QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 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
Amneal Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
93-4225266
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
Amneal Pharmaceuticals, Inc.
400 Crossing Boulevard,Bridgewater, NJ
08807
(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
Class A Common Stock, par value $0.01 per share
AMRX
The Nasdaq Stock Market LLC
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:
Large accelerated filer
☒
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 July 31, 2025, there were 314,079,309 shares of the registrant’s Class A common stock outstanding, with a par value of $0.01.
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;
2
•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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Net revenue
$
724,508
$
701,780
$
1,419,928
$
1,360,971
Cost of goods sold
438,255
451,833
877,784
872,964
Gross profit
286,253
249,947
542,144
488,007
Selling, general and administrative
124,266
116,462
242,554
229,057
Research and development
47,964
36,054
88,004
75,352
Intellectual property legal development expenses
2,017
1,042
3,784
2,026
Restructuring and other charges
1,024
220
1,595
1,690
(Credit) charges related to legal matters, net
(390)
699
(390)
95,058
Other operating (income) expense
—
—
(5,122)
100
Operating income
111,372
95,470
211,719
84,724
Other (expense) income:
Interest expense, net
(65,101)
(65,719)
(122,040)
(131,422)
Foreign exchange gain (loss), net
8,256
(262)
12,503
(1,459)
Increase in tax receivable agreement liability
(4,420)
(13,444)
(15,107)
(15,392)
Other income, net
1,604
4,360
2,122
8,432
Total other expense, net
(59,661)
(75,065)
(122,522)
(139,841)
Income (loss) before income taxes
51,711
20,405
89,197
(55,117)
Provision for income taxes
16,101
3,618
28,969
9,774
Net income (loss)
35,610
16,787
60,228
(64,891)
Less: Net income attributable to non-controlling interests
(13,193)
(10,793)
(25,616)
(20,758)
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
$
22,417
$
5,994
$
34,612
$
(85,649)
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:
Basic
$
0.07
$
0.02
$
0.11
$
(0.28)
Diluted
$
0.07
$
0.02
$
0.11
$
(0.28)
Weighted-average common shares outstanding:
Basic
313,739
309,117
312,404
308,198
Diluted
322,363
318,957
323,171
308,198
The accompanying notes are an integral part of these consolidated financial statements.
4
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Income (Loss)
(unaudited; in thousands)
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Net income (loss)
$
35,610
$
16,787
$
60,228
$
(64,891)
Less: Net income attributable to non-controlling interests
(13,193)
(10,793)
(25,616)
(20,758)
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
22,417
5,994
34,612
(85,649)
Other comprehensive (loss) income:
Foreign currency translation adjustments arising during the period
(4,928)
(39)
(6,560)
(429)
Unrealized (loss) gain on cash flow hedge, net of tax of $0
(7,331)
(170)
(19,485)
15,373
Reclassification of cash flow hedge to earnings, net of tax of $0
568
(6,516)
(5,876)
(13,031)
Other comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc.
(11,691)
(6,725)
(31,921)
1,913
Comprehensive income (loss) attributable to Amneal Pharmaceuticals, Inc.
$
10,726
$
(731)
$
2,691
$
(83,736)
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)
June 30, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
71,544
$
110,552
Restricted cash
9,642
7,868
Trade accounts receivable, net
807,637
775,731
Inventories
608,973
612,454
Prepaid expenses and other current assets
85,304
80,717
Related party receivables
1,592
484
Total current assets
1,584,692
1,587,806
Property, plant and equipment, net
440,327
424,908
Goodwill
597,406
597,436
Intangible assets, net
649,547
732,377
Operating lease right-of-use assets
33,241
31,388
Operating lease right-of-use assets - related party
17,658
10,964
Financing lease right-of-use assets
55,068
56,433
Other assets
44,849
60,133
Total assets
$
3,422,788
$
3,501,445
Liabilities and Stockholders’ Deficiency
Current liabilities:
Accounts payable and accrued expenses
$
666,817
$
735,450
Current portion of liabilities for legal matters
41,515
31,755
Revolving credit facility
290,000
100,000
Current portion of long-term debt, net
31,175
224,213
Current portion of operating lease liabilities
8,223
9,435
Current portion of operating lease liabilities - related party
2,701
3,396
Current portion of financing lease liabilities
3,307
3,211
Related party payables - short term
63,396
22,311
Total current liabilities
1,107,134
1,129,771
Long-term debt, net
2,146,403
2,161,790
Operating lease liabilities
27,623
24,814
Operating lease liabilities - related party
16,441
9,391
Financing lease liabilities
56,020
56,889
Related party payables - long term
15,607
50,900
Liabilities for legal matters - long term
74,477
85,479
Other long-term liabilities
25,814
26,949
Total long-term liabilities
2,362,385
2,416,212
Commitments and contingencies (Notes 3, 16 and 18)
Redeemable non-controlling interests
65,802
64,974
Stockholders’ Deficiency
Preferred stock, $0.01 par value, 2,000 shares authorized at both June 30, 2025 and December 31, 2024; none issued at both June 30, 2025 and December 31, 2024
—
—
Class A common stock, $0.01 par value, 900,000 shares authorized at both June 30, 2025 and December 31, 2024; 314,043 and 309,881 shares issued at June 30, 2025 and December 31, 2024, respectively
3,140
3,099
Class B common stock, $0.01 par value, 300,000 shares authorized at both June 30, 2025 and December 31, 2024; none issued at both June 30, 2025 and December 31, 2024
—
—
Additional paid-in capital
554,623
560,206
Stockholders' accumulated deficit
(572,450)
(607,062)
Accumulated other comprehensive loss
(97,431)
(65,510)
Total Amneal Pharmaceuticals, Inc. stockholders’ deficiency
(112,118)
(109,267)
Non-controlling interests
(415)
(245)
Total stockholders' deficiency
(112,533)
(109,512)
Total liabilities and stockholders’ deficiency
$
3,422,788
$
3,501,445
The accompanying notes are an integral part of these consolidated financial statements.
6
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(unaudited; in thousands)
Six Months Ended June 30,
2025
2024
Cash flows from operating activities:
Net income (loss)
$
60,228
$
(64,891)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization
120,272
111,100
Unrealized foreign currency (gain) loss
(11,813)
2,080
Amortization of debt issuance costs and discount
13,686
14,252
Reclassification of cash flow hedge
(5,876)
(13,031)
Intangible asset impairment charges
—
920
Stock-based compensation
15,532
13,446
Inventory provision
38,432
41,493
Other operating charges and credits, net
2,254
(1,431)
Changes in assets and liabilities:
Trade accounts receivable, net
(32,615)
(155,843)
Inventories
(36,039)
(35,447)
Prepaid expenses, other current assets and other assets
(10,015)
(8,418)
Related party receivables
(1,108)
(628)
Accounts payable, accrued expenses and other liabilities
(67,004)
122,026
Related party payables
5,293
9,619
Net cash provided by operating activities
91,227
35,247
Cash flows from investing activities:
Purchases of property, plant and equipment
(35,992)
(19,824)
Acquisition of intangible assets
(5,100)
(10,450)
Deposits for future acquisition of property, plant and equipment
(4,632)
(940)
Proceeds from sale of property, plant and equipment
1,379
—
Proceeds from sale of subsidiary
—
4,989
Net cash used in investing activities
(44,345)
(26,225)
Cash flows from financing activities:
Payments of principal on debt, revolving credit facilities, financing leases and other
(251,076)
(78,877)
Borrowings on revolving credit facilities
218,000
48,000
Proceeds from exercise of stock options
754
386
Employee payroll tax withholding on restricted stock unit and performance stock unit vesting
(21,828)
(7,371)
Tax and other distributions to non-controlling interests
(24,958)
(8,883)
Payment of principal on notes payable - related party
—
(11,496)
Payments of deferred financing and refinancing costs
(1,745)
—
Net cash used in financing activities
(80,853)
(58,241)
Effect of foreign exchange rate on cash
(777)
(266)
Net decrease in cash, cash equivalents, and restricted cash
(34,748)
(49,485)
Cash, cash equivalents, and restricted cash - beginning of period
118,420
99,107
Cash, cash equivalents, and restricted cash - end of period
$
83,672
$
49,622
Cash and cash equivalents - end of period
$
71,544
$
43,769
Restricted cash - end of period
9,642
5,853
Long-term restricted cash included in other assets - end of period
2,486
—
Cash, cash equivalents, and restricted cash - end of period
$
83,672
$
49,622
The accompanying notes are an integral part of these consolidated financial statements.
7
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows (continued)
(unaudited; in thousands)
Six Months Ended June 30,
2025
2024
Supplemental disclosure of cash flow information:
Cash paid for interest
$
112,643
$
136,541
Cash paid, net for income taxes
$
12,565
$
10,209
Supplemental disclosure of non-cash investing and financing activity:
Payable for acquisition of intangible assets
$
7,000
$
—
Note receivable for sale of subsidiary - related party
$
—
$
7,177
Loan for land purchase - related party
$
502
$
—
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 March 31, 2025
313,385
$
3,134
$
545,806
$
(594,867)
$
(85,740)
$
(333)
$
(132,000)
$
72,611
Net income (loss)
—
—
—
22,417
—
(82)
22,335
13,275
Foreign currency translation adjustments
—
—
—
—
(4,928)
—
(4,928)
—
Stock-based compensation
—
—
8,274
—
—
—
8,274
—
Exercise of stock options
249
2
683
—
—
—
685
—
Restricted stock unit and performance stock unit vesting, net of shares withheld to cover payroll taxes
409
4
(140)
—
—
—
(136)
—
Unrealized loss on cash flow hedge, net of tax of $0
—
—
—
—
(7,331)
—
(7,331)
—
Tax and other distributions, net
—
—
—
—
—
—
—
(20,084)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
—
—
—
568
—
568
—
Balance at June 30, 2025
314,043
$
3,140
$
554,623
$
(572,450)
$
(97,431)
$
(415)
$
(112,533)
$
65,802
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
309,881
$
3,099
$
560,206
$
(607,062)
$
(65,510)
$
(245)
$
(109,512)
$
64,974
Net income (loss)
—
—
—
34,612
—
(170)
34,442
25,786
Foreign currency translation adjustments
—
—
—
—
(6,560)
—
(6,560)
—
Stock-based compensation
—
—
15,532
—
—
—
15,532
—
Exercise of stock options
274
2
752
—
—
—
754
—
Restricted stock unit and performance stock unit vesting, net of shares withheld to cover payroll taxes
3,888
39
(21,867)
—
—
—
(21,828)
—
Unrealized loss on cash flow hedge, net of tax of $0
—
—
—
—
(19,485)
—
(19,485)
—
Tax and other distributions, net
—
—
—
—
—
—
—
(24,958)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
—
—
—
(5,876)
—
(5,876)
—
Balance at June 30, 2025
314,043
$
3,140
$
554,623
$
(572,450)
$
(97,431)
$
(415)
$
(112,533)
$
65,802
The accompanying notes are an integral part of these consolidated financial statements.
9
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 March 31, 2024
308,623
$
3,086
$
538,720
$
(581,819)
$
(23,711)
$
95
$
(63,629)
$
47,022
Net income (loss)
—
—
—
5,994
—
(119)
5,875
10,912
Foreign currency translation adjustments
—
—
—
—
(39)
—
(39)
—
Stock-based compensation
—
—
6,724
—
—
—
6,724
—
Exercise of stock options
129
1
357
—
—
—
358
—
Restricted stock unit vesting, net of shares withheld to cover payroll taxes
747
8
(100)
—
—
—
(92)
—
Unrealized loss on cash flow hedge, net of tax of $0
—
—
—
—
(170)
—
(170)
—
Tax distributions
—
—
—
—
—
—
—
(4,512)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
—
—
—
(6,516)
—
(6,516)
—
Balance at June 30, 2024
309,499
$
3,095
$
545,701
$
(575,825)
$
(30,436)
$
(24)
$
(57,489)
$
53,422
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
306,565
$
3,066
$
539,240
$
(490,176)
$
(32,349)
$
230
$
20,011
$
41,293
Net (loss) income
—
—
—
(85,649)
—
(254)
(85,903)
21,012
Foreign currency translation adjustments
—
—
—
—
(429)
—
(429)
—
Stock-based compensation
—
—
13,446
—
—
—
13,446
—
Exercise of stock options
139
1
385
—
—
—
386
—
Restricted stock unit vesting, net of shares withheld to cover payroll taxes
2,795
28
(7,370)
—
—
—
(7,342)
—
Unrealized gain on cash flow hedge, net of tax of $0
—
—
—
—
15,373
—
15,373
—
Tax distributions, net
—
—
—
—
—
—
—
(8,883)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
—
—
—
(13,031)
—
(13,031)
—
Balance at June 30, 2024
309,499
$
3,095
$
545,701
$
(575,825)
$
(30,436)
$
(24)
$
(57,489)
$
53,422
The accompanying notes are an integral part of these consolidated financial statements.
10
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
The preparation of financial statements requires the Company’s management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, valuation of intangible and other assets acquired in business combinations, allowances for accounts receivable, accrued liabilities, liabilities for legal matters, contingent liabilities, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights and the assessment of expected cash flows used in evaluating goodwill and other long-lived assets for impairment. Actual results could differ from those estimates.
Reclassification
The prior period balance of $0.1 million, formerly included in the caption “change in fair value of contingent consideration” for the six months ended June 30, 2024 has been reclassified to the caption “other operating (income) expense” in the consolidated statements of operations to conform to the current period presentation. This reclassification did not impact operating income or net loss.
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the transparency and usefulness of income tax disclosures. ASU 2023-09 requires that public business entities on an annual basis disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain categories of expenses that are included in expense captions on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning December 15, 2027, with early adoption permitted. Upon adoption, ASU 2024-03 may be applied prospectively for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
11
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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Customer A
23
%
22
%
23
%
21
%
Customer B
16
%
16
%
16
%
15
%
Customer C
21
%
22
%
21
%
22
%
Disaggregated Revenue
During the fourth quarter of 2024, the Company changed the presentation of disaggregated net revenue in its Affordable Medicines segment from a classification primarily based on significant therapeutic classes to a classification primarily based on significant dosage forms to reflect the full product offering of the segment. The new presentation did not change the composition of the Company’s reportable segments and, therefore, did not change historical total net revenue in any segment. All prior periods were changed to conform to the current period’s presentation.
The Company’s significant dosage forms for its Affordable Medicines segment, therapeutic classes for its Specialty segment and sales channels for its AvKARE segment, as determined based on net revenue for the three and six months ended June 30, 2025 and 2024, are set forth below (in thousands):
12
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Affordable Medicines
Oral solid
$
178,262
$
175,956
$
357,215
$
345,269
Auto-Injector
66,594
58,281
114,754
100,899
Transdermal
40,710
49,697
83,773
90,222
Injectable
34,646
39,081
69,434
74,303
Biosimilar
25,248
29,500
53,788
56,192
Oral liquid
17,879
24,096
41,427
56,025
Other dosage forms (1)
68,185
49,287
124,607
92,561
Subtotal dosage forms
431,524
425,898
844,998
815,471
International
1,901
1,430
3,135
3,151
Total Affordable Medicines Revenue
433,425
427,328
848,133
818,622
Specialty
Hormonal / allergy
35,418
31,775
69,617
61,150
Central nervous system
83,425
63,906
151,035
130,182
Other therapeutic classes
8,700
8,360
15,188
13,464
Subtotal therapeutic classes
127,543
104,041
235,840
204,796
License agreement(2)
500
—
500
4,479
Total Specialty net revenue
128,043
104,041
236,340
209,275
AvKARE
Distribution
99,663
116,135
204,558
225,848
Government label
45,418
36,210
95,558
71,162
Institutional
10,132
11,768
21,141
22,626
Other
7,827
6,298
14,198
13,438
Total AvKARE net revenue
163,040
170,411
335,455
333,074
Total net revenue
$
724,508
$
701,780
$
1,419,928
$
1,360,971
(1)Includes net revenue from sales of transmucosal, ophthalmic, topical, nasal and inhalation dosage forms.
(2)Refer to Note 5. Alliance and Collaboration in the Company’s 2024 Annual Report on Form 10-K for information about revenue recognized under license agreements for the three and six months ended June 30, 2024. Revenue recognized under license agreements for the three and six months ended June 30, 2025 was not material.
A rollforward of the major categories of sales-related deductions for the six months ended June 30, 2025 is as follows (in thousands):
Contract Charge - Backs and Sales Volume Allowances
Cash Discount Allowances
Accrued Returns Allowance
Accrued Medicaid and Commercial Rebates
Balance at December 31, 2024
$
498,537
$
25,968
$
160,490
$
135,488
Provision related to sales recorded in the period
1,930,680
65,110
37,504
133,909
Credits/payments issued during the period
(1,930,660)
(62,648)
(37,691)
(151,947)
Balance at June 30, 2025
$
498,557
$
28,430
$
160,303
$
117,450
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.
13
These agreements generally obligate the Company to provide research and development (“R&D”) services over multiple periods.
Except as disclosed below, as of and for the three and six months ended June 30, 2025, there were no material changes to our alliance and collaboration agreements as described in Note 5. Alliance and Collaboration in our2024 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 and six months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
Partner
Caption in Statement of Operations
2025
2024
2025
2024
Orion Corporation
Research and development (1)
$
(912)
$
(683)
$
(2,524)
$
(1,294)
Zambon Biotech S.A.
Net revenue (2)
$
—
$
—
$
—
$
3,479
Knight Therapeutics International S.A.
Net revenue (3)
$
—
$
—
$
—
$
1,000
mAbxience S.L.
Research and development (4)
$
—
$
—
$
—
$
3,000
Metsera, Inc.
Net revenue(5)
$
1,973
$
—
$
1,973
$
—
(1)Services performed for Orion Corporation on a cost basis are recorded as a reduction to R&D expense.
(2)Delivery of a functional license (out-licensing revenue).
(3)Non-refundable license fee.
(4)Clinical milestone payment.
(5)Development activities performed on behalf of Metsera, Inc. on a cost plus margin basis are recorded as net revenue.
The following table summarizes the balances in the Company’s consolidated balance sheets related to alliance and collaboration agreements as of June 30, 2025 and December 31, 2024 (in thousands):
Party
Caption in Balance Sheet
June 30, 2025
December 31, 2024
Orion Corporation
Accounts payable and accrued expenses (1)
$
5,071
$
5,008
Orion Corporation
Other long-term liabilities (1)
$
1,624
$
3,453
Zambon Biotech S.A.
Other long-term liabilities (1)
$
2,530
$
2,530
Metsera, Inc.
Prepaid expenses and other current assets (2)
$
1,973
$
335
Metsera, Inc.
Other long-term liabilities (3)
$
1,557
$
—
(1)Comprised of deferred income as of June 30, 2025 and December 31, 2024.
(2)Comprised primarily of unbilled receivables for R&D services performed as of December 31, 2024.
(3)Comprised of construction costs contributed.
ApiJect Systems Collaboration Agreement
On May 8, 2025, the Company entered into a 15-year strategic collaboration agreement with ApiJect Systems, Corp. and related entities (“ApiJect”), a medical technology company focused on advanced drug delivery (“ApiJect Agreement”). Under the ApiJect Agreement, Amneal will install and operate manufacturing equipment leased from Apiject at the Company’s Brookhaven, New York facility. This equipment will be used to support production of ApiJect’s proprietary blow fill seal (“BFS”) delivery systems and Amneal’s growing injectable portfolio.
The Company concluded the agreement contains a financing lease pursuant to Accounting Standards Codification Topic 842, Leases. The lease will commence on the date the equipment is available for Amneal’s use, which is expected to be in the second half of 2025. During the lease term, the Company shall pay ApiJect a low-digit royalty for any of Amneal’s commercial products that are manufactured utilizing the equipment, which will be accounted for as variable lease payments. At the conclusion of the ApiJect Agreement, the Company has the right to purchase the equipment from ApiJect for a nominal amount. Amneal and ApiJect will also collaborate on the development of additional injectable product programs utilizing ApiJect’s BFS platform. The Company is entitled to receive consideration from ApiJect for development work performed under these programs.
The ApiJect Agreement did not have a material impact on the Company’s financial statements as of and for the three and six months ended June 30, 2025.
14
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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Provision for income taxes
$
16,101
$
3,618
$
28,969
$
9,774
Effective tax rate
31.1
%
17.7
%
32.5
%
(17.7)
%
For the three and six months ended June 30, 2025, the period-over-period change in the provision for income taxes was primarily related to differences in jurisdictional mix of income, the utilization of net operating losses in the prior period and discrete items related to share-based compensation in the current period.
Tax Receivable Agreement
The following table summarizes the Company’s tax receivable agreement (“TRA”) (in thousands)
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Increase in tax receivable agreement liability
$
4,420
$
13,444
$
15,107
$
15,392
June 30, 2025
December 31, 2024
Tax receivable agreement liability- short term
$
50,900
$
2,985
Tax receivable agreement liability- long term
15,107
50,900
Total
$
66,007
$
53,885
Refer to Note 6. Income Taxes in the Company’s 2024 Annual Report on Form 10-K for information about the Company’s TRA. During the six months ended June 30, 2025, the Company made payments of $3.0 million, associated with the TRA.
Contingent Tax Receivable Agreement Liability
The Company had an unrecorded contingent TRA liability of $118.7 million as of June 30, 2025. If utilization of the Company’s deferred tax assets becomes more-likely-than-not in the future, at such time, the unrecorded contingent TRA liability will be recorded through charges in the Company’s consolidated statements of operations.
15
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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Numerator:
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
$
22,417
$
5,994
$
34,612
$
(85,649)
Denominator:
Weighted-average shares outstanding - basic
313,739
309,117
312,404
308,198
Effect of dilutive securities:
Stock options
964
1,095
1,031
—
Restricted stock units
3,155
4,522
4,390
—
Performance stock units
4,505
4,223
5,346
—
Weighted-average shares outstanding - diluted
322,363
318,957
323,171
308,198
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:
Basic
$
0.07
$
0.02
$
0.11
$
(0.28)
Diluted
$
0.07
$
0.02
$
0.11
$
(0.28)
The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of Class A common stock (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Stock options
347
(1)
347
(1)
347
(1)
2,277
(3)
Restricted stock units
—
—
—
10,207
(3)
Performance stock units
1,953
(2)
2,871
(2)
1,953
(2)
7,639
(3)
(1)Excluded from the computation of diluted earnings per share of Class A common stock because the exercise price of the stock options exceeded the average market price of the Class A common stock during the period (out-of-the-money).
(2)Excluded from the computation of diluted earnings per share of Class A common stock because the performance vesting conditions were not met during the period.
(3)Excluded from the computation of diluted loss per share of Class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period.
6. Trade Accounts Receivable, Net
Trade accounts receivable, net was comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Gross accounts receivable
$
1,338,536
$
1,303,788
Allowance for credit losses
(3,912)
(3,552)
Contract charge-backs and sales volume allowances
(498,557)
(498,537)
Cash discount allowances
(28,430)
(25,968)
Subtotal
(530,899)
(528,057)
Trade accounts receivable, net
$
807,637
$
775,731
16
Concentration of Receivables
Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
June 30, 2025
December 31, 2024
Customer A
34
%
37
%
Customer B
25
%
21
%
Customer C
27
%
29
%
7. Inventories
Inventories were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Raw materials
$
211,203
$
207,697
Work in process
55,096
52,835
Finished goods
342,674
351,922
Total inventories
$
608,973
$
612,454
8. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Deposits and advances
$
3,738
$
1,868
Prepaid insurance
6,168
8,264
Prepaid regulatory fees
2,319
6,958
Income and other tax receivables
17,594
16,829
Prepaid taxes
5,489
7,516
Other current receivables
16,327
9,142
Chargebacks receivable
6,115
6,378
Other prepaid assets
27,554
23,762
Total prepaid expenses and other current assets
$
85,304
$
80,717
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
$
162,852
$
366,312
$
69,465
$
598,629
Currency translation
(1,193)
—
—
(1,193)
Balance as of December 31, 2024
161,659
366,312
69,465
597,436
Currency translation
(30)
—
—
(30)
Balance as of June 30, 2025
$
161,629
$
366,312
$
69,465
$
597,406
17
Intangible assets as of June 30, 2025 and December 31, 2024 were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Weighted-Average Amortization Period (in years)
Cost
Accumulated Amortization
Net
Cost
Accumulated Amortization
Net
Amortizing intangible assets:
Product rights
6.7
$
1,564,668
$
(942,244)
$
622,424
$
1,550,469
$
(856,914)
$
693,555
Other intangible assets
2.2
83,200
(64,177)
19,023
83,200
(58,678)
24,522
Subtotal
1,647,868
(1,006,421)
641,447
1,633,669
(915,592)
718,077
In-process research and development
8,100
—
8,100
14,300
—
14,300
Total intangible assets
$
1,655,968
$
(1,006,421)
$
649,547
$
1,647,969
$
(915,592)
$
732,377
Amortization expense related to intangible assets for the three months ended June 30, 2025 and 2024 was $45.8 million and $40.1 million, respectively. Amortization expense related to intangible assets for the six months ended June 30, 2025 and 2024 was $91.0 million and $80.0 million, respectively.
The Company reviews intangible assets with finite lives for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. Indefinite-lived intangible assets, including in-process research and development intangible assets, are tested for impairment if impairment indicators arise and, at a minimum, annually. Intangible asset impairments were immaterial for the three and six months ended June 30, 2024 (none for the three and six months ended June 30, 2025).
10. Other Assets
Other assets were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Interest rate swap (1)
$
16,436
$
35,921
Security deposits
4,013
3,752
Long-term prepaid expenses
12,269
12,362
Deferred revolving credit facility costs
3,820
2,820
Long-term restricted cash
2,486
—
Other long term assets
5,825
5,278
Total other assets
$
44,849
$
60,133
(1)Refer to Note 14. Fair Value Measurements and Note 15. Financial Instruments for information about the Company’s interest rate swap.
18
11. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Accounts payable
$
205,812
$
258,691
Accrued returns allowance (1)
160,303
160,490
Accrued compensation
57,012
72,959
Accrued Medicaid and commercial rebates (1)
117,450
135,488
Accrued royalties
23,851
23,687
Commercial chargebacks and rebates
10,226
10,226
Accrued professional fees
14,441
17,339
Accrued other
77,722
56,570
Total accounts payable and accrued expenses
$
666,817
$
735,450
(1)Refer to Note 2. Revenue Recognition for a rollforward of the balance from December 31, 2024 to June 30, 2025.
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):
June 30, 2025
December 31, 2024
Term Loan Due 2025
$
—
$
191,979
Term Loan Due 2028
2,263,460
2,292,856
Total debt
2,263,460
2,484,835
Less: debt issuance costs
(85,882)
(98,832)
Total debt, net of debt issuance costs
2,177,578
2,386,003
Less: current portion of long-term debt
(31,175)
(224,213)
Total long-term debt, net
$
2,146,403
$
2,161,790
Term Loan Due 2025
In January 2025, the Company paid the entire remaining principal balance of $192.0 million then outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. As of June 30, 2025 and December 31, 2024, $290.0 million and $100.0 million, respectively, were outstanding on the Amended New Revolving Credit Facility.
Rondo Revolving Credit Facility
On April 9, 2025, the Company executed an amendment to the Rondo Revolving Credit Facility (“Amended Rondo Revolving Credit Facility”) that, among other things, (i) increased the aggregate revolving commitment from $70 million to $125 million, (ii) increased the letter of credit commitment from $60 million to $90 million, and (iii) extended the maturity to April 9, 2030. The Amended Rondo Credit Facility bears a variable annual interest rate of one-month adjusted term SOFR, subject to a floor of 0.1% plus 2.00%. The annual interest rate for borrowings may be reduced or increased by 0.25% based on step-downs and step-ups determined by the total net leverage ratio, as defined in that agreement.
In addition, a commitment fee based on the average daily unused amount of the Amended Rondo Revolving Credit Facility is assessed at a rate based on total net leverage ratio, between 0.25% and 0.50% per annum.
19
In connection with this amendment, the Company incurred costs of $1.7 million associated with the Amended Rondo Revolving Credit Facility, which were capitalized and will be amortized over the life of the Amended Rondo Revolving Credit Facility.
13. Other Long-Term Liabilities
Other long-term liabilities were comprised of the following (in thousands):
June 30, 2025
December 31, 2024
Uncertain tax positions
$
524
$
1,252
Long-term compensation
17,095
17,125
Other long-term liabilities
8,195
8,572
Total other long-term liabilities
$
25,814
$
26,949
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 June 30, 2025 and December 31, 2024 (in thousands):
Fair Value Measurement Based on
June 30, 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)
$
16,436
$
—
$
16,436
$
—
December 31, 2024
Assets
Interest rate swap (1)
$
35,921
$
—
$
35,921
$
—
(1)The fair value measurement of the Company’s interest rate swap classified within Level 2 of the fair value hierarchy is a model-derived valuation as of a given date in which all significant inputs are observable in active markets including certain financial information and certain assumptions regarding past, present, and future market conditions. Refer to Note 15. Financial Instruments for information on the Company’s interest rate swap.
There were no transfers between levels in the fair value hierarchy during the six months ended June 30, 2025.
Assets and Liabilities Not Measured at Fair Value on a Recurring Basis
The carrying amounts of cash, accounts receivable and accounts payable approximate their fair values due to the short-term maturity of these instruments.
The following is a summary of the Company’s indebtedness at fair value (in thousands):
June 30, 2025
December 31, 2024
Term Loan Due 2025
$
—
$
192,579
Term Loan Due 2028
$
2,305,900
$
2,364,508
The Term Loan Due 2025 and Term Loan Due 2028 are each in the Level 2 category within the fair value level hierarchy. The fair values were determined using market data for valuation.
20
Refer to Note 15. Debt in the Company’s 2024 Annual Report on Form 10-K for detailed information about its indebtedness, including definitions of terms.
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
There were no non-recurring fair value measurements during the six months ended June 30, 2025 and 2024.
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 and six months ended June 30, 2025, the Company reclassified a net loss of $0.6 million (increase in interest expense, net) and net gain of $5.9 million (decrease in interest expense, net), respectively, from accumulated other comprehensive loss. Approximately $19.2 million of net losses included in accumulated other comprehensive loss as of June 30, 2025 are expected to be reclassified into earnings within the next 12 months as interest payments are made on the Company’s Term Loan Due 2028 and amortization of the amounts included in accumulated other comprehensive loss occurs.
As of June 30, 2025, the total loss, net of income taxes of $0, related to the Company’s cash flow hedge of $19.0 million, was recognized in accumulated other comprehensive loss. Refer to Note 17. Stockholders’ Deficiency in this Quarterly Report on Form 10-Q andNote 19. Financial Instruments in our Annual Report on Form 10-K for additional information.
A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands):
June 30, 2025
December 31, 2024
Derivatives Designated as Hedging Instruments
Balance Sheet Classification
Fair Value
Balance Sheet Classification
Fair Value
Variable-to-fixed interest rate swap
Other Assets
$
16,436
Other Assets
$
35,921
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.
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.
21
For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized.
For the six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the U.S. (refer to the section Civil Prescription Opioid Litigation below). (Credit) charges related to legal matters, net for all other periods presented were immaterial.
Liabilities for legal matters were comprised of the following (in thousands):
Matter
June 30, 2025
December 31, 2024
Civil prescription opioid litigation
$
40,006
$
29,671
Other
1,509
2,084
Current portion of liabilities for legal matters
$
41,515
$
31,755
Civil prescription opioid litigation (Liabilities for legal matters - long term)
$
74,477
$
85,479
Refer to the respective discussions below for information about the significant matters summarized above.
Refer to Note 20.Commitments and Contingencies in our Annual Report on Form 10-K for a general discussion of Medicaid Reimbursement and Price Reporting Matters and Patent Litigation.
Other Litigation Related to the Company’s Business
United States Department of Justice Investigations
On May 15, 2023, Amneal Pharmaceuticals LLC (“Amneal”) received a Civil Investigative Demand (“CID”) from the Civil Division of the United States Department of Justice (the “Civil Division”) requesting information and documents related to the manufacturing and shipping of diclofenac sodium 1% gel labeled as “prescription only” after the reference listed drug’s label was converted to over-the-counter. In October 2024, the Company received supplemental CIDs seeking additional information related to the same subject matter. The Company is continuing to cooperate with the Civil Division’s investigation. However, no assurance can be given as to the timing or outcome of the investigation.
In Re Generic Pharmaceuticals Pricing Antitrust Litigation
Beginning in March 2016, various purchasers of generic drugs filed multiple putative antitrust class action complaints against a substantial number of generic pharmaceutical manufacturers, including the Company and Impax Laboratories, Inc. (“Impax”), alleging an illegal conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers. They seek unspecified monetary damages and equitable relief, including disgorgement and restitution. Most of these lawsuits were consolidated in the United States District Court for the Eastern District of Pennsylvania (See In re Generic Pharmaceuticals Pricing Antitrust Litigation, No. 2724 (E.D. Pa.)). Some purchasers have brought similar lawsuits in state courts in Pennsylvania, Connecticut, and New York.
22
In 2019 and 2020, Attorneys General of 43 States and the Commonwealth of Puerto Rico named the Company in two complaints alleging a similar conspiracy and seeking similar damages. These cases are pending in the District of Connecticut. See Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al., 3:19-cv-00710-MPS and Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MPS.
In these matters, the Company and Impax have filed various motions to dismiss, some of which remain pending. Fact discovery is underway in MDL No. 2724 and in one of the State Attorneys General cases naming the Company as a defendant, Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al.. In the other, Connecticut, et al. v. Sandoz, Inc. et al., defendants’ joint motions for summary judgement were fully briefed on April 7, 2025, and defendant-specific motions for summary judgement were filed on July 9, 2025.
Trials for the first multi-district litigation (“MDL”) cases chosen for bellwether treatment, none of which name the Company or Impax as defendants, have been stayed pending the Third Circuit’s review of the MDL court’s class certification decision. The MDL court has chosen a second round of MDL cases for bellwether treatment, one of which names Impax as a defendant. No scheduling orders have been set.
Civil Prescription Opioid Litigation
The Company is named in over 900 state and federal cases relating to the sale of prescription opioid pain relievers. Plaintiffs are political subdivisions, schools, hospitals, Native American tribes, pension funds, third-party payors, and individuals. Nearly all federal court cases are consolidated for pre-trial proceedings in Case No. 17-mdl-2804 (N.D. Ohio). The Company also is named in state court cases pending in seven 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. In April 2025, the Company finalized documentation for the nationwide resolution, which is contingent upon reaching sufficient participation from state Attorneys General, political subdivisions, and Native American tribes. In June 2025, the Company confirmed participation from all state Attorneys General and territorial Attorneys General. The process for political subdivision and Native American tribe participation is ongoing.
As of March 31, 2024, the Company concluded the loss related to the opioid litigation was probable, and the related loss was reasonably estimable considering the settlement in principle. As a result, the Company recorded a charge of $94.4 million associated with the settlement in principle during the three months ended March 31, 2024, to increase the liability as of March 31, 2024 to $115.6 million. The liability as of June 30, 2025 was $114.5 million, of which $74.5 million was classified as long-term. While this liability has been deemed reasonable by the Company’s management, it could significantly change as the definitive settlement agreement is finalized. As of December 31, 2024, the Company had a liability of $115.2 million related to its prescription opioid litigation, of which $85.5 million was classified as long-term. For the remaining cases not covered by the settlement in principle, primarily brought by other hospitals, schools and individuals, the Company has not recorded a liability as of June 30, 2025 or December 31, 2024, because it concluded that a loss was not probable and estimable.
United States Department of Justice / Drug Enforcement Administration Subpoenas
On July 7, 2017, Amneal Pharmaceuticals of New York, LLC received an administrative subpoena issued by the Long Island, NY District Office of the Drug Enforcement Administration (the “DEA”) requesting information related to compliance with certain recordkeeping and reporting requirements. On or about April 12, 2019 and May 28, 2019, the Company received grand jury subpoenas from the U.S. Attorney’s Office for the Eastern District of New York (the “USAO”) relating to similar topics concerning the Company’s suspicious order monitoring program and its compliance with the Controlled Substances Act. The Company is cooperating with the USAO in responding to the subpoenas. The Company has entered into a tolling agreement with respect to potential criminal charges through November 15, 2025. The Company entered into a tolling agreement with the
23
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 October 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. 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, LLCet al., No. 2:23-cv-22902 (D.N.J.) as standalone actions. Defendants filed a motion to dismiss the Fourth Amended Complaint. Plaintiffs’ response in opposition was filed on April 7, 2025 and defendants’ reply was filed on April 22, 2025.
On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of valsartan, losartan, and metformin based on the alleged presence of nitrosamines in those products. The only allegations against the Company concern metformin (See Davis v. Camber Pharmaceuticals, Inc., et al., C.A. No. 2:21-00254 (M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the United States Judicial Panel on Multidistrict Litigation transferred the Davis Action into the In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation MDL for pretrial proceedings.
UFCW Local 1500 Welfare Fund v. Takeda Pharmaceuticals U.S.A., Inc.
On November 14, 2023, UFCW Local 1500 Welfare Fund and other health plans filed a purported class action lawsuit in the United States District Court for the Southern District of New York against multiple manufacturers, including the Company, alleging an illegal conspiracy to restrict output of generic COLCRYS®. See UFCW Local 1500 Welfare Fund et al. v. Takeda Pharma. U.S.A., Inc. et al, No. 1:23-cv-10030 (S.D.N.Y.). On February 28, 2024, Takeda Pharmaceuticals U.S.A., Inc. filed a motion to transfer the case to the United States District Court for the Eastern District of Pennsylvania. On March 13, 2024 and
24
March 27, 2024, Amneal submitted a letter and brief, respectively, informing the Court of its position that the Eastern District of Pennsylvania lacks personal jurisdiction over Amneal. That motion remains pending and the deadline to respond to the complaint is set at 45 days after the court resolves the motion to transfer.
Indian Tax Authority Matters
Amneal Pharmaceuticals Pvt. Ltd. and RAKS Pharmaceuticals Pvt. Ltd., which are subsidiaries of the Company, are currently involved in litigations with Indian tax authorities concerning Central Excise Tax, Service Tax, Goods & Services Tax, and Value Added Tax for various periods of time between 2014 and 2017. These subsidiaries have contested certain of these assessments, which are at various stages of the administrative process. The Company strongly believes its Indian subsidiaries have meritorious defenses in the matter.
Guaifenesin Litigation
On September 5, 2024, Amneal was named as a defendant along with CVS Pharmacy, Inc. (“CVS”) in a putative consumer class action lawsuit in the United States District Court for the Northern District of California alleging that generic guaifenesin products manufactured by Amneal contain benzene through the use of carbomer, an inactive ingredient. See Leonard v. CVS Pharmacy, Inc., No. 5:24-cv-06280 (N.D. Cal.). The complaint purports to plead, on behalf of a nationwide class and California subclass, the following counts: breach of warranty; unjust enrichment; fraud; and violation of California’s Unfair Competition Law. The complaint seeks damages, including punitive damages, restitution, other equitable monetary relief, injunctive relief, prejudgment interest and attorneys’ fees and costs. On December 30, 2024, the Company and CVS jointly filed a motion to dismiss. On January 21, 2025, in lieu of filing a response to defendants’ motion to dismiss, plaintiff filed an amended complaint. Defendants’ motion to dismiss the amended complaint was filed on February 20, 2025, plaintiff filed her response to the motion to dismiss on March 24, 2025, and defendants filed their reply on April 14, 2025. That motion is fully briefed, and the Court notified the parties that it will take the motion under submission without oral argument.
Amneal Pharmaceuticals LLC et al. v. Sandoz Inc.
On November 25, 2024, the Company and Impax Laboratories, LLC received a notice letter from Sandoz Inc. (“Sandoz”) stating that it had filed an ANDA with the U.S. Food and Drug Administration (“FDA”) seeking approval to market generic versions of CREXONT®, an extended-release oral capsule formulation of carbidopa and levodopa for the treatment of Parkinson’s disease. The notice letter included a Paragraph IV certification alleging that certain patents covering CREXONT® are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of Sandoz’s generic product.
In response to this notice letter, on January 7, 2025, the Company and Impax Laboratories, LLC filed a patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, Case Nos. 3:25-cv-00181-GC-TJB and 2:25-11981. On April 1, 2025, the Company and Impax Laboratories, LLC filed a First Amended Complaint in response to a second notice letter from Sandoz, adding claims for infringement of additional patents. On April 14, 2025, Sandoz filed an Answer, Affirmative Defense, and Counterclaims for non-infringement and invalidity of the asserted patents. This lawsuit is currently in discovery. The filing of this lawsuit triggered a 30-month stay of FDA approval of the Sandoz ANDA from the date of receipt of the notice letter. CREXONT® is also subject to a regulatory exclusivity until August 7, 2027.
On June 20, 2025, the Company and Impax Laboratories, LLC filed a new patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, captioned Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 2:25-11981, in response to a third notice letter from Sandoz relating to CREXONT®. This lawsuit is in its initial pleadings stage.
Carickhoff v. Amneal Pharmaceuticals, Inc., et al.
On May 7, 2025, the Liquidating Trustee on Behalf of the Vyera Liquidating Trust Established Under the Subchapter V Plan of Reorganization of debtors Vyera Pharmaceuticals, LLC and Phoenixus AG filed an adversary proceeding in the United States Bankruptcy Court for the District of Delaware against the Company and Impax Laboratories, LLC, seeking to recover approximately $55.4 million in allegedly fraudulent transfers made by the debtors to Impax Laboratories, LLC to purchase the drug Daraprim in 2015. (See Carickhoff v. Amneal Pharmaceuticals, Inc, et al., Adv. Pro. No. 25-50903-JKS (Bankr. D. Del.)). The deadline to respond to the trustee’s Complaint is September 9, 2025.
25
17. Stockholders’ (Deficiency) Equity
Refer to Note 21. Stockholders’ (Deficiency) Equity in our 2024 Annual Report on Form 10-K for additional information.
Changes in Accumulated Other Comprehensive Loss by Component (in thousands):
Foreign currency translation adjustments
Unrealized gain (loss) on cash
flow hedge, net
of tax
Accumulated
other
comprehensive loss
Balance December 31, 2024
$
(71,860)
$
6,350
$
(65,510)
Other comprehensive loss before reclassification
(6,560)
(19,485)
(26,045)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
(5,876)
(5,876)
Balance June 30, 2025
$
(78,420)
$
(19,011)
$
(97,431)
Balance December 31, 2023
$
(66,072)
$
33,723
$
(32,349)
Other comprehensive (loss) income before reclassification
(429)
15,373
14,944
Reclassification of cash flow hedge to earnings, net of tax of $0
—
(13,031)
(13,031)
Balance June 30, 2024
$
(66,501)
$
36,065
$
(30,436)
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 and six months ended June 30, 2025, there were no material changes to our related party agreements or relationships as described in Note 23. Related Party Transactions and Note 21. Stockholders’ (Deficiency) Equity in our2024 Annual Report on Form 10-K.
26
The following table summarizes the Company’s related party transactions (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
Related Party and Nature of Transaction
Caption in Balance Sheet and Statement of Operations
2025
2024
2025
2024
Kashiv Biosciences LLC
Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko and Fylnetra)
Cost of goods sold
$
3,564
$
4,194
$
7,795
$
8,720
Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko and Fylnetra)
Inventory and cost of goods sold
$
1,293
$
2,426
$
5,616
$
3,642
Development and commercialization agreement - Pegfilgrastim Auto Injector - milestone
Research and development
$
3,000
$
—
$
3,000
$
—
Development and commercialization agreement - Carfilzomib
Research and development
$
2,000
$
—
$
2,000
$
—
Parking space lease
Research and development
$
—
$
25
$
25
$
50
Development and commercialization agreement - long-acting injectable
Research and development
$
—
$
—
$
—
$
500
Generic development supply agreement - research and development material
Research and development
$
—
$
—
$
—
$
(48)
Sale of subsidiary - interest income on loan receivable
Interest expense, net
$
—
$
(132)
$
—
$
(132)
Sale of subsidiary - gain on sale
Other income, net
$
—
$
(3,760)
$
—
$
(3,760)
Generic development supply agreement - development activity deferred income
Accounts payable and accrued expenses
$
—
$
—
$
(103)
$
(422)
Storage agreement
Research and development
$
(71)
$
(49)
$
(118)
$
(126)
Other Related Parties
Members - tax receivable agreement (TRA liability)
Land purchase from family members of the Co-Chief Executive Officers
Property, plant and equipment
$
11,289
$
—
$
11,289
$
—
Ellodi Pharmaceuticals, L.P. - securities purchase and license and collaboration agreements
Research and development
$
1,438
$
—
$
5,708
$
—
Kanan, LLC - operating lease
Inventory and cost of goods sold
$
592
$
592
$
1,184
$
1,184
Sutaria Family Realty, LLC - operating lease
Inventory and cost of goods sold
$
330
$
324
$
654
$
638
Tracy Properties LLC - operating lease
Selling, general and administrative
$
149
$
221
$
326
$
364
AzaTech Pharma LLC - supply agreement
Inventory and cost of goods sold
$
10
$
2,933
$
2,327
$
5,245
R&S Solutions - equipment purchase
Property, plant and equipment
$
—
$
—
$
160
$
—
Avtar Investments, LLC - consulting services
Research and development
$
60
$
60
$
120
$
129
AvPROP, LLC - operating lease
Selling, general and administrative
$
51
$
50
$
104
$
94
Alkermes Plc
Inventory and cost of goods sold
$
(28)
$
94
$
64
$
106
27
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
June 30, 2025
December 31, 2024
AzaTech Pharma LLC - supply agreement
$
1,130
$
21
Kashiv - various agreements
420
447
Alkermes
42
16
Related party receivables - short term
$
1,592
$
484
Members - tax receivable agreement
$
50,900
$
2,985
Kashiv - various agreements
7,375
16,908
Apace Packaging, LLC - packaging agreement
2,099
1,205
Ellodi Pharmaceuticals, L.P.
1,752
—
AzaTech Pharma LLC - supply agreement
1,170
1,151
Avtar Investments LLC - consulting services
100
60
Alkermes Plc
—
2
Related party payables - short term
$
63,396
$
22,311
Members - tax receivable agreement
$
15,107
$
50,900
Land purchase from family members of the Co-Chief Executive Officers
500
—
Related party payables - long term
$
15,607
$
50,900
Equipment Purchases
The Company purchased $0.2 million of equipment from R&S Solutions LLC during the six months ended June 30, 2025, which is included in property, plant and equipment in the Company’s consolidated balance sheets. A member of Company management beneficially owns equity securities of R&S Solutions LLC.
Securities Purchase Agreement and License and Collaboration Agreement
On January 3, 2025, the Company entered into a securities purchase agreement and a license and collaboration agreement with Ellodi Pharmaceuticals, L.P. (“Ellodi”) and certain entities affiliated with TPG for which the Company paid $3.0 million for limited liability partnership units of Ellodi and committed to fund certain research and development expenses. Ellodi is a pre-clinical gastroenterology-focused specialty pharmaceutical company. An observer of our Board is a partner in TPG Capital and a board director of Ellodi. During the three and six ended June 30, 2025, the Company recorded research and development expense of $1.4 million and $5.7 million, respectively, related to these agreements, including a $1.4 million and $2.7 million estimate for funding the research and development commitment, respectively. As of June 30, 2025, the Company has a remaining liability of $1.8 million associated with these agreements.
Amneal has the option to obtain, under certain conditions, an exclusive royalty bearing and sub-licensable world-wide license to a late-stage gastroenterology-focused pipeline product under development. If exercised, the Company will be responsible for remaining development activities and obtaining regulatory approval of the product. The license and collaboration agreement provides for potential future milestone payments to Ellodi for regulatory and commercial milestones of up to $48.5 million and royalties on commercial sales.
Acquisition of Land From Related Parties
On April 18, 2025, the Company executed an agreement to acquire parcels of land in India 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 $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.
28
Kashiv Biosciences LLC Development Supply Agreement
In December 2022, Amneal and Kashiv entered into a development supply agreement specific to four generic product candidates. Under that agreement, Amneal maintained a right of first offer and negotiation to the in-licensing of each generic product candidate. Amneal and Kashiv previously entered into a license and supply agreement for one product candidate in March 2024. Refer to Note 23. Related Party Transactions in our 2024 Annual Report on Form 10-K for additional information.
In May 2025, Amneal and Kashiv entered into a separate license agreement for the development and commercialization of Carfilzomib (the “Carfilzomib License Agreement"). The existing development supply agreement remains effective for the remaining two generic product candidates. Subject to the terms of the Carfilzomib License Agreement, Amneal is responsible for development, regulatory approval, and commercialization of the product candidate in the U.S. The term of the agreement is 10 years from the respective product’s launch date in the U.S.
During the three and six months ended June 30, 2025, the Company recorded R&D expense for a $2.0 million payment made upon execution of the license agreement. The agreement provides for potential future milestone payments to Kashiv of up to $23.0 million as follows: (i) up to $18.0 million for U.S. regulatory approval and initial commercial launch milestones and (ii) up to $5.0 million for the achievement of annual commercial milestones. In addition, the agreement provides for Amneal to pay a profit share up 50% of net profits, after considering manufacturing and allowable costs to deduct as defined in the agreement.
Sale of Subsidiary
On April 30, 2024, Amneal closed on the sale of a wholly owned subsidiary in India to a subsidiary of Kashiv for total consideration of ₹1.0 billion, or $12.2 million. Total consideration consisted of a ₹416.2 million, or $5.0 million, cash payment at closing and the assumption of a loan payable of ₹598.6 million, or $7.2 million, payable to another subsidiary of Amneal in India. The loan payable bore interest of 11% on the unpaid principal and was due on or before December 31, 2024. The subsidiary’s assets and liabilities were primarily comprised of a building under construction and a note payable, respectively. The subsidiary had no business activity, other than the construction of the building. As a result of the sale, the Company recognized a pre-tax gain of $3.8 million in other income for the three and six months ended June 30, 2024. The entire receivable was collected by Amneal in December 2024.
Lease Extension
Refer to Note 20. Leases in this Quarterly Report on Form 10-Q for information on a lease extension with a related party.
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, 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):
29
Three Months Ended June 30, 2025
Affordable Medicines (1)
Specialty
AvKARE
Corporate and Other
Total Company
Net revenue
$
433,425
$
128,043
$
163,040
$
—
$
724,508
Cost of goods sold
252,646
55,795
129,814
—
438,255
Gross profit
180,779
72,248
33,226
—
286,253
Selling, general and administrative
34,226
30,314
A
15,079
44,647
124,266
Research and development
41,899
B
6,065
B
—
—
47,964
Intellectual property legal development expenses
1,978
39
—
—
2,017
Restructuring and other charges
683
341
—
—
1,024
Credit related to legal matters, net
(390)
—
—
—
(390)
Operating income (loss)
$
102,383
$
35,489
$
18,147
$
(44,647)
$
111,372
Three Months Ended June 30, 2024
Affordable Medicines (1)
Specialty
AvKARE
Corporate and Other
Total Company
Net revenue
$
427,328
$
104,041
$
170,411
$
—
$
701,780
Cost of goods sold
260,903
46,142
144,788
—
451,833
Gross profit
166,425
57,899
25,623
—
249,947
Selling, general and administrative
31,627
26,610
A
14,642
43,583
116,462
Research and development
31,703
B
4,351
B
—
—
36,054
Intellectual property legal development expenses
1,032
10
—
—
1,042
Restructuring and other charges
53
78
—
89
220
Charges related to legal matters, net
699
—
—
—
699
Operating income (loss)
$
101,311
$
26,850
$
10,981
$
(43,672)
$
95,470
Six Months Ended June 30, 2025
Affordable Medicines (1)
Specialty
AvKARE
Corporate
and Other
Total
Company
Net revenue
$
848,133
$
236,340
$
335,455
$
—
$
1,419,928
Cost of goods sold
495,279
108,878
273,627
—
877,784
Gross profit
352,854
127,462
61,828
—
542,144
Selling, general and administrative
67,941
61,292
A
30,773
82,548
242,554
Research and development
72,879
B
15,125
B
—
—
88,004
Intellectual property legal development expenses
3,691
93
—
—
3,784
Restructuring and other charges
683
471
—
441
1,595
Credit related to legal matters, net
(390)
—
—
—
(390)
Other operating income
(5,122)
—
—
—
(5,122)
Operating income (loss)
$
213,172
$
50,481
$
31,055
$
(82,989)
$
211,719
30
Six Months Ended June 30, 2024
Affordable Medicines (1)
Specialty
AvKARE
Corporate and Other
Total Company
Net revenue
$
818,622
$
209,275
$
333,074
$
—
$
1,360,971
Cost of goods sold
500,825
90,942
281,197
—
872,964
Gross profit
317,797
118,333
51,877
—
488,007
Selling, general and administrative
64,712
51,806
A
29,549
82,990
229,057
Research and development
66,074
B
9,278
B
—
—
75,352
Intellectual property legal development expenses
1,992
34
—
—
2,026
Restructuring and other charges
53
1,024
—
613
1,690
Charges related to legal matters, net
95,058
—
—
—
95,058
Other operating expense
—
100
—
—
100
Operating income (loss)
$
89,908
$
56,091
$
22,328
$
(83,603)
$
84,724
(1)Revenue, cost of goods sold, and gross profit from the sale of Amneal products by AvKARE were included in Affordable Medicines.
Significant Expense Categories Provided to the Chief Operating Decision Makers
Selling, General and Administrative Expenses - Specialty Segment
A.The CODMs review certain selling, general and administrative expenses (“SG&A”) for the Specialty segment and, separately, on a departmental basis. The CODMs do not review SG&A for the Affordable Medicines and AvKARE segments. SG&A for the Specialty segment was comprised of the following (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Employee compensation and benefits
$
10,791
$
9,055
$
21,663
$
17,892
Product marketing
9,884
11,615
17,895
20,143
Commercial operations and salesforce
8,787
4,762
19,578
11,027
Other (1)
852
1,178
2,156
2,744
Total
$
30,314
$
26,610
$
61,292
$
51,806
(1)Other includes professional fees and other expenses not presented to the CODMs.
Research and Development Expenses - Affordable Medicines and Specialty Segments
B.Research and development expenses for the Affordable Medicines and Specialty segments were comprised of the following (in thousands):
Three Months Ended June 30,
2025
2024
Affordable Medicines
Specialty
Affordable Medicines
Specialty
Employee compensation and benefits
$
14,693
$
1,279
$
12,487
$
2,049
Materials and supplies
8,108
450
6,025
281
Product development and studies (1)
756
2,371
635
82
Milestones
6,350
—
1,125
—
Facilities costs
1,793
735
1,693
1,498
Regulatory fees
2,932
—
834
—
Other (2)
7,267
1,230
8,904
441
Total
$
41,899
$
6,065
$
31,703
$
4,351
31
Six Months Ended June 30,
2025
2024
Affordable Medicines
Specialty
Affordable Medicines
Specialty
Employee compensation and benefits
$
28,234
$
2,819
$
24,076
$
4,134
Materials and supplies
16,635
653
15,983
712
Product development and studies (1)
687
4,690
1,600
515
Milestones
6,600
3,000
4,625
—
Facilities costs
3,427
1,485
3,385
2,745
Regulatory fees
2,517
—
788
788
—
Other (2)
14,779
2,478
15,617
1,172
Total
$
72,879
$
15,125
$
66,074
$
9,278
(1)For the three and six months ended June 30, 2025, Affordable Medicines included a $0.9 million and $2.5 million, respectively, reduction to product development and studies expense for services performed under the license agreement with Orion Corporation. Refer to Note 3. Alliance and Collaboration.
(2)For the Affordable Medicines segment, other includes repairs and maintenance, outside testing, professional fees, equipment calibration and other expenses not presented to the CODMs. For the Specialty segment, other includes repairs and maintenance, outside testing, professional fees and other expenses not presented to the CODMs.
20. Leases
Except as disclosed below, as of and for the three and six months ended June 30, 2025, there were no material changes to our lease agreements as described in Note 17. Leases in our2024 Annual Report on Form 10-K.
On April 23, 2025, the Company executed a lease renewal for an R&D and manufacturing facility in New Jersey. This renewal extended the lease term 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 with a related party, Sutaria Family Realty, LLC, for a manufacturing facility in Hauppauge, 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.
21. Subsequent Events
Opioid Settlement in Principle
As discussed in Note 16. Commitments and Contingencies, the Company reached a nationwide settlement in principle for a resolution to the opioid cases filed and that might have been filed by state Attorneys General, political subdivisions and Native American tribes. During July 2025, the Company deposited an aggregate of $24.2 million into dedicated accounts as a step in the process to finalize a definitive settlement agreement. These deposits remain the property of the Company until a definitive settlement agreement is reached and the funds are used to make the first installment payment.
Refinancing
On August 1, 2025, Amneal issued $600 million aggregate principal amount of 6.875% senior secured notes due 2032 (the “Senior Notes Due 2032”) at par in a private offering. Concurrently with the offering of the Senior Notes Due 2032, Amneal borrowed $2.1 billion aggregate principal amount of new seven-year term loans (the “Term Loans Due 2032”) under a new term loan facility, and used the net proceeds of the Term Loans Due 2032 and the Senior Notes Due 2032 to refinance its existing Term Loan Due 2028 in full, repay outstanding amounts borrowed under its Amended New Revolving Credit Facility and to pay related fees, premiums and expenses.
Interest is payable on the Term Loans Due 2032 at a rate equal to the term SOFR benchmark rate or the base rate, plus an applicable margin, in each case, subject to a term SOFR benchmark rate floor of 0.50% or a base rate floor of 1.00%, as applicable. The applicable margin for the Term Loans Due 2032 is 3.50% per annum for term SOFR benchmark rate loans and 2.50% per annum for base rate loans.
In addition, Amneal entered into a second amendment to the Amended New Revolving Credit Facility which extends the maturity to August 1, 2030.
32
AvKARE Excess Cash Distribution
On July 31, 2025, we made a $7.0 million cash distribution to the AvKARE Sellers from excess cash on hand.
33
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 and six months ended June 30, 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.
During 2025, 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.
34
One Big Beautiful Bill Act
On July 4, 2025, President Trump signed the One Big Beautiful Bill Act (“OBBBA”), which includes a broad range of tax reform provisions affecting businesses. The OBBBA includes numerous changes to existing tax law including, extending or making permanent certain business and international tax measures initially established under the 2017 Tax Cuts and Jobs Act, which were set to expire. Additionally, the OBBBA permanently eliminates the requirement to capitalize and amortize U.S.-based research and experimental expenditures over five years, making these expenditures fully deductible in the period incurred. The Company expects these provisions to result in a reduction of current income tax liabilities. The Company will continue to analyze the OBBBA and its impact on its financial statements and will reflect any impact in the period of enactment.
Results of Operations
Comparison of Three Months Ended June 30, 2025 to Three Months Ended June 30, 2024
Consolidated Results
The following table sets forth our summarized, consolidated results of operations for the three months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
724,508
$
701,780
$
22,728
3.2
%
Cost of goods sold
438,255
451,833
(13,578)
(3.0)
%
Gross profit
286,253
249,947
36,306
14.5
%
Selling, general and administrative
124,266
116,462
7,804
6.7
%
Research and development
47,964
36,054
11,910
33.0
%
Intellectual property legal development expenses
2,017
1,042
975
93.6
%
Restructuring and other charges
1,024
220
804
nm
(Credit) charges related to legal matters, net
(390)
699
(1,089)
nm
Operating income
111,372
95,470
15,902
16.7
%
Total other expense, net
(59,661)
(75,065)
15,404
(20.5)
%
Income before income taxes
51,711
20,405
31,306
nm
Provision for income taxes
16,101
3,618
12,483
nm
Net income
$
35,610
$
16,787
$
18,823
nm
nm - not meaningful
Net Revenue
Net revenue for the three months ended June 30, 2025 increased 3.2% from the prior year period, primarily due to:
•Growth in our Affordable Medicines segment net revenue of $6.1 million, primarily due to new products launched in 2025 and 2024, which contributed $33.0 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
•Growth in our Specialty segment net revenue of $24.0 million, primarily driven by increases of $11.2 million, $9.0 million and $3.7 million in sales of CREXONT®, RYTARY® and UNITHROID®, respectively, partially offset by a decline in our non-promoted products.
•Decline in our AvKARE segment net revenue of $7.4 million, primarily driven by a reduction in our low margin distribution sales partially offset by expansion of our government label channel from new product introductions.
Cost of Goods Sold and Gross Profit
35
Cost of goods sold decreased 3.0%for the three months ended June 30, 2025 as compared to the prior year period. The decrease in cost of goods sold was primarily due to manufacturing efficiencies, partially offset by increased amortization related to CREXONT®.
Gross profit as a percentage of net revenue increased to 39.5% for the three months ended June 30, 2025 from 35.6% in the prior year period primarily as a result of the factors noted above.
Selling, General, and Administrative
Selling, general, and administrative (“SG&A”) expenses for the three months ended June 30, 2025 increased 6.7% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT®.
Research and Development
Research and development (“R&D”) expenses for the three months ended June 30, 2025 increased 33.0% as compared to the prior year period, primarily due to increases in employee compensation, increase in project spend and increase in in-licensing and upfront milestone payments.
Total Other Expense, Net
Total other expense, net for the three months ended June 30, 2025 decreased 20.5% as compared to the prior year period. The decrease was primarily driven by a $9.0 million period-over-period decrease in the increase in tax receivable agreement liability and the favorable impact of foreign exchange, primarily from the Euro.
Provision For Income Taxes
For the three months ended June 30, 2025, our provision for income taxes and effective tax rate were $16.1 million and 31.1%, respectively, as compared to $3.6 million and 17.7%, respectively, for the three months ended June 30, 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 June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
433,425
$
427,328
$
6,097
1.4
%
Cost of goods sold
252,646
260,903
(8,257)
(3.2)
%
Gross profit
180,779
166,425
14,354
8.6
%
Selling, general and administrative
34,226
31,627
2,599
8.2
%
Research and development
41,899
31,703
10,196
32.2
%
Intellectual property legal development expenses
1,978
1,032
946
91.7
%
Restructuring and other charges
683
53
630
nm
(Credit) charges related to legal matters, net
(390)
699
(1,089)
nm
Operating income
$
102,383
$
101,311
$
1,072
1.1
%
nm - not meaningful
Net Revenue
Affordable Medicines net revenue for the three months ended June 30, 2025 increased 1.4% as compared to the prior year period, primarily due to new products launched in 2025 and 2024, which contributed $33.0 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
36
Cost of Goods Sold and Gross Profit
Affordable Medicines cost of goods sold for the three months ended June 30, 2025 decreased 3.2% as compared to the prior year period, primarily due to manufacturing efficiencies and favorable product mix, partially offset by increased plant and freight costs.
Affordable Medicines gross profit as a percentage of net revenue increased to 41.7% for the three months ended June 30, 2025 from 38.9% 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 June 30, 2025 increased 8.2% 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 June 30, 2025 increased 32.2% as compared to the prior year period, primarily due to increases in employee compensation, increase in project spend and increase in in-licensing and upfront milestone payments.
Specialty
The following table sets forth results of operations for our Specialty segment for the three months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
128,043
$
104,041
$
24,002
23.1
%
Cost of goods sold
55,795
46,142
9,653
20.9
%
Gross profit
72,248
57,899
14,349
24.8
%
Selling, general and administrative
30,314
26,610
3,704
13.9
%
Research and development
6,065
4,351
1,714
39.4
%
Intellectual property legal development expenses
39
10
29
nm
Restructuring and other charges
341
78
263
nm
Operating income
$
35,489
$
26,850
$
8,639
32.2
%
nm - not meaningful
Net Revenue
Specialty net revenue for the three months ended June 30, 2025 increased 23.1% compared to the prior year period, primarily driven by increases of $11.2 million, $9.0 million and $3.7 million in sales of CREXONT®, RYTARY® and UNITHROID®, respectively, partially offset by a decline in our non-promoted products.
Cost of Goods Sold and Gross Profit
Specialty cost of goods sold for the three months ended June 30, 2025 increased 20.9% 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 increased to 56.4% for the three months ended June 30, 2025 as compared to 55.7% 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 June 30, 2025 increased 13.9% as compared to the prior year period, primarily due to launch costs associated with CREXONT® and increases in employee compensation.
Research and Development
37
Specialty R&D expense for the three months ended June 30, 2025 increased 39.4% as compared to the prior year period, primarily due to higher project spend.
AvKARE
The following table sets forth results of operations for our AvKARE segment for the three months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
163,040
$
170,411
$
(7,371)
(4.3)
%
Cost of goods sold
129,814
144,788
(14,974)
(10.3)
%
Gross profit
33,226
25,623
7,603
29.7
%
Selling, general and administrative
15,079
14,642
437
3.0
%
Operating income
$
18,147
$
10,981
$
7,166
65.3
%
Net Revenue
AvKARE net revenue for the three months ended June 30, 2025 decreased 4.3% as compared to the prior year period, primarily driven by a reduction in our low margin distribution sales partially offset by expansion of our government label channel from new product introductions.
Cost of Goods Sold and Gross Profit
AvKARE cost of goods sold for the three months ended June 30, 2025 decreased 10.3% as compared to the prior year period, primarily due to a reduction of sales in our low margin distribution channel partially offset by higher sales in our government label channel.
Gross profit as a percentage of net revenue increased to 20.4% for the three months ended June 30, 2025 from 15.0% 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 June 30, 2025 increased 3.0% as compared to the prior year period, primarily due to increases in employee compensation and freight costs.
38
Comparison of Six Months Ended June 30, 2025 to Six Months Ended June 30, 2024
Consolidated Results
The following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
1,419,928
$
1,360,971
$
58,957
4.3
%
Cost of goods sold
877,784
872,964
4,820
0.6
%
Gross profit
542,144
488,007
54,137
11.1
%
Selling, general and administrative
242,554
229,057
13,497
5.9
%
Research and development
88,004
75,352
12,652
16.8
%
Intellectual property legal development expenses
3,784
2,026
1,758
86.8
%
Restructuring and other charges
1,595
1,690
(95)
(5.6)
%
(Credit) charges related to legal matters, net
(390)
95,058
(95,448)
(100.4)
%
Other operating (income) expense
(5,122)
100
(5,222)
nm
Operating income
211,719
84,724
126,995
nm
Total other expense, net
(122,522)
(139,841)
17,319
(12.4)
%
Income (loss) before income taxes
89,197
(55,117)
144,314
nm
Provision for income taxes
28,969
9,774
19,195
nm
Net income (loss)
$
60,228
$
(64,891)
$
125,119
nm
nm - not meaningful
Net Revenue
Net revenue for the six months ended June 30, 2025 increased 4.3% from the prior year period primarily due to:
•Growth in our Affordable Medicines segment net revenue of $29.5 million, primarily due to new products launched in 2025 and 2024, which contributed $73.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
•Growth in our Specialty segment net revenue of $27.1 million, primarily driven by increases of $20.3 million, $3.9 million and $7.7 million in sales of CREXONT®, RYTARY® and UNITHROID®, respectively, partially offset by a decline in our non-promoted products. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
•Growth in our AvKARE segment net revenue of $2.4 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.
Cost of Goods Sold and Gross Profit
Cost of goods sold for the six months ended June 30, 2025 was relatively flat compared to the prior year period, as increased amortization related to CREXONT® and increased plant and freight costs, partially offset by manufacturing efficiencies and a decline of sales in our lower margin distribution channel.
Gross profit as a percentage of net revenue increased to 38.2% for the six months ended June 30, 2025 from 35.9% in the prior year period, primarily as a result of the factors noted above.
Selling, General, and Administrative
SG&A expenses for the six months ended June 30, 2025 increased 5.9% 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.
39
Research and Development
R&D expenses for the six months ended June 30, 2025 increased 16.8% as compared to the prior year period, primarily due to increases in employee compensation, increase in project spend and increase in in-licensing and upfront milestone payments.
(Credit) charges Related to Legal Matters, Net
For the six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against 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 six months ended June 30, 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 six months ended June 30, 2025 decreased 12.4% as compared to the prior year period. The decrease was primarily driven by a $9.4 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, primarily from the Euro.
Provision For Income Taxes
For the six months ended June 30, 2025, our provision for income taxes and effective tax rate were $29.0 million and 32.5%, respectively, as compared to $9.8 million and (17.7)%, respectively, for the six months ended June 30, 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 six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
848,133
$
818,622
$
29,511
3.6
%
Cost of goods sold
495,279
500,825
(5,546)
(1.1)
%
Gross profit
352,854
317,797
35,057
11.0
%
Selling, general and administrative
67,941
64,712
3,229
5.0
%
Research and development
72,879
66,074
6,805
10.3
%
Intellectual property legal development expenses
3,691
1,992
1,699
85.3
%
Restructuring and other charges
683
53
630
nm
Charges related to legal matters, net
(390)
95,058
(95,448)
(100.4)
%
Other operating income
(5,122)
—
(5,122)
nm
Operating income
$
213,172
$
89,908
$
123,264
nm
nm - not meaningful
Net Revenue
Affordable Medicines net revenue for the six months ended June 30, 2025 increased 3.6% as compared to the prior year period, primarily due to new products launched in 2025 and 2024, which contributed $73.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
40
Cost of Goods Sold and Gross Profit
Affordable Medicines cost of goods sold for the six months ended June 30, 2025 decreased 1.1% as compared to the prior year period, primarily due to manufacturing efficiencies and favorable product mix, partially offset by increased plant and freight costs.
Affordable Medicines gross profit as a percentage of net revenue increased to 41.6% for the six months ended June 30, 2025 from 38.8% 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 six months ended June 30, 2025 increased 5.0% 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 six months ended June 30, 2025 increased 10.3% as compared to the prior year period, primarily due to increases in employee compensation and increase in in-licensing and upfront milestone payments.
Charges Related to Legal Matters, Net
For the six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against 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 six months ended June 30, 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 six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
236,340
$
209,275
$
27,065
12.9
%
Cost of goods sold
108,878
90,942
17,936
19.7
%
Gross profit
127,462
118,333
9,129
7.7
%
Selling, general and administrative
61,292
51,806
9,486
18.3
%
Research and development
15,125
9,278
5,847
63.0
%
Intellectual property legal development expenses
93
34
59
nm
Restructuring and other charges
471
1,024
(553)
(54.0)
%
Other operating expense
—
100
(100)
nm
Operating income
$
50,481
$
56,091
$
(5,610)
(10.0)
%
nm - not meaningful
Net Revenue
Specialty net revenue for the six months ended June 30, 2025 increased 12.9% as compared to the prior year period, primarily driven by increases of $20.3 million, $3.9 million and $7.7 million in sales of CREXONT®, RYTARY® and UNITHROID®, respectively, partially offset by a decline in our non-promoted products. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
Cost of Goods Sold and Gross Profit
41
Specialty cost of goods sold for the six months ended June 30, 2025 increased 19.7% 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 53.9% for the six months ended June 30, 2025 as compared to 56.5% 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 six months ended June 30, 2025 increased 18.3% 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 six months ended June 30, 2025 increased 63.0% 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 six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30,
Change
2025
2024
$
%
Net revenue
$
335,455
$
333,074
$
2,381
0.7
%
Cost of goods sold
273,627
281,197
(7,570)
(2.7)
%
Gross profit
61,828
51,877
9,951
19.2
%
Selling, general and administrative
30,773
29,549
1,224
4.1
%
Operating income
$
31,055
$
22,328
$
8,727
39.1
%
Net Revenue
AvKARE net revenue for the six months ended June 30, 2025 increased 0.7% 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 six months ended June 30, 2025 decreased 2.7% as compared to the prior year period primarily due to a reduction of sales in our low margin distribution channel partially offset by higher sales in our government label channel and an increase in the inventory provision.
Gross profit as a percentage of net revenue increased to 18.4% for the six months ended June 30, 2025 from 15.6% in the prior year period, primarily as a result of the factors noted above.
Selling, General and Administrative
AvKARE SG&A expense for the six months ended June 30, 2025 increased 4.1% as compared to the prior year period, primarily due to increases in employee compensation and shipping costs.
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). On April 9, 2025, the Company executed an amendment to the Amended Rondo Revolving Credit Facility that, among other things, (i) increased the aggregate revolving commitment from $70 million to $125 million, (ii) increased the letter of credit commitment from $60 million to $90 million, and (iii) extended the maturity to April 9, 2030. As of June 30, 2025, we had access to $304.7 million of available capacity under the Amended New Revolving Credit Facility and $83.0 million of available capacity under the Amended Rondo Revolving Credit Facility. We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations, 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
42
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 and Note 21. Subsequent Events 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 June 30, 2025, the contingent TRA liability, including the impact of the amendment, was approximately $118.7 million. During the six months ended June 30, 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 six months ended June 30, 2025 and 2024, we made cash distributions of $25.0 million and $8.9 million, respectively, to the AvKARE Sellers. During July 2025, we made cash tax distributions of $6.0 million to the AvKARE Sellers.
AvKARE Excess Cash Distribution
On July 31, 2025, we made a $7.0 million cash distribution to the AvKARE Sellers from excess cash on hand.
43
Refinancing
On August 1, 2025, Amneal issued $600 million aggregate principal amount of 6.875% senior secured notes due 2032 (the “Senior Notes Due 2032”) at par in a private offering. Concurrently with the offering of the Senior Notes Due 2032, Amneal borrowed $2.1 billion aggregate principal amount of new seven-year term loans (the “Term Loans Due 2032”) under a new term loan facility, and used the net proceeds of the Term Loans Due 2032 and the Senior Notes Due 2032 to refinance its existing Term Loan Due 2028 in full, repay outstanding amounts borrowed under its Amended New Revolving Credit Facility and to pay related fees, premiums and expenses.
Interest is payable on the Term Loans Due 2032 at a rate equal to the term SOFR benchmark rate or the base rate, plus an applicable margin, in each case, subject to a term SOFR benchmark rate floor of 0.50% or a base rate floor of 1.00%, as applicable. The applicable margin for the Term Loans Due 2032 is 3.50% per annum for term SOFR benchmark rate loans and 2.50% per annum for base rate loans.
In addition, Amneal entered into a second amendment to the Amended New Revolving Credit Facility which extends the maturity to August 1, 2030.
Cash Balances
As of June 30, 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 six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30,
Change
2025
2024
$
%
Net cash provided by (used in):
Operating activities
$
91,227
$
35,247
$
55,980
158.8
%
Investing activities
(44,345)
(26,225)
(18,120)
69.1
%
Financing activities
(80,853)
(58,241)
(22,612)
38.8
%
Effect of exchange rate changes on cash
(777)
(266)
(511)
192.1
%
Net decrease in cash, cash equivalents, and restricted cash
$
(34,748)
$
(49,485)
$
14,737
(29.8)
%
Cash Flows from Operating Activities
Net cash provided by operating activities was $91.2 million for the six months ended June 30, 2025 as compared to $35.2 million in the prior year period. The period-over-period increase was primarily driven by the payment of $52.4 million associated with the Opana ER® antitrust litigation settlement during the six months ended June 30, 2024. Excluding the Opana ER® antitrust litigation settlement payment, net cash provided by operating activities were relatively flat period-over-period.
Cash Flows from Investing Activities
Net cash used in investing activities for the six months ended June 30, 2025 was $44.3 million as compared to $26.2 million in the prior year period. The period-over-period increase in net cash used in investing activities was primarily due to an increase in higher capital expenditures, partially offset by 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.
Cash Flows from Financing Activities
44
Net cash used in financing activities was $80.9 million for the six months ended June 30, 2025 as compared to $58.2 million in the prior year period. The period-over-period increase in net cash used in financing activities was primarily due to increases in employee payroll tax withholding on restricted stock unit and performance stock unit vesting and tax and other distributions to non-controlling interests, partially offset by payments on the Sellers Notes in the prior year period.
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 June 30, 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 June 30, 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 June 30, 2025.
Changes in Internal Control over Financial Reporting
During the quarter ended June 30, 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.
45
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.
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
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.
47
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: August 7, 2025
Amneal Pharmaceuticals, Inc.
(Registrant)
By:
/s/ Anastasios Konidaris
Anastasios Konidaris
Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)