Audit Information |
12 Months Ended |
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Dec. 31, 2024 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Iselin, NJ |
Auditor Firm ID | 42 |
Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) |
12 Months Ended | ||
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Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
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Statement of Comprehensive Income [Abstract] | |||
Unrealized gain (loss) on cash flow hedge, net of tax | $ 0 | $ 0 | $ 0 |
Reclassification of cash flow hedge, tax | $ 0 | $ 0 | $ 0 |
Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2024 |
Dec. 31, 2023 |
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Preferred stock, par value (in dollars 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 dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 900,000,000 | 900,000,000 |
Common stock, shares issued (in shares) | 309,881,000 | 306,565,000 |
Common Class B | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 300,000 | 300,000 |
Common stock, shares issued (in shares) | 0 | 0 |
Consolidated Statement of Changes in Stockholders' Equity (Deficiency) (Parenthetical) - USD ($) |
12 Months Ended | |
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Dec. 31, 2024 |
Dec. 31, 2023 |
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Statement of Stockholders' Equity [Abstract] | ||
Unrealized gain (loss) on cash flow hedge, net of tax | $ 0 | $ 0 |
Reclassification of cash flow hedge to earnings, net of tax | $ 0 | $ 0 |
Nature of Operations |
12 Months Ended |
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Dec. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations Amneal Pharmaceuticals, Inc. (the “Company”) is a global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines. The Company’s Affordable Medicines segment includes retail generics, injectables, and biosimilars. In its Specialty segment, the Company offers a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through the Company’s AvKARE segment, it is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. The Company operates principally in the United States (“U.S.”), India, and Ireland. Refer to Note 25. Segment Information for an overview of our segments, including the change in segment name from “Generics” to “Affordable Medicines” during the fourth quarter of 2024. The Company is a holding company, whose principal assets are common units (“Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”). Immediately prior to the Reorganization (as defined herein), the Company held 50.4% of the Amneal Common Units and the group, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Members” or the “Amneal Group”) held the remaining 49.6%. On November 7, 2023, the Company implemented a plan pursuant to which the Company and Amneal reorganized and simplified the Company’s corporate structure by eliminating its umbrella partnership-C-corporation structure and converting to a more traditional C-corporation structure whereby all stockholders hold their voting and economic interests directly through the public company (the “Reorganization”). Effective with the Reorganization, the Company holds 100% of the Amneal Common Units. Following the implementation of the Reorganization, Amneal Pharmaceuticals, Inc. (“Old PubCo”) became a wholly owned subsidiary of a new holding company, Amneal NewCo Inc. (“New PubCo”), which replaced Old PubCo as the public company trading on the New York Stock Exchange under Old PubCo’s ticker symbol “AMRX.” In addition, New PubCo changed its name to “Amneal Pharmaceuticals, Inc.” and Old PubCo changed its name to “Amneal Intermediate, Inc.” In connection with the Reorganization, holders of shares of Class A common stock, par value $0.01 per share, of Old PubCo (“Old PubCo Class A Common Stock”) ceased to hold such shares and received an equivalent number of shares of Class A common stock, par value $0.01 per share, of New PubCo that have the same voting and economic rights as Old PubCo Class A Common Stock. Additionally, holders of shares of Class B common stock, par value $0.01 per share, of Old PubCo (“Old PubCo Class B Common Stock”), ceased to hold such shares and received an equivalent number of shares of Class A common stock, par value $0.01 per share, of New PubCo that have the same voting and economic rights as Old PubCo Class A Common Stock. All outstanding shares of Old PubCo Class B Common Stock were surrendered and canceled. Accordingly, upon consummation of the Reorganization, Old PubCo stockholders automatically became stockholders of New PubCo, on a one-for-one basis, with the same number and ownership percentage of shares they held in Old PubCo immediately prior to the effective time of the Reorganization. On December 27, 2023, the Company voluntarily withdrew the listing of its Class A common stock from the New York Stock Exchange and transferred the listing to the Nasdaq Stock Market LLC under the same name and ticker symbol.
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Summary of Significant Accounting Policies |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Accounting Principles The financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated. Principles of Consolidation The consolidated financial statements include the accounts of all entities controlled by the Company, including Amneal and its subsidiaries, through the Company’s direct or indirect ownership of a majority voting interest. The Company records non-controlling interests for the portion of its subsidiaries’ economic interests that it does not hold. Although the Company had a minority economic interest in Amneal prior to March 31, 2023, it was Amneal’s sole managing member (and it continues to be the sole managing member), having the sole voting power to make all of Amneal’s business decisions and control its management. Therefore, the Company also consolidated the financial statements of Amneal and its subsidiaries for all periods prior to the Reorganization. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP 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, contingent liabilities, 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. Revenue Recognition When assessing its revenue recognition, the Company performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies the performance obligation. The Company recognizes revenue when it transfers control of its products to customers, in an amount that reflects the consideration to which the Company expects to be entitled to receive in exchange for those products. From time to time, the Company may enter into arrangements where it licenses certain products to a third-party distributor. Licensing arrangement performance obligations generally include intellectual property (“IP”) rights and research and development (“R&D”) and contract manufacturing services. The Company accounts for IP rights and services separately if they are distinct. The consideration is allocated between IP rights and services based on their relative stand-alone selling prices. Revenue for distinct IP rights is accounted for based on the nature of the promise to grant the license. In determining whether the Company’s promise is to provide a right to access its IP or a right to use its IP, the Company considers the nature of the IP to which the customer will have rights. IP is either functional IP which has significant standalone functionality or symbolic IP which does not have significant standalone functionality. Revenue from functional IP is recognized at the point in time when control of the distinct license is transferred to the customer. Revenue from symbolic IP is recognized over the access period to the Company’s IP. Revenue from sales-based milestones and royalties promised in exchange for a license of IP is recognized only when, or as, the later of subsequent sale or the performance obligation to which some or all of the sales-based royalty has been allocated, is satisfied. For further details on the Company’s revenue recognition policies, refer to Note 4. Revenue Recognition. Stock-Based Compensation The Company’s stock-based compensation consists of stock options, restricted stock units (“RSUs”) and market performance-based restricted stock units (“MPRSUs”) awarded to employees and non-employee directors. Stock options are measured at their fair value on the grant date or date of modification, as applicable. RSUs, including MPRSUs, are measured at the stock price on the grant date or date of modification, as applicable. The Company recognizes compensation expense on a straight-line basis over the requisite service and/or performance period, as applicable. Forfeitures of awards are accounted for as a reduction in stock-based compensation expense in the period such awards are forfeited. The Company's policy is to issue new shares upon option exercises and the vesting of RSUs and MPRSUs. Contingent consideration Business acquisitions may include future payments that are contingent upon the occurrence of certain pharmaceutical regulatory milestones or net sales of pharmaceutical products. For acquisitions that are accounted for as a business combination, the obligations for such contingent consideration payments are recorded at fair value on the acquisition date. For contingent milestone payments, the Company uses a probability-weighted income approach utilizing an appropriate discount rate. For contingent tiered royalties on net sales, the Company uses a Monte Carlo simulation model. Contingent consideration liabilities are revalued to fair value at the end of each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in fair value of contingent consideration in the consolidated statements of operations. Refer to Note 3. Acquisition and Note 18. Fair Value Measurements for additional information. Foreign Currencies The Company has operations in the U.S., India, Ireland, and other foreign jurisdictions. Generally, the Company’s foreign operating subsidiaries’ functional currency is the local currency. The results of its non-U.S. dollar based operations are translated to U.S. dollars at the average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Translation adjustments are included in accumulated other comprehensive (loss) income and non-controlling interests in the consolidated balance sheets and are included in comprehensive loss. Transaction gains and losses are included in net loss in the Company’s consolidated statements of operations as a component of foreign exchange (loss) gain, net. Such foreign currency transaction gains and losses include fluctuations related to long-term intercompany loans that are payable in the foreseeable future. Translation gains and losses on intercompany balances of a long-term investment nature are included in foreign currency translation adjustments in accumulated other comprehensive (loss) income and non-controlling interests, and comprehensive loss. Business Combinations Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, the acquiring entity in a business combination records the assets acquired and liabilities assumed at the date of acquisition at their fair values. Any excess of the purchase price over the fair value of net assets and other identifiable intangible assets acquired is recorded as goodwill. Acquisition-related costs, primarily professional fees, are expensed as incurred. Cash and Cash Equivalents Cash and cash equivalents consist of cash on deposit and highly liquid investments with original maturities of three months or less. A portion of the Company’s cash flows are derived outside the U.S. As a result, the Company is subject to market risk associated with changes in foreign exchange rates. The Company maintains cash balances at both U.S.-based and international-based commercial banks. At various times during the year, cash balances in the U.S. may exceed amounts that are insured by the Federal Deposit Insurance Corporation. Restricted Cash At December 31, 2024 and 2023, the Company had restricted cash balances of $7.9 million and $7.6 million, respectively, in its bank accounts primarily related to the purchase of certain land and equipment in India. Accounts Receivable and Allowance for Credit Losses Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company limits its credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary. The Company does not require collateral to secure amounts owed to it by its customers. Trade accounts receivable are stated at their net realizable value. The allowance for credit losses reflects the best estimate of expected credit losses of the accounts receivable portfolio determined on the basis of historical experience, current information, and forecasts of future economic conditions. The Company determines its allowance methodology by pooling receivable balances at the customer level. The Company considers various factors, including its previous loss history, individual credit risk associated to each customer, and the current and future condition of the general economy. These credit risk factors are monitored on a quarterly basis and updated as necessary. To the extent that any individual debtor is identified whose credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics of such customer. The Company makes concerted efforts to collect all outstanding balances due from customers; however, account balances are charged off against the allowance when management believes it is probable the receivable will not be recovered. The Company does not have any off-balance-sheet credit exposure related to customers. Chargebacks Received from Manufacturers When a sale occurs on a contracted item, the difference between the cost the Company pays to the manufacturer of that item and the contract price that the end customer has with the manufacturer is rebated to the Company by the manufacturer as a chargeback. Chargebacks are recorded as a reduction to cost of sales and either a reduction in the amount due to the manufacturer (if there is a right of offset) or as a receivable from the manufacturer. Inventories Inventories consist of finished goods held for sale, raw materials, and work in process. Inventories are stated at net realizable value, with cost determined using the first-in, first-out method. Adjustments for excess and obsolete inventories are established based upon historical experience and management’s assessment of current product demand. These assessments include inventory obsolescence based on its expiration date, damaged or rejected product, and slow-moving products. Property, Plant, and Equipment Property, plant, and equipment are stated at historical cost less accumulated depreciation. Depreciation expense is computed primarily using the straight-line method over the estimated useful lives of the assets, which are as follows:
Upon retirement or disposal, the cost of the asset disposed and the accumulated depreciation are removed from the accounts, and any gain or loss is reflected as part of operating income (loss) in the period of disposal. Expenditures that significantly increase value or extend useful lives of property, plant, and equipment are capitalized, whereas those for normal maintenance and repairs are expensed. The Company capitalizes interest on borrowings during the construction period of major capital projects as part of the related asset and amortizes the capitalized interest into earnings over the related asset’s remaining useful life. Leases All significant lease arrangements are recognized as right-of-use (“ROU”) assets and lease liabilities at lease commencement. ROU assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of the future lease payments using the Company's incremental borrowing rate. Operating lease expense is recognized on a straight-line basis over the lease term. At each balance sheet date, operating and financing lease liabilities continue to represent the present value of the future payments. Financing lease ROU assets are expensed using the straight-line method, unless another basis is more representative of the pattern of economic benefit, to lease expense. Interest on financing lease liabilities is recognized in interest expense. Leases with an initial term of 12 months or less (short-term leases) are not recognized in the balance sheet and the related lease payments are recognized as incurred over the lease term. The Company separates lease and non-lease components. A portion of the Company's real estate leases are subject to periodic changes in the Consumer Price Index (“CPI”). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred. For further details regarding the Company's leases, refer to Note 17. Leases. In-Process Research and Development The fair value of in-process research and development (“IPR&D”) acquired in a business combination is determined based on the present value of each research project’s projected cash flows using an income approach. Revenues are estimated based on relevant market size and growth factors, expected industry trends, individual project life cycles and the life of each research project’s underlying marketability. In determining the fair value of each research project, expected cash flows are adjusted for certain risks of completion, including technical and regulatory risk. The value attributable to IPR&D projects at the time of acquisition is capitalized as an indefinite-lived intangible asset and tested for impairment until the project is completed or abandoned. Upon completion of the project, the indefinite-lived intangible asset is then accounted for as a finite-lived intangible asset and amortized over the estimated useful life of the asset based on the pattern in which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. If the project is abandoned, the indefinite-lived intangible asset is charged to expense. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance. Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value based test. The Company reviews goodwill for possible impairment annually during the fourth quarter, or whenever events or circumstances indicate that the carrying amount may not be recoverable. In order to test goodwill for impairment, an entity is permitted to first assess qualitative factors to determine whether a quantitative assessment of goodwill is necessary. The qualitative factors considered by the Company may include, but are not limited to, general economic conditions, the Company’s outlook, market performance of the Company’s industry and recent and forecasted financial performance. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that a reporting unit’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. If a quantitative assessment is required, the Company determines the fair value of its reporting unit using a combination of the income and market approaches. If the net book value of the reporting unit exceeds its fair value, the Company recognizes a goodwill impairment charge for the reporting unit equal to the lesser of (i) the total goodwill allocated to that reporting unit and (ii) the amount by which that reporting unit’s carrying amount exceeds its fair value. See Note 12. Goodwill and Other Intangible Assets, for further discussion of the Company's qualitative and quantitative assessments of goodwill. Assumptions and estimates used in the evaluation of impairment may affect the carrying value of long-lived assets, which could result in impairment charges in future periods. Such assumptions include projections of future cash flows and the current fair value of the asset. Amortization of Intangible Assets with Finite Lives Intangible assets, other than indefinite-lived intangible assets, are amortized over the estimated useful life of the asset based on the pattern in which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. The useful life is the period over which the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are not written-off in the period of acquisition unless they become impaired during that period. The Company regularly evaluates the remaining useful life of each intangible asset that is being amortized to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life. See Note 12. Goodwill and Other Intangible Assets for further discussion of the Company’s intangible assets. Impairment of Long-Lived Assets (Including Intangible Assets with Finite Lives) The Company reviews its long-lived assets, including intangible assets with finite lives, for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company evaluates assets for potential impairment by comparing estimated future undiscounted net cash flows to the carrying amount of the asset. If the carrying amount of the assets exceeds the estimated future undiscounted cash flows, impairment is measured based on the difference between the carrying amount of the assets and fair value, which is generally an expected present value cash flow technique. Management’s policy in determining whether an impairment indicator exists comprises measurable operating performance criteria as well as other qualitative measures. See Note 12. Goodwill and Other Intangible Assets for further discussion of the Company’s assessment of intangible asset impairments. Financial Instruments The Company minimizes its risks from interest fluctuations through its normal operating and financing activities and, when deemed appropriate through the use of derivative financial instruments. Derivative financial instruments are used to manage risk and are not used for trading or other speculative purposes. The Company does not use leveraged derivative financial instruments. Derivative financial instruments that qualify for hedge accounting must be designated and effective as a hedge of the identified risk exposure at the inception of the contract. Accordingly, changes in fair value of the derivative contract must be highly correlated with changes in fair value of the underlying hedged item at inception of the hedge and over the life of the hedge contract. All derivatives are recorded on the balance sheet as assets or liabilities and measured at fair value. For derivatives designated as cash flow hedges, the effective portion of the changes in fair value of the derivatives are recorded in accumulated other comprehensive (loss) income net of income taxes and subsequently amortized as an adjustment to interest expense over the period during which the hedged forecasted transaction affects earnings, which is when the Company recognizes interest expense on the hedged cash flows. Cash flows of such derivative financial instruments are classified consistent with the underlying hedged item. Highly effective hedging relationships that use interest rate swaps as the hedging instrument and that meet criteria under ASC 815, Derivatives and Hedging (“ASC 815”), may qualify for the “short-cut method” of assessing effectiveness. The short-cut method allows the Company to make the assumption of no ineffectiveness, which means that the change in fair value of the hedged item can be assumed to be equal to the change in fair value of the derivative. Unless critical terms change, no further evaluation of effectiveness is performed for these hedging relationships unless a critical term is changed. For a hedging relationship that does not qualify for the short-cut method, the Company measures its effectiveness using the “hypothetical derivative method”, in which the change in fair value of the hedged item must be measured separately from the change in fair value of the derivative. At inception and quarterly thereafter, the Company formally assesses whether the derivatives that are used in hedging transactions are highly effective in offsetting changes in the fair value or cash flows of the hedged item. The Company compares the change in the fair value of the actual interest rate derivative to the change in the fair value of a hypothetical interest rate derivative with critical terms that match the hedged interest rate payments. After the initial quantitative assessment, this analysis is performed on a qualitative basis and, if it is determined that the hedging relationship was and continues to be highly effective, no further analysis is required. All components of each derivative financial instrument's gain or loss are included in the assessment of hedge effectiveness. If it is determined that a derivative ceases to be a highly effective hedge, the Company discontinues hedge accounting and any deferred gains or losses related to a discontinued cash flow hedge shall continue to be reported in accumulated other comprehensive (loss) income net of income taxes, unless it is probable that the forecasted transaction will not occur. If it is probable that the forecasted transaction will not occur by the originally specified time period, the Company discontinues hedge accounting, and any deferred gains or losses reported in accumulated other comprehensive (loss) income are reclassified into earnings immediately. The Company is subject to credit risk as a result of nonperformance by counterparties to the derivative agreements. Upon inception and quarterly thereafter, the Company makes judgments on each counterparty’s creditworthiness for nonperformance by counterparties. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which requires the recognition of tax benefits or expenses on temporary differences between the financial reporting and tax bases of its assets and liabilities by applying the enacted tax rates in effect for the year in which the differences are expected to reverse. Such net tax effects on temporary differences are reflected on the Company’s consolidated balance sheets as deferred tax assets and liabilities. Deferred tax assets are reduced by a valuation allowance when the Company believes that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. ASC 740-10 prescribes a two-step approach for the recognition and measurement of tax benefits associated with the positions taken or expected to be taken in a tax return that affect amounts reported in the financial statements. The Company has reviewed and will continue to review the conclusions reached regarding uncertain tax positions, which may be subject to review and adjustment at a later date based on ongoing analyses of tax laws, regulations and interpretations thereof. To the extent that the Company’s assessment of the conclusions reached regarding uncertain tax positions changes as a result of the evaluation of new information, such change in estimate will be recorded in the period in which such determination is made. The Company reports income tax-related interest and penalties relating to uncertain tax positions, if applicable, as a component of income tax expense. Comprehensive Loss Comprehensive loss includes net loss and all changes in stockholders’ equity (except those arising from transactions with stockholders) including foreign currency translation adjustments resulting from the consolidation of foreign subsidiaries’ financial statements and unrealized (losses) gains on cash flows hedges, net of income taxes. Research and Development R&D activities are expensed as incurred. R&D expenses primarily consist of direct and allocated expenses incurred with the process of formulation, clinical research, and validation associated with new product development. Upfront and milestone payments made to third parties in connection with R&D collaborations are expensed as incurred up to the point of regulatory approval or when there is no alternative future use. Intellectual Property Legal Development Expenses The Company expenses external IP legal development expenses as incurred. These costs relate to legal challenges of innovator’s patents for invalidity or non-infringement, which are customary in the generic pharmaceutical industry, and are incurred predominately during development of a product and prior to regulatory approval. Associated costs include, but are not limited to, formulation assessments, patent challenge opinions and strategy, and litigation expenses to defend the IP supporting the Company's regulatory filings. Shipping Costs The Company records the costs of shipping product to its customers as a component of selling, general, and administrative expenses as incurred. Shipping costs were $18.9 million, $21.7 million and $18.7 million for the years ended December 31, 2024, 2023 and 2022, respectively. Advertising Costs Advertising costs are expensed as incurred. Advertising costs are included in selling, general and administrative expenses and were $34.4 million, $12.4 million, and $16.8 million for the years ended December 31, 2024, 2023 and 2022, respectively. Recently Adopted Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which provides improvements to reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 requires disclosures to include the title and position of the chief operating decision maker (“CODM”), significant segment expenses that are regularly provided to the CODM, a description of other segment items by reportable segment, and any additional measures of a segment’s profit or loss used by the CODM when deciding how to allocate resources. ASU 2023-07 also requires all annual disclosures currently required by Topic 280 to be included in interim periods. The Company adopted the annual and interim disclosure requirements of ASU 2023-07 effective December 31, 2024 (refer to Note 25. Segment Information). The adoption of this ASU only affects the Company’s disclosures, with no impact to its financial condition and results of operations. Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the transparency and usefulness of income tax disclosures. ASU 2023-09 requires that public business entities on an annual basis disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. The update is effective for fiscal years beginning after December 15, 2024, with early adoption permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements. In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain categories of expenses that are included in expense line items on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning December 15, 2027, with early adoption permitted. Upon adoption, ASU 2024-03 may be applied prospectively for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements. Reclassification The prior period balances related to the TRA (as defined in Note 6. Income Taxes) of $3.1 million and $0.6 million, formerly included in “Other income, net”, for the year ended December 31, 2023 and 2022, respectively, have been reclassified to the income statement caption “Increase in tax receivable agreement liability” to conform to the current period presentation in the consolidated statements of operations. This reclassification did not impact total other expense, net or net income. The prior period balance related to long-term liabilities for legal matters of $0.3 million, formerly included in “Other long-term liabilities” as of December 31, 2023, has been reclassified to the balance sheet caption “Liabilities for legal matters - long term” to conform to the current period presentation in the consolidated balance sheets. This reclassification did not impact total long-term liabilities or total liabilities.
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Acquisition |
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Dec. 31, 2024 | |||||||||||||||||||||||||
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |||||||||||||||||||||||||
Acquisition | Acquisition Saol Baclofen Franchise Acquisition On December 30, 2021, the Company entered into an asset purchase agreement with certain entities affiliated with Saol International Limited (collectively, “Saol”), a private specialty pharmaceutical company, pursuant to which it agreed to acquire Saol’s baclofen franchise, including Lioresal®, LYVISPAH™, and a pipeline product under development (the “Saol Acquisition”). The Saol Acquisition expanded the Company’s commercial institutional and specialty portfolio in neurology while adding 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 year ended December 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):
(1)The estimated fair value of contingent consideration on the acquisition date of $8.8 million 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 18. Fair Value Measurements for additional information on the methodology and determination of this liability. From the acquisition date of February 9, 2022 to December 31, 2022, the Saol Acquisition contributed net revenue and an operating loss of $19.8 million and $7.1 million, respectively. Acquisition, Transaction-Related and Integration Expenses For the year ended December 31, 2022, acquisition, transaction-related and integration expenses of $0.7 million primarily consisted of professional services fees associated with the Saol Acquisition.
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Revenue Recognition |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition | Revenue Recognition Pharmaceutical Product Sales Performance Obligations The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist primarily of major wholesalers, distributors, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies, institutions and pharmaceutical companies. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Customers purchase product by direct channel sales from the Company or by indirect channel sales through various distribution channels. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, 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. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product sales are subject to variable consideration, as described further below. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. Variable consideration includes but is not limited to: chargebacks, distribution fees, rebates, group purchasing organization (“GPO”) fees, prompt payment (cash) discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns, and profit shares. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Chargebacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is lower than the wholesaler pricing, the Company pays the direct customer (wholesaler) a chargeback for the price differential. The Company estimates its chargeback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to chargebacks, current contract terms and historical experience. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Rebates The Company pays fixed or volume-based rebates to its customers based on a fixed amount, fixed percentage of product sales or based on the achievement of a specified level of purchases. The Company’s rebate accruals are based on actual net sales, contractual rebate rates negotiated with customers, and expected purchase volumes / corresponding tiers based on actual sales to date and forecasted amounts. Group Purchasing Organization Fees The Company pays fees to GPOs for administrative services that the GPOs perform in connection with the purchases of product by the GPO participants who are the Company’s customers. The Company’s GPO fee accruals are based on actual net sales, contractual fee rates negotiated with GPOs and the mix of the products in the distribution channel that remain subject to GPO fees. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount accruals are based on actual net sales and contractual discount rates. Consideration Payable to the Customer The Company pays administrative and service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company accrues for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Billbacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is higher than contractual pricing, the Company pays the indirect customer a billback for the price differential. The Company estimates its billback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to billbacks, current contract terms and historical experience. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Medicaid and Other Government Pricing Programs The Company complies with required rebates mandated by law under Medicaid and other government pricing programs. The Company estimates its government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rates and estimated lag time of the rebate invoices. Price Protection and Shelf Stock Adjustments The Company provides customers with price protection and shelf stock adjustments which may result in an adjustment to the price charged for the product transferred, based on differences between old and new prices which may be applied to the customer’s on-hand inventory at the time of the price change. The Company accrues for these adjustments when its expected value of an adjustment is greater than zero, based on contractual pricing, actual net sales, accrual rates based on historical average rates, and estimates of the level of inventory of its products in the distribution channel that remain subject to these adjustments. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Sales Returns The Company permits the return of product under certain circumstances, mainly due to product expiration, instances of shipping errors or where product is damaged in transit, and occurrences of product recalls. The Company’s product returns accrual is primarily based on estimates of future product returns based generally on actual net sales, estimates of the level of inventory of its products in the distribution and retail channels that remain subject to returns, estimated lag time of returns and historical return rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Profit Shares For certain product sale arrangements, the Company earns a profit share upon the customer’s sell-through of the product purchased from the Company. The Company estimates its profit shares based on actual net sales by third parties, estimated inventory sold to our partners not yet sold by them, and historical rates of profit shares earned. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. 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 the percentages of net revenues from each of the Company's customers that individually accounted for 10% or more of its net revenues:
Disaggregated Revenue During the fourth quarter of 2024, the Company changed the presentation of disaggregated net revenue in its Affordable Medicines segment from a classification primarily based on significant therapeutic classes to a classification primarily based on significant dosage forms to reflect the full product offering of the segment. The new presentation did not change the composition of the Company’s reportable segments and, therefore, did not change historical total net revenue in any segment. All prior periods were changed to conform to the current period’s presentation. The Company’s significant dosage forms for its Affordable Medicines segment, therapeutic classes for its Specialty segment and sales channels for its AvKARE segment, as determined based on net revenue for the years ended December 31, 2024, 2023 and 2022, are set forth below (in thousands):
(1)Includes net revenue from sales of transmucosal, ophthalmic, topical, nasal and inhalation dosage forms. (2)Refer to Note 5. Alliance and Collaboration for information on revenue recognized under license agreements. A rollforward of the major categories of sales-related deductions for the years ended December 31, 2024, 2023 and 2022 is as follows (in thousands):
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Alliance and Collaboration |
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Dec. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Alliance and Collaboration | Alliance and Collaboration The 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 R&D services over multiple periods. The Company's significant arrangements are discussed below. Orion Corporation 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 our 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 at that date). Amneal is eligible to receive certain one-time sales-based milestones in the aggregate of €45.0 million, or $46.7 million (based on the exchange rate as of December 31, 2024) 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 will record 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. For the years ended December 31, 2024 and 2023, Amneal recognized $0.9 million and $0.5 million, respectively, as a reduction of R&D expense for reimbursable R&D activities under the Orion Agreement. 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 of $46.7 million are variable consideration and were not included in the transaction price because they were fully constrained under ASC 606. As of December 31, 2022, the Company had recorded a $21.4 million receivable in prepaid expenses and other current assets for the upfront payment due from Orion, which was received in January 2023. 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 year ended December 31, 2023, the Company recognized $0.9 million as a reduction to R&D expense related to services performed under the Orion Agreement. As of December 31, 2023, deferred income of $7.8 million and $4.7 million was recorded in accounts payable and accrued expenses and other long-term liabilities, respectively. During the year ended December 31, 2024, the Company recognized $4.0 million as a reduction to R&D expense related to services performed under the Orion Agreement. As of December 31, 2024, deferred income of $5.0 million and $3.5 million was recorded in accounts payable and accrued expenses and other long-term liabilities, respectively. As of December 31, 2024, no products have been supplied by Amneal under the Orion Agreement. ONGENTYS® License Agreement On December 5, 2023, the Company entered into a license agreement with BIAL-Portela & Ca., S.A. (“BIAL”) for the exclusive royalty-free right to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023 and ending at such time when generic opicapone sales reach certain predetermined thresholds (the “BIAL License Agreement”). ONGENTYS® is BIAL’s proprietary, once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor approved by the FDA in 2020 as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes. Under the BIAL Agreement, the Company is responsible for commercialization and marketing of ONGENTYS® in the U.S., and BIAL is responsible for manufacturing and supply. The BIAL Agreement also requires the Company to spend a minimum of $6.0 million in medical and marketing activities directly related to ONGENTYS® of which $5.7 million was expensed through December 31, 2024. The Company commenced distribution of ONGENTYS® in January 2024. During December 2023, the Company paid a nonrefundable license fee of $12.5 million to BIAL, which was capitalized as an intangible asset and will be amortized to cost of sales over a period of eight years. The BIAL License Agreement provides for potential future milestone payments totaling $22.5 million, depending on cumulative net sales of ONGENTYS®. Knight Therapeutics International S.A. License Agreement On January 24, 2024, the Company entered into a 15-year license, distribution and supply agreement with Knight Therapeutics International S.A. (“Knight”) granting Knight the exclusive rights to seek regulatory approval for and commercialize IPX203 in Canada and Latin America (the “Knight License Agreement”). The Knight License Agreement will automatically renew for successive two-year periods unless either party provides notice declining such renewal at least one year in advance. Knight will be responsible for the performance of all R&D activities, regulatory approval, commercialization, and marketing activities for the territories in the agreement to be conducted to obtain regulatory approval for each product. Upon achieving regulatory approval for products, Amneal will be responsible for manufacturing and supplying products to Knight. During the year ended December 31, 2024, the Company recorded net revenue of $2.0 million for payments received for a nonrefundable license fee and a regulatory milestone. The Knight License Agreement provides for potential future milestone payments totaling $9.5 million, contingent upon regulatory approval, launch dates and cumulative net sales targets by Knight. The agreement also includes low-double digit royalty payments based on net sales of IPX203. License Agreement with Zambon Biotech On February 23, 2024, the Company entered into a license, distribution and supply agreement with Zambon Biotech S.A. (“Zambon”) granting Zambon the exclusive rights to seek regulatory approval for and commercialize IPX203 in Europe (the “Zambon License Agreement”). The term for the Zambon License Agreement is 15 years commencing from the commercial launch of the product, which can automatically renew for successive two-year periods unless either party provides notice declining such renewal at least one year in advance. Zambon will be responsible for the performance of all R&D activities, regulatory approval, commercialization, and marketing activities for the territories in the agreement to be conducted to obtain regulatory approval for each product. Upon achieving regulatory approval for products, Amneal will be responsible for manufacturing and supplying products to Zambon. In connection with the execution of the agreement, the Company was entitled to a nonrefundable license fee of €5.0 million, or $5.4 million, which was received in April 2024. Of the license fee, the Company allocated €3.2 million, or $3.5 million, to the delivery of a functional license, which was recorded as net revenue during the year ended December 31, 2024. In September 2024, the Company received €1.5 million, or $1.6 million, for a regulatory milestone. Of the regulatory milestone, the Company allocated €1.0 million, or $1.0 million, to the delivery of a functional license, which was recorded as net revenue during the year ended December 31, 2024. In addition, the Company is eligible to receive future milestone payments totaling €70.0 million, or $72.7 million, as of December 31, 2024, from Zambon, contingent upon regulatory approval of the product, and achievement of certain annual net sales targets by Zambon. The Zambon License Agreement also includes single-digit to low-double digit royalty payments based on net sales of IPX203. Biosimilar Licensing and Supply Agreements Bevacizumab On May 7, 2018, the Company entered into a licensing and supply agreement with mAbxience S.L. (“mAbxience”), 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. The Company is the exclusive partner in the U.S. market. On April 13, 2022, the Food and Drug Administration (“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 during the year ended December 31, 2022, which were capitalized as product rights intangible assets and are being amortized to cost of sales over their estimated useful lives of seven years. On March 29, 2024, the Company paid a sales-based milestone of $9.5 million, which was capitalized as a product rights intangible asset and is being amortized to cost of sales. The agreement provides for potential future milestone payments to mAbxience of up to $14.0 million for commercial milestones. Denosumab On October 12, 2023, the Company entered into a licensing and supply agreement with mAbxience to be the exclusive U.S. partner for two denosumab biosimilars referencing both Prolia® and XGEVA®. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. mAbxience is responsible for the clinical and regulatory approval for the two products and regulatory fees will be shared by the parties. Upon approval of each product, mAbxience will be responsible for supply and the Company will be responsible for commercialization. During the year ended December 31, 2023, the Company recorded R&D expense for a $2.5 million payment made upon execution of the agreement and an additional $2.5 million for a developmental milestone. During the year ended December 31, 2024, the Company recorded R&D expense of $6.5 million for clinical, development and regulatory milestones. The agreement provides for potential additional future milestone payments to mAbxience of up to $62.5 million as follows: up to $15.0 million for regulatory approval and initial commercial launch milestones; and up to $47.5 million for the achievement of annual commercial milestones. Collaboration to Develop and Supply Medicines for Obesity and Metabolic Diseases On September 30, 2024, the Company and Metsera, Inc. (“Metsera”), a clinical stage biopharmaceutical company, entered into a collaboration agreement to develop and supply a new portfolio of weight loss medicines globally (the “Metsera Agreement”). The Company will serve as Metsera’s preferred supply partner for developed markets, including the United States and Europe. In addition, the Company has been granted an exclusive license to commercialize Metsera products covered under the agreement in selected emerging markets, including India and certain countries in Southeast Asia, Africa and the Middle East. Under the terms of the Metsera Agreement, the Company will be responsible for performing certain development activities on behalf of Metsera and will receive cost plus a margin, as defined. Upon Metsera obtaining regulatory approval for any or all the weight loss medicines referred to above, the Company will manufacture commercial products on behalf of Metsera for cost plus a margin, as defined. The Company is also entitled to a tiered quarterly earn-out calculated as a low-single digit percentage of Metsera’s gross profit, as defined in the Metsera Agreement. The Company plans to construct two new greenfield manufacturing facilities (the “Manufacturing Facilities”) in India: one for peptide synthesis and one for sterile fill-finish manufacturing. Metsera will contribute an agreed percentage of the construction costs, up to $100 million, subject to annual maximums, as defined. In consideration for the funding by Metsera, the Company will (i) provide a rebate on the price of each unit of commercial injectable product produced by the Company and purchased by Metsera and (ii) provide a payment to Metsera for each unit of commercial product manufactured on behalf of itself or third parties using the Manufacturing Facilities, in aggregate, up to the amount funded by Metsera for construction costs. The initial term of the Metsera Agreement is seven years from the first commercial sale. Metsera has the sole right to renew the agreement for an additional five-year period. Following this initial renewal, the agreement may be extended by mutual written consent. The Metsera Agreement did not have a material impact on the Company’s consolidated financial statements as of and for the year ended December 31, 2024. Agreements with Kashiv Biosciences, LLC For detail on the Company’s related party agreements with Kashiv Biosciences, LLC, refer to Note 23. Related Party Transactions.
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Income Taxes |
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Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | Income Taxes Amneal is a limited liability company that is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, Amneal is not subject to U.S. federal and certain state and local income taxes. Any taxable income or loss generated by Amneal is passed through to and included in the taxable income or loss of its members, including the Company, on a pro rata basis subject to applicable tax regulations. The Company is subject to U.S. federal income taxes, in addition to state and local income taxes with respect to its allocable share of any taxable income or loss of Amneal, as well as any stand-alone income or loss generated by the Company. Amneal provides for income taxes in the various foreign jurisdictions in which it operates. Effective with the Reorganization on November 7, 2023, the Company and a wholly-owned subsidiary are the only members of Amneal. The Company records its valuation allowances against its deferred tax assets (“DTAs”) when it is more likely than not that all or a portion of a DTA will not be realized. The Company routinely evaluates the realizability of its DTAs by assessing the likelihood that its DTAs will be recovered based on all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, estimates of future taxable income, tax planning strategies and results of operations. The Company established a valuation allowance 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 December 31, 2024. As a result of the losses through December 31, 2024, 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 December 31, 2024, this valuation allowance was $590.3 million, and it reduced the carrying value of these gross DTAs, net of the impact of the reversal of taxable temporary differences, to zero. In 2018, the Company entered into a tax receivable agreement (“TRA”) with the Members pursuant to which it was generally required to pay the Members, on a one-to-one basis, 85% of the applicable tax savings, if any, in U.S. federal and state income tax that it is deemed to realize as a result of certain tax attributes of their Amneal common units sold to the Company (or exchanged in a taxable sale) and that were created as a result of (i) the sales of their Amneal common units for shares of Class A common stock of the Company prior to the Reorganization (as defined in Note 1. Nature of Operations) and (ii) tax benefits attributable to payments made under the TRA. As part of the Reorganization, the TRA was amended to reduce the Company’s future obligation to pay 85% of the tax benefits subject to the TRA to 75% of such realized benefits. The Reorganization’s amendment to the agreement will not cause the acceleration of TRA payments. In conjunction with the valuation allowance recorded on the DTAs, the Company reversed the entire accrued TRA liability of $192.8 million during 2019. The Company did not record a TRA liability as of December 31, 2021, 2020, and 2019 because future TRA payments were not probable and estimable. Payments made under the TRA represent amounts that otherwise would have been due to taxing authorities in the absence of attributes obtained by the Company as a result of the sales or exchanges of Amneal common units discussed above. Such amounts will be paid after cash tax savings are realized from the TRA attributes. Payments under the TRA are only expected to be made in periods following the filing of a tax return in which the Company is able to utilize certain tax benefits to reduce its cash taxes paid to a taxing authority. For the years ended December 31, 2024, 2023, and 2022, the Company recorded expenses associated with the TRA in total other expense, net of $50.7 million, $3.1 million, and $0.6 million, respectively, as a result of the realization of cash tax savings from the TRA attributes for those years. As of December 31, 2024 and 2023, the Company had TRA liabilities of $53.9 million and $3.7 million, respectively (refer to Note 23. Related Party Transactions for the current and long-term portions of the TRA liability). The Company’s cumulative cash tax benefit recorded through December 31, 2024 associated with the TRA was approximately $72.3 million, of which the Company recognized cumulative expenses under the TRA of $54.4 million. As noted above, the Company has determined it is more-likely-than-not it will be unable to utilize its DTAs subject to the TRA; therefore, as of December 31, 2024, the Company had not recognized the contingent liability under the TRA related to the tax savings it may realize in future years from Amneal common units sold or exchanged. If utilization of these DTAs becomes more-likely-than-not in the future, at such time, the unrecorded contingent TRA liability (which amounted to $133.8 million as of December 31, 2024) will be recorded through charges in the Company’s consolidated statements of operations. If the TRA attributes are not utilized in future years, it is reasonably possible no amounts would be paid under the TRA in excess of the $53.9 million accrued as of December 31, 2024. The timing and amount of any payments under the TRA may vary, depending upon a number of factors including the timing and amount of the Company’s taxable income, and the corporate tax rate in effect at the time of realization of the Company’s taxable income. The timing and amount of payments may also be accelerated under certain conditions, such as a change of control or other early termination event, which could give rise to the Company being obligated to make TRA payments in advance of tax benefits being realized. For the years ended December 31, 2024, 2023 and 2022 the Company's provision for income taxes and effective tax rates were $18.9 million and (34.3)%, $8.5 million and (21.0)%, and $6.7 million and (2.7)%, respectively. The Company and its subsidiaries file income tax returns in the U.S. federal, and various state, local and foreign jurisdictions. In the U.S., income tax returns are generally subject to examination for a period of three years. The majority of states in which the Company files income tax returns follow the three-year U.S. federal statute of limitations, and a few states have a four-year statute of limitations in which to assess state taxes four years after the return is filed. Because the Company has unused state NOL carryovers generated more than three or four years ago, the relevant state taxing authorities may audit and adjust otherwise closed carryover tax years to the extent such NOL carryover is utilized in an open year. Neither the Company nor any of its other affiliates is currently under audit by the Internal Revenue Service. The Amneal partnership is currently under examination in certain states and the Company does not expect any material adjustments as of December 31, 2024. The components of the Company's (loss) income before income taxes were as follows (in thousands):
The provision for (benefit from) income taxes was comprised of the following (in thousands):
For the years ended December 31, 2024, 2023, and 2022, the Company did not record a provision for deferred income taxes as a result of recording a full valuation allowance on its DTAs. The Company’s effective tax rates were as follows:
The change in effective income tax rate for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily due to the timing and jurisdictional mix of income and the exit of the umbrella partnership-C-corporation structure as a result of the Reorganization (refer to Note 1. Nature of Operations), which has the effect of allocating all of the operating company’s income to the corporate parent. The change in effective income tax rate for the year ended December 31, 2023 compared to the year ended December 31, 2022 was primarily due to the timing and mix of income and the reversal of liabilities for uncertain tax positions in 2022. The following table summarizes the changes in the Company’s valuation allowance on deferred tax assets (in thousands):
At December 31, 2024, the Company had approximately $167.4 million of foreign net operating loss carryforwards. These net operating loss carryforwards will partially expire, if unused, between 2029 and 2033. At December 31, 2024, the Company had approximately $19.0 million of federal and $147.3 million of state net operating loss carry forwards. The federal net operating losses are generally allowed to be carried forward indefinitely, and the majority of the state net operating losses will expire, if unused, between 2032 and 2042. At December 31, 2024, the Company had approximately $7.1 million of federal R&D credit carry forwards and $12.3 million of state R&D credit carry forwards. The majority of the federal R&D credit carry forwards will expire if unused, between 2038 and 2044, and the majority of state credits will expire if unused by 2037. At December 31, 2024, the Company had approximately $5.0 million of federal capital loss carry forwards, which will expire, if unused, in 2028. The tax effects of temporary differences that give rise to deferred taxes were as follows (in thousands):
The Company's Indian subsidiaries are primarily export-oriented, and the tax holiday benefits provided by the Indian government for export activities within Special Economic Zones (“SEZ”) expired in March 2023. Without availing the SEZ benefit in India, the Company is eligible to claim a reduced tax rate of approximately 25.17%. The Company accounts for income tax contingencies using the benefit recognition model. The Company will recognize a benefit if a tax position is more likely than not to be sustained upon audit, based solely on the technical merits. The benefit is measured by determining the amount that is greater than 50% likely of being realized upon settlement, presuming that the tax position is examined by the appropriate taxing authority that has full knowledge of all relevant information. The amount of unrecognized tax benefits at December 31, 2024, 2023, and 2022, was $3.9 million, $3.7 million and $3.6 million, respectively, of which $3.9 million, $3.6 million and $3.5 million, respectively, would impact the Company’s effective tax rate if recognized. The Company currently does not believe that the total amount of unrecognized tax benefits will increase or decrease significantly over the next 12 months. Interest expense related to income taxes is included in provision for income taxes. Net interest expense (benefit) related to unrecognized tax benefits for the years ended December 31, 2024 and 2022 was $0.8 million and $(0.7) million, respectively (minimal for the year ended December 31, 2023). Accrued interest expense as of December 31, 2024, 2023, and 2022 was $0.9 million, $0.1 million, and $0.1 million, respectively. Income tax penalties are included in provision for income taxes. Accrued tax penalties as of December 31, 2024, 2023 and 2022 were immaterial. A rollforward of unrecognized tax benefits for the years ended December 31, 2024, 2023 and 2022 is as follows (in thousands):
In India, the income tax returns for the fiscal years ending March 31, 2022 and 2023 are currently being reviewed by tax authorities as part of the normal procedures, and the Company is not expecting any material adjustments. There are no other income tax returns in the process of examination, administrative appeal, or litigation. Income tax returns are generally subject to examination for a period of three years, five years, and four years after the tax year in India, Switzerland, and Ireland, respectively. Applicable foreign taxes (including withholding taxes) have not been provided on the approximately $137.8 million of undistributed earnings of foreign subsidiaries as of December 31, 2024. These earnings have been and currently are considered to be indefinitely reinvested. Quantification of additional taxes that may be payable on distribution is not practicable. The Company continuously monitors government proposals to make changes to tax laws, including comprehensive tax reform in the U.S. and proposed legislation in certain foreign jurisdictions resulting from the adoption of the Organization for Economic Cooperation and Development (“OECD”) policies. If legislative changes are enacted in other countries, any of these proposals may include increasing or decreasing existing statutory tax rates. A change in statutory tax rates in any country would result in the revaluation of Amneal’s deferred tax assets and liabilities related to that particular jurisdiction in the period in which the new tax law is enacted. As a U.S. company with subsidiaries in, among other countries, India, Switzerland, Ireland and the U.K, we carefully evaluate how many of these many countries are implementing legislation and other guidance to align their international tax rules with the OECD Base Erosion and Profit Shifting recommendations and action plan that aim to standardize and modernize global corporate tax policy, including changes to cross-border tax, transfer pricing documentation rules, and nexus-based tax incentive practices. The OECD has issued a two-pillar approach to global taxation, focusing on global profit allocation and a global minimum tax rate. The “Pillar One” global profit allocation proposal would not apply to the Company, since it generally applies to companies with global revenues exceeding €20 billion (approximately $21 billion using the exchange rate as of December 31, 2024). The “Pillar Two” proposal focuses on a global minimum tax of at least 15%. Legislation for the “Pillar Two” proposal, applying to the Company, has been enacted in Ireland, and became effective with the financial year beginning on January 1, 2024. As the tax rates of the other jurisdictions in which the Company operates exceed 15%, the Company does not believe there is any potential additional exposure besides in Ireland. The Company assessed that no top-up tax under Pillar 2 of the OECD Inclusive Framework on Base Erosion and Profit Shifting is expected to be due for the year ended December 31, 2024. This assessment is based on the application of safe harbor provisions available in all relevant jurisdictions including UK, Germany, Ireland, Switzerland, U.S. and India. Since Pillar Two taxes are an alternative minimum tax, deferred taxes will not need to be recorded or remeasured. Instead, Pillar Two taxes will be expensed as incurred.
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Loss per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss per Share | Loss per Share Following the implementation of the Reorganization on November 7, 2023 (refer to Note 1. Nature of Operations for additional information), all outstanding shares of Old PubCo Class A Common Stock and Old PubCo Class B Common Stock were exchanged for an equivalent number of shares of Class A common stock of the Company. Basic loss per share of Class A common stock was 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 was 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, adjusted to give effect to potentially dilutive securities. The weighted-average number of shares of Class A common stock for all periods prior to the Reorganization includes shares of Old PubCo Class A Common Stock. 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):
Prior to the Reorganization, shares of Old PubCo Class B Common Stock did not share in the earnings or losses of the Company and, therefore, were not participating securities. As such, separate presentation of basic and diluted loss per share of Old PubCo Class B Common Stock under the two-class method was not presented. Effective with the Reorganization, all outstanding shares of Old PubCo Class B Common Stock were surrendered and canceled. The following table presents potentially dilutive securities excluded from the computations of diluted loss per share of Class A common stock (in thousands):
(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. (2)Shares of Old PubCo Class B Common Stock were considered potentially dilutive shares of Class A common stock. Shares of Old PubCo Class B Common Stock were excluded from the computations of diluted loss per share of Class A common stock for the year ended December 31, 2022 because the effect of their inclusion would have been anti-dilutive under the if-converted method.
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Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade Accounts Receivable, Net | Trade Accounts Receivable, Net Trade accounts receivable, net is comprised of the following (in thousands):
(1) Refer to Note 4. Revenue Recognition for additional information. Concentration of Receivables Trade accounts receivables from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
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Inventories |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories Inventories are comprised of the following (in thousands):
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Prepaid Expenses and Other Current Assets |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 are comprised of the following (in thousands):
(1)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.
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Property, Plant, and Equipment, Net |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant, and Equipment, Net | Property, Plant, and Equipment, Net Property, plant, and equipment, net was comprised of the following (in thousands):
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Goodwill and Other Intangible Assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets The changes in goodwill by segment were as follows (in thousands):
Annual Goodwill Impairment Test The Company performed a quantitative annual goodwill impairment test for each reporting unit on October 1, 2024, the measurement date. The analysis performed included estimating the fair value of each reporting unit using both the income and market approaches. Based on the results of the annual impairment test, the Company determined that the estimated fair values of the Affordable Medicines, Specialty and AvKARE reporting units exceeded their respective carrying amounts as of the measurement date; therefore, the Company did not record an impairment charge for the year ended December 31, 2024. There were no indicators of goodwill impairment during the year ended December 31, 2024, including the period subsequent to the measurement date. In performing the quantitative annual goodwill impairment test, the Company utilized long-term growth rates for its reporting units ranging from no growth to 1.0% and a discount rate ranging from 10.5% to 14.0% in its estimation of fair value. As of October 1, 2024, the estimated fair value of the Affordable Medicines reporting unit was in excess of its carrying value by approximately 112%, the estimated fair value of the Specialty reporting unit was in excess of its carrying value by approximately 113%, and the estimated fair value of the AvKARE reporting unit was in excess of its carrying value by approximately 728%. A 500-basis point increase in the assumed discount rates utilized in each test would not have resulted in a goodwill impairment charge in any of the Company's reporting units. While management believes the assumptions used were reasonable and commensurate with the views of a market participant, changes in key assumptions for these reporting units, including increasing the discount rate, lowering forecasts for revenue and operating margin or lowering the long-term growth rate, could result in a future goodwill impairment. Intangible assets were comprised of the following (in thousands):
For the year ended December 31, 2024, intangible asset impairment charges were immaterial. For the year ended December 31, 2023, the Company recognized a total of $66.9 million of intangible asset impairment charges, of which $36.1 million was recognized in cost of goods sold and $30.8 million was recognized in in-process research and development impairment charges. Cost of sales impairment charges for the year ended December 31, 2023 of $36.1 million primarily related to a reduction in promotional focus on LYVISPAH™, resulting in significantly lower than forecasted future cash flows. IPR&D impairment charges for the year ended December 31, 2023 of $30.8 million were related to one Affordable Medicines asset and one Specialty asset, both of which experienced adverse clinical trials results in the fourth quarter of 2023 and resulted in significantly lower than expected future cash flows. For the year ended December 31, 2022, the Company recognized a total of $24.1 million of intangible asset impairment charges, of which $11.1 million was recognized in cost of goods sold and $13.0 million was recognized in in-process research and development impairment charges. Cost of sales impairment charges for the year ended December 31, 2022 of $11.1 million related to currently marketed products of which (i) one product experienced significant price erosion during 2022, resulting in significantly lower than expected future cash flows and negative margins, (ii) the supply agreement of one product was terminated during 2022 and therefore the asset was not recoverable and (iii) one product was no longer expected to be sold to a key customer, and therefore the asset was not recoverable. IPR&D impairment charges for the year ended December 31, 2022 of $13.0 million related to (i) one asset that experienced a delay in its expected launch date and (ii) one asset that experienced significant expected price erosion, both of which resulted in significantly lower than expected future cash flows. Amortization expense related to intangible assets for the years ended December 31, 2024, 2023 and 2022 was $173.6 million, $163.2 million and $172.1 million, respectively. The following table presents future amortization expense for the next five years and thereafter, excluding $14.3 million of IPR&D intangible assets (in thousands):
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Other Assets |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Assets | Other Assets Other assets were comprised of the following (in thousands):
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Accounts Payable and Accrued Expenses |
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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):
(1)Refer to Note 4. Revenue Recognition for additional information.
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Debt |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt | Debt The following is a summary of the Company’s term loan indebtedness (in thousands):
Overview of Amneal Credit Facilities On May 4, 2018 the Company entered into a Term Loan Credit Agreement (the “Term Loan Credit Agreement”) that provided a term loan (“Term Loan Due 2025”) with a principal amount of $2.7 billion and an asset backed revolving credit facility (“Revolving Credit Facility”) under which loans and letters of credit up to a principal amount of $500.0 million were available (principal amount of up to $25.0 million was available for letters of credit). On June 2, 2022, the Company entered into a revolving credit agreement (the “New Credit Agreement”) that terminated the lender commitments under the Revolving Credit Facility, and replaced them with a new $350.0 million senior secured revolving credit facility that matures on June 2, 2027 (the “New Revolving Credit Facility”). In addition, the New Credit Agreement (i) provided for up to $25.0 million for the purpose of issuing letters of credit, (ii) provided for up to $35.0 million for the purpose of issuing swingline loans, and (iii) allowed the Company to request an incremental increase in the revolving facility commitments by up to $150.0 million. On November 14, 2023, the Company and certain existing consenting lenders under the Term Loan Credit Agreement entered into an amendment to the Term Loan Due 2025 (the “New Term Loan Credit Agreement”). As a result of this transaction (the “Refinancing”), the Company exchanged and refinanced $2.35 billion of the $2.54 billion of principal then outstanding under the Term Loan Due 2025, at par, for new term loans that mature on May 4, 2028 (the “Term Loan Due 2028”). After the Refinancing, the principal remaining on the Term Loan Due 2025 was $192.0 million. 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 with its Term Loan Due 2025. In connection with the Refinancing, the Company amended this interest rate agreement. For further details on this, refer to Note 19. Financial Instruments. Additionally on November 14, 2023, the Company entered into an amendment to the New Revolving Credit Facility (the “Amended New Revolving Credit Facility”), pursuant to which certain lenders agreed to increase their commitments such that the aggregate revolving commitments increased to up to $600.0 million. The Term Loan Due 2028, Term Loan Due 2025, Amended New Revolving Credit Facility, New Revolving Credit Facility and Revolving Credit Facility are collectively referred to as the “Senior Secured Credit Facilities”. The proceeds of any loans made under the Senior Secured Credit Facilities can be used for capital expenditures, acquisitions, working capital needs and other general purposes, subject to covenants as described below. Amneal Term Loans Term Loan Due 2025 The Term Loan Due 2025 required principal repayments in equal quarterly installments at a rate of 1.00% of the original principal amount annually, with the balance payable at maturity on May 4, 2025. Subject to the refinancing on November 14, 2023, the Company is no longer required to repay quarterly principal installments, and as a result, the Company was required to repay the remaining principal balance of $192.0 million at maturity on May 4, 2025. In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. Prior to May 31, 2023, the variable annual interest rate of the Term Loan Due 2025 was a LIBOR-designated rate plus 3.5%. On May 31, 2023, the Company executed an amendment to the Term Loan Due 2025, which changed the variable reference rate from LIBOR to the one-month adjusted term secured overnight financing rate (“SOFR”), subject to a floor of (0.11448%) plus 3.5%. After adopting ASC 848, Reference Rate Reform and electing certain applicable practical expedients, this amendment did not have a material impact on the Company’s consolidated financial statements for the year ended December 31, 2023. As of December 31, 2024, the interest rate for borrowings under the Term Loan Due 2025 was approximately 8.0%. The Term Loan Due 2025 was recorded in the balance sheet net of issuance costs. In 2018, the Company incurred costs associated with the Term Loan Due 2025 of $38.1 million, which were capitalized and amortized over the life of the Term Loan Due 2025 to interest expense using the effective interest method. Subject to the amendment to the Term Loan Due 2025, unamortized debt issuance costs of $0.6 million and $7.3 million were allocated on a pro rata basis to the Term Loan Due 2025 and Term Loan Due 2028, respectively. The remaining unamortized debt issuance costs will be amortized over the life of the Term Loan Due 2025 to interest expense using the effective interest method. Amortization of debt issuance costs related to the Term Loan Due 2025 was not material for the year ended December 31, 2024. For the years ended December 31, 2023 and 2022, amortization of debt issuance costs related to the Term Loan Due 2025 were $4.7 million and $5.4 million, respectively. Refinancing and Term Loan Due 2028 The Term Loan Due 2028 is repayable in equal quarterly installments in an amount equal to 2.50% per annum of the original principal amount thereof, with the remaining balance due at final maturity on May 4, 2028. Interest is payable on borrowings under the Term Loan Due 2028 at a rate equal to the term SOFR benchmark rate or the base rate, plus an applicable margin, in each case, subject to a term SOFR benchmark rate floor of 0.00% or a base rate floor of 1.00%, as applicable. The applicable margin for borrowings under the Term Loan Due 2028 is 5.50% per annum for term SOFR benchmark rate loans and 4.50% per annum for base rate loans. As of December 31, 2024, the interest rate for borrowings under the Term Loan Due 2028 was approximately 9.9%. The Refinancing involved multiple lenders that were considered members of a loan syndicate. In determining whether the refinancing of the Term Loan Due 2025 was to be accounted for as a debt extinguishment or a debt modification, the Company considered whether creditors remained the same or changed and whether the changes in debt terms were substantial, on a lender-by-lender basis, in accordance with the guidance in ASC 470, Debt. As a result of this analysis, the Company legally has separate loans from each lender in the syndicate of the Term Loan Due 2028 and each lender has a contractual right to payments from the Company. The Company concluded that, on a lender-by-lender basis, debt held by 99% of the lenders included in the Refinancing is considered modified, with the remaining debt held by lenders considered to be extinguished. In accordance with ASC 470, Debt, the Company capitalized costs of $118.6 million associated with the Term Loan Due 2028, primarily comprised of lender fees, which were combined with $7.3 million of unamortized debt issuance costs associated with the Term Loan Due 2025 (as discussed above), both to be amortized to interest expense over the life of the Term Loan Due 2028 using the effective interest method. In connection with the Refinancing, the Company recognized a loss of $40.8 million for the year ended December 31, 2023, which was primarily comprised of debt issuance costs associated with the portion of the Term Loan Due 2025 that was modified. For the years ended December 31, 2024 and 2023, amortization of debt issuance costs related to the Term Loan Due 2028 was $24.3 million and $2.9 million, respectively. The borrowings under the Term Loan Due 2028 are guaranteed by certain wholly-owned subsidiaries of the Company that also guarantee the Term Loan Due 2025 (together with the Company, the “Loan Parties”). The Loan Parties’ obligations under the New Term Loan Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in (i) all tangible and intangible assets of the Loan Parties, except for certain excluded assets, and (ii) all of the equity interests of the subsidiaries of the Loan Parties (except for certain excluded subsidiaries and excluded assets and limited, in the case of the voting equity interests of certain foreign subsidiaries and certain domestic subsidiaries that hold no assets other than equity interests of foreign subsidiaries, to 65% of the voting equity interests of such subsidiaries). New Credit Agreement, New Revolving Credit Facility and Amended New Credit Facility The New Revolving Credit Facility bears an interest rate equal to the alternate base rate (“ABR”) or SOFR, plus an applicable margin, in each case, subject to an ABR floor of 1.00% or a SOFR floor of 0.00%, as applicable. The applicable margin for the New Revolving Credit Facility was initially 0.25% per annum for ABR loans and 1.25% per annum for SOFR loans. The applicable margin on borrowings under the New Revolving Credit Facility thereafter adjusts, ranging from 0.25% to 0.50% per annum for ABR loans and from 1.25% to 1.50% per annum for SOFR loans determined by the average historical excess availability. The Company paid a commitment fee based on the average daily unused amount of the New Revolving Credit Facility at a rate of 0.25% per annum. The Amended New Revolving Credit Facility bears interest rate consistent with the New Revolving Credit Facility. The maturity date of the Amended New Revolving Credit Facility is June 2, 2027, subject to a springing maturity in certain circumstances set forth in the Amended New Revolving Credit Facility. The Company incurred costs associated with the Revolving Credit Facility of $4.6 million, which were capitalized and are being amortized over the life of the agreement. Subject to the June 2, 2022 refinancing, there was a decrease in the borrowing capacity of certain lenders between the New Revolving Credit Facility and the Revolving Credit Facility. As a result, the Company recorded a $0.3 million charge for the year ended December 31, 2022 in loss on refinancing. Additionally, the Company incurred costs of $1.6 million associated with the New Credit Agreement, which were capitalized as deferred financing costs with the remaining unamortized costs associated with the Revolving Credit Facility, and were amortized over the life of the New Credit Agreement. Subject to the November 14, 2023 amendment, there was an increase in the borrowing capacity of all lenders between the Amended New Revolving Credit Facility and the New Revolving Credit Facility. The Company incurred costs of $2.4 million associated with the Amended New Revolving Credit Facility, which were capitalized as deferred financing costs with the remaining unamortized costs associated with the New Revolving Credit Facility, and will be amortized over the life of the Amended New Credit Agreement. Costs associated with the Amended New Revolving Credit Facility and the New Revolving Credit Facility have been recorded in other assets. For the years ended December 31, 2024, 2023 and 2022, amortization of deferred financing costs were $1.1 million, $0.5 million and $0.7 million, respectively. During the year ended December 31, 2024, the Company borrowed $20.0 million and repaid $99.0 million under the Amended New Revolving Credit Facility. As of December 31, 2024, the Company had $100.0 million in borrowings and $495.2 million of available capacity under the Amended New Revolving Credit Facility (principal amount of up to $20.2 million remained available for letters of credit). As discussed above, in January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. As of December 31, 2023, the Company had $179.0 million in borrowings and $225.2 million of available capacity under the Amended New Revolving Credit Facility (principal amount of up to $20.9 million remained available for letters of credit). Covenants to the Senior Secured Credit Facilities The Senior Secured Credit Facilities contain a number of covenants that, among other things, create liens on Amneal’s and its subsidiaries’ assets. The Senior Secured Credit Facilities contain certain negative covenants that, among other things and subject to certain exceptions, restrict Amneal’s and its subsidiaries’ ability to incur additional debt or guarantees, grant liens, make loans, acquisitions or other investments, dispose of assets, merge, dissolve, liquidate or consolidate, pay dividends or other payments on capital stock, make optional payments or modify certain debt instruments, modify certain organizational documents, enter into arrangements that restrict the ability to pay dividends or grant liens, or enter into or consummate transactions with affiliates. The Senior Secured Credit Facilities contain customary events of default, subject to certain exceptions. Upon the occurrence of certain events of default, the obligations under the Senior Secured Credit Facilities may be accelerated and the commitments may be terminated. In addition, the Amended New Revolving Credit Facility also included a financial covenant whereby the Company was required to maintain a minimum fixed-charge coverage ratio if certain borrowing conditions were met. At December 31, 2024, Amneal was in compliance with all covenants associated with the Senior Secured Credit Facilities. Annually, the Company is also required to calculate the amount of excess cash flows, as defined in the Term Loan Credit Agreement and New Term Loan Credit Agreement. Based on the results of the excess cash flows calculation for the years ended December 31, 2024, 2023 and 2022, no additional principal payments were due. Rondo Credit Facilities and Note Payable - Related Party Rondo Acquisitions Financing - Revolving Credit and Term Loan Agreement On January 31, 2020, in connection with the Rondo Acquisitions, Rondo Intermediate Holdings, LLC (“Rondo Holdings”), a wholly-owned subsidiary of Rondo Holdings, LLC, entered into a revolving credit and term loan agreement (“Rondo Credit Facility”) that provided a term loan (“Rondo Term Loan”) with a principal amount of $180.0 million and a revolving credit facility (“Rondo Revolving Credit Facility”), which loaned up to a principal amount of $30.0 million. During the year ended December 31, 2023, the Company paid the remaining outstanding principal under the Rondo Term Loan from cash on hand. The Rondo Credit Facility bore a variable annual interest rate, which originated as one-month LIBOR plus 3.0%. On April 30, 2023, the Company executed an amendment to the Rondo Revolving Credit Facility, which changed the variable reference rate in the Rondo Term Loan from LIBOR to the one-month adjusted term SOFR, subject to a floor of 0.1% plus 2.25%. This amendment to the Rondo Revolving Credit Facility did not have a material impact on the Company’s consolidated financial statements for the year ended December 31, 2023. On September 21, 2023, the Company executed an amendment to the Rondo Revolving Credit Facility (the “Amended Rondo Revolving Credit Facility”) that, among other things, (i) increased the aggregate revolving commitment from $30.0 million to $70.0 million, and (ii) increased the letter of credit commitment from $10.0 million to $60.0 million. The Amended Rondo Revolving Credit Facility bears a variable annual interest rate, which did not change as a result of this amendment, of one-month adjusted term SOFR, subject to a floor of 0.1% plus 2.25%. On December 16, 2024, the Company executed an amendment to the Amended Rondo Revolving Credit Facility to extend the maturity from January 31, 2025 to April 30, 2025. No other material changes were made to the terms of the Revolving Credit facility. At December 31, 2024, the variable annual interest rate was one-month SOFR plus 2.5%. Additionally, the annual interest rate for borrowings under the Amended Rondo Revolving Credit Facility may be reduced or increased by 0.25% based on step-downs and step-ups determined by the total net leverage ratio, as defined in that agreement. A commitment fee based on the average daily unused amount of the Amended Rondo Revolving Credit Facility is assessed at a rate based on total net leverage ratio, between 0.25% and 0.50% per annum. At December 31, 2024, the Amended Rondo Revolving Credit Facility commitment fee rate was 0.25% per annum. Costs associated with the Amended Rondo Revolving Credit Facility of $0.6 million were capitalized and amortized over the life of the facility to interest expense using the effective interest method. Costs associated with the Amended Rondo Revolving Credit Facility were recorded in other assets. For the years ended December 31, 2024 and 2023, amortization of deferred financing costs associated with the Amended Rondo Revolving Credit Facility were $0.6 million and $0.2 million, respectively. The Amended Rondo Revolving Credit Facility contains a number of covenants that, among other things, create liens on the equity securities and assets of Rondo Holdings, Rondo, AvKARE, LLC and Dixon-Shane, LLC d/b/a R&S Northeast LLC (“R&S”). The Amended Rondo Revolving Credit Facility contains certain negative, affirmative and financial covenants that, among other things, restrict the ability to incur additional debt, grant liens, transact in mergers and acquisitions, make certain investments and payments or engage in certain transactions with affiliates. The Amended Rondo Revolving Credit Facility also contains customary events of default. Upon the occurrence of certain events of default, the obligations under the Amended Rondo Revolving Credit Facility may be accelerated and/or the interest rate may be increased. At December 31, 2024, Rondo was in compliance with all covenants. The Company is not party to the Amended Rondo Revolving Credit Facility and is not a guarantor of any debt incurred thereunder. During the year ended December 31, 2024, the Company borrowed $28.0 million under the Amended Rondo Revolving Credit Facility for working capital purposes. The Company repaid $28.0 million of these borrowings during the year ended December 31, 2024 from cash on hand. On September 26, 2023, Rondo entered into a standby letter of credit guarantee arrangement under the Amended Rondo Revolving Credit Facility in the amount of $42.0 million for purposes of securing inventory from a certain supplier. As of December 31, 2024, the Company had no outstanding borrowings and outstanding letters of credit of $42.0 million under the Amended Rondo Revolving Credit Facility and unused borrowing capacity of $28.0 million. Rondo Acquisitions Financing – Notes Payable-Related Party On January 31, 2020, the closing date of the Rondo Acquisitions, Rondo Partners, LLC or its subsidiary, Rondo Top Holdings, LLC, issued notes to the sellers (the “Sellers Notes”) with a stated aggregate principal amount of $44.2 million and a short-term note to a seller (the “Short-Term Seller Note”) with a stated principal amount of $1.0 million. The Sellers Notes were unsecured and accrued interest at a rate of 5% per annum, not compounded, until June 30, 2025. The Sellers Notes were subject to prepayment at the option of Rondo, as the obligor, without premium or penalty. Mandatory payment of the outstanding principal and interest was due on June 30, 2025 if certain financial targets were achieved, the borrowers’ cash flows were sufficient (as defined in the Sellers Notes) and repayment was not prohibited by senior debt. If repayment of all outstanding principal and accrued interest on the Sellers Notes was not made on June 30, 2025, the requirements for repayment were to be revisited on June 30 of each subsequent year until all principal and accrued interest were satisfied no later than January 31, 2030 or earlier, upon a change in control, as defined. The Short-Term Sellers Note was also unsecured, accrued interest at a rate of 1.6%, and was paid during February 2021. In accordance with ASC 805, Business Combinations, all consideration transferred was measured at its acquisition-date fair value. The Sellers Notes were stated at the fair value estimate of $35.0 million, which was estimated using the Monte-Carlo simulation approach under the option pricing framework. The Short-Term Sellers Note of $1.0 million was recorded at the stated principal amount of $1.0 million, which approximated fair value. The $9.2 million discount on the Sellers Notes was to be amortized to interest expense using the effective interest method from January 31, 2020 to June 30, 2025 and the carrying value of the Sellers Notes was to accrete to the stated principal amount of $44.2 million. During the year ended December 31, 2024, the Company repaid principal of $44.2 million and interest of $10.0 million associated with the Sellers Notes from cash on hand. As of December 31, 2024, the Sellers Notes and accrued interest had been fully repaid. The Sellers Notes, net of unamortized discount, were included in notes payable-related party and accrued interest was included in related party payables-short term and long-term as of December 31, 2023. During the year ended December 31, 2024, 2023 and 2022, amortization of the discount related to the Sellers Notes was $1.1 million, $1.7 million, and $1.7 million, respectively. The Company was not party to or a guarantor of the Sellers Notes.
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Other Long-Term Liabilities |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Long-Term Liabilities | Other Long-Term Liabilities Other long-term liabilities were comprised of the following (in thousands):
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Leases |
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Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases | Leases The majority of the Company's operating and financing lease portfolio consists of corporate offices, manufacturing sites, warehouse space, R&D facilities, and land. The Company's leases have remaining lease terms of 1 year to 20 years (excluding international land easements with remaining terms of approximately 19-94 years). Rent expense for the years ended December 31, 2024, 2023 and 2022 was $21.0 million, $21.7 million, and $22.6 million, respectively. The components of total lease costs were as follows (in thousands):
(1)Includes variable and short-term lease costs. Supplemental balance sheet information related to the Company's leases was as follows (in thousands):
(1) Refer to Note 23. Related Party Transactions for information about related party leases. Supplemental cash flow information related to leases was as follows (in thousands):
The table below reflects the weighted average remaining lease term and weighted average discount rate for the Company's operating and finance leases:
Maturities of lease liabilities as of December 31, 2024 were as follow (in thousands):
Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands):
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Leases | Leases The majority of the Company's operating and financing lease portfolio consists of corporate offices, manufacturing sites, warehouse space, R&D facilities, and land. The Company's leases have remaining lease terms of 1 year to 20 years (excluding international land easements with remaining terms of approximately 19-94 years). Rent expense for the years ended December 31, 2024, 2023 and 2022 was $21.0 million, $21.7 million, and $22.6 million, respectively. The components of total lease costs were as follows (in thousands):
(1)Includes variable and short-term lease costs. Supplemental balance sheet information related to the Company's leases was as follows (in thousands):
(1) Refer to Note 23. Related Party Transactions for information about related party leases. Supplemental cash flow information related to leases was as follows (in thousands):
The table below reflects the weighted average remaining lease term and weighted average discount rate for the Company's operating and finance leases:
Maturities of lease liabilities as of December 31, 2024 were as follow (in thousands):
Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands):
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Fair Value Measurements |
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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:
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 (in thousands):
(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 19. Financial Instruments for information about 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 liability has been classified as a Level 3 recurring liability as its valuation requires judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for various inputs, the estimated fair value could be higher or lower than what the Company determined. As of December 31, 2023, the contingent consideration liability associated with the Saol Acquisition included $0.1 million recorded in accounts payable and accrued expenses and $0.4 million recorded in other-longer term liabilities. As of December 31, 2023, the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC was $0.4 million and was recorded within related party payables - long term. Contingent consideration liability was $0 as of December 31, 2024. There were no transfers between levels in the fair value hierarchy during the year ended December 31, 2024. Contingent Consideration On February 9, 2022, the Company completed the Saol Acquisition (refer to Note 3. Acquisition), which provides for contingent royalty payments that are tiered depending on the aggregate annual net sales for certain pharmaceutical products, beginning in 2023. Contingent royalty payments for the years ended December 31, 2024 and 2023 were not material. 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) for the year ended December 31, 2023 (in thousands):
The fair value measurement of the contingent consideration liabilities was determined based on significant unobservable inputs, including the discount rate, estimated probabilities of success, timing of achieving specified regulatory milestones and the estimated amount of future sales of the acquired products. The contingent consideration liability is estimated by applying a probability-weighted expected payment model for contingent milestone payments and a Monte Carlo simulation model for contingent royalty payments, which are then discounted to present value. Changes to fair value 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 change in the fair value of the contingent consideration liability for the year ended December 31, 2024 and the contingent consideration liability as of December 31, 2024 was not material. 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 following is a summary of the Company’s indebtedness at fair value (in thousands):
The Term Loan Due 2025 and Term Loan Due 2028 are in the Level 2 category within the fair value level hierarchy. The fair values were determined using market data for valuation. The Sellers Notes were in the Level 2 category within the fair value level hierarchy. During the year ended December 31, 2024, the Company fully repaid amounts outstanding under the Sellers Notes. Refer to Note 15. Debt for additional 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 years ended December 31, 2024 and 2023.
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Financial Instruments |
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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 and 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 (for further details, refer to Note 15. Debt). 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 initially entered into an interest rate swap on the Term Loan Due 2025. On November 14, 2023, in connection with the refinancing of the Term Loan Due 2025 and the New Credit Facility, the Company novated its swap agreement to another counterparty and, in connection with such novation, amended the interest rate swap agreement. Refer to section “Interest Rate Derivative - Cash Flow Hedge” below for additional information. 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 its Term Loan Due 2025 (the “October 2019 Swap”). On May 31, 2023, the Company executed an amendment to the October 2019 Swap that, among other things, changed the variable reference rate from LIBOR to the one-month SOFR (the “Amended October 2019 Swap”). On November 14, 2023, in connection with the Company’s refinancing of the Term Loan Due 2025 and the New Credit Facility (refer to Note 15. Debt), the Company novated its Amended October 2019 Swap to another counterparty and subsequently amended the interest rate agreement. Specifically, the amendments modified (i) the fixed rate payable by the counterparty from 1.3660% to a new fixed rate of 2.7877% and (ii) extended the termination date through May 4, 2027 (i.e., one year before the Term Loan Due 2028 matures) (the “November 2023 Swap”). The amendments did not change the notional amount of $1.3 billion. The purpose of the November 2023 Swap is to hedge part of the Company's interest rate exposure associated with the variability in future cash flows from changes in the one-month SOFR associated with the Term Loan Due 2028. The Company used a strategy commonly referred to as “blend and extend,” which allows the existing asset position of the swap agreement to be effectively blended into the new interest rate swap agreement. As a result of this transaction, on November 14, 2023, the Amended October 2019 Swap was de-designated and the unrealized gain of $66.7 million was recorded within accumulated other comprehensive loss and will be amortized as a reduction of interest expense, net, over the original term of the of the Amended October 2019 Swap (until May 2025), as the hedged transactions affect earnings. Additionally, the November 2023 Swap had a fair value of $66.7 million at inception, and will be ratably recorded to accumulated other comprehensive loss and reclassified to interest expense, net, over the term of the November 2023 Swap (until May 2027), as the hedged transactions affect earnings. At the inception of the November 2023 Swap, the Company determined that the swap qualified for cash flow hedge accounting under ASC 815. Therefore, changes in the fair value of the swap, net of taxes, will be recognized in other comprehensive loss each period, then reclassified into the consolidated statements of operations as a component of interest expense, net in the period in which the hedged transaction affects earnings. The November 2023 Swap is the only swap agreement outstanding as of December 31, 2024. The effectiveness of the outstanding November 2023 Swap will be assessed qualitatively by the Company during the life of the hedge by (i) comparing the current terms of the hedge with the related hedged debt to assure they continue to coincide based upon initial quantitative assessment of the amended swap and (ii) through an evaluation of the ability of the counterparty to the hedge to honor its obligations under the hedge. During the year ended December 31, 2024, the Company reclassified a net gain of $26.2 million from accumulated other comprehensive loss to a reduction of interest expense, net. Approximately $3.8 million of net losses included in accumulated other comprehensive loss as of December 31, 2024 are expected to be reclassified into earnings as interest expense within the next 12 months as interest payments are made on the Company’s Term Loan Due 2028 and amortization of the amounts included in accumulated other comprehensive loss occurs. As of December 31, 2024, the total gain, net of income taxes, related to the Company’s cash flow hedge of $6.4 million was recognized in accumulated other comprehensive loss. As of December 31, 2023, the total gain, net of income taxes, related to the Company’s cash flow hedge of $33.7 million was recognized in accumulated other comprehensive loss. A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands):
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Commitments and Contingencies | Commitments and Contingencies Commitments Commercial Manufacturing, Collaboration, License, and Distribution Agreements The Company continues to seek to enhance its product line and develop a balanced portfolio of differentiated products through product acquisitions and in-licensing. Accordingly, the Company, in certain instances, may be contractually obligated to make potential future development, regulatory, and commercial milestone, royalty and/or profit-sharing payments in conjunction with collaborative agreements or acquisitions that the Company has entered with third parties. The Company has also licensed certain technologies or IP from various third parties. The Company is generally required to make upfront payments and 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 23. Related Party Transactions for additional information. Contingencies Legal Proceedings The Company's legal proceedings are complex, constantly evolving, and subject to uncertainty. As such, the Company cannot predict the outcome or impact of its significant legal proceedings which are set forth below. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs and may therefore face claims arising from the regulation and/or consumption of such products. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized. For the year ended December 31, 2024, charges related to legal matters, net of $96.7 million were primarily associated with the Affordable Medicines segment’s settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the U.S. (refer to the section Civil Prescription Opioid Litigation below). For the year ended December 31, 2023, charges related to legal matters, net of $1.8 million were comprised of $3.9 million in charges associated with Affordable Medicines civil prescription opioid litigation, a $3.0 million charge for the settlement of an Affordable Medicines customer claim, a $3.0 million charge for the settlement of Affordable Medicines commercial antitrust litigation, and a $1.9 million charge for the settlement of a corporate stockholder derivative lawsuit, partially offset by a $10.0 million credit from the settlement of Affordable Medicines patent infringement matters. For the year ended December 31, 2022, the Company recorded charges related to legal matters, net of $269.9 million, primarily for corporate Opana® ER antitrust litigation of $262.8 million and Affordable Medicines civil prescription opioid litigation of $18.0 million, partially offset by corporate insurance recoveries associated with securities class actions of $15.5 million. Liabilities for legal matters were comprised of the following (in thousands):
Refer to the respective discussions below for information about the significant matters summarized 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. 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 IP 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 Affordable Medicines 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 Affordable Medicines segment, the potential consequences in the event of an unfavorable outcome in such litigation include delaying 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® 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 Pharmaceuticals Inc. and Impax Laboratories, Inc. (“Impax”) and consolidated into multi-district litigation (“MDL”) in the U.S. District Court for the Northern District of Illinois. Impax subsequently entered into settlement agreements with all of the plaintiffs that were subsequently approved by the court. Pursuant to the settlement agreements, the Company agreed to pay a total of $265.0 million between 2022 and mid-January 2024 to resolve substantially all of the plaintiffs’ claims. As of December 31, 2023, the liability for the final settlement payment of $50.0 million, plus 3% stated interest thereon, was included in the current portion of liabilities for legal matters and was paid in January 2024 with cash on hand. The settlement agreements are not an admission of liability or fault by Impax, the Company or its subsidiaries. Upon court approval of the final settlement agreements as discussed above, substantially all the claims and lawsuits in the litigation were resolved. United States Department of Justice Investigations On May 15, 2023, Amneal received a Civil Investigative Demand (“CID”) from the Civil Division of the United States Department of Justice (the “Civil Division”) requesting information and documents related to the manufacturing and shipping of diclofenac sodium 1% gel labeled as “prescription only” after the reference listed drug’s label was converted to over-the-counter. In October 2024, the Company received supplemental CIDs seeking additional information related to the same subject matter. The Company is continuing to cooperate 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 Beginning in March 2016, various purchasers of generic drugs filed multiple putative antitrust class action complaints against a substantial number of generic pharmaceutical manufacturers, including the Company and Impax, alleging an illegal conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers. They seek unspecified monetary damages and equitable relief, including disgorgement and restitution. The lawsuits were consolidated in the United States District Court for the Eastern District of Pennsylvania (See In re Generic Pharmaceuticals Pricing Antitrust Litigation, No. 2724 (E.D. Pa.)) (“MDL No. 2724”). In 2019 and 2020, Attorneys General of 43 States and the Commonwealth of Puerto Rico named the Company in two complaints alleging a similar conspiracy and seeking similar damages. These cases are pending in the District of Connecticut. See Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al., 3:19-cv-00710-MPS and Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MPS. Fact discovery is underway in MDL No. 2724 and in the State Attorneys General cases naming the Company as a defendant. Expert discovery is complete in Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MPS. In Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MSP, defendants’ joint motions for summary judgment were filed in November 2024 and defendant-specific motions for summary judgment are due in July 2025. In Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al., 3:19-cv-00710-MPS, defendants jointly moved to dismiss the complaint and Amneal individually moved to dismiss the states’ Ranitidine, Bethanechol, and overarching conspiracy claims. These motions were fully briefed on February 14, 2025. In the MDL, defendants including the Company and Impax jointly moved to dismiss certain complaints in December 2024. Amneal individually moved to dismiss plaintiffs’ Bethanechol Chloride claims in American Airlines, Inc., et al v. Actavis Holdco U.S., Inc., et al, 2:24-cv-01430. These motions were fully briefed on February 20, 2025. The MDL Court ordered that trials for the first MDL cases chosen for bellwether treatment, none of which name the Company or Impax as defendants, will begin August 8, 2025. The MDL Court has identified the second round of MDL cases chosen for bellwether treatment, one of which names Impax as a defendant. No scheduling orders have been set. Civil Prescription Opioid Litigation The Company is named in over 900 state and federal cases relating to the sale of prescription opioid pain relievers. Plaintiffs are political subdivisions, schools, hospitals, Native American tribes, pension funds, third-party payors, and individuals. Nearly all federal court cases are consolidated for pre-trial proceedings in Case No. 17-mdl-2804, USDC N.D. OH. The Company also is named in state court cases pending in seven states. There are no firm trial dates in those state-court cases except in Texas, where the trial date in the Dallas County case is September 29, 2025, and the trial-ready date in the Bexar County case is March 16, 2026. The Company has received a subpoena from the New York Attorney General, a subpoena from the Maryland Attorney General, and a CID issued by the Alaska Attorney General all seeking information regarding its business concerning opioid-containing products. The Company has cooperated and continues to cooperate with these requests. In 2023, the Company reached settlements with the New Mexico Attorney General and West Virginia political subdivisions and a settlement in principle with a group of private hospitals in Alabama. In late April 2024, the Company reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases filed and that might have been filed by state Attorneys General, political subdivisions and Native American tribes. The settlement in principle is subject to execution of a definitive settlement agreement. The settlement would be payable over ten years. Under the settlement in principle, the Company would agree to pay $92.5 million in cash and provide $180.0 million (valued at $125/twin pack) in naloxone nasal spray to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive 25% of the naloxone nasal spray’s value (up to $45.0 million) in cash during the last four years of the ten years payment term, which could increase the total amount of cash the Company would agree to pay up to $137.5 million. As of March 31, 2024, the Company concluded the loss related to the opioid litigation was probable, and the related loss was reasonably estimable considering the settlement in principle. As a result, the Company recorded a charge of $94.4 million associated with the settlement in principle during the three months ended March 31, 2024, to increase the liability as of March 31, 2024 to $115.6 million. The liability as of December 31, 2024 was $115.2 million, of which $85.5 million was classified as long-term. While this liability has been deemed reasonable by the Company’s management, it could significantly change as the definitive settlement agreement is finalized. As of December 31, 2023, the Company had a liability of $21.5 million related to its prescription opioid litigation, of which $0.3 million was classified as long-term. For the remaining cases not covered by the settlement in principle, primarily brought by other hospitals, schools and individuals, the Company has not recorded a liability as of December 31, 2024 or 2023, because it concluded that a loss was not probable and estimable. United States Department of Justice / Drug Enforcement Administration Subpoenas On July 7, 2017, Amneal 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. The Company has entered into a tolling agreement with respect to potential criminal charges through May 15, 2025. The Company entered into a tolling agreement with the USAO that tolled the statute of limitations for potential civil claims through November 15, 2024. It is not possible to determine the exact outcome of these investigations. On March 14, 2019, Amneal received a subpoena from an Assistant U.S. Attorney for the Southern District of Florida (the “AUSA”). The subpoena requested information and documents generally related to the marketing, sale, and distribution of oxymorphone. The Company is cooperating with the AUSA regarding the subpoena. However, no assurance can be given as to the timing or outcome of its underlying investigation. On October 7, 2019, Amneal received a subpoena from the New York State Department of Financial Services seeking documents and information related to sales of opioid products in the state of New York. The Company is cooperating with the request and providing responsive information. It is not possible to determine the exact outcome of this investigation. Ranitidine Litigation The Company was named, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products in a federal MDL (In re Zantac/Ranitidine NDMA Litigation (MDL No. 2924), Southern District of Florida). Plaintiffs alleged defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in ranitidine products and the alleged associated risk of cancer. The MDL Court’s dismissal of claims by all plaintiffs against the Company and other generic drug manufacturers on preemption grounds is on appeal in the 11th Circuit. Plaintiffs filed their merits brief on April 10, 2024. The generic drug manufacturers, including the Company, filed their briefs on July 25, 2024. Plaintiffs’ reply brief was filed November 8, 2024. The briefing also addresses the MDL Court’s December 6, 2022 exclusion of plaintiff’s general causation experts. The 11th Circuit has not set an oral argument date. The Company has also been named in state court cases in four states. The Company has filed motions to dismiss those cases. On August 17, 2023, the judge in the consolidated Illinois state court cases granted a motion to dismiss all such cases in which the Company had been named, holding all claims preempted. On December 10, 2024, plaintiffs filed a motion in the Illinois state court cases seeking entry of partial final judgment as to the Company and other generic drug manufacturer defendants to allow plaintiffs to appeal the dismissals of those defendants. The Company has reached an agreement in principle, which is not material, to settle the 95 cases pending against it in California state court. Currently, there is a September 15, 2025 trial date in the one case pending in New Mexico brought by the Attorney General, but the court recently indicated that date is likely to be continued. There are no other trial dates involving the Company in any of the state court cases. Metformin Litigation Beginning in 2020, Amneal was named as a defendant in several putative class action lawsuits filed and consolidated in the United States District Court for the District of New Jersey, seeking compensation for economic loss allegedly incurred in connection with their purchase of generic metformin allegedly contaminated with NDMA. See In Re Metformin Marketing and Sales Practices Litigation (No. 2:20-cv-02324-MCA-MAH) (“In re Metformin”), Marcia E. Brice v. Amneal Pharmaceuticals, Inc., No. 2:20-cv-13728 (D.N.J.), and Michael Hann v. Amneal Pharmaceuticals of New York, LLC et al., No. 2:23-cv-22902 (D.N.J.). On January 7, 2025, the court dismissed the Third Amended Complaint in In Re Metformin without prejudice and granted plaintiffs the opportunity to amend their complaint. On February 20, 2025, plaintiffs filed a Fourth Amended Complaint in In Re Metformin, which incorporated the allegations of plaintiff Brice and plaintiff Hann, and then filed notices of voluntary dismissal of Marcia E. Brice v. Amneal Pharmaceuticals, Inc., No. 2:20-cv-13728 (D.N.J.) and Michael Hann v. Amneal Pharmaceuticals of New York, LLC et al., No. 2:23-cv-22902 (D.N.J.) as standalone actions. Defendants will file a motion to dismiss the Fourth Amended Complaint by March 7, 2025. Plaintiffs’ response in opposition is due on April 7, 2025 and defendants’ reply is due on April 22, 2025. On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of valsartan, losartan, and metformin based on the alleged presence of nitrosamines in those products. The only allegations against the Company concern metformin (See Davis v. Camber Pharmaceuticals, Inc., et al., C.A. No. 2:21-00254 (M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the United States Judicial Panel on Multidistrict Litigation transferred the Davis Action into the In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation MDL for pretrial proceedings. Xyrem® (Sodium Oxybate) Antitrust Litigation Amneal was named as a defendant, along with Jazz Pharmaceuticals, Inc. (“Jazz”) and numerous other manufacturers of generic versions of Jazz’s Xyrem® (sodium oxybate), in several class action lawsuits filed in the United States District Court for the Northern District of California and the United States District Court for the Southern District of New York, alleging that the generic manufacturers entered into anticompetitive agreements with Jazz in connection with the settlement of patent litigation related to Xyrem®. The actions were consolidated in the United States District Court for the Northern District of California for pretrial proceedings (In re Xyrem (Sodium Oxybate) Antitrust Litigation, No. 5:20-md-02966-LHK (N.D. Cal.)). Amneal was also named as a defendant in a similar action filed by Aetna Inc. (“Aetna”) in California state court (Aetna Inc. v. Jazz Pharms., Inc. et. al, No. 22CV010951 (Cal. Super. Ct.)). The California state court held that it lacks jurisdiction over several defendants, including Amneal, on December 27, 2022, and later issued an order dismissing Amneal without prejudice. On August 25, 2023, Aetna filed a motion seeking leave to file a second amended complaint adding Amneal as a defendant, which the Court tentatively granted on October 20, 2023. Aetna filed a second amended complaint naming Amneal on November 17, 2023. On February 28, 2023, Amneal executed a $1.9 million settlement agreement with class plaintiffs in the federal litigation. Class plaintiffs filed a motion for final approval of the settlement on November 10, 2023, and entered an order granting final approval, certifying settlement class, and dismissing class plaintiffs’ against Amneal with prejudice on April 17, 2024. On December 18, 2023, Amneal executed a $4.0 million settlement with Aetna, United Healthcare Services, Inc. (“United”), Humana Inc. (“Humana”), Molina Healthcare Inc. (“Molina”), and Health Care Service Corporation (“HCSC”). Pursuant to that settlement, the federal court dismissed United, Humana, Molina and HCSC’s claims against Amneal, with prejudice, on February 26, 2024, and the California state court dismissed Aetna’s claims against Amneal, with prejudice, on February 29, 2024. Thus, all claims against Amneal in the federal and state court have been voluntarily dismissed with prejudice pursuant to settlements. In December 2023, the Company recorded $3.0 million for the settlement of claims associated with Xyrem® antitrust litigation. As of December 31, 2023, the Company had a liability of $2.0 million associated with this settlement, which was paid in January 2024. UFCW Local 1500 Welfare Fund v. Takeda Pharmaceuticals U.S.A., Inc. On November 14, 2023, UFCW Local 1500 Welfare Fund and other health plans filed a purported class action lawsuit in the United States District Court for the Southern District of New York against multiple manufacturers, including the Company, alleging an illegal conspiracy to restrict output of generic COLCRYS®. See UFCW Local 1500 Welfare Fund et al. v. Takeda Pharma. U.S.A., Inc. et al, No. 1:23-cv-10030 (S.D.N.Y.). On February 28, 2024, Takeda Pharmaceuticals U.S.A., Inc. filed a motion to transfer the case to the United States District Court for the Eastern District of Pennsylvania. On March 13, 2024 and March 27, 2024, Amneal submitted a letter and brief, respectively, informing the Court of its position that the Eastern District of Pennsylvania lacks personal jurisdiction over Amneal. That motion remains pending, and the deadline to respond to the complaint is set at 45 days after the court resolves the motion to transfer. Indian Tax Authority Matters Amneal Pharmaceuticals Pvt. Ltd., RAKS Pharmaceuticals Pvt. Ltd., and Puniska Healthcare Pvt. Ltd., which are subsidiaries of the Company, are currently involved in litigations with Indian tax authorities concerning Central Excise Tax, Service Tax, Goods & Services Tax, and Value Added Tax for various periods of time between 2014 and 2017. These subsidiaries have contested certain of these assessments, which are at various stages of the administrative process. The Company strongly believes its Indian subsidiaries have meritorious defenses in the matter. Guaifenesin Litigation On September 5, 2024, Amneal was named as a defendant along with CVS Pharmacy, Inc. (“CVS”) in a putative consumer class action lawsuit in the United States District Court for the Northern District of California alleging that generic guaifenesin products manufactured by Amneal contain benzene through the use of carbomer, an inactive ingredient. See Leonard v. CVS Pharmacy, Inc., No. 5:24-cv-06280 (N.D. Cal.). The complaint purports to plead, on behalf of a nationwide class and California subclass, the following counts: breach of warranty; unjust enrichment; fraud; and violation of California’s Unfair Competition Law. The complaint seeks damages, including punitive damages, restitution, other equitable monetary relief, injunctive relief, prejudgment interest and attorneys’ fees and costs. On December 30, 2024, the Company and CVS jointly filed a motion to dismiss. On January 21, 2025, in lieu of filing a response to defendants’ motion to dismiss, plaintiff filed an amended complaint. Defendants’ motion to dismiss the amended complaint was filed on February 20, 2025. Plaintiff’s response to the motion to dismiss is due March 24, 2025, and defendants’ reply is due April 14, 2025. Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 3:25-cv-00181-GC-TJB On November 25, 2024, the Company and Impax received a notice letter from Sandoz Inc. (“Sandoz”) stating that it had filed an ANDA with the FDA seeking approval to market generic versions of CREXONT®, an extended-release oral capsule formulation of carbidopa and levodopa for the treatment of Parkinson’s disease. The notice letter included a Paragraph IV certification alleging that certain patents covering CREXONT® are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of Sandoz’s generic product. In response to this notice letter, on January 7, 2025, the Company and Impax filed a patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos. 10,098,845, 10,292,935, 10,688,058, 10,973,769, 10,987,313, 11,357,733, 11,622,941, 11,666,538, 11,986,449, 12,064,521, 12,109,185, and 12,128,141. The current deadline for Sandoz to respond to the complaint is March 11, 2025. The filing of this lawsuit triggered a 30-month stay of FDA approval of the Sandoz ANDA from the date of receipt of the notice letter. CREXONT® is also subject to a regulatory exclusivity until August 7, 2027.
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Stockholders’ (Deficiency) Equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders’ (Deficiency) Equity | Stockholders’ (Deficiency) Equity On November 7, 2023, the Company implemented the Reorganization, a plan pursuant to which the Company and Amneal reorganized and simplified the Company’s corporate structure by eliminating its umbrella partnership-C-corporation structure and converting to a more traditional C-corporation structure whereby all stockholders hold their voting and economic interests directly through the public company. Effective with the Reorganization, the Company holds 100% of the Amneal Common Units. Refer to Note 1. Nature of Operations for additional information on the Reorganization. In connection with the Reorganization, the Company amended and restated its certificate of incorporation (“Charter”). The voting rights, dividend rights and participation rights of holders of Class A common stock of the Company did not materially change as a result of the amendment. There were no shares of Class B common stock of the Company outstanding as of December 31, 2024 and 2023. Voting Rights Holders of Class A common stock and Class B common stock are entitled to one vote for each share of stock held, except as required by law. Holders of Class A common stock and Class B common stock vote together as a single class on each matter submitted to a stockholder vote, including to elect, remove or replace all other directors to the Board subject to rights of holders of any preferred stock. Holders of Class A common stock and Class B common stock are not entitled to vote on any amendment to the Company’s Charter that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote on such terms pursuant to the Company’s Charter or law. Holders of Class A common stock do not have cumulative voting rights. Dividend Rights The holders of Class A common stock are entitled to receive dividends, if any, payable in cash, property, or securities of the Company, as may be declared by the Company's board of directors, out of funds legally available for the payment of dividends, subject to any preferential or other rights of the holders of any outstanding shares of preferred stock. The holders of Class B common stock will not be entitled to receive any dividends. Participation Rights The holders of Class A common stock and Class B common stock have no participation rights. Issuance and Restrictions on Company Common Stock No shares of Class B common stock may be issued except to a holder of Common Units or its affiliates. Liquidation Rights On the liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the holders of Class A common stock are entitled to share equally in all assets of the Company available for distribution among the stockholders of the Company after payment to all creditors and subject to any preferential or other rights of the holders of any outstanding shares of preferred stock. The holders of Class B common stock are not entitled to share in such net assets. Preferred Stock Under the Company’s Charter, the Company’s Board of Directors has the authority to issue preferred stock and set its rights and preferences. As of December 31, 2024 and 2023, no preferred stock had been issued. Non-Controlling Interests As discussed in Note 2. Summary of Significant Accounting Policies, the consolidated financial statements of the Company include the accounts of all entities controlled by the Company, including Amneal and its subsidiaries, through the Company’s direct or indirect ownership of a majority voting interest. The Company records non-controlling interests for the portion of its subsidiaries’ economic interests that it does not hold. Prior to the Reorganization, non-controlling interests were adjusted for capital transactions that impacted the non-publicly held economic interests in Amneal. Prior to the Reorganization, Amneal was obligated to make tax distributions to the Members. For the years ended December 31, 2023 and 2022, the Company recorded net tax distributions of $56.7 million and $10.6 million, respectively, as a reduction of non-controlling interests. Subsequent to the Reorganization, the Company is no longer obligated to make tax distributions to the Members. There was no liability for tax distributions payable to Members as of December 31, 2024 and 2023. The Company acquired a 98% interest in Kashiv Specialty Pharmaceuticals, LLC (“KSP”) on April 2, 2021. The sellers of KSP, a related party, hold the remaining interest. The Company attributes 2% of the net income or loss of KSP to these non-controlling interests. Redeemable Non-Controlling Interests - AvKARE, LLC and R&S The Company acquired a 65.1% interest in both AvKARE, LLC and R&S on January 31, 2020. The sellers 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 “Call Option”). The sellers holding the Rondo Class B Units have the one-time right to defer the exercise of the Call Option until the subsequent calendar year. 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 of Rondo to the redeemable non-controlling interests. The Company will also accrete the redeemable non-controlling interests to redemption value upon an event that makes redemption certain. For the years ended December 31, 2024, 2023 and 2022, tax distributions of $19.8 million, $14.2 million and $6.9 million, respectively, were recorded as reductions of redeemable non-controlling interests. As of December 31, 2024 and 2023, there were no amounts due for tax distributions related to these redeemable non-controlling interests. Redeemable Non-Controlling Interests - Puniska Healthcare Pvt. Ltd. The Company acquired a 74% interest 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 Puniska Acquisition, 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 year ended December 31, 2022, the Company recorded accretion of $0.9 million to increase the redeemable non-controlling interests to redemption value. Changes in Accumulated Other Comprehensive Income (Loss) by Component (in thousands):
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Stock-Based Compensation |
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Stock-Based Compensation | Stock-Based Compensation Amneal Pharmaceuticals, Inc. 2018 Incentive Award Plan In May 2018, the Company adopted the Amneal Pharmaceuticals, Inc. 2018 Incentive Award Plan (“2018 Plan”) under which the Company may grant stock options, restricted stock units and other equity-based awards to employees and non-employee directors providing services to the Company and its subsidiaries. The stock option, RSU and MPRSU award grants are made in accordance with the Company’s 2018 Plan and are subject to forfeiture if the vesting conditions are not met. On May 5, 2020, the stockholders of the Company approved an amendment to the 2018 Plan, which authorized an additional 14 million shares of Class A common stock available for issuance under the 2018 Plan. On May 9, 2023, the stockholders of the Company approved an amendment and restatement of the 2018 Plan, which authorized an additional 20 million shares of Class A common stock available for issuance under the 2018 Plan, resulting in a total shares reserved under the Stock Plan of 57 million shares, and extends the term of the 2018 Plan until May 9, 2033. As of December 31, 2024, the Company had 23,723,461 shares available for issuance under the 2018 Plan. The Company recognizes the grant date fair value of each option and share of restricted stock unit over its vesting period. Stock options and RSU awards are granted under the Company’s 2018 Plan and generally vest over a 4 year period and, in the case of stock options, have a term of 10 years. The following table summarizes all of the Company’s stock option activity for the years ended December 31, 2024, 2023, and 2022:
The intrinsic value of options exercised during the year ended December 31, 2024 was approximately $1.8 million. There were no options granted in the years ended December 31, 2024, 2023 and 2022. The following table summarizes all of the Company's restricted stock unit activity for the years ended December 31, 2024, 2023, and 2022:
The table above includes 2,893,669 MPRSUs granted to executives during 2024. Vesting of these awards is contingent upon the Company’s achievement of stock price hurdles over the performance period starting March 4, 2024 and requires the employee’s continued employment or service through February 28, 2027. The MPRSUs cliff vest at the end of the three-year period and have a maximum potential to vest at 200% (5,787,338 shares) based on the Company's stock price performance. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. The estimated fair value per share of the MPRSUs was $5.21 and was calculated using a Monte Carlo simulation model. 2,857,002 of these MPRSUs remained outstanding and unvested at December 31, 2024. The table above includes 2,431,521 MPRSUs granted to executives during March and April 2023. Vesting of the March 2023 awards is contingent upon the Company’s achievement of stock price hurdles over the performance period starting March 3, 2023 and requires the employee’s continued employment or service through February 28, 2026. Vesting of the April 2023 awards is contingent upon the Company’s achievement of stock price hurdles over the performance period starting April 28, 2023 and requires the employee’s continued employment or service through February 28, 2026. The MPRSUs cliff vest at the end of the three-year period and have a maximum potential to vest at 200% (4,863,042 shares) based on the Company's stock price performance. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. The estimated fair value per share of the MPRSUs ranged from $1.81 to $2.17 and was calculated using a Monte Carlo simulation model. 2,291,995 of these MPRSUs remained outstanding and unvested at December 31, 2024. The table above includes 3,053,738 MPRSUs granted to executives during 2022. Vesting of these awards is contingent upon the Company’s achievement of stock price hurdles over the performance period starting March 1, 2022 and requires the employee’s continued employment or service through February 28, 2025. The MPRSUs cliff vest at the end of the three-year period and have a maximum potential to vest at 200% (6,107,476 shares) based on the Company's stock price performance. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. The estimated fair value per share of the MPRSUs was $6.22 and was calculated using a Monte Carlo simulation model. 2,460,107 of these MPRSUs remained outstanding and unvested at December 31, 2024. As of December 31, 2024, the Company had total unrecognized stock-based compensation expense of $40.7 million related to all of its stock-based awards, which is expected to be recognized over a weighted average period of 1.8 years. The amount of stock-based compensation expense recognized by the Company was as follows (in thousands):
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Related Party Transactions |
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Related Party Transactions | Related Party Transactions The Company has various business agreements with certain third-party companies in which there is some common ownership and/or management between those entities, on the one hand, and the Company, on the other hand. The Company has no direct ownership or management in any of such related party companies. The following table summarizes the Company’s related party transactions (in thousands):
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
Related Party Transaction Descriptions A. Kashiv Biosciences LLC Kashiv Biosciences LLC (“Kashiv”) is a vertically integrated biopharmaceutical company with a diverse portfolio of commercial and clinical-stage assets. Amneal has various business agreements with Kashiv. Certain executive officers of the Company beneficially own, directly and through certain revocable or irrevocable trusts for the benefit of their immediate families, outstanding equity securities of Kashiv. In addition, they serve on the Board of Managers of Kashiv. On January 11, 2021, the Company and Kashiv entered into a definitive agreement for Amneal to acquire a 98% interest in KSP, which was a subsidiary of Kashiv and focuses on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs. The acquisition closed on April 2, 2021 and included contingent payments for the achievement of certain regulatory milestones and potential royalty payments based on annual net sales for certain future pharmaceutical products. As of December 31, 2023, the contingent consideration liability associated with the acquisition of KSP of $0.4 million was recorded within related party payables - long term. Contingent consideration liability was $0 as of December 31, 2024. Below is a summary of the related party arrangements held between the Company and Kashiv that were not impacted by the KSP Acquisition: i.On July 1, 2024, Kashiv and Amneal entered into an exclusive license and commercialization agreement to distribute and sell Omalizumab, a biosimilar to XOLAIR®, in the U.S. and India. Kashiv is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing for the product, and Amneal is responsible for marketing, selling, and pricing activities. The term of the agreement is 10 years from the respective product’s launch date and automatically renews for terms of three years unless either party provides written notification of termination. The agreement requires the Company to pay $10.0 million as an up-front amount to Kashiv and potential future milestone payments of up to $75.0 million, upon achieving certain developmental and regulatory achievements within agreed-upon timelines. The milestones include: (i) up to $32.5 million in developmental milestone payments, (ii) $22.5 million in regulatory approval and commercial launch milestone payments, and (iii) a $20.0 million sales-based milestone payment, which is contingent upon reaching a defined annual commercial sales volume for the product. In addition, the agreement provides for Amneal to pay a profit share up to 45% of net profits, after considering manufacturing, marketing, royalty and shipping costs. During the year ended December 31, 2024, the Company expensed amounts paid to Kashiv for: (i) the upfront amount of $10.0 million in connection with the execution of the agreement and (ii) an additional $10.0 million related to the first developmental milestone. ii.In 2017, Kashiv and Amneal entered into an exclusive license and commercialization agreement (the “Kashiv Biosimilar Agreement”) to distribute and sell two biosimilar products, Filgrastim and Pegfilgrastim, in the U.S. Kashiv is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing, and Amneal is responsible for marketing, selling, and pricing activities. The term of the agreement is 10 years from the respective product’s launch date. The Kashiv Biosimilar Agreement provided for potential future milestone payments to Kashiv of up to $183.0 million, as follows: (i) up to $22.5 million relating to regulatory approval and execution, (ii) up to $43.0 million for successful delivery of commercial launch inventory, (iii) up to $50.0 million depending on the number of competitors at launch for one product, and (iv) between $15.0 million and $67.5 million for the achievement of cumulative net sales for both products. In July 2022, the Company and Kashiv amended the Kashiv Biosimilar Agreement to, among other things, (i) eliminate milestones related to the manufacturing and delivery of the Kashiv products, (ii) revise the net sales milestones to provide for future milestone payments by the Company to Kashiv of up to $37.5 million for the achievement of cumulative combined net sales goals for both products, and (iii) adjust the supply price of product that Kashiv manufacturers and supplies to the Company, which will lower the cost per unit of both products. The remaining milestones are subject to reaching certain commercial sales volume objectives. In addition, the agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs. On May 27, 2022, the FDA approved the Company’s biologic license application, associated with the amended Kashiv Biosimilar Agreement, for Pegfilgrastim-pbbk. In connection with this regulatory approval and associated activity, the Company incurred and paid a milestone of $15.0 million during the year ended December 31, 2022, payable to Kashiv. The milestone was capitalized as an intangible asset and will be amortized to cost of sales over an estimated useful life of 8.3 years. The Company recognized a $5.0 million milestone in selling, general and administrative expense upon FDA approval of Filgrastim in February 2022. In March 2024, the Company amended the Kashiv Biosimilar Agreement to include two additional in-development products, a pre-filled auto-injector delivery system for peg-filgrastim and a pre-filled on-body injector (OBI) delivery system for peg-filgrastim. Consistent with the existing terms, Kashiv is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing, and Amneal is responsible for marketing, selling, and pricing activities of these product candidates. The amendment did not change the contractual terms related to existing commercialized biosimilar products. The amendment provides an incremental $14.5 million in potential future milestone payments specific to these in-development products, including $7.0 million for clinical and developmental milestones and $7.5 million for regulatory approval and first commercial-sales milestones. In addition, the amendment clarifies that future net sales milestones payments of up to $37.5 million, which did not change, shall be contingent upon reaching certain commercial sales volume objectives for the aggregate of all products under the amended agreement. The agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs. No amounts were paid or recognized during the year ended December 31, 2024, pursuant to this amendment. iii.In December 2022, Amneal and Kashiv entered into a development and supply agreement specific to four generic product candidates. Amneal is responsible for manufacturing batch products and performing certain developmental activities on behalf of Kashiv. Kashiv, as owner of the intellectual property, is responsible for regulatory filings, obtaining FDA approval, marketing, selling, and pricing activities. Pursuant to the terms of the development supply agreement, Amneal is eligible to earn up to $2.4 million related to the aforementioned services. As of December 31, 2024 and 2023, deferred revenue related to this arrangement was $0.2 within accounts payable and accrued expenses on the consolidated balance sheet. Pursuant to the development supply agreement, Amneal maintained a right of first offer and negotiation to the licensing of each generic product candidate. In March 2024, Amneal and Kashiv entered into a license and supply agreement for the development and commercialization of a long-acting injectable (the “Injectable License and Supply Agreement”). The existing development supply agreement remains effective for the remaining three generic product candidates. Subject to the terms of the Injectable License and Supply Agreement, Amneal is responsible for development, regulatory approval, and commercialization of the product candidate in the U.S., whereas Kashiv is responsible for development and regulatory approval of the product candidate for all other territories outside the U.S. Contingent upon Kashiv obtaining regulatory approval outside the U.S., Amneal shall manufacture the commercial supply for Kashiv at a stated price. The term of the agreement is 10 years from the respective product’s launch date in the U.S. During the year ended December 31, 2024, the Company recorded R&D expense of $10.5 million comprised of (i) $0.5 million for payment made upon execution of the license and supply agreement and (ii) $10.0 million for the achievement of a regulatory milestone upon the FDA’s written acceptance of a drug approval application filing. The agreement provides for potential future milestone payments to Kashiv of up to $25.0 million as follows: (i) up to $10.0 million relating to developmental milestones; (ii) up to $10.0 million for U.S. regulatory approval and initial commercial launch milestones; and (iii) up to $5.0 million for the achievement of annual commercial milestones. In addition, the agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs. As of December 31, 2024, the Company had a liability of $10.0 million related to the achievement of a regulatory milestone, which was paid by the Company in February 2025. iv.On April 30, 2024, Amneal closed on the sale of a wholly owned subsidiary in India to a subsidiary of Kashiv for total consideration of ₹1.0 billion, or $12.2 million. Total consideration consisted of a ₹416.2 million, or $5.0 million, cash payment at closing and the assumption of a loan payable of ₹598.6 million, or $7.2 million, payable to another subsidiary of Amneal in India. The loan payable bore interest of 11% on the unpaid principal and was due on or before December 31, 2024. The Company was permitted to offset royalties or other amounts payable to Kashiv with any overdue principal and accrued interest on the loan payable. On December 27, 2024, Kashiv paid the loan of ₹598.6 million, or $7.0 million (based on foreign exchange rates at that date) and accrued interest in full. The subsidiary’s assets and liabilities were primarily comprised of a building under construction and a note payable, respectively. The subsidiary had no business activity, other than the construction of the building. As a result of the sale, the Company recognized a pre-tax gain of $3.8 million in other income, net in its Affordable Medicines segment for the year ended December 31, 2024. v.The parties entered into a pallet storage agreement for Amneal to store materials for Kashiv. vi.The parties entered into a lease for parking spaces in Piscataway, NJ. The annual lease cost is $0.1 million per year for the lease agreement. vii.Amneal and Kashiv entered into a product development agreement for the development and commercialization of two generic peptide products, Ganirelix Acetate and Cetrorelix Acetate. Under the agreement, the IP and abbreviated new drug application for these products are owned by Amneal, and Kashiv will receive a profit share for all sales of the products made by Amneal. In connection with the agreement, Amneal made an upfront payment of $1.1 million in August 2020. The agreement also provides for potential future milestone payments to Kashiv of (i) up to $2.1 million relating to development milestones, and (ii) up to $0.3 million relating to regulatory filings. The milestones are subject to certain performance conditions which may or may not be achieved, including FDA filings. In addition, Amneal agreed to pay $2.6 million of development fees to Kashiv as the development work is completed. B. Tax Receivable Agreement In 2018, the Company entered into the TRA pursuant to which it was generally required to pay the holders of Amneal Common Units, on a one-to-one basis, 85% of the applicable tax savings, if any, in U.S. federal and state income tax that it is deemed to realize as a result of certain tax attributes of their Amneal common units sold to the Company (or exchanged in a taxable sale) and that were created as a result of (i) the sales of their Amneal common units for shares of Class A common stock of the Company prior to the Reorganization (as defined in Note 1. Nature of Operations) and (ii) tax benefits attributable to payments made under the TRA. As part of the Reorganization, the TRA was amended to reduce the Company’s future obligation to pay 85% of the tax benefits subject to the TRA to 75% of such realized benefits. Refer to Note 6. Income Taxes for additional information. C. Apace KY, LLC d/b/a Apace Packaging LLC Apace KY, LLC d/b/a Apace Packaging LLC (“Apace”) provides packaging solutions pursuant to packaging agreements for Amneal and R&S. Apace markets its services which include bottling and blistering for the pharmaceutical industry. A member of Company management beneficially owns outstanding equity securities of Apace. D. AzaTech Pharma, LLC R&S purchases inventory from AzaTech Pharma LLC (“AzaTech”) for resale. A member of Company management beneficially owns outstanding equity securities of AzaTech. E. Kanan, LLC Kanan, LLC (“Kanan”) is a real estate company that owns Amneal’s manufacturing facilities located at 65 Readington Road, Branchburg, New Jersey, 131 Chambers Brook Road, Branchburg, New Jersey and 1 New England Avenue, Piscataway, New Jersey. Certain executive officers of the Company beneficially own, through certain revocable trusts, equity securities of Kanan. In addition, they serve on the Board of Managers of Kanan. Amneal leases these facilities from Kanan under two separate triple-net lease agreements that expire in 2027 and 2031, respectively, at an annual rental cost of approximately $2.0 million combined, subject to CPI rent escalation adjustments as provided in the lease agreements. F. Sellers of AvKARE LLC and R&S Notes Payable – Related Party Certain holders of the Rondo Class B Units were also holders of the Sellers Notes. During the year ended December 31, 2024, the Company repaid principal of $44.2 million and interest of $10.0 million associated with the Sellers Notes from cash on hand. As of December 31, 2024, the Sellers Notes and accrued interest had been fully repaid. The Sellers Notes, net of unamortized discount, were included in notes payable-related party and accrued interest was included in related party payables-short term and long-term as of December 31, 2023. For additional information, refer to Note 15. Debt. Refer to Note 21. Stockholders’ (Deficiency) Equity for related party transactions associated with Rondo. Tax Distributions Under the terms of the limited liability company agreement between the Company and the holders of the Rondo Class B Units, Rondo is obligated to make tax distributions to those holders, subject to certain limitations as defined in the Rondo Credit Facility. For the years ended December 31, 2024, 2023 and 2022, tax distributions of $19.8 million, $14.2 million and $6.9 million, respectively, were recorded as reductions of redeemable non-controlling interests. As of December 31, 2024 and 2023, there were no amounts due for tax distributions related to these redeemable non-controlling interests. For further details, refer to Note 21. Stockholders’ (Deficiency) Equity. G. Sutaria Family Realty, LLC Industrial Real Estate Holdings NY, LLC (“IRE”) is a real estate management entity, which was the sub-landlord of Amneal’s leased manufacturing facility located at 75 Adams Avenue, Hauppauge, New York. IRE is controlled by a member of the Amneal Group who also serves as an observer on our Board of Directors. Effective June 1, 2020, the lease was assigned to the Company with the consent of the landlord, Sutaria Family Realty, LLC, which is also a related party because a member of Company management is a beneficial owner. Concurrently with the assignment of the lease, the Company exercised a renewal option for $0.1 million to extend the lease by five years until March 31, 2026. Monthly rent payments are $0.1 million and increase by 3% annually. H. Tracy Properties LLC R&S leases operating facilities, office and warehouse space from Tracy Properties LLC (“Tracy”). A member of Company management beneficially owns outstanding equity securities of Tracy. I. Avtar Investments, LLC Avtar Investments, LLC (“Avtar”) is a private investment firm. Certain executive officers of the Company beneficially own, directly and through certain revocable or irrevocable trusts for the benefit of their immediate families, outstanding equity securities of Avtar. During April 2020, the Company entered into an agreement under which Avtar will provide R&D consulting services. J. Alkermes Plc Rondo Partners LLC purchases inventory from Alkermes Plc for resale. A member of the Board of Directors of the Company is also a member of the Board of Directors of Alkermes Plc. K. AvPROP, LLC AvKARE LLC leases its operating facilities from AvPROP, LLC (“AvPROP”). A member of Company management beneficially owns outstanding equity securities of AvPROP. L. Fosun International Limited Fosun International Limited (“Fosun”) is a Chinese international conglomerate and investment company that was a significant shareholder of the Company. On June 6, 2019, the Company entered into a license and supply agreement with a subsidiary of Fosun, which is a Chinese pharmaceutical company. Under the terms of the agreement, the Company will hold the imported drug license required for pharmaceutical products manufactured outside of China and will supply Fosun with finished, packaged products for Fosun to then sell in the China market. Fosun will be responsible for obtaining regulatory approval in China and for shipping the product from Amneal’s facility to Fosun’s customers in China. In consideration for access to the Company’s U.S. regulatory filings to support its China regulatory filings and for the supply of product, Fosun paid the Company a $1.0 million non-refundable fee, net of tax, in July 2019 and was required to pay the Company $0.3 million for each of eight products upon the first commercial sale of each in China in addition to a supply price and a profit share. On August 11, 2023, the Company and Fosun amended the license and supply agreement to, among other things, (i) increase the products in the agreement from eight to ten, (ii) eliminate the first commercial sales milestone of $0.3 million for each product and (iii) decrease the profit share percentage applicable to all products. On August 12, 2021, the Company entered into an active pharmaceutical ingredient (“API”) co-development agreement with a subsidiary of Fosun. Under the terms of the agreement, the Company provided Fosun a license to manufacture and sell two pharmaceutical products outside of the U.S. Fosun will be responsible for obtaining regulatory approval outside the U.S. Fosun paid the Company a $0.2 million non-refundable fee in 2021 and will be required to pay the Company $0.1 million for each of the two products upon the first commercial sale of each in China in addition to a profit share. Effective March 31, 2024, Fosun was no longer a significant shareholder of the Company; therefore, it was no longer a related party as of that date. M. TPG Capital BD, LLC TPG Capital BD, LLC (“TPG Capital”), provided the Company with advice and assistance with respect to the refinancing of the Term Loan Due 2025 and the Amended New Revolving Credit Facility for which the Company paid TPG Capital $3.0 million. An observer of our Board is a partner in TPG Capital. Refer to Note 15. Debt for additional information on the refinancing of the Company’s debt. N. R&S Solutions LLC R&S Solutions LLC provides logistic services to the Company. A member of Company management beneficially owns outstanding equity securities of R&S Solutions LLC. O. PharmaSophia, LLC PharmaSophia, LLC (“PharmaSophia”) is a joint venture formed by Nava Pharma, LLC (“Nava”) and Oakwood Laboratories, LLC for the purpose of developing certain products. Certain executive officers of the Company beneficially own, directly and through certain revocable or irrevocable trusts for the benefit of their immediate families, outstanding equity securities of Nava. Nava beneficially owns 50% of the outstanding equity securities of PharmaSophia. In addition, these executive officers also serve on the Board of Managers of PharmaSophia. PharmaSophia and Nava are parties to an R&D agreement pursuant to which Nava provides R&D services to PharmaSophia (the “Nava Agreement”). Nava subcontracted this obligation to Amneal under a subcontract R&D services agreement pursuant to which Amneal provides R&D services to Nava in connection with the products being developed by PharmaSophia. On August 28, 2023, Amneal and Nava terminated the subcontract R&D services agreement by mutual consent. In October 2022, PharmaSophia and Amneal entered into an exclusive license and commercialization agreement (the “PharmaSophia Agreement”) to develop, manufacture, and sell one injectable product. Under the terms of the agreement, Amneal committed to spend up to $6.0 million to further develop the product, including all related expenses up to submission of the ANDA, which will be owned by Amneal. Also under the terms of the PharmaSophia Agreement, PharmaSophia settled a liability of $1.1 million payable to Amneal under the terms of the Nava Agreement by reducing the amount of Amneal’s committed spending under the terms of the PharmaSophia Agreement to $4.9 million. Amneal recorded $1.1 million of research and development expense for the year ended December 31, 2022 as a result of the settlement. PharmaSophia will receive a 50% profit share for all sales of product made by Amneal under the PharmaSophia Agreement. P. TPG Operations, LLC TPG Operations LLC (“TPG Operations”) is a private investment firm that provides financial services. An observer of our Board is a partner in TPG Capital. In March 2020, the Company entered into an agreement in which TPG Operations provided financial consulting services for a period of seven months. The agreement was subsequently extended until March 2022. Q. Asana Biosciences, LLC Asana Biosciences, LLC (“Asana”) is an early-stage drug discovery and R&D company focusing on several therapeutic areas, including oncology, pain and inflammation. Certain executive officers of the Company beneficially own, directly and through certain revocable or irrevocable trusts for the benefit of their immediate families, outstanding equity securities of Asana. In addition, they serve on the Board of Managers of Asana. From time to time, Amneal provides R&D services to Asana under a development and manufacturing agreement and storage services under a storage agreement. Other Agreements Tarsadia Investments, LLC Tarsadia Investments, LLC (“Tarsadia”) is a private investment firm that provides financial services. Tarsadia is a significant shareholder of the Company. A member of Amneal Group, and an observer to the Board, is the Chairman and Founder of Tarsadia. Another member of the Amneal Group, and a member of the Board, is a Managing Director of Tarsadia. Tarsadia offers capital and strategic support for companies with substantial growth potential primarily in the healthcare, financial services, real estate, and clean technology sectors. The Company entered into an agreement in which Tarsadia will provide financial consulting services. The services are not expected to have a material impact to the Company’s financial statements. There was no activity for the years ended December 31, 2024, 2023 and 2022.
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Retirement Benefits [Abstract] | |
Employee Benefit Plans | Employee Benefit Plans The Company has voluntary defined contribution plans covering eligible employees in the U.S. which provide for a Company match. For the years ended December 31, 2024, 2023 and 2022, the Company made matching contributions of $9.2 million, $9.9 million and $9.5 million, respectively. The Company also has a deferred compensation plan for certain former executives and employees of Impax, which the Company acquired in 2018, some of whom are currently employed by the Company. In January 2019, the Company announced that it will no longer accept contributions from employees or make matching contributions for the deferred compensation plan. Deferred compensation 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 by reference to hypothetical investments selected by the participants and is included in accounts payable and accrued expenses and other long-term liabilities. Refer to Note 16. Other Long-Term Liabilities and Note 18. Fair Value Measurements for additional information.
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Segment Information | Segment Information The Company has three reportable segments: Affordable Medicines (formerly known as Generics), Specialty, and AvKARE. During the fourth quarter of 2024, the Company changed the name of its Generics segment to “Affordable Medicines” to reflect the full product offering of the segment. The name change did not result in any change to the composition of the Company’s reportable segments and, therefore, did not result in any change to its historical results. Affordable Medicines The Company’s Affordable Medicines segment includes approximately 270 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 includes branded products, primarily focused on 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, predominantly focused on the U.S. Department of Defense and the U.S. Department of Veterans Affairs. AvKARE is a re-packager of bottle and unit dose pharmaceuticals under the registered names of AvKARE and AvPAK. AvKARE is also a wholesale distributor of pharmaceuticals, over the counter drugs and medical supplies to its retail and institutional customers that are located throughout the U.S. focused primarily on entities that provide care to low-income and uninsured patients. Operating results for the sale of Amneal products by AvKARE are included in the Company’s Affordable Medicines reportable segment. Chief Operating Decision Makers The Company’s Co-Chief Executive Officers are the Company’s chief operating decision makers (“CODMs”). The CODMs evaluate the financial performance of the Company 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 CODMs. 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 CODMs. 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):
(1)Operating results for the sale of Amneal products by AvKARE are included in Affordable Medicines. (2)Net revenue from external customers is attributed to countries based on the location of the product shipment. For the years ended December 31, 2024, 2023, and 2022, net revenue from external customers attributed to foreign countries was immaterial. Significant Expense Categories Provided to the Chief Operating Decision Makers Selling, General and Administrative Expenses - Specialty Segment A The CODMs review certain selling, general and administrative expenses (“SG&A”) for the Specialty segment and, separately, on a departmental basis. The CODMs do not review SG&A for the Affordable Medicines and AvKARE segments. SG&A for the Specialty segment was comprised of the following (in thousands):
(1)Other includes professional fees and other expenses not presented to the CODMs. Research and Development Expenses - Affordable Medicines and Specialty Segments B Research and development expenses for the Affordable Medicines and Specialty segments were comprised of the following (in thousands):
(1)For the Affordable Medicines segment, other includes repairs and maintenance, outside testing, equipment calibration and other expenses not presented to the CODMs. For the Specialty segment, other includes repairs and maintenance, outside testing, professional fees and other expenses not presented to the CODMs. Long-Lived Assets Long-lived assets, which are comprised of property, plant and equipment, net and operating and financing lease right-of-use assets, are attributed based on physical location. Long-lived assets by country were as follows (in thousands):
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Subsequent Events |
12 Months Ended |
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Dec. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Term Loan Due 2025 In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. Securities Purchase Agreement and License and Collaboration Agreement - Related Party On January 3, 2025, the Company entered into a securities purchase agreement and a license and collaboration agreement with Ellodi Pharmaceuticals, L.P. (“Ellodi”) and certain entities affiliated with TPG for $3 million. An observer of our Board is a partner in TPG Capital and a board director of Ellodi. Ellodi is a gastroenterology-focused specialty pharmaceutical company. Amneal has the option to obtain, under certain conditions, an exclusive royalty bearing and sub-licensable world-wide license to a late-stage gastroenterology-focused pipeline product under development. If exercised, the Company will be responsible for remaining development activities and obtaining regulatory approval of the product. The license and collaboration agreement provides for potential future milestone payments to Ellodi for regulatory and commercial milestones of up to $48.5 million and royalties on commercial sales.
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Insider Trading Arrangements |
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Dec. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Insider Trading Policies and Procedures |
12 Months Ended |
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Dec. 31, 2024 | |
Insider Trading Policies and Procedures [Line Items] | |
Insider Trading Policies and Procedures Adopted | true |
Cybersecurity Risk Management and Strategy Disclosure |
12 Months Ended |
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Dec. 31, 2024 | |
Cybersecurity Risk Management, Strategy, and Governance [Line Items] | |
Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block] | Our cybersecurity program includes policies and procedures designed to protect our systems and operations as well as sensitive information and data from anticipated cybersecurity threats. This program is a key component of our approach to enterprise risk management. Key Processes Our cybersecurity defenses include multiple layers of processes and technologies that can help prevent, detect and respond to cybersecurity threats. We administer multiple cybersecurity-related training and awareness events annually. These include baseline cybersecurity training for all new employees and an annual, mandatory, interactive cybersecurity training for all who are assigned our user accounts, and frequent cybersecurity topic awareness broadcast emails and targeted training to specific user groups. Additionally, we use a variety of detective and preventive technologies, including: •email threat detection; •endpoint detection and response; •a 24 hours a day, 7 days a week security operations center that monitors system log telemetry and threat intelligence via a security incident and event management platform; •vulnerability scanning on both internal and externally-facing infrastructure; •next-generation firewalls with geographic access restriction for sensitive externally-facing systems; •multi-factor authentication for remote access and certain internal systems; •data loss prevention for email traffic containing sensitive information; •domain name service threat detection; and •internal incident response procedures based on NIST Special Publication 800-61. We also conduct periodic phishing attack simulations to evaluate users’ vulnerability to emerging email threats. We conduct remediation training where failures occur. On a quarterly basis, our cybersecurity team also conducts scenario-based tabletop exercises with critical business teams to simulate disasters and cyberattacks. The tabletop exercises test and fine-tune our business continuity plans and incident response procedures. Program Assessments Our cybersecurity processes are evaluated as part of an ongoing assessment of our internal control environment, which are informed by the five pillars of the NIST Cybersecurity Framework (“NIST CSF”). We employ a third-party service provider to conduct periodic penetration tests and scan different parts of our IT environment for potential vulnerabilities. We prioritize critical or high vulnerabilities for swift remediation. Additionally, we employ a third-party service provider for continuous cybersecurity risk and vulnerability monitoring. We make continuous adjustments to system and network configurations to mitigate or remediate identified vulnerabilities. Incident Response Cybersecurity incident response procedures are informed by NIST Special Publication 800-61, and continuously improved following periodic exercises and live incidents. Incident response emphasizes rapid containment following detection of a range of threats including: •suspicious repeated login failures; •suspicious network traffic; •malware detection; and •other threats as prioritized through a combination of industry threat intelligence via the Healthcare Information Sharing and Analysis Center and the Company’s security operation center. Third-party Risk Management We focus on further building cybersecurity resiliency throughout our value chain. We perform risk management via an industry third-party risk management service provider for all critical vendors, partners, and systems (including third-party hosted information systems) meeting our risk management policy criteria, to minimize the likelihood and impact of malicious cybersecurity incidents. During the onboarding phase, our cybersecurity team under the direction of the Sr. Director Information Security, Compliance, and Privacy, performs a technological risk assessment on, and utilizes certain tools to detect external risk posed by, the vendor, partner and/or system. Vendors identified as posing elevated risk are escalated to senior management for informed risk tolerance determination. Following the onboarding phase, the cybersecurity team continuously monitors risks related to the vendor, partner and/or system. All third-party cybersecurity incidents are tracked though the third-party service provider and are communicated to our cybersecurity team upon discovery. We prioritize our mitigation of cybersecurity risks based on relative likelihood and severity (e.g., critical risk, high risk, low risk) and document a mitigation plan that details a resolution timeline. Risks Identified cybersecurity risks, including third-party risks and internal risks, are documented and managed in a risk register, which is reviewed regularly with leaders of our internal audit, compliance, and IT departments to ensure visibility and consensus in a separation-of-duties structure. Risks are stratified according to a standard calculus of probability, severity and materiality. As of the date of this report, we do not believe that any risks from any cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition. However, a significant cybersecurity incident may materially impact our business strategy, results of operations and financial condition. Such significant cybersecurity incidents include, but are not limited to: •ransomware infiltrating our critical systems resulting in production delays and/or loss of critical information; •cyber theft of our IP; •cyber theft of employee and family member, customer and/or patient information; •cyberattack on a critical partner that disrupts our supply chain and/or services; and, •cyberattacks that significantly impact our brand perception. As discussed more fully under Part 1, Item 1A, Risk Factors, “We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks,” the sophistication of cybersecurity threats continues to increase, and the preventative actions we take to reduce the risk of cybersecurity incidents and protect our systems and information may be insufficient. Accordingly, no matter how well designed or implemented our controls are, we will not be able to anticipate all security breaches of these types, and we may not be able to implement effective preventive measures against such security breaches in a timely manner.
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Cybersecurity Risk Management Processes Integrated [Flag] | true |
Cybersecurity Risk Management Processes Integrated [Text Block] | Our cybersecurity program includes policies and procedures designed to protect our systems and operations as well as sensitive information and data from anticipated cybersecurity threats. This program is a key component of our approach to enterprise risk management.
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Cybersecurity Risk Management Third Party Engaged [Flag] | true |
Cybersecurity Risk Third Party Oversight and Identification Processes [Flag] | true |
Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] | false |
Cybersecurity Risk Board of Directors Oversight [Text Block] | Board Oversight While our Board of Directors is ultimately responsible for risk oversight, committees of the Board of Directors assist in fulfilling oversight responsibilities in certain areas of risk. The Audit Committee of the Board of Directors (the “Audit Committee”) is responsible for overseeing risks from cybersecurity threats. The Audit Committee receives cybersecurity updates from IT leadership at least twice a year. When meeting with the Audit Committee, the IT leadership team highlights significant accomplishments and issues related to our IT infrastructure, including cybersecurity incidents, risks, industry trends, notable incidents facing other companies, incident preparedness and other developments. The Audit Committee also receives updates regarding progress on initiatives to further align with the five pillars of the NIST CSF. These briefings are designed to provide visibility to the Audit Committee about the identification, assessment, and management of critical risks, audit findings, and management’s risk mitigation strategies. Management Oversight Our IT department, in conjunction with the compliance department, assess and manage risks related to cybersecurity. The Senior Director of Global Information Security, Compliance and Privacy, is the primary management personnel responsible for our cybersecurity program. He has more than twenty years of experience as an information security specialist and holds various cybersecurity professional certifications, including as a Certified Information Security Manager by the Information Systems Audit and Control Association and a Certified Information Systems Security Professional by the International Information System Security Certification Consortium. In addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity. Specific cybersecurity incidents are tracked by a third-party service provider through a ticketing system. Should cybersecurity issues arise throughout the quarter, management would determine whether a cybersecurity incident was material and decide on appropriate reporting and mitigation measures. Following this determination, management would promptly schedule a meeting with the Audit Committee.
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Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block] | The Audit Committee of the Board of Directors (the “Audit Committee”) is responsible for overseeing risks from cybersecurity threats. |
Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block] | While our Board of Directors is ultimately responsible for risk oversight, committees of the Board of Directors assist in fulfilling oversight responsibilities in certain areas of risk. The Audit Committee of the Board of Directors (the “Audit Committee”) is responsible for overseeing risks from cybersecurity threats. The Audit Committee receives cybersecurity updates from IT leadership at least twice a year. When meeting with the Audit Committee, the IT leadership team highlights significant accomplishments and issues related to our IT infrastructure, including cybersecurity incidents, risks, industry trends, notable incidents facing other companies, incident preparedness and other developments. The Audit Committee also receives updates regarding progress on initiatives to further align with the five pillars of the NIST CSF. These briefings are designed to provide visibility to the Audit Committee about the identification, assessment, and management of critical risks, audit findings, and management’s risk mitigation strategies. |
Cybersecurity Risk Role of Management [Text Block] | Our IT department, in conjunction with the compliance department, assess and manage risks related to cybersecurity. The Senior Director of Global Information Security, Compliance and Privacy, is the primary management personnel responsible for our cybersecurity program. He has more than twenty years of experience as an information security specialist and holds various cybersecurity professional certifications, including as a Certified Information Security Manager by the Information Systems Audit and Control Association and a Certified Information Systems Security Professional by the International Information System Security Certification Consortium. In addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity. Specific cybersecurity incidents are tracked by a third-party service provider through a ticketing system.
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Cybersecurity Risk Management Positions or Committees Responsible [Flag] | true |
Cybersecurity Risk Management Positions or Committees Responsible [Text Block] | While our Board of Directors is ultimately responsible for risk oversight, committees of the Board of Directors assist in fulfilling oversight responsibilities in certain areas of risk. The Audit Committee of the Board of Directors (the “Audit Committee”) is responsible for overseeing risks from cybersecurity threats. |
Cybersecurity Risk Management Expertise of Management Responsible [Text Block] | The Senior Director of Global Information Security, Compliance and Privacy, is the primary management personnel responsible for our cybersecurity program. He has more than twenty years of experience as an information security specialist and holds various cybersecurity professional certifications, including as a Certified Information Security Manager by the Information Systems Audit and Control Association and a Certified Information Systems Security Professional by the International Information System Security Certification Consortium. In addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity. |
Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] | Our IT department, in conjunction with the compliance department, assess and manage risks related to cybersecurity. The Senior Director of Global Information Security, Compliance and Privacy, is the primary management personnel responsible for our cybersecurity program. He has more than twenty years of experience as an information security specialist and holds various cybersecurity professional certifications, including as a Certified Information Security Manager by the Information Systems Audit and Control Association and a Certified Information Systems Security Professional by the International Information System Security Certification Consortium. In addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity. Specific cybersecurity incidents are tracked by a third-party service provider through a ticketing system.
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Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag] | true |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Principles | Accounting Principles The financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated.
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Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of all entities controlled by the Company, including Amneal and its subsidiaries, through the Company’s direct or indirect ownership of a majority voting interest. The Company records non-controlling interests for the portion of its subsidiaries’ economic interests that it does not hold. Although the Company had a minority economic interest in Amneal prior to March 31, 2023, it was Amneal’s sole managing member (and it continues to be the sole managing member), having the sole voting power to make all of Amneal’s business decisions and control its management. Therefore, the Company also consolidated the financial statements of Amneal and its subsidiaries for all periods prior to the Reorganization.
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Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP 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, contingent liabilities, 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.
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Revenue Recognition | Revenue Recognition When assessing its revenue recognition, the Company performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies the performance obligation. The Company recognizes revenue when it transfers control of its products to customers, in an amount that reflects the consideration to which the Company expects to be entitled to receive in exchange for those products. From time to time, the Company may enter into arrangements where it licenses certain products to a third-party distributor. Licensing arrangement performance obligations generally include intellectual property (“IP”) rights and research and development (“R&D”) and contract manufacturing services. The Company accounts for IP rights and services separately if they are distinct. The consideration is allocated between IP rights and services based on their relative stand-alone selling prices. Revenue for distinct IP rights is accounted for based on the nature of the promise to grant the license. In determining whether the Company’s promise is to provide a right to access its IP or a right to use its IP, the Company considers the nature of the IP to which the customer will have rights. IP is either functional IP which has significant standalone functionality or symbolic IP which does not have significant standalone functionality. Revenue from functional IP is recognized at the point in time when control of the distinct license is transferred to the customer. Revenue from symbolic IP is recognized over the access period to the Company’s IP. Revenue from sales-based milestones and royalties promised in exchange for a license of IP is recognized only when, or as, the later of subsequent sale or the performance obligation to which some or all of the sales-based royalty has been allocated, is satisfied. Pharmaceutical Product Sales Performance Obligations The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist primarily of major wholesalers, distributors, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies, institutions and pharmaceutical companies. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Customers purchase product by direct channel sales from the Company or by indirect channel sales through various distribution channels. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, 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. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product sales are subject to variable consideration, as described further below. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. Variable consideration includes but is not limited to: chargebacks, distribution fees, rebates, group purchasing organization (“GPO”) fees, prompt payment (cash) discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns, and profit shares. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Chargebacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is lower than the wholesaler pricing, the Company pays the direct customer (wholesaler) a chargeback for the price differential. The Company estimates its chargeback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to chargebacks, current contract terms and historical experience. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Rebates The Company pays fixed or volume-based rebates to its customers based on a fixed amount, fixed percentage of product sales or based on the achievement of a specified level of purchases. The Company’s rebate accruals are based on actual net sales, contractual rebate rates negotiated with customers, and expected purchase volumes / corresponding tiers based on actual sales to date and forecasted amounts. Group Purchasing Organization Fees The Company pays fees to GPOs for administrative services that the GPOs perform in connection with the purchases of product by the GPO participants who are the Company’s customers. The Company’s GPO fee accruals are based on actual net sales, contractual fee rates negotiated with GPOs and the mix of the products in the distribution channel that remain subject to GPO fees. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount accruals are based on actual net sales and contractual discount rates. Consideration Payable to the Customer The Company pays administrative and service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company accrues for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Billbacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is higher than contractual pricing, the Company pays the indirect customer a billback for the price differential. The Company estimates its billback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to billbacks, current contract terms and historical experience. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Medicaid and Other Government Pricing Programs The Company complies with required rebates mandated by law under Medicaid and other government pricing programs. The Company estimates its government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rates and estimated lag time of the rebate invoices. Price Protection and Shelf Stock Adjustments The Company provides customers with price protection and shelf stock adjustments which may result in an adjustment to the price charged for the product transferred, based on differences between old and new prices which may be applied to the customer’s on-hand inventory at the time of the price change. The Company accrues for these adjustments when its expected value of an adjustment is greater than zero, based on contractual pricing, actual net sales, accrual rates based on historical average rates, and estimates of the level of inventory of its products in the distribution channel that remain subject to these adjustments. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Sales Returns The Company permits the return of product under certain circumstances, mainly due to product expiration, instances of shipping errors or where product is damaged in transit, and occurrences of product recalls. The Company’s product returns accrual is primarily based on estimates of future product returns based generally on actual net sales, estimates of the level of inventory of its products in the distribution and retail channels that remain subject to returns, estimated lag time of returns and historical return rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Profit Shares For certain product sale arrangements, the Company earns a profit share upon the customer’s sell-through of the product purchased from the Company. The Company estimates its profit shares based on actual net sales by third parties, estimated inventory sold to our partners not yet sold by them, and historical rates of profit shares earned. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. The 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 R&D services over multiple periods.
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Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based compensation consists of stock options, restricted stock units (“RSUs”) and market performance-based restricted stock units (“MPRSUs”) awarded to employees and non-employee directors. Stock options are measured at their fair value on the grant date or date of modification, as applicable. RSUs, including MPRSUs, are measured at the stock price on the grant date or date of modification, as applicable. The Company recognizes compensation expense on a straight-line basis over the requisite service and/or performance period, as applicable. Forfeitures of awards are accounted for as a reduction in stock-based compensation expense in the period such awards are forfeited. The Company's policy is to issue new shares upon option exercises and the vesting of RSUs and MPRSUs.
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Contingent consideration | Contingent consideration Business acquisitions may include future payments that are contingent upon the occurrence of certain pharmaceutical regulatory milestones or net sales of pharmaceutical products. For acquisitions that are accounted for as a business combination, the obligations for such contingent consideration payments are recorded at fair value on the acquisition date. For contingent milestone payments, the Company uses a probability-weighted income approach utilizing an appropriate discount rate. For contingent tiered royalties on net sales, the Company uses a Monte Carlo simulation model. Contingent consideration liabilities are revalued to fair value at the end of each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in fair value of contingent consideration in the consolidated statements of operations.
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Foreign Currencies | Foreign Currencies The Company has operations in the U.S., India, Ireland, and other foreign jurisdictions. Generally, the Company’s foreign operating subsidiaries’ functional currency is the local currency. The results of its non-U.S. dollar based operations are translated to U.S. dollars at the average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Translation adjustments are included in accumulated other comprehensive (loss) income and non-controlling interests in the consolidated balance sheets and are included in comprehensive loss. Transaction gains and losses are included in net loss in the Company’s consolidated statements of operations as a component of foreign exchange (loss) gain, net. Such foreign currency transaction gains and losses include fluctuations related to long-term intercompany loans that are payable in the foreseeable future. Translation gains and losses on intercompany balances of a long-term investment nature are included in foreign currency translation adjustments in accumulated other comprehensive (loss) income and non-controlling interests, and comprehensive loss.
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Business Combinations | Business Combinations Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, the acquiring entity in a business combination records the assets acquired and liabilities assumed at the date of acquisition at their fair values. Any excess of the purchase price over the fair value of net assets and other identifiable intangible assets acquired is recorded as goodwill. Acquisition-related costs, primarily professional fees, are expensed as incurred.
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Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash on deposit and highly liquid investments with original maturities of three months or less. A portion of the Company’s cash flows are derived outside the U.S. As a result, the Company is subject to market risk associated with changes in foreign exchange rates. The Company maintains cash balances at both U.S.-based and international-based commercial banks. At various times during the year, cash balances in the U.S. may exceed amounts that are insured by the Federal Deposit Insurance Corporation.
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Restricted Cash | Restricted Cash At December 31, 2024 and 2023, the Company had restricted cash balances of $7.9 million and $7.6 million, respectively, in its bank accounts primarily related to the purchase of certain land and equipment in India.
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Accounts Receivable and Allowance for Credit Losses | Accounts Receivable and Allowance for Credit Losses Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company limits its credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary. The Company does not require collateral to secure amounts owed to it by its customers. Trade accounts receivable are stated at their net realizable value. The allowance for credit losses reflects the best estimate of expected credit losses of the accounts receivable portfolio determined on the basis of historical experience, current information, and forecasts of future economic conditions. The Company determines its allowance methodology by pooling receivable balances at the customer level. The Company considers various factors, including its previous loss history, individual credit risk associated to each customer, and the current and future condition of the general economy. These credit risk factors are monitored on a quarterly basis and updated as necessary. To the extent that any individual debtor is identified whose credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics of such customer. The Company makes concerted efforts to collect all outstanding balances due from customers; however, account balances are charged off against the allowance when management believes it is probable the receivable will not be recovered. The Company does not have any off-balance-sheet credit exposure related to customers.
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Chargebacks Received From Manufacturers | Chargebacks Received from Manufacturers When a sale occurs on a contracted item, the difference between the cost the Company pays to the manufacturer of that item and the contract price that the end customer has with the manufacturer is rebated to the Company by the manufacturer as a chargeback. Chargebacks are recorded as a reduction to cost of sales and either a reduction in the amount due to the manufacturer (if there is a right of offset) or as a receivable from the manufacturer.
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Inventories | Inventories Inventories consist of finished goods held for sale, raw materials, and work in process. Inventories are stated at net realizable value, with cost determined using the first-in, first-out method. Adjustments for excess and obsolete inventories are established based upon historical experience and management’s assessment of current product demand. These assessments include inventory obsolescence based on its expiration date, damaged or rejected product, and slow-moving products.
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Property, Plant and Equipment | Upon retirement or disposal, the cost of the asset disposed and the accumulated depreciation are removed from the accounts, and any gain or loss is reflected as part of operating income (loss) in the period of disposal. Expenditures that significantly increase value or extend useful lives of property, plant, and equipment are capitalized, whereas those for normal maintenance and repairs are expensed. The Company capitalizes interest on borrowings during the construction period of major capital projects as part of the related asset and amortizes the capitalized interest into earnings over the related asset’s remaining useful life.
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Leases | Leases All significant lease arrangements are recognized as right-of-use (“ROU”) assets and lease liabilities at lease commencement. ROU assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of the future lease payments using the Company's incremental borrowing rate. Operating lease expense is recognized on a straight-line basis over the lease term. At each balance sheet date, operating and financing lease liabilities continue to represent the present value of the future payments. Financing lease ROU assets are expensed using the straight-line method, unless another basis is more representative of the pattern of economic benefit, to lease expense. Interest on financing lease liabilities is recognized in interest expense. Leases with an initial term of 12 months or less (short-term leases) are not recognized in the balance sheet and the related lease payments are recognized as incurred over the lease term. The Company separates lease and non-lease components. A portion of the Company's real estate leases are subject to periodic changes in the Consumer Price Index (“CPI”). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred.
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In-Process Research and Development | In-Process Research and Development The fair value of in-process research and development (“IPR&D”) acquired in a business combination is determined based on the present value of each research project’s projected cash flows using an income approach. Revenues are estimated based on relevant market size and growth factors, expected industry trends, individual project life cycles and the life of each research project’s underlying marketability. In determining the fair value of each research project, expected cash flows are adjusted for certain risks of completion, including technical and regulatory risk. The value attributable to IPR&D projects at the time of acquisition is capitalized as an indefinite-lived intangible asset and tested for impairment until the project is completed or abandoned. Upon completion of the project, the indefinite-lived intangible asset is then accounted for as a finite-lived intangible asset and amortized over the estimated useful life of the asset based on the pattern in which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. If the project is abandoned, the indefinite-lived intangible asset is charged to expense. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance.
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Goodwill | Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value based test. The Company reviews goodwill for possible impairment annually during the fourth quarter, or whenever events or circumstances indicate that the carrying amount may not be recoverable. In order to test goodwill for impairment, an entity is permitted to first assess qualitative factors to determine whether a quantitative assessment of goodwill is necessary. The qualitative factors considered by the Company may include, but are not limited to, general economic conditions, the Company’s outlook, market performance of the Company’s industry and recent and forecasted financial performance. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that a reporting unit’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. If a quantitative assessment is required, the Company determines the fair value of its reporting unit using a combination of the income and market approaches. If the net book value of the reporting unit exceeds its fair value, the Company recognizes a goodwill impairment charge for the reporting unit equal to the lesser of (i) the total goodwill allocated to that reporting unit and (ii) the amount by which that reporting unit’s carrying amount exceeds its fair value. See Note 12. Goodwill and Other Intangible Assets, for further discussion of the Company's qualitative and quantitative assessments of goodwill. Assumptions and estimates used in the evaluation of impairment may affect the carrying value of long-lived assets, which could result in impairment charges in future periods. Such assumptions include projections of future cash flows and the current fair value of the asset.
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Amortization of Intangible Assets with Finite Lives | Amortization of Intangible Assets with Finite Lives Intangible assets, other than indefinite-lived intangible assets, are amortized over the estimated useful life of the asset based on the pattern in which the economic benefits are expected to be consumed or otherwise used up or, if that pattern is not readily determinable, on a straight-line basis. The useful life is the period over which the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are not written-off in the period of acquisition unless they become impaired during that period. The Company regularly evaluates the remaining useful life of each intangible asset that is being amortized to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life.
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Impairment of Long-Lived Assets (Including Intangible Assets with Finite Lives) | Impairment of Long-Lived Assets (Including Intangible Assets with Finite Lives) The Company reviews its long-lived assets, including intangible assets with finite lives, for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company evaluates assets for potential impairment by comparing estimated future undiscounted net cash flows to the carrying amount of the asset. If the carrying amount of the assets exceeds the estimated future undiscounted cash flows, impairment is measured based on the difference between the carrying amount of the assets and fair value, which is generally an expected present value cash flow technique. Management’s policy in determining whether an impairment indicator exists comprises measurable operating performance criteria as well as other qualitative measures.
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Financial Instruments | Financial Instruments The Company minimizes its risks from interest fluctuations through its normal operating and financing activities and, when deemed appropriate through the use of derivative financial instruments. Derivative financial instruments are used to manage risk and are not used for trading or other speculative purposes. The Company does not use leveraged derivative financial instruments. Derivative financial instruments that qualify for hedge accounting must be designated and effective as a hedge of the identified risk exposure at the inception of the contract. Accordingly, changes in fair value of the derivative contract must be highly correlated with changes in fair value of the underlying hedged item at inception of the hedge and over the life of the hedge contract. All derivatives are recorded on the balance sheet as assets or liabilities and measured at fair value. For derivatives designated as cash flow hedges, the effective portion of the changes in fair value of the derivatives are recorded in accumulated other comprehensive (loss) income net of income taxes and subsequently amortized as an adjustment to interest expense over the period during which the hedged forecasted transaction affects earnings, which is when the Company recognizes interest expense on the hedged cash flows. Cash flows of such derivative financial instruments are classified consistent with the underlying hedged item. Highly effective hedging relationships that use interest rate swaps as the hedging instrument and that meet criteria under ASC 815, Derivatives and Hedging (“ASC 815”), may qualify for the “short-cut method” of assessing effectiveness. The short-cut method allows the Company to make the assumption of no ineffectiveness, which means that the change in fair value of the hedged item can be assumed to be equal to the change in fair value of the derivative. Unless critical terms change, no further evaluation of effectiveness is performed for these hedging relationships unless a critical term is changed. For a hedging relationship that does not qualify for the short-cut method, the Company measures its effectiveness using the “hypothetical derivative method”, in which the change in fair value of the hedged item must be measured separately from the change in fair value of the derivative. At inception and quarterly thereafter, the Company formally assesses whether the derivatives that are used in hedging transactions are highly effective in offsetting changes in the fair value or cash flows of the hedged item. The Company compares the change in the fair value of the actual interest rate derivative to the change in the fair value of a hypothetical interest rate derivative with critical terms that match the hedged interest rate payments. After the initial quantitative assessment, this analysis is performed on a qualitative basis and, if it is determined that the hedging relationship was and continues to be highly effective, no further analysis is required. All components of each derivative financial instrument's gain or loss are included in the assessment of hedge effectiveness. If it is determined that a derivative ceases to be a highly effective hedge, the Company discontinues hedge accounting and any deferred gains or losses related to a discontinued cash flow hedge shall continue to be reported in accumulated other comprehensive (loss) income net of income taxes, unless it is probable that the forecasted transaction will not occur. If it is probable that the forecasted transaction will not occur by the originally specified time period, the Company discontinues hedge accounting, and any deferred gains or losses reported in accumulated other comprehensive (loss) income are reclassified into earnings immediately. The Company is subject to credit risk as a result of nonperformance by counterparties to the derivative agreements. Upon inception and quarterly thereafter, the Company makes judgments on each counterparty’s creditworthiness for nonperformance by counterparties.
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Income Taxes | Income Taxes The Company accounts for income taxes in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which requires the recognition of tax benefits or expenses on temporary differences between the financial reporting and tax bases of its assets and liabilities by applying the enacted tax rates in effect for the year in which the differences are expected to reverse. Such net tax effects on temporary differences are reflected on the Company’s consolidated balance sheets as deferred tax assets and liabilities. Deferred tax assets are reduced by a valuation allowance when the Company believes that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. ASC 740-10 prescribes a two-step approach for the recognition and measurement of tax benefits associated with the positions taken or expected to be taken in a tax return that affect amounts reported in the financial statements. The Company has reviewed and will continue to review the conclusions reached regarding uncertain tax positions, which may be subject to review and adjustment at a later date based on ongoing analyses of tax laws, regulations and interpretations thereof. To the extent that the Company’s assessment of the conclusions reached regarding uncertain tax positions changes as a result of the evaluation of new information, such change in estimate will be recorded in the period in which such determination is made. The Company reports income tax-related interest and penalties relating to uncertain tax positions, if applicable, as a component of income tax expense.
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Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss and all changes in stockholders’ equity (except those arising from transactions with stockholders) including foreign currency translation adjustments resulting from the consolidation of foreign subsidiaries’ financial statements and unrealized (losses) gains on cash flows hedges, net of income taxes.
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Research and Development and Intellectual Property Legal Development Expenses | Research and Development R&D activities are expensed as incurred. R&D expenses primarily consist of direct and allocated expenses incurred with the process of formulation, clinical research, and validation associated with new product development. Upfront and milestone payments made to third parties in connection with R&D collaborations are expensed as incurred up to the point of regulatory approval or when there is no alternative future use. Intellectual Property Legal Development Expenses The Company expenses external IP legal development expenses as incurred. These costs relate to legal challenges of innovator’s patents for invalidity or non-infringement, which are customary in the generic pharmaceutical industry, and are incurred predominately during development of a product and prior to regulatory approval. Associated costs include, but are not limited to, formulation assessments, patent challenge opinions and strategy, and litigation expenses to defend the IP supporting the Company's regulatory filings.
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Shipping Costs | Shipping Costs The Company records the costs of shipping product to its customers as a component of selling, general, and administrative expenses as incurred.
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Advertising Costs | Advertising Costs Advertising costs are expensed as incurred.
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Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which provides improvements to reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 requires disclosures to include the title and position of the chief operating decision maker (“CODM”), significant segment expenses that are regularly provided to the CODM, a description of other segment items by reportable segment, and any additional measures of a segment’s profit or loss used by the CODM when deciding how to allocate resources. ASU 2023-07 also requires all annual disclosures currently required by Topic 280 to be included in interim periods. The Company adopted the annual and interim disclosure requirements of ASU 2023-07 effective December 31, 2024 (refer to Note 25. Segment Information). The adoption of this ASU only affects the Company’s disclosures, with no impact to its financial condition and results of operations. Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the transparency and usefulness of income tax disclosures. ASU 2023-09 requires that public business entities on an annual basis disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. The update is effective for fiscal years beginning after December 15, 2024, with early adoption permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements. In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain categories of expenses that are included in expense line items on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning December 15, 2027, with early adoption permitted. Upon adoption, ASU 2024-03 may be applied prospectively for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
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Reclassification | Reclassification The prior period balances related to the TRA (as defined in Note 6. Income Taxes) of $3.1 million and $0.6 million, formerly included in “Other income, net”, for the year ended December 31, 2023 and 2022, respectively, have been reclassified to the income statement caption “Increase in tax receivable agreement liability” to conform to the current period presentation in the consolidated statements of operations. This reclassification did not impact total other expense, net or net income. The prior period balance related to long-term liabilities for legal matters of $0.3 million, formerly included in “Other long-term liabilities” as of December 31, 2023, has been reclassified to the balance sheet caption “Liabilities for legal matters - long term” to conform to the current period presentation in the consolidated balance sheets. This reclassification did not impact total long-term liabilities or total liabilities.
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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:
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Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Property, Plant, and Equipment Estimated Useful Lives | Depreciation expense is computed primarily using the straight-line method over the estimated useful lives of the assets, which are as follows:
Property, plant, and equipment, net was comprised of the following (in thousands):
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Acquisition (Tables) |
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Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] | |||||||||||||||||||||||||
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):
(1)The estimated fair value of contingent consideration on the acquisition date of $8.8 million 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 18. Fair Value Measurements for additional information on the methodology and determination of this liability.
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Revenue Recognition (Tables) |
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Revenue from Contract with Customer [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Revenue by Major Customers by Reporting Segments | The following table summarizes the percentages of net revenues from each of the Company's customers that individually accounted for 10% or more of its net revenues:
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Schedule of Disaggregated Revenue | The Company’s significant dosage forms for its Affordable Medicines segment, therapeutic classes for its Specialty segment and sales channels for its AvKARE segment, as determined based on net revenue for the years ended December 31, 2024, 2023 and 2022, are set forth below (in thousands):
(1)Includes net revenue from sales of transmucosal, ophthalmic, topical, nasal and inhalation dosage forms. (2)Refer to Note 5. Alliance and Collaboration for information on revenue recognized under license agreements.
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Schedule of Major Categories of Sales-Related Deductions | A rollforward of the major categories of sales-related deductions for the years ended December 31, 2024, 2023 and 2022 is as follows (in thousands):
The following table summarizes the changes in the Company’s valuation allowance on deferred tax assets (in thousands):
|
Income Taxes (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of (Loss) Income Before Income Taxes | The components of the Company's (loss) income before income taxes were as follows (in thousands):
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Schedule of Provision for (Benefit From) Income Tax Expense | The provision for (benefit from) income taxes was comprised of the following (in thousands):
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Schedule of Effective Income Tax Rate | The Company’s effective tax rates were as follows:
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Schedule of Major Categories of Sales-Related Deductions | A rollforward of the major categories of sales-related deductions for the years ended December 31, 2024, 2023 and 2022 is as follows (in thousands):
The following table summarizes the changes in the Company’s valuation allowance on deferred tax assets (in thousands):
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Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to deferred taxes were as follows (in thousands):
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Schedule of Unrecognized Tax Benefits Roll Forward | A rollforward of unrecognized tax benefits for the years ended December 31, 2024, 2023 and 2022 is as follows (in thousands):
|
Loss per Share (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
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Schedule of Antidilutive Securities Excluded from Computation of Loss 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):
(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. (2)Shares of Old PubCo Class B Common Stock were considered potentially dilutive shares of Class A common stock. Shares of Old PubCo Class B Common Stock were excluded from the computations of diluted loss per share of Class A common stock for the year ended December 31, 2022 because the effect of their inclusion would have been anti-dilutive under the if-converted method.
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Trade Accounts Receivable, Net (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Trade Accounts Receivable, Net | Trade accounts receivable, net is comprised of the following (in thousands):
(1) Refer to Note 4. Revenue Recognition for additional information.
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Schedules of Percent of Gross Trade Receivables | Trade accounts receivables from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
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Inventories (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Inventories | Inventories are comprised of the following (in thousands):
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Prepaid Expenses and Other Current Assets (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are comprised of the following (in thousands):
(1)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.
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Property, Plant, and Equipment, Net (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property, Plant and Equipment, Net Estimated Useful Lives | Depreciation expense is computed primarily using the straight-line method over the estimated useful lives of the assets, which are as follows:
Property, plant, and equipment, net was comprised of the following (in thousands):
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Goodwill and Other Intangible Assets (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Goodwill | The changes in goodwill by segment were as follows (in thousands):
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Schedule of Finite-Lived Intangible Assets | Intangible assets were comprised of the following (in thousands):
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Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The following table presents future amortization expense for the next five years and thereafter, excluding $14.3 million of IPR&D intangible assets (in thousands):
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Other Assets (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Assets | Other assets were comprised of the following (in thousands):
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Accounts Payable and Accrued Expenses (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses were comprised of the following (in thousands):
(1)Refer to Note 4. Revenue Recognition for additional information.
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Debt (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Long-term Debt | The following is a summary of the Company’s term loan indebtedness (in thousands):
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Other Long-Term Liabilities (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Long-Term Liabilities | Other long-term liabilities were comprised of the following (in thousands):
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Leases (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Lease Costs / Supplemental Cash Flow Information | The components of total lease costs were as follows (in thousands):
(1)Includes variable and short-term lease costs. Supplemental cash flow information related to leases was as follows (in thousands):
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Schedule of Supplemental Balance Sheet Information | Supplemental balance sheet information related to the Company's leases was as follows (in thousands):
(1) Refer to Note 23. Related Party Transactions for information about related party leases. The table below reflects the weighted average remaining lease term and weighted average discount rate for the Company's operating and finance leases:
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Schedule of Operating Lease Maturities | Maturities of lease liabilities as of December 31, 2024 were as follow (in thousands):
Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands):
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Schedule of Finance Lease Maturities | Maturities of lease liabilities as of December 31, 2024 were as follow (in thousands):
Maturities of lease liabilities as of December 31, 2023 were as follows (in thousands):
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Fair Value Measurements (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis (in thousands):
(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 19. Financial Instruments for information about 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 liability has been classified as a Level 3 recurring liability as its valuation requires judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for various inputs, the estimated fair value could be higher or lower than what the Company determined. As of December 31, 2023, the contingent consideration liability associated with the Saol Acquisition included $0.1 million recorded in accounts payable and accrued expenses and $0.4 million recorded in other-longer term liabilities. As of December 31, 2023, the contingent consideration liability associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC was $0.4 million and was recorded within related party payables - long term. Contingent consideration liability was $0 as of December 31, 2024.
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Summary of the Company’s Indebtedness at Fair Value | The following is a summary of the Company’s indebtedness at fair value (in thousands):
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Schedule of Reconciliation of Contingent Consideration Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Level 3) | The following table provides a reconciliation of the contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the year ended December 31, 2023 (in thousands):
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Financial Instruments (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
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Commitments and Contingencies (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
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Stockholders’ (Deficiency) Equity (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Changes in Accumulated Other Comprehensive Income (Loss) by Component | Changes in Accumulated Other Comprehensive Income (Loss) by Component (in thousands):
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Stock-Based Compensation (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option Activity | The following table summarizes all of the Company’s stock option activity for the years ended December 31, 2024, 2023, and 2022:
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Schedule of Nonvested Restricted Stock Units Activity | The following table summarizes all of the Company's restricted stock unit activity for the years ended December 31, 2024, 2023, and 2022:
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Schedule of Employee Service Share-based Compensation | The amount of stock-based compensation expense recognized by the Company was as follows (in thousands):
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Related Party Transactions (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Related Party Transactions [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Related Party Transactions | The following table summarizes the Company’s related party transactions (in thousands):
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
|
Segment Information (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Segment Reporting Information, by Segment | 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):
(1)Operating results for the sale of Amneal products by AvKARE are included in Affordable Medicines. (2)Net revenue from external customers is attributed to countries based on the location of the product shipment. For the years ended December 31, 2024, 2023, and 2022, net revenue from external customers attributed to foreign countries was immaterial. Significant Expense Categories Provided to the Chief Operating Decision Makers Selling, General and Administrative Expenses - Specialty Segment A The CODMs review certain selling, general and administrative expenses (“SG&A”) for the Specialty segment and, separately, on a departmental basis. The CODMs do not review SG&A for the Affordable Medicines and AvKARE segments. SG&A for the Specialty segment was comprised of the following (in thousands):
(1)Other includes professional fees and other expenses not presented to the CODMs. Research and Development Expenses - Affordable Medicines and Specialty Segments B Research and development expenses for the Affordable Medicines and Specialty segments were comprised of the following (in thousands):
(1)For the Affordable Medicines segment, other includes repairs and maintenance, outside testing, equipment calibration and other expenses not presented to the CODMs. For the Specialty segment, other includes repairs and maintenance, outside testing, professional fees and other expenses not presented to the CODMs.
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Schedule of Long-Lived Assets, by Geographical Areas | Long-lived assets, which are comprised of property, plant and equipment, net and operating and financing lease right-of-use assets, are attributed based on physical location. Long-lived assets by country were as follows (in thousands):
|
Nature of Operations (Details) |
Dec. 31, 2024
$ / shares
|
Dec. 31, 2023
$ / shares
|
Nov. 07, 2023
$ / shares
|
Nov. 06, 2023 |
---|---|---|---|---|
Class A Common Stock | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Class A Common Stock | Old PubCo | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.01 | |||
Class A Common Stock | New PubCo | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.01 | |||
Reorganization, common stock conversion ratio | 1 | |||
Class B common stock | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Class B common stock | Old PubCo | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.01 | |||
Amneal Pharmaceuticals, LLC | ||||
Class of Stock [Line Items] | ||||
Ownership by parent (percent) | 100.00% | 50.40% | ||
Amneal Pharmaceuticals, LLC | Amneal Group | ||||
Class of Stock [Line Items] | ||||
Ownership percentage by noncontrolling owners (percent) | 49.60% |
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Product Information [Line Items] | |||
Restricted cash | $ 7,868 | $ 7,565 | $ 9,251 |
Increase in tax receivable agreement liability | (50,680) | (3,124) | (631) |
long-term liabilities for legal matters | 85,479 | 316 | |
Selling, general and administrative | |||
Product Information [Line Items] | |||
Shipping Expense | 18,900 | 21,700 | 18,700 |
Advertising costs | $ 34,400 | $ 12,400 | $ 16,800 |
Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment Estimated Useful Lives (Details) |
Dec. 31, 2024 |
---|---|
Buildings | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 30 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years |
Machinery and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Machinery and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 10 years |
Vehicles | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Acquisition - Additional Information (Details) - USD ($) $ in Thousands |
11 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
Feb. 09, 2022 |
Dec. 31, 2022 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Business Acquisition [Line Items] | |||||
Net revenue | $ 2,793,957 | $ 2,393,607 | $ 2,212,304 | ||
Operating loss | $ 249,326 | 204,374 | (94,928) | ||
Acquisition, transaction-related and integration expenses | $ 700 | ||||
Saol Baclofen Franchise Acquisition | |||||
Business Acquisition [Line Items] | |||||
Cash | $ 84,714 | ||||
Asset acquisition, inventory acquired | $ 1,100 | ||||
Asset acquisition, transaction cost | $ 100 | ||||
Net revenue | $ 19,800 | ||||
Operating loss | $ 7,100 |
Acquisition - Payments to Acquire Business (Details) - Saol Baclofen Franchise Acquisition $ in Thousands |
Feb. 09, 2022
USD ($)
|
---|---|
Business Acquisition [Line Items] | |
Cash | $ 84,714 |
Contingent consideration (royalties) | 8,796 |
Fair value of consideration transferred | $ 93,510 |
Revenue Recognition - Concentration of Revenue (Details) - Revenue from Contract with Customer Benchmark - Customer Concentration Risk |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Customer A | |||
Concentration Risk [Line Items] | |||
Concentration risk (percent) | 23.00% | 24.00% | 21.00% |
Customer B | |||
Concentration Risk [Line Items] | |||
Concentration risk (percent) | 15.00% | 16.00% | 18.00% |
Customer C | |||
Concentration Risk [Line Items] | |||
Concentration risk (percent) | 23.00% | 21.00% | 22.00% |
Customer D | |||
Concentration Risk [Line Items] | |||
Concentration risk (percent) | 9.00% | 9.00% | 10.00% |
Alliance and Collaboration - ONGENTYS® License Agreement (Details) - ONGENTYS® License Agreement - USD ($) $ in Millions |
1 Months Ended | 13 Months Ended | |
---|---|---|---|
Dec. 31, 2023 |
Dec. 31, 2024 |
Dec. 05, 2023 |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaborative arrangement, medical and marketing activities | $ 6.0 | ||
Collaborative arrangement, medical and marketing activities expense | $ 5.7 | ||
Collaborative arrangement non-refundable license fee | $ 12.5 | ||
Collaborative arrangement non-refundable license fee, amortization period | 8 years | ||
License supply agreement, potential future milestone payments | $ 22.5 |
Alliance and Collaboration - Knight Therapeutics International S.A. License Agreement (Details) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Jul. 01, 2024 |
Jan. 24, 2024 |
Dec. 31, 2024 |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaborative arrangement renew for successive term | 3 years | ||
Knight Therapeutics International S.A. License Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Collaborative arrangement term | 15 years | ||
Collaborative arrangement renew for successive term | 2 years | ||
Collaborative arrangement, renewal decline notice period | 1 year | ||
Collaborative arrangement net revenue agreement | $ 2.0 | ||
License supply agreement, potential future milestone payments | $ 9.5 |
Alliance and Collaboration - Collaboration to Develop and Supply Medicines for Obesity and Metabolic Diseases (Details) - Metsera Arrangement $ in Millions |
12 Months Ended | |
---|---|---|
Sep. 30, 2024
facility
|
Dec. 31, 2024
USD ($)
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Number of greenfield manufacturing facilities | facility | 2 | |
Collaborative arrangement term | 7 years | |
Collaborative arrangement, additional renew agreement term | 5 years | |
Metsera, Inc. | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Maximum potential future construction costs | $ | $ 100 |
Income Taxes - Components of (Loss) Income Before Income Taxes (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Operating Loss Carryforwards [Line Items] | |||
Total loss before income taxes | $ (55,013) | $ (40,270) | $ (248,127) |
United States | |||
Operating Loss Carryforwards [Line Items] | |||
Total loss before income taxes | (69,020) | (59,781) | (260,616) |
International | |||
Operating Loss Carryforwards [Line Items] | |||
Total loss before income taxes | $ 14,007 | $ 19,511 | $ 12,489 |
Income Taxes - Provision for (Benefit From) Income Tax Expense (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Current: | |||
Domestic | $ 8,314 | $ 2,470 | $ (1,073) |
Foreign | 10,549 | 5,982 | 7,735 |
Total current income tax | $ 18,863 | $ 8,452 | $ 6,662 |
Income Taxes - Effective Income Tax Rate (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Income Tax Disclosure [Abstract] | |||
Federal income tax at the statutory rate | 21.00% | 21.00% | 21.00% |
State income tax, net of federal benefit | (7.20%) | (5.50%) | (0.80%) |
Income not subject to tax | 16.30% | 14.50% | (10.70%) |
Foreign rate differential | (17.00%) | (19.50%) | (3.40%) |
Permanent book/tax differences | (30.20%) | (2.10%) | (0.30%) |
Change in prior year estimates | (4.80%) | 7.70% | 0.70% |
Deferred tax adjustment | 0.00% | (5.70%) | 0.00% |
Valuation allowance | (15.50%) | (32.30%) | (10.30%) |
Other | 3.10% | 0.90% | 1.10% |
Effective income tax rate | (34.30%) | (21.00%) | (2.70%) |
Income Taxes - Deferred Tax Assets, Changes in Valuation Allowance (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Deferred Tax Assets, Valuation Allowance [Roll Forward] | |||
Balance at the beginning of the period | $ 566,544 | $ 434,895 | $ 416,588 |
Increase due to net operating losses and temporary differences | 15,139 | 23,078 | 25,589 |
Increase due to stock-based compensation | 2,665 | 1,652 | 224 |
Decrease recorded against goodwill | 0 | 0 | (1,590) |
Increase recorded against additional paid-in capital | (1,794) | 96,316 | 2,720 |
Increase (decrease) recorded against other comprehensive income | 7,779 | 10,603 | (8,636) |
Balance at the end of the period | $ 590,333 | $ 566,544 | $ 434,895 |
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
---|---|---|---|---|
Deferred tax assets: | ||||
Partnership interest in Amneal | $ 360,055 | $ 318,140 | ||
Projected imputed interest on TRA | 18,169 | 22,730 | ||
Net operating loss carryforward | 33,403 | 74,340 | ||
IRC Section 163(j) interest carryforward | 105,621 | 72,513 | ||
Capitalized costs | 2,048 | 2,537 | ||
Accrued expenses | 0 | 648 | ||
Stock-based compensation | 17,337 | 14,672 | ||
Intangible assets | 19,701 | 21,901 | ||
Tax credits and other | 33,999 | 39,063 | ||
Total deferred tax assets | 590,333 | 566,544 | ||
Valuation allowance | (590,333) | (566,544) | $ (434,895) | $ (416,588) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Unrecognized tax benefits at the beginning of the period | $ 3,735 | $ 3,616 | $ 5,489 |
Gross change for current period positions | 210 | 170 | 110 |
Gross change for prior period positions | (1) | (51) | (1,983) |
Unrecognized tax benefits at the end of the period | $ 3,944 | $ 3,735 | $ 3,616 |
Loss per Share - Computation of Basic and Diluted Loss per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Numerator: | |||
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (116,886) | $ (83,993) | $ (129,986) |
Denominator: | |||
Weighted-average shares outstanding - basic (in shares) | 308,978 | 176,136 | 150,944 |
Weighted-average shares outstanding - diluted (in shares) | 308,978 | 176,136 | 150,944 |
Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s Class A common stockholders: | |||
Basic (in dollars per share) | $ (0.38) | $ (0.48) | $ (0.86) |
Diluted (in dollars per share) | $ (0.38) | $ (0.48) | $ (0.86) |
Loss per Share - Securities Excluded from Diluted Loss per Share Computation (Details) - shares shares in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Common Class B | Old PubCo | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from earnings per share (in shares) | 0 | 0 | 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) | 2,019 | 2,416 | 2,648 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from earnings per share (in shares) | 9,967 | 10,511 | 10,755 |
Performance stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from earnings per share (in shares) | 7,609 | 6,944 | 7,174 |
Trade Accounts Receivable, Net - Schedule of Trade Accounts Receivable, Net (Details) - Nonrelated Party - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Related Party Transaction [Line Items] | ||
Gross accounts receivable | $ 1,303,788 | $ 1,199,980 |
Allowance for credit losses | (3,552) | (3,022) |
Contract charge-backs and sales volume allowances | (498,537) | (559,334) |
Cash discount allowances | (25,968) | (23,892) |
Subtotal | (528,057) | (586,248) |
Trade accounts receivable, net | $ 775,731 | $ 613,732 |
Trade Accounts Receivable, Net - Concentration of Receivables (Details) - Customer Concentration Risk - Accounts Receivable |
12 Months Ended | |
---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 37.00% | 40.00% |
Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 21.00% | 24.00% |
Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk (percent) | 29.00% | 22.00% |
Inventories - Components of Inventories (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 207,697 | $ 217,744 |
Work in process | 52,835 | 59,563 |
Finished goods | 351,922 | 304,077 |
Total inventories | $ 612,454 | $ 581,384 |
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Deposits and advances | $ 1,868 | $ 2,200 |
Prepaid insurance | 8,264 | 8,334 |
Prepaid regulatory fees | 6,958 | 6,331 |
Income and other tax receivables | 16,829 | 13,168 |
Prepaid taxes | 7,516 | 11,899 |
Other current receivables | 9,142 | 9,929 |
Chargebacks receivable | 6,378 | 7,876 |
Other prepaid assets | 23,762 | 22,948 |
Total prepaid expenses and other current assets | $ 80,717 | $ 82,685 |
Property, Plant, and Equipment, Net - Additional Information (Details) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 62.6 | $ 66.2 | $ 68.1 |
Goodwill and Other Intangible Assets - Schedule of Goodwill (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
Goodwill [Roll Forward] | ||
Balance, beginning of period | $ 598,629 | $ 598,853 |
Currency translation | (1,193) | (224) |
Balance, end of period | 597,436 | 598,629 |
Affordable Medicines | ||
Goodwill [Roll Forward] | ||
Balance, beginning of period | 162,852 | 163,076 |
Currency translation | (1,193) | (224) |
Balance, end of period | 161,659 | 162,852 |
Specialty | ||
Goodwill [Roll Forward] | ||
Balance, beginning of period | 366,312 | 366,312 |
Currency translation | 0 | 0 |
Balance, end of period | 366,312 | 366,312 |
AvKARE | ||
Goodwill [Roll Forward] | ||
Balance, beginning of period | 69,465 | 69,465 |
Currency translation | 0 | 0 |
Balance, end of period | $ 69,465 | $ 69,465 |
Goodwill and Other Intangible Assets - Intangible Assets (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 1,633,669 | $ 1,310,771 |
Accumulated Amortization | (915,592) | (776,193) |
Net | 718,077 | 534,578 |
In-process research and development | 14,300 | 355,845 |
Intangible assets, cost | 1,647,969 | 1,666,616 |
Intangible assets, net | $ 732,377 | 890,423 |
Product rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted- Average Amortization Period (in years) | 6 years 10 months 24 days | |
Cost | $ 1,550,469 | 1,198,971 |
Accumulated Amortization | (856,914) | (703,297) |
Net | $ 693,555 | 495,674 |
Other intangible assets | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted- Average Amortization Period (in years) | 2 years 7 months 6 days | |
Cost | $ 83,200 | 111,800 |
Accumulated Amortization | (58,678) | (72,896) |
Net | $ 24,522 | $ 38,904 |
Goodwill and Other Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Goodwill and Intangible Assets Disclosure [Abstract] | ||
In-process research and development | $ 14,300 | $ 355,845 |
Future Amortization | ||
2025 | 163,086 | |
2026 | 115,497 | |
2027 | 95,063 | |
2028 | 75,677 | |
2029 | 68,909 | |
Thereafter | 199,845 | |
Net | $ 718,077 | $ 534,578 |
Other Assets - Schedule of Other Assets (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Other Assets [Abstract] | ||
Interest rate swap | $ 35,921 | $ 37,089 |
Security deposits | 3,752 | 3,602 |
Long-term prepaid expenses | 12,362 | 3,273 |
Deferred revolving credit facility costs | 2,820 | 4,427 |
Other long-term assets | 5,278 | 7,126 |
Total | $ 60,133 | $ 55,517 |
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Liabilities (Details) - Nonrelated Party - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Related Party Transaction [Line Items] | ||
Accounts payable | $ 258,691 | $ 143,572 |
Accrued returns allowance | 160,490 | 136,486 |
Accrued compensation | 72,959 | 71,122 |
Accrued Medicaid and commercial rebates | 135,488 | 90,690 |
Accrued royalties | 23,687 | 23,342 |
Commercial chargebacks and rebates | 10,226 | 10,226 |
Accrued professional fees | 17,339 | 11,005 |
Accrued other | 56,570 | 48,219 |
Total accounts payable and accrued expenses | $ 735,450 | $ 534,662 |
Debt - Summary of Long-term Debt (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Debt Instrument [Line Items] | ||
Long-term debt | $ 2,484,835 | $ 2,543,626 |
Less: debt issuance costs | (98,832) | (123,497) |
Total debt, net of debt issuance costs | 2,386,003 | 2,420,129 |
Less: current portion of long-term debt | (224,213) | (34,125) |
Total long-term debt, net | 2,161,790 | 2,386,004 |
Term Loan Due 2025 | ||
Debt Instrument [Line Items] | ||
Long-term debt | 191,979 | 191,979 |
Term Loan Due 2028 | ||
Debt Instrument [Line Items] | ||
Long-term debt | $ 2,292,856 | $ 2,351,647 |
Debt - Rondo Acquisitions Financing – Notes Payable-Related Party (Details) - USD ($) $ in Millions |
12 Months Ended | ||||
---|---|---|---|---|---|
Jan. 31, 2020 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Feb. 28, 2021 |
|
Notes Payable, Other Payables | Sellers Notes - interest | |||||
Debt Instrument [Line Items] | |||||
Prepayment of outstanding principal | $ 44.2 | ||||
Debt instrument, periodic payment, interest | 10.0 | ||||
Rondo Partners LLC | Long Term Promissory Notes | |||||
Debt Instrument [Line Items] | |||||
Liabilities incurred | $ 44.2 | ||||
Interest rate | 5.00% | ||||
Liabilities incurred, fair value | $ 35.0 | ||||
Unamortized discount | 9.2 | ||||
Amortization of debt issuance costs | $ 1.1 | $ 1.7 | $ 1.7 | ||
Rondo Partners LLC | Short Term Promissory Notes | |||||
Debt Instrument [Line Items] | |||||
Liabilities incurred | 1.0 | ||||
Interest rate | 1.60% | ||||
Liabilities incurred, fair value | $ 1.0 |
Other Long-Term Liabilities - Schedule of Other Long-Term Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Related Party Transaction [Line Items] | ||
Deferred compensation plan liabilities | $ 8,500 | $ 11,100 |
Long-term employee benefit | 8,600 | 10,200 |
Nonrelated Party | ||
Related Party Transaction [Line Items] | ||
Uncertain tax positions | 1,252 | 497 |
Long-term compensation | 17,125 | 21,283 |
Contingent consideration | 0 | 433 |
Other long-term liabilities | 8,572 | 7,466 |
Total other long-term liabilities | $ 26,949 | $ 29,679 |
Leases - Additional Information (Details) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Lessee, Lease, Description [Line Items] | |||
Operating and finance lease, rent expense | $ 21.0 | $ 21.7 | $ 22.6 |
Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Operating and finance lease term | 1 year | ||
Minimum | International Land Easements | |||
Lessee, Lease, Description [Line Items] | |||
Operating and finance lease term | 19 years | ||
Maximum | |||
Lessee, Lease, Description [Line Items] | |||
Operating and finance lease term | 20 years | ||
Maximum | International Land Easements | |||
Lessee, Lease, Description [Line Items] | |||
Operating and finance lease term | 94 years |
Leases - Components of Total Lease Costs (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Leases [Abstract] | |||
Operating lease cost | $ 16,429 | $ 16,734 | $ 17,800 |
Finance lease cost: | |||
Amortization of right-of-use assets | 4,583 | 4,972 | 4,808 |
Interest on lease liabilities | 4,542 | 4,583 | 4,508 |
Total finance lease cost | 9,125 | 9,555 | 9,316 |
Total lease cost | $ 25,554 | $ 26,289 | $ 27,116 |
Leases - Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from finance leases | $ 4,542 | $ 4,583 |
Operating cash flows from operating leases | 17,117 | 16,036 |
Financing cash flows from finance leases | 3,251 | 3,588 |
Non-cash activity: | ||
Right-of-use assets obtained in exchange for new operating lease liabilities | 9,981 | 773 |
Right-of-use assets obtained in exchange for new financing lease liabilities | $ 1,889 | $ 856 |
Leases - Term and Discount Rate Information (Details) |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Leases [Abstract] | ||
Weighted average remaining lease term - operating leases | 4 years | 5 years |
Weighted average remaining lease term - finance leases | 17 years | 18 years |
Weighted average discount rate - operating leases | 9.60% | 8.90% |
Weighted average discount rate - finance leases | 7.30% | 7.30% |
Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Operating Leases | ||
Year one | $ 16,914 | $ 15,978 |
Year two | 13,496 | 14,544 |
Year three | 10,563 | 10,693 |
Year four | 8,195 | 7,742 |
Year five | 6,567 | 5,467 |
Thereafter | 3,019 | 6,916 |
Total lease payments | 58,754 | 61,340 |
Less: Imputed interest | (11,718) | (12,426) |
Total | 47,036 | 48,914 |
Financing Leases | ||
Year one | 7,508 | 6,856 |
Year two | 7,007 | 6,874 |
Year three | 5,890 | 6,140 |
Year four | 5,667 | 5,647 |
Year five | 5,653 | 5,647 |
Thereafter | 73,907 | 79,573 |
Total lease payments | 105,632 | 110,737 |
Less: Imputed interest | (45,532) | (49,704) |
Total | $ 60,100 | $ 61,033 |
Fair Value Measurements - Summary of the Company’s Indebtedness at Fair Value (Details) - Level 2 - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Long Term Promissory Notes | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Long-term debt fair value | $ 0 | $ 41,033 |
Term Loan Due 2025 | Senior Secured Credit Facility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Long-term debt fair value | 192,579 | 190,779 |
Term Loan Due 2028 | Senior Secured Credit Facility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Long-term debt fair value | $ 2,364,508 | $ 2,328,130 |
Fair Value Measurements - Reconciliation of Contingent Consideration Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Net change in fair value during period | $ (930) | $ (14,497) | $ 731 |
Acquisitions | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Balance, beginning of period | $ 921 | 15,427 | |
Net change in fair value during period | (14,491) | ||
Payments | (15) | ||
Balance, end of period | $ 921 | $ 15,427 |
Financial Instruments - Additional Information (Details) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
Nov. 14, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Oct. 31, 2019 |
|
Derivative [Line Items] | ||||
Fair Value | $ 35,921,000 | $ 37,089,000 | ||
Derivative gain reclassified from accumulated OCI into income (loss) | (26,200,000) | |||
Cash flow hedge loss to be reclassified within 12 months | 3,800,000 | |||
Total gain, net of income taxes, recognized in accumulated other comprehensive loss | $ 6,400,000 | $ 33,700,000 | ||
Interest Rate Lock Agreement | ||||
Derivative [Line Items] | ||||
Notional amount | $ 1,300,000,000 | |||
November 2023 Swap | ||||
Derivative [Line Items] | ||||
Notional amount | $ 1,300,000,000 | |||
Derivative, fixed interest rate | 2.7877% | |||
Fair Value | $ 66,700,000 | |||
Amended October 2019 Swap | ||||
Derivative [Line Items] | ||||
Derivative, fixed interest rate | 1.366% | |||
Unrealized gain recorded within accumulated other comprehensive loss | $ 66,700,000 |
Financial Instruments - Summary of Fair Values of Derivative Instruments in Consolidated Balance Sheets (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Derivative [Line Items] | ||
Fair Value | $ 35,921 | $ 37,089 |
Derivatives Designated as Hedging Instruments | Variable-to-fixed interest rate swap | Other Assets | ||
Derivative [Line Items] | ||
Fair Value | $ 35,921 | $ 37,089 |
Commitments and Contingencies - Contingencies (Details) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2024 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | $ 96,692 | $ 1,824 | $ 269,930 | |
Civil prescription opioid litigation | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | $ 94,400 | $ 96,700 | 3,900 | 18,000 |
Customer Claim | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | 3,000 | |||
Antitrust Litigation | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | 3,000 | |||
Stockholder Derivative Lawsuit | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | 1,900 | |||
Patent Infringement Matters | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | $ 10,000 | |||
Opana ER® antitrust litigation | ||||
Loss Contingencies [Line Items] | ||||
Charges related to legal matters, net | 262,800 | |||
Charges (insurance recoveries) for property losses and associated expenses | $ 15,500 |
Commitments and Contingencies - Schedule of Liabilities For Legal Matters (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | $ 31,755 | $ 76,988 |
Opana ER® antitrust litigation | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 0 | 50,000 |
Opana ER® antitrust litigation-accrued interest | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 0 | 2,347 |
Civil prescription opioid litigation | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | 29,671 | 21,189 |
Long-term portion of liabilities for legal matters, excluding interest | 85,479 | 316 |
Other | ||
Loss Contingencies [Line Items] | ||
Current portion of liabilities for legal matters | $ 2,084 | $ 3,452 |
Stock-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units - USD ($) $ / shares in Units, $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Number of Restricted Stock Units | |||
Non-vested beginning balance (in shares) | 17,454,703 | 17,928,613 | 13,183,600 |
Granted (in shares) | 7,268,315 | 7,519,565 | 10,117,037 |
Vested (in shares) | (4,325,941) | (3,888,602) | (2,697,134) |
Forfeited (in shares) | (2,820,894) | (4,104,873) | (2,674,890) |
Non-vested ending balance (in shares) | 17,576,183 | 17,454,703 | 17,928,613 |
Weighted- Average Grant Date Fair Value | |||
Non-vested beginning balance (in dollars per share) | $ 3.92 | $ 4.77 | $ 5.25 |
Granted (in dollars per share) | 5.40 | 1.91 | 4.54 |
Vested (in dollars per share) | 3.33 | 4.53 | 5.95 |
Forfeited (in dollars per share) | 6.12 | 3.41 | 5.07 |
Non-vested ending balance (in dollars per share) | $ 4.32 | $ 3.92 | $ 4.77 |
Weighted- Average Remaining Years | 1 year 2 months 12 days | 1 year 2 months 12 days | 1 year 3 months 18 days |
Aggregate Intrinsic Value, Non-vested | $ 139.2 | $ 105.4 | $ 35.7 |
Stock-Based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | $ 27,768 | $ 26,822 | $ 31,847 |
Cost of goods sold | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | 3,564 | 3,561 | 4,811 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | 20,343 | 18,922 | 20,746 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | 3,645 | 4,339 | 6,290 |
Restructuring and other charges | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total | $ 216 | $ 0 | $ 0 |
Related Party Transactions - Related Party Descriptions 4 (Details) - USD ($) $ in Millions |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Oct. 31, 2022 |
Mar. 31, 2020 |
Dec. 31, 2022 |
Dec. 31, 2024 |
|
TPG Operations, LLC | ||||
Related Party Transaction [Line Items] | ||||
Consulting agreement, term | 7 months | |||
Pharma Sophia L L C | Affiliated Entity | ||||
Related Party Transaction [Line Items] | ||||
Ownership interest (percent) | 50.00% | 50.00% | ||
Pharma Sophia L L C | Affiliated Entity | Development Costs | ||||
Related Party Transaction [Line Items] | ||||
Amounts of transaction with related party | $ 6.0 | $ 1.1 | ||
Pharma Sophia L L C | Affiliated Entity | Development Costs | Minimum | ||||
Related Party Transaction [Line Items] | ||||
Trade accounts receivable, net | 1.1 | |||
Pharma Sophia L L C | Affiliated Entity | Development Costs | Maximum | ||||
Related Party Transaction [Line Items] | ||||
Trade accounts receivable, net | $ 4.9 |
Employee Benefit Plans - Additional Information (Details) - USD ($) |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Jan. 31, 2019 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Retirement Benefits [Abstract] | ||||
Contributions to defined contribution plan | $ 9,200,000 | $ 9,900,000 | $ 9,500,000 | |
Deferred compensation plan, employer contributions | $ 0 |
Segment Information - Additional Information (Details) |
12 Months Ended |
---|---|
Dec. 31, 2024
product
segment
| |
Segment Reporting [Abstract] | |
Number of reportable segments | segment | 3 |
Number of product families | product | 270 |
Segment Information - Schedule of Selling, General and Administrative Expenses on a Departmental Basis (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Segment Reporting Information [Line Items] | |||
Total | $ 476,436 | $ 429,675 | $ 399,700 |
Selling, general and administrative | Specialty | |||
Segment Reporting Information [Line Items] | |||
Employee compensation and benefits | 34,908 | 36,352 | 34,893 |
Product marketing | 44,179 | 27,431 | 31,481 |
Commercial operations and salesforce | 25,567 | 20,748 | 20,256 |
Other | 5,004 | 3,606 | 3,401 |
Total | $ 109,658 | $ 88,137 | $ 90,031 |
Segment Information - Schedule of Long-Lived Assets, by Geographical Areas (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 523,693 | $ 550,137 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 310,702 | 316,947 |
India | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 159,650 | 179,401 |
Ireland | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 53,341 | $ 53,789 |
Subsequent Events (Details) - USD ($) $ in Thousands |
1 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
Jan. 03, 2025 |
Jan. 31, 2025 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
Subsequent Event [Line Items] | |||||
Borrowings on revolving credit facility | $ 48,000 | $ 219,000 | $ 85,000 | ||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
License agreement | $ 48,500 | ||||
Subsequent Event | Ellodi Pharmaceuticals, L.P. | |||||
Subsequent Event [Line Items] | |||||
Amounts of transaction with related party | $ 3,000 | ||||
Revolving Credit Facility | Term Loan Due 2025 | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Repayments of debt | $ 192,000 | ||||
Interest expense | 700 | ||||
Borrowings on revolving credit facility | $ 190,000 |