Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
Entity Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38485 | |
Entity Registrant Name | Amneal Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 32-0546926 | |
Entity Address, Address Line One | 400 Crossing Boulevard, | |
Entity Address, City or Town | Bridgewater | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08807 | |
City Area Code | 908 | |
Local Phone Number | 947-3120 | |
Title of 12(b) Security | Class A Common Stock, par value $0.01 per share | |
Trading Symbol | AMRX | |
Security Exchange Name | NYSE | |
Entity Current Reporting | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001723128 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Class A Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding (in shares) | 306,544,199 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net revenue | $ 620,040 | $ 545,557 | $ 1,776,626 | $ 1,602,545 |
Cost of goods sold | 387,509 | 351,327 | 1,145,888 | 1,033,225 |
Gross profit | 232,531 | 194,230 | 630,738 | 569,320 |
Selling, general and administrative | 113,006 | 100,071 | 320,672 | 297,542 |
Research and development | 41,375 | 50,235 | 117,864 | 153,781 |
Intellectual property legal development expenses | 886 | 1,411 | 3,350 | 2,996 |
Acquisition, transaction-related and integration expenses | 0 | 39 | 0 | 714 |
Restructuring and other charges | 1,043 | 581 | 1,635 | 1,312 |
Change in fair value of contingent consideration | 3,120 | (1,425) | (787) | (1,495) |
Insurance recoveries for property losses and associated expenses | 0 | 0 | 0 | (1,911) |
(Credit) charges related to legal matters, net | (2,620) | 285 | (1,039) | 249,836 |
Other operating expense (income) | 73 | (1,320) | (1,138) | (2,495) |
Operating income (loss) | 75,648 | 44,353 | 190,181 | (130,960) |
Other (expense) income: | ||||
Interest expense, net | (50,909) | (42,391) | (151,081) | (111,349) |
Foreign exchange loss, net | (2,939) | (5,491) | (617) | (12,933) |
Other income, net | 1,157 | 5,709 | 4,708 | 14,770 |
Total other expense, net | (52,691) | (42,173) | (146,990) | (109,512) |
Income (loss) before income taxes | 22,957 | 2,180 | 43,191 | (240,472) |
(Benefit from) provision for income taxes | (2,076) | 4,570 | (1,431) | 8,459 |
Net income (loss) | 25,033 | (2,390) | 44,622 | (248,931) |
Less: Net (income) loss attributable to non-controlling interests | (15,351) | (299) | (29,966) | 123,716 |
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest | 9,682 | (2,689) | 14,656 | (125,215) |
Accretion of redeemable non-controlling interest | 0 | 0 | 0 | (438) |
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | $ 9,682 | $ (2,689) | $ 14,656 | $ (125,653) |
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.'s class A common stockholders: | ||||
Basic (in dollars per share) | $ 0.06 | $ (0.02) | $ 0.10 | $ (0.83) |
Diluted (in dollars per share) | $ 0.06 | $ (0.02) | $ 0.09 | $ (0.83) |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 154,219 | 151,393 | 153,363 | 150,765 |
Diluted (in shares) | 159,691 | 151,393 | 156,284 | 150,765 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Other Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 25,033 | $ (2,390) | $ 44,622 | $ (248,931) |
Less: Net (income) loss attributable to non-controlling interests | (15,351) | (299) | (29,966) | 123,716 |
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest | 9,682 | (2,689) | 14,656 | (125,215) |
Accretion of redeemable non-controlling interest | 0 | 0 | 0 | (438) |
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | 9,682 | (2,689) | 14,656 | (125,653) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustments arising during the period | (3,086) | (9,243) | (1,029) | (24,950) |
Unrealized (loss) gain on cash flow hedge, net of tax | (5,292) | 32,639 | (11,250) | 100,333 |
Less: Other comprehensive loss (income) attributable to non-controlling interests | 4,160 | (11,725) | 6,133 | (37,905) |
Other comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc. | (4,218) | 11,671 | (6,146) | 37,478 |
Comprehensive income (loss) attributable to Amneal Pharmaceuticals, Inc. | $ 5,464 | $ 8,982 | $ 8,510 | $ (88,175) |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 86,929 | $ 25,976 |
Restricted cash | 8,678 | 9,251 |
Inventories | 576,474 | 530,735 |
Prepaid expenses and other current assets | 91,444 | 103,565 |
Total current assets | 1,456,075 | 1,411,818 |
Property, plant and equipment, net | 451,852 | 469,815 |
Goodwill | 598,631 | 598,853 |
Intangible assets, net | 982,531 | 1,096,093 |
Other assets | 89,043 | 103,217 |
Total assets | 3,687,079 | 3,799,341 |
Current liabilities: | ||
Current portion of liabilities for legal matters | 76,828 | 107,483 |
Revolving credit facilities | 76,000 | 60,000 |
Current portion of long-term debt, net | 30,533 | 29,961 |
Total current liabilities | 760,601 | 752,800 |
Long-term debt, net | 2,541,814 | 2,591,981 |
Note payable - related party | 41,001 | 39,706 |
Total long-term liabilities | 2,735,098 | 2,837,613 |
Commitments and contingencies (Notes 5 and 19) | ||
Redeemable non-controlling interests | 37,144 | 24,949 |
Stockholders' Equity | ||
Preferred stock, $0.01 par value, 2,000 shares authorized, none issued at both September 30, 2023 and December 31, 2022 | 0 | 0 |
Additional paid-in capital | 715,450 | 691,629 |
Stockholders' accumulated deficit | (391,527) | (406,183) |
Accumulated other comprehensive income | 3,873 | 9,939 |
Total Amneal Pharmaceuticals, Inc. stockholders' equity | 330,860 | 298,421 |
Non-controlling interests | (176,624) | (114,442) |
Total stockholders' equity | 154,236 | 183,979 |
Total liabilities and stockholders' equity | 3,687,079 | 3,799,341 |
Related Party | ||
Current assets: | ||
Trade accounts receivable, net | 1,603 | 500 |
Operating lease right-of-use assets | 15,876 | 17,910 |
Current liabilities: | ||
Accounts payable and accrued expenses | 3,500 | 2,479 |
Current portion of operating lease liabilities - related party | 3,055 | 2,869 |
Operating lease liabilities | 13,598 | 15,914 |
Other long-term liabilities | 11,534 | 9,649 |
Nonrelated Party | ||
Current assets: | ||
Trade accounts receivable, net | 690,947 | 741,791 |
Operating lease right-of-use assets | 32,523 | 38,211 |
Financing lease right-of-use assets | 60,548 | 63,424 |
Current liabilities: | ||
Accounts payable and accrued expenses | 557,761 | 538,199 |
Current portion of operating lease liabilities | 9,826 | 8,321 |
Current portion of financing lease liabilities | 3,098 | 3,488 |
Operating lease liabilities | 26,412 | 32,126 |
Financing lease liabilities | 59,351 | 60,769 |
Other long-term liabilities | 41,388 | 87,468 |
Class A Common Stock | ||
Stockholders' Equity | ||
Common stock | 1,542 | 1,514 |
Class B Common Stock | ||
Stockholders' Equity | ||
Common stock | $ 1,522 | $ 1,522 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Class A Common Stock | ||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 900,000,000 | 900,000,000 |
Common stock, shares issued (in shares) | 154,346,000 | 151,490,000 |
Class B Common Stock | ||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 152,117,000 | 152,117,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 44,622 | $ (248,931) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Depreciation and amortization | 172,467 | 179,119 |
Unrealized foreign currency loss | 1,563 | 12,893 |
Amortization of debt issuance costs and discount | 6,884 | 6,489 |
Loss on refinancing - revolving credit facility | 0 | 291 |
Intangible asset impairment charges | 2,036 | 5,786 |
Change in fair value of contingent consideration | (787) | (1,495) |
Stock-based compensation | 20,848 | 24,016 |
Inventory provision | 56,637 | 28,884 |
Insurance recoveries for property and equipment losses | 0 | (1,000) |
Other operating charges and credits, net | 6,370 | 7,077 |
Changes in assets and liabilities: | ||
Trade accounts receivable, net | 49,055 | 33,570 |
Inventories | (103,092) | (91,326) |
Prepaid expenses, other current assets and other assets | 24,810 | (34,380) |
Related party receivables | (1,131) | (517) |
Accounts payable, accrued expenses and other liabilities | (74,685) | 165,437 |
Related party payables | 4,157 | 2,479 |
Net cash provided by operating activities | 209,754 | 88,392 |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (33,351) | (34,941) |
Saol Acquisition | 0 | (84,714) |
Acquisition of intangible assets | (2,488) | (41,800) |
Deposits for future acquisition of property, plant and equipment | (1,658) | (2,388) |
Proceeds from insurance recoveries for property and equipment losses | 0 | 1,000 |
Net cash used in investing activities | (37,497) | (162,843) |
Cash flows from financing activities: | ||
Payments of deferred financing and refinancing costs | (542) | (1,663) |
Payments of principal on debt, revolving credit facilities, financing leases and other | (151,510) | (105,618) |
Borrowings on revolving credit facilities | 110,000 | 85,000 |
Proceeds from exercise of stock options | 408 | 662 |
Employee payroll tax withholding on restricted stock unit vesting | (2,222) | (3,483) |
Payments of deferred consideration for acquisitions - related party | 0 | (44,498) |
Acquisition of redeemable non-controlling interest | 0 | (1,722) |
Tax distributions to non-controlling interests | (67,875) | (13,131) |
Net cash used in financing activities | (111,741) | (84,453) |
Effect of foreign exchange rate on cash | (136) | (1,944) |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 60,380 | (160,848) |
Cash, cash equivalents, and restricted cash - beginning of period | 35,227 | 256,739 |
Cash, cash equivalents, and restricted cash - end of period | 95,607 | 95,891 |
Cash and cash equivalents - end of period | 86,929 | 87,335 |
Restricted cash - end of period | 8,678 | 8,556 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 136,600 | 92,215 |
Cash received (paid), net for income taxes | 426 | (9,942) |
Supplemental disclosure of non-cash investing and financing activity: | ||
Tax distributions to non-controlling interests | 1,062 | 0 |
Contingent consideration for acquisition | 0 | 8,796 |
Payable for acquisition of intangible assets | $ 8,500 | $ 0 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock Class A Common Stock | Common Stock Class B Common Stock | Additional Paid-in Capital | Stockholders' Accumulated Deficit | Accumulated Other Comprehensive Income | Non- Controlling Interests |
Shares beginning balance (in shares) at Dec. 31, 2021 | 149,413 | 152,117 | |||||
Stockholders' equity beginning balance at Dec. 31, 2021 | $ 366,973 | $ 1,492 | $ 1,522 | $ 658,350 | $ (276,197) | $ (24,827) | $ 6,633 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net (loss) income | (258,558) | (125,215) | (133,343) | ||||
Foreign currency translation adjustments | (24,950) | (12,426) | (12,524) | ||||
Stock-based compensation | 24,016 | 24,016 | |||||
Exercise of stock options (in shares) | 208 | ||||||
Exercise of stock options | 662 | $ 2 | 615 | 45 | |||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 1,805 | ||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (3,493) | $ 19 | 764 | (112) | (4,164) | ||
Unrealized loss on cash flow hedge, net of tax | 100,333 | 49,904 | 50,429 | ||||
Tax distributions | (9,811) | (9,811) | |||||
Reclassification of redeemable non-controlling interest | (883) | (438) | (445) | ||||
Shares ending balance (in shares) at Sep. 30, 2022 | 151,426 | 152,117 | |||||
Stockholders' equity ending balance at Sep. 30, 2022 | 194,289 | $ 1,513 | $ 1,522 | 683,745 | (401,850) | 12,539 | (103,180) |
Redeemable Non-Controlling Interests, beginning balance at Dec. 31, 2021 | 16,907 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||
Net (loss) income | 9,627 | ||||||
Tax distributions | (3,320) | ||||||
Reclassification of redeemable non-controlling interest | 883 | ||||||
Acquisition of redeemable non-controlling interest | (1,722) | ||||||
Redeemable Non-Controlling Interests, ending balance at Sep. 30, 2022 | 22,375 | ||||||
Shares beginning balance (in shares) at Jun. 30, 2022 | 151,196 | 152,117 | |||||
Stockholders' equity beginning balance at Jun. 30, 2022 | 172,991 | $ 1,510 | $ 1,522 | 675,588 | (399,161) | 868 | (107,336) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net (loss) income | (7,613) | (2,689) | (4,924) | ||||
Foreign currency translation adjustments | (9,243) | (4,610) | (4,633) | ||||
Stock-based compensation | 7,689 | 7,689 | |||||
Exercise of stock options (in shares) | 154 | ||||||
Exercise of stock options | 423 | $ 2 | 422 | (1) | |||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 76 | ||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (116) | $ 1 | 46 | (163) | |||
Unrealized loss on cash flow hedge, net of tax | 32,639 | 16,281 | 16,358 | ||||
Tax distributions | (2,481) | (2,481) | |||||
Shares ending balance (in shares) at Sep. 30, 2022 | 151,426 | 152,117 | |||||
Stockholders' equity ending balance at Sep. 30, 2022 | 194,289 | $ 1,513 | $ 1,522 | 683,745 | (401,850) | 12,539 | (103,180) |
Redeemable Non-Controlling Interests, beginning balance at Jun. 30, 2022 | 17,885 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||
Net (loss) income | 5,223 | ||||||
Tax distributions | (733) | ||||||
Redeemable Non-Controlling Interests, ending balance at Sep. 30, 2022 | 22,375 | ||||||
Shares beginning balance (in shares) at Dec. 31, 2022 | 151,490 | 152,117 | |||||
Stockholders' equity beginning balance at Dec. 31, 2022 | 183,979 | $ 1,514 | $ 1,522 | 691,629 | (406,183) | 9,939 | (114,442) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net (loss) income | 22,141 | 14,656 | 7,485 | ||||
Foreign currency translation adjustments | (1,029) | (525) | (504) | ||||
Stock-based compensation | 20,848 | 20,848 | |||||
Exercise of stock options (in shares) | 149 | ||||||
Exercise of stock options | 408 | $ 1 | 405 | 4 | (2) | ||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 2,707 | ||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (2,210) | $ 27 | 2,568 | 76 | (4,881) | ||
Unrealized loss on cash flow hedge, net of tax | (11,250) | (5,621) | (5,629) | ||||
Tax distributions | (58,651) | (58,651) | |||||
Shares ending balance (in shares) at Sep. 30, 2023 | 154,346 | 152,117 | |||||
Stockholders' equity ending balance at Sep. 30, 2023 | 154,236 | $ 1,542 | $ 1,522 | 715,450 | (391,527) | 3,873 | (176,624) |
Redeemable Non-Controlling Interests, beginning balance at Dec. 31, 2022 | 24,949 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||
Net (loss) income | 22,481 | ||||||
Tax distributions | (10,286) | ||||||
Redeemable Non-Controlling Interests, ending balance at Sep. 30, 2023 | 37,144 | ||||||
Shares beginning balance (in shares) at Jun. 30, 2023 | 154,050 | 152,117 | |||||
Stockholders' equity beginning balance at Jun. 30, 2023 | 150,768 | $ 1,540 | $ 1,522 | 708,233 | (401,209) | 8,083 | (167,401) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net (loss) income | 15,540 | 9,682 | 5,858 | ||||
Foreign currency translation adjustments | (3,086) | (1,554) | (1,532) | ||||
Stock-based compensation | 6,691 | 6,691 | |||||
Exercise of stock options (in shares) | 149 | ||||||
Exercise of stock options | 408 | $ 1 | 405 | 4 | (2) | ||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 147 | ||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (153) | $ 1 | 121 | 4 | (279) | ||
Unrealized loss on cash flow hedge, net of tax | (5,292) | (2,664) | (2,628) | ||||
Tax distributions | (10,640) | (10,640) | |||||
Shares ending balance (in shares) at Sep. 30, 2023 | 154,346 | 152,117 | |||||
Stockholders' equity ending balance at Sep. 30, 2023 | 154,236 | $ 1,542 | $ 1,522 | $ 715,450 | $ (391,527) | $ 3,873 | $ (176,624) |
Redeemable Non-Controlling Interests, beginning balance at Jun. 30, 2023 | 32,106 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||
Net (loss) income | 9,493 | ||||||
Tax distributions | (4,455) | ||||||
Redeemable Non-Controlling Interests, ending balance at Sep. 30, 2023 | $ 37,144 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations Amneal Pharmaceuticals, Inc. (the “Company”) is a global pharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines, including complex generics and specialty branded pharmaceuticals. The Company operates principally in the United States (the “U.S.”), India, and Ireland, and sells to wholesalers, distributors, hospitals, chain pharmacies and individual pharmacies, either directly or indirectly. Prior to the Reorganization (as defined herein) and during the period covered by this report, the Company was a holding company, whose principal assets were common units (“Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”). As of September 30, 2023, the Company held 50.4% of Amneal Common Units and the group, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Members” or the “Amneal Group”) held the remaining 49.6%. For further information regarding the Reorganization, refer to Note 24. Subsequent Events . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited consolidated financial statements, which are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”), should be read in conjunction with the Company’s annual audited financial statements for the year ended December 31, 2022 included in the Company’s 2022 Annual Report on Form 10-K. Certain information and footnote disclosures normally included in annual financial statements have been omitted from the accompanying unaudited consolidated financial statements. In the opinion of management, the accompanying unaudited consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2023, cash flows for the nine months ended September 30, 2023 and 2022 and the results of its operations, its comprehensive income (loss) and its changes in stockholders’ equity for the three and nine months ended September 30, 2023 and 2022. The consolidated balance sheet data at December 31, 2022 was derived from the Company’s audited annual financial statements, but does not include all disclosures required by U.S. GAAP. Except for the updates included in this note, the accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies contained in the Company’s 2022 Annual Report on Form 10-K. Use of Estimates The preparation of financial statements requires the Company's management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, billbacks, valuation of intangible and other assets acquired in business combinations, allowances for accounts receivable, accrued liabilities, liabilities for legal matters, initial and subsequent valuation of contingent consideration recognized in business combinations, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights and the assessment of expected cash flows used in evaluating goodwill and other long-lived assets for impairment. Actual results could differ from those estimates. Recently Adopted Accounting Pronouncements In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU 2021-08”) , which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers (“ASC 606”). The update will generally result in an entity recognizing contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value. ASU 2021-08 was effective on a prospective basis for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company adopted ASU 2021-08 effective January 1, 2023 and will apply the guidance to subsequent acquisitions. The adoption of ASU 2021-08 did not have an impact on the Company’s consolidated financial statements because the Company did not acquire a business during the nine months ended September 30, 2023. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”), which provides elective amendments for entities that have contracts, hedging relationships and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848) , to expand and clarify the scope of Topic 848 to include derivative instruments on discounting transactions. In December 2022, the FASB issued ASU 2022-06, Reference Rate reform (Topic 848): Deferral of the Sunset Date of Topic 848 , which deferred the sunset date of Topic 848, Reference Rate Reform to December 31, 2024. The Company adopted ASU 2020-04 during the three months ended June 30, 2023 (refer to Note 15. Debt and Note 18. Financial Instruments for additional information). The adoption of ASU 2020-04 did not have a material impact on the Company’s consolidated financial statements. Reclassifications The prior period balances related to cost of goods sold impairment charges of $0.7 million and $5.8 million, formerly included in a separate income statement caption for both the three and nine months ended September 30, 2022, respectively, have been reclassified to be included within the income statement caption cost of goods sold to conform with the current period presentation. This reclassification did not impact gross profit or net income. The prior period balance related to loss on refinancing of $0.3 million, formerly included in a separate income statement caption for the nine months ended September 30, 2022, has been reclassified to be included within the income statement caption other income, net to conform to the current period presentation. This reclassification did not impact net income. |
Acquisition
Acquisition | 9 Months Ended |
Sep. 30, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisition | Acquisition Saol Baclofen Franchise Acquisition On December 30, 2021, the Company entered into an asset purchase agreement with certain entities affiliated with Saol International Limited (collectively, “Saol”), a private specialty pharmaceutical company, pursuant to which it agreed to acquire Saol’s baclofen franchise, including Lioresal®, LYVISPAH™, and a pipeline product under development (the “Saol Acquisition”). The Saol Acquisition expanded the Company’s commercial institutional and specialty portfolio in neurology and added commercial infrastructure in advance of its entry into the biosimilar institutional market. The transaction closed on February 9, 2022. Consideration for the Saol Acquisition included $84.7 million, paid at closing with cash on hand, and contingent royalty payments based on annual net sales for certain acquired assets, beginning in June 2023. Refer to Note 3. Acquisitions in the Company’s 2022 Annual Report on Form 10-K for additional information. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time. License Agreements Refer to Note 5. Alliance and Collaboration for further information related to revenue recognition associated with a license agreement with multiple performance obligations. Concentration of Revenue The following table summarizes revenues from each of the Company’s customers which individually accounted for 10% or more of its total net revenue: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Customer A 24 % 21 % 24 % 20 % Customer B 17 % 17 % 15 % 17 % Customer C 21 % 23 % 21 % 23 % Customer D 10 % 9 % 10 % 11 % Disaggregated Revenue The Company’s significant therapeutic classes for its Generics and Specialty segments and sales channels for its AvKARE segment, as determined based on net revenue for the three and nine months ended September 30, 2023 and 2022, are set forth below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Generics Anti-infective $ 7,382 $ 4,957 $ 18,648 $ 16,768 Hormonal / allergy 126,425 119,726 357,711 334,403 Antiviral 7,150 5,782 36,221 17,649 Central nervous system 96,587 96,877 264,773 286,789 Cardiovascular system 32,459 28,926 98,108 84,422 Gastroenterology 18,858 17,129 53,127 51,280 Oncology 37,722 12,240 76,846 47,872 Metabolic disease/ endocrine 11,026 9,276 35,227 30,497 Respiratory 7,832 8,720 31,783 26,503 Dermatology 17,279 17,327 53,232 48,741 Other therapeutic classes 27,270 29,101 80,974 86,790 International and other 867 205 1,714 1,194 Total Generics net revenue 390,857 350,266 1,108,364 1,032,908 Specialty Hormonal / allergy 28,494 22,012 82,268 65,751 Central nervous system 61,142 61,785 180,844 185,309 Other therapeutic classes 7,668 5,687 22,864 20,511 Total Specialty net revenue 97,304 89,484 285,976 271,571 AvKARE Distribution 81,904 66,057 248,929 190,560 Government label 32,764 26,000 87,150 72,739 Institutional 10,551 8,297 28,395 20,672 Other 6,660 5,453 17,812 14,095 Total AvKARE net revenue 131,879 105,807 382,286 298,066 Total net revenue $ 620,040 $ 545,557 $ 1,776,626 $ 1,602,545 A rollforward of the major categories of sales-related deductions for the nine months ended September 30, 2023 is as follows (in thousands): Contract Cash Discount Accrued Accrued Balance at December 31, 2022 $ 573,592 $ 27,454 $ 145,060 $ 86,030 Provision related to sales recorded in the period 2,502,481 84,465 50,786 187,161 Credits/payments issued during the period (2,601,904) (87,767) (65,878) (183,028) Balance at September 30, 2023 $ 474,169 $ 24,152 $ 129,968 $ 90,163 |
Alliance and Collaboration
Alliance and Collaboration | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Alliance and Collaboration | Alliance and CollaborationThe Company has entered into several alliance, collaboration, license, distribution and similar agreements with respect to certain of its products and services with third-party pharmaceutical companies. The consolidated statements of operations include revenue recognized under agreements the Company has entered into to develop marketing and/or distribution relationships with its partners to fully leverage the technology platform and revenue recognized under development agreements which generally obligate the Company to provide research and development (“R&D”) services over multiple periods. The Company’s significant arrangements are discussed below. License Agreement On December 28, 2022, Amneal signed a long-term license agreement with Orion Corporation (“Orion”), a globally operating Finnish pharmaceutical company, to commercialize a number of its complex generic products in most parts of Europe, Australia and New Zealand (the “Orion Agreement”). The initial term of the Orion Agreement commences upon commercial launch of the products and will continue for eight years. The Orion Agreement will automatically renew for successive two-year terms unless either party declines such renewal in writing at least one year in advance. Under the terms of the Orion Agreement, Amneal granted Orion licenses to certain generic products commercially available in the U.S. today and select high-value pipeline products currently under development. In addition, Amneal will be responsible for the performance of all R&D activities to be conducted to obtain regulatory approval for each product. Amneal is entitled to be reimbursed for a percentage of mutually agreed upon R&D expenses from Orion. Orion will be responsible for preparing and filing regulatory documentation, along with paying any application fees seeking regulatory approval for the products. Upon achieving regulatory approval for products, Amneal will be responsible for manufacturing and supplying products to Orion. Orion will be responsible for all commercialization and marketing activities for the territories described above. Amneal will earn revenue for supplying products to Orion at the greater of: (i) cost plus a stated margin, or (ii) a fixed percentage of the net selling price, as defined in the Orion Agreement. Upon signing of the Orion Agreement, Amneal was entitled to an upfront, non-refundable payment of €20.0 million, or $21.4 million (based on the exchange rate as of that date), which was collected in January 2023. Amneal is eligible to receive certain one-time sales-based milestones in the aggregate of €45.0 million, or $47.6 million, based on the exchange rate as of September 30, 2023, contingent upon whether Orion achieves certain annual sales targets. The Orion Agreement is within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”). The Company identified performance obligations related to: (1) the grant of a license of functional intellectual property (“IP”), (2) the performance of R&D activities, and (3) the supply of products. The Company evaluated that the grant of licenses is in the scope of ASC 606, whereas the performance of R&D activities is in the scope of ASC 730-20, Research and Development Arrangements , because the Company determined that performing R&D activities on behalf of other parties is not part of the ordinary activities of its business. The Company records reimbursement received from Orion for R&D activities as a reduction of R&D expense. The Company concluded each future purchase order from Orion represents a separate contract. Amneal will record revenue related to each purchase order when it transfers control of the products to Orion. At December 31, 2022, Amneal had not performed any reimbursable R&D activities under the Orion Agreement or supplied any products to Orion. The Company determined that the transaction price under the arrangement was the upfront payment of $21.4 million, which was allocated to the performance obligations based on their relative standalone selling prices. The remaining sales-based milestones payments are variable consideration and were not included in the transaction price because they were fully constrained under ASC 606. For the year ended December 31, 2022, the Company recognized $8.0 million in license revenue related to the delivery of functional IP, which was recorded in net revenues. The remaining $13.4 million of the transaction price was allocated to the R&D activities performance obligation and was recorded as deferred income, of which $6.7 million was recorded in accounts payable and accrued expenses and $6.7 million was recorded in other long-term liabilities as of December 31, 2022. During the three and nine months ended September 30, 2023, the Company recognized $0.3 million and $0.9 million, respectively, as a reduction to R&D expense related to services performed under the Orion Agreement. As of September 30, 2023, deferred income of $9.1 million and $3.4 million was recorded in accounts payable and accrued expenses and other long-term liabilities, respectively. As of September 30, 2023, no products have been supplied by Amneal under the Orion Agreement. Biosimilar Licensing and Supply Agreement On May 7, 2018, the Company entered into a licensing and supply agreement with Mabxience S.L. for its biosimilar candidate for Avastin® (bevacizumab). The supply agreement was subsequently amended on March 2, 2021 and the licensing agreement was amended on March 4, 2021. Pursuant to the agreement, the Company will be the exclusive partner in the U.S. market and will pay development and regulatory milestone payments as well as commercial milestone payments on reaching pre-agreed sales targets in the market to Mabxience, up to $78.3 million. On April 13, 2022, the Food and Drug Administration (the “ FDA”) approved the Company’s biologics license application for bevacizumab-maly, a biosimilar referencing Avastin®. In connection with this regulatory approval and associated activity, the Company paid milestones of $26.5 million in 2022, which were capitalized as product rights intangible assets and are being amortized to cost of sales over their estimated useful lives of 7 years. Agreements with K ashiv Biosciences, LLC For details on the Company’s related party agreements with Kashiv Biosciences, LLC (“Kashiv”), refer to Note 21. Related Party Transactions in this Form 10-Q and Note 24. Related Party Transactions in the Company’s 2022 Annual Report on Form 10-K. |
Government Grants
Government Grants | 9 Months Ended |
Sep. 30, 2023 | |
Receivables [Abstract] | |
Government Grants | Government Grants In November 2021, Amneal Pharmaceuticals Private Limited, a subsidiary of the Company in India, was selected as one of 55 companies to participate in the India Production Linked Incentive Scheme for the Pharmaceutical Sector (“PLI Scheme”). The government of India established the PLI Scheme to make India’s domestic manufacturing more globally competitive and to create global champions within the pharmaceutical sector by encouraging investment and product diversification with a focus on manufacturing complex and high value goods. Under the PLI Scheme, the Company is eligible to receive up to 10 billion Indian rupees, or approximately $120.2 million (based on the exchange rate as of September 30, 2023), over a maximum six-year period, starting in 2022. To be eligible to receive the cash incentives, Amneal must achieve (i) minimum cumulative expenditures towards developmental and/or capital investments and (ii) a minimum percentage growth in sales of eligible products. The Company concluded the PLI Scheme is government assistance in the form of a grant and, in the absence of specific accounting guidance under U.S. GAAP, the Company has analogized to International Accounting Standards 20, Accounting for Government Grants and Disclosure of Government Assistance . The Company evaluated the PLI Scheme to be a grant related to income and will recognize the cash incentives on a systematic basis in other operating income. For the nine months ended September 30, 2023, the Company recognized $1.2 million of other operating income from the PLI Scheme. For the three and nine months ended September 30, 2022, the Company recognized $1.3 million and $2.5 million, respectively, of other operating income from the PLI Scheme. As of September 30, 2023 and December 31, 2022, the Company had receivables from the government of India of $5.0 million and $4.0 million, respectively, within prepaid expenses and other current assets. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the three months ended September 30, 2023, the Company’s benefit from income taxes and effective tax rate were $(2.1) million and (9.0)%, respectively, as compared to a provision for income taxes and effective tax rate of $4.6 million and 209.6%, respectively, for the three months ended September 30, 2022. For the nine months ended September 30, 2023, the Company’s benefit from income taxes and effective tax rate were $(1.4) million and (3.3)%, respectively, as compared to $8.5 million and (3.5)%, respectively, for the nine months ended September 30, 2022. For the three and nine months ended September 30, 2023, the period-over-period changes in the (benefit from) provision for income taxes were primarily related to changes in the jurisdictional mix of income and a discrete Indian tax benefit. The Company recognized a discrete Indian tax benefit of approximately $2.9 million from the utilization of a loss carryforward after the completion of a merger of certain of our subsidiaries in India during the three months ended September 30, 2023. The Company established a valuation allowance on its deferred tax assets (“DTAs”) based upon all available objective and verifiable evidence, both positive and negative, including historical levels of pre-tax income (loss) both on a consolidated basis and tax reporting entity basis, legislative developments, expectations and risks associated with estimates of future pre-tax income, and prudent and feasible tax planning strategies. Since first establishing a valuation allowance, the Company has generated cumulative consolidated three-year pre-tax losses through September 30, 2023. As a result of the losses through September 30, 2023, the Company determined that it is more likely than not that it will not realize the benefits of its gross DTAs and therefore maintained its valuation allowance. As of September 30, 2023 and December 31, 2022, this valuation allowance was $434.5 million and $434.9 million, respectively, and it reduced the carrying value of these gross DTAs to zero. The Company previously entered into a tax receivable agreement (“TRA”) for which it was generally required to pay the holders of Amneal Common Units on a one-to-one basis, 85% of the applicable tax savings, if any, in U.S. federal and state income tax that it is deemed to realize as a result of certain tax attributes of their Amneal Common Units sold to the Company (or exchanged in a taxable sale) and that are created as a result of (i) the sales of their Amneal Common Units for shares of class A common stock prior to the Reorganization and (ii) tax benefits attributable to payments made under the TRA. In conjunction with the valuation allowance recorded on the DTAs, the Company reversed the accrued TRA liability of $192.8 million during 2019. The projection of future taxable income involves significant judgment. Actual taxable income may differ from the Company’s estimates, which could significantly impact the timing of the recognition of the contingent liability under the TRA. As noted above, the Company has determined it is more-likely-than-not it will be unable to utilize all of its DTAs subject to the TRA; therefore, as of September 30, 2023, the Company has not recognized the contingent liability under the TRA related to the tax savings it may realize from common units sold or exchanged. If utilization of these DTAs becomes more likely than not in the future, at such time, Amneal will recognize a liability under the TRA as a result of basis adjustments under Internal Revenue Code Section 754. As of both September 30, 2023 and December 31, 2022, the contingent liability associated with the TRA was approximately $202.7 million, of which approximately $2.5 million and $0.6 million were recorded as of September 30, 2023 and December 31, 2022, respectively (refer to Note 21. Related Party Transactions .) The timing and amount of any payments under the TRA may vary depending upon a number of factors, including the timing of the Company’s taxable income and the tax rate in effect at the time of realization of the Company’s taxable income (the TRA liability is determined based on a percentage of the corporate tax savings from the use of the TRA’s attributes). The Reorganization reduced the Company’s contingent liability under the TRA (see below) subsequent to September 30, 2023. Under certain conditions, such as a change of control or other early termination event, the Company could be obligated to make TRA payments in advance of tax benefits being realized. Payments could also be in excess of the tax savings that the Company may ultimately realize. Any future recognition of these TRA liabilities will be recorded through charges in the Company’s consolidated statements of operations. However, if the tax attributes are not utilized in future years, it is reasonably possible no amounts would be paid under the TRA in excess of the $2.5 million accrued as of September 30, 2023 . Should the Company determine that a DTA with a valuation allowance is realizable in a subsequent period, the related valuation allowance will be reversed and, if a resulting TRA payment is determined to be probable, a corresponding TRA liability will be recorded. Refer to Note 24. Subsequent Events for information about the Reorganization, pursuant to which the parties have agreed, among other things, to reduce the Company’s contingent obligation to pay 85% of the tax benefits subject to the TRA to 75% of such tax benefits. This agreement will not cause the acceleration of payments under the TRA. |
Earnings (Loss) per Share
Earnings (Loss) per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) per Share | Earnings (Loss) per ShareBasic earnings (loss) per share of the Company’s class A common stock is computed by dividing net income (loss) attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of class A common stock outstanding during the period. Diluted earnings (loss) per share of class A common stock is computed by dividing net income (loss) attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of class A common stock outstanding, adjusted to give effect to potentially dilutive securities. The following table sets forth reconciliations of the numerators and denominators used to compute basic and diluted earnings (loss) per share of class A common stock (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net income (loss) attributable to Amneal Pharmaceuticals, Inc. $ 9,682 $ (2,689) $ 14,656 $ (125,653) Denominator: Weighted-average shares outstanding - basic 154,219 151,393 153,363 150,765 Effect of dilutive securities: Stock options 534 — 178 — Restricted stock units 4,052 — 2,448 — Performance stock units 886 — 295 — Weighted-average shares outstanding - diluted 159,691 151,393 156,284 150,765 Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: Basic $ 0.06 $ (0.02) $ 0.10 $ (0.83) Diluted $ 0.06 $ (0.02) $ 0.09 $ (0.83) Shares of the Company’s class B common stock do not share in the earnings or losses of the Company and, therefore, are not participating securities. As such, separate presentation of basic and diluted earnings (loss) per share of class B common stock under the two-class method has not been presented. The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of class A common stock (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Stock options 432 (1) 2,728 (2) 432 (1) 2,728 (2) Restricted stock units — 10,874 (2) — 10,874 (2) Performance stock units 4,636 (3) 7,266 (2) 4,636 (3) 7,266 (2) Shares of class B common stock 152,117 (4) 152,117 (4) 152,117 (4) 152,117 (4) (1) Excluded from the computation of diluted earnings per share of class A common stock because the exercise price of the stock options exceeded the average market price of class A common stock during the period (out-of-the-money). (2) Excluded from the computation of diluted loss per share of class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period. (3) Excluded from the computation of diluted earnings per share of class A common stock because the performance vesting conditions were not met during the period. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net | 9 Months Ended |
Sep. 30, 2023 | |
Receivables [Abstract] | |
Trade Accounts Receivable, Net | Trade Accounts Receivable, Net Trade accounts receivable, net was comprised of the following (in thousands): September 30, December 31, Gross accounts receivable $ 1,193,505 $ 1,344,959 Allowance for credit losses (4,237) (2,122) Contract charge-backs and sales volume allowances (474,169) (573,592) Cash discount allowances (24,152) (27,454) Subtotal (502,558) (603,168) Trade accounts receivable, net $ 690,947 $ 741,791 Concentration of Receivables Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows: September 30, December 31, Customer A 36 % 41 % Customer B 27 % 25 % Customer C 23 % 21 % |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories were comprised of the following (in thousands): September 30, December 31, Raw materials $ 224,980 $ 224,607 Work in process 63,397 58,522 Finished goods 288,097 247,606 Total inventories $ 576,474 $ 530,735 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets were comprised of the following (in thousands): September 30, December 31, Deposits and advances $ 5,123 $ 1,821 Prepaid insurance 8,091 8,090 Prepaid regulatory fees 2,936 5,298 Income and other tax receivables 12,817 12,881 Prepaid taxes 17,213 16,593 Other current receivables (1) 15,107 33,133 Chargebacks receivable (2) 10,683 8,605 Other prepaid assets 19,474 17,144 Total prepaid expenses and other current assets $ 91,444 $ 103,565 (1) Other current receivables as of December 31, 2022 included a $21.4 million receivable for an upfront payment associated with the Orion Agreement, which was collected in January 2023. Refer to Note 5. Alliance and Collaboration for additional information. (2) When a sale occurs on a contract item in the Company’s AvKARE segment, the difference between the cost paid to the manufacturer by the Company and the contract cost that the end customer has with the manufacturer is rebated back to the Company by the manufacturer. The Company establishes a chargeback (rebate) receivable and a reduction to cost of goods sold in the same period as the related sale. |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets The changes in goodwill for the nine months ended September 30, 2023 and for the year ended December 31, 2022 were as follows (in thousands): September 30, December 31, Balance, beginning of period $ 598,853 $ 593,017 Goodwill acquired during the period — 7,553 Adjustment during the period for the acquisition of Puniska Healthcare Pvt. Ltd. — 3,075 Currency translation (222) (4,792) Balance, end of period $ 598,631 $ 598,853 As of September 30, 2023, $366.3 million, $162.8 million, and $69.5 million of goodwill was allocated to the Specialty, Generics, and AvKARE segments, respectively. As of December 31, 2022, $366.3 million, $163.1 million, and $69.5 million of goodwill was allocated to the Specialty, Generics, and AvKARE segments, respectively. For the year ended December 31, 2022, goodwill acquired during the period was associated with the Saol Acquisition. Refer to Note 3. Acquisition for additional information. Intangible assets as of September 30, 2023 and December 31, 2022 were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Weighted-Average Cost Accumulated Net Cost Accumulated Net Amortizing intangible assets: Product rights 6.4 $ 1,229,662 $ (678,128) $ 551,534 $ 1,222,762 $ (573,281) $ 649,481 Other intangible assets 3.5 133,800 (90,658) 43,142 133,800 (77,943) 55,857 Subtotal $ 1,363,462 $ (768,786) $ 594,676 $ 1,356,562 $ (651,224) $ 705,338 In-process research and development 387,855 — 387,855 390,755 — 390,755 Total intangible assets $ 1,751,317 $ (768,786) $ 982,531 $ 1,747,317 $ (651,224) $ 1,096,093 Amortization expense related to intangible assets for the three months ended September 30, 2023 and 2022 was $40.6 million and $44.5 million, respectively. Amortization expense related to intangible assets for the nine months ended September 30, 2023 and 2022 was $122.5 million and $127.4 million, respectively. The following table presents future amortization expense for the next five years and thereafter, excluding $387.9 million of in-process research and development (“IPR&D”) intangible assets (in thousands): Future Remainder of 2023 $ 40,609 2024 164,276 2025 126,861 2026 76,542 2027 54,765 2028 32,361 Thereafter 99,262 Total $ 594,676 The Company reviews intangible assets with finite lives for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. Indefinite-lived intangible assets, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. Intangible asset impairment charges were immaterial for the three and nine months ended September 30, 2023. For the three and nine months ended September 30, 2022, the Company recognized $0.7 million and $5.8 million, respectively, of intangible asset impairment charges, which were recognized in cost of goods sold. The impairment charge for the three months ended September 30, 2022 was related to a product that is no longer expected to be sold to a key customer, and therefore the asset is not expected to be recoverable. The impairment charges for the nine months ended September 30, 2022 related to the aforementioned charge and a marketed product that experienced significant price erosion without an offsetting increase in customer demand, resulting in significantly lower than expected future margins. Interim Goodwill and In-Process Research and Development Intangible Asset Impairment Tests On June 30, 2023, the Company received a complete response letter (“CRL”) from the FDA regarding its new drug application (“NDA”) for IPX203 for the treatment of Parkinson’s disease. The CRL indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa, based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa, and the FDA requested additional information. The CRL did not identify any issues with respect to the efficacy or manufacturing of IPX203. As of June 30, 2023, the Company identified the receipt of this CRL as an indicator of impairment, performed the necessary fair value test, and concluded that the IPX203 IPR&D intangible asset was not impaired. During October 2023, the Company met with the FDA to align on the path to approval for IPX203. During the meeting, the FDA asked the Company to perform a QT study, a routine cardiac safety study that is required for new drugs. The Company considered the requirement for a QT study in its June 30, 2023 assessment, therefore, there were no indicators of impairment of the IPX203 IPR&D intangible asset as of September 30, 2023. The Company is in the process of completing this study and expects to resubmit its new drug application for IPX203 in early 2024. Additionally, in light of the significance of IPX203 to the Specialty reporting unit, the Company performed an interim goodwill impairment test for its Specialty reporting unit, which is the same as the Company’s Specialty reportable segment, as of June 30, 2023. Based on the results of this test, the Company determined that the estimated fair value of the Specialty reporting unit exceeded its carrying value and there was no impairment of goodwill. There were no new indicators identified as of September 30, 2023. |
Other Assets
Other Assets | 9 Months Ended |
Sep. 30, 2023 | |
Other Assets [Abstract] | |
Other Assets | Other Assets Other assets were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Interest rate swap (1) $ 74,336 $ 85,586 Security deposits 3,573 3,523 Long-term prepaid expenses 2,401 3,711 Deferred revolving credit facility costs 2,387 2,206 Other long term assets 6,346 8,191 Total $ 89,043 $ 103,217 (1) Refer to Note 17. Fair Value Measurements and Note 18. Financial Instruments |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | Accounts Payable and Accrued Expenses Accounts payable and accrued expenses were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Accounts payable $ 177,400 $ 165,980 Accrued returns allowance (1) 129,968 145,060 Accrued compensation 52,826 54,038 Accrued Medicaid and commercial rebates (1) 90,163 86,030 Accrued royalties 27,064 19,309 Commercial chargebacks and rebates 10,226 10,226 Accrued professional fees 14,665 11,386 Accrued other 55,449 46,170 Total accounts payable and accrued expenses $ 557,761 $ 538,199 (1) Refer to Note 4. Revenue Recognition for a rollforward of the balance from December 31, 2022 to September 30, 2023. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following is a summary of the Company’s indebtedness under its term loans (in thousands): September 30, 2023 December 31, 2022 Term Loan due May 2025 $ 2,543,626 $ 2,563,876 Rondo Term Loan due January 2025 37,500 72,000 Total debt 2,581,126 2,635,876 Less: debt issuance costs (8,779) (13,934) Total debt, net of debt issuance costs 2,572,347 2,621,942 Less: current portion of long-term debt (30,533) (29,961) Total long-term debt, net $ 2,541,814 $ 2,591,981 There have been no material changes in the Company’s long-term debt since December 31, 2022, except as disclosed below. Refer to Note 16. Debt in the Company’s 2022 Annual Report on Form 10-K for additional information and definitions of terms used in this note. In January 2023, the Company borrowed $80.0 million under the New Revolving Credit Facility to fund an $83.9 million payment related to the O pana ER® antitrust litigation settlement agreements (refer to Note 19. Commitments and Contingencies ). During the three and nine months ended September 30, 2023, the Company repaid $30.0 million and $70.0 million, respectively, of its borrowings on the New Revolving Credit Facility from cash on hand. As of September 30, 2023, the Company had $70.0 million in borrowings and $275.9 million of available capacity under the New Revolving Credit Facility. On September 21, 2023, the Company executed an amendment to the Rondo Revolving Credit Facility (the “Amended Rondo Revolving Credit Facility”) that, among other things, (i) increased the aggregate revolving commitment from $30.0 million to $70.0 million, and (ii) increased the letter of credit commitment from $10.0 million to $60.0 million. The Amended Rondo Revolving Credit Facility bears a variable annual interest rate, which did not change as a result of this amendment, of one-month adjusted term secured overnight financing rate (“SOFR”), subject to a floor of 0.1% plus 2.25%. The Amended Rondo Revolving Credit Facility matures on January 31, 2025. During the three and nine months ended September 30, 2023, the Company borrowed $10.0 million and $30.0 million, respectively, under the Amended Rondo Revolving Credit Facility for working capital purposes. The Company repaid $24.0 million of its borrowings on the Amended Rondo Revolving Credit Facility during the three months ended September 30, 2023 from cash on hand. On September 26, 2023, Rondo entered into a standby letter of credit guarantee arrangement under the Amended Rondo Revolving Credit Facility in the amount of $42.0 million for purposes of securing inventory from a certain supplier. As of September 30, 2023, the Company had outstanding borrowings of $6.0 million and outstanding letters of credit of $42.0 million under the Amended Rondo Revolving Credit Facility and unused borrowing capacity of $22.0 million. During the three and nine months ended September 30, 2023, the Company repaid $2.2 million and $34.5 million, respectively, of principal outstanding on the Rondo Term Loan, of which $27.8 million was prepaid as of September 30, 2023. Reference Rate Reform On May 31, 2023, the Company executed an amendment to the Term Loan (the “Amended Term Loan”), which changed the variable reference rate from the London interbank offered rate (“LIBOR”) to the one-month adjusted term SOFR, subject to a floor of (0.11448%) plus 3.5%. The Company also executed an amendment to the related interest rate swap (the “Amended Swap”) that: (i) set a new fixed rate equal to 1.366%, (ii) changed the referenced floating rate from LIBOR to the one-month SOFR and (iii) established a floating rate floor of (0.11448%). After adopting ASC 848, Reference Rate Reform and electing certain applicable practical expedients, the Company determined that the amendments do not modify its existing accounting conclusions. As a result, the Company determined that the hedging relationship between the Amended Swap and the Amended Term Loan remained highly effective. On April 20, 2023, the Company executed an amendment to the Rondo Revolving Credit Facility, which changed the variable reference rate in the Rondo Term Loan from LIBOR to the one-month adjusted term SOFR, subject to a floor of 0.1% plus 2.25%. The amendments to the term loans and swap agreement did not have a material impact on the Company’s consolidated financial statements as of September 30, 2023 |
Other Long-Term Liabilities
Other Long-Term Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Long-Term Liabilities | Other Long-Term Liabilities Other long-term liabilities were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Uncertain tax positions $ 483 $ 563 Long-term portion of liabilities for legal matters (1) 486 49,442 Long-term compensation 22,610 16,737 Contingent consideration (2) 11,800 11,997 Other long-term liabilities 6,009 8,729 Total other long-term liabilities $ 41,388 $ 87,468 (1) Refer to Note 19. Commitments and Contingencies for additional information. (2) Refer to Note 17. Fair Value Measurements for additional information. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. Valuation techniques used to measure fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and also includes instruments for which the determination of fair value requires significant judgment or estimation. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period. The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurement Based on September 30, 2023 Total Quoted Significant Significant Assets Interest rate swap (1) $ 74,336 $ — $ 74,336 $ — Liabilities Deferred compensation plan liabilities (2) $ 8,727 $ — $ 8,727 $ — Contingent consideration liabilities (3) $ 14,640 $ — $ — $ 14,640 December 31, 2022 Assets Interest rate swap (1) $ 85,586 $ — $ 85,586 $ — Liabilities Deferred compensation plan liabilities (2) $ 9,674 $ — $ 9,674 $ — Contingent consideration liability (3) $ 15,427 $ — $ — $ 15,427 (1) The fair value measurement of the Company’s interest rate swap classified within Level 2 of the fair value hierarchy is a model-derived valuation as of a given date in which all significant inputs are observable in active markets including certain financial information and certain assumptions regarding past, present, and future market conditions. Refer to Note 18. Financial Instruments for information on the Company's interest rate swap. (2) These liabilities are recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants. (3) The fair value measurement of contingent consideration liabilities has been classified as Level 3 recurring liabilities as the valuations require judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for various inputs, the estimated fair values could be higher or lower than what the Company determined. As of September 30, 2023 and December 31, 2022 , the contingent consideration liability associated with the Saol Acquisition included $0.8 million and $0.1 million, respectively, recorded in accounts payable and accrued expenses and $11.8 million and $12.0 million, respectively, recorded in other-longer term liabilities. As of September 30, 2023 and December 31, 2022 , the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC (“KSP”) was valued at approximately $2.0 million and $3.3 million, respectively, and recorded within related party payables - long term. There were no transfers between levels in the fair value hierarchy during the nine months ended September 30, 2023. Contingent consideration On April 2, 2021 , the Company completed the acquisition of KSP, which provides for contingent milestone payments of up to an aggregate of $8.0 million (undiscounted) upon the achievement of certain regulatory milestones, as well as contingent royalty payments that are tiered depending on the aggregate annual net sales for certain future pharmaceutical products. On February 9, 2022, the Company completed the Saol Acquisition, which provides for contingent royalty payments that are tiered depending on the aggregate annual net sales for certain pharmaceutical products, beginning in 2023. There were no contingent royalty payments for the nine months ended September 30, 2023. The following table provides a reconciliation of the contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands): Nine Months Ended Balance, beginning of period $ 15,427 Change in fair value during the period (787) Balance, end of period $ 14,640 The fair value measurement of the contingent consideration liabilities were determined based on significant unobservable inputs, including the discount rate, the cost of debt, estimated probabilities of success, timing of achieving specified regulatory milestones and the estimated amount of future sales of the acquired products. The contingent consideration liabilities were estimated by applying a probability-weighted expected payment model for contingent milestone payments and Monte Carlo simulation models for contingent royalty payments, which were then discounted to present value. Changes to the fair values of the contingent consideration liabilities can result from changes to one or a number of the aforementioned inputs. If different assumptions were used for various inputs, the estimated fair value could be higher or lower than what the Company determined. The following table summarizes the significant unobservable inputs used in the fair value measurement of the Company’s material contingent consideration liabilities as of September 30, 2023: Contingent Consideration Liability Fair Value as of September 30, 2023 (in thousands) Unobservable input Range Weighted Average (1) Royalties (Saol Acquisition) $12,600 Discount rate 17.0% - 17.0% 17.0% Projected year of payment 2023 - 2033 2027 (1) Unobservable inputs were weighted by the relative fair value of each product candidate acquired. Assets and Liabilities Not Measured at Fair Value on a Recurring Basis The carrying amounts of cash, accounts receivable and accounts payable approximate their fair values due to the short-term maturity of these instruments. The Term Loan, as defined in Note 16. Debt in the Company’s 2022 Annual Report on Form 10-K, is in the Level 2 category within the fair value level hierarchy. The fair value was determined using market data for valuation. The fair value of the Term Loan at September 30, 2023 was approximately $2.5 billion as compared to approximately $2.3 billion at December 31, 2022. The Rondo Term Loan, as defined in Note 16. Debt in the Company’s 2022 Annual Report on Form 10-K, is in the Level 2 category within the fair value level hierarchy. The fair value of the Rondo Term Loan at September 30, 2023 and December 31, 2022 was $37.3 million and $70.9 million, respectively. The Sellers Notes, as defined in Note 16. Debt in the Company’s 2022 Annual Report on Form 10-K, are in the Level 2 category within the fair value level hierarchy. The fair value of the Sellers Notes at September 30, 2023 and December 31, 2022 was $40.8 million and $39.1 million, respectively. Refer to Note 16 . Debt in the Company’s 2022 Annual Report on Form 10-K for detailed information about its indebtedness, including definitions of terms. Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis There were no non-recurring fair value measurements during the nine months ended September 30, 2023 and 2022. |
Financial Instruments
Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Financial Instruments | Financial Instruments The Company uses an interest rate swap to manage its exposure to market risks for changes in interest rates. Interest Rate Risk Interest income earned on cash and cash equivalents may fluctuate as interest rates change; however, due to their relatively short maturities, the Company does not hedge these assets or their investment cash flows because the impact of interest rate risk is not material. The Company is exposed to interest rate risk on its debt obligations. The Company’s debt obligations consist of variable-rate and fixed-rate debt instruments. The Company’s primary objective is to achieve the lowest overall cost of funding while managing the variability in cash outflows within an acceptable range. To achieve this objective, the Company has entered into an interest rate swap on the Term Loan. Interest Rate Derivative – Cash Flow Hedge The interest rate swap involves the periodic exchange of payments without the exchange of underlying principal or notional amounts. In October 2019, the Company entered into an interest rate lock agreement for a total notional amount of $1.3 billion to hedge part of the Company's interest rate exposure associated with the variability in future cash flows from changes in the one-month LIBOR associated with the Term Loan. On May 31, 2023, the Company executed the Amended Swap Agreement that, among other things, changed the variable reference rate from LIBOR to the one-month SOFR (refer to Note 15. Debt ). As of September 30, 2023, the total gain, net of income taxes, related to the Company’s cash flow hedge was $74.3 million, of which $37.1 million was recognized in accumulated other comprehensive income and $37.2 million was recognized in non-controlling interests. A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands): September 30, 2023 December 31, 2022 Derivatives Designated as Hedging Instruments Balance Sheet Fair Value Balance Sheet Fair Value Variable-to-fixed interest rate swap Other assets $ 74,336 Other assets $ 85,586 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments Commercial Manufacturing, Collaboration, License, and Distribution Agreements The Company continues to seek to enhance its product line and develop a balanced portfolio of differentiated products through product acquisitions and in-licensing. Accordingly, the Company, in certain instances, may be contractually obligated to make potential future development, regulatory, and commercial milestone, royalty and/or profit-sharing payments in conjunction with collaborative agreements or acquisitions that the Company has entered with third parties. The Company has also licensed certain technologies or intellectual property from various third parties. The Company is generally required to make upfront payments as well as other payments upon successful completion of regulatory or sales milestones. The agreements generally permit the Company to terminate the agreement with no significant continuing obligation. The Company could be required to make significant payments pursuant to these arrangements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to pay such amounts. Further, the timing of any future payment is not reasonably estimable. Refer to Note 5. Alliance and Collaboration for additional information. Certain of these arrangements are with related parties. Refer to Note 21. Related Party Transactions for additional information . Contingencies Legal Proceedings The Company's legal proceedings are complex, constantly evolving, and subject to uncertainty. As such, the Company cannot predict the outcome or impact of its significant legal proceedings which are set forth below. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs and may therefore face claims arising from the regulation and/or consumption of such products. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized. For the three months ended September 30, 2023, credit related to legal matters, net of $2.6 million primarily related to a $5.5 million gain from the settlement of patent infringement matters, partially offset by a $3.0 million charge for the settlement of a customer claim. For the three months ended September 30, 2022, charges related to legal matters, net, were immaterial. For the nine months ended September 30, 2023, credit related to legal matters, net was $1.0 million, primarily comprised of $10.0 million from the settlement of patent infringement matters, partially offset by $4.1 million in charges associated with prescription opioid litigation, a $3.0 million charge for the settlement of a customer claim, and a $1.9 million charge for the settlement of a stockholder derivative lawsuit. For the nine months ended September 30, 2022, charges related to legal matters, net was $249.8 million, primarily comprised of a charge associated with Opana® ER antitrust litigation of $262.8 million , net of insurance recoveries associated with a securities class action settled during 2022. Liabilities for legal matters were comprised of the following (in thousands): Matter September 30, 2023 December 31, 2022 Opana ER® antitrust litigation $ 50,000 $ 83,944 Opana ER® antitrust litigation-accrued interest 1,968 1,423 Opana ER® antitrust litigation-imputed interest (398) — Civil prescription opioid litigation 21,222 17,993 Other 4,036 4,123 Current portion of liabilities for legal matters $ 76,828 $ 107,483 Opana ER® antitrust litigation $ — $ 50,000 Opana ER ® antitrust litigation-accrued interest — 847 Opana ER ® antitrust litigation-imputed interest — (1,405) Prescription Opioid Litigation 486 — Long-term portion of liabilities for legal matters (included in other long-term liabilities) $ 486 $ 49,442 Refer to the respective discussions below for additional information about the significant matters in the tables above. Refer to Note 21. Commitments and Contingencies in our Annual Report on Form 10-K for a general discussion of Medicaid Reimbursement and Price Reporting Matters and Patent Litigation. Other Litigation Related to the Company’s Business Opana ER® FTC Matters On July 12, 2019, the Company received a Civil Investigative Demand (“CID”) from the Federal Trade Commission (the “FTC”) concerning an August 2017 settlement agreement between Impax Laboratories, Inc. (“Impax”) and Endo Pharmaceuticals Inc. (“Endo”), which resolved a subsequent patent infringement and breach of contract dispute between the parties regarding the June 2010 settlement agreement related to Opana® ER. The Company cooperated with the FTC regarding the CID. On January 25, 2021, the FTC filed a complaint against Endo, Impax and Amneal in the U.S. District Court for the District of Columbia, alleging that the 2017 settlement violated antitrust laws. In April 2021, the Company filed a motion to dismiss the FTC’s complaint, which the District Court granted on March 24, 2022. The FTC appealed the District Court’s decision in May 2022. The D.C. Circuit Court of Appeals affirmed the District Court’s dismissal on August 25, 2023. If the FTC petitions the U.S. Supreme Court for review, the Company believes it has strong defenses to the FTC’s allegations and intends to continue to vigorously defend the action, however, no assurance can be given as to the timing or outcome of the litigation. Opana ER® Antitrust Litigation From June 2014 to April 2015, a number of complaints styled as class actions on behalf of direct purchasers and indirect purchasers (or end-payors) and several separate individual complaints on behalf of certain direct purchasers (the “opt-out plaintiffs”) of Opana ER® were filed against Endo and Impax and consolidated into multi-district litigation (“MDL”) in the U.S. District Court for the Northern District of Illinois. Impax subsequently entered into settlement agreements with all of the Plaintiffs that were subsequently approved by the court. Pursuant to the settlement agreements, the Company agreed to pay a total of $265.0 million between 2022 and mid-January 2024 to resolve substantially all of the plaintiffs’ claims. The cumulative amount of payments made by the Company pursuant to the settlement agreements was $215.0 million as of September 30, 2023, of which $83.9 million was paid during January 2023, primarily using borrowings under the New Revolving Credit Facility (refer to Note 15. Debt ). As of September 30, 2023, the liability for the remaining settlement payment of $50.0 million and 3% stated interest thereon was included in the current portion of liabilities for legal matters. The remaining imputed interest of $0.4 million as of September 30, 2023 will be recognized to interest expense during the final payment period. The settlement agreements are not an admission of liability or fault by Impax, the Company or its subsidiaries. Upon court approval of the final settlement agreements as discussed above, substantially all the claims and lawsuits in the litigation were resolved. United States Department of Justice Investigations On November 6, 2014, Impax disclosed that one of its sales representatives received a grand jury subpoena from the Antitrust Division of the United States Department of Justice (the “DOJ”). On March 13, 2015, Impax received a grand jury subpoena from the DOJ requesting the production of information and documents regarding the sales, marketing, and pricing of four generic prescription medications. Impax cooperated in the investigation and produced documents and information in response to the subpoenas from 2014 to 2016. However, no assurance can be given as to the timing or outcome of the investigation. On April 30, 2018, Impax received a CID from the Civil Division of the DOJ (the “Civil Division”). The CID requests the production of information and documents regarding the pricing and sale of Impax’s pharmaceuticals and interactions with other generic pharmaceutical manufacturers regarding whether generic pharmaceutical manufacturers engaged in market allocation and price-fixing agreements, paid illegal remuneration, and caused false claims to be submitted to the federal government. Impax has cooperated with the Civil Division’s investigation. However, no assurance can be given as to the timing or outcome of the investigation. On May 15, 2023, Amneal received a CID from the Civil Division requesting information and documents related to the manufacturing and shipping of diclofenac sodium 1% gel labeled as “prescription only” after the reference listed drug’s label was converted to over-the-counter. The Company is cooperating with the Civil Division’s investigation and is currently producing documents responsive to the CID. The Civil Division has not made any claim or demand for damages. However, no assurance can be given as to the timing or outcome of the investigation In Re Generic Pharmaceuticals Pricing Antitrust Litigation Since March 2016, multiple putative antitrust class action complaints have been filed on behalf of direct purchasers, indirect purchasers (or end-payors), and indirect resellers, as well as individual complaints on behalf of certain direct and indirect purchasers, and municipalities (the “opt-out plaintiffs”) against manufacturers of generic drugs, including Impax and the Company. The complaints allege a conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers for various generic drugs in violation of federal and state antitrust and consumer protection laws. Plaintiffs seek unspecified monetary damages and equitable relief, including disgorgement and restitution. The lawsuits have been consolidated in an MDL in the United States District Court for the Eastern District of Pennsylvania ( In re Generic Pharmaceuticals Pricing Antitrust Litigation, No. 2724, (E.D. Pa . )). On May 10, 2019, Attorneys General of 43 States and the Commonwealth of Puerto Rico filed a complaint in the United States District Court for the District of Connecticut against various manufacturers and individuals, including the Company, alleging a conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers for multiple generic drugs. On November 1, 2019, the State Attorneys General filed an Amended Complaint on behalf of nine additional states and territories. On June 10, 2020, Attorneys General of 46 States, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Territory of Guam, the U.S. Virgin Islands, and the District of Columbia filed a new complaint against various manufacturers and individuals, including the Company, alleging a conspiracy to fix prices, rig bids, and allocate markets or customers for additional generic drugs. Plaintiff states seek unspecified monetary damages and penalties and equitable relief, including disgorgement and restitution. On September 9, 2021, the State Attorneys General filed an Amended Complaint on behalf of California in addition to the original plaintiff states. Both the May 10, 2019 and June 10, 2020 lawsuits have been incorporated into MDL No. 2724, and the June 10, 2020 lawsuit has been selected for bellwether status. The States of Alabama, Hawaii and Arkansas, and the Territory of Guam voluntarily dismissed all of their claims in the two actions against all defendants, including the Company. American Samoa voluntarily dismissed its claims in the May 10, 2019 action and was not named as a plaintiff in the June 10, 2020 action. On February 27, 2023, the Court addressed defendants’ motions to dismiss the bellwether action filed on June 10, 2020, holding that the states may not pursue certain federal remedies, and otherwise denying Amneal’s joint and individual motion to dismiss. Fact and document discovery in MDL No. 2724 are proceeding. No trial date has been set. On July 1, 2023, 152 hospital systems, health care centers, and retail pharmacies filed a complaint in the United States District Court for the Northern District of California against manufacturers of generic drugs, including Impax and the Company. On September 15, 2023, this lawsuit was transferred to the MDL. On June 3, 2020, the Company and Impax were also named in a putative class action complaint filed in the Federal Court of Canada in Toronto, Ontario against numerous generic pharmaceutical manufacturers, on behalf of a putative class of individuals who purchased generic drugs in the private sector from 2012 to the present ( Kathryn Eaton v. Teva Canada Limited, et. al., No. T-607-20). The complaint alleges price fixing, among other claims. On August 23, 2022, the plaintiff filed a second amended complaint. On May 30, 2023, the plaintiff served materials for their motion to certify the action as a class proceeding, define the class and certify the common questions to be decided, among other things. The Court has not set a date for the return of the plaintiff’s motion. Civil Prescription Opioid Litigation The Company and certain of its affiliates are named as defendants in over 900 cases filed in state and federal courts relating to the sale of prescription opioid pain relievers. Plaintiffs in these actions include county and municipal governments, hospitals, Native American tribes, pension funds, third-party payors, and individuals. Plaintiffs seek unspecified monetary damages and other forms of relief based on various causes of action, including negligence, public nuisance, unjust enrichment, and civil conspiracy, as well as alleged violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), state and federal controlled substances laws and other statutes. All cases involving the Company also name other manufacturers, distributors, and retail pharmacies as defendants, and there have been numerous other cases involving allegations relating to prescription opioid pain relievers against other manufacturers, distributors, and retail pharmacies in which the Company and its affiliates are not named. Nearly all cases pending in federal district courts have been consolidated for pre-trial proceedings in an MDL in the United States District Court for the Northern District of Ohio (In re: National Prescription Opiate Litigation, Case No. 17-mdl-2804). The Company is also named in various state court cases pending in seven states. No firm trial dates have been set except in Alabama (August 12, 2024 (Mobile County Board of Health)) and Texas (September 20, 2024 (Dallas County) and September 30, 2024 (Bexar County)). The Company reached a settlement agreement with the New Mexico Attorney General to resolve its claims against the Company, which was finalized on April 24, 2023. A Consent Judgment dismissing the case was entered on May 15, 2023. The Company reached a settlement agreement to resolve all pending litigation brought by West Virginia political subdivisions, which was signed on May 25, 2023. The two neonatal abstinence syndrome cases in West Virginia state court were dismissed on May 31, 2023 and were subsequently appealed by the plaintiffs. These appeals remain pending. The hospital cases pending in West Virginia state court were dismissed on May 2, 2023. The Company reached a preliminary settlement with a group of private hospitals in Alabama (the “Alabama Hospitals”) in June 2023 to resolve the hospitals’ claims against the Company. The Company anticipates a final determination approving the settlement in 2023. On January 13, 2023, Amneal Pharmaceuticals, Inc., Amneal, and Amneal Pharmaceuticals of New York, LLC (“Amneal New York”), received a subpoena from the New York Attorney General, seeking information regarding its business concerning opioid-containing products. The Company is cooperating with the request and providing responsive information. Based on the settlement agreements with the states of New Mexico and West Virginia and an assessment of the information available, the Company recorded an $18.0 million charge for the year ended December 31, 2022, related to the majority of the MDL and state court cases. Based on an increase in the number of political subdivision cases and the preliminary settlement with the Alabama Hospitals, the Company recorded charges of $4.0 million for the nine months ended September 30, 2023. For the remaining cases, primarily brought by other hospitals, pension funds, third-party payors and individuals, the Company has not recorded a liability as of September 30, 2023 and December 31, 2022, because it concluded that a loss was not probable and estimable. United States Department of Justice / Drug Enforcement Administration Subpoenas On July 7, 2017, Amneal New York received an administrative subpoena issued by the Long Island, NY District Office of the Drug Enforcement Administration (the “DEA”) requesting information related to compliance with certain recordkeeping and reporting requirements. On or about April 12, 2019 and May 28, 2019, the Company received grand jury subpoenas from the U.S. Attorney’s Office for the Eastern District of New York (the “USAO”) relating to similar topics concerning the Company’s suspicious order monitoring program and its compliance with the Controlled Substances Act. The Company is cooperating with the USAO in responding to the subpoenas and has entered civil and criminal tolling agreements with the USAO through May 15, 2024. It is not possible to determine the exact outcome of these investigations. On March 14, 2019, Amneal received a subpoena from an Assistant U.S. Attorney for the Southern District of Florida (the “AUSA”). The subpoena requested information and documents generally related to the marketing, sale, and distribution of oxymorphone. The Company intends to cooperate with the AUSA regarding the subpoena. However, no assurance can be given as to the timing or outcome of its underlying investigation. On October 7, 2019, Amneal received a subpoena from the New York State Department of Financial Services seeking documents and information related to sales of opioid products in the state of New York. The Company is cooperating with the request and providing responsive information. It is not possible to determine the exact outcome of this investigation. Ranitidine Litigation The Company and its affiliates were named as defendants, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products, in In re Zantac/Ranitidine NDMA Litigation (MDL No. 2924), in the Southern District of Florida. Plaintiffs allege that defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in brand-name Zantac® or generic ranitidine and the alleged associated risk of cancer. On July 8, 2021, the MDL Court dismissed all claims by all plaintiffs against the generic drug manufacturers, including the Company and its affiliates, without leave to file further amended complaints, holding all claims were preempted. Plaintiffs appealed the MDL Court’s dismissals to the 11th Circuit Court of Appeals. On November 7, 2022, the 11th Circuit affirmed the MDL Court’s dismissal of cases brought by third-party payors. The 11th Circuit raised questions in the appeals of the other cases about the finality of the MDL Court’s judgments. During September 2023, the 11th Circuit and the MDL Court addressed procedural issues relating to those finality questions that should position the appeals of those other cases to be heard by the 11th Circuit on all of the MDL Court’s grounds for dismissal. The Company and its affiliates have also been named as defendants in various state lawsuits in four states in which the Company has already filed motions to dismiss or plans to file motions to dismiss in the future. On August 17, 2023, the judge in the consolidated Illinois state court cases granted a motion to dismiss all the Illinois cases in which the Company and affiliates had been named, holding all the claims preempted. There are no trial dates involving the Company or its affiliates in any of the state court cases. Metformin Litigation Amneal and AvKARE, Inc. were named as defendants, along with numerous other manufacturers, retail pharmacies, and wholesalers, in several putative class action lawsuits pending in the United States District Court for the District of New Jersey, consolidated as In Re Metformin Marketing and Sales Practices Litigation (No. 2:20-cv-02324-MCA-MAH). The lawsuits allege economic loss in connection with their purchase or reimbursements due to the alleged contamination of generic metformin products with NDMA. Plaintiffs have voluntarily dismissed their claims seeking medical monitoring or evaluation due to their consummation of allegedly contaminated metformin. The parties are currently engaged in discovery. On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of Valsartan, Losartan, and Metformin based on the alleged presence of nitrosamines in those products. The only allegations against the Company concern Metformin ( Davis v. Camber Pharmaceuticals, Inc. , et al., C.A. No. 2:21-00254 (M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the United States Judicial Panel on Multidistrict Litigation transferred the Davis Action into the In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation multi-district litigation for pretrial proceedings. Xyrem® (Sodium Oxybate) Antitrust Litigation Amneal has been named as a defendant, along with Jazz Pharmaceuticals, Inc. (“Jazz”) and numerous other manufacturers of generic versions of Jazz’s Xyrem® (sodium oxybate), in several class action lawsuits filed in the United States District Court for the Northern District of California and the United States District Court for the Southern District of New York, alleging that the generic manufacturers entered into anticompetitive agreements with Jazz in connection with the settlement of patent litigation related to Xyrem®. The actions have been consolidated in the United States District Court for the Northern District of California for pretrial proceedings ( In re Xyrem (Sodium Oxybate) Antitrust Litigation , No. 5:20-md-02966-LHK (N.D. Cal.)). On January 9, 2023, Amneal reached a settlement in principle with the class plaintiffs and executed a settlement agreement on February 28, 2023. The remaining opt-out plaintiffs in the federal case are United Healthcare Services, Inc., Humana Inc., Molina Healthcare Inc., and Health Care Services Corporation. In a separate action in California state court filed by Aetna Inc., another opt-out plaintiff, the court held that it lacks jurisdiction over several defendants, including Amneal, on December 27, 2022, and later issued an order dismissing Amneal without prejudice. On January 27, 2023, Aetna filed an amended complaint identifying several parties, including Amneal, as alleged non-party co-conspirators. On August 25, 2023, Aetna filed a motion seeking leave to file a second amended complaint adding Amneal as a defendant. Value Drug Company v. Takeda Pharmaceuticals U.S.A., Inc. On August 5, 2021, Value Drug Company filed a purported class action lawsuit in the United States District Court for the Eastern District of Pennsylvania against Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and numerous other manufacturers of generic versions of Takeda’s Colcrys® (colchicine), including Amneal, alleging that the generic manufacturers conspired with Takeda to restrict output of generic Colcrys® in order to maintain higher prices, in violation of the antitrust laws. On April 10, 2023, plaintiff filed a motion for leave to amend its complaint to add 18 former absent class members as plaintiffs, which the Court subsequently granted. Plaintiffs’ second amended complaint did not add any new legal theories or allegations. On April 14, 2023, the Court entered a scheduling order requiring the new plaintiffs to provide discovery on their claims by May 1, 2023, and setting a 22-day jury trial to begin on September 5, 2023. On September 5, 2023, Amneal entered into a $3.0 million settlement agreement with plaintiffs, pursuant to which plaintiffs dismissed with prejudice all claims against Amneal. Russell Thiele, et al. v. Kashiv Biosciences, LLC, et.al. On March 22, 2022, two purported Amneal Pharmaceuticals, Inc. stockholders filed a stockholder derivative lawsuit in the Court of Chancery of the State of Delaware against Kashiv and certain members of the Company’s Board of Directors. The Company was named as a nominal defendant. For additional details of the claim, refer to Note 21. Commitments and Contingencies of our 2022 Annual Report on Form 10-K. On May 2, 2023, the parties entered into a final settlement agreement, which was approved by the Court of Chancery on July 27, 2023. Pursuant to the settlement, the Company has agreed to amend the January 11, 2021 Membership Interest Purchase Agreement with Kashiv to reduce certain royalties on future sales payable by Kashiv, adopt certain governance changes, and pay to plaintiffs’ counsel a court-ordered attorneys’ fees and expense award in an amount of $1.9 million. The Court of Chancery approved the final settlement agreement on July 27, 2023. |
Stockholders_ Equity and Redeem
Stockholders’ Equity and Redeemable Non-Controlling Interests | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity and Redeemable Non-Controlling Interests | Stockholders’ Equity and Redeemable Non-Controlling Interests On May 9, 2023, the stockholders of the Company approved an amendment and restatement of the Amneal Pharmaceuticals, Inc. 2018 Incentive Award Plan (the “Stock Plan”), which authorizes an additional 20 million shares of class A common stock available for issuance under the Stock Plan, resulting in a total shares reserved under the Stock Plan of 57 million shares, and extends the term of the Stock Plan until May 9, 2033. Non-Controlling Interests The Company consolidates the financial statements of Amneal and its subsidiaries and records non-controlling interests for the portion of Amneal’s economic interests that is not held by the Company. Non-controlling interests are adjusted for capital transactions that impact the non-publicly held economic interests in Amneal. Under the terms of Amneal’s previous limited liability company agreement, as amended, Amneal was obligated to make tax distributions to its members. During the three and nine months ended September 30, 2023, the Company recorded net tax distributions of $10.64 million and $58.65 million, respectively, as a reduction of non-controlling interests. During the three and nine months ended September 30, 2022, the Company recorded net tax distributions of $2.48 million and $9.81 million, respectively, as a reduction of non-controlling interests. In connection with the Reorganization, Amneal amended and restated its limited liability company agreement to remove the obligation for Amneal to make tax distributions to its members. The Company acquired a 98% interest in KSP on April 2, 2021. The sellers of KSP , a related party, hold the remaining interests. The Company attributes 2% of the net income or loss of KSP to the non-controlling interests. Redeemable Non-Controlling Interests The Company acquired a 65.1% controlling interest in both AvKARE Inc., a Tennessee corporation, now a limited liability company (“AvKARE, LLC”), and Dixon-Shane, LLC d/b/a R&S Northeast LLC, a Kentucky limited liability company (“R&S”), in 2020. The sellers of AvKARE, LLC and R&S hold the remaining 34.9% interest (“Rondo Class B Units”) in the holding company that directly owns the acquired companies (“Rondo”). Beginning on January 1, 2026, the holders of the Rondo Class B Units have the right (“Put Right”) to require the Company to acquire the Rondo Class B Units for a purchase price that is based on a multiple of Rondo’s earnings before income taxes, depreciation, and amortization (EBITDA) if certain financial targets and other conditions are met. Additionally, beginning on January 31, 2020, the Company has the right to acquire the Rondo Class B Units based on the same value and conditions as the Put Right. The Rondo Class B Units are also redeemable by the holders upon a change in control. Because the redemption of the Rondo Class B Units is outside of the Company’s control, the units have been presented outside of stockholders’ equity as redeemable non-controlling interests. The Company attributes 34.9% of the net income or loss associated with Rondo to redeemable non-controlling interests. The Company will also accrete the redeemable non-controlling interests to redemption value upon an event that makes redemption probable. For the three and nine months ended September 30, 2023 , the Company recorded tax distributions of $4.46 million and $10.29 million as a reduction of redeemable non-controlling interests, respectively. For the three and nine months ended September 30, 2022 , the Company recorded tax distributions of $0.73 million and $3.32 million as a reduction of redeemable non-controlling interests, respectively. Redeemable Non-Controlling Interests - Puniska The Company acquired 74% of the equity interests in Puniska on November 2, 2021. Amneal was required pursuant to the purchase agreement to acquire the remaining 26% of Puniska upon approval of the transaction by the government of India. Because approval of the government of India was outside of the Company’s control, upon closing of the acquisition of Puniska, the equity interests of Puniska that the Company did not own were presented outside of stockholders’ equity as redeemable non-controlling interests. The Company attributed 26% of the net losses of Puniska to the redeemable non-controlling interests. Upon approval of the transaction by the government of India in March 2022, the Company paid the $1.7 million redemption value for the remaining 26% of the equity interests of Puniska. For the nine months ended September 30, 2022, the Company recorded accretion of $0.9 million to increase the redeemable non-controlling interests to redemption value. Changes in Accumulated Other Comprehensive (Loss) Income by Component (in thousands): Foreign Unrealized (loss) gain on cash Accumulated Balance December 31, 2021 $ (18,845) $ (5,982) $ (24,827) Other comprehensive loss before reclassification (13,394) 48,270 34,876 Reallocation of ownership interests (143) 33 (110) Balance December 31, 2022 (32,382) 42,321 9,939 Other comprehensive loss before reclassification (525) (5,621) (6,146) Reallocation of ownership interests (300) 380 80 Balance September 30, 2023 $ (33,207) $ 37,080 $ 3,873 Refer to Note 22. Stockholders’ Equity in the Company’s 2022 Annual Report on Form 10-K for additional information. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three and nine months ended September 30, 2023, there were no material changes to our related party agreements or relationships as described in Note 24. Related Party Transactions and Note 22. Stockholders’ Equity in our 2022 Annual Report on Form 10-K. The following table summarizes the Company’s related party transactions (in thousands): Three months ended September 30, Nine months ended September 30, Related Party and Nature of Transaction Caption in Balance Sheet and Statement of Operations 2023 2022 2023 2022 Kashiv Biosciences LLC Parking space lease Research and development $ 25 $ 25 $ 75 $ 75 License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Filgrastim Selling, general and administrative $ — $ — $ — $ 5,000 Development and commercialization agreement - Ganirelix Acetate and Cetrorelix Acetate Research and development $ (75) $ 104 $ (25) $ 1,827 License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Pegfilgrastim Intangible asset $ — $ — $ — $ 15,000 Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko) Cost of goods sold $ 844 $ — $ 988 $ — Storage agreement Research and development $ (18) $ — $ (100) $ — Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko) Inventory and cost of goods sold $ 90 $ — $ 590 $ — Generic development supply agreement - research and development material Research and development $ (2,209) $ — $ (2,209) $ — Generic development supply agreement - development activity deferred income Deferred revenue $ (246) $ — $ (246) $ — Other Related Parties Kanan, LLC - operating lease Inventory and cost of goods sold $ 592 $ 526 $ 1,750 $ 1,578 Sutaria Family Realty, LLC - operating lease Inventory and cost of goods sold $ 314 $ 305 $ 933 $ 906 PharmaSophia, LLC - research and development services income Research and development $ — $ (15) $ — $ (45) Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement Inventory and cost of goods sold $ 5,528 $ 800 $ 11,095 $ 2,222 Tracy Properties LLC - operating lease Selling, general and administrative $ 258 $ 155 $ 521 $ 426 AzaTech Pharma LLC - supply agreement Inventory and cost of goods sold $ 2,588 $ 1,340 $ 5,132 $ 3,992 AvPROP, LLC - operating lease Selling, general and administrative $ 44 $ 46 $ 134 $ 136 Avtar Investments, LLC - consulting services Research and development $ 70 $ 47 $ 267 $ 216 TPG Operations, LLC - consulting services Selling, general and administrative $ — $ — $ — $ 19 Alkermes Inventory and cost of goods sold $ 232 $ 64 $ 322 $ 171 R&S Solutions - logistics services Selling, general and administrative $ 46 $ 26 $ 86 $ 65 Members - tax receivable agreement (TRA liability) Other expense $ 677 $ — $ 1,908 $ — The following table summarizes the amounts due to or from the Company for related party transactions (in thousands): September 30, 2023 December 31, 2022 Sellers of AvKARE LLC and R&S - state tax indemnification $ — $ 486 Kashiv - various agreements 1,472 12 Asana BioSciences, LLC — 2 Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement 106 — AzaTech Pharma 25 — Related party receivables - short term $ 1,603 $ 500 Kashiv - various agreements $ 25 $ 110 Apace Packaging, LLC - packaging agreement 920 756 AzaTech Pharma LLC - supply agreement 1,351 863 Avtar Investments LLC - consulting services 62 72 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 442 442 Members - tax receivable agreement 630 201 R&S Solutions LLC - logistics services 6 7 Alkermes Plc 64 28 Related party payables - short term $ 3,500 $ 2,479 Kashiv - contingent consideration (1) $ 2,040 $ 3,290 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 7,586 5,929 Members - tax receivable agreement 1,908 430 Related party payables - long term $ 11,534 $ 9,649 (1) The c ontingent consideration liability was associated with the acquisition of KSP. Refer to Note 17. Fair Value Measurements for additional information. TPG Capital TPG is a significant stockholder of the Company. A Managing Director of TPG is an observer of the Company’s Board. TPG Capital BD, LLC (“TPG Capital”) has been providing the Company with advice and assistance with respect to the planned refinancing or replacement of certain indebtedness of the Company and will receive a customary fee, in an amount to be negotiated. For the three and nine months ended September 30, 2023, the Company did not incur any costs related to services provided by TPG Capital. Fosun International Limited Fosun International Limited (“Fosun”) is a Chinese international conglomerate and investment company that is a shareholder of the Company. On June 6, 2019, the Company entered into a license and supply agreement with a subsidiary of Fosun. Under the terms of the agreement, the Company will hold the imported drug license required for pharmaceutical products manufactured outside of China and will supply Fosun with finished, packaged products for Fosun to then sell in the China market. Fosun will be responsible for obtaining regulatory approval in China and for shipping the product from Amneal’s facility to Fosun’s customers in China. On August 11, 2023, the Company and Fosun amended the license and supply agreement to, among other things, (i) increase the products in the agreement from eight to ten, (ii) eliminate the first commercial sales milestone of $0.3 million for each product, and (iii) decrease profit share percentage applicable to all products. Refer to Note 24. Related Party Transactions in the Company’s 2022 Annual Report on Form 10-K for additional information. Kashiv Biosciences Refer to Note 3. Acquisitions and Note 24. Related Party Transactions in the Company’s 2022 Annual Report on Form 10-K for information on the Company’s agreements with Kashiv. Refer to Note 19. Commitments and Contingencies in this Form 10-Q for information on an amendment to the Membership Interest Purchase Agreement with Kashiv resulting from the settlement of litigation. Refer to Note 24. Related Party Transactions |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information The Company has three reportable segments: Generics, Specialty, and AvKARE. Generics The Company’s Generics segment includes a retail and institutional portfolio of approximately 260 product families covering an extensive range of dosage forms and delivery systems, including both immediate and extended release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches and topicals. Specialty The Company’s Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease, and endocrine disorders. AvKARE The Company’s AvKARE segment provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a wholesale distributor of bottle and unit dose pharmaceuticals under the registered names of AvKARE and AvPAK, and medical and surgical products. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the U.S. focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. Chief Operating Decision Makers The Company’s chief operating decision makers evaluate the financial performance of the Company’s segments based upon segment operating income (loss). Items below operating income (loss) are not reported by segment, because they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements, and non-operating income and expenses are included in “Corporate and Other.” The Company does not report balance sheet information by segment because it is not reviewed by the Company’s chief operating decision makers. The tables below present segment information reconciled to total Company financial results, with segment operating income or loss, including gross profit less direct selling expenses, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands): Three Months Ended September 30, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 390,857 $ 97,304 $ 131,879 $ — $ 620,040 Cost of goods sold 236,268 45,551 105,690 — 387,509 Gross profit 154,589 51,753 26,189 — 232,531 Selling, general and administrative 33,538 22,756 14,313 42,399 113,006 Research and development 35,103 6,272 — — 41,375 Intellectual property legal development expenses 815 71 — — 886 Restructuring and other charges 112 931 — — 1,043 Change in fair value of contingent consideration — 3,120 — — 3,120 Credit related to legal matters, net (2,500) — — (120) (2,620) Other operating expense 73 — — — 73 Operating income (loss) $ 87,448 $ 18,603 $ 11,876 $ (42,279) $ 75,648 Nine Months Ended September 30, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 1,108,364 $ 285,976 $ 382,286 $ — $ 1,776,626 Cost of goods sold 692,008 135,254 318,626 — 1,145,888 Gross profit 416,356 150,722 63,660 — 630,738 Selling, general and administrative 89,178 67,894 41,268 122,332 320,672 Research and development 98,570 19,294 — — 117,864 Intellectual property legal development expenses 3,240 110 — — 3,350 Restructuring and other charges 211 1,013 — 411 1,635 Change in fair value of contingent consideration — (787) — — (787) (Credit) charges related to legal matters, net (2,927) — — 1,888 (1,039) Other operating income (1,138) — — — (1,138) Operating income (loss) $ 229,222 $ 63,198 $ 22,392 $ (124,631) $ 190,181 Three Months Ended September 30, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 350,266 $ 89,484 $ 105,807 $ — $ 545,557 Cost of goods sold 218,671 43,719 88,937 — 351,327 Gross profit 131,595 45,765 16,870 — 194,230 Selling, general and administrative 30,259 22,201 13,216 34,395 100,071 Research and development 41,987 8,248 — — 50,235 Intellectual property legal development expenses 1,369 42 — — 1,411 Acquisition, transaction-related and integration expenses 16 15 — 8 39 Restructuring and other charges 507 — — 74 581 Change in fair value of contingent consideration — (1,425) — — (1,425) Charges related to legal matters, net 285 — — — 285 Other operating income (1,320) — — — (1,320) Operating income (loss) $ 58,492 $ 16,684 $ 3,654 $ (34,477) $ 44,353 Nine Months Ended September 30, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 1,032,908 $ 271,571 $ 298,066 $ — $ 1,602,545 Cost of goods sold 646,236 130,363 256,626 — 1,033,225 Gross profit 386,672 141,208 41,440 — 569,320 Selling, general and administrative 84,410 69,772 39,361 103,999 297,542 Research and development 129,382 24,399 — — 153,781 Intellectual property legal development expenses 2,919 77 — — 2,996 Acquisition, transaction-related and integration expenses 24 47 — 643 714 Restructuring and other charges 713 — — 599 1,312 Change in fair value of contingent consideration — (1,495) — — (1,495) Insurance recoveries for property losses and associated expenses (1,911) — — — (1,911) Charges related to legal matters, net 2,442 — — 247,394 249,836 Other operating income (2,495) — — — (2,495) Operating income (loss) $ 171,188 $ 48,408 $ 2,079 $ (352,635) $ (130,960) (1) Operating results for the sale of Amneal products by AvKARE are included in Generics. |
Insurance Recoveries for Proper
Insurance Recoveries for Property Losses and Associated Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Unusual or Infrequent Items, or Both [Abstract] | |
Insurance Recoveries for Property Losses and Associated Expenses | Insurance Recoveries for Property Losses and Associated Expenses On September 1, 2021, Tropical Storm Ida brought extreme rainfall and flash flooding to New Jersey that caused damage to two of the Company’s facilities. Operations at these facilities were closed for the majority of September 2021 in order to assess the damage, make repairs and restore operations. The Company concluded that all inventory on-hand at the time of the flooding was damaged and unsellable and that a majority of the equipment was damaged beyond repair. In addition, the Company incurred significant costs to repair both facilities. The Company has insurance policies for property damage, inventory losses and business interruption. Insurance recoveries are recorded in the periods when it is probable they will be realized. During the nine months ended September 30, 2022, insurance recoveries of $1.9 million associated with property damage and inventory losses were received and recorded in insurance recoveries for property losses and associated expenses. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Up-C Corporate Structure Elimination On October 17, 2023, the Company, Amneal and a representative of the Amneal Group, executed a binding term sheet (the “Term Sheet”) pursuant to which the Company and Amneal have agreed to reorganize and simplify the Company’s corporate structure by eliminating the Company’s umbrella partnership-C-corporation (“Up-C”) structure and converting to a more traditional structure whereby all stockholders hold their voting and economic interests directly through the public company (the “Reorganization”). On November 7, 2023, the Company implemented the Reorganization. Following the implementation, Amneal Pharmaceuticals, Inc. (“Old PubCo”) became a wholly owned subsidiary of a new holding company, Amneal NewCo Inc. (“New PubCo”), which replaced Old PubCo as the public company trading on the New York Stock Exchange under Old PubCo’s ticker symbol “AMRX.” In addition, New PubCo changed its name to “Amneal Pharmaceuticals, Inc.” and Old PubCo changed its name to “Amneal Intermediate Inc.” In connection with the Reorganization, holders of shares of class A common stock, par value $0.01 per share, of Old PubCo (“Old PubCo Class A Common Stock”) ceased to hold such shares and received an equivalent number of shares of class A common stock, par value $0.01 per share, of New PubCo that have the same voting and economic rights as Old PubCo Class A Common Stock. Additionally, holders of shares of class B common stock, par value $0.01 per share, of Old PubCo (“Old PubCo Class B Common Stock”), ceased to hold such shares and received an equivalent number of shares of class A common stock, par value $0.01 per share, of New PubCo that have the same voting and economic rights as Old PubCo Class A Common Stock. All outstanding shares of OldPubCo Class B Common Stock were surrendered and canceled. Accordingly, upon consummation of the Reorganization, Old PubCo stockholders automatically became stockholders of New PubCo, on a one-for-one basis, with the same number and ownership percentage of shares they held in Old PubCo immediately prior to the effective time of the Reorganization. Additionally, the parties have agreed to reduce the Company’s future obligation to pay 85% of the tax benefits subject to the TRA (as described in Note 7. Income Taxes) to 75% of such tax benefits. The Reorganization will not cause the acceleration of payments under the TRA. Rondo Term Loan and Amended Rondo Revolving Credit Facility Payments During October 2023, the Company prepaid $20.0 million of principal outstanding on the Rondo Term Loan from cash on hand and repaid $6.0 million of borrowings from the Amended Rondo Revolving Credit Facility from cash on hand. Mabxience License Agreement On October 12, 2023, the Company announced that it entered into a licensing and supply agreement with Mabxience S.L. to be the exclusive U.S. partner for two indications of denosumab, biosimilars referencing Prolia® and XGEVA®. Upon execution, the Company paid $2.5 million to Mabxcience, which will be recorded as research and development expense during the three months ended December 31, 2023. In addition, the agreement provides for potential future milestone payments to Mabxience of up to $71.5 million, as follows: (i) up to $9.0 million relating to clinical and developmental milestones; (ii) up to $15.0 million for regulatory approval and initial commercial launch milestones; and (iii) up to $47.5 million for the achievement of annual commercial milestones. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||
Net (loss) income | $ 15,540 | $ (7,613) | $ 22,141 | $ (258,558) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
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 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements, which are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”), should be read in conjunction with the Company’s annual audited financial statements for the year ended December 31, 2022 included in the Company’s 2022 Annual Report on Form 10-K. Certain information and footnote disclosures normally included in annual financial statements have been omitted from the accompanying unaudited consolidated financial statements. In the opinion of management, the accompanying unaudited consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2023, cash flows for the nine months ended September 30, 2023 and 2022 and the results of its operations, its comprehensive income (loss) and its changes in stockholders’ equity for the three and nine months ended September 30, 2023 and 2022. The consolidated balance sheet data at December 31, 2022 was derived from the Company’s audited annual financial statements, but does not include all disclosures required by U.S. GAAP. Except for the updates included in this note, the accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies contained in the Company’s 2022 Annual Report on Form 10-K. |
Use of Estimates | Use of Estimates The preparation of financial statements requires the Company's management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, billbacks, valuation of intangible and other assets acquired in business combinations, allowances for accounts receivable, accrued liabilities, liabilities for legal matters, initial and subsequent valuation of contingent consideration recognized in business combinations, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights and the assessment of expected cash flows used in evaluating goodwill and other long-lived assets for impairment. Actual results could differ from those estimates. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU 2021-08”) , which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers (“ASC 606”). The update will generally result in an entity recognizing contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value. ASU 2021-08 was effective on a prospective basis for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company adopted ASU 2021-08 effective January 1, 2023 and will apply the guidance to subsequent acquisitions. The adoption of ASU 2021-08 did not have an impact on the Company’s consolidated financial statements because the Company did not acquire a business during the nine months ended September 30, 2023. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”), which provides elective amendments for entities that have contracts, hedging relationships and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848) , to expand and clarify the scope of Topic 848 to include derivative instruments on discounting transactions. In December 2022, the FASB issued ASU 2022-06, Reference Rate reform (Topic 848): Deferral of the Sunset Date of Topic 848 , which deferred the sunset date of Topic 848, Reference Rate Reform to December 31, 2024. The Company adopted ASU 2020-04 during the three months ended June 30, 2023 (refer to Note 15. Debt and Note 18. Financial Instruments for additional information). The adoption of ASU 2020-04 did not have a material impact on the Company’s consolidated financial statements. |
Reclassifications | Reclassifications The prior period balances related to cost of goods sold impairment charges of $0.7 million and $5.8 million, formerly included in a separate income statement caption for both the three and nine months ended September 30, 2022, respectively, have been reclassified to be included within the income statement caption cost of goods sold to conform with the current period presentation. This reclassification did not impact gross profit or net income. The prior period balance related to loss on refinancing of $0.3 million, formerly included in a separate income statement caption for the nine months ended September 30, 2022, has been reclassified to be included within the income statement caption other income, net to conform to the current period presentation. This reclassification did not impact net income. |
Performance Obligations | The Company recognizes revenue in accordance with ASC 606. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenue by Major Customers by Reporting Segments | The following table summarizes revenues from each of the Company’s customers which individually accounted for 10% or more of its total net revenue: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Customer A 24 % 21 % 24 % 20 % Customer B 17 % 17 % 15 % 17 % Customer C 21 % 23 % 21 % 23 % Customer D 10 % 9 % 10 % 11 % |
Schedule of Disaggregated Revenue | The Company’s significant therapeutic classes for its Generics and Specialty segments and sales channels for its AvKARE segment, as determined based on net revenue for the three and nine months ended September 30, 2023 and 2022, are set forth below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Generics Anti-infective $ 7,382 $ 4,957 $ 18,648 $ 16,768 Hormonal / allergy 126,425 119,726 357,711 334,403 Antiviral 7,150 5,782 36,221 17,649 Central nervous system 96,587 96,877 264,773 286,789 Cardiovascular system 32,459 28,926 98,108 84,422 Gastroenterology 18,858 17,129 53,127 51,280 Oncology 37,722 12,240 76,846 47,872 Metabolic disease/ endocrine 11,026 9,276 35,227 30,497 Respiratory 7,832 8,720 31,783 26,503 Dermatology 17,279 17,327 53,232 48,741 Other therapeutic classes 27,270 29,101 80,974 86,790 International and other 867 205 1,714 1,194 Total Generics net revenue 390,857 350,266 1,108,364 1,032,908 Specialty Hormonal / allergy 28,494 22,012 82,268 65,751 Central nervous system 61,142 61,785 180,844 185,309 Other therapeutic classes 7,668 5,687 22,864 20,511 Total Specialty net revenue 97,304 89,484 285,976 271,571 AvKARE Distribution 81,904 66,057 248,929 190,560 Government label 32,764 26,000 87,150 72,739 Institutional 10,551 8,297 28,395 20,672 Other 6,660 5,453 17,812 14,095 Total AvKARE net revenue 131,879 105,807 382,286 298,066 Total net revenue $ 620,040 $ 545,557 $ 1,776,626 $ 1,602,545 |
Schedule of Major Categories of Sales-Related Deductions | A rollforward of the major categories of sales-related deductions for the nine months ended September 30, 2023 is as follows (in thousands): Contract Cash Discount Accrued Accrued Balance at December 31, 2022 $ 573,592 $ 27,454 $ 145,060 $ 86,030 Provision related to sales recorded in the period 2,502,481 84,465 50,786 187,161 Credits/payments issued during the period (2,601,904) (87,767) (65,878) (183,028) Balance at September 30, 2023 $ 474,169 $ 24,152 $ 129,968 $ 90,163 |
Earnings (Loss) per Share (Tabl
Earnings (Loss) per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings (Loss) per Share, Basic and Diluted | The following table sets forth reconciliations of the numerators and denominators used to compute basic and diluted earnings (loss) per share of class A common stock (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net income (loss) attributable to Amneal Pharmaceuticals, Inc. $ 9,682 $ (2,689) $ 14,656 $ (125,653) Denominator: Weighted-average shares outstanding - basic 154,219 151,393 153,363 150,765 Effect of dilutive securities: Stock options 534 — 178 — Restricted stock units 4,052 — 2,448 — Performance stock units 886 — 295 — Weighted-average shares outstanding - diluted 159,691 151,393 156,284 150,765 Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: Basic $ 0.06 $ (0.02) $ 0.10 $ (0.83) Diluted $ 0.06 $ (0.02) $ 0.09 $ (0.83) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Loss Per Share | The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of class A common stock (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Stock options 432 (1) 2,728 (2) 432 (1) 2,728 (2) Restricted stock units — 10,874 (2) — 10,874 (2) Performance stock units 4,636 (3) 7,266 (2) 4,636 (3) 7,266 (2) Shares of class B common stock 152,117 (4) 152,117 (4) 152,117 (4) 152,117 (4) (1) Excluded from the computation of diluted earnings per share of class A common stock because the exercise price of the stock options exceeded the average market price of class A common stock during the period (out-of-the-money). (2) Excluded from the computation of diluted loss per share of class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period. (3) Excluded from the computation of diluted earnings per share of class A common stock because the performance vesting conditions were not met during the period. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Receivables [Abstract] | |
Schedule of Trade Accounts Receivable, Net | Trade accounts receivable, net was comprised of the following (in thousands): September 30, December 31, Gross accounts receivable $ 1,193,505 $ 1,344,959 Allowance for credit losses (4,237) (2,122) Contract charge-backs and sales volume allowances (474,169) (573,592) Cash discount allowances (24,152) (27,454) Subtotal (502,558) (603,168) Trade accounts receivable, net $ 690,947 $ 741,791 |
Schedules of Percent of Gross Trade Receivables | Concentration of Receivables Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows: September 30, December 31, Customer A 36 % 41 % Customer B 27 % 25 % Customer C 23 % 21 % |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Components of Inventories | Inventories were comprised of the following (in thousands): September 30, December 31, Raw materials $ 224,980 $ 224,607 Work in process 63,397 58,522 Finished goods 288,097 247,606 Total inventories $ 576,474 $ 530,735 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets were comprised of the following (in thousands): September 30, December 31, Deposits and advances $ 5,123 $ 1,821 Prepaid insurance 8,091 8,090 Prepaid regulatory fees 2,936 5,298 Income and other tax receivables 12,817 12,881 Prepaid taxes 17,213 16,593 Other current receivables (1) 15,107 33,133 Chargebacks receivable (2) 10,683 8,605 Other prepaid assets 19,474 17,144 Total prepaid expenses and other current assets $ 91,444 $ 103,565 (1) Other current receivables as of December 31, 2022 included a $21.4 million receivable for an upfront payment associated with the Orion Agreement, which was collected in January 2023. Refer to Note 5. Alliance and Collaboration for additional information. (2) When a sale occurs on a contract item in the Company’s AvKARE segment, the difference between the cost paid to the manufacturer by the Company and the contract cost that the end customer has with the manufacturer is rebated back to the Company by the manufacturer. The Company establishes a chargeback (rebate) receivable and a reduction to cost of goods sold in the same period as the related sale. |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The changes in goodwill for the nine months ended September 30, 2023 and for the year ended December 31, 2022 were as follows (in thousands): September 30, December 31, Balance, beginning of period $ 598,853 $ 593,017 Goodwill acquired during the period — 7,553 Adjustment during the period for the acquisition of Puniska Healthcare Pvt. Ltd. — 3,075 Currency translation (222) (4,792) Balance, end of period $ 598,631 $ 598,853 |
Schedule of Finite-Lived Intangible Assets | Intangible assets as of September 30, 2023 and December 31, 2022 were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Weighted-Average Cost Accumulated Net Cost Accumulated Net Amortizing intangible assets: Product rights 6.4 $ 1,229,662 $ (678,128) $ 551,534 $ 1,222,762 $ (573,281) $ 649,481 Other intangible assets 3.5 133,800 (90,658) 43,142 133,800 (77,943) 55,857 Subtotal $ 1,363,462 $ (768,786) $ 594,676 $ 1,356,562 $ (651,224) $ 705,338 In-process research and development 387,855 — 387,855 390,755 — 390,755 Total intangible assets $ 1,751,317 $ (768,786) $ 982,531 $ 1,747,317 $ (651,224) $ 1,096,093 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The following table presents future amortization expense for the next five years and thereafter, excluding $387.9 million of in-process research and development (“IPR&D”) intangible assets (in thousands): Future Remainder of 2023 $ 40,609 2024 164,276 2025 126,861 2026 76,542 2027 54,765 2028 32,361 Thereafter 99,262 Total $ 594,676 |
Other Assets (Tables)
Other Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Other Assets [Abstract] | |
Schedule of Other Assets | Other assets were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Interest rate swap (1) $ 74,336 $ 85,586 Security deposits 3,573 3,523 Long-term prepaid expenses 2,401 3,711 Deferred revolving credit facility costs 2,387 2,206 Other long term assets 6,346 8,191 Total $ 89,043 $ 103,217 (1) Refer to Note 17. Fair Value Measurements and Note 18. Financial Instruments |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Accounts payable $ 177,400 $ 165,980 Accrued returns allowance (1) 129,968 145,060 Accrued compensation 52,826 54,038 Accrued Medicaid and commercial rebates (1) 90,163 86,030 Accrued royalties 27,064 19,309 Commercial chargebacks and rebates 10,226 10,226 Accrued professional fees 14,665 11,386 Accrued other 55,449 46,170 Total accounts payable and accrued expenses $ 557,761 $ 538,199 (1) Refer to Note 4. Revenue Recognition for a rollforward of the balance from December 31, 2022 to September 30, 2023. |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | The following is a summary of the Company’s indebtedness under its term loans (in thousands): September 30, 2023 December 31, 2022 Term Loan due May 2025 $ 2,543,626 $ 2,563,876 Rondo Term Loan due January 2025 37,500 72,000 Total debt 2,581,126 2,635,876 Less: debt issuance costs (8,779) (13,934) Total debt, net of debt issuance costs 2,572,347 2,621,942 Less: current portion of long-term debt (30,533) (29,961) Total long-term debt, net $ 2,541,814 $ 2,591,981 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Other Long-Term Liabilities | Other long-term liabilities were comprised of the following (in thousands): September 30, 2023 December 31, 2022 Uncertain tax positions $ 483 $ 563 Long-term portion of liabilities for legal matters (1) 486 49,442 Long-term compensation 22,610 16,737 Contingent consideration (2) 11,800 11,997 Other long-term liabilities 6,009 8,729 Total other long-term liabilities $ 41,388 $ 87,468 (1) Refer to Note 19. Commitments and Contingencies for additional information. (2) Refer to Note 17. Fair Value Measurements for additional information. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurement Based on September 30, 2023 Total Quoted Significant Significant Assets Interest rate swap (1) $ 74,336 $ — $ 74,336 $ — Liabilities Deferred compensation plan liabilities (2) $ 8,727 $ — $ 8,727 $ — Contingent consideration liabilities (3) $ 14,640 $ — $ — $ 14,640 December 31, 2022 Assets Interest rate swap (1) $ 85,586 $ — $ 85,586 $ — Liabilities Deferred compensation plan liabilities (2) $ 9,674 $ — $ 9,674 $ — Contingent consideration liability (3) $ 15,427 $ — $ — $ 15,427 (1) The fair value measurement of the Company’s interest rate swap classified within Level 2 of the fair value hierarchy is a model-derived valuation as of a given date in which all significant inputs are observable in active markets including certain financial information and certain assumptions regarding past, present, and future market conditions. Refer to Note 18. Financial Instruments for information on the Company's interest rate swap. (2) These liabilities are recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants. (3) The fair value measurement of contingent consideration liabilities has been classified as Level 3 recurring liabilities as the valuations require judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for various inputs, the estimated fair values could be higher or lower than what the Company determined. As of September 30, 2023 and December 31, 2022 , the contingent consideration liability associated with the Saol Acquisition included $0.8 million and $0.1 million, respectively, recorded in accounts payable and accrued expenses and $11.8 million and $12.0 million, respectively, recorded in other-longer term liabilities. As of September 30, 2023 and December 31, 2022 , the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC (“KSP”) was valued at approximately $2.0 million and $3.3 million, respectively, and recorded within related party payables - long term. |
Schedule of Reconciliation of Contingent Consideration Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Level 3) | The following table provides a reconciliation of the contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands): Nine Months Ended Balance, beginning of period $ 15,427 Change in fair value during the period (787) Balance, end of period $ 14,640 |
Schedule of Significant Inputs Used in Fair Value Measurements | The following table summarizes the significant unobservable inputs used in the fair value measurement of the Company’s material contingent consideration liabilities as of September 30, 2023: Contingent Consideration Liability Fair Value as of September 30, 2023 (in thousands) Unobservable input Range Weighted Average (1) Royalties (Saol Acquisition) $12,600 Discount rate 17.0% - 17.0% 17.0% Projected year of payment 2023 - 2033 2027 (1) Unobservable inputs were weighted by the relative fair value of each product candidate acquired. |
Financial Instruments (Tables)
Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Fair Values of Derivative Instruments in Consolidated Balance Sheets | A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands): September 30, 2023 December 31, 2022 Derivatives Designated as Hedging Instruments Balance Sheet Fair Value Balance Sheet Fair Value Variable-to-fixed interest rate swap Other assets $ 74,336 Other assets $ 85,586 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Charges and Liabilities Related to Legal Matters | Liabilities for legal matters were comprised of the following (in thousands): Matter September 30, 2023 December 31, 2022 Opana ER® antitrust litigation $ 50,000 $ 83,944 Opana ER® antitrust litigation-accrued interest 1,968 1,423 Opana ER® antitrust litigation-imputed interest (398) — Civil prescription opioid litigation 21,222 17,993 Other 4,036 4,123 Current portion of liabilities for legal matters $ 76,828 $ 107,483 Opana ER® antitrust litigation $ — $ 50,000 Opana ER ® antitrust litigation-accrued interest — 847 Opana ER ® antitrust litigation-imputed interest — (1,405) Prescription Opioid Litigation 486 — Long-term portion of liabilities for legal matters (included in other long-term liabilities) $ 486 $ 49,442 |
Stockholders_ Equity and Rede_2
Stockholders’ Equity and Redeemable Non-Controlling Interests (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Changes in Accumulated Other Comprehensive (Loss) Income by Component | Changes in Accumulated Other Comprehensive (Loss) Income by Component (in thousands): Foreign Unrealized (loss) gain on cash Accumulated Balance December 31, 2021 $ (18,845) $ (5,982) $ (24,827) Other comprehensive loss before reclassification (13,394) 48,270 34,876 Reallocation of ownership interests (143) 33 (110) Balance December 31, 2022 (32,382) 42,321 9,939 Other comprehensive loss before reclassification (525) (5,621) (6,146) Reallocation of ownership interests (300) 380 80 Balance September 30, 2023 $ (33,207) $ 37,080 $ 3,873 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of Related Party Transactions | The following table summarizes the Company’s related party transactions (in thousands): Three months ended September 30, Nine months ended September 30, Related Party and Nature of Transaction Caption in Balance Sheet and Statement of Operations 2023 2022 2023 2022 Kashiv Biosciences LLC Parking space lease Research and development $ 25 $ 25 $ 75 $ 75 License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Filgrastim Selling, general and administrative $ — $ — $ — $ 5,000 Development and commercialization agreement - Ganirelix Acetate and Cetrorelix Acetate Research and development $ (75) $ 104 $ (25) $ 1,827 License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Pegfilgrastim Intangible asset $ — $ — $ — $ 15,000 Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko) Cost of goods sold $ 844 $ — $ 988 $ — Storage agreement Research and development $ (18) $ — $ (100) $ — Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko) Inventory and cost of goods sold $ 90 $ — $ 590 $ — Generic development supply agreement - research and development material Research and development $ (2,209) $ — $ (2,209) $ — Generic development supply agreement - development activity deferred income Deferred revenue $ (246) $ — $ (246) $ — Other Related Parties Kanan, LLC - operating lease Inventory and cost of goods sold $ 592 $ 526 $ 1,750 $ 1,578 Sutaria Family Realty, LLC - operating lease Inventory and cost of goods sold $ 314 $ 305 $ 933 $ 906 PharmaSophia, LLC - research and development services income Research and development $ — $ (15) $ — $ (45) Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement Inventory and cost of goods sold $ 5,528 $ 800 $ 11,095 $ 2,222 Tracy Properties LLC - operating lease Selling, general and administrative $ 258 $ 155 $ 521 $ 426 AzaTech Pharma LLC - supply agreement Inventory and cost of goods sold $ 2,588 $ 1,340 $ 5,132 $ 3,992 AvPROP, LLC - operating lease Selling, general and administrative $ 44 $ 46 $ 134 $ 136 Avtar Investments, LLC - consulting services Research and development $ 70 $ 47 $ 267 $ 216 TPG Operations, LLC - consulting services Selling, general and administrative $ — $ — $ — $ 19 Alkermes Inventory and cost of goods sold $ 232 $ 64 $ 322 $ 171 R&S Solutions - logistics services Selling, general and administrative $ 46 $ 26 $ 86 $ 65 Members - tax receivable agreement (TRA liability) Other expense $ 677 $ — $ 1,908 $ — The following table summarizes the amounts due to or from the Company for related party transactions (in thousands): September 30, 2023 December 31, 2022 Sellers of AvKARE LLC and R&S - state tax indemnification $ — $ 486 Kashiv - various agreements 1,472 12 Asana BioSciences, LLC — 2 Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement 106 — AzaTech Pharma 25 — Related party receivables - short term $ 1,603 $ 500 Kashiv - various agreements $ 25 $ 110 Apace Packaging, LLC - packaging agreement 920 756 AzaTech Pharma LLC - supply agreement 1,351 863 Avtar Investments LLC - consulting services 62 72 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 442 442 Members - tax receivable agreement 630 201 R&S Solutions LLC - logistics services 6 7 Alkermes Plc 64 28 Related party payables - short term $ 3,500 $ 2,479 Kashiv - contingent consideration (1) $ 2,040 $ 3,290 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 7,586 5,929 Members - tax receivable agreement 1,908 430 Related party payables - long term $ 11,534 $ 9,649 (1) The c ontingent consideration liability was associated with the acquisition of KSP. Refer to Note 17. Fair Value Measurements for additional information. |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Schedule of Segment Reporting Information, by Segment | Three Months Ended September 30, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 390,857 $ 97,304 $ 131,879 $ — $ 620,040 Cost of goods sold 236,268 45,551 105,690 — 387,509 Gross profit 154,589 51,753 26,189 — 232,531 Selling, general and administrative 33,538 22,756 14,313 42,399 113,006 Research and development 35,103 6,272 — — 41,375 Intellectual property legal development expenses 815 71 — — 886 Restructuring and other charges 112 931 — — 1,043 Change in fair value of contingent consideration — 3,120 — — 3,120 Credit related to legal matters, net (2,500) — — (120) (2,620) Other operating expense 73 — — — 73 Operating income (loss) $ 87,448 $ 18,603 $ 11,876 $ (42,279) $ 75,648 Nine Months Ended September 30, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 1,108,364 $ 285,976 $ 382,286 $ — $ 1,776,626 Cost of goods sold 692,008 135,254 318,626 — 1,145,888 Gross profit 416,356 150,722 63,660 — 630,738 Selling, general and administrative 89,178 67,894 41,268 122,332 320,672 Research and development 98,570 19,294 — — 117,864 Intellectual property legal development expenses 3,240 110 — — 3,350 Restructuring and other charges 211 1,013 — 411 1,635 Change in fair value of contingent consideration — (787) — — (787) (Credit) charges related to legal matters, net (2,927) — — 1,888 (1,039) Other operating income (1,138) — — — (1,138) Operating income (loss) $ 229,222 $ 63,198 $ 22,392 $ (124,631) $ 190,181 Three Months Ended September 30, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 350,266 $ 89,484 $ 105,807 $ — $ 545,557 Cost of goods sold 218,671 43,719 88,937 — 351,327 Gross profit 131,595 45,765 16,870 — 194,230 Selling, general and administrative 30,259 22,201 13,216 34,395 100,071 Research and development 41,987 8,248 — — 50,235 Intellectual property legal development expenses 1,369 42 — — 1,411 Acquisition, transaction-related and integration expenses 16 15 — 8 39 Restructuring and other charges 507 — — 74 581 Change in fair value of contingent consideration — (1,425) — — (1,425) Charges related to legal matters, net 285 — — — 285 Other operating income (1,320) — — — (1,320) Operating income (loss) $ 58,492 $ 16,684 $ 3,654 $ (34,477) $ 44,353 Nine Months Ended September 30, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 1,032,908 $ 271,571 $ 298,066 $ — $ 1,602,545 Cost of goods sold 646,236 130,363 256,626 — 1,033,225 Gross profit 386,672 141,208 41,440 — 569,320 Selling, general and administrative 84,410 69,772 39,361 103,999 297,542 Research and development 129,382 24,399 — — 153,781 Intellectual property legal development expenses 2,919 77 — — 2,996 Acquisition, transaction-related and integration expenses 24 47 — 643 714 Restructuring and other charges 713 — — 599 1,312 Change in fair value of contingent consideration — (1,495) — — (1,495) Insurance recoveries for property losses and associated expenses (1,911) — — — (1,911) Charges related to legal matters, net 2,442 — — 247,394 249,836 Other operating income (2,495) — — — (2,495) Operating income (loss) $ 171,188 $ 48,408 $ 2,079 $ (352,635) $ (130,960) (1) Operating results for the sale of Amneal products by AvKARE are included in Generics. |
Nature of Operations - Addition
Nature of Operations - Additional Information (Details) - Amneal Group | Sep. 30, 2023 |
Noncontrolling Interest [Line Items] | |
Ownership by parent (percent) | 50.40% |
Amneal Group | |
Noncontrolling Interest [Line Items] | |
Ownership percentage by noncontrolling owners (percent) | 49.60% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accounting Policies [Abstract] | |||
Cost of goods sold impairment charges | $ 700 | $ 5,800 | |
Loss on refinancing - revolving credit facility | $ 0 | $ 291 |
Acquisition (Details)
Acquisition (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Feb. 09, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Business Acquisition [Line Items] | |||
Saol Acquisition | $ 0 | $ 84,714 | |
Saol Baclofen Franchise Acquisition | |||
Business Acquisition [Line Items] | |||
Saol Acquisition | $ 84,700 |
Revenue Recognition - Concentra
Revenue Recognition - Concentration of Revenue (Details) - Revenue from Contract with Customer Benchmark - Customer Concentration Risk | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Customer A | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (percent) | 24% | 21% | 24% | 20% |
Customer B | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (percent) | 17% | 17% | 15% | 17% |
Customer C | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (percent) | 21% | 23% | 21% | 23% |
Customer D | ||||
Concentration Risk [Line Items] | ||||
Concentration risk (percent) | 10% | 9% | 10% | 11% |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Disaggregated Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Net revenue | $ 620,040 | $ 545,557 | $ 1,776,626 | $ 1,602,545 |
Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 390,857 | 350,266 | 1,108,364 | 1,032,908 |
Specialty | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 97,304 | 89,484 | 285,976 | 271,571 |
AvKARE | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 131,879 | 105,807 | 382,286 | 298,066 |
International and other | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 867 | 205 | 1,714 | 1,194 |
Anti-infective | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 7,382 | 4,957 | 18,648 | 16,768 |
Hormonal / allergy | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 126,425 | 119,726 | 357,711 | 334,403 |
Hormonal / allergy | US | Specialty | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 28,494 | 22,012 | 82,268 | 65,751 |
Antiviral | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 7,150 | 5,782 | 36,221 | 17,649 |
Central nervous system | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 96,587 | 96,877 | 264,773 | 286,789 |
Central nervous system | US | Specialty | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 61,142 | 61,785 | 180,844 | 185,309 |
Cardiovascular system | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 32,459 | 28,926 | 98,108 | 84,422 |
Gastroenterology | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 18,858 | 17,129 | 53,127 | 51,280 |
Oncology | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 37,722 | 12,240 | 76,846 | 47,872 |
Metabolic disease/ endocrine | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 11,026 | 9,276 | 35,227 | 30,497 |
Respiratory | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 7,832 | 8,720 | 31,783 | 26,503 |
Dermatology | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 17,279 | 17,327 | 53,232 | 48,741 |
Other therapeutic classes | US | Generics | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 27,270 | 29,101 | 80,974 | 86,790 |
Other therapeutic classes | US | Specialty | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 7,668 | 5,687 | 22,864 | 20,511 |
Distribution | US | AvKARE | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 81,904 | 66,057 | 248,929 | 190,560 |
Government label | US | AvKARE | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 32,764 | 26,000 | 87,150 | 72,739 |
Institutional | US | AvKARE | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | 10,551 | 8,297 | 28,395 | 20,672 |
Other | US | AvKARE | ||||
Disaggregation of Revenue [Line Items] | ||||
Net revenue | $ 6,660 | $ 5,453 | $ 17,812 | $ 14,095 |
Revenue Recognition - Schedul_2
Revenue Recognition - Schedule of Major Categories of Sales-Related Deductions (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Contract Charge - Backs and Sales Volume Allowances | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance, beginning of period | $ 573,592 |
Provision related to sales recorded in the period | 2,502,481 |
Credits/payments issued during the period | (2,601,904) |
Balance, end of period | 474,169 |
Cash Discount Allowances | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance, beginning of period | 27,454 |
Provision related to sales recorded in the period | 84,465 |
Credits/payments issued during the period | (87,767) |
Balance, end of period | 24,152 |
Accrued Returns Allowance | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance, beginning of period | 145,060 |
Provision related to sales recorded in the period | 50,786 |
Credits/payments issued during the period | (65,878) |
Balance, end of period | 129,968 |
Accrued Medicaid and Commercial Rebates | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance, beginning of period | 86,030 |
Provision related to sales recorded in the period | 187,161 |
Credits/payments issued during the period | (183,028) |
Balance, end of period | $ 90,163 |
Alliance and Collaboration - Ad
Alliance and Collaboration - Additional Information (Details) € in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2023 USD ($) | Dec. 28, 2022 USD ($) | Dec. 28, 2022 EUR (€) | May 07, 2018 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Research and development | $ 41,375,000 | $ 50,235,000 | $ 117,864,000 | $ 153,781,000 | |||||
Collaborative arrangement maximum milestone paid | $ 26,500,000 | ||||||||
License Agreement with Orion Corporation | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Collaborative arrangement term | 8 years | 8 years | |||||||
Collaborative arrangement renew for successive term | 2 years | 2 years | |||||||
Collaborative arrangement non-refundable milestone payment | € | € 20 | ||||||||
Collaborative arrangement upfront payment | $ 21,400,000 | ||||||||
Collaborative arrangement aggregate sales-based milestone payment | € | € 45 | ||||||||
Collaborative arrangement maximum contingent payments amount | $ 47,600,000 | ||||||||
Research and development | 0 | ||||||||
Collaborative arrangement license revenue agreement | 300,000 | 900,000 | 8,000,000 | ||||||
Collaborative arrangement remaining upfront amount | 13,400,000 | ||||||||
License Agreement with Orion Corporation | Accounts Payable and Accrued Liabilities | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Deferred income | 9,100,000 | 9,100,000 | 9,100,000 | 6,700,000 | |||||
License Agreement with Orion Corporation | Other long-term liabilities | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Deferred income | $ 3,400,000 | $ 3,400,000 | $ 3,400,000 | $ 6,700,000 | |||||
Biosimilar Licensing and Supply Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Collaborative arrangement maximum contingent payments amount | $ 78,300,000 | ||||||||
Estimated useful life (in years) | 7 years |
Government Grants - Additional
Government Grants - Additional Information (Details) $ in Thousands, ₨ in Billions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Nov. 30, 2021 INR (₨) company | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Other operating expense (income) | $ 1,300 | $ 1,200 | $ 2,500 | ||
Prepaid expenses and other current assets | 91,444 | $ 103,565 | |||
Government of India | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Number of companies | company | 55 | ||||
Grants receivable | ₨ 10 | 120,200 | |||
Government grant eligible term | 6 years | ||||
Government of India | Prepaid and other current assets | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Prepaid expenses and other current assets | $ 5,000 | $ 4,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Nov. 07, 2023 | Jul. 21, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2019 | |
Tax Credit Carryforward [Line Items] | ||||||||
Income tax expense (benefit) | $ (2,076) | $ 4,570 | $ (1,431) | $ 8,459 | ||||
Effective tax rate (percent) | (9.00%) | 209.60% | (3.30%) | (3.50%) | ||||
Tax credit carryforward, utilized amount | $ 2,900 | |||||||
Valuation allowance | $ 434,500 | $ 434,500 | $ 434,900 | |||||
Tax receivable agreement, payment ratio | 0.01 | |||||||
Percentage of tax receivable agreement paid to other holders of Amneal common units (percent) | 85% | |||||||
Reversal of accrued tax receivable agreement liability | $ 192,800 | |||||||
Contingent liabilities under tax receivable agreement | 202,700 | $ 202,700 | 202,700 | |||||
Liabilities recorded under tax receivable agreement | $ 2,500 | $ 2,500 | $ 600 | |||||
Subsequent Event | ||||||||
Tax Credit Carryforward [Line Items] | ||||||||
Percentage of tax receivable agreement paid to other holders of Amneal common units (percent) | 75% |
Earnings (Loss) per Share - Com
Earnings (Loss) per Share - Computation of Basic and Diluted Earnings (Loss) per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | $ 9,682 | $ (2,689) | $ 14,656 | $ (125,653) |
Denominator: | ||||
Weighted-average shares outstanding - basic (in shares) | 154,219 | 151,393 | 153,363 | 150,765 |
Effect of dilutive securities: | ||||
Weighted-average shares outstanding - diluted (in shares) | 159,691 | 151,393 | 156,284 | 150,765 |
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: | ||||
Basic (in dollars per share) | $ 0.06 | $ (0.02) | $ 0.10 | $ (0.83) |
Diluted (in dollars per share) | $ 0.06 | $ (0.02) | $ 0.09 | $ (0.83) |
Stock options | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 534 | 0 | 178 | 0 |
Restricted stock units | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 4,052 | 0 | 2,448 | 0 |
Performance stock units | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities (in shares) | 886 | 0 | 295 | 0 |
Earnings (Loss) per Share - Sec
Earnings (Loss) per Share - Securities Excluded from Diluted Earnings per Share Computation (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Shares of class B common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from earnings per share (in shares) | 152,117 | 152,117 | 152,117 | 152,117 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from earnings per share (in shares) | 432 | 2,728 | 432 | 2,728 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from earnings per share (in shares) | 0 | 10,874 | 0 | 10,874 |
Performance stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities excluded from earnings per share (in shares) | 4,636 | 7,266 | 4,636 | 7,266 |
Trade Accounts Receivable, Ne_2
Trade Accounts Receivable, Net - Schedule of Trade Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Related Party Transaction [Line Items] | ||
Gross accounts receivable | $ 1,193,505 | $ 1,344,959 |
Allowance for credit losses | (4,237) | (2,122) |
Contract charge-backs and sales volume allowances | (474,169) | (573,592) |
Cash discount allowances | (24,152) | (27,454) |
Subtotal | (502,558) | (603,168) |
Nonrelated Party | ||
Related Party Transaction [Line Items] | ||
Trade accounts receivable, net | $ 690,947 | $ 741,791 |
Trade Accounts Receivable, Ne_3
Trade Accounts Receivable, Net - Concentration of Receivables (Details) - Customer Concentration Risk - Accounts Receivable | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 36% | 41% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 27% | 25% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 23% | 21% |
Inventories - Components of Inv
Inventories - Components of Inventories, Net of Reserves (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 224,980 | $ 224,607 |
Work in process | 63,397 | 58,522 |
Finished goods | 288,097 | 247,606 |
Total inventories | $ 576,474 | $ 530,735 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Gain Contingencies [Line Items] | ||
Deposits and advances | $ 5,123 | $ 1,821 |
Prepaid insurance | 8,091 | 8,090 |
Prepaid regulatory fees | 2,936 | 5,298 |
Income and other tax receivables | 12,817 | 12,881 |
Prepaid taxes | 17,213 | 16,593 |
Other current receivables | 15,107 | 33,133 |
Chargebacks receivable | 10,683 | 8,605 |
Other prepaid assets | 19,474 | 17,144 |
Total prepaid expenses and other current assets | $ 91,444 | 103,565 |
Prepaid and other current assets | License Agreement with Orion Corporation | ||
Gain Contingencies [Line Items] | ||
Collaborative arrangement upfront payment receivable | $ 21,400 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Assets - Schedule of Goodwill (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Goodwill [Roll Forward] | ||
Balance, beginning of period | $ 598,853 | $ 593,017 |
Goodwill acquired during the period | 0 | 7,553 |
Adjustment during the period for the acquisition of Puniska Healthcare Pvt. Ltd. | 0 | 3,075 |
Currency translation | (222) | (4,792) |
Balance, end of period | $ 598,631 | $ 598,853 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill [Line Items] | |||
Goodwill | $ 598,631 | $ 598,853 | $ 593,017 |
Specialty | |||
Goodwill [Line Items] | |||
Goodwill | 366,300 | 366,300 | |
Generics | |||
Goodwill [Line Items] | |||
Goodwill | 162,800 | 163,100 | |
AvKARE | |||
Goodwill [Line Items] | |||
Goodwill | $ 69,500 | $ 69,500 |
Goodwill and Other Intangible_5
Goodwill and Other Intangible Assets - Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 1,363,462 | $ 1,356,562 |
Accumulated Amortization | (768,786) | (651,224) |
Net | 594,676 | 705,338 |
In-process research and development | 387,855 | 390,755 |
Intangible assets, cost | 1,751,317 | 1,747,317 |
Intangible assets, net | $ 982,531 | 1,096,093 |
Product rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period (in years) | 6 years 4 months 24 days | |
Cost | $ 1,229,662 | 1,222,762 |
Accumulated Amortization | (678,128) | (573,281) |
Net | $ 551,534 | 649,481 |
Other intangible assets | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period (in years) | 3 years 6 months | |
Cost | $ 133,800 | 133,800 |
Accumulated Amortization | (90,658) | (77,943) |
Net | $ 43,142 | $ 55,857 |
Goodwill and Other Intangible_6
Goodwill and Other Intangible Assets - Amortization Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization of intangible assets | $ 40.6 | $ 44.5 | $ 122.5 | $ 127.4 |
Goodwill and Other Intangible_7
Goodwill and Other Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Remainder of 2023 | $ 40,609 | |
2024 | 164,276 | |
2025 | 126,861 | |
2026 | 76,542 | |
2027 | 54,765 | |
2028 | 32,361 | |
Thereafter | 99,262 | |
Net | $ 594,676 | $ 705,338 |
Goodwill and Other Intangible_8
Goodwill and Other Intangible Assets - Impairment of Intangible Assets (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||||
Impairment charges | $ 0 | $ 700,000 | $ 0 | $ 0 | $ 5,800,000 |
Other Assets - Schedule of Othe
Other Assets - Schedule of Other Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Other Assets [Line Items] | ||
Other assets | $ 89,043 | $ 103,217 |
Interest rate swap | ||
Other Assets [Line Items] | ||
Other assets | 74,336 | 85,586 |
Security deposits | ||
Other Assets [Line Items] | ||
Other assets | 3,573 | 3,523 |
Long-term prepaid expenses | ||
Other Assets [Line Items] | ||
Other assets | 2,401 | 3,711 |
Deferred revolving credit facility costs | ||
Other Assets [Line Items] | ||
Other assets | 2,387 | 2,206 |
Other long term assets | ||
Other Assets [Line Items] | ||
Other assets | $ 6,346 | $ 8,191 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Related Party Transaction [Line Items] | ||
Accounts payable | $ 177,400 | $ 165,980 |
Accrued returns allowance | 129,968 | 145,060 |
Accrued compensation | 52,826 | 54,038 |
Accrued Medicaid and commercial rebates | 90,163 | 86,030 |
Accrued royalties | 27,064 | 19,309 |
Commercial chargebacks and rebates | 10,226 | 10,226 |
Accrued professional fees | 14,665 | 11,386 |
Accrued other | 55,449 | 46,170 |
Nonrelated Party | ||
Related Party Transaction [Line Items] | ||
Accounts payable and accrued expenses | $ 557,761 | $ 538,199 |
Debt - Summary of Long-term Deb
Debt - Summary of Long-term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Total debt | $ 2,581,126 | $ 2,635,876 |
Less: debt issuance costs | (8,779) | (13,934) |
Total debt, net of debt issuance costs | 2,572,347 | 2,621,942 |
Less: current portion of long-term debt | (30,533) | (29,961) |
Total long-term debt, net | 2,541,814 | 2,591,981 |
Term Loan due May 2025 | ||
Debt Instrument [Line Items] | ||
Total debt | 2,543,626 | 2,563,876 |
Rondo Term Loan due January 2025 | ||
Debt Instrument [Line Items] | ||
Total debt | $ 37,500 | $ 72,000 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Sep. 21, 2023 | May 31, 2023 | Apr. 20, 2023 | Jan. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 26, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||||||
Term loan | $ 2,581,126 | $ 2,581,126 | $ 2,635,876 | |||||
Rondo Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding principal | 2,200 | 34,500 | ||||||
Available maximum borrowing capacity | 22,000 | 22,000 | ||||||
Principal payments | 27,800 | |||||||
Term loan | 6,000 | 6,000 | ||||||
Opana ER® antitrust litigation | ||||||||
Debt Instrument [Line Items] | ||||||||
Litigation settlement expense | $ 83,900 | 215,000 | ||||||
Revolving Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Revolving credit facilities | $ 80,000 | 70,000 | 70,000 | |||||
Repayment of outstanding principal | 30,000 | 70,000 | ||||||
Available maximum borrowing capacity | 275,900 | 275,900 | ||||||
Maximum borrowing capacity | $ 30,000 | |||||||
Revolving Credit Facility | Amended Rondo Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayment of outstanding principal | 24,000 | |||||||
Maximum borrowing capacity | $ 70,000 | |||||||
Borrowings | 10,000 | 30,000 | ||||||
Secured Debt | Line of Credit | Secured Overnight Financing Rate (SOFR) | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate floor (percent) | 0.10% | 0.11448% | ||||||
Basis spread on variable rate (percent) | 2.25% | 3.50% | ||||||
Interest rate (percent) | 1.366% | |||||||
Secured Debt | Line of Credit | Secured Overnight Financing Rate (SOFR) | Rondo Revolving Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate floor (percent) | 0.10% | |||||||
Basis spread on variable rate (percent) | 2.25% | |||||||
Letter of Credit | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing capacity | $ 10,000 | |||||||
Letter of Credit | Amended Rondo Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Revolving credit facilities | $ 42,000 | $ 42,000 | ||||||
Maximum borrowing capacity | $ 60,000 | |||||||
Standby Letters of Credit | Amended Rondo Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing capacity | $ 42,000 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Nonrelated Party | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | $ 41,388 | $ 87,468 |
Uncertain tax positions | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 483 | 563 |
Long-term portion of liabilities for legal matters | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 486 | 49,442 |
Long-term compensation | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 22,610 | 16,737 |
Contingent Consideration | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 11,800 | 11,997 |
Other long-term liabilities | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | $ 6,009 | $ 8,729 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets | ||
Interest rate swap | $ 74,336 | $ 85,586 |
Liabilities | ||
Deferred compensation plan liabilities | 8,727 | 9,674 |
Contingent consideration liabilities | 14,640 | 15,427 |
Saol Baclofen Franchise Acquisition | Accounts Payable And Accrued Expenses | ||
Liabilities | ||
Contingent consideration liabilities | 800 | 100 |
Saol Baclofen Franchise Acquisition | Other long-term liabilities | ||
Liabilities | ||
Contingent consideration liabilities | 11,800 | 12,000 |
Kashiv Specialty Pharmaceuticals, LLC | ||
Liabilities | ||
Contingent consideration liabilities | 2,000 | 3,300 |
Quoted Prices in Active Markets (Level 1) | ||
Assets | ||
Interest rate swap | 0 | 0 |
Liabilities | ||
Deferred compensation plan liabilities | 0 | 0 |
Contingent consideration liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Assets | ||
Interest rate swap | 74,336 | 85,586 |
Liabilities | ||
Deferred compensation plan liabilities | 8,727 | 9,674 |
Contingent consideration liabilities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Assets | ||
Interest rate swap | 0 | 0 |
Liabilities | ||
Deferred compensation plan liabilities | 0 | 0 |
Contingent consideration liabilities | $ 14,640 | $ 15,427 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Apr. 02, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long term debt | $ 2,572,347 | $ 2,621,942 | |
Term Loan | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-term debt fair value | 2,500,000 | 2,300,000 | |
Term Loan | Significant Other Observable Inputs (Level 2) | Rondo Partners L L C | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long-term debt fair value | 37,300 | 70,900 | |
Sellers Notes | Significant Other Observable Inputs (Level 2) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long term debt | $ 40,800 | $ 39,100 | |
Kashiv Specialty Pharmaceuticals, LLC | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Contingent consideration, maximum liability | $ 8,000 |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of Contingent Consideration Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Balance, beginning of period | $ 15,427 | |||
Change in fair value during the period | $ (3,120) | $ 1,425 | 787 | $ 1,495 |
Balance, end of period | $ 14,640 | 14,640 | ||
Saol Baclofen Franchise and Kashiv Specialty Pharmaceuticals LLC | ||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Change in fair value during the period | $ (787) |
Fair Value Measurements - Signi
Fair Value Measurements - Significant Inputs Used in Fair Value Measurements (Details) $ in Thousands | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | $ 14,640 | $ 15,427 |
Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | $ 12,600 | |
Minimum | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.170 | |
Maximum | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.170 | |
Weighted Average | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.170 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Oct. 31, 2019 |
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | $ 74.3 | |
Accumulated Other Comprehensive Income | ||
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | 37.1 | |
Non- Controlling Interests | ||
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | $ 37.2 | |
Interest Rate Lock Agreement | ||
Derivative [Line Items] | ||
Notional amount | $ 1,300 |
Financial Instruments - Summary
Financial Instruments - Summary of Fair Values of Derivative Instruments in Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Variable to Fixed Interest Rate Swap | Designated as Hedging Instrument | Other assets | ||
Derivative [Line Items] | ||
Fair Value | $ 74,336 | $ 85,586 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||
Sep. 05, 2023 USD ($) | Jul. 27, 2023 USD ($) | Jul. 01, 2023 complaint | May 30, 2023 case | Mar. 22, 2022 lawsuit | Jun. 10, 2020 state action | Mar. 13, 2015 medication | Nov. 06, 2014 representative | Jan. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) state case | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) state case | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Apr. 10, 2023 plaintiff | Nov. 01, 2019 state | May 10, 2019 state | |
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | $ 2,620 | $ (285) | $ 1,039 | $ (249,836) | |||||||||||||
Litigation settlement amount | 0 | ||||||||||||||||
Number of lawsuit filed | lawsuit | 2 | ||||||||||||||||
December 2022 and Mid-January 2024 | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Interest rate | 3% | 3% | |||||||||||||||
Customer Claim | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | $ (3,000) | $ (3,000) | |||||||||||||||
Patent Infringement Matters | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | 5,500 | (10,000) | |||||||||||||||
Prescription Opioid Litigation | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | (4,100) | ||||||||||||||||
Stockholder Derivative Lawsuit | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | (1,900) | ||||||||||||||||
Opana ER® antitrust litigation | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | 249,800 | (249,836) | |||||||||||||||
Litigation settlement expense, net of insurance recoveries | 262,800 | ||||||||||||||||
Loss contingency accrual | $ 50,000 | $ 265,000 | 50,000 | $ 265,000 | |||||||||||||
Litigation settlement expense | $ 83,900 | 215,000 | |||||||||||||||
Takeda Pharmaceuticals U.S.A., Inc | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Litigation settlement amount | $ 3,000 | ||||||||||||||||
Length of jury trial | 22 days | ||||||||||||||||
Russell Thiele, et al. v. Kashiv Biosciences, LLC, et al. | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Litigation settlement amount | $ 1,900 | ||||||||||||||||
United States Department of Justice Investigations | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Number of sales representatives | representative | 1 | ||||||||||||||||
Number of generic prescription medications | medication | 4 | ||||||||||||||||
Generic Digoxin and Doxycycline Antitrust Litigation | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Number of states, filed civil lawsuit | state | 46 | 43 | |||||||||||||||
Loss contingency civil lawsuit filed number of additional states | state | 9 | ||||||||||||||||
Number of actions | action | 2 | ||||||||||||||||
Number of lawsuit filed | complaint | 152 | ||||||||||||||||
Civil prescription opioid litigation | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Credit related to legal matters, net | $ (4,000) | $ (18,000) | |||||||||||||||
Number of cases | case | 900 | 900 | |||||||||||||||
Number of states with cases | state | 7 | 7 | |||||||||||||||
Number of cases dismissed | case | 2 | ||||||||||||||||
Ranitidine Litigation | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Number of states with cases | state | 4 | 4 | |||||||||||||||
Value Drug Company v. Takeda Pharmaceuticals U.S.A., Inc. | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Number of former absent members added as plaintiffs | plaintiff | 18 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Liabilities For Legal Matters (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | $ 76,828 | $ 107,483 |
Long-term portion of liabilities for legal matters (included in other long-term liabilities) | 486 | 49,442 |
Opana ER® antitrust litigation | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 50,000 | 83,944 |
Opana ER® antitrust litigation | 0 | 50,000 |
Opana ER® antitrust litigation-accrued interest | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 1,968 | 1,423 |
Opana ER ® antitrust litigation-accrued interest | 0 | 847 |
Opana ER® antitrust litigation-imputed interest | ||
Loss Contingencies [Line Items] | ||
Opana ER ® antitrust litigation-imputed interest | (398) | 0 |
Opana ER ® antitrust litigation-imputed interest | 0 | (1,405) |
Civil prescription opioid litigation | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 21,222 | 17,993 |
Other | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 4,036 | 4,123 |
Prescription Opioid Litigation | ||
Loss Contingencies [Line Items] | ||
Opana ER® antitrust litigation | $ 486 | $ 0 |
Stockholders' Equity and Redeem
Stockholders' Equity and Redeemable Non-Controlling Interests - Additional Information (Details) - USD ($) $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
May 09, 2023 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Nov. 02, 2021 | Apr. 02, 2021 | Dec. 31, 2020 | Jan. 31, 2020 | |
Class of Stock [Line Items] | ||||||||||
Tax distribution | $ 10,640 | $ 2,480 | $ 58,650 | $ 9,810 | ||||||
Kashiv Specialty Pharmaceuticals, LLC | ||||||||||
Class of Stock [Line Items] | ||||||||||
Voting interest acquired (percent) | 98% | |||||||||
Kashiv Specialty Pharmaceuticals, LLC | Sellers of KSP | ||||||||||
Class of Stock [Line Items] | ||||||||||
Ownership percentage by noncontrolling owners (percent) | 2% | |||||||||
Av Kare Incorporation And R And S Northeast L L C | ||||||||||
Class of Stock [Line Items] | ||||||||||
Voting interest acquired (percent) | 65.10% | |||||||||
Tax distribution recorded as a reduction to redeemable non-controlling interest | $ 4,460 | $ 730 | $ 10,290 | 3,320 | ||||||
Av Kare Incorporation And R And S Northeast L L C | Rondo Partners L L C | ||||||||||
Class of Stock [Line Items] | ||||||||||
Ownership percentage by noncontrolling owners (percent) | 34.90% | 34.90% | 34.90% | |||||||
Puniska | ||||||||||
Class of Stock [Line Items] | ||||||||||
Voting interest acquired (percent) | 26% | 26% | 26% | 74% | ||||||
Consideration paid in cash on hand | $ 1,700 | |||||||||
Increase in redeemable non-controlling interest to redemption value | $ 900 | |||||||||
Amneal Pharmaceuticals Inc 2018 Incentive Award Plan | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of additional shares authorized (in shares) | 20 | |||||||||
Shares reserved (in shares) | 57 |
Stockholders' Equity and Rede_2
Stockholders' Equity and Redeemable Non-Controlling Interests - Schedule of Changes in Accumulated Other Comprehensive Loss by Component (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Stockholders' equity beginning balance | $ 183,979 | $ 366,973 |
Other comprehensive loss before reclassification | (6,146) | 34,876 |
Reallocation of ownership interests | 80 | (110) |
Stockholders' equity ending balance | 154,236 | 183,979 |
Foreign currency translation adjustments | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Stockholders' equity beginning balance | (32,382) | (18,845) |
Other comprehensive loss before reclassification | (525) | (13,394) |
Reallocation of ownership interests | (300) | (143) |
Stockholders' equity ending balance | (33,207) | (32,382) |
Unrealized (loss) gain on cash flow hedge, net of tax | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Stockholders' equity beginning balance | 42,321 | (5,982) |
Other comprehensive loss before reclassification | (5,621) | 48,270 |
Reallocation of ownership interests | 380 | 33 |
Stockholders' equity ending balance | 37,080 | 42,321 |
Accumulated Other Comprehensive Income | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Stockholders' equity beginning balance | 9,939 | (24,827) |
Stockholders' equity ending balance | $ 3,873 | $ 9,939 |
Related Party Transactions - Re
Related Party Transactions - Related Party Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Research and development - Parking Space Lease | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | $ 25 | $ 25 | $ 75 | $ 75 | |
Selling, General and Administrative - Development and Commercialization Agreement | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 0 | 0 | 0 | 5,000 | |
Research and Development - Development and Commercialization Agreement - Ganirelix Acetate and Centrorelix Acetate | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | (75) | 104 | (25) | 1,827 | |
Intangible Asset - License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Pegfilgrastim | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 0 | 0 | 0 | 15,000 | |
Cost of Goods Sold Development And Commercialization Agreement - Filgrastim And Pegfilgrastim | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 844 | 0 | 988 | 0 | |
Research and Development Storage Income | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | (18) | 0 | (100) | 0 | |
Inventory and Cost of Goods Sold | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 90 | 0 | 590 | 0 | |
Inventory and Cost of Goods Sold | Kanan L L C | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 592 | 526 | 1,750 | 1,578 | |
Inventory and Cost of Goods Sold | Sutaria Family Realty, LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 314 | 305 | 933 | 906 | |
Inventory and Cost of Goods Sold | Apace Packaging, LLC - packaging agreement | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 5,528 | 800 | 11,095 | 2,222 | |
Inventory and Cost of Goods Sold | AzaTech Pharma LLC - supply agreement | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 2,588 | 1,340 | 5,132 | 3,992 | |
Inventory and Cost of Goods Sold | Alkermes Plc | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 232 | 64 | 322 | 171 | |
Research and Development - Generic Development Supply Agreement - Research and Development Material | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | (2,209) | 0 | (2,209) | 0 | |
Deferred Revenue - Generic Development Supply Agreement - Development Activity Deferred Income | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | (246) | 0 | (246) | 0 | |
Research and Development | Pharma Sophia LLC | |||||
Related Party Transaction [Line Items] | |||||
Income from related parties | 0 | (15) | 0 | (45) | |
Research and Development | Avtar Investments LLC - consulting services | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 70 | 47 | 267 | 216 | |
Selling, General and Administrative - Operating Lease | Tracy Properties LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 258 | 155 | 521 | 426 | |
Selling, General and Administrative - Operating Lease | Av Prop LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 44 | 46 | 134 | 136 | |
Selling, General and Administrative - Consulting Services | TPG Operations, LLC | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 0 | 0 | 0 | 19 | |
Selling, General and Administrative - Logistics Services | R&S Solutions | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 46 | 26 | 86 | 65 | |
Other Expense | Members - tax receivable agreement | |||||
Related Party Transaction [Line Items] | |||||
Amounts of transaction with related party | 677 | $ 0 | 1,908 | $ 0 | |
Related Party | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 1,603 | 1,603 | $ 500 | ||
Accounts payable and accrued expenses | 3,500 | 3,500 | 2,479 | ||
Other long-term liabilities | 11,534 | 11,534 | 9,649 | ||
Related Party | Kashiv Biosciences LLC | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 1,472 | 1,472 | 12 | ||
Accounts payable and accrued expenses | 25 | 25 | 110 | ||
Other long-term liabilities | 2,040 | 2,040 | 3,290 | ||
Related Party | Apace Packaging, LLC - packaging agreement | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 106 | 106 | 0 | ||
Accounts payable and accrued expenses | 920 | 920 | 756 | ||
Related Party | AzaTech Pharma LLC - supply agreement | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 25 | 25 | 0 | ||
Accounts payable and accrued expenses | 1,351 | 1,351 | 863 | ||
Related Party | Avtar Investments LLC - consulting services | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable and accrued expenses | 62 | 62 | 72 | ||
Related Party | Alkermes Plc | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable and accrued expenses | 64 | 64 | 28 | ||
Related Party | R&S Solutions | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable and accrued expenses | 6 | 6 | 7 | ||
Related Party | Members - tax receivable agreement | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable and accrued expenses | 630 | 630 | 201 | ||
Other long-term liabilities | 1,908 | 1,908 | 430 | ||
Related Party | Rondo Partners L L C | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 0 | 0 | 486 | ||
Other long-term liabilities | 7,586 | 7,586 | 5,929 | ||
Related Party | Asana Biosciences L L C | |||||
Related Party Transaction [Line Items] | |||||
Trade accounts receivable, net | 0 | 0 | 2 | ||
Related Party | Sellers of AvKARE LLC and R&S | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable and accrued expenses | $ 442 | $ 442 | $ 442 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) - Fosun International Limited $ in Millions | Aug. 11, 2023 USD ($) product | Aug. 10, 2023 product |
Related Party Transaction [Line Items] | ||
Number of products in agreement | product | 10 | 8 |
First commercial sales milestone | $ | $ 0.3 |
Segment Information - Additiona
Segment Information - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2023 product segment | |
Segment Reporting [Abstract] | |
Number of reportable segments | segment | 3 |
Number of products families | product | 260 |
Segment Information - Schedules
Segment Information - Schedules of Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Segment Reporting Information [Line Items] | ||||
Net revenue | $ 620,040 | $ 545,557 | $ 1,776,626 | $ 1,602,545 |
Cost of goods sold | 387,509 | 351,327 | 1,145,888 | 1,033,225 |
Gross profit | 232,531 | 194,230 | 630,738 | 569,320 |
Selling, general and administrative | 113,006 | 100,071 | 320,672 | 297,542 |
Research and development | 41,375 | 50,235 | 117,864 | 153,781 |
Intellectual property legal development expenses | 886 | 1,411 | 3,350 | 2,996 |
Acquisition, transaction-related and integration expenses | 0 | 39 | 0 | 714 |
Restructuring and other charges | 1,043 | 581 | 1,635 | 1,312 |
Change in fair value during the period | 3,120 | (1,425) | (787) | (1,495) |
Insurance recoveries for property losses and associated expenses | (1,911) | |||
(Credit) charges related to legal matters, net | (2,620) | 285 | (1,039) | 249,836 |
Other operating income (expense) | (1,300) | (1,200) | (2,500) | |
Other operating expense (income) | 73 | (1,320) | (1,138) | (2,495) |
Operating income (loss) | 75,648 | 44,353 | 190,181 | (130,960) |
Generics | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 390,857 | 350,266 | 1,108,364 | 1,032,908 |
AvKARE | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 131,879 | 105,807 | 382,286 | 298,066 |
Operating Segments | Generics | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 390,857 | 350,266 | 1,108,364 | 1,032,908 |
Cost of goods sold | 236,268 | 218,671 | 692,008 | 646,236 |
Gross profit | 154,589 | 131,595 | 416,356 | 386,672 |
Selling, general and administrative | 33,538 | 30,259 | 89,178 | 84,410 |
Research and development | 35,103 | 41,987 | 98,570 | 129,382 |
Intellectual property legal development expenses | 815 | 1,369 | 3,240 | 2,919 |
Acquisition, transaction-related and integration expenses | 16 | 24 | ||
Restructuring and other charges | 112 | 507 | 211 | 713 |
Change in fair value during the period | 0 | 0 | 0 | 0 |
Insurance recoveries for property losses and associated expenses | (1,911) | |||
(Credit) charges related to legal matters, net | (2,500) | 285 | (2,927) | 2,442 |
Other operating expense (income) | 73 | (1,320) | (1,138) | (2,495) |
Operating income (loss) | 87,448 | 58,492 | 229,222 | 171,188 |
Operating Segments | Specialty | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 97,304 | 89,484 | 285,976 | 271,571 |
Cost of goods sold | 45,551 | 43,719 | 135,254 | 130,363 |
Gross profit | 51,753 | 45,765 | 150,722 | 141,208 |
Selling, general and administrative | 22,756 | 22,201 | 67,894 | 69,772 |
Research and development | 6,272 | 8,248 | 19,294 | 24,399 |
Intellectual property legal development expenses | 71 | 42 | 110 | 77 |
Acquisition, transaction-related and integration expenses | 15 | 47 | ||
Restructuring and other charges | 931 | 0 | 1,013 | 0 |
Change in fair value during the period | 3,120 | (1,425) | (787) | (1,495) |
Insurance recoveries for property losses and associated expenses | 0 | |||
(Credit) charges related to legal matters, net | 0 | 0 | 0 | 0 |
Other operating expense (income) | 0 | 0 | 0 | 0 |
Operating income (loss) | 18,603 | 16,684 | 63,198 | 48,408 |
Operating Segments | AvKARE | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 131,879 | 105,807 | 382,286 | 298,066 |
Cost of goods sold | 105,690 | 88,937 | 318,626 | 256,626 |
Gross profit | 26,189 | 16,870 | 63,660 | 41,440 |
Selling, general and administrative | 14,313 | 13,216 | 41,268 | 39,361 |
Research and development | 0 | 0 | 0 | 0 |
Intellectual property legal development expenses | 0 | 0 | 0 | 0 |
Acquisition, transaction-related and integration expenses | 0 | 0 | ||
Restructuring and other charges | 0 | 0 | 0 | 0 |
Change in fair value during the period | 0 | 0 | 0 | 0 |
Insurance recoveries for property losses and associated expenses | 0 | |||
(Credit) charges related to legal matters, net | 0 | 0 | 0 | 0 |
Other operating expense (income) | 0 | 0 | 0 | 0 |
Operating income (loss) | 11,876 | 3,654 | 22,392 | 2,079 |
Corporate and Other | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 0 | 0 | 0 | 0 |
Cost of goods sold | 0 | 0 | 0 | 0 |
Gross profit | 0 | 0 | 0 | 0 |
Selling, general and administrative | 42,399 | 34,395 | 122,332 | 103,999 |
Research and development | 0 | 0 | 0 | 0 |
Intellectual property legal development expenses | 0 | 0 | 0 | 0 |
Acquisition, transaction-related and integration expenses | 8 | 643 | ||
Restructuring and other charges | 0 | 74 | 411 | 599 |
Change in fair value during the period | 0 | 0 | 0 | 0 |
Insurance recoveries for property losses and associated expenses | 0 | |||
(Credit) charges related to legal matters, net | (120) | 0 | 1,888 | 247,394 |
Other operating expense (income) | 0 | 0 | 0 | 0 |
Operating income (loss) | $ (42,279) | $ (34,477) | $ (124,631) | $ (352,635) |
Insurance Recoveries for Prop_2
Insurance Recoveries for Property Losses and Associated Expenses (Details) $ in Thousands | 9 Months Ended | |
Sep. 01, 2021 facility | Sep. 30, 2022 USD ($) | |
Unusual or Infrequent Items, or Both [Abstract] | ||
Number of facilities damaged | facility | 2 | |
Insurance recoveries for property losses and associated expenses | $ | $ 1,911 |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Nov. 07, 2023 $ / shares | Oct. 12, 2023 USD ($) indication | Oct. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares | Dec. 31, 2022 $ / shares | |
Subsequent Event [Line Items] | |||||||
Percentage of tax receivable agreement paid to other holders of Amneal common units (percent) | 85% | ||||||
Class A Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Class B Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Forecast | Mabxcience | |||||||
Subsequent Event [Line Items] | |||||||
License supply agreement, upfront payment | $ 2.5 | ||||||
Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Percentage of tax receivable agreement paid to other holders of Amneal common units (percent) | 75% | ||||||
Subsequent Event | Mabxcience | |||||||
Subsequent Event [Line Items] | |||||||
License supply agreement, number of indications | indication | 2 | ||||||
Potential future milestone payments | $ 71.5 | ||||||
Clinical and development milestone payments | 9 | ||||||
Regulatory approval and initial commercial launch milestone payments | 15 | ||||||
Achievement of annual milestone payments | $ 47.5 | ||||||
Subsequent Event | Old Public Company | Class A Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | ||||||
Subsequent Event | Old Public Company | Class B Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, par value (in usd per share) | $ / shares | 0.01 | ||||||
Subsequent Event | New Public Company | Class A Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | ||||||
Reorganization, common stock conversion ratio | 1 | ||||||
Rondo Term Loan | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Repayment of outstanding principal | $ 20 | ||||||
Revolving Credit Facility | |||||||
Subsequent Event [Line Items] | |||||||
Repayment of outstanding principal | $ 30 | $ 70 | |||||
Revolving Credit Facility | Rondo Term Loan | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Repayment of outstanding principal | $ 6 |