Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 21, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2023 | |
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 | 166,121,384 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
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 | Mar. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 321,401 | $ 292,473 |
Investments—short-term | 279,058 | 315,992 |
Receivables, net | 269,178 | 287,967 |
Inventory | 184,984 | 181,418 |
Contract assets | 8,429 | 8,929 |
Prepaid expenses and other current assets | 47,008 | 43,527 |
Total current assets | 1,110,058 | 1,130,306 |
PROPERTY, PLANT AND EQUIPMENT, NET | 321,109 | 325,361 |
DEFERRED TAX ASSETS | 151,232 | 115,602 |
RIGHT-OF-USE ASSETS | 111,586 | 115,855 |
INVESTMENTS—LONG-TERM | 92,083 | 131,610 |
GOODWILL | 92,873 | 92,873 |
INTANGIBLE ASSETS, NET | 28,880 | 37,680 |
OTHER ASSETS | 14,906 | 14,691 |
TOTAL ASSETS | 1,922,727 | 1,963,978 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 190,149 | 220,089 |
Accrued sales discounts, allowances and reserves | 282,264 | 252,115 |
Operating lease liabilities—short-term | 15,304 | 15,722 |
Contract liabilities—short-term | 2,193 | 6,816 |
Current portion of long-term debt | 3,000 | 3,000 |
Total current liabilities | 492,910 | 497,742 |
LONG-TERM DEBT | 289,635 | 290,270 |
OPERATING LEASE LIABILITIES—LONG-TERM | 86,112 | 89,829 |
OTHER LONG-TERM LIABILITIES | 48,494 | 42,384 |
Total liabilities | 917,151 | 920,225 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 14) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at March 31, 2023 and December 31, 2022, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 171,518,796 and 168,951,193 shares issued; 166,058,960 and 164,377,009 shares outstanding at March 31, 2023 and December 31, 2022, respectively | 1,715 | 1,690 |
Treasury shares, at cost (5,459,836 and 4,574,184 shares at March 31, 2023 and December 31, 2022, respectively) | (185,606) | (160,862) |
Additional paid-in capital | 2,938,726 | 2,913,099 |
Accumulated other comprehensive loss | (8,129) | (10,889) |
Accumulated deficit | (1,741,130) | (1,699,285) |
Total shareholders’ equity | 1,005,576 | 1,043,753 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,922,727 | $ 1,963,978 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 171,518,796 | 168,951,193 |
Ordinary shares, shares outstanding | 166,058,960 | 164,377,009 |
Treasury shares | 5,459,836 | 4,574,184 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
REVENUES: | ||
Total revenues | $ 287,595 | $ 278,545 |
EXPENSES: | ||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 58,175 | 55,159 |
Research and development | 93,637 | 95,953 |
Selling, general and administrative | 174,477 | 145,052 |
Amortization of acquired intangible assets | 8,800 | 8,966 |
Total expenses | 335,089 | 305,130 |
OPERATING LOSS | (47,494) | (26,585) |
OTHER EXPENSE, NET: | ||
Interest income | 4,966 | 573 |
Interest expense | (5,288) | (2,350) |
Change in the fair value of contingent consideration | (19,067) | |
Other (expense) income, net | (39) | 2,431 |
Total other expense, net | (361) | (18,413) |
LOSS BEFORE INCOME TAXES | (47,855) | (44,998) |
INCOME TAX BENEFIT | (6,010) | (9,095) |
NET LOSS | $ (41,845) | $ (35,903) |
LOSS PER ORDINARY SHARE: | ||
Basic | $ (0.25) | $ (0.22) |
Diluted | $ (0.25) | $ (0.22) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||
Basic | 165,085 | 162,483 |
Diluted | 165,085 | 162,483 |
COMPREHENSIVE LOSS: | ||
Net loss | $ (41,845) | $ (35,903) |
Holding gain (loss), net of a tax provision (benefit) of $488 and $(1,382), respectively | 2,760 | (4,511) |
COMPREHENSIVE LOSS | (39,085) | (40,414) |
Product sales, net | ||
REVENUES: | ||
Total revenues | 214,727 | 171,268 |
Manufacturing and royalty revenues | ||
REVENUES: | ||
Total revenues | 72,862 | 105,170 |
License revenue | ||
REVENUES: | ||
Total revenues | 2,000 | |
Research and development revenue | ||
REVENUES: | ||
Total revenues | $ 6 | $ 107 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Tax provision (benefit) | $ 488 | $ (1,382) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (41,845) | $ (35,903) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 18,714 | 19,197 |
Share-based compensation expense | 22,643 | 18,343 |
Deferred income taxes | (36,117) | (29,301) |
Change in the fair value of contingent consideration | 19,067 | |
Other non-cash charges | 369 | 371 |
Changes in assets and liabilities: | ||
Receivables | 18,789 | 63,290 |
Contract assets | 500 | (6,849) |
Inventory | (2,029) | (4,285) |
Prepaid expenses and other assets | (3,697) | (15,351) |
Right-of-use assets | 4,269 | 4,129 |
Accounts payable and accrued expenses | (30,154) | (33,414) |
Accrued sales discounts, allowances and reserves | 30,148 | 27,956 |
Contract liabilities | (4,287) | (2,980) |
Operating lease liabilities | (4,379) | (4,411) |
Other long-term liabilities | 5,774 | 1,819 |
Cash flows (used in) provided by operating activities | (21,302) | 21,678 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (6,860) | (7,791) |
Proceeds from contingent consideration | 501 | |
Return of Fountain Healthcare Partners II, L.P. investment | 485 | |
Purchases of investments | (23,898) | (114,615) |
Sales and maturities of investments | 103,608 | 60,779 |
Cash flows provided by (used in) investing activities | 72,850 | (60,641) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 2,874 | 1,795 |
Employee taxes paid related to net share settlement of equity awards | (24,744) | (17,069) |
Principal payments of long-term debt | (750) | (750) |
Cash flows used in financing activities | (22,620) | (16,024) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 28,928 | (54,987) |
CASH AND CASH EQUIVALENTS—Beginning of period | 292,473 | 337,544 |
CASH AND CASH EQUIVALENTS—End of period | 321,401 | 282,557 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 1,762 | $ 4,058 |
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, 2021 | $ 1,112,584 | $ 1,658 | $ 2,798,325 | $ (3,723) | $ (1,541,018) | $ (142,658) |
BALANCE (in shares) at Dec. 31, 2021 | 165,790,549 | (3,853,222) | ||||
Issuance of ordinary shares under employee stock plans | 1,795 | $ 19 | 1,776 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,953,293 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (17,069) | $ (17,069) | ||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (678,209) | |||||
Share-based compensation | 18,494 | 18,494 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | (4,511) | (4,511) | ||||
Net loss | (35,903) | (35,903) | ||||
BALANCE at Mar. 31, 2022 | 1,075,390 | $ 1,677 | 2,818,595 | (8,234) | (1,576,921) | $ (159,727) |
BALANCE (in shares) at Mar. 31, 2022 | 167,743,842 | (4,531,431) | ||||
BALANCE at Dec. 31, 2022 | 1,043,753 | $ 1,690 | 2,913,099 | (10,889) | (1,699,285) | $ (160,862) |
BALANCE (in shares) at Dec. 31, 2022 | 168,951,193 | (4,574,184) | ||||
Issuance of ordinary shares under employee stock plans | 2,874 | $ 25 | 2,849 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 2,567,603 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (24,744) | $ (24,744) | ||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (885,652) | |||||
Share-based compensation | 22,778 | 22,778 | ||||
Unrealized gain (loss) on marketable securities, net of tax provision | 2,760 | 2,760 | ||||
Net loss | (41,845) | (41,845) | ||||
BALANCE at Mar. 31, 2023 | $ 1,005,576 | $ 1,715 | $ 2,938,726 | $ (8,129) | $ (1,741,130) | $ (185,606) |
BALANCE (in shares) at Mar. 31, 2023 | 171,518,796 | (5,459,836) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement Of Stockholders Equity [Abstract] | ||
Tax provision (benefit) | $ 488 | $ (1,382) |
The Company
The Company | 3 Months Ended |
Mar. 31, 2023 | |
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 the fields of neuroscience and oncology. Alkermes has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of product candidates in development for neurological 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. On November 2, 2022, the Company announced its intent, as approved by its board of directors, to separate its neuroscience business and oncology business. The Company is exploring a separation of the oncology business into an independent, publicly-traded company (referred to herein as “Oncology Co.”) as part of an ongoing review of strategic alternatives for the oncology business. Following the potential separation, the Company would retain its focus on driving growth of its proprietary commercial products: LYBALVI, ARISTADA/ARISTADA INITIO and VIVITROL, and advancing the development of pipeline programs focused on neurological disorders. The Company also expects to retain manufacturing and royalty revenues related to its licensed products and third-party products using its proprietary technologies under license. Oncology Co. would focus on the discovery and development of cancer therapies, including the continued development of nemvaleukin alfa and the Company’s portfolio of novel, preclinical engineered cytokines. The separation, if consummated, is expected to be completed in the second half of 2023 and is subject to customary closing conditions, including final approval by the Company’s board of directors and receipt of a private letter ruling from the IRS and/or a tax opinion from the Company’s tax advisor. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three months ended March 31, 2023 and 2022 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2022. 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 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 accompanying 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 Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments , contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions . Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas. The Company’s chief decision maker, its Chief Executive Officer and chairman of its board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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 accounting pronouncements that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 31, 2023 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 3. REVENUE FROM CONTRACTS WITH CUSTOMERS Product Sales, Net The Company’s product sales, net consist of sales in the U.S. of VIVITROL, ARISTADA and ARISTADA INITIO and, following its commercial launch in October 2021, LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. During the three months ended March 31, 2023 and 2022, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2023 2022 VIVITROL $ 96,659 $ 84,854 ARISTADA and ARISTADA INITIO 80,077 72,485 LYBALVI 37,991 13,929 Total product sales, net $ 214,727 $ 171,268 Manufacturing and Royalty Revenues During the three months ended March 31, 2023 and 2022, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Three Months Ended March 31, 2023 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 13,562 $ 13,562 VUMERITY 12,649 16,225 28,874 RISPERDAL CONSTA 10,416 566 10,982 Other 15,375 4,069 19,444 $ 38,440 $ 34,422 $ 72,862 Three Months Ended March 31, 2022 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 37,054 $ 37,054 VUMERITY 11,395 19,200 30,595 RISPERDAL CONSTA 15,578 1,848 17,426 Other 11,854 8,241 20,095 $ 38,827 $ 66,343 $ 105,170 (1) “Long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate). In November 2021, the Company received notice of partial termination of an exclusive license agreement with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson (“Janssen Pharmaceutica”). Under this license agreement, the Company provided Janssen Pharmaceutica with rights to, and know-how, training and technical assistance in respect of, the Company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI. When the partial termination became effective in February 2022, Janssen Pharmaceutica ceased paying royalties related to sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA in the U.S. Accordingly, the Company has not recognized royalty revenue related to U.S. sales of these products since February 2022. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen Pharmaceutica’s partial termination of this license agreement and Janssen Pharmaceutica’s royalty and other obligations under the agreement. On December 21, 2022, the Company received an interim award (the “Initial Interim Award”) in these proceedings from the arbitral tribunal (the “Tribunal”), in which the Tribunal agreed with the Company’s position that, while Janssen Pharmaceutica may terminate the agreement, it may not continue to sell Products (as defined in the agreement) developed during the term of the agreement without paying royalties pursuant to the terms of the agreement. On April 19, 2023, the Company received a second interim award (the “Second Interim Award”) from the Tribunal. Pursuant to the Second Interim Award, back royalties related to fiscal year 2022 and interest are due to the Company under the license agreement and a separate Know-How Royalty (as defined in the license agreement) term applies for each of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, as follows: (i) the term for INVEGA SUSTENNA ends on August 20, 2024, (ii) the term for INVEGA TRINZA ends in the second quarter of 2030 (but no later than May 2030 when the license agreement expires), and (iii) the term for INVEGA HAFYERA ends in May 2030 (when the license agreement expires. The Tribunal directed the parties to confer and advise within 21 days concerning the rate of interest and proposed further proceedings, including whether any issues remain for resolution by the Tribunal prior to the Tribunal’s issuance of a final award. Refer to Note 14, Commitments and Contingencies Contract Assets Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time. The amounts included in the contract assets table below are classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they relate to manufacturing processes that are completed in ten days to eight weeks Total contract assets at March 31, 2023 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2022 $ 8,929 Additions 10,115 Transferred to receivables, net (10,615 ) Contract assets at March 31, 2023 $ 8,429 Contract Liabilities Contract liabilities consist of contractual obligations related to deferred revenue. At March 31, 2023 and December 31, 2022, $2.2 million and $6.8 million of the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying condensed consolidated balance sheets and $4.2 million and $3.9 million of the contract liabilities, respectively, were classified as “Other long-term liabilities” in the accompanying condensed consolidated balance sheets. Total contract liabilities at March 31, 2023 (In thousands) Contract Liabilities Contract liabilities at December 31, 2022 $ 10,701 Additions (934 ) Amounts recognized into revenue (3,354 ) Contract liabilities at March 31, 2023 $ 6,413 |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 4. INVESTMENTS Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated March 31, 2023 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 125,254 $ 129 $ (114 ) $ (1,683 ) $ 123,586 U.S. government and agency debt securities 135,633 39 (87 ) (1,103 ) 134,482 Non-U.S. government debt securities 21,444 — — (454 ) 20,990 Total short-term investments 282,331 168 (201 ) (3,240 ) 279,058 Long-term investments: Available-for-sale securities: Corporate debt securities 47,232 — (664 ) (703 ) 45,865 U.S. government and agency debt securities 45,859 — (415 ) (1,046 ) 44,398 93,091 — (1,079 ) (1,749 ) 90,263 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 94,911 — (1,079 ) (1,749 ) 92,083 Total investments $ 377,242 $ 168 $ (1,280 ) $ (4,989 ) $ 371,141 December 31, 2022 Short-term investments: Available-for-sale securities: Corporate debt securities $ 141,418 $ — $ (424 ) $ (2,054 ) $ 138,940 U.S. government and agency debt securities 143,710 16 (266 ) (1,289 ) 142,171 Non-U.S. government debt securities 35,455 — (28 ) (546 ) 34,881 Total short-term investments 320,583 16 (718 ) (3,889 ) 315,992 Long-term investments: Available-for-sale securities: Corporate debt securities 68,229 — (1,550 ) (676 ) 66,003 U.S. government and agency debt securities 62,220 — (917 ) (1,424 ) 59,879 Non-U.S. government debt securities 4,099 — — (191 ) 3,908 134,548 — (2,467 ) (2,291 ) 129,790 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 136,368 — (2,467 ) (2,291 ) 131,610 Total investments $ 456,951 $ 16 $ (3,185 ) $ (6,180 ) $ 447,602 At March 31, 2023, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were temporary. Investments with unrealized losses consisted primarily of corporate debt securities and debt securities issued and backed by U.S. agencies and the U.S. government. At March 31, 2023, 207 of the Company’s 239 investment securities were in an unrealized loss position and had an aggregate estimated fair value of $371.1 million. Approximately 46% and 48% of the Company’s investment securities at March 31, 2023 are in corporate debt securities, with a minimum rating of A2 (Moody’s)/A (Standard and Poor’s), and debt securities issued by the U.S. government or its agencies, respectively. In a rising interest rate environment, the Company expects its fixed-rate investment securities will carry unrealized losses. 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. The Company has the intent and ability to hold these investments until recovery, which may be at maturity. In May 2014, the Company entered into an agreement whereby it is committed to provide up to €7.4 million to a partnership, Fountain Healthcare Partners II, L.P. of Ireland (“Fountain”), which was created to carry on the business of investing exclusively in companies and businesses engaged in the healthcare, pharmaceutical and life sciences sectors. As of March 31, 2023, the Company’s total contribution in Fountain was equal to €7.4 million, and its commitment represented approximately 7 % of the partnership’s total funding . The Company’s net investment in Fountain was $ 7.9 million at March 31, 2023 and December 31, 2022, respectively, and was included within “Other assets” in the accompanying condensed consolidated balance sheets. During the three months ended March 3 1 , 2023 and 2022 , the Company recorded a decrease of $ 0.2 million and an increase of less than $ 0.1 million in its investment in Fountain, which represented the Company’s proportional share of Fountain’s net (losses) gains for the period. The Company is accounting for its investment in Fountain under the equity method . Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows: Three Months Ended March 31, (In thousands) 2023 2022 Proceeds from the sales and maturities of investments $ 103,608 $ 60,779 Realized gains $ — $ — Realized losses $ — $ — The Company’s available-for-sale and held-to-maturity securities at March 31, 2023 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 $ 272,122 $ 268,811 $ 1,820 $ 1,820 After 1 year through 5 years 103,300 100,510 — — Total $ 375,422 $ 369,321 $ 1,820 $ 1,820 |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 5. FAIR VALUE The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques that the Company utilized to determine such fair value: March 31, (In thousands) 2023 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 178,880 $ 149,681 $ 29,199 $ — Corporate debt securities 169,451 — 169,451 — Non-U.S. government debt securities 20,990 — 20,990 — Total $ 369,321 $ 149,681 $ 219,640 $ — December 31, 2022 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 19,857 $ 19,857 $ — $ — U.S. government and agency debt securities 202,050 168,639 33,411 — Corporate debt securities 204,943 — 204,943 — Non-U.S. government debt securities 38,789 — 38,789 — Total $ 465,639 $ 188,496 $ 277,143 $ — The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were no transfers of any securities between levels during the three months ended March 31, 2023. At March 31, 2023, the Company had no investments whose fair value was determined using Level 3 inputs. The Company’s investments in U.S. government and agency debt securities, non-U.S. government agency debt securities and corporate debt securities classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. In April 2015, the Company sold its Gainesville, GA manufacturing facility, the related manufacturing and royalty revenue associated with certain products manufactured at the facility, and the rights to intravenous/intramuscular (“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, including milestone payments and royalties on net sales of the IV/IM and parenteral forms of Meloxicam and other products covered under the relevant agreements (such products, the “Meloxicam Products”). In November 2019, Recro spun out its acute care segment to Baudax Bio, Inc. (“Baudax”), a publicly-traded pharmaceutical company. As part of this transaction, Recro’s obligations to pay certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax. In March 2022, Baudax reduced its workforce by approximately 80%, which was designed to reduce its operational expenses and conserve its cash resources. As a result of these events and the fact that, at March 31, 2022, Baudax had only paid $0.5 million of the $6.4 million that was due to the Company in March 2022, the Company recorded a reduction in the fair value of the contingent consideration of $19.1 million within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive loss in the three months ended March 31, 2022. In September 2022, the Company determined that it was unlikely to collect any further proceeds under this arrangement and reduced the fair value of the contingent consideration to zero. In December 2022, Baudax announced that it would discontinue sales of ANJESO, the first approved Meloxicam Product, and on December 28, 2022, the U.S. Food and Drug Administration (“FDA”) acknowledged the discontinuation of sales of ANJESO via listing in the Orange Book. In March 2023, the Company and Baudax entered into an agreement pursuant to which Baudax transferred to the Company the rights to certain patents, trademarks, equipment, data and other rights related to ANJESO and agreed to the termination of all prior agreements between the parties and any and all financial and other obligations thereunder. 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 (such debt, the “2026 Term Loans”), which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $281.5 million and $278.9 million at March 31, 2023 and December 31, 2022, respectively. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. INVENTORY Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: March 31, December 31, (In thousands) 2023 2022 Raw materials $ 59,045 $ 61,064 Work in process 74,661 76,228 Finished goods ( 1) 51,278 44,126 Total inventory $ 184,984 $ 181,418 (1) At March 31, 2023 and December 31, 2022, the Company had $32.6 million and $30.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment
Property, Plant and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property Plant And Equipment [Abstract] | |
Property, Plant and Equipment | 7. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consisted of the following: March 31, December 31, (In thousands) 2023 2022 Land $ 6,560 $ 6,560 Building and improvements 195,602 195,144 Furniture, fixtures and equipment 423,835 418,448 Leasehold improvements 52,820 54,152 Construction in progress 85,852 84,715 Subtotal 764,669 759,019 Less: accumulated depreciation and amortization (443,560 ) (433,658 ) Total property, plant and equipment, net $ 321,109 $ 325,361 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 8. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consisted of the following: March 31, 2023 (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 $ (443,255 ) $ 22,335 Capitalized IP 11-13 118,160 (111,615 ) 6,545 Total $ 583,750 $ (554,870 ) $ 28,880 Based on the Company’s most recent analysis, amortization of intangible assets included in the accompanying condensed consolidated balance sheet at March 31, 2023 is expected to be approximately $35.0 million and $1.0 million in the years ending December 31, 2023 and 2024, respectively. Although the Company believes that such analysis, and the available information and assumptions underlying such analysis, are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets will change in proportion to the change in revenues. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | 9. LEASES Future lease payments under non-cancelable leases at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, (In thousands) 2023 2022 2023 $ 12,306 $ 16,665 2024 16,627 16,608 2025 16,874 16,855 2026 12,786 12,767 2027 9,506 9,506 Thereafter 69,474 69,474 Total operating lease payments $ 137,573 $ 141,875 Less: imputed interest (36,157 ) (36,324 ) Total operating lease liabilities $ 101,416 $ 105,551 At March 31, 2023, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.27% and 8.53 years, respectively. Cash paid for lease liabilities was $4.4 million during each of the three months ended March 31, 2023 and 2022. The Company recorded operating lease expense of $4.3 million and $4.1 million during the three months ended March 31, 2023 and 2022, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following: March 31, December 31, (In thousands) 2023 2022 Accounts payable $ 37,147 $ 32,843 Accrued compensation 47,700 79,085 Accrued other 105,302 108,161 Total accounts payable and accrued expenses $ 190,149 $ 220,089 A summary of the Company’s current provision for sales discounts, allowances and reserves is as follows: March 31, December 31, (In thousands) 2023 2022 Medicaid rebates $ 234,685 $ 208,332 Product discounts 15,397 13,204 Medicare Part D 21,337 18,409 Other 10,845 12,170 Total accrued sales discounts, allowances and reserves $ 282,264 $ 252,115 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: March 31, December 31, (In thousands) 2023 2022 2026 Term Loans, due March 12, 2026 $ 292,635 $ 293,270 Less: current portion (3,000 ) (3,000 ) Long-term debt $ 289,635 $ 290,270 The 2026 Term Loans mature on March 12, 2026 and bear interest payable at LIBOR plus 2.50% with a LIBOR floor of 0.5%. The 2026 Term Loans include customary Alternative Reference Rate Committee hardwired benchmark replacement language to transition from LIBOR to the Secured Overnight Financing Rate (“SOFR”). |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
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 accompanying condensed consolidated statements of operations and comprehensive loss: Three Months Ended March 31, (In thousands) 2023 2022 Cost of goods manufactured and sold $ 2,682 $ 2,382 Research and development 6,907 5,608 Selling, general and administrative 13,054 10,353 Total share-based compensation expense $ 22,643 $ 18,343 At March 31, 2023 and December 31, 2022, $3.4 million and $3.3 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets. |
Loss Per Share
Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Loss Per Share | 13. LOSS PER SHARE Basic loss per ordinary share is calculated based upon net loss available to holders of ordinary shares divided by the weighted average number of shares outstanding. For the three months ended March 31, 2023 and 2022, as the Company was in a net loss position, the diluted loss per share calculation did not assume conversion or exercise of stock options and restricted stock unit awards, as they would have had an anti-dilutive effect on loss per share. The following potential ordinary share equivalents were not included in the net loss per share calculation because the effect would have been anti-dilutive: Three Months Ended March 31, (In thousands) 2023 2022 Stock options 13,007 13,461 Restricted stock unit awards 6,093 5,959 Total 19,100 19,420 |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 14. COMMITMENTS AND CONTINGENT LIABILITIES Litigation From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At March 31, 2023, there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. Janssen Arbitration Proceedings In April 2022, Alkermes Pharma Ireland Limited commenced binding arbitration proceedings to settle, among other things, whether, notwithstanding Janssen Pharmaceutica’s partial termination of two license agreements with the Company, Janssen Pharmaceutica has a continuing obligation to pay royalties on sales in the U.S. of INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA. The request for arbitration seeks, among other remedies, a declaration that Janssen Pharmaceutica is in breach of the license agreements and a resumption of royalty payments for sales of the relevant products in the U.S. In December 2022, the Company received the Initial Interim Award in these proceedings from the Tribunal. In the Initial Interim Award, the Tribunal agreed with the Company’s position that, while Janssen Pharmaceutica may terminate the agreements, it may not continue to sell Products (as defined in the agreements) developed during the term of the agreements without paying royalties pursuant to the terms of the respective agreements. On April 19, 2023, the Company received the Second Interim Award from the Tribunal. Pursuant to the Second Interim Award, back royalties related to fiscal year 2022 of approximately $194.0 million (inclusive of interest) are due to the Company under the two agreements; a separate Know-How Royalty (as defined in the applicable license agreement) term applies for each of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, as follows: (i) the term for INVEGA SUSTENNA ends on August 20, 2024, (ii) the term for INVEGA TRINZA ends in the second quarter of 2030 (but no later than May 2030 when the applicable license agreement expires), and (iii) the term for INVEGA HAFYERA ends in May 2030 (when the applicable license agreement expires); and royalties for CABENUVA in the United States are owed until December 31, 2036. The Tribunal directed the parties to confer and advise within 21 days concerning the rate of interest and proposed further proceedings, including whether any issues remain for resolution by the Tribunal prior to the Tribunal’s issuance of a final award. The arbitration is being conducted pursuant to the Institute for Conflict Prevention and Resolution (CPR) Rules for Non-Administered Arbitration. INVEGA SUSTENNA ANDA Litigation Janssen Pharmaceutica 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”) (such lawsuit, the “Teva Lawsuit”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities (the “Mylan Lawsuit”), in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), and in February 2022 against Accord Healthcare, Inc., Accord Healthcare, Ltd. and Intas Pharmaceuticals, Ltd (“Accord” and such lawsuit, the “Accord Lawsuit”), and in the U.S. District Court for the District of Delaware in December 2021 against Tolmar Holding, Inc., Tolmar Pharmaceuticals, Inc., Tolmar Therapeutics, Inc., and Tolmar, Inc. (“Tolmar” and such lawsuit, the “Tolmar Lawsuit”), following the respective filings by each of Teva, Mylan Labs, Pharmascience, Accord and Tolmar 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 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Teva Lawsuit. In December 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Mylan Lawsuit, based on the parties’ prior stipulation to be bound by the judgment in the Teva Lawsuit. The Teva entities and Mylan Labs each filed notices of appeal of their respective judgments with the U.S. Court of Appeals for the Federal Circuit, which were consolidated in January 2022 (the “Teva Appeal”). A trial has been scheduled in the Tolmar Lawsuit for October 2023. The Pharmascience Lawsuit and the Accord Lawsuit were administratively terminated in July 2022, pending the outcome of the Teva Appeal. The Company is not a party to any of these proceedings. INVEGA TRINZA ANDA Litigation In September 2020, Janssen Pharmaceutica, 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. A bench trial concluded in December 2022. The Company is not a party to this proceeding. 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. A bench trial was held in February 2023, and the Company anticipates a decision in the second half of 2023. The Company intends to continue to vigorously defend its IP. 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. 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. In addition, on January 10, 2023, Acorda Therapeutics, Inc. filed a petition with the U.S. District Court for the Southern District of New York asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $66.0 million in damages. The Company believes the petition is without merit and filed opposition papers asking the court to deny the petition and confirm the final arbitration award unchanged. 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 proceedings 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) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three months ended March 31, 2023 and 2022 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2022. 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 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 accompanying 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 Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments , contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions . |
Segment Information | Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas. The Company’s chief decision maker, its Chief Executive Officer and chairman of its board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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 accounting pronouncements that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Schedule of Contract Assets and Contract Liabilities | Total contract assets at March 31, 2023 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2022 $ 8,929 Additions 10,115 Transferred to receivables, net (10,615 ) Contract assets at March 31, 2023 $ 8,429 Total contract liabilities at March 31, 2023 (In thousands) Contract Liabilities Contract liabilities at December 31, 2022 $ 10,701 Additions (934 ) Amounts recognized into revenue (3,354 ) Contract liabilities at March 31, 2023 $ 6,413 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three months ended March 31, 2023 and 2022, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2023 2022 VIVITROL $ 96,659 $ 84,854 ARISTADA and ARISTADA INITIO 80,077 72,485 LYBALVI 37,991 13,929 Total product sales, net $ 214,727 $ 171,268 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three months ended March 31, 2023 and 2022, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Three Months Ended March 31, 2023 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 13,562 $ 13,562 VUMERITY 12,649 16,225 28,874 RISPERDAL CONSTA 10,416 566 10,982 Other 15,375 4,069 19,444 $ 38,440 $ 34,422 $ 72,862 Three Months Ended March 31, 2022 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 37,054 $ 37,054 VUMERITY 11,395 19,200 30,595 RISPERDAL CONSTA 15,578 1,848 17,426 Other 11,854 8,241 20,095 $ 38,827 $ 66,343 $ 105,170 (1) “Long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate). |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Investments | Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated March 31, 2023 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 125,254 $ 129 $ (114 ) $ (1,683 ) $ 123,586 U.S. government and agency debt securities 135,633 39 (87 ) (1,103 ) 134,482 Non-U.S. government debt securities 21,444 — — (454 ) 20,990 Total short-term investments 282,331 168 (201 ) (3,240 ) 279,058 Long-term investments: Available-for-sale securities: Corporate debt securities 47,232 — (664 ) (703 ) 45,865 U.S. government and agency debt securities 45,859 — (415 ) (1,046 ) 44,398 93,091 — (1,079 ) (1,749 ) 90,263 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 94,911 — (1,079 ) (1,749 ) 92,083 Total investments $ 377,242 $ 168 $ (1,280 ) $ (4,989 ) $ 371,141 December 31, 2022 Short-term investments: Available-for-sale securities: Corporate debt securities $ 141,418 $ — $ (424 ) $ (2,054 ) $ 138,940 U.S. government and agency debt securities 143,710 16 (266 ) (1,289 ) 142,171 Non-U.S. government debt securities 35,455 — (28 ) (546 ) 34,881 Total short-term investments 320,583 16 (718 ) (3,889 ) 315,992 Long-term investments: Available-for-sale securities: Corporate debt securities 68,229 — (1,550 ) (676 ) 66,003 U.S. government and agency debt securities 62,220 — (917 ) (1,424 ) 59,879 Non-U.S. government debt securities 4,099 — — (191 ) 3,908 134,548 — (2,467 ) (2,291 ) 129,790 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 136,368 — (2,467 ) (2,291 ) 131,610 Total investments $ 456,951 $ 16 $ (3,185 ) $ (6,180 ) $ 447,602 |
Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses | Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows: Three Months Ended March 31, (In thousands) 2023 2022 Proceeds from the sales and maturities of investments $ 103,608 $ 60,779 Realized gains $ — $ — Realized losses $ — $ — |
Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities | The Company’s available-for-sale and held-to-maturity securities at March 31, 2023 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 $ 272,122 $ 268,811 $ 1,820 $ 1,820 After 1 year through 5 years 103,300 100,510 — — Total $ 375,422 $ 369,321 $ 1,820 $ 1,820 |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques that the Company utilized to determine such fair value: March 31, (In thousands) 2023 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 178,880 $ 149,681 $ 29,199 $ — Corporate debt securities 169,451 — 169,451 — Non-U.S. government debt securities 20,990 — 20,990 — Total $ 369,321 $ 149,681 $ 219,640 $ — December 31, 2022 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 19,857 $ 19,857 $ — $ — U.S. government and agency debt securities 202,050 168,639 33,411 — Corporate debt securities 204,943 — 204,943 — Non-U.S. government debt securities 38,789 — 38,789 — Total $ 465,639 $ 188,496 $ 277,143 $ — |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: March 31, December 31, (In thousands) 2023 2022 Raw materials $ 59,045 $ 61,064 Work in process 74,661 76,228 Finished goods ( 1) 51,278 44,126 Total inventory $ 184,984 $ 181,418 (1) At March 31, 2023 and December 31, 2022, the Company had $32.6 million and $30.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following: March 31, December 31, (In thousands) 2023 2022 Land $ 6,560 $ 6,560 Building and improvements 195,602 195,144 Furniture, fixtures and equipment 423,835 418,448 Leasehold improvements 52,820 54,152 Construction in progress 85,852 84,715 Subtotal 764,669 759,019 Less: accumulated depreciation and amortization (443,560 ) (433,658 ) Total property, plant and equipment, net $ 321,109 $ 325,361 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: March 31, 2023 (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 $ (443,255 ) $ 22,335 Capitalized IP 11-13 118,160 (111,615 ) 6,545 Total $ 583,750 $ (554,870 ) $ 28,880 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, (In thousands) 2023 2022 2023 $ 12,306 $ 16,665 2024 16,627 16,608 2025 16,874 16,855 2026 12,786 12,767 2027 9,506 9,506 Thereafter 69,474 69,474 Total operating lease payments $ 137,573 $ 141,875 Less: imputed interest (36,157 ) (36,324 ) Total operating lease liabilities $ 101,416 $ 105,551 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: March 31, December 31, (In thousands) 2023 2022 Accounts payable $ 37,147 $ 32,843 Accrued compensation 47,700 79,085 Accrued other 105,302 108,161 Total accounts payable and accrued expenses $ 190,149 $ 220,089 |
Summary of Current Provision for Sales, Discounts, Allowances and Reserves | A summary of the Company’s current provision for sales discounts, allowances and reserves is as follows: March 31, December 31, (In thousands) 2023 2022 Medicaid rebates $ 234,685 $ 208,332 Product discounts 15,397 13,204 Medicare Part D 21,337 18,409 Other 10,845 12,170 Total accrued sales discounts, allowances and reserves $ 282,264 $ 252,115 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: March 31, December 31, (In thousands) 2023 2022 2026 Term Loans, due March 12, 2026 $ 292,635 $ 293,270 Less: current portion (3,000 ) (3,000 ) Long-term debt $ 289,635 $ 290,270 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 accompanying condensed consolidated statements of operations and comprehensive loss: Three Months Ended March 31, (In thousands) 2023 2022 Cost of goods manufactured and sold $ 2,682 $ 2,382 Research and development 6,907 5,608 Selling, general and administrative 13,054 10,353 Total share-based compensation expense $ 22,643 $ 18,343 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share | The following potential ordinary share equivalents were not included in the net loss per share calculation because the effect would have been anti-dilutive: Three Months Ended March 31, (In thousands) 2023 2022 Stock options 13,007 13,461 Restricted stock unit awards 6,093 5,959 Total 19,100 19,420 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 287,595 | $ 278,545 |
VIVITROL | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 96,659 | 84,854 |
ARISTADA and ARISTADA INITIO | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 80,077 | 72,485 |
LYBALVI | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 37,991 | 13,929 |
Product sales, net | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 214,727 | $ 171,268 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 287,595 | $ 278,545 |
Manufacturing Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 38,440 | 38,827 |
Manufacturing Revenue | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 12,649 | 11,395 |
Manufacturing Revenue | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 10,416 | 15,578 |
Manufacturing Revenue | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 15,375 | 11,854 |
Royalty | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 34,422 | 66,343 |
Royalty | Long-Acting INVEGA Products | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 13,562 | 37,054 |
Royalty | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 16,225 | 19,200 |
Royalty | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 566 | 1,848 |
Royalty | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 4,069 | 8,241 |
Manufacturing and royalty revenues | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 72,862 | 105,170 |
Manufacturing and royalty revenues | Long-Acting INVEGA Products | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 13,562 | 37,054 |
Manufacturing and royalty revenues | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 28,874 | 30,595 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 10,982 | 17,426 |
Manufacturing and royalty revenues | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 19,444 | $ 20,095 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) | 2 Months Ended | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Royalty revenue recognized | $ 287,595,000 | $ 278,545,000 | ||
Contract liabilities | 6,413,000 | $ 10,701,000 | ||
Contract liabilities–short-term | ||||
Disaggregation Of Revenue [Line Items] | ||||
Contract liabilities | 2,200,000 | 6,800,000 | ||
Other long-term liabilities | ||||
Disaggregation Of Revenue [Line Items] | ||||
Contract liabilities | $ 4,200,000 | $ 3,900,000 | ||
U.S. Based Royalties | Long-Acting INVEGA Products | ||||
Disaggregation Of Revenue [Line Items] | ||||
Royalty revenue recognized | $ 0 | |||
Minimum | ||||
Disaggregation Of Revenue [Line Items] | ||||
Manufacturing Process period | 10 days | |||
Maximum | ||||
Disaggregation Of Revenue [Line Items] | ||||
Manufacturing Process period | 56 days |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Contract Assets and Contract Liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 8,929 |
Additions | 10,115 |
Transferred to receivables, net | (10,615) |
Contract assets at end of period | 8,429 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 10,701 |
Additions | (934) |
Amounts recognized into revenue | (3,354) |
Contract liabilities at end of the period | $ 6,413 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | $ 282,331 | $ 320,583 |
Short-term investments, Gross Unrealized Gains | 168 | 16 |
Short-term investments, Gross Unrealized Losses, Less than One Year | (201) | (718) |
Short-term investments, Gross Unrealized Losses, Greater than One Year | (3,240) | (3,889) |
Investments—short-term | 279,058 | 315,992 |
Long-term investments, Amortized Cost | 93,091 | 134,548 |
Long-term investments, Gross Unrealized Losses, Less than One Year | (1,079) | (2,467) |
Long-term investments, Gross Unrealized Losses, Greater than One Year | (1,749) | (2,291) |
Long-term investments, Estimated Fair Value | 90,263 | 129,790 |
Held-to-maturity securities: | ||
Estimated Fair Value | 1,820 | |
Long-term Investments | ||
Amortized Cost | 94,911 | 136,368 |
Gross Unrealized Losses, Less than One Year | (1,079) | (2,467) |
Gross Unrealized Losses, Greater than One Year | (1,749) | (2,291) |
Total long-term investments | 92,083 | 131,610 |
Total investments | ||
Amortized Cost | 377,242 | 456,951 |
Gross Unrealized Gains | 168 | 16 |
Gross Unrealized Losses, Less than One Year | (1,280) | (3,185) |
Gross Unrealized Losses, Greater than One Year | (4,989) | (6,180) |
Estimated Fair Value | 371,141 | 447,602 |
Certificates of deposit | ||
Held-to-maturity securities: | ||
Amortized Cost | 1,820 | 1,820 |
Estimated Fair Value | 1,820 | 1,820 |
Corporate debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 125,254 | 141,418 |
Short-term investments, Gross Unrealized Gains | 129 | |
Short-term investments, Gross Unrealized Losses, Less than One Year | (114) | (424) |
Short-term investments, Gross Unrealized Losses, Greater than One Year | (1,683) | (2,054) |
Investments—short-term | 123,586 | 138,940 |
Long-term investments, Amortized Cost | 47,232 | 68,229 |
Long-term investments, Gross Unrealized Losses, Less than One Year | (664) | (1,550) |
Long-term investments, Gross Unrealized Losses, Greater than One Year | (703) | (676) |
Long-term investments, Estimated Fair Value | 45,865 | 66,003 |
U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 135,633 | 143,710 |
Short-term investments, Gross Unrealized Gains | 39 | 16 |
Short-term investments, Gross Unrealized Losses, Less than One Year | (87) | (266) |
Short-term investments, Gross Unrealized Losses, Greater than One Year | (1,103) | (1,289) |
Investments—short-term | 134,482 | 142,171 |
Long-term investments, Amortized Cost | 45,859 | 62,220 |
Long-term investments, Gross Unrealized Losses, Less than One Year | (415) | (917) |
Long-term investments, Gross Unrealized Losses, Greater than One Year | (1,046) | (1,424) |
Long-term investments, Estimated Fair Value | 44,398 | 59,879 |
Non-U.S. government debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 21,444 | 35,455 |
Short-term investments, Gross Unrealized Losses, Less than One Year | (28) | |
Short-term investments, Gross Unrealized Losses, Greater than One Year | (454) | (546) |
Investments—short-term | $ 20,990 | 34,881 |
Long-term investments, Amortized Cost | 4,099 | |
Long-term investments, Gross Unrealized Losses, Greater than One Year | (191) | |
Long-term investments, Estimated Fair Value | $ 3,908 |
Investments - Additional Inform
Investments - Additional Information (Details) € in Millions | 3 Months Ended | |||
Mar. 31, 2023 USD ($) InvestmentSecurity | Mar. 31, 2022 USD ($) | Mar. 31, 2023 EUR (€) | Dec. 31, 2022 USD ($) | |
Investment Holdings [Line Items] | ||||
Aggregate estimated fair value of investments in unrealized loss position | $ 371,100,000 | |||
Number of investment securities | InvestmentSecurity | 207 | |||
Number of unrealized investment securities | InvestmentSecurity | 239 | |||
Fountain Healthcare Partners II | ||||
Investment Holdings [Line Items] | ||||
Funding commitment as percentage of partnership's total funding | 7% | 7% | ||
Equity method commitment | € | € 7.4 | |||
Gain (loss) on sale of investment | $ 200,000 | |||
Fountain Healthcare Partners II | Maximum | ||||
Investment Holdings [Line Items] | ||||
Commitment on equity method investment | € | € 7.4 | |||
Gain (loss) on sale of investment | $ 100,000 | |||
Fountain Healthcare Partners II | Other Assets | ||||
Investment Holdings [Line Items] | ||||
Carrying value of equity investment | $ 7,900,000 | $ 7,900,000 | ||
Corporate debt securities | ||||
Investment Holdings [Line Items] | ||||
Percentage of investment securities available for sale unrealized loss position | 46% | 46% | ||
U.S. government and agency debt securities | ||||
Investment Holdings [Line Items] | ||||
Percentage of investment securities available for sale unrealized loss position | 48% | 48% |
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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Investments Debt And Equity Securities [Abstract] | ||
Sales and maturities of investments | $ 103,608 | $ 60,779 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 272,122 |
After 1 year through 5 years | 103,300 |
Total | 375,422 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 268,811 |
After 1 year through 5 years | 100,510 |
Total | 369,321 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 1,820 |
Total | 1,820 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 1,820 |
Total | $ 1,820 |
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 | Mar. 31, 2023 | Dec. 31, 2022 |
Fair value | ||
Debt securities | $ 369,321 | |
Recurring Basis | ||
Fair value | ||
Cash equivalents | $ 19,857 | |
Assets, Total | 369,321 | 465,639 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 19,857 | |
Assets, Total | 149,681 | 188,496 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 219,640 | 277,143 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 178,880 | 202,050 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 149,681 | 168,639 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 29,199 | 33,411 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 169,451 | 204,943 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 169,451 | 204,943 |
Non-U.S. government debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 20,990 | 38,789 |
Non-U.S. government debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 20,990 | $ 38,789 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Fair Value | ||||
Transfers between Level 1 to Level 2 | $ 0 | |||
Transfers between Level 2 to Level 1 | 0 | |||
Investments determined using Level 3 inputs | 0 | |||
Increase (decrease) in fair value of contingent consideration | $ (19,067,000) | |||
2026 Term Loans | ||||
Fair Value | ||||
Amount to be realized in future | $ 281,500,000 | $ 278,900,000 | ||
Baudax | ||||
Fair Value | ||||
Percentage of reduction in workforce | 80% | |||
Milestone payments received | $ 500,000 | |||
Milestone payment receivable | $ 6,400,000 | 6,400,000 | ||
Increase (decrease) in fair value of contingent consideration | $ (19,100,000) |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 59,045 | $ 61,064 | |
Work in process | 74,661 | 76,228 | |
Finished goods | [1] | 51,278 | 44,126 |
Total inventory | $ 184,984 | $ 181,418 | |
[1] At March 31, 2023 and December 31, 2022, the Company had $32.6 million and $30.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 32.6 | $ 30.9 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 764,669 | $ 759,019 |
Less: accumulated depreciation and amortization | (443,560) | (433,658) |
Total property, plant and equipment, net | 321,109 | 325,361 |
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 | 195,602 | 195,144 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 423,835 | 418,448 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 52,820 | 54,152 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 85,852 | $ 84,715 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | |
Net Carrying Amount | 92,873 | $ 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 583,750 | |
Accumulated Amortization | (554,870) | |
Net Carrying Amount | $ 28,880 | $ 37,680 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | |
Accumulated Amortization | (443,255) | |
Net Carrying Amount | 22,335 | |
Capitalized IP | ||
Finite-lived intangible assets: | ||
Gross Carrying Amount | 118,160 | |
Accumulated Amortization | (111,615) | |
Net Carrying Amount | $ 6,545 | |
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 | Mar. 31, 2023 USD ($) |
Expected amortization of intangible assets | |
2023 | $ 35 |
2024 | $ 1 |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 | $ 12,306 | $ 16,665 |
2024 | 16,627 | 16,608 |
2025 | 16,874 | 16,855 |
2026 | 12,786 | 12,767 |
2027 | 9,506 | 9,506 |
Thereafter | 69,474 | 69,474 |
Total operating lease payments | 137,573 | 141,875 |
Less: imputed interest | (36,157) | (36,324) |
Total operating lease liabilities | $ 101,416 | $ 105,551 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||
Weighted average incremental borrowing rate | 5.27% | |
Payments for operating leases | $ 4.4 | $ 4.4 |
Weighted average remaining lease term | 8 years 6 months 10 days | |
Operating lease expense | $ 4.3 | $ 4.1 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 37,147 | $ 32,843 |
Accrued compensation | 47,700 | 79,085 |
Accrued other | 105,302 | 108,161 |
Total accounts payable and accrued expenses | $ 190,149 | $ 220,089 |
Accounts Payable and Accrued _4
Accounts Payable and Accrued Expenses - Summary of Current Provision for Sales, Discounts, Allowances and Reserves (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 282,264 | $ 252,115 |
Medicaid Rebate | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 234,685 | 208,332 |
Product Discounts | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 15,397 | 13,204 |
Medicare Part D | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 21,337 | 18,409 |
Other | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 10,845 | $ 12,170 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Long-term debt | ||
Less: current portion | $ (3,000) | $ (3,000) |
Long-term debt | 289,635 | 290,270 |
2026 Term Loans, due March 12, 2026 | ||
Long-term debt | ||
Term Loans | 292,635 | 293,270 |
Less: current portion | (3,000) | (3,000) |
Long-term debt | $ 289,635 | $ 290,270 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) - 2026 Term Loans $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Long-term debt | |
Due date of loan | Mar. 12, 2026 |
Variable interest rate base | LIBOR |
Incremental capacity | $ 175 |
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% |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based compensation Expense | ||
Total share-based compensation expense | $ 22,643 | $ 18,343 |
Cost of goods manufactured and sold | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 2,682 | 2,382 |
Research and development | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 6,907 | 5,608 |
Selling, general and administrative | ||
Share-based compensation Expense | ||
Total share-based compensation expense | $ 13,054 | $ 10,353 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Share based compensation cost capitalized | $ 3.4 | $ 3.3 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 19,100 | 19,420 |
Stock Options | ||
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 13,007 | 13,461 |
Restricted Stock Unit Awards | ||
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 6,093 | 5,959 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 3 Months Ended | 12 Months Ended | |
Jan. 10, 2023 USD ($) | Mar. 31, 2023 USD ($) Agreement | Dec. 31, 2022 USD ($) | |
Commitments And Contingencies [Line Items] | |||
Potential material losses from claims, legal proceedings probable of occurring | $ 0 | ||
Additional sought value for damages as part of requested modification | $ 66,000,000 | ||
Janssen Pharmaceutica N.V. | |||
Commitments And Contingencies [Line Items] | |||
Number of license agreements partially terminated | Agreement | 2 | ||
Potential back royalties to Alkermes related to arbitration | $ 194,000,000 |