Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 23, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
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 | 159,149,785 | |
Document Fiscal Year Focus | 2020 | |
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, $0.01 par value | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 240,866 | $ 203,771 |
Investments—short-term | 328,516 | 331,208 |
Receivables, net | 265,644 | 257,086 |
Contract assets | 14,395 | 8,386 |
Inventory | 122,823 | 101,803 |
Prepaid expenses and other current assets | 52,697 | 59,716 |
Total current assets | 1,024,941 | 961,970 |
PROPERTY, PLANT AND EQUIPMENT, NET | 355,215 | 362,168 |
INTANGIBLE ASSETS, NET | 121,108 | 150,643 |
RIGHT-OF-USE ASSETS | 106,681 | 12,379 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 86,336 | 96,558 |
INVESTMENTS—LONG-TERM | 27,774 | 79,391 |
CONTINGENT CONSIDERATION | 46,200 | 32,400 |
OTHER ASSETS | 15,692 | 17,021 |
TOTAL ASSETS | 1,876,820 | 1,805,403 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 354,780 | 373,037 |
Operating lease liabilities—short-term | 13,375 | 8,466 |
Contract liabilities—short-term | 7,153 | 6,766 |
Long-term debt—short-term | 2,843 | 2,843 |
Total current liabilities | 378,151 | 391,112 |
LONG-TERM DEBT | 272,663 | 274,295 |
OPERATING LEASE LIABILITIES—LONG-TERM | 96,717 | 5,342 |
CONTRACT LIABILITIES—LONG-TERM | 18,635 | 22,068 |
OTHER LONG-TERM LIABILITIES | 26,296 | 27,144 |
Total liabilities | 792,462 | 719,961 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 15) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at September 30, 2020 and December 31, 2019, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 162,208,145 and 160,489,888 shares issued; 159,105,433 and 157,779,002 shares outstanding at September 30, 2020 and December 31, 2019, respectively | 1,619 | 1,602 |
Treasury shares, at cost (3,102,712 and 2,710,886 shares at September 30, 2020 and December 31, 2019, respectively) | (125,993) | (118,386) |
Additional paid-in capital | 2,659,699 | 2,586,030 |
Accumulated other comprehensive loss | (760) | (1,816) |
Accumulated deficit | (1,450,207) | (1,381,988) |
Total shareholders’ equity | 1,084,358 | 1,085,442 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,876,820 | $ 1,805,403 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock shares, authorized | 50,000,000 | 50,000,000 |
Preferred stock shares, issued | 0 | 0 |
Preferred stock shares, outstanding | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 450,000,000 | 450,000,000 |
Ordinary shares, shares issued | 162,208,145 | 160,489,888 |
Ordinary shares, shares outstanding | 159,105,433 | 157,779,002 |
Treasury shares | 3,102,712 | 2,710,886 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
REVENUES: | ||||
Total revenues | $ 265,012 | $ 255,243 | $ 758,761 | $ 758,217 |
EXPENSES: | ||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 43,129 | 42,319 | 135,394 | 133,903 |
Research and development | 94,980 | 107,671 | 282,481 | 314,676 |
Selling, general and administrative | 127,653 | 148,701 | 393,049 | 444,996 |
Amortization of acquired intangible assets | 9,917 | 10,173 | 29,535 | 30,187 |
Total expenses | 275,679 | 308,864 | 840,459 | 923,762 |
OPERATING LOSS | (10,667) | (53,621) | (81,698) | (165,545) |
OTHER INCOME (EXPENSE), NET: | ||||
Interest income | 1,376 | 3,509 | 5,924 | 10,785 |
Interest expense | (1,811) | (3,385) | (6,790) | (10,405) |
Change in the fair value of contingent consideration | 3,926 | 1,300 | 16,626 | (27,800) |
Other income (expense), net | 9,368 | (1,664) | 11,047 | (1,534) |
Total other income (expense), net | 12,859 | (240) | 26,807 | (28,954) |
INCOME (LOSS) BEFORE INCOME TAXES | 2,192 | (53,861) | (54,891) | (194,499) |
INCOME TAX PROVISION (BENEFIT) | 2,326 | (983) | 13,328 | (3,233) |
NET LOSS | $ (134) | $ (52,878) | $ (68,219) | $ (191,266) |
LOSS PER ORDINARY SHARE: | ||||
Basic and diluted (in dollars loss per ordinary share) | $ 0 | $ (0.34) | $ (0.43) | $ (1.22) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic and diluted | 159,062 | 157,199 | 158,685 | 156,845 |
COMPREHENSIVE LOSS: | ||||
Net loss | $ (134) | $ (52,878) | $ (68,219) | $ (191,266) |
Unrealized (loss) gain, net of a tax (benefit) provision of $(193), $(15), $303 and $479, respectively | (659) | (24) | 1,056 | 1,642 |
COMPREHENSIVE LOSS | (793) | (52,902) | (67,163) | (189,624) |
Product sales, net | ||||
REVENUES: | ||||
Total revenues | 142,658 | 138,774 | 402,799 | 374,890 |
Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | 120,351 | 103,783 | 353,107 | 340,595 |
Research and development revenue | ||||
REVENUES: | ||||
Total revenues | 953 | $ 12,686 | 1,805 | 41,732 |
License revenue | ||||
REVENUES: | ||||
Total revenues | $ 1,050 | $ 1,050 | $ 1,000 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||||||
Tax provision (benefit) | $ (193) | $ 409 | $ 87 | $ (15) | $ 265 | $ 229 | $ 303 | $ 479 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (68,219) | $ (191,266) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Share-based compensation expense | 65,279 | 79,590 |
Depreciation and amortization | 61,525 | 59,901 |
Deferred income taxes | 9,939 | (3,025) |
Change in the fair value of contingent consideration | (16,626) | 27,800 |
Other non-cash charges | 2,105 | 90 |
Changes in assets and liabilities: | ||
Receivables | (8,551) | 41,988 |
Contract assets | (6,009) | 3,207 |
Inventory | (20,748) | (10,324) |
Prepaid expenses and other assets | 5,597 | 2,120 |
Right-of-use assets | 13,251 | 6,306 |
Accounts payable and accrued expenses | (6,222) | 20,542 |
Contract liabilities | (3,045) | 292 |
Operating lease liabilities | (11,910) | (6,845) |
Other long-term liabilities | (867) | (369) |
Cash flows provided by operating activities | 15,499 | 30,007 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (36,780) | (58,972) |
Proceeds from the sale of equipment | 61 | 900 |
Proceeds from contingent consideration | 2,819 | 10,000 |
Return of Fountain Healthcare Partners II, L.P. investment | 2,751 | |
Purchases of investments | (151,324) | (141,749) |
Sales and maturities of investments | 206,089 | 149,459 |
Cash flows provided by (used in) investing activities | 23,616 | (40,362) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 7,719 | 16,381 |
Employee taxes paid related to net share settlement of equity awards | (7,607) | (9,230) |
Principal payments of long-term debt | (2,132) | (2,132) |
Cash flows (used in) provided by financing activities | (2,020) | 5,019 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 37,095 | (5,336) |
CASH AND CASH EQUIVALENTS—Beginning of period | 203,771 | 266,762 |
CASH AND CASH EQUIVALENTS—End of period | 240,866 | 261,426 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 2,169 | $ 14,664 |
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, 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 | 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) | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | 1,642 | |||||
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 | 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 | (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) | ||||
BALANCE at Dec. 31, 2019 | 1,085,442 | $ 1,602 | 2,586,030 | (1,816) | (1,381,988) | $ (118,386) |
BALANCE (in shares) at Dec. 31, 2019 | 160,489,888 | (2,710,886) | ||||
Issuance of ordinary shares under employee stock plans | 3,071 | $ 3 | 3,068 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 258,137 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (7,283) | $ 10 | (10) | $ (7,283) | ||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 1,020,510 | (372,846) | ||||
Share-based compensation expense | 20,125 | 20,125 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | 317 | 317 | ||||
Net loss | (38,654) | (38,654) | ||||
BALANCE at Mar. 31, 2020 | 1,063,018 | $ 1,615 | 2,609,213 | (1,499) | (1,420,642) | $ (125,669) |
BALANCE (in shares) at Mar. 31, 2020 | 161,768,535 | (3,083,732) | ||||
BALANCE at Dec. 31, 2019 | 1,085,442 | $ 1,602 | 2,586,030 | (1,816) | (1,381,988) | $ (118,386) |
BALANCE (in shares) at Dec. 31, 2019 | 160,489,888 | (2,710,886) | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | 1,056 | |||||
Net loss | (68,219) | |||||
BALANCE at Sep. 30, 2020 | 1,084,358 | $ 1,619 | 2,659,699 | (760) | (1,450,207) | $ (125,993) |
BALANCE (in shares) at Sep. 30, 2020 | 162,208,145 | (3,102,712) | ||||
BALANCE at Mar. 31, 2020 | 1,063,018 | $ 1,615 | 2,609,213 | (1,499) | (1,420,642) | $ (125,669) |
BALANCE (in shares) at Mar. 31, 2020 | 161,768,535 | (3,083,732) | ||||
Issuance of ordinary shares under employee stock plans | 3,848 | $ 3 | 3,845 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 327,251 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (123) | $ (123) | ||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 24,175 | (7,874) | ||||
Share-based compensation expense | 23,136 | 23,136 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | 1,398 | 1,398 | ||||
Net loss | (29,431) | (29,431) | ||||
BALANCE at Jun. 30, 2020 | 1,061,846 | $ 1,618 | 2,636,194 | (101) | (1,450,073) | $ (125,792) |
BALANCE (in shares) at Jun. 30, 2020 | 162,119,961 | (3,091,606) | ||||
Issuance of ordinary shares under employee stock plans | 800 | 800 | ||||
Issuance of ordinary shares under employee stock plans (in shares) | 53,509 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (201) | $ 1 | (1) | $ (201) | ||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share based awards (in shares) | 34,675 | (11,106) | ||||
Share-based compensation expense | 22,706 | 22,706 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | (659) | (659) | ||||
Net loss | (134) | (134) | ||||
BALANCE at Sep. 30, 2020 | $ 1,084,358 | $ 1,619 | $ 2,659,699 | $ (760) | $ (1,450,207) | $ (125,993) |
BALANCE (in shares) at Sep. 30, 2020 | 162,208,145 | (3,102,712) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement Of Stockholders Equity [Abstract] | ||||||||
Tax provision (benefit) | $ (193) | $ 409 | $ 87 | $ (15) | $ 265 | $ 229 | $ 303 | $ 479 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2020 | |
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. Alkermes has a diversified portfolio of marketed products focused on CNS disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, the Company has a research and development (“R&D”) center in Waltham, Massachusetts; 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, 2020 | |
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, 2020 and 2019 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2019. 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 Chief Executive Officer and Chairman of the Company’s board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. Risks and Uncertainties In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and recommendations, and the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. While the Company has begun to observe a gradual normalization in patient and healthcare provider practices, the impacts and extent of such normalization are not yet known, and it remains difficult to predict the nature and extent of the future impacts that the pandemic will have on such practices and, as a result, on the Company’s business. The Company continues to closely monitor and rapidly respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the Company is unable to predict the extent of the impact that the COVID-19 pandemic may continue to have on the Company’s future financial condition and operating results. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of the pandemic on the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia; impacts of the pandemic on the regulatory agencies with which the Company interacts in the development, review, approval and commercialization of its medicines; impacts of the pandemic on reimbursement for the Company’s products, including the Company’s Medicaid rebate liability, and for services related to the use of its products; and impacts of the pandemic on the U.S., Irish and global economies more broadly. The Company relies upon third parties for many aspects of its business, including the provision of goods and services related to the manufacture of its clinical products and its and its partners’ marketed products, the conduct of its clinical trials, and the sale of marketed products from which the Company receives manufacturing and royalty revenue. Any prolonged material disruption to the third parties on which the Company relies could negatively impact the Company’s ability to conduct business in the manner and on the timelines presently planned, which could have a material adverse impact on the Company’s business, results of operations and financial condition. The marketed products from which the Company derives revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including the implementation of “shelter-in-place” policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and the Company expects commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists. As it relates to the Company’s proprietary marketed products, despite continuing COVID-19-related impacts on access to healthcare provider facilities and patient flow, during the three months ended September 30, 2020, the Company saw an increase of 22% in the number of VIVITROL units sold compared to the three months ended June 30, 2020. ARISTADA units sold during the three months ended September 30, 2020 increased 7% compared to the three months ended June 30, 2020. During the three months ended September 30, 2020, the Company continued to take actions to support uninterrupted access to its proprietary marketed products. However, the Company currently expects commercial sales of its marketed products, particularly VIVITROL, to continue to be impacted by the COVID-19 pandemic over the next few quarters, including, for VIVITROL, as a result of the impact that the decrease in patient volume during the previous two quarters is expected to have on overall unit demand in the fourth quarter of 2020 and beyond. These items are discussed in greater detail in the “Results of Operations” section in “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q. The Company continues to operate its manufacturing facilities and supply its medicines. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of its early-stage discovery efforts and clinical trials . T he Company is working with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impact s of COVID-19 on its manufacturing operations and R&D activities . New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU 2018-13, 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 In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes Income Taxes In March 202 0 , the FASB issued ASU 2020-04, Reference Rate Reform , which provides optional guidance for a limited period of time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. This amendment applies to all entities, subject to meeting certain criteria, that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. This ASU became effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. The Company is currently assessing the impact that this ASU may have on its consolidated financial statements . |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 9 Months Ended |
Sep. 30, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS Under FASB ASC 606, Revenue from Contracts with Customers 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 specialty 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, 2020 and 2019, the Company recorded product sales, net, as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2020 2019 2020 2019 VIVITROL $ 80,258 $ 85,164 $ 230,673 $ 242,546 ARISTADA/ARISTADA INITIO 62,400 53,610 172,126 132,344 Total product sales, net $ 142,658 $ 138,774 $ 402,799 $ 374,890 Manufacturing and Royalty Revenues During the three and nine months ended September 30, 2020 and 2019, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 73,366 $ 73,366 $ — $ 197,678 $ 197,678 RISPERDAL CONSTA 10,993 3,517 14,510 44,769 10,786 55,555 Other 14,312 18,163 32,475 46,088 53,786 99,874 $ 25,305 $ 95,046 $ 120,351 $ 90,857 $ 262,250 $ 353,107 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 Other 11,562 15,506 27,068 42,460 53,953 96,413 $ 16,082 $ 87,701 $ 103,783 $ 85,408 $ 255,187 $ 340,595 Research and Development Revenue The Company recorded R&D revenue of $1.0 million and $1.8 million during the three and nine months ended September 30, 2020, respectively, of which $0.1 million and $0.3 million, respectively, related to its license and collaboration agreement with Biogen for VUMERITY. The Company recorded R&D revenue of $12.7 million and $41.7 million during the three and nine months ended September 30, 2019, respectively, of which $12.1 million and $39.5 million, respectively, related to its license and collaboration agreement with Biogen for VUMERITY. The Company expects to earn less than $0.1 million in additional R&D revenue under this agreement with Biogen through the end of 2020. Contract Assets Contract assets include unbilled amounts under certain of the Company’s contracts with customers where revenue is recognized over time. Total contract assets as of September 30, 2020 include $14.4 million of assets that are classified as “Current assets” in the accompanying condensed consolidated balance sheet, as they related to manufacturing processes that are completed in ten days to eight weeks Total contract assets at September 30, 2020 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2019 $ 13,386 Additions 36,569 Transferred to receivables, net (30,560 ) Contract assets at September 30, 2020 $ 19,395 Contract Liabilities Contract liabilities consist of contractual obligations related to deferred revenue. Total contract liabilities at September 30, 2020 (In thousands) Contract Liabilities Contract liabilities at December 31, 2019 $ 28,834 Additions — Amounts recognized into revenue (3,046 ) Contract liabilities at September 30, 2020 $ 25,788 |
Investments
Investments | 9 Months Ended |
Sep. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENTS Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Allowance for Estimated September 30, 2020 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 163,511 $ 1,484 $ (2 ) $ — $ (977 ) $ 164,016 U.S. government and agency debt securities 85,207 535 (1 ) — — 85,741 International government agency debt securities 76,264 659 (8 ) — — 76,915 324,982 2,678 (11 ) — (977 ) 326,672 Held-to-maturity securities: Fixed term deposit account 1,668 176 — — — 1,844 Total short-term investments 326,650 2,854 (11 ) — (977 ) 328,516 Long-term investments: Available-for-sale securities: Corporate debt securities 10,505 — (21 ) — — 10,484 U.S. government and agency debt securities 8,584 — (1 ) — — 8,583 International government agency debt securities 6,899 — (12 ) — — 6,887 25,988 — (34 ) — — 25,954 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 27,808 — (34 ) — — 27,774 Total investments $ 354,458 $ 2,854 $ (45 ) $ — $ (977 ) $ 356,290 December 31, 2019 Short-term investments: Available-for-sale securities: Corporate debt securities $ 144,161 $ 676 $ — $ — $ — $ 144,837 U.S. government and agency debt securities 112,948 434 (1 ) (1 ) — 113,380 International government agency debt securities 72,753 248 (10 ) — — 72,991 Total short-term investments 329,862 1,358 (11 ) (1 ) — 331,208 Long-term investments: Available-for-sale securities: Corporate debt securities 51,070 — (45 ) (7 ) — 51,018 International government agency debt securities 20,806 — (18 ) — — 20,788 U.S. government and agency debt securities 4,000 — (4 ) — — 3,996 75,876 — (67 ) (7 ) — 75,802 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Fixed term deposit account 1,667 102 — — — 1,769 3,487 102 — — — 3,589 Total long-term investments 79,363 102 (67 ) (7 ) — 79,391 Total investments $ 409,225 $ 1,460 $ (78 ) $ (8 ) $ — $ 410,599 At September 30, 2020, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were temporary or other-than-temporary. The investments with unrealized losses consisted primarily of corporate debt securities. In making the determination whether 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 of the securities; 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. At September 30, 2020, the Company determined that the loss on one of its corporate debt securities was other - than - t emporary and recorded a $ 1.0 million impairment within “Other income (expense), net” in the accompanying condensed consolidated statements of operations and comprehensive loss . In May 2014, the Company entered into an agreement whereby it committed to provide up to €7.4 million to Fountain Healthcare Partners II, L.P., an Irish partnership (“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. The Company’s commitment to Fountain represents approximately 7% of Fountain’s total funding. As of September 30, 2020, the Company had invested €5.8 million in Fountain. The Company is accounting for its investment in Fountain under the equity method. During the three months ended September 30, 2020, two of the companies within the Fountain portfolio were acquired by third parties. The Company’s proportional share of the proceeds from these transactions was $11.1 million, of which $10.4 million was received in September 2020 and $0.7 million is held in escrow. The transactions were accounted for under the cumulative earnings approach whereby the return on investment of $8.3 million was recorded as a gain within “Other income (expense), net” in the accompanying condensed consolidated statements of operations and comprehensive loss and the return of investment of $2.8 million was recorded as a reduction in the Company’s net investment in Fountain. The Company’s net investment in Fountain was $4.7 million and $5.9 million at September 30, 2020 and December 31, 2019, respectively, and was included within “Other assets” in the accompanying condensed consolidated balance sheets. The proceeds from 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) 2020 2019 Proceeds from the sales and maturities of marketable securities $ 206,089 $ 149,459 Realized gains $ 8,336 $ — Realized losses $ 977 $ 497 The Company’s available-for-sale and held-to-maturity securities at September 30, 2020 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 221,539 $ 221,770 $ 3,488 $ 3,664 After 1 year through 5 years 129,431 130,856 — — Total $ 350,970 $ 352,626 $ 3,488 $ 3,664 |
Fair Value
Fair Value | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 5. FAIR VALUE The following table presents information about the Company’s assets and liabilities at September 30, 2020 and December 31, 2019 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) 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 43,089 $ 43,089 $ — $ — U.S. government and agency debt securities 94,324 61,880 32,444 — Corporate debt securities 174,500 — 173,523 977 International government agency debt securities 83,802 — 83,802 — Contingent consideration 46,200 — — 46,200 Total $ 441,915 $ 104,969 $ 289,769 $ 47,177 December 31, 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,064 $ 8,064 $ — $ — U.S. government and agency debt securities 117,376 73,795 43,581 — Corporate debt securities 195,855 — 193,902 1,953 International government agency debt securities 93,779 — 93,779 — Contingent consideration 32,400 — — 32,400 Total $ 447,474 $ 81,859 $ 331,262 $ 34,353 The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were no transfers of any securities between the fair value hierarchies during the nine months ended September 30, 2020. 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, 2020: (In thousands) Fair Value Balance, January 1, 2020 $ 34,353 Change in the fair value of contingent consideration 16,626 Payments received by the Company related to contingent consideration (2,819 ) Payments due to the Company related to contingent consideration (6 ) Impairment of corporate debt security (977 ) Balance, September 30, 2020 $ 47,177 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 Company’s sale in April 2015 of its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to IV/IM and parenteral forms of Meloxicam (collectively, the “Gainesville Transaction”) to Recro Pharma, Inc. (“Recro”) and Recro Pharma LLC. As part of the Gainesville Transaction, the Company obtained rights to receive contingent payments upon the achievement by such Meloxicam products of certain regulatory and sales milestones and royalties on future net sales of such Meloxicam products. Additional details regarding the Gainesville Transaction can be found in Note 5, Fair Value In November 2019, Recro completed a spin out of its acute care segment into a new entity named Baudax Bio, Inc. (“Baudax”), a publicly traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay certain of the contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax. On February 20, 2020, ANJESO (formerly referred to as Meloxicam IV/IM), was approved by the U.S. Food and Drug Administration (the “FDA”). At September 30, 2020 and December 31, 2019, the Company determined that the value of the contingent consideration was $46.2 million and $32.4 million, respectively. The Company recorded an increase of $3.9 million and $16.6 million during the three and nine months ended September 30, 2020, respectively, and an increase of $1.3 million and a decrease of $27.8 million during the three and nine months ended September 30, 2019, respectively, within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive loss. The fair value of the contingent consideration was developed using the same valuation approaches as described in Note 5, Fair Value, On August 17, 2020, the Company and Baudax agreed to amend the timing of payment of the $5.0 million milestone payment due to the Company in August 2020 as a result of the approval of the new drug application (“NDA”) for ANJESO, such that the Company received $2.5 million in August 2020 and will receive: (i) $1.1 million on or prior to December 20, 2020; and (ii) $1.4 million on or prior to June 20, 2021. In consideration of the amendment of the timing of this milestone payment, Baudax paid the Company an additional $0.3 million in August 2020. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term nature. The estimated fair value of the Company’s long-term debt under its amended and restated credit agreement (such debt, the “2023 Term Loans”), which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $274.0 million and $277.9 million at September 30, 2020 and December 31, 2019, respectively. Please refer to Note 11, Long-Term Debt |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Raw materials $ 42,163 $ 34,577 Work in process 53,336 54,061 Finished goods (1) 27,324 13,165 Total inventory $ 122,823 $ 101,803 (1) At September 30, 2020 and December 31, 2019, the Company had $27.2 million and $7.6 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. As of September 30, 2020 and December 31, 2019, the carrying value of inventory includes $15.3 million and none, respectively, associated with the Company’s ALKS 3831 development program, which was capitalized in advance of potential regulatory approval. |
Property, Plant and Equipment
Property, Plant and Equipment | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Land $ 6,560 $ 6,560 Building and improvements 178,193 177,087 Furniture, fixtures and equipment 362,936 340,146 Leasehold improvements 52,438 20,737 Construction in progress 103,917 134,683 Subtotal 704,044 679,213 Less: accumulated depreciation (348,829 ) (317,045 ) Total property, plant and equipment, net $ 355,215 $ 362,168 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (370,404 ) $ 95,186 NanoCrystal technology 13 74,600 (52,476 ) 22,124 OCR (1) 12 42,560 (38,762 ) 3,798 Total $ 582,750 $ (461,642 ) $ 121,108 (1) OCR refers to the Company’s oral controlled release technologies. Based on the Company’s most recent analysis, amortization of intangible assets included within its condensed consolidated balance sheet at September 30, 2020 is expected to be approximately $40.0 million, $40.0 million, $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 2020 through 2024, respectively. Although the Company believes such available information and assumptions are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the change in revenues. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Leases | 9. LEASES In March 2018, the Company entered into a lease agreement for approximately 220,000 square feet of office and laboratory space at 900 Winter Street, Waltham, Massachusetts (“900 Winter Street”). The initial term of the operating lease for 900 Winter Street commenced on January 20, 2020 and expires in 2035, with an option to extend for an additional 10 years. The Company did not assume this option would be exercised in the calculation of its right-of-use asset and lease liability amounts. The Company has determined that the identified operating lease did not contain non-lease components and required no further allocation of the total lease cost. Additionally, the agreement in place did not contain information to determine the rate implicit in the lease. At September 30, 2020, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.58% and 14.0 years, respectively. During the three and nine months ended September 30, 2020, cash paid for amounts included for the measurement of lease liabilities was $5.0 million and $11.9 million, respectively, compared to $2.2 million and $6.8 million during the three and nine months ended September 30, 2019, respectively. The Company recorded operating lease expense of $4.7 million and $13.3 million, during the three and nine months ended September 30, 2020, respectively, compared to $2.1 million and $6.3 million during the three and nine months ended September 30, 2019, respectively. Future lease payments under non-cancelable leases as of September 30, 2020 and December 31, 2019 consisted of the following: September 30, December 31, (In thousands) 2020 2019 (1) 2020 $ 4,335 $ 9,053 2021 12,948 2,727 2022 10,788 500 2023 10,913 509 2024 11,040 520 Thereafter 117,994 2,579 Total lease payments 168,018 15,888 Less: imputed interest (57,926 ) (2,080 ) Total operating lease liabilities $ 110,092 $ 13,808 (1) As of December 31, 2019, the term of the 900 Winter Street lease had not commenced and the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets, and thus, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed. As such, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined above do not include the 900 Winter Street lease payments as of December 31, 2019 under ASU 2016-02, Leases In July 2020, the Company entered into an amendment to its existing lease at 852 Winter Street, Waltham, Massachusetts (as amended, the “852 Winter Street Lease”). The amendment became effective on October 7, 2020. The 852 Winter Street Lease governs approximately 180,000 square feet of corporate office space, administrative areas and laboratories. The amendment served to, among other things, extend the term of the 852 Winter Street Lease for a period of approximately five years, to commence in March 2021 and expire in April 2026 with respect to approximately 163,000 square feet of the 852 Winter Street Lease premises (the “Base Premises”) and to commence in September 2021 and expire in October 2026 with respect to approximately 17,000 square feet of the 852 Winter Street Lease premises (the “Additional Premises”). The Company expects to make annual lease payments of approximately $5.7 million for the Base Premises and $0.5 million for the Additional Premises, subject to annual increases. Under the terms of the 852 Winter Street Lease, the Company will have the option to extend for an additional five-year |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Accounts payable $ 82,835 $ 54,261 Accrued compensation 72,832 72,072 Accrued sales discounts, allowances and reserves 145,347 153,902 Accrued other 53,766 92,802 Total accounts payable and accrued expenses $ 354,780 $ 373,037 |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: September 30, December 31, (In thousands) 2020 2019 2023 Term Loans, due March 26, 2023 $ 275,506 $ 277,138 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 272,663 $ 274,295 The 2023 Term Loans have a due date of March 26, 2023 and interest payable of LIBOR 2.25 0 |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | 12. SHARE-BASED COMPENSATION The following table presents share-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive loss: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2020 2019 2020 2019 Cost of goods manufactured and sold $ 2,344 $ 2,912 $ 6,324 $ 7,395 Research and development 6,762 8,195 19,400 24,076 Selling, general and administrative 13,514 15,622 39,555 48,119 Total share-based compensation expense $ 22,620 $ 26,729 $ 65,279 $ 79,590 At September 30, 2020 and December 31, 2019, $2.2 million and $1.5 million, respectively, of share-based compensation expense 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 three specified performance criteria over a performance period of three years from the date of the grant. The Company achieved one of the three performance criteria in December 2018, resulting in the vesting of a portion of the performance-based RSUs. In February 2020, the compensation committee of the Company’s board of directors acknowledged that the two remaining performance criteria had not been achieved prior to the expiration of the three-year |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 and 2019, as the Company was in a net loss position, the diluted loss per ordinary share calculation did not assume conversion or exercise of stock options and restricted stock units, as they would have had an anti-dilutive effect on loss per ordinary share. The following potential ordinary share equivalents have not been included in the loss per ordinary share calculations because the effect would have been anti-dilutive: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2020 2019 2020 2019 Stock options 15,322 13,867 15,352 14,077 Restricted stock units 2,351 3,344 3,678 3,110 Total 17,673 17,211 19,030 17,187 |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2020 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 14. RESTRUCTURING In October 2019, the Company approved a restructuring plan following a review of its operations, cost structure and growth opportunities (the “Restructuring”). The Restructuring included a reduction in headcount of approximately 160 employees across the Company. The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which were expected to result in cash expenditures and substantially all of which would be paid out within one year. Restructuring activity during the nine months ended September 30, 2020 was as follows: (In thousands) Balance, December 31, 2019 $ 9,201 Amounts paid during the period: Severance (6,714 ) Outplacement services (108 ) Benefits (1,224 ) Balance, September 30, 2020 $ 1,155 At September 30, 2020 and December 31, 2019, $1.2 million and $9.0 million of the restructuring accrual, respectively, was included within “Accounts payable and accrued expenses” and none and $0.2 million of the restructuring accrual, respectively, was included within “Other long-term liabilities” in the accompanying condensed consolidated balance sheets. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 9 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 15. 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, 2020, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. INVEGA SUSTENNA ANDA Litigation Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC, following the respective filings by each of Teva, Mylan Labs, and Pharmascience of an abbreviated new drug application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. Requested judicial remedies in each of the lawsuits included recovery of litigation costs and injunctive relief. The Company is not a party to any of these proceedings. INVEGA TRINZA ANDA Litigation In September 2020, Janssen Pharmaceuticals NV, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC, initiated a patent infringement lawsuit in the NJ District Court against Mylan Labs, Mylan, and Mylan Institutional LLC following the filing by Mylan Labs of an ANDA seeking approval from the FDA to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693. Requested judicial remedies include recovery of litigation costs and injunctive relief. The Company is not a party to this proceeding. RISPERDAL CONSTA European Opposition Proceedings In December 2016, Nanjing Luye Pharmaceutical Co., Ltd., Pharmathen SA, Teva PI and Dehns Ltd (a law firm representing an unidentified opponent) filed notices of opposition with the European Patent Office (the “EPO”) in respect of EP 2 269 577 B (the “EP ’577 Patent”), which is a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. Following a hearing on the matter in January 2019, the EPO issued a written decision revoking the EP’577 Patent in April 2019. The Company filed a notice of appeal of the decision to the EPO’s Technical Boards of Appeal in June 2019. Pharmathen SA submitted a reply on November 5, 2019 and Nanjing Luye Pharmaceutical Co Ltd. and Teva Pharmaceutical Industries Ltd. submitted replies on December 20, 2019. The Company will continue to vigorously defend the EP ’577 Patent. VIVITROL ANDA Litigation In September 2020, Alkermes, Inc. and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the NJ District Court against Teva and Teva PI following the filing by Teva of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VIVITROL (naltrexone for extended-release injectable suspension) before the expiration of the Company’s U.S. Patent No. 7,919,499. The Company intends to vigorously defend its intellectual property. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). Government Matters The Company has received a subpoena and civil investigative demands from U.S. state and Federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations. Securities Litigation In December 2018 and January 2019, purported stockholders of the Company filed putative class actions against the Company and certain of its officers in the U.S. District Court for the Eastern District of New York (the “EDNY District Court”) captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410 McDermott v. Alkermes plc, et al., No. 1:19-cv-00624 Product Liability and Other Legal Proceedings The Company is also involved in product liability cases and other legal proceedings incidental to its normal business activities, including product liability cases alleging that the FDA-approved VIVITROL labeling was inadequate and caused the users of the product to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters. While the outcome of any of these proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these existing matters would have a material adverse effect on the Company’s business or financial condition. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 and 2019 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2019. 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 Chief Executive Officer and Chairman of the Company’s board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. |
Risks and Uncertainties | Risks and Uncertainties In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and recommendations, and the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. While the Company has begun to observe a gradual normalization in patient and healthcare provider practices, the impacts and extent of such normalization are not yet known, and it remains difficult to predict the nature and extent of the future impacts that the pandemic will have on such practices and, as a result, on the Company’s business. The Company continues to closely monitor and rapidly respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the Company is unable to predict the extent of the impact that the COVID-19 pandemic may continue to have on the Company’s future financial condition and operating results. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of the pandemic on the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia; impacts of the pandemic on the regulatory agencies with which the Company interacts in the development, review, approval and commercialization of its medicines; impacts of the pandemic on reimbursement for the Company’s products, including the Company’s Medicaid rebate liability, and for services related to the use of its products; and impacts of the pandemic on the U.S., Irish and global economies more broadly. The Company relies upon third parties for many aspects of its business, including the provision of goods and services related to the manufacture of its clinical products and its and its partners’ marketed products, the conduct of its clinical trials, and the sale of marketed products from which the Company receives manufacturing and royalty revenue. Any prolonged material disruption to the third parties on which the Company relies could negatively impact the Company’s ability to conduct business in the manner and on the timelines presently planned, which could have a material adverse impact on the Company’s business, results of operations and financial condition. The marketed products from which the Company derives revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including the implementation of “shelter-in-place” policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and the Company expects commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists. As it relates to the Company’s proprietary marketed products, despite continuing COVID-19-related impacts on access to healthcare provider facilities and patient flow, during the three months ended September 30, 2020, the Company saw an increase of 22% in the number of VIVITROL units sold compared to the three months ended June 30, 2020. ARISTADA units sold during the three months ended September 30, 2020 increased 7% compared to the three months ended June 30, 2020. During the three months ended September 30, 2020, the Company continued to take actions to support uninterrupted access to its proprietary marketed products. However, the Company currently expects commercial sales of its marketed products, particularly VIVITROL, to continue to be impacted by the COVID-19 pandemic over the next few quarters, including, for VIVITROL, as a result of the impact that the decrease in patient volume during the previous two quarters is expected to have on overall unit demand in the fourth quarter of 2020 and beyond. These items are discussed in greater detail in the “Results of Operations” section in “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q. The Company continues to operate its manufacturing facilities and supply its medicines. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of its early-stage discovery efforts and clinical trials . T he Company is working with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impact s of COVID-19 on its manufacturing operations and R&D activities . |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU 2018-13, 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 In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes Income Taxes In March 202 0 , the FASB issued ASU 2020-04, Reference Rate Reform , which provides optional guidance for a limited period of time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. This amendment applies to all entities, subject to meeting certain criteria, that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. This ASU became effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. The Company is currently assessing the impact that this ASU may have on its consolidated financial statements . |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Schedule of Contract Assets and Contract Liabilities | Total contract assets at September 30, 2020 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2019 $ 13,386 Additions 36,569 Transferred to receivables, net (30,560 ) Contract assets at September 30, 2020 $ 19,395 Total contract liabilities at September 30, 2020 (In thousands) Contract Liabilities Contract liabilities at December 31, 2019 $ 28,834 Additions — Amounts recognized into revenue (3,046 ) Contract liabilities at September 30, 2020 $ 25,788 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three and nine months ended September 30, 2020 and 2019, the Company recorded product sales, net, as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2020 2019 2020 2019 VIVITROL $ 80,258 $ 85,164 $ 230,673 $ 242,546 ARISTADA/ARISTADA INITIO 62,400 53,610 172,126 132,344 Total product sales, net $ 142,658 $ 138,774 $ 402,799 $ 374,890 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three and nine months ended September 30, 2020 and 2019, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 73,366 $ 73,366 $ — $ 197,678 $ 197,678 RISPERDAL CONSTA 10,993 3,517 14,510 44,769 10,786 55,555 Other 14,312 18,163 32,475 46,088 53,786 99,874 $ 25,305 $ 95,046 $ 120,351 $ 90,857 $ 262,250 $ 353,107 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 Other 11,562 15,506 27,068 42,460 53,953 96,413 $ 16,082 $ 87,701 $ 103,783 $ 85,408 $ 255,187 $ 340,595 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Investments | Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Allowance for Estimated September 30, 2020 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 163,511 $ 1,484 $ (2 ) $ — $ (977 ) $ 164,016 U.S. government and agency debt securities 85,207 535 (1 ) — — 85,741 International government agency debt securities 76,264 659 (8 ) — — 76,915 324,982 2,678 (11 ) — (977 ) 326,672 Held-to-maturity securities: Fixed term deposit account 1,668 176 — — — 1,844 Total short-term investments 326,650 2,854 (11 ) — (977 ) 328,516 Long-term investments: Available-for-sale securities: Corporate debt securities 10,505 — (21 ) — — 10,484 U.S. government and agency debt securities 8,584 — (1 ) — — 8,583 International government agency debt securities 6,899 — (12 ) — — 6,887 25,988 — (34 ) — — 25,954 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 27,808 — (34 ) — — 27,774 Total investments $ 354,458 $ 2,854 $ (45 ) $ — $ (977 ) $ 356,290 December 31, 2019 Short-term investments: Available-for-sale securities: Corporate debt securities $ 144,161 $ 676 $ — $ — $ — $ 144,837 U.S. government and agency debt securities 112,948 434 (1 ) (1 ) — 113,380 International government agency debt securities 72,753 248 (10 ) — — 72,991 Total short-term investments 329,862 1,358 (11 ) (1 ) — 331,208 Long-term investments: Available-for-sale securities: Corporate debt securities 51,070 — (45 ) (7 ) — 51,018 International government agency debt securities 20,806 — (18 ) — — 20,788 U.S. government and agency debt securities 4,000 — (4 ) — — 3,996 75,876 — (67 ) (7 ) — 75,802 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Fixed term deposit account 1,667 102 — — — 1,769 3,487 102 — — — 3,589 Total long-term investments 79,363 102 (67 ) (7 ) — 79,391 Total investments $ 409,225 $ 1,460 $ (78 ) $ (8 ) $ — $ 410,599 |
Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses | The proceeds from 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) 2020 2019 Proceeds from the sales and maturities of marketable securities $ 206,089 $ 149,459 Realized gains $ 8,336 $ — Realized losses $ 977 $ 497 |
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, 2020 had contractual maturities in the following periods: Available-for-sale Held-to-maturity Amortized Estimated Amortized Estimated (In thousands) Cost Fair Value Cost Fair Value Within 1 year $ 221,539 $ 221,770 $ 3,488 $ 3,664 After 1 year through 5 years 129,431 130,856 — — Total $ 350,970 $ 352,626 $ 3,488 $ 3,664 |
Fair Value (Tables)
Fair Value (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Company’s assets and liabilities at September 30, 2020 and December 31, 2019 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) 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 43,089 $ 43,089 $ — $ — U.S. government and agency debt securities 94,324 61,880 32,444 — Corporate debt securities 174,500 — 173,523 977 International government agency debt securities 83,802 — 83,802 — Contingent consideration 46,200 — — 46,200 Total $ 441,915 $ 104,969 $ 289,769 $ 47,177 December 31, 2019 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,064 $ 8,064 $ — $ — U.S. government and agency debt securities 117,376 73,795 43,581 — Corporate debt securities 195,855 — 193,902 1,953 International government agency debt securities 93,779 — 93,779 — Contingent consideration 32,400 — — 32,400 Total $ 447,474 $ 81,859 $ 331,262 $ 34,353 |
Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs | The following table is a rollforward of the fair value of the Company’s assets whose fair values were determined using Level 3 inputs at September 30, 2020: (In thousands) Fair Value Balance, January 1, 2020 $ 34,353 Change in the fair value of contingent consideration 16,626 Payments received by the Company related to contingent consideration (2,819 ) Payments due to the Company related to contingent consideration (6 ) Impairment of corporate debt security (977 ) Balance, September 30, 2020 $ 47,177 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Raw materials $ 42,163 $ 34,577 Work in process 53,336 54,061 Finished goods (1) 27,324 13,165 Total inventory $ 122,823 $ 101,803 (1) At September 30, 2020 and December 31, 2019, the Company had $27.2 million and $7.6 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Land $ 6,560 $ 6,560 Building and improvements 178,193 177,087 Furniture, fixtures and equipment 362,936 340,146 Leasehold improvements 52,438 20,737 Construction in progress 103,917 134,683 Subtotal 704,044 679,213 Less: accumulated depreciation (348,829 ) (317,045 ) Total property, plant and equipment, net $ 355,215 $ 362,168 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: September 30, 2020 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 92,873 $ — $ 92,873 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ (370,404 ) $ 95,186 NanoCrystal technology 13 74,600 (52,476 ) 22,124 OCR (1) 12 42,560 (38,762 ) 3,798 Total $ 582,750 $ (461,642 ) $ 121,108 (1) OCR refers to the Company’s oral controlled release technologies. |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of September 30, 2020 and December 31, 2019 consisted of the following: September 30, December 31, (In thousands) 2020 2019 (1) 2020 $ 4,335 $ 9,053 2021 12,948 2,727 2022 10,788 500 2023 10,913 509 2024 11,040 520 Thereafter 117,994 2,579 Total lease payments 168,018 15,888 Less: imputed interest (57,926 ) (2,080 ) Total operating lease liabilities $ 110,092 $ 13,808 (1) As of December 31, 2019, the term of the 900 Winter Street lease had not commenced and the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets, and thus, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed. As such, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined above do not include the 900 Winter Street lease payments as of December 31, 2019 under ASU 2016-02, Leases |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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) 2020 2019 Accounts payable $ 82,835 $ 54,261 Accrued compensation 72,832 72,072 Accrued sales discounts, allowances and reserves 145,347 153,902 Accrued other 53,766 92,802 Total accounts payable and accrued expenses $ 354,780 $ 373,037 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: September 30, December 31, (In thousands) 2020 2019 2023 Term Loans, due March 26, 2023 $ 275,506 $ 277,138 Less: current portion (2,843 ) (2,843 ) Long-term debt $ 272,663 $ 274,295 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Share-based Compensation Expense | The following table presents share-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive loss: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2020 2019 2020 2019 Cost of goods manufactured and sold $ 2,344 $ 2,912 $ 6,324 $ 7,395 Research and development 6,762 8,195 19,400 24,076 Selling, general and administrative 13,514 15,622 39,555 48,119 Total share-based compensation expense $ 22,620 $ 26,729 $ 65,279 $ 79,590 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share | The following potential ordinary share equivalents have not been included in the loss per ordinary share calculations because the effect would have been anti-dilutive: Three Months Ended Nine Months Ended September 30, September 30, (In thousands) 2020 2019 2020 2019 Stock options 15,322 13,867 15,352 14,077 Restricted stock units 2,351 3,344 3,678 3,110 Total 17,673 17,211 19,030 17,187 |
Restructuring (Tables)
Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Restructuring And Related Activities [Abstract] | |
Schedule of Restructuring Activity | Restructuring activity during the nine months ended September 30, 2020 was as follows: (In thousands) Balance, December 31, 2019 $ 9,201 Amounts paid during the period: Severance (6,714 ) Outplacement services (108 ) Benefits (1,224 ) Balance, September 30, 2020 $ 1,155 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020segment | |
Summary Of Significant Accounting Policies [Line Items] | ||
Number of business segments | 1 | |
ASU 2016-13 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | Jan. 1, 2020 |
Change in accounting principle, accounting standards update, immaterial effect | true | true |
ASU 2018-13 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | Jan. 1, 2020 |
Change in accounting principle, accounting standards update, immaterial effect | true | true |
ASU 2018-15 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | Jan. 1, 2020 |
Change in accounting principle, accounting standards update, immaterial effect | true | true |
Change in accounting principle, accounting standards update, transition option elected | us-gaap:AccountingStandardsUpdate201815ProspectiveMember | |
ASU 2019-12 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | Jan. 1, 2020 |
Change in accounting principle, accounting standards update, immaterial effect | true | true |
VIVITROL | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Increase (decrease) in units sold due to COVID19 pandemic, percentage | 22.00% | |
ARISTADA | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Increase (decrease) in units sold due to COVID19 pandemic, percentage | 7.00% |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 265,012 | $ 255,243 | $ 758,761 | $ 758,217 |
VIVITROL | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 80,258 | 85,164 | 230,673 | 242,546 |
ARISTADA/ARISTADA INITIO | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 62,400 | 53,610 | 172,126 | 132,344 |
Product sales, net | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 142,658 | $ 138,774 | $ 402,799 | $ 374,890 |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 265,012 | $ 255,243 | $ 758,761 | $ 758,217 |
Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 25,305 | 16,082 | 90,857 | 85,408 |
Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 95,046 | 87,701 | 262,250 | 255,187 |
Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 120,351 | 103,783 | 353,107 | 340,595 |
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 73,366 | 68,382 | 197,678 | 188,968 |
INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 73,366 | 68,382 | 197,678 | 188,968 |
RISPERDAL CONSTA | Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 10,993 | 4,520 | 44,769 | 42,948 |
RISPERDAL CONSTA | Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 3,517 | 3,813 | 10,786 | 12,266 |
RISPERDAL CONSTA | Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 14,510 | 8,333 | 55,555 | 55,214 |
Other | Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 14,312 | 11,562 | 46,088 | 42,460 |
Other | Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 18,163 | 15,506 | 53,786 | 53,953 |
Other | Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 32,475 | $ 27,068 | $ 99,874 | $ 96,413 |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||||
Revenues | $ 265,012 | $ 255,243 | $ 758,761 | $ 758,217 | ||
Contract asset, current | 14,395 | $ 14,395 | $ 8,386 | |||
Consideration expects to receive | 2 years | |||||
Other Assets | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Contract asset, non-current | 5,000 | $ 5,000 | $ 5,000 | |||
Maximum | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Manufacturing Process period | 56 days | |||||
Minimum | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Manufacturing Process period | 10 days | |||||
Research and development revenue | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Revenues | 953 | 12,686 | $ 1,805 | 41,732 | ||
Research and development revenue | Biogen | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Revenues | $ 100 | $ 12,100 | $ 300 | $ 39,500 | ||
Research and development revenue | Biogen | Forecast | Maximum | ||||||
Disaggregation Of Revenue [Line Items] | ||||||
Additional revenue expected | $ 100 |
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, 2020USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 13,386 |
Additions | 36,569 |
Transferred to receivables, net | (30,560) |
Contract assets at end of period | 19,395 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 28,834 |
Amounts recognized into revenue | (3,046) |
Contract liabilities at end of the period | $ 25,788 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Available-for-sale securities: | ||
Amortized Cost | $ 350,970 | |
Estimated Fair Value | 352,626 | |
Held-to-maturity securities: | ||
Gross Unrealized Losses, Less than One Year | (11) | |
Estimated Fair Value | 3,664 | |
Long-term Investments | ||
Amortized Cost | 27,808 | $ 79,363 |
Gross Unrealized Gains | 102 | |
Gross Unrealized Losses, Less than One Year | (34) | (67) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Total long-term investments | 27,774 | 79,391 |
Total investments | ||
Amortized Cost | 354,458 | 409,225 |
Gross Unrealized Gains | 2,854 | 1,460 |
Gross Unrealized Losses, Less than One Year | (45) | (78) |
Gross Unrealized Losses, Greater than One Year | (8) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 356,290 | 410,599 |
Short-term Investments | ||
Amortized Cost | 326,650 | 329,862 |
Gross Unrealized Gains | 2,854 | 1,358 |
Gross Unrealized Losses, Less than One Year | (11) | (11) |
Gross Unrealized Losses, Greater than One Year | (1) | |
Allowance for Credit Losses | (977) | |
Total short-term investments | 328,516 | 331,208 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 324,982 | |
Gross Unrealized Gains | 2,678 | |
Gross Unrealized Losses, Less than One Year | (11) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 326,672 | |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 163,511 | 144,161 |
Gross Unrealized Gains | 1,484 | 676 |
Gross Unrealized Losses, Less than One Year | (2) | |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 164,016 | 144,837 |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 85,207 | 112,948 |
Gross Unrealized Gains | 535 | 434 |
Gross Unrealized Losses, Less than One Year | (1) | (1) |
Gross Unrealized Losses, Greater than One Year | (1) | |
Estimated Fair Value | 85,741 | 113,380 |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 76,264 | 72,753 |
Gross Unrealized Gains | 659 | 248 |
Gross Unrealized Losses, Less than One Year | (8) | (10) |
Estimated Fair Value | 76,915 | 72,991 |
Short-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,668 | |
Gross Unrealized Gains | 176 | |
Estimated Fair Value | 1,844 | |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 25,988 | 75,876 |
Gross Unrealized Losses, Less than One Year | (34) | (67) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Estimated Fair Value | 25,954 | 75,802 |
Held-to-maturity securities: | ||
Amortized Cost | 3,487 | |
Gross Unrealized Gains | 102 | |
Estimated Fair Value | 3,589 | |
Long-term investments | Certificates of deposit | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,820 | 1,820 |
Estimated Fair Value | 1,820 | 1,820 |
Long-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 10,505 | 51,070 |
Gross Unrealized Losses, Less than One Year | (21) | (45) |
Gross Unrealized Losses, Greater than One Year | (7) | |
Estimated Fair Value | 10,484 | 51,018 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 8,584 | 4,000 |
Gross Unrealized Losses, Less than One Year | (1) | (4) |
Estimated Fair Value | 8,583 | 3,996 |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 6,899 | 20,806 |
Gross Unrealized Losses, Less than One Year | (12) | (18) |
Estimated Fair Value | $ 6,887 | 20,788 |
Long-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | |
Gross Unrealized Gains | 102 | |
Estimated Fair Value | $ 1,769 |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($)Portfolio | Sep. 30, 2020USD ($) | Sep. 30, 2020EUR (€) | Dec. 31, 2019USD ($) | May 31, 2014EUR (€) | |
Investment Holdings [Line Items] | ||||||
Other-than-temporary impairment charge | $ 1,000 | |||||
Return of Fountain Healthcare Partners II, L.P. investment | $ 2,751 | |||||
Fountain Healthcare Partners II | ||||||
Investment Holdings [Line Items] | ||||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | 7.00% | 7.00% | ||
Equity method commitment | € | € 5,800,000 | |||||
Number of portfolio sold | Portfolio | 2 | |||||
Proceeds from sale of portfolio | $ 10,400 | $ 11,100 | ||||
Gain on sale of investment | 8,300 | |||||
Return of Fountain Healthcare Partners II, L.P. investment | 2,800 | |||||
Fountain Healthcare Partners II | Other Assets | ||||||
Investment Holdings [Line Items] | ||||||
Carrying value of equity investment | 4,700 | $ 4,700 | $ 4,700 | $ 5,900 | ||
Fountain Healthcare Partners II | Held-in Escrow | ||||||
Investment Holdings [Line Items] | ||||||
Proceeds from sale of portfolio | $ 700 | |||||
Fountain Healthcare Partners II | Maximum | ||||||
Investment Holdings [Line Items] | ||||||
Commitment on equity method investment | € | € 7,400,000 |
Investments - Schedule of Proce
Investments - Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | ||
Proceeds from the sales and maturities of marketable securities | $ 206,089 | $ 149,459 |
Realized gains | 8,336 | |
Realized losses | $ 977 | $ 497 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 221,539 |
After 1 year through 5 years | 129,431 |
Amortized Cost | 350,970 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 221,770 |
After 1 year through 5 years | 130,856 |
Total | 352,626 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 3,488 |
Total | 3,488 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 3,664 |
Total | $ 3,664 |
Fair Value - Summary of the Com
Fair Value - Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair value | ||
Debt securities | $ 352,626 | |
Contingent consideration | 46,200 | $ 32,400 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 43,089 | 8,064 |
Contingent consideration | 46,200 | 32,400 |
Assets, Total | 441,915 | 447,474 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 43,089 | 8,064 |
Assets, Total | 104,969 | 81,859 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 289,769 | 331,262 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 46,200 | 32,400 |
Assets, Total | 47,177 | 34,353 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 94,324 | 117,376 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 61,880 | 73,795 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 32,444 | 43,581 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 174,500 | 195,855 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 173,523 | 193,902 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 977 | 1,953 |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 83,802 | 93,779 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 83,802 | $ 93,779 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 31, 2020USD ($) | Sep. 30, 2020USD ($)item | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)item | Sep. 30, 2019USD ($) | Jun. 20, 2021USD ($) | Dec. 20, 2020USD ($) | Aug. 17, 2020USD ($) | Dec. 31, 2019USD ($)item | |
Fair Value | |||||||||
Transfers between the levels | $ 0 | ||||||||
Contingent consideration | $ 46,200,000 | 46,200,000 | $ 32,400,000 | ||||||
Increase (decrease) in the fair value of contingent consideration | 3,926,000 | $ 1,300,000 | 16,626,000 | $ (27,800,000) | |||||
Milestone payments receivable | $ 5,000,000 | ||||||||
Milestone payments received | $ 2,500,000 | ||||||||
Additional milestone payments received | $ 300,000 | ||||||||
2023 Term Loan | |||||||||
Fair Value | |||||||||
Amount to be realized in future | $ 274,000,000 | $ 274,000,000 | $ 277,900,000 | ||||||
Forecast | |||||||||
Fair Value | |||||||||
Milestone payments receivable | $ 1,400,000 | $ 1,100,000 | |||||||
Discount Rate | |||||||||
Fair Value | |||||||||
Discount rate (as a percent) | item | 16 | 16 | 16 |
Fair Value - Rollforward of the
Fair Value - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Roll forward of the fair value of the Company's investments whose fair value was determined using Level 3 inputs | |
Balance at the beginning of the period | $ 34,353 |
Payments received by the Company related to contingent consideration | (2,819) |
Payments due to the Company related to contingent consideration | (6) |
Impairment of corporate debt security | (977) |
Balance at the end of the period | 47,177 |
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 | $ 16,626 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 42,163 | $ 34,577 |
Work in process | 53,336 | 54,061 |
Finished goods | 27,324 | 13,165 |
Total inventory | $ 122,823 | $ 101,803 |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 27.2 | $ 7.6 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Inventory capitalized in advance of potential regulatory approval | $ 15,300,000 | $ 0 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 704,044 | $ 679,213 |
Less: accumulated depreciation | (348,829) | (317,045) |
Total property, plant and equipment, net | 355,215 | 362,168 |
Land | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 6,560 | 6,560 |
Building and Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 178,193 | 177,087 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 362,936 | 340,146 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 52,438 | 20,737 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 103,917 | $ 134,683 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | |
Net Carrying Amount | 92,873 | $ 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 582,750 | |
Accumulated Amortization | (461,642) | |
Net Carrying Amount | $ 121,108 | $ 150,643 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | |
Accumulated Amortization | (370,404) | |
Net Carrying Amount | $ 95,186 | |
NanoCrystal technology | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years | |
Gross Carrying Amount | $ 74,600 | |
Accumulated Amortization | (52,476) | |
Net Carrying Amount | $ 22,124 | |
OCR technologies | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 42,560 | |
Accumulated Amortization | (38,762) | |
Net Carrying Amount | $ 3,798 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) $ in Millions | Sep. 30, 2020USD ($) |
Expected amortization of intangible assets | |
2020 | $ 40 |
2021 | 40 |
2022 | 35 |
2023 | 35 |
2024 | $ 1 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Oct. 07, 2020USD ($)ft² | Mar. 31, 2018ft² | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | [1] |
Lessee Lease Description [Line Items] | ||||||||
Area of real estate property | ft² | 220,000 | |||||||
Lessee operating lease term of option to extend | 10 years | |||||||
Operating lease, existence of option to extend | true | |||||||
Lease, commencement date | Jan. 20, 2020 | |||||||
Lease, expiration year | 2035 | |||||||
Weighted average incremental borrowing rate | 5.58% | 5.58% | ||||||
Weighted average remaining lease term | 14 years | 14 years | ||||||
Payments for operating leases | $ 5,000 | $ 2,200 | $ 11,900 | $ 6,800 | ||||
Operating lease expense | 4,700 | $ 2,100 | 13,300 | $ 6,300 | ||||
Annual lease payments | $ 168,018 | $ 168,018 | $ 15,888 | |||||
Subsequent Event | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Area of real estate property | ft² | 180,000 | |||||||
Lessee operating lease term of option to extend | 5 years | |||||||
Subsequent Event | Base Premises | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Area of real estate property | ft² | 163,000 | |||||||
Lease period | 5 years | |||||||
Lease agreement commencement period | 2021-03 | |||||||
Lease, expiration period | 2026-04 | |||||||
Annual lease payments | $ 5,700 | |||||||
Subsequent Event | Additional Premises | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Area of real estate property | ft² | 17,000 | |||||||
Lease agreement commencement period | 2021-09 | |||||||
Lease, expiration period | 2026-10 | |||||||
Annual lease payments | $ 500 | |||||||
[1] | As of December 31, 2019, the term of the 900 Winter Street lease had not commenced and the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets, and thus, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed. As such, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined above do not include the 900 Winter Street lease payments as of December 31, 2019 under ASU 2016-02, Leases |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | ||
Leases [Abstract] | ||||
Remainder of fiscal year | $ 4,335 | |||
Year 1 | 12,948 | $ 9,053 | [1] | |
Year 2 | 10,788 | 2,727 | [1] | |
Year 3 | 10,913 | 500 | [1] | |
Year 4 | 11,040 | 509 | [1] | |
Thereafter | 117,994 | |||
Year 5 | [1] | 520 | ||
Thereafter | [1] | 2,579 | ||
Total lease payments | 168,018 | 15,888 | [1] | |
Less: imputed interest | (57,926) | (2,080) | [1] | |
Total operating lease liabilities | $ 110,092 | $ 13,808 | [1] | |
[1] | As of December 31, 2019, the term of the 900 Winter Street lease had not commenced and the Company (a) did not have the right to obtain or control the leased premises during the construction period; (b) did not have the right of payment for the partially constructed assets, and thus, the partially constructed assets could have potentially been leased to another tenant; and (c) did not legally own or control the land on which the property improvements were being constructed. As such, the lease assets were not included as right-of-use assets at December 31, 2019. The future lease payments outlined above do not include the 900 Winter Street lease payments as of December 31, 2019 under ASU 2016-02, Leases |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 82,835 | $ 54,261 |
Accrued compensation | 72,832 | 72,072 |
Accrued sales discounts, allowances and reserves | 145,347 | 153,902 |
Accrued other | 53,766 | 92,802 |
Total accounts payable and accrued expenses | $ 354,780 | $ 373,037 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Long-term debt | ||
Less: current portion | $ (2,843) | $ (2,843) |
Long-term debt | 272,663 | 274,295 |
2023 Term Loans | ||
Long-term debt | ||
2023 Term Loans, due March 26, 2023 | 275,506 | 277,138 |
Less: current portion | (2,843) | (2,843) |
Long-term debt | $ 272,663 | $ 274,295 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) - 2023 Term Loans | 9 Months Ended |
Sep. 30, 2020 | |
Long-term debt | |
Due date of loan | Mar. 26, 2023 |
Variable interest rate base | LIBOR |
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, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 22,620 | $ 26,729 | $ 65,279 | $ 79,590 |
Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 2,344 | 2,912 | 6,324 | 7,395 |
Research and development | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 6,762 | 8,195 | 19,400 | 24,076 |
Selling, general and administrative | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 13,514 | $ 15,622 | $ 39,555 | $ 48,119 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Performance-based RSUs | ||
Share-based compensation Expense | ||
Number of years from the date of the grant | 3 years | |
Expiration period | 3 years | |
Inventory | ||
Share-based compensation Expense | ||
Share based compensation cost capitalized | $ 2.2 | $ 1.5 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 17,673 | 17,211 | 19,030 | 17,187 |
Stock Options | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 15,322 | 13,867 | 15,352 | 14,077 |
Restricted Stock Units | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 2,351 | 3,344 | 3,678 | 3,110 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) | 1 Months Ended | 9 Months Ended | |
Oct. 31, 2019USD ($)Position | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) | |
Restructuring Cost And Reserve [Line Items] | |||
Restructuring and related activities initiation month and year | October 2019 | ||
Expected number of positions eliminated | Position | 160 | ||
Restructuring and related charges | $ 13,400,000 | ||
Restructuring and related activities description | The Restructuring included a reduction in headcount of approximately 160 employees across the Company. The Company recorded a charge of $13.4 million in the fourth quarter of 2019 as a result of the Restructuring, which consisted of one-time termination benefits for employee severance, benefits and related costs, all of which were expected to result in cash expenditures and substantially all of which would be paid out within one year. | ||
Restructuring accrual | $ 1,155,000 | $ 9,201,000 | |
Accounts payable and accrued expenses | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring accrual | 1,200,000 | 9,000,000 | |
Other long-term liabilities | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring accrual | $ 0 | $ 200,000 |
Restructuring - Schedule of Res
Restructuring - Schedule of Restructuring Activity (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Restructuring And Related Activities [Abstract] | |
Balance, December 31, 2019 | $ 9,201 |
Amounts paid during the period: | |
Severance | (6,714) |
Outplacement services | (108) |
Benefits | (1,224) |
Balance, September 30, 2020 | $ 1,155 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Potential losses from claims, legal proceedings probable of occurring | $ 0 | |
Maximum number of months before FDA can approve patent request | 30 months |