Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 18, 2019 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 157,522,247 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ALKS | |
Entity File Number | 001-35299 | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 98-1007018 | |
Entity Address, Address Line One | Connaught House | |
Entity Address, Address Line Two | 1 Burlington Road | |
Entity Address, City or Town | Dublin 4 | |
Entity Address, Country | IE | |
Entity Address, Postal Zip Code | D04 C5Y6 | |
City Area Code | 353 | |
Local Phone Number | 1-772-8000 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Ordinary shares, $0.01 par value | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 261,426 | $ 266,762 |
Investments—short-term | 325,756 | 272,533 |
Receivables, net | 250,234 | 292,223 |
Contract assets | 5,022 | 8,230 |
Inventory | 100,987 | 90,196 |
Prepaid expenses and other current assets | 54,493 | 53,308 |
Total current assets | 997,918 | 983,252 |
PROPERTY, PLANT AND EQUIPMENT, NET | 341,406 | 309,987 |
INTANGIBLE ASSETS, NET | 160,814 | 191,001 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 87,615 | 85,807 |
CONTINGENT CONSIDERATION | 27,400 | 65,200 |
INVESTMENTS—LONG-TERM | 21,352 | 80,744 |
RIGHT-OF-USE ASSETS | 13,835 | |
OTHER ASSETS | 14,782 | 16,143 |
TOTAL ASSETS | 1,757,995 | 1,825,007 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 357,126 | 333,762 |
Operating lease liabilities—short-term | 8,627 | |
Long-term debt—short-term | 2,843 | 2,843 |
Contract liabilities—short-term | 1,798 | 3,169 |
Total current liabilities | 370,394 | 339,774 |
LONG-TERM DEBT | 274,838 | 276,465 |
CONTRACT LIABILITIES—LONG-TERM | 11,188 | 9,525 |
OPERATING LEASE LIABILITIES—LONG-TERM | 6,657 | |
OTHER LONG-TERM LIABILITIES | 26,734 | 27,958 |
Total liabilities | 689,811 | 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 September 30, 2019 and December 31, 2018, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 160,203,448 and 158,180,833 shares issued; 157,496,990 and 155,757,344 shares outstanding at September 30, 2019 and December 31, 2018, respectively | 1,599 | 1,579 |
Treasury shares, at cost (2,706,458 and 2,423,489 shares at September 30, 2019 and December 31, 2018, respectively) | (118,300) | (108,969) |
Additional paid-in capital | 2,563,157 | 2,467,323 |
Accumulated other comprehensive loss | (1,638) | (3,280) |
Accumulated deficit | (1,376,634) | (1,185,368) |
Total shareholders’ equity | 1,068,184 | 1,171,285 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,757,995 | $ 1,825,007 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock shares, authorized | 50,000,000 | 50,000,000 |
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 450,000,000 | 450,000,000 |
Ordinary shares, shares issued | 160,203,448 | 158,180,833 |
Ordinary shares, shares outstanding | 157,496,990 | 155,757,344 |
Treasury shares | 2,706,458 | 2,423,489 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
REVENUES: | ||||
Total revenues | $ 255,243 | $ 248,720 | $ 758,217 | $ 778,512 |
EXPENSES: | ||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 42,319 | 39,410 | 133,903 | 127,303 |
Research and development | 107,671 | 101,265 | 314,676 | 316,434 |
Selling, general and administrative | 148,701 | 128,777 | 444,996 | 385,181 |
Amortization of acquired intangible assets | 10,173 | 16,426 | 30,187 | 48,742 |
Total expenses | 308,864 | 285,878 | 923,762 | 877,660 |
OPERATING LOSS | (53,621) | (37,158) | (165,545) | (99,148) |
OTHER (EXPENSE) INCOME, NET: | ||||
Interest income | 3,509 | 2,561 | 10,785 | 5,946 |
Interest expense | (3,385) | (3,346) | (10,405) | (11,959) |
Change in the fair value of contingent consideration | 1,300 | 4,200 | (27,800) | (17,300) |
Other expense, net | (1,664) | (90) | (1,534) | (2,815) |
Total other (expense) income, net | (240) | 3,325 | (28,954) | (26,128) |
LOSS BEFORE INCOME TAXES | (53,861) | (33,833) | (194,499) | (125,276) |
INCOME TAX (BENEFIT) PROVISION | (983) | 611 | (3,233) | 4,322 |
NET LOSS | $ (52,878) | $ (34,444) | $ (191,266) | $ (129,598) |
LOSS PER ORDINARY SHARE: | ||||
Basic and diluted (in dollars loss per ordinary share) | $ (0.34) | $ (0.22) | $ (1.22) | $ (0.84) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic and diluted (in shares) | 157,199 | 155,328 | 156,845 | 154,979 |
COMPREHENSIVE LOSS: | ||||
Net loss | $ (52,878) | $ (34,444) | $ (191,266) | $ (129,598) |
Holding gain (loss), net of a tax provision (benefit) of $(15), $95, $479 and $42, respectively | (24) | 314 | 1,642 | 126 |
COMPREHENSIVE LOSS | (52,902) | (34,130) | (189,624) | (129,472) |
Product sales, net | ||||
REVENUES: | ||||
Total revenues | 138,774 | 116,035 | 374,890 | 317,684 |
Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | 103,783 | 116,411 | 340,595 | 359,253 |
Research and development revenue | ||||
REVENUES: | ||||
Total revenues | $ 12,686 | $ 16,274 | 41,732 | 53,325 |
License revenue | ||||
REVENUES: | ||||
Total revenues | $ 1,000 | $ 48,250 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Statement [Abstract] | ||||||||
Tax (benefit) provision | $ (15) | $ 265 | $ 229 | $ 95 | $ 47 | $ (100) | $ 479 | $ 42 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (191,266) | $ (129,598) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 59,901 | 77,758 |
Share-based compensation expense | 79,590 | 76,043 |
Deferred income taxes | (3,025) | 3,879 |
Change in the fair value of contingent consideration | 27,800 | 17,300 |
Loss on debt refinancing | 2,298 | |
Payment made for debt refinancing | (2,251) | |
Other non-cash charges | 90 | 1,209 |
Changes in assets and liabilities: | ||
Receivables | 41,988 | (17,322) |
Contract assets | 3,207 | (4,366) |
Inventory | (10,324) | (2,596) |
Prepaid expenses and other assets | 2,120 | (3,291) |
Right-of-use assets | 6,306 | |
Accounts payable and accrued expenses | 20,542 | 12,899 |
Contract liabilities | 292 | 2,485 |
Operating lease liabilities | (6,845) | |
Other long-term liabilities | (369) | 4,321 |
Cash flows provided by operating activities | 30,007 | 38,768 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (58,972) | (51,841) |
Proceeds from the sale of equipment | 900 | 428 |
Proceeds from contingent consideration | 10,000 | |
Purchases of investments | (141,749) | (307,603) |
Sales and maturities of investments | 149,459 | 344,624 |
Cash flows used in investing activities | (40,362) | (14,392) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 16,381 | 18,318 |
Employee taxes paid related to net share settlement of equity awards | (9,230) | (15,785) |
Principal payments of long-term debt | (2,132) | (1,421) |
Payment made for debt refinancing | (743) | |
Cash flows provided by financing activities | 5,019 | 369 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (5,336) | 24,745 |
CASH AND CASH EQUIVALENTS—Beginning of period | 266,762 | 191,296 |
CASH AND CASH EQUIVALENTS—End of period | 261,426 | 216,041 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 14,664 | $ 7,117 |
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 exercise 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 (benefit) | (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, 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) | ||||
Net loss | (129,598) | |||||
BALANCE at Sep. 30, 2018 | 1,150,715 | $ 1,574 | 2,433,594 | (3,666) | (1,175,655) | $ (105,132) |
BALANCE (in shares) at Sep. 30, 2018 | 157,674,736 | (2,310,756) | ||||
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) | ||||
Issuance of ordinary shares under employee stock plans | 3,835 | $ 2 | 3,833 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 297,889 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (18) | $ 1 | (2) | $ (17) | ||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 1,250 | (369) | ||||
Share-based compensation expense | 30,947 | 30,947 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) | 149 | 149 | ||||
Net loss | (32,649) | (32,649) | ||||
BALANCE at Jun. 30, 2018 | 1,158,155 | $ 1,573 | 2,406,861 | (3,980) | (1,141,211) | $ (105,088) |
BALANCE (in shares) at Jun. 30, 2018 | 157,612,457 | (2,309,704) | ||||
Issuance of ordinary shares under employee stock plans | 1,318 | $ 1 | 1,317 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 56,945 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (43) | 1 | $ (44) | |||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 5,334 | (1,052) | ||||
Share-based compensation expense | 25,415 | 25,415 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) | 314 | 314 | ||||
Net loss | (34,444) | (34,444) | ||||
BALANCE at Sep. 30, 2018 | 1,150,715 | $ 1,574 | 2,433,594 | (3,666) | (1,175,655) | $ (105,132) |
BALANCE (in shares) at Sep. 30, 2018 | 157,674,736 | (2,310,756) | ||||
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 exercise 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 (benefit) | 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) | ||||
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) | ||||
Net loss | (191,266) | |||||
BALANCE at Sep. 30, 2019 | 1,068,184 | $ 1,599 | 2,563,157 | (1,638) | (1,376,634) | $ (118,300) |
BALANCE (in shares) at Sep. 30, 2019 | 160,203,448 | (2,706,458) | ||||
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) | ||||
Issuance of ordinary shares under employee stock plans | 2,054 | $ 2 | 2,052 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 197,953 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (194) | $ (194) | ||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 20,289 | (6,397) | ||||
Share-based compensation expense | 28,261 | 28,261 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) | 896 | 896 | ||||
Net loss | (41,990) | (41,990) | ||||
BALANCE at Jun. 30, 2019 | 1,091,168 | $ 1,595 | 2,533,086 | (1,614) | (1,323,756) | $ (118,143) |
BALANCE (in shares) at Jun. 30, 2019 | 159,796,116 | (2,699,243) | ||||
Issuance of ordinary shares under employee stock plans | 3,773 | $ 3 | 3,770 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 383,957 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (156) | $ 1 | $ (157) | |||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 23,375 | (7,215) | ||||
Share-based compensation expense | 26,301 | 26,301 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision (benefit) | (24) | (24) | ||||
Net loss | (52,878) | (52,878) | ||||
BALANCE at Sep. 30, 2019 | $ 1,068,184 | $ 1,599 | $ 2,563,157 | $ (1,638) | $ (1,376,634) | $ (118,300) |
BALANCE (in shares) at Sep. 30, 2019 | 160,203,448 | (2,706,458) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement Of Stockholders Equity [Abstract] | ||||||||
Tax (benefit) provision | $ (15) | $ 265 | $ 229 | $ 95 | $ 47 | $ (100) | $ 479 | $ 42 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. THE COMPANY Alkermes plc 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 CNS disorders such as schizophrenia, depression, addiction and MS, and oncology. Headquartered in Dublin, Ireland, the Company has an R&D center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 and nine months ended September 30, 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 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 Annual Report. 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 any 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 from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. 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) provision primarily relates 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 September 30, 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 Compensation – Stock Compensation In August 2018, the FASB issued ASU 2018-14, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement Conceptual Framework for Financial Reporting - Chapter 8: Notes to Financial Statements 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 has not yet adopted this ASU and 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 | 9 Months Ended |
Sep. 30, 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). 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 and nine months ended September 30, 2019 and 2018, the Company recorded product sales, net, as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2019 2018 2019 2018 VIVITROL $ 85,164 $ 79,893 $ 242,546 $ 218,778 ARISTADA 53,610 36,142 132,344 98,906 Total product sales, net $ 138,774 $ 116,035 $ 374,890 $ 317,684 Manufacturing and Royalty Revenues During the three and nine months ended September 30, 2019 and 2018, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended September 30, 2019 Nine Months Ended September 30, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 68,382 $ 68,382 $ — $ 188,968 $ 188,968 RISPERDAL CONSTA 4,520 3,813 8,333 42,948 12,266 55,214 AMPYRA/FAMPYRA 5,134 2,582 7,716 17,287 12,405 29,692 Other 6,428 12,924 19,352 25,173 41,548 66,721 $ 16,082 $ 87,701 $ 103,783 $ 85,408 $ 255,187 $ 340,595 Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 65,620 $ 65,620 $ — $ 174,956 $ 174,956 RISPERDAL CONSTA 7,267 4,316 11,583 42,296 13,922 56,218 AMPYRA/FAMPYRA 12,894 7,445 20,339 38,000 30,276 68,276 Other 5,036 13,833 18,869 19,420 40,383 59,803 $ 25,197 $ 91,214 $ 116,411 $ 99,716 $ 259,537 $ 359,253 Research and Development Revenue The Company recorded research and development (“R&D”) revenue of $12.1 million and $39.5 million during the three and nine months ended September 30, 2019, respectively, and $15.7 million and $51.0 million during the three and nine months ended September 30, 2018, respectively, related to its license and collaboration agreement with Biogen for diroximel fumarate (“BIIB098”). The Company expects to earn an additional $26.9 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 24,506 Transferred to receivables, net (27,714 ) Contract assets at September 30, 2019 $ 5,022 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 2,182 Amounts recognized into revenue (1,890 ) Contract liabilities at September 30, 2019 $ 12,986 |
Investments
Investments | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENTS Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated September 30, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 159,490 $ 775 $ (5 ) $ (7 ) $ 160,253 U.S. government and agency debt securities 99,582 490 (1 ) — 100,071 International government agency debt securities 65,133 306 — (7 ) 65,432 Total short-term investments 324,205 1,571 (6 ) (14 ) 325,756 Long-term investments: Available-for-sale securities: Corporate debt securities 11,017 — (8 ) (30 ) 10,979 U.S. government and agency debt securities 3,497 — (2 ) — 3,495 International government agency debt securities 3,351 — (8 ) — 3,343 17,865 — (18 ) (30 ) $ 17,817 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 48 — — 1,715 3,487 48 — — 3,535 Total long-term investments 21,352 48 (18 ) (30 ) 21,352 Total investments $ 345,557 $ 1,619 $ (24 ) $ (44 ) $ 347,108 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: Nine Months Ended September 30, (In thousands) 2019 2018 Proceeds from the sales and maturities of marketable securities $ 149,459 $ 344,624 Realized gains $ — $ 4 Realized losses $ 497 $ 268 The Company’s available-for-sale and held-to-maturity securities at September 30, 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 $ 232,284 $ 232,939 $ 1,820 $ 1,820 After 1 year through 5 years 109,786 110,634 1,667 1,715 Total $ 342,070 $ 343,573 $ 3,487 $ 3,535 At September 30, 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 September 30, 2019, the Company’s total contribution in Fountain was equal to €5.6 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 and nine months ended September 30, 2019, the Company recorded a decrease in its investment in Fountain of $0.3 million and $0.4 million, respectively. During the three and nine months ended September 30, 2018, the Company recorded an increase in its investment in Fountain of less than $0.1 million and a decrease in its investment in Fountain of $0.4 million, respectively. The changes recorded 5.3 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 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: September 30, (In thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 25,155 $ 25,155 $ — $ — U.S. government and agency debt securities 103,566 66,573 36,993 — Corporate debt securities 171,232 — 169,279 1,953 International government agency debt securities 68,775 — 68,775 — Contingent consideration 27,400 — — 27,400 Common stock warrants 2,111 — — 2,111 Total $ 398,239 $ 91,728 $ 275,047 $ 31,464 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 nine months ended September 30, 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 September 30, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Purchase of corporate debt security 1,953 Change in the fair value of contingent consideration (27,800 ) Payments received from contingent consideration (10,000 ) Impairment of corporate debt security (492 ) Increase in the fair value of warrants 906 Balance, September 30, 2019 $ 31,464 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 a $5.0 million payment in the first quarter of 2019 and 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 product with the same active ingredient as Meloxicam IV/IM that is discovered or identified using certain of the Company’s IP to which Recro was provided a right of use, through license or transfer (the “Meloxicam Product(s)”); 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 September 30, 2019 was determined as follows: • The Company received a $5.0 million payment in the first quarter of 2019 and another $5.0 million payment 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 will occur to the balance sheet date. The Company expects the regulatory milestone event to occur in the third quarter of 2020 and used a discount rate of 16.7%; • 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 17.0%, 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 16.7%. 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 September 30, 2019 and December 31, 2018, the Company determined that the value of the contingent consideration was $27.4 million and $65.2 million, respectively. The Company recorded an increase of $1.3 million and a decrease of $27.8 million during the three and nine months ended September 30, 2019, respectively, and an increase of $4.2 million and a decrease of $17.3 million during the three and nine months ended September 30, 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 | 9 Months Ended |
Sep. 30, 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: September 30, December 31, (In thousands) 2019 2018 Raw materials $ 34,336 $ 31,824 Work in process 48,315 38,019 Finished goods (1) 18,336 20,353 Total inventory $ 100,987 $ 90,196 (1) At September 30, 2019 and December 31, 2018, the Company had $11.5 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 | 9 Months Ended |
Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | 7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consisted of the following: September 30, December 31, (In thousands) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 173,220 157,053 Furniture, fixtures and equipment 332,886 314,831 Leasehold improvements 20,737 20,105 Construction in progress 114,905 88,983 Subtotal 648,308 587,458 Less: accumulated depreciation (306,902 ) (277,471 ) Total property, plant and equipment, net $ 341,406 $ 309,987 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consisted of the following: September 30, 2019 December 31, 2018 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (341,214 ) $ 124,376 $ 465,590 $ (319,311 ) $ 146,279 NanoCrystal technology 13 74,600 (44,800 ) 29,800 74,600 (38,942 ) 35,658 OCR (1) 12 42,560 (35,922 ) 6,638 42,560 (33,496 ) 9,064 Total $ 582,750 $ (421,936 ) $ 160,814 $ 582,750 $ (391,749 ) $ 191,001 (1) OCR refers to the Company’s oral control released technologies. Based on the Company’s most recent analysis, amortization of intangible assets included within its condensed consolidated balance sheet at September 30, 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 | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 9. LEASES The Company adopted Topic 842 on January 1, 2019. Upon adoption, the Company elected the package of transition practical expedients, which allowed it to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. The Company also elected the practical expedient to not reassess certain land easements and made an accounting policy election to not recognize leases with an initial term of 12 months or less within its condensed consolidated balance sheets and to instead recognize those lease payments on a straight-line basis in its condensed consolidated statements of operations over the lease term. The Company elected to adopt this standard using the optional modified retrospective transition method with no restatement of its prior periods or cumulative adjustment to retained earnings. With the adoption of Topic 842 , the Company’s 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. 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 September 30, 2019, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 4.71% and 4.1 years, respectively. As of September 30, 2019, right-of-use assets and liabilities arising from operating leases were $13.8 million and $15.3 million, respectively. During the three and nine months ended September 30, 2019, cash paid for amounts included for the measurement of lease liabilities was $2.2 million and $6.8 million, respectively and the Company recorded operating lease expense of $2.1 million and $6.3 million, respectively. Future lease payments under non-cancelable leases as of September 30, 2019 and December 31, 2018 consisted of the following: September 30, December 31, (In thousands) 2019 2018 2019 $ 2,219 $ 9,394 2020 8,610 10,717 2021 2,482 4,706 2022 500 2,455 2023 509 2,389 Thereafter 3,101 23,940 Total lease payments $ 17,421 $ 53,601 Less: imputed interest (2,137 ) — Total operating lease liabilities $ 15,284 $ 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 the later of (a) 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 September 3 0 , 2019 . Additionally, the future lease payments, outlined above, included the 900 Winter Street payments as of December 31, 201 8 ; these payments are not included in the table as of September 30, 2019, under Topic 84 2. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 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: September 30, December 31, (In thousands) 2019 2018 Accounts payable $ 81,417 $ 39,767 Accrued compensation 69,191 67,613 Accrued sales discounts, allowances and reserves 130,107 152,911 Accrued other 76,411 73,471 Total accounts payable and accrued expenses $ 357,126 $ 333,762 |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: September 30, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 277,681 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 274,838 $ 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 | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | 12. SHARE-BASED COMPENSATION Share-based compensation expense consisted of the following: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2019 2018 2019 2018 Cost of goods manufactured and sold $ 2,912 $ 2,140 $ 7,395 $ 6,012 Research and development 8,195 7,937 24,076 23,203 Selling, general and administrative 15,622 14,991 48,119 46,828 Total share-based compensation expense $ 26,729 $ 25,068 $ 79,590 $ 76,043 At September 30, 2019 and December 31, 2018, $2.5 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 September 30, 2019, there was $31.6 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 | 9 Months Ended |
Sep. 30, 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 and nine months ended September 30, 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 share equivalents have not been included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2019 2018 2019 2018 Stock options 13,867 11,553 14,077 10,274 Restricted stock units 3,344 2,678 3,110 2,621 Total 17,211 14,231 17,187 12,895 |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 9 Months Ended |
Sep. 30, 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 September 30, 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 and in August 2019, Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the United States District Court for the District of New Jersey against Teva entities (Teva Pharmaceuticals USA, Inc.(“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”)) and Mylan entities (Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC), respectively, following filings by each of Teva and Mylan Labs of an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. Requested judicial remedies in each of the lawsuits included recovery of litigation costs and injunctive relief. The Company is not a party to either of these proceedings. For information about risks relating to the INVEGA SUSTENNA Paragraph IV litigation, see “Part I, Item 1A—Risk Factors” of the 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 had been received by the Company and/or its partner Acorda from: Accord Healthcare, Inc. (“Accord”); Actavis Laboratories FL, Inc. (“Actavis”); Alkem Laboratories Ltd. (“Alkem”); Apotex Corporation and Apotex, Inc. (collectively, “Apotex”); Aurobindo Pharma Ltd. (“Aurobindo”); MicroLabs Limited (“MicroLabs”); Mylan; Par Pharmaceutical, Inc. (“Par”); Roxane Laboratories, Inc. (“Roxane”); Sun Pharmaceutical Industries Limited and Sun Pharmaceuticals Industries Inc. (collectively, “Sun”); and Teva (collectively with Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Mylan, Par, Roxane and Sun, the “ANDA Filers”) advising that each of the ANDA Filers had submitted an ANDA to the FDA seeking marketing approval for generic versions of AMPYRA (dalfampridine) Extended-Release Tablets, 10 mg. The ANDA Filers challenged the validity of one or more of the Orange Book-listed patents for AMPYRA, and they also asserted that their generic versions do not infringe certain claims of these patents. In response, the Company and/or Acorda filed lawsuits against the ANDA Filers asserting infringement of one or more of the Orange Book-listed patents for AMPYRA. Requested judicial remedies included recovery of litigation costs and injunctive relief. All lawsuits were filed within 45 days from the date of receipt of each of the Paragraph IV Certification Notices from the ANDA Filers. As a result, a 30-month statutory stay of approval period applied to each of the ANDA Filers’ ANDAs under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). The first 30-month stay restricted the FDA from approving the ANDA Filers’ ANDAs until July 2017 at the earliest, unless a Federal district court issued a decision adverse to all of the asserted Orange Book-listed patents prior to that date. Lawsuits with eight of the ANDA Filers were consolidated into a single case. The Company and/or Acorda entered into a settlement agreement with each of Accord, Actavis, Alkem, Apotex, Aurobindo, MicroLabs, Par and Sun to resolve the patent litigation that the Company and/or Acorda brought against these settling ANDA Filers. The settlements with these settling ANDA Filers did not impact the patent litigation that the Company and Acorda brought against the remaining ANDA Filers, including as described below. I n M arch 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 pertain ed to the formulation of AMPYRA, but that patent expired on July 30, 2018. In May 2017, Acorda filed an appeal with the Federal Circuit of the Delaware Court Decision with respect to the findings on U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685. On September 10, 2018, the Federal Circuit affirmed the Delaware Court Decision, which invalidated U.S. Patent Nos. 8,007,826; 8,354,437; 8,440,703; and 8,663,685 . I n October 2018 , Acorda filed a petition for rehearing and rehearing en banc of the Federal Circuit’s decision . I n January 2019, the Federal Circuit denied Acorda’s petition. I n April 2019 , Acorda filed a petition for writ of certiorari to the Supreme Court of the United States (the “Supreme Court”). On October 7, 2019, the Supreme Court denied Acorda’s petition requesting review of the case , rendering the Federal Circuit decision as final. For information about risks relating to the AMPYRA Paragraph IV litigation and other proceedings see “Part I, Item 1A—Risk Factors” of the 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 In April 2018, Amneal Pharmaceuticals LLC (“Amneal”) 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, and specifically requesting the cancellation of claims 1-13 of the ’499 Patent. In November 2018, the PTAB instituted an IPR of all of the challenged claims. On July 26, 2019, the Company entered into a settlement and license agreement (the “Settlement Agreement”) with Amneal. Under the terms of the Settlement Agreement, the parties agreed to request termination of the IPR and Alkermes granted Amneal the non-exclusive right to market a generic formulation of VIVITROL in the U.S. beginning sometime in 2028 or earlier under certain circumstances. The PTAB subsequently cancelled the scheduled IPR hearing and terminated the IPR. RISPERDAL CONSTA European Opposition Proceedings In December 2016, Nanjing Luye Pharmaceutical Co., Ltd., Pharmathen SA, Teva PI and Dehns Ltd (a law firm representing an unidentified opponent) filed notices of opposition with the European Patent Office (the “EPO”) in respect of EP 2 269 577 B (the “EP ’577” Patent), which is a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter in January 2019, the EPO issued a written decision revoking the EP’577 Patent in April 2019. The Company filed a notice of appeal of the decision to the EPO’s Technical Boards of Appeal on June 12, 2019 and 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 Annual Report, including the sections entitled “— Patent protection for our products is important and uncertain” and “— Uncertainty over intellectual property in the biopharmaceutical industry has been the source of litigation, which is inherently costly and unpredictable, could significantly delay or prevent approval or commercialization of our products, and could adversely affect our business.” RISPERDAL CONSTA ANDA Litigation On July 17, 2019, the Company, together with Janssen Pharmaceuticals, Inc., initiated a patent infringement lawsuit in the United States District Court for the District of Delaware against Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Nanjing Luye Pharmaceutical Co., Ltd. and Shandong Luye Pharmaceutical Co., Ltd. (collectively, “Luye”). Luye filed a 505(b)(2) NDA seeking approval to market a competing product to RISPERDAL CONSTA before the expiration of U.S. Patent No. 6,667,061. Requested judicial remedies included, among other things, recovery of litigation costs and injunctive relief. On July 23, 2019, Luye filed its answer and affirmative defenses. For information about risks relating to the RISPERDAL CONSTA Paragraph IV litigation, see “Part I, Item 1A—Risk Factors” of the 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.” Government Matters In June 2017 and January 2019, the Company received a subpoena and a civil investigative demand, respectively, each from an Office of the U.S. Attorney for documents related to VIVITROL. The Company is cooperating with the government. Securities Litigation In November 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 (the “SDNY District Court”) captioned Gagnon v. Alkermes plc, et al., No. 1:17-cv-09178 In December 2018 and January 2019, purported stockholders of the Company filed putative class actions against the Company and certain of its officers in the United States District Court for the Eastern District of New York (the “EDNY District Court”) captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410 McDermott v. Alkermes plc, et al., No. 1:19-cv-00624, |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. SUBSEQUENT EVENTS Following a review of the Company’s operations, cost structure and growth opportunities, on October 18, 2019, the Board of Directors of the Company approved a plan of restructuring, which includes the elimination of approximately 160 current positions across the Company and other cost-saving measures (the “Restructuring”). The Company expects to record a charge in the range of $13.0 million to $15.0 million in the fourth quarter of 2019 as a result of the Restructuring, consisting of one-time termination benefits for employee severance, benefits and related costs, all of which are expected to result in cash expenditures and substantially all of which will be paid out over the next 12 months. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three and nine months ended September 30, 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 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 Annual Report. 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 any 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 from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. |
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) provision primarily relates 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 September 30, 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 Compensation – Stock Compensation In August 2018, the FASB issued ASU 2018-14, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement Conceptual Framework for Financial Reporting - Chapter 8: Notes to Financial Statements 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 has not yet adopted this ASU and 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) | 9 Months Ended |
Sep. 30, 2019 | |
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 24,506 Transferred to receivables, net (27,714 ) Contract assets at September 30, 2019 $ 5,022 Contract liabilities consisted of the following: (In thousands) Contract Liabilities Contract liabilities at January 1, 2019 $ 12,694 Additions 2,182 Amounts recognized into revenue (1,890 ) Contract liabilities at September 30, 2019 $ 12,986 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three and nine months ended September 30, 2019 and 2018, the Company recorded product sales, net, as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2019 2018 2019 2018 VIVITROL $ 85,164 $ 79,893 $ 242,546 $ 218,778 ARISTADA 53,610 36,142 132,344 98,906 Total product sales, net $ 138,774 $ 116,035 $ 374,890 $ 317,684 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three and nine months ended September 30, 2019 and 2018, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended September 30, 2019 Nine Months Ended September 30, 2019 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 68,382 $ 68,382 $ — $ 188,968 $ 188,968 RISPERDAL CONSTA 4,520 3,813 8,333 42,948 12,266 55,214 AMPYRA/FAMPYRA 5,134 2,582 7,716 17,287 12,405 29,692 Other 6,428 12,924 19,352 25,173 41,548 66,721 $ 16,082 $ 87,701 $ 103,783 $ 85,408 $ 255,187 $ 340,595 Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 65,620 $ 65,620 $ — $ 174,956 $ 174,956 RISPERDAL CONSTA 7,267 4,316 11,583 42,296 13,922 56,218 AMPYRA/FAMPYRA 12,894 7,445 20,339 38,000 30,276 68,276 Other 5,036 13,833 18,869 19,420 40,383 59,803 $ 25,197 $ 91,214 $ 116,411 $ 99,716 $ 259,537 $ 359,253 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2019 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 159,490 $ 775 $ (5 ) $ (7 ) $ 160,253 U.S. government and agency debt securities 99,582 490 (1 ) — 100,071 International government agency debt securities 65,133 306 — (7 ) 65,432 Total short-term investments 324,205 1,571 (6 ) (14 ) 325,756 Long-term investments: Available-for-sale securities: Corporate debt securities 11,017 — (8 ) (30 ) 10,979 U.S. government and agency debt securities 3,497 — (2 ) — 3,495 International government agency debt securities 3,351 — (8 ) — 3,343 17,865 — (18 ) (30 ) $ 17,817 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Fixed term deposit account 1,667 48 — — 1,715 3,487 48 — — 3,535 Total long-term investments 21,352 48 (18 ) (30 ) 21,352 Total investments $ 345,557 $ 1,619 $ (24 ) $ (44 ) $ 347,108 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: Nine Months Ended September 30, (In thousands) 2019 2018 Proceeds from the sales and maturities of marketable securities $ 149,459 $ 344,624 Realized gains $ — $ 4 Realized losses $ 497 $ 268 |
Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities | The Company’s available-for-sale and held-to-maturity securities at September 30, 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 $ 232,284 $ 232,939 $ 1,820 $ 1,820 After 1 year through 5 years 109,786 110,634 1,667 1,715 Total $ 342,070 $ 343,573 $ 3,487 $ 3,535 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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: September 30, (In thousands) 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 25,155 $ 25,155 $ — $ — U.S. government and agency debt securities 103,566 66,573 36,993 — Corporate debt securities 171,232 — 169,279 1,953 International government agency debt securities 68,775 — 68,775 — Contingent consideration 27,400 — — 27,400 Common stock warrants 2,111 — — 2,111 Total $ 398,239 $ 91,728 $ 275,047 $ 31,464 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 September 30, 2019: (In thousands) Fair Value Balance, January 1, 2019 $ 66,897 Purchase of corporate debt security 1,953 Change in the fair value of contingent consideration (27,800 ) Payments received from contingent consideration (10,000 ) Impairment of corporate debt security (492 ) Increase in the fair value of warrants 906 Balance, September 30, 2019 $ 31,464 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 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: September 30, December 31, (In thousands) 2019 2018 Raw materials $ 34,336 $ 31,824 Work in process 48,315 38,019 Finished goods (1) 18,336 20,353 Total inventory $ 100,987 $ 90,196 (1) At September 30, 2019 and December 31, 2018, the Company had $11.5 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) | 9 Months Ended |
Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following: September 30, December 31, (In thousands) 2019 2018 Land $ 6,560 $ 6,486 Building and improvements 173,220 157,053 Furniture, fixtures and equipment 332,886 314,831 Leasehold improvements 20,737 20,105 Construction in progress 114,905 88,983 Subtotal 648,308 587,458 Less: accumulated depreciation (306,902 ) (277,471 ) Total property, plant and equipment, net $ 341,406 $ 309,987 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: September 30, 2019 December 31, 2018 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (341,214 ) $ 124,376 $ 465,590 $ (319,311 ) $ 146,279 NanoCrystal technology 13 74,600 (44,800 ) 29,800 74,600 (38,942 ) 35,658 OCR (1) 12 42,560 (35,922 ) 6,638 42,560 (33,496 ) 9,064 Total $ 582,750 $ (421,936 ) $ 160,814 $ 582,750 $ (391,749 ) $ 191,001 (1) OCR refers to the Company’s oral control released technologies. |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of September 30, 2019 and December 31, 2018 consisted of the following: September 30, December 31, (In thousands) 2019 2018 2019 $ 2,219 $ 9,394 2020 8,610 10,717 2021 2,482 4,706 2022 500 2,455 2023 509 2,389 Thereafter 3,101 23,940 Total lease payments $ 17,421 $ 53,601 Less: imputed interest (2,137 ) — Total operating lease liabilities $ 15,284 $ 53,601 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: September 30, December 31, (In thousands) 2019 2018 Accounts payable $ 81,417 $ 39,767 Accrued compensation 69,191 67,613 Accrued sales discounts, allowances and reserves 130,107 152,911 Accrued other 76,411 73,471 Total accounts payable and accrued expenses $ 357,126 $ 333,762 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: September 30, December 31, (In thousands) 2019 2018 2023 Term Loans, due March 26, 2023 $ 277,681 $ 279,308 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 274,838 $ 276,465 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Share-based Compensation Expense | Share-based compensation expense consisted of the following: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2019 2018 2019 2018 Cost of goods manufactured and sold $ 2,912 $ 2,140 $ 7,395 $ 6,012 Research and development 8,195 7,937 24,076 23,203 Selling, general and administrative 15,622 14,991 48,119 46,828 Total share-based compensation expense $ 26,729 $ 25,068 $ 79,590 $ 76,043 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Share Equivalents Excluded from Calculation of Net (Loss) Income Per Share | The following potential ordinary share equivalents have not been included in the net loss per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2019 2018 2019 2018 Stock options 13,867 11,553 14,077 10,274 Restricted stock units 3,344 2,678 3,110 2,621 Total 17,211 14,231 17,187 12,895 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2019USD ($)segment | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |||
Number of business segments | segment | 1 | ||
Operating lease, right-of-use asset | $ 13,835 | $ 20,100 | |
Operating lease liability | $ 15,284 | $ 22,100 | $ 53,601 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 255,243 | $ 248,720 | $ 758,217 | $ 778,512 |
VIVITROL | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 85,164 | 79,893 | 242,546 | 218,778 |
ARISTADA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 53,610 | 36,142 | 132,344 | 98,906 |
Product sales, net | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 138,774 | $ 116,035 | $ 374,890 | $ 317,684 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 255,243 | $ 248,720 | $ 758,217 | $ 778,512 |
Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 16,082 | 25,197 | 85,408 | 99,716 |
Manufacturing Revenue | AMPYRA/ FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 5,134 | 12,894 | 17,287 | 38,000 |
Manufacturing Revenue | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 4,520 | 7,267 | 42,948 | 42,296 |
Manufacturing Revenue | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 6,428 | 5,036 | 25,173 | 19,420 |
Royalty Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 87,701 | 91,214 | 255,187 | 259,537 |
Royalty Revenue | INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 68,382 | 65,620 | 188,968 | 174,956 |
Royalty Revenue | AMPYRA/ FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 2,582 | 7,445 | 12,405 | 30,276 |
Royalty Revenue | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 3,813 | 4,316 | 12,266 | 13,922 |
Royalty Revenue | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 12,924 | 13,833 | 41,548 | 40,383 |
Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 103,783 | 116,411 | 340,595 | 359,253 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 68,382 | 65,620 | 188,968 | 174,956 |
Manufacturing and royalty revenues | AMPYRA/ FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 7,716 | 20,339 | 29,692 | 68,276 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 8,333 | 11,583 | 55,214 | 56,218 |
Manufacturing and royalty revenues | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 19,352 | $ 18,869 | $ 66,721 | $ 59,803 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||||
Total revenues related to license and collaboration agreement for Diroximel fumarate | $ 255,243 | $ 248,720 | $ 758,217 | $ 778,512 | |
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 | 12,100 | 15,700 | 39,500 | $ 51,000 | |
Research and development revenue | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total revenues related to license and collaboration agreement for Diroximel fumarate | $ 12,686 | $ 16,274 | $ 41,732 | $ 53,325 | |
Research and development revenue | Biogen | Forecast | |||||
Disaggregation Of Revenue [Line Items] | |||||
Additional revenue expected | $ 26,900 |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Contract Assets and Contract Liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 8,230 |
Additions | 24,506 |
Transferred to receivables, net | (27,714) |
Contract assets at end of period | 5,022 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 12,694 |
Additions | 2,182 |
Amounts recognized into revenue | (1,890) |
Contract liabilities at end of the period | $ 12,986 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Available-for-sale securities: | ||
Amortized Cost | $ 342,070 | |
Estimated Fair Value | 343,573 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 3,535 | |
Long-term Investments | ||
Amortized Cost | 21,352 | $ 80,923 |
Gross Unrealized Gains | 48 | 136 |
Gross Unrealized Losses, Less than One Year | (18) | (210) |
Gross Unrealized Losses, Greater than One Year | (30) | (105) |
Total long-term investments | 21,352 | 80,744 |
Total investments | ||
Amortized Cost | 345,557 | 353,758 |
Gross Unrealized Gains | 1,619 | 393 |
Gross Unrealized Losses, Less than One Year | (24) | (291) |
Gross Unrealized Losses, Greater than One Year | (44) | (583) |
Estimated Fair Value | 347,108 | 353,277 |
Short-term Investments | ||
Amortized Cost | 272,835 | |
Gross Unrealized Gains | 257 | |
Gross Unrealized Losses, Less than One Year | (81) | |
Gross Unrealized Losses, Greater than One Year | (478) | |
Total short-term investments | 272,533 | |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 324,205 | 272,343 |
Gross Unrealized Gains | 1,571 | 257 |
Gross Unrealized Losses, Less than One Year | (6) | (81) |
Gross Unrealized Losses, Greater than One Year | (14) | (478) |
Estimated Fair Value | 325,756 | 272,041 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 159,490 | 120,197 |
Gross Unrealized Gains | 775 | 57 |
Gross Unrealized Losses, Less than One Year | (5) | (62) |
Gross Unrealized Losses, Greater than One Year | (7) | (274) |
Estimated Fair Value | 160,253 | 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 | 99,582 | 80,055 |
Gross Unrealized Gains | 490 | 115 |
Gross Unrealized Losses, Less than One Year | (1) | (11) |
Gross Unrealized Losses, Greater than One Year | (87) | |
Estimated Fair Value | 100,071 | 80,072 |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 65,133 | 72,091 |
Gross Unrealized Gains | 306 | 85 |
Gross Unrealized Losses, Less than One Year | (8) | |
Gross Unrealized Losses, Greater than One Year | (7) | (117) |
Estimated Fair Value | 65,432 | 72,051 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 17,865 | 77,436 |
Gross Unrealized Losses, Less than One Year | (18) | (210) |
Gross Unrealized Losses, Greater than One Year | (30) | (105) |
Estimated Fair Value | 17,817 | 77,121 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | 3,487 |
Gross Unrealized Gains | 48 | 136 |
Estimated Fair Value | 3,535 | 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 | 11,017 | 53,505 |
Gross Unrealized Losses, Less than One Year | (8) | (185) |
Gross Unrealized Losses, Greater than One Year | (30) | (93) |
Estimated Fair Value | 10,979 | 53,227 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 3,497 | 18,474 |
Gross Unrealized Losses, Less than One Year | (2) | (21) |
Gross Unrealized Losses, Greater than One Year | (12) | |
Estimated Fair Value | 3,495 | 18,441 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 3,351 | 5,457 |
Gross Unrealized Losses, Less than One Year | (8) | (4) |
Estimated Fair Value | 3,343 | 5,453 |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | 1,667 |
Gross Unrealized Gains | 48 | 136 |
Estimated Fair Value | $ 1,715 | $ 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 | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Proceeds from the sales and maturities of marketable securities | $ 149,459 | $ 344,624 |
Realized gains | 4 | |
Realized losses | $ 497 | $ 268 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 232,284 |
After 1 year through 5 years | 109,786 |
Amortized Cost | 342,070 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 232,939 |
After 1 year through 5 years | 110,634 |
Total | 343,573 |
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 | 1,715 |
Total | $ 3,535 |
Investments - Additional Inform
Investments - Additional Information (Details) - Fountain Healthcare Partners II, LP of Ireland $ in Millions | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019EUR (€) | Dec. 31, 2018USD ($) | May 31, 2014EUR (€) | |
Equity method investment | |||||||
Funding commitment as percentage of partnership's total funding | 7.00% | 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) | $ (0.3) | $ (0.4) | $ (0.4) | ||||
Maximum | |||||||
Equity method investment | |||||||
Maximum commitment on equity method investment | € | € 7,400,000 | ||||||
Increase (decrease) in carrying value of investment of the entity, which represents the Company's share of investee's net gains (losses) | $ 0.1 | ||||||
Other Assets | |||||||
Equity method investment | |||||||
Total equity method commitment | € | € 5,600,000 | ||||||
Carrying value of equity investment | $ 5.3 | $ 5.3 | $ 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 | Sep. 30, 2019 | Dec. 31, 2018 |
Fair value | ||
Debt securities | $ 343,573 | |
Contingent consideration | 27,400 | $ 65,200 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 25,155 | 54,590 |
Contingent consideration | 27,400 | 65,200 |
Common stock warrants | 2,111 | 1,205 |
Assets, Total | 398,239 | 470,649 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 25,155 | 54,590 |
Assets, Total | 91,728 | 114,697 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 275,047 | 289,055 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 27,400 | 65,200 |
Common stock warrants | 2,111 | 1,205 |
Assets, Total | 31,464 | 66,897 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 103,566 | 98,513 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 66,573 | 60,107 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 36,993 | 38,406 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 171,232 | 173,637 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 169,279 | 173,145 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 1,953 | 492 |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 68,775 | 77,504 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 68,775 | $ 77,504 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019USD ($)itemMilestone | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)itemMilestone | Sep. 30, 2018USD ($) | Sep. 30, 2020item | Dec. 31, 2018USD ($) | |
Fair Value | ||||||||
Transfers between the levels | $ 0 | |||||||
Contingent consideration | $ 27,400,000 | 27,400,000 | $ 65,200,000 | |||||
Increase (decrease) in the fair value of contingent consideration | $ 1,300,000 | $ 4,200,000 | $ (27,800,000) | $ (17,300,000) | ||||
Discount Rate | Real options approach | ||||||||
Fair Value | ||||||||
Discount rate (as a percent) | item | 16.7 | 16.7 | ||||||
Discount Rate | Future royalties | ||||||||
Fair Value | ||||||||
Discount rate (as a percent) | item | 17 | 17 | ||||||
Recro | ||||||||
Fair Value | ||||||||
Milestone payments received | $ 5,000,000 | $ 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 | $ 45,000,000 | ||||||
Number of milestone payment upon approval of New Drug Application | Milestone | 7 | 7 | ||||||
Recro | Maximum | ||||||||
Fair Value | ||||||||
Milestone payments receivable | $ 80,000,000 | |||||||
Recro | Discount Rate | Forecast | ||||||||
Fair Value | ||||||||
Discount rate (as a percent) | item | 16.7 |
Fair Value Measurements - Rollf
Fair Value Measurements - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Balance at the beginning of the period | $ 66,897 |
Payments received from contingent consideration | (10,000) |
Impairment of corporate debt security | (492) |
Balance at the end of the period | 31,464 |
Corporate Debt Security | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Purchase of corporate debt security | 1,953 |
Change In The Fair Value Of Contingent Consideration | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value | (27,800) |
Warrants | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Change in the fair value | $ 906 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 34,336 | $ 31,824 |
Work in process | 48,315 | 38,019 |
Finished goods | 18,336 | 20,353 |
Total inventory | $ 100,987 | $ 90,196 |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 11.5 | $ 11 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 648,308 | $ 587,458 |
Less: accumulated depreciation | (306,902) | (277,471) |
Total property, plant and equipment, net | 341,406 | 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 | 173,220 | 157,053 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 332,886 | 314,831 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 20,737 | 20,105 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 114,905 | $ 88,983 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | $ 92,873 |
Net Carrying Amount | 92,873 | 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 582,750 | 582,750 |
Accumulated Amortization | (421,936) | (391,749) |
Net Carrying Amount | $ 160,814 | 191,001 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | 465,590 |
Accumulated Amortization | (341,214) | (319,311) |
Net Carrying Amount | $ 124,376 | 146,279 |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | 74,600 |
Accumulated Amortization | (44,800) | (38,942) |
Net Carrying Amount | $ 29,800 | 35,658 |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | 42,560 |
Accumulated Amortization | (35,922) | (33,496) |
Net Carrying Amount | $ 6,638 | $ 9,064 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) $ in Millions | Sep. 30, 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 ($)ft²Option | Mar. 31, 2018ft² | Sep. 30, 2019USD ($) | Sep. 30, 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 | ||||
Operating lease, existence of option to extend | true | ||||
Number of additional operating leases | lease | 2 | ||||
Weighted average incremental borrowing rate | 4.71% | 4.71% | |||
Weighted average remaining lease term | 4 years 1 month 6 days | 4 years 1 month 6 days | |||
Right-of-use assets | $ | $ 20,100 | $ 13,835 | $ 13,835 | ||
Operating lease liability | $ | $ 22,100 | 15,284 | 15,284 | $ 53,601 | |
Payments for operating leases | $ | 2,200 | 6,800 | |||
Operating lease expense | $ | $ 2,100 | $ 6,300 | |||
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 | Sep. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Abstract] | |||
2019 | $ 2,219 | ||
2020 | 8,610 | ||
2021 | 2,482 | ||
2022 | 500 | ||
2023 | 509 | ||
Thereafter | 3,101 | ||
Total lease payments | 17,421 | ||
Less: imputed interest | (2,137) | ||
Total operating lease liabilities | $ 15,284 | $ 22,100 | $ 53,601 |
2019 | 9,394 | ||
2020 | 10,717 | ||
2021 | 4,706 | ||
2022 | 2,455 | ||
2023 | 2,389 | ||
Thereafter | 23,940 | ||
Total lease payments | $ 53,601 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 81,417 | $ 39,767 |
Accrued compensation | 69,191 | 67,613 |
Accrued sales discounts, allowances and reserves | 130,107 | 152,911 |
Accrued other | 76,411 | 73,471 |
Total accounts payable and accrued expenses | $ 357,126 | $ 333,762 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (2,843) |
Long-term debt | 274,838 | 276,465 |
2023 Term Loans | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | 277,681 | 279,308 |
Less: current portion | (2,843) | (2,843) |
Long-term debt | $ 274,838 | $ 276,465 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | Oct. 12, 2016 | Mar. 31, 2019Lender | Mar. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Mar. 31, 2019 | Dec. 31, 2018USD ($) |
Long-term debt | ||||||
Number of lender holding percentage of outstanding amount | Lender | 1 | |||||
Percentage of outstanding principal amount held by lender | 1.00% | |||||
Level 2 | ||||||
Long-term debt | ||||||
Amount to be realized in the future | $ 273.3 | $ 274.7 | ||||
Interest Expense | ||||||
Long-term debt | ||||||
Refinancing charges | $ 2.3 | |||||
Minimum | ||||||
Long-term debt | ||||||
Threshold percentage comparing present value of remaining cash flows | 10.00% | |||||
Term Loan B-1 | ||||||
Long-term debt | ||||||
Due date of loan | Sep. 25, 2021 | |||||
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 | 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 | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 26,729 | $ 25,068 | $ 79,590 | $ 76,043 |
Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 2,912 | 2,140 | 7,395 | 6,012 |
Research and development | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 8,195 | 7,937 | 24,076 | 23,203 |
Selling, General and Administrative | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 15,622 | $ 14,991 | $ 48,119 | $ 46,828 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)item | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Share-based compensation Expense | ||||||
Share-based compensation expense | $ 26,729 | $ 25,068 | $ 79,590 | $ 76,043 | ||
Cost of goods manufactured and sold | ||||||
Share-based compensation Expense | ||||||
Share-based compensation expense | 2,912 | 2,140 | 7,395 | 6,012 | ||
Research and development | ||||||
Share-based compensation Expense | ||||||
Share-based compensation expense | 8,195 | 7,937 | 24,076 | 23,203 | ||
Selling, General and Administrative | ||||||
Share-based compensation Expense | ||||||
Share-based compensation expense | 15,622 | $ 14,991 | $ 48,119 | $ 46,828 | ||
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 | $ 31,600 | $ 31,600 | ||||
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 | $ 2,500 | $ 2,700 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalents Excluded from Calculation of Net (Loss) Income Per Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Denominator: | ||||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 17,211 | 14,231 | 17,187 | 12,895 |
Stock Options | ||||
Denominator: | ||||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 13,867 | 11,553 | 14,077 | 10,274 |
Restricted Stock Units | ||||
Denominator: | ||||
Anti-dilutive potential common equivalent shares excluded from calculation of net loss per ordinary share | 3,344 | 2,678 | 3,110 | 2,621 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2019USD ($)NoticeFiler | |
Commitments And Contingencies [Line Items] | |
Potential losses from claims, legal proceedings probable of occurring | $ | $ 0 |
Number of separate Paragraph IV notices received | Notice | 11 |
Maximum number of days for lawsuit | 45 days |
Minimum number of months before FDA can approve patent request | 30 months |
Number of ANDA Filers consolidated to a single case | Filer | 8 |
Loss contingency lead plaintiff filing date | April 2019 |
Loss contingency denied date | Jul. 2, 2019 |
Amneal | |
Commitments And Contingencies [Line Items] | |
Settlement agreement entered date | Jul. 26, 2019 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Events $ in Millions | Oct. 18, 2019USD ($)Position |
Subsequent Event [Line Items] | |
Restructuring and related activities, initiation date | Oct. 18, 2019 |
Expected number of positions eliminated | Position | 160 |
Restructuring and related activities description | The Company expects to record a charge in the range of $13.0 million to $15.0 million in the fourth quarter of 2019 as a result of the Restructuring, consisting of one-time termination benefits for employee severance, benefits and related costs, all of which are expected to result in cash expenditures and substantially all of which will be paid out over the next 12 months |
Minimum | |
Subsequent Event [Line Items] | |
Restructuring and related expected charges | $ 13 |
Maximum | |
Subsequent Event [Line Items] | |
Restructuring and related expected charges | $ 15 |