share) | $ (1.25) | $ (0.90) | $ (1.03) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | |||
Basic and diluted (in shares) | 157,051 | 155,112 | 153,415 |
COMPREHENSIVE LOSS: | |||
Net loss | $ (196,620) | $ (139,311) | $ (157,945) |
Holding gain (loss), net of a tax provision (benefit) of $426, $159, $(295), respectively | 1,464 | 512 | (518) |
COMPREHENSIVE LOSS | (195,156) | (138,799) | (158,463) |
Manufacturing and royalty revenues | |||
REVENUES: | |||
Total revenues | 447,882 | 526,675 | 505,308 |
Product sales, net | |||
REVENUES: | |||
Total revenues | 524,499 | 450,334 | 362,834 |
Research and development revenue | |||
REVENUES: | |||
Total revenues | 52,816 | 68,895 | 7,232 |
License revenue | |||
REVENUES: | |||
Total revenues | $ 145,750 | $ 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | |||
Tax provision (benefit) | $ 426 | $ 159 | $ (295) |
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, 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) | ||||
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) | (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) | ||||
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) | 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) | ||||
Issuance of ordinary shares under employee stock plans | 18,925 | $ 15 | 18,910 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,510,177 | |||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (9,317) | $ 8 | 92 | $ (9,417) | ||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 798,878 | (287,397) | ||||
Share-based compensation expense | 99,705 | 99,705 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) | 1,464 | 1,464 | ||||
Net loss | (196,620) | (196,620) | ||||
BALANCE at Dec. 31, 2019 | $ 1,085,442 | $ 1,602 | $ 2,586,030 | $ (1,816) | $ (1,381,988) | $ (118,386) |
BALANCE (in shares) at Dec. 31, 2019 | 160,489,888 | (2,710,886) |
CONSOLIDATED STATEMENTS OF SH_2
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Stockholders Equity [Abstract] | |||
Tax provision (benefit) | $ 426 | $ 159 | $ (295) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (196,620) | $ (139,311) | $ (157,945) |
Adjustments to reconcile net loss to cash flows from operating activities: | |||
Depreciation and amortization | 80,413 | 103,660 | 98,523 |
Share-based compensation expense | 100,977 | 105,357 | 83,917 |
Deferred income taxes | (319) | 10,623 | 7,234 |
Change in the fair value of contingent consideration | 22,800 | 19,600 | (21,600) |
Loss on debt refinancing | 2,298 | ||
Payment made for debt refinancing | (2,251) | ||
Impairment of property, plant and equipment | 5,746 | ||
Impairment of investment in Synchronicity Pharma, Inc. | 10,471 | ||
Other non-cash charges | (580) | ||
Other non-cash charges | 979 | 3,471 | |
Changes in assets and liabilities, excluding the effect of acquisitions: | |||
Receivables | 35,136 | (58,632) | (42,489) |
Contract assets | (5,156) | 880 | |
Inventory | (13,077) | (2,665) | (30,191) |
Prepaid expenses and other assets | (1,784) | (5,990) | (9,506) |
Right-of-use assets | 8,399 | ||
Accounts payable and accrued expenses | 34,847 | 46,739 | 72,658 |
Contract liabilities | 16,140 | 3,252 | (1,447) |
Operating lease liabilities | (9,117) | ||
Other long-term liabilities | 18 | 8,996 | 6,094 |
Cash flows provided by operating activities | 72,077 | 99,281 | 19,190 |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Additions of property, plant and equipment | (90,942) | (69,431) | (51,300) |
Proceeds from the sale of equipment | 900 | 507 | 162 |
Proceeds from contingent consideration | 10,000 | ||
Purchases of investments | (277,518) | (397,727) | (431,712) |
Sales and maturities of investments | 224,602 | 444,456 | 464,494 |
Acquisition of Rodin Therapeutics, Inc.'s net assets, net of cash acquired | (8,875) | ||
Cash flows used in investing activities | (141,833) | (22,195) | (18,356) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 18,925 | 20,877 | 23,517 |
Employee taxes paid related to net share settlement of equity awards | (9,317) | (19,622) | (16,433) |
Principal payments of long-term debt | (2,843) | (743) | |
Payment made for debt refinancing | (2,132) | (3,000) | |
Cash flows provided by (used in) financing activities | 6,765 | (1,620) | 4,084 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (62,991) | 75,466 | 4,918 |
CASH AND CASH EQUIVALENTS—Beginning of period | 266,762 | 191,296 | 186,378 |
CASH AND CASH EQUIVALENTS—End of period | 203,771 | 266,762 | 191,296 |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | |||
Cash paid for interest | 13,254 | 12,526 | 11,143 |
Cash paid for taxes | 2,508 | 754 | 2,992 |
Non-cash investing and financing activities: | |||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 13,789 | $ 11,720 | $ 11,151 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2019 | |
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. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience 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, 2019 | |
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 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; Alkermes Finance S.à r.l; and Rodin Therapeutics, Inc. 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 (“GAAP”) requires that Company management 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 United States (“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, 2019, 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. At December 31, 2019, the Company’s financial assets consisted of cash equivalents, investments and contingent consideration 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, 2019 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 utilizing Level 2 inputs at December 31, 2019 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, 2019, assets utilizing Level 3 inputs included contingent consideration 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 assumptions, including adjustments to discount rates, changes in the amount and timing of cash flows, changes in the assumed achievement and timing of any development and 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. 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. Because the Company adopted Topic 606 using the modified retrospective method, 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 at December 31, 2017 has not been adjusted and continues to be reported under the old revenue recognition guidance (“Topic 605”). 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; • Product Returns —the Company records an estimate for product returns at the time our customers take control of their product. The Company estimates this liability using the expected value based on 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; and • 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. 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 . 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 by its licensees of products 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 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 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. 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 each of December 31, 2019 and 2018. Contract Assets Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time, except for $5.0 million of consideration related to the Company’s collaboration with Biogen related to Vumerity, which the Company expects to receive in approximately three years, and is included in “Other assets” in the accompanying consolidated balance sheets. The manufacturing related amounts included in the contract assets table below complete the manufacturing process in ten days to eight weeks and are classified as current assets. 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 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 $ 13,386 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 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 $ 28,834 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, 2019, 2018 and 2017, the Company recorded a (loss) gain on foreign currency translation of $(0.9) million, $(2.3) million and $3.7 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 and pharmaceutical wholesalers 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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 29 % 28 % 27 % 29 % 31 % 33 % Biogen * 17 % * 10 % * * Cardinal Health 12 % * * 13 % * * AmerisourceBergen 10 % * * * * * Acorda * * 15 % 10 % 14 % 13 % * 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, 2019, 2018 and 2017, 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) 2019 2018 2017 Revenue by region: U.S. $ 966,929 $ 884,600 $ 700,090 Ireland 3,195 4,915 9,706 Rest of world 200,823 204,759 193,578 Assets by region: Current assets: U.S. $ 551,799 $ 546,533 $ 402,481 Ireland 407,791 433,837 403,167 Rest of world 2,381 2,882 3,196 Long-term assets: U.S.: Other $ 382,029 $ 312,243 $ 360,641 Ireland: Intangible assets $ 150,643 $ 191,001 $ 256,168 Goodwill 92,873 92,873 92,873 Other 217,887 245,638 278,701 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 VUMERITY, are not tracked by individual program as they benefit multiple programs or the Company’s technologies in general. 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, 2019, 2018 and 2017, advertising costs totaled $31.1 million, $54.7 million and $34.4 million, respectively. Share‑Based Compensation The Company’s share‑based compensation programs grant awards in the form of stock options and restricted stock units (“RSUs”), which vest with the passage of time and/or vest based on the achievement of certain performance criteria. The Company issues new shares upon the exercise of stock option or the vesting of RSUs. Under the terms of the Company’s stock option plans (the “Plans”), certain of the Company’s employees may become eligible upon retirement for accelerated vesting of certain awards granted to them under the Plans. Since there are no effective future service requirements for such employees, the fair value of awards to such employees is expensed in full on the grant date or upon meeting the retirement eligibility criteria, whichever is later. Time-Based Stock Options Stock option grants to employees expire ten years from the grant date and generally vest one fourth 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 clo |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS During the years ended December 31, 2019, 2018 and 2017, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2019 2018 2017 VIVITROL $ 335,365 $ 302,609 $ 269,321 ARISTADA/ARISTADA INITIO 189,134 147,725 93,513 Total product sales, net $ 524,499 $ 450,334 $ 362,834 During the years ended December 31, 2019, 2018 and 2017, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 256,947 $ 256,947 RISPERDAL CONSTA 50,433 15,950 66,383 AMPYRA/FAMPYRA 22,071 15,170 37,241 Other 31,750 55,561 87,311 $ 104,254 $ 343,628 $ 447,882 Year Ended December 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 241,423 $ 241,423 RISPERDAL CONSTA 52,770 18,352 71,122 AMPYRA/FAMPYRA 53,044 54,009 107,053 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 RISPERDAL CONSTA 64,793 20,129 84,922 AMPYRA/FAMPYRA 55,373 61,646 117,019 Other 32,655 55,781 88,436 $ 152,821 $ 352,487 $ 505,308 The research and development revenue and license revenue recorded during the years ended December 31, 2019, 2018 and 2017 primarily related to revenue earned under the Company’s license and collaboration agreement with Biogen for VUMERITY. Under a license and collaboration agreement with Biogen, which the Company entered into in November 2017 and amended in October 2018, January 2019 and October 2019, the Company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under the agreement. Upon entering into the November 2017 license and collaboration agreement, the Company received an up-front cash payment of $28.0 million and was also eligible to receive additional payments upon achievement of developmental milestones with respect to VUMERITY. 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 clinical development program for VUMERITY. In November 2019, the Company also received an additional payment of $150.0 million following FDA approval of the NDA for VUMERITY and transfer of such NDA to Biogen. The Company is also eligible to receive additional payments upon achievement of developmental milestones with respect to the first two products other than VUMERITY covered by patents licensed to Biogen under the November 2017 license and collaboration agreement. Biogen paid a portion of the VUMERITY development costs the Company incurred in 2017 and, since January 1, 2018, Biogen has been responsible for all VUMERITY development costs the Company incurs, subject to annual budget limitations. Following FDA approval of the NDA for VUMERITY in October 2019, the NDA and any further development responsibilities with respect to VUMERITY were transferred to Biogen. The Company evaluated the license and collaboration 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 VUMERITY and estimated the expected future cash flows assuming FDA approval and maintenance of the IP protecting VUMERITY. 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. Under Topic 606, the Company allocated the $28.0 million up-front payment and the $50.0 million June 2018 payments as follows: $27.0 million and $48.3 million to the delivery of the license; $0.9 million and $1.5 million to future development services; and $0.1 million and $0.2 million to clinical supply, respectively. In November 2019, following FDA acceptance of the NDA for VUMERITY and transfer of such NDA to Biogen, the Company received a $150.0 million milestone payment, $144.8 million of which was allocated to the delivery of the license; and $5.2 million of which was allocated to future development services and 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 into 2020. The Company expects to earn an additional $0.3 million in research and development revenue under this agreement with Biogen through 2020. In addition, the Company will receive a 15% royalty on worldwide net sales of VUMERITY, subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY. The Company is also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration 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 VUMERITY are subject to customary reductions, as set forth in the license and collaboration agreement. The Company determined that the future development milestones and sales-based royalties that it may be entitled to receive 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. The royalties are subject to the sales-based exception and will be recorded when the corresponding sale occurs. Under the license and collaboration agreement, Biogen appointed the Company as the toll manufacturer of clinical and commercial supplies of VUMERITY, 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. In October 2019, the Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the November 2017 license and collaboration agreement with Biogen. Under these agreements, Biogen has an option to assume responsibility, subject to a transition period, for the manufacture (itself or through a designee) of clinical supplies of VUMERITY and up to 100% of commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of product that is manufactured by Biogen or its designee. The Company evaluated the commercial supply agreement and the related amendments under Topic 606 and determined that these agreements should be combined and accounted for as a separate contract since the commercial supply agreement and amendment to the November 2017 license and collaboration agreement were negotiated together to achieve a common economic objective and the additional performance obligations under the commercial supply agreement are considered distinct obligations priced at their standalone selling prices. The Company determined that it had two separate performance obligations, the commercial supply of VUMERITY and, upon an election by Biogen to commence a transfer of technology relating to the manufacture of VUMERITY (a “Tech Transfer”), services to be performed by the Company in connection with such Tech Transfer. There are other deliverables under the agreements that were determined to be perfunctory or immaterial. In connection with the entry into the commercial supply agreement and the related amendments, the Company received payments in the aggregate amount of $5.8 million in the fourth quarter of 2019 and, if Biogen opts to assume responsibility for the manufacture of VUMERITY, the Company will be eligible to receive an additional $5.0 million payment upon the earlier of successful completion of the Tech Transfer or a date in the fourth quarter of 2022. The $5.8 million received in the fourth quarter of 2019 plus amounts received in connection with the Tech Transfer, if any, will be allocated to each of the performance obligations using the standalone selling prices based on the Company’s estimate of selling price for the commercial supply of VUMERITY and the services related to the Tech Transfer, and this additional arrangement consideration will be recognized as the Company delivers commercial supply of VUMERITY and/or provides services relating to the Tech Transfer. The Company expects to begin performing under this commercial supply agreement in the first quarter of 2020. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 144,161 $ 676 $ — $ — $ 144,837 U.S. government and agency debt securities 112,948 434 (1 ) (1 ) 113,380 International government agency debt securities 72,753 248 (10 ) — 72,991 Total short-term investments 329,862 1,358 (11 ) (1 ) 331,208 Long-term investments: Available-for-sale securities: Corporate debt securities 51,070 — (45 ) (7 ) 51,018 International government agency debt securities 20,806 — (18 ) — 20,788 U.S. government and agency debt securities 4,000 — (4 ) — 3,996 75,876 — (67 ) (7 ) $ 75,802 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 102 — — 1,769 3,487 102 — — 3,589 Total long-term investments 79,363 102 (67 ) (7 ) 79,391 Total investments $ 409,225 $ 1,460 $ (78 ) $ (8 ) $ 410,599 December 31, 2018 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 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) 2019 2018 2017 Proceeds from the sales and maturities of marketable securities $ 224,602 $ 444,456 $ 464,494 Realized gains $ 997 $ 4 $ 9 Realized losses $ 497 $ 268 $ 3 The Company’s available‑for‑sale and held‑to‑maturity securities at December 31, 2019 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 $ 216,084 $ 216,764 $ 1,820 $ 1,820 After 1 year through 5 years 189,654 190,246 1,667 1,769 Total $ 405,738 $ 407,010 $ 3,487 $ 3,589 At December 31, 2019, 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., a related party. The Company 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, 2019, the Company’s total contribution in Fountain was equal to €6.0 million, |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,064 $ 8,064 $ — $ — U.S. government and agency debt securities 117,376 73,795 43,581 — Corporate debt securities 195,855 — 193,902 1,953 International government agency debt securities 93,779 — 93,779 — Contingent consideration 32,400 — — 32,400 Total $ 447,474 $ 81,859 $ 331,262 $ 34,353 December 31, 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 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, 2019. 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, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Purchase of corporate debt security 1,953 Change in the fair value of warrants 1,837 Change in the fair value of contingent consideration (22,800 ) Payments received from contingent consideration (10,000 ) Proceeds from the sale of shares acquired upon exercise of warrants (3,042 ) Impairment of corporate debt security (492 ) Balance, December 31, 2019 $ 34,353 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. In April 2015, the Company completed the sale of its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to IV/IM and parenteral forms of Meloxicam. 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, 2019, 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 received the second $5.0 million in April 2019. Additionally, the Company expects the regulatory milestone event to occur in the first quarter of 2020 and to receive milestone payments on the subsequent seven anniversary years thereafter. A discount rate of 16.0% 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 was 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 16.0%. At December 31, 2019 and 2018, the Company determined that the value of the contingent consideration was $32.4 million and $65.2 million, respectively. The Company recorded a decrease of $22.8 million and $19.6 million and an increase of $21.6 million during the years ended December 31, 2019, 2018 and 2017, respectively, within “Change in the fair value of contingent consideration” in the accompanying consolidated statements of operations and comprehensive loss. In November 2019, Recro completed a spin out of its acute care segment, Baudax Bio, Inc. (“Baudax”), a publicly traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay certain of the contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax. 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. In November 2019, the Company elected to convert those warrants into shares and sell those shares. The Company sold the shares for $3.0 million and recorded a realized gain of $0.9 million within “Other (expense) income, net” in the accompanying consolidated statement of operations and comprehensive loss during the year ended December 31, 2019. During the years ended December 31, 2018 and 2017, the Company recorded a decrease of $0.2 million and an increase of less than $0.1 million, respectively, in the fair value of the warrants. These changes were 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. The estimated fair value of the Company’s long-term debt under 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 $277.9 million and $274.7 million at December 31, 2019 and 2018, respectively. Please refer to Note 11, Long-Term Debt |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. INVENTORY Inventory consists of the following: December 31, December 31, (In thousands) 2019 2018 Raw materials $ 34,577 $ 31,824 Work in process 54,061 38,019 Finished goods (1) 13,165 20,353 Total inventory $ 101,803 $ 90,196 (1) At December 31, 2019 and 2018, the Company had $7.6 million and $11.0 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, 2019 | |
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) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 177,087 157,053 Furniture, fixtures and equipment 340,146 314,831 Leasehold improvements 20,737 20,105 Construction in progress 134,683 88,983 Subtotal 679,213 587,458 Less: accumulated depreciation (317,045 ) (277,471 ) Total property, plant and equipment, net $ 362,168 $ 309,987 Depreciation expense was $40.1 million, $38.5 million and $36.5 million for the years ended December 31, 2019, 2018 and 2017, respectively. Also, during the years ended December 31, 2019, 2018 and 2017, the Company wrote off furniture, fixtures and equipment that had a carrying value of approximately $0.9 million, $0.5 million and $0.1 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. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 December 31, 2018 (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 $ (348,595 ) $ 116,995 $ 465,590 $ (319,311 ) $ 146,279 NanoCrystal technology 13 74,600 (46,773 ) 27,827 74,600 (38,942 ) 35,658 OCR (1) 12 42,560 (36,739 ) 5,821 42,560 (33,496 ) 9,064 Total $ 582,750 $ (432,107 ) $ 150,643 $ 582,750 $ (391,749 ) $ 191,001 (1) OCR refers to the Company’s oral control 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 $40.4 million, $65.2 million and $62.1 million of amortization expense related to its finite‑lived intangible assets during the years ended December 31, 2019, 2018 and 2017, respectively. Based on the Company’s most recent analysis, amortization of intangible assets included within its consolidated balance sheets at December 31, 2019 is expected to be approximately $40.0 million, $40.0 million, $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 2020 through 2024, 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, 2019. The Company elected to perform a qualitative assessment to determine whether it was necessary to perform a quantitative impairment test. Based on the weight of all available evidence, the Company determined that the fair value of the reporting unit more-likely-than-not exceeded its carrying value. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | 9. LEASES The Company adopted Topic 842 on January 1, 2019. Upon adoption, the Company elected the package of transition practical expedients, which allowed it to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. The Company also elected the practical expedient to not reassess certain land easements and made an accounting policy election to not recognize leases with an initial term of 12 months or less within its consolidated balance sheets and to instead recognize those lease payments on a straight-line basis in its consolidated statements of operations over the lease term. The Company elected to adopt this standard using the optional modified retrospective transition method with no restatement of its prior periods or cumulative adjustment to retained earnings. With the adoption of Topic 842 , the Company’s consolidated balance sheet now contains the following line items: Right-of-use assets, Operating lease liabilities—short-term and Operating lease liabilities—long-term. The Company determined that it held the following significant operating leases of office and laboratory space as of January 1, 2019: • An operating lease for 175,000 square feet of office and laboratory space in Waltham, Massachusetts that expires in 2021, with an option to extend the term for up to two five year periods, both of which the Company assumed would be exercised in its right-of-use asset and lease liability amounts • An operating lease for 67,000 square feet of office space in Waltham, Massachusetts that expires in 2020, with an option to extend the term for up to two one year periods, • An operating lease for 14,600 square feet of office space in Dublin, Ireland that expires in 2022, with an option to extend the term for an additional five year period which the Company did not assume would be exercised in its right-of-use asset and lease liability amounts; and • An operating lease for 7,000 square feet of corporate office and administrative space in Washington, D.C. that expires in 2029 and includes an option to extend the term for an additional five year period which the Company did not assume would be exercised in its right-of-use asset and lease liability amounts. The Company also has two additional operating leases that are included in its lease accounting but are not considered significant. As all the existing leases subject to the new lease standard were previously classified as operating leases by the Company, they were similarly classified as operating leases under the new standard. The Company has determined that the identified operating leases did not contain non-lease components and require no further allocation of the total lease cost. Additionally, the agreements in place did not contain information to determine the rate implicit in the leases. As such, the Company calculated the incremental borrowing rate based on the assumed remaining lease term for each lease in order to calculate the present value of the remaining lease payments. At December 31, 2019, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 4.73% and 4.0 years, respectively. On November 18, 2019, the Company entered into a definitive agreement to acquire Rodin Therapeutics, Inc. (“Rodin”), a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies. As part of this transaction, the Company assumed an operating lease for 5,300 square feet of office space in Boston, Massachusetts that expires in 2021, with an option to extend the term for an additional year. As of December 31, 2019, right-of-use assets and liabilities arising from operating leases were $12.4 million and $13.8 million, respectively. During the year ended December 31, 2019, cash paid for amounts included for the measurement of lease liabilities was $9.1 million. The Company recorded operating lease expense of $8.1 million, $10.8 million and $9.4 million for the years ended December 31, 2019, 2018 and 2017, respectively. Future lease payments under non-cancelable leases as of December 31, 2019 consisted of the following: December 31, (In thousands) 2019 2020 $ 9,053 2021 2,727 2022 500 2023 509 2024 520 Thereafter 2,579 Total lease payments $ 15,888 Less: imputed interest (2,080 ) Total operating lease liabilities $ 13,808 For comparable purposes, future lease payments under non-cancelable leases as of December 31, 2018 consisted of the following: December 31, (In thousands) 2018 2019 $ 9,394 2020 10,717 2021 4,706 2022 2,455 2023 2,389 Thereafter 23,940 Total lease payments $ 53,601 In March 2018, the Company entered into a lease agreement for approximately 220,000 square feet of office and laboratory space located in a building to be built at 900 Winter Street, Waltham, Massachusetts (“900 Winter Street”). The initial term of the lease commenced on January 20, 2020 (the “Commencement Date”). The initial lease term expires on January 31, 2035, with an option to extend for an additional ten years. As the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets and, thus, could have been potentially leased to another tenant; and (c) did not legally own or control the land on which the property improvements are being constructed, it was not included as a right-of-use asset at December 31, 2019. Additionally, the future lease payments, outlined above, did not include the 900 Winter Street payments as of December 31, 2019 under Topic 842. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consist of the following: December 31, December 31, (In thousands) 2019 2018 Accounts payable $ 54,261 $ 39,767 Accrued compensation 72,072 67,613 Accrued sales discounts, allowances and reserves 153,902 152,911 Accrued other 92,802 73,471 Total accounts payable and accrued expenses $ 373,037 $ 333,762 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG‑TERM DEBT Long‑term debt consists of the following: December 31, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 277,138 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 274,295 $ 276,465 2023 Term Loans 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 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: 2020 $ 2,843 2021 2,843 2022 2,843 2023 270,747 2024 — Total $ 279,276 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. To date, the Company has not been required to make any such mandatory prepayments. 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, 2019. At December 31, 2019, the Company’s balance of unamortized deferred financing costs and unamortized original issue discount costs were $0.6 million and $1.5 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, 2019, 2018 and 2017, the Company had amortization expense of $0.7 million, $0.7 million and $0.8 million, respectively, related to deferred financing costs and original issue discount. |
Loss Per Share
Loss Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Loss Per Share | 12. 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, 2019, 2018 and 2017, 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) 2019 2018 2017 Stock options 13,814 11,331 9,540 Restricted stock units 3,177 2,592 2,119 Total 16,991 13,923 11,659 |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | 13. 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, 2019, 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, 2019 and 2018, the Company did not acquire any ordinary shares under the repurchase program. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | 14. 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) 2019 2018 2017 Cost of goods manufactured and sold $ 9,948 $ 9,174 $ 7,596 Research and development 29,924 32,943 22,635 Selling, general and administrative 61,105 63,240 53,686 Total share-based compensation expense $ 100,977 $ 105,357 $ 83,917 During the years ended December 31, 2019, 2018 and 2017, $1.5 million, $2.7 million and $0.4 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 two share-based compensation plan pursuant to which awards are currently being made: the 2011 Stock Option and Incentive Plan, as amended (the “2011 Plan”) and the 2018 Stock Option and Incentive Plan, as amended (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, as amended. The 2018 Plan and the 2011 Plan allow 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 the provisions of the 2018 Plan and the 2011 Plan, as applicable. At December 31, 2019, there were 10.6 million ordinary shares available for issuance in the aggregate under the Company’s stock plans. The 2018 Plan and the 2011 Plan each 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, 2019 14,852,457 $ 40.48 Granted 3,812,103 $ 31.49 Exercised (1,515,957 ) $ 12.55 Expired (1,104,967 ) $ 48.42 Forfeited (807,791 ) $ 42.32 Outstanding, December 31, 2019 15,235,845 $ 40.34 Exercisable, December 31, 2019 9,874,065 $ 39.15 The weighted average grant date fair value of stock options granted during the years ended December 31, 2019, 2018 and 2017 was $15.57, $30.47 and $25.81, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2019, 2018 and 2017 was $21.3 million, $35.5 million and $40.4 million, respectively. At December 31, 2019, there were 5.2 million stock options expected to vest with a weighted average exercise price of $42.64 per share, a weighted average contractual remaining life of 8.5 years with an aggregate intrinsic value of less than $0.1 million. At December 31, 2019, the aggregate intrinsic value of stock options exercisable was $12.9 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, 2019, there was $48.0 million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted average period of 1.9 years. Cash received from option exercises under the Company’s award plans during the years ended December 31, 2019, 2018 and 2017 was $18.9 million, $20.9 million and $23.5 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, 2019 2,266,286 $ 55.32 Granted 2,826,092 $ 30.47 Vested (791,484 ) $ 53.62 Forfeited (556,094 ) $ 41.44 Unvested, December 31, 2019 3,744,800 $ 38.99 The weighted average grant date fair value of time‑vested RSUs granted during the years ended December 31, 2019, 2018 and 2017 were $30.47, $63.01 and $54.85, respectively. The total fair value of time‑vested RSUs that vested during the years ended December 31, 2019, 2018 and 2017, was $42.4 million, $34.5 million and $31.5 million, respectively. At December 31, 2019, there was $66.6 million of total unrecognized compensation cost related to unvested time‑vested RSUs, which will be recognized over a weighted average remaining contractual term of 1.9 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 were to be assessed over a performance period of three years from the date of the grant. 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, 2019 626,168 $ 54.75 Granted — $ — Forfeited (81,000 ) $ 54.77 Vested (1,614 ) $ 48.48 Unvested, December 31, 2019 543,554 $ 54.75 The grant date fair value of the performance-based RSUs was equal to the closing price of the Company’s stock on the Nasdaq Global Select Market on the date of 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. In the first quarter of 2020, the compensation committee of the Company’s board of directors will meet to determine whether the two remaining performance criteria were achieved. At December 31, 2019, the Company does not consider it probable that the performance criteria will be met on these remaining performance obligations and has not recognized any additional share-based compensation expense related to these performance-based RSUs. At December 31, 2019, there was $29.8 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 should the Company deem that the performance criteria were met. The unvested awards will expire if it is determined that the performance conditions were not met on or before the three year anniversary of the grant date. |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 15. RESTRUCTURING On October 18, 2019, the Company approved a restructuring plan following a review of its operations, cost structure and growth opportunities (the “Restructuring”). The Restructuring included a reduction in headcount of approximately 160 employees across the Company. The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which are expected to result in cash expenditures and substantially all of which will be paid out over the next 12 months. Restructuring activity during the year ended December 31, 2019 was as follows: (In thousands) Balance, January 1, 2019 $ — Restructuring charge 13,401 Amounts paid during the period: Severance (3,621 ) Outplacement services (398 ) Benefits (181 ) Balance, December 31, 2019 $ 9,201 At December 31, 2019, $9.0 million and $0.2 million of the restructuring accrual were included within “Accounts payable and accrued expenses” and “Other long-term liabilities” in the accompanying consolidated balance sheets, respectively. |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisition | 16. ACQUISITION On November 18, 2019, the Company entered into a definitive agreement to acquire Rodin, a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies. The acquisition was completed on November 25, 2019 and, under the terms of the agreement, the Company made an upfront cash payment of $98.1 million to Rodin's security holders and may make up to $850.0 million in future payments, $225.0 million of which are triggered upon achievement by the development candidates acquired in the acquisition of Rodin of certain specified clinical milestones, $300.0 million of which are triggered by the development candidates acquired in the acquisition of Rodin of certain regulatory milestones and $325.0 million of which are triggered upon the attainment of certain sales thresholds. The Company accounted for the transaction, as an asset acquisition as substantially all of the fair value of Rodin’s gross assets acquired were concentrated in its in-process research and development (“IPR&D”), which is largely in the pre-clinical stage. As the IPR&D was determined to not have an alternative future use, the Company recorded a charge to R&D expense in the accompanying consolidated statements of operations and comprehensive loss of $86.6 million, which was the amount determined to be the relative fair value of the $98.1 million payment attributed to the acquired IPR&D. The Company has not recorded any of the $850.0 million in contingent consideration as a liability in the accompanying consolidated balance sheet as none of the future events which would trigger a milestone payment are considered probable of occurring at December 31, 2019. The following were the amounts allocated to the assets acquired, liabilities assumed and amounts expensed at the acquisition date based on their respective fair values: (In thousands) Cash 2,658 Prepaid expenses and other current assets 461 Deferred tax assets 11,642 Right-of-use assets 637 Other assets 137 Accounts payable and accrued expenses (3,364 ) Operating lease liabilities—short-term (400 ) Operating lease liabilities—long-term (237 ) Research and development expense 86,594 |
Collaborative Arrangements
Collaborative Arrangements | 12 Months Ended |
Dec. 31, 2019 | |
Collaborative Arrangements Disclosure [Abstract] | |
Collaborative Arrangements | 17. 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 “Item 1— Business” of this Annual Report for information with respect to IP protection for these products. The collaboration revenue the Company has earned in the years ended December 31, 2019, 2018 and 2017 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 a 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 rate resets to 3.5% at the beginning of each calendar year and is payable until 15 years from first commercial sale of a product, subject 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 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 by both Janssen and the Company. Revenue is 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%. Biogen Under a license and collaboration agreement with Biogen, which the Company entered into in November 2017 and amended in October 2018, January 2019 and October 2019, the Company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under the agreement. Under this license and collaboration agreement, the Company received an upfront cash payment of $28.0 million in November 2017, and milestone payments of $50.0 million, $150.0 million and $5.0 million in June 2018, November 2019 and December 2019, respectively, upon the achievement of certain developmental milestones, including FDA approval of the NDA for VUMERITY in October 2019, and amendment of the license and collaboration agreement in October 2019. The Company is also eligible to receive additional payments upon achievement of milestones with respect to the first two products, other than VUMERITY, covered by patents licensed to Biogen under the license and collaboration agreement. In addition, the Company receives a 15% royalty on worldwide net sales of VUMERITY, subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY. The Company is also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration 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 VUMERITY are subject to customary reductions, as set forth in the license and collaboration agreement. Except in limited circumstances, we were responsible for the development of VUMERITY until it was approved by the FDA. Following FDA approval of VUMERITY in October 2019 and except for the manufacturing responsibilities discussed below, Biogen is now responsible for all development and commercialization activities for VUMERITY and all other products covered by patents licensed to Biogen. Under the license and collaboration agreement, Biogen appointed the Company as the toll manufacturer of clinical and commercial supplies of VUMERITY, 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. In October 2019, the Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the November 2017 license and collaboration agreement with Biogen. Under these agreements, Biogen has an option to assume responsibility, subject to a transition period, for the manufacture (itself or through a designee) of clinical supplies of VUMERITY and up to 100% of commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of product that is manufactured by Biogen or its designee. If VUMERITY discontinuations due to gastrointestinal adverse events in VUMERITY’s long-term safety clinical trial exceed a certain pre-defined threshold, 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, and (ii) the minimum annual payments Biogen owes to the Company shall terminate. Unless earlier terminated, the license and collaboration agreement will remain in effect until the expiry of all royalty obligations. Biogen has the right to terminate the license and collaboration agreement at will, on a product-by-product basis or in its entirety upon 180 days’ prior notice to the Company. Either party has the right to terminate the license and collaboration 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 license and collaboration agreement by either party, then, at the Company’s request, the VUMERITY program will revert to the Company. 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 selling price of AMPYRA and FAMPYRA by Acorda and its sub‑licensee, Biogen, respectively. 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 te rminates 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 (or higher under certain circumstances) 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 an 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 18. INCOME TAXES The Company’s (benefit) provision for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2019 2018 2017 Current income tax (benefit) provision: U.S. federal $ (471 ) $ (53 ) $ 6,964 U.S. state 354 1,774 350 Rest of world — — 123 Deferred income tax (benefit) provision: U.S. federal (1,503 ) 10,624 8,188 U.S. state 881 62 (933 ) Ireland 303 (63 ) (21 ) Total tax (benefit) provision $ (436 ) $ 12,344 $ 14,671 The income tax benefit in 2019 and the income tax provision in 2018 and 2017 were primarily due to U.S. federal and state taxes. The favorable change in income taxes in 2019, as compared to 2018, was primarily due the foreign derived intangible income proposed regulations issued by the U.S. Department of the Treasury and the U.S. Internal Revenue Service (“IRS”) in March 2019. The favorable change in income taxes in 2018, as compared to 2017, was due to 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 $418.1 million at December 31, 2019. 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 $12.9 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 (benefit) provision for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2019 2018 2017 Ireland $ (141,869 ) $ (180,195 ) $ (172,363 ) U.S. (55,102 ) 53,287 2,414 Rest of world (85 ) (59 ) 26,675 Loss before (benefit) provision for income taxes $ (197,056 ) $ (126,967 ) $ (143,274 ) The components of the Company’s net deferred tax assets (liabilities) were as follows: December 31, December 31, (In thousands) 2019 2018 Deferred tax assets: NOL carryforwards $ 227,872 $ 198,633 Tax credits 57,385 52,395 Share-based compensation 45,214 44,873 Accrued expenses and reserves 20,337 15,892 Other 8,756 8,669 Less: valuation allowance (242,059 ) (219,093 ) Total deferred tax assets 117,505 101,369 Deferred tax liabilities: Intangible assets — — Property, plant and equipment (19,926 ) (14,533 ) Other (1,590 ) (1,274 ) Total deferred tax liabilities (21,516 ) (15,807 ) Net deferred tax assets $ 95,989 $ 85,562 In February 2016 the FASB issued Topic 842, Leases, 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, 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 ) Deferred tax asset valuation allowance for the year ended December 31, 2019 $ (219,093 ) $ (22,966 ) $ (242,059 ) (1) The additions in each of the periods presented relate primarily to Irish NOLs. Additionally, in 2019 the Company’s valuation allowance was increased by $3.0 million as a result of the attributes acquired as part of the acquisition of Rodin. At December 31, 2019, the Company maintained a valuation allowance of $17.3 million against certain U.S. state deferred tax assets and $224.8 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, 2019, the Company had $1.5 billion of Irish NOL carryforwards, $49.5 million of U.S. federal NOL carryforwards, $44.5 million of state NOL carryforwards, $49.6 million of federal R&D credits and $18.0 million of state tax credits which will either expire on various dates through 2039 or can be carried forward indefinitely. These loss and credit carryforwards are available to reduce certain future Irish and foreign taxable income and tax. 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. As a result of the acquisition of Rodin, the Company acquired $51.4 million of U.S. federal NOL carryforwards, $43.3 million of state NOL carryforwards, $0.8 million of U.S. federal R&D credit carryforwards and $0.4 million of state R&D credit carryforwards. These attributes are subject to multiple limitations based upon prior changes in the ownership of the ordinary shares of Rodin. 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) 2019 2018 2017 Statutory tax rate 12.5 % 12.5 % 12.5 % Income tax provision at statutory rate $ (24,632 ) $ (15,871 ) $ (17,909 ) Change in valuation allowance 19,882 28,371 26,771 In-process R&D (1) 10,824 — — Share-based compensation 6,287 1,163 (1,205 ) Foreign rate differential (2) 5,390 5,405 (682 ) U.S. state income taxes, net of U.S. federal benefit 1,051 1,732 (558 ) Foreign derived intangible income (3,450 ) — — Intercompany amounts (3) (1,125 ) (751 ) (5,041 ) R&D credit (8,846 ) (7,698 ) (9,326 ) Federal tax law change (4) (8,111 ) — 21,453 Irish rate differential (5) (146 ) (2,350 ) (2,675 ) Impairment on equity method investment — — 1,662 Other permanent items (6) 2,440 2,343 2,181 Income tax (benefit) provision $ (436 ) $ 12,344 $ 14,671 Effective tax rate 0.2 % (9.7 ) % (10.2 ) % (1) Represents the tax effect of the research and development expense recorded on the acquisition of Rodin. (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) During the year ended December 31, 2019, federal tax law change represents federal income tax benefit related to the foreign derived intangible income deductions for 2018 following the publications by the IRS and the Department of Treasury of proposed regulations in March 2019. During the year ended December 31, 2017, federal tax law change resulted in a $21.5 million deferred tax expense related to the reduction in the U.S. federal tax rate from 35% to 21%. ( 5 ) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. ( 6 ) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses, non-deductible lobbying expenses, the impact of the tax treatment of the FDA branded prescription drug fee 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, 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 Additions based on tax positions related to prior periods 38 Additions based on tax positions related to the current period 738 Balance, December 31, 2019 $ 6,857 The unrecognized tax benefits at December 31, 2019, 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, 2019, 2018 and 2017, 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 2016 through 2019 fiscal years remain subject to examination by the respective tax authorities. In Ireland, the years 2015 to 2019 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, 2018 and 2017 for Alkermes U.S. Holdings, Inc. are currently under examination by the State of California. The years ended December 31, 2015 and 2014 for Alkermes U.S. Holdings, Inc. are currently under examination by the State of Illinois. There are no uncertain tax positions or adjustments associated with the audits at this time. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 19. COMMITMENTS AND CONTINGENT LIABILITIES 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, 2019, 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 and in August 2019, Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the United States District Court for the District of New Jersey against Teva entities (Teva Pharmaceuticals USA, Inc.(“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”)) and Mylan entities (Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC), respectively, following filings by each of Teva and Mylan Labs of 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 in each of the lawsuits included recovery of litigation costs and injunctive relief. The Company is not a party to either of these proceedings. For information about risks relating to the INVEGA SUSTENNA Paragraph IV litigation, see “Item 1A—Risk Factors” in 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 had 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; 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 were 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 pertained 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 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. In October 2018, Acorda filed a petition for rehearing and rehearing en banc of the Federal Circuit’s decision. In January 2019, the Federal Circuit denied Acorda’s petition. In April 2019, Acorda filed a petition for writ of certiorari to the Supreme Court of the United States (the “Supreme Court”). On October 7, 2019, the Supreme Court denied Acorda’s petition requesting review of the case, rendering the Federal Circuit decision as final. For information about risks relating to the AMPYRA Paragraph IV litigations and other proceedings see “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.” RISPERDAL CONSTA European Opposition Proceedings In December 2016, Nanjing Luye Pharmaceutical Co., Ltd., Pharmathen SA, Teva PI 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 in January 2019, the EPO issued a written decision revoking the EP’577 Patent in April 2019. The Company filed a notice of appeal of the decision to the EPO’s Technical Boards of Appeal in June 2019. Pharmathen SA submitted a reply on November 5, 2019. The Company will continue to vigorously defend the EP ’577 Patent. For information about risks relating to the EP ’577 Patent opposition proceedings see “Item 1A—Risk Factors” in this Annual Report, including 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.” RISPERDAL CONSTA ANDA Litigation On July 17, 2019, the Company, together with Janssen Pharmaceuticals, Inc., initiated a patent infringement lawsuit in the United States District Court for the District of Delaware (the “Delaware District Court”) against Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Nanjing Luye Pharmaceutical Co., Ltd. and Shandong Luye Pharmaceutical Co., Ltd. (collectively, “Luye”). Luye filed a 505(b)(2) NDA seeking approval to market a competing product to RISPERDAL CONSTA before the expiration of U.S. Patent No. 6,667,061. Requested judicial remedies included, among other things, recovery of litigation costs and injunctive relief. On July 23, 2019, Luye filed its answer and affirmative defenses. On November 22, 2019, the parties submitted a stipulation and order of dismissal to the Delaware District Court stating that the parties had resolved the litigation. On December 2, 2019, the Delaware District Court signed the stipulation and order of dismissal terminating the lawsuit. 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 In December 2018 and January 2019, purported stockholders of the Company filed putative class actions against the Company and certain of its officers in the United States District Court for the Eastern District of New York (the “EDNY District Court”) captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410 McDermott v. Alkermes plc, et al., No. 1:19-cv-00624, Purchase Commitments The Company has open purchase orders for materials, supplies, services and property, plant and equipment as part of the normal course of business. At December 31, 2019, the Company had open purchase orders totaling $395.3 million and $33.5 million for non-capital and capital commitments, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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 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; Alkermes Finance S.à r.l; and Rodin Therapeutics, Inc. 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 (“GAAP”) requires that Company management 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 United States (“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, 2019, 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. At December 31, 2019, the Company’s financial assets consisted of cash equivalents, investments and contingent consideration 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, 2019 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 utilizing Level 2 inputs at December 31, 2019 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, 2019, assets utilizing Level 3 inputs included contingent consideration 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 assumptions, including adjustments to discount rates, changes in the amount and timing of cash flows, changes in the assumed achievement and timing of any development and 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. 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. Because the Company adopted Topic 606 using the modified retrospective method, 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 at December 31, 2017 has not been adjusted and continues to be reported under the old revenue recognition guidance (“Topic 605”). 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; • Product Returns —the Company records an estimate for product returns at the time our customers take control of their product. The Company estimates this liability using the expected value based on 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; and • 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. 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 . 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 by its licensees of products 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 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 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. |
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 each of December 31, 2019 and 2018. |
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, except for $5.0 million of consideration related to the Company’s collaboration with Biogen related to Vumerity, which the Company expects to receive in approximately three years, and is included in “Other assets” in the accompanying consolidated balance sheets. The manufacturing related amounts included in the contract assets table below complete the manufacturing process in ten days to eight weeks and are classified as current assets. 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 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 $ 13,386 |
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 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 $ 28,834 |
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, 2019, 2018 and 2017, the Company recorded a (loss) gain on foreign currency translation of $(0.9) million, $(2.3) million and $3.7 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 and pharmaceutical wholesalers 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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 29 % 28 % 27 % 29 % 31 % 33 % Biogen * 17 % * 10 % * * Cardinal Health 12 % * * 13 % * * AmerisourceBergen 10 % * * * * * Acorda * * 15 % 10 % 14 % 13 % * 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, 2019, 2018 and 2017, 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) 2019 2018 2017 Revenue by region: U.S. $ 966,929 $ 884,600 $ 700,090 Ireland 3,195 4,915 9,706 Rest of world 200,823 204,759 193,578 Assets by region: Current assets: U.S. $ 551,799 $ 546,533 $ 402,481 Ireland 407,791 433,837 403,167 Rest of world 2,381 2,882 3,196 Long-term assets: U.S.: Other $ 382,029 $ 312,243 $ 360,641 Ireland: Intangible assets $ 150,643 $ 191,001 $ 256,168 Goodwill 92,873 92,873 92,873 Other 217,887 245,638 278,701 |
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 VUMERITY, are not tracked by individual program as they benefit multiple programs or the Company’s 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, 2019, 2018 and 2017, advertising costs totaled $31.1 million, $54.7 million and $34.4 million, respectively. |
Share-Based Compensation | Share‑Based Compensation The Company’s share‑based compensation programs grant awards in the form of stock options and restricted stock units (“RSUs”), which vest with the passage of time and/or vest based on the achievement of certain performance criteria. The Company issues new shares upon the exercise of stock option or the vesting of RSUs. Under the terms of the Company’s stock option plans (the “Plans”), certain of the Company’s employees may become eligible upon retirement for accelerated vesting of certain awards granted to them under the Plans. Since there are no effective future service requirements for such employees, the fair value of awards to such employees is expensed in full on the grant date or upon meeting the retirement eligibility criteria, whichever is later. Time-Based Stock Options Stock option grants to employees expire ten years from the grant date and generally vest one fourth 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 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, 2019 2018 2017 Expected option term 5 - 7 years 5 - 8 years 5 - 8 years Expected stock volatility 46 % - 50 % 44 % - 49 % 43 % - 47 % Risk-free interest rate 1.34 % - 2.59 % 2.25 % - 3.10 % 1.69 % - 2.38 % Expected annual dividend yield — — — Performance-Based Stock Options Certain of the Company’s granted stock options are subject to achievement of a specified market condition prior to vesting in addition to being subject to time-based vesting. The estimated fair value of these stock options that vest upon the achievement of a market condition was determined through the use of a Monte Carlo simulation model, which utilizes input variables that determine the probability of satisfying the market condition stipulated in the award and calculates the fair market value for the award. The Monte Carlo simulation model used the following assumptions: Grant Date Weighted-Average Expected Volatility Cost of Equity Risk-Free Interest Rate February 21, 2019 45.0% 12.0% 2.69% Compensation expense for the stock options that vest upon the achievement of a market condition is recognized over a derived service period as determined by the Monte Carlo simulation model. The vesting of these stock options is also subject to continued employment of the grantee. Time‑Based Restricted Stock Units Time‑based RSUs awarded to employees generally vest one‑fourth 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 closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market 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 business. 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, 2019, 2018 and 2017, the Company contributed $14.8 million, $12.1 million and $9.8 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 a 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, 2019, 2018 and 2017, the Company contributed $4.1 million, $4.0 million and $3.7 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. Effective January 1, 2019, the Company adopted the requirements under Accounting Standards Update (“ASU”) 2016-02, Leases (“Topic 842”) using the optional modified retrospective transition method and recognized a cumulative-effect adjustment to the consolidated balance sheet on the date of adoption. Comparative periods have not been restated. Topic 842 was issued in order to increase transparency and comparability among organizations by recognizing right-of-use lease assets and operating lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The main difference between previous GAAP (“Topic 840”) and Topic 842 is the recognition of right-of-use lease assets and lease liabilities by lessees for those leases classified as operating leases under Topic 840. At January 1, 2019, the Company recorded a right-of-use asset of $20.1 million and an operating lease liability of $22.1 million. For additional information regarding how the Company is accounting for leases under Topic 842, refer to Note 9, Leases In April 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting update established that: (i) all excess tax benefits and tax deficiencies be recognized as income tax expense or benefit in the income statement; (ii) excess tax benefits be classified as an operating activity in the statement of cash flows; (iii) the entity make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest, which is current GAAP, or account for forfeitures as they occur; (iv) the threshold to qualify for equity classification permits withholding up to the maximum statutory tax rates in the applicable jurisdictions; and (v) cash paid by an employer when directly withholding shares for tax withholding purposes be classified as a financing activity in the statement of cash flows. This ASU became effective for the Company on January 1, 2017. The amendments related to (i), (iii) and (iv) were adopted by the Company on a modified retrospective basis, which resulted in a cumulative-effect adjustment to reduce accumulated deficit by $ 61.5 million related to the timing of when excess tax benefits are recognized. The Company elected to continue to record expense only for those awards that are expected to vest. The amendments related to (ii) and (v) were adopted using the prospective transition method. In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-13, 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 In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, Income Taxes amendment, adoption may be applied on a retrospective, modified retrospective or prospective basis. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
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 Balance Sheet Accounts Impacted for Topic 606 | 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 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 $ 13,386 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 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 $ 28,834 |
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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 29 % 28 % 27 % 29 % 31 % 33 % Biogen * 17 % * 10 % * * Cardinal Health 12 % * * 13 % * * AmerisourceBergen 10 % * * * * * Acorda * * 15 % 10 % 14 % 13 % |
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) 2019 2018 2017 Revenue by region: U.S. $ 966,929 $ 884,600 $ 700,090 Ireland 3,195 4,915 9,706 Rest of world 200,823 204,759 193,578 Assets by region: Current assets: U.S. $ 551,799 $ 546,533 $ 402,481 Ireland 407,791 433,837 403,167 Rest of world 2,381 2,882 3,196 Long-term assets: U.S.: Other $ 382,029 $ 312,243 $ 360,641 Ireland: Intangible assets $ 150,643 $ 191,001 $ 256,168 Goodwill 92,873 92,873 92,873 Other 217,887 245,638 278,701 |
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, 2019 2018 2017 Expected option term 5 - 7 years 5 - 8 years 5 - 8 years Expected stock volatility 46 % - 50 % 44 % - 49 % 43 % - 47 % Risk-free interest rate 1.34 % - 2.59 % 2.25 % - 3.10 % 1.69 % - 2.38 % Expected annual dividend yield — — — |
Summary of Estimated Fair Value of Stock Options | The Monte Carlo simulation model used the following assumptions: Grant Date Weighted-Average Expected Volatility Cost of Equity Risk-Free Interest Rate February 21, 2019 45.0% 12.0% 2.69% |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the years ended December 31, 2019, 2018 and 2017, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2019 2018 2017 VIVITROL $ 335,365 $ 302,609 $ 269,321 ARISTADA/ARISTADA INITIO 189,134 147,725 93,513 Total product sales, net $ 524,499 $ 450,334 $ 362,834 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the years ended December 31, 2019, 2018 and 2017, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 256,947 $ 256,947 RISPERDAL CONSTA 50,433 15,950 66,383 AMPYRA/FAMPYRA 22,071 15,170 37,241 Other 31,750 55,561 87,311 $ 104,254 $ 343,628 $ 447,882 Year Ended December 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 241,423 $ 241,423 RISPERDAL CONSTA 52,770 18,352 71,122 AMPYRA/FAMPYRA 53,044 54,009 107,053 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 RISPERDAL CONSTA 64,793 20,129 84,922 AMPYRA/FAMPYRA 55,373 61,646 117,019 Other 32,655 55,781 88,436 $ 152,821 $ 352,487 $ 505,308 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 144,161 $ 676 $ — $ — $ 144,837 U.S. government and agency debt securities 112,948 434 (1 ) (1 ) 113,380 International government agency debt securities 72,753 248 (10 ) — 72,991 Total short-term investments 329,862 1,358 (11 ) (1 ) 331,208 Long-term investments: Available-for-sale securities: Corporate debt securities 51,070 — (45 ) (7 ) 51,018 International government agency debt securities 20,806 — (18 ) — 20,788 U.S. government and agency debt securities 4,000 — (4 ) — 3,996 75,876 — (67 ) (7 ) $ 75,802 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 102 — — 1,769 3,487 102 — — 3,589 Total long-term investments 79,363 102 (67 ) (7 ) 79,391 Total investments $ 409,225 $ 1,460 $ (78 ) $ (8 ) $ 410,599 December 31, 2018 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 |
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) 2019 2018 2017 Proceeds from the sales and maturities of marketable securities $ 224,602 $ 444,456 $ 464,494 Realized gains $ 997 $ 4 $ 9 Realized losses $ 497 $ 268 $ 3 |
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, 2019 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 $ 216,084 $ 216,764 $ 1,820 $ 1,820 After 1 year through 5 years 189,654 190,246 1,667 1,769 Total $ 405,738 $ 407,010 $ 3,487 $ 3,589 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,064 $ 8,064 $ — $ — U.S. government and agency debt securities 117,376 73,795 43,581 — Corporate debt securities 195,855 — 193,902 1,953 International government agency debt securities 93,779 — 93,779 — Contingent consideration 32,400 — — 32,400 Total $ 447,474 $ 81,859 $ 331,262 $ 34,353 December 31, 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 |
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, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Purchase of corporate debt security 1,953 Change in the fair value of warrants 1,837 Change in the fair value of contingent consideration (22,800 ) Payments received from contingent consideration (10,000 ) Proceeds from the sale of shares acquired upon exercise of warrants (3,042 ) Impairment of corporate debt security (492 ) Balance, December 31, 2019 $ 34,353 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory consists of the following: December 31, December 31, (In thousands) 2019 2018 Raw materials $ 34,577 $ 31,824 Work in process 54,061 38,019 Finished goods (1) 13,165 20,353 Total inventory $ 101,803 $ 90,196 (1) At December 31, 2019 and 2018, the Company had $7.6 million and $11.0 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, 2019 | |
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) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 177,087 157,053 Furniture, fixtures and equipment 340,146 314,831 Leasehold improvements 20,737 20,105 Construction in progress 134,683 88,983 Subtotal 679,213 587,458 Less: accumulated depreciation (317,045 ) (277,471 ) Total property, plant and equipment, net $ 362,168 $ 309,987 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consist of the following: December 31, 2019 December 31, 2018 (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 $ (348,595 ) $ 116,995 $ 465,590 $ (319,311 ) $ 146,279 NanoCrystal technology 13 74,600 (46,773 ) 27,827 74,600 (38,942 ) 35,658 OCR (1) 12 42,560 (36,739 ) 5,821 42,560 (33,496 ) 9,064 Total $ 582,750 $ (432,107 ) $ 150,643 $ 582,750 $ (391,749 ) $ 191,001 (1) OCR refers to the Company’s oral control |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of December 31, 2019 consisted of the following: December 31, (In thousands) 2019 2020 $ 9,053 2021 2,727 2022 500 2023 509 2024 520 Thereafter 2,579 Total lease payments $ 15,888 Less: imputed interest (2,080 ) Total operating lease liabilities $ 13,808 |
Summary of Future Lease Payments Under Non-Cancelable Leases | For comparable purposes, future lease payments under non-cancelable leases as of December 31, 2018 consisted of the following: December 31, (In thousands) 2018 2019 $ 9,394 2020 10,717 2021 4,706 2022 2,455 2023 2,389 Thereafter 23,940 Total lease payments $ 53,601 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 2018 Accounts payable $ 54,261 $ 39,767 Accrued compensation 72,072 67,613 Accrued sales discounts, allowances and reserves 153,902 152,911 Accrued other 92,802 73,471 Total accounts payable and accrued expenses $ 373,037 $ 333,762 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long‑term debt consists of the following: December 31, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 277,138 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 274,295 $ 276,465 |
Scheduled Maturities of Term Loan Facility | Scheduled maturities with respect to the 2023 Term Loans are as follows (in thousands): Year Ending December 31: 2020 $ 2,843 2021 2,843 2022 2,843 2023 270,747 2024 — Total $ 279,276 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 2018 2017 Stock options 13,814 11,331 9,540 Restricted stock units 3,177 2,592 2,119 Total 16,991 13,923 11,659 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
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) 2019 2018 2017 Cost of goods manufactured and sold $ 9,948 $ 9,174 $ 7,596 Research and development 29,924 32,943 22,635 Selling, general and administrative 61,105 63,240 53,686 Total share-based compensation expense $ 100,977 $ 105,357 $ 83,917 |
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, 2019 14,852,457 $ 40.48 Granted 3,812,103 $ 31.49 Exercised (1,515,957 ) $ 12.55 Expired (1,104,967 ) $ 48.42 Forfeited (807,791 ) $ 42.32 Outstanding, December 31, 2019 15,235,845 $ 40.34 Exercisable, December 31, 2019 9,874,065 $ 39.15 |
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, 2019 2,266,286 $ 55.32 Granted 2,826,092 $ 30.47 Vested (791,484 ) $ 53.62 Forfeited (556,094 ) $ 41.44 Unvested, December 31, 2019 3,744,800 $ 38.99 |
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, 2019 626,168 $ 54.75 Granted — $ — Forfeited (81,000 ) $ 54.77 Vested (1,614 ) $ 48.48 Unvested, December 31, 2019 543,554 $ 54.75 |
Restructuring (Tables)
Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring And Related Activities [Abstract] | |
Schedule of Restructuring Activity | Restructuring activity during the year ended December 31, 2019 was as follows: (In thousands) Balance, January 1, 2019 $ — Restructuring charge 13,401 Amounts paid during the period: Severance (3,621 ) Outplacement services (398 ) Benefits (181 ) Balance, December 31, 2019 $ 9,201 |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Schedule of Assets Acquired, Liabilities Assumed and Amounts Expensed | The following were the amounts allocated to the assets acquired, liabilities assumed and amounts expensed at the acquisition date based on their respective fair values: (In thousands) Cash 2,658 Prepaid expenses and other current assets 461 Deferred tax assets 11,642 Right-of-use assets 637 Other assets 137 Accounts payable and accrued expenses (3,364 ) Operating lease liabilities—short-term (400 ) Operating lease liabilities—long-term (237 ) Research and development expense 86,594 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of (Benefit) Provision for Income Taxes | The Company’s (benefit) provision for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2019 2018 2017 Current income tax (benefit) provision: U.S. federal $ (471 ) $ (53 ) $ 6,964 U.S. state 354 1,774 350 Rest of world — — 123 Deferred income tax (benefit) provision: U.S. federal (1,503 ) 10,624 8,188 U.S. state 881 62 (933 ) Ireland 303 (63 ) (21 ) Total tax (benefit) provision $ (436 ) $ 12,344 $ 14,671 |
Schedule of (Loss) Income Before Provision for Income Taxes by Geographical Area | The distribution of the Company’s loss before the (benefit) provision for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2019 2018 2017 Ireland $ (141,869 ) $ (180,195 ) $ (172,363 ) U.S. (55,102 ) 53,287 2,414 Rest of world (85 ) (59 ) 26,675 Loss before (benefit) provision for income taxes $ (197,056 ) $ (126,967 ) $ (143,274 ) |
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) 2019 2018 Deferred tax assets: NOL carryforwards $ 227,872 $ 198,633 Tax credits 57,385 52,395 Share-based compensation 45,214 44,873 Accrued expenses and reserves 20,337 15,892 Other 8,756 8,669 Less: valuation allowance (242,059 ) (219,093 ) Total deferred tax assets 117,505 101,369 Deferred tax liabilities: Intangible assets — — Property, plant and equipment (19,926 ) (14,533 ) Other (1,590 ) (1,274 ) Total deferred tax liabilities (21,516 ) (15,807 ) Net deferred tax assets $ 95,989 $ 85,562 |
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, 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 ) Deferred tax asset valuation allowance for the year ended December 31, 2019 $ (219,093 ) $ (22,966 ) $ (242,059 ) (1) The additions in each of the periods presented relate primarily to Irish NOLs. Additionally, in 2019 the Company’s valuation allowance was increased by $3.0 million as a result of the attributes acquired as part of the acquisition of Rodin. |
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) 2019 2018 2017 Statutory tax rate 12.5 % 12.5 % 12.5 % Income tax provision at statutory rate $ (24,632 ) $ (15,871 ) $ (17,909 ) Change in valuation allowance 19,882 28,371 26,771 In-process R&D (1) 10,824 — — Share-based compensation 6,287 1,163 (1,205 ) Foreign rate differential (2) 5,390 5,405 (682 ) U.S. state income taxes, net of U.S. federal benefit 1,051 1,732 (558 ) Foreign derived intangible income (3,450 ) — — Intercompany amounts (3) (1,125 ) (751 ) (5,041 ) R&D credit (8,846 ) (7,698 ) (9,326 ) Federal tax law change (4) (8,111 ) — 21,453 Irish rate differential (5) (146 ) (2,350 ) (2,675 ) Impairment on equity method investment — — 1,662 Other permanent items (6) 2,440 2,343 2,181 Income tax (benefit) provision $ (436 ) $ 12,344 $ 14,671 Effective tax rate 0.2 % (9.7 ) % (10.2 ) % (1) Represents the tax effect of the research and development expense recorded on the acquisition of Rodin. (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) During the year ended December 31, 2019, federal tax law change represents federal income tax benefit related to the foreign derived intangible income deductions for 2018 following the publications by the IRS and the Department of Treasury of proposed regulations in March 2019. During the year ended December 31, 2017, federal tax law change resulted in a $21.5 million deferred tax expense related to the reduction in the U.S. federal tax rate from 35% to 21%. ( 5 ) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. ( 6 ) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses, non-deductible lobbying expenses, the impact of the tax treatment of the FDA branded prescription drug fee 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, 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 Additions based on tax positions related to prior periods 38 Additions based on tax positions related to the current period 738 Balance, December 31, 2019 $ 6,857 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
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 ($) | Dec. 31, 2019USD ($)segment | Dec. 31, 2019EUR (€)segment | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | Jan. 01, 2018USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ (1,381,988) | $ (1,185,368) | |||||
Allowance for doubtful accounts | 200 | 200 | |||||
(Loss) gain on foreign currency translation | $ (900) | $ (2,300) | $ 3,700 | ||||
Threshold percentage for disclosure of revenue and receivables | 10.00% | 10.00% | 10.00% | 10.00% | |||
Advertising Expense | $ 31,100 | $ 54,700 | $ 34,400 | ||||
Number of business segments | segment | 1 | 1 | |||||
Operating lease, right-of-use asset | $ 12,379 | $ 20,100 | |||||
Operating lease liability | $ 13,808 | $ 22,100 | |||||
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 | $ 14,800 | 12,100 | 9,800 | ||||
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 | $ 4,100 | $ 4,000 | $ 3,700 | ||||
Per employee contribution limit | € | € 115,000 | ||||||
Maximum percentage of employer contribution matched of employee's | 18.00% | 18.00% | |||||
Time-Based 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 | |||||
Time-Based Stock Options | Non-employee 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 | |||||
VUMERITY | Other Assets | Biogen | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Contract assets, noncurrent | $ 5,000 | ||||||
Contract with customer assets expected to receive period | 3 years | 3 years | |||||
ASU 2014-09 | Adjustment | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ 818 | ||||||
ASU 2016-09 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Cumulative-effect adjustment to reduce accumulated deficit | $ 61,500 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Balance Sheet Accounts Impacted for Topic 606 (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Contract assets | $ 8,386 | $ 8,230 | |
Inventory | 101,803 | 90,196 | |
Deferred tax asset | 96,558 | 85,807 | |
Contract liabilities—short-term | 6,766 | 3,169 | |
Contract liabilities—long-term | 22,068 | 9,525 | |
Accumulated deficit | $ (1,381,988) | $ (1,185,368) | |
ASU 2014-09 | Adjustment | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
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 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Contract Asset [Abstract] | |||
Contract assets | $ 13,386 | $ 8,230 | $ 9,110 |
Additions | 37,911 | 57,617 | |
Transferred to receivables, net | (32,755) | (58,497) | |
Contract Liabilities [Abstract] | |||
Contract liabilities at beginning of the period | 12,694 | 9,442 | |
Additions | 18,677 | 6,381 | |
Amounts recognized into revenue | (2,537) | (3,129) | |
Contract liabilities at end of the period | $ 28,834 | $ 12,694 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Concentration (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Janssen | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 29.00% | 27.00% | 31.00% |
Janssen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 28.00% | 29.00% | 33.00% |
Biogen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 17.00% | 10.00% | |
Cardinal Health | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 12.00% | ||
Cardinal Health | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 13.00% | ||
AmerisourceBergen | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | ||
Acorda | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 15.00% | 14.00% | |
Acorda | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | 13.00% |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Concentration Parenthetical (Details) - Customer Concentration Risk - Minimum | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Geographic Information | |||
Revenue by region: | $ 1,170,947 | $ 1,094,274 | $ 903,374 |
Current assets: | 961,970 | 983,252 | |
Long-term assets: | |||
OTHER ASSETS | 17,021 | 16,143 | |
Intangible assets | 150,643 | 191,001 | |
GOODWILL | 92,873 | 92,873 | |
U.S. | |||
Geographic Information | |||
Revenue by region: | 966,929 | 884,600 | 700,090 |
Current assets: | 551,799 | 546,533 | 402,481 |
Long-term assets: | |||
OTHER ASSETS | 382,029 | 312,243 | 360,641 |
Ireland | |||
Geographic Information | |||
Revenue by region: | 3,195 | 4,915 | 9,706 |
Current assets: | 407,791 | 433,837 | 403,167 |
Long-term assets: | |||
OTHER ASSETS | 217,887 | 245,638 | 278,701 |
Intangible assets | 150,643 | 191,001 | 256,168 |
GOODWILL | 92,873 | 92,873 | 92,873 |
Rest of world | |||
Geographic Information | |||
Revenue by region: | 200,823 | 204,759 | 193,578 |
Current assets: | $ 2,381 | $ 2,882 | $ 3,196 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Summary of Estimated Fair Value of Stock Option Grant on Weighted Average Assumptions (Details) - Time-Based Stock Options | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted-average assumptions | |||
Expected stock volatility, minimum (as a percent) | 46.00% | 44.00% | 43.00% |
Expected stock volatility, maximum (as a percent) | 50.00% | 49.00% | 47.00% |
Risk-free interest rate, minimum (as a percent) | 1.34% | 2.25% | 1.69% |
Risk-free interest rate, maximum (as a percent) | 2.59% | 3.10% | 2.38% |
Minimum | |||
Weighted-average assumptions | |||
Expected option term | 5 years | 5 years | 5 years |
Maximum | |||
Weighted-average assumptions | |||
Expected option term | 7 years | 8 years | 8 years |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Summary of Estimated Fair Value of Stock Options (Details) - Performance Based Stock Options - Monte Carlo Simulation Model | 12 Months Ended |
Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Grant Date | Feb. 21, 2019 |
Weighted-Average Expected Volatility | 45.00% |
Cost of Equity | 12.00% |
Risk-Free Interest Rate | 2.69% |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 1,170,947 | $ 1,094,274 | $ 903,374 |
VIVITROL | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 335,365 | 302,609 | 269,321 |
ARISTADA/ARISTADA INITIO | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 189,134 | 147,725 | 93,513 |
Product sales, net | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 524,499 | $ 450,334 | $ 362,834 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 1,170,947 | $ 1,094,274 | $ 903,374 |
Manufacturing Revenue | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 104,254 | 133,028 | 152,821 |
Manufacturing Revenue | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 50,433 | 52,770 | 64,793 |
Manufacturing Revenue | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 22,071 | 53,044 | 55,373 |
Manufacturing Revenue | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 31,750 | 27,214 | 32,655 |
Royalty | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 343,628 | 393,647 | 352,487 |
Royalty | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 256,947 | 241,423 | 214,931 |
Royalty | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 15,950 | 18,352 | 20,129 |
Royalty | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 15,170 | 54,009 | 61,646 |
Royalty | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 55,561 | 79,863 | 55,781 |
Manufacturing and royalty revenues | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 447,882 | 526,675 | 505,308 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 256,947 | 241,423 | 214,931 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 66,383 | 71,122 | 84,922 |
Manufacturing and royalty revenues | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 37,241 | 107,053 | 117,019 |
Manufacturing and royalty revenues | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 87,311 | $ 107,077 | $ 88,436 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Dec. 31, 2019USD ($) | Nov. 30, 2019USD ($) | Oct. 31, 2019 | Jun. 30, 2018USD ($) | Nov. 30, 2017USD ($)item | Dec. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | $ 1,170,947 | $ 1,094,274 | $ 903,374 | |||||||
License revenue | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | 145,750 | 48,370 | 28,000 | |||||||
Research and development revenue | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | $ 52,816 | $ 68,895 | $ 7,232 | |||||||
Biogen | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Up-front payment received | $ 28,000 | |||||||||
Additional cash payment received | $ 150,000 | $ 50,000 | ||||||||
Number of initial performance obligations | item | 4 | |||||||||
Discount Rate (As a percent) | 8.00% | |||||||||
Biogen | License revenue | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | 144,800 | 48,300 | $ 27,000 | |||||||
Biogen | Research and development revenue | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | 5,200 | 1,500 | 900 | |||||||
Biogen | Research and development revenue | Forecast | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Additional revenue expected | $ 300 | |||||||||
Biogen | Clinical Supply | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | 200 | 100 | ||||||||
Biogen | License | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Total revenues | $ 5,000 | $ 150,000 | $ 50,000 | $ 28,000 | ||||||
Percentage of net sales in royalty payment | 15.00% | |||||||||
Biogen | License | Commercial Supply Agreements | ||||||||||
Disaggregation Of Revenue [Line Items] | ||||||||||
Maximum percentage of product supplies on net sales | 100.00% | |||||||||
Milestone payments received | $ 5,800 | |||||||||
Milestone payments receivable | $ 5,000 | $ 5,000 | $ 5,000 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Available-for-sale securities: | ||
Amortized Cost | $ 405,738 | |
Estimated Fair Value | 407,010 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 3,589 | |
Long-term Investments | ||
Total long-term investments | 79,391 | $ 80,744 |
Total investments | ||
Amortized Cost | 409,225 | 353,758 |
Gross Unrealized Gains | 1,460 | 393 |
Gross Unrealized Losses, Less than One Year | (78) | (291) |
Gross Unrealized Losses, Greater than One Year | (8) | (583) |
Estimated Fair Value | 410,599 | 353,277 |
Short-term Investments | ||
Amortized Cost | 329,862 | 272,835 |
Gross Unrealized Gains | 1,358 | 257 |
Gross Unrealized Losses, Less than One Year | (11) | (81) |
Gross Unrealized Losses, Greater than One Year | (1) | (478) |
Total short-term investments | 331,208 | 272,533 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 272,343 | |
Gross Unrealized Gains | 257 | |
Gross Unrealized Losses, Less than One Year | (81) | |
Gross Unrealized Losses, Greater than One Year | (478) | |
Estimated Fair Value | 272,041 | |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 112,948 | 80,055 |
Gross Unrealized Gains | 434 | 115 |
Gross Unrealized Losses, Less than One Year | (1) | (11) |
Gross Unrealized Losses, Greater than One Year | (1) | (87) |
Estimated Fair Value | 113,380 | 80,072 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 144,161 | 120,197 |
Gross Unrealized Gains | 676 | 57 |
Gross Unrealized Losses, Less than One Year | (62) | |
Gross Unrealized Losses, Greater than One Year | (274) | |
Estimated Fair Value | 144,837 | 119,918 |
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 | 72,753 | 72,091 |
Gross Unrealized Gains | 248 | 85 |
Gross Unrealized Losses, Less than One Year | (10) | (8) |
Gross Unrealized Losses, Greater than One Year | (117) | |
Estimated Fair Value | 72,991 | 72,051 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 75,876 | 77,436 |
Gross Unrealized Losses, Less than One Year | (67) | (210) |
Gross Unrealized Losses, Greater than One Year | (7) | (105) |
Estimated Fair Value | 75,802 | 77,121 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | 3,487 |
Gross Unrealized Gains | 102 | 136 |
Estimated Fair Value | 3,589 | 3,623 |
Long-term Investments | ||
Amortized Cost | 79,363 | 80,923 |
Gross Unrealized Gains | 102 | 136 |
Gross Unrealized Losses, Less than One Year | (67) | (210) |
Gross Unrealized Losses, Greater than One Year | (7) | (105) |
Total long-term investments | 79,391 | 80,744 |
Long-term investments | Certificates of deposit | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,820 | 1,820 |
Estimated Fair Value | 1,820 | 1,820 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 4,000 | 18,474 |
Gross Unrealized Losses, Less than One Year | (4) | (21) |
Gross Unrealized Losses, Greater than One Year | (12) | |
Estimated Fair Value | 3,996 | 18,441 |
Long-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 51,070 | 53,505 |
Gross Unrealized Losses, Less than One Year | (45) | (185) |
Gross Unrealized Losses, Greater than One Year | (7) | (93) |
Estimated Fair Value | 51,018 | 53,227 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 20,806 | 5,457 |
Gross Unrealized Losses, Less than One Year | (18) | (4) |
Estimated Fair Value | 20,788 | 5,453 |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | 1,667 |
Gross Unrealized Gains | 102 | 136 |
Estimated Fair Value | $ 1,769 | $ 1,803 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |||
Proceeds from the sales and maturities of marketable securities | $ 224,602 | $ 444,456 | $ 464,494 |
Realized gains | 997 | 4 | 9 |
Realized losses | $ 497 | $ 268 | $ 3 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 216,084 |
After 1 year through 5 years | 189,654 |
Amortized Cost | 405,738 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 216,764 |
After 1 year through 5 years | 190,246 |
Total | 407,010 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 1,820 |
After 1 year through 5 years | 1,667 |
Total | 3,487 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 1,820 |
After 1 year through 5 years | 1,769 |
Total | $ 3,589 |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Sep. 30, 2017USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2019EUR (€) | Feb. 29, 2016USD ($) | May 31, 2014EUR (€) | |
Equity method investment | |||||||
Other-than-temporary impairment charge | $ 10,471 | ||||||
Synchronicity Pharma Inc | |||||||
Equity method investment | |||||||
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) | $ (400) | $ 500 | $ (100) | ||||
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 | € | € 7,400,000 | ||||||
Fountain Healthcare Partners II, LP of Ireland | Other Assets | |||||||
Equity method investment | |||||||
Carrying value of equity investment | $ 5,900 | $ 5,500 | |||||
Total equity method commitment | € | € 6,000,000 |
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, 2019 | Dec. 31, 2018 |
Fair value | ||
Debt securities | $ 407,010 | |
Contingent consideration | 32,400 | $ 65,200 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 8,064 | 54,590 |
Contingent consideration | 32,400 | 65,200 |
Common stock warrants | 1,205 | |
Assets, Total | 447,474 | 470,649 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 8,064 | 54,590 |
Assets, Total | 81,859 | 114,697 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 331,262 | 289,055 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 32,400 | 65,200 |
Common stock warrants | 1,205 | |
Assets, Total | 34,353 | 66,897 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 117,376 | 98,513 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 73,795 | 60,107 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 43,581 | 38,406 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 195,855 | 173,637 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 193,902 | 173,145 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 1,953 | 492 |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 93,779 | 77,504 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 93,779 | $ 77,504 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | Dec. 20, 2018USD ($)Milestone | Apr. 30, 2019USD ($) | Jan. 31, 2019USD ($) | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($) | Apr. 23, 2019USD ($) | 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 | $ 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 | |||||||||
Milestone payments received | $ 5,000,000 | $ 5,000,000 | ||||||||
Contingent consideration | $ 32,400,000 | $ 65,200,000 | ||||||||
(Decrease) increase in the fair value of contingent consideration | (22,800,000) | (19,600,000) | $ 21,600,000 | |||||||
2023 Term Loan | ||||||||||
Fair Value | ||||||||||
Amount to be realized in future | 277,900,000 | $ 274,700,000 | ||||||||
Warrants | ||||||||||
Fair Value | ||||||||||
Proceeds from the sale of warrants | 3,000,000 | |||||||||
Recro | ||||||||||
Fair Value | ||||||||||
Warrants purchase under amendments | shares | 350,000 | |||||||||
Warrant strike price | $ / shares | $ 8.26 | $ 19.46 | ||||||||
Maximum | Recro | ||||||||||
Fair Value | ||||||||||
Milestone payment receivable | 80,000,000 | |||||||||
Other (Expense) Income, Net | ||||||||||
Fair Value | ||||||||||
Increase (decrease) in fair value of warrants | $ (200,000) | |||||||||
Warrants realized gain losses | $ 900,000 | |||||||||
Other (Expense) Income, Net | Maximum | ||||||||||
Fair Value | ||||||||||
Increase (decrease) in fair value of warrants | $ 100,000 | |||||||||
Discount Rate | Future royalties | ||||||||||
Fair Value | ||||||||||
Discount rate (as a percent) | item | 16 | |||||||||
Discount Rate | Real options approach | ||||||||||
Fair Value | ||||||||||
Discount rate (as a percent) | item | 16 |
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, 2019USD ($) | |
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 | $ 66,897 |
Payments received from contingent consideration | (10,000) |
Impairment of corporate debt security | (492) |
Balance at the end of the period | 34,353 |
Corporate Debt Security | |
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 | 1,953 |
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 | (22,800) |
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 | 1,837 |
Proceeds from the sale of shares acquired | (3,000) |
Exercise of Warrants | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Proceeds from the sale of shares acquired | $ (3,042) |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 34,577 | $ 31,824 |
Work in process | 54,061 | 38,019 |
Finished goods | 13,165 | 20,353 |
Total inventory | $ 101,803 | $ 90,196 |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 7.6 | $ 11 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 679,213 | $ 587,458 |
Less: accumulated depreciation | (317,045) | (277,471) |
Total property, plant and equipment, net | 362,168 | 309,987 |
Land | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 6,560 | 6,486 |
Building and Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 177,087 | 157,053 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 340,146 | 314,831 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 20,737 | 20,105 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 134,683 | $ 88,983 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Line Items] | |||
Depreciation expense | $ 40.1 | $ 38.5 | $ 36.5 |
Furniture, Fixtures and Equipment | |||
Property Plant And Equipment [Line Items] | |||
Carrying value at the time of disposition | $ 0.9 | $ 0.5 | $ 0.1 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Goodwill | ||
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 | (432,107) | (391,749) |
Net Carrying Amount | $ 150,643 | 191,001 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | 465,590 |
Accumulated Amortization | (348,595) | (319,311) |
Net Carrying Amount | $ 116,995 | 146,279 |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | 74,600 |
Accumulated Amortization | (46,773) | (38,942) |
Net Carrying Amount | $ 27,827 | 35,658 |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | 42,560 |
Accumulated Amortization | (36,739) | (33,496) |
Net Carrying Amount | $ 5,821 | $ 9,064 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |||
Amortization of acquired intangible assets | $ 40,358 | $ 65,168 | $ 62,059 |
Expected amortization of intangible assets | |||
2020 | 40,000 | ||
2021 | 40,000 | ||
2022 | 35,000 | ||
2023 | 35,000 | ||
2024 | $ 1,000 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Nov. 18, 2019ft² | Jan. 01, 2019USD ($)ft²Option | Mar. 31, 2018ft² | Dec. 31, 2019USD ($)lease | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 220,000 | |||||
Lessee operating lease term of option to extend | 10 years | |||||
Operating lease, existence of option to extend | true | |||||
Number of additional operating leases | lease | 2 | |||||
Weighted average incremental borrowing rate | 4.73% | |||||
Weighted average remaining lease term | 4 years | |||||
Operating lease, right-of-use asset | $ | $ 20,100 | $ 12,379 | ||||
Operating lease liabilities | $ | $ 22,100 | 13,808 | ||||
Payments for operating leases | $ | 9,100 | |||||
Operating lease expense | $ | $ 8,100 | $ 10,800 | $ 9,400 | |||
Lease, commencement date | Jan. 20, 2020 | |||||
Lease, expiration date | Jan. 31, 2035 | |||||
MASSACHUSETTS | Corporate office and administrative space expire in 2021 | ||||||
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 175,000 | |||||
Maximum number of option to extend lease term | Option | 2 | |||||
Lessee operating lease term of option to extend | 5 years | |||||
Operating lease, existence of option to extend | true | |||||
MASSACHUSETTS | Corporate office and administrative space expire in 2021 | Rodin Therapeutics, Inc. | ||||||
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 5,300 | |||||
Lessee operating lease term of option to extend | 1 year | |||||
Operating lease, existence of option to extend | true | |||||
MASSACHUSETTS | Corporate office and administrative space expire in 2020 | ||||||
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 67,000 | |||||
Maximum number of option to extend lease term | Option | 2 | |||||
Lessee operating lease term of option to extend | 1 year | |||||
Operating lease, existence of option to extend | true | |||||
Ireland | Corporate office and administrative space expire in 2022 | ||||||
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 14,600 | |||||
Lessee operating lease term of option to extend | 5 years | |||||
Operating lease, existence of option to extend | true | |||||
Washington | Corporate office and administrative space expire In 2029 | ||||||
Lessee Lease Description [Line Items] | ||||||
Area of real estate property | 7,000 | |||||
Lessee operating lease term of option to extend | 5 years | |||||
Operating lease, existence of option to extend | true |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
2020 | $ 9,053 | ||
2021 | 2,727 | ||
2022 | 500 | ||
2023 | 509 | ||
2024 | 520 | ||
Thereafter | 2,579 | ||
Total lease payments | 15,888 | ||
Less: imputed interest | (2,080) | ||
Total operating lease liabilities | $ 13,808 | $ 22,100 | |
Operating Leases, Future Minimum Payments | |||
2019 | $ 9,394 | ||
2020 | 10,717 | ||
2021 | 4,706 | ||
2022 | 2,455 | ||
2023 | 2,389 | ||
Thereafter | 23,940 | ||
Total lease payments | $ 53,601 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 54,261 | $ 39,767 |
Accrued compensation | 72,072 | 67,613 |
Accrued sales discounts, allowances and reserves | 153,902 | 152,911 |
Accrued other | 92,802 | 73,471 |
Total accounts payable and accrued expenses | $ 373,037 | $ 333,762 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (2,843) |
Long-term debt | 274,295 | 276,465 |
2023 Term Loans | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | 277,138 | 279,308 |
Less: current portion | (2,843) | (2,843) |
Long-term debt | $ 274,295 | $ 276,465 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | Oct. 12, 2016 | Mar. 31, 2018USD ($) | Dec. 31, 2019USD ($)Lender | Mar. 31, 2019 | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
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 | $ 0.6 | |||||
Original issue discount | 1.5 | |||||
Amortization of offering costs and discount | $ 0.7 | $ 0.7 | $ 0.8 | |||
Interest Expense | ||||||
Long-term debt | ||||||
Refinancing charges | $ 2.3 | |||||
Minimum | ||||||
Long-term debt | ||||||
Threshold percentage comparing present value of remaining cash flows | 10.00% | |||||
2023 Term Loans | ||||||
Long-term debt | ||||||
Due date of loan | Mar. 26, 2023 | |||||
Variable interest rate base | LIBOR | |||||
Incremental capacity | $ 175 | |||||
Term Loan B-1 | ||||||
Long-term debt | ||||||
Due date of loan | Sep. 25, 2021 | |||||
LIBOR | 2023 Term Loans | ||||||
Long-term debt | ||||||
Interest rate added to base rate (as a percent) | 2.25% | |||||
Interest rate, variable interest rate floor (as a percent) | 0.00% | |||||
LIBOR | Term Loan B-1 | ||||||
Long-term debt | ||||||
Interest rate added to base rate (as a percent) | 2.75% | |||||
Interest rate, variable interest rate floor (as a percent) | 0.75% |
Long-term Debt - Scheduled Matu
Long-term Debt - Scheduled Maturities of Term Loan Facility (Details) - 2023 Term Loans $ in Thousands | Dec. 31, 2019USD ($) |
Long-term debt | |
2020 | $ 2,843 |
2021 | 2,843 |
2022 | 2,843 |
2023 | 270,747 |
Total | $ 279,276 |
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 | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 16,991 | 13,923 | 11,659 |
Stock Options | |||
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 13,814 | 11,331 | 9,540 |
Restricted Stock Units | |||
Denominator: | |||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 3,177 | 2,592 | 2,119 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) | Dec. 31, 2019 | 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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation Expense | |||
Total share-based compensation expense | $ 100,977 | $ 105,357 | $ 83,917 |
Cost of goods manufactured and sold | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 9,948 | 9,174 | 7,596 |
Research and development | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 29,924 | 32,943 | 22,635 |
Selling, general and administrative | |||
Share-based compensation Expense | |||
Total share-based compensation expense | $ 61,105 | $ 63,240 | $ 53,686 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2019USD ($)itemshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Share-based compensation Expense | |||
Number of share-based compensation plan under which awards are currently made | 2 | ||
Number of share-based compensation plan under which no further awards will be made | 1 | ||
Shares of common stock available for issuance | shares | 10.6 | ||
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 | $ | $ 1.5 | $ 2.7 | $ 0.4 |
Share-based Compensation - Sc_2
Share-based Compensation - Schedule of Stock Option Activity (Details) - Stock options | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Number of Shares | |
Outstanding at the beginning of the period (in shares) | shares | 14,852,457 |
Granted (in shares) | shares | 3,812,103 |
Exercised (in shares) | shares | (1,515,957) |
Expired (in shares) | shares | (1,104,967) |
Forfeited (in shares) | shares | (807,791) |
Outstanding at the end of the period (in shares) | shares | 15,235,845 |
Exercisable at the end of the period (in shares) | shares | 9,874,065 |
Weighted Average Exercise Price | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 40.48 |
Granted (in dollars per share) | $ / shares | 31.49 |
Exercised (in dollars per share) | $ / shares | 12.55 |
Expired (in dollars per share) | $ / shares | 48.42 |
Forfeited (in dollars per share) | $ / shares | 42.32 |
Outstanding at the end of the period (in dollars per share) | $ / shares | 40.34 |
Exercisable at the end of the period (in dollars per share) | $ / shares | $ 39.15 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation Expense | |||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 15.57 | $ 30.47 | $ 25.81 |
Aggregate intrinsic value of stock options exercised | $ 21,300,000 | $ 35,500,000 | $ 40,400,000 |
Stock options expected to vest (in shares) | 5.2 | ||
Weighted average exercise price (in dollars per share) | $ 42.64 | ||
Weighted average contractual remaining life | 8 years 6 months | ||
Aggregate intrinsic value of stock options exercisable | $ 12,900,000 | ||
Weighted average remaining contractual term of stock options exercisable | 4 years 6 months | ||
Unrecognized compensation cost | $ 48,000,000 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 1 year 10 months 24 days | ||
Cash received from option exercises | $ 18,900,000 | $ 20,900,000 | $ 23,500,000 |
Maximum | |||
Share-based compensation Expense | |||
Aggregate intrinsic value | $ 100,000 |
Share-based Compensation - Summ
Share-based Compensation - Summary of RSU Activity (Details) - Time-vested RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | |||
Unvested at the beginning of the period (in shares) | 2,266,286 | ||
Granted (in shares) | 2,826,092 | ||
Vested (in shares) | (791,484) | ||
Forfeited (in shares) | (556,094) | ||
Unvested at the end of the period (in shares) | 3,744,800 | 2,266,286 | |
Weighted Average Grant Date Fair Value | |||
Unvested at the beginning of the period (in dollars per share) | $ 55.32 | ||
Granted (in dollars per share) | 30.47 | $ 63.01 | $ 54.85 |
Vested (in dollars per share) | 53.62 | ||
Forfeited (in dollars per share) | 41.44 | ||
Unvested at the end of the period (in dollars per share) | $ 38.99 | $ 55.32 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based compensation Expense | |||
Granted (in dollars per share) | $ 30.47 | $ 63.01 | $ 54.85 |
Fair value of RSU's vested | $ 42.4 | $ 34.5 | $ 31.5 |
Unrecognized compensation cost | $ 66.6 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 1 year 10 months 24 days |
Share-based Compensation - Perf
Share-based Compensation - Performance-Based Restricted Stock Units - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Share-based compensation Expense | ||||
Share-based compensation expense | $ 100,977 | $ 105,357 | $ 83,917 | |
Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 9,948 | 9,174 | 7,596 | |
Research and development | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 29,924 | 32,943 | 22,635 | |
Selling, general and administrative | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | $ 61,105 | $ 63,240 | $ 53,686 | |
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 | |||
Share-based compensation expense | $ 17,100 | |||
Expiration period | 3 years | |||
Unrecognized compensation cost | $ 29,800 | |||
Performance-based RSUs | Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 2,100 | |||
Performance-based RSUs | Research and development | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 6,700 | |||
Performance-based RSUs | Selling, general and administrative | ||||
Share-based compensation Expense | ||||
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, 2019$ / sharesshares | |
Number of Shares | |
Unvested at the beginning of the period (in shares) | shares | 626,168 |
Forfeited (in shares) | shares | (81,000) |
Vested (in shares) | shares | (1,614) |
Unvested at the end of the period (in shares) | shares | 543,554 |
Weighted Average Grant Date Fair Value | |
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 54.75 |
Forfeited (in dollars per share) | $ / shares | 54.77 |
Vested (in dollars per share) | $ / shares | 48.48 |
Unvested at the end of the period (in dollars per share) | $ / shares | $ 54.75 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) $ in Thousands | Oct. 18, 2019USD ($)Position | Dec. 31, 2019USD ($) |
Restructuring Cost And Reserve [Line Items] | ||
Restructuring and related activities, initiation date | Oct. 18, 2019 | |
Expected number of positions eliminated | Position | 160 | |
Restructuring and related charges | $ 13,400 | $ 13,401 |
Restructuring and related activities description | The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which are expected to result in cash expenditures and substantially all of which will be paid out over the next 12 months. | |
Restructuring accrual | $ 9,201 | |
Accounts payable and accrued expenses | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring accrual | 9,000 | |
Other long-term liabilities | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring accrual | $ 200 |
Restructuring - Schedule of Res
Restructuring - Schedule of Restructuring Activity (Details) - USD ($) $ in Thousands | Oct. 18, 2019 | Dec. 31, 2019 |
Restructuring And Related Activities [Abstract] | ||
Restructuring expense | $ 13,400 | $ 13,401 |
Amounts paid during the period: | ||
Severance | (3,621) | |
Outplacement services | (398) | |
Benefits | (181) | |
Balance, December 31, 2019 | $ 9,201 |
Acquisition - Additional Inform
Acquisition - Additional Information (Details) - Rodin Therapeutics, Inc. | Nov. 18, 2019USD ($) |
Business Acquisition [Line Items] | |
Business acquisition, date of acquisition agreement | Nov. 18, 2019 |
Business acquisition, date of acquisition completed | Nov. 25, 2019 |
Upfront cash payment | $ 98,100,000 |
Research and development expense | 86,594,000 |
Milestones future payments | 850,000,000 |
IPR&D | |
Business Acquisition [Line Items] | |
Payment attributed to acquire IPR&D | 98,100,000 |
Maximum | |
Business Acquisition [Line Items] | |
Upfront cash future payments | 850,000,000 |
Achievement of Specified Clinical Milestones | Maximum | |
Business Acquisition [Line Items] | |
Upfront cash future payments | 225,000,000 |
Achievement of Regulatory Milestones | Maximum | |
Business Acquisition [Line Items] | |
Upfront cash future payments | 300,000,000 |
Attainment of Sales Thresholds | Maximum | |
Business Acquisition [Line Items] | |
Upfront cash future payments | $ 325,000,000 |
Acquisition - Schedule of Asset
Acquisition - Schedule of Assets Acquired, Liabilities Assumed and Amounts Expensed (Details) - Rodin Therapeutics, Inc. $ in Thousands | Nov. 18, 2019USD ($) |
Business Acquisition [Line Items] | |
Cash | $ 2,658 |
Prepaid expenses and other current assets | 461 |
Deferred tax assets | 11,642 |
Right-of-use assets | 637 |
Other assets | 137 |
Accounts payable and accrued expenses | (3,364) |
Operating lease liabilities—short-term | (400) |
Operating lease liabilities—long-term | (237) |
Research and development expense | $ 86,594 |
Collaborative Arrangements - Si
Collaborative Arrangements - Significant collaborative arrangements (Details) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2019USD ($) | Nov. 30, 2019USD ($) | Oct. 31, 2019 | Jun. 30, 2018USD ($) | Nov. 30, 2017USD ($) | Dec. 31, 2019USD ($)Agreement | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Cash payments received | $ 1,170,947,000 | $ 1,094,274,000 | $ 903,374,000 | |||||
VUMERITY | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Percentage of net sales in royalty payment | 15.00% | |||||||
Maximum percentage of product supplies on net sales | 100.00% | |||||||
Biogen | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Payment received upon the initiation of phase 3 clinical trial | $ 50,000,000 | |||||||
Biogen | License | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Cash payments received | $ 5,000,000 | $ 150,000,000 | $ 50,000,000 | $ 28,000,000 | ||||
Percentage of net sales in royalty payment | 15.00% | |||||||
License agreement | Janssen | INVEGA SUSTENNA/XEPLION | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Patent royalty rate (as a percent) | 1.50% | |||||||
Know-how royalty rate resets (as a percent) | 3.50% | |||||||
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 | |||||||
Notice period required to be given before termination of agreement | 30 days | |||||||
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 | $ 1,000,000 | ||||||
Milestone payment entitled to be received upon the acceptance of NDA by the FDA | 1,000,000 | 1,000,000 | ||||||
Milestone payment entitled to be received upon the approval of NDA by the FDA | 1,500,000 | 1,500,000 | ||||||
Milestone payment entitled to be received upon the first commercial sale | $ 1,500,000 | $ 1,500,000 | ||||||
License agreement | Acorda | AMPYRA/ FAMPYRA | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Royalty rate (as a percent) | 10.00% | |||||||
Notice period required to be given before termination of agreement | 90 days | |||||||
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 | |||||||
Notice period required to be given before termination of agreement | 6 months | |||||||
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 | |||||||
Manufacturing and supply agreement | Acorda | AMPYRA/ FAMPYRA | Maximum | ||||||||
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% |
Income Taxes - Schedule of (Ben
Income Taxes - Schedule of (Benefit) Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Deferred income tax (benefit) provision | |||
Deferred income tax provision (benefit) | $ (319) | $ 10,623 | $ 7,234 |
Total tax (benefit) provision | (436) | 12,344 | 14,671 |
Ireland | |||
Deferred income tax (benefit) provision | |||
Deferred income tax provision (benefit) | 303 | (63) | (21) |
U.S. federal | |||
Current income tax (benefit) provision: | |||
Current income tax (benefit) provision | (471) | (53) | 6,964 |
Deferred income tax (benefit) provision | |||
Deferred income tax provision (benefit) | (1,503) | 10,624 | 8,188 |
U.S. state | |||
Current income tax (benefit) provision: | |||
Current income tax (benefit) provision | 354 | 1,774 | 350 |
Deferred income tax (benefit) provision | |||
Deferred income tax provision (benefit) | $ 881 | $ 62 | (933) |
Rest of world | |||
Current income tax (benefit) provision: | |||
Current income tax (benefit) provision | $ 123 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2016 | |
Income Taxes [Line Items] | ||||
Tax expense from enactment of Tax Cuts and Jobs Act | $ 21,453 | |||
Cumulative unremitted earnings of overseas subsidiaries | $ 418,100 | |||
Deferred tax asset in respect of accrued lease liability | 4,300 | |||
Deferred tax liability in respect of right to use asset | 4,300 | |||
Less: valuation allowance | (242,059) | (172,797) | $ (219,093) | $ (141,859) |
Federal research and development credits | 49,600 | |||
State tax credits | $ 18,000 | |||
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 | |||
U.S. state | ||||
Income Taxes [Line Items] | ||||
Less: valuation allowance | $ (17,300) | |||
Operating loss carryforwards | 44,500 | |||
U.S. state | Rodin Therapeutics, Inc. | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards | 43,300 | |||
Federal research and development credits | 400 | |||
U.S. federal | ||||
Income Taxes [Line Items] | ||||
Tax expense from enactment of Tax Cuts and Jobs Act | $ 21,500 | |||
Operating loss carryforwards | 49,500 | |||
U.S. federal | Rodin Therapeutics, Inc. | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards | 51,400 | |||
Federal research and development credits | 800 | |||
Ireland | ||||
Income Taxes [Line Items] | ||||
Income taxes payable on repatriation of unremitted earnings | 12,900 | |||
Less: valuation allowance | (224,800) | |||
Operating loss carryforwards | $ 1,500,000 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before (benefit) provision for income taxes | $ (197,056) | $ (126,967) | $ (143,274) |
Ireland | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before (benefit) provision for income taxes | (141,869) | (180,195) | (172,363) |
U.S. | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before (benefit) provision for income taxes | (55,102) | 53,287 | 2,414 |
Rest of world | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before (benefit) provision for income taxes | $ (85) | $ (59) | $ 26,675 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Net Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||||
NOL carryforwards | $ 227,872 | $ 198,633 | ||
Tax credits | 57,385 | 52,395 | ||
Share-based compensation | 45,214 | 44,873 | ||
Accrued expenses and reserves | 20,337 | 15,892 | ||
Other | 8,756 | 8,669 | ||
Less: valuation allowance | (242,059) | (219,093) | $ (172,797) | $ (141,859) |
Total deferred tax assets | 117,505 | 101,369 | ||
Deferred tax liabilities: | ||||
Property, plant and equipment | (19,926) | (14,533) | ||
Other | (1,590) | (1,274) | ||
Total deferred tax liabilities | (21,516) | (15,807) | ||
Net deferred tax assets | $ 95,989 | $ 85,562 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Balance at Beginning of Period | $ (219,093) | $ (172,797) | $ (141,859) |
Additions | (22,966) | (46,296) | (30,938) |
Balance at End of Period | $ (242,059) | $ (219,093) | $ (172,797) |
Income Taxes - Schedule of Ac_2
Income Taxes - Schedule of Activity in Valuation Allowance Associated with Deferred taxes (Parenthetical) (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Rodin Therapeutics, Inc. | |
Income Taxes [Line Items] | |
Valuation allowance increased due to acquisition | $ 3 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of effective income tax rate | |||
Statutory tax rate (as a percent) | 12.50% | 12.50% | 12.50% |
Income tax provision at statutory rate | $ (24,632) | $ (15,871) | $ (17,909) |
Change in valuation allowance | 19,882 | 28,371 | 26,771 |
In-process R&D | 10,824 | ||
Share-based compensation | 6,287 | 1,163 | (1,205) |
Foreign rate differential | 5,390 | 5,405 | (682) |
U.S. state income taxes, net of U.S. federal benefit | 1,051 | 1,732 | (558) |
Foreign derived intangible income | (3,450) | ||
Intercompany amounts | (1,125) | (751) | (5,041) |
R&D credit | (8,846) | (7,698) | (9,326) |
Federal tax law change | (8,111) | ||
Federal tax law change | 21,453 | ||
Irish rate differential | (146) | (2,350) | (2,675) |
Impairment on equity method investment | 1,662 | ||
Other permanent items | 2,440 | 2,343 | 2,181 |
Total tax (benefit) provision | $ (436) | $ 12,344 | $ 14,671 |
Effective tax rate (as a percent) | 0.20% | (9.70%) | (10.20%) |
Income Taxes - Schedule of Re_2
Income Taxes - Schedule of Reconciliation of Statutory Tax Rate to Effective Tax Rate (Parenthetical) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Balance at the beginning of the period | $ 6,081 | $ 5,518 | $ 4,688 |
Reductions based on tax positions related to prior periods | (47) | ||
Additions based on tax positions related to prior periods | 38 | 4 | |
Additions based on tax positions related to the current period | 738 | 559 | 877 |
Balance at the end of the period | $ 6,857 | $ 6,081 | $ 5,518 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019USD ($)NoticeFiler | |
Commitments And Contingencies [Line Items] | |
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 |
Non-Capital Commitments | |
Commitments And Contingencies [Line Items] | |
Open purchase order commitments | $ 395,300,000 |
Capital Commitments | |
Commitments And Contingencies [Line Items] | |
Open purchase order commitments | $ 33,500,000 |