SEC Form 10-Q filed by Amneal Pharmaceuticals Inc.
$AMRX
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended March 31, 2025
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from to
Commission file number 001-38485
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
Amneal Pharmaceuticals, Inc. | |||||
| (Address of principal executive offices) | (Zip Code) | ||||
(908 ) 947-3120
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
☒ | Accelerated filer | ☐ | ||||||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
| Emerging growth company | ||||||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of April 30, 2025, there were 313,419,599 shares of the registrant’s Class A common stock outstanding, with a par value of $0.01.
Amneal Pharmaceuticals, Inc.
Table of Contents
1
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q and other publicly available documents of Amneal Pharmaceuticals, Inc. contain “forward-looking statements” within the meaning of the safe harbor provisions of the United States (“U.S.”) Private Securities Litigation Reform Act of 1995. Management and representatives of Amneal Pharmaceuticals, Inc. and its subsidiaries (“the Company”, “we”, “us”, or “our”) also may from time to time make forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and reflect management’s assumptions, views, plans, objectives and projections about the future. Forward-looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “targets,” “estimates,” and other words of similar meaning in conjunction with, among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; our strategy for growth; product development; regulatory approvals; market position and expenditures.
Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of our control. Investors should realize that if underlying assumptions prove inaccurate, known or unknown risks or uncertainties materialize, or other factors or circumstances change, our actual results and financial condition could vary materially from expectations and projections expressed or implied in our forward-looking statements. Investors are therefore cautioned not to rely on these forward-looking statements.
Summary of Material Risks
Risks and uncertainties that make an investment in the Company speculative or risky or that could cause our actual results to differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to:
•our ability to successfully develop, license, acquire and commercialize new products on a timely basis;
•the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices;
•our ability to obtain exclusive marketing rights for our products;
•the impact of illegal distribution and sale by third parties of counterfeit versions of our products or stolen products;
•the impact of negative market perceptions of us and the safety and quality of our products;
•our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers;
•the continuing trend of consolidation of certain customer groups;
•our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods;
•the imposition of tariffs may adversely affect our business, results of operations and financial condition;
•legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives;
•our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents, and risks associated with artificial intelligence;
•the impact of a prolonged business interruption within our supply chain;
•our ability to attract, hire and retain highly skilled personnel;
•risks related to federal regulation of arrangements between manufacturers of branded and generic products;
•our reliance on certain licenses to proprietary technologies from time to time;
•the significant amount of resources we expend on research and development;
•the risk of claims brought against us by third parties such as those described in Note 16. Commitments and Contingencies - Other Litigation Related to the Company’s Business;
•risks related to changes in the regulatory environment, including U.S. federal and state laws related to government contracting, healthcare fraud abuse and health information privacy and security and changes in such laws;
•changes to Food and Drug Administration product approval requirements;
•the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers;
•our dependence on third-party agreements for a portion of our product offerings;
•our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness;
•our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties;
•our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms;
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•the impact of global economic, political or other catastrophic events;
•our obligations under a tax receivable agreement may be significant;
•the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group (as defined in Item 1. Business in the Company’s 2024 Annual Report on Form 10-K); and
•such other factors as may be set forth elsewhere in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, particularly in the section entitled 1A. Risk Factors and our public filings with the SEC.
Investors should carefully read our Annual Report on Form 10-K for the year ended December 31, 2024, including the section 1A. Risk Factors, for a description of certain risks that could, among other things, cause our actual results to differ materially from those expressed in our forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described herein and in our Annual Report to be a complete statement of all potential risks and uncertainties. The Company does not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments.
3
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Operations
(unaudited; in thousands, except per share amounts)
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Net revenue | $ | $ | |||||||||
| Cost of goods sold | |||||||||||
| Gross profit | |||||||||||
| Selling, general and administrative | |||||||||||
| Research and development | |||||||||||
| Intellectual property legal development expenses | |||||||||||
| Restructuring and other charges | |||||||||||
| Charges related to legal matters, net | |||||||||||
| Other operating (income) expense | ( | ||||||||||
| Operating income (loss) | ( | ||||||||||
| Other (expense) income: | |||||||||||
| Interest expense, net | ( | ( | |||||||||
| Foreign exchange gain (loss), net | ( | ||||||||||
| Increase in tax receivable agreement liability | ( | ( | |||||||||
| Other income, net | |||||||||||
| Total other expense, net | ( | ( | |||||||||
| Income (loss) before income taxes | ( | ||||||||||
| Provision for income taxes | |||||||||||
| Net income (loss) | ( | ||||||||||
| Less: Net income attributable to non-controlling interests | ( | ( | |||||||||
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | $ | $ | ( | ||||||||
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders: | |||||||||||
Basic | $ | $ | ( | ||||||||
Diluted | $ | $ | ( | ||||||||
| Weighted-average common shares outstanding: | |||||||||||
Basic | |||||||||||
Diluted | |||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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Amneal Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Loss
(unaudited; in thousands)
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Net income (loss) | $ | $ | ( | ||||||||
| Less: Net income attributable to non-controlling interests | ( | ( | |||||||||
| Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | ( | ||||||||||
| Other comprehensive (loss) income: | |||||||||||
| Foreign currency translation adjustments arising during the period | ( | ( | |||||||||
Unrealized (loss) gain on cash flow hedge, net of tax of $ | ( | ||||||||||
Reclassification of cash flow hedge to earnings, net of tax of $ | ( | ( | |||||||||
| Other comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc. | ( | ||||||||||
| Comprehensive loss attributable to Amneal Pharmaceuticals, Inc. | $ | ( | $ | ( | |||||||
The accompanying notes are an integral part of these consolidated financial statements.
5
Amneal Pharmaceuticals, Inc.
Consolidated Balance Sheets
(unaudited; in thousands, except per share amounts)
| March 31, 2025 | December 31, 2024 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Restricted cash | |||||||||||
| Trade accounts receivable, net | |||||||||||
| Inventories | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Related party receivables | |||||||||||
| Total current assets | |||||||||||
| Property, plant and equipment, net | |||||||||||
| Goodwill | |||||||||||
| Intangible assets, net | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Operating lease right-of-use assets - related party | |||||||||||
| Financing lease right-of-use assets | |||||||||||
| Other assets | |||||||||||
| Total assets | $ | $ | |||||||||
Liabilities and Stockholders’ Deficiency | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | $ | |||||||||
| Current portion of liabilities for legal matters | |||||||||||
| Revolving credit facility | |||||||||||
| Current portion of long-term debt, net | |||||||||||
| Current portion of operating lease liabilities | |||||||||||
| Current portion of operating lease liabilities - related party | |||||||||||
| Current portion of financing lease liabilities | |||||||||||
| Related party payables - short term | |||||||||||
| Total current liabilities | |||||||||||
| Long-term debt, net | |||||||||||
| Operating lease liabilities | |||||||||||
| Operating lease liabilities - related party | |||||||||||
| Financing lease liabilities | |||||||||||
| Related party payables - long term | |||||||||||
| Liabilities for legal matters - long term | |||||||||||
| Other long-term liabilities | |||||||||||
| Total long-term liabilities | |||||||||||
| Commitments and contingencies (Notes 3, 16 and 18) | |||||||||||
| Redeemable non-controlling interests | |||||||||||
Stockholders’ Deficiency | |||||||||||
Preferred stock, $ | |||||||||||
Class A common stock, $ | |||||||||||
Class B common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Stockholders' accumulated deficit | ( | ( | |||||||||
| Accumulated other comprehensive loss | ( | ( | |||||||||
Total Amneal Pharmaceuticals, Inc. stockholders’ deficiency | ( | ( | |||||||||
| Non-controlling interests | ( | ( | |||||||||
| Total stockholders' deficiency | ( | ( | |||||||||
Total liabilities and stockholders’ deficiency | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
6
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(unaudited; in thousands)
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net income (loss) | $ | $ | ( | ||||||||
| Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||||||||||
| Depreciation and amortization | |||||||||||
| Unrealized foreign currency (gain) loss | ( | ||||||||||
| Amortization of debt issuance costs and discount | |||||||||||
| Reclassification of cash flow hedge | ( | ( | |||||||||
| Intangible asset impairment charges | |||||||||||
| Stock-based compensation | |||||||||||
| Inventory provision | |||||||||||
| Other operating charges and credits, net | |||||||||||
| Changes in assets and liabilities: | |||||||||||
| Trade accounts receivable, net | ( | ||||||||||
| Inventories | ( | ( | |||||||||
| Prepaid expenses, other current assets and other assets | ( | ( | |||||||||
| Related party receivables | ( | ( | |||||||||
| Accounts payable, accrued expenses and other liabilities | ( | ||||||||||
| Related party payables | ( | ||||||||||
| Net cash provided by (used in) operating activities | ( | ||||||||||
| Cash flows from investing activities: | |||||||||||
| Purchases of property, plant and equipment | ( | ( | |||||||||
| Acquisition of intangible assets | ( | ( | |||||||||
| Deposits for future acquisition of property, plant and equipment | ( | ( | |||||||||
| Proceeds from sale of property, plant and equipment | |||||||||||
| Net cash used in investing activities | ( | ( | |||||||||
| Cash flows from financing activities: | |||||||||||
| Payments of principal on debt, revolving credit facilities, financing leases and other | ( | ( | |||||||||
| Borrowings on revolving credit facilities | |||||||||||
| Proceeds from exercise of stock options | |||||||||||
| Employee payroll tax withholding on restricted stock unit and performance stock unit vesting | ( | ( | |||||||||
| Tax distributions to non-controlling interests | ( | ( | |||||||||
| Net cash used in financing activities | ( | ( | |||||||||
| Effect of foreign exchange rate on cash | ( | ( | |||||||||
| Net decrease in cash, cash equivalents, and restricted cash | ( | ( | |||||||||
| Cash, cash equivalents, and restricted cash - beginning of period | |||||||||||
| Cash, cash equivalents, and restricted cash - end of period | $ | $ | |||||||||
| Cash and cash equivalents - end of period | $ | $ | |||||||||
| Restricted cash - end of period | |||||||||||
| Long-term restricted cash included in other assets - end of period | |||||||||||
| Cash, cash equivalents, and restricted cash - end of period | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows (continued)
(unaudited; in thousands)
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Supplemental disclosure of cash flow information: | |||||||||||
| Cash paid for interest | $ | $ | |||||||||
| Cash paid, net for income taxes | $ | $ | |||||||||
| Supplemental disclosure of non-cash investing and financing activity: | |||||||||||
| Tax distributions to non-controlling interests | $ | $ | |||||||||
| Payable for acquisition of intangible assets | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
8
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ (Deficiency) Equity
(unaudited; in thousands)
| Class A Common Stock | Additional Paid-in Capital | Stockholders' Accumulated Deficit | Accumulated Other Comprehensive Loss | Non- Controlling Interests | Total Deficiency | Redeemable Non-Controlling Interests | |||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||||||||||
| Net income (loss) | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||
| Foreign currency translation adjustments | — | — | — | — | ( | — | ( | — | |||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of stock options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Restricted stock unit and performance stock unit vesting, net of shares withheld to cover payroll taxes | ( | — | — | — | ( | — | |||||||||||||||||||||||||||||||||||||||||
Unrealized loss on cash flow hedge, net of tax of $ | — | — | — | — | ( | — | ( | — | |||||||||||||||||||||||||||||||||||||||
| Tax distributions, net | — | — | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Reclassification of cash flow hedge to earnings, net of tax of $ | — | — | — | — | ( | — | ( | — | |||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||||||||||
| Class A Common Stock | Additional Paid-in Capital | Stockholders' Accumulated Deficit | Accumulated Other Comprehensive Loss | Non- Controlling Interests | Total Equity (Deficiency) | Redeemable Non-Controlling Interests | ||||||||||||||||||||||||||||||||||||||
| Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||
| Net (loss) income | — | — | — | ( | — | ( | ( | |||||||||||||||||||||||||||||||||||||
| Foreign currency translation adjustments | — | — | — | — | ( | — | ( | — | ||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
| Exercise of stock options | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Restricted stock unit vesting, net of shares withheld to cover payroll taxes | ( | — | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||
Unrealized gain on cash flow hedge, net of tax of $ | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
| Tax distributions, net | — | — | — | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||
Reclassification of cash flow hedge to earnings, net of tax of $0 | — | — | — | — | ( | — | ( | $ | — | |||||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | ( | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
9
Amneal Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
(unaudited)
1. 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
Reclassification
The prior period balance of $0.1 million, formerly included in the caption “change in fair value of contingent consideration” for the three months ended March 31, 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 (loss) or net income (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.
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2. 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 Collaboration in 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 March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Customer A | % | % | |||||||||
| Customer B | % | % | |||||||||
| Customer C | % | % | |||||||||
| Customer D | % | % | |||||||||
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 months ended March 31, 2025 and 2024, are set forth below (in thousands):
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| Three Months Ended March 31, | ||||||||||||||
| 2025 | 2024 | |||||||||||||
Affordable Medicines | ||||||||||||||
| Oral solid | $ | $ | ||||||||||||
Auto-Injector | ||||||||||||||
| Transdermal | ||||||||||||||
| Injectable | ||||||||||||||
| Biosimilar | ||||||||||||||
| Oral liquid | ||||||||||||||
Other dosage forms (1) | ||||||||||||||
Subtotal dosage forms | ||||||||||||||
| International | ||||||||||||||
| Total Affordable Medicines Revenue | ||||||||||||||
| Specialty | ||||||||||||||
| Hormonal / allergy | ||||||||||||||
| Central nervous system | ||||||||||||||
| Other therapeutic classes | ||||||||||||||
Subtotal therapeutic classes | ||||||||||||||
License agreement (2) | ||||||||||||||
| Total Specialty net revenue | ||||||||||||||
AvKARE | ||||||||||||||
| Distribution | ||||||||||||||
| Government label | ||||||||||||||
| Institutional | ||||||||||||||
| Other | ||||||||||||||
| Total AvKARE net revenue | ||||||||||||||
| Total net revenue | $ | $ | ||||||||||||
(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.
A rollforward of the major categories of sales-related deductions for the three months ended March 31, 2025 is as follows (in thousands):
| Contract Charge - Backs and Sales Volume Allowances | Cash Discount Allowances | Accrued Returns Allowance | Accrued Medicaid and Commercial Rebates | ||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | |||||||||||||||||||
| Provision related to sales recorded in the period | |||||||||||||||||||||||
| Credits/payments issued during the period | ( | ( | ( | ( | |||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | $ | |||||||||||||||||||
3. 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.
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These agreements generally obligate the Company to provide research and development (“R&D”) services over multiple periods.
As of and for the three months ended March 31, 2025, there were no material changes to our alliance and collaboration agreements as described in Note 5. Alliance and Collaboration in 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 the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | ||||||||||||||
| Partner | Caption in Statement of Operations | 2025 | 2024 | |||||||||||
| Orion Corporation | Research and development (1) | $ | ( | $ | ( | |||||||||
| Zambon Biotech S.A. | Net revenue (2) | $ | $ | |||||||||||
| Knight Therapeutics International S.A. | Net revenue (3) | $ | $ | |||||||||||
| mAbxience S.L. | Research and development (4) | $ | $ | |||||||||||
(1)The Company recognizes reductions to R&D for services performed.
(2)Delivery of a functional license (out-licensing revenue).
(3)Non-refundable license fee.
(4)Clinical milestone payment.
The following table summarizes the balances in the Company’s consolidated balance sheets related to alliance and collaboration agreements as of March 31, 2025 and December 31, 2024 (in thousands):
Party | Caption in Balance Sheet | March 31, 2025 | December 31, 2024 | |||||||||||
Orion Corporation | Accounts payable and accrued expenses (1) | $ | $ | |||||||||||
Orion Corporation | Other long-term liabilities (1) | $ | $ | |||||||||||
Zambon Biotech S.A. | Other long-term liabilities (1) | $ | $ | |||||||||||
Metsera, Inc. | Prepaid expenses and other current assets (2) | $ | $ | |||||||||||
(1)Comprised of deferred income as of March 31, 2025 and December 31, 2024.
(2)Comprised primarily of unbilled receivables for R&D services performed as of December 31, 2024.
4. 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 March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Provision for income taxes | $ | $ | |||||||||
| Effective tax rate | % | ( | % | ||||||||
For the three months ended March 31, 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.
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Tax Receivable Agreement
The following table summarizes the Company’s tax receivable agreement (“TRA”) (in thousands)
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Increase in tax receivable agreement liability | $ | $ | |||||||||
| March 31, 2025 | December 31, 2024 | ||||||||||
| Tax receivable agreement liability- short term | $ | $ | |||||||||
| Tax receivable agreement liability- long term | |||||||||||
| Total | $ | $ | |||||||||
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 three months ended March 31, 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 $123.1 million as of March 31, 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.
5. Earnings (Loss) per Share
The computation of basic and diluted earnings per share was as follows (in thousands, except per share amounts):
| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Numerator: | |||||||||||
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. | $ | $ | ( | ||||||||
| Denominator: | |||||||||||
Weighted-average shares outstanding - basic | |||||||||||
Effect of dilutive securities: | |||||||||||
| Stock options | |||||||||||
Restricted stock units | |||||||||||
| Performance stock units | |||||||||||
Weighted-average shares outstanding - diluted | |||||||||||
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders: | |||||||||||
Basic | $ | $ | ( | ||||||||
Diluted | $ | $ | ( | ||||||||
The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of Class A common stock (in thousands):
| Three Months Ended March 31, | ||||||||||||||
| 2025 | 2024 | |||||||||||||
| Stock options | (1) | (3) | ||||||||||||
| Restricted stock units | (3) | |||||||||||||
| Performance stock units | (2) | (3) | ||||||||||||
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(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 for the three months ended March 31, 2025.
(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.
6. Trade Accounts Receivable, Net
Trade accounts receivable, net was comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Gross accounts receivable | $ | $ | |||||||||
| Allowance for credit losses | ( | ( | |||||||||
| Contract charge-backs and sales volume allowances | ( | ( | |||||||||
| Cash discount allowances | ( | ( | |||||||||
| Subtotal | ( | ( | |||||||||
| Trade accounts receivable, net | $ | $ | |||||||||
Concentration of Receivables
Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
| March 31, 2025 | December 31, 2024 | ||||||||||
| Customer A | % | % | |||||||||
| Customer B | % | % | |||||||||
| Customer C | % | % | |||||||||
7. Inventories
Inventories were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
Raw materials | $ | $ | |||||||||
Work in process | |||||||||||
Finished goods | |||||||||||
| Total inventories | $ | $ | |||||||||
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8. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Deposits and advances | $ | $ | |||||||||
| Prepaid insurance | |||||||||||
| Prepaid regulatory fees | |||||||||||
| Income and other tax receivables | |||||||||||
| Prepaid taxes | |||||||||||
Other current receivables | |||||||||||
Chargebacks receivable | |||||||||||
| Other prepaid assets | |||||||||||
| Total prepaid expenses and other current assets | $ | $ | |||||||||
9. 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 | $ | $ | $ | $ | |||||||||||||||||||
| Currency translation | ( | ( | |||||||||||||||||||||
| Balance as of December 31, 2024 | |||||||||||||||||||||||
| Currency translation | |||||||||||||||||||||||
| Balance as of March 31, 2025 | $ | $ | $ | $ | |||||||||||||||||||
Intangible assets as of March 31, 2025 and December 31, 2024 were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||||||||||||||||||||||||||||||||
| Weighted-Average Amortization Period (in years) | Cost | Accumulated Amortization | Net | Cost | Accumulated Amortization | Net | |||||||||||||||||||||||||||||||||||
| Amortizing intangible assets: | |||||||||||||||||||||||||||||||||||||||||
| Product rights | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||
| Other intangible assets | ( | ( | |||||||||||||||||||||||||||||||||||||||
| Subtotal | ( | ( | |||||||||||||||||||||||||||||||||||||||
| In-process research and development | — | — | |||||||||||||||||||||||||||||||||||||||
| Total intangible assets | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||
Amortization expense related to intangible assets for the three months ended March 31, 2025 and 2024 was $45.2 million and $39.9 million, respectively.
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10. Other Assets
Other assets were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
Interest rate swap (1) | $ | $ | |||||||||
| Security deposits | |||||||||||
| Long-term prepaid expenses | |||||||||||
| Deferred revolving credit facility costs | |||||||||||
Long-term restricted cash | |||||||||||
| Other long term assets | |||||||||||
Total other assets | $ | $ | |||||||||
11. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Accounts payable | $ | $ | |||||||||
Accrued returns allowance (1) | |||||||||||
| Accrued compensation | |||||||||||
Accrued Medicaid and commercial rebates (1) | |||||||||||
| Accrued royalties | |||||||||||
| Commercial chargebacks and rebates | |||||||||||
| Accrued professional fees | |||||||||||
| Accrued other | |||||||||||
| Total accounts payable and accrued expenses | $ | $ | |||||||||
(1)Refer to Note 2. Revenue Recognition for a rollforward of the balance from December 31, 2024 to March 31, 2025.
12. 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):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Term Loan Due 2025 | $ | $ | |||||||||
| Term Loan Due 2028 | |||||||||||
| Total debt | |||||||||||
| Less: debt issuance costs | ( | ( | |||||||||
| Total debt, net of debt issuance costs | |||||||||||
| Less: current portion of long-term debt | ( | ( | |||||||||
| Total long-term debt, net | $ | $ | |||||||||
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13. Other Long-Term Liabilities
Other long-term liabilities were comprised of the following (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Uncertain tax positions | $ | $ | |||||||||
| Long-term compensation | |||||||||||
| Other long-term liabilities | |||||||||||
| Total other long-term liabilities | $ | $ | |||||||||
14. 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 March 31, 2025 and December 31, 2024 (in thousands):
| Fair Value Measurement Based on | ||||||||||||||||||||||||||
| March 31, 2025 | Total | Quoted Prices in Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||||||||||||
| Assets | ||||||||||||||||||||||||||
Interest rate swap (1) | $ | $ | $ | $ | ||||||||||||||||||||||
| December 31, 2024 | ||||||||||||||||||||||||||
| Assets | ||||||||||||||||||||||||||
Interest rate swap (1) | $ | $ | $ | $ | ||||||||||||||||||||||
There were no transfers between levels in the fair value hierarchy during the three months ended March 31, 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):
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| March 31, 2025 | December 31, 2024 | |||||||||||||
| Term Loan Due 2025 | $ | $ | ||||||||||||
| Term Loan Due 2028 | $ | $ | ||||||||||||
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 three months ended March 31, 2025 and 2024.
15. Financial Instruments
The Company uses an interest rate swap to manage its exposure to market risks for changes in interest rates. During the three months ended March 31, 2025, the Company reclassified a net gain of $6.4 million from accumulated other comprehensive loss to a reduction of interest expense, net. Approximately $15.0 million of net losses included in accumulated other comprehensive loss as of March 31, 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 March 31, 2025, the total loss, net of income taxes, related to the Company’s cash flow hedge of $12.2 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):
| March 31, 2025 | December 31, 2024 | |||||||||||||||||||||||||
| Derivatives Designated as Hedging Instruments | Balance Sheet Classification | Fair Value | Balance Sheet Classification | Fair Value | ||||||||||||||||||||||
| Variable-to-fixed interest rate swap | Other Assets | $ | Other Assets | $ | ||||||||||||||||||||||
16. 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 Collaboration for additional information. Certain of these arrangements are with related parties. Refer to Note 18. Related Party Transactions for additional information.
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Contingencies
Legal Proceedings
The Company's legal proceedings are complex, constantly evolving, and subject to uncertainty. As such, the Company cannot predict the outcome or impact of its significant legal proceedings which are set forth below. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs and may therefore face claims arising from the regulation and/or consumption of such products. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such proceedings could include damages, fines, penalties and injunctive or administrative remedies.
For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized.
For the three months ended March 31, 2024, charges related to legal matters, net of $94.4 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).
Liabilities for legal matters were comprised of the following (in thousands):
| Matter | March 31, 2025 | December 31, 2024 | |||||||||
| Civil prescription opioid litigation | $ | $ | |||||||||
Other | |||||||||||
| Current portion of liabilities for legal matters | $ | $ | |||||||||
| Civil prescription opioid litigation (Liabilities for legal matters - long term) | $ | $ | |||||||||
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.
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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. 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 two
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 judgement were fully briefed on April 7, 2025, and defendant-specific motions for summary judgement 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 MDL No. 2724, 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 multi-district litigation (“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 six 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 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 March 31, 2025 was $114.9 million, of which $73.0 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 March 31, 2025 or December 31, 2024, because it concluded that a loss was not probable and estimable.
21
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 (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 will set an oral argument date in July 2025.
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 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.,
22
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 a hearing on the motion is scheduled for June 12, 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 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 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. On April 1, 2025, the Company and Impax filed a First Amended Complaint in response to a second notice from Sandoz, adding claims for infringement relating to U.S. Patents Nos. 12,178,918, 12,178,919, and 12,194,150. On April 14, 2025, Sandoz filed an Answer, Affirmative Defense, and Counterclaims for non-infringement and invalidity of the asserted patents. 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.
23
17. Stockholders’ Deficiency
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):
| Foreign currency translation adjustments | Unrealized gain (loss) on cash flow hedge, net of tax | Accumulated other comprehensive loss | |||||||||||||||
| Balance December 31, 2024 | $ | ( | $ | $ | ( | ||||||||||||
| Other comprehensive loss before reclassification | ( | ( | ( | ||||||||||||||
Reclassification of cash flow hedge to earnings, net of tax of $0 | ( | ( | |||||||||||||||
| Balance March 31, 2025 | $ | ( | $ | ( | $ | ( | |||||||||||
| Balance December 31, 2023 | $ | ( | $ | $ | ( | ||||||||||||
Other comprehensive (loss) income before reclassification | ( | ||||||||||||||||
Reclassification of cash flow hedge to earnings, net of tax of $ | ( | ( | |||||||||||||||
| Balance March 31, 2024 | $ | ( | $ | $ | ( | ||||||||||||
18. Related Party Transactions
The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three months ended March 31, 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.
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The following table summarizes the Company’s related party transactions (in thousands):
| Three Months Ended March 31, | ||||||||||||||
| Related Party and Nature of Transaction | Caption in Balance Sheet and Statement of Operations | 2025 | 2024 | |||||||||||
| Kashiv Biosciences LLC | ||||||||||||||
| Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko and Fylnetra) | Inventory and cost of goods sold | $ | $ | |||||||||||
| Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko and Fylnetra) | Cost of goods sold | $ | $ | |||||||||||
| Parking space lease | Research and development | $ | $ | |||||||||||
| Storage agreement | Research and development | $ | ( | $ | ( | |||||||||
| Generic development supply agreement - development activity deferred income | Accounts payable and accrued expenses | $ | ( | $ | ( | |||||||||
| Development and commercialization agreement - long-acting injectable | Research and development | $ | $ | |||||||||||
| Generic development supply agreement - research and development material | Research and development | $ | $ | ( | ||||||||||
| Other Related Parties | ||||||||||||||
| Members - tax receivable agreement (TRA liability) | Increase in tax receivable agreement liability | $ | $ | |||||||||||
| Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement | Inventory and cost of goods sold | $ | $ | |||||||||||
| Ellodi Pharmaceuticals, L.P. - securities purchase and license and collaboration agreements | Research and development | $ | $ | |||||||||||
| AzaTech Pharma LLC - supply agreement | Inventory and cost of goods sold | $ | $ | |||||||||||
| Kanan, LLC - operating lease | Inventory and cost of goods sold | $ | $ | |||||||||||
| Sutaria Family Realty, LLC - operating lease | Inventory and cost of goods sold | $ | $ | |||||||||||
| Tracy Properties LLC - operating lease | Selling, general and administrative | $ | $ | |||||||||||
R&S Solutions LLC | Property, plant and equipment, net | $ | $ | |||||||||||
| Alkermes Plc | Inventory and cost of goods sold | $ | $ | |||||||||||
| Avtar Investments, LLC - consulting services | Research and development | $ | $ | |||||||||||
| AvPROP, LLC - operating lease | Selling, general and administrative | $ | $ | |||||||||||
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The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
| March 31, 2025 | December 31, 2024 | ||||||||||
| Kashiv - various agreements | $ | $ | |||||||||
| AzaTech Pharma LLC - supply agreement | |||||||||||
| Alkermes | |||||||||||
| Related party receivables - short term | $ | $ | |||||||||
| Members - tax receivable agreement | $ | $ | |||||||||
| Kashiv - various agreements | |||||||||||
| Rondo Class B unit holders - tax distributions | |||||||||||
| Apace Packaging, LLC - packaging agreement | |||||||||||
| AzaTech Pharma LLC - supply agreement | |||||||||||
| Ellodi Pharmaceuticals, L.P. | |||||||||||
| Avtar Investments LLC - consulting services | |||||||||||
| Alkermes Plc | |||||||||||
| Related party payables - short term | $ | $ | |||||||||
| Members - tax receivable agreement | $ | $ | |||||||||
| Related party payables - long term | $ | $ | |||||||||
Equipment Purchases
The Company purchased $0.2 million of equipment from R&S Solutions LLC during the three months ended March 31, 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 months ended March 31, 2025, the Company recorded research and development expense of $4.3 million related to these agreements, including a $1.3 million estimate for funding the research and development commitment. As of March 31, 2025, the Company has a remaining liability of $1.1 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.
19. 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.
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,
26
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 March 31, 2025 | Affordable Medicines (1) | Specialty | AvKARE | Corporate and Other | Total Company | |||||||||||||||||||||||||||
| Net revenue | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||
| Cost of goods sold | ||||||||||||||||||||||||||||||||
| Gross profit | ||||||||||||||||||||||||||||||||
| Selling, general and administrative | A | |||||||||||||||||||||||||||||||
| Research and development | B | B | ||||||||||||||||||||||||||||||
| Intellectual property legal development expenses | ||||||||||||||||||||||||||||||||
| Restructuring and other charges | ||||||||||||||||||||||||||||||||
| Other operating income | ( | ( | ||||||||||||||||||||||||||||||
Operating income (loss) | $ | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||
| Three Months Ended March 31, 2024 | Affordable Medicines (1) | Specialty | AvKARE | Corporate and Other | Total Company | |||||||||||||||||||||||||||
| Net revenue | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||
| Cost of goods sold | ||||||||||||||||||||||||||||||||
| Gross profit | ||||||||||||||||||||||||||||||||
| Selling, general and administrative | A | |||||||||||||||||||||||||||||||
| Research and development | B | B | ||||||||||||||||||||||||||||||
| Intellectual property legal development expenses | ||||||||||||||||||||||||||||||||
| Restructuring and other charges | ||||||||||||||||||||||||||||||||
| Charges related to legal matters, net | ||||||||||||||||||||||||||||||||
| Other operating expense | ||||||||||||||||||||||||||||||||
Operating (loss) income | $ | ( | $ | $ | $ | ( | $ | ( | ||||||||||||||||||||||||
(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):
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| Three Months Ended March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Employee compensation and benefits | $ | $ | |||||||||
| Product marketing | |||||||||||
| Commercial operations and salesforce | |||||||||||
Other (1) | |||||||||||
| Total | $ | $ | |||||||||
(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 March 31, | ||||||||||||||||||||||||||
| 2025 | 2024 | |||||||||||||||||||||||||
| Affordable Medicines | Specialty | Affordable Medicines | Specialty | |||||||||||||||||||||||
| Employee compensation and benefits | $ | $ | $ | $ | ||||||||||||||||||||||
| Materials and supplies | ||||||||||||||||||||||||||
Product development and studies (1) | ( | |||||||||||||||||||||||||
| Milestones | ||||||||||||||||||||||||||
| Facilities costs | ||||||||||||||||||||||||||
Other (2) | ||||||||||||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||||||||||||
(1)For the three months ended March 31, 2025, Affordable Medicines included a $1.6 million 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.
20. Subsequent Events
Rondo Revolving Credit Facility
On April 9, 2025, the Company executed an amendment to the Amended Rondo Revolving Credit Facility (as defined in Note 15. Debt in our 2024 Annual Report on Form 10-K) to increase (i) the borrowing capacity from $70.0 million to $125.0 million and (ii) the letter of credit commitment from $60.0 million to $90.0 million, and to extend the maturity to April 9, 2030.
Leases
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 by ten 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 for a manufacturing facility in New York. This agreement extended the existing lease term by seven years through March 31, 2033. The aggregate payments over the extension period are $12.4 million.
Acquisition of Land From Related Parties
During the second quarter of 2025, the Company executed an agreement to acquire parcels of land in India from two family members of the Company’s Co-Chief Executive Officers. The Company plans to utilize this land to construct two new greenfield peptide manufacturing facilities. The total purchase price for this acquisition was $11.4 million, of which
28
$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.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Amneal Pharmaceuticals, Inc. (the “Company”, “we,” “us,” or “our”) is a global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines. Our Affordable Medicines segment includes retail generics, injectables, and biosimilars. In our Specialty segment, we offer a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through our AvKARE segment, we are a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. We operate principally in the United States (“U.S.”), India, and Ireland.
The following discussion and analysis contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth under Item 1A. Risk Factors in our 2024 Annual Report on Form 10-K and under the heading Cautionary Note Regarding Forward-Looking Statements included elsewhere in this Quarterly Report on Form 10-Q.
The following discussion and analysis for the three months ended March 31, 2025 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2024 included in our 2024 Annual Report on Form 10-K.
Overview
We have three reportable segments: Affordable Medicines, Specialty, and AvKARE. Refer to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K for a description of our segments. During the fourth quarter of 2024, we changed the name of our 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 our reportable segments and, therefore, did not result in any change to our historical results.
The Pharmaceutical Industry
The pharmaceutical industry is highly competitive and highly regulated. As a result, we face a number of industry-specific factors and challenges, which can significantly impact our results. For a more detailed explanation of our business and its risks, refer to our 2024 Annual Report on Form 10-K, as supplemented by Part II, Item 1A “Risk Factors” of our subsequent Quarterly Reports on Form 10-Q.
Inflation
While it is difficult to accurately measure the impact of inflation, we do not currently expect a material impact related to inflation for the year ending December 31, 2025. Notwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, tariff impacts on supply, labor and other costs, could exceed our expectations, which would further adversely impact our operating results in future periods.
Trade Policy and Tariffs
We are subject to certain trade and tariff requirements imposed by the U.S. and various foreign governments. The great majority of our net sales rely on finished dosage forms (“FDF”) or active pharmaceutical ingredients (“API”) produced in the U.S. or India. We have limited reliance on imports from Europe and China, and no reliance on imports from Mexico or Canada.
Over the past few months, President Trump has announced a number of tariff actions, and while there are currently no reciprocal tariffs on pharmaceutical products imported into the U.S., this can change at any moment. In addition, on April 14, 2025, the Department of Commerce Bureau of Industry and Security announced that it had initiated, as of April 1, 2025, a broad investigation under section 232 of the Trade Expansion Act to determine the effects on national security of imports of pharmaceuticals (i.e. FDF, API, key starting materials, derivatives, and medical countermeasures). This is currently an investigation into whether trade remedies such as tariffs should be imposed and covers both generic and brand products.
Given the global nature of pharmaceutical supply chains, any changes to historically prevailing tariff requirements could impact us and our industry (i.e. increase costs, product availability, and supply chain disruptions). The Company is closely monitoring these tariff and trade developments and will take actions to reduce or minimize any material negative impact.
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Results of Operations
Consolidated Results
The following table sets forth our summarized, consolidated results of operations for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
| Net revenue | $ | 695,420 | $ | 659,191 | $ | 36,229 | 5.5 | % | |||||||||||||||
| Cost of goods sold | 439,529 | 421,131 | 18,398 | 4.4 | % | ||||||||||||||||||
| Gross profit | 255,891 | 238,060 | 17,831 | 7.5 | % | ||||||||||||||||||
| Selling, general and administrative | 118,288 | 112,595 | 5,693 | 5.1 | % | ||||||||||||||||||
| Research and development | 40,040 | 39,298 | 742 | 1.9 | % | ||||||||||||||||||
| Intellectual property legal development expenses | 1,767 | 984 | 783 | 79.6 | % | ||||||||||||||||||
| Restructuring and other charges | 571 | 1,470 | (899) | (61.2) | % | ||||||||||||||||||
Charges related to legal matters, net | — | 94,359 | (94,359) | (100.0) | % | ||||||||||||||||||
| Other operating (income) expense | (5,122) | 100 | (5,222) | nm | |||||||||||||||||||
| Operating income (loss) | 100,347 | (10,746) | 111,093 | nm | |||||||||||||||||||
| Total other expense, net | (62,861) | (64,776) | 1,915 | (3.0) | % | ||||||||||||||||||
Income (loss) before income taxes | 37,486 | (75,522) | 113,008 | nm | |||||||||||||||||||
Provision for income taxes | 12,868 | 6,156 | 6,712 | 109.0 | % | ||||||||||||||||||
Net income (loss) | $ | 24,618 | $ | (81,678) | $ | 106,296 | nm | ||||||||||||||||
nm - not meaningful
Net Revenue
Net revenue for the three months ended March 31, 2025 increased 5.5% from the prior year period primarily due to:
•Growth in our Affordable Medicines segment net revenue of $23.4 million, primarily due to new products launched in 2025 and 2024, which contributed $40.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
•Growth in our AvKARE segment net revenue of $9.8 million, primarily driven by growth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel.
•Growth in our Specialty segment net revenue of $3.1 million, primarily driven by increases of $9.1 million and $4.0 million in sales of CREXONT® and UNITHROID®, respectively, partially offset by a $5.1 million decline in sales of RYTARY®. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
Cost of Goods Sold and Gross Profit
Cost of goods sold increased 4.4% for the three months ended March 31, 2025 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased Affordable Medicines and AvKARE volume, increased amortization related to CREXONT® and increased plant and freight costs, partially offset by manufacturing efficiencies.
Gross profit as a percentage of net revenue increased to 36.8% for the three months ended March 31, 2025 from 36.1% in the prior year period, primarily as a result of the factors noted above.
Selling, General, and Administrative
SG&A expenses for the three months ended March 31, 2025 increased 5.1% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT®, partially offset by a reduction in legal expenses primarily resulting from insurance coverage for certain legal fees.
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Research and Development
R&D expenses for the three months ended March 31, 2025 increased 1.9% as compared to the prior year period, primarily due to increases in employee compensation.
Charges Related to Legal Matters, Net
For the three months ended March 31, 2024, charges related to legal matters, net of $94.4 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 us by political subdivisions and Native American tribes across the U.S. Refer to Note 16. Commitments and Contingencies for additional information.
Other Operating Income
Other operating income for the three months ended March 31, 2025 was comprised of income earned from the India Production Linked Incentive Scheme for the Pharmaceutical Sector (the “PLI Scheme”).
Total Other Expense, Net
Total other expense, net for the three months ended March 31, 2025 decreased 3.0% as compared to the prior year period. The decrease was primarily driven by an $8.8 million decrease in interest expense as a result of lower rates and lower amounts outstanding on our variable-rate debt and the favorable impact of foreign exchange, partially offset by an $8.7 million period-over-period increase in our tax receivable agreement liability.
Provision For Income Taxes
For the three months ended March 31, 2025, our provision for income taxes and effective tax rate were $12.9 million and 34.3%, respectively, as compared to $6.2 million and (8.2)%, respectively, for the three months ended March 31, 2024. The period-over-period changes in the provision for income taxes and effective tax rate 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.
Affordable Medicines
The following table sets forth results of operations for our Affordable Medicines segment for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
| Net revenue | $ | 414,708 | $ | 391,294 | $ | 23,414 | 6.0 | % | |||||||||||||||
| Cost of goods sold | 242,633 | 239,922 | 2,711 | 1.1 | % | ||||||||||||||||||
| Gross profit | 172,075 | 151,372 | 20,703 | 13.7 | % | ||||||||||||||||||
| Selling, general and administrative | 33,715 | 33,085 | 630 | 1.9 | % | ||||||||||||||||||
| Research and development | 30,980 | 34,371 | (3,391) | (9.9) | % | ||||||||||||||||||
| Intellectual property legal development expenses | 1,713 | 960 | 753 | 78.4 | % | ||||||||||||||||||
Charges related to legal matters, net | — | 94,359 | (94,359) | (100.0) | % | ||||||||||||||||||
| Other operating income | (5,122) | — | (5,122) | nm | |||||||||||||||||||
Operating income (loss) | $ | 110,789 | $ | (11,403) | $ | 122,192 | nm | ||||||||||||||||
nm - not meaningful
Net Revenue
Affordable Medicines net revenue for the three months ended March 31, 2025 increased 6.0% as compared to the prior year period, primarily due to new products launched in 2025 and 2024, which contributed $40.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
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Cost of Goods Sold and Gross Profit
Affordable Medicines cost of goods sold for the three months ended March 31, 2025 increased 1.1% as compared to the prior year period, primarily due to costs associated with increased sales volume and increased plant and freight costs, partially offset by manufacturing efficiencies.
Affordable Medicines gross profit as a percentage of net revenue increased to 41.5% for the three months ended March 31, 2025 from 38.7% in the prior year period, primarily as a result of the factors noted above.
Selling, General, and Administrative
Affordable Medicines SG&A expense for the three months ended March 31, 2025 increased 1.9% as compared to the prior year period, primarily due to increases in employee compensation and shipping costs.
Research and Development
Affordable Medicines R&D expenses for the three months ended March 31, 2025 decreased 9.9% as compared to the prior year period, primarily due to a decrease in in-licensing and upfront milestone payments of $3.3 million and reduced project spend, partially offset by increases in employee compensation.
Charges Related to Legal Matters, Net
For the three months ended March 31, 2024, charges related to legal matters, net of $94.4 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 us by political subdivisions and Native American tribes across the U.S. Refer to Note 16. Commitments and Contingencies for additional information.
Other Operating Income
Other operating income for the three months ended March 31, 2025 was comprised of income earned from the PLI Scheme.
Specialty
The following table sets forth results of operations for our Specialty segment for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
| Net revenue | $ | 108,297 | $ | 105,234 | $ | 3,063 | 2.9 | % | |||||||||||||||
| Cost of goods sold | 53,083 | 44,800 | 8,283 | 18.5 | % | ||||||||||||||||||
| Gross profit | 55,214 | 60,434 | (5,220) | (8.6) | % | ||||||||||||||||||
| Selling, general and administrative | 30,978 | 25,196 | 5,782 | 22.9 | % | ||||||||||||||||||
| Research and development | 9,060 | 4,927 | 4,133 | 83.9 | % | ||||||||||||||||||
| Intellectual property legal development expenses | 54 | 24 | 30 | nm | |||||||||||||||||||
| Restructuring and other charges | 130 | 946 | (816) | (86.3) | % | ||||||||||||||||||
Other operating expense | — | 100 | (100) | (100.0) | % | ||||||||||||||||||
| Operating income | $ | 14,992 | $ | 29,241 | $ | (14,249) | (48.7) | % | |||||||||||||||
nm - not meaningful
Net Revenue
Specialty net revenue for the three months ended March 31, 2025 increased 2.9% as compared to the prior year period, primarily driven by increases of $9.1 million and $4.0 million in sales of CREXONT® and UNITHROID®, respectively, partially offset by a $5.1 million decline in sales of RYTARY®. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
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Cost of Goods Sold and Gross Profit
Specialty cost of goods sold for the three months ended March 31, 2025 increased 18.5% as compared to the prior year period, primarily due to increases in amortization related to CREXONT® and sales volume.
Specialty gross profit as a percentage of net revenue decreased to 51.0% for the three months ended March 31, 2025 as compared to 57.4% in the prior year period due to the impact of increased amortization related to CREXONT®.
Selling, General, and Administrative
Specialty SG&A expense for the three months ended March 31, 2025 increased 22.9% as compared to the prior year period, primarily due to launch costs associated with CREXONT® and increases in employee compensation.
Research and Development
Specialty R&D expenses for the three months ended March 31, 2025 increased 83.9% as compared to the prior year period, primarily due to increased in-licensing and upfront milestone payments of $3.0 million and higher project spend.
AvKARE
The following table sets forth results of operations for our AvKARE segment for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
| Net revenue | $ | 172,415 | $ | 162,663 | $ | 9,752 | 6.0 | % | |||||||||||||||
| Cost of goods sold | 143,813 | 136,409 | 7,404 | 5.4 | % | ||||||||||||||||||
| Gross profit | 28,602 | 26,254 | 2,348 | 8.9 | % | ||||||||||||||||||
| Selling, general and administrative | 15,694 | 14,907 | 787 | 5.3 | % | ||||||||||||||||||
| Operating income | $ | 12,908 | $ | 11,347 | $ | 1,561 | 13.8 | % | |||||||||||||||
Net Revenue
AvKARE net revenue for the three months ended March 31, 2025 increased 6.0% as compared to the prior year period primarily driven by growth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel.
Cost of Goods Sold and Gross Profit
AvKARE cost of goods sold for the three months ended March 31, 2025 increased 5.4% as compared to the prior year period primarily due to an increased inventory provision and higher sales in our government label channel, partially offset by decreased sales in our lower margin distribution channel.
Gross profit as a percentage of net revenue increased to 16.6% for the three months ended March 31, 2025 from 16.1% in the prior year period, primarily as a result of the factors noted above.
Selling, General and Administrative
AvKARE SG&A expense for the three months ended March 31, 2025 increased 5.3% as compared to the prior year period, primarily due to increases in employee compensation and higher sales-related expenses.
Liquidity and Capital Resources
Our primary source of liquidity is cash generated from operations, available cash on hand, and borrowings under debt financing arrangements (as defined and discussed in Note 15. Debt in our 2024 Annual Report on Form 10-K). As of March 31, 2025, we had access to $305.2 million of available capacity under the Amended New Revolving Credit Facility and $28.0 million of available capacity under the Amended Rondo Revolving Credit Facility. On April 9, 2025, the Company executed an amendment to the Amended Rondo Revolving Credit Facility to increase (i) the borrowing capacity from $70 million to $125.0 million and (ii) the letter of credit commitment from $60 million to $90 million, and extend the maturity to April 9, 2030. We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations,
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including acquisitions, and provide sufficient liquidity over the next 12 months from the date of filing of this Quarterly Report on Form 10-Q. However, our ability to satisfy our working capital requirements and debt obligations will depend upon economic conditions, the impact of international trade policy, including tariffs, our ability to negotiate and maintain satisfactory terms under our borrowing and debt facilities in the future, and demand for our products, which are factors that may be out of our control. Our primary uses of capital resources are to fund operating activities, including R&D expenses associated with new product filings, and pharmaceutical product manufacturing expenses, license payments, spending on production facility expansions, capital equipment, acquisitions, and legal settlements.
We estimate that we will invest approximately $120.0 million during 2025 for capital expenditures to support and grow our existing operations, primarily related to investments in manufacturing equipment, information technology, and facilities. Our 2025 estimate includes capital expenditures for our collaboration and supply agreement with Metsera, Inc. (“Metsera”), of which we expect Metsera to reimburse us approximately $20.0 million. We expect such reimbursements to primarily be included in our cash flows from financing activities.
Debt Instruments
Over the next 12 months, we expect to make substantial payments, including monthly interest and quarterly principal amounts due for our Term Loan Due 2028, monthly interest on our Amended New Credit Facility, and contractual payments for leased premises. Refer to Note 12. Debt in this Quarterly Report on Form 10-Q and Note 15. Debt, Note 17. Leases, and Commitments and Contractual Obligations under Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K for additional information.
Settlement in Principle on Nationwide Civil Prescription Opioid Litigation
In late April 2024, we reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed by Attorneys General, political subdivisions and Native American tribes. Refer to Note 16. Commitments and Contingencies for additional information.
Tax Receivable Agreement
As part of the Reorganization (as defined in Note 1. Nature of Operations in our 2024 Annual Report on Form 10-K), the tax receivable agreement (“TRA”) was amended to reduce our future obligation to pay 85% of the realized tax benefits subject to the TRA to 75% of such realized benefits. As of March 31, 2025, the contingent TRA liability, including the impact of the amendment, was approximately $123.1 million. During the three months ended March 31, 2025, the Company made payments of $3.0 million associated with the TRA.
The timing and amount of any payments under the TRA may vary, depending upon a number of factors including the timing and amount of our taxable income, and the corporate tax rate in effect at the time of realization of our 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 our obligation to make TRA payments in advance of tax benefits being realized. For further information, including our recognized current and long-term liabilities for the TRA, refer to Note 4. Income Taxes in this Quarterly Report on Form 10-Q and Item 1A. Risk Factors and Note 6. Income Taxes in our 2024 Annual Report on Form 10-K.
Tax-Related Distributions
In 2020, we acquired a 65.1% controlling interest in both AvKARE Inc., a Tennessee corporation, now a limited liability company (“AvKARE, LLC”), and Dixon-Shane, LLC d/b/a R&S Northeast LLC, a Kentucky limited liability company (“R&S”). The sellers of AvKARE, LLC and R&S (the “AvKARE Sellers”) hold the remaining 34.9% interest in the holding company that directly owns the acquired companies (“Rondo”). We attribute 34.9% of the net income or loss associated with Rondo to redeemable non-controlling interests. During the three months ended March 31, 2025 and 2024, we made cash tax distributions of $0.1 million and $0.6 million, respectively, to the AvKARE Sellers. During April 2025, we made cash tax distributions of $4.8 million to the AvKARE Sellers.
Development and Supply Agreement
Pursuant to a development and supply agreement with Kashiv Biosciences LLC (“Kashiv”) for a long-acting injectable, we paid Kashiv $10.0 million in February 2025 for the achievement of a regulatory milestone, which was accrued as of December 31, 2024. Refer to Note 23. Related Party Transactions in our Annual Report on Form 10-K for additional information.
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Acquisition of Land From Related Parties
During the second quarter of 2025, we executed an agreement to acquire parcels of land in India from two family members of the Co-Chief Executive Officers. We plan to utilize this land to construct two 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 us, as well as support our collaboration agreement with Metsera, Inc. For additional information related to our 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 our 2024 Annual Report on Form 10-K.
Cash Balances
As of March 31, 2025, our cash and cash equivalents consist of cash on deposit and highly liquid investments. A portion of our cash flows are derived outside the U.S. As a result, we are subject to market risk associated with changes in foreign exchange rates. We maintain cash balances at both U.S. based and foreign country based commercial banks. At various times during the year, our cash balances held in the U.S. may exceed amounts that are insured by the Federal Deposit Insurance Corporation (FDIC). We make our investments in accordance with our investment policy. The primary objectives of our investment policy are liquidity and safety of principal.
Cash Flows
The following table sets forth our summarized, consolidated cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
Net cash provided by (used in): | |||||||||||||||||||||||
| Operating activities | $ | 7,408 | $ | (4,410) | $ | 11,818 | nm | ||||||||||||||||
| Investing activities | (17,798) | (19,760) | 1,962 | (9.9) | % | ||||||||||||||||||
| Financing activities | (39,166) | (23,155) | (16,011) | 69.1 | % | ||||||||||||||||||
| Effect of exchange rate changes on cash | (470) | (165) | (305) | 184.8 | % | ||||||||||||||||||
Net decrease in cash, cash equivalents, and restricted cash | $ | (50,026) | $ | (47,490) | $ | (2,536) | 5.3 | % | |||||||||||||||
nm - not meaningful
Cash Flows from Operating Activities
Net cash provided by operating activities was $7.4 million for the three months ended March 31, 2025 as compared to net cash used in operating activities of $4.4 million in the prior year period. The period-over-period increase was primarily driven by (i) payment of $52.4 million associated with the Opana ER® antitrust litigation settlement during the three months ended March 31, 2024, (ii) higher period-over-period collections of outstanding receivables, and (iii) increased profitability adjusted for non-cash items, partially offset by a decrease in accounts payables due to timing.
Cash Flows from Investing Activities
Net cash used in investing activities for the three months ended March 31, 2025 was $17.8 million as compared to $19.8 million in the prior year period. The period-over-period decrease in net cash used in investing activities was primarily due to a decrease in acquired intangible assets primarily driven by the payment of a sales-based milestone related to a licensing and supply agreement in the prior year period, partially offset by higher capital expenditures.
Cash Flows from Financing Activities
Net cash used in financing activities was $39.2 million for the three months ended March 31, 2025 as compared to $23.2 million in the prior year period. The period-over-period increase in net cash used in financing activities was primarily due to an increase in employee payroll tax withholding on restricted stock unit and performance stock unit vesting.
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Commitments and Contractual Obligations
Our contractual obligations are set forth in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our 2024 Annual Report on Form 10-K. As of March 31, 2025, there have been no material changes to the disclosure presented in our 2024 Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of March 31, 2025.
Critical Accounting Policies and Estimates
For a discussion of our critical accounting policies and estimates, see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K. There have been no material changes to the disclosures presented in our 2024 Annual Report on Form 10-K.
Recently Issued Accounting Standards
Recently issued accounting standards are discussed in Note 1. Summary of Significant Accounting Policies.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There has not been any material change in our assessment of market risk as set forth in Item 7A. Quantitative and Qualitative Disclosures About Market Risk, in our 2024 Annual Report on Form 10-K.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Co-Chief Executive Officers and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our Co-Chief Executive Officers and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, our Co-Chief Executive Officers and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2025.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2025, there were no changes in our internal control over financial reporting which materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Management, including our Co-Chief Executive Officers and Chief Financial Officer, does not expect that our disclosure controls and procedures or our system of internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed or operated, can provide only reasonable, but not absolute, assurance that the objectives of the system of internal control are met. The design of our control system reflects the fact that there are resource constraints, and that the benefits of such control system must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control failures and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the intentional acts of individuals, by collusion of two or more people, or by management override of the controls. The design of any system of controls is also based in part on certain assumptions about the likelihood of future events, and there can be no assurance that the design of any particular control will always succeed in achieving its objective under all potential future conditions.
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Part II – OTHER INFORMATION
Item 1. Legal Proceedings
Information pertaining to legal proceedings can be found in Note 16. Commitments and Contingencies and is incorporated by reference herein.
Item 1A. Risk Factors
There have been no material changes to the disclosures presented in our 2024 Annual Report on Form 10-K under Item 1A. Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
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Item 6. Exhibits
| Exhibit No. | Description of Document | |||||||
| 101 | The following materials from this report, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Statements of Operations, (ii) Consolidated Statements of Comprehensive Loss, (iii) Consolidated Balance Sheets, (iv) Consolidated Statements of Cash Flows, (v) Consolidated Statements of Changes in Stockholders’ (Deficiency) Equity and (vi) Notes to Consolidated Financial Statements.* | |||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |||||||
| * | Filed herewith | |||||||
| ** | This certificate is being furnished solely to accompany the report pursuant to 18 U.S.C. 1350 and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. | |||||||
| † | Denotes management compensatory plan or arrangement. | |||||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Date: May 7, 2025 | Amneal Pharmaceuticals, Inc. | |||||||
| (Registrant) | ||||||||
| By: | /s/ Anastasios Konidaris | |||||||
| Anastasios Konidaris | ||||||||
| Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) | ||||||||
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