Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 23, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2021 | |
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 | 161,331,522 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
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 | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 258,341 | $ 272,961 |
Investments—short-term | 280,004 | 362,066 |
Receivables, net | 297,357 | 275,143 |
Contract assets | 8,793 | 14,401 |
Inventory | 136,077 | 125,738 |
Prepaid expenses and other current assets | 57,186 | 60,662 |
Total current assets | 1,037,758 | 1,110,971 |
PROPERTY, PLANT AND EQUIPMENT, NET | 343,949 | 350,003 |
INVESTMENTS—LONG-TERM | 131,032 | 24,780 |
RIGHT-OF-USE ASSETS | 123,012 | 131,718 |
INTANGIBLE ASSETS, NET | 93,274 | 111,191 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 75,643 | 86,228 |
CONTINGENT CONSIDERATION | 22,632 | 24,651 |
OTHER ASSETS | 17,396 | 17,315 |
TOTAL ASSETS | 1,937,569 | 1,949,730 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 357,961 | 412,171 |
Operating lease liabilities—short-term | 15,847 | 15,732 |
Contract liabilities—short-term | 6,634 | 7,512 |
Current portion of long-term debt | 3,000 | 2,843 |
Total current liabilities | 383,442 | 438,258 |
LONG-TERM DEBT | 294,070 | 272,118 |
OPERATING LEASE LIABILITIES—LONG-TERM | 111,664 | 119,464 |
CONTRACT LIABILITIES—LONG-TERM | 14,167 | 16,397 |
OTHER LONG-TERM LIABILITIES | 36,324 | 36,511 |
Total liabilities | 839,667 | 882,748 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 14) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at June 30, 2021 and December 31, 2020, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 164,965,774 and 162,269,220 shares issued; 161,296,126 and 159,161,141 shares outstanding at June 30, 2021 and December 31, 2020, respectively | 1,650 | 1,620 |
Treasury shares, at cost (3,669,648 and 3,108,079 shares at June 30, 2021 and December 31, 2020, respectively) | (137,207) | (126,087) |
Additional paid-in capital | 2,748,584 | 2,685,647 |
Accumulated other comprehensive loss | (2,222) | (1,349) |
Accumulated deficit | (1,512,903) | (1,492,849) |
Total shareholders’ equity | 1,097,902 | 1,066,982 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,937,569 | $ 1,949,730 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 | 164,965,774 | 162,269,220 |
Ordinary shares, shares outstanding | 161,296,126 | 159,161,141 |
Treasury shares | 3,669,648 | 3,108,079 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
REVENUES: | ||||
Total revenues | $ 303,717 | $ 247,529 | $ 555,147 | $ 493,749 |
EXPENSES: | ||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 53,124 | 45,053 | 94,144 | 92,264 |
Research and development | 97,473 | 94,222 | 189,741 | 187,501 |
Selling, general and administrative | 139,188 | 132,025 | 264,356 | 265,397 |
Amortization of acquired intangible assets | 9,511 | 9,890 | 18,917 | 19,618 |
Total expenses | 299,296 | 281,190 | 567,158 | 564,780 |
OPERATING INCOME (LOSS) | 4,421 | (33,661) | (12,011) | (71,031) |
OTHER INCOME (EXPENSE), NET: | ||||
Other (expense) income, net | (222) | 2,337 | (615) | 1,679 |
Interest income | 623 | 1,788 | 1,487 | 4,548 |
Interest expense | (2,407) | (2,122) | (6,377) | (4,979) |
Change in the fair value of contingent consideration | 3,240 | 5,900 | 4,518 | 12,700 |
Total other income (expense), net | 1,234 | 7,903 | (987) | 13,948 |
INCOME (LOSS) BEFORE INCOME TAXES | 5,655 | (25,758) | (12,998) | (57,083) |
INCOME TAX PROVISION | 3,291 | 3,673 | 7,056 | 11,002 |
NET INCOME (LOSS) | $ 2,364 | $ (29,431) | $ (20,054) | $ (68,085) |
EARNINGS (LOSS) PER ORDINARY SHARE: | ||||
Basic and diluted | $ 0.01 | $ (0.19) | $ (0.13) | $ (0.43) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic | 160,817 | 158,895 | 160,229 | 158,495 |
Diluted | 163,937 | 158,895 | 160,229 | 158,495 |
COMPREHENSIVE INCOME (LOSS): | ||||
Net income (loss) | $ 2,364 | $ (29,431) | $ (20,054) | $ (68,085) |
Holding (loss) gain, net of a tax (benefit) provision of $(79), $409, $(253) and $496, respectively | (272) | 1,398 | (873) | 1,715 |
COMPREHENSIVE INCOME (LOSS) | 2,092 | (28,033) | (20,927) | (66,370) |
Product sales, net | ||||
REVENUES: | ||||
Total revenues | 160,808 | 130,415 | 290,771 | 260,141 |
Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | 142,294 | 116,505 | 262,141 | 232,756 |
Research and development revenue | ||||
REVENUES: | ||||
Total revenues | $ 615 | $ 609 | 735 | $ 852 |
License revenue | ||||
REVENUES: | ||||
Total revenues | $ 1,500 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||||
Tax (benefit) provision | $ (79) | $ (174) | $ 409 | $ 87 | $ (253) | $ 496 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (20,054) | $ (68,085) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 38,119 | 40,946 |
Share-based compensation expense | 43,003 | 42,659 |
Deferred income taxes | 10,806 | 7,665 |
Change in the fair value of contingent consideration | (4,518) | (12,700) |
Loss on debt extinguishment | 171 | |
Other non-cash charges | 1,302 | 690 |
Changes in assets and liabilities: | ||
Receivables | (22,194) | 19,731 |
Contract assets | 5,607 | (854) |
Inventory | (11,232) | (13,782) |
Prepaid expenses and other assets | 2,029 | 7,645 |
Right-of-use assets | 8,595 | 8,594 |
Accounts payable and accrued expenses | (52,629) | (68,260) |
Contract liabilities | (3,108) | (2,364) |
Operating lease liabilities | (7,821) | (6,940) |
Other long-term liabilities | (159) | 351 |
Cash flows used in operating activities | (12,083) | (44,704) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (14,546) | (30,372) |
Proceeds from the sale of equipment | 177 | 5 |
Proceeds from contingent consideration | 7,889 | |
Payment made for licensed IP | (1,000) | |
Purchases of investments | (201,774) | (85,649) |
Sales and maturities of investments | 175,499 | 147,859 |
Cash flows (used in) provided by investing activities | (33,755) | 31,843 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 20,498 | 6,919 |
Employee taxes paid related to net share settlement of equity awards | (11,120) | (7,406) |
Proceeds from the issuance of long-term debt | 23,567 | |
Payment made for debt extinguishment | (977) | |
Principal payments of long-term debt | (750) | (1,421) |
Cash flows provided by (used in) financing activities | 31,218 | (1,908) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (14,620) | (14,769) |
CASH AND CASH EQUIVALENTS—Beginning of period | 272,961 | 203,771 |
CASH AND CASH EQUIVALENTS—End of period | 258,341 | 189,002 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 1,023 | $ 4,431 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Treasury Stock |
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 | 20,125 | 20,125 | ||||
Unrealized (loss) gain on marketable securities, net of tax (benefit) provision | 317 | 317 | ||||
Net income (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 (loss) gain on marketable securities, net of tax (benefit) provision | 1,715 | |||||
Net income (loss) | (68,085) | |||||
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) | ||||
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 purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (123) | $ (123) | ||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | 24,175 | (7,874) | ||||
Share-based compensation | 23,136 | 23,136 | ||||
Unrealized (loss) gain on marketable securities, net of tax (benefit) provision | 1,398 | 1,398 | ||||
Net income (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) | ||||
BALANCE at Dec. 31, 2020 | 1,066,982 | $ 1,620 | 2,685,647 | (1,349) | (1,492,849) | $ (126,087) |
BALANCE (in shares) at Dec. 31, 2020 | 162,269,220 | (3,108,079) | ||||
Issuance of ordinary shares under employee stock plans | 2,053 | $ 4 | 2,049 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 134,163 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (10,413) | $ 14 | (14) | $ (10,413) | ||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | 1,432,522 | (529,817) | ||||
Share-based compensation | 15,552 | 15,552 | ||||
Unrealized (loss) gain on marketable securities, net of tax (benefit) provision | (601) | (601) | ||||
Net income (loss) | (22,418) | (22,418) | ||||
BALANCE at Mar. 31, 2021 | 1,051,155 | $ 1,638 | 2,703,234 | (1,950) | (1,515,267) | $ (136,500) |
BALANCE (in shares) at Mar. 31, 2021 | 163,835,905 | (3,637,896) | ||||
BALANCE at Dec. 31, 2020 | 1,066,982 | $ 1,620 | 2,685,647 | (1,349) | (1,492,849) | $ (126,087) |
BALANCE (in shares) at Dec. 31, 2020 | 162,269,220 | (3,108,079) | ||||
Unrealized (loss) gain on marketable securities, net of tax (benefit) provision | (873) | |||||
Net income (loss) | (20,054) | |||||
BALANCE at Jun. 30, 2021 | 1,097,902 | $ 1,650 | 2,748,584 | (2,222) | (1,512,903) | $ (137,207) |
BALANCE (in shares) at Jun. 30, 2021 | 164,965,774 | (3,669,648) | ||||
BALANCE at Mar. 31, 2021 | 1,051,155 | $ 1,638 | 2,703,234 | (1,950) | (1,515,267) | $ (136,500) |
BALANCE (in shares) at Mar. 31, 2021 | 163,835,905 | (3,637,896) | ||||
Issuance of ordinary shares under employee stock plans | 18,445 | $ 11 | 18,434 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,035,941 | |||||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (707) | $ 1 | (1) | $ (707) | ||
Receipt of Alkermes' shares for the purchase of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | 93,928 | (31,752) | ||||
Share-based compensation | 26,917 | 26,917 | ||||
Unrealized (loss) gain on marketable securities, net of tax (benefit) provision | (272) | (272) | ||||
Net income (loss) | 2,364 | 2,364 | ||||
BALANCE at Jun. 30, 2021 | $ 1,097,902 | $ 1,650 | $ 2,748,584 | $ (2,222) | $ (1,512,903) | $ (137,207) |
BALANCE (in shares) at Jun. 30, 2021 | 164,965,774 | (3,669,648) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Parenthetical) (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement Of Stockholders Equity [Abstract] | ||||||
Tax provision (benefit) | $ (79) | $ (174) | $ 409 | $ 87 | $ (253) | $ 496 |
The Company
The Company | 6 Months Ended |
Jun. 30, 2021 | |
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 portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. 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 | 6 Months Ended |
Jun. 30, 2021 | |
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 six months ended June 30, 2021 and 2020 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2020. 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 Company’s 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 that management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an 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 the Company’s 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. Ireland, all U.S. states, and many local jurisdictions and countries around the world have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, restrictions, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and/or recommendations, and/or the perception that additional orders, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. The Company continues to closely monitor and respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact of the pandemic on the Company’s financial condition and operating results may differ from current projections. These uncertainties include, among others, the ultimate severity and duration of the pandemic; the emergence and prevalence of COVID-19 variants; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of the pandemic on the Company’s employees, the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder; 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 Irish, U.S. and global economies more broadly. In addition, 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 its proprietary marketed products and the marketed products of its licensees 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 business closures, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees during the pandemic and may continue to be adversely impacted while the pandemic persists. The Company has continued to operate its manufacturing facilities and supply its medicines throughout the pandemic. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has, at times, impacted the timelines of certain of the Company’s early-stage discovery efforts and clinical trials, and may continue to impact such timelines while the pandemic persists. The Company works with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impacts of COVID-19 on its manufacturing operations and R&D activities. New Accounting Pronouncements 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 March 2020, the FASB issued Accounting Standards Update (“ Reference Rate Reform |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS Under FASB Accounting Standards Codification 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 six months ended June 30, 2021 and 2020, the Company recorded product sales, net, as follows: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2021 2020 2021 2020 VIVITROL $ 88,417 $ 71,646 $ 162,951 $ 150,415 ARISTADA and ARISTADA INITIO 72,391 58,769 127,820 109,726 Total product sales, net $ 160,808 $ 130,415 $ 290,771 $ 260,141 Manufacturing and Royalty Revenues During the three and six months ended June 30, 2021 and 2020, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 81,072 $ 81,072 $ — $ 142,642 $ 142,642 VUMERITY 6,724 13,624 20,348 9,172 24,616 33,788 RISPERDAL CONSTA 12,003 2,448 14,451 22,686 5,927 28,613 AMPYRA/FAMPYRA 7,549 5,767 13,316 15,627 12,361 27,988 Other 3,017 10,090 13,107 6,893 22,217 29,110 $ 29,293 $ 113,001 $ 142,294 $ 54,378 $ 207,763 $ 262,141 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 69,385 $ 69,385 $ — $ 124,312 $ 124,312 VUMERITY 1,305 1,289 2,594 2,632 1,654 4,286 RISPERDAL CONSTA 10,193 3,536 13,729 33,776 7,269 41,045 AMPYRA/FAMPYRA 7,154 5,354 12,508 14,976 12,501 27,477 Other 6,689 11,600 18,289 14,168 21,468 35,636 $ 25,341 $ 91,164 $ 116,505 $ 65,552 $ 167,204 $ 232,756 Contract assets include unbilled amounts under certain of the Company’s contracts with customers where revenue is recognized over time. Total contract assets at June 30, 2021 included $8.8 million of assets that were classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they related to manufacturing processes that are completed in ten days to eight weeks Total contract assets at June 30, 2021 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2020 $ 19,401 Additions 18,152 Transferred to receivables, net (23,760 ) Contract assets at June 30, 2021 $ 13,793 Contract Liabilities Contract liabilities consist of contractual obligations related to deferred revenue. Total contract liabilities at June 30, 2021 (In thousands) Contract Liabilities Contract liabilities at December 31, 2020 $ 23,909 Additions — Amounts recognized into revenue (3,108 ) Contract liabilities at June 30, 2021 $ 20,801 |
Investments
Investments | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 136,404 $ 570 $ (16 ) $ — $ — $ 136,958 International government agency debt securities 72,982 190 (5 ) — — 73,167 U.S. government and agency debt securities 67,868 139 — — — 68,007 277,254 899 (21 ) — — 278,132 Held-to-maturity securities: Fixed term deposit account 1,667 205 — — — 1,872 Total short-term investments 278,921 1,104 (21 ) — — 280,004 Long-term investments: Available-for-sale securities: Corporate debt securities 52,638 — (46 ) — — 52,592 International government agency debt securities 30,877 — (46 ) — — 30,831 U.S. government and agency debt securities 45,831 — (42 ) — — 45,789 129,346 — (134 ) — — 129,212 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 131,166 — (134 ) — — 131,032 Total investments $ 410,087 $ 1,104 $ (155 ) $ — $ — $ 411,036 December 31, 2020 Short-term investments: Available-for-sale securities: Corporate debt securities $ 176,937 $ 1,105 $ (7 ) $ — $ (977 ) $ 177,058 U.S. government and agency debt securities 103,011 336 (2 ) — — 103,345 International government agency debt securities 79,346 469 (6 ) — — 79,809 359,294 1,910 (15 ) — (977 ) 360,212 Held-to-maturity securities: Fixed term deposit account 1,667 187 — — — 1,854 Total short-term investments 360,961 2,097 (15 ) — (977 ) 362,066 Long-term investments: Available-for-sale securities: Corporate debt securities 7,908 — (10 ) — — 7,898 International government agency debt securities 15,077 — (15 ) — — 15,062 22,985 — (25 ) — — 22,960 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 24,805 — (25 ) — — 24,780 Total investments $ 385,766 $ 2,097 $ (40 ) $ — $ (977 ) $ 386,846 At June 30, 2021, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were other-than-temporary. Investments with unrealized losses consisted primarily of corporate debt securities and debt securities issued by non-U.S. agencies and backed by non-U.S. governments. In making the determination whether the decline in fair value of these securities was other-than-temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. If the Company intends to sell a security, or it is more likely than not that the Company would be required to sell a security prior to recovering its amortized cost basis, an other-than-temporary impairment is deemed to have occurred. The amount of an other-than-temporary impairment related to a credit loss, or investments that the Company intends to sell before recovery, is recognized in earnings. In September 2019, the Company purchased a convertible promissory note in the principal amount of $1.9 million from Synchronicity Pharma, Inc., a related party. The note was classified as an available-for-sale corporate debt instrument. In September 2020, the Company recorded an other-than-temporary credit loss of $1.0 million against the value of this investment. During the three months ended June 30, 2021, the Company determined that the remaining $0.9 million value of the investment was impaired and recorded an additional other-than-temporary credit loss. The loss was recorded within “Other (expense) income, net” in the accompanying condensed consolidated statements of operations and comprehensive income (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 June 30, 2021, the Company had invested €7.2 million in Fountain. The Company is accounting for its investment in Fountain under the equity method. The Company’s net investment in Fountain was $5.9 million and $6.2 million at June 30, 2021 and December 31, 2020, 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: Six Months Ended June 30, (In thousands) 2021 2020 Proceeds from the sales and maturities of marketable securities $ 175,499 $ 147,859 Realized gains $ — $ 51 Realized losses $ 977 $ — The Company’s available-for-sale and held-to-maturity securities at June 30, 2021 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 $ 194,815 $ 195,149 $ 3,487 $ 3,692 After 1 year through 5 years 211,785 212,195 — — Total $ 406,600 $ 407,344 $ 3,487 $ 3,692 |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 5. FAIR VALUE The following table presents information about the Company’s assets and liabilities at June 30, 2021 and December 31, 2020 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: June 30, (In thousands) 2021 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,872 $ 1,872 $ — $ — U.S. government and agency debt securities 113,796 76,337 37,459 — Corporate debt securities 189,550 — 189,550 — International government agency debt securities 103,998 — 103,998 — Contingent consideration 29,061 — — 29,061 Total $ 438,277 $ 78,209 $ 331,007 $ 29,061 December 31, 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 41,849 $ 41,849 $ — $ — U.S. government and agency debt securities 103,345 73,451 29,894 — Corporate debt securities 184,956 — 183,979 977 International government agency debt securities 94,871 — 94,871 — Contingent consideration 32,451 — — 32,451 Total $ 457,472 $ 115,300 $ 308,744 $ 33,428 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 six months ended June 30, 2021. 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 June 30, 2021: (In thousands) Fair Value Balance, January 1, 2021 $ 33,428 Change in the fair value of contingent consideration 4,518 Milestone and royalty payments received by the Company related to contingent consideration (7,889 ) Impairment of corporate debt security (977 ) Royalty payments due to the Company related to contingent consideration (19 ) Balance, June 30, 2021 $ 29,061 The Company’s investments in U.S. government and agency debt securities, international government agency debt securities and corporate debt securities classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. In April 2015, the Company sold its Gainesville, GA manufacturing facility, the manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to IV/IM and parenteral forms of Meloxicam to Recro Pharma, Inc. (“Recro”) and Recro Gainesville LLC (such transaction, the “Gainesville Transaction”). The Gainesville Transaction included in the purchase price contingent consideration tied to low double digit royalties on net sales of the IV/IM and parenteral forms of Meloxicam and any other product with the same active ingredient as Meloxicam IV/IM that is discovered or identified using certain of the Company’s IP to which Recro was provided a right of use, through license or transfer, pursuant to the Gainesville Transaction (such products, the “Meloxicam Products”), and milestone payments upon the achievement of certain regulatory and sales milestones related to the Meloxicam Products. In November 2019, Recro spun out its acute care segment to Baudax Bio, Inc. (“ Baudax ”), a publicly-traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay the Company certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax . In Baudax’s Quarterly Report on Form 10-Q for the period ended March 31, 2021, Baudax included disclosures regarding its ability to continue as a going concern. At June 30, 2021, the Company determined the fair value of the contingent consideration due to the Company from Baudax as follows: • The Company is due to receive $38.6 million related to the FDA approval in February 2020 of the New Drug Application (“NDA”) for ANJESO, the first Meloxicam Product, to be paid in six equal, annual installments on the anniversary of such approval; • The Company is entitled to receive royalties on future net sales of Meloxicam Products; and • The Company is entitled to receive payments of up to $80.0 million upon achieving certain sales milestones on future net sales of Meloxicam Products. The fair value of the sales milestones was determined through the use of a real options approach, where net sales are simulated in a risk-neutral world. To employ this methodology, the Company used a risk-adjusted expected growth rate based on its assessments of expected growth in net sales of ANJESO, adjusted by an appropriate factor capturing their respective correlation with the market. In order to address the substantial doubt about Baudax’s ability to continue as a going concern, the Company split its fair value analysis into two scenarios. In the first scenario, to which the Company applied a 55% and 50% likelihood at June 30, 2021 and December 31, 2020, respectively, the amounts above were discounted using a rate of 13 18 At June 30, 2021 and December 31, 2020, the Company determined that the fair value of the contingent consideration related to the Gainesville Transaction was $29.1 million and $32.5 million, respectively. At June 30, 2021 and December 31, 2020, $6.5 million and $7.8 million, respectively, of the fair value of the contingent consideration was included within “Prepaid expenses and other current assets” in the accompanying condensed consolidated balance sheets, and $22.6 million and $24.7 million, respectively, of the fair value of the contingent consideration was included within “Contingent consideration” in the accompanying condensed consolidated balance sheets. The Company recorded an increase of $3.2 million and $4.5 million during the three and six months ended June 30, 2021, respectively, and an increase of $5.9 million and $12.7 million during the three and six months ended June 30, 2020, respectively, within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive income (loss). The carrying amounts reflected in the accompanying condensed 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, 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 $297.8 million and $275.1 million at June 30, 2021 and December 31, 2020, respectively. See Note 11, Long-Term Debt |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
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: June 30, December 31, (In thousands) 2021 2020 Raw materials $ 50,650 $ 44,944 Work in process 51,394 53,243 Finished goods ( 1) 34,033 27,551 Total inventory $ 136,077 $ 125,738 (1) At June 30, 2021 and December 31, 2020, the Company had $25.3 million and $26.5 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. At June 30, 2021 and December 31, 2020, the carrying value of inventory included $14.5 million and $13.8 million, respectively, associated with LYBALVI, which was capitalized in advance of validation of LYBALVI’s manufacturing line. |
Property, Plant and Equipment
Property, Plant and Equipment | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | 7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consisted of the following: June 30, December 31, (In thousands) 2021 2020 Land $ 6,560 $ 6,560 Building and improvements 179,387 178,194 Furniture, fixtures and equipment 371,787 366,051 Leasehold improvements 53,027 52,508 Construction in progress 108,034 102,833 Subtotal 718,795 706,146 Less: accumulated depreciation (374,846 ) (356,143 ) Total property, plant and equipment, net $ 343,949 $ 350,003 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consisted of the following: June 30, 2021 (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 $ (392,249 ) $ 73,341 Capitalized IP 11-13 118,160 (98,227 ) 19,933 Total $ 583,750 $ (490,476 ) $ 93,274 Based on the Company’s most recent analysis, amortization of intangible assets included within the Company’s condensed consolidated balance sheet at June 30, 2021 is expected to be approximately $40.0 million, $35.0 million, $35.0 million, $1.0 million and less than $0.1 million in the years ending December 31, 2021 through 2025, respectively. Given the assumptions and inherent risks and uncertainties underlying the Company’s expectations regarding future revenues, the Company’s actual results may vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the projected change in revenues. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | 9. LEASES Future lease payments under non-cancelable leases at June 30, 2021 and December 31, 2020 consisted of the following: June 30, December 31, (In thousands) 2021 2020 2021 $ 8,793 $ 16,882 2022 17,001 17,001 2023 17,266 17,266 2024 17,536 17,536 2025 17,810 17,810 Thereafter 109,002 109,311 Total operating lease payments $ 187,408 $ 195,806 Less: imputed interest (59,897 ) (60,610 ) Total operating lease liabilities $ 127,511 $ 135,196 At June 30, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.26% and 12.2 years, respectively. During the three and six months ended June 30, 2021, cash paid for lease liabilities was $4.4 million and $8.1 million, respectively, as compared to $4.5 million and $6.9 million, respectively, during the three and six months ended June 30, 2020. The Company recorded operating lease expense of $4.4 million and $8.6 million during the three and six months ended June 30, 2021, respectively, as compared to $4.7 million and $8.6 million during the three and six months ended June 30, 2020, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following: June 30, December 31, (In thousands) 2021 2020 Accounts payable $ 32,798 $ 46,034 Accrued compensation 52,560 71,178 Accrued sales discounts, allowances and reserves 204,556 218,877 Accrued other 68,047 76,082 Total accounts payable and accrued expenses $ 357,961 $ 412,171 |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: June 30, December 31, (In thousands) 2021 2020 2026 Term Loans, due March 12, 2026 $ 297,070 $ — 2023 Term Loans, due March 26, 2023 — 274,961 Less: current portion (3,000 ) (2,843 ) Long-term debt $ 294,070 $ 272,118 In March 2021, the Company amended and refinanced its existing term loans, previously referred to as the 2023 Term Loans, in order to, among other things, provide for a new class of replacement term loans equal to $300.0 million; extend the due date from March 26, 2023 to March 12, 2026; amend the interest payable from LIBOR plus 2.25% with no LIBOR floor to LIBOR plus 2.50% with a LIBOR floor of 0.50%; and increase covenant flexibility (such refinancing, the “Term Loan Refinancing” and the 2023 Term Loans as so amended and refinanced the “2026 Term Loans”). Under the 2026 Term Loans, the Company is subject to mandatory prepayments of principal if certain excess cash flow thresholds, as defined in the 2026 Term Loans, are met. To date, the Company has not been required to make any such mandatory prepayments. The 2026 Term Loans have an incremental facility capacity in the amount of $ 175.0 million plus potential additional amounts , as long as the Company meets certain conditions, including a specified leverage ratio. The 2026 Term Loans include a number of restrictive covenants that, among other things and subject to certain exceptions and baskets, impose operating and financial restrictions on the Company and certain of its subsidiaries. The 2026 Term Loans also contain customary affirmative covenants and events of default. At June 30, 2021, t he Company was in compliance with its debt covenants under the 2026 Term Loans . The Term Loan Refinancing involved multiple lenders who were considered members of a loan syndicate. In determining whether the Term Loan Refinancing should be accounted for as a debt extinguishment or a debt modification, the Company considered whether, prior to and following the Term Loan Refinancing, creditors remained the same or changed, and whether the changes in debt terms were substantial. A change in the debt terms was considered to be substantial if the present value of the remaining cash flows under the 2026 Term Loans were at least 10% different from the present value of the remaining cash flows under the 2023 Term Loans (commonly referred to as the “10% Test”). The Company performed a separate 10% Test for each individual creditor participating in the loan syndication. With the exception of three lenders with respective holdings ranging from 2%-7% of the total outstanding principal amount of the 2023 Term Loans immediately prior to the Term Loan Refinancing whose holding amounts were accounted for as a debt extinguishment, the Term Loan Refinancing was otherwise accounted for as a debt modification. The Term Loan Refinancing resulted in a $2.1 million charge in March 2021, which was included in “Interest expense” in the accompanying condensed consolidated statement of operations and comprehensive income (loss). |
Share-based Compensation
Share-based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
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 income (loss): Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Cost of goods manufactured and sold $ 2,683 $ 2,015 $ 4,861 $ 3,980 Research and development 7,131 6,478 11,194 12,638 Selling, general and administrative 17,738 14,353 26,948 26,041 Total share-based compensation expense $ 27,552 $ 22,846 $ 43,003 $ 42,659 At June 30, 2021 and December 31, 2020, $2.0 million and $2.6 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets. On June 14, 2021, the Company’s shareholders approved amendments to the Alkermes plc 2018 Stock Option and Incentive Plan that served to, among other things, increase the number of ordinary shares authorized for issuance thereunder by 8,000,000. |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share | 13. EARNINGS (LOSS) PER SHARE Basic earnings (loss) per ordinary share is calculated based upon net income (loss) available to holders of ordinary shares divided by the weighted average number of shares outstanding. For the calculation of diluted earnings (loss) per ordinary share, the Company uses the weighted average number of ordinary shares outstanding, as adjusted for the effect of potential outstanding shares, including stock options and restricted stock unit awards. Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Numerator: Net income (loss) $ 2,364 $ (29,431 ) $ (20,054 ) $ (68,085 ) Denominator: Weighted average number of ordinary shares outstanding 160,817 158,895 160,229 158,495 Effect of dilutive securities: Stock options 461 — — — Restricted stock units 2,659 — — — Dilutive ordinary share equivalents 3,120 — — — Shares used in calculating diluted earnings (loss) per share 163,937 158,895 160,229 158,495 The following potential ordinary share equivalents have not been included in the net earnings (loss) per ordinary share calculations because the effect would have been anti-dilutive: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Stock options 15,465 16,882 15,265 15,375 Restricted stock unit awards 596 4,683 3,189 4,226 Total 16,061 21,565 18,454 19,601 |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 14. COMMITMENTS AND CONTINGENT LIABILITIES Litigation From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At June 30, 2021, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. INVEGA SUSTENNA ANDA Litigation Janssen Pharmaceuticals NV and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals Inc. (“Mylan”), and Mylan Institutional LLC and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC, following the respective filings by each of Teva, Mylan Labs, and Pharmascience of an Abbreviated New Drug Application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. In October 2020, a trial was held in the lawsuit between the Janssen entities and the Teva entities and closing arguments for such trial were heard in March 2021. Requested judicial remedies in each of the lawsuits include 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 in November 2019 and Nanjing Luye Pharmaceutical Co., Ltd. and Teva PI submitted replies in December 2019. The Company will continue to vigorously defend the EP ’577 Patent. VIVITROL ANDA Litigation In September 2020, Alkermes, Inc. and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the NJ District Court against Teva and Teva PI following the filing by Teva of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VIVITROL (naltrexone for extended-release injectable suspension) before the expiration of the Company’s U.S. Patent No. 7,919,499. Teva filed its answer in November 2020, which included counterclaims against the Company. The Company filed its reply to Teva’s counterclaims in December 2020. The Company intends to vigorously defend its IP. 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”). VUMERITY ANDA Litigation On March 17, 2021, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals Development Inc. (“Teva PD”) following the filing by Teva PD of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) before the expiration of the Company’s U.S. Patent Nos. 8,669,281, 9,090,558 and 10,080,733. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the Hatch-Waxman Act. On May 17, 2021, Teva PD filed its answer and counterclaims, and on June 7, 2021, the plaintiffs filed their answer to Teva PD’s counterclaims. Government Matters The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations. Securities Litigation In December 2018 and January 2019, purported stockholders of the Company filed putative class actions against the Company and certain of its officers in the U.S. District Court for the Eastern District of New York (the “EDNY District Court”) captioned Karimian v. Alkermes plc, et al., No. 1:18-cv-07410 and McDermott v. Alkermes plc, et al., No. 1:19-cv-00624 In re Alkermes Public Limited Co. Securities Litig., No. 21-801 Product Liability and Other Legal Proceedings The Company is involved in litigation 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. The outcome of these proceedings cannot be accurately predicted. 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) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three and six months ended June 30, 2021 and 2020 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2020. 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 Company’s 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 that management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an 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 the Company’s 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. Ireland, all U.S. states, and many local jurisdictions and countries around the world have, at times during the pandemic, issued “shelter-in-place” orders, quarantines, executive orders and similar government orders, restrictions, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and/or recommendations, and/or the perception that additional orders, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects. The Company continues to closely monitor and respond to the ongoing impact of COVID-19 on its employees, communities and business operations. Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact of the pandemic on the Company’s financial condition and operating results may differ from current projections. These uncertainties include, among others, the ultimate severity and duration of the pandemic; the emergence and prevalence of COVID-19 variants; governmental, business or other actions that have been, are being or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions, and imposition of social distancing measures; impacts of the pandemic on the Company’s employees, the vendors or distribution channels in the Company’s supply chain and on the Company’s ability to continue to manufacture its products; impacts of the pandemic on the conduct of the Company’s clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder; 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 Irish, U.S. and global economies more broadly. In addition, 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 its proprietary marketed products and the marketed products of its licensees 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 business closures, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees during the pandemic and may continue to be adversely impacted while the pandemic persists. The Company has continued to operate its manufacturing facilities and supply its medicines throughout the pandemic. While the Company continues to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has, at times, impacted the timelines of certain of the Company’s early-stage discovery efforts and clinical trials, and may continue to impact such timelines while the pandemic persists. The Company works with its internal teams, its clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, any potential adverse impacts of COVID-19 on its manufacturing operations and R&D activities. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the 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 March 2020, the FASB issued Accounting Standards Update (“ Reference Rate Reform |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Schedule of Contract Assets and Contract Liabilities | Total contract assets at June 30, 2021 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2020 $ 19,401 Additions 18,152 Transferred to receivables, net (23,760 ) Contract assets at June 30, 2021 $ 13,793 Total contract liabilities at June 30, 2021 (In thousands) Contract Liabilities Contract liabilities at December 31, 2020 $ 23,909 Additions — Amounts recognized into revenue (3,108 ) Contract liabilities at June 30, 2021 $ 20,801 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three and six months ended June 30, 2021 and 2020, the Company recorded product sales, net, as follows: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2021 2020 2021 2020 VIVITROL $ 88,417 $ 71,646 $ 162,951 $ 150,415 ARISTADA and ARISTADA INITIO 72,391 58,769 127,820 109,726 Total product sales, net $ 160,808 $ 130,415 $ 290,771 $ 260,141 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three and six months ended June 30, 2021 and 2020, the Company recorded manufacturing and royalty revenues as follows: Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 81,072 $ 81,072 $ — $ 142,642 $ 142,642 VUMERITY 6,724 13,624 20,348 9,172 24,616 33,788 RISPERDAL CONSTA 12,003 2,448 14,451 22,686 5,927 28,613 AMPYRA/FAMPYRA 7,549 5,767 13,316 15,627 12,361 27,988 Other 3,017 10,090 13,107 6,893 22,217 29,110 $ 29,293 $ 113,001 $ 142,294 $ 54,378 $ 207,763 $ 262,141 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 (In thousands) Manufacturing Revenue Royalty Revenue Total Manufacturing Revenue Royalty Revenue Total INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA $ — $ 69,385 $ 69,385 $ — $ 124,312 $ 124,312 VUMERITY 1,305 1,289 2,594 2,632 1,654 4,286 RISPERDAL CONSTA 10,193 3,536 13,729 33,776 7,269 41,045 AMPYRA/FAMPYRA 7,154 5,354 12,508 14,976 12,501 27,477 Other 6,689 11,600 18,289 14,168 21,468 35,636 $ 25,341 $ 91,164 $ 116,505 $ 65,552 $ 167,204 $ 232,756 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 Cost Gains One Year One Year Credit Losses Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 136,404 $ 570 $ (16 ) $ — $ — $ 136,958 International government agency debt securities 72,982 190 (5 ) — — 73,167 U.S. government and agency debt securities 67,868 139 — — — 68,007 277,254 899 (21 ) — — 278,132 Held-to-maturity securities: Fixed term deposit account 1,667 205 — — — 1,872 Total short-term investments 278,921 1,104 (21 ) — — 280,004 Long-term investments: Available-for-sale securities: Corporate debt securities 52,638 — (46 ) — — 52,592 International government agency debt securities 30,877 — (46 ) — — 30,831 U.S. government and agency debt securities 45,831 — (42 ) — — 45,789 129,346 — (134 ) — — 129,212 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 131,166 — (134 ) — — 131,032 Total investments $ 410,087 $ 1,104 $ (155 ) $ — $ — $ 411,036 December 31, 2020 Short-term investments: Available-for-sale securities: Corporate debt securities $ 176,937 $ 1,105 $ (7 ) $ — $ (977 ) $ 177,058 U.S. government and agency debt securities 103,011 336 (2 ) — — 103,345 International government agency debt securities 79,346 469 (6 ) — — 79,809 359,294 1,910 (15 ) — (977 ) 360,212 Held-to-maturity securities: Fixed term deposit account 1,667 187 — — — 1,854 Total short-term investments 360,961 2,097 (15 ) — (977 ) 362,066 Long-term investments: Available-for-sale securities: Corporate debt securities 7,908 — (10 ) — — 7,898 International government agency debt securities 15,077 — (15 ) — — 15,062 22,985 — (25 ) — — 22,960 Held-to-maturity securities: Certificates of deposit 1,820 — — — — 1,820 Total long-term investments 24,805 — (25 ) — — 24,780 Total investments $ 385,766 $ 2,097 $ (40 ) $ — $ (977 ) $ 386,846 |
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: Six Months Ended June 30, (In thousands) 2021 2020 Proceeds from the sales and maturities of marketable securities $ 175,499 $ 147,859 Realized gains $ — $ 51 Realized losses $ 977 $ — |
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 June 30, 2021 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 $ 194,815 $ 195,149 $ 3,487 $ 3,692 After 1 year through 5 years 211,785 212,195 — — Total $ 406,600 $ 407,344 $ 3,487 $ 3,692 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 and December 31, 2020 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: June 30, (In thousands) 2021 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,872 $ 1,872 $ — $ — U.S. government and agency debt securities 113,796 76,337 37,459 — Corporate debt securities 189,550 — 189,550 — International government agency debt securities 103,998 — 103,998 — Contingent consideration 29,061 — — 29,061 Total $ 438,277 $ 78,209 $ 331,007 $ 29,061 December 31, 2020 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 41,849 $ 41,849 $ — $ — U.S. government and agency debt securities 103,345 73,451 29,894 — Corporate debt securities 184,956 — 183,979 977 International government agency debt securities 94,871 — 94,871 — Contingent consideration 32,451 — — 32,451 Total $ 457,472 $ 115,300 $ 308,744 $ 33,428 |
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 June 30, 2021: (In thousands) Fair Value Balance, January 1, 2021 $ 33,428 Change in the fair value of contingent consideration 4,518 Milestone and royalty payments received by the Company related to contingent consideration (7,889 ) Impairment of corporate debt security (977 ) Royalty payments due to the Company related to contingent consideration (19 ) Balance, June 30, 2021 $ 29,061 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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: June 30, December 31, (In thousands) 2021 2020 Raw materials $ 50,650 $ 44,944 Work in process 51,394 53,243 Finished goods ( 1) 34,033 27,551 Total inventory $ 136,077 $ 125,738 (1) At June 30, 2021 and December 31, 2020, the Company had $25.3 million and $26.5 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) | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following: June 30, December 31, (In thousands) 2021 2020 Land $ 6,560 $ 6,560 Building and improvements 179,387 178,194 Furniture, fixtures and equipment 371,787 366,051 Leasehold improvements 53,027 52,508 Construction in progress 108,034 102,833 Subtotal 718,795 706,146 Less: accumulated depreciation (374,846 ) (356,143 ) Total property, plant and equipment, net $ 343,949 $ 350,003 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: June 30, 2021 (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 $ (392,249 ) $ 73,341 Capitalized IP 11-13 118,160 (98,227 ) 19,933 Total $ 583,750 $ (490,476 ) $ 93,274 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases at June 30, 2021 and December 31, 2020 consisted of the following: June 30, December 31, (In thousands) 2021 2020 2021 $ 8,793 $ 16,882 2022 17,001 17,001 2023 17,266 17,266 2024 17,536 17,536 2025 17,810 17,810 Thereafter 109,002 109,311 Total operating lease payments $ 187,408 $ 195,806 Less: imputed interest (59,897 ) (60,610 ) Total operating lease liabilities $ 127,511 $ 135,196 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: June 30, December 31, (In thousands) 2021 2020 Accounts payable $ 32,798 $ 46,034 Accrued compensation 52,560 71,178 Accrued sales discounts, allowances and reserves 204,556 218,877 Accrued other 68,047 76,082 Total accounts payable and accrued expenses $ 357,961 $ 412,171 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: June 30, December 31, (In thousands) 2021 2020 2026 Term Loans, due March 12, 2026 $ 297,070 $ — 2023 Term Loans, due March 26, 2023 — 274,961 Less: current portion (3,000 ) (2,843 ) Long-term debt $ 294,070 $ 272,118 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 income (loss): Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Cost of goods manufactured and sold $ 2,683 $ 2,015 $ 4,861 $ 3,980 Research and development 7,131 6,478 11,194 12,638 Selling, general and administrative 17,738 14,353 26,948 26,041 Total share-based compensation expense $ 27,552 $ 22,846 $ 43,003 $ 42,659 |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Basic Earnings (loss) Per Ordinary Share | Basic earnings (loss) per ordinary share is calculated based upon net income (loss) available to holders of ordinary shares divided by the weighted average number of shares outstanding. For the calculation of diluted earnings (loss) per ordinary share, the Company uses the weighted average number of ordinary shares outstanding, as adjusted for the effect of potential outstanding shares, including stock options and restricted stock unit awards. Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Numerator: Net income (loss) $ 2,364 $ (29,431 ) $ (20,054 ) $ (68,085 ) Denominator: Weighted average number of ordinary shares outstanding 160,817 158,895 160,229 158,495 Effect of dilutive securities: Stock options 461 — — — Restricted stock units 2,659 — — — Dilutive ordinary share equivalents 3,120 — — — Shares used in calculating diluted earnings (loss) per share 163,937 158,895 160,229 158,495 |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net Earnings (Loss) Per Share | The following potential ordinary share equivalents have not been included in the net earnings (loss) per ordinary share calculations because the effect would have been anti-dilutive: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2021 2020 2021 2020 Stock options 15,465 16,882 15,265 15,375 Restricted stock unit awards 596 4,683 3,189 4,226 Total 16,061 21,565 18,454 19,601 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2021segment | |
Accounting Policies [Abstract] | |
Number of business segments | 1 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 303,717 | $ 247,529 | $ 555,147 | $ 493,749 |
VIVITROL | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 88,417 | 71,646 | 162,951 | 150,415 |
ARISTADA and ARISTADA INITIO | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 72,391 | 58,769 | 127,820 | 109,726 |
Product sales, net | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 160,808 | $ 130,415 | $ 290,771 | $ 260,141 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 303,717 | $ 247,529 | $ 555,147 | $ 493,749 |
Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 29,293 | 25,341 | 54,378 | 65,552 |
Manufacturing Revenue | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 6,724 | 1,305 | 9,172 | 2,632 |
Manufacturing Revenue | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 12,003 | 10,193 | 22,686 | 33,776 |
Manufacturing Revenue | AMPYRA/FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 7,549 | 7,154 | 15,627 | 14,976 |
Manufacturing Revenue | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 3,017 | 6,689 | 6,893 | 14,168 |
Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 113,001 | 91,164 | 207,763 | 167,204 |
Royalty | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 81,072 | 69,385 | 142,642 | 124,312 |
Royalty | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 13,624 | 1,289 | 24,616 | 1,654 |
Royalty | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 2,448 | 3,536 | 5,927 | 7,269 |
Royalty | AMPYRA/FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 5,767 | 5,354 | 12,361 | 12,501 |
Royalty | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 10,090 | 11,600 | 22,217 | 21,468 |
Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 142,294 | 116,505 | 262,141 | 232,756 |
Manufacturing and royalty revenues | INVEGA SUSTENNA/XEPLION & INVEGA TRINZA/TREVICTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 81,072 | 69,385 | 142,642 | 124,312 |
Manufacturing and royalty revenues | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 20,348 | 2,594 | 33,788 | 4,286 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 14,451 | 13,729 | 28,613 | 41,045 |
Manufacturing and royalty revenues | AMPYRA/FAMPYRA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 13,316 | 12,508 | 27,988 | 27,477 |
Manufacturing and royalty revenues | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 13,107 | $ 18,289 | $ 29,110 | $ 35,636 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Contract asset, current | $ 8,793 | $ 14,401 |
VUMERITY | Biogen | Other Assets | ||
Disaggregation Of Revenue [Line Items] | ||
Contract asset, non-current | $ 5,000 | |
Minimum | ||
Disaggregation Of Revenue [Line Items] | ||
Manufacturing Process period | 10 days | |
Maximum | ||
Disaggregation Of Revenue [Line Items] | ||
Manufacturing Process period | 56 days | |
Consideration expects to receive | 2 years |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Contract Assets and Contract Liabilities (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 19,401 |
Additions | 18,152 |
Transferred to receivables, net | (23,760) |
Contract assets at end of period | 13,793 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 23,909 |
Amounts recognized into revenue | (3,108) |
Contract liabilities at end of the period | $ 20,801 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Available-for-sale securities: | ||
Amortized Cost | $ 406,600 | |
Estimated Fair Value | 407,344 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 3,692 | |
Long-term Investments | ||
Amortized Cost | 131,166 | $ 24,805 |
Gross Unrealized Losses, Less than One Year | (134) | (25) |
Total long-term investments | 131,032 | 24,780 |
Total investments | ||
Amortized Cost | 410,087 | 385,766 |
Gross Unrealized Gains | 1,104 | 2,097 |
Gross Unrealized Losses, Less than One Year | (155) | (40) |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 411,036 | 386,846 |
Short-term Investments | ||
Amortized Cost | 278,921 | 360,961 |
Gross Unrealized Gains | 1,104 | 2,097 |
Gross Unrealized Losses, Less than One Year | (21) | (15) |
Allowance for Credit Losses | (977) | |
Total short-term investments | 280,004 | 362,066 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 277,254 | 359,294 |
Gross Unrealized Gains | 899 | 1,910 |
Gross Unrealized Losses, Less than One Year | (21) | (15) |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 278,132 | 360,212 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 136,404 | 176,937 |
Gross Unrealized Gains | 570 | 1,105 |
Gross Unrealized Losses, Less than One Year | (16) | (7) |
Allowance for Credit Losses | (977) | |
Estimated Fair Value | 136,958 | 177,058 |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 67,868 | 103,011 |
Gross Unrealized Gains | 139 | 336 |
Gross Unrealized Losses, Less than One Year | (2) | |
Estimated Fair Value | 68,007 | 103,345 |
Short-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 72,982 | 79,346 |
Gross Unrealized Gains | 190 | 469 |
Gross Unrealized Losses, Less than One Year | (5) | (6) |
Estimated Fair Value | 73,167 | 79,809 |
Short-term investments | Fixed Term Deposit Account | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,667 | 1,667 |
Gross Unrealized Gains | 205 | 187 |
Estimated Fair Value | 1,872 | 1,854 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 129,346 | 22,985 |
Gross Unrealized Losses, Less than One Year | (134) | (25) |
Estimated Fair Value | 129,212 | 22,960 |
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 | 52,638 | 7,908 |
Gross Unrealized Losses, Less than One Year | (46) | (10) |
Estimated Fair Value | 52,592 | 7,898 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 45,831 | |
Gross Unrealized Losses, Less than One Year | (42) | |
Estimated Fair Value | 45,789 | |
Long-term investments | International government agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 30,877 | 15,077 |
Gross Unrealized Losses, Less than One Year | (46) | (15) |
Estimated Fair Value | $ 30,831 | $ 15,062 |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Millions | 1 Months Ended | 3 Months Ended | ||||
Sep. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2021EUR (€) | Dec. 31, 2020USD ($) | Sep. 30, 2019USD ($) | May 31, 2014EUR (€) | |
Synchronicity Pharma Inc | Investee | Other (Expense) Income, Net | ||||||
Investment Holdings [Line Items] | ||||||
Other-than-temporary impairment charge | $ 1 | $ 0.9 | ||||
Synchronicity Pharma Inc | Convertible Promissory Notes | Investee | ||||||
Investment Holdings [Line Items] | ||||||
Purchase of convertible promissory notes | $ 1.9 | |||||
Fountain Healthcare Partners II | ||||||
Investment Holdings [Line Items] | ||||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | ||||
Equity method commitment | € | € 7,200,000 | |||||
Fountain Healthcare Partners II | Other Assets | ||||||
Investment Holdings [Line Items] | ||||||
Carrying value of equity investment | $ 5.9 | $ 6.2 | ||||
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 | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | ||
Proceeds from the sales and maturities of marketable securities | $ 175,499 | $ 147,859 |
Realized gains | $ 51 | |
Realized losses | $ 977 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 194,815 |
After 1 year through 5 years | 211,785 |
Amortized Cost | 406,600 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 195,149 |
After 1 year through 5 years | 212,195 |
Total | 407,344 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 3,487 |
Total | 3,487 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 3,692 |
Total | $ 3,692 |
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 | Jun. 30, 2021 | Dec. 31, 2020 |
Fair value | ||
Debt securities | $ 407,344 | |
Contingent consideration | 29,100 | $ 32,500 |
Recurring Basis | ||
Fair value | ||
Cash equivalents | 1,872 | 41,849 |
Contingent consideration | 29,061 | 32,451 |
Assets, Total | 438,277 | 457,472 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 1,872 | 41,849 |
Assets, Total | 78,209 | 115,300 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 331,007 | 308,744 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 29,061 | 32,451 |
Assets, Total | 29,061 | 33,428 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 113,796 | 103,345 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 76,337 | 73,451 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 37,459 | 29,894 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 189,550 | 184,956 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 189,550 | 183,979 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 977 | |
International government agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 103,998 | 94,871 |
International government agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 103,998 | $ 94,871 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($)itemInstallment | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)itemInstallment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)item | |
Fair Value | |||||
Transfers between Level 1 to Level 2 | $ 0 | ||||
Transfers between Level 2 to Level 1 | 0 | ||||
Milestone payment receivable | $ 38,600,000 | $ 38,600,000 | |||
Number of equal annual installments milestone payment | Installment | 6 | 6 | |||
Percentage of discount recovery rate | 18.00% | 18.00% | 18.00% | ||
Contingent consideration | $ 29,100,000 | $ 29,100,000 | $ 32,500,000 | ||
Contingent consideration included within prepaid expenses and other current assets | 6,500,000 | 6,500,000 | 7,800,000 | ||
Contingent consideration included within contingent consideration | 22,632,000 | 22,632,000 | 24,651,000 | ||
Increase (decrease) in the fair value of contingent consideration | 3,240,000 | $ 5,900,000 | 4,518,000 | $ 12,700,000 | |
2026 Term Loans | |||||
Fair Value | |||||
Amount to be realized in future | $ 297,800,000 | $ 297,800,000 | |||
2023 Term Loans | |||||
Fair Value | |||||
Amount to be realized in future | $ 275,100,000 | ||||
First Scenario | |||||
Fair Value | |||||
Percentage of substantial doubt about going concern | 55.00% | 55.00% | 50.00% | ||
Second Scenario | |||||
Fair Value | |||||
Percentage of substantial doubt about going concern | 45.00% | 45.00% | 50.00% | ||
Discount Rate | |||||
Fair Value | |||||
Discount rate (as a percent) | item | 13 | 13 | 13 | ||
Maximum | |||||
Fair Value | |||||
Milestone payment receivable | $ 80,000,000 | $ 80,000,000 |
Fair Value - Rollforward of the
Fair Value - Rollforward of the Fair Value of the Assets Determined using Level 3 Inputs (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
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 | $ 33,428 |
Milestone and royalty payments received by the Company related to contingent consideration | (7,889) |
Impairment of corporate debt security | (977) |
Royalty payments due to the Company related to contingent consideration | (19) |
Balance at the end of the period | 29,061 |
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 | $ 4,518 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 50,650 | $ 44,944 | |
Work in process | 51,394 | 53,243 | |
Finished goods | [1] | 34,033 | 27,551 |
Total inventory | $ 136,077 | $ 125,738 | |
[1] | At June 30, 2021 and December 31, 2020, the Company had $25.3 million and $26.5 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 25.3 | $ 26.5 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Inventory capitalized in advance of validation of LYBALVI’s manufacturing line | $ 14.5 | $ 13.8 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 718,795 | $ 706,146 |
Less: accumulated depreciation | (374,846) | (356,143) |
Total property, plant and equipment, net | 343,949 | 350,003 |
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 | 179,387 | 178,194 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 371,787 | 366,051 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 53,027 | 52,508 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 108,034 | $ 102,833 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | |
Net Carrying Amount | 92,873 | $ 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 583,750 | |
Accumulated Amortization | (490,476) | |
Net Carrying Amount | $ 93,274 | $ 111,191 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | |
Accumulated Amortization | (392,249) | |
Net Carrying Amount | 73,341 | |
Capitalized IP | ||
Finite-lived intangible assets: | ||
Gross Carrying Amount | 118,160 | |
Accumulated Amortization | (98,227) | |
Net Carrying Amount | $ 19,933 | |
Capitalized IP | Minimum | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 11 years | |
Capitalized IP | Maximum | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 13 years |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Additional Information (Details) $ in Millions | Jun. 30, 2021USD ($) |
Expected amortization of intangible assets | |
2021 | $ 40 |
2022 | 35 |
2023 | 35 |
2024 | 1 |
Maximum | |
Expected amortization of intangible assets | |
2025 | $ 0.1 |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Remainder of fiscal year | $ 8,793 | |
Year 1 | 17,001 | $ 16,882 |
Year 2 | 17,266 | 17,001 |
Year 3 | 17,536 | 17,266 |
Year 4 | 17,810 | 17,536 |
Year 5 | 17,810 | |
Thereafter | 109,311 | |
Thereafter | 109,002 | |
Total operating lease payments | 187,408 | 195,806 |
Less: imputed interest | (59,897) | (60,610) |
Total operating lease liabilities | $ 127,511 | $ 135,196 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Weighted average incremental borrowing rate | 5.26% | 5.26% | ||
Weighted average remaining lease term | 12 years 2 months 12 days | 12 years 2 months 12 days | ||
Payments for operating leases | $ 4.4 | $ 4.5 | $ 8.1 | $ 6.9 |
Operating lease expense | $ 4.4 | $ 4.7 | $ 8.6 | $ 8.6 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 32,798 | $ 46,034 |
Accrued compensation | 52,560 | 71,178 |
Accrued sales discounts, allowances and reserves | 204,556 | 218,877 |
Accrued other | 68,047 | 76,082 |
Total accounts payable and accrued expenses | $ 357,961 | $ 412,171 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Long-term debt | ||
Less: current portion | $ (3,000) | $ (2,843) |
Long-term debt | 294,070 | 272,118 |
2026 Term Loans, due March 12, 2026 | ||
Long-term debt | ||
Term Loans | 297,070 | |
Less: current portion | (3,000) | |
Long-term debt | $ 294,070 | |
2023 Term Loans, due March 26, 2023 | ||
Long-term debt | ||
Term Loans | 274,961 | |
Less: current portion | (2,843) | |
Long-term debt | $ 272,118 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)Lender | Dec. 31, 2020 | |
Long-term debt | ||
Number of lender holding percentage of outstanding amount | Lender | 3 | |
Interest Expense | ||
Long-term debt | ||
Refinancing charges | $ 2.1 | |
Minimum | ||
Long-term debt | ||
Threshold percentage comparing present value of remaining cash flows | 10.00% | |
Percentage of outstanding principal amount held by lender | 2.00% | |
Maximum | ||
Long-term debt | ||
Percentage of outstanding principal amount held by lender | 7.00% | |
2026 Term Loans | ||
Long-term debt | ||
Due date of loan | Mar. 12, 2026 | |
Term Loans | $ 300 | |
Variable interest rate base | LIBOR | |
Incremental capacity | $ 175 | |
2026 Term Loans | LIBOR | ||
Long-term debt | ||
Interest rate added to base rate (as a percent) | 2.50% | |
Interest rate, variable interest rate floor (as a percent) | 0.50% | |
2023 Term Loans | ||
Long-term debt | ||
Due date of loan | Mar. 26, 2023 | |
Variable interest rate base | LIBOR | |
2023 Term Loans | LIBOR | ||
Long-term debt | ||
Interest rate added to base rate (as a percent) | 2.25% | |
Interest rate, variable interest rate floor (as a percent) | 0.00% |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 27,552 | $ 22,846 | $ 43,003 | $ 42,659 |
Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 2,683 | 2,015 | 4,861 | 3,980 |
Research and development | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 7,131 | 6,478 | 11,194 | 12,638 |
Selling, general and administrative | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 17,738 | $ 14,353 | $ 26,948 | $ 26,041 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions | Jun. 14, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Share-based compensation Expense | |||
Share based compensation cost capitalized | $ 2 | $ 2.6 | |
2018 Plan | |||
Share-based compensation Expense | |||
Number of increase in ordinary shares authorized for issuance thereunder | 8,000,000 |
Earnings (Loss) Per Share - Sch
Earnings (Loss) Per Share - Schedule of Basic Earnings (loss) Per Ordinary Share (Details) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||||
Net income (loss) | $ 2,364 | $ (22,418) | $ (29,431) | $ (38,654) | $ (20,054) | $ (68,085) |
Basic | 160,817 | 158,895 | 160,229 | 158,495 | ||
Effect of dilutive securities: | ||||||
Dilutive ordinary share equivalents | 3,120 | |||||
Shares used in calculating diluted earnings (loss) per share | 163,937 | 158,895 | 160,229 | 158,495 | ||
Stock Options | ||||||
Effect of dilutive securities: | ||||||
Dilutive effect of securities | 461 | |||||
Restricted Stock Units | ||||||
Effect of dilutive securities: | ||||||
Dilutive effect of securities | 2,659 |
Earnings (Loss) Per Share - S_2
Earnings (Loss) Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net Earnings (Loss) Per Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 16,061 | 21,565 | 18,454 | 19,601 |
Stock Options | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 15,465 | 16,882 | 15,265 | 15,375 |
Restricted Stock Unit Awards | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 596 | 4,683 | 3,189 | 4,226 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) - USD ($) | Mar. 17, 2021 | Sep. 30, 2020 | Jun. 30, 2021 |
Commitments And Contingencies [Line Items] | |||
Potential losses from claims, legal proceedings probable of occurring | $ 0 | ||
Maximum number of months before FDA can approve patent request | 30 months | ||
VUMERITY ANDA Litigation | |||
Commitments And Contingencies [Line Items] | |||
Maximum number of months before FDA can approve patent request | 30 months |