Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 30, 2023 | |
Entity Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 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 $0.01 per share | |
Trading Symbol | AMRX | |
Security Exchange Name | NYSE | |
Entity Current Reporting | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001723128 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Class A Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding (in shares) | 153,337,273 | |
Class B Common Stock | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding (in shares) | 152,116,890 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Net revenue | $ 557,540 | $ 497,633 |
Cost of goods sold | 379,354 | 323,062 |
Gross profit | 178,186 | 174,571 |
Selling, general and administrative | 102,096 | 98,665 |
Research and development | 38,690 | 52,798 |
Intellectual property legal development expenses | 1,644 | 764 |
Acquisition, transaction-related and integration expenses | 0 | 434 |
Restructuring and other charges | 510 | 731 |
Change in fair value of contingent consideration | 2,457 | 200 |
Credit related to legal matters, net | (436) | (2,326) |
Other operating income | (1,224) | 0 |
Operating income | 34,449 | 23,305 |
Other (expense) income: | ||
Interest expense, net | (49,315) | (33,335) |
Foreign exchange gain (loss), net | 1,901 | (2,013) |
Other income, net | 3,539 | 2,122 |
Total other expense, net | (43,875) | (33,226) |
Loss before income taxes | (9,426) | (9,921) |
Provision for (benefit from) income taxes | 668 | (3,461) |
Net loss | (10,094) | (6,460) |
Less: Net loss attributable to non-controlling interests | 3,151 | 4,742 |
Net loss attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest | (6,943) | (1,718) |
Accretion of redeemable non-controlling interest | 0 | (438) |
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (6,943) | $ (2,156) |
Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s class A common stockholders: | ||
Basic (in dollars per share) | $ (0.05) | $ (0.01) |
Diluted (in dollars per share) | $ (0.05) | $ (0.01) |
Weighted-average common shares outstanding: | ||
Basic (in shares) | 152,109 | 149,892 |
Diluted (in shares) | 152,109 | 149,892 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Other Comprehensive Income [Abstract] | ||
Net loss | $ (10,094) | $ (6,460) |
Less: Net loss attributable to non-controlling interests | 3,151 | 4,742 |
Net loss attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest | (6,943) | (1,718) |
Accretion of redeemable non-controlling interest | 0 | (438) |
Net loss attributable to Amneal Pharmaceuticals, Inc. | (6,943) | (2,156) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustments arising during the period | 1,797 | (4,079) |
Unrealized (loss) gain on cash flow hedge, net of tax | (14,270) | 53,624 |
Less: Other comprehensive loss (income) attributable to non-controlling interests | 6,236 | (24,955) |
Other comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc. | (6,237) | 24,590 |
Comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc. | $ (13,180) | $ 22,434 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 144,674 | $ 25,976 |
Restricted cash | 6,395 | 9,251 |
Trade accounts receivable, net | 545,760 | 741,791 |
Inventories | 529,042 | 530,735 |
Prepaid expenses and other current assets | 81,424 | 103,565 |
Related party receivables | 30 | 500 |
Total current assets | 1,307,325 | 1,411,818 |
Property, plant and equipment, net | 462,606 | 469,815 |
Goodwill | 599,156 | 598,853 |
Intangible assets, net | 1,055,319 | 1,096,093 |
Other assets | 86,428 | 103,217 |
Total assets | 3,626,605 | 3,799,341 |
Current liabilities: | ||
Accounts payable and accrued expenses | 467,421 | 538,199 |
Current portion of liabilities for legal matters | 76,317 | 107,483 |
Revolving credit facility | 100,000 | 60,000 |
Current portion of long-term debt, net | 29,965 | 29,961 |
Related party payables - short term | 14,750 | 2,479 |
Total current liabilities | 703,709 | 752,800 |
Long-term debt, net | 2,561,724 | 2,591,981 |
Note payable - related party | 40,128 | 39,706 |
Related party payables - long term | 11,207 | 9,649 |
Other long-term liabilities | 41,456 | 87,468 |
Total long-term liabilities | 2,760,701 | 2,837,613 |
Commitments and contingencies (Notes 5 and 19) | ||
Redeemable non-controlling interests | 27,527 | 24,949 |
Stockholders' Equity | ||
Preferred stock, $0.01 par value, 2,000 shares authorized, none issued at both March 31, 2023 and December 31, 2022 | 0 | 0 |
Additional paid-in capital | 700,722 | 691,629 |
Stockholders' accumulated deficit | (413,126) | (406,183) |
Accumulated other comprehensive income | 3,764 | 9,939 |
Total Amneal Pharmaceuticals, Inc. stockholders' equity | 294,414 | 298,421 |
Non-controlling interests | (159,746) | (114,442) |
Total stockholders' equity | 134,668 | 183,979 |
Total liabilities and stockholders' equity | 3,626,605 | 3,799,341 |
Class A Common Stock | ||
Stockholders' Equity | ||
Common stock | 1,532 | 1,514 |
Class B Common Stock | ||
Stockholders' Equity | ||
Common stock | 1,522 | 1,522 |
Excluding Related Party | ||
Current assets: | ||
Operating lease right-of-use assets | 36,127 | 38,211 |
Financing lease right-of-use assets | 62,400 | 63,424 |
Current liabilities: | ||
Current portion of operating lease liabilities | 9,017 | 8,321 |
Current portion of financing lease liabilities | 3,309 | 3,488 |
Operating lease liabilities | 30,782 | 32,126 |
Financing lease liabilities | 60,241 | 60,769 |
Related Party | ||
Current assets: | ||
Operating lease right-of-use assets | 17,244 | 17,910 |
Current liabilities: | ||
Current portion of operating lease liabilities - related party | 2,930 | 2,869 |
Operating lease liabilities | $ 15,163 | $ 15,914 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 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) | 153,321,000 | 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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (10,094) | $ (6,460) |
Adjustments to reconcile net loss to net cash provided by operating activities: | ||
Depreciation and amortization | 58,150 | 57,815 |
Unrealized foreign currency (gain) loss | (1,987) | 3,140 |
Amortization of debt issuance costs and discount | 2,058 | 2,195 |
Change in fair value of contingent consideration | 2,457 | 200 |
Stock-based compensation | 7,596 | 8,065 |
Inventory provision | 25,204 | 3,578 |
Other operating charges and credits, net | 2,047 | 1,155 |
Changes in assets and liabilities: | ||
Trade accounts receivable, net | 195,970 | 124,268 |
Inventories | (22,508) | (25,549) |
Prepaid expenses, other current assets and other assets | 29,160 | (4,423) |
Related party receivables | 470 | 4 |
Accounts payable, accrued expenses and other liabilities | (150,483) | (48,777) |
Related party payables | 1,672 | 5,132 |
Net cash provided by operating activities | 139,712 | 120,343 |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (9,688) | (10,793) |
Acquisition of business | 0 | (84,714) |
Acquisition of intangible assets | (338) | 0 |
Deposits for future acquisition of property, plant, and equipment | (1,711) | (1,888) |
Net cash used in investing activities | (11,737) | (97,395) |
Cash flows from financing activities: | ||
Payments of principal on debt, revolving credit facility, financing leases and other | (72,659) | (9,796) |
Borrowings on revolving credit facility | 80,000 | 0 |
Proceeds from exercise of stock options | 0 | 111 |
Employee payroll tax withholding on restricted stock unit vesting | (2,022) | (3,001) |
Payments of deferred consideration for acquisitions - related party | 0 | (43,998) |
Acquisition of redeemable non-controlling interest | 0 | (1,722) |
Tax distributions to non-controlling interests | (18,219) | (3,164) |
Net cash used in financing activities | (12,900) | (61,570) |
Effect of foreign exchange rate on cash | 767 | (1,572) |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 115,842 | (40,194) |
Cash, cash equivalents, and restricted cash - beginning of period | 35,227 | 256,739 |
Cash, cash equivalents, and restricted cash - end of period | 151,069 | 216,545 |
Cash and cash equivalents - end of period | 144,674 | 210,477 |
Restricted cash - end of period | 6,395 | 6,068 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 41,066 | 27,289 |
Cash received (paid), net for income taxes | 3,421 | (4,387) |
Supplemental disclosure of non-cash investing and financing activity: | ||
Tax distributions to non-controlling interests | 11,548 | 3,284 |
Contingent consideration for acquisition | $ 0 | $ 8,796 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Subsequent To Combination | 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 | Non- Controlling Interests Subsequent To Combination |
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 | (8,817) | (1,718) | (7,099) | ||||||
Foreign currency translation adjustments | (4,079) | (2,024) | (2,055) | ||||||
Stock-based compensation | 8,065 | 8,065 | |||||||
Exercise of stock options (in shares) | 7 | ||||||||
Exercise of stock options | 111 | 65 | 46 | ||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 1,355 | ||||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (3,144) | $ 14 | 319 | (112) | (3,365) | ||||
Unrealized (loss) gain on cash flow hedge, net of tax | 53,624 | 26,614 | 27,010 | ||||||
Tax distributions | $ (4,443) | $ (4,443) | |||||||
Reclassification of redeemable non-controlling interest | (883) | (438) | (445) | ||||||
Shares ending balance (in shares) at Mar. 31, 2022 | 150,775 | 152,117 | |||||||
Stockholders' equity ending balance at Mar. 31, 2022 | 407,407 | $ 1,506 | $ 1,522 | 666,799 | (278,353) | (349) | 16,282 | ||
Redeemable Non-Controlling Interests, beginning balance at Dec. 31, 2021 | 16,907 | ||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||
Net (loss) income | 2,357 | ||||||||
Tax distributions | (2,005) | ||||||||
Reclassification of redeemable non-controlling interest | 883 | ||||||||
Acquisition of redeemable non-controlling interest | (1,722) | ||||||||
Redeemable Non-Controlling Interests, ending balance at Mar. 31, 2022 | 16,420 | ||||||||
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 | (15,631) | (6,943) | (8,688) | ||||||
Foreign currency translation adjustments | 1,797 | 898 | 899 | ||||||
Stock-based compensation | 7,596 | 7,596 | |||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes (in shares) | 1,831 | ||||||||
Restricted stock unit vesting, net of shares withheld to cover payroll taxes | (1,995) | $ 18 | 1,497 | 62 | (3,572) | ||||
Unrealized (loss) gain on cash flow hedge, net of tax | (14,270) | (7,135) | (7,135) | ||||||
Tax distributions | $ (26,808) | $ (26,808) | |||||||
Shares ending balance (in shares) at Mar. 31, 2023 | 153,321 | 152,117 | |||||||
Stockholders' equity ending balance at Mar. 31, 2023 | 134,668 | $ 1,532 | $ 1,522 | $ 700,722 | $ (413,126) | $ 3,764 | $ (159,746) | ||
Redeemable Non-Controlling Interests, beginning balance at Dec. 31, 2022 | 24,949 | ||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||
Net (loss) income | 5,537 | ||||||||
Tax distributions | (2,959) | ||||||||
Redeemable Non-Controlling Interests, ending balance at Mar. 31, 2023 | $ 27,527 |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 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. The Company is a holding company, whose principal assets are common units (“Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”). The Company held 50.2% 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 49.8% as of March 31, 2023. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 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 March 31, 2023, cash flows for the three months ended March 31, 2023 and 2022 and the results of its operations, its comprehensive (loss) income and its changes in stockholders’ equity for the three months ended March 31, 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 since the Company did not acquire a business during the three months ended March 31, 2023. Recently Issued Accounting Pronouncements 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 is currently evaluating the impact this guidance will have on its consolidated financial statements. |
Acquisitions
Acquisitions | 3 Months Ended |
Mar. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisitions | Acquisitions 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. Cash paid at closing included $1.1 million for inventory acquired in excess of the normalized level, as defined in the asset purchase agreement (working capital adjustment). For the three months ended March 31, 2022, the Company incurred $0.1 million in transaction costs associated with the Saol Acquisition, which was recorded in acquisition, transaction-related and integration expenses. The Saol Acquisition was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer. The purchase price was calculated as follows (in thousands): Cash $ 84,714 Contingent consideration (royalties) (1) 8,796 Fair value of consideration transferred $ 93,510 (1) The estimated fair value of contingent consideration on the acquisition date was $8.8 million and was based on significant Level 3 inputs that were not observable in the market. Key assumptions included the discount rate, projected year of payments and expected net product sales. Refer to Note 17. Fair Value Measurements , for additional information on the methodology and determination of this liability. The following is a summary of the purchase price allocation for the Saol Acquisition (in thousands): Final F air Values as of February 9, 2022 Inventory $ 2,162 Prepaid expenses and other current assets 98 Goodwill 7,553 Intangible assets 83,815 Total assets acquired 93,628 Accounts payable and accrued expenses 118 Fair value of consideration transferred $ 93,510 The Company acquired $83.8 million of marketed product rights intangible assets with a weighted average useful life of 11.5 years in the Saol Acquisition. The acquired intangible assets are being amortized over their estimated useful lives. The estimated fair value of the identifiable intangible assets was determined using the “income approach,” which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. The assumptions, including the expected projected cash flows, utilized in the purchase price allocation and in determining the purchase price were based on management's best estimates as of the closing date of the Saol Acquisition on February 9, 2022. Some of the more significant assumptions inherent in the development of those asset valuations included the estimated net cash flows for each year for each asset (including net revenues, cost of sales, selling and marketing costs and working capital / contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream, as well as other factors. The underlying assumptions used to prepare the discounted cash flow analysis may change; accordingly, for these and other reasons, actual results may vary significantly from estimated results. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized. Of the total goodwill acquired in connection with the Saol Acquisition, $5.2 million was allocated to the Company’s Generics segment and $2.4 million was allocated to the Company’s Specialty segment, of which $4.9 million was deductible for tax purposes. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers . 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 March 31, 2023 2022 Customer A 22 % 19 % Customer B 14 % 18 % Customer C 20 % 23 % Customer D 9 % 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 months ended March 31, 2023 and 2022, are set forth below (in thousands): Three Months Ended 2023 2022 Generics Anti-Infective $ 5,174 $ 6,245 Hormonal / Allergy 104,851 96,368 Antiviral 25,474 10,571 Central Nervous System 84,582 81,125 Cardiovascular System 32,503 23,453 Gastroenterology 14,364 16,620 Oncology 10,578 17,208 Metabolic Disease/Endocrine 9,265 11,233 Respiratory 12,815 5,665 Dermatology 18,004 13,477 Other therapeutic classes 25,895 35,360 International and other 301 422 Total Generics net revenue 343,806 317,747 Specialty Hormonal / Allergy 24,763 19,419 Central Nervous System 60,139 58,168 Other therapeutic classes 6,776 7,499 Total Specialty net revenue 91,678 85,086 AvKARE Distribution 83,230 60,263 Government Label 24,516 24,459 Institutional 8,862 6,315 Other 5,448 3,763 Total AvKARE net revenue 122,056 94,800 Total net revenue $ 557,540 $ 497,633 A rollforward of the major categories of sales-related deductions for the three months ended March 31, 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 760,744 25,462 15,920 49,573 Credits/payments issued during the period (908,454) (28,995) (20,996) (64,149) Balance at March 31, 2023 $ 425,882 $ 23,921 $ 139,984 $ 71,454 |
Alliance and Collaboration
Alliance and Collaboration | 3 Months Ended |
Mar. 31, 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 $49.0 million, based on the exchange rate as of March 31, 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 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 months ended March 31, 2023, the Company recognized $0.6 million as a reduction to R&D expense related to services performed under the Orion Agreement. As of March 31, 2023, deferred income of $6.1 million and $6.7 million, respectively, was recorded in accounts payable and accrued expenses and other long-term liabilities. As of March 31, 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, refer to Note 21. Related Party Transactions in this Form 10-Q and Note 24. Related Party Transactions |
Government Grants
Government Grants | 3 Months Ended |
Mar. 31, 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 $121.7 million (based on the exchange rate as of March 31, 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 three months ended March 31, 2023, the Company recognized approximately $1.2 million of other operating income (none during the three months ended March 31, 2022) from the PLI Scheme. As of March 31, 2023 and December 31, 2022, the Company recorded a corresponding receivable from the government of India of $5.2 million and $4.0 million, respectively, within prepaid and other current assets. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the three months ended March 31, 2023, the Company’s provision for (benefit from) income taxes and effective tax rates were $0.7 million and (7.1)%, respectively, compared to $(3.5) million and 34.9%, respectively, for the three months ended March 31, 2022. The period-over-period change in the provision for income taxes was primarily related to a change in the jurisdictional mix of income and a discrete benefit as a result of the completion of an Internal Revenue Service examination and Joint Committee review of the 2012-2018 federal income tax returns, which enabled the Company to recognize previously unrecognized tax benefits during the three months ended March 31, 2022. 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 March 31, 2023. As a result of the losses through March 31, 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 March 31, 2023 and December 31, 2022, this valuation allowance was $435.4 million and $434.9 million, respectively, and it reduced the carrying value of these gross DTAs to zero. The Company entered into a tax receivable agreement (“TRA”) for which it is generally required to pay the holders of Amneal Common Units 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 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 March 31, 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 March 31, 2023 and December 31, 2022, the contingent liability associated with the TRA was approximately $202.7 million, out of which approximately $1.5 million was recorded. The timing and amount of any payments under the TRA may vary depending upon a number of factors, including the timing and number of Amneal Common Units sold or exchanged for the Company’s class A common stock, the price of the Company’s class A common stock on the date of sale or exchange, the timing and amount 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). Further sales or exchanges occurring subsequent to March 31, 2023 could result in future Amneal tax deductions and obligations to pay 85% of such benefits to the holders of Amneal Common Units. These obligations could be incremental to and substantially larger than the approximate $202.7 million contingent liability as of March 31, 2023 described above. 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 $1.5 million accrued as of March 31, 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. |
Loss per Share
Loss per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share Basic loss per share of the Company’s class A common stock is computed by dividing net loss attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of class A common stock outstanding during the period. Diluted loss per share of class A common stock is computed by dividing net 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 loss per share of class A common stock (in thousands, except per share amounts): Three Months Ended 2023 2022 Numerator: Net loss attributable to Amneal Pharmaceuticals, Inc. $ (6,943) $ (2,156) Denominator: Weighted-average shares outstanding - basic and diluted 152,109 149,892 Net loss per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: Basic and diluted $ (0.05) $ (0.01) 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 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 loss per share of class A common stock (in thousands): Three Months Ended 2023 2022 Stock options 2,632 (1) 3,035 (1) Restricted stock units 11,576 (1) 11,430 (1) Performance stock units 7,018 (1) 7,947 (1) Shares of class B common stock 152,117 (2) 152,117 (2) (1) 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. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net | 3 Months Ended |
Mar. 31, 2023 | |
Receivables [Abstract] | |
Trade Accounts Receivable, Net | Trade Accounts Receivable, Net Trade accounts receivable, net was comprised of the following (in thousands): March 31, December 31, Gross accounts receivable $ 998,134 $ 1,344,959 Allowance for credit losses (2,571) (2,122) Contract charge-backs and sales volume allowances (425,882) (573,592) Cash discount allowances (23,921) (27,454) Subtotal (452,374) (603,168) Trade accounts receivable, net $ 545,760 $ 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: March 31, December 31, Customer A 36 % 41 % Customer B 17 % 25 % Customer C 28 % 21 % |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories were comprised of the following (in thousands): March 31, December 31, Raw materials $ 218,065 $ 224,607 Work in process 54,169 58,522 Finished goods 256,808 247,606 Total inventories $ 529,042 $ 530,735 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 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): March 31, December 31, Deposits and advances $ 3,306 $ 1,821 Prepaid insurance 4,514 8,090 Prepaid regulatory fees 3,540 5,298 Income and other tax receivables 12,943 12,881 Prepaid taxes 13,634 16,593 Other current receivables (1) 14,016 33,133 Chargebacks receivable (2) 10,964 8,605 Other prepaid assets 18,507 17,144 Total prepaid expenses and other current assets $ 81,424 $ 103,565 (1) Other current receivables as of December 31, 2022 include 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, 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 | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets The changes in goodwill for the three months ended March 31, 2023 and for the year ended December 31, 2022 were as follows (in thousands): March 31, December 31, Balance, beginning of period $ 598,853 $ 593,017 Goodwill acquired during the period — 7,553 Adjustment during the period for Puniska Acquisition — 3,075 Currency translation 303 (4,792) Balance, end of period $ 599,156 $ 598,853 As of March 31, 2023, $366.3 million, $163.4 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. Acquisitions for additional information. Intangible assets at March 31, 2023 and December 31, 2022 were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Weighted-Average Cost Accumulated Net Cost Accumulated Net Amortizing intangible assets: Product rights 7.4 $ 1,222,612 $ (609,267) $ 613,345 $ 1,222,762 $ (573,281) $ 649,481 Other intangible assets 3.9 133,800 (82,181) 51,619 133,800 (77,943) 55,857 Subtotal $ 1,356,412 $ (691,448) $ 664,964 $ 1,356,562 $ (651,224) $ 705,338 In-process research and development 390,355 — 390,355 390,755 — 390,755 Total intangible assets $ 1,746,767 $ (691,448) $ 1,055,319 $ 1,747,317 $ (651,224) $ 1,096,093 Amortization expense related to intangible assets was $41.1 million and $40.9 million for the three months ended March 31, 2023 and 2022, respectively. The following table presents future amortization expense for the next five years and thereafter, excluding $390.4 million of IPR&D intangible assets (in thousands): Future Remainder of 2023 $ 121,942 2024 162,793 2025 124,439 2026 73,893 2027 52,448 2028 30,753 Thereafter 98,696 Total $ 664,964 |
Other Assets
Other Assets | 3 Months Ended |
Mar. 31, 2023 | |
Other Assets [Abstract] | |
Other Assets | Other Assets Other assets were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Interest rate swap (1) $ 71,316 $ 85,586 Security deposits 3,566 3,523 Long-term prepaid expenses 4,119 3,711 Deferred revolving credit facility costs 2,068 2,206 Other long term assets 5,359 8,191 Total $ 86,428 $ 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 | 3 Months Ended |
Mar. 31, 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): March 31, 2023 December 31, 2022 Accounts payable $ 136,922 $ 165,980 Accrued returns allowance (1) 139,984 145,060 Accrued compensation 32,115 54,038 Accrued Medicaid and commercial rebates (1) 71,454 86,030 Accrued royalties 17,370 19,309 Commercial chargebacks and rebates 10,226 10,226 Accrued professional fees 13,826 11,386 Taxes payable 1,069 359 Accrued other 44,455 45,811 Total accounts payable and accrued expenses $ 467,421 $ 538,199 (1) Refer to Note 4. Revenue Recognition for a rollforward of the balance from December 31, 2022 to March 31, 2023. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following is a summary of the Company’s total indebtedness (in thousands): March 31, 2023 December 31, 2022 Term Loan due May 2025 $ 2,557,126 $ 2,563,876 Rondo Term Loan due January 2025 47,000 72,000 Total debt 2,604,126 2,635,876 Less: debt issuance costs (12,437) (13,934) Total debt, net of debt issuance costs 2,591,689 2,621,942 Less: current portion of long-term debt (29,965) (29,961) Total long-term debt, net $ 2,561,724 $ 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 ). In March 2023, the Company repaid $40.0 million of its borrowings on the New Revolving Credit Facility from cash on hand. As of March 31, 2023, the Company had $100.0 million in borrowings and $245.9 million of available capacity under the New Revolving Credit Facility. During the three months ended March 31, 2023, the Company repaid $25.0 million of principal outstanding on the Rondo Term Loan , of which $22.8 million was prepaid. |
Other Long-Term Liabilities
Other Long-Term Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Long-Term Liabilities | Other Long-Term Liabilities Other long-term liabilities were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Uncertain tax positions $ 572 $ 563 Long-term portion of liabilities for legal matters (1) — 49,442 Long-term compensation 18,207 16,737 Contingent consideration (2) 13,384 11,997 Other long-term liabilities 9,293 8,729 Total other long-term liabilities $ 41,456 $ 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 | 3 Months Ended |
Mar. 31, 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 March 31, 2023 and December 31, 2022 (in thousands): Fair Value Measurement Based on March 31, 2023 Total Quoted Significant Significant Assets Interest rate swap (1) $ 71,316 $ — $ 71,316 $ — Liabilities Deferred compensation plan liabilities (2) $ 9,832 $ — $ 9,832 $ — Contingent consideration liabilities (3) $ 17,884 $ — $ — $ 17,884 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 March 31, 2023 and December 31, 2022 , the contingent consideration liability associated with the Saol Acquisition included $0.6 million and $0.1 million, respectively, recorded in accounts payable and accrued expenses and $13.4 million and $12.0 million, respectively, recorded in other-longer term liabilities. As of March 31, 2023 and December 31, 2022 , the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC (“KSP”) was valued at approximately $3.9 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 three months ended March 31, 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 three months ended March 31, 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): Three Months Ended Balance, beginning of period $ 15,427 Change in fair value during the period 2,457 Balance, end of period $ 17,884 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 contingent consideration liabilities as of March 31, 2023: Contingent Consideration Liability Fair Value as of March 31, 2023 (in thousands) Unobservable input Range Weighted Average (1) Regulatory Milestones (KSP acquisition) $400 Discount rate 6.5% - 7.4% 6.6% Probability of payment 1.8% - 20.0% 18.6% Projected year of payment 2024 - 2026 2024 Royalties (KSP acquisition) $3,500 Discount rate 12.5% - 12.5% 12.5% Probability of payment 1.8% - 20.0% 18.6% Projected year of payment 2024 - 2033 2028 Royalties (Saol Acquisition) $13,984 Discount rate 17.5% - 17.5% 17.5% 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 March 31, 2023 was approximately $2.4 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 March 31, 2023 and December 31, 2022 was $46.5 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 March 31, 2023 and December 31, 2022 was $39.7 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 three months ended March 31, 2023 and 2022. |
Financial Instruments
Financial Instruments | 3 Months Ended |
Mar. 31, 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. As of March 31, 2023, the total gain, net of income taxes, related to the Company’s cash flow hedge was $71.3 million, of which $35.4 million was recognized in accumulated other comprehensive income and $35.9 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): March 31, 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 $ 71,316 Other assets $ 85,586 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 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 into 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 the 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 March 31, 2023 and 2022, credit related to legal matters, net was $0.4 million and $2.3 million, respectively. Liabilities for legal matters were comprised of the following (in thousands): Matter March 31, 2023 December 31, 2022 Opana ER® antitrust litigation $ 50,000 $ 83,944 Opana ER® antitrust litigation-accrued interest 1,216 1,423 Opana ER® antitrust litigation-imputed interest (1,070) — Civil prescription opioid litigation 20,048 17,993 Galeas v. Amneal 1,200 1,200 Other 4,923 2,923 Current portion of liabilities for legal matters $ 76,317 $ 107,483 Opana ER® antitrust litigation $ — $ 50,000 Opana ER ® antitrust litigation-accrued interest — 847 Opana ER ® antitrust litigation-imputed interest — (1,405) Long-term portion of liabilities for legal matters (included in other long-term liabilities) $ — $ 49,442 Refer to the respective discussions below for additional information on the significant matters in the tables above. Medicaid Reimbursement and Price Reporting Matters The Company is required to provide pricing information to state agencies, including agencies that administer federal Medicaid programs. Certain state agencies have alleged that manufacturers have reported improper pricing information, which allegedly caused them to overpay reimbursement costs. Other agencies have alleged that manufacturers have failed to timely file required reports concerning pricing information. Liabilities are periodically established by the Company for any potential claims or settlements of overpayment. The Company intends to vigorously defend against any such claims. The ultimate settlement of any potential liability for such claims may be higher or lower than estimated. Federal and State Healthcare Programs In the United Sta tes, many of our products are eligible for reimbursement under federal and state health care programs such as Medicaid, Medicare, TRICARE, and/or state pharmaceutical assistance programs, and as a result, certain federal and state healthcare laws and regulations pertaining to reimbursement are applicable to our business. We could be subject to claims from federal and state healthcare programs for non-compliance with these laws and regulations. Patent Litigation There is substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new products which are the subject of conflicting patent and intellectual property claims. One or more patents often cover the brand name products for which the Company is developing generic versions and the Company typically has patent rights covering the Company’s branded products. Under federal law, when a drug developer files an Abbreviated New Drug Application (“ANDA”) for a generic drug seeking approval before expiration of a patent which has been listed with the FDA as covering the brand name product, the developer must certify its product will not infringe the listed patent(s) and/or the listed patent is invalid or unenforceable (commonly referred to as a “Paragraph IV” certification). Notices of such certification must be provided to the patent holder, who may file a suit for patent infringement within 45 days of the patent holder’s receipt of such notice. If the patent holder files suit within the 45-day period, the FDA can review and tentatively approve the ANDA, but generally is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered in favor of the generic drug developer, or 30 months from the date the notice was received, whichever is sooner. The Company’s Generics segment is typically subject to patent infringement litigation brought by branded pharmaceutical manufacturers in connection with the Company’s Paragraph IV certifications seeking an order delaying the approval of the Company’s ANDA until expiration of the patent(s) at issue in the litigation. The uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. For the Company’s Generics segment, the potential consequences in the event of an unfavorable outcome in such litigation include delaying the launch of its generic products until patent expiration. If the Company were to launch its generic product prior to successful resolution of a patent litigation, the Company could be liable for potential damages measured by the profits lost by the branded product manufacturer rather than the profits earned by the Company if it is found to infringe a valid, enforceable patent, or enhanced treble damages in cases of willful infringement. For the Company’s Specialty segment, an unfavorable outcome may significantly accelerate generic competition ahead of expiration of the patents covering the Company’s branded products. All such litigation typically involves significant expense. The Company is generally responsible for all of the patent litigation fees and costs associated with current and future products not covered by its alliance and collaboration agreements. The Company has agreed to share legal expenses with respect to third-party and Company products under the terms of certain of the alliance and collaboration agreements. The Company records the costs of patent litigation as expense in the period when incurred for products it has developed, as well as for products which are the subject of an alliance or collaboration agreement with a third-party. Other Litigation Related to the Company’s Business Opana ER® FTC Matters On February 25, 2014, Impax Laboratories, Inc. (“Impax”) received a Civil Investigative Demands (“CID”) from the Federal Trade Commission (“FTC”) concerning its investigation into the drug Opana® ER and its generic equivalents. On March 30, 2016, the FTC filed a complaint against Impax, Endo Pharmaceuticals Inc. (“Endo”), and others in the United States District Court for the Eastern District of Pennsylvania, alleging that Impax and Endo violated antitrust laws when they entered into a June 2010 settlement agreement that resolved patent litigation in connection with the submission of Impax’s ANDA for generic original Opana® ER. In October 2016, the Court granted Impax’s motion to sever, formally terminating the suit against Impax. In January 2017, the FTC filed a Part 3 Administrative Complaint against Impax with similar allegations regarding the 2010 settlement. Following trial, in May 2018, the Administrative Law Judge ruled in favor of Impax and dismissed the Complaint in its entirety. FTC Complaint Counsel appealed the decision to the full Commission, and in March 2019, the FTC issued an Opinion & Order reversing the Administrative Law Judge’s decision. The Opinion & Order did not provide for any monetary damages but enjoined Impax from entering into future agreements containing certain terms. Impax filed a Petition for Review of the FTC’s Opinion & Order with the United States Court of Appeals for the Fifth Circuit, and on April 13, 2021, the Fifth Circuit issued a decision denying Impax’s Petition for Review, effectively affirming the FTC’s Opinion & Order. On September 10, 2021, Impax filed a petition for writ of certiorari in the Supreme Court, which was denied in December 2021. On July 12, 2019, the Company received a CID from the FTC concerning an August 2017 settlement agreement between Impax and Endo, which resolved a subsequent patent infringement and breach of contract dispute between the parties regarding the above-referenced 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 United States 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, which appeal remains pending. The Company believes it has strong defenses to the FTC’s allegations and intends 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. In June 2022, Impax entered into a preliminary settlement agreement with the class of direct purchasers that, if all conditions are satisfied, would result in the resolution of substantially all the direct purchasers’ and individual complainants’ underlying claims and lawsuits in the MDL. At the same time, Impax entered into a settlement agreement with individual complainants that resolved all of their claims and lawsuits in the MDL. Subsequently, Impax entered into a separate preliminary settlement agreement with the class of indirect purchasers that, if all conditions are satisfied, would result in the resolution of substantially all the indirect purchasers’ underlying claims and lawsuits in the MDL. The direct purchaser plaintiffs, indirect purchaser plaintiffs, and individual complainants are referred to herein collectively as “the Plaintiffs.” On November 3, 2022, the N.D. Ill. approved the direct purchasers’ settlement. On December 15, 2022, the N.D. Ill. approved the indirect purchasers’ settlement. 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 the Plaintiffs’ claims. The cumulative amount of payments made by the Company pursuant to the settlement agreements was $215.0 million as of March 31, 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 March 31, 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 $1.1 million as of March 31, 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. Sergeants Benevolent Association Health & Welfare Fund v. Actavis, PLC, et. al. In August 2015, a complaint styled as a class action was filed against Forest Laboratories (a subsidiary of Actavis plc) and numerous generic drug manufacturers, including Amneal, in the United States District Court for the Southern District of New York involving patent litigation settlement agreements between Forest Laboratories and the generic drug manufacturers concerning generic versions of Forest’s Namenda ® IR product. The complaint (as amended on February 12, 2016) asserts federal and state antitrust claims on behalf of indirect purchasers, who allege in relevant part that during the class period they indirectly purchased Namenda® IR or its generic equivalents in various states at higher prices than they would have absent the defendants’ allegedly unlawful anticompetitive conduct. Plaintiff sought, among other things, unspecified monetary damages, and equitable relief, including disgorgement and restitution. In June 2019, the Company reached a settlement with the plaintiff, subject to Court approval. On September 10, 2019, the Court entered an order preliminarily approving the settlement and indefinitely staying the case as to the settling defendants (including the Company), until the disposition of the claims against the non-settling defendants. The remaining defendants subsequently also settled with the plaintiff. The plaintiff filed proposed materials seeking final approval of all settlements, including with the Company, and to finally resolve the case. The Court held a fairness hearing on the proposed settlements on March 23, 2023. All settlements were approved, including as to the Company, and no further action is required. The amount of the settlement was not material to the Company’s consolidated financial statements. 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 has 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. 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. On March 30, 2022, the State of Alabama voluntarily dismissed all its claims in the two actions against all defendants, including the Company, without prejudice. On February 21, 2023, the Territory of Guam voluntarily dismissed all its claims in the two actions against all defendants, including the Company, with prejudice. On February 27, 2023, the Court addressed defendants’ motions to dismiss the June 10, 2020 bellwether action, holding that the states may not pursue certain federal remedies, and otherwise denying Amneal’s joint and individual motion to dismiss. The court did not analyze the substance of the states’ state law claims, reserving those issues for a separate ruling. On March 24, 2023, certain Defendants including the Company filed a motion requesting that the Court certify for appeal its February 27, 2023 order denying Defendants’ motion to dismiss, arguing that the Order involved two controlling questions of law as to which immediate appellate review is warranted (1) whether the complaint adequately alleges an “overarching conspiracy,” and (2) whether the Court properly deferred adjudication of Defendants’ claim-splitting defense. Fact and document discovery in MDL No. 2724 are proceeding. The court has entered a Pretrial Order setting a schedule for the bellwether cases, which includes a June 1, 2023 deadline for bellwether fact discovery and a March 13, 2024 deadline for the filing of summary judgment motions. No trial date has been set. 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, plaintiff filed a second amended complaint. The case has otherwise not progressed to date. Civil Prescription Opioid Litigation The Company and certain of its affiliates have been named as defendants in various matters filed in state and federal courts relating to the sale of prescription opioid pain relievers. Plaintiffs in these actions include state Attorneys General, 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 are 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). There are approximately 922 cases in the MDL in which the Company or its affiliates have been named as defendants. Three third-party payor cases were dismissed from the MDL on April 18, 2023. Since December 31, 2022, three additional opioid cases have been filed against the Company or come to the Company’s attention as result of service of a complaint upon the Company. The three cases are: (1) Cuyahoga County, OH et al. v. Mylan Pharmaceuticals, Inc. et al., Civil Action No. 1:23-op-45003-DAP, which was directly filed in the MDL pending in the United States District Court for the Northern District of Ohio; (2) The City of Atlanta, GA et al. v. Mylan Pharmaceuticals, Inc. et al., Case 1:23-cv-01193-TWT (N.D. Ga.), which is a federal case that will not be consolidated into the MDL; and (3) Palm Beach County, FL et al. v. Mylan Pharmaceuticals, Inc. et al., Case 9:23-cv-80431-RLR (S.D. Fla.), another federal case that will not be consolidated into the MDL. The Company is also named in approximately 77 state court cases pending in ten states. The Company has filed motions to dismiss in many of these cases. No firm trial dates have been set except in Alabama (July 24, 2023) and Texas (May 20, 2024 (Dallas County) and September 30, 2024 (Bexar County)). The Company was not involved in the September 2022 trial in New Mexico previously reported because of the settlement the Company reached with the New Mexico Attorney General to resolve the New Mexico Attorney General’s claims against the Company, which was finalized on April 24, 2023. The Company anticipates entry of a Consent Judgment dismissing the New Mexico Attorney General’s lawsuit in May 2023. On August 3, 2022, the Company and certain of its affiliates were named as defendants in a Complaint filed in Tennessee state court, along with numerous other manufacturers, distributors, retailers, and healthcare providers, in which it is alleged the defendants are liable in civil damages to six minors who allegedly were born with neonatal abstinence syndrome (“NAS”) allegedly as a result of their biological mothers’ alleged use of diverted prescription opioid medications. The plaintiffs’ claim against each defendant in that case requires plaintiffs to prove by clear and convincing evidence that the defendant intentionally participated in Tennessee in that state’s illegal drug market as defined in the Tennessee Drug Dealer Liability Act. The case is currently stayed, but the Company intends to file a motion to dismiss the complaint when the case resumes. On November 1, 2022, the Company entered into a preliminary settlement agreement to resolve all pending litigation brought by West Virginia political subdivisions. The Company also was named in two NAS cases in West Virginia state court which have been consolidated with other West Virginia state court NAS cases before the West Virginia Mass Litigation Panel. The Company filed a motion to dismiss the complaints on February 3, 2023, which the court granted on April 17, 2023. The Company anticipates entry of an order dismissing the NAS cases in May 2023. Based on the preliminary settlement agreement and preliminary settlement agreement with the states of New Mexico and West Virginia, respectively, 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, the Company recorded a $2.1 million charge for the three months ended March 31, 2023. For the remaining cases, primarily brought by hospitals, pension funds, third-party payors and individuals, the Company has not recorded a liability as of March 31, 2023 and December 31, 2022, because it concluded that a loss was not probable and estimable. Securities Class Action On December 18, 2019, Cambridge Retirement System filed a putative class action complaint in the Superior Court of New Jersey, Somerset County against the Company and certain current or former officers alleging violations of Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 (Cambridge Retirement System v. Amneal Pharmaceuticals, Inc., et al., No. SOM-L-1701-19). Plaintiffs alleged that the May 7, 2018, amended registration statement and prospectus issued in connection with the Amneal/Impax business combination was materially false and/or misleading because it failed to disclose that Amneal allegedly engaged in anticompetitive conduct to fix generic drug prices. On March 28, 2022, the parties executed a settlement agreement for $25.0 million. On April 29, 2022, the court preliminarily approved the settlement. On August 16, 2022, the court gave final approval to the settlement. For the year ended December 31, 2021, the Company recorded a $25.0 million charge associated with this case. For the three months ended March 31, 2022, the Company recorded an insurance recovery of $4.0 million. United States Department of Justice / Drug Enforcement Administration Subpoenas / New York Subpoenas On July 7, 2017, Amneal Pharmaceuticals of New York, LLC 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 approximately November 15, 2023. 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 (“AUSA”) for the Southern District of Florida. 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. On January 13, 2023, Amneal Pharmaceuticals, Inc., Amneal, and Amneal Pharmaceuticals of New York, LLC, 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. It is not possible to determine the exact timing or outcome of the investigation. Ranitidine Litigation The Company and its affiliates have been 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), pending 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. Consolidated groups of (a) personal injury plaintiffs, (b) economic loss/medical monitoring class action plaintiffs, and (c) third-party payor plaintiffs have each filed master complaints. The Company or its affiliates have been named in these three master complaints and approximately 313 personal injury short form complaints. On July 8, 2021, the MDL dismissed all claims against the generic drug manufacturers, including the Company and its affiliates, without leave to file further amended complaints. Plaintiffs have appealed the MDL court’s dismissal to the 11th Circuit Court of Appeals, which has consolidated the appeals of the personal injury cases. The 11th Circuit Court of Appeals has not established a briefing schedule yet in the appeals. On June 18, 2020, Amneal was named in a lawsuit filed in New Mexico brought by the New Mexico Attorney General alleging claims of public nuisance, negligence, and violations of consumer protection laws against various brand and generic manufacturers and store-brand distributors of Zantac®/Ranitidine. Plaintiff seeks unspecified compensatory and punitive damages, as well as abatement, medical monitoring, restitution, and injunctive relief. The Company filed a motion to dismiss based on lack of personal jurisdiction on January 26, 2022, that remains pending. On October 1, 2021, Amneal and Amneal Pha |
Stockholders_ Equity and Redeem
Stockholders’ Equity and Redeemable Non-Controlling Interests | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity and Redeemable Non-Controlling Interests | Stockholders’ Equity and Redeemable Non-Controlling Interests 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 limited liability company agreement, as amended, Amneal is obligated to make tax distributions to its members. During the three months ended March 31, 2023 and 2022, the Company recorded net tax distributions of $26.81 million and $4.44 million as a reduction of non-controlling interests, respectively. 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. Since 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 months ended March 31, 2023 and 2022 , the Company recorded tax distributions of $2.96 million and $2.01 million as a reduction of redeemable non-controlling interests, respectively. Redeemable Non-Controlling Interests - Puniska Healthcare Pvt. Ltd. The Company acquired 74% of the equity interests in Puniska Healthcare Pvt. Ltd. (“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. Since 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 three months ended March 31, 2022, t he 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 898 (7,135) (6,237) Reallocation of ownership interests (195) 257 62 Balance March 31, 2023 $ (31,679) $ 35,443 $ 3,764 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 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 months ended March 31, 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 March 31, Related Party and Nature of Transaction Caption in Balance Sheet and Statement of Operations 2023 2022 Kashiv Biosciences LLC Parking space lease Research and development $ 17 $ 25 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 50 17 Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko) Cost of goods sold 144 — Storage agreement Research and development (48) — Total $ 163 $ 5,042 Other Related Parties Kanan, LLC - operating lease Inventory and cost of goods sold $ 566 $ 526 Sutaria Family Realty, LLC - operating lease Inventory and cost of goods sold $ 305 $ 296 PharmaSophia, LLC - research and development services income Research and development $ — $ (15) Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement Inventory and cost of goods sold $ 1,836 $ 458 Tracy Properties LLC - operating lease Selling, general and administrative $ 169 $ 135 AzaTech Pharma LLC - supply agreement Inventory and cost of goods sold $ 575 $ 1,221 AvPROP, LLC - operating lease Selling, general and administrative $ 47 $ 40 Avtar Investments, LLC - consulting services Research and development $ 188 $ 84 TPG Operations, LLC - consulting services Selling, general and administrative $ — $ 19 Alkermes Inventory and cost of goods sold $ 2 $ — R&S Solutions - logistics services Selling, general and administrative $ 20 $ — Members - tax receivable agreement (TRA liability) Other expense $ 826 $ — The following table summarizes the amounts due to or from the Company for related party transactions (in thousands): March 31, 2023 December 31, 2022 Sellers of AvKARE LLC and R&S - state tax indemnification $ — $ 486 Kashiv - various agreements 28 12 Asana BioSciences, LLC 2 2 Related party receivables - short term $ 30 $ 500 Kashiv - various agreements $ 75 $ 110 Apace Packaging, LLC - packaging agreement 1,061 756 AzaTech Pharma LLC - supply agreement 855 863 Avtar Investments LLC - consulting services 85 72 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 442 442 Members - tax receivable agreement 631 201 R&S Solutions LLC - logistics services 13 7 Alkermes Plc — 28 Kanan LLC - operating lease 41 — Members - tax distributions 8,767 — Rondo Class B unit holders - tax distributions 2,780 — Related party payables - short term $ 14,750 $ 2,479 Kashiv - contingent consideration (1) $ 3,900 $ 3,290 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 6,481 5,929 Members - tax receivable agreement 826 430 Related party payables - long term $ 11,207 $ 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 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, contingent on the closing of a transaction. For the three months ended March 31, 2023, the Company did not incur any costs related to services provided by TPG Capital. |
Segment Information
Segment Information | 3 Months Ended |
Mar. 31, 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, since 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 since 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, R&D expenses, and other operating expenses to the extent specifically identified by segment (in thousands): Three Months Ended March 31, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 343,806 $ 91,678 $ 122,056 $ — $ 557,540 Cost of goods sold 230,551 43,191 105,612 — 379,354 Gross profit 113,255 48,487 16,444 — 178,186 Selling, general and administrative 27,600 22,379 12,940 39,177 102,096 Research and development 32,359 6,331 — — 38,690 Intellectual property legal development expenses 1,624 20 — — 1,644 Restructuring and other charges 99 — — 411 510 Change in fair value of contingent consideration — 2,457 — — 2,457 (Credit) charges related to legal matters, net (2,444) — — 2,008 (436) Other operating income (1,224) — — — (1,224) Operating income (loss) $ 55,241 $ 17,300 $ 3,504 $ (41,596) $ 34,449 Three Months Ended March 31, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 317,747 $ 85,086 $ 94,800 $ — $ 497,633 Cost of goods sold 199,030 43,853 80,179 — 323,062 Gross profit 118,717 41,233 14,621 — 174,571 Selling, general and administrative 27,593 24,400 13,410 33,262 98,665 Research and development 43,221 9,577 — — 52,798 Intellectual property legal development expenses (credit) 772 (8) — — 764 Acquisition, transaction-related and integration expenses — — — 434 434 Restructuring and other charges 206 — — 525 731 Change in fair value of contingent consideration — 200 — — 200 Charges (credit) related to legal matters, net 1,674 — — (4,000) (2,326) Operating income (loss) $ 45,251 $ 7,064 $ 1,211 $ (30,221) $ 23,305 (1) Operating results for the sale of Amneal products by AvKARE are included in Generics. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying 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 March 31, 2023, cash flows for the three months ended March 31, 2023 and 2022 and the results of its operations, its comprehensive (loss) income and its changes in stockholders’ equity for the three months ended March 31, 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 and Recently Issued 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 since the Company did not acquire a business during the three months ended March 31, 2023. Recently Issued Accounting Pronouncements 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 is currently evaluating the impact this guidance will have on its consolidated financial statements. |
Performance Obligations | The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers . 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. |
Acquisitions (Tables)
Acquisitions (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Business Acquisition [Line Items] | |
Schedule of Asset Acquisition | The Saol Acquisition was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer. The purchase price was calculated as follows (in thousands): Cash $ 84,714 Contingent consideration (royalties) (1) 8,796 Fair value of consideration transferred $ 93,510 (1) The estimated fair value of contingent consideration on the acquisition date was $8.8 million and was based on significant Level 3 inputs that were not observable in the market. Key assumptions included the discount rate, projected year of payments and expected net product sales. Refer to Note 17. Fair Value Measurements , for additional information on the methodology and determination of this liability. The following is a summary of the purchase price allocation for the Saol Acquisition (in thousands): Final F air Values as of February 9, 2022 Inventory $ 2,162 Prepaid expenses and other current assets 98 Goodwill 7,553 Intangible assets 83,815 Total assets acquired 93,628 Accounts payable and accrued expenses 118 Fair value of consideration transferred $ 93,510 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 2022 Customer A 22 % 19 % Customer B 14 % 18 % Customer C 20 % 23 % Customer D 9 % 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 months ended March 31, 2023 and 2022, are set forth below (in thousands): Three Months Ended 2023 2022 Generics Anti-Infective $ 5,174 $ 6,245 Hormonal / Allergy 104,851 96,368 Antiviral 25,474 10,571 Central Nervous System 84,582 81,125 Cardiovascular System 32,503 23,453 Gastroenterology 14,364 16,620 Oncology 10,578 17,208 Metabolic Disease/Endocrine 9,265 11,233 Respiratory 12,815 5,665 Dermatology 18,004 13,477 Other therapeutic classes 25,895 35,360 International and other 301 422 Total Generics net revenue 343,806 317,747 Specialty Hormonal / Allergy 24,763 19,419 Central Nervous System 60,139 58,168 Other therapeutic classes 6,776 7,499 Total Specialty net revenue 91,678 85,086 AvKARE Distribution 83,230 60,263 Government Label 24,516 24,459 Institutional 8,862 6,315 Other 5,448 3,763 Total AvKARE net revenue 122,056 94,800 Total net revenue $ 557,540 $ 497,633 |
Schedule of Major Categories of Sales-Related Deductions | A rollforward of the major categories of sales-related deductions for the three months ended March 31, 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 760,744 25,462 15,920 49,573 Credits/payments issued during the period (908,454) (28,995) (20,996) (64,149) Balance at March 31, 2023 $ 425,882 $ 23,921 $ 139,984 $ 71,454 |
Loss per Share (Tables)
Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Loss Per Share, Basic and Diluted | The following table sets forth reconciliations of the numerators and denominators used to compute basic and diluted loss per share of class A common stock (in thousands, except per share amounts): Three Months Ended 2023 2022 Numerator: Net loss attributable to Amneal Pharmaceuticals, Inc. $ (6,943) $ (2,156) Denominator: Weighted-average shares outstanding - basic and diluted 152,109 149,892 Net loss per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: Basic and diluted $ (0.05) $ (0.01) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following table presents potentially dilutive securities excluded from the computations of diluted loss per share of class A common stock (in thousands): Three Months Ended 2023 2022 Stock options 2,632 (1) 3,035 (1) Restricted stock units 11,576 (1) 11,430 (1) Performance stock units 7,018 (1) 7,947 (1) Shares of class B common stock 152,117 (2) 152,117 (2) (1) 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. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Receivables [Abstract] | |
Schedule of Trade Accounts Receivable, Net | Trade accounts receivable, net was comprised of the following (in thousands): March 31, December 31, Gross accounts receivable $ 998,134 $ 1,344,959 Allowance for credit losses (2,571) (2,122) Contract charge-backs and sales volume allowances (425,882) (573,592) Cash discount allowances (23,921) (27,454) Subtotal (452,374) (603,168) Trade accounts receivable, net $ 545,760 $ 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: March 31, December 31, Customer A 36 % 41 % Customer B 17 % 25 % Customer C 28 % 21 % |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of Components of Inventories | Inventories were comprised of the following (in thousands): March 31, December 31, Raw materials $ 218,065 $ 224,607 Work in process 54,169 58,522 Finished goods 256,808 247,606 Total inventories $ 529,042 $ 530,735 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 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): March 31, December 31, Deposits and advances $ 3,306 $ 1,821 Prepaid insurance 4,514 8,090 Prepaid regulatory fees 3,540 5,298 Income and other tax receivables 12,943 12,881 Prepaid taxes 13,634 16,593 Other current receivables (1) 14,016 33,133 Chargebacks receivable (2) 10,964 8,605 Other prepaid assets 18,507 17,144 Total prepaid expenses and other current assets $ 81,424 $ 103,565 (1) Other current receivables as of December 31, 2022 include 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, 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) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The changes in goodwill for the three months ended March 31, 2023 and for the year ended December 31, 2022 were as follows (in thousands): March 31, December 31, Balance, beginning of period $ 598,853 $ 593,017 Goodwill acquired during the period — 7,553 Adjustment during the period for Puniska Acquisition — 3,075 Currency translation 303 (4,792) Balance, end of period $ 599,156 $ 598,853 |
Schedule of Finite-Lived Intangible Assets | Intangible assets at March 31, 2023 and December 31, 2022 were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Weighted-Average Cost Accumulated Net Cost Accumulated Net Amortizing intangible assets: Product rights 7.4 $ 1,222,612 $ (609,267) $ 613,345 $ 1,222,762 $ (573,281) $ 649,481 Other intangible assets 3.9 133,800 (82,181) 51,619 133,800 (77,943) 55,857 Subtotal $ 1,356,412 $ (691,448) $ 664,964 $ 1,356,562 $ (651,224) $ 705,338 In-process research and development 390,355 — 390,355 390,755 — 390,755 Total intangible assets $ 1,746,767 $ (691,448) $ 1,055,319 $ 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 $390.4 million of IPR&D intangible assets (in thousands): Future Remainder of 2023 $ 121,942 2024 162,793 2025 124,439 2026 73,893 2027 52,448 2028 30,753 Thereafter 98,696 Total $ 664,964 |
Other Assets (Tables)
Other Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Other Assets [Abstract] | |
Schedule of Other Assets | Other assets were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Interest rate swap (1) $ 71,316 $ 85,586 Security deposits 3,566 3,523 Long-term prepaid expenses 4,119 3,711 Deferred revolving credit facility costs 2,068 2,206 Other long term assets 5,359 8,191 Total $ 86,428 $ 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) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Accounts payable $ 136,922 $ 165,980 Accrued returns allowance (1) 139,984 145,060 Accrued compensation 32,115 54,038 Accrued Medicaid and commercial rebates (1) 71,454 86,030 Accrued royalties 17,370 19,309 Commercial chargebacks and rebates 10,226 10,226 Accrued professional fees 13,826 11,386 Taxes payable 1,069 359 Accrued other 44,455 45,811 Total accounts payable and accrued expenses $ 467,421 $ 538,199 (1) Refer to Note 4. Revenue Recognition for a rollforward of the balance from December 31, 2022 to March 31, 2023. |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Debt | The following is a summary of the Company’s total indebtedness (in thousands): March 31, 2023 December 31, 2022 Term Loan due May 2025 $ 2,557,126 $ 2,563,876 Rondo Term Loan due January 2025 47,000 72,000 Total debt 2,604,126 2,635,876 Less: debt issuance costs (12,437) (13,934) Total debt, net of debt issuance costs 2,591,689 2,621,942 Less: current portion of long-term debt (29,965) (29,961) Total long-term debt, net $ 2,561,724 $ 2,591,981 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Other Long-Term Liabilities | Other long-term liabilities were comprised of the following (in thousands): March 31, 2023 December 31, 2022 Uncertain tax positions $ 572 $ 563 Long-term portion of liabilities for legal matters (1) — 49,442 Long-term compensation 18,207 16,737 Contingent consideration (2) 13,384 11,997 Other long-term liabilities 9,293 8,729 Total other long-term liabilities $ 41,456 $ 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) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary 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 March 31, 2023 and December 31, 2022 (in thousands): Fair Value Measurement Based on March 31, 2023 Total Quoted Significant Significant Assets Interest rate swap (1) $ 71,316 $ — $ 71,316 $ — Liabilities Deferred compensation plan liabilities (2) $ 9,832 $ — $ 9,832 $ — Contingent consideration liabilities (3) $ 17,884 $ — $ — $ 17,884 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 March 31, 2023 and December 31, 2022 , the contingent consideration liability associated with the Saol Acquisition included $0.6 million and $0.1 million, respectively, recorded in accounts payable and accrued expenses and $13.4 million and $12.0 million, respectively, recorded in other-longer term liabilities. As of March 31, 2023 and December 31, 2022 , the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC (“KSP”) was valued at approximately $3.9 million and $3.3 million, respectively, and recorded within related party payables - long term. |
Summary 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): Three Months Ended Balance, beginning of period $ 15,427 Change in fair value during the period 2,457 Balance, end of period $ 17,884 |
Summary 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 contingent consideration liabilities as of March 31, 2023: Contingent Consideration Liability Fair Value as of March 31, 2023 (in thousands) Unobservable input Range Weighted Average (1) Regulatory Milestones (KSP acquisition) $400 Discount rate 6.5% - 7.4% 6.6% Probability of payment 1.8% - 20.0% 18.6% Projected year of payment 2024 - 2026 2024 Royalties (KSP acquisition) $3,500 Discount rate 12.5% - 12.5% 12.5% Probability of payment 1.8% - 20.0% 18.6% Projected year of payment 2024 - 2033 2028 Royalties (Saol Acquisition) $13,984 Discount rate 17.5% - 17.5% 17.5% 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) | 3 Months Ended |
Mar. 31, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Summary 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): March 31, 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 $ 71,316 Other assets $ 85,586 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 December 31, 2022 Opana ER® antitrust litigation $ 50,000 $ 83,944 Opana ER® antitrust litigation-accrued interest 1,216 1,423 Opana ER® antitrust litigation-imputed interest (1,070) — Civil prescription opioid litigation 20,048 17,993 Galeas v. Amneal 1,200 1,200 Other 4,923 2,923 Current portion of liabilities for legal matters $ 76,317 $ 107,483 Opana ER® antitrust litigation $ — $ 50,000 Opana ER ® antitrust litigation-accrued interest — 847 Opana ER ® antitrust litigation-imputed interest — (1,405) Long-term portion of liabilities for legal matters (included in other long-term liabilities) $ — $ 49,442 |
Stockholders_ Equity and Rede_2
Stockholders’ Equity and Redeemable Non-Controlling Interests (Tables) | 3 Months Ended |
Mar. 31, 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 898 (7,135) (6,237) Reallocation of ownership interests (195) 257 62 Balance March 31, 2023 $ (31,679) $ 35,443 $ 3,764 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, Related Party and Nature of Transaction Caption in Balance Sheet and Statement of Operations 2023 2022 Kashiv Biosciences LLC Parking space lease Research and development $ 17 $ 25 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 50 17 Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko) Cost of goods sold 144 — Storage agreement Research and development (48) — Total $ 163 $ 5,042 Other Related Parties Kanan, LLC - operating lease Inventory and cost of goods sold $ 566 $ 526 Sutaria Family Realty, LLC - operating lease Inventory and cost of goods sold $ 305 $ 296 PharmaSophia, LLC - research and development services income Research and development $ — $ (15) Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement Inventory and cost of goods sold $ 1,836 $ 458 Tracy Properties LLC - operating lease Selling, general and administrative $ 169 $ 135 AzaTech Pharma LLC - supply agreement Inventory and cost of goods sold $ 575 $ 1,221 AvPROP, LLC - operating lease Selling, general and administrative $ 47 $ 40 Avtar Investments, LLC - consulting services Research and development $ 188 $ 84 TPG Operations, LLC - consulting services Selling, general and administrative $ — $ 19 Alkermes Inventory and cost of goods sold $ 2 $ — R&S Solutions - logistics services Selling, general and administrative $ 20 $ — Members - tax receivable agreement (TRA liability) Other expense $ 826 $ — The following table summarizes the amounts due to or from the Company for related party transactions (in thousands): March 31, 2023 December 31, 2022 Sellers of AvKARE LLC and R&S - state tax indemnification $ — $ 486 Kashiv - various agreements 28 12 Asana BioSciences, LLC 2 2 Related party receivables - short term $ 30 $ 500 Kashiv - various agreements $ 75 $ 110 Apace Packaging, LLC - packaging agreement 1,061 756 AzaTech Pharma LLC - supply agreement 855 863 Avtar Investments LLC - consulting services 85 72 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 442 442 Members - tax receivable agreement 631 201 R&S Solutions LLC - logistics services 13 7 Alkermes Plc — 28 Kanan LLC - operating lease 41 — Members - tax distributions 8,767 — Rondo Class B unit holders - tax distributions 2,780 — Related party payables - short term $ 14,750 $ 2,479 Kashiv - contingent consideration (1) $ 3,900 $ 3,290 Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes 6,481 5,929 Members - tax receivable agreement 826 430 Related party payables - long term $ 11,207 $ 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) | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
Schedule of Segment Reporting Information, by Segment | Three Months Ended March 31, 2023 Generics (1) Specialty AvKARE (1) Corporate and Other Total Company Net revenue $ 343,806 $ 91,678 $ 122,056 $ — $ 557,540 Cost of goods sold 230,551 43,191 105,612 — 379,354 Gross profit 113,255 48,487 16,444 — 178,186 Selling, general and administrative 27,600 22,379 12,940 39,177 102,096 Research and development 32,359 6,331 — — 38,690 Intellectual property legal development expenses 1,624 20 — — 1,644 Restructuring and other charges 99 — — 411 510 Change in fair value of contingent consideration — 2,457 — — 2,457 (Credit) charges related to legal matters, net (2,444) — — 2,008 (436) Other operating income (1,224) — — — (1,224) Operating income (loss) $ 55,241 $ 17,300 $ 3,504 $ (41,596) $ 34,449 Three Months Ended March 31, 2022 Generics (1) Specialty AvKARE (1) Corporate Total Net revenue $ 317,747 $ 85,086 $ 94,800 $ — $ 497,633 Cost of goods sold 199,030 43,853 80,179 — 323,062 Gross profit 118,717 41,233 14,621 — 174,571 Selling, general and administrative 27,593 24,400 13,410 33,262 98,665 Research and development 43,221 9,577 — — 52,798 Intellectual property legal development expenses (credit) 772 (8) — — 764 Acquisition, transaction-related and integration expenses — — — 434 434 Restructuring and other charges 206 — — 525 731 Change in fair value of contingent consideration — 200 — — 200 Charges (credit) related to legal matters, net 1,674 — — (4,000) (2,326) Operating income (loss) $ 45,251 $ 7,064 $ 1,211 $ (30,221) $ 23,305 (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 | Mar. 31, 2023 |
Noncontrolling Interest [Line Items] | |
Ownership by parent (percent) | 50.20% |
Amneal Group | |
Noncontrolling Interest [Line Items] | |
Ownership percentage by noncontrolling owners (percent) | 49.80% |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Details) - USD ($) $ in Thousands | 2 Months Ended | 3 Months Ended | ||||
Feb. 09, 2022 | Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||||||
Acquisition of business | $ 0 | $ 84,714 | ||||
Goodwill | 599,156 | $ 598,853 | $ 593,017 | |||
Net revenue | 557,540 | 497,633 | ||||
Operating loss | 34,449 | 23,305 | ||||
Specialty | ||||||
Business Acquisition [Line Items] | ||||||
Goodwill | 366,300 | $ 366,300 | ||||
Net revenue | $ 91,678 | 85,086 | ||||
Saol Baclofen Franchise Acquisition | Generics | ||||||
Business Acquisition [Line Items] | ||||||
Goodwill | $ 5,200 | |||||
Goodwill deductible for tax purposes | 4,900 | |||||
Saol Baclofen Franchise Acquisition | Specialty | ||||||
Business Acquisition [Line Items] | ||||||
Goodwill | 2,400 | |||||
Saol Baclofen Franchise Acquisition | ||||||
Business Acquisition [Line Items] | ||||||
Acquisition of business | 84,714 | |||||
Asset acquisition, inventory acquired | $ 1,100 | |||||
Asset acquisition, transaction cost | $ 100 | |||||
Net revenue | $ 2,900 | |||||
Operating loss | $ 100 |
Acquisitions - Payments to Acqu
Acquisitions - Payments to Acquire Business (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Feb. 09, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Business Acquisition [Line Items] | |||
Cash | $ 0 | $ 84,714 | |
Saol Baclofen Franchise Acquisition | |||
Business Acquisition [Line Items] | |||
Cash | $ 84,714 | ||
Contingent consideration (royalties) | 8,796 | ||
Fair value of consideration transferred | $ 93,510 |
Acquisitions - Preliminary Purc
Acquisitions - Preliminary Purchase Price Allocation for the Acquisitions (Details) - Saol Baclofen Franchise Acquisition $ in Thousands | Feb. 09, 2022 USD ($) |
Asset Acquisition [Line Items] | |
Inventory | $ 2,162 |
Prepaid expenses and other current assets | 98 |
Goodwill | 7,553 |
Intangible assets | 83,815 |
Total assets acquired | 93,628 |
Accounts payable and accrued expenses | 118 |
Fair value of consideration transferred | $ 93,510 |
Acquisitions - Acquired Intangi
Acquisitions - Acquired Intangible Assets (Details) - Saol Baclofen Franchise Acquisition - Marketed Product Rights $ in Millions | Feb. 09, 2022 USD ($) |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Intangible assets acquired | $ 83.8 |
Useful life of intangible assets acquired | 11 years 6 months |
Revenue Recognition - Concentra
Revenue Recognition - Concentration of Revenue (Details) - Revenue from Contract with Customer Benchmark - Customer Concentration Risk | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 22% | 19% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 14% | 18% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 20% | 23% |
Customer D | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 9% | 11% |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Disaggregated Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 557,540 | $ 497,633 |
Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 343,806 | 317,747 |
Specialty | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 91,678 | 85,086 |
AvKARE | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 122,056 | 94,800 |
International and other | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 301 | 422 |
Anti-Infective | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 5,174 | 6,245 |
Hormonal / Allergy | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 104,851 | 96,368 |
Hormonal / Allergy | US | Specialty | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 24,763 | 19,419 |
Antiviral | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 25,474 | 10,571 |
Central Nervous System | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 84,582 | 81,125 |
Central Nervous System | US | Specialty | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 60,139 | 58,168 |
Cardiovascular System | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 32,503 | 23,453 |
Gastroenterology | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 14,364 | 16,620 |
Oncology | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 10,578 | 17,208 |
Metabolic Disease/Endocrine | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 9,265 | 11,233 |
Respiratory | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 12,815 | 5,665 |
Dermatology | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 18,004 | 13,477 |
Other therapeutic classes | US | Generics | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 25,895 | 35,360 |
Other therapeutic classes | US | Specialty | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 6,776 | 7,499 |
Distribution | US | AvKARE | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 83,230 | 60,263 |
Government Label | US | AvKARE | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 24,516 | 24,459 |
Institutional | US | AvKARE | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 8,862 | 6,315 |
Other | US | AvKARE | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 5,448 | $ 3,763 |
Revenue Recognition - Schedul_2
Revenue Recognition - Schedule of Major Categories of Sales-Related Deductions (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 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 | 760,744 |
Credits/payments issued during the period | (908,454) |
Balance, end of period | 425,882 |
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 | 25,462 |
Credits/payments issued during the period | (28,995) |
Balance, end of period | 23,921 |
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 | 15,920 |
Credits/payments issued during the period | (20,996) |
Balance, end of period | 139,984 |
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 | 49,573 |
Credits/payments issued during the period | (64,149) |
Balance, end of period | $ 71,454 |
Alliance and Collaboration - Ad
Alliance and Collaboration - Additional Information (Details) € in Millions | 3 Months Ended | 12 Months Ended | |||||
Dec. 28, 2022 EUR (€) | Dec. 28, 2022 USD ($) | Mar. 31, 2022 USD ($) | May 07, 2018 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development | $ 38,690,000 | $ 52,798,000 | |||||
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 | $ 49,000,000 | ||||||
Collaborative arrangement remaining upfront amount | 13,400,000 | ||||||
Research and development | 0 | ||||||
Collaborative arrangement license revenue agreement | 600,000 | 8,000,000 | |||||
License Agreement with Orion Corporation | Accounts Payable and Accrued Liabilities | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Deferred income | $ 6,100,000 | 6,700,000 | |||||
License Agreement with Orion Corporation | Other long-term liabilities | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Deferred income | $ 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 | ||
Nov. 30, 2021 INR (₨) company | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Other operating income | $ 1,224 | $ 0 | ||
Prepaid expenses and other current assets | 81,424 | $ 103,565 | ||
Government of India | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Number of companies | company | 55 | |||
Grants receivable | ₨ 10 | 121,700 | ||
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 | $ 5,200 | $ 4,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Nov. 08, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||||
Income tax expense (benefit) | $ 668 | $ (3,461) | |||
Effective tax rate (percent) | (7.10%) | 34.90% | |||
Valuation allowance | $ 435,400 | $ 434,900 | |||
Percentage of tax receivable agreement paid to other holders of Amneal common units (percent) | 85% | 85% | |||
Reversal Of accrued tax receivable agreement liability | $ 192,800 | ||||
Liabilities under tax receivable agreement | $ 202,700 | $ 1,500 | |||
Accrued expenses | $ 1,500 |
Loss per Share - Computation of
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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Numerator: | ||
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (6,943) | $ (2,156) |
Denominator: | ||
Weighted-average shares outstanding - basic (in shares) | 152,109 | 149,892 |
Weighted-average shares outstanding - diluted (in shares) | 152,109 | 149,892 |
Net loss per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: | ||
Basic (in dollars per share) | $ (0.05) | $ (0.01) |
Diluted (in dollars per share) | $ (0.05) | $ (0.01) |
Loss per Share - Securities Exc
Loss per Share - Securities Excluded from Diluted Earnings per Share Computation (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 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 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from earnings per share (in shares) | 2,632 | 3,035 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from earnings per share (in shares) | 11,576 | 11,430 |
Performance stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from earnings per share (in shares) | 7,018 | 7,947 |
Trade Accounts Receivable, Ne_2
Trade Accounts Receivable, Net - Schedule of Trade Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Receivables [Abstract] | ||
Gross accounts receivable | $ 998,134 | $ 1,344,959 |
Allowance for credit losses | (2,571) | (2,122) |
Contract charge-backs and sales volume allowances | (425,882) | (573,592) |
Cash discount allowances | (23,921) | (27,454) |
Subtotal | (452,374) | (603,168) |
Trade accounts receivable, net | $ 545,760 | $ 741,791 |
Trade Accounts Receivable, Ne_3
Trade Accounts Receivable, Net - Concentration of Receivables (Details) - Customer Concentration Risk - Accounts Receivable | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 36% | 41% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 17% | 25% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 28% | 21% |
Inventories - Components of Inv
Inventories - Components of Inventories, Net of Reserves (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 218,065 | $ 224,607 |
Work in process | 54,169 | 58,522 |
Finished goods | 256,808 | 247,606 |
Total inventories | $ 529,042 | $ 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 | Mar. 31, 2023 | Dec. 31, 2022 |
Gain Contingencies [Line Items] | ||
Deposits and advances | $ 3,306 | $ 1,821 |
Prepaid insurance | 4,514 | 8,090 |
Prepaid regulatory fees | 3,540 | 5,298 |
Income and other tax receivables | 12,943 | 12,881 |
Prepaid taxes | 13,634 | 16,593 |
Other current receivables | 14,016 | 33,133 |
Chargebacks receivable | 10,964 | 8,605 |
Other prepaid assets | 18,507 | 17,144 |
Total prepaid expenses and other current assets | $ 81,424 | 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 | 3 Months Ended | 12 Months Ended |
Mar. 31, 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 Puniska Acquisition | 0 | 3,075 |
Currency translation | 303 | (4,792) |
Balance, end of period | $ 599,156 | $ 598,853 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill [Line Items] | |||
Goodwill | $ 599,156 | $ 598,853 | $ 593,017 |
Specialty | |||
Goodwill [Line Items] | |||
Goodwill | 366,300 | 366,300 | |
Generics | |||
Goodwill [Line Items] | |||
Goodwill | 163,400 | 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 | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 1,356,412 | $ 1,356,562 |
Accumulated Amortization | (691,448) | (651,224) |
Net | 664,964 | 705,338 |
In-process research and development | 390,355 | 390,755 |
Intangible assets, cost | 1,746,767 | 1,747,317 |
Intangible assets, net | 1,055,319 | 1,096,093 |
In-process research and development | ||
Finite-Lived Intangible Assets [Line Items] | ||
Accumulated Amortization | $ 0 | 0 |
Product rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period (in years) | 7 years 4 months 24 days | |
Cost | $ 1,222,612 | 1,222,762 |
Accumulated Amortization | (609,267) | (573,281) |
Net | $ 613,345 | 649,481 |
Other intangible assets | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period (in years) | 3 years 10 months 24 days | |
Cost | $ 133,800 | 133,800 |
Accumulated Amortization | (82,181) | (77,943) |
Net | $ 51,619 | $ 55,857 |
Goodwill and Other Intangible_6
Goodwill and Other Intangible Assets - Amortization Expense (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of intangible assets | $ 41.1 | $ 40.9 |
Goodwill and Other Intangible_7
Goodwill and Other Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Remainder of 2023 | $ 121,942 | |
2024 | 162,793 | |
2025 | 124,439 | |
2026 | 73,893 | |
2027 | 52,448 | |
2028 | 30,753 | |
Thereafter | 98,696 | |
Net | $ 664,964 | $ 705,338 |
Other Assets - Schedule of Othe
Other Assets - Schedule of Other Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other Assets [Line Items] | ||
Other assets | $ 86,428 | $ 103,217 |
Interest rate swap | ||
Other Assets [Line Items] | ||
Other assets | 71,316 | 85,586 |
Security deposits | ||
Other Assets [Line Items] | ||
Other assets | 3,566 | 3,523 |
Long-term prepaid expenses | ||
Other Assets [Line Items] | ||
Other assets | 4,119 | 3,711 |
Deferred revolving credit facility costs | ||
Other Assets [Line Items] | ||
Other assets | 2,068 | 2,206 |
Other long term assets | ||
Other Assets [Line Items] | ||
Other assets | $ 5,359 | $ 8,191 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 136,922 | $ 165,980 |
Accrued returns allowance | 139,984 | 145,060 |
Accrued compensation | 32,115 | 54,038 |
Accrued Medicaid and commercial rebates | 71,454 | 86,030 |
Accrued royalties | 17,370 | 19,309 |
Commercial chargebacks and rebates | 10,226 | 10,226 |
Accrued professional fees | 13,826 | 11,386 |
Taxes payable | 1,069 | 359 |
Accrued other | 44,455 | 45,811 |
Accounts payable and accrued expenses | $ 467,421 | $ 538,199 |
Debt - Summary of Long-term Deb
Debt - Summary of Long-term Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Total debt | $ 2,604,126 | $ 2,635,876 |
Less: debt issuance costs | (12,437) | (13,934) |
Total debt, net of debt issuance costs | 2,591,689 | 2,621,942 |
Less: current portion of long-term debt | (29,965) | (29,961) |
Total long-term debt, net | 2,561,724 | 2,591,981 |
Term Loan due May 2025 | ||
Debt Instrument [Line Items] | ||
Total debt | 2,557,126 | 2,563,876 |
Rondo Term Loan due January 2025 | ||
Debt Instrument [Line Items] | ||
Total debt | $ 47,000 | $ 72,000 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2023 | Jan. 31, 2023 | Mar. 31, 2023 | |
Debt Instrument [Line Items] | |||
Available maximum borrowing capacity | $ 245.9 | $ 245.9 | |
Rondo Term Loan | |||
Debt Instrument [Line Items] | |||
Repayment of outstanding principal | 25 | ||
Principal payments | 22.8 | ||
Opana ER® antitrust litigation | |||
Debt Instrument [Line Items] | |||
Litigation settlement expense | $ 83.9 | ||
Revolving Credit Facility | |||
Debt Instrument [Line Items] | |||
Revolving credit facility | 100 | $ 80 | $ 100 |
Repayment of outstanding principal | $ 40 |
Other Long-Term Liabilities (De
Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other Liabilities [Line Items] | ||
Other long-term liabilities | $ 41,456 | $ 87,468 |
Uncertain tax positions | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 572 | 563 |
Long-term portion of liabilities for legal matters | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 0 | 49,442 |
Long-term compensation | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 18,207 | 16,737 |
Contingent Consideration | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | 13,384 | 11,997 |
Other long-term liabilities | ||
Other Liabilities [Line Items] | ||
Other long-term liabilities | $ 9,293 | $ 8,729 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Interest rate swap asset | $ 71,316 | $ 85,586 |
Liabilities | ||
Deferred compensation plan liabilities | 9,832 | 9,674 |
Contingent consideration liability | 17,884 | 15,427 |
Saol Baclofen Franchise Acquisition | Accounts Payable And Accrued Expenses | ||
Liabilities | ||
Contingent consideration liability | 600 | 100 |
Saol Baclofen Franchise Acquisition | Other long-term liabilities | ||
Liabilities | ||
Contingent consideration liability | 13,400 | 12,000 |
Kashiv Specialty Pharmaceuticals, LLC | ||
Liabilities | ||
Contingent consideration liability | 3,900 | 3,300 |
Quoted Prices in Active Markets (Level 1) | ||
Assets | ||
Interest rate swap asset | 0 | 0 |
Liabilities | ||
Deferred compensation plan liabilities | 0 | 0 |
Contingent consideration liability | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Assets | ||
Interest rate swap asset | 71,316 | 85,586 |
Liabilities | ||
Deferred compensation plan liabilities | 9,832 | 9,674 |
Contingent consideration liability | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Assets | ||
Interest rate swap asset | 0 | 0 |
Liabilities | ||
Deferred compensation plan liabilities | 0 | 0 |
Contingent consideration liability | $ 17,884 | $ 15,427 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Apr. 02, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Long term debt | $ 2,591,689 | $ 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 | 2,400,000 | 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 | 46,500 | 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 | $ 39,700 | $ 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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | $ 15,427 | |
Change in fair value during the period | (2,457) | $ (200) |
Balance, end of period | 17,884 | |
Saol Baclofen Franchise and Kashiv Specialty Pharmaceuticals LLC | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Change in fair value during the period | $ 2,457 |
Fair Value Measurements - Signi
Fair Value Measurements - Significant Inputs Used in Fair Value Measurements (Details) $ in Thousands | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | $ 17,884 | $ 15,427 |
Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | 400 | |
Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | 3,500 | |
Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value | $ 13,984 | |
Minimum | Discount rate | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.065 | |
Minimum | Discount rate | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.125 | |
Minimum | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.175 | |
Minimum | Probability of payment | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.018 | |
Minimum | Probability of payment | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.018 | |
Maximum | Discount rate | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.074 | |
Maximum | Discount rate | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.125 | |
Maximum | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.175 | |
Maximum | Probability of payment | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.200 | |
Maximum | Probability of payment | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.200 | |
Weighted Average | Discount rate | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.066 | |
Weighted Average | Discount rate | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.125 | |
Weighted Average | Discount rate | Royalties Saol Acquisition | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.175 | |
Weighted Average | Probability of payment | Regulatory Milestones | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.186 | |
Weighted Average | Probability of payment | Royalties | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.186 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Details) - USD ($) | Mar. 31, 2023 | Oct. 31, 2019 |
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | $ 71,300,000 | |
Accumulated Other Comprehensive Income | ||
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | 35,400,000 | |
Non- Controlling Interests | ||
Derivative [Line Items] | ||
Net of income taxes, recognized in accumulated other comprehensive income | $ 35,900,000 | |
Interest Rate Lock Agreement | ||
Derivative [Line Items] | ||
Notional amount | $ 1,300,000,000 |
Financial Instruments - Summary
Financial Instruments - Summary of Fair Values of Derivative Instruments in Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Variable to Fixed Interest Rate Swap | Designated as Hedging Instrument | Other assets | ||
Derivative [Line Items] | ||
Fair Value | $ 71,316 | $ 85,586 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||||||||||
Feb. 21, 2023 lawsuit | Jan. 13, 2023 motion expert | Dec. 31, 2022 case | Mar. 30, 2022 lawsuit | Mar. 28, 2022 USD ($) | Mar. 22, 2022 USD ($) lawsuit | Mar. 01, 2022 defendant | Feb. 08, 2022 defendant | Oct. 01, 2021 defendant pharmacy case complaint | Mar. 13, 2015 medication | Nov. 06, 2014 representative | Jan. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) case claim county complaint state | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Apr. 10, 2023 plaintiff | Sep. 30, 2022 USD ($) | Aug. 03, 2022 minor | Jun. 30, 2022 USD ($) | Oct. 31, 2020 complaint | Jun. 10, 2020 state | Nov. 01, 2019 state | May 10, 2019 state | |
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Credit related to legal matters, net | $ 436 | $ 2,326 | ||||||||||||||||||||||
Litigation settlement | $ 1,100 | |||||||||||||||||||||||
Number of pending claims, including third parties | case | 922 | |||||||||||||||||||||||
Number of cases | case | 77 | |||||||||||||||||||||||
Number of states with cases | state | 10 | |||||||||||||||||||||||
Number of motions filed | motion | 2 | |||||||||||||||||||||||
Number of lawsuit filed | lawsuit | 2 | |||||||||||||||||||||||
December 2022 and Mid-January 2024 | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Interest rate | 3% | |||||||||||||||||||||||
Opana ER® antitrust litigation | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Loss contingency accrual | $ 50,000 | $ 265,000 | ||||||||||||||||||||||
Charges related to legal matters, net | 215,000 | |||||||||||||||||||||||
Litigation settlement expense | $ 83,900 | |||||||||||||||||||||||
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 defendants | lawsuit | 2 | 2 | ||||||||||||||||||||||
Neonatal Abstinence Syndrome | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of minors | minor | 6 | |||||||||||||||||||||||
Civil prescription opioid litigation | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Credit related to legal matters, net | $ (2,100) | $ (18,000) | ||||||||||||||||||||||
Cambridge Retirement System v. Amneal Pharmaceuticals, Inc., et al. | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Litigation settlement amount | $ 25,000 | $ 25,000 | ||||||||||||||||||||||
Insurance recoveries | $ 4,000 | |||||||||||||||||||||||
Ranitidine | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of claims dismissed | claim | 3 | |||||||||||||||||||||||
Number of personal injury short form complaints | complaint | 313 | |||||||||||||||||||||||
Ranitidine Pennsylvania Lawsuit | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of complaints | complaint | 2 | |||||||||||||||||||||||
Number of co-defendants | defendant | 7 | 20 | 25 | |||||||||||||||||||||
Number of pharmacies | pharmacy | 1 | |||||||||||||||||||||||
Number of multi-plaintiff cases | case | 6 | |||||||||||||||||||||||
Number of counties where cases were filed | county | 3 | |||||||||||||||||||||||
Number of lawsuit filed | case | 2 | 3 | ||||||||||||||||||||||
Ranitidine California Lawsuit | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of multi-plaintiff cases | case | 94 | |||||||||||||||||||||||
Metformin Litigation | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of medical monitoring class action complaints | complaint | 2 | |||||||||||||||||||||||
Value Drug Company v. Takeda Pharmaceuticals U.S.A., Inc. | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of motions filed | motion | 1 | |||||||||||||||||||||||
Number of experts included in motion to exclude | expert | 5 | |||||||||||||||||||||||
Number of experts | expert | 6 | |||||||||||||||||||||||
Value Drug Company v. Takeda Pharmaceuticals U.S.A., Inc. | Subsequent Event | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Number of former absent members added as plaintiffs | plaintiff | 18 | |||||||||||||||||||||||
Galeas v. Amneal | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Loss contingency accrual | $ 1,200 | |||||||||||||||||||||||
Litigation settlement amount | $ 1,200 | |||||||||||||||||||||||
Russell Thiele, et al. v. Kashiv Biosciences, LLC, et al. | Maximum | ||||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||||
Litigation settlement amount | $ 2,000 |
Commitment and Contingencies -
Commitment and Contingencies - Schedule of Liabilities For Legal Matters (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | $ 76,317 | $ 107,483 |
Long-term portion of liabilities for legal matters (included in other long-term liabilities) | 0 | 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 | 1,216 | 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 | (1,070) | 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 | 20,048 | 17,993 |
Galeas v. Amneal | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 1,200 | 1,200 |
Other | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | $ 4,923 | $ 2,923 |
Stockholders' Equity and Redeem
Stockholders' Equity and Redeemable Non-Controlling Interests - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Nov. 02, 2021 | Apr. 02, 2021 | Jan. 31, 2020 | |
Class of Stock [Line Items] | ||||||
Tax distribution | $ 26,810 | $ 4,440 | ||||
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 | $ 2,960 | $ 2,010 | ||||
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% | ||||
Puniska Healthcare Pvt Ltd | ||||||
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 |
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 | 3 Months Ended | 12 Months Ended |
Mar. 31, 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 | (6,237) | 34,876 |
Reallocation of ownership interests | 62 | (110) |
Stockholders' equity ending balance | 134,668 | 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 | 898 | (13,394) |
Reallocation of ownership interests | (195) | (143) |
Stockholders' equity ending balance | (31,679) | (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 | (7,135) | 48,270 |
Reallocation of ownership interests | 257 | 33 |
Stockholders' equity ending balance | 35,443 | 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 | $ 3,764 | $ 9,939 |
Related Party Transactions - Re
Related Party Transactions - Related Party Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||
Related party receivables | $ 30 | $ 500 | |
Related party payables - short term | 14,750 | 2,479 | |
Related party payables - long term | 11,207 | 9,649 | |
Kashiv Biosciences LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 163 | $ 5,042 | |
Related party payables - short term | 75 | 110 | |
Inventory and Cost of Goods Sold - Kanan, LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 566 | 526 | |
Inventory and Cost of Goods Sold - Sutaria Family Realty, LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 305 | 296 | |
Research and Development - PharmaSophia LLC | |||
Related Party Transaction [Line Items] | |||
Income from related parties | 0 | (15) | |
Inventory and Cost of Goods Sold - Apace KY, LLC d/b/a Apace Packaging LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 1,836 | 458 | |
Selling, General and Administrative - Tracy Properties LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 169 | 135 | |
Inventory and Cost of Goods Sold - AzaTech Pharma LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 575 | 1,221 | |
Selling, General and Administrative - AvPROP, LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 47 | 40 | |
Related Party | Kashiv Biosciences LLC | |||
Related Party Transaction [Line Items] | |||
Related party receivables | 28 | 12 | |
Related party payables - long term | 3,900 | 3,290 | |
Related Party | Avtar Investments LLC - consulting services | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 85 | 72 | |
Related Party | Research and development - Parking Space Lease | Kashiv Biosciences LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 17 | 25 | |
Related Party | Selling, General and Administrative - Development and Commercialization Agreement | Kashiv Biosciences LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 0 | 5,000 | |
Related Party | 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 | 50 | 17 | |
Related Party | 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 | 144 | 0 | |
Related Party | Research and Development Storage Income | Kashiv Biosciences LLC | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | (48) | 0 | |
Related Party | Sales Milestone Expenses | Avtar Investments LLC - consulting services | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 188 | 84 | |
TPG Operations, LLC | Sales Milestone Expenses | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 0 | 19 | |
Rondo Partners L L C | |||
Related Party Transaction [Line Items] | |||
Related party receivables | 0 | 486 | |
Related party payables - short term | 2,780 | 0 | |
Related party payables - long term | 6,481 | 5,929 | |
Apace Packaging, LLC - packaging agreement | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 1,061 | 756 | |
AzaTech Pharma LLC - supply agreement | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 855 | 863 | |
Sellers of AvKARE LLC and R&S | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 442 | 442 | |
Kashiv - contingent consideration | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 631 | 201 | |
Related party payables - long term | 826 | 430 | |
R&S Solutions LLC - logistics services | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 13 | 7 | |
R&S Solutions LLC - logistics services | Selling, General and Administrative - R&S Solutions - Logistics Services | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 20 | 0 | |
Alkermes Plc | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 0 | 28 | |
Kanan L L C | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 41 | 0 | |
Amneal Group | |||
Related Party Transaction [Line Items] | |||
Related party payables - short term | 8,767 | 0 | |
Asana Biosciences L L C | |||
Related Party Transaction [Line Items] | |||
Related party receivables | 2 | $ 2 | |
Alkermes Plc | Inventory and Cost of Goods Sold - Alkermes | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | 2 | 0 | |
Members | Other Expense - Tax Receivable Agreement (TRA liability) | |||
Related Party Transaction [Line Items] | |||
Amounts of transaction with related party | $ 826 | $ 0 |
Segment Information - Additiona
Segment Information - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2023 segment product | |
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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Segment Reporting Information [Line Items] | ||
Net revenue | $ 557,540 | $ 497,633 |
Cost of goods sold | 379,354 | 323,062 |
Gross profit | 178,186 | 174,571 |
Selling, general and administrative | 102,096 | 98,665 |
Research and development | 38,690 | 52,798 |
Intellectual property legal development expenses (credit) | 1,644 | 764 |
Acquisition, transaction-related and integration expenses | 0 | 434 |
Restructuring and other charges | 510 | 731 |
Change in fair value of contingent consideration | 2,457 | 200 |
(Credit) charges related to legal matters, net | (436) | (2,326) |
Other operating income | (1,224) | 0 |
Operating income | 34,449 | 23,305 |
Generics | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 343,806 | 317,747 |
AvKARE | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 122,056 | 94,800 |
Operating Segments | Generics | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 343,806 | 317,747 |
Cost of goods sold | 230,551 | 199,030 |
Gross profit | 113,255 | 118,717 |
Selling, general and administrative | 27,600 | 27,593 |
Research and development | 32,359 | 43,221 |
Intellectual property legal development expenses (credit) | 1,624 | 772 |
Acquisition, transaction-related and integration expenses | 0 | |
Restructuring and other charges | 99 | 206 |
Change in fair value of contingent consideration | 0 | 0 |
(Credit) charges related to legal matters, net | (2,444) | 1,674 |
Other operating income | (1,224) | |
Operating income | 55,241 | 45,251 |
Operating Segments | Specialty | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 91,678 | 85,086 |
Cost of goods sold | 43,191 | 43,853 |
Gross profit | 48,487 | 41,233 |
Selling, general and administrative | 22,379 | 24,400 |
Research and development | 6,331 | 9,577 |
Intellectual property legal development expenses (credit) | 20 | (8) |
Acquisition, transaction-related and integration expenses | 0 | |
Restructuring and other charges | 0 | 0 |
Change in fair value of contingent consideration | 2,457 | 200 |
(Credit) charges related to legal matters, net | 0 | 0 |
Other operating income | 0 | |
Operating income | 17,300 | 7,064 |
Operating Segments | AvKARE | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 122,056 | 94,800 |
Cost of goods sold | 105,612 | 80,179 |
Gross profit | 16,444 | 14,621 |
Selling, general and administrative | 12,940 | 13,410 |
Research and development | 0 | 0 |
Intellectual property legal development expenses (credit) | 0 | 0 |
Acquisition, transaction-related and integration expenses | 0 | |
Restructuring and other charges | 0 | 0 |
Change in fair value of contingent consideration | 0 | 0 |
(Credit) charges related to legal matters, net | 0 | 0 |
Other operating income | 0 | |
Operating income | 3,504 | 1,211 |
Corporate and Other | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 0 | 0 |
Cost of goods sold | 0 | 0 |
Gross profit | 0 | 0 |
Selling, general and administrative | 39,177 | 33,262 |
Research and development | 0 | 0 |
Intellectual property legal development expenses (credit) | 0 | 0 |
Acquisition, transaction-related and integration expenses | 434 | |
Restructuring and other charges | 411 | 525 |
Change in fair value of contingent consideration | 0 | 0 |
(Credit) charges related to legal matters, net | 2,008 | (4,000) |
Other operating income | 0 | |
Operating income | $ (41,596) | $ (30,221) |