Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 22, 2019 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 156,904,489 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ALKS |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 225,234 | $ 266,762 |
Investments—short-term | 356,894 | 272,533 |
Receivables, net | 222,811 | 292,223 |
Contract assets | 8,447 | 8,230 |
Inventory | 92,861 | 90,196 |
Prepaid expenses and other current assets | 56,492 | 53,308 |
Total current assets | 962,739 | 983,252 |
PROPERTY, PLANT AND EQUIPMENT, NET | 320,004 | 309,987 |
INTANGIBLE ASSETS, NET | 181,049 | 191,001 |
INVESTMENTS—LONG-TERM | 43,005 | 80,744 |
GOODWILL | 92,873 | 92,873 |
CONTINGENT CONSIDERATION | 37,600 | 65,200 |
RIGHT-OF-USE ASSETS | 18,010 | |
DEFERRED TAX ASSETS | 87,605 | 85,807 |
OTHER ASSETS | 13,651 | 16,143 |
TOTAL ASSETS | 1,756,536 | 1,825,007 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 313,969 | 333,762 |
Contract liabilities—short-term | 2,078 | 3,169 |
Operating lease liabilities—short-term | 8,795 | |
Long-term debt—short-term | 2,843 | 2,843 |
Total current liabilities | 327,685 | 339,774 |
LONG-TERM DEBT | 275,923 | 276,465 |
OTHER LONG-TERM LIABILITIES | 28,425 | 27,958 |
OPERATING LEASE LIABILITIES—LONG-TERM | 11,020 | |
CONTRACT LIABILITIES—LONG-TERM | 11,342 | 9,525 |
Total liabilities | 654,395 | 653,722 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 14) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at March 31, 2019 and December 31, 2018, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 159,577,874 and 158,180,833 shares issued; 156,885,028 and 155,757,344 shares outstanding at March 31, 2019 and December 31, 2018, respectively | 1,593 | 1,579 |
Treasury shares, at cost (2,692,846 and 2,423,489 shares at March 31, 2019 and December 31, 2018, respectively) | (117,949) | (108,969) |
Additional paid-in capital | 2,502,773 | 2,467,323 |
Accumulated other comprehensive loss | (2,510) | (3,280) |
Accumulated deficit | (1,281,766) | (1,185,368) |
Total shareholders’ equity | 1,102,141 | 1,171,285 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,756,536 | $ 1,825,007 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock shares, authorized | 50,000,000 | 50,000,000 |
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 450,000,000 | 450,000,000 |
Ordinary shares, shares issued | 159,577,874 | 158,180,833 |
Ordinary shares, shares outstanding | 156,885,028 | 155,757,344 |
Treasury shares | 2,692,846 | 2,423,489 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
REVENUES: | ||
Total revenues | $ 223,102 | $ 225,150 |
EXPENSES: | ||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 45,361 | 44,476 |
Research and development | 102,570 | 108,346 |
Selling, general and administrative | 141,220 | 118,147 |
Amortization of acquired intangible assets | 9,952 | 16,069 |
Total expenses | 299,103 | 287,038 |
OPERATING LOSS | (76,001) | (61,888) |
OTHER EXPENSE, NET: | ||
Interest income | 3,570 | 1,485 |
Interest expense | (3,500) | (5,487) |
Change in the fair value of contingent consideration | (22,600) | (1,900) |
Other (expense) income, net | (1,721) | 792 |
Total other expense, net | (24,251) | (5,110) |
LOSS BEFORE INCOME TAXES | (100,252) | (66,998) |
INCOME TAX BENEFIT | (3,854) | (4,493) |
NET LOSS | $ (96,398) | $ (62,505) |
LOSS PER ORDINARY SHARE: | ||
Basic and diluted (in dollars loss per ordinary share) | $ (0.62) | $ (0.40) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||
Basic and diluted (in shares) | 156,336 | 154,424 |
COMPREHENSIVE LOSS: | ||
Net loss | $ (96,398) | $ (62,505) |
Holding gain (loss), net of a tax provision (benefit) of $229 and $(100), respectively | 770 | (336) |
COMPREHENSIVE LOSS | (95,628) | (62,841) |
Manufacturing and royalty revenues | ||
REVENUES: | ||
Total revenues | 108,915 | 114,601 |
Product sales, net | ||
REVENUES: | ||
Total revenues | 99,481 | 91,842 |
Research and development revenue | ||
REVENUES: | ||
Total revenues | $ 14,706 | $ 18,707 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Tax (benefit) provision | $ 229 | $ (100) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (96,398) | $ (62,505) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 19,642 | 25,722 |
Share-based compensation expense | 24,616 | 20,042 |
Deferred income taxes | (3,225) | (4,101) |
Change in the fair value of contingent consideration | 22,600 | 1,900 |
Loss on debt refinancing | 2,298 | |
Payment made for debt refinancing | (1,840) | |
Other non-cash charges | 1,116 | |
Other non-cash charges | (75) | |
Changes in assets and liabilities: | ||
Receivables | 69,411 | 19,430 |
Contract assets | (217) | (16,959) |
Inventory | (1,700) | (431) |
Prepaid expenses and other assets | (69) | 890 |
Right-of-use assets | 2,131 | |
Accounts payable and accrued expenses | (15,888) | (14,123) |
Contract liabilities | 725 | 245 |
Operating lease liabilities | (2,297) | |
Other long-term liabilities | 1,765 | 2,669 |
Cash flows provided by (used in) operating activities | 22,212 | (26,838) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (23,639) | (18,485) |
Proceeds from the sale of equipment | 85 | 324 |
Proceeds from contingent consideration | 5,000 | |
Purchases of investments | (102,127) | (35,995) |
Sales and maturities of investments | 55,978 | 79,500 |
Cash flows (used in) provided by investing activities | (64,703) | 25,344 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 10,554 | 13,164 |
Employee taxes paid related to net share settlement of equity awards | (8,880) | (15,724) |
Principal payments of long-term debt | (711) | |
Payment made for debt refinancing | (737) | |
Cash flows provided by (used in) financing activities | 963 | (3,297) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (41,528) | (4,791) |
CASH AND CASH EQUIVALENTS—Beginning of period | 266,762 | 191,296 |
CASH AND CASH EQUIVALENTS—End of period | 225,234 | 186,505 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 7,850 | $ 7,516 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Treasury Stock |
BALANCE at Dec. 31, 2017 | $ 1,202,808 | $ 1,557 | $ 2,338,755 | $ (3,792) | $ (1,044,365) | $ (89,347) |
BALANCE (in shares) at Dec. 31, 2017 | 156,057,632 | (2,048,176) | ||||
Issuance of ordinary shares under employee stock plans | 13,165 | $ 6 | 13,159 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 539,563 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (15,724) | $ 7 | (7) | $ (15,724) | ||
Receipt of Alkermes' shares for the excersise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 716,123 | (261,159) | ||||
Share-based compensation expense | 20,176 | 20,176 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision of $229 | (337) | (337) | ||||
Cumulative effect adjustment related to the adoption of new accounting standards | (1,692) | (1,692) | ||||
Net loss | (62,505) | (62,505) | ||||
BALANCE at Mar. 31, 2018 | 1,155,891 | $ 1,570 | 2,372,083 | (4,129) | (1,108,562) | $ (105,071) |
BALANCE (in shares) at Mar. 31, 2018 | 157,313,318 | (2,309,335) | ||||
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 | 10,554 | $ 7 | 10,547 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 656,352 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (8,880) | $ 7 | 93 | $ (8,980) | ||
Receipt of Alkermes' shares for the excersise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 740,689 | (269,357) | ||||
Share-based compensation expense | 24,810 | 24,810 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision of $229 | 770 | 770 | ||||
Net loss | (96,398) | (96,398) | ||||
BALANCE at Mar. 31, 2019 | $ 1,102,141 | $ 1,593 | $ 2,502,773 | $ (2,510) | $ (1,281,766) | $ (117,949) |
BALANCE (in shares) at Mar. 31, 2019 | 159,577,874 | (2,692,846) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Stockholders Equity [Abstract] | ||
Tax (benefit) provision | $ 229 | $ (100) |
The Company
The Company | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. THE COMPANY Alkermes plc (the “Company”) is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. The Company has a diversified portfolio of commercial drug products and a clinical pipeline of product candidates focused on central nervous system (“CNS”) disorders such as schizophrenia, depression, addiction and multiple sclerosis (“MS”), and oncology. Headquartered in Dublin, Ireland, the Company has a research and development (“R&D”) center in Waltham, Massachusetts; R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three months ended March 31, 2019 and 2018 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2018. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States (“U.S.”) (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, that are necessary to state fairly the results of operations for the reported periods. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Company’s Annual Report that has been filed with the SEC. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for a full fiscal year. Principles of Consolidation The condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies, Use of Estimates The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including those related to revenue recognition and related allowances, its collaborative relationships, clinical trial expenses, the valuation of inventory, 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. Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines. The Company’s chief decision maker, the Chairman of the Board 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. Income Taxes The Company’s income tax benefit in the three months ended March 31, 2019 and 2018 primarily related to U.S. federal and state taxes. The Company records a deferred tax asset or liability based on the difference between the financial statement and tax basis of its assets and liabilities, as measured by enacted jurisdictional tax rates assumed to be in effect when these differences reverse. At March 31, 2019, the Company maintained a valuation allowance against certain of its U.S. and foreign deferred tax assets. The Company evaluates, at each reporting period, the need for a valuation allowance on its deferred tax assets on a jurisdiction-by-jurisdiction basis. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“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 guidance that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Effective January 1, 2019, the Company adopted the requirements under Accounting Standards Update (“ASU”) 2016-02, Leases Leases In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-14, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This ASU also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. This ASU becomes effective for the Company in the year ending December 31, 2020 and early adoption is permitted. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Clarifying the Interaction Between Topic 808 and Topic 606 |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS Under Topic 606, the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under Topic 606: (i) identify contract(s) with a customer; (ii) identify the performance obligation(s) in the contract(s); (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract(s); and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s). Manufacturing and Royalty Revenue During the three months ended March 31, 2019 and 2018, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended March 31, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 53,298 $ 53,298 RISPERDAL CONSTA 17,921 4,385 22,306 AMPYRA/FAMPYRA 5,680 6,506 12,186 Other 7,346 13,779 21,125 $ 30,947 $ 77,968 $ 108,915 Three Months Ended March 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 46,086 $ 46,086 AMPYRA/FAMPYRA 13,563 14,696 28,259 RISPERDAL CONSTA 17,792 4,912 22,704 Other 6,236 11,316 17,552 $ 37,591 $ 77,010 $ 114,601 Product Sales, Net The Company’s product sales, net consist of sales of VIVITROL and ARISTADA (together with ARISTADA INITIO) 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. During the three months ended March 31, 2019 and 2018, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2019 2018 VIVITROL $ 69,183 $ 62,682 ARISTADA 30,298 29,160 Total product sales, net $ 99,481 $ 91,842 Research and Development Revenue The Company recorded research and development (“R&D”) revenue of $13.9 million and $17.5 million during the three months ended March 31, 2019 and 2018, respectively, related to its license and collaboration agreement with Biogen for Diroximel fumarate (“BIIB098”). The Company expects to earn an additional $77.6 million in R&D revenue under this agreement with Biogen through 2021. Contract Assets —Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time. The products included in the contract assets table below complete the manufacturing process in ten days to eight weeks. Contract assets are classified as current. Contract assets consisted of the following: (In thousands) Contract Assets Contract assets at January 1, 2019 $ 8,230 Additions 7,346 Transferred to receivables, net (7,129 ) Contract assets at March 31, 2019 $ 8,447 Contract Liabilities —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 1,516 Amounts recognized into revenue (790 ) Contract liabilities at March 31, 2019 $ 13,420 |
Investments
Investments | 3 Months Ended |
Mar. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENT S Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated March 31, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 156,443 $ 349 $ (11 ) $ (149 ) $ 156,632 U.S. government and agency debt securities 108,113 257 (4 ) (45 ) 108,321 International government agency debt securities 91,818 193 — (70 ) 91,941 Total short-term investments 356,374 799 (15 ) (264 ) 356,894 Long-term investments: Available-for-sale securities: Corporate debt securities 28,570 — (84 ) (45 ) 28,441 U.S. government and agency debt securities 10,984 — (4 ) (5 ) 10,975 39,554 — (88 ) (50 ) $ 39,416 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 43,041 102 (88 ) (50 ) 43,005 Total investments 399,415 901 (103 ) (314 ) 399,899 December 31, 2018 Short-term investments: Available-for-sale securities: Corporate debt securities $ 120,197 $ 57 $ (62 ) $ (274 ) $ 119,918 U.S. government and agency debt securities 80,055 115 (11 ) (87 ) 80,072 International government agency debt securities 72,091 85 (8 ) (117 ) 72,051 272,343 257 (81 ) (478 ) 272,041 Held-to-maturity securities: Corporate debt securities 492 — — — 492 Total short-term investments 272,835 257 (81 ) (478 ) 272,533 Long-term investments: Available-for-sale securities: Corporate debt securities 53,505 — (185 ) (93 ) $ 53,227 U.S. government and agency debt securities 18,474 — (21 ) (12 ) 18,441 International government agency debt securities 5,457 — (4 ) — 5,453 77,436 — (210 ) (105 ) 77,121 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 136 — — 1,803 3,487 136 — — 3,623 Total long-term investments 80,923 136 (210 ) (105 ) 80,744 Total investments $ 353,758 $ 393 $ (291 ) $ (583 ) $ 353,277 The proceeds from the sales and maturities of marketable securities, which were identified using the specific identification method and were primarily reinvested, were as follows: Three Months Ended March 31, (In thousands) 2019 2018 Proceeds from the sales and maturities of marketable securities $ 55,978 $ 79,500 Realized gains $ — $ 1 Realized losses $ 492 $ 4 The Company’s available-for-sale and held-to-maturity securities at March 31, 2019 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 213,318 $ 213,172 $ 1,820 $ 1,820 After 1 year through 5 years 182,610 183,138 1,667 1,769 Total $ 395,928 $ 396,310 $ 3,487 $ 3,589 At March 31, 2019, the Company believed that the unrealized losses on its available-for-sale investments were temporary. The investments with unrealized losses consisted primarily of corporate debt securities. In making the determination that the decline in fair value of these securities was temporary, the Company considered various factors, including, but not limited to: the length of time each security was in an unrealized loss position; the extent to which fair value was less than cost; financial condition and near-term prospects of the issuers; the Company’s intent not to sell these securities; and the assessment that it is more likely than not that the Company would not be required to sell these securities before the recovery of their amortized cost basis. In 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 March 31, 2019, the Company’s total contribution in Fountain was equal to €5.5 million. The Company’s commitment represents approximately 7% of the partnership’s total funding. The Company is accounting for its investment in Fountain under the equity method. During the three months ended March 31, 2019 and 2018, the Company recorded a decrease in its investment in Fountain of less than $0.1 million. The changes recorded 5.6 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. FAIR VALUE MEASUREMENTS 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 of the valuation techniques the Company utilized to determine such fair value: March 31, (In thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 62,556 $ 62,556 $ — $ — U.S. government and agency debt securities 119,296 68,704 50,592 — Corporate debt securities 185,073 — 185,073 — International government agency debt securities 91,941 — 91,941 — Contingent consideration 37,600 — — 37,600 Common stock warrants 772 — — 772 Total $ 497,238 $ 131,260 $ 327,606 $ 38,372 December 31, 2018 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 54,590 $ 54,590 $ — $ — U.S. government and agency debt securities 98,513 60,107 38,406 — Corporate debt securities 173,637 — 173,145 492 International government agency debt securities 77,504 — 77,504 — Contingent consideration 65,200 — — 65,200 Common stock warrants 1,205 — — 1,205 Total $ 470,649 $ 114,697 $ 289,055 $ 66,897 The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were no transfers of any securities between the fair value hierarchies during the three months ended March 31, 2019. The following table is a rollforward of the fair value of the Company’s assets whose fair values were determined using Level 3 inputs at March 31, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Change in the fair value of contingent consideration (22,600 ) Payment received for contingent consideration (5,000 ) Impairment of corporate debt security (492 ) Decrease in the fair value of warrants (433 ) Balance, March 31, 2019 $ 38,372 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. The Company’s contingent consideration relates to the divestiture of its Gainesville, GA facility in March 2015 (the “Gainesville Transaction”). On December 20, 2018, the Company entered into a Second Amendment to the Purchase and Sale Agreement (“Purchase and Sale Agreement Amendment”) with Recro Pharma, Inc. (“Recro”), pursuant to which the Company received one $5.0 million payment in the first quarter of 2019 and will receive another $5.0 million payment in the second quarter of 2019; the Company is eligible to receive low double-digit royalties on net sales of IV/IM and parenteral forms of Meloxicam and any other Meloxicam Product(s); and is eligible to receive up to $130.0 million in milestone payments upon the achievement of certain regulatory and sales milestones related to the Meloxicam Products. In accordance with the accounting standard for fair value measurements, the Company’s contingent consideration has been classified as a Level 3 asset as its fair value is based on significant inputs not observable in the market. The fair value of the contingent consideration at March 31, 2019 was determined as follows: • The Company received $5.0 million in the first quarter of 2019 and expects to receive another $5.0 million in the second quarter of 2019; the Company is entitled to receive $5.0 million upon regulatory approval of a New Drug Application (“NDA”) for the first Meloxicam Product; and $45.0 million in seven equal, annual installments beginning on the first anniversary of such approval. The fair value of the regulatory milestone was estimated based on applying the likelihood of achieving the regulatory milestone and applying a discount rate from the expected time the milestone occurs to the balance sheet date. The Company expects the regulatory milestone event to occur in the first quarter of 2020 and used a discount rate of 16.0%; • The Company is entitled to receive future royalties on net sales of Meloxicam Products. To estimate the fair value of the future royalties, the Company assessed the likelihood of a Meloxicam Product being approved for sale and estimated the expected future sales given approval and IP protection. These expected payments were then discounted using a discount rate of 16.0%, which the Company believes captures a market participant’s view of the risk associated with the expected payments; and • The Company is entitled to receive payments of up to $80.0 million upon achieving certain sales milestones on future sales of the Meloxicam Products. The sales milestones were determined through the use of a real options approach, where net sales are simulated in a risk-neutral world. To employ this methodology, the Company used a risk-adjusted expected growth rate based on its assessments of expected growth in net sales of the approved Meloxicam Product, adjusted by an appropriate factor capturing their respective correlation with the market. A resulting expected (probability-weighted) milestone payment was then discounted at a cost of debt of 15.0 %. 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. In March 2019, Recro received a second complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its NDA for IV Meloxicam. As a result of Recro’s receipt of this second CRL, the Company delayed its anticipated date for the FDA’s approval of the IV Meloxicam NDA and reduced the probability of success and amount of forecasted sales due to this delay in our valuation model. At March 31, 2019 and December 31, 2018, the Company determined that the value of the contingent consideration was $37.6 million and $65.2 million, respectively. The Company recorded a decrease of $22.6 million and $1.9 million during the three months ended March 31, 2019 and 2018, respectively, within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive loss. The carrying amounts reflected in the condensed 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 | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. INVENTORY Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: March 31, December 31, (In thousands) 2019 2018 Raw materials $ 33,526 $ 31,824 Work in process 41,548 38,019 Finished goods (1) 17,787 20,353 Total inventory $ 92,861 $ 90,196 (1) At March 31, 2019 and December 31, 2018, the Company had $11.7 million and $11.0 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment
Property, Plant and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | 7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consisted of the following: March 31, December 31, (In thousands) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 170,289 157,053 Furniture, fixtures and equipment 320,882 314,831 Leasehold improvements 20,105 20,105 Construction in progress 89,245 88,983 Subtotal 607,081 587,458 Less: accumulated depreciation (287,077 ) (277,471 ) Total property, plant and equipment, net $ 320,004 $ 309,987 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consisted of the following: March 31, 2019 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (326,532 ) $ 139,058 NanoCrystal technology 13 74,600 (40,873 ) 33,727 OCR technologies 12 42,560 (34,296 ) 8,264 Total $ 582,750 $ (401,701 ) $ 181,049 Based on the Company’s most recent analysis, amortization of intangible assets included within its condensed consolidated balance sheet at March 31, 2019 is expected to be approximately $40.0 million, $40.0 million, $40.0 million, $35.0 million and $35.0 million in the years ending December 31, 2019 through 2023, respectively. Although the Company believes such available information and assumptions are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the change in revenues. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | 9. LEASES The Company adopted Topic 842 on January 1, 2019. Topic 842 allows the Company to elect a package of practical expedients, which include: (i) an entity need not reassess whether any expired or existing contracts are or contain leases; (ii) an entity need not reassess the lease classification for any expired or existing leases; and (iii) an entity need not reassess any initial direct costs for any existing leases. Another practical expedient allows the Company to use hindsight in determining the lease term when considering lessee options to extend or terminate the lease and to purchase the underlying asset. The Company has elected to utilize this package of practical expedients and has not elected the hindsight methodology in its implementation of Topic 842. The Company elected to adopt this standard using the optional modified retrospective transition method and recognized a cumulative-effect adjustment to the condensed consolidated balance sheet on the date of adoption. Comparative periods have not been restated. With the adoption of Topic 842 , the Company’s condensed consolidated balance sheet now contains the following line items: Right-of-use assets, Operating lease liabilities—short-term and Operating lease liabilities—long-term. The Company determined that it held the following significant operating leases of office and laboratory space as of January 1, 2019: • An operating lease for 175,000 square feet of office and laboratory space in Waltham, Massachusetts that expires in 2021, with an option to extend the term for up to two five-year periods • An operating lease for 67,000 square feet of office space in Waltham, Massachusetts that expires in 2020, with an option to extend the term for up to two one-year periods; • An operating lease for 14,600 square feet of office space in Dublin, Ireland that expires in 2022, with an option to extend the term for an additional five-year period; and • An operating lease for 7,000 square feet of corporate office and administrative space in Washington, D.C. that expires in 2029 and includes an option to extend the term for an additional five-year period The Company also has two additional operating leases that are included in its lease accounting but are not considered significant. The Company has elected to not recognize right-of-use assets and lease liabilities arising from short-term leases, which are leases that, at the commencement date, have a lease term of 12 months or less and do not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. As all the existing leases subject to the new lease standard were previously classified as operating leases by the Company, they were similarly classified as operating leases under the new standard. The Company has determined that the identified operating leases did not contain non-lease components and require no further allocation of the total lease cost. Additionally, the agreements in place did not contain information to determine the rate implicit in the leases. As such, the Company calculated the incremental borrowing rate based on the assumed remaining lease term for each lease in order to calculate the present value of the remaining lease payments. At March 31, 2019, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 4.46% and 4.1 years, respectively. As of March 31, 2019, right-of-use assets and liabilities arising from operating leases were $18.0 million and $19.8 million, respectively. During the three months ended March 31, 2019, cash paid for amounts included for the measurement of lease liabilities was $2.3 million and the Company recorded operating lease expense of $2.1 million. Future lease payments under non-cancelable leases as of March 31, 2019 and December 31, 2018: March 31, December 31, (In thousands) 2019 2018 2019 $ 6,806 $ 9,394 2020 8,652 10,717 2021 2,520 4,706 2022 500 2,455 2023 509 2,389 Thereafter 3,100 23,940 Total lease payments $ 22,087 $ 53,601 Less: imputed interest (2,272 ) — Total operating lease liabilities $ 19,815 $ 53,601 In March 2018, the Company entered into a lease agreement for approximately 220,000 square feet of office and laboratory space located in a building that is being built at 900 Winter Street, Waltham, Massachusetts (“900 Winter Street”). The Company plans to occupy the premises in early 2020. The initial term of the lease shall commence on the earlier of: (i) the Delivery Date (defined as (a) the later of January 20, 2020, or (b) the date on which the landlord substantially completes its work in accordance with the terms of the lease), or (ii) the date the Company enters into possession of all or any substantial portion of 900 Winter Street for the conduct of its business (the “Commencement Date”). The initial lease term expires on the last day of the calendar month in which the fifteenth (15 th As the Company (a) does not have the right to obtain or control the leased premises during the construction period; (b) does not have the right of payment for the partially constructed assets and, thus, could be potentially leased to another tenant; and (c) does not legally own or control the land on which the property improvements are being constructed, it was not included as a right-of-use asset at March 31, 2019. Additionally, the future lease payments, outlined above, included the 900 Winter Street payments as of December 31, 2018; these payments are not included in the table under Topic 842. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following: March 31, December 31, (In thousands) 2019 2018 Accounts payable $ 48,956 $ 39,767 Accrued compensation 48,653 67,613 Accrued sales discounts, allowances and reserves 140,736 152,911 Accrued other 75,624 73,471 Total accounts payable and accrued expenses $ 313,969 $ 333,762 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: March 31, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 278,766 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 275,923 $ 276,465 In March 2018, the Company amended and refinanced its existing term loan, referred to as Term Loan B-1 (as so amended and refinanced, the “2023 Term Loans”), in order to, among other things, extend the due date of the loan from September 25, 2021 to March 26, 2023, reduce the interest payable from LIBOR plus 2.75% with a LIBOR floor of 0.75% to LIBOR 2.25 0 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 condensed consolidated statement of operations and comprehensive loss. The estimated fair value of the 2023 Term Loans, which was based on quoted market price indications (Level 2 in the fair value hierarchy, as described in Note 5, Fair Value Measurements |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | 12. SHARE-BASED COMPENSATION Share-based compensation expense consisted of the following: March 31, (In thousands) 2019 2018 Cost of goods manufactured and sold $ 1,978 $ 1,418 Research and development 7,746 6,714 Selling, general and administrative 14,892 11,910 Total share-based compensation expense $ 24,616 $ 20,042 At March 31, 2019 and December 31, 2018, $2.9 million and $2.7 million, respectively, of share-based compensation cost was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets. In February 2017, the compensation committee of the Company’s board of directors approved awards of restricted stock units (“RSUs”) to all employees employed by the Company during 2017, in each case subject to vesting on the achievement of the following performance criteria: (i) FDA approval of the NDA for ALKS 5461, (ii) the achievement of the pre-specified primary efficacy endpoints in each of two phase 3 studies of ALKS 3831, and (iii) revenues equal to or greater than a pre-specified amount for the year ending December 31, 2019. These performance criteria are being assessed over a performance period of three years from the date of the grant. In December 2018, the Company achieved the pre-specified primary efficacy endpoints on its second of the two phase 3 studies of ALKS 3831, resulting in the vesting of a portion of the performance-based RSUs and the recognition of $ 17.1 million in share-based compensation expense related to these awards. The Company recognized $ 2.1 million, $ 6.7 million and $ 8.3 million of this expense in cost of goods manufactured and sold; R&D expense; and SG&A expense, respectively. At March 31, 2019, there was $33.2 million of unrecognized compensation cost related to the remaining unvested portion of the performance-based RSUs, which would be recognized in accordance with the terms of the award if and when the Company deems it probable that the performance criteria will be met. The unvested portion of the awards will expire if the performance conditions have not been met on or before the three-year anniversary of the grant date. |
Loss Per Share
Loss Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Loss Per Share | 13. 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 three months ended March 31, 2019 and 2018, as the Company was in a net loss position, the diluted loss per share calculation 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 equivalent shares have not been included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended March 31, (In thousands) 2019 2018 Stock options 12,522 10,217 Restricted stock units 2,232 2,808 Total 14,754 13,025 |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 14. 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 March 31, 2019, there were no potential material losses from claims, asserted or unasserted, or legal proceedings the Company determined were probable of occurring. INVEGA SUSTENNA ANDA Litigation In January 2018, Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Teva Pharmaceuticals USA, Inc. (“Teva”), who filed an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. Requested judicial remedies included recovery of litigation costs and injunctive relief. The Company is not a party to these proceedings. For information about risks relating to the INVEGA SUSTENNA Paragraph IV litigation, see “Part I, Item 1A—Risk Factors” of the Company’s Annual Report, including the section entitled “—We or our licensees may face claims against intellectual property rights covering our products and competition from generic drug manufacturers.” AMPYRA ANDA Litigation Eleven separate Paragraph IV Certification Notices have been received by the Company and/or its partner Acorda from: Accord Healthcare, Inc. (“Accord”); Actavis Laboratories FL, Inc. (“Actavis”); Alkem Laboratories Ltd. (“Alkem”); Apotex Corporation and Apotex, Inc. (collectively, “Apotex”); Aurobindo Pharma Ltd. (“Aurobindo”); MicroLabs Limited (“MicroLabs”); Mylan Pharmaceuticals, Inc. (“Mylan”); Par Pharmaceutical, Inc. (“Par”); Roxane Laboratories, Inc. (“Roxane”); Sun Pharmaceutical Industries Limited and Sun Pharmaceuticals Industries Inc. (collectively, “Sun”); and Teva (collectively with Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Mylan, Par, Roxane and Sun, the “ANDA Filers”) advising that each of the ANDA Filers had submitted an ANDA to the FDA seeking marketing approval for generic versions of AMPYRA (dalfampridine) Extended-Release Tablets, 10 mg. The ANDA Filers challenged the validity of one or more of the Orange Book-listed patents for AMPYRA, and they also asserted that their generic versions do not infringe certain claims of these patents. In response, the Company and/or Acorda filed lawsuits against the ANDA Filers asserting infringement of one or more of the Orange Book-listed patents for AMPYRA. Requested judicial remedies included recovery of litigation costs and injunctive relief. All lawsuits were filed within 45 days from the date of receipt of each of the Paragraph IV Certification Notices from the ANDA Filers. As a result, a 30-month statutory stay of approval period applied to each of the ANDA Filers’ ANDAs under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). The first 30-month stay restricted the FDA from approving the ANDA Filers’ ANDAs until July 2017 at the earliest, unless a Federal district court issued a decision adverse to all of the asserted Orange Book-listed patents prior to that date. Lawsuits with eight of the ANDA Filers were consolidated into a single case. The Company and/or Acorda entered into a settlement agreement with each of Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Par and Sun to resolve the patent litigation that the Company and/or Acorda brought against these settling ANDA Filers. The settlements with these settling ANDA Filers did not impact the patent litigation that the Company and Acorda brought against the remaining ANDA Filers, including as described below. In March 2017, after a bench trial, the U.S. District Court for the District of Delaware (the “Delaware Court”) issued an opinion (the “Delaware Court Decision”), which, among other things, invalidated U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. The Delaware Court also upheld the validity of the U.S. Patent No. 5,540,938 which pertained to the formulation of AMPYRA, but that patent expired on July 30, 2018. In May 2017, Acorda filed an appeal with the Federal Circuit of the Delaware Court Decision with respect to the findings on U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. On July 27, 2018, Acorda and the Company entered into a settlement agreement with Mylan, pursuant to which, among other things, Mylan was permitted to market an authorized generic version of AMPYRA in the U.S. in the event of an affirmance by the Federal Circuit of the Delaware Court Decision. On September 10, 2018, the Federal Circuit affirmed the Delaware Court Decision, which invalidated U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. On October 24, 2018, Acorda filed a petition for rehearing and rehearing en banc of the Federal Circuit’s decision. On January 4, 2019, the Federal Circuit denied Acorda’s petition. On April 4, 2019, Acorda filed a petition for writ of certiorari to the Supreme Court of the United States. For information about risks relating to the AMPYRA Paragraph IV litigations and other proceedings see “Part I, Item 1A—Risk Factors” of the Company’s Annual Report, including the section entitled “—We or our licensees may face claims against intellectual property rights covering our products and competition from generic drug manufacturers.” VIVITROL IPR Proceeding On April 20, 2018, Amneal Pharmaceuticals LLC filed a petition with the Patent Trial and Appeal Board (the “PTAB”) of the U.S. Patent and Trademark Office seeking an inter partes review (“IPR”) of U.S. Patent Number 7,919,499 (the “ ‘499 Patent”), which is an Orange Book-listed patent for VIVITROL, seeking cancellation of claims 1-13 of the ’499 Patent. On November 7, 2018, the PTAB issued an order instituting an IPR of all challenged claims. On February 7, 2019, the Company filed its patent owner’s response. Amneal’s reply is due on May 7, 2019. A decision on the matter is expected by November 7, 2019. The Company will vigorously defend the ’499 Patent in the IPR proceedings. For information about risks relating to the ’499 Patent IPR proceedings see “Part I, Item 1A—Risk Factors” in the Company’s Annual Report, including the sections entitled “— Patent protection for our products is important and uncertain” and “— Uncertainty over intellectual property in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or commercialization of our products, and could adversely affect our business.” RISPERDAL CONSTA European Opposition Proceedings In December 2016, Nanjing Luye Pharmaceutical Co Ltd, Pharmathen SA, Teva Pharmaceutical Industries Ltd and Dehns Ltd (a law firm representing an unidentified opponent) filed notices of opposition with the European Patent Office (the “EPO”) in respect of EP 2 269 577 B (the “EP ’577” Patent), which is a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter on January 23, 2019, on April 8, 2019, the EPO issued a written decision revoking the EP’577 Patent. The Company has approximately two months from the date of the decision to appeal the decision to the EPO’s Technical Boards of Appeal. The Company will continue to vigorously defend the EP ’577 Patent. For information about risks relating to the EP ’577 Patent opposition proceedings see “Part I, Item 1A—Risk Factors” of the Company’s Annual Report , including the sections entitled “— Patent protection for our products is important and uncertain” and “— Uncertainty over intellectual property in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or commercialization of our products, and could adversely affect our business.” Government Matters On June 22, 2017 and January 17, 2019, the Company received a subpoena and a civil investigative demand, respectively, each from an Office of the U.S. Attorney for documents related to VIVITROL. The Company is cooperating with the government. Securities Litigation On November 22, 2017, a purported stockholder of the Company filed a putative class action against the Company and certain of its officers (collectively, “Defendants”) in the United States District Court for the Southern District of New York captioned Gagnon v. Alkermes plc, et al., No. 1:17-cv-09178. This complaint was amended twice since its initial filing. The second amended complaint was filed on behalf of a putative class of purchasers of Alkermes securities during the period of February 24, 2015 through November 14, 2017 and alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, based on allegedly false or misleading statements and omissions regarding the Company’s marketing practices related to VIVITROL. The lawsuit sought, among other things, unspecified damages for alleged inflation in the price of securities, and reasonable costs and expenses, including attorneys’ fees. On June 29, 2018, Defendants filed a motion to dismiss the second amended complaint. On March 28, 2019, the United States District Court for the Southern District of New York issued an order granting Defendants’ motion to dismiss and dismissing the case in its entirety and with prejudice. On April 11, 2019, the lead plaintiff filed a motion for reconsideration. Briefing on the motion for reconsideration will be completed on May 2, 2019. For information about risks relating to this action, see “Part I, Item 1A—Risk Factors” of the Company’s Annual Report, including the section entitled “—Litigation or arbitration against Alkermes, including securities litigation, or citizen petitions filed with the FDA, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business.” On December 27, 2018, a purported stockholder of the Company filed a putative class action against the Company and certain of its officers in the United States District Court for the Eastern District of New York captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410. On January 31, 2019, a purported stockholder of the Company filed a similar putative class action against the Company and the same officers in the United States District Court for the Eastern District of New York captioned McDermott v. Alkermes plc, et al., No. 1:19-cv-00624. These complaints were filed on behalf of putative classes of purchasers of Alkermes securities during the period of February 17, 2017 through November 1, 2018 and allege violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, based on allegedly false or misleading statements and omissions regarding the Company’s regulatory submission for ALKS 5461 and the FDA’s review and consideration of that submission. The lawsuits seek, among other things, unspecified money damages, prejudgment and postjudgment interest, reasonable attorneys’ fees, expert fees and other costs. On March 12, 2019, the United States District Court for the Eastern District of New York consolidated the two cases and appointed a lead plaintiff. For information about risks relating to these actions, see “Part I, Item 1A—Risk Factors” of the Company’s Annual Report, including the section entitled “—Litigation or arbitration against Alkermes, including securities litigation, or citizen petitions filed with the FDA, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business.” |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three months ended March 31, 2019 and 2018 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2018. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States (“U.S.”) (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, that are necessary to state fairly the results of operations for the reported periods. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Company’s Annual Report that has been filed with the SEC. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for a full fiscal year. |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies, |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including those related to revenue recognition and related allowances, its collaborative relationships, clinical trial expenses, the valuation of inventory, 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. |
Segment Information | Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines. The Company’s chief decision maker, the Chairman of the Board 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. |
Income Taxes | Income Taxes The Company’s income tax benefit in the three months ended March 31, 2019 and 2018 primarily related to U.S. federal and state taxes. The Company records a deferred tax asset or liability based on the difference between the financial statement and tax basis of its assets and liabilities, as measured by enacted jurisdictional tax rates assumed to be in effect when these differences reverse. At March 31, 2019, the Company maintained a valuation allowance against certain of its U.S. and foreign deferred tax assets. The Company evaluates, at each reporting period, the need for a valuation allowance on its deferred tax assets on a jurisdiction-by-jurisdiction basis. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“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 guidance that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Effective January 1, 2019, the Company adopted the requirements under Accounting Standards Update (“ASU”) 2016-02, Leases Leases In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-14, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This ASU also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. This ASU becomes effective for the Company in the year ending December 31, 2020 and early adoption is permitted. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Clarifying the Interaction Between Topic 808 and Topic 606 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Schedule of Manufacturing and Royalty Revenues | During the three months ended March 31, 2019 and 2018, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended March 31, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 53,298 $ 53,298 RISPERDAL CONSTA 17,921 4,385 22,306 AMPYRA/FAMPYRA 5,680 6,506 12,186 Other 7,346 13,779 21,125 $ 30,947 $ 77,968 $ 108,915 Three Months Ended March 31, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 46,086 $ 46,086 AMPYRA/FAMPYRA 13,563 14,696 28,259 RISPERDAL CONSTA 17,792 4,912 22,704 Other 6,236 11,316 17,552 $ 37,591 $ 77,010 $ 114,601 |
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 7,346 Transferred to receivables, net (7,129 ) Contract assets at March 31, 2019 $ 8,447 Contract Liabilities —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 1,516 Amounts recognized into revenue (790 ) Contract liabilities at March 31, 2019 $ 13,420 |
Product sales, net | |
Schedule of Disaggregation of Revenue | During the three months ended March 31, 2019 and 2018, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2019 2018 VIVITROL $ 69,183 $ 62,682 ARISTADA 30,298 29,160 Total product sales, net $ 99,481 $ 91,842 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Investments | Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated March 31, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 156,443 $ 349 $ (11 ) $ (149 ) $ 156,632 U.S. government and agency debt securities 108,113 257 (4 ) (45 ) 108,321 International government agency debt securities 91,818 193 — (70 ) 91,941 Total short-term investments 356,374 799 (15 ) (264 ) 356,894 Long-term investments: Available-for-sale securities: Corporate debt securities 28,570 — (84 ) (45 ) 28,441 U.S. government and agency debt securities 10,984 — (4 ) (5 ) 10,975 39,554 — (88 ) (50 ) $ 39,416 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 43,041 102 (88 ) (50 ) 43,005 Total investments 399,415 901 (103 ) (314 ) 399,899 December 31, 2018 Short-term investments: Available-for-sale securities: Corporate debt securities $ 120,197 $ 57 $ (62 ) $ (274 ) $ 119,918 U.S. government and agency debt securities 80,055 115 (11 ) (87 ) 80,072 International government agency debt securities 72,091 85 (8 ) (117 ) 72,051 272,343 257 (81 ) (478 ) 272,041 Held-to-maturity securities: Corporate debt securities 492 — — — 492 Total short-term investments 272,835 257 (81 ) (478 ) 272,533 Long-term investments: Available-for-sale securities: Corporate debt securities 53,505 — (185 ) (93 ) $ 53,227 U.S. government and agency debt securities 18,474 — (21 ) (12 ) 18,441 International government agency debt securities 5,457 — (4 ) — 5,453 77,436 — (210 ) (105 ) 77,121 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 136 — — 1,803 3,487 136 — — 3,623 Total long-term investments 80,923 136 (210 ) (105 ) 80,744 Total investments $ 353,758 $ 393 $ (291 ) $ (583 ) $ 353,277 |
Schedule of Proceeds From Sales and Maturities of Marketable Securities Plus the Resulting Realized Gains and Losses | The proceeds from the sales and maturities of marketable securities, which were identified using the specific identification method and were primarily reinvested, were as follows: Three Months Ended March 31, (In thousands) 2019 2018 Proceeds from the sales and maturities of marketable securities $ 55,978 $ 79,500 Realized gains $ — $ 1 Realized losses $ 492 $ 4 |
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 March 31, 2019 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 213,318 $ 213,172 $ 1,820 $ 1,820 After 1 year through 5 years 182,610 183,138 1,667 1,769 Total $ 395,928 $ 396,310 $ 3,487 $ 3,589 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: March 31, (In thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 62,556 $ 62,556 $ — $ — U.S. government and agency debt securities 119,296 68,704 50,592 — Corporate debt securities 185,073 — 185,073 — International government agency debt securities 91,941 — 91,941 — Contingent consideration 37,600 — — 37,600 Common stock warrants 772 — — 772 Total $ 497,238 $ 131,260 $ 327,606 $ 38,372 December 31, 2018 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 54,590 $ 54,590 $ — $ — U.S. government and agency debt securities 98,513 60,107 38,406 — Corporate debt securities 173,637 — 173,145 492 International government agency debt securities 77,504 — 77,504 — Contingent consideration 65,200 — — 65,200 Common stock warrants 1,205 — — 1,205 Total $ 470,649 $ 114,697 $ 289,055 $ 66,897 |
Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs | The following table is a rollforward of the fair value of the Company’s assets whose fair values were determined using Level 3 inputs at March 31, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Change in the fair value of contingent consideration (22,600 ) Payment received for contingent consideration (5,000 ) Impairment of corporate debt security (492 ) Decrease in the fair value of warrants (433 ) Balance, March 31, 2019 $ 38,372 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: March 31, December 31, (In thousands) 2019 2018 Raw materials $ 33,526 $ 31,824 Work in process 41,548 38,019 Finished goods (1) 17,787 20,353 Total inventory $ 92,861 $ 90,196 (1) At March 31, 2019 and December 31, 2018, the Company had $11.7 million and $11.0 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following: March 31, December 31, (In thousands) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 170,289 157,053 Furniture, fixtures and equipment 320,882 314,831 Leasehold improvements 20,105 20,105 Construction in progress 89,245 88,983 Subtotal 607,081 587,458 Less: accumulated depreciation (287,077 ) (277,471 ) Total property, plant and equipment, net $ 320,004 $ 309,987 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: March 31, 2019 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (326,532 ) $ 139,058 NanoCrystal technology 13 74,600 (40,873 ) 33,727 OCR technologies 12 42,560 (34,296 ) 8,264 Total $ 582,750 $ (401,701 ) $ 181,049 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of March 31, 2019 and December 31, 2018: March 31, December 31, (In thousands) 2019 2018 2019 $ 6,806 $ 9,394 2020 8,652 10,717 2021 2,520 4,706 2022 500 2,455 2023 509 2,389 Thereafter 3,100 23,940 Total lease payments $ 22,087 $ 53,601 Less: imputed interest (2,272 ) — Total operating lease liabilities $ 19,815 $ 53,601 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: March 31, December 31, (In thousands) 2019 2018 Accounts payable $ 48,956 $ 39,767 Accrued compensation 48,653 67,613 Accrued sales discounts, allowances and reserves 140,736 152,911 Accrued other 75,624 73,471 Total accounts payable and accrued expenses $ 313,969 $ 333,762 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: March 31, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 278,766 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 275,923 $ 276,465 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Share-based Compensation Expense | Share-based compensation expense consisted of the following: March 31, (In thousands) 2019 2018 Cost of goods manufactured and sold $ 1,978 $ 1,418 Research and development 7,746 6,714 Selling, general and administrative 14,892 11,910 Total share-based compensation expense $ 24,616 $ 20,042 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Equivalent Shares Excluded from Calculation of Net (Loss) Income Per Share | The following potential ordinary equivalent shares have not been included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended March 31, (In thousands) 2019 2018 Stock options 12,522 10,217 Restricted stock units 2,232 2,808 Total 14,754 13,025 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019USD ($)segment | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |||
Number of business segments | segment | 1 | ||
Operating lease, right-of-use asset | $ 18,010 | $ 20,100 | |
Operating lease liability | $ 19,815 | $ 22,100 | $ 53,601 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 223,102 | $ 225,150 |
Manufacturing Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 30,947 | 37,591 |
Manufacturing Revenue | AMPYRA/ FAMPYRA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 5,680 | 13,563 |
Manufacturing Revenue | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 17,921 | 17,792 |
Manufacturing Revenue | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 7,346 | 6,236 |
Royalty Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 77,968 | 77,010 |
Royalty Revenue | INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 53,298 | 46,086 |
Royalty Revenue | AMPYRA/ FAMPYRA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 6,506 | 14,696 |
Royalty Revenue | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 4,385 | 4,912 |
Royalty Revenue | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 13,779 | 11,316 |
Manufacturing and royalty revenues | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 108,915 | 114,601 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 53,298 | 46,086 |
Manufacturing and royalty revenues | AMPYRA/ FAMPYRA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 12,186 | 28,259 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 22,306 | 22,704 |
Manufacturing and royalty revenues | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 21,125 | $ 17,552 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 223,102 | $ 225,150 |
VIVITROL | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 69,183 | 62,682 |
ARISTADA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 30,298 | 29,160 |
Product sales, net | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 99,481 | $ 91,842 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||
Total revenues related to license and collaboration agreement for Diroximel fumarate | $ 223,102 | $ 225,150 | |
Minimum | |||
Disaggregation Of Revenue [Line Items] | |||
Manufacturing Process period | 10 days | ||
Maximum | |||
Disaggregation Of Revenue [Line Items] | |||
Manufacturing Process period | 56 days | ||
Biogen | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues related to license and collaboration agreement for Diroximel fumarate | $ 13,900 | 17,500 | |
Research and development revenue | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenues related to license and collaboration agreement for Diroximel fumarate | $ 14,706 | $ 18,707 | |
Research and development revenue | Biogen | Forecast | |||
Disaggregation Of Revenue [Line Items] | |||
Additional revenue expected | $ 77,600 |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Contract Assets and Contract Liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 8,230 |
Additions | 7,346 |
Transferred to receivables, net | (7,129) |
Contract assets at end of period | 8,447 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 12,694 |
Additions | 1,516 |
Amounts recognized into revenue | (790) |
Contract liabilities at end of the period | $ 13,420 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Available-for-sale securities: | ||
Amortized Cost | $ 395,928 | |
Estimated Fair Value | 396,310 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 3,589 | |
Long-term Investments | ||
Amortized Cost | 43,041 | $ 80,923 |
Gross Unrealized Gains | 102 | 136 |
Gross Unrealized Losses, Less than One Year | (88) | (210) |
Gross Unrealized Losses, Greater than One Year | (50) | (105) |
Total long-term investments | 43,005 | 80,744 |
Total investments | ||
Amortized Cost | 399,415 | 353,758 |
Gross Unrealized Gains | 901 | 393 |
Gross Unrealized Losses, Less than One Year | (103) | (291) |
Gross Unrealized Losses, Greater than One Year | (314) | (583) |
Estimated Fair Value | 399,899 | 353,277 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 356,374 | 272,343 |
Gross Unrealized Gains | 799 | 257 |
Gross Unrealized Losses, Less than One Year | (15) | (81) |
Gross Unrealized Losses, Greater than One Year | (264) | (478) |
Estimated Fair Value | 356,894 | 272,041 |
Held-to-maturity securities: | ||
Amortized Cost | 272,835 | |
Gross Unrealized Gains | 257 | |
Gross Unrealized Losses, Less than One Year | (81) | |
Gross Unrealized Losses, Greater than One Year | (478) | |
Estimated Fair Value | 272,533 | |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 156,443 | 120,197 |
Gross Unrealized Gains | 349 | 57 |
Gross Unrealized Losses, Less than One Year | (11) | (62) |
Gross Unrealized Losses, Greater than One Year | (149) | (274) |
Estimated Fair Value | 156,632 | 119,918 |
Held-to-maturity securities: | ||
Amortized Cost | 492 | |
Estimated Fair Value | 492 | |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 108,113 | 80,055 |
Gross Unrealized Gains | 257 | 115 |
Gross Unrealized Losses, Less than One Year | (4) | (11) |
Gross Unrealized Losses, Greater than One Year | (45) | (87) |
Estimated Fair Value | 108,321 | 80,072 |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 91,818 | 72,091 |
Gross Unrealized Gains | 193 | 85 |
Gross Unrealized Losses, Less than One Year | (8) | |
Gross Unrealized Losses, Greater than One Year | (70) | (117) |
Estimated Fair Value | 91,941 | 72,051 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 39,554 | 77,436 |
Gross Unrealized Losses, Less than One Year | (88) | (210) |
Gross Unrealized Losses, Greater than One Year | (50) | (105) |
Estimated Fair Value | 39,416 | 77,121 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | 3,487 |
Gross Unrealized Gains | 102 | 136 |
Estimated Fair Value | 3,589 | 3,623 |
Long-term investments | Certificates of deposit | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,820 | 1,820 |
Estimated Fair Value | 1,820 | 1,820 |
Long-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 28,570 | 53,505 |
Gross Unrealized Losses, Less than One Year | (84) | (185) |
Gross Unrealized Losses, Greater than One Year | (45) | (93) |
Estimated Fair Value | 28,441 | 53,227 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 10,984 | 18,474 |
Gross Unrealized Losses, Less than One Year | (4) | (21) |
Gross Unrealized Losses, Greater than One Year | (5) | (12) |
Estimated Fair Value | 10,975 | 18,441 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 5,457 | |
Gross Unrealized Losses, Less than One Year | (4) | |
Estimated Fair Value | 5,453 | |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | 1,667 |
Gross Unrealized Gains | 102 | 136 |
Estimated Fair Value | $ 1,769 | $ 1,803 |
Investments - Schedule of Proce
Investments - Schedule of Proceeds From Sales and Maturities of Marketable Securities Plus the Resulting Realized Gains and Losses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Proceeds from the sales and maturities of marketable securities | $ 55,978 | $ 79,500 |
Realized gains | 1 | |
Realized losses | $ 492 | $ 4 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Mar. 31, 2019USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 213,318 |
After 1 year through 5 years | 182,610 |
Amortized Cost | 395,928 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 213,172 |
After 1 year through 5 years | 183,138 |
Total | 396,310 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 1,820 |
After 1 year through 5 years | 1,667 |
Total | 3,487 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 1,820 |
After 1 year through 5 years | 1,769 |
Total | $ 3,589 |
Investments - Additional Inform
Investments - Additional Information (Details) - Fountain Healthcare Partners II, LP of Ireland € in Millions, $ in Millions | 3 Months Ended | ||||
Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Mar. 31, 2019EUR (€) | Dec. 31, 2018USD ($) | May 31, 2014EUR (€) | |
Equity method investment | |||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | |||
Increase (decrease) in carrying value of investment of the entity, which represents the Company's share of investee's net gains (losses) | $ | $ (0.1) | $ (0.1) | |||
Maximum | |||||
Equity method investment | |||||
Maximum commitment on equity method investment | € | € 7.4 | ||||
Other Assets | |||||
Equity method investment | |||||
Total equity method commitment | € | € 5.5 | ||||
Carrying value of equity investment | $ | $ 5.6 | $ 5.5 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair value | ||
Debt securities | $ 396,310 | |
Contingent consideration | 37,600 | $ 65,200 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 62,556 | 54,590 |
Contingent consideration | 37,600 | 65,200 |
Common stock warrants | 772 | 1,205 |
Assets, Total | 497,238 | 470,649 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 62,556 | 54,590 |
Assets, Total | 131,260 | 114,697 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 327,606 | 289,055 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 37,600 | 65,200 |
Common stock warrants | 772 | 1,205 |
Assets, Total | 38,372 | 66,897 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 119,296 | 98,513 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 68,704 | 60,107 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 50,592 | 38,406 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 185,073 | 173,637 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 185,073 | 173,145 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 492 | |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 91,941 | 77,504 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 91,941 | $ 77,504 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 3 Months Ended | ||||
Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($)itemMilestone | Mar. 31, 2018USD ($) | Mar. 31, 2020item | Dec. 31, 2018USD ($) | |
Fair Value | |||||
Transfers between the levels | $ 0 | ||||
Contingent consideration | 37,600,000 | $ 65,200,000 | |||
Increase (decrease) in the fair value of contingent consideration | $ (22,600,000) | $ (1,900,000) | |||
Discount Rate | Real options approach | |||||
Fair Value | |||||
Discount rate (as a percent) | item | 15 | ||||
Discount Rate | Future royalties | |||||
Fair Value | |||||
Discount rate (as a percent) | item | 16 | ||||
Recro | |||||
Fair Value | |||||
Milestone payments received | $ 5,000,000 | ||||
Milestone payments receivable upon achievement of certain regulatory and sales milestones | 130,000,000 | ||||
Milestone payment upon regulatory approval of New Drug Application | 5,000,000 | ||||
Milestone annual payable | $ 45,000,000 | ||||
Number of milestone payment upon approval of New Drug Application | Milestone | 7 | ||||
Contingent consideration | $ 37,600,000 | $ 65,200,000 | |||
Increase (decrease) in the fair value of contingent consideration | (22,600,000) | $ (1,900,000) | |||
Recro | Maximum | |||||
Fair Value | |||||
Milestone payments receivable | $ 80,000,000 | ||||
Recro | Forecast | |||||
Fair Value | |||||
Milestone payments receivable | $ 5,000,000 | ||||
Recro | Forecast | Discount Rate | |||||
Fair Value | |||||
Discount rate (as a percent) | item | 16 |
Fair Value Measurements - Rollf
Fair Value Measurements - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Balance at the beginning of the period | $ 66,897 |
Payment received for contingent consideration | (5,000) |
Impairment of corporate debt security | (492) |
Balance at the end of the period | 38,372 |
Change in the fair value of contingent consideration | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value | (22,600) |
Decrease in the fair value of warrants | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value | $ (433) |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 33,526 | $ 31,824 |
Work in process | 41,548 | 38,019 |
Finished goods | 17,787 | 20,353 |
Total inventory | $ 92,861 | $ 90,196 |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 11.7 | $ 11 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 607,081 | $ 587,458 |
Less: accumulated depreciation | (287,077) | (277,471) |
Total property, plant and equipment, net | 320,004 | 309,987 |
Land | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 6,560 | 6,486 |
Building and Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 170,289 | 157,053 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 320,882 | 314,831 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 20,105 | 20,105 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 89,245 | $ 88,983 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | |
Net Carrying Amount | 92,873 | $ 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 582,750 | |
Accumulated Amortization | (401,701) | |
Net Carrying Amount | $ 181,049 | $ 191,001 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | |
Accumulated Amortization | (326,532) | |
Net Carrying Amount | $ 139,058 | |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | |
Accumulated Amortization | (40,873) | |
Net Carrying Amount | $ 33,727 | |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | |
Accumulated Amortization | (34,296) | |
Net Carrying Amount | $ 8,264 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) $ in Millions | Mar. 31, 2019USD ($) |
Expected amortization of intangible assets | |
2019 | $ 40 |
2020 | 40 |
2021 | 40 |
2022 | 35 |
2023 | $ 35 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Jan. 01, 2019USD ($)ft²Option | Mar. 31, 2018ft² | Mar. 31, 2019USD ($)lease | Dec. 31, 2018USD ($) |
Lessee Lease Description [Line Items] | ||||
Area of real estate property | 220,000 | |||
Lessee operating lease term of option to extend | 10 years | |||
Number of additional operating leases | lease | 2 | |||
Weighted average incremental borrowing rate | 4.46% | |||
Weighted average remaining lease term | 4 years 1 month 6 days | |||
Right-of-use assets | $ | $ 20,100 | $ 18,010 | ||
Operating lease liability | $ | $ 22,100 | 19,815 | $ 53,601 | |
Payments for operating leases | $ | 2,300 | |||
Operating lease expense | $ | $ 2,100 | |||
MASSACHUSETTS | Corporate office and administrative space expire in 2021 | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | 175,000 | |||
Maximum number of option to extend lease term | Option | 2 | |||
Lessee operating lease term of option to extend | 5 years | |||
Operating lease, existence of option to extend | true | |||
MASSACHUSETTS | Corporate office and administrative space expire in 2020 | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | 67,000 | |||
Maximum number of option to extend lease term | Option | 2 | |||
Lessee operating lease term of option to extend | 1 year | |||
Operating lease, existence of option to extend | true | |||
Ireland | Corporate office and administrative space expire in 2022 | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | 14,600 | |||
Lessee operating lease term of option to extend | 5 years | |||
Operating lease, existence of option to extend | true | |||
Washington | Corporate office and administrative space expire In 2029 | ||||
Lessee Lease Description [Line Items] | ||||
Area of real estate property | 7,000 | |||
Lessee operating lease term of option to extend | 5 years | |||
Operating lease, existence of option to extend | true |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
2019 | $ 6,806 | ||
2019 | $ 9,394 | ||
2020 | 8,652 | 10,717 | |
2021 | 2,520 | 4,706 | |
2022 | 500 | 2,455 | |
2023 | 509 | 2,389 | |
Thereafter | 3,100 | 23,940 | |
Total lease payments | 22,087 | 53,601 | |
Less: imputed interest | (2,272) | ||
Total operating lease liabilities | $ 19,815 | $ 22,100 | $ 53,601 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 48,956 | $ 39,767 |
Accrued compensation | 48,653 | 67,613 |
Accrued sales discounts, allowances and reserves | 140,736 | 152,911 |
Accrued other | 75,624 | 73,471 |
Total accounts payable and accrued expenses | $ 313,969 | $ 333,762 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (2,843) |
Long-term debt | 275,923 | 276,465 |
2023 Term Loans | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | 278,766 | 279,308 |
Less: current portion | (2,843) | (2,843) |
Long-term debt | $ 275,923 | $ 276,465 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | Oct. 12, 2016 | Mar. 31, 2019USD ($)Lender | Mar. 31, 2018USD ($) | Mar. 26, 2018 | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Long-term debt | ||||||
Number of lender holding percentage of outstanding amount | Lender | 1 | |||||
Percentage of outstanding principal amount held by lender | 1.00% | |||||
Interest Expense | ||||||
Long-term debt | ||||||
Refinancing charges | $ 2.3 | |||||
Minimum | ||||||
Long-term debt | ||||||
Threshold percentage comparing present value of remaining cash flows | 10.00% | |||||
Term Loan B-1 | ||||||
Long-term debt | ||||||
Due date of loan | Sep. 25, 2021 | |||||
Variable interest rate base | LIBOR | |||||
Term Loan B-1 | LIBOR | ||||||
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% | |||||
2023 Term Loans | ||||||
Long-term debt | ||||||
Due date of loan | Mar. 26, 2023 | |||||
Variable interest rate base | LIBOR | |||||
2023 Term Loans | Level 2 | ||||||
Long-term debt | ||||||
Amount to be realized in the future | $ 277.5 | $ 277.5 | $ 274.7 | |||
2023 Term Loans | LIBOR | ||||||
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% |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based compensation Expense | ||
Total share-based compensation expense | $ 24,616 | $ 20,042 |
Cost of goods manufactured and sold | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 1,978 | 1,418 |
Research and development | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 7,746 | 6,714 |
Selling, General and Administrative | ||
Share-based compensation Expense | ||
Total share-based compensation expense | $ 14,892 | $ 11,910 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2018USD ($) | Mar. 31, 2019USD ($)item | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | |
Share-based compensation Expense | ||||
Share-based compensation expense | $ 24,616 | $ 20,042 | ||
Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 1,978 | 1,418 | ||
Research and development | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 7,746 | 6,714 | ||
Selling, General and Administrative | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | $ 14,892 | $ 11,910 | ||
Performance-based RSUs | ||||
Share-based compensation Expense | ||||
Number of Phase 3 studies of ALKS 3831 | item | 2 | |||
Number of years from the date of the grant | 3 years | |||
Unrecognized compensation cost | $ 33,200 | |||
Expiration period | 3 years | |||
Share-based compensation expense | $ 17,100 | |||
Performance-based RSUs | Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 2,100 | |||
Performance-based RSUs | Research and development | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | 6,700 | |||
Performance-based RSUs | Selling, General and Administrative | ||||
Share-based compensation Expense | ||||
Share-based compensation expense | $ 8,300 | |||
Inventory | ||||
Share-based compensation Expense | ||||
Share based compensation cost capitalized | $ 2,900 | $ 2,700 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Equivalent Shares Excluded from Calculation of Net (Loss) Income Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Denominator: | ||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 14,754 | 13,025 |
Stock Options | ||
Denominator: | ||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 12,522 | 10,217 |
Restricted Stock Units | ||
Denominator: | ||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 2,232 | 2,808 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2019USD ($)NoticeFiler | |
Commitments And Contingencies Disclosure [Abstract] | |
Potential losses from claims, legal proceedings probable of occurring | $ | $ 0 |
Number of separate Paragraph IV notices received | Notice | 11 |
Maximum number of days for lawsuit | 45 days |
Minimum number of months before FDA can approve patent request | 30 months |
Number of ANDA Filers consolidated to a single case | Filer | 8 |
Loss contingency lead plaintiff filing date | April 11, 2019 |
Loss contingency completion date | May 2, 2019 |