Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 22, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2022 | |
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 | 163,426,943 | |
Document Fiscal Year Focus | 2022 | |
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, 2022 | Dec. 31, 2021 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 282,557 | $ 337,544 |
Receivables, net | 249,942 | 313,193 |
Investments—short-term | 246,315 | 198,767 |
Inventory | 154,786 | 150,335 |
Contract assets | 20,212 | 13,363 |
Prepaid expenses and other current assets | 61,018 | 48,967 |
Total current assets | 1,014,830 | 1,062,169 |
PROPERTY, PLANT AND EQUIPMENT, NET | 336,740 | 341,054 |
INVESTMENTS—LONG-TERM | 229,825 | 229,430 |
RIGHT-OF-USE ASSETS | 115,321 | 115,627 |
INTANGIBLE ASSETS, NET | 65,077 | 74,043 |
GOODWILL | 92,873 | 92,873 |
DEFERRED TAX ASSETS | 112,515 | 81,833 |
OTHER ASSETS | 10,664 | 27,455 |
TOTAL ASSETS | 1,977,845 | 2,024,484 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 173,126 | 208,491 |
Accrued sales discounts, allowances and reserves | 265,172 | 237,216 |
Operating lease liabilities—short-term | 16,144 | 16,240 |
Contract liabilities—short-term | 4,919 | 6,339 |
Current portion of long-term debt | 3,000 | 3,000 |
Total current liabilities | 462,361 | 471,286 |
LONG-TERM DEBT | 292,171 | 292,804 |
OPERATING LEASE LIABILITIES—LONG-TERM | 104,014 | 104,162 |
OTHER LONG-TERM LIABILITIES | 43,909 | 43,648 |
Total liabilities | 902,455 | 911,900 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 15) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; zero issued and outstanding at March 31, 2022 and December 31, 2021, respectively | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 167,743,842 and 165,790,549 shares issued; 163,212,411 and 161,937,327 shares outstanding at March 31, 2022 and December 31, 2021, respectively | 1,677 | 1,658 |
Treasury shares, at cost (4,531,431 and 3,853,222 shares at March 31, 2022 and December 31, 2021, respectively) | (159,727) | (142,658) |
Additional paid-in capital | 2,818,595 | 2,798,325 |
Accumulated other comprehensive loss | (8,234) | (3,723) |
Accumulated deficit | (1,576,921) | (1,541,018) |
Total shareholders’ equity | 1,075,390 | 1,112,584 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 1,977,845 | $ 2,024,484 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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 | 167,743,842 | 165,790,549 |
Ordinary shares, shares outstanding | 163,212,411 | 161,937,327 |
Treasury shares | 4,531,431 | 3,853,222 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
REVENUES: | ||
Total revenues | $ 278,545 | $ 251,430 |
EXPENSES: | ||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 55,159 | 41,020 |
Research and development | 95,953 | 92,268 |
Selling, general and administrative | 145,052 | 125,168 |
Amortization of acquired intangible assets | 8,966 | 9,406 |
Total expenses | 305,130 | 267,862 |
OPERATING LOSS | (26,585) | (16,432) |
OTHER EXPENSE, NET: | ||
Interest income | 573 | 864 |
Interest expense | (2,350) | (3,970) |
Change in the fair value of contingent consideration | (19,067) | 1,278 |
Other income (expense), net | 2,431 | (393) |
Total other expense, net | (18,413) | (2,221) |
LOSS BEFORE INCOME TAXES | (44,998) | (18,653) |
INCOME TAX (BENEFIT) PROVISION | (9,095) | 3,765 |
NET LOSS | $ (35,903) | $ (22,418) |
LOSS PER ORDINARY SHARE: | ||
Basic and diluted | $ (0.22) | $ (0.14) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||
Basic and diluted | 162,483 | 159,634 |
COMPREHENSIVE LOSS: | ||
Net loss | $ (35,903) | $ (22,418) |
Holding loss, net of a tax benefit of $(1,382) and $(174), respectively | (4,511) | (601) |
COMPREHENSIVE LOSS | (40,414) | (23,019) |
Product sales, net | ||
REVENUES: | ||
Total revenues | 171,268 | 129,963 |
Manufacturing and royalty revenues | ||
REVENUES: | ||
Total revenues | 105,170 | 119,847 |
License revenue | ||
REVENUES: | ||
Total revenues | 2,000 | 1,500 |
Research and development revenue | ||
REVENUES: | ||
Total revenues | $ 107 | $ 120 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Tax (benefit) provision | $ (1,382) | $ (174) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (35,903) | $ (22,418) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 19,197 | 19,643 |
Share-based compensation expense | 18,343 | 15,451 |
Deferred income taxes | (29,301) | 5,255 |
Change in the fair value of contingent consideration | 19,067 | (1,278) |
Loss on debt extinguishment | 171 | |
Payment made for debt modification | (248) | |
Other non-cash charges | 371 | 195 |
Changes in assets and liabilities: | ||
Receivables | 63,290 | 31,648 |
Contract assets | (6,849) | 5,122 |
Inventory | (4,285) | (8,652) |
Prepaid expenses and other assets | (15,351) | (16,807) |
Right-of-use assets | 4,129 | 4,177 |
Accounts payable and accrued expenses | (5,458) | (71,949) |
Contract liabilities | (2,980) | (1,243) |
Operating lease liabilities | (4,411) | (3,996) |
Other long-term liabilities | 1,819 | (217) |
Cash flows provided by (used in) operating activities | 21,678 | (45,146) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (7,791) | (7,986) |
Proceeds from the sale of equipment | 176 | |
Proceeds from contingent consideration | 501 | 6,430 |
Return of Fountain Healthcare Partners II, L.P. investment | 485 | |
Purchases of investments | (114,615) | (122,545) |
Sales and maturities of investments | 60,779 | 86,193 |
Cash flows used in investing activities | (60,641) | (37,732) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 1,795 | 2,053 |
Employee taxes paid related to net share settlement of equity awards | (17,069) | (10,413) |
Proceeds from the issuance of long-term debt | 23,567 | |
Payment made for debt extinguishment | (262) | |
Principal payments of long-term debt | (750) | |
Cash flows (used in) provided by financing activities | (16,024) | 14,945 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (54,987) | (67,933) |
CASH AND CASH EQUIVALENTS—Beginning of period | 337,544 | 272,961 |
CASH AND CASH EQUIVALENTS—End of period | 282,557 | 205,028 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 4,058 | $ 995 |
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, 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 | $ 18 | 2,035 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 1,566,685 | |||||
Receipt of Alkermes' shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (10,413) | $ (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) | (529,817) | |||||
Share-based compensation | 15,552 | 15,552 | ||||
Unrealized loss on marketable securities, net of tax (benefit) | (601) | (601) | ||||
Net 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, 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 loss on marketable securities, net of tax (benefit) | (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) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement Of Stockholders Equity [Abstract] | ||
Tax (benefit) | $ (1,382) | $ (174) |
The Company
The Company | 3 Months Ended |
Mar. 31, 2022 | |
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 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 | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 and 2021 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2021. 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, Reclassification The Company reclassified certain prior year amounts on the condensed consolidated balance sheet to conform to the current year presentation. These reclassifications had no impact on the previously reported total assets, liabilities or shareholders’ equity. 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, 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 and implemented quarantines, vaccine and masking mandates, restrictive executive orders and other similar government orders, restrictions, and recommendations for their residents to help control the spread of COVID-19, and may continue to do so while the pandemic persists. Such orders, mandates, restrictions and/or recommendations, and/or the perception that additional orders, mandates, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread interruptions and closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, remote work policies and travel restrictions, among other effects. The COVID-19 pandemic has caused, and the Company expects may continue to cause, varying degrees of disruption to its employees and its business operations. While the Company has continued to operate its manufacturing facilities and supply its medicines without interruption throughout the pandemic, it has at times during the pandemic experienced labor or supply chain disruptions at its manufacturing facilities, and may continue to experience such disruptions while the pandemic persists. In addition, while the Company has continued to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has at times impacted the timelines of certain of its 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, the potential impact of COVID-19 on its manufacturing operations and R&D activities. A number of the marketed products from which the Company derives revenue, including manufacturing and royalty revenue, are 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, travel restrictions, quarantine, testing and/or vaccine mandates and other protocols, labor shortages, 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. 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. 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 its current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic and the manner in which it continues to evolve, including the emergence, prevalence and severity of new or existing COVID-19 variants, and future developments in response thereto, which are highly uncertain and cannot be predicted as of the date of this Form 10-Q. 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. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 and 2021, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2022 2021 VIVITROL $ 84,854 $ 74,534 ARISTADA and ARISTADA INITIO 72,485 55,429 LYBALVI 13,929 — Total product sales, net $ 171,268 $ 129,963 Manufacturing and Royalty Revenues During the three months ended March 31, 2022 and 2021, the Company recorded manufacturing and royalty revenues as follows: 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 Three Months Ended March 31, 2021 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 61,570 $ 61,570 VUMERITY 2,448 10,992 13,440 RISPERDAL CONSTA 10,683 3,479 14,162 Other 11,954 18,721 30,675 $ 25,085 $ 94,762 $ 119,847 (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 in the U.S. of its license agreement with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson Corporation (“Janssen Pharmaceutica”) in respect of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, pursuant to which Janssen Pharmaceutica received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology. 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. and the Company stopped recognizing royalty revenue related to net sales of these products. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen Pharmaceutica’s partial termination of the license agreement in the U.S. and Janssen Pharmaceutica’s royalty and other obligations under the agreement. Refer to Note 15, Commitments and Contingencies within the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information regarding the arbitration proceedings with Janssen Pharmaceutica. Contract Assets Contract assets include unbilled amounts resulting from sales under certain of the Company’s manufacturing contracts where revenue is recognized over time, except for $5.0 million of expected consideration from the Company’s collaboration with Biogen related to VUMERITY. 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, 2022 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2021 $ 13,363 Additions 11,451 Transferred to receivables, net (4,602 ) Contract assets at March 31, 2022 $ 20,212 Contract Liabilities Contract liabilities consist of contractual obligations related to deferred revenue. Total contract liabilities at March 31, 2022 (In thousands) Contract Liabilities Contract liabilities at December 31, 2021 $ 17,830 Additions 83 Amounts recognized into revenue (3,063 ) Contract liabilities at March 31, 2022 $ 14,850 |
Investments
Investments | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 96,729 $ 16 $ (483 ) $ — $ 96,262 U.S. government and agency debt securities 83,261 7 (356 ) — 82,912 Non-U.S. government debt securities 67,533 14 (406 ) — 67,141 Total short-term investments 247,523 37 (1,245 ) — 246,315 Long-term investments: Available-for-sale securities: Corporate debt securities 132,275 — (3,055 ) — 129,220 U.S. government and agency debt securities 79,824 — (2,237 ) — 77,587 Non-U.S. government debt securities 21,801 — (414 ) (189 ) 21,198 233,900 — (5,706 ) (189 ) 228,005 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 235,720 — (5,706 ) (189 ) 229,825 Total investments $ 483,243 $ 37 $ (6,951 ) $ (189 ) $ 476,140 December 31, 2021 Short-term investments: Available-for-sale securities: Corporate debt securities $ 85,201 $ 177 $ (39 ) $ — $ 85,339 U.S. government and agency debt securities 45,349 35 (24 ) — 45,360 Non-U.S. government debt securities 68,046 75 (53 ) — 68,068 Total short-term investments 198,596 287 (116 ) — 198,767 Long-term investments: Available-for-sale securities: Corporate debt securities 111,793 — (654 ) — 111,139 U.S. government and agency debt securities 81,296 — (517 ) — 80,779 Non-U.S. government debt securities 35,902 — (210 ) — 35,692 228,991 — (1,381 ) — 227,610 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 230,811 — (1,381 ) — 229,430 Total investments $ 429,407 $ 287 $ (1,497 ) $ — $ 428,197 At March 31, 2022, 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, 2022, the aggregate estimated fair value of investments in an unrealized loss position was $445.1 million. In making the determination whether the decline in fair value of these securities were 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. In January 2022, the Company purchased a convertible promissory note in the amount of $0.5 million from Synchronicity Pharma, Inc., a related party, that matures on the earlier of September 30, 2022, the closing of a preferred equity financing, the closing of a merger, business combination or sale of stock resulting in Synchronicity’s stockholders owning less than 50% of the surviving entity, or an event of default. The convertible promissory note was classified as an available-for-sale corporate debt instrument. In May 2014, the Company entered into an agreement to invest in 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, 2022, the Company’s total contribution in Fountain was equal to €7.8 million, and its commitment represented approximately 7% of the partnership’s total funding. The Company is accounting for its investment in Fountain under the equity method. During the three months ended March 31, 2022, one of the companies within the Fountain portfolio was acquired by a third party. The Company’s proportional share of the proceeds from this transaction was $1.1 million, of which $1.0 million was received during the three months ended March 31, 2022 and the remaining $0.1 million was held in escrow. The transaction was accounted for under the cumulative earnings approach whereby the return on investment of $0.6 million was recorded as a gain within “Other expense, net” in the accompanying condensed consolidated statements of operations and comprehensive loss and the return of investment of $0.5 million was recorded as a reduction in the Company’s net investment in Fountain. The Company’s net investment in Fountain was $5.8 million and $6.1 million at March 31, 2022 and December 31, 2021, respectively, and was included within “Other assets” in the accompanying condensed consolidated balance sheets. During the three months ended March 31, 2022 and 2021, the Company recorded an increase of less than $0.1 million and a decrease of $0.3 million, respectively, in its investment in Fountain, which represented the Company’s proportional share of Fountain’s net gains or 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) 2022 2021 Proceeds from the sales and maturities of investments $ 60,779 $ 86,193 Realized gains $ — $ — Realized losses $ — $ — The Company’s available-for-sale and held-to-maturity securities at March 31, 2022 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 $ 247,523 $ 246,315 $ 1,820 $ 1,820 After 1 year through 5 years 233,900 228,005 — — Total $ 481,423 $ 474,320 $ 1,820 $ 1,820 |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 160,499 $ 130,612 $ 29,887 $ — Corporate debt securities 225,482 — 224,982 500 Non-U.S. government debt securities 88,339 — 88,339 — Contingent consideration 3,440 — — 3,440 Total $ 477,760 $ 130,612 $ 343,208 $ 3,940 December 31, 2021 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 126,139 $ 96,597 $ 29,542 $ — Corporate debt securities 196,478 — 196,478 — Non-U.S. government debt securities 103,760 — 103,760 — Contingent consideration 23,048 — — 23,048 Total $ 449,425 $ 96,597 $ 329,780 $ 23,048 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, 2022. The following table is a rollforward of the fair value of the Company’s investments with fair values that were determined using Level 3 inputs at March 31, 2022: (In thousands) Fair Value Balance, January 1, 2022 $ 23,048 Purchase of corporate debt security 500 Change in the fair value of contingent consideration (19,067 ) Milestone and royalty payments received by the Company related to contingent consideration (501 ) Royalty payments due to the Company related to contingent consideration (40 ) Balance, March 31, 2022 $ 3,940 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 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 certain contingent consideration from the Gainesville Transaction were assigned and/or transferred to Baudax. At March 31, 2022, the Company determined the fair value of the contingent consideration to be received as follows: • As of December 31, 2021, the Company had received $7.8 million in milestone payments and was due to receive an additional $38.6 million related to the FDA approval of the New Drug Application (“NDA”) for ANJESO. This amount is due in six equal, annual installments from March 2022 through March 2027. At March 31, 2022, Baudax had paid the Company $0.5 million of the $6.4 million payment that was due in March 2022; • The Company is entitled to receive future royalties on net sales of Meloxicam Products; and • The Company is entitled to receive payments of up to $80.0 million related to the achievement of certain sales milestones on future sales of the Meloxicam Products. At March 31, 2022, the Company did not believe it was probable that any of the sales milestones would be achieved. In Baudax’s Annual Report on Form 10-K for the year ended December 31, 2021, Baudax included disclosures regarding its ability to continue as a going concern and a subsequent event note that announced a plan to reduce expenses including an approximately 80% reduction in its workforce, effective in March 2022. In light of Baudax’s disclosures regarding its ability to continue as a going concern and the fact that Baudax paid $0.5 million of the $6.4 million that was due in March 2022, the Company has applied a 100% likelihood that Baudax would default on its obligations and applied a recovery rate of 9% based on an analysis performed by Standard and Poor’s regarding post-default recoveries. However, for avoidance of doubt, the Company has not waived its right to receive any portion of the payments owing by Baudax. For discussion on the calculation of the fair value of the contingent consideration at December 31, 2021, refer to Note 5, Fair Value within the “Notes to Consolidated Financial Statements” in the At March 31, 2022 and December 31, 2021, the Company determined that the fair value of the contingent consideration was $3.4 million and $23.0 million, respectively. At March 31, 2022 and December 31, 2021, $3.4 million and $6.4 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 none and $16.6 million, respectively, of the fair value of the contingent consideration was included within “Other assets” in the accompanying condensed consolidated balance sheets. Changes in the fair value of the contingent consideration are recorded within “Change in the fair value of contingent consideration” in the accompanying condensed consolidated statements of operations and comprehensive loss. The carrying amounts reflected in the 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 $285.1 million and $285.8 million at March 31, 2022 and December 31, 2021, respectively. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Raw materials $ 51,430 $ 56,125 Work in process 64,385 59,105 Finished goods ( 1) 38,971 35,105 Total inventory $ 154,786 $ 150,335 (1) At March 31, 2022 and December 31, 2021, the Company had $34.4 million and $25.1 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, 2022 | |
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) 2022 2021 Land $ 6,560 $ 6,560 Building and improvements 193,101 192,920 Furniture, fixtures and equipment 401,161 398,099 Leasehold improvements 52,526 52,526 Construction in progress 88,638 86,512 Subtotal 741,986 736,617 Less: accumulated depreciation (405,246 ) (395,563 ) Total property, plant and equipment, net $ 336,740 $ 341,054 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 (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 $ (414,132 ) $ 51,458 Capitalized IP 11-13 118,160 (104,541 ) 13,619 Total $ 583,750 $ (518,673 ) $ 65,077 Based on the Company’s most recent analysis, amortization of intangible assets included in the accompanying condensed consolidated balance sheet at March 31, 2022 is expected to be approximately $35.0 million, $35.0 million and $1.0 million in the years ending December 31, 2022 through 2024, respectively. Although the Company believes 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, 2022 | |
Leases [Abstract] | |
Leases | 9. LEASES Future lease payments under non-cancelable leases at March 31, 2022 and December 31, 2021 consisted of the following: March 31, December 31, (In thousands) 2022 2021 2022 $ 13,561 $ 17,991 2023 18,271 17,329 2024 18,541 17,535 2025 18,814 17,808 2026 14,783 13,777 Thereafter 95,293 95,229 Total operating lease payments $ 179,263 $ 179,669 Less: imputed interest (59,105 ) (59,267 ) Total operating lease liabilities $ 120,158 $ 120,402 At March 31, 2022, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 5.19% and 11.3 years, respectively. During the three months ended March 31, 2022 and 2021, cash paid for lease liabilities was $4.4 million and $3.7 million, respectively. The Company recorded operating lease expense of $4.1 million and $4.2 million during the three months ended March 31, 2022 and 2021, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Accounts payable $ 27,697 $ 55,721 Accrued compensation 54,413 77,256 Accrued other 91,016 75,514 Total accounts payable and accrued expenses $ 173,126 $ 208,491 A summary of the Company’s provisions for sales and allowances is as follows: March 31, December 31, (In thousands) 2022 2021 Medicaid rebates $ 224,216 $ 195,413 Product discounts 13,204 14,951 Medicare Part D 17,350 14,348 Other 10,402 12,504 Total accrued sales discounts, allowances and reserves $ 265,172 $ 237,216 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 11. LONG-TERM DEBT Long-term debt consisted of the following: March 31, December 31, (In thousands) 2022 2021 2026 Term Loans, due March 12, 2026 $ 295,171 $ 295,804 Less: current portion (3,000 ) (3,000 ) Long-term debt $ 292,171 $ 292,804 In March 2021, the Company amended and refinanced its existing term loans, resulting in the 2026 Term Loans (such refinancing, the “Term Loan Refinancing”). 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 have an incremental facility capacity in the amount of $175.0 million plus additional amounts, provided that the Company meets certain conditions, including a specified leverage ratio. The Company was in compliance with its debt covenants at March 31, 2022. Included in “Interest expense” in the accompanying condensed consolidated statement of operations and comprehensive loss in the three months ended March 31, 2021 is $2.1 million related to the Term Loan Refinancing. Refer to Note 11, Long-Term Debt |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Cost of goods manufactured and sold $ 2,382 $ 2,178 Research and development 5,608 4,063 Selling, general and administrative 10,353 9,210 Total share-based compensation expense $ 18,343 $ 15,451 At March 31, 2022 and December 31, 2021, $2.5 million and $2.3 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, 2022 | |
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, 2022 and 2021, 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) 2022 2021 Stock options 13,461 15,451 Restricted stock unit awards 5,959 2,877 Total 19,420 18,328 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. INCOME TAXES The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In determining future taxable income, the Company is responsible for assumptions utilized including the amount of Irish and non-Irish pre‑tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying business. During the three months ended March 31, 2022, the Company recorded an income tax benefit of $9.1 million, which was primarily due to a change to Section 174 of the Tax Cuts and Jobs Act of 2017 (as amended, the “TCJA”) which became effective on January 1, 2022. Under the TCJA, the Company is required to capitalize, and subsequently amortize R&D expenses over five years for research activities conducted in the U.S. and over fifteen years for research activities conducted outside of the U.S. The capitalization of R&D expenses resulted in an increase to the Company’s taxable income and foreign derived intangible income (“FDII”), resulting in a significant increase in the Company’s FDII deduction. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 15. COMMITMENTS AND CONTINGENT LIABILITIES Litigation From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At March 31, 2022, 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 On April 19, 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, it has a continuing obligation to pay royalties on sales in the U.S. of INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA, products developed under or enabled by these license agreements. The arbitration is to be conducted pursuant to the Institute for Conflict Prevention and Resolution (CPR) Rules for Non-Administered Arbitration. 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. 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”) and in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience 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 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. A trial was scheduled in the Tolmar Lawsuit for October 2022. The Pharmascience Lawsuit remains pending. 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 trial has been scheduled for October 2022. 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 the Company’s EP 2 269 577 B (the “EP ’577 Patent”), a patent directed to certain risperidone microsphere compositions, including RISPERDAL CONSTA. In April 2019, the EPO issued a written decision revoking the EP ’577 Patent and in June 2019, the Company filed a notice of appeal of the decision to the EPO’s Technical Boards of Appeal. The EP ’577 Patent has since expired, and in February 2022 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. 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. 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, 2022 | |
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, 2022 and 2021 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2021. 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, |
Reclassification | Reclassification The Company reclassified certain prior year amounts on the condensed consolidated balance sheet to conform to the current year presentation. These reclassifications had no impact on the previously reported total assets, liabilities or shareholders’ equity. |
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, 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 and implemented quarantines, vaccine and masking mandates, restrictive executive orders and other similar government orders, restrictions, and recommendations for their residents to help control the spread of COVID-19, and may continue to do so while the pandemic persists. Such orders, mandates, restrictions and/or recommendations, and/or the perception that additional orders, mandates, restrictions or recommendations could occur, have, at times during the pandemic, resulted in widespread interruptions and closures of businesses, including healthcare systems that serve people living with addiction and serious mental illness, work stoppages, slowdowns and/or delays, remote work policies and travel restrictions, among other effects. The COVID-19 pandemic has caused, and the Company expects may continue to cause, varying degrees of disruption to its employees and its business operations. While the Company has continued to operate its manufacturing facilities and supply its medicines without interruption throughout the pandemic, it has at times during the pandemic experienced labor or supply chain disruptions at its manufacturing facilities, and may continue to experience such disruptions while the pandemic persists. In addition, while the Company has continued to conduct R&D activities, including its ongoing clinical trials, the COVID-19 pandemic has at times impacted the timelines of certain of its 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, the potential impact of COVID-19 on its manufacturing operations and R&D activities. A number of the marketed products from which the Company derives revenue, including manufacturing and royalty revenue, are 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, travel restrictions, quarantine, testing and/or vaccine mandates and other protocols, labor shortages, 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. 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. 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 its current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic and the manner in which it continues to evolve, including the emergence, prevalence and severity of new or existing COVID-19 variants, and future developments in response thereto, which are highly uncertain and cannot be predicted as of the date of this Form 10-Q. |
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. |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Schedule of Contract Assets and Contract Liabilities | Total contract assets at March 31, 2022 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2021 $ 13,363 Additions 11,451 Transferred to receivables, net (4,602 ) Contract assets at March 31, 2022 $ 20,212 Total contract liabilities at March 31, 2022 (In thousands) Contract Liabilities Contract liabilities at December 31, 2021 $ 17,830 Additions 83 Amounts recognized into revenue (3,063 ) Contract liabilities at March 31, 2022 $ 14,850 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three months ended March 31, 2022 and 2021, the Company recorded product sales, net, as follows: Three Months Ended March 31, (In thousands) 2022 2021 VIVITROL $ 84,854 $ 74,534 ARISTADA and ARISTADA INITIO 72,485 55,429 LYBALVI 13,929 — Total product sales, net $ 171,268 $ 129,963 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three months ended March 31, 2022 and 2021, the Company recorded manufacturing and royalty revenues as follows: 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 Three Months Ended March 31, 2021 (In thousands) Manufacturing Revenue Royalty Revenue Total Long-acting INVEGA products (1) $ — $ 61,570 $ 61,570 VUMERITY 2,448 10,992 13,440 RISPERDAL CONSTA 10,683 3,479 14,162 Other 11,954 18,721 30,675 $ 25,085 $ 94,762 $ 119,847 (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, 2022 | |
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, 2022 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: Corporate debt securities $ 96,729 $ 16 $ (483 ) $ — $ 96,262 U.S. government and agency debt securities 83,261 7 (356 ) — 82,912 Non-U.S. government debt securities 67,533 14 (406 ) — 67,141 Total short-term investments 247,523 37 (1,245 ) — 246,315 Long-term investments: Available-for-sale securities: Corporate debt securities 132,275 — (3,055 ) — 129,220 U.S. government and agency debt securities 79,824 — (2,237 ) — 77,587 Non-U.S. government debt securities 21,801 — (414 ) (189 ) 21,198 233,900 — (5,706 ) (189 ) 228,005 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 235,720 — (5,706 ) (189 ) 229,825 Total investments $ 483,243 $ 37 $ (6,951 ) $ (189 ) $ 476,140 December 31, 2021 Short-term investments: Available-for-sale securities: Corporate debt securities $ 85,201 $ 177 $ (39 ) $ — $ 85,339 U.S. government and agency debt securities 45,349 35 (24 ) — 45,360 Non-U.S. government debt securities 68,046 75 (53 ) — 68,068 Total short-term investments 198,596 287 (116 ) — 198,767 Long-term investments: Available-for-sale securities: Corporate debt securities 111,793 — (654 ) — 111,139 U.S. government and agency debt securities 81,296 — (517 ) — 80,779 Non-U.S. government debt securities 35,902 — (210 ) — 35,692 228,991 — (1,381 ) — 227,610 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 230,811 — (1,381 ) — 229,430 Total investments $ 429,407 $ 287 $ (1,497 ) $ — $ 428,197 |
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) 2022 2021 Proceeds from the sales and maturities of investments $ 60,779 $ 86,193 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, 2022 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 $ 247,523 $ 246,315 $ 1,820 $ 1,820 After 1 year through 5 years 233,900 228,005 — — Total $ 481,423 $ 474,320 $ 1,820 $ 1,820 |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 160,499 $ 130,612 $ 29,887 $ — Corporate debt securities 225,482 — 224,982 500 Non-U.S. government debt securities 88,339 — 88,339 — Contingent consideration 3,440 — — 3,440 Total $ 477,760 $ 130,612 $ 343,208 $ 3,940 December 31, 2021 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 126,139 $ 96,597 $ 29,542 $ — Corporate debt securities 196,478 — 196,478 — Non-U.S. government debt securities 103,760 — 103,760 — Contingent consideration 23,048 — — 23,048 Total $ 449,425 $ 96,597 $ 329,780 $ 23,048 |
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 investments with fair values that were determined using Level 3 inputs at March 31, 2022: (In thousands) Fair Value Balance, January 1, 2022 $ 23,048 Purchase of corporate debt security 500 Change in the fair value of contingent consideration (19,067 ) Milestone and royalty payments received by the Company related to contingent consideration (501 ) Royalty payments due to the Company related to contingent consideration (40 ) Balance, March 31, 2022 $ 3,940 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Raw materials $ 51,430 $ 56,125 Work in process 64,385 59,105 Finished goods ( 1) 38,971 35,105 Total inventory $ 154,786 $ 150,335 (1) At March 31, 2022 and December 31, 2021, the Company had $34.4 million and $25.1 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, 2022 | |
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) 2022 2021 Land $ 6,560 $ 6,560 Building and improvements 193,101 192,920 Furniture, fixtures and equipment 401,161 398,099 Leasehold improvements 52,526 52,526 Construction in progress 88,638 86,512 Subtotal 741,986 736,617 Less: accumulated depreciation (405,246 ) (395,563 ) Total property, plant and equipment, net $ 336,740 $ 341,054 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: March 31, 2022 (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 $ (414,132 ) $ 51,458 Capitalized IP 11-13 118,160 (104,541 ) 13,619 Total $ 583,750 $ (518,673 ) $ 65,077 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases at March 31, 2022 and December 31, 2021 consisted of the following: March 31, December 31, (In thousands) 2022 2021 2022 $ 13,561 $ 17,991 2023 18,271 17,329 2024 18,541 17,535 2025 18,814 17,808 2026 14,783 13,777 Thereafter 95,293 95,229 Total operating lease payments $ 179,263 $ 179,669 Less: imputed interest (59,105 ) (59,267 ) Total operating lease liabilities $ 120,158 $ 120,402 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Accounts payable $ 27,697 $ 55,721 Accrued compensation 54,413 77,256 Accrued other 91,016 75,514 Total accounts payable and accrued expenses $ 173,126 $ 208,491 |
Summary of Provision for Sales and Allowances | A summary of the Company’s provisions for sales and allowances is as follows: March 31, December 31, (In thousands) 2022 2021 Medicaid rebates $ 224,216 $ 195,413 Product discounts 13,204 14,951 Medicare Part D 17,350 14,348 Other 10,402 12,504 Total accrued sales discounts, allowances and reserves $ 265,172 $ 237,216 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: March 31, December 31, (In thousands) 2022 2021 2026 Term Loans, due March 12, 2026 $ 295,171 $ 295,804 Less: current portion (3,000 ) (3,000 ) Long-term debt $ 292,171 $ 292,804 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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) 2022 2021 Cost of goods manufactured and sold $ 2,382 $ 2,178 Research and development 5,608 4,063 Selling, general and administrative 10,353 9,210 Total share-based compensation expense $ 18,343 $ 15,451 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net 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) 2022 2021 Stock options 13,461 15,451 Restricted stock unit awards 5,959 2,877 Total 19,420 18,328 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2022segment | |
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, 2022 | Mar. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 278,545 | $ 251,430 |
VIVITROL | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 84,854 | 74,534 |
ARISTADA and ARISTADA INITIO | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 72,485 | 55,429 |
LYBALVI | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 13,929 | |
Product sales, net | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 171,268 | $ 129,963 |
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, 2022 | Mar. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 278,545 | $ 251,430 |
Manufacturing Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 38,827 | 25,085 |
Manufacturing Revenue | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 11,395 | 2,448 |
Manufacturing Revenue | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 15,578 | 10,683 |
Manufacturing Revenue | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 11,854 | 11,954 |
Royalty | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 66,343 | 94,762 |
Royalty | Long-Acting INVEGA Products | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 37,054 | 61,570 |
Royalty | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 19,200 | 10,992 |
Royalty | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 1,848 | 3,479 |
Royalty | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 8,241 | 18,721 |
Manufacturing and royalty revenues | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 105,170 | 119,847 |
Manufacturing and royalty revenues | Long-Acting INVEGA Products | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 37,054 | 61,570 |
Manufacturing and royalty revenues | VUMERITY | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 30,595 | 13,440 |
Manufacturing and royalty revenues | RISPERDAL CONSTA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | 17,426 | 14,162 |
Manufacturing and royalty revenues | Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 20,095 | $ 30,675 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Contract assets | $ 20,212 | $ 13,363 |
VUMERITY | Biogen | ||
Disaggregation Of Revenue [Line Items] | ||
Contract assets | $ 5,000 | |
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, 2022USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 13,363 |
Additions | 11,451 |
Transferred to receivables, net | (4,602) |
Contract assets at end of period | 20,212 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 17,830 |
Additions | 83 |
Amounts recognized into revenue | (3,063) |
Contract liabilities at end of the period | $ 14,850 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Available-for-sale securities: | ||
Amortized Cost | $ 481,423 | |
Estimated Fair Value | 474,320 | |
Held-to-maturity securities: | ||
Estimated Fair Value | 1,820 | |
Long-term Investments | ||
Amortized Cost | 235,720 | $ 230,811 |
Gross Unrealized Losses, Less than One Year | (5,706) | (1,381) |
Gross Unrealized Losses, Greater than One Year | (189) | |
Total long-term investments | 229,825 | 229,430 |
Total investments | ||
Amortized Cost | 483,243 | 429,407 |
Gross Unrealized Gains | 37 | 287 |
Gross Unrealized Losses, Less than One Year | (6,951) | (1,497) |
Gross Unrealized Losses, Greater than One Year | (189) | |
Estimated Fair Value | 476,140 | 428,197 |
Short-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 247,523 | 198,596 |
Gross Unrealized Gains | 37 | 287 |
Gross Unrealized Losses, Less than One Year | (1,245) | (116) |
Estimated Fair Value | 246,315 | 198,767 |
Short-term investments | Corporate debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 96,729 | 85,201 |
Gross Unrealized Gains | 16 | 177 |
Gross Unrealized Losses, Less than One Year | (483) | (39) |
Estimated Fair Value | 96,262 | 85,339 |
Short-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 83,261 | 45,349 |
Gross Unrealized Gains | 7 | 35 |
Gross Unrealized Losses, Less than One Year | (356) | (24) |
Estimated Fair Value | 82,912 | 45,360 |
Short-term investments | Non-U.S. government debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 67,533 | 68,046 |
Gross Unrealized Gains | 14 | 75 |
Gross Unrealized Losses, Less than One Year | (406) | (53) |
Estimated Fair Value | 67,141 | 68,068 |
Long-term investments | ||
Available-for-sale securities: | ||
Amortized Cost | 233,900 | 228,991 |
Gross Unrealized Losses, Less than One Year | (5,706) | (1,381) |
Gross Unrealized Losses, Greater than One Year | (189) | |
Estimated Fair Value | 228,005 | 227,610 |
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 | 132,275 | 111,793 |
Gross Unrealized Losses, Less than One Year | (3,055) | (654) |
Estimated Fair Value | 129,220 | 111,139 |
Long-term investments | U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 79,824 | 81,296 |
Gross Unrealized Losses, Less than One Year | (2,237) | (517) |
Estimated Fair Value | 77,587 | 80,779 |
Long-term investments | Non-U.S. government debt securities | ||
Available-for-sale securities: | ||
Amortized Cost | 21,801 | 35,902 |
Gross Unrealized Losses, Less than One Year | (414) | (210) |
Gross Unrealized Losses, Greater than One Year | (189) | |
Estimated Fair Value | $ 21,198 | $ 35,692 |
Investments - Additional Inform
Investments - Additional Information (Details) € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jan. 31, 2022USD ($) | Mar. 31, 2022USD ($)Portfolio | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Mar. 31, 2022EUR (€) | |
Investment Holdings [Line Items] | |||||
Aggregate estimated fair value of investments in unrealized loss position | $ 445,100,000 | ||||
Return of Fountain Healthcare Partners II, L.P. investment | $ 485,000 | ||||
Synchronicity Pharma Inc | Investee | Maximum | |||||
Investment Holdings [Line Items] | |||||
Equity method investment percentage | 50.00% | ||||
Synchronicity Pharma Inc | Convertible Promissory Notes | Investee | |||||
Investment Holdings [Line Items] | |||||
Purchase of convertible promissory notes | $ 500,000 | ||||
Convertible promissory notes, maturity date | Sep. 30, 2022 | ||||
Fountain Healthcare Partners II | |||||
Investment Holdings [Line Items] | |||||
Funding commitment as percentage of partnership's total funding | 7.00% | 7.00% | |||
Equity method commitment | € | € 7.8 | ||||
Number of portfolio sold | Portfolio | 1 | ||||
Proceeds from sale of portfolio | $ 1,000,000 | $ 1,100,000 | |||
Escrow deposit | 100,000 | ||||
Gain (loss) on sale of investment | $ (300,000) | ||||
Return of Fountain Healthcare Partners II, L.P. investment | 500,000 | ||||
Fountain Healthcare Partners II | Other Assets | |||||
Investment Holdings [Line Items] | |||||
Carrying value of equity investment | 5,800,000 | $ 6,100,000 | |||
Fountain Healthcare Partners II | Other Expense, Net | |||||
Investment Holdings [Line Items] | |||||
Gain (loss) on sale of investment | 600,000 | ||||
Fountain Healthcare Partners II | Maximum | |||||
Investment Holdings [Line Items] | |||||
Gain (loss) on sale of investment | $ 100,000 |
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 | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Investments Debt And Equity Securities [Abstract] | ||
Sales and maturities of investments | $ 60,779 | $ 86,193 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 247,523 |
After 1 year through 5 years | 233,900 |
Amortized Cost | 481,423 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 246,315 |
After 1 year through 5 years | 228,005 |
Total | 474,320 |
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, 2022 | Dec. 31, 2021 |
Fair value | ||
Debt securities | $ 474,320 | |
Contingent consideration | 3,400 | $ 23,000 |
Recurring Basis | ||
Fair value | ||
Contingent consideration | 3,440 | 23,048 |
Assets, Total | 477,760 | 449,425 |
Recurring Basis | Level 1 | ||
Fair value | ||
Assets, Total | 130,612 | 96,597 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 343,208 | 329,780 |
Recurring Basis | Level 3 | ||
Fair value | ||
Contingent consideration | 3,440 | 23,048 |
Assets, Total | 3,940 | 23,048 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 160,499 | 126,139 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 130,612 | 96,597 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 29,887 | 29,542 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 225,482 | 196,478 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 224,982 | 196,478 |
Corporate debt securities | Recurring Basis | Level 3 | ||
Fair value | ||
Debt securities | 500 | |
Non-U.S. government debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 88,339 | 103,760 |
Non-U.S. government debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 88,339 | $ 103,760 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022USD ($)Installment | Dec. 31, 2021USD ($) | |
Fair Value | ||
Transfers between Level 1 to Level 2 | $ 0 | |
Transfers between Level 2 to Level 1 | 0 | |
Milestone payments received | $ 7,800,000 | |
Milestone payment receivable | $ 38,600,000 | |
Number of equal annual installments milestone payment | Installment | 6 | |
Contingent consideration | $ 3,400,000 | 23,000,000 |
Contingent consideration included within prepaid expenses and other current assets | 3,400,000 | 6,400,000 |
Contingent consideration included within other assets | 0 | 16,600,000 |
2026 Term Loans | ||
Fair Value | ||
Amount to be realized in future | 285,100,000 | $ 285,800,000 |
Baudax | ||
Fair Value | ||
Milestone payments received | 500,000 | |
Milestone payment receivable | $ 6,400,000 | |
Percentage of reduction in workforce planned | 80.00% | |
Weighting percentage of default on obligations | 100.00% | |
Percentage of discount recovery rate | 9.00% | |
Baudax | Maximum | ||
Fair Value | ||
Milestone payment receivable | $ 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 | 3 Months Ended |
Mar. 31, 2022USD ($) | |
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 | $ 23,048 |
Purchase of corporate debt security | 500 |
Milestone and royalty payments received by the Company related to contingent consideration | (501) |
Royalty payments due to the Company related to contingent consideration | (40) |
Balance at the end of the period | 3,940 |
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 | $ (19,067) |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 51,430 | $ 56,125 | |
Work in process | 64,385 | 59,105 | |
Finished goods | [1] | 38,971 | 35,105 |
Total inventory | $ 154,786 | $ 150,335 | |
[1] | At March 31, 2022 and December 31, 2021, the Company had $34.4 million and $25.1 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 34.4 | $ 25.1 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 741,986 | $ 736,617 |
Less: accumulated depreciation | (405,246) | (395,563) |
Total property, plant and equipment, net | 336,740 | 341,054 |
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 | 193,101 | 192,920 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 401,161 | 398,099 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 52,526 | 52,526 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 88,638 | $ 86,512 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Goodwill | ||
Gross Carrying Amount | $ 92,873 | |
Net Carrying Amount | 92,873 | $ 92,873 |
Finite-lived intangible assets: | ||
Gross Carrying Amount | 583,750 | |
Accumulated Amortization | (518,673) | |
Net Carrying Amount | $ 65,077 | $ 74,043 |
Collaboration agreements | ||
Finite-lived intangible assets: | ||
Weighted Amortizable Life | 12 years | |
Gross Carrying Amount | $ 465,590 | |
Accumulated Amortization | (414,132) | |
Net Carrying Amount | 51,458 | |
Capitalized IP | ||
Finite-lived intangible assets: | ||
Gross Carrying Amount | 118,160 | |
Accumulated Amortization | (104,541) | |
Net Carrying Amount | $ 13,619 | |
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, 2022USD ($) |
Expected amortization of intangible assets | |
2022 | $ 35 |
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, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Remainder of fiscal year | $ 13,561 | |
Year 1 | 18,271 | $ 17,991 |
Year 2 | 18,541 | 17,329 |
Year 3 | 18,814 | 17,535 |
Year 4 | 14,783 | 17,808 |
Year 5 | 13,777 | |
Thereafter | 95,229 | |
Thereafter | 95,293 | |
Total operating lease payments | 179,263 | 179,669 |
Less: imputed interest | (59,105) | (59,267) |
Total operating lease liabilities | $ 120,158 | $ 120,402 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Leases [Abstract] | ||
Weighted average incremental borrowing rate | 5.19% | |
Weighted average remaining lease term | 11 years 3 months 18 days | |
Payments for operating leases | $ 4.4 | $ 3.7 |
Operating lease expense | $ 4.1 | $ 4.2 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 27,697 | $ 55,721 |
Accrued compensation | 54,413 | 77,256 |
Accrued other | 91,016 | 75,514 |
Total accounts payable and accrued expenses | $ 173,126 | $ 208,491 |
Accounts Payable and Accrued _4
Accounts Payable and Accrued Expenses - Summary of Provision for Sales and Allowances (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Accounts Payable And Accrued Expenses [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 265,172 | $ 237,216 |
Medicaid Rebate | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 224,216 | 195,413 |
Product Discounts | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 13,204 | 14,951 |
Medicare Part D | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 17,350 | 14,348 |
Other | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 10,402 | $ 12,504 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Long-term debt | ||
Less: current portion | $ (3,000) | $ (3,000) |
Long-term debt | 292,171 | 292,804 |
2026 Term Loans, due March 12, 2026 | ||
Long-term debt | ||
Term Loans | 295,171 | 295,804 |
Less: current portion | (3,000) | (3,000) |
Long-term debt | $ 292,171 | $ 292,804 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Interest Expense | ||
Long-term debt | ||
Refinancing charges | $ 2.1 | |
2026 Term Loans | ||
Long-term debt | ||
Due date of loan | Mar. 12, 2026 | |
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% |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based compensation Expense | ||
Total share-based compensation expense | $ 18,343 | $ 15,451 |
Cost of goods manufactured and sold | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 2,382 | 2,178 |
Research and development | ||
Share-based compensation Expense | ||
Total share-based compensation expense | 5,608 | 4,063 |
Selling, general and administrative | ||
Share-based compensation Expense | ||
Total share-based compensation expense | $ 10,353 | $ 9,210 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Share based compensation cost capitalized | $ 2.5 | $ 2.3 |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 19,420 | 18,328 |
Stock Options | ||
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 13,461 | 15,451 |
Restricted Stock Unit Awards | ||
Denominator: | ||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 5,959 | 2,877 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit | $ 9,095 | $ (3,765) |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 1 Months Ended | 3 Months Ended |
Sep. 30, 2020 | Mar. 31, 2022USD ($)Agreement | |
Commitments And Contingencies [Line Items] | ||
Potential material losses from claims, legal proceedings probable of occurring | $ | $ 0 | |
Maximum number of months before FDA can approve patent request | 30 months | |
EP ’577 Patent | ||
Commitments And Contingencies [Line Items] | ||
Proceedings termination date | Feb. 28, 2022 | |
Janssen Pharmaceutica N.V. | ||
Commitments And Contingencies [Line Items] | ||
Number of license agreements partially terminated | Agreement | 2 |