Amneal Pharmaceuticals, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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Jun 30, 2025 · Filed Aug 7, 2025
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Notes to Consolidated Financial Statements
(unaudited)
- Summary of Significant Accounting Policies
Basis of Presentation
The interim unaudited consolidated financial statements have been prepared in accordance with the requirements of the U.S. Securities and Exchange Commission and U.S. generally accepted accounting principles (“U.S. GAAP”) for interim reporting. These financial statements include all adjustments that in the opinion of management are necessary for a fair presentation of the financial position, results of operations, and cash flows of Amneal Pharmaceuticals, Inc. (the “Company”) for the periods presented. However, these financial statements do not include all information and accompanying notes required for annual financial statements prepared in accordance with U.S. GAAP. The interim unaudited consolidated financial statements should be read in conjunction with the audited annual financial statements included in the Company’s 2024 Annual Report on Form 10-K.
Use of Estimates
The preparation of financial statements requires the Company’s management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, valuation of intangible and other assets acquired in business combinations, allowances for accounts receivable, accrued liabilities, liabilities for legal matters, contingent liabilities, 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.
Reclassification
The prior period balance of $0.1 million, formerly included in the caption “change in fair value of contingent consideration” for the six months ended June 30, 2024 has been reclassified to the caption “other operating (income) expense” in the consolidated statements of operations to conform to the current period presentation. This reclassification did not impact operating income or net loss.
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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. ASU 2023-09 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 captions 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.
- Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time.
License Agreements
Refer to Note 5. Alliance and Collaborationin the Company’s 2024 Annual Report on Form 10-K for further information related to revenue recognition associated with license agreements.
Concentration of Revenue
The following table summarizes revenues from each of the Company’s customers which individually accounted for 10% or more of its total net revenue:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Customer A | 23% | 22% | 23% | 21% |
| Customer B | 16% | 16% | 16% | 15% |
| Customer C | 21% | 22% | 21% | 22% |
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 three and six months ended June 30, 2025 and 2024, are set forth below (in thousands):
| Three Months Ended June 30, · Six Months Ended June 30, | ||||
|---|---|---|---|---|
| 2025 · 2024 · 2025 · 2024 | ||||
| Affordable Medicines | ||||
| Oral solid | $178,262 | $175,956 | $357,215 | $345,269 |
| Auto-Injector | 66,594 | 58,281 | 114,754 | 100,899 |
| Transdermal | 40,710 | 49,697 | 83,773 | 90,222 |
| Injectable | 34,646 | 39,081 | 69,434 | 74,303 |
| Biosimilar | 25,248 | 29,500 | 53,788 | 56,192 |
| Oral liquid | 17,879 | 24,096 | 41,427 | 56,025 |
| Other dosage forms (1) | 68,185 | 49,287 | 124,607 | 92,561 |
| Subtotal dosage forms | 431,524 | 425,898 | 844,998 | 815,471 |
| International | 1,901 | 1,430 | 3,135 | 3,151 |
| Total Affordable Medicines Revenue | 433,425 | 427,328 | 848,133 | 818,622 |
| Specialty | ||||
| Hormonal / allergy | 35,418 | 31,775 | 69,617 | 61,150 |
| Central nervous system | 83,425 | 63,906 | 151,035 | 130,182 |
| Other therapeutic classes | 8,700 | 8,360 | 15,188 | 13,464 |
| Subtotal therapeutic classes | 127,543 | 104,041 | 235,840 | 204,796 |
| License agreement (2) | 500 | — | 500 | 4,479 |
| Total Specialty net revenue | 128,043 | 104,041 | 236,340 | 209,275 |
| AvKARE | ||||
| Distribution | 99,663 | 116,135 | 204,558 | 225,848 |
| Government label | 45,418 | 36,210 | 95,558 | 71,162 |
| Institutional | 10,132 | 11,768 | 21,141 | 22,626 |
| Other | 7,827 | 6,298 | 14,198 | 13,438 |
| Total AvKARE net revenue | 163,040 | 170,411 | 335,455 | 333,074 |
| Total net revenue | $724,508 | $701,780 | $1,419,928 | $1,360,971 |
(1)Includes net revenue from sales of transmucosal, ophthalmic, topical, nasal and inhalation dosage forms.
(2)Refer to Note 5. Alliance and Collaboration in the Company’s 2024 Annual Report on Form 10-K for information about revenue recognized under license agreements for the three and six months ended June 30, 2024. Revenue recognized under license agreements for the three and six months ended June 30, 2025 was not material.
A rollforward of the major categories of sales-related deductions for the six months ended June 30, 2025 is as follows (in thousands):
| ContractCharge - Backsand SalesVolumeAllowances | Cash DiscountAllowances | AccruedReturnsAllowance | AccruedMedicaid andCommercialRebates | |
|---|---|---|---|---|
| Balance at December 31, 2024 | $498,537 | $25,968 | $160,490 | $135,488 |
| Provision related to sales recorded in the period | 1,930,680 | 65,110 | 37,504 | 133,909 |
| Credits/payments issued during the period | (1,930,660) | (62,648) | (37,691) | (151,947) |
| Balance at June 30, 2025 | $498,557 | $28,430 | $160,303 | $117,450 |
- 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.
These agreements generally obligate the Company to provide research and development (“R&D”) services over multiple periods.
Except as disclosed below, as of and for the three and six months ended June 30, 2025, there were no material changes to our alliance and collaboration agreements as described in Note 5. Alliance and Collaborationin our 2024 Annual Report on Form 10-K.
The following table summarizes the activity in the Company’s consolidated statements of operations related to alliance and collaboration agreements for thethree and six months ended June 30, 2025 and 2024 (in thousands):
| Three Months Ended June 30, · Six Months Ended June 30, | |||||
|---|---|---|---|---|---|
| Partner | Caption in Statement of Operations | 2025 | 2024 | 2025 | 2024 |
| Orion Corporation | Research and development (1) | $(912) | $(683) | $(2,524) | $(1,294) |
| Zambon Biotech S.A. | Net revenue (2) | $— | $— | $— | $3,479 |
| Knight Therapeutics International S.A. | Net revenue (3) | $— | $— | $— | $1,000 |
| mAbxience S.L. | Research and development (4) | $— | $— | $— | $3,000 |
| Metsera, Inc. | Net revenue(5) | $1,973 | $— | $1,973 | $— |
(1)Services performed for Orion Corporation on a cost basis are recorded as a reduction to R&D expense.
(2)Delivery of a functional license (out-licensing revenue).
(3)Non-refundable license fee.
(4)Clinical milestone payment.
(5)Development activities performed on behalf of Metsera, Inc. on a cost plus margin basis are recorded as net revenue.
The following table summarizes the balances in the Company’s consolidated balance sheets related to alliance and collaboration agreements as of June 30, 2025 and December 31, 2024 (in thousands):
| Party | Caption in Balance Sheet | June 30, 2025 | December 31, 2024 |
|---|---|---|---|
| Orion Corporation | Accounts payable and accrued expenses (1) | $5,071 | $5,008 |
| Orion Corporation | Other long-term liabilities (1) | $1,624 | $3,453 |
| Zambon Biotech S.A. | Other long-term liabilities (1) | $2,530 | $2,530 |
| Metsera, Inc. | Prepaid expenses and other current assets (2) | $1,973 | $335 |
| Metsera, Inc. | Other long-term liabilities (3) | $1,557 | $— |
(1)Comprised of deferred income as of June 30, 2025 and December 31, 2024.
(2)Comprised primarily of unbilled receivables for R&D services performed as of December 31, 2024.
(3)Comprised of construction costs contributed.
ApiJect Systems Collaboration Agreement
On May 8, 2025, the Company entered into a 15-year strategic collaboration agreement with ApiJect Systems, Corp. and related entities (“ApiJect”), a medical technology company focused on advanced drug delivery (“ApiJect Agreement”). Under the ApiJect Agreement, Amneal will install and operate manufacturing equipment leased from Apiject at the Company’s Brookhaven, New York facility. This equipment will be used to support production of ApiJect’s proprietary blow fill seal (“BFS”) delivery systems and Amneal’s growing injectable portfolio.
The Company concluded the agreement contains a financing lease pursuant to Accounting Standards Codification Topic 842, Leases. The lease will commence on the date the equipment is available for Amneal’s use, which is expected to be in the second half of 2025. During the lease term, the Company shall pay ApiJect a low-digit royalty for any of Amneal’s commercial products that are manufactured utilizing the equipment, which will be accounted for as variable lease payments. At the conclusion of the ApiJect Agreement, the Company has the right to purchase the equipment from ApiJect for a nominal amount. Amneal and ApiJect will also collaborate on the development of additional injectable product programs utilizing ApiJect’s BFS platform. The Company is entitled to receive consideration from ApiJect for development work performed under these programs.
The ApiJect Agreement did not have a material impact on the Company’s financial statements as of and for the three and six months ended June 30, 2025.
- Income Taxes
Provision for Income Taxes
Set forth in the following table is the Company’s provision for income taxes (in thousands) and effective tax rate:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Provision for income taxes | $16,101 | $3,618 | $28,969 | $9,774 |
| Effective tax rate | 31.1% | 17.7% | 32.5% | (17.7)% |
For the three and six months ended June 30, 2025, the period-over-period change in the provision for income taxes was primarily related to differences in jurisdictional mix of income, the utilization of net operating losses in the prior period and discrete items related to share-based compensation in the current period.
Tax Receivable Agreement
The following table summarizes the Company’s tax receivable agreement (“TRA”) (in thousands)
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Increase in tax receivable agreement liability | $4,420 | $13,444 | $15,107 | $15,392 |
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Tax receivable agreement liability- short term | $50,900 | $2,985 |
| Tax receivable agreement liability- long term | 15,107 | 50,900 |
| Total | $66,007 | $53,885 |
Refer to Note 6. Income Taxes in the Company’s 2024 Annual Report on Form 10-K for information about the Company’s TRA. During the six months ended June 30, 2025, the Company made payments of $3.0 million, associated with the TRA.
Contingent Tax Receivable Agreement Liability
The Company had an unrecorded contingent TRA liability of $118.7 million as of June 30, 2025. If utilization of the Company’s deferred tax assets becomes more-likely-than-not in the future, at such time, the unrecorded contingent TRA liability will be recorded through charges in the Company’s consolidated statements of operations.
- Earnings (Loss) per Share
The computation of basic and diluted earnings per share was as follows (in thousands, except per share amounts):
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Numerator: | ||||
| Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | $22,417 | $5,994 | $34,612 | $(85,649) |
| Denominator: | ||||
| Weighted-average shares outstanding - basic | 313,739 | 309,117 | 312,404 | 308,198 |
| Effect of dilutive securities: | ||||
| Stock options | 964 | 1,095 | 1,031 | — |
| Restricted stock units | 3,155 | 4,522 | 4,390 | — |
| Performance stock units | 4,505 | 4,223 | 5,346 | — |
| Weighted-average shares outstanding - diluted | 322,363 | 318,957 | 323,171 | 308,198 |
| Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders: | ||||
| Basic | $0.07 | $0.02 | $0.11 | $(0.28) |
| Diluted | $0.07 | $0.02 | $0.11 | $(0.28) |
The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of Class A common stock (in thousands):
| Three Months EndedJune 30, · Six Months EndedJune 30, | ||||||||
|---|---|---|---|---|---|---|---|---|
| 2025 · 2024 · 2025 · 2024 | ||||||||
| Stock options | 347 | (1) | 347 | (1) | 347 | (1) | 2,277 | (3) |
| Restricted stock units | — | — | — | 10,207 | (3) | |||
| Performance stock units | 1,953 | (2) | 2,871 | (2) | 1,953 | (2) | 7,639 | (3) |
(1)Excluded from the computation of diluted earnings per share of Class A common stock because the exercise price of the stock options exceeded the average market price of the Class A common stock during the period (out-of-the-money).
(2)Excluded from the computation of diluted earnings per share of Class A common stock because the performance vesting conditions were not met during the period.
(3)Excluded from the computation of diluted loss per share of Class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period.
- Trade Accounts Receivable, Net
Trade accounts receivable, net was comprised of the following (in thousands):
| June 30,2025 | December 31,2024 | |
|---|---|---|
| Gross accounts receivable | $1,338,536 | $1,303,788 |
| Allowance for credit losses | (3,912) | (3,552) |
| Contract charge-backs and sales volume allowances | (498,557) | (498,537) |
| Cash discount allowances | (28,430) | (25,968) |
| Subtotal | (530,899) | (528,057) |
| Trade accounts receivable, net | $807,637 | $775,731 |
Concentration of Receivables
Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
| June 30,2025 | December 31,2024 | |
|---|---|---|
| Customer A | 34% | 37% |
| Customer B | 25% | 21% |
| Customer C | 27% | 29% |
- Inventories
Inventories were comprised of the following (in thousands):
| June 30,2025 | December 31,2024 | |
|---|---|---|
| Raw materials | $211,203 | $207,697 |
| Work in process | 55,096 | 52,835 |
| Finished goods | 342,674 | 351,922 |
| Total inventories | $608,973 | $612,454 |
- Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets were comprised of the following (in thousands):
| June 30,2025 | December 31,2024 | |
|---|---|---|
| Deposits and advances | $3,738 | $1,868 |
| Prepaid insurance | 6,168 | 8,264 |
| Prepaid regulatory fees | 2,319 | 6,958 |
| Income and other tax receivables | 17,594 | 16,829 |
| Prepaid taxes | 5,489 | 7,516 |
| Other current receivables | 16,327 | 9,142 |
| Chargebacks receivable | 6,115 | 6,378 |
| Other prepaid assets | 27,554 | 23,762 |
| Total prepaid expenses and other current assets | $85,304 | $80,717 |
- Goodwill and Other Intangible Assets
The changes in goodwill by segment were as follows (in thousands):
| Affordable Medicines | Specialty | AvKARE | Total | |
|---|---|---|---|---|
| Balance as of December 31, 2023 | $162,852 | $366,312 | $69,465 | $598,629 |
| Currency translation | (1,193) | — | — | (1,193) |
| Balance as of December 31, 2024 | 161,659 | 366,312 | 69,465 | 597,436 |
| Currency translation | (30) | — | — | (30) |
| Balance as of June 30, 2025 | $161,629 | $366,312 | $69,465 | $597,406 |
Intangible assets as of June 30, 2025 and December 31, 2024 were comprised of the following (in thousands):
| June 30, 2025 · December 31, 2024 | |||||||
|---|---|---|---|---|---|---|---|
| Weighted-AverageAmortization Period(in years) | Cost | AccumulatedAmortization | Net | Cost | AccumulatedAmortization | Net | |
| Amortizing intangible assets: | |||||||
| Product rights | 6.7 | $1,564,668 | $(942,244) | $622,424 | $1,550,469 | $(856,914) | $693,555 |
| Other intangible assets | 2.2 | 83,200 | (64,177) | 19,023 | 83,200 | (58,678) | 24,522 |
| Subtotal | 1,647,868 | (1,006,421) | 641,447 | 1,633,669 | (915,592) | 718,077 | |
| In-process research and development | 8,100 | — | 8,100 | 14,300 | — | 14,300 | |
| Total intangible assets | $1,655,968 | $(1,006,421) | $649,547 | $1,647,969 | $(915,592) | $732,377 | |
Amortization expense related to intangible assets for the three months ended June 30, 2025 and 2024 was $45.8 million and $40.1 million, respectively. Amortization expense related to intangible assets for the six months ended June 30, 2025 and 2024 was $91.0 million and $80.0 million, respectively.
The Company reviews intangible assets with finite lives for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. Indefinite-lived intangible assets, including in-process research and development intangible assets, are tested for impairment if impairment indicators arise and, at a minimum, annually. Intangible asset impairments were immaterial for the three and six months ended June 30, 2024 (none for the three and six months ended June 30, 2025).
- Other Assets
Other assets were comprised of the following (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Interest rate swap (1) | $16,436 | $35,921 |
| Security deposits | 4,013 | 3,752 |
| Long-term prepaid expenses | 12,269 | 12,362 |
| Deferred revolving credit facility costs | 3,820 | 2,820 |
| Long-term restricted cash | 2,486 | — |
| Other long term assets | 5,825 | 5,278 |
| Total other assets | $44,849 | $60,133 |
(1)Refer to Note 14. Fair Value Measurements and Note 15. Financial Instruments for information about the Company’s interest rate swap.
- Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses were comprised of the following (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Accounts payable | $205,812 | $258,691 |
| Accrued returns allowance (1) | 160,303 | 160,490 |
| Accrued compensation | 57,012 | 72,959 |
| Accrued Medicaid and commercial rebates (1) | 117,450 | 135,488 |
| Accrued royalties | 23,851 | 23,687 |
| Commercial chargebacks and rebates | 10,226 | 10,226 |
| Accrued professional fees | 14,441 | 17,339 |
| Accrued other | 77,722 | 56,570 |
| Total accounts payable and accrued expenses | $666,817 | $735,450 |
(1)Refer to Note 2. Revenue Recognition for a rollforward of the balance from December 31, 2024 to June 30, 2025.
- Debt
There have been no material changes in the Company’s long-term debt since December 31, 2024, except as disclosed below. Refer to Note 15. Debt in the Company’s 2024 Annual Report on Form 10-K for additional information and definitions of terms used in this note.
Term Loans
The following is a summary of the Company’s indebtedness under its term loans (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Term Loan Due 2025 | $— | $191,979 |
| Term Loan Due 2028 | 2,263,460 | 2,292,856 |
| Total debt | 2,263,460 | 2,484,835 |
| Less: debt issuance costs | (85,882) | (98,832) |
| Total debt, net of debt issuance costs | 2,177,578 | 2,386,003 |
| Less: current portion of long-term debt | (31,175) | (224,213) |
| Total long-term debt, net | $2,146,403 | $2,161,790 |
Term Loan Due 2025
In January 2025, the Company paid the entire remaining principal balance of $192.0 million then 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 June 30, 2025 and December 31, 2024, $290.0 million and $100.0 million, respectively, were outstanding on the Amended New Revolving Credit Facility.
Rondo Revolving Credit Facility
On April 9, 2025, the Company executed an amendment to the Rondo Revolving Credit Facility (“Amended Rondo Revolving Credit Facility”) that, among other things, (i) increased the aggregate revolving commitment from $70 million to $125 million, (ii) increased the letter of credit commitment from $60 million to $90 million, and (iii) extended the maturity to April 9, 2030. The Amended Rondo Credit Facility bears a variable annual interest rate of one-month adjusted term SOFR, subject to a floor of 0.1% plus 2.00%. The annual interest rate for borrowings 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.
In addition, 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.
In connection with this amendment, the Company incurred costs of $1.7 million associated with the Amended Rondo Revolving Credit Facility, which were capitalized and will be amortized over the life of the Amended Rondo Revolving Credit Facility.
- Other Long-Term Liabilities
Other long-term liabilities were comprised of the following (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Uncertain tax positions | $524 | $1,252 |
| Long-term compensation | 17,095 | 17,125 |
| Other long-term liabilities | 8,195 | 8,572 |
| Total other long-term liabilities | $25,814 | $26,949 |
- Fair Value Measurements
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period. The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024 (in thousands):
| Fair Value Measurement Based on | ||||
|---|---|---|---|---|
| June 30, 2025 | Total | QuotedPrices inActiveMarkets(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) |
| Assets | ||||
| Interest rate swap (1) | $16,436 | $— | $16,436 | $— |
| Assets | ||||
| Interest rate swap (1) | $35,921 | $— | $35,921 | $— |
(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 15. Financial Instruments for information on the Company’s interest rate swap.
There were no transfers between levels in the fair value hierarchy during the six months ended June 30, 2025.
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):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Term Loan Due 2025 | $— | $192,579 |
| Term Loan Due 2028 | $2,305,900 | $2,364,508 |
The Term Loan Due 2025 and Term Loan Due 2028 are each in the Level 2 category within the fair value level hierarchy. The fair values were determined using market data for valuation.
Refer to Note 15. Debt in the Company’s 2024 Annual Report on Form 10-K for detailed information about its indebtedness, including definitions of terms.
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
There were no non-recurring fair value measurements during the six months ended June 30, 2025 and 2024.
- Financial Instruments
The Company uses an interest rate swap to manage its exposure to market risks for changes in interest rates. During thethree and sixmonths ended June 30, 2025, the Company reclassified a net loss of $0.6 million (increase in interest expense, net) and net gain of $5.9 million (decrease in interest expense, net), respectively, from accumulated other comprehensive loss. Approximately $19.2 million of net losses included in accumulated other comprehensive loss as of June 30, 2025 are expected to be reclassified into earnings 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 June 30, 2025, the total loss, net of income taxes of $0, related to the Company’s cash flow hedge of$19.0 million, was recognized in accumulated other comprehensive loss. Refer to Note 17. Stockholders’ Deficiency in this Quarterly Report on Form 10-Q and Note 19. Financial Instruments in our Annual Report on Form 10-K for additional information.
A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands):
| June 30, 2025 | December 31, 2024 | |||
|---|---|---|---|---|
| Derivatives Designated as Hedging Instruments | Balance SheetClassification | Fair Value | Balance SheetClassification | Fair Value |
| Variable-to-fixed interest rate swap | Other Assets | $16,436 | Other Assets | $35,921 |
- 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 3. Alliance and Collaborationfor additional information. Certain of these arrangements are with related parties. Refer to Note 18. Related Party Transactionsfor 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 six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a 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). (Credit) charges related to legal matters, net for all other periods presented were immaterial.
Liabilities for legal matters were comprised of the following (in thousands):
| Matter | June 30, 2025 | December 31, 2024 |
|---|---|---|
| Civil prescription opioid litigation | $40,006 | $29,671 |
| Other | 1,509 | 2,084 |
| Current portion of liabilities for legal matters | $41,515 | $31,755 |
| Civil prescription opioid litigation (Liabilities for legal matters - long term) | $74,477 | $85,479 |
Refer to the respective discussions below for information about the significant matters summarized above.
Refer to Note 20. Commitments and Contingencies in our Annual Report on Form 10-K for a general discussion of Medicaid Reimbursement and Price Reporting Matters and Patent Litigation.
Other Litigation Related to the Company’s Business
United States Department of Justice Investigations
On May 15, 2023, Amneal Pharmaceuticals LLC (“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 Laboratories, Inc. (“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. Most of these 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.)). Some purchasers have brought similar lawsuits in state courts in Pennsylvania, Connecticut, and New York.
In 2019 and 2020, Attorneys General of 43 States and the Commonwealth of Puerto Rico named the Company intwo 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.
In these matters, the Company and Impax have filed various motions to dismiss, some of which remain pending. Fact discovery is underway in MDL No. 2724 and in one of the State Attorneys General cases naming the Company as a defendant, Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al.. In the other, Connecticut, et al. v. Sandoz, Inc. et al., defendants’ joint motions for summary judgement were fully briefed on April 7, 2025, and defendant-specific motions for summary judgement were filed on July 9, 2025.
Trials for the first multi-district litigation (“MDL”) cases chosen for bellwether treatment, none of which name the Company or Impax as defendants, have been stayed pending the Third Circuit’s review of the MDL court’s class certification decision. The MDL court has chosen a second round of MDL cases 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 (N.D. Ohio). The Company also is named in state court cases pending inseven states. There are no firm trial dates in those state-court cases.
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 overten 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 theten years payment term, which could increase the total amount of cash the Company would agree to pay up to $137.5 million. In April 2025, the Company finalized documentation for the nationwide resolution, which is contingent upon reaching sufficient participation from state Attorneys General, political subdivisions, and Native American tribes. In June 2025, the Company confirmed participation from all state Attorneys General and territorial Attorneys General. The process for political subdivision and Native American tribe participation is ongoing.
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 June 30, 2025 was $114.5 million, of which $74.5 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, 2024, the Company had a liability of $115.2 million related to its prescription opioid litigation, of which $85.5 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 June 30, 2025 or December 31, 2024, 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 November 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 (Inre 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 will set an oral argument date in October 2025.
The Company has also been named in state court cases infour 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. 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 indicated that date will 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 filed a motion to dismiss the Fourth Amended Complaint. Plaintiffs’ response in opposition was filed on April 7, 2025 and defendants’ reply was filed 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.
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. and RAKS Pharmaceuticals 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 filed her response to the motion to dismiss on March 24, 2025, and defendants filed their reply on April 14, 2025. That motion is fully briefed, and the Court notified the parties that it will take the motion under submission without oral argument.
Amneal Pharmaceuticals LLC et al. v. Sandoz Inc.
On November 25, 2024, the Company and Impax Laboratories, LLC received a notice letter from Sandoz Inc. (“Sandoz”) stating that it had filed an ANDA with the U.S. Food and Drug Administration (“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 Laboratories, LLC filed a patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, Case Nos. 3:25-cv-00181-GC-TJB and 2:25-11981. On April 1, 2025, the Company and Impax Laboratories, LLC filed a First Amended Complaint in response to a second notice letter from Sandoz, adding claims for infringement of additional patents. On April 14, 2025, Sandoz filed an Answer, Affirmative Defense, and Counterclaims for non-infringement and invalidity of the asserted patents. This lawsuit is currently in discovery. 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.
On June 20, 2025, the Company and Impax Laboratories, LLC filed a new patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, captioned Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 2:25-11981, in response to a third notice letter from Sandoz relating to CREXONT®. This lawsuit is in its initial pleadings stage.
Carickhoff v. Amneal Pharmaceuticals, Inc., et al.
On May 7, 2025, the Liquidating Trustee on Behalf of the Vyera Liquidating Trust Established Under the Subchapter V Plan of Reorganization of debtors Vyera Pharmaceuticals, LLC and Phoenixus AG filed an adversary proceeding in the United States Bankruptcy Court for the District of Delaware against the Company and Impax Laboratories, LLC, seeking to recover approximately $55.4 million in allegedly fraudulent transfers made by the debtors to Impax Laboratories, LLC to purchase the drug Daraprim in 2015. (See Carickhoff v. Amneal Pharmaceuticals, Inc, et al., Adv. Pro. No. 25-50903-JKS (Bankr. D. Del.)). The deadline to respond to the trustee’s Complaint is September 9, 2025.
- Stockholders’ (Deficiency) Equity
Refer to Note 21. Stockholders’ (Deficiency) Equity in our 2024 Annual Report on Form 10-K for additional information.
Changes in Accumulated Other Comprehensive Loss by Component (in thousands):
| Foreigncurrencytranslationadjustments | Unrealized gain (loss) on cashflow hedge, netof tax | Accumulatedothercomprehensive loss | |
|---|---|---|---|
| Balance December 31, 2024 | $(71,860) | $6,350 | $(65,510) |
| Other comprehensive loss before reclassification | (6,560) | (19,485) | (26,045) |
| Reclassification of cash flow hedge to earnings, net of tax of $0 | — | (5,876) | (5,876) |
| Balance June 30, 2025 | $(78,420) | $(19,011) | $(97,431) |
| Balance December 31, 2023 | $(66,072) | $33,723 | $(32,349) |
| Other comprehensive (loss) income before reclassification | (429) | 15,373 | 14,944 |
| Reclassification of cash flow hedge to earnings, net of tax of $0 | — | (13,031) | (13,031) |
| Balance June 30, 2024 | $(66,501) | $36,065 | $(30,436) |
- Related Party Transactions
The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three and six months ended June 30, 2025, there were no material changes to our related party agreements or relationships as described in Note 23. Related Party Transactions and Note 21. Stockholders’ (Deficiency) Equity in our 2024 Annual Report on Form 10-K.
The following table summarizes the Company’s related party transactions (in thousands):
| Three Months Ended June 30, · Six Months Ended June 30, | |||||
|---|---|---|---|---|---|
| Related Party and Nature of Transaction | Caption in Balance Sheet and Statement of Operations | 2025 | 2024 | 2025 | 2024 |
| Kashiv Biosciences LLC | |||||
| Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko and Fylnetra) | Cost of goods sold | $3,564 | $4,194 | $7,795 | $8,720 |
| Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko and Fylnetra) | Inventory and cost of goods sold | $1,293 | $2,426 | $5,616 | $3,642 |
| Development and commercialization agreement - Pegfilgrastim Auto Injector - milestone | Research and development | $3,000 | $— | $3,000 | $— |
| Development and commercialization agreement - Carfilzomib | Research and development | $2,000 | $— | $2,000 | $— |
| Parking space lease | Research and development | $— | $25 | $25 | $50 |
| Development and commercialization agreement - long-acting injectable | Research and development | $— | $— | $— | $500 |
| Generic development supply agreement - research and development material | Research and development | $— | $— | $— | $(48) |
| Sale of subsidiary - interest income on loan receivable | Interest expense, net | $— | $(132) | $— | $(132) |
| Sale of subsidiary - gain on sale | Other income, net | $— | $(3,760) | $— | $(3,760) |
| Generic development supply agreement - development activity deferred income | Accounts payable and accrued expenses | $— | $— | $(103) | $(422) |
| Storage agreement | Research and development | $(71) | $(49) | $(118) | $(126) |
| Other Related Parties | |||||
| Members - tax receivable agreement (TRA liability) | Increase in tax receivable agreement liability | $4,420 | $13,444 | $15,107 | $15,392 |
| Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement | Inventory and cost of goods sold | $6,204 | $5,220 | $11,339 | $10,221 |
| Land purchase from family members of the Co-Chief Executive Officers | Property, plant and equipment | $11,289 | $— | $11,289 | $— |
| Ellodi Pharmaceuticals, L.P. - securities purchase and license and collaboration agreements | Research and development | $1,438 | $— | $5,708 | $— |
| Kanan, LLC - operating lease | Inventory and cost of goods sold | $592 | $592 | $1,184 | $1,184 |
| Sutaria Family Realty, LLC - operating lease | Inventory and cost of goods sold | $330 | $324 | $654 | $638 |
| Tracy Properties LLC - operating lease | Selling, general and administrative | $149 | $221 | $326 | $364 |
| AzaTech Pharma LLC - supply agreement | Inventory and cost of goods sold | $10 | $2,933 | $2,327 | $5,245 |
| R&S Solutions - equipment purchase | Property, plant and equipment | $— | $— | $160 | $— |
| Avtar Investments, LLC - consulting services | Research and development | $60 | $60 | $120 | $129 |
| AvPROP, LLC - operating lease | Selling, general and administrative | $51 | $50 | $104 | $94 |
| Alkermes Plc | Inventory and cost of goods sold | $(28) | $94 | $64 | $106 |
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| AzaTech Pharma LLC - supply agreement | $1,130 | $21 |
| Kashiv - various agreements | 420 | 447 |
| Alkermes | 42 | 16 |
| Related party receivables - short term | $1,592 | $484 |
| Members - tax receivable agreement | $50,900 | $2,985 |
| Kashiv - various agreements | 7,375 | 16,908 |
| Apace Packaging, LLC - packaging agreement | 2,099 | 1,205 |
| Ellodi Pharmaceuticals, L.P. | 1,752 | — |
| AzaTech Pharma LLC - supply agreement | 1,170 | 1,151 |
| Avtar Investments LLC - consulting services | 100 | 60 |
| Alkermes Plc | — | 2 |
| Related party payables - short term | $63,396 | $22,311 |
| Members - tax receivable agreement | $15,107 | $50,900 |
| Land purchase from family members of the Co-Chief Executive Officers | 500 | — |
| Related party payables - long term | $15,607 | $50,900 |
Equipment Purchases
The Company purchased $0.2 million of equipment from R&S Solutions LLC during thesix months ended June 30, 2025, which is included in property, plant and equipment in the Company’s consolidated balance sheets. A member of Company management beneficially owns equity securities of R&S Solutions LLC.
Securities Purchase Agreement and License and Collaboration Agreement
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 which the Company paid $3.0 million for limited liability partnership units of Ellodi and committed to fund certain research and development expenses. Ellodi is a pre-clinical gastroenterology-focused specialty pharmaceutical company. An observer of our Board is a partner in TPG Capital and a board director of Ellodi. During the three and six ended June 30, 2025, the Company recorded research and development expense of $1.4 million and $5.7 million, respectively, related to these agreements, including a $1.4 million and $2.7 million estimate for funding the research and development commitment, respectively. As of June 30, 2025, the Company has a remaining liability of $1.8 million associated with these agreements.
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.
Acquisition of Land From Related Parties
On April 18, 2025, the Company executed an agreement to acquire parcels of land in India fromtwo family members of the Company’s Co-Chief Executive Officers. The Company plans to utilize this land to constructtwo new greenfield peptide manufacturing facilities. The total purchase price for this acquisition was $11.4 million, of which $10.9 million was paid to the sellers. The remaining payment of $0.5 million will be deferred until three years following the acquisition date as partial security for the sellers’ indemnity obligations. It is anticipated that the facilities will be used to manufacture products for the Company, as well as support the Company’s collaboration agreement with Metsera, Inc. For additional information related to the Company’s agreement with Metsera, Inc., refer to Note 3. Alliance and Collaboration in this Quarterly Report on Form 10-Q and Note 5. Alliance and Collaboration in the Company’s 2024 Annual Report on Form 10-K.
Kashiv Biosciences LLC Development Supply Agreement
In December 2022, Amneal and Kashiv entered into a development supply agreement specific tofour generic product candidates. Under that agreement, Amneal maintained a right of first offer and negotiation to the in-licensing of each generic product candidate. Amneal and Kashiv previously entered into a license and supply agreement forone product candidate in March 2024. Refer to Note 23. Related Party Transactionsin our 2024 Annual Report on Form 10-K for additional information.
In May 2025, Amneal and Kashiv entered into a separate license agreement for the development and commercialization of Carfilzomib (the “Carfilzomib License Agreement"). The existing development supply agreement remains effective for the remaining two generic product candidates. Subject to the terms of the Carfilzomib License Agreement, Amneal is responsible for development, regulatory approval, and commercialization of the product candidate in the U.S. The term of the agreement is 10 years from the respective product’s launch date in the U.S.
During the three and six months ended June 30, 2025, the Company recorded R&D expense for a $2.0 million payment made upon execution of the license agreement. The agreement provides for potential future milestone payments to Kashiv of up to $23.0 million as follows: (i) up to $18.0 million for U.S. regulatory approval and initial commercial launch milestones and (ii) up to $5.0 million for the achievement of annual commercial milestones. In addition, the agreement provides for Amneal to pay a profit share up 50% of net profits, after considering manufacturing and allowable costs to deduct as defined in the agreement.
Sale of Subsidiary
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 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 for the three and six months ended June 30, 2024. The entire receivable was collected by Amneal in December 2024.
Lease Extension
Refer to Note 20. Leases in this Quarterly Report on Form 10-Q for information on a lease extension with a related party.
- Segment Information
The Company hasthree 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.
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, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands):
| Three Months Ended June 30, 2025 · Affordable Medicines (1) · Specialty · AvKARE · Corporateand Other · TotalCompany | |||||||
|---|---|---|---|---|---|---|---|
| Net revenue | $433,425 | $128,043 | $163,040 | $— | $724,508 | ||
| Cost of goods sold | 252,646 | 55,795 | 129,814 | — | 438,255 | ||
| Gross profit | 180,779 | 72,248 | 33,226 | — | 286,253 | ||
| Selling, general and administrative | 34,226 | 30,314 | A | 15,079 | 44,647 | 124,266 | |
| Research and development | 41,899 | B | 6,065 | B | — | — | 47,964 |
| Intellectual property legal development expenses | 1,978 | 39 | — | — | 2,017 | ||
| Restructuring and other charges | 683 | 341 | — | — | 1,024 | ||
| Credit related to legal matters, net | (390) | — | — | — | (390) | ||
| Operating income (loss) | $102,383 | $35,489 | $18,147 | $(44,647) | $111,372 | ||
| Three Months Ended June 30, 2024 · Affordable Medicines (1) · Specialty · AvKARE · Corporateand Other · TotalCompany | |||||||
|---|---|---|---|---|---|---|---|
| Net revenue | $427,328 | $104,041 | $170,411 | $— | $701,780 | ||
| Cost of goods sold | 260,903 | 46,142 | 144,788 | — | 451,833 | ||
| Gross profit | 166,425 | 57,899 | 25,623 | — | 249,947 | ||
| Selling, general and administrative | 31,627 | 26,610 | A | 14,642 | 43,583 | 116,462 | |
| Research and development | 31,703 | B | 4,351 | B | — | — | 36,054 |
| Intellectual property legal development expenses | 1,032 | 10 | — | — | 1,042 | ||
| Restructuring and other charges | 53 | 78 | — | 89 | 220 | ||
| Charges related to legal matters, net | 699 | — | — | — | 699 | ||
| Operating income (loss) | $101,311 | $26,850 | $10,981 | $(43,672) | $95,470 | ||
| Six Months Ended June 30, 2025 · Affordable Medicines (1) · Specialty · AvKARE · Corporateand Other · TotalCompany | |||||||
|---|---|---|---|---|---|---|---|
| Net revenue | $848,133 | $236,340 | $335,455 | $— | $1,419,928 | ||
| Cost of goods sold | 495,279 | 108,878 | 273,627 | — | 877,784 | ||
| Gross profit | 352,854 | 127,462 | 61,828 | — | 542,144 | ||
| Selling, general and administrative | 67,941 | 61,292 | A | 30,773 | 82,548 | 242,554 | |
| Research and development | 72,879 | B | 15,125 | B | — | — | 88,004 |
| Intellectual property legal development expenses | 3,691 | 93 | — | — | 3,784 | ||
| Restructuring and other charges | 683 | 471 | — | 441 | 1,595 | ||
| Credit related to legal matters, net | (390) | — | — | — | (390) | ||
| Other operating income | (5,122) | — | — | — | (5,122) | ||
| Operating income (loss) | $213,172 | $50,481 | $31,055 | $(82,989) | $211,719 | ||
| Six Months Ended June 30, 2024 · Affordable Medicines (1) · Specialty · AvKARE · Corporateand Other · TotalCompany | |||||||
|---|---|---|---|---|---|---|---|
| Net revenue | $818,622 | $209,275 | $333,074 | $— | $1,360,971 | ||
| Cost of goods sold | 500,825 | 90,942 | 281,197 | — | 872,964 | ||
| Gross profit | 317,797 | 118,333 | 51,877 | — | 488,007 | ||
| Selling, general and administrative | 64,712 | 51,806 | A | 29,549 | 82,990 | 229,057 | |
| Research and development | 66,074 | B | 9,278 | B | — | — | 75,352 |
| Intellectual property legal development expenses | 1,992 | 34 | — | — | 2,026 | ||
| Restructuring and other charges | 53 | 1,024 | — | 613 | 1,690 | ||
| Charges related to legal matters, net | 95,058 | — | — | — | 95,058 | ||
| Other operating expense | — | 100 | — | — | 100 | ||
| Operating income (loss) | $89,908 | $56,091 | $22,328 | $(83,603) | $84,724 | ||
(1)Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in Affordable Medicines.
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):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Employee compensation and benefits | $10,791 | $9,055 | $21,663 | $17,892 |
| Product marketing | 9,884 | 11,615 | 17,895 | 20,143 |
| Commercial operations and salesforce | 8,787 | 4,762 | 19,578 | 11,027 |
| Other (1) | 852 | 1,178 | 2,156 | 2,744 |
| Total | $30,314 | $26,610 | $61,292 | $51,806 |
(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):
| Three Months Ended June 30, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Affordable Medicines | Specialty | Affordable Medicines | Specialty | |
| Employee compensation and benefits | $14,693 | $1,279 | $12,487 | $2,049 |
| Materials and supplies | 8,108 | 450 | 6,025 | 281 |
| Product development and studies (1) | 756 | 2,371 | 635 | 82 |
| Milestones | 6,350 | — | 1,125 | — |
| Facilities costs | 1,793 | 735 | 1,693 | 1,498 |
| Regulatory fees | 2,932 | — | 834 | — |
| Other (2) | 7,267 | 1,230 | 8,904 | 441 |
| Total | $41,899 | $6,065 | $31,703 | $4,351 |
| Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|
| 2025 · 2024 | |||||||
| Affordable Medicines · Specialty · Affordable Medicines · Specialty | |||||||
| Employee compensation and benefits | $28,234 | $2,819 | $24,076 | $4,134 | |||
| Materials and supplies | 16,635 | 653 | 15,983 | 712 | |||
| Product development and studies (1) | 687 | 4,690 | 1,600 | 515 | |||
| Milestones | 6,600 | 3,000 | 4,625 | — | |||
| Facilities costs | 3,427 | 1,485 | 3,385 | 2,745 | |||
| Regulatory fees | 2,517 | — | 788 | 788 | — | ||
| Other (2) | 14,779 | 2,478 | 15,617 | 1,172 | |||
| Total | $72,879 | $15,125 | $66,074 | $9,278 | |||
(1)For the three and six months ended June 30, 2025, Affordable Medicines included a $0.9 million and $2.5 million, respectively, reduction to product development and studies expense for services performed under the license agreement with Orion Corporation. Refer to Note 3. Alliance and Collaboration.
(2)For the Affordable Medicines segment, other includes repairs and maintenance, outside testing, professional fees, 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.
- Leases
Except as disclosed below, as of and for the three and six months ended June 30, 2025, there were no material changes to our lease agreements as described in Note 17. Leases in our 2024 Annual Report on Form 10-K.
On April 23, 2025, the Company executed a lease renewal for an R&D and manufacturing facility in New Jersey. This renewal extended the lease term byten years through November 30, 2035. The aggregate payments over the renewal period are $11.6 million.
On May 7, 2025, the Company executed a lease extension with a related party, Sutaria Family Realty, LLC, for a manufacturing facility in Hauppauge, New York. This agreement extended the existing lease term byseven years through March 31, 2033. The aggregate payments over the extension period are $12.4 million.
- Subsequent Events
Opioid Settlement in Principle
As discussed in Note 16. Commitments and Contingencies, the Company reached a nationwide settlement in principle for a resolution to the opioid cases filed and that might have been filed by state Attorneys General, political subdivisions and Native American tribes. During July 2025, the Company deposited an aggregate of $24.2 million into dedicated accounts as a step in the process to finalize a definitive settlement agreement. These deposits remain the property of the Company until a definitive settlement agreement is reached and the funds are used to make the first installment payment.
Refinancing
On August 1, 2025, Amneal issued $600 million aggregate principal amount of 6.875% senior secured notes due 2032 (the “Senior Notes Due 2032”) at par in a private offering. Concurrently with the offering of the Senior Notes Due 2032, Amneal borrowed $2.1 billion aggregate principal amount of newseven-year term loans (the “Term Loans Due 2032”) under a new term loan facility, and used the net proceeds of the Term Loans Due 2032 and the Senior Notes Due 2032 to refinance its existing Term Loan Due 2028 in full, repay outstanding amounts borrowed under its Amended New Revolving Credit Facility and to pay related fees, premiums and expenses.
Interest is payable on the Term Loans Due 2032 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 0.50% or a base rate floor of 1.00%, as applicable. The applicable margin for the Term Loans Due 2032 is 3.50% per annum for term SOFR benchmark rate loans and 2.50% per annum for base rate loans.
In addition, Amneal entered into a second amendment to the Amended New Revolving Credit Facility which extends the maturity to August 1, 2030.
AvKARE Excess Cash Distribution
On July 31, 2025, we made a $7.0 million cash distribution to the AvKARE Sellers from excess cash on hand.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.