Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 05, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Entity Registrant Name | Alkermes plc. | ||
Entity Central Index Key | 0001520262 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 3,057,878,108 | ||
Entity Common Stock, Shares Outstanding | 159,237,889 | ||
Document Fiscal Year Focus | 2020 | ||
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, $0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Documents Incorporated by Reference | Portions of the definitive proxy statement for our 2021 Annual General Meeting of Shareholders are incorporated by reference into Part III of this report. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 272,961 | $ 203,771 |
Investments—short-term | 362,066 | 331,208 |
Receivables, net | 275,143 | 257,086 |
Contract assets | 14,401 | 8,386 |
Inventory | 125,738 | 101,803 |
Prepaid expenses and other current assets | 60,662 | 59,716 |
Total current assets | 1,110,971 | 961,970 |
PROPERTY, PLANT AND EQUIPMENT, NET | 350,003 | 362,168 |
RIGHT-OF-USE ASSETS | 131,718 | 12,379 |
INTANGIBLE ASSETS, NET | 111,191 | 150,643 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 86,228 | 96,558 |
INVESTMENTS—LONG-TERM | 24,780 | 79,391 |
CONTINGENT CONSIDERATION | 24,651 | 32,400 |
OTHER ASSETS | 17,315 | 17,021 |
TOTAL ASSETS | 1,949,730 | 1,805,403 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 412,171 | 373,037 |
Operating lease liabilities—short-term | 15,732 | 8,466 |
Contract liabilities—short-term | 7,512 | 6,766 |
Current portion of long-term debt | 2,843 | 2,843 |
Total current liabilities | 438,258 | 391,112 |
LONG-TERM DEBT | 272,118 | 274,295 |
OPERATING LEASE LIABILITIES—LONG-TERM | 119,464 | 5,342 |
CONTRACT LIABILITIES—LONG-TERM | 16,397 | 22,068 |
OTHER LONG-TERM LIABILITIES | 36,511 | 27,144 |
Total liabilities | 882,748 | 719,961 |
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, 2020 and 2019, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 162,269,220 and 160,489,888 shares issued; 159,161,141 and 157,779,002 shares outstanding at December 31, 2020 and 2019, respectively | 1,620 | 1,602 |
Treasury shares, at cost (3,108,079 and 2,710,886 shares at December 31, 2020 and 2019, respectively) | (126,087) | (118,386) |
Additional paid-in capital | 2,685,647 | 2,586,030 |
Accumulated other comprehensive loss | (1,349) | (1,816) |
Accumulated deficit | (1,492,849) | (1,381,988) |
Total shareholders’ equity | 1,066,982 | 1,085,442 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,949,730 | $ 1,805,403 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 162,269,220 | 160,489,888 |
Ordinary shares, shares outstanding | 159,161,141 | 157,779,002 |
Treasury shares | 3,108,079 | 2,710,886 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
REVENUES: | |||
Total revenues | $ 1,038,756 | $ 1,170,947 | $ 1,094,274 |
EXPENSES: | |||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 178,316 | 180,385 | 176,420 |
Research and development | 394,588 | 512,833 | 425,406 |
Selling, general and administrative | 538,827 | 599,449 | 526,408 |
Amortization of acquired intangible assets | 39,452 | 40,358 | 65,168 |
Restructuring expense | 13,401 | ||
Total expenses | 1,151,183 | 1,346,426 | 1,193,402 |
OPERATING LOSS | (112,427) | (175,479) | (99,128) |
OTHER INCOME (EXPENSE), NET: | |||
Interest income | 6,960 | 13,976 | 9,238 |
Interest expense | (8,659) | (13,601) | (15,437) |
Change in the fair value of contingent consideration | 3,945 | (22,800) | (19,600) |
Other income (expense), net | 13,644 | 848 | (2,040) |
Total other income (expense), net | 15,890 | (21,577) | (27,839) |
LOSS BEFORE INCOME TAXES | (96,537) | (197,056) | (126,967) |
INCOME TAX PROVISION (BENEFIT) | 14,324 | (436) | 12,344 |
NET LOSS | $ (110,861) | $ (196,620) | $ (139,311) |
LOSS PER ORDINARY SHARE: | |||
Basic and diluted (in dollars loss per ordinary share) | $ (0.70) | $ (1.25) | $ (0.90) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | |||
Basic and diluted (in shares) | 158,803 | 157,051 | 155,112 |
COMPREHENSIVE LOSS: | |||
Net loss | $ (110,861) | $ (196,620) | $ (139,311) |
Holding gain, net of a tax provision of $130, $426, $159, respectively | 467 | 1,464 | 512 |
COMPREHENSIVE LOSS | (110,394) | (195,156) | (138,799) |
Manufacturing and royalty revenues | |||
REVENUES: | |||
Total revenues | 484,000 | 447,882 | 526,675 |
Product sales, net | |||
REVENUES: | |||
Total revenues | 551,760 | 524,499 | 450,334 |
Research and development revenue | |||
REVENUES: | |||
Total revenues | 1,946 | 52,816 | 68,895 |
License revenue | |||
REVENUES: | |||
Total revenues | $ 1,050 | $ 145,750 | $ 48,370 |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Tax provision (benefit) | $ 130 | $ 426 | $ 159 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Cumulative Effect Adjustment Related to the Adoption of New Accounting Standards | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Accumulated DeficitCumulative Effect Adjustment Related to the Adoption of New Accounting Standards | Treasury Stock |
BALANCE at Dec. 31, 2017 | $ 1,202,808 | $ (1,692) | $ 1,557 | $ 2,338,755 | $ (3,792) | $ (1,044,365) | $ (1,692) | $ (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 on marketable securities, net of tax provision | 512 | 512 | ||||||
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 on marketable securities, net of tax provision | 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) | ||||||
Issuance of ordinary shares under employee stock plans | 8,373 | $ 7 | 8,366 | |||||
Issuance of ordinary shares under employee stock plans (in shares) | 682,122 | |||||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (7,701) | $ 11 | (11) | $ (7,701) | ||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 1,097,210 | (397,193) | ||||||
Share-based compensation expense | 91,262 | 91,262 | ||||||
Unrealized gain on marketable securities, net of tax provision | 467 | 467 | ||||||
Net loss | (110,861) | (110,861) | ||||||
BALANCE at Dec. 31, 2020 | $ 1,066,982 | $ 1,620 | $ 2,685,647 | $ (1,349) | $ (1,492,849) | $ (126,087) | ||
BALANCE (in shares) at Dec. 31, 2020 | 162,269,220 | (3,108,079) |
CONSOLIDATED STATEMENTS OF SH_2
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Stockholders Equity [Abstract] | |||
Tax provision (benefit) | $ 130 | $ 426 | $ 159 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (110,861) | $ (196,620) | $ (139,311) |
Adjustments to reconcile net loss to cash flows from operating activities: | |||
Share-based compensation expense | 90,164 | 100,977 | 105,357 |
Depreciation and amortization | 81,854 | 80,413 | 103,660 |
Deferred income taxes | 9,985 | (319) | 10,623 |
Change in the fair value of contingent consideration | (3,945) | 22,800 | 19,600 |
Loss on debt refinancing | 2,298 | ||
Payment made for debt refinancing | (2,251) | ||
Impairment of property, plant and equipment | 5,746 | ||
Other non-cash charges | 2,514 | 979 | |
Other non-cash charges | (580) | ||
Changes in assets and liabilities, excluding the effect of acquisitions: | |||
Receivables | (18,050) | 35,136 | (58,632) |
Contract assets | (6,015) | (5,156) | 880 |
Inventory | (22,933) | (13,077) | (2,665) |
Prepaid expenses and other assets | 4,022 | (1,784) | (5,990) |
Right-of-use assets | 17,336 | 8,399 | |
Accounts payable and accrued expenses | 50,600 | 34,847 | 46,739 |
Contract liabilities | (4,924) | 16,140 | 3,252 |
Operating lease liabilities | (16,273) | (9,117) | |
Other long-term liabilities | 9,368 | 18 | 8,996 |
Cash flows provided by operating activities | 82,842 | 72,077 | 99,281 |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Additions of property, plant and equipment | (42,219) | (90,942) | (69,431) |
Proceeds from the sale of equipment | 643 | 900 | 507 |
Proceeds from contingent consideration | 3,886 | 10,000 | |
Return of Fountain Healthcare Partners II, L.P. investment | 2,751 | ||
Purchases of investments | (229,543) | (277,518) | (397,727) |
Sales and maturities of investments | 253,001 | 224,602 | 444,456 |
Acquisition of Rodin Therapeutics, Inc.'s net assets, net of cash acquired | (8,875) | ||
Cash flows used in investing activities | (11,481) | (141,833) | (22,195) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 8,373 | 18,925 | 20,877 |
Employee taxes paid related to net share settlement of equity awards | (7,701) | (9,317) | (19,622) |
Principal payments of long-term debt | (2,843) | (2,843) | (743) |
Payment made for debt refinancing | (2,132) | ||
Cash flows (used in) provided by financing activities | (2,171) | 6,765 | (1,620) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 69,190 | (62,991) | 75,466 |
CASH AND CASH EQUIVALENTS—Beginning of period | 203,771 | 266,762 | 191,296 |
CASH AND CASH EQUIVALENTS—End of period | 272,961 | 203,771 | 266,762 |
SUPPLEMENTAL CASH FLOW DISCLOSURE: | |||
Cash paid for interest | 8,288 | 13,254 | 12,526 |
Cash paid for taxes | 620 | 2,508 | 754 |
Non-cash investing and financing activities: | |||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 2,420 | $ 13,789 | $ 11,720 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
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. Intercompany accounts and transactions have been eliminated. During the year ended December 31, 2020, Alkermes Finance S.à r.l, an indirect subsidiary of Alkermes plc, was liquidated and its net assets were transferred to its parent company, Alkermes Pharma Ireland Limited. 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 cash equivalents only those investments that 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. 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, 2020, 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, 2020, 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, 2020 included U.S. treasury securities, marketable securities classified as cash equivalents and a fixed term deposit account; • Level 2 –these valuations are based on quoted prices for identical or similar assets in active markets or other market observable inputs such as interest rates, yield curves, foreign currency spot rates and option pricing valuation models. Assets utilizing Level 2 inputs at December 31, 2020 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, 2020, 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 preclinical 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. The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management’s judgment, future commercialization of the product is considered probable and future economic benefit from such product is expected to be realized. The Company assesses the regulatory approval process and where the particular product stands in relation to that approval process, including any known safety, efficacy or quality concerns, potential labeling restrictions and other potential impediments to approval. The Company also considers the shelf life of the product in relation to the expected timeline for approval and considers issues that may prevent or delay commercialization, including issues that may arise in relation to the manufacturing of the product. The Company expenses previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or significant delay of approval by relevant regulatory agencies or other issues that may make the pre-approval inventory batches less likely or unlikely to be commercialized and to result in future economic benefit. 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 likelihood of achievement of milestones and of receipt of the 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, changes in the assumed probability associated with regulatory approvals and creditworthiness of the counterparty. 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; a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset; an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset; a current-period operating or cash flow loss combined with a history of operating or cash-flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset; or a current expectation that, more likely than not, a long-lived asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. 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. In the fourth quarter of 2020, the Company determined that an impairment triggering event occurred and evaluated certain of its long-lived assets for impairment under a held-and-used model. The Company concluded that the long-lived assets evaluated for impairment were recoverable based on an analysis of the undiscounted net cash flows to be generated from the use of these assets. Revenue from Contracts with Customers The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers 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. 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 — • Chargebacks — 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 returns of product sold 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 reduction of sales. Once product is returned, it is destroyed; and • Medicare Part D — Collaborative Arrangements The Company has entered into collaboration agreements with pharmaceutical companies including, among others, 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. Substantially all of the Company’s royalties 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. 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, preclinical 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 amounts unbilled but currently unconditionally due from customers. The amounts due are stated at their net estimated realizable value. The Company’s unbilled receivable balance was $110.9 million and $89.7 million at December 31, 2020 and 2019, respectively, and related primarily to royalty revenues. 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 approximately $0.1 million and $0.2 million at December 31, 2020 and 2019, respectively. 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 two years, and is included in “Other assets” in the accompanying consolidated balance sheets. The manufacturing-related amounts included in the contract assets table below are classified as “Current assets” in the accompanying consolidated balance sheets, as they related to manufacturing processes that are completed in ten days to eight weeks. Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2019 $ 8,230 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 13,386 Additions 46,325 Transferred to receivables, net (40,310 ) Contract assets at December 31, 2020 $ 19,401 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, 2019 $ 12,694 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 28,834 Additions — Amounts recognized into revenue (4,925 ) Contract liabilities at December 31, 2020 $ 23,909 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 income (expense), net” in the accompanying consolidated statements of operations and comprehensive loss. During the years ended December 31, 2020, 2019 and 2018, the Company recorded a gain (loss) on foreign currency translation of $2.4 million, $(0.9) million and $(2.3) 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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 30 % 33 % 29 % 28 % 27 % 29 % Biogen * * * 17 % * 10 % Cardinal Health 16 % 21 % 12 % * * 13 % AmerisourceBergen 11 % 10 % 10 % * * * McKesson * 14 % * * * * Acorda * * * * 15 % 10 % * Indicates the revenues or receivables for the customer did not exceed 10% of the Company’s total in each category as of or for the years ended December 31, 2020, 2019 and 2018, 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 ensure 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) 2020 2019 2018 Revenue by region: U.S. $ 838,995 $ 966,929 $ 884,600 Ireland 3,233 3,195 4,915 Rest of world 196,528 200,823 204,759 Assets by region: Current assets: U.S. $ 662,615 $ 551,799 $ 546,533 Ireland 448,356 407,791 433,837 Rest of world — 2,381 2,882 Long-term assets: U.S.: Other $ 472,999 $ 382,029 $ 312,243 Ireland: Intangible assets $ 111,191 $ 150,643 $ 191,001 Goodwill 92,873 92,873 92,873 Other 161,696 217,887 245,638 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 selling and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising, financial and legal expenses and other general and administrative costs. Advertising costs are expensed as incurred. During the years ended December 31, 2020, 2019 and 2018, advertising costs totaled $25.5 million, $31.1 million and $54.7 million, respectively. Share‑Based Compensation The Company’s share‑based compensation programs grant awards in the form of stock options and restricted stock unit awards (“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 options or the vesting of RSUs. Under the terms of the Company’s stock option plans (the “Plans”), certain of the Company’s employees may, at the discretion of the plan administrator, 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 would be expensed in full on the grant date or upon meeting the retirement eligibility criteria, whichever is later. Time-Based Stock Options Except as otherwise provided in the applicable Plan, stock option grants to employees expire ten years from the grant date and generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed with the Company during the applicable vesting period. Except as otherwise provided in the applicable Plan, stock option grants to non-employee directors expire ten years from the grant date and generally vest over a one year period provided that the director continues to serve on the Company’s board of directors through the vesting date. The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period. Share‑based compensation expense is based on awards ultimately expected to vest. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The fair value of stock option grants is based on estimates as of the date of grant using a Black‑Scholes option valuation model. The Company uses historical data as the basis for estimating stock 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 of 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 weekly price changes of the Company’s ordinary shares. The risk‑free interest rate for periods commensurate with the expected term of the stock 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 dividends, and does not expect to pay dividends in the near future. 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 gra |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS During the years ended December 31, 2020, 2019 and 2018, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2020 2019 2018 VIVITROL $ 310,722 $ 335,365 $ 302,609 ARISTADA and ARISTADA INITIO 241,038 189,134 147,725 Total product sales, net $ 551,760 $ 524,499 $ 450,334 During the years ended December 31, 2020, 2019 and 2018, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 274,200 $ 274,200 RISPERDAL CONSTA 56,893 14,468 71,361 AMPYRA/FAMPYRA 26,909 20,984 47,893 Other 35,232 55,314 90,546 $ 119,034 $ 364,966 $ 484,000 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 The research and development revenue and license revenue recorded during the years ended December 31, 2020, 2019 and 2018 primarily related to revenue earned under the Company’s license and collaboration agreement with Biogen for VUMERITY. In addition to the research and development revenue and license revenue, during the year ended December 31, 2020, 2019 and 2018 the Company recognized $22.5 million. $1.0 million and none, respectively, of manufacturing and royalty revenue related to 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 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 received an additional payment of $150.0 million following the U.S. Food and Drug Administration’s (“FDA”) approval of the New Drug Application (“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 license and collaboration agreement. Biogen paid a portion of the VUMERITY development costs the Company incurred in 2017 and, in January 2018, Biogen became responsible for all VUMERITY development costs that the Company incurred, 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. The Company allocated the $150.0 million milestone payment received in November 2019 to the relevant performance obligations as follows: $144.8 million to the delivery of the license; and $5.2 million 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 were recognized over the course of the development work and as clinical supply was delivered to Biogen in 2020. 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. 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 are 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 that portion 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 (the “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 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 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 began performing under this commercial supply agreement in 2020. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENTS Investments consist of the following: Gross Unrealized Losses Amortized Less than Greater than Allowance for Estimated December 31, 2020 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 176,937 $ 1,105 $ (7 ) $ — $ (977 ) $ 177,058 U.S. government and agency debt securities 103,011 336 (2 ) — — 103,345 International government agency debt securities 79,346 469 (6 ) — — 79,809 359,294 1,910 (15 ) — (977 ) 360,212 Held-to-maturity securities: Fixed term deposit account 1,667 187 — — — 1,854 Total short-term investments 360,961 2,097 (15 ) — (977 ) 362,066 Long-term investments: Available-for-sale securities: Corporate debt securities 7,908 — (10 ) — — 7,898 International government agency debt securities 15,077 — (15 ) — — 15,062 22,985 — (25 ) — — $ 22,960 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 24,805 — (25 ) — — 24,780 Total investments $ 385,766 $ 2,097 $ (40 ) $ — $ (977 ) $ 386,846 December 31, 2019 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 At December 31, 2020, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were other-than-temporary. Investments with unrealized losses consisted primarily of corporate debt securities and debt securities issued by foreign agencies and backed by foreign governments. In making the determination whether the decline in fair value of these securities was other-than-temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. If the Company intends to sell a security, or it is more likely than not that the Company would be required to sell a security prior to recovering its amortized cost basis, an other-than-temporary impairment is deemed to have occurred. The amount of an other-than-temporary impairment related to a credit loss, or investments that the Company intends to sell before recovery, is recognized in earnings. The amount of an other-than-temporary impairment on available-for-sale investments related to other factors is recorded as a component of accumulated other comprehensive income. In September 2019, the Company purchased $1.9 million of convertible promissory notes from Synchronicity Pharma, Inc. (“Synchronicity”), a related party. The notes mature on the earlier of June 30, 2021 or the closing of a preferred equity financing or closing of a merger, business combination or sale of stock resulting in Synchronicity’s stockholders owning less than 50% of the surviving entity. The note is classified as a corporate debt instrument and is classified as available-for-sale. During the year ended December 31, 2020, the Company recorded an other-than-temporary credit loss of $1.0 million against the value of this investment. The loss was recorded within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive loss. 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, 2020, the Company’s total contribution in Fountain was equal to €7.0 million, During the year ended December 31, 2020, two of the companies within the Fountain portfolio were acquired by third parties. The Company’s proportional share of the proceeds from these transactions was $11.1 million, of which $10.4 million was received in September 2020 and $0.7 million is being held in escrow. The Company expects to collect the funds in escrow in 2021. The transactions were accounted for under the cumulative earnings approach whereby the return on investment of $8.3 million was recorded as a gain within “Other income (expense), net” in the accompanying consolidated statements of operations and comprehensive loss and the return of investment of $2.8 million was recorded as a reduction in the Company’s net investment in Fountain. The Company’s net investment in Fountain was $6.2 million and $5.9 million at December 31, 2020 and 2019, respectively, and was included within “Other assets” in the accompanying consolidated balance sheets. During the years ended December 31, 2020, 2019 and 2018, the Company recorded an increase in its investment in Fountain of $0.3 million, a reduction of $0.4 million and an increase of $0.5 million, respectively, which represented the Company’s proportional share of Fountain’s net gains or losses for such periods. 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) 2020 2019 2018 Proceeds from the sales and maturities of marketable securities $ 253,001 $ 224,602 $ 444,456 Realized gains $ 76 $ 997 $ 4 Realized losses $ 977 $ 497 $ 268 The Company’s available‑for‑sale and held‑to‑maturity securities at December 31, 2020 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 $ 242,605 $ 242,365 $ 3,487 $ 3,674 After 1 year through 5 years 139,674 140,807 — — Total $ 382,279 $ 383,172 $ 3,487 $ 3,674 |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 41,849 $ 41,849 $ — $ — U.S. government and agency debt securities 103,345 73,451 29,894 — Corporate debt securities 184,956 — 183,979 977 International government agency debt securities 94,871 — 94,871 — Contingent consideration 32,451 — — 32,451 Total $ 457,472 $ 115,300 $ 308,744 $ 33,428 December 31, 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 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 between levels during the year ended December 31, 2020. 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, 2020: (In thousands) Fair Value Balance, January 1, 2020 $ 34,353 Change in the fair value of contingent consideration 3,945 Milestone and royalty payments received by the Company related to contingent consideration (3,886 ) Royalty payments due to the Company related to contingent consideration (7 ) Impairment of corporate debt security (977 ) Balance, December 31, 2020 $ 33,428 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 sold 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 to Recro Pharma, Inc. (“Recro”) and Recro Gainesville LLC (such transaction the “Gainesville Transaction”). The Gainesville Transaction included in the purchase price contingent consideration tied to low double digit royalties on net sales of the IV/IM and parenteral forms of Meloxicam and 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, pursuant to the Gainesville Transaction (such products, the “Meloxicam Products”), and milestone payments upon the achievement of certain regulatory and sales milestones related to the Meloxicam Products. In November 2019, Recro spun out its acute care segment to Baudax Bio, Inc. (“Baudax”), a publicly-traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax. In Baudax’s Quarterly Report on Form 10-Q for the period ended September 30, 2020, Baudax included disclosures around its ability to continue as a going concern. At December 3 1 , 2020 , the Company determined the fair value of the contingent consideration to be received as follows : • The Company received $3.8 million and $10.0 million in milestone payments during 2020 and 2019, respectively, and is due to receive an additional $1.5 million in June 2021 related to the FDA approval in February 2020 of the NDA for ANJESO, the first Meloxicam Product, and $45.0 million in seven equal, annual installments beginning in February 2021, which is the first anniversary of such approval; • The Company is entitled to receive future royalties on net sales of Meloxicam Products; 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. In order to address the substantial doubt about Baudax’s ability to continue as a going concern, the Company split its fair value analysis into two scenarios and applied an equal weighting to each. In the first scenario, the amounts above were all discounted using a rate of 13%, which the Company believes captures a market participant’s view of the risk associated with the expected payments assuming Baudax is able to continue as a going concern. In the second scenario, the Company used the undiscounted values derived from the amounts summarized above and applied a recovery rate of 18%, based on an analysis performed by Moody’s Investor Service regarding recoveries in a pandemic-driven default cycle. At December 31, 2020 and 2019, the Company determined that the fair value of the contingent consideration was $32.5 million and $32.4 million, respectively. At December 31, 2020 and 2019, $7.8 million and none, respectively, of the fair value of the contingent consideration was included within “Prepaid expenses and other current assets” in the accompanying consolidated balance sheets, and $24.7 million and $32.4 million, respectively, of the fair value of the contingent consideration was included within “Contingent consideration” in the accompanying consolidated balance sheets. The Company recorded an increase of $3.9 million, and decreases of $22.8 million and $19.6 million during the years ended December 31, 2020, 2019 and 2018, respectively, within “Change in the fair value of contingent consideration” in the accompanying consolidated statements of operations and comprehensive loss. The carrying amounts reflected in the accompanying 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 $275.1 million and $277.9 million at December 31, 2020 and 2019, respectively. Please refer to Note 11, Long-Term Debt |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. INVENTORY Inventory consists of the following: December 31, December 31, (In thousands) 2020 2019 Raw materials $ 44,944 $ 34,577 Work in process 53,243 54,061 Finished goods (1) 27,551 13,165 Total inventory $ 125,738 $ 101,803 (1) At December 31, 2020 and 2019, the Company had $26.5 million and $7.6 million, respectively, of finished goods inventory located at its third‑party warehouse and shipping service provider. In November 2020, the Company received a complete response letter, which included a request for information, from the FDA regarding the LYBALVI (formerly referred to as ALKS 3831) NDA, following the FDA’s remote review of manufacturing records to the manufacture of LYBALVI at the Company’s Wilmington, Ohio facility. The NDA was resubmitted in December 2020 and the assigned the NDA a Prescription Drug User Fee Act target action date of June 1, 2021. In the third quarter of 2020, the Company capitalized a total of $15.3 million of LYBALVI inventory in advance of regulatory approval, of which $6.3 million was subsequently expensed in the fourth quarter of 2020 as the Company determined that certain lots were no longer probable of being sold commercially. As of December 31, 2020 and 2019, the carrying value of inventory included $13.8 million and none, respectively, associated with LYBALVI, which was capitalized in advance of regulatory approval. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 Land $ 6,560 $ 6,560 Building and improvements 178,194 177,087 Furniture, fixtures and equipment 366,051 340,146 Leasehold improvements 52,508 20,737 Construction in progress 102,833 134,683 Subtotal 706,146 679,213 Less: accumulated depreciation (356,143 ) (317,045 ) Total property, plant and equipment, net $ 350,003 $ 362,168 Depreciation expense was $42.4 million, $40.1 million and $38.5 million for the years ended December 31, 2020, 2019 and 2018, respectively. Also, during the years ended December 31, 2020, 2019 and 2018, the Company wrote off furniture, fixtures and equipment that had an approximate carrying value of less than $0.1 million, $0.9 million and $0.5 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. Approximately $24.2 million of the construction in progress balance at December 31, 2020 relates to certain building and equipment that the Company would place into service upon approval by the FDA of the NDA for LYBALVI. 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, 2020 | |
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, 2020 December 31, 2019 (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 $ (377,727 ) $ 87,863 $ 465,590 $ (348,595 ) $ 116,995 NanoCrystal technology 13 74,600 (54,391 ) 20,209 74,600 (46,773 ) 27,827 OCR (1) 12 42,560 (39,441 ) 3,119 42,560 (36,739 ) 5,821 Total $ 582,750 $ (471,559 ) $ 111,191 $ 582,750 $ (432,107 ) $ 150,643 (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 $39.5 million, $40.4 million and $65.2 million of amortization expense related to its finite‑lived intangible assets during the years ended December 31, 2020, 2019 and 2018, respectively. Based on the Company’s most recent analysis, amortization of intangible assets included within its consolidated balance sheets at December 31, 2020 is expected to be approximately $40.0 million, $35.0 million, $35.0 million, $1.0 million and none in the years ending December 31, 20 2 1 through 202 5 , 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, 2020. The Company elected to perform a quantitative impairment test and determined that the fair value of the reporting unit exceeded its carrying value. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 9. LEASES Leases are recorded in accordance with FASB Topic 842, which the Company adopted on January 1, 2019 under the modified retrospective transition method. The Company determines if an arrangement includes a lease at the inception of the agreement. For each of the Company’s lease arrangements, a right-of-use asset representing its right to use an underlying asset for the lease term and a lease liability representing its obligation to make lease payments are recorded. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the net present value of lease payments over the term of the lease. “Item 2—Properties” in this Annual Report for a description of the significant operating leases of offices and laboratory space the Company had as of December 31, 2020. The Company did not assume lease extension options would be exercised in its right-of-use asset and lease liability amounts. The Company has three additional operating leases that are included in its lease accounting but are not considered significant. The Company determined that the identified operating leases did not contain non-lease components and required 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, 2020, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 5.25% and 12.6 years, respectively. In July 2020, the Company entered into an amendment to its existing lease at 852 Winter Street, Waltham, Massachusetts (as amended, the “852 Winter Street Lease”). The amendment became effective on October 7, 2020. The 852 Winter Street Lease governs approximately 180,000 square feet of corporate office space, administrative areas and laboratories. The amendment served to, among other things, extend the term of the 852 Winter Street Lease for a period of approximately five years, to commence in March 2021 and expire in April 2026 with respect to approximately 163,000 square feet of the 852 Winter Street Lease premises (the “Base Premises”) and to commence in September 2021 and expire in October 2026 with respect to approximately 17,000 square feet of the 852 Winter Street Lease premises (the “Additional Premises”). The Company expects to make annual lease payments of approximately $5.7 million for the Base Premises and $0.5 million for the Additional Premises, subject to annual increases. Under the terms of the 852 Winter Street Lease, the Company will have the option to extend the term for an additional five-year 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 that was to be built at 900 Winter Street, Waltham, Massachusetts (the “900 Winter Street Lease”). The initial term of the lease commenced on January 20, 2020 (the “Commencement Date”) and includes an option to extend the term for an additional ten-year lease had not commenced as of December 31, 2019 and 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, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined below do not include the 900 Winter Street Lease payments as of December 31, 2019 under Topic 842. As of December 31, 2020 and 2019, right-of-use assets arising from operating leases were $131.7 million and $12.4 million, respectively, and right-of-use liabilities arising from operating leases were $135.2 million and $13.8 million, respectively. During the year ended December 31, 2020 and 2019, cash paid for amounts included for the measurement of lease liabilities was $17.3 million and $9.1 million, respectively. The Company recorded operating lease expense of $16.3 million, $8.1 million and $10.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. Future lease payments under non-cancelable leases as of December 31, 2020 consisted of the following: December 31, (In thousands) 2020 2021 $ 16,882 2022 17,001 2023 17,266 2024 17,536 2025 17,810 Thereafter 109,311 Total lease payments $ 195,806 Less: imputed interest (60,610 ) Total operating lease liabilities $ 135,196 For comparable purposes, 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 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 Accounts payable $ 46,034 $ 54,261 Accrued compensation 71,178 72,072 Accrued sales discounts, allowances and reserves 218,877 153,902 Accrued other 76,082 92,802 Total accounts payable and accrued expenses $ 412,171 $ 373,037 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG‑TERM DEBT Long‑term debt consists of the following: December 31, December 31, (In thousands) 2020 2019 2023 Term Loans, due March 26, 2023 $ 274,961 $ 277,138 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 272,118 $ 274,295 2023 Term Loans In March 2018, the Company amended and refinanced its existing term loan, previously 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: 2021 $ 2,843 2022 2,843 2023 270,747 2024 — 2025 — Total $ 276,433 The Company is subject to mandatory prepayments of principal if certain excess cash flow thresholds, as defined in the 2023 Term Loans, are 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, 2020. At December 31, 2020, the Company’s balance of unamortized deferred financing costs and unamortized original issue discount costs were $0.4 million and $1.0 million, respectively. These costs are being amortized to interest expense over the estimated repayment period of the 2023 Term Loans using the effective interest method. During each of the years ended December 31, 2020, 2019 and 2018, the Company had amortization expense of $0.7 million related to deferred financing costs and original issue discount. |
Loss Per Share
Loss Per Share | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 2019 and 2018, 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 had an anti-dilutive effect on loss per share. The following potential ordinary share equivalents 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) 2020 2019 2018 Stock options 15,274 13,814 11,331 Restricted stock units 3,279 3,177 2,592 Total 18,553 16,991 13,923 |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 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, 2020 and 2019, the Company did not acquire any ordinary shares under the repurchase program. |
Share-based Compensation
Share-based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 2018 Cost of goods manufactured and sold $ 8,430 $ 9,948 $ 9,174 Research and development 26,408 29,924 32,943 Selling, general and administrative 55,326 61,105 63,240 Total share-based compensation expense $ 90,164 $ 100,977 $ 105,357 During the years ended December 31, 2020, 2019 and 2018, $2.6 million, $1.5 million and $2.7 million, respectively, of share‑based compensation expense was capitalized and recorded as “Inventory” in the accompanying consolidated balance sheets. Share‑Based Compensation Plans The Company has one share-based compensation plan pursuant to which awards are currently being made: the 2018 Stock Option and Incentive Plan, as amended (the “2018 Plan”). The Company has two share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: the Alkermes plc Amended and Restated 2008 Stock Option and Incentive Plan, as amended, (the “2008 Plan”) and the Alkermes plc 2011 Stock Option and Incentive Plan, as amended (the “2011 Plan”). Effective May 20, 2020, the 2018 Plan was amended such that any shares underlying any outstanding awards granted under the 2011 Plan or the 2008 Plan that are forfeited, canceled, repurchased or otherwise terminated (other than by exercise) from and after such date will become available for issuance pursuant to the 2018 Plan, notwithstanding anything to the contrary in the terms of the 2011 Plan or the 2008 Plan. The 2018 Plan allows 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, as applicable. At December 31, 2020, there were 13.9 million ordinary shares available for issuance in the aggregate under the 2018 Plan. The 2018 Plan provides 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, 2020 15,235,845 $ 40.34 Granted 3,799,952 $ 20.20 Exercised (682,122 ) $ 12.27 Expired (1,266,999 ) $ 49.81 Forfeited (974,487 ) $ 36.28 Outstanding, December 31, 2020 16,112,189 $ 36.27 Exercisable, December 31, 2020 9,842,531 $ 40.08 The weighted average grant date fair value of stock options granted during the years ended December 31, 2020, 2019 and 2018 was $9.52, $15.57 and $30.47, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2020, 2019 and 2018 was $2.0 million, $21.3 million and $35.5 million, respectively. At December 31, 2020, there were 6.1 million stock options expected to vest with a weighted average exercise price of $30.46 per share, a weighted average contractual remaining life of 8.5 years with an aggregate intrinsic value of $0.2 million. At December 31, 2020, the aggregate intrinsic value of stock options exercisable was $6.9 million with a weighted average remaining contractual term of 4.3 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, 2020, there was $34.6 million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted average period of 1.8 years. Included within the outstanding stock option balances at December 31, 2020 was 0.4 million performance-based stock options that were granted in 2019 and valued using a Monte Carlo simulation model. The weighted average grant date fair value of such performance-based stock options was $16.78. The unrecognized compensation cost related to these performance-based stock options was $1.9 million at December 31, 2020 and is included in the unrecognized compensation cost noted above. Cash received from option exercises under the Company’s award plans during the years ended December 31, 2020, 2019 and 2018 was $8.4 million, $18.9 million and $20.9 million, respectively. Time‑Based Restricted Stock Unit Awards 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, 2020 3,744,800 $ 38.99 Granted 3,494,759 $ 20.22 Vested (1,097,210 ) $ 41.84 Forfeited (587,087 ) $ 31.16 Unvested, December 31, 2020 5,555,262 $ 27.45 The weighted average grant date fair value of time‑vested RSUs granted during the years ended December 31, 2020, 2019 and 2018 were $20.22, $30.47 and $63.01, respectively. The total fair value of time‑vested RSUs that vested during the years ended December 31, 2020, 2019 and 2018, was $45.9 million, $42.4 million and $34.5 million, respectively. At December 31, 2020, there was $61.0 million of total unrecognized compensation cost related to unvested time‑vested RSUs, which will be recognized over a weighted average remaining contractual term of 1.8 years. Performance-Based Restricted Stock Unit Awards In February 2020, the compensation committee of the Company’s board of directors approved awards of performance-based RSUs to employees of the Company at the Senior Vice President level and above, in each case subject to vesting on the achievement of certain commercial and R&D performance criteria to be assessed over a performance period of three years from the date of the grant, and subject, at the end of such three-year performance period, to upward or downward adjustment based on a market condition tied to relative share price performance over the three-year performance period. 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, 2020 543,554 $ 54.75 Granted 529,578 $ 23.43 Forfeited (574,148 ) $ 53.08 Vested — $ — Unvested, December 31, 2020 498,984 $ 23.43 As the performance-based RSUs granted in February 2020 are subject to a market condition, the grant date fair value for such RSUs was based on a Monte Carlo simulation model. At December 31, 2020, the Company believed it probable that commercial performance criteria underlying the RSUs will be met and, accordingly, has recognized share-based compensation expense related to this portion of the performance-based RSUs. At December 31, 2020, the Company did not consider it probable that the performance criteria related to the R&D portion of the awards will be met and has not recognized any additional share-based compensation expense related to this portion of the performance-based RSUs. At December 31, 2020, there was $ 10.4 million of unrecognized compensation cost related to the R&D portion of the performance-based RSUs, which would be recognized in accordance with the terms of the award when the Company deems it probable that the performance criteria will be met. The unvested awards will expire if it is determined that the performance criteria have not been met on or before December 31, 2022. 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 certain performance criteria which were to be assessed over a performance period of three years from the date of the grant (the “2017 Performance Awards”). The grant date fair value of the 2017 Performance Awards was equal to the closing price of the Company’s stock on the Nasdaq Global Select Market on the dates of grant. In December 2018, the Company achieved one such performance criteria, resulting in the vesting of a portion of the 2017 Performance Awards. Prior to December 2018, the Company did not consider it probable that the performance criteria related to the awards would be met and had not recognized any share-based compensation expense related to the 2017 Performance Awards. Once it was deemed probable that certain performance conditions would be achieved, the Company In the first quarter of 2020, the compensation committee of the Company’s board of directors determined the two remaining performance criteria of the 2017 Performance Awards were not achieved. The unvested portion of the 2017 Performance Awards expired as the performance conditions were not met on or before the three year anniversary of the grant date. |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2020 | |
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 resulted in cash expenditures and substantially all of which were paid out by December 31, 2020. Restructuring activity during the year ended December 31, 2020 was as follows: (In thousands) Balance, January 1, 2020 $ 9,201 Amounts paid during the period: Severance (7,354 ) Outplacement services (108 ) Benefits (1,277 ) Balance, December 31, 2020 $ 462 At December 31, 2020 and 2019, $0.5 million and $9.0 million of the restructuring accrual were included within “Accounts payable and accrued expenses” in the accompanying consolidated balance sheets, respectively, and none and $0.2 million of the restructuring accrual were included within “Other long-term liabilities” in the accompanying consolidated balance sheets, respectively. |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Acquisition | 16. ACQUISITION 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. 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 former 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 was largely in the preclinical 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 were considered probable of occurring at December 31, 2020 and 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, 2020 | |
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, 2020, 2019 and 2018 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%. 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 terminates Acorda’s license in any country, the Company is entitled to a license from Acorda of its patent rights and know-how relating to the product as well as the related data, information and regulatory files, and to market the product in the applicable country, subject to an initial payment equal to Acorda’s cost of developing such data, information and regulatory files and to ongoing royalty payments to Acorda. Subject to the termination of the amended and restated license agreement, licenses granted under the license agreement terminate on a country-by-country basis upon the expiration of the last to expire of our patents or the existence of a threshold level of competition in the marketplace. Under its commercial manufacturing supply agreement with Acorda, the Company manufactures and supplies AMPYRA/FAMPYRA for Acorda (and its sub‑licensee, Biogen). Under the terms of the agreement, Acorda may obtain up to 25% of its total annual requirements of product from a second‑source manufacturer. The Company receives manufacturing royalties equal to 8% of net selling price (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: (i) initiation of a phase 3 clinical trial: $1.0 million; (ii) acceptance of an NDA by the FDA: $1.0 million; (iii) approval of the NDA by the FDA: $1.5 million; and (iv) the first commercial sale: $1.5 million. 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. Biogen has elected to initiate a technology transfer and, following a transition period, assume responsibility 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 that portion 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 18. INCOME TAXES The Company’s provision (benefit) for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2020 2019 2018 Current income tax provision (benefit): U.S. federal $ 2,943 $ (471 ) $ (53 ) U.S. state 1,396 354 1,774 Rest of world — — — Deferred income tax provision (benefit): U.S. federal 9,876 (1,503 ) 10,624 U.S. state 109 881 62 Ireland — 303 (63 ) Total tax provision (benefit) $ 14,324 $ (436 ) $ 12,344 The income tax provision in 2020, the income tax benefit in 2019 and the income tax provision in 2018 were primarily due to U.S. federal and state taxes. The unfavorable change in income taxes in 2020, as compared to 2019, and the favorable change in income taxes in 2019, as compared to 2018 was primarily due to a significant benefit recorded in 2019 relating to the foreign derived intangible income (“FDII”) proposed regulations issued by the U.S. Department of the Treasury and the U.S. Internal Revenue Service in March 2019. On March 27, 2020 the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was passed by the U.S. Congress and signed into law by the President of the United States. The CARES Act, among other things, includes certain income tax provisions for individuals and corporations; however, these benefits have limited impact on the Company’s income tax provision. 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. Cumulative unremitted earnings of overseas subsidiaries totaled approximately $369.0 million at December 31, 2020. 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 $38.0 million of income taxes would be payable on the repatriation of the unremitted earnings to Ireland. The distribution of the Company’s loss before the provision (benefit) for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2020 2019 2018 Ireland $ (138,070 ) $ (141,869 ) $ (180,195 ) U.S. 41,599 (55,102 ) 53,287 Rest of world (66 ) (85 ) (59 ) Loss before provision (benefit) for income taxes $ (96,537 ) $ (197,056 ) $ (126,967 ) The components of the Company’s net deferred tax assets (liabilities) were as follows: December 31, December 31, (In thousands) 2020 2019 Deferred tax assets: NOL carryforwards $ 233,755 $ 227,872 Tax credits 59,098 57,385 Accrued expenses and reserves 49,730 20,337 Share-based compensation 44,480 45,214 Other 6,651 8,756 Less: valuation allowance (253,649 ) (242,059 ) Total deferred tax assets 140,065 117,505 Deferred tax liabilities: Property, plant and equipment (52,707 ) (19,926 ) Other (1,697 ) (1,590 ) Total deferred tax liabilities (54,404 ) (21,516 ) Net deferred tax assets $ 85,661 $ 95,989 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, 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 ) Deferred tax asset valuation allowance for the year ended December 31, 2020 $ (242,059 ) $ (11,590 ) $ (253,649 ) (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, 2020, the Company maintained a valuation allowance of $20.9 million against certain U.S. state deferred tax assets and $232.8 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, 2020, the Company had $1.6 billion of Irish NOL carryforwards, $33.3 million of U.S. federal NOL carryforwards, $43.2 million of state NOL carryforwards, $48.6 million of federal R&D credits and $23.0 million of state tax credits which will either expire on various dates through 2040 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 $51.3 million of U.S. federal NOL carryforwards, $43.2 million of state NOL carryforwards, $0.7 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) 2020 2019 2018 Statutory tax rate 12.5 % 12.5 % 12.5 % Loss before income taxes at statutory rate $ (12,067 ) $ (24,632 ) $ (15,871 ) Change in valuation allowance 11,590 19,882 28,371 Share-based compensation 8,972 6,287 1,163 Foreign rate differential ( 1) 7,798 5,390 5,405 Intercompany amounts ( 2) 6,234 (1,125 ) (751 ) U.S. state income taxes, net of U.S. federal benefit 1,298 1,051 1,732 Irish rate differential ( 3) 2,511 (146 ) (2,350 ) Uncertain tax positions 811 776 563 Non deductible lobbying expenses 683 736 661 Federal tax law change ( 4) 248 (8,111 ) — In-process R&D ( 5) 84 10,824 — Foreign derived intangible income (3,125 ) (3,450 ) — R&D credit (11,198 ) (8,846 ) (7,698 ) Other permanent items ( 6) 485 928 1,119 Income tax provision (benefit) $ 14,324 $ (436 ) $ 12,344 Effective tax rate (14.8 ) % 0.2 % (9.7 ) % ( 1 ) Represents income or losses of non-Irish subsidiaries, including U.S. subsidiaries, subject to tax at a rate other than the Irish statutory rate. ( 2 ) 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. (3) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. (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. (5) Represents the tax effect of the research and development expense recorded on the acquisition of Rodin. ( 6 ) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses and non-deductible compensation of senior officers of the Company. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Unrecognized (In thousands) Tax Benefits Balance, December 31, 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 Additions based on tax positions related to prior periods 15 Additions based on tax positions related to the current period 796 Balance, December 31, 2020 $ 7,668 The unrecognized tax benefits at December 31, 2020, 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, 2020, 2019 and 2018, 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 2017 through 2020 fiscal years remain subject to examination by the respective tax authorities. In Ireland, the years 201 6 to 2020 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 Finance S.a.r.l are currently under examination by the Tax Authorities in Luxembourg. There are no uncertain tax positions or adjustments associated with the audit at this time. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
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, utilizing all 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, 2020, 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 Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC, following the respective filings by each of Teva, Mylan Labs, and Pharmascience of an Abbreviated New Drug Application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. In October 2020, a trial was held in the lawsuit between the Janssen entities and the Teva entities. Requested judicial remedies in each of the lawsuits included recovery of litigation costs and injunctive relief. The Company is not a party to any of these proceedings. INVEGA TRINZA ANDA Litigation In September 2020, Janssen Pharmaceuticals NV, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC, initiated a patent infringement lawsuit in the NJ District Court against Mylan Labs, Mylan, and Mylan Institutional LLC following the filing by Mylan Labs of an ANDA seeking approval from the FDA to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693. Requested judicial remedies include recovery of litigation costs and injunctive relief. The Company is not a party to this proceeding. 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 and Nanjing Luye Pharmaceutical Co Ltd. and Teva Pharmaceutical Industries Ltd. submitted replies on December 20, 2019. The Company will continue to vigorously defend the EP ’577 Patent. VIVITROL ANDA Litigation In September 2020, Alkermes, Inc. and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the NJ District Court against Teva and Teva PI following the filing by Teva of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VIVITROL (naltrexone for extended-release injectable suspension) before the expiration of the Company’s U.S. Patent No. 7,919,499. Teva filed its Answer on November 16, 2020, which included counterclaims against the Company. The Company filed its Reply to Teva’s counterclaims on December 7, 2020. The Company intends to vigorously defend its intellectual property. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). Government Matters The Company has received a subpoena and civil investigative demands from U.S. state and Federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations. 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 U.S. 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 and McDermott v. Alkermes plc, et al., No. 1:19-cv-00624 Product Liability and Other Legal Proceedings The Company is also involved in product liability cases and other legal proceedings incidental to its normal business activities, including product liability cases alleging that the FDA-approved VIVITROL labeling was inadequate and caused the users of the product to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters. While the outcome of any of these proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these existing matters would have a material adverse effect on the Company’s business or financial condition. Purchase Commitments The Company has open purchase orders for plant and equipment as part of the normal course of business. At December 31, 2020, the Company’s open purchase orders were $3.5 million for capital commitments. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated. During the year ended December 31, 2020, Alkermes Finance S.à r.l, an indirect subsidiary of Alkermes plc, was liquidated and its net assets were transferred to its parent company, Alkermes Pharma Ireland Limited. |
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 cash equivalents only those investments that 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. |
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, 2020, 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, 2020, 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, 2020 included U.S. treasury securities, marketable securities classified as cash equivalents and a fixed term deposit account; • Level 2 –these valuations are based on quoted prices for identical or similar assets in active markets or other market observable inputs such as interest rates, yield curves, foreign currency spot rates and option pricing valuation models. Assets utilizing Level 2 inputs at December 31, 2020 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, 2020, 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 preclinical 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. The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management’s judgment, future commercialization of the product is considered probable and future economic benefit from such product is expected to be realized. The Company assesses the regulatory approval process and where the particular product stands in relation to that approval process, including any known safety, efficacy or quality concerns, potential labeling restrictions and other potential impediments to approval. The Company also considers the shelf life of the product in relation to the expected timeline for approval and considers issues that may prevent or delay commercialization, including issues that may arise in relation to the manufacturing of the product. The Company expenses previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or significant delay of approval by relevant regulatory agencies or other issues that may make the pre-approval inventory batches less likely or unlikely to be commercialized and to result in future economic benefit. |
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 likelihood of achievement of milestones and of receipt of the 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, changes in the assumed probability associated with regulatory approvals and creditworthiness of the counterparty. 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; a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset; an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset; a current-period operating or cash flow loss combined with a history of operating or cash-flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset; or a current expectation that, more likely than not, a long-lived asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life. 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. In the fourth quarter of 2020, the Company determined that an impairment triggering event occurred and evaluated certain of its long-lived assets for impairment under a held-and-used model. The Company concluded that the long-lived assets evaluated for impairment were recoverable based on an analysis of the undiscounted net cash flows to be generated from the use of these assets. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers 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. 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 — • Chargebacks — 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 returns of product sold 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 reduction of sales. Once product is returned, it is destroyed; and • Medicare Part D — Collaborative Arrangements The Company has entered into collaboration agreements with pharmaceutical companies including, among others, 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. Substantially all of the Company’s royalties 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. 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, preclinical 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 amounts unbilled but currently unconditionally due from customers. The amounts due are stated at their net estimated realizable value. The Company’s unbilled receivable balance was $110.9 million and $89.7 million at December 31, 2020 and 2019, respectively, and related primarily to royalty revenues. 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 approximately $0.1 million and $0.2 million at December 31, 2020 and 2019, respectively. |
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 two years, and is included in “Other assets” in the accompanying consolidated balance sheets. The manufacturing-related amounts included in the contract assets table below are classified as “Current assets” in the accompanying consolidated balance sheets, as they related to manufacturing processes that are completed in ten days to eight weeks. Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2019 $ 8,230 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 13,386 Additions 46,325 Transferred to receivables, net (40,310 ) Contract assets at December 31, 2020 $ 19,401 |
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, 2019 $ 12,694 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 28,834 Additions — Amounts recognized into revenue (4,925 ) Contract liabilities at December 31, 2020 $ 23,909 |
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 income (expense), net” in the accompanying consolidated statements of operations and comprehensive loss. During the years ended December 31, 2020, 2019 and 2018, the Company recorded a gain (loss) on foreign currency translation of $2.4 million, $(0.9) million and $(2.3) 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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 30 % 33 % 29 % 28 % 27 % 29 % Biogen * * * 17 % * 10 % Cardinal Health 16 % 21 % 12 % * * 13 % AmerisourceBergen 11 % 10 % 10 % * * * McKesson * 14 % * * * * Acorda * * * * 15 % 10 % * Indicates the revenues or receivables for the customer did not exceed 10% of the Company’s total in each category as of or for the years ended December 31, 2020, 2019 and 2018, 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 ensure 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) 2020 2019 2018 Revenue by region: U.S. $ 838,995 $ 966,929 $ 884,600 Ireland 3,233 3,195 4,915 Rest of world 196,528 200,823 204,759 Assets by region: Current assets: U.S. $ 662,615 $ 551,799 $ 546,533 Ireland 448,356 407,791 433,837 Rest of world — 2,381 2,882 Long-term assets: U.S.: Other $ 472,999 $ 382,029 $ 312,243 Ireland: Intangible assets $ 111,191 $ 150,643 $ 191,001 Goodwill 92,873 92,873 92,873 Other 161,696 217,887 245,638 |
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 selling and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising, financial and legal expenses and other general and administrative costs. Advertising costs are expensed as incurred. During the years ended December 31, 2020, 2019 and 2018, advertising costs totaled $25.5 million, $31.1 million and $54.7 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 unit awards (“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 options or the vesting of RSUs. Under the terms of the Company’s stock option plans (the “Plans”), certain of the Company’s employees may, at the discretion of the plan administrator, 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 would be expensed in full on the grant date or upon meeting the retirement eligibility criteria, whichever is later. Time-Based Stock Options Except as otherwise provided in the applicable Plan, stock option grants to employees expire ten years from the grant date and generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed with the Company during the applicable vesting period. Except as otherwise provided in the applicable Plan, stock option grants to non-employee directors expire ten years from the grant date and generally vest over a one year period provided that the director continues to serve on the Company’s board of directors through the vesting date. The estimated fair value of options is recognized over the requisite service period, which is generally the vesting period. Share‑based compensation expense is based on awards ultimately expected to vest. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The fair value of stock option grants is based on estimates as of the date of grant using a Black‑Scholes option valuation model. The Company uses historical data as the basis for estimating stock 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 of 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 weekly price changes of the Company’s ordinary shares. The risk‑free interest rate for periods commensurate with the expected term of the stock 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 dividends, and does not expect to pay dividends in the near future. 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, 2020 2019 2018 Expected option term 5 - 7 years 5 - 7 years 5 - 8 years Expected stock volatility 47 % - 54 % 46 % - 50 % 44 % - 49 % Risk-free interest rate 0.24 % - 1.69 % 1.34 % - 2.59 % 2.25 % - 3.10 % 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 Unit Awards Except as otherwise provided in the applicable Plan, time‑based RSUs awarded to employees generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed with the Company during the applicable vesting period. Shares subject to these RSUs are delivered to the employee upon vesting, subject to payment of applicable withholding taxes. The fair value of time‑based RSUs is equal to the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. Performance-Based Restricted Stock Unit Awards Performance-based RSUs awarded to employees vest upon the achievement of certain performance criteria, typically during or at the end of a specified performance period. The estimated fair value of these RSUs are generally based on the closing price of the Company’s ordinary shares traded on the Nasdaq Global Select Market on the date of grant, unless the RSU is also subject to a market condition. In that case, the fair value of the RSU is based on a Monte Carlo simulation model. Compensation expense for performance-based RSUs is recognized from the date the Company determines the performance criteria probable of being achieved to the date the award, or relevant portion of the award, is expected to vest. Cumulative adjustments are recorded on a quarterly basis to reflect subsequent changes to the estimated outcome of the performance criteria 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 and 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 address unmet medical needs of patients in major therapeutic areas. 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, 2020, 2019 and 2018, the Company contributed $14.7 million, $14.8 million and $12.1 million, respectively, to match employee deferrals under the 401(k) Plan. Defined Contribution Plan The Company maintains a defined contribution plan for its Ireland‑based employees (the “Defined Contribution Plan”). The Defined Contribution Plan provides for eligible employees to contribute up to 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, 2020, 2019 and 2018, the Company contributed $4.4 million, $4.1 million and $4.0 million, respectively, in contributions to the Defined Contribution Plan. |
Risk and Uncertainties | Risks and Uncertainties In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, restrictions, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and/or recommendations, and/or the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. The Company continues to closely monitor and rapidly respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact on the Company’s financial condition and operating results resulting from the pandemic may differ from current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of the pandemic on the Company’s employees, the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia; impacts of the pandemic on the regulatory agencies with which the Company interacts in the development, review, approval and commercialization of its medicines; impacts of the pandemic on reimbursement for the Company’s products, including the Company’s Medicaid rebate liability, and for services related to the use of its products; and impacts of the pandemic on the U.S., Irish and global economies more broadly. The Company relies upon third parties for many aspects of its business, including the provision of goods and services related to the manufacture of its clinical products and its and its partners’ marketed products, the conduct of its clinical trials, and the sale of marketed products from which the Company receives manufacturing and royalty revenue. Any prolonged material disruption to the third parties on which the Company relies could negatively impact the Company’s ability to conduct business in the manner and on the timelines presently planned, which could have a material adverse impact on the Company’s business, results of operations and financial condition. The marketed products from which the Company derives revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including the implementation of “shelter-in-place” policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and the Company expects commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists. As it relates to the Company’s proprietary marketed products, during the three months ended December 31, 2020, the Company saw a decrease of 5% in the number of VIVITROL units sold compared to the three months ended September 30, 2020. ARISTADA units sold during the three months ended December 31, 2020 increased 12% compared to the three months ended September 30, 2020. During the three months ended December 31, 2020, the Company continued to take actions to support uninterrupted access to its proprietary marketed products. However, the Company currently expects commercial sales of its marketed products, particularly VIVITROL, to continue to be impacted by the COVID-19 pandemic over the next few quarters. These items are discussed in greater detail in the “Results of Operations” section in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Annual Report. The Company continues to operate its manufacturing facilities and supply its medicines. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of its early-stage discovery efforts and clinical trials. The Company is working with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impacts of COVID-19 on its manufacturing operations and R&D activities. |
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. Recently Adopted Accounting Pronouncements The Company adopted ASU 2014-09, Topic 606, as of January 1, 2018, using the modified retrospective method for all contracts not completed as of the date of adoption. The Company adopted ASU 2016-02, Leases In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments account for credit losses and requires an impairment model, known as the current expected credit loss model (“CECL”), that is based on expected losses rather than incurred losses. Companies are required to carry an allowance for expected credit losses for most debt instruments (except those carried at fair value), trade receivables, certain lease receivables, reinsurance receivables, financial guarantee contracts and loan commitments. Available- for - sale debt securities are largely scoped out of th is guidance. The Company’s investment portfolio primarily consists of available- for - sale securities carried at fair value. Further, the Company’s trade receivables do not have abnormally long terms and the Company has rarely ever written off trade receivables. The adoption of this ASU did not have an impact on the Company’s consolidated financial statements. 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 New Accounting Pronouncements not Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 Contract Assets and Contract Liabilities | Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2019 $ 8,230 Additions 37,911 Transferred to receivables, net (32,755 ) Contract assets at December 31, 2019 13,386 Additions 46,325 Transferred to receivables, net (40,310 ) Contract assets at December 31, 2020 $ 19,401 Contract liabilities consisted of the following: (In thousands) Contract Liabilities Contract liabilities at January 1, 2019 $ 12,694 Additions 18,677 Amounts recognized into revenue (2,537 ) Contract liabilities at December 31, 2019 28,834 Additions — Amounts recognized into revenue (4,925 ) Contract liabilities at December 31, 2020 $ 23,909 |
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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Customer Receivables Revenue Receivables Revenue Receivables Revenue Janssen 30 % 33 % 29 % 28 % 27 % 29 % Biogen * * * 17 % * 10 % Cardinal Health 16 % 21 % 12 % * * 13 % AmerisourceBergen 11 % 10 % 10 % * * * McKesson * 14 % * * * * Acorda * * * * 15 % 10 % |
Schedule of Revenues by Geographic Location, as Determined by the Location of the Customer, and the Location of its Long-term Assets | Company revenues by geographic location, as determined by the location of the customer, and the location of its assets, are as follows: Year Ended December 31, (In thousands) 2020 2019 2018 Revenue by region: U.S. $ 838,995 $ 966,929 $ 884,600 Ireland 3,233 3,195 4,915 Rest of world 196,528 200,823 204,759 Assets by region: Current assets: U.S. $ 662,615 $ 551,799 $ 546,533 Ireland 448,356 407,791 433,837 Rest of world — 2,381 2,882 Long-term assets: U.S.: Other $ 472,999 $ 382,029 $ 312,243 Ireland: Intangible assets $ 111,191 $ 150,643 $ 191,001 Goodwill 92,873 92,873 92,873 Other 161,696 217,887 245,638 |
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, 2020 2019 2018 Expected option term 5 - 7 years 5 - 7 years 5 - 8 years Expected stock volatility 47 % - 54 % 46 % - 50 % 44 % - 49 % Risk-free interest rate 0.24 % - 1.69 % 1.34 % - 2.59 % 2.25 % - 3.10 % 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, 2020 | |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the years ended December 31, 2020, 2019 and 2018, the Company recorded product sales, net, as follows: Year Ended December 31, (In thousands) 2020 2019 2018 VIVITROL $ 310,722 $ 335,365 $ 302,609 ARISTADA and ARISTADA INITIO 241,038 189,134 147,725 Total product sales, net $ 551,760 $ 524,499 $ 450,334 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the years ended December 31, 2020, 2019 and 2018, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Year Ended December 31, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 274,200 $ 274,200 RISPERDAL CONSTA 56,893 14,468 71,361 AMPYRA/FAMPYRA 26,909 20,984 47,893 Other 35,232 55,314 90,546 $ 119,034 $ 364,966 $ 484,000 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 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Investments | Investments consist of the following: Gross Unrealized Losses Amortized Less than Greater than Allowance for Estimated December 31, 2020 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 176,937 $ 1,105 $ (7 ) $ — $ (977 ) $ 177,058 U.S. government and agency debt securities 103,011 336 (2 ) — — 103,345 International government agency debt securities 79,346 469 (6 ) — — 79,809 359,294 1,910 (15 ) — (977 ) 360,212 Held-to-maturity securities: Fixed term deposit account 1,667 187 — — — 1,854 Total short-term investments 360,961 2,097 (15 ) — (977 ) 362,066 Long-term investments: Available-for-sale securities: Corporate debt securities 7,908 — (10 ) — — 7,898 International government agency debt securities 15,077 — (15 ) — — 15,062 22,985 — (25 ) — — $ 22,960 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 24,805 — (25 ) — — 24,780 Total investments $ 385,766 $ 2,097 $ (40 ) $ — $ (977 ) $ 386,846 December 31, 2019 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 |
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) 2020 2019 2018 Proceeds from the sales and maturities of marketable securities $ 253,001 $ 224,602 $ 444,456 Realized gains $ 76 $ 997 $ 4 Realized losses $ 977 $ 497 $ 268 |
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, 2020 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 $ 242,605 $ 242,365 $ 3,487 $ 3,674 After 1 year through 5 years 139,674 140,807 — — Total $ 382,279 $ 383,172 $ 3,487 $ 3,674 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 41,849 $ 41,849 $ — $ — U.S. government and agency debt securities 103,345 73,451 29,894 — Corporate debt securities 184,956 — 183,979 977 International government agency debt securities 94,871 — 94,871 — Contingent consideration 32,451 — — 32,451 Total $ 457,472 $ 115,300 $ 308,744 $ 33,428 December 31, 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 |
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, 2020: (In thousands) Fair Value Balance, January 1, 2020 $ 34,353 Change in the fair value of contingent consideration 3,945 Milestone and royalty payments received by the Company related to contingent consideration (3,886 ) Royalty payments due to the Company related to contingent consideration (7 ) Impairment of corporate debt security (977 ) Balance, December 31, 2020 $ 33,428 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory consists of the following: December 31, December 31, (In thousands) 2020 2019 Raw materials $ 44,944 $ 34,577 Work in process 53,243 54,061 Finished goods (1) 27,551 13,165 Total inventory $ 125,738 $ 101,803 (1) At December 31, 2020 and 2019, the Company had $26.5 million and $7.6 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, 2020 | |
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) 2020 2019 Land $ 6,560 $ 6,560 Building and improvements 178,194 177,087 Furniture, fixtures and equipment 366,051 340,146 Leasehold improvements 52,508 20,737 Construction in progress 102,833 134,683 Subtotal 706,146 679,213 Less: accumulated depreciation (356,143 ) (317,045 ) Total property, plant and equipment, net $ 350,003 $ 362,168 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consist of the following: December 31, 2020 December 31, 2019 (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 $ (377,727 ) $ 87,863 $ 465,590 $ (348,595 ) $ 116,995 NanoCrystal technology 13 74,600 (54,391 ) 20,209 74,600 (46,773 ) 27,827 OCR (1) 12 42,560 (39,441 ) 3,119 42,560 (36,739 ) 5,821 Total $ 582,750 $ (471,559 ) $ 111,191 $ 582,750 $ (432,107 ) $ 150,643 (1) OCR refers to the Company’s oral control |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of December 31, 2020 consisted of the following: December 31, (In thousands) 2020 2021 $ 16,882 2022 17,001 2023 17,266 2024 17,536 2025 17,810 Thereafter 109,311 Total lease payments $ 195,806 Less: imputed interest (60,610 ) Total operating lease liabilities $ 135,196 For comparable purposes, 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 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 Accounts payable $ 46,034 $ 54,261 Accrued compensation 71,178 72,072 Accrued sales discounts, allowances and reserves 218,877 153,902 Accrued other 76,082 92,802 Total accounts payable and accrued expenses $ 412,171 $ 373,037 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long‑term debt consists of the following: December 31, December 31, (In thousands) 2020 2019 2023 Term Loans, due March 26, 2023 $ 274,961 $ 277,138 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 272,118 $ 274,295 |
Scheduled Maturities of Term Loan Facility | Scheduled maturities with respect to the 2023 Term Loans are as follows (in thousands): Year Ending December 31: 2021 $ 2,843 2022 2,843 2023 270,747 2024 — 2025 — Total $ 276,433 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share | The following potential ordinary share equivalents 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) 2020 2019 2018 Stock options 15,274 13,814 11,331 Restricted stock units 3,279 3,177 2,592 Total 18,553 16,991 13,923 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 2018 Cost of goods manufactured and sold $ 8,430 $ 9,948 $ 9,174 Research and development 26,408 29,924 32,943 Selling, general and administrative 55,326 61,105 63,240 Total share-based compensation expense $ 90,164 $ 100,977 $ 105,357 |
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, 2020 15,235,845 $ 40.34 Granted 3,799,952 $ 20.20 Exercised (682,122 ) $ 12.27 Expired (1,266,999 ) $ 49.81 Forfeited (974,487 ) $ 36.28 Outstanding, December 31, 2020 16,112,189 $ 36.27 Exercisable, December 31, 2020 9,842,531 $ 40.08 |
Time-based RSU Awards | |
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, 2020 3,744,800 $ 38.99 Granted 3,494,759 $ 20.22 Vested (1,097,210 ) $ 41.84 Forfeited (587,087 ) $ 31.16 Unvested, December 31, 2020 5,555,262 $ 27.45 |
Performance-based RSUs Awards | |
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, 2020 543,554 $ 54.75 Granted 529,578 $ 23.43 Forfeited (574,148 ) $ 53.08 Vested — $ — Unvested, December 31, 2020 498,984 $ 23.43 |
Restructuring (Tables)
Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring And Related Activities [Abstract] | |
Schedule of Restructuring Activity | Restructuring activity during the year ended December 31, 2020 was as follows: (In thousands) Balance, January 1, 2020 $ 9,201 Amounts paid during the period: Severance (7,354 ) Outplacement services (108 ) Benefits (1,277 ) Balance, December 31, 2020 $ 462 |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision (Benefit) for Income Taxes | The Company’s provision (benefit) for income taxes is comprised of the following: Year Ended December 31, (In thousands) 2020 2019 2018 Current income tax provision (benefit): U.S. federal $ 2,943 $ (471 ) $ (53 ) U.S. state 1,396 354 1,774 Rest of world — — — Deferred income tax provision (benefit): U.S. federal 9,876 (1,503 ) 10,624 U.S. state 109 881 62 Ireland — 303 (63 ) Total tax provision (benefit) $ 14,324 $ (436 ) $ 12,344 |
Schedule of (Loss) Income Before Provision for Income Taxes by Geographical Area | The distribution of the Company’s loss before the provision (benefit) for income taxes by geographical area consisted of the following: Year Ended December 31, (In thousands) 2020 2019 2018 Ireland $ (138,070 ) $ (141,869 ) $ (180,195 ) U.S. 41,599 (55,102 ) 53,287 Rest of world (66 ) (85 ) (59 ) Loss before provision (benefit) for income taxes $ (96,537 ) $ (197,056 ) $ (126,967 ) |
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) 2020 2019 Deferred tax assets: NOL carryforwards $ 233,755 $ 227,872 Tax credits 59,098 57,385 Accrued expenses and reserves 49,730 20,337 Share-based compensation 44,480 45,214 Other 6,651 8,756 Less: valuation allowance (253,649 ) (242,059 ) Total deferred tax assets 140,065 117,505 Deferred tax liabilities: Property, plant and equipment (52,707 ) (19,926 ) Other (1,697 ) (1,590 ) Total deferred tax liabilities (54,404 ) (21,516 ) Net deferred tax assets $ 85,661 $ 95,989 |
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, 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 ) Deferred tax asset valuation allowance for the year ended December 31, 2020 $ (242,059 ) $ (11,590 ) $ (253,649 ) (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) 2020 2019 2018 Statutory tax rate 12.5 % 12.5 % 12.5 % Loss before income taxes at statutory rate $ (12,067 ) $ (24,632 ) $ (15,871 ) Change in valuation allowance 11,590 19,882 28,371 Share-based compensation 8,972 6,287 1,163 Foreign rate differential ( 1) 7,798 5,390 5,405 Intercompany amounts ( 2) 6,234 (1,125 ) (751 ) U.S. state income taxes, net of U.S. federal benefit 1,298 1,051 1,732 Irish rate differential ( 3) 2,511 (146 ) (2,350 ) Uncertain tax positions 811 776 563 Non deductible lobbying expenses 683 736 661 Federal tax law change ( 4) 248 (8,111 ) — In-process R&D ( 5) 84 10,824 — Foreign derived intangible income (3,125 ) (3,450 ) — R&D credit (11,198 ) (8,846 ) (7,698 ) Other permanent items ( 6) 485 928 1,119 Income tax provision (benefit) $ 14,324 $ (436 ) $ 12,344 Effective tax rate (14.8 ) % 0.2 % (9.7 ) % ( 1 ) Represents income or losses of non-Irish subsidiaries, including U.S. subsidiaries, subject to tax at a rate other than the Irish statutory rate. ( 2 ) 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. (3) Represents income or losses of Irish companies subject to tax at a rate other than the Irish statutory rate. (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. (5) Represents the tax effect of the research and development expense recorded on the acquisition of Rodin. ( 6 ) Other permanent items include, but are not limited to, non-deductible meals and entertainment expenses and non-deductible compensation of senior officers of the Company. |
Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Unrecognized (In thousands) Tax Benefits Balance, December 31, 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 Additions based on tax positions related to prior periods 15 Additions based on tax positions related to the current period 796 Balance, December 31, 2020 $ 7,668 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2020 | |
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 Millions | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2020USD ($) | Dec. 31, 2020USD ($)Installmentsegment | Dec. 31, 2020EUR (€)Installmentsegment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Unbilled receivable | $ 110.9 | $ 110.9 | $ 89.7 | ||
Allowance for doubtful accounts | $ 0.1 | 0.1 | 0.2 | ||
Gain (loss) on foreign currency translation | $ 2.4 | $ (0.9) | $ (2.3) | ||
Threshold percentage for disclosure of revenue and receivables | 10.00% | 10.00% | 10.00% | 10.00% | |
Advertising Expense | $ 25.5 | $ 31.1 | $ 54.7 | ||
Number of business segments | segment | 1 | 1 | |||
ASU 2016-13 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2020 | Dec. 31, 2020 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
ASU 2014-09 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2018 | Jan. 1, 2018 | |||
ASU 2016-02 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2019 | Jan. 1, 2019 | |||
ASU 2018-13 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2020 | Dec. 31, 2020 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
ASU 2018-15 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2020 | Dec. 31, 2020 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
Change in accounting principle, accounting standards update, transition option elected | us-gaap:AccountingStandardsUpdate201815ProspectiveMember | us-gaap:AccountingStandardsUpdate201815ProspectiveMember | |||
ASU 2018-18 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2020 | Dec. 31, 2020 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
ASU 2019-12 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2020 | Dec. 31, 2020 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
Change in accounting principle, accounting standards update, early adoption | true | true | |||
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 | $ 14.7 | 14.8 | 12.1 | ||
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 | $ 4.4 | $ 4.1 | $ 4 | ||
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 | |||
Number of equal annual installments for stock vested | Installment | 4 | 4 | |||
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-Based RSUs | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Number of equal annual installments for stock vested | Installment | 4 | 4 | |||
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 | Biogen | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Consideration expects to receive | 2 years | 2 years | |||
VUMERITY | Other Assets | Biogen | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Contract assets, noncurrent | $ 5 | $ 5 | |||
VIVITROL | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Increase (decrease) in units sold due to COVID19 pandemic, percentage | (5.00%) | ||||
ARISTADA | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Increase (decrease) in units sold due to COVID19 pandemic, percentage | 12.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Contract Assets and Contract Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Contract Asset [Abstract] | ||
Contract assets | $ 13,386 | $ 8,230 |
Additions | 46,325 | 37,911 |
Transferred to receivables, net | (40,310) | (32,755) |
Contract assets | 19,401 | 13,386 |
Contract Liabilities [Abstract] | ||
Contract liabilities at beginning of the period | 28,834 | 12,694 |
Additions | 18,677 | |
Amounts recognized into revenue | (4,925) | (2,537) |
Contract liabilities at end of the period | $ 23,909 | $ 28,834 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Concentration (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Janssen | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 30.00% | 29.00% | 27.00% |
Janssen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 33.00% | 28.00% | 29.00% |
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 | 16.00% | 12.00% | |
Cardinal Health | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 21.00% | 13.00% | |
AmerisourceBergen | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 11.00% | 10.00% | |
AmerisourceBergen | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% | ||
McKesson | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 14.00% | ||
Acorda | Accounts Receivable | Credit Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 15.00% | ||
Acorda | Revenues Net | Customer Concentration Risk | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Concentration risk percentage | 10.00% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Concentration (Parenthetical) (Details) - Customer Concentration Risk - Minimum | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
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 Accoun_9
Summary of Significant Accounting Policies - Schedule of Revenues by Geographic Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Geographic Information | |||
Revenue by region: | $ 1,038,756 | $ 1,170,947 | $ 1,094,274 |
Current assets: | 1,110,971 | 961,970 | |
Long-term assets: | |||
OTHER ASSETS | 17,315 | 17,021 | |
Intangible assets | 111,191 | 150,643 | |
GOODWILL | 92,873 | 92,873 | |
U.S. | |||
Geographic Information | |||
Revenue by region: | 838,995 | 966,929 | 884,600 |
Current assets: | 662,615 | 551,799 | 546,533 |
Long-term assets: | |||
OTHER ASSETS | 472,999 | 382,029 | 312,243 |
Ireland | |||
Geographic Information | |||
Revenue by region: | 3,233 | 3,195 | 4,915 |
Current assets: | 448,356 | 407,791 | 433,837 |
Long-term assets: | |||
OTHER ASSETS | 161,696 | 217,887 | 245,638 |
Intangible assets | 111,191 | 150,643 | 191,001 |
GOODWILL | 92,873 | 92,873 | 92,873 |
Rest of world | |||
Geographic Information | |||
Revenue by region: | $ 196,528 | 200,823 | 204,759 |
Current assets: | $ 2,381 | $ 2,882 |
Summary of Significant Accou_10
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Weighted-average assumptions | |||
Expected stock volatility, minimum (as a percent) | 47.00% | 46.00% | 44.00% |
Expected stock volatility, maximum (as a percent) | 54.00% | 50.00% | 49.00% |
Risk-free interest rate, minimum (as a percent) | 0.24% | 1.34% | 2.25% |
Risk-free interest rate, maximum (as a percent) | 1.69% | 2.59% | 3.10% |
Minimum | |||
Weighted-average assumptions | |||
Expected option term | 5 years | 5 years | 5 years |
Maximum | |||
Weighted-average assumptions | |||
Expected option term | 7 years | 7 years | 8 years |
Summary of Significant Accou_11
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, 2020 | |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 1,038,756 | $ 1,170,947 | $ 1,094,274 |
VIVITROL | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 310,722 | 335,365 | 302,609 |
ARISTADA and ARISTADA INITIO | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 241,038 | 189,134 | 147,725 |
Product sales, net | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 551,760 | $ 524,499 | $ 450,334 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 1,038,756 | $ 1,170,947 | $ 1,094,274 |
Manufacturing Revenue | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 119,034 | 104,254 | 133,028 |
Manufacturing Revenue | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 56,893 | 50,433 | 52,770 |
Manufacturing Revenue | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 26,909 | 22,071 | 53,044 |
Manufacturing Revenue | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 35,232 | 31,750 | 27,214 |
Royalty | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 364,966 | 343,628 | 393,647 |
Royalty | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 274,200 | 256,947 | 241,423 |
Royalty | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 14,468 | 15,950 | 18,352 |
Royalty | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 20,984 | 15,170 | 54,009 |
Royalty | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 55,314 | 55,561 | 79,863 |
Manufacturing and royalty revenues | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 484,000 | 447,882 | 526,675 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 274,200 | 256,947 | 241,423 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 71,361 | 66,383 | 71,122 |
Manufacturing and royalty revenues | AMPYRA/FAMPYRA | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | 47,893 | 37,241 | 107,053 |
Manufacturing and royalty revenues | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues | $ 90,546 | $ 87,311 | $ 107,077 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) | 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 ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | $ 1,038,756,000 | $ 1,170,947,000 | $ 1,094,274,000 | ||||||
Milestone payments received | 3,800,000 | 10,000,000 | |||||||
Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Up-front payment received | $ 28,000,000 | ||||||||
Additional cash payment received | $ 150,000,000 | $ 50,000,000 | |||||||
Number of initial performance obligations | item | 4 | ||||||||
Discount Rate (As a percent) | 8.00% | ||||||||
Manufacturing and royalty revenues | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 484,000,000 | 447,882,000 | 526,675,000 | ||||||
Manufacturing and royalty revenues | Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 22,500,000 | 1,000,000 | 0 | ||||||
License revenue | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 1,050,000 | 145,750,000 | 48,370,000 | ||||||
License revenue | Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 144,800,000 | 48,300,000 | $ 27,000,000 | ||||||
Research and development revenue | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | $ 1,946,000 | 52,816,000 | $ 68,895,000 | ||||||
Research and development revenue | Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 5,200,000 | 1,500,000 | 900,000 | ||||||
Clinical Supply | Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | 200,000 | 100,000 | |||||||
License | Biogen | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Total revenues | $ 5,000,000 | $ 150,000,000 | $ 50,000,000 | $ 28,000,000 | |||||
Percentage of net sales in royalty payment | 15.00% | ||||||||
License | Biogen | Commercial Supply Agreements | |||||||||
Disaggregation Of Revenue [Line Items] | |||||||||
Maximum percentage of product supplies on net sales | 100.00% | ||||||||
Milestone payments received | $ 5,800,000 | ||||||||
Milestone payments receivable | $ 5,000,000 | $ 5,000,000 | $ 5,000,000 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Available-for-sale securities: | ||
Amortized Cost | $ 382,279 | |
Estimated Fair Value | 383,172 | |
Held-to-maturity securities: | ||
Gross Unrealized Losses, Less than One Year | (15) | |
Estimated Fair Value | 3,674 | |
Long-term Investments | ||
Amortized Cost | 24,805 | $ 79,363 |
Gross Unrealized Gains | 102 | |
Gross Unrealized Losses, Less than One Year | (25) | (67) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Total long-term investments | 24,780 | 79,391 |
Total investments | ||
Amortized Cost | 385,766 | 409,225 |
Gross Unrealized Gains | 2,097 | 1,460 |
Gross Unrealized Losses, Less than One Year | (40) | (78) |
Gross Unrealized Losses, Greater than One Year | (8) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 386,846 | 410,599 |
Short-term Investments | ||
Amortized Cost | 360,961 | 329,862 |
Gross Unrealized Gains | 2,097 | 1,358 |
Gross Unrealized Losses, Less than One Year | (15) | (11) |
Gross Unrealized Losses, Greater than One Year | (1) | |
Allowance for Credit Losses | (977) | |
Total short-term investments | 362,066 | 331,208 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 359,294 | |
Gross Unrealized Gains | 1,910 | |
Gross Unrealized Losses, Less than One Year | (15) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 360,212 | |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 103,011 | 112,948 |
Gross Unrealized Gains | 336 | 434 |
Gross Unrealized Losses, Less than One Year | (2) | (1) |
Gross Unrealized Losses, Greater than One Year | (1) | |
Estimated Fair Value | 103,345 | 113,380 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 176,937 | 144,161 |
Gross Unrealized Gains | 1,105 | 676 |
Gross Unrealized Losses, Less than One Year | (7) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 177,058 | 144,837 |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 79,346 | 72,753 |
Gross Unrealized Gains | 469 | 248 |
Gross Unrealized Losses, Less than One Year | (6) | (10) |
Estimated Fair Value | 79,809 | 72,991 |
Short-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | |
Gross Unrealized Gains | 187 | |
Estimated Fair Value | 1,854 | |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 22,985 | 75,876 |
Gross Unrealized Losses, Less than One Year | (25) | (67) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Estimated Fair Value | 22,960 | 75,802 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | |
Gross Unrealized Gains | 102 | |
Estimated Fair Value | 3,589 | |
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 | |
Gross Unrealized Losses, Less than One Year | (4) | |
Estimated Fair Value | 3,996 | |
Long-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 7,908 | 51,070 |
Gross Unrealized Losses, Less than One Year | (10) | (45) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Estimated Fair Value | 7,898 | 51,018 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 15,077 | 20,806 |
Gross Unrealized Losses, Less than One Year | (15) | (18) |
Estimated Fair Value | $ 15,062 | 20,788 |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | |
Gross Unrealized Gains | 102 | |
Estimated Fair Value | $ 1,769 |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($)Portfolio | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2020EUR (€) | Sep. 30, 2019USD ($) | May 31, 2014EUR (€) | |
Investment Holdings [Line Items] | |||||||
Return of Fountain Healthcare Partners II, L.P. investment | $ 2,751 | ||||||
Synchronicity Pharma Inc | Investee | |||||||
Investment Holdings [Line Items] | |||||||
Equity method investment percentage | 50.00% | 50.00% | |||||
Other-than-temporary impairment charge | $ 1,000 | ||||||
Synchronicity Pharma Inc | Investee | Convertible Promissory Notes | |||||||
Investment Holdings [Line Items] | |||||||
Purchase of convertible promissory notes | $ 1,900 | ||||||
Convertible promissory notes, maturity date | Jun. 30, 2021 | ||||||
Fountain Healthcare Partners II | |||||||
Investment Holdings [Line Items] | |||||||
Equity method commitment | € | € 7,000,000 | ||||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | |||||
Number of portfolio sold | Portfolio | 2 | ||||||
Proceeds from sale of portfolio | $ 10,400 | $ 11,100 | |||||
Gain (loss) on sale of investment | 300 | $ (400) | $ 500 | ||||
Return of Fountain Healthcare Partners II, L.P. investment | 2,800 | ||||||
Fountain Healthcare Partners II | Other Income (Expense), Net | |||||||
Investment Holdings [Line Items] | |||||||
Gain (loss) on sale of investment | 8,300 | ||||||
Fountain Healthcare Partners II | Held-in Escrow | |||||||
Investment Holdings [Line Items] | |||||||
Proceeds from sale of portfolio | $ 700 | ||||||
Fountain Healthcare Partners II | Other Assets | |||||||
Investment Holdings [Line Items] | |||||||
Carrying value of equity investment | $ 6,200 | $ 5,900 | |||||
Fountain Healthcare Partners II | Maximum | |||||||
Investment Holdings [Line Items] | |||||||
Commitment on equity method investment | € | € 7,400,000 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |||
Proceeds from the sales and maturities of marketable securities | $ 253,001 | $ 224,602 | $ 444,456 |
Realized gains | 76 | 997 | 4 |
Realized losses | $ 977 | $ 497 | $ 268 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 242,605 |
After 1 year through 5 years | 139,674 |
Amortized Cost | 382,279 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 242,365 |
After 1 year through 5 years | 140,807 |
Total | 383,172 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 3,487 |
Total | 3,487 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 3,674 |
Total | $ 3,674 |
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, 2020 | Dec. 31, 2019 |
Fair value | ||
Debt securities | $ 383,172 | |
Contingent consideration | 32,500 | $ 32,400 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 41,849 | 8,064 |
Contingent consideration | 32,451 | 32,400 |
Assets, Total | 457,472 | 447,474 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 41,849 | 8,064 |
Assets, Total | 115,300 | 81,859 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 308,744 | 331,262 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 32,451 | 32,400 |
Assets, Total | 33,428 | 34,353 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 103,345 | 117,376 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 73,451 | 73,795 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 29,894 | 43,581 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 184,956 | 195,855 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 183,979 | 193,902 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 977 | 1,953 |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 94,871 | 93,779 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 94,871 | $ 93,779 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2020USD ($)itemInstallment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Fair Value | |||
Transfers between Level 1 to Level 2 | $ 0 | ||
Transfers between Level 2 to Level 1 | 0 | ||
Milestone payments received | 3,800,000 | $ 10,000,000 | |
Additional milestone payments received | $ 1,500,000 | ||
Number of equal annual installments milestone payment | Installment | 7 | ||
Milestone annual payment | $ 45,000,000 | ||
Percentage of discount recovery rate | 18.00% | ||
Contingent consideration | $ 32,500,000 | 32,400,000 | |
Contingent consideration included within prepaid expenses and other current assets | 7,800,000 | 0 | |
Contingent consideration included within contingent consideration | 24,651,000 | 32,400,000 | |
Increase (decrease) in the fair value of contingent consideration | 3,945,000 | (22,800,000) | $ (19,600,000) |
2023 Term Loan | |||
Fair Value | |||
Amount to be realized in future | $ 275,100,000 | $ 277,900,000 | |
Discount Rate | |||
Fair Value | |||
Discount rate (as a percent) | item | 13 | ||
Maximum | |||
Fair Value | |||
Milestone payments receivable | $ 80,000,000 |
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, 2020USD ($) | |
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 | $ 34,353 |
Milestone and royalty payments received by the Company related to contingent consideration | (3,886) |
Royalty payments due to the Company related to contingent consideration | (7) |
Impairment of corporate debt security | (977) |
Balance at the end of the period | 33,428 |
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 | $ 3,945 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 44,944 | $ 34,577 | |
Work in process | 53,243 | 54,061 | |
Finished goods | [1] | 27,551 | 13,165 |
Total inventory | $ 125,738 | $ 101,803 | |
[1] | At December 31, 2020 and 2019, the Company had $26.5 million and $7.6 million, respectively, of finished goods inventory located at its third‑party warehouse and shipping service provider. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 26.5 | $ 7.6 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |||
Inventory capitalized in advance of potential regulatory approval | $ 13,800,000 | $ 15,300,000 | $ 0 |
Capitalized inventory charged during period | $ 6,300,000 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 706,146 | $ 679,213 |
Less: accumulated depreciation | (356,143) | (317,045) |
Total property, plant and equipment, net | 350,003 | 362,168 |
Land | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 6,560 | 6,560 |
Building and Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 178,194 | 177,087 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 366,051 | 340,146 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 52,508 | 20,737 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 102,833 | $ 134,683 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Line Items] | |||
Depreciation expense | $ 42.4 | $ 40.1 | $ 38.5 |
Furniture, Fixtures and Equipment | |||
Property Plant And Equipment [Line Items] | |||
Carrying value at the time of disposition | $ 0.9 | $ 0.5 | |
Furniture, Fixtures and Equipment | Maximum | |||
Property Plant And Equipment [Line Items] | |||
Carrying value at the time of disposition | 0.1 | ||
Certain Building and Equipment Service Upon Approval From LYBALVI | |||
Property Plant And Equipment [Line Items] | |||
Construction in progress to start on approval | $ 24.2 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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 | (471,559) | (432,107) |
Net Carrying Amount | $ 111,191 | 150,643 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | 465,590 |
Accumulated Amortization | (377,727) | (348,595) |
Net Carrying Amount | $ 87,863 | 116,995 |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | 74,600 |
Accumulated Amortization | (54,391) | (46,773) |
Net Carrying Amount | $ 20,209 | 27,827 |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | 42,560 |
Accumulated Amortization | (39,441) | (36,739) |
Net Carrying Amount | $ 3,119 | $ 5,821 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |||
Amortization of acquired intangible assets | $ 39,452 | $ 40,358 | $ 65,168 |
Expected amortization of intangible assets | |||
2021 | 40,000 | ||
2022 | 35,000 | ||
2023 | 35,000 | ||
2024 | 1,000 | ||
2025 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Oct. 07, 2020USD ($)ft² | Mar. 31, 2018ft² | Dec. 31, 2020USD ($)lease | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Lessee Lease Description [Line Items] | |||||
Number of additional operating leases | lease | 3 | ||||
Weighted average incremental borrowing rate | 5.25% | ||||
Weighted average remaining lease term | 12 years 7 months 6 days | ||||
Area of real estate property | ft² | 180,000 | 220,000 | |||
Annual lease payments | $ 195,806 | $ 15,888 | |||
Lessee operating lease term of option to extend | 5 years | ||||
Lease, commencement date | Jan. 20, 2020 | ||||
Lease agreement option to extend renewal term | 10 years | ||||
Right-of-use assets | 131,718 | 12,379 | |||
Operating lease liabilities | 135,196 | 13,808 | |||
Payments for operating leases | 17,300 | 9,100 | |||
Operating lease expense | $ 16,300 | $ 8,100 | $ 10,800 | ||
Base Premises | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 163,000 | ||||
Lease period | 5 years | ||||
Lease agreement commencement period | 2021-03 | ||||
Lease, expiration period | 2026-04 | ||||
Annual lease payments | $ 5,700 | ||||
Additional Premises | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 17,000 | ||||
Lease agreement commencement period | 2021-09 | ||||
Lease, expiration period | 2026-10 | ||||
Annual lease payments | $ 500 |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Year 1 | $ 16,882 | $ 9,053 |
Year 2 | 17,001 | 2,727 |
Year 3 | 17,266 | 500 |
Year 4 | 17,536 | 509 |
Year 5 | 17,810 | 520 |
Thereafter | 109,311 | 2,579 |
Total lease payments | 195,806 | 15,888 |
Less: imputed interest | (60,610) | (2,080) |
Operating lease liabilities | $ 135,196 | $ 13,808 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 46,034 | $ 54,261 |
Accrued compensation | 71,178 | 72,072 |
Accrued sales discounts, allowances and reserves | 218,877 | 153,902 |
Accrued other | 76,082 | 92,802 |
Total accounts payable and accrued expenses | $ 412,171 | $ 373,037 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (2,843) |
Long-term debt | 272,118 | 274,295 |
2023 Term Loans | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | 274,961 | 277,138 |
Less: current portion | (2,843) | (2,843) |
Long-term debt | $ 272,118 | $ 274,295 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | Oct. 12, 2016 | Mar. 31, 2018USD ($) | Dec. 31, 2020USD ($)Lender | Dec. 31, 2019USD ($) | Mar. 31, 2019 | Dec. 31, 2018USD ($) |
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 | $ 0.4 | |||||
Original issue discount | 1 | |||||
Amortization of offering costs and discount | $ 0.7 | $ 0.7 | $ 0.7 | |||
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, 2020USD ($) |
Long-term debt | |
2021 | $ 2,843 |
2022 | 2,843 |
2023 | 270,747 |
Total | $ 276,433 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Denominator: | |||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 18,553 | 16,991 | 13,923 |
Stock Options | |||
Denominator: | |||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 15,274 | 13,814 | 11,331 |
Restricted Stock Units | |||
Denominator: | |||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 3,279 | 3,177 | 2,592 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) | Dec. 31, 2020 | 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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based compensation Expense | |||
Total share-based compensation expense | $ 90,164 | $ 100,977 | $ 105,357 |
Cost of goods manufactured and sold | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 8,430 | 9,948 | 9,174 |
Research and development | |||
Share-based compensation Expense | |||
Total share-based compensation expense | 26,408 | 29,924 | 32,943 |
Selling, general and administrative | |||
Share-based compensation Expense | |||
Total share-based compensation expense | $ 55,326 | $ 61,105 | $ 63,240 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) shares in Millions, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020USD ($)itemshares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Share-based compensation Expense | |||
Share based compensation cost capitalized | $ | $ 2.6 | $ 1.5 | $ 2.7 |
Number of share-based compensation plan under which awards are currently made | 1 | ||
Number of share-based compensation plan under which no further awards will be made | 2 | ||
2018 Plan | |||
Share-based compensation Expense | |||
Shares of common stock available for issuance | shares | 13.9 | ||
Ratio of awards other than stock options counted against the total number of shares available for issuance | 1.8 |
Share-based Compensation - Sc_2
Share-based Compensation - Schedule of Stock Option Activity (Details) - Stock options | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Number of Shares | |
Outstanding at the beginning of the period (in shares) | shares | 15,235,845 |
Granted (in shares) | shares | 3,799,952 |
Exercised (in shares) | shares | (682,122) |
Expired (in shares) | shares | (1,266,999) |
Forfeited (in shares) | shares | (974,487) |
Outstanding at the end of the period (in shares) | shares | 16,112,189 |
Exercisable at the end of the period (in shares) | shares | 9,842,531 |
Weighted Average Exercise Price | |
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 40.34 |
Granted (in dollars per share) | $ / shares | 20.20 |
Exercised (in dollars per share) | $ / shares | 12.27 |
Expired (in dollars per share) | $ / shares | 49.81 |
Forfeited (in dollars per share) | $ / shares | 36.28 |
Outstanding at the end of the period (in dollars per share) | $ / shares | 36.27 |
Exercisable at the end of the period (in dollars per share) | $ / shares | $ 40.08 |
Share-based Compensation - Stoc
Share-based Compensation - Stock Options - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock options | |||
Share-based compensation Expense | |||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 9.52 | $ 15.57 | $ 30.47 |
Aggregate intrinsic value of stock options exercised | $ 2,000,000 | $ 21,300,000 | $ 35,500,000 |
Stock options expected to vest (in shares) | 6,100,000 | ||
Weighted average exercise price (in dollars per share) | $ 30.46 | ||
Weighted average contractual remaining life | 8 years 6 months | ||
Aggregate intrinsic value of stock options exercisable | $ 6,900,000 | ||
Weighted average remaining contractual term of stock options exercisable | 4 years 3 months 18 days | ||
Unrecognized compensation cost | $ 34,600,000 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 1 year 9 months 18 days | ||
Outstanding stock option | 16,112,189 | 15,235,845 | |
Cash received from option exercises | $ 8,400,000 | $ 18,900,000 | $ 20,900,000 |
Stock options | Maximum | |||
Share-based compensation Expense | |||
Aggregate intrinsic value | $ 200,000 | ||
Performance-based stock options | |||
Share-based compensation Expense | |||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 16.78 | ||
Unrecognized compensation cost | $ 1,900,000 | ||
Outstanding stock option | 400,000 |
Share-based Compensation - Summ
Share-based Compensation - Summary of RSU Activity (Details) - Time-based RSU Awards - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | |||
Unvested at the beginning of the period (in shares) | 3,744,800 | ||
Granted (in shares) | 3,494,759 | ||
Vested (in shares) | (1,097,210) | ||
Forfeited (in shares) | (587,087) | ||
Unvested at the end of the period (in shares) | 5,555,262 | 3,744,800 | |
Weighted Average Grant Date Fair Value | |||
Unvested at the beginning of the period (in dollars per share) | $ 38.99 | ||
Granted (in dollars per share) | 20.22 | $ 30.47 | $ 63.01 |
Vested (in dollars per share) | 41.84 | ||
Forfeited (in dollars per share) | 31.16 | ||
Unvested at the end of the period (in dollars per share) | $ 27.45 | $ 38.99 |
Share-based Compensation - Time
Share-based Compensation - Time-Based Restricted Stock Units Award - Additional Information (Details) - Time-based RSU Awards - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based compensation Expense | |||
Granted (in dollars per share) | $ 20.22 | $ 30.47 | $ 63.01 |
Fair value of RSU's vested | $ 45.9 | $ 42.4 | $ 34.5 |
Unrecognized compensation cost | $ 61 | ||
Weighted average period for unrecognized compensation cost expected to be recognized | 1 year 9 months 18 days |
Share-based Compensation - Perf
Share-based Compensation - Performance-Based Restricted Stock Units Awards - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2018 | Feb. 28, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based compensation Expense | |||||
Share-based compensation expense | $ 90,164 | $ 100,977 | $ 105,357 | ||
Cost of goods manufactured and sold | |||||
Share-based compensation Expense | |||||
Share-based compensation expense | 8,430 | 9,948 | 9,174 | ||
Research and development | |||||
Share-based compensation Expense | |||||
Share-based compensation expense | 26,408 | 29,924 | 32,943 | ||
Selling, general and administrative | |||||
Share-based compensation Expense | |||||
Share-based compensation expense | $ 55,326 | $ 61,105 | $ 63,240 | ||
Performance-based RSUs Awards | |||||
Share-based compensation Expense | |||||
Number of years from the date of the grant | 3 years | ||||
Unrecognized compensation cost | $ 10,400 | ||||
2017 Performance Awards | |||||
Share-based compensation Expense | |||||
Number of years from the date of the grant | 3 years | ||||
Share-based compensation expense | $ 17,100 | ||||
2017 Performance Awards | Cost of goods manufactured and sold | |||||
Share-based compensation Expense | |||||
Share-based compensation expense | 2,100 | ||||
2017 Performance Awards | Research and development | |||||
Share-based compensation Expense | |||||
Share-based compensation expense | 6,700 | ||||
2017 Performance Awards | 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 Awards | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Number of Shares | |
Unvested at the beginning of the period (in shares) | shares | 543,554 |
Granted (in shares) | shares | 529,578 |
Forfeited (in shares) | shares | (574,148) |
Unvested at the end of the period (in shares) | shares | 498,984 |
Weighted Average Grant Date Fair Value | |
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 54.75 |
Granted (in dollars per share) | $ / shares | 23.43 |
Forfeited (in dollars per share) | $ / shares | 53.08 |
Unvested at the end of the period (in dollars per share) | $ / shares | $ 23.43 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) | Oct. 18, 2019USD ($)Position | Dec. 31, 2020USD ($) | 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 | $ 13,400,000 | $ 13,401,000 | |
Restructuring and related activities description | 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 resulted in cash expenditures and substantially all of which were paid out by December 31, 2020. | ||
Restructuring accrual | $ 462,000 | 9,201,000 | |
Accounts payable and accrued expenses | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring accrual | 500,000 | 9,000,000 | |
Other long-term liabilities | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring accrual | $ 0 | $ 200,000 |
Restructuring - Schedule of Res
Restructuring - Schedule of Restructuring Activity (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Restructuring And Related Activities [Abstract] | |
Balance, January 1, 2020 | $ 9,201 |
Amounts paid during the period: | |
Severance | (7,354) |
Outplacement services | (108) |
Benefits | (1,277) |
Balance, December 31, 2020 | $ 462 |
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, 2020USD ($)Agreement | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Cash payments received | $ 1,038,756,000 | $ 1,170,947,000 | $ 1,094,274,000 | |||||
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 | |||||||
Milestone payment entitled to be received upon the acceptance of NDA by the FDA | 1,000,000 | |||||||
Milestone payment entitled to be received upon the approval of NDA by the FDA | 1,500,000 | |||||||
Milestone payment entitled to be received upon the first commercial sale | $ 1,500,000 | |||||||
License agreement | Acorda | AMPYRA/ FAMPYRA | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Royalty rate (as a percent) | 10.00% | |||||||
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 Prov
Income Taxes - Schedule of Provision (Benefit) for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current income tax provision (benefit): | |||
U.S. federal | $ 2,943 | $ (471) | $ (53) |
U.S. state | 1,396 | 354 | 1,774 |
Deferred income tax provision (benefit): | |||
U.S. federal | 9,876 | (1,503) | 10,624 |
U.S. state | 109 | 881 | 62 |
Total tax provision (benefit) | $ 14,324 | (436) | 12,344 |
Ireland | |||
Deferred income tax provision (benefit): | |||
Ireland | $ 303 | $ (63) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | ||||
Cumulative unremitted earnings of overseas subsidiaries | $ 369,000 | |||
Less: valuation allowance | (253,649) | $ (242,059) | $ (219,093) | $ (172,797) |
Federal research and development credits | 48,600 | |||
State tax credits | $ 23,000 | |||
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 | $ (20,900) | |||
Operating loss carryforwards | 43,200 | |||
U.S. state | Rodin Therapeutics, Inc. | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards | 43,200 | |||
Federal research and development credits | 400 | |||
U.S. federal | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards | 33,300 | |||
U.S. federal | Rodin Therapeutics, Inc. | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards | 51,300 | |||
Federal research and development credits | 700 | |||
Ireland | ||||
Income Taxes [Line Items] | ||||
Income taxes payable on repatriation of unremitted earnings | 38,000 | |||
Less: valuation allowance | (232,800) | |||
Operating loss carryforwards | $ 1,600,000 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | $ (96,537) | $ (197,056) | $ (126,967) |
Ireland | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | (138,070) | (141,869) | (180,195) |
U.S. | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | 41,599 | (55,102) | 53,287 |
Rest of world | |||
Distribution of income (loss) before provision for income taxes | |||
(Loss) Gain before provision (benefit) for income taxes | $ (66) | $ (85) | $ (59) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Net Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||||
NOL carryforwards | $ 233,755 | $ 227,872 | ||
Tax credits | 59,098 | 57,385 | ||
Accrued expenses and reserves | 49,730 | 20,337 | ||
Share-based compensation | 44,480 | 45,214 | ||
Other | 6,651 | 8,756 | ||
Less: valuation allowance | (253,649) | (242,059) | $ (219,093) | $ (172,797) |
Total deferred tax assets | 140,065 | 117,505 | ||
Deferred tax liabilities: | ||||
Property, plant and equipment | (52,707) | (19,926) | ||
Other | (1,697) | (1,590) | ||
Total deferred tax liabilities | (54,404) | (21,516) | ||
Net deferred tax assets | $ 85,661 | $ 95,989 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Balance at Beginning of Period | $ (242,059) | $ (219,093) | $ (172,797) |
Additions | (11,590) | (22,966) | (46,296) |
Balance at End of Period | $ (253,649) | $ (242,059) | $ (219,093) |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of effective income tax rate | |||
Statutory tax rate (as a percent) | 12.50% | 12.50% | 12.50% |
Loss before income taxes at statutory rate | $ (12,067) | $ (24,632) | $ (15,871) |
Change in valuation allowance | 11,590 | 19,882 | 28,371 |
Share-based compensation | 8,972 | 6,287 | 1,163 |
Foreign rate differential | 7,798 | 5,390 | 5,405 |
Intercompany amounts | 6,234 | (1,125) | (751) |
U.S. state income taxes, net of U.S. federal benefit | 1,298 | 1,051 | 1,732 |
Irish rate differential | 2,511 | (146) | (2,350) |
Uncertain tax positions | 811 | 776 | 563 |
Non deductible lobbying expenses | 683 | 736 | 661 |
Federal tax law change | 248 | (8,111) | |
In-process R&D | 84 | 10,824 | |
Foreign derived intangible income | (3,125) | (3,450) | |
R&D credit | (11,198) | (8,846) | (7,698) |
Other permanent items | 485 | 928 | 1,119 |
Total tax provision (benefit) | $ 14,324 | $ (436) | $ 12,344 |
Effective tax rate (as a percent) | (14.80%) | 0.20% | (9.70%) |
Income Taxes - Schedule of Re_2
Income Taxes - Schedule of Reconciliation of Beginning and Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Balance at the beginning of the period | $ 6,857 | $ 6,081 | $ 5,518 |
Additions based on tax positions related to prior periods | 15 | 38 | 4 |
Additions based on tax positions related to the current period | 796 | 738 | 559 |
Balance at the end of the period | $ 7,668 | $ 6,857 | $ 6,081 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2020 | |
Commitments And Contingencies [Line Items] | ||
Potential losses from claims, legal proceedings probable of occurring | $ 0 | |
Maximum number of months before FDA can approve patent request | 30 months | |
Capital Commitments | ||
Commitments And Contingencies [Line Items] | ||
Open purchase order commitments | $ 3,500,000 |