Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 19, 2024 | |
Cover [Abstract] | ||
Entity Registrant Name | Alkermes plc. | |
Entity Central Index Key | 0001520262 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2024 | |
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 | 164,668,329 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ALKS | |
Entity File Number | 001-35299 | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 98-1007018 | |
Entity Address, Address Line One | Connaught House | |
Entity Address, Address Line Two | 1 Burlington Road | |
Entity Address, City or Town | Dublin 4 | |
Entity Address, Country | IE | |
Entity Address, Postal Zip Code | D04 C5Y6 | |
City Area Code | 353 | |
Local Phone Number | 1-772-8000 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Ordinary shares, $0.01 par value | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 535,150 | $ 457,469 |
Receivables, net | 366,415 | 332,477 |
Investments—short-term | 340,967 | 316,022 |
Inventory | 194,731 | 186,406 |
Contract assets | 3,492 | 706 |
Prepaid expenses and other current assets | 101,435 | 98,166 |
Assets held for sale | 94,260 | |
Total current assets | 1,542,190 | 1,485,506 |
PROPERTY, PLANT AND EQUIPMENT, NET | 222,738 | 226,943 |
RIGHT-OF-USE ASSETS | 87,889 | 91,460 |
INVESTMENTS—LONG-TERM | 86,402 | 39,887 |
INTANGIBLE ASSETS, NET AND GOODWILL | 83,945 | 85,018 |
DEFERRED TAX ASSETS | 167,382 | 195,888 |
OTHER ASSETS | 16,296 | 11,521 |
TOTAL ASSETS | 2,206,842 | 2,136,223 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 239,774 | 240,561 |
Accrued sales discounts, allowances and reserves | 263,457 | 263,641 |
Operating lease liabilities—short-term | 6,007 | 5,746 |
Contract liabilities—short-term | 3,311 | 2,730 |
Current portion of long-term debt | 3,000 | 3,000 |
Liabilities related to discontinued operations | 4,542 | |
Total current liabilities | 515,549 | 520,220 |
LONG-TERM DEBT | 286,459 | 287,730 |
OPERATING LEASE LIABILITIES—LONG-TERM | 72,535 | 75,709 |
OTHER LONG-TERM LIABILITIES | 48,294 | 49,878 |
Total liabilities | 922,837 | 933,537 |
COMMITMENTS AND CONTINGENT LIABILITIES (Note 17) | ||
SHAREHOLDERS’ EQUITY: | ||
Preferred shares, par value, $0.01 per share; 50,000,000 shares authorized; and zero issued and outstanding at June 30, 2024 and December 31, 2023 | ||
Ordinary shares, par value, $0.01 per share; 450,000,000 shares authorized; 175,959,272 and 172,569,051 shares issued; and 165,886,689 and 166,979,833 shares outstanding at June 30, 2024 and December 31, 2023, respectively | 1,760 | 1,726 |
Treasury shares, at cost (10,072,583 and 5,589,218 shares at June 30, 2024 and December 31, 2023, respectively) | (303,025) | (189,336) |
Additional paid-in capital | 2,804,202 | 2,736,934 |
Accumulated other comprehensive loss | (3,590) | (3,110) |
Accumulated deficit | (1,215,342) | (1,343,528) |
Total shareholders’ equity | 1,284,005 | 1,202,686 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 2,206,842 | $ 2,136,223 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (unaudited) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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 | 175,959,272 | 172,569,051 |
Ordinary shares, shares outstanding | 165,886,689 | 166,979,833 |
Treasury shares | 10,072,583 | 5,589,218 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
REVENUES: | ||||
Total revenues | $ 399,131 | $ 617,397 | $ 749,503 | $ 904,992 |
EXPENSES: | ||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 61,472 | 63,249 | 120,116 | 121,413 |
Research and development | 59,649 | 68,225 | 127,260 | 131,995 |
Selling, general and administrative | 168,113 | 195,756 | 347,862 | 363,589 |
Amortization of acquired intangible assets | 14 | 8,898 | 1,073 | 17,698 |
Total expenses | 289,248 | 336,128 | 596,311 | 634,695 |
OPERATING INCOME FROM CONTINUING OPERATIONS | 109,883 | 281,269 | 153,192 | 270,297 |
OTHER INCOME, NET: | ||||
Interest income | 10,735 | 6,769 | 20,134 | 11,735 |
Interest expense | (5,952) | (5,684) | (11,930) | (10,972) |
Other income (expense), net | 2,053 | (525) | 2,235 | (564) |
Total other income, net | 6,836 | 560 | 10,439 | 199 |
INCOME BEFORE INCOME TAXES | 116,719 | 281,829 | 163,631 | 270,496 |
INCOME TAX PROVISION | 22,061 | 2,728 | 30,025 | 3,445 |
NET INCOME FROM CONTINUING OPERATIONS | 94,658 | 279,101 | 133,606 | 267,051 |
DISCONTINUED OPERATIONS, NET OF TAX | (3,300) | (42,036) | (5,420) | (71,831) |
NET INCOME | $ 91,358 | $ 237,065 | $ 128,186 | $ 195,220 |
EARNINGS (LOSS) PER ORDINARY SHARE: | ||||
Earnings per ordinary share from continuing operations - basic | $ 0.56 | $ 1.68 | $ 0.79 | $ 1.61 |
Loss per ordinary share from discontinued operations - basic | (0.02) | (0.25) | (0.03) | (0.43) |
Earnings per ordinary share - basic | 0.54 | 1.43 | 0.76 | 1.18 |
Earnings per ordinary share from continuing operations - diluted | 0.55 | 1.63 | 0.78 | 1.56 |
Loss per ordinary share from discontinued operations - diluted | (0.02) | (0.25) | (0.03) | (0.42) |
Earnings per ordinary share - diluted | $ 0.53 | $ 1.38 | $ 0.75 | $ 1.14 |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: | ||||
Basic | 168,321 | 166,279 | 168,152 | 165,686 |
Diluted | 170,977 | 171,553 | 171,960 | 170,747 |
COMPREHENSIVE INCOME: | ||||
Net income | $ 91,358 | $ 237,065 | $ 128,186 | $ 195,220 |
Holding gain (loss), net of a tax (benefit) provision of $(8), $99, $(83) and $587, respectively | 11 | 692 | (480) | 3,452 |
COMPREHENSIVE INCOME | 91,369 | 237,757 | 127,706 | 198,672 |
Product sales, net | ||||
REVENUES: | ||||
Total revenues | 269,273 | 231,477 | 502,809 | 446,204 |
Manufacturing and royalty revenues | ||||
REVENUES: | ||||
Total revenues | $ 129,858 | 385,913 | 246,691 | 458,775 |
Research and development revenue | ||||
REVENUES: | ||||
Total revenues | $ 7 | $ 3 | $ 13 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||||
Tax provision (benefit) | $ (8) | $ (75) | $ 99 | $ 488 | $ (83) | $ 587 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 128,186 | $ 195,220 |
Adjustments to reconcile net income to cash flows from operating activities: | ||
Depreciation and amortization | 14,714 | 37,725 |
Share-based compensation expense | 53,356 | 51,147 |
Deferred income taxes | 21,724 | (38,137) |
Gain on sale of the Athlone Facility | (1,462) | |
Other non-cash charges | 2,136 | 691 |
Changes in assets and liabilities: | ||
Receivables | (33,939) | (46,511) |
Contract assets | (2,786) | 8,929 |
Inventory | (9,538) | (6,879) |
Prepaid expenses and other assets | (1,206) | (774) |
Right-of-use assets | 3,571 | 8,498 |
Accounts payable and accrued expenses | (1,930) | 19,995 |
Accrued sales discounts, allowances and reserves | (185) | (29,347) |
Contract liabilities | (1,463) | (5,032) |
Operating lease liabilities | (5,049) | (8,471) |
Other long-term liabilities | 1,009 | 7,354 |
Cash flows provided by operating activities | 167,138 | 194,408 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Additions of property, plant and equipment | (15,453) | (16,565) |
Proceeds from the sale of equipment | 434 | 3 |
Proceeds from the sale of the Athlone Facility | 97,933 | |
Purchases of investments | (209,962) | (30,284) |
Sales and maturities of investments | 138,947 | 240,544 |
Cash flows provided by investing activities | 11,899 | 193,698 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements | 13,833 | 12,000 |
Employee taxes paid related to net share settlement of equity awards | (29,000) | (25,284) |
Payment for the repurchase of ordinary shares | (84,689) | |
Principal payments of long-term debt | (1,500) | (1,500) |
Cash flows used in financing activities | (101,356) | (14,784) |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 77,681 | 373,322 |
CASH AND CASH EQUIVALENTS—Beginning of period | 457,469 | 292,473 |
CASH AND CASH EQUIVALENTS—End of period | 535,150 | 665,795 |
Non-cash investing and financing activities: | ||
Purchased capital expenditures included in accounts payable and accrued expenses | $ 1,649 | $ 4,863 |
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, 2022 | $ 1,043,753 | $ 1,690 | $ 2,913,099 | $ (10,889) | $ (1,699,285) | $ (160,862) |
BALANCE (in shares) at Dec. 31, 2022 | 168,951,193 | (4,574,184) | ||||
Issuance of ordinary shares under employee stock plans | 2,874 | $ 25 | 2,849 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 2,567,603 | |||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (24,744) | $ (24,744) | ||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (885,652) | |||||
Share-based compensation | 22,778 | 22,778 | ||||
Unrealized gain (loss) on marketable securities, net of tax benefit | 2,760 | 2,760 | ||||
Net Income (Loss) | (41,845) | (41,845) | ||||
BALANCE at Mar. 31, 2023 | 1,005,576 | $ 1,715 | 2,938,726 | (8,129) | (1,741,130) | $ (185,606) |
BALANCE (in shares) at Mar. 31, 2023 | 171,518,796 | (5,459,836) | ||||
BALANCE at Dec. 31, 2022 | 1,043,753 | $ 1,690 | 2,913,099 | (10,889) | (1,699,285) | $ (160,862) |
BALANCE (in shares) at Dec. 31, 2022 | 168,951,193 | (4,574,184) | ||||
Unrealized gain (loss) on marketable securities, net of tax benefit | 3,452 | |||||
Net Income (Loss) | 195,220 | |||||
BALANCE at Jun. 30, 2023 | 1,280,437 | $ 1,720 | 2,976,365 | (7,437) | (1,504,065) | $ (186,146) |
BALANCE (in shares) at Jun. 30, 2023 | 171,975,901 | (5,477,613) | ||||
BALANCE at Mar. 31, 2023 | 1,005,576 | $ 1,715 | 2,938,726 | (8,129) | (1,741,130) | $ (185,606) |
BALANCE (in shares) at Mar. 31, 2023 | 171,518,796 | (5,459,836) | ||||
Issuance of ordinary shares under employee stock plans | 9,126 | $ 5 | 9,121 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 457,105 | |||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (540) | $ (540) | ||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (17,777) | |||||
Share-based compensation | 28,518 | 28,518 | ||||
Unrealized gain (loss) on marketable securities, net of tax benefit | 692 | 692 | ||||
Net Income (Loss) | 237,065 | 237,065 | ||||
BALANCE at Jun. 30, 2023 | 1,280,437 | $ 1,720 | 2,976,365 | (7,437) | (1,504,065) | $ (186,146) |
BALANCE (in shares) at Jun. 30, 2023 | 171,975,901 | (5,477,613) | ||||
BALANCE at Dec. 31, 2023 | 1,202,686 | $ 1,726 | 2,736,934 | (3,110) | (1,343,528) | $ (189,336) |
BALANCE (in shares) at Dec. 31, 2023 | 172,569,051 | (5,589,218) | ||||
Issuance of ordinary shares under employee stock plans | 11,226 | $ 31 | 11,195 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 3,165,169 | |||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (28,349) | $ (28,349) | ||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (960,486) | |||||
Share-based compensation | 32,863 | 32,863 | ||||
Unrealized gain (loss) on marketable securities, net of tax benefit | (491) | (491) | ||||
Net Income (Loss) | 36,828 | 36,828 | ||||
BALANCE at Mar. 31, 2024 | 1,254,763 | $ 1,757 | 2,780,992 | (3,601) | (1,306,700) | $ (217,685) |
BALANCE (in shares) at Mar. 31, 2024 | 175,734,220 | (6,549,704) | ||||
BALANCE at Dec. 31, 2023 | 1,202,686 | $ 1,726 | 2,736,934 | (3,110) | (1,343,528) | $ (189,336) |
BALANCE (in shares) at Dec. 31, 2023 | 172,569,051 | (5,589,218) | ||||
Repurchase of Alkermes' ordinary shares | $ (84,700) | |||||
Repurchase of Alkermes' ordinary shares (in shares) | (3,500,000) | |||||
Unrealized gain (loss) on marketable securities, net of tax benefit | $ (480) | |||||
Net Income (Loss) | 128,186 | |||||
BALANCE at Jun. 30, 2024 | 1,284,005 | $ 1,760 | 2,804,202 | (3,590) | (1,215,342) | $ (303,025) |
BALANCE (in shares) at Jun. 30, 2024 | 175,959,272 | (10,072,583) | ||||
BALANCE at Mar. 31, 2024 | 1,254,763 | $ 1,757 | 2,780,992 | (3,601) | (1,306,700) | $ (217,685) |
BALANCE (in shares) at Mar. 31, 2024 | 175,734,220 | (6,549,704) | ||||
Issuance of ordinary shares under employee stock plans | 2,607 | $ 3 | 2,604 | |||
Issuance of ordinary shares under employee stock plans (in shares) | 225,052 | |||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards | (651) | $ (651) | ||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards (in shares) | (26,692) | |||||
Repurchase of Alkermes' ordinary shares | (84,689) | $ (84,689) | ||||
Repurchase of Alkermes' ordinary shares (in shares) | (3,496,187) | |||||
Share-based compensation | 20,606 | 20,606 | ||||
Unrealized gain (loss) on marketable securities, net of tax benefit | 11 | 11 | ||||
Net Income (Loss) | 91,358 | 91,358 | ||||
BALANCE at Jun. 30, 2024 | $ 1,284,005 | $ 1,760 | $ 2,804,202 | $ (3,590) | $ (1,215,342) | $ (303,025) |
BALANCE (in shares) at Jun. 30, 2024 | 175,959,272 | (10,072,583) |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of Stockholders' Equity [Abstract] | ||||||
Tax provision (benefit) | $ (8) | $ (75) | $ 99 | $ 488 | $ (83) | $ 587 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ 91,358 | $ 36,828 | $ 237,065 | $ (41,845) | $ 128,186 | $ 195,220 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |
The Company
The Company | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company | 1. THE COMPANY Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. Headquartered in Ireland, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio. On May 1, 2024, the Company completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) to Novo Nordisk (“Novo”). The Company and Novo also entered into subcontracting arrangements to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction; these activities may continue through the end of 2025. In connection with the sale of the Athlone Facility, the Company received approximately $ 97.9 million from Novo, which included a payment of approximately $ 91.0 million for the facility and certain related assets, and recorded a gain of approximately $ 1.5 million within “ Other income (expense), net ” in the accompanying condensed consolidated statements of operations and comprehensive income for the three and six months ended June 30, 2024. At December 31, 2023, the Company classified the assets described under the asset purchase agreement for the sale as “Assets held for sale” in the accompanying condensed consolidated balance sheets. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three and six months ended June 30, 2024 and 2023 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2023. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments of a normal recurring nature that are necessary to state fairly the results of operations for the reported periods. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” accompanying the Annual Report. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding. Reclassification The Company has presented operations from its former oncology business as discontinued operations in its accompanying condensed consolidated statement of operations and comprehensive income for the three and six months ended June 30, 2023. See Note 3, Discontinued Operations in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information. Discontinued Operations The Company determined that the separation of its oncology business in November 2023 met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations (“Topic 205”). Accordingly, the financial statements have been updated to present the results of the oncology business as discontinued operations for the three and six months ended June 30, 2023 in the accompanying condensed consolidated statement of operations and comprehensive income. Assets Held for Sale In connection with the sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations (“Topic 805”) and, based on the definitions therein, determined that the Athlone Facility constituted a business. Accordingly, the assets associated with the sale of the Athlone Facility were classified as “Assets held for sale” in the accompanying condensed consolidated balance sheets as of December 31, 2023. 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 long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions. Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas. The Company’s chief decision maker, its Chief Executive Officer and chairman of its board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company on or prior to the specified effective date. Unless otherwise described in this Form 10-Q, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure , which requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the Company’s chief operating decision maker. The amendments in this guidance also expand the interim segment disclosure requirements. All disclosure requirements under this guidance are required for public entities with a single reportable segment. This ASU became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this guidance are required to be applied on a retrospective basis. The Company elected to early adopt this guidance and determined this ASU did not have an impact on its consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures. |
Discontinued Operations
Discontinued Operations | 6 Months Ended |
Jun. 30, 2024 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | 3. DISCONTINUED OPERATIONS Mural Oncology Separation On November 15, 2023 (the “Separation Date”), the Company completed the separation of its oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”). The Separation was effected by means of a distribution of all of the outstanding ordinary shares of Mural to the Company’s shareholders (the “Distribution”), in which each of the Company’s shareholders received one ordinary share, nominal value $ 0.01 per share, of Mural for every ten ordinary shares, par value $ 0.01 per share, of the Company (the “Distribution Ratio”) held by such shareholder as of the close of business on November 6, 2023, the record date for the Distribution. The historical results of the oncology business have been reflected as discontinued operations in the Company’s accompanying condensed consolidated financial statements for the three and six months ended June 30, 2023 and as of December 31, 2023. In connection with the Separation, the Company entered into a separation agreement with Mural, dated as of November 13, 2023 (the “Separation Agreement”), that, among other things, sets forth the Company’s agreements with Mural regarding the principal actions taken or to be taken in connection with the Separation, including the Distribution. The Separation Agreement identified those assets to be transferred to, liabilities to be assumed by, and contracts to be assigned to Mural, including the operating lease for the office and laboratory space at 852 Winter Street in Waltham, Massachusetts, and it provided for when and how such transfers, assumptions and assignments were to occur. The purpose of the Separation Agreement was to provide Mural and the Company with those assets necessary to operate their respective businesses and to retain or assume the respective liabilities related to those assets. Under the terms of the Separation Agreement, the Company granted Mural a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to certain IP controlled by the Company as of the date of the Distribution to allow Mural to use such IP for the oncology business, and Mural granted the Company a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to the IP transferred to Mural as part of the Separation for the Company’s use outside of the oncology business. Each of Mural and the Company agreed to releases with respect to pre-Distribution claims, and cross-indemnities with respect to post-Distribution claims, that are principally designed to place financial responsibility for the obligations and liabilities allocated to Mural under the Separation Agreement, and financial responsibility for the obligations and liabilities allocated to the Company under the Separation Agreement. The Company and Mural are also each subject to certain confidentiality restrictions and information sharing obligations. The transfer of assets and liabilities to Mural was effected through a contribution in accordance with the Separation Agreement, as summarized below: (In thousands) November 15, 2023 ASSETS Current Assets: Cash and cash equivalents $ 275,000 Total current assets 275,000 Property, plant and equipment, net 10,096 Right-of-use assets 14,513 Goodwill 7,800 Deferred tax asset 1,799 Total assets $ 309,208 LIABILITIES Current Liabilities Operating lease liabilities—short-term $ 6,036 Total current liabilities 6,036 Operating lease liabilities—long-term 9,412 Total liabilities 15,448 Net assets transferred to Mural $ 293,760 The Company determined that the Separation and the Distribution qualified as tax-free for U.S. federal income tax purposes, which required significant judgment by management. In making such determination, the Company applied U.S. federal tax law to relevant facts and circumstances and obtained: (i) a favorable private letter ruling from the Internal Revenue Service; (ii) a tax opinion; and (iii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for U.S. federal income tax purposes, the Company and/or its shareholders could be subject to significant liabilities, which could have material adverse impacts on the Company’s business, financial condition, results of operations and cash flows in future reporting periods. Furthermore, other than taxes recorded on the transfer of IP, the Company determined that the Separation and related Distribution qualified as tax-free for Irish tax purposes, which required significant judgment by management. In making such determination, the Company applied Irish tax law to relevant facts and circumstances and obtained: (i) a tax opinion; and (ii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for Irish tax purposes, the Company and/or its shareholders could be subject to significant liabilities, which could have material adverse impacts on the Company’s business, financial condition, results of operations and cash flows in future reporting periods. In connection with the Separation, the Company also entered into a tax matters agreement with Mural, dated as of November 13, 2023 . The tax matters agreement governs the Company’s and Mural’s respective rights, responsibilities and obligations with respect to taxes (including taxes arising in the ordinary course of business and taxes, if any, incurred as a result of any failure of the Distribution, together with certain related transactions, to qualify as tax-free for U.S. federal income tax purposes), tax attributes, the preparation and filing of tax returns, the control of audits and other tax proceedings, and assistance and cooperation in respect of tax matters. In connection with the Separation, the Company also entered into an employee matters agreement with Mural, dated as of November 13, 2023 (as amended, the “Employee Matters Agreement”). The Employee Matters Agreement governs the Company’s, Mural’s and their respective subsidiaries’ and affiliates’ rights, responsibilities and obligations after the Separation with respect to, employment, benefits and compensation matters relating to employees and former employees (and their respective dependents and beneficiaries) who are or were associated with the Company, including those who became employees of Mural in connection with the Separation; the allocation of assets and liabilities generally relating to employees, employment or service-related matters and employee benefit plans; other human resources, employment and employee benefits matters; and the treatment of equity-based awards granted by the Company prior to the Separation. The Company entered into two transition services agreements with Mural. On November 13, 2023, Alkermes, Inc., a wholly-owned subsidiary of the Company (“Alkermes US”), and Mural Oncology, Inc., a wholly-owned subsidiary of Mural (“Mural US”), entered into one transition services agreement, pursuant to which the Company and its subsidiaries will provide, on an interim, transitional basis, various services to Mural and its subsidiaries, and a second transition services agreement, pursuant to which Mural and its subsidiaries will provide certain services to the Company and its subsidiaries, in each case for a term of two years , unless earlier terminated in accordance with the terms of the applicable agreement. Discontinued Operations The Company determined that the Separation met the criteria for classification of the oncology business as discontinued operations in accordance with Topic 205. The following summarizes the loss from discontinued operations for the three and six months ended June 30, 2024 and 2023: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Operating expenses from discontinued operations Cost of goods manufactured $ — $ 11 $ — $ 22 Research and development 3,913 32,563 6,429 62,430 Selling, general and administrative — 9,502 — 16,146 Total operating expenses from discontinued operations 3,913 42,076 6,429 78,598 Operating loss from discontinued operations ( 3,913 ) ( 42,076 ) ( 6,429 ) ( 78,598 ) Income tax benefit from discontinued operations ( 613 ) ( 40 ) ( 1,009 ) ( 6,767 ) Net loss and comprehensive loss from discontinued operations $ ( 3,300 ) $ ( 42,036 ) $ ( 5,420 ) $ ( 71,831 ) There were no assets and $ 4.5 million of liabilities related to the Separation at December 31, 2023. All assets related to the Separation were transferred to Mural as of the Separation Date. The $ 4.5 million of liabilities classified as “Liabilities related to discontinued operations” in the accompanying condensed consolidated balance sheet related to bonus amounts accrued for employees that transferred to Mural during 2023 and through the Separation Date that were paid by the Company in the first quarter of 2024, in accordance with the terms of the Employee Matters Agreement. The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the accompanying condensed consolidated statements of cash flows for the six months ended June 30, 2023: Six Months Ended (In thousands) June 30, 2023 OPERATING ACTIVITIES: Depreciation $ 240 Share-based compensation expense 2,937 Right-of-use assets 4,364 Operating lease liabilities ( 2,927 ) INVESTING ACTIVITIES: Additions of property, plant and equipment $ ( 173 ) |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | 4. REVENUE FROM CONTRACTS WITH CUSTOMERS Product Sales, Net During the three and six months ended June 30, 2024 and 2023, the Company recorded product sales, net, as follows: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2024 2023 2024 2023 VIVITROL $ 111,873 $ 102,071 $ 209,532 $ 198,730 ARISTADA and ARISTADA INITIO 86,049 82,409 164,919 162,486 LYBALVI 71,351 46,997 128,358 84,988 Total product sales, net $ 269,273 $ 231,477 $ 502,809 $ 446,204 Manufacturing and Royalty Revenues During the three and six months ended June 30, 2024 and 2023, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 (In thousands) Manufacturing Royalty Total Manufacturing Royalty Total Long-acting INVEGA products (1) $ — $ 78,739 $ 78,739 $ — $ 141,412 $ 141,412 VUMERITY 9,863 25,371 35,234 21,987 44,501 66,488 Other 10,417 5,468 15,885 28,323 10,468 38,791 $ 20,280 $ 109,578 $ 129,858 $ 50,310 $ 196,381 $ 246,691 Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 (In thousands) Manufacturing Royalty Total Manufacturing Royalty Total Long-acting INVEGA products (1) $ — $ 321,239 $ 321,239 $ — $ 334,801 $ 334,801 VUMERITY 10,369 21,926 32,295 23,018 38,151 61,169 Other 21,529 10,850 32,379 47,320 15,485 62,805 $ 31,898 $ 354,015 $ 385,913 $ 70,338 $ 388,437 $ 458,775 (1) “long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate). In November 2021, the Company received notice of partial termination of an exclusive license agreement with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson (“Janssen Pharmaceutica”). Under this license agreement, the Company provided Janssen Pharmaceutica with rights to, and know-how, training and technical assistance in respect of, the Company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA products. 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. Accordingly, the Company ceased recognizing royalty revenue related to sales of these products in February 2022. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen Pharmaceutica’s partial termination of this license agreement and Janssen Pharmaceutica’s royalty and other obligations under the agreement. In May 2023, the arbitral tribunal (the “Tribunal”) in the arbitration proceedings issued a final award (the “Final Award”) which concluded the arbitration proceedings. The Final Award provided, among other things, that the Company was due back royalties and late-payment interest related to 2022 U.S. net sales of the long-acting INVEGA products and is entitled to 2023 and future royalty revenues from Janssen Pharmaceutica related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires). Following issuance of the Final Award and receipt in June 2023 of back royalties of $ 195.4 million, inclusive of $ 8.1 million in late-payment interest, the Company recognized such back royalties and resumed recognizing royalty revenue related to ongoing U.S. sales of the long-acting INVEGA products. Contract Assets Contract assets include unbilled amounts related to the manufacture of a product that, once complete, will be sold under certain of the Company’s manufacturing contracts. 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 June 30, 2024 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2023 $ 706 Additions 4,721 Transferred to receivables, net ( 1,935 ) Contract assets at June 30, 2024 $ 3,492 Contract Liabilities Contract liabilities consist of contractual obligations related to deferred revenue. At June 30, 2024 and December 31, 2023, $ 3.3 million and $ 2.7 million of the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying condensed consolidated balance sheets and no ne and $ 2.1 million of the contract liabilities, respectively, were classified as “Other long-term liabilities” in the accompanying condensed consolidated balance sheets. Total contract liabilities at June 30, 2024 were as follows: (In thousands) Contract Liabilities Contract liabilities at December 31, 2023 $ 4,775 Additions 34 Amounts recognized into revenue ( 1,498 ) Contract liabilities at June 30, 2024 $ 3,311 |
Investments
Investments | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | . INVESTMENTS Investments consisted of the following (in thousands): Gross Unrealized Losses Amortized Less than Greater than Estimated June 30, 2024 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 214,637 $ 97 $ ( 69 ) $ ( 340 ) $ 214,325 Corporate debt securities 126,865 132 ( 52 ) ( 303 ) 126,642 Total short-term investments 341,502 229 ( 121 ) ( 643 ) 340,967 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 42,808 — ( 107 ) ( 99 ) 42,602 Corporate debt securities 43,853 — ( 136 ) ( 62 ) 43,655 86,661 — ( 243 ) ( 161 ) 86,257 Held-to-maturity securities: Certificates of deposit 145 — — — 145 Total long-term investments 86,806 — ( 243 ) ( 161 ) 86,402 Total investments $ 428,308 $ 229 $ ( 364 ) $ ( 804 ) $ 427,369 December 31, 2023 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 199,708 $ 758 $ ( 36 ) $ ( 611 ) $ 199,819 Corporate debt securities 112,055 703 ( 15 ) ( 536 ) 112,207 Non-U.S. government debt securities 4,004 — — ( 8 ) 3,996 Total short-term investments 315,767 1,461 ( 51 ) ( 1,155 ) 316,022 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 19,392 — ( 27 ) ( 315 ) 19,050 Corporate debt securities 19,306 — — ( 289 ) 19,017 38,698 — ( 27 ) ( 604 ) 38,067 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 40,518 — ( 27 ) ( 604 ) 39,887 Total investments $ 356,285 $ 1,461 $ ( 78 ) $ ( 1,759 ) $ 355,909 At June 30, 2024, 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 of corporate debt securities and debt securities issued and backed by U.S. agencies and the U.S. government. At June 30, 2024 , 175 of the Company’s 272 investment securities were in an unrealized loss position and had an aggregate estimated fair value of $ 286.1 million. The Company’s corporate debt securities investments have a minimum rating of A2 (Moody’s)/A (Standard and Poor’s). The primary reason for the unrealized losses in the Company’s investment portfolio is that its investments are fixed-rate securities acquired in a rising interest rate environment. In making the determination whether the decline in fair value of these securities was temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. The Company has the intent and ability to hold these investments until recovery, which may be at maturity. Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows: Six Months Ended June 30, (In thousands) 2024 2023 Proceeds from the sales and maturities of investments $ 138,947 $ 240,544 Realized gains $ — $ — Realized losses $ — $ — The Company’s available-for-sale and held-to-maturity securities at June 30, 2024 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 $ 244,162 $ 243,407 $ 145 $ 145 After 1 year through 5 years 184,001 183,817 — — Total $ 428,163 $ 427,224 $ 145 $ 145 |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 6. 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: June 30, (In thousands) 2024 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 256,927 $ 224,306 $ 32,621 $ — Corporate debt securities 170,297 — 170,297 — Total $ 427,224 $ 224,306 $ 202,918 $ — December 31, 2023 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 34,316 $ 34,316 $ — $ — U.S. government and agency debt securities 218,869 181,041 37,828 — Corporate debt securities 131,224 — 131,224 — Non-U.S. government debt securities 3,996 — 3,996 — Total $ 388,405 $ 215,357 $ 173,048 $ — 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 six months ended June 30, 2024. At June 30, 2024 , the Company had no investments with fair values that were determined using Level 3 inputs. The Company’s investments classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The 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, sales discounts, allowances and reserves, 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 $ 290.3 million and $ 291.0 million at June 30, 2024 and December 31, 2023 , respectively. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | 7. INVENTORY Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: June 30, December 31, (In thousands) 2024 2023 Raw materials $ 76,117 $ 71,416 Work in process 69,093 68,843 Finished goods (1) 49,521 46,147 Total inventory $ 194,731 $ 186,406 (1) At June 30, 2024 and December 31, 2023 , the Company had $ 37.8 million and $ 33.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment
Property, Plant and Equipment | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | 8. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment consisted of the following: June 30, December 31, (In thousands) 2024 2023 (1) Land $ 957 $ 957 Building and improvements 131,819 132,735 Furniture, fixtures and equipment 242,823 237,728 Leasehold improvements 39,971 39,893 Construction in progress 49,354 45,791 Subtotal 464,924 457,104 Less: accumulated depreciation ( 242,186 ) ( 230,161 ) Total property, plant and equipment, net $ 222,738 $ 226,943 (1) In connection with the sale of the Athlone Facility, $ 92.2 million of the Company’s property, plant and equipment was classified as “Assets held for sale” in the accompanying condensed consolidated balance sheet at December 31, 2023 and was not included in these amounts. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 9. GOODWILL AND INTANGIBLE ASSETS Goodwill and intangible assets consisted of the following: June 30, 2024 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 83,027 $ — $ 83,027 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ ( 465,590 ) $ — Capitalized IP 11 - 13 118,160 ( 117,242 ) 918 Total $ 583,750 $ ( 582,832 ) $ 918 In connection with the sale of the Athlone Facility, the Company reviewed Topic 805 and determined that the Athlone Facility constituted a business and, accordingly, $ 2.0 million of the Company’s goodwill was allocated to the Athlone Facility and was classified as “Assets held for sale” in the accompanying condensed consolidated balance sheet as of December 31, 2023. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | 10. LEASES Future lease payments under non-cancelable leases at June 30, 2024 consisted of the following: June 30, (In thousands) 2024 2024 $ 5,070 2025 10,217 2026 10,288 2027 9,507 2028 9,574 Thereafter 59,695 Total operating lease payments $ 104,351 Less: imputed interest ( 25,809 ) Total operating lease liabilities $ 78,542 At June 30, 2024 , the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 4.2 % and 7.9 years, respectively. Cash paid for lease liabilities was $ 2.5 million and $ 5.0 million during the three and six months ended June 30, 2024, respectively, as compared to $ 2.5 million and $ 5.3 million during the three and six months ended June 30, 2023, respectively. The Company recorded operating lease expense from continuing operations of $ 1.8 million and $ 3.6 million during the three and six months ended June 30, 2024, respectively, as compared to $ 2.8 million and $ 5.6 million during the three and six months ended June 30, 2023, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following: June 30, December 31, (In thousands) 2024 2023 Accounts payable $ 104,747 $ 65,649 Accrued compensation 49,390 83,107 Accrued other 85,637 91,805 Total accounts payable and accrued expenses $ 239,774 $ 240,561 A summary of the Company’s current provision for sales discounts, allowances and reserves was as follows: June 30, December 31, (In thousands) 2024 2023 Medicaid rebates $ 212,995 $ 213,845 Product discounts 16,207 15,121 Medicare Part D 18,246 20,569 Other 16,009 14,106 Total accrued sales discounts, allowances and reserves $ 263,457 $ 263,641 Included in accounts payable was approximately $ 50.3 million and $ 34.5 million of amounts payable related to state U.S. Medicaid rebates as of June 30, 2024 and December 31, 2023, respectively. |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 12. LONG-TERM DEBT Long-term debt consisted of the following: June 30, December 31, (In thousands) 2024 2023 2026 Term Loans, due March 12, 2026 $ 289,459 $ 290,730 Less: current portion ( 3,000 ) ( 3,000 ) Long-term debt $ 286,459 $ 287,730 The 2026 Term Loans mature on March 12, 2026 . The 2026 Term Loans bear interest at the Secured Overnight Financing Rate plus a credit spread adjustment applicable to the interest period and an applicable margin of 2.50 % with a 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 June 30, 2024 . |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
SHAREHOLDERS' EQUITY | 13. SHAREHOLDERS’ EQUITY In February 2024, the Company announced approval by its board of directors of a new share repurchase program authorizing the Company to repurchase its ordinary shares in an aggregate amount of up to $ 400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from time to time (the “Repurchase Program”). The specific timing and amounts of repurchases under the Repurchase Program will depend on a variety of factors, including but not limited to ongoing assessments of the Company’s needs, alternative investment opportunities, the market price of its ordinary shares and general market conditions. The Repurchase Program has no set expiration date and may be suspended or discontinued at any time. During the six months ended June 30, 2024, the Company repurchased approximately 3.5 million of its ordinary shares under the Repurchase Program at an average purchase price of $ 24.22 per share, resulting in a total cost of $ 84.7 million. All ordinary shares repurchased were returned to treasury. As of June 30, 2024, the remaining amount authorized under the Repurchase Program was $ 315.3 million. |
Share-based Compensation
Share-based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation | 14. SHARE-BASED COMPENSATION The following table presents share-based compensation expense from continuing and discontinued operations included in the accompanying condensed consolidated statements of operations and comprehensive income: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Cost of goods manufactured and sold $ ( 279 ) $ 2,921 $ 2,627 $ 5,603 Research and development 6,021 6,687 16,299 12,451 Selling, general and administrative 14,859 17,579 34,430 30,156 Share-based compensation expense from continuing operations 20,601 27,187 53,356 48,210 Cost of goods manufactured and sold — — — — Research and development — 819 — 1,962 Selling, general and administrative — 498 — 975 Share-based compensation expense from discontinued operations — 1,317 — 2,937 Total share-based compensation expense $ 20,601 $ 28,504 $ 53,356 $ 51,147 At June 30, 2024 and December 31, 2023 , $ 3.3 million and $ 3.2 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory” in the accompanying condensed consolidated balance sheets. In February 2021, the compensation committee of the Company’s board of directors approved the grant of performance-based restricted stock unit awards to employees of the Company at the Senior Vice President level and above, in each case subject to vesting based on the achievement of certain financial, commercial and R&D performance criteria to be assessed over a performance period of three years, and subject, following the end of such three-year performance period, to upward or downward adjustment based on a market condition tied to relative share price performance over the three-year performance period. On February 8, 2024, the compensation committee of the Company’s board of directors determined that the Company partially achieved the financial performance criteria. This was considered a modification in accordance with FASB ASC 718, Compensation—Stock Compensation (“Topic 718”) and resulted in a modification charge of approximately $ 6.8 million. On February 8, 2024, the compensation committee of the Company’s board of directors also determined that the Company achieved the pipeline performance criteria for these awards, resulting in a $ 2.6 million incremental share-based compensation expense, as it was deemed such pipeline performance criteria had been met. The share-based compensation expense related to these achievements was recognized in the first quarter of 2024. |
Earnings (Loss) Per _Ordinary_
Earnings (Loss) Per [Ordinary] Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per [Ordinary] Share | 15. EARNINGS (LOSS) PER ORDINARY SHARE Basic earnings (loss) per ordinary share is calculated based upon net income (loss) available to holders of ordinary shares divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the effect of outstanding ordinary share equivalents such as stock options and restricted stock unit awards. Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 (1) 2024 2023 (1) Numerator: Net income from continuing operations $ 94,658 $ 279,101 $ 133,606 $ 267,051 Net loss from discontinued operations ( 3,300 ) ( 42,036 ) ( 5,420 ) ( 71,831 ) Net income $ 91,358 $ 237,065 $ 128,186 $ 195,220 Denominator: Weighted average number of ordinary shares outstanding 168,321 166,279 168,152 165,686 Effect of dilutive securities: Stock options 839 1,896 1,284 1,634 Restricted stock unit awards 1,817 3,378 2,524 3,427 Dilutive ordinary share equivalents 2,656 5,274 3,808 5,061 Shares used in calculating diluted earnings (loss) per ordinary share 170,977 171,553 171,960 170,747 (1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation. The following potential ordinary share equivalents were not included in the net earnings (loss) per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Stock options 14,049 12,138 12,339 12,288 Restricted stock unit awards 2,765 1,180 2,507 3,024 Total 16,814 13,318 14,846 15,312 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 16. 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 that it utilizes, 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 uses to manage the underlying business. The Company recorded income tax provisions of $ 22.1 million and $ 30.0 million during the three and six months ended June 30, 2024, respectively, and of $ 2.7 million and $ 3.4 million during the three and six months ended June 30, 2023, respectively. The income tax provisions during the three and six months ended June 30, 2024 were primarily attributable to taxes on income earned in Ireland. The income tax provisions during the three and six months ended June 30, 2023 were primarily due to U.S. federal and state taxes on income earned in the U.S. As of June 30, 2023, the Company maintained a valuation allowance against its Irish deferred tax assets and did no t record an income tax provision in connection with the utilization of its net operating losses to offset the income earned in Ireland during the three and six months ended June 30, 2023. The Company’s effective tax rate during the six months ended June 30, 2024 was 18.3 %, which exceeds the Irish statutory tax rate of 12.5 %, primarily due to non-deductible expenses and income that was taxable at rates higher than the Irish statutory tax rate. The income tax provision recorded as of June 30, 2024 took into account the estimated impact of the global minimum tax rate component, known as Pillar Two, of the Organization for Economic Co-operation and Development’s two-pillar plan on global tax reform, which became effective in Ireland as of January 1, 2024 for multinational companies with consolidated annual revenue of at least € 750.0 million. The Company does not expect Pillar Two to have a material impact for the current year. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 17. COMMITMENTS AND CONTINGENT LIABILITIES Litigation From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At June 30, 2024 , there were no potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. INVEGA SUSTENNA ANDA Litigation Janssen Pharmaceutica and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”) (such lawsuit, the “Teva Lawsuit”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities (the “Mylan Lawsuit”), in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), in February 2022 against Accord Healthcare, Inc., Accord Healthcare, Ltd. and Intas Pharmaceuticals, Ltd (“Accord” and such lawsuit, the “Accord Lawsuit”), and in June 2024 against Qilu Pharmaceutical Co., Ltd. and Qilu Pharma, Inc. (together, “Qilu”), and in the U.S. District Court for the District of Delaware (the “DE District Court”) in December 2021 against Tolmar Holding, Inc., Tolmar Pharmaceuticals, Inc., Tolmar Therapeutics, Inc., and Tolmar, Inc. (“Tolmar” and such lawsuit, the “Tolmar Lawsuit”), following the respective filings by each of Teva, Mylan Labs, Pharmascience, Accord, Qilu 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 (“Federal Circuit Court”), which were consolidated in January 2022 (the “Teva Appeal”). The Pharmascience Lawsuit and the Accord Lawsuit were administratively terminated in July 2022, pending the outcome of the Teva Appeal. In March 2024, the DE District Court issued a decision in the Tolmar Lawsuit, following which both parties filed notices of appeal with the Federal Circuit Court. On April 1, 2024, the Federal Circuit Court issued a decision in the Teva Appeal, affirming in part and vacating and remanding in part the NJ District Court’s judgment, and on June 14, 2024, opening briefs were filed with the NJ District Court for the remanded matters. 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 (the “’693 Patent”). Requested judicial remedies include recovery of litigation costs and injunctive relief. In May 2023, the NJ District Court issued an opinion in favor of the Janssen entities on the issues of infringement and validity of the ’693 Patent and the Mylan entities filed a notice of appeal of the decision. The Company is not a party to this proceeding. VUMERITY ANDA Litigation In July 2023, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the DE District Court against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) following the filing by Zydus of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) delayed-release capsules for oral use, 231 mg, before expiration of the Company’s U.S. Patent Nos. 8,669,281; 9,090,558; and 10,080,733. The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). A bench trial is scheduled to begin on July 28, 2025. 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 a product liability case alleging that the FDA-approved VIVITROL labeling was inadequate and that VIVITROL caused the individual to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters. In addition, in January 2023, Acorda filed a petition with the U.S. District Court for the Southern District of New York (the “NY Southern District Court”) asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $ 66.0 million in damages. In August 2023, the NY Southern District Court confirmed the final arbitral award and declined to modify the final award to increase the damages awarded thereunder. In September 2023, Acorda filed a notice of appeal of the NY Southern District Court decision to the Federal Circuit Court, and the Company filed a motion to transfer the appeal to the U.S. Court of Appeals for the Second Circuit. In January 2024, the Federal Circuit Court denied without prejudice the Company’s motion to transfer the appeal and instructed the parties to brief the jurisdictional question as part of the merits appeal. Briefing in the Federal Circuit Court is complete, and the matter is pending decision. 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. Guarantees In connection with the Separation, the Company entered into an assignment and assumption of lease agreement (the “Assignment”) pursuant to which Alkermes US assigned to Mural US an operating lease for approximately 180,000 square feet of corporate office space, administrative areas and laboratories located at 852 Winter Street in Waltham, Massachusetts (the “852 Winter Street Lease”), which is described in more detail in Note 10, Leases in the “Notes to Consolidated Financial Statements” in the Annual Report. Although all of the rights, title and interest in, to and under the 852 Winter Street Lease were transferred to Mural US as of November 15, 2023 pursuant to the Assignment, the Company ratified and reaffirmed for the remainder of the lease term its guarantor obligations in respect of the lease under that certain Guaranty dated as of May 16, 2014 . This lease expires in 2026 and includes a tenant option to extend the term for an additional five-year period. Upon completion of the Separation, the Assignment was accounted for as a termination of the original lease and the Company de-recognized the right-of-use asset and lease liability related to the 852 Winter Street Lease. At June 30, 2024, the fair value of the guarantee was no t material to the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements of the Company for the three and six months ended June 30, 2024 and 2023 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2023. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments of a normal recurring nature that are necessary to state fairly the results of operations for the reported periods. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” accompanying the Annual Report. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding. |
Reclassification | Reclassification The Company has presented operations from its former oncology business as discontinued operations in its accompanying condensed consolidated statement of operations and comprehensive income for the three and six months ended June 30, 2023. See Note 3, Discontinued Operations in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information. |
Discontinued Operations | Discontinued Operations The Company determined that the separation of its oncology business in November 2023 met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations (“Topic 205”). Accordingly, the financial statements have been updated to present the results of the oncology business as discontinued operations for the three and six months ended June 30, 2023 in the accompanying condensed consolidated statement of operations and comprehensive income. |
Assets Held for Sale | Assets Held for Sale In connection with the sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations (“Topic 805”) and, based on the definitions therein, determined that the Athlone Facility constituted a business. Accordingly, the assets associated with the sale of the Athlone Facility were classified as “Assets held for sale” in the accompanying condensed consolidated balance sheets as of December 31, 2023. |
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 long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions. |
Segment Information | Segment Information The Company operates as one business segment, which is the business of developing, manufacturing and commercializing medicines designed to address unmet medical needs of patients in major therapeutic areas. The Company’s chief decision maker, its Chief Executive Officer and chairman of its board of directors, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company on or prior to the specified effective date. Unless otherwise described in this Form 10-Q, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure , which requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the Company’s chief operating decision maker. The amendments in this guidance also expand the interim segment disclosure requirements. All disclosure requirements under this guidance are required for public entities with a single reportable segment. This ASU became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this guidance are required to be applied on a retrospective basis. The Company elected to early adopt this guidance and determined this ASU did not have an impact on its consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures. |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Transfer of Assets and Liabilities Effected in Accordance with Separation Agreements | The transfer of assets and liabilities to Mural was effected through a contribution in accordance with the Separation Agreement, as summarized below: (In thousands) November 15, 2023 ASSETS Current Assets: Cash and cash equivalents $ 275,000 Total current assets 275,000 Property, plant and equipment, net 10,096 Right-of-use assets 14,513 Goodwill 7,800 Deferred tax asset 1,799 Total assets $ 309,208 LIABILITIES Current Liabilities Operating lease liabilities—short-term $ 6,036 Total current liabilities 6,036 Operating lease liabilities—long-term 9,412 Total liabilities 15,448 Net assets transferred to Mural $ 293,760 |
Summary of Discontinued Operations | The following summarizes the loss from discontinued operations for the three and six months ended June 30, 2024 and 2023: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Operating expenses from discontinued operations Cost of goods manufactured $ — $ 11 $ — $ 22 Research and development 3,913 32,563 6,429 62,430 Selling, general and administrative — 9,502 — 16,146 Total operating expenses from discontinued operations 3,913 42,076 6,429 78,598 Operating loss from discontinued operations ( 3,913 ) ( 42,076 ) ( 6,429 ) ( 78,598 ) Income tax benefit from discontinued operations ( 613 ) ( 40 ) ( 1,009 ) ( 6,767 ) Net loss and comprehensive loss from discontinued operations $ ( 3,300 ) $ ( 42,036 ) $ ( 5,420 ) $ ( 71,831 ) |
Summary of Significant Non-cash Items and Capital Expenditures of Discontinued Operations | The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the accompanying condensed consolidated statements of cash flows for the six months ended June 30, 2023: Six Months Ended (In thousands) June 30, 2023 OPERATING ACTIVITIES: Depreciation $ 240 Share-based compensation expense 2,937 Right-of-use assets 4,364 Operating lease liabilities ( 2,927 ) INVESTING ACTIVITIES: Additions of property, plant and equipment $ ( 173 ) |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Schedule of Contract Assets and Contract Liabilities | Total contract assets at June 30, 2024 were as follows: (In thousands) Contract Assets Contract assets at December 31, 2023 $ 706 Additions 4,721 Transferred to receivables, net ( 1,935 ) Contract assets at June 30, 2024 $ 3,492 Total contract liabilities at June 30, 2024 were as follows: (In thousands) Contract Liabilities Contract liabilities at December 31, 2023 $ 4,775 Additions 34 Amounts recognized into revenue ( 1,498 ) Contract liabilities at June 30, 2024 $ 3,311 |
Product sales, net | |
Schedule of Disaggregation of Revenues | During the three and six months ended June 30, 2024 and 2023, the Company recorded product sales, net, as follows: Three Months Ended June 30, Six Months Ended June 30, (In thousands) 2024 2023 2024 2023 VIVITROL $ 111,873 $ 102,071 $ 209,532 $ 198,730 ARISTADA and ARISTADA INITIO 86,049 82,409 164,919 162,486 LYBALVI 71,351 46,997 128,358 84,988 Total product sales, net $ 269,273 $ 231,477 $ 502,809 $ 446,204 |
Manufacturing and royalty revenues | |
Schedule of Disaggregation of Revenues | During the three and six months ended June 30, 2024 and 2023, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows: Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 (In thousands) Manufacturing Royalty Total Manufacturing Royalty Total Long-acting INVEGA products (1) $ — $ 78,739 $ 78,739 $ — $ 141,412 $ 141,412 VUMERITY 9,863 25,371 35,234 21,987 44,501 66,488 Other 10,417 5,468 15,885 28,323 10,468 38,791 $ 20,280 $ 109,578 $ 129,858 $ 50,310 $ 196,381 $ 246,691 Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 (In thousands) Manufacturing Royalty Total Manufacturing Royalty Total Long-acting INVEGA products (1) $ — $ 321,239 $ 321,239 $ — $ 334,801 $ 334,801 VUMERITY 10,369 21,926 32,295 23,018 38,151 61,169 Other 21,529 10,850 32,379 47,320 15,485 62,805 $ 31,898 $ 354,015 $ 385,913 $ 70,338 $ 388,437 $ 458,775 (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) | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 Cost Gains One Year One Year Fair Value Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 214,637 $ 97 $ ( 69 ) $ ( 340 ) $ 214,325 Corporate debt securities 126,865 132 ( 52 ) ( 303 ) 126,642 Total short-term investments 341,502 229 ( 121 ) ( 643 ) 340,967 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 42,808 — ( 107 ) ( 99 ) 42,602 Corporate debt securities 43,853 — ( 136 ) ( 62 ) 43,655 86,661 — ( 243 ) ( 161 ) 86,257 Held-to-maturity securities: Certificates of deposit 145 — — — 145 Total long-term investments 86,806 — ( 243 ) ( 161 ) 86,402 Total investments $ 428,308 $ 229 $ ( 364 ) $ ( 804 ) $ 427,369 December 31, 2023 Short-term investments: Available-for-sale securities: U.S. government and agency debt securities $ 199,708 $ 758 $ ( 36 ) $ ( 611 ) $ 199,819 Corporate debt securities 112,055 703 ( 15 ) ( 536 ) 112,207 Non-U.S. government debt securities 4,004 — — ( 8 ) 3,996 Total short-term investments 315,767 1,461 ( 51 ) ( 1,155 ) 316,022 Long-term investments: Available-for-sale securities: U.S. government and agency debt securities 19,392 — ( 27 ) ( 315 ) 19,050 Corporate debt securities 19,306 — — ( 289 ) 19,017 38,698 — ( 27 ) ( 604 ) 38,067 Held-to-maturity securities: Certificates of deposit 1,820 — — — 1,820 Total long-term investments 40,518 — ( 27 ) ( 604 ) 39,887 Total investments $ 356,285 $ 1,461 $ ( 78 ) $ ( 1,759 ) $ 355,909 |
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: Six Months Ended June 30, (In thousands) 2024 2023 Proceeds from the sales and maturities of investments $ 138,947 $ 240,544 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 June 30, 2024 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 $ 244,162 $ 243,407 $ 145 $ 145 After 1 year through 5 years 184,001 183,817 — — Total $ 428,163 $ 427,224 $ 145 $ 145 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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: June 30, (In thousands) 2024 Level 1 Level 2 Level 3 Assets: U.S. government and agency debt securities $ 256,927 $ 224,306 $ 32,621 $ — Corporate debt securities 170,297 — 170,297 — Total $ 427,224 $ 224,306 $ 202,918 $ — December 31, 2023 Level 1 Level 2 Level 3 Assets: Cash equivalents $ 34,316 $ 34,316 $ — $ — U.S. government and agency debt securities 218,869 181,041 37,828 — Corporate debt securities 131,224 — 131,224 — Non-U.S. government debt securities 3,996 — 3,996 — Total $ 388,405 $ 215,357 $ 173,048 $ — |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consisted of the following: June 30, December 31, (In thousands) 2024 2023 Raw materials $ 76,117 $ 71,416 Work in process 69,093 68,843 Finished goods (1) 49,521 46,147 Total inventory $ 194,731 $ 186,406 (1) At June 30, 2024 and December 31, 2023 , the Company had $ 37.8 million and $ 33.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | Property, plant and equipment consisted of the following: June 30, December 31, (In thousands) 2024 2023 (1) Land $ 957 $ 957 Building and improvements 131,819 132,735 Furniture, fixtures and equipment 242,823 237,728 Leasehold improvements 39,971 39,893 Construction in progress 49,354 45,791 Subtotal 464,924 457,104 Less: accumulated depreciation ( 242,186 ) ( 230,161 ) Total property, plant and equipment, net $ 222,738 $ 226,943 (1) In connection with the sale of the Athlone Facility, $ 92.2 million of the Company’s property, plant and equipment was classified as “Assets held for sale” in the accompanying condensed consolidated balance sheet at December 31, 2023 and was not included in these amounts. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets | Goodwill and intangible assets consisted of the following: June 30, 2024 (In thousands) Weighted Amortizable Life (Years) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Goodwill $ 83,027 $ — $ 83,027 Finite-lived intangible assets: Collaboration agreements 12 $ 465,590 $ ( 465,590 ) $ — Capitalized IP 11 - 13 118,160 ( 117,242 ) 918 Total $ 583,750 $ ( 582,832 ) $ 918 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Summary of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases at June 30, 2024 consisted of the following: June 30, (In thousands) 2024 2024 $ 5,070 2025 10,217 2026 10,288 2027 9,507 2028 9,574 Thereafter 59,695 Total operating lease payments $ 104,351 Less: imputed interest ( 25,809 ) Total operating lease liabilities $ 78,542 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consisted of the following: June 30, December 31, (In thousands) 2024 2023 Accounts payable $ 104,747 $ 65,649 Accrued compensation 49,390 83,107 Accrued other 85,637 91,805 Total accounts payable and accrued expenses $ 239,774 $ 240,561 |
Summary of Current Provision for Sales, Discounts, Allowances and Reserves | A summary of the Company’s current provision for sales discounts, allowances and reserves was as follows: June 30, December 31, (In thousands) 2024 2023 Medicaid rebates $ 212,995 $ 213,845 Product discounts 16,207 15,121 Medicare Part D 18,246 20,569 Other 16,009 14,106 Total accrued sales discounts, allowances and reserves $ 263,457 $ 263,641 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | Long-term debt consisted of the following: June 30, December 31, (In thousands) 2024 2023 2026 Term Loans, due March 12, 2026 $ 289,459 $ 290,730 Less: current portion ( 3,000 ) ( 3,000 ) Long-term debt $ 286,459 $ 287,730 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Expense from Continuing and Discontinued Operations | The following table presents share-based compensation expense from continuing and discontinued operations included in the accompanying condensed consolidated statements of operations and comprehensive income: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Cost of goods manufactured and sold $ ( 279 ) $ 2,921 $ 2,627 $ 5,603 Research and development 6,021 6,687 16,299 12,451 Selling, general and administrative 14,859 17,579 34,430 30,156 Share-based compensation expense from continuing operations 20,601 27,187 53,356 48,210 Cost of goods manufactured and sold — — — — Research and development — 819 — 1,962 Selling, general and administrative — 498 — 975 Share-based compensation expense from discontinued operations — 1,317 — 2,937 Total share-based compensation expense $ 20,601 $ 28,504 $ 53,356 $ 51,147 |
Earnings (Loss) Per _Ordinary_2
Earnings (Loss) Per [Ordinary] Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Basic Earnings (Loss) Per Ordinary Share | Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 (1) 2024 2023 (1) Numerator: Net income from continuing operations $ 94,658 $ 279,101 $ 133,606 $ 267,051 Net loss from discontinued operations ( 3,300 ) ( 42,036 ) ( 5,420 ) ( 71,831 ) Net income $ 91,358 $ 237,065 $ 128,186 $ 195,220 Denominator: Weighted average number of ordinary shares outstanding 168,321 166,279 168,152 165,686 Effect of dilutive securities: Stock options 839 1,896 1,284 1,634 Restricted stock unit awards 1,817 3,378 2,524 3,427 Dilutive ordinary share equivalents 2,656 5,274 3,808 5,061 Shares used in calculating diluted earnings (loss) per ordinary share 170,977 171,553 171,960 170,747 (1) Prior period amounts have been retrospectively adjusted to reflect the effects of the Separation. |
Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net Earnings (Loss) Per Ordinary Share | The following potential ordinary share equivalents were not included in the net earnings (loss) per ordinary share calculation because the effect would have been anti-dilutive: Three Months Ended Six Months Ended June 30, June 30, (In thousands) 2024 2023 2024 2023 Stock options 14,049 12,138 12,339 12,288 Restricted stock unit awards 2,765 1,180 2,507 3,024 Total 16,814 13,318 14,846 15,312 |
The Company - Additional Inform
The Company - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Line Items] | |
Procceds from sale of development and manufacturing facility | $ 97.9 |
Gain on sale of assets | $ 1.5 |
Disposal Group, Not Discontinued Operation, Gain (Loss) on Disposal, Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense) |
Facility and Certain Related Assets [Member] | |
Organization, Consolidation and Presentation of Financial Statements [Line Items] | |
Procceds from sale of development and manufacturing facility | $ 91 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2024 Segment | |
Accounting Policies [Abstract] | |
Number of business segments | 1 |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) | 6 Months Ended | ||
Jun. 30, 2024 Agreement $ / shares | Dec. 31, 2023 USD ($) $ / shares | Nov. 15, 2023 $ / shares | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Discontinued operation agreement date | Nov. 13, 2023 | ||
Number of transation service agreement | Agreement | 2 | ||
Service agreement term | 2 years | ||
Assets | $ | $ 0 | ||
Liabilities related to discontinued operations | $ | $ 4,542,000 | ||
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 |
Mural Oncology plc | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 |
Discontinued Operations - Sched
Discontinued Operations - Schedule of Transfer of Assets and Liabilities Effected in Accordance with Separation Agreements (Details) - USD ($) | Dec. 31, 2023 | Nov. 15, 2023 |
Current Assets: | ||
Total assets | $ 0 | |
Current Liabilities: | ||
Total current liabilities | $ 4,542,000 | |
Mural Oncology plc | Separation Agreement | ||
Current Assets: | ||
Cash and cash equivalents | $ 275,000,000 | |
Total currents assets | 275,000,000 | |
Property, plant and equipment, net | 10,096,000 | |
Right-of-use assets | 14,513,000 | |
Goodwill | 7,800,000 | |
Deferred tax asset | 1,799,000 | |
Total assets | 309,208,000 | |
Current Liabilities: | ||
Operating lease liabilities-short-term | 6,036,000 | |
Total current liabilities | 6,036,000 | |
Operating lease liabilities-long-term | 9,412,000 | |
Total liabilities | 15,448,000 | |
Disposal Group Including Discontinued Operation Assets and Liabilities Net, Total | $ 293,760,000 |
Discontinued Operations - Summa
Discontinued Operations - Summary of Expenses of Discontinued Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total operating expenses from discontinued operations | $ 3,913 | $ 42,076 | $ 6,429 | $ 78,598 |
Disposal Group, Including Discontinued Operation, Operating Income (Loss), Total | (3,913) | (42,076) | (6,429) | (78,598) |
Income tax benefit from discontinued operations | (613) | (40) | (1,009) | (6,767) |
Net loss and comprehensive loss from discontinued operations | (3,300) | (42,036) | (5,420) | (71,831) |
Cost of goods manufactured | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total operating expenses from discontinued operations | 11 | 22 | ||
Research and development | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total operating expenses from discontinued operations | $ 3,913 | 32,563 | $ 6,429 | 62,430 |
Selling, general and administrative | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total operating expenses from discontinued operations | $ 9,502 | $ 16,146 |
Discontinued Operations - Sum_2
Discontinued Operations - Summary of Significant Non-cash Items and Capital Expenditures of Discontinued Operations (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
OPERATING ACTIVITIES: | |
Depreciation | $ 240 |
Share-based compensation expense | 2,937 |
Right-of-use assets | 4,364 |
Operating lease liabilities | (2,927) |
INVESTING ACTIVITIES: | |
Additions of property, plant and equipment | $ (173) |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 399,131 | $ 617,397 | $ 749,503 | $ 904,992 |
VIVITROL | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 111,873 | 102,071 | 209,532 | 198,730 |
ARISTADA and ARISTADA INITIO | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 86,049 | 82,409 | 164,919 | 162,486 |
LYBALVI | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 71,351 | 46,997 | 128,358 | 84,988 |
Product sales, net | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 269,273 | $ 231,477 | $ 502,809 | $ 446,204 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Schedule of Manufacturing and Royalty Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 399,131 | $ 617,397 | $ 749,503 | $ 904,992 |
Manufacturing Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 20,280 | 31,898 | 50,310 | 70,338 |
Manufacturing Revenue | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 9,863 | 10,369 | 21,987 | 23,018 |
Manufacturing Revenue | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 10,417 | 21,529 | 28,323 | 47,320 |
Royalty | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 109,578 | 354,015 | 196,381 | 388,437 |
Royalty | Long-Acting INVEGA Products | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 78,739 | 321,239 | 141,412 | 334,801 |
Royalty | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 25,371 | 21,926 | 44,501 | 38,151 |
Royalty | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 5,468 | 10,850 | 10,468 | 15,485 |
Manufacturing and royalty revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 129,858 | 385,913 | 246,691 | 458,775 |
Manufacturing and royalty revenues | Long-Acting INVEGA Products | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 78,739 | 321,239 | 141,412 | 334,801 |
Manufacturing and royalty revenues | VUMERITY | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | 35,234 | 32,295 | 66,488 | 61,169 |
Manufacturing and royalty revenues | Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 15,885 | $ 32,379 | $ 38,791 | $ 62,805 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) | 1 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Disaggregation Of Revenue [Line Items] | |||
Contract liabilities | $ 3,311,000 | $ 3,311,000 | $ 4,775,000 |
Janssen Pharmaceutica N.V. | |||
Disaggregation Of Revenue [Line Items] | |||
Royalty revenue related to back royalties | 195,400,000 | ||
Back royalties late payment interest | 8,100,000 | ||
Contract liabilities–short-term | |||
Disaggregation Of Revenue [Line Items] | |||
Contract liabilities | 3,300,000 | 3,300,000 | 2,700,000 |
Other long-term liabilities | |||
Disaggregation Of Revenue [Line Items] | |||
Contract liabilities | $ 0 | $ 0 | $ 2,100,000 |
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 | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Contract Asset [Abstract] | |
Contract assets at beginning of period | $ 706 |
Additions | 4,721 |
Transferred to receivables, net | (1,935) |
Contract assets at end of period | 3,492 |
Contract Liabilities [Abstract] | |
Contract liabilities at beginning of the period | 4,775 |
Additions | 34 |
Amounts recognized into revenue | (1,498) |
Contract liabilities at end of the period | $ 3,311 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | $ 341,502 | $ 315,767 |
Gross Unrealized Gains | 229 | 1,461 |
Gross Unrealized Losses less than one year | (364) | (78) |
Gross Unrealized Losses greater than one year | (804) | (1,759) |
Short-term investments, Estimated Fair Value | 340,967 | 316,022 |
Long-term investments, Amortized Cost | 86,661 | 38,698 |
Total long-term investments | 86,402 | 39,887 |
Long-term investments, Estimated Fair Value | 86,257 | 38,067 |
Amortized Cost | 428,308 | 356,285 |
Estimated Fair Value | 427,369 | 355,909 |
Short-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Gains | 229 | 1,461 |
Gross Unrealized Losses less than one year | (121) | (51) |
Gross Unrealized Losses greater than one year | (643) | (1,155) |
Long-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Losses less than one year | (243) | (27) |
Gross Unrealized Losses greater than one year | (161) | (604) |
Total long-term investments | 86,402 | 39,887 |
Amortized Cost | 86,806 | 40,518 |
Certificates of deposit | ||
Available-for-sale securities: | ||
Amortized Cost | 145 | 1,820 |
Estimated Fair Value | 145 | 1,820 |
Corporate debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 126,865 | 112,055 |
Short-term investments, Estimated Fair Value | 126,642 | 112,207 |
Long-term investments, Amortized Cost | 43,853 | 19,306 |
Long-term investments, Estimated Fair Value | 43,655 | 19,017 |
Corporate debt securities | Short-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Gains | 132 | 703 |
Gross Unrealized Losses less than one year | (52) | (15) |
Gross Unrealized Losses greater than one year | (303) | (536) |
Corporate debt securities | Long-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Losses less than one year | (136) | |
Gross Unrealized Losses greater than one year | (62) | (289) |
U.S. government and agency debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 214,637 | 199,708 |
Short-term investments, Estimated Fair Value | 214,325 | 199,819 |
Long-term investments, Amortized Cost | 42,808 | 19,392 |
Long-term investments, Estimated Fair Value | 42,602 | 19,050 |
U.S. government and agency debt securities | Short-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Gains | 97 | 758 |
Gross Unrealized Losses less than one year | (69) | (36) |
Gross Unrealized Losses greater than one year | (340) | (611) |
U.S. government and agency debt securities | Long-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Losses less than one year | (107) | (27) |
Gross Unrealized Losses greater than one year | $ (99) | (315) |
Non-U.S. government debt securities | ||
Available-for-sale securities: | ||
Short-term investments, Amortized Cost | 4,004 | |
Short-term investments, Estimated Fair Value | 3,996 | |
Non-U.S. government debt securities | Short-term investments | ||
Available-for-sale securities: | ||
Gross Unrealized Losses greater than one year | $ (8) |
Investments - Additional Inform
Investments - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) Investmentsecurity | |
Summary of Investment Holdings [Line Items] | |
Number of investment securities | 272 |
Number of investment securities in an unrealized loss position | 175 |
Aggregate estimated fair value of investments in unrealized loss position | $ | $ 286.1 |
Investments - Schedule of Proce
Investments - Schedule of Proceeds from Sales and Maturities of Marketable Securities Plus Resulting Realized Gains and Losses (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | ||
Proceeds from the sales and maturities of investments | $ 138,947 | $ 240,544 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Available-for-Sale and Held-to-Maturity Securities (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Available-for-sale, Amortized Cost | |
Within 1 year | $ 244,162 |
After 1 year through 5 years | 184,001 |
Total | 428,163 |
Available-for-sale, Estimated Fair Value | |
Within 1 year | 243,407 |
After 1 year through 5 years | 183,817 |
Total | 427,224 |
Held-to-maturity, Amortized Cost | |
Within 1 year | 145 |
Total | 145 |
Held-to-maturity, Estimated Fair Value | |
Within 1 year | 145 |
Total | $ 145 |
Fair Value - Summary of the Com
Fair Value - Summary of the Company's Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair value | ||
Debt securities | $ 427,224 | |
Recurring Basis | ||
Fair value | ||
Cash equivalents | $ 34,316 | |
Assets, Total | 427,224 | 388,405 |
Recurring Basis | Level 1 | ||
Fair value | ||
Cash equivalents | 34,316 | |
Assets, Total | 224,306 | 215,357 |
Recurring Basis | Level 2 | ||
Fair value | ||
Assets, Total | 202,918 | 173,048 |
U.S. government and agency debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 256,927 | 218,869 |
U.S. government and agency debt securities | Recurring Basis | Level 1 | ||
Fair value | ||
Debt securities | 224,306 | 181,041 |
U.S. government and agency debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | 32,621 | 37,828 |
Corporate debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 170,297 | 131,224 |
Corporate debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 170,297 | 131,224 |
Non-U.S. government debt securities | Recurring Basis | ||
Fair value | ||
Debt securities | 3,996 | |
Non-U.S. government debt securities | Recurring Basis | Level 2 | ||
Fair value | ||
Debt securities | $ 3,996 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Fair Value | ||
Transfers between Level 1 to Level 2 | $ 0 | |
Transfers between Level 2 to Level 1 | 0 | |
Investments determined using Level 3 inputs | 0 | |
2026 Term Loans | ||
Fair Value | ||
Amount to be realized in future | $ 290,300,000 | $ 291,000,000 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 76,117 | $ 71,416 | |
Work in process | 69,093 | 68,843 | |
Finished goods | [1] | 49,521 | 46,147 |
Total inventory | $ 194,731 | $ 186,406 | |
[1] At June 30, 2024 and December 31, 2023 , the Company had $ 37.8 million and $ 33.9 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider. |
Inventory - Schedule of Inven_2
Inventory - Schedule of Inventories (Parenthetical) (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Finished goods inventory located at third-party warehouse and shipping service provider | $ 37.8 | $ 33.9 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 464,924 | $ 457,104 |
Less: accumulated depreciation | (242,186) | (230,161) |
Total property, plant and equipment, net | 222,738 | 226,943 |
Land | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 957 | 957 |
Building and Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 131,819 | 132,735 |
Furniture, Fixtures and Equipment | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 242,823 | 237,728 |
Leasehold Improvements | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | 39,971 | 39,893 |
Construction in Progress | ||
Property, plant and equipment | ||
Property, plant and equipment, gross | $ 49,354 | $ 45,791 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Parenthetical) (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 222,738 | $ 226,943 |
Assets Held For Sale | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 92,200 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill and Intangible Assets (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Goodwill | |
Gross Carrying Amount | $ 83,027 |
Net Carrying Amount | 83,027 |
Finite-lived intangible assets: | |
Gross Carrying Amount | 583,750 |
Accumulated Amortization | (582,832) |
Net Carrying Amount | $ 918 |
Collaboration agreements | |
Finite-lived intangible assets: | |
Weighted Amortizable Life | 12 years |
Gross Carrying Amount | $ 465,590 |
Accumulated Amortization | (465,590) |
Capitalized IP | |
Finite-lived intangible assets: | |
Gross Carrying Amount | 118,160 |
Accumulated Amortization | (117,242) |
Net Carrying Amount | $ 918 |
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) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Goodwill [Line Items] | ||
Goodwill | $ 83,027 | |
Athlone Facility | Assets Held for Sale | ||
Goodwill [Line Items] | ||
Goodwill | $ 2,000 |
Leases - Summary of Future Leas
Leases - Summary of Future Lease Payments Under Non-Cancelable Leases (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Leases [Abstract] | |
2024 | $ 5,070 |
2025 | 10,217 |
2026 | 10,288 |
2027 | 9,507 |
2028 | 9,574 |
Thereafter | 59,695 |
Total operating lease payments | 104,351 |
Less: imputed interest | (25,809) |
Total operating lease liabilities | $ 78,542 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Lessee Lease Description [Line Items] | ||||
Weighted average incremental borrowing rate | 4.20% | 4.20% | ||
Payments for operating leases | $ 2.5 | $ 2.5 | $ 5 | $ 5.3 |
Weighted average remaining lease term | 7 years 10 months 24 days | 7 years 10 months 24 days | ||
Operating lease expense from continuing operations | $ 1.8 | $ 2.8 | $ 3.6 | $ 5.6 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 104,747 | $ 65,649 |
Accrued compensation | 49,390 | 83,107 |
Accrued other | 85,637 | 91,805 |
Total accounts payable and accrued expenses | $ 239,774 | $ 240,561 |
Accounts Payable and Accrued _4
Accounts Payable and Accrued Expenses - Summary of Current Provision for Sales, Discounts, Allowances and Reserves (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 263,457 | $ 263,641 |
Medicaid Rebate | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 212,995 | 213,845 |
Product Discounts | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 16,207 | 15,121 |
Medicare Part D | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | 18,246 | 20,569 |
Other | ||
Accrued Sales Discount Allowances And Reserves [Line Items] | ||
Total accrued sales discounts, allowances and reserves | $ 16,009 | $ 14,106 |
Accounts Payable and Accrued _5
Accounts Payable and Accrued Expenses - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accounts Payable And Accrued Expenses [Line Items] | ||
Accounts payable | $ 104,747 | $ 65,649 |
State U.S. Medicaid Rebates | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Accounts payable | $ 50,300 | $ 34,500 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Long-term debt | ||
Less: current portion | $ (3,000) | $ (3,000) |
Long-term debt | 286,459 | 287,730 |
2026 Term Loans, due March 12, 2026 | ||
Long-term debt | ||
Term Loans | 289,459 | 290,730 |
Less: current portion | (3,000) | (3,000) |
Long-term debt | $ 286,459 | $ 287,730 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Details) - 2026 Term Loans $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Long-term debt | |
Due date of loan | Mar. 12, 2026 |
Interest rate, variable interest rate floor (as a percent) | 0.50% |
Incremental capacity | $ 175 |
SOFR | |
Long-term debt | |
Interest rate added to base rate (as a percent) | 2.50% |
Shareholders' Equity (Additiona
Shareholders' Equity (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | Feb. 29, 2024 | |
Stockholders' Equity Note [Abstract] | |||
Share repurchase aggregate amount | $ 400,000 | ||
Shares repurchased | 3.5 | ||
Shares repurchased price per share | $ 24.22 | ||
Shares repurchased value | $ 84,689 | $ 84,700 | |
Share repurchase program remaining authorized amount | $ 315,300 | $ 315,300 |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense from Continuing and Discontinued Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 20,601 | $ 28,504 | $ 53,356 | $ 51,147 |
Continuing Operations | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 20,601 | 27,187 | 53,356 | 48,210 |
Continuing Operations | Cost of goods manufactured and sold | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | (279) | 2,921 | 2,627 | 5,603 |
Continuing Operations | Research and development | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 6,021 | 6,687 | 16,299 | 12,451 |
Continuing Operations | Selling, general and administrative | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 14,859 | 17,579 | $ 34,430 | 30,156 |
Discontinued Operations | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 1,317 | 2,937 | ||
Discontinued Operations | Research and development | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | 819 | 1,962 | ||
Discontinued Operations | Selling, general and administrative | ||||
Share-based compensation Expense | ||||
Total share-based compensation expense | $ 498 | $ 975 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended | |
Feb. 08, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share based compensation cost capitalized | $ 3.3 | $ 3.2 | |
Share-based compensation, accounting modification charge | $ 6.8 | ||
Incremental share-based compensation expense due to achievement of performance criteria | $ 2.6 |
Earnings (Loss) Per _Ordinary_3
Earnings (Loss) Per [Ordinary] Share - Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net income from continuing operations | $ 94,658 | $ 279,101 | $ 133,606 | $ 267,051 | ||
Net loss from discontinued operations | (3,300) | (42,036) | (5,420) | (71,831) | ||
NET INCOME | $ 91,358 | $ 36,828 | $ 237,065 | $ (41,845) | $ 128,186 | $ 195,220 |
Denominator: | ||||||
Basic | 168,321 | 166,279 | 168,152 | 165,686 | ||
Dilutive ordinary share equivalents | 2,656 | 5,274 | 3,808 | 5,061 | ||
Shares used in calculating diluted earnings (loss) per ordinary share | 170,977 | 171,553 | 171,960 | 170,747 | ||
Stock Options | ||||||
Denominator: | ||||||
Dilutive ordinary share equivalents | 839 | 1,896 | 1,284 | 1,634 | ||
Restricted Stock Unit Awards | ||||||
Denominator: | ||||||
Dilutive ordinary share equivalents | 1,817 | 3,378 | 2,524 | 3,427 |
Earnings (Loss) Per _Ordinary_4
Earnings (Loss) Per [Ordinary] Share - Schedule of Anti-Dilutive Potential Common Share Equivalent Excluded from Calculation of Net Earnings (Loss) Per Ordinary Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 16,814 | 13,318 | 14,846 | 15,312 |
Stock Options | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 14,049 | 12,138 | 12,339 | 12,288 |
Restricted Stock Unit Awards | ||||
Denominator: | ||||
Anti-dilutive potential common share equivalent excluded from calculation of net loss per ordinary share | 2,765 | 1,180 | 2,507 | 3,024 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) € in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2024 EUR (€) | Jun. 30, 2023 USD ($) | |
Income Taxes [Line Items] | |||||
Income tax provisions | $ 22,061,000 | $ 2,728,000 | $ 30,025,000 | $ 3,445,000 | |
Effective tax rate | 18.30% | 18.30% | |||
Statutory tax rate | 12.50% | 12.50% | |||
Ireland | |||||
Income Taxes [Line Items] | |||||
Income tax provisions | $ 0 | $ 0 | |||
Minimum | Pillar Two | |||||
Income Taxes [Line Items] | |||||
Revenue | € | € 750 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities - Additional Information (Details) | 1 Months Ended | 6 Months Ended |
Jan. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) ft² | |
Commitments And Contingencies [Line Items] | ||
Potential material losses from claims, legal proceedings probable of occurring | $ 0 | |
Additional sought value for damages as part of requested modification | $ 66,000,000 | |
852 Winter Street Lease | ||
Commitments And Contingencies [Line Items] | ||
Area of real estate property | ft² | 180,000 | |
Guaranty date | May 16, 2014 | |
Fair value of guarantee | $ 0 | |
Option to extend, description | This lease expires in 2026 and includes a tenant option to extend the term for an additional five-year period. | |
Option to extend | true | |
Lease term of contract | 5 years |