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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
March 31, 2025
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission file number
001-38485
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 April 30, 2025, there were
313,419,599
shares of the registrant’s Class A common stock outstanding, with a par value of $0.01.
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 March 31,
2025
2024
Net revenue
$
695,420
$
659,191
Cost of goods sold
439,529
421,131
Gross profit
255,891
238,060
Selling, general and administrative
118,288
112,595
Research and development
40,040
39,298
Intellectual property legal development expenses
1,767
984
Restructuring and other charges
571
1,470
Charges related to legal matters, net
—
94,359
Other operating (income) expense
(
5,122
)
100
Operating income (loss)
100,347
(
10,746
)
Other (expense) income:
Interest expense, net
(
56,939
)
(
65,703
)
Foreign exchange gain (loss), net
4,247
(
1,197
)
Increase in tax receivable agreement liability
(
10,687
)
(
1,948
)
Other income, net
518
4,072
Total other expense, net
(
62,861
)
(
64,776
)
Income (loss) before income taxes
37,486
(
75,522
)
Provision for income taxes
12,868
6,156
Net income (loss)
24,618
(
81,678
)
Less: Net income attributable to non-controlling interests
(
12,423
)
(
9,965
)
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
$
12,195
$
(
91,643
)
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:
Basic
$
0.04
$
(
0.30
)
Diluted
$
0.04
$
(
0.30
)
Weighted-average common shares outstanding:
Basic
311,054
307,279
Diluted
323,961
307,279
The accompanying notes are an integral part of these consolidated financial statements.
4
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Loss
(unaudited; in thousands)
Three Months Ended March 31,
2025
2024
Net income (loss)
$
24,618
$
(
81,678
)
Less: Net income attributable to non-controlling interests
(
12,423
)
(
9,965
)
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
12,195
(
91,643
)
Other comprehensive (loss) income:
Foreign currency translation adjustments arising during the period
(
1,632
)
(
390
)
Unrealized (loss) gain on cash flow hedge, net of tax of $
0
(
12,154
)
15,543
Reclassification of cash flow hedge to earnings, net of tax of $
0
(
6,444
)
(
6,515
)
Other comprehensive (loss) income attributable to Amneal Pharmaceuticals, Inc.
(
20,230
)
8,638
Comprehensive loss attributable to Amneal Pharmaceuticals, Inc.
$
(
8,035
)
$
(
83,005
)
The accompanying notes are an integral part of these consolidated financial statements.
5
Amneal Pharmaceuticals, Inc.
Consolidated Balance Sheets
(unaudited; in thousands, except per share amounts)
March 31, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
59,187
$
110,552
Restricted cash
6,583
7,868
Trade accounts receivable, net
754,236
775,731
Inventories
601,433
612,454
Prepaid expenses and other current assets
88,524
80,717
Related party receivables
487
484
Total current assets
1,510,450
1,587,806
Property, plant and equipment, net
427,231
424,908
Goodwill
597,497
597,436
Intangible assets, net
689,136
732,377
Operating lease right-of-use assets
29,103
31,388
Operating lease right-of-use assets - related party
10,447
10,964
Financing lease right-of-use assets
55,967
56,433
Other assets
45,418
60,133
Total assets
$
3,365,249
$
3,501,445
Liabilities and Stockholders’ Deficiency
Current liabilities:
Accounts payable and accrued expenses
$
628,572
$
735,450
Current portion of liabilities for legal matters
43,503
31,755
Revolving credit facility
290,000
100,000
Current portion of long-term debt, net
31,790
224,213
Current portion of operating lease liabilities
8,986
9,435
Current portion of operating lease liabilities - related party
3,449
3,396
Current portion of financing lease liabilities
3,319
3,211
Related party payables - short term
66,205
22,311
Total current liabilities
1,075,824
1,129,771
Long-term debt, net
2,153,979
2,161,790
Operating lease liabilities
22,854
24,814
Operating lease liabilities - related party
8,520
9,391
Financing lease liabilities
56,604
56,889
Related party payables - long term
10,687
50,900
Liabilities for legal matters - long term
72,979
85,479
Other long-term liabilities
23,191
26,949
Total long-term liabilities
2,348,814
2,416,212
Commitments and contingencies (Notes 3, 16 and 18)
Redeemable non-controlling interests
72,611
64,974
Stockholders’ Deficiency
Preferred stock, $
0.01
par value,
2,000
shares authorized at both March 31, 2025 and December 31, 2024;
none
issued at both March 31, 2025 and December 31, 2024
—
—
Class A common stock, $
0.01
par value,
900,000
shares authorized at both March 31, 2025 and December 31, 2024;
313,385
and
309,881
shares issued at March 31, 2025 and December 31, 2024, respectively
3,134
3,099
Class B common stock, $
0.01
par value,
300,000
shares authorized at both March 31, 2025 and December 31, 2024;
none
issued at both March 31, 2025 and December 31, 2024
—
—
Additional paid-in capital
545,806
560,206
Stockholders' accumulated deficit
(
594,867
)
(
607,062
)
Accumulated other comprehensive loss
(
85,740
)
(
65,510
)
Total Amneal Pharmaceuticals, Inc. stockholders’ deficiency
(
131,667
)
(
109,267
)
Non-controlling interests
(
333
)
(
245
)
Total stockholders' deficiency
(
132,000
)
(
109,512
)
Total liabilities and stockholders’ deficiency
$
3,365,249
$
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)
Three Months Ended March 31,
2025
2024
Cash flows from operating activities:
Net income (loss)
$
24,618
$
(
81,678
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
60,159
55,528
Unrealized foreign currency (gain) loss
(
3,596
)
1,511
Amortization of debt issuance costs and discount
6,811
6,803
Reclassification of cash flow hedge
(
6,444
)
(
6,515
)
Intangible asset impairment charges
—
920
Stock-based compensation
7,258
6,722
Inventory provision
23,669
22,923
Other operating charges and credits, net
1,313
1,350
Changes in assets and liabilities:
Trade accounts receivable, net
21,148
(
55,173
)
Inventories
(
13,263
)
(
12,200
)
Prepaid expenses, other current assets and other assets
(
513
)
(
11,708
)
Related party receivables
(
2
)
(
562
)
Accounts payable, accrued expenses and other liabilities
(
112,626
)
62,174
Related party payables
(
1,124
)
5,495
Net cash provided by (used in) operating activities
7,408
(
4,410
)
Cash flows from investing activities:
Purchases of property, plant and equipment
(
13,162
)
(
9,198
)
Acquisition of intangible assets
(
4,200
)
(
9,700
)
Deposits for future acquisition of property, plant and equipment
(
960
)
(
862
)
Proceeds from sale of property, plant and equipment
524
—
Net cash used in investing activities
(
17,798
)
(
19,760
)
Cash flows from financing activities:
Payments of principal on debt, revolving credit facilities, financing leases and other
(
235,528
)
(
63,377
)
Borrowings on revolving credit facilities
218,000
48,000
Proceeds from exercise of stock options
69
28
Employee payroll tax withholding on restricted stock unit and performance stock unit vesting
(
21,639
)
(
7,212
)
Tax distributions to non-controlling interests
(
68
)
(
594
)
Net cash used in financing activities
(
39,166
)
(
23,155
)
Effect of foreign exchange rate on cash
(
470
)
(
165
)
Net decrease in cash, cash equivalents, and restricted cash
(
50,026
)
(
47,490
)
Cash, cash equivalents, and restricted cash - beginning of period
118,420
99,107
Cash, cash equivalents, and restricted cash - end of period
$
68,394
$
51,617
Cash and cash equivalents - end of period
$
59,187
$
46,520
Restricted cash - end of period
6,583
5,097
Long-term restricted cash included in other assets - end of period
2,624
—
Cash, cash equivalents, and restricted cash - end of period
$
68,394
$
51,617
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)
Three Months Ended March 31,
2025
2024
Supplemental disclosure of cash flow information:
Cash paid for interest
$
56,323
$
64,514
Cash paid, net for income taxes
$
3,613
$
4,567
Supplemental disclosure of non-cash investing and financing activity:
Tax distributions to non-controlling interests
$
4,806
$
3,777
Payable for acquisition of intangible assets
$
1,700
$
—
The accompanying notes are an integral part of these consolidated financial statements.
8
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ (Deficiency) Equity
(unaudited; in thousands)
Class A Common Stock
Additional
Paid-in Capital
Stockholders'
Accumulated Deficit
Accumulated
Other
Comprehensive Loss
Non-
Controlling Interests
Total Deficiency
Redeemable Non-Controlling Interests
Shares
Amount
Balance at December 31, 2024
309,881
$
3,099
$
560,206
$
(
607,062
)
$
(
65,510
)
$
(
245
)
$
(
109,512
)
$
64,974
Net income (loss)
—
—
—
12,195
—
(
88
)
12,107
12,511
Foreign currency translation adjustments
—
—
—
—
(
1,632
)
—
(
1,632
)
—
Stock-based compensation
—
—
7,258
—
—
—
7,258
—
Exercise of stock options
25
—
69
—
—
—
69
—
Restricted stock unit and performance stock unit vesting, net of shares withheld to cover payroll taxes
3,479
35
(
21,727
)
—
—
—
(
21,692
)
—
Unrealized loss on cash flow hedge, net of tax of $
0
—
—
—
—
(
12,154
)
—
(
12,154
)
—
Tax distributions, net
—
—
—
—
—
—
—
(
4,874
)
Reclassification of cash flow hedge to earnings, net of tax of $
0
—
—
—
—
(
6,444
)
—
(
6,444
)
—
Balance at March 31, 2025
313,385
$
3,134
$
545,806
$
(
594,867
)
$
(
85,740
)
$
(
333
)
$
(
132,000
)
$
72,611
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
—
—
—
(
91,643
)
—
(
135
)
(
91,778
)
10,100
Foreign currency translation adjustments
—
—
—
—
(
390
)
—
(
390
)
—
Stock-based compensation
—
—
6,722
—
—
—
6,722
—
Exercise of stock options
10
—
28
—
—
—
28
—
Restricted stock unit vesting, net of shares withheld to cover payroll taxes
2,048
20
(
7,270
)
—
—
—
(
7,250
)
—
Unrealized gain on cash flow hedge, net of tax of $
0
—
—
—
—
15,543
—
15,543
—
Tax distributions, net
—
—
—
—
—
—
—
(
4,371
)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
—
—
—
(
6,515
)
—
(
6,515
)
$
—
Balance at March 31, 2024
308,623
$
3,086
$
538,720
$
(
581,819
)
$
(
23,711
)
$
95
$
(
63,629
)
$
47,022
The accompanying notes are an integral part of these consolidated financial statements.
9
Amneal Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
(unaudited)
1.
Summary of Significant Accounting Policies
Basis of Presentation
The interim unaudited consolidated financial statements have been prepared in accordance with the requirements of the U.S. Securities and Exchange Commission and U.S. generally accepted accounting principles (“U.S. GAAP”) for interim reporting. These financial statements include all adjustments that in the opinion of management are necessary for a fair presentation of the financial position, results of operations, and cash flows of Amneal Pharmaceuticals, Inc. (the “Company”) for the periods presented. However, these financial statements do not include all information and accompanying notes required for annual financial statements prepared in accordance with U.S. GAAP. The interim unaudited consolidated financial statements should be read in conjunction with the audited annual financial statements included in the Company’s 2024 Annual Report on Form 10-K.
Use of Estimates
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 three months ended March 31, 2024 has been reclassified to the caption “other operating income (expense)” in the consolidated statements of operations to conform to the current period presentation. This reclassification did not impact operating income (loss) or net income (loss).
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09,
Income Taxes (Topic 740): Improvements to Income Tax Disclosures
(“ASU 2023-09”), which enhances the transparency and usefulness of income tax disclosures. ASU 2023-09 requires that public business entities on an annual basis disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03,
Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses
(“ASU 2024-03”), which requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain categories of expenses that are included in expense captions on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning December 15, 2027, with early adoption permitted. Upon adoption, ASU 2024-03 may be applied prospectively for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
10
2.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606,
Revenue from Contracts with Customers
(“ASC 606”). Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time.
License Agreements
Refer to
Note 5. Alliance and Collaboration
in the Company’s 2024 Annual Report on Form 10-K for further information related to revenue recognition associated with license agreements.
Concentration of Revenue
The following table summarizes revenues from each of the Company’s customers which individually accounted for 10% or more of its total net revenue:
Three Months Ended March 31,
2025
2024
Customer A
24
%
21
%
Customer B
15
%
15
%
Customer C
21
%
23
%
Customer D
9
%
10
%
Disaggregated Revenue
During the fourth quarter of 2024, the Company changed the presentation of disaggregated net revenue in its Affordable Medicines segment from a classification primarily based on significant therapeutic classes to a classification primarily based on significant dosage forms to reflect the full product offering of the segment. The new presentation did not change the composition of the Company’s reportable segments and, therefore, did not change historical total net revenue in any segment. All prior periods were changed to conform to the current period’s presentation.
The Company’s significant dosage forms for its Affordable Medicines segment, therapeutic classes for its Specialty segment and sales channels for its AvKARE segment, as determined based on net revenue for the three months ended March 31, 2025 and 2024, are set forth below (in thousands):
11
Three Months Ended March 31,
2025
2024
Affordable Medicines
Oral solid
$
178,953
$
169,313
Auto-Injector
48,160
42,618
Transdermal
43,063
40,525
Injectable
34,788
35,222
Biosimilar
28,540
26,692
Oral liquid
23,548
31,929
Other dosage forms
(1)
56,422
43,274
Subtotal dosage forms
413,474
389,573
International
1,234
1,721
Total Affordable Medicines Revenue
414,708
391,294
Specialty
Hormonal / allergy
34,199
29,375
Central nervous system
67,610
66,276
Other therapeutic classes
6,488
5,104
Subtotal therapeutic classes
108,297
100,755
License agreement
(2)
—
4,479
Total Specialty net revenue
108,297
105,234
AvKARE
Distribution
104,895
109,713
Government label
50,140
34,952
Institutional
11,009
10,858
Other
6,371
7,140
Total AvKARE net revenue
172,415
162,663
Total net revenue
$
695,420
$
659,191
(1)
Includes net revenue from sales of transmucosal, ophthalmic, topical, nasal and inhalation dosage forms.
(2)
Refer to
Note 5. Alliance and Collaboration
in the Company’s 2024 Annual Report on Form 10-K for information about revenue recognized under license agreements.
A rollforward of the major categories of sales-related deductions for the three months ended March 31, 2025 is as follows (in thousands):
Contract
Charge - Backs
and Sales
Volume
Allowances
Cash Discount
Allowances
Accrued
Returns
Allowance
Accrued
Medicaid and
Commercial
Rebates
Balance at December 31, 2024
$
498,537
$
25,968
$
160,490
$
135,488
Provision related to sales recorded in the period
947,394
31,957
20,822
65,370
Credits/payments issued during the period
(
951,607
)
(
28,158
)
(
15,836
)
(
85,105
)
Balance at March 31, 2025
$
494,324
$
29,767
$
165,476
$
115,753
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.
12
These agreements
generally obligate the Company to provide research and development (“R&D”) services over multiple periods.
As of and for the three months ended March 31, 2025, there were no material changes to our alliance and collaboration agreements as described in
Note 5. Alliance and Collaboration
in our
2024 Annual Report on Form 10-K.
The following table summarizes the activity in the Company’s consolidated statements of operations related to alliance and collaboration agreements for the
three
months ended
March 31, 2025
and
2024
(in thousands):
Three Months Ended March 31,
Partner
Caption in Statement of Operations
2025
2024
Orion Corporation
Research and development
(1)
$
(
1,612
)
$
(
611
)
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
(1)
The Company recognizes reductions to R&D for services performed.
(2)
Delivery of a functional license (out-licensing revenue).
(3)
Non-refundable license fee.
(4)
Clinical milestone payment.
The following table summarizes the balances in the Company’s consolidated balance sheets related to alliance and collaboration agreements as of March 31, 2025 and December 31, 2024 (in thousands):
Party
Caption in Balance Sheet
March 31, 2025
December 31, 2024
Orion Corporation
Accounts payable and accrued expenses
(1)
$
5,281
$
5,008
Orion Corporation
Other long-term liabilities
(1)
$
2,033
$
3,453
Zambon Biotech S.A.
Other long-term liabilities
(1)
$
2,530
$
2,530
Metsera, Inc.
Prepaid expenses and other current assets
(2)
$
—
$
335
(1)
Comprised of deferred income as of March 31, 2025 and December 31, 2024.
(2)
Comprised primarily of unbilled receivables for R&D services performed as of December 31, 2024.
4.
Income Taxes
Provision for Income Taxes
Set forth in the
following table is the Company’s provision for income taxes (in thousands) and effective tax rate:
Three Months Ended March 31,
2025
2024
Provision for income taxes
$
12,868
$
6,156
Effective tax rate
34.3
%
(
8.2
)
%
For the three months ended March 31, 2025, the period-over-period change in the provision for income taxes was primarily related to differences in jurisdictional mix of income, the utilization of net operating losses in the prior period and discrete items related to share-based compensation in the current period.
13
Tax Receivable Agreement
The following table summarizes the Company’s tax receivable agreement (“TRA”) (in thousands)
Three Months Ended March 31,
2025
2024
Increase in tax receivable agreement liability
$
10,687
$
1,948
March 31, 2025
December 31, 2024
Tax receivable agreement liability- short term
$
50,900
$
2,985
Tax receivable agreement liability- long term
10,687
50,900
Total
$
61,587
$
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 three months ended March 31, 2025, the Company made payments of $
3.0
million associated with the TRA.
Contingent tax receivable agreement liability
The Company had an unrecorded contingent TRA liability of $
123.1
million as of March 31, 2025. If utilization of the Company’s deferred tax assets becomes more-likely-than-not in the future, at such time, the unrecorded contingent TRA liability will be recorded through charges in the Company’s consolidated statements of operations.
5.
Earnings (Loss) per Share
The computation of basic and diluted earnings per share was as follows (in thousands, except per share amounts):
Three Months Ended
March 31,
2025
2024
Numerator:
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.
$
12,195
$
(
91,643
)
Denominator:
Weighted-average shares outstanding - basic
311,054
307,279
Effect of dilutive securities:
Stock options
1,097
—
Restricted stock units
5,624
—
Performance stock units
6,186
—
Weighted-average shares outstanding - diluted
323,961
307,279
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:
Basic
$
0.04
$
(
0.30
)
Diluted
$
0.04
$
(
0.30
)
The following table presents potentially dilutive securities excluded from the computations of diluted earnings (loss) per share of Class A common stock (in thousands):
Three Months Ended
March 31,
2025
2024
Stock options
347
(1)
2,406
(3)
Restricted stock units
—
10,837
(3)
Performance stock units
1,961
(2)
7,827
(3)
14
(1)
Excluded from the computation of diluted earnings per share of Class A common stock because the exercise price of the stock options exceeded the average market price of the Class A common stock during the period (out-of-the-money).
(2)
Excluded from the computation of diluted earnings per share of Class A common stock because the performance vesting conditions were not met for the three months ended March 31, 2025.
(3)
Excluded from the computation of diluted loss per share of Class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period.
6.
Trade Accounts Receivable, Net
Trade accounts receivable, net was comprised of the following (in thousands):
March 31,
2025
December 31,
2024
Gross accounts receivable
$
1,282,214
$
1,303,788
Allowance for credit losses
(
3,887
)
(
3,552
)
Contract charge-backs and sales volume allowances
(
494,324
)
(
498,537
)
Cash discount allowances
(
29,767
)
(
25,968
)
Subtotal
(
527,978
)
(
528,057
)
Trade accounts receivable, net
$
754,236
$
775,731
Concentration of Receivables
Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
March 31,
2025
December 31,
2024
Customer A
36
%
37
%
Customer B
20
%
21
%
Customer C
29
%
29
%
7.
Inventories
Inventories were comprised of the following (in thousands):
March 31,
2025
December 31,
2024
Raw materials
$
207,575
$
207,697
Work in process
58,645
52,835
Finished goods
335,213
351,922
Total inventories
$
601,433
$
612,454
15
8.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets were comprised of the following (in thousands):
March 31,
2025
December 31,
2024
Deposits and advances
$
2,438
$
1,868
Prepaid insurance
5,203
8,264
Prepaid regulatory fees
4,640
6,958
Income and other tax receivables
19,726
16,829
Prepaid taxes
3,227
7,516
Other current receivables
20,509
9,142
Chargebacks receivable
5,336
6,378
Other prepaid assets
27,445
23,762
Total prepaid expenses and other current assets
$
88,524
$
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
61
—
—
61
Balance as of March 31, 2025
$
161,720
$
366,312
$
69,465
$
597,497
Intangible assets as of March 31, 2025 and December 31, 2024 were comprised of the following (in thousands):
March 31, 2025
December 31, 2024
Weighted-Average
Amortization Period
(in years)
Cost
Accumulated
Amortization
Net
Cost
Accumulated
Amortization
Net
Amortizing intangible assets:
Product rights
6.8
$
1,558,670
$
(
899,407
)
$
659,263
$
1,550,469
$
(
856,914
)
$
693,555
Other intangible assets
2.4
83,200
(
61,427
)
21,773
83,200
(
58,678
)
24,522
Subtotal
1,641,870
(
960,834
)
681,036
1,633,669
(
915,592
)
718,077
In-process research and development
8,100
—
8,100
14,300
—
14,300
Total intangible assets
$
1,649,970
$
(
960,834
)
$
689,136
$
1,647,969
$
(
915,592
)
$
732,377
Amortization expense related to intangible assets for the three months ended March 31, 2025 and 2024 was $
45.2
million and $
39.9
million, respectively.
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 months ended March 31, 2024 (
none
for the three months ended March 31, 2025).
16
10.
Other Assets
Other assets were comprised of the following (in thousands):
March 31, 2025
December 31, 2024
Interest rate swap
(1)
$
23,767
$
35,921
Security deposits
3,795
3,752
Long-term prepaid expenses
10,957
12,362
Deferred revolving credit facility costs
2,451
2,820
Long-term restricted cash
2,624
—
Other long term assets
1,824
5,278
Total other assets
$
45,418
$
60,133
(1)
Refer to
Note 14. Fair Value Measurements
and
Note 15. Financial Instruments
for information about the Company’s interest rate swap.
11.
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses were comprised of the following (in thousands):
March 31, 2025
December 31, 2024
Accounts payable
$
192,532
$
258,691
Accrued returns allowance
(1)
165,476
160,490
Accrued compensation
41,598
72,959
Accrued Medicaid and commercial rebates
(1)
115,753
135,488
Accrued royalties
24,506
23,687
Commercial chargebacks and rebates
10,226
10,226
Accrued professional fees
18,410
17,339
Accrued other
60,071
56,570
Total accounts payable and accrued expenses
$
628,572
$
735,450
(1)
Refer to
Note 2. Revenue Recognition
for a rollforward of the balance from December 31, 2024 to March 31, 2025.
12.
Debt
There have been no material changes in the Company’s long-term debt since December 31, 2024, except as disclosed below. Refer to
Note 15. Debt
in the Company’s 2024 Annual Report on Form 10-K for additional information and definitions of terms used in this note.
Term Loans
The following is a summary of the Company’s indebtedness under its term loans (in thousands):
March 31, 2025
December 31, 2024
Term Loan Due 2025
$
—
$
191,979
Term Loan Due 2028
2,278,158
2,292,856
Total debt
2,278,158
2,484,835
Less: debt issuance costs
(
92,389
)
(
98,832
)
Total debt, net of debt issuance costs
2,185,769
2,386,003
Less: current portion of long-term debt
(
31,790
)
(
224,213
)
Total long-term debt, net
$
2,153,979
$
2,161,790
17
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
March 31, 2025
and
December 31, 2024
, $
290.0
million and $
100.0
million, respectively, was outstanding on the Amended New Revolving Credit Facility.
13.
Other Long-Term Liabilities
Other long-term liabilities were comprised of the following (in thousands):
March 31, 2025
December 31, 2024
Uncertain tax positions
$
549
$
1,252
Long-term compensation
15,535
17,125
Other long-term liabilities
7,107
8,572
Total other long-term liabilities
$
23,191
$
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 March 31, 2025 and December 31, 2024 (in thousands):
Fair Value Measurement Based on
March 31, 2025
Total
Quoted
Prices in
Active
Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Assets
Interest rate swap
(1)
$
23,767
$
—
$
23,767
$
—
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 three months ended March 31, 2025.
Assets and Liabilities Not Measured at Fair Value on a Recurring Basis
The carrying amounts of cash, accounts receivable and accounts payable approximate their fair values due to the short-term maturity of these instruments.
The following is a summary of the Company’s indebtedness at fair value (in thousands):
18
March 31, 2025
December 31, 2024
Term Loan Due 2025
$
—
$
192,579
Term Loan Due 2028
$
2,320,873
$
2,364,508
The Term Loan Due 2025 and Term Loan Due 2028 are each in the Level 2 category within the fair value level hierarchy. The fair values were determined using market data for valuation.
Refer to
Note 15
.
Debt
in the Company’s 2024 Annual Report on Form 10-K for detailed information about its indebtedness, including definitions of terms.
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
There were no non-recurring fair value measurements during the three months ended March 31, 2025 and 2024.
15.
Financial Instruments
The Company uses an interest rate swap to manage its exposure to market risks for changes in interest rates.
During the
three
months
ended
March 31, 2025
, the Company reclassified a net gain of
$
6.4
million
from accumulated other comprehensive loss to a reduction of interest expense, net. Approximately $
15.0
million of net losses included in accumulated other comprehensive loss as of
March 31, 2025
are expected to be reclassified into earnings within the next 12 months as interest payments are made on the Company’s Term Loan Due 2028 and amortization of the amounts included in accumulated other comprehensive loss occurs.
As of March 31, 2025,
the total loss, net of income taxes, related to the Company’s cash flow hedge of
$
12.2
million
, was recognized in accumulated other comprehensive loss. Refer to
Note
17. Stockholders’ Deficiency
in this Quarterly Report on Form 10-Q and
Note 19. Financial Instruments
in our Annual Report on Form 10-K for additional information.
A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands):
March 31, 2025
December 31, 2024
Derivatives Designated as Hedging Instruments
Balance Sheet
Classification
Fair Value
Balance Sheet
Classification
Fair Value
Variable-to-fixed interest rate swap
Other Assets
$
23,767
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
.
19
Contingencies
Legal Proceedings
The Company's legal proceedings are complex, constantly evolving, and subject to uncertainty. As such, the Company cannot predict the outcome or impact of its significant legal proceedings which are set forth below. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs and may therefore face claims arising from the regulation and/or consumption of such products. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such proceedings could include damages, fines, penalties and injunctive or administrative remedies.
For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any
such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, how
ever, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized.
For the three months ended March 31, 2024, charges related to legal matters, net of $
94.4
million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the U.S. (refer to the section
Civil Prescription Opioid Litigation
below).
Liabilities for legal matters were comprised of the following (in thousands):
Matter
March 31, 2025
December 31, 2024
Civil prescription opioid litigation
$
41,903
$
29,671
Other
1,600
2,084
Current portion of liabilities for legal matters
$
43,503
$
31,755
Civil prescription opioid litigation (Liabilities for legal matters - long term)
$
72,979
$
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.
20
In Re Generic Pharmaceuticals Pricing Antitrust Litigation
Beginning in March 2016, various purchasers of generic drugs filed multiple putative antitrust class action complaints against a substantial number of generic pharmaceutical manufacturers, including the Company and Impax Laboratories, Inc. (“Impax”), alleging an illegal conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers. They seek unspecified monetary damages and equitable relief, including disgorgement and restitution. The lawsuits were consolidated in the United States District Court for the Eastern District of Pennsylvania (See
In re Generic Pharmaceuticals Pricing Antitrust Litigation, No. 2724
(E.D. Pa
.
)) (“MDL No. 2724”).
In 2019 and 2020, Attorneys General of
43
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., 3:2
0-cv-00802-MPS.
Fact discovery is underway in MDL No. 2724 and in the State Attorneys General cases naming the Company as a defendant. Expert discovery is complete in
Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MPS
. In
Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MSP
, defendants’ joint motions for summary judgement were fully briefed on April 7, 2025, and defendant-specific motions for summary judgement are due in July 2025. In
Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al., 3:19-cv-00710-MPS
, defendants jointly moved to dismiss the complaint and Amneal individually moved to dismiss the states’ Ranitidine, Bethanechol, and overarching conspiracy claims. These motions were fully briefed on February 14, 2025.
In MDL No. 2724, defendants including the Company and Impax jointly moved to dismiss certain complaints in December 2024. Amneal individually moved to dismiss plaintiffs’ Bethanechol Chloride claims in
American Airlines, Inc., et al v. Actavis Holdco U.S., Inc., et al, 2:24-cv-01430
. These motions were fully briefed on February 20, 2025. The MDL Court ordered that trials for the first multi-district litigation (“MDL”) cases chosen for bellwether treatment, none of which name the Company or Impax as defendants, will begin August 8, 2025. The MDL Court has identified the second round of MDL cases chosen for bellwether treatment, one of which names Impax as a defendant. No scheduling orders have been set.
Civil Prescription Opioid Litigation
The Company is named in over
900
state and federal cases relating to the sale of prescription opioid pain relievers. Plaintiffs are political subdivisions, schools, hospitals, Native American tribes, pension funds, third-party payors, and individuals. Nearly all federal court cases are consolidated for pre-trial proceedings in Case No. 17-mdl-2804, USDC N.D. OH. The Company also is named in state court cases pending in
six
states. There are no firm trial dates in those state-court cases.
The Company has received a subpoena from the New York Attorney General, a subpoena from the Maryland Attorney General, and a CID issued by the Alaska Attorney General all seeking information regarding its business concerning opioid-containing products. The Company has cooperated and continues to cooperate with these requests.
In 2023, the Company reached settlements with the New Mexico Attorney General and West Virginia political subdivisions and a settlement in principle with a group of private hospitals in Alabama. In late April 2024, the Company reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases filed and that might have been filed by state Attorneys General, political subdivisions and Native American tribes. The settlement in principle is subject to execution of a definitive settlement agreement. The settlement would be payable over
ten years
. Under the settlement in principle, the Company would agree to pay $
92.5
million in cash and provide $
180.0
million (valued at $
125
/twin pack) in naloxone nasal spray to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive
25
% of the naloxone nasal spray’s value (up to $
45.0
million) in cash during the last
four years
of the
ten years
payment term, which could increase the total amount of cash the Company would agree to pay up to $
137.5
million.
As of March 31, 2024, the Company concluded the loss related to the opioid litigation was probable, and the related loss was reasonably estimable considering the settlement in principle. As a result, the Company recorded a charge of $
94.4
million associated with the settlement in principle during the three months ended March 31, 2024, to increase the liability as of March 31, 2024 to $
115.6
million. The liability as of March 31, 2025 was $
114.9
million, of which $
73.0
million was classified as long-term. While this liability has been deemed reasonable by the Company’s management, it could significantly change as the definitive settlement agreement is finalized. As of December 31, 2024, the Company had a liability of $
115.2
million related to its prescription opioid litigation, of which $
85.5
million was classified as long-term. For the remaining cases not covered by the settlement in principle, primarily brought by other hospitals, schools and individuals, the Company has not recorded a liability as of March 31, 2025 or December 31, 2024, because it concluded that a loss was not probable and estimable.
21
United States Department of Justice / Drug Enforcement Administration Subpoenas
On July 7, 2017, Amneal Pharmaceuticals of New York, LLC received an administrative subpoena issued by the Long Island, NY District Office of the Drug Enforcement Administration (the “DEA”) requesting information related to compliance with certain recordkeeping and reporting requirements. On or about April 12, 2019 and May 28, 2019, the Company received grand jury subpoenas from the U.S. Attorney’s Office for the Eastern District of New York (the “USAO”) relating to similar topics concerning the Company’s suspicious order monitoring program and its compliance with the Controlled Substances Act. The Company is cooperating with the USAO in responding to the subpoenas. The Company has entered into a tolling agreement with respect to potential criminal charges through November 15, 2025. The Company entered into a tolling agreement with the USAO that tolled the statute of limitations for potential civil claims through November 15, 2024. It is not possible to determine the exact outcome of these investigations.
On March 14, 2019, Amneal received a subpoena from an Assistant U.S. Attorney for the Southern District of Florida (the “AUSA”). The subpoena requested information and documents generally related to the marketing, sale, and distribution of oxymorphone. The Company is cooperating with the AUSA regarding the subpoena. However, no assurance can be given as to the timing or outcome of its underlying investigation.
On October 7, 2019, Amneal received a subpoena from the New York State Department of Financial Services seeking documents and information related to sales of opioid products in the state of New York. The Company is cooperating with the request and providing responsive information. It is not possible to determine the exact outcome of this investigation.
Ranitidine Litigation
The Company was named, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products in a federal MDL (In
re Zantac/Ranitidine NDMA Litigation
(MDL No. 2924), Southern District of Florida). Plaintiffs alleged defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in ranitidine products and the alleged associated risk of cancer. The MDL Court’s dismissal of claims by all plaintiffs against the Company and other generic drug manufacturers on preemption grounds is on appeal in the 11th Circuit. Plaintiffs filed their merits brief on April 10, 2024. The generic drug manufacturers, including the Company, filed their briefs on July 25, 2024. Plaintiffs’ reply brief was filed November 8, 2024. The briefing also addresses the MDL Court’s December 6, 2022 exclusion of plaintiff’s general causation experts. The 11th Circuit will set an oral argument date in July 2025.
The Company has also been named in state court cases in
four
states. The Company has filed motions to dismiss those cases. On August 17, 2023, the judge in the consolidated Illinois state court cases granted a motion to dismiss all such cases in which the Company had been named, holding all claims preempted. On December 10, 2024, plaintiffs filed a motion in the Illinois state court cases seeking entry of partial final judgment as to the Company and other generic drug manufacturer defendants to allow plaintiffs to appeal the dismissals of those defendants. The Company has reached an agreement in principle, which is not material, to settle the
95
cases pending against it in California state court. Currently, there is a September 15, 2025 trial date in the one case pending in New Mexico brought by the Attorney General, but the court indicated that date will be continued. There are no other trial dates involving the Company in any of the state court cases.
Metformin Litigation
Beginning in 2020, Amneal was named as a defendant in several putative class action lawsuits filed and consolidated in the United States District Court for the District of New Jersey, seeking compensation for economic loss allegedly incurred in connection with their purchase of generic metformin allegedly contaminated with NDMA. See
In Re Metformin Marketing and Sales Practices Litigation
(No. 2:20-cv-02324-MCA-MAH) (“
In re Metformin
”),
Marcia E. Brice v. Amneal Pharmaceuticals, Inc
.,
No. 2:20-cv-13728
(D.N.J.), and
Michael Hann v. Amneal Pharmaceuticals of New York, LLC
et al.,
No. 2:23-cv-22902
(D.N.J.). On January 7, 2025, the court dismissed the Third Amended Complaint in
In re Metformin
without prejudice and granted plaintiffs the opportunity to amend their complaint. On February 20, 2025, plaintiffs filed a Fourth Amended Complaint in
In re Metformin
, which incorporated the allegations of plaintiff Brice and plaintiff Hann, and then filed notices of voluntary dismissal of
Marcia E. Brice v. Amneal Pharmaceuticals, Inc.
,
No. 2:20-cv-13728
(D.N.J.) and
Michael Hann v. Amneal Pharmaceuticals of New York, LLC
et al., No. 2:23-cv-22902
(D.N.J.) as standalone actions. Defendants filed a motion to dismiss the Fourth Amended Complaint. Plaintiffs’ response in opposition was filed on April 7, 2025 and defendants’ reply was filed on April 22, 2025.
On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of valsartan, losartan, and metformin based on the alleged presence of nitrosamines in those products. The only allegations against the Company concern metformin (See
Davis v. Camber Pharmaceuticals, Inc.
,
et al.,
22
C.A. No. 2:21-00254
(M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the United States Judicial Panel on Multidistrict Litigation transferred the Davis Action into the
In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation
MDL for pretrial proceedings.
UFCW Local 1500 Welfare Fund v. Takeda Pharmaceuticals U.S.A., Inc.
On November 14, 2023, UFCW Local 1500 Welfare Fund and other health plans filed a purported class action lawsuit in the United States District Court for the Southern District of New York against multiple manufacturers, including the Company, alleging an illegal conspiracy to restrict output of generic COLCRYS®. See
UFCW Local 1500 Welfare Fund et al. v. Takeda Pharma. U.S.A., Inc. et al, No. 1:23-cv-10030 (S.D.N.Y.).
On February 28, 2024, Takeda Pharmaceuticals U.S.A., Inc. filed a motion to transfer the case to the United States District Court for the Eastern District of Pennsylvania. On March 13, 2024 and March 27, 2024, Amneal submitted a letter and brief, respectively, informing the Court of its position that the Eastern District of Pennsylvania lacks personal jurisdiction over Amneal. That motion remains pending and the deadline to respond to the complaint is set at
45
days after the court resolves the motion to transfer.
Indian Tax Authority Matters
Amneal Pharmaceuticals Pvt. Ltd. and RAKS Pharmaceuticals Pvt. Ltd., which are subsidiaries of the Company, are currently involved in litigations with Indian tax authorities concerning Central Excise Tax, Service Tax, Goods & Services Tax, and Value Added Tax for various periods of time between 2014 and 2017. These subsidiaries have contested certain of these assessments, which are at various stages of the administrative process. The Company strongly believes its Indian subsidiaries have meritorious defenses in the matter.
Guaifenesin Litigation
On September 5, 2024, Amneal was named as a defendant along with CVS Pharmacy, Inc. (“CVS”) in a putative consumer class action lawsuit in the United States District Court for the Northern District of California alleging that generic guaifenesin products manufactured by Amneal contain benzene through the use of carbomer, an inactive ingredient. See
Leonard v. CVS Pharmacy, Inc., No. 5:24-cv-06280
(N.D. Cal.). The complaint purports to plead, on behalf of a nationwide class and California subclass, the following counts: breach of warranty; unjust enrichment; fraud; and violation of California’s Unfair Competition Law. The complaint seeks damages, including punitive damages, restitution, other equitable monetary relief, injunctive relief, prejudgment interest and attorneys’ fees and costs. On December 30, 2024, the Company and CVS jointly filed a motion to dismiss. On January 21, 2025, in lieu of filing a response to defendants’ motion to dismiss, plaintiff filed an amended complaint. Defendants’ motion to dismiss the amended complaint was filed on February 20, 2025, plaintiff filed her response to the motion to dismiss on March 24, 2025, and defendants filed their reply on April 14, 2025. That motion is fully briefed, and a hearing on the motion is scheduled for June 12, 2025.
Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 3:25-cv-00181-GC-TJB
On November 25, 2024, the Company and Impax received a notice letter from Sandoz Inc. (“Sandoz”) stating that it had filed an ANDA with the U.S. Food and Drug Administration (“FDA”) seeking approval to market generic versions of CREXONT®, an extended-release oral capsule formulation of carbidopa and levodopa for the treatment of Parkinson’s disease. The notice letter included a Paragraph IV certification alleging that certain patents covering CREXONT® are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of Sandoz’s generic product.
In response to this notice letter, on January 7, 2025, the Company and Impax filed a patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos. 10,098,845, 10,292,935, 10,688,058, 10,973,769, 10,987,313, 11,357,733, 11,622,941, 11,666,538, 11,986,449, 12,064,521, 12,109,185, and 12,128,141. On April 1, 2025, the Company and Impax filed a First Amended Complaint in response to a second notice from Sandoz, adding claims for infringement relating to U.S. Patents Nos. 12,178,918, 12,178,919, and 12,194,150. On April 14, 2025, Sandoz filed an Answer, Affirmative Defense, and Counterclaims for non-infringement and invalidity of the asserted patents. The filing of this lawsuit triggered a 30-month stay of FDA approval of the Sandoz ANDA from the date of receipt of the notice letter. CREXONT® is also subject to a regulatory exclusivity until August 7, 2027.
23
17.
Stockholders’ Deficiency
Refer to
Note 21. Stockholders’ (Deficiency) Equity
in our 2024 Annual Report on Form 10-K for additional information.
Changes in Accumulated Other Comprehensive Loss by Component (in thousands):
Foreign
currency
translation
adjustments
Unrealized gain (loss) on cash
flow hedge, net
of tax
Accumulated
other
comprehensive loss
Balance December 31, 2024
$
(
71,860
)
$
6,350
$
(
65,510
)
Other comprehensive loss before reclassification
(
1,632
)
(
12,154
)
(
13,786
)
Reclassification of cash flow hedge to earnings, net of tax of $0
—
(
6,444
)
(
6,444
)
Balance March 31, 2025
$
(
73,492
)
$
(
12,248
)
$
(
85,740
)
Balance December 31, 2023
$
(
66,072
)
$
33,723
$
(
32,349
)
Other comprehensive (loss) income before reclassification
(
390
)
15,543
15,153
Reclassification of cash flow hedge to earnings, net of tax of $
0
—
(
6,515
)
(
6,515
)
Balance March 31, 2024
$
(
66,462
)
$
42,751
$
(
23,711
)
18.
Related Party Transactions
The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three months ended March 31, 2025, there were no material changes to our related party agreements or relationships as described in
Note 23. Related Party Transactions
and
Note 21. Stockholders’ (Deficiency) Equity
in our
2024 Annual Report on Form 10-K.
24
The following table summarizes the Company’s related party transactions (in thousands):
Three Months Ended March 31,
Related Party and Nature of Transaction
Caption in Balance Sheet and Statement of Operations
2025
2024
Kashiv Biosciences LLC
Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko and Fylnetra)
Inventory and cost of goods sold
$
4,323
$
1,216
Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko and Fylnetra)
Cost of goods sold
$
4,231
$
4,526
Parking space lease
Research and development
$
25
$
25
Storage agreement
Research and development
$
(
47
)
$
(
77
)
Generic development supply agreement - development activity deferred income
Accounts payable and accrued expenses
$
(
182
)
$
(
422
)
Development and commercialization agreement - long-acting injectable
Research and development
$
—
$
500
Generic development supply agreement - research and development material
Research and development
$
—
$
(
48
)
Other Related Parties
Members - tax receivable agreement (TRA liability)
Ellodi Pharmaceuticals, L.P. - securities purchase and license and collaboration agreements
Research and development
$
4,270
$
—
AzaTech Pharma LLC - supply agreement
Inventory and cost of goods sold
$
2,317
$
2,312
Kanan, LLC - operating lease
Inventory and cost of goods sold
$
592
$
592
Sutaria Family Realty, LLC - operating lease
Inventory and cost of goods sold
$
324
$
314
Tracy Properties LLC - operating lease
Selling, general and administrative
$
177
$
143
R&S Solutions LLC
Property, plant and equipment, net
$
160
$
—
Alkermes Plc
Inventory and cost of goods sold
$
92
$
12
Avtar Investments, LLC - consulting services
Research and development
$
60
$
69
AvPROP, LLC - operating lease
Selling, general and administrative
$
53
$
44
25
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
March 31, 2025
December 31, 2024
Kashiv - various agreements
$
446
$
447
AzaTech Pharma LLC - supply agreement
25
21
Alkermes
16
16
Related party receivables - short term
$
487
$
484
Members - tax receivable agreement
$
50,900
$
2,985
Kashiv - various agreements
5,996
16,908
Rondo Class B unit holders - tax distributions
4,806
—
Apace Packaging, LLC - packaging agreement
1,819
1,205
AzaTech Pharma LLC - supply agreement
1,535
1,151
Ellodi Pharmaceuticals, L.P.
1,107
—
Avtar Investments LLC - consulting services
40
60
Alkermes Plc
2
2
Related party payables - short term
$
66,205
$
22,311
Members - tax receivable agreement
$
10,687
$
50,900
Related party payables - long term
$
10,687
$
50,900
Equipment Purchases
The Company purchased $
0.2
million of equipment from R&S Solutions LLC during the three months ended March 31, 2025, which is included in property, plant and equipment in the Company’s consolidated balance sheets. A member of Company management beneficially owns equity securities of R&S Solutions LLC.
Securities Purchase Agreement and License and Collaboration Agreement
On January 3, 2025, the Company entered into a securities purchase agreement and a license and collaboration agreement with Ellodi Pharmaceuticals, L.P. (“Ellodi”) and certain entities affiliated with TPG for which the Company paid $
3.0
million for limited liability partnership units of Ellodi and committed to fund certain research and development expenses. Ellodi is a pre-clinical gastroenterology-focused specialty pharmaceutical company. An observer of our Board is a partner in TPG Capital and a board director of Ellodi. During the three months ended March 31, 2025, the Company recorded research and development expense of $
4.3
million related to these agreements, including a $
1.3
million estimate for funding the research and development commitment. As of March 31, 2025, the Company has a remaining liability of $
1.1
million associated with these agreements.
Amneal has the option to obtain, under certain conditions, an exclusive royalty bearing and sub-licensable world-wide license to a late-stage gastroenterology-focused pipeline product under development. If exercised, the Company will be responsible for remaining development activities and obtaining regulatory approval of the product. The license and collaboration agreement provides for potential future milestone payments to Ellodi for regulatory and commercial milestones of up to $
48.5
million and royalties on commercial sales.
19.
Segment Information
The Company has
three
reportable segments: Affordable Medicines (formerly known as Generics), Specialty, and AvKARE. During the fourth quarter of 2024, the Company changed the name of its Generics segment to “Affordable Medicines” to reflect the full product offering of the segment. The name change did not result in any change to the composition of the Company’s reportable segments and, therefore, did not result in any change to its historical results.
Chief Operating Decision Makers
The Company’s Co-Chief Executive Officers are the Company’s chief operating decision makers (“CODMs”). The CODMs evaluate the financial performance of the Company based upon segment operating income (loss). Items below operating income (loss) are not reported by segment, since they are excluded from the measure of segment profitability reviewed by the Company’s CODMs. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements,
26
and non-operating income and expenses are included in “Corporate and Other.” The Company does not report balance sheet information by segment since it is not reviewed by the Company’s CODMs.
The tables below present segment information reconciled to total Company financial results, with segment operating income or loss, including gross profit less direct selling expenses, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands):
Three Months Ended March 31, 2025
Affordable Medicines
(1)
Specialty
AvKARE
Corporate
and Other
Total
Company
Net revenue
$
414,708
$
108,297
$
172,415
$
—
$
695,420
Cost of goods sold
242,633
53,083
143,813
—
439,529
Gross profit
172,075
55,214
28,602
—
255,891
Selling, general and administrative
33,715
30,978
A
15,694
37,901
118,288
Research and development
30,980
B
9,060
B
—
—
40,040
Intellectual property legal development expenses
1,713
54
—
—
1,767
Restructuring and other charges
—
130
—
441
571
Other operating income
(
5,122
)
—
—
—
(
5,122
)
Operating income (loss)
$
110,789
$
14,992
$
12,908
$
(
38,342
)
$
100,347
Three Months Ended March 31, 2024
Affordable Medicines
(1)
Specialty
AvKARE
Corporate
and Other
Total
Company
Net revenue
$
391,294
$
105,234
$
162,663
$
—
$
659,191
Cost of goods sold
239,922
44,800
136,409
—
421,131
Gross profit
151,372
60,434
26,254
—
238,060
Selling, general and administrative
33,085
25,196
A
14,907
39,407
112,595
Research and development
34,371
B
4,927
B
—
—
39,298
Intellectual property legal development expenses
960
24
—
—
984
Restructuring and other charges
—
946
—
524
1,470
Charges related to legal matters, net
94,359
—
—
—
94,359
Other operating expense
—
100
—
—
100
Operating (loss) income
$
(
11,403
)
$
29,241
$
11,347
$
(
39,931
)
$
(
10,746
)
(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):
27
Three Months Ended March 31,
2025
2024
Employee compensation and benefits
$
10,872
$
8,837
Product marketing
8,011
8,528
Commercial operations and salesforce
10,791
6,265
Other
(1)
1,304
1,566
Total
$
30,978
$
25,196
(1)
Other includes professional fees and other expenses not presented to the CODMs.
Research and Development Expenses - Affordable Medicines and Specialty Segments
B.
Research and development expenses for the Affordable Medicines and Specialty segments were comprised of the following (in thousands):
Three Months Ended March 31,
2025
2024
Affordable Medicines
Specialty
Affordable Medicines
Specialty
Employee compensation and benefits
$
13,541
$
1,540
$
11,589
$
2,085
Materials and supplies
8,527
203
9,958
431
Product development and studies
(1)
(
69
)
2,319
965
433
Milestones
250
3,000
3,500
—
Facilities costs
1,634
750
1,692
1,247
Other
(2)
7,097
1,248
6,667
731
Total
$
30,980
$
9,060
$
34,371
$
4,927
(1)
For the three months ended March 31, 2025, Affordable Medicines included a $
1.6
million reduction to product development and studies expense for services performed under the license agreement with Orion Corporation. Refer to
Note 3. Alliance and Collaboration
.
(2)
For the Affordable Medicines segment, other includes repairs and maintenance, outside testing, professional fees, equipment calibration and other expenses not presented to the CODMs. For the Specialty segment, other includes repairs and maintenance, outside testing, professional fees and other expenses not presented to the CODMs.
20.
Subsequent Events
Rondo Revolving Credit Facility
On April 9, 2025, the Company executed an amendment to the Amended Rondo Revolving Credit Facility (as defined in
Note 15. Debt
in our 2024 Annual Report on Form 10-K) to increase (i) the borrowing capacity from $
70.0
million to $
125.0
million and (ii) the letter of credit commitment from $
60.0
million to $
90.0
million, and to extend the maturity to April 9, 2030.
Leases
On April 23, 2025, the Company executed a lease renewal for an R&D and manufacturing facility in New Jersey. This renewal extended the lease term by
ten years
through November 30, 2035. The aggregate payments over the renewal period are $
11.6
million.
On May 7, 2025, the Company executed a lease extension for a manufacturing facility in New York. This agreement extended the existing lease term by
seven years
through March 31, 2033. The aggregate payments over the extension period are $
12.4
million.
Acquisition of Land From Related Parties
During the second quarter of 2025, the Company executed an agreement to acquire parcels of land in India from two family members of the Company’s Co-Chief Executive Officers. The Company plans to utilize this land to construct
two
new greenfield peptide manufacturing facilities. The total purchase price for this acquisition was $
11.4
million, of which
28
$
10.9
million was paid to the sellers. The remaining payment of $
0.5
million will be deferred until
three years
following the acquisition date as partial security for the sellers’ indemnity obligations. It is anticipated that the facilities will be used to manufacture products for the Company, as well as support the Company’s collaboration agreement with Metsera, Inc. For additional information related to the Company’s agreement with Metsera, Inc., refer to
Note 3. Alliance and Collaboration
in this Quarterly Report on Form 10-Q and
Note 5. Alliance and Collaboration
in the Company’s 2024 Annual Report on Form 10-K.
29
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Amneal Pharmaceuticals, Inc. (the “Company”, “we,” “us,” or “our”) is a global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines. Our Affordable Medicines segment includes retail generics, injectables, and biosimilars. In our Specialty segment, we offer a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through our AvKARE segment, we are a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. We operate principally in the United States (“U.S.”), India, and Ireland.
The following discussion and analysis contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth under
Item 1A. Risk Factors
in our 2024 Annual Report on Form 10-K and under the heading
Cautionary Note Regarding Forward-Looking Statements
included elsewhere in this Quarterly Report on Form 10-Q.
The following discussion and analysis for the three months ended March 31, 2025 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2024 included in our 2024 Annual Report on Form 10-K.
Overview
We have three reportable segments: Affordable Medicines, Specialty, and AvKARE. Refer to
Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
in our 2024 Annual Report on Form 10-K for a description of our segments. During the fourth quarter of 2024, we changed the name of our Generics segment to “Affordable Medicines” to reflect the full product offering of the segment. The name change did not result in any change to the composition of our reportable segments and, therefore, did not result in any change to our historical results.
The Pharmaceutical Industry
The pharmaceutical industry is highly competitive and highly regulated. As a result, we face a number of industry-specific factors and challenges, which can significantly impact our results. For a more detailed explanation of our business and its risks, refer to our
2024 Annual Report on Form 10-K
,
as supplemented by
Part II, Item 1A
“
Risk Factors
”
of our subsequent Quarterly Reports on Form 10-Q.
Inflation
While it is difficult to accurately measure the impact of inflation, we do not currently expect a material impact related to inflation for the year ending December 31, 2025. Notwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, tariff impacts on supply, labor and other costs, could exceed our expectations, which would further adversely impact our operating results in future periods.
Trade Policy and Tariffs
We are subject to certain trade and tariff requirements imposed by the U.S. and various foreign governments. The great majority of our net sales rely on finished dosage forms (“FDF”) or active pharmaceutical ingredients (“API”) produced in the U.S. or India. We have limited reliance on imports from Europe and China, and no reliance on imports from Mexico or Canada.
Over the past few months, President Trump has announced a number of tariff actions, and while there are currently no reciprocal tariffs on pharmaceutical products imported into the U.S., this can change at any moment. In addition, on April 14, 2025, the Department of Commerce Bureau of Industry and Security announced that it had initiated, as of April 1, 2025, a broad investigation under section 232 of the Trade Expansion Act to determine the effects on national security of imports of pharmaceuticals (i.e. FDF, API, key starting materials, derivatives, and medical countermeasures). This is currently an investigation into whether trade remedies such as tariffs should be imposed and covers both generic and brand products.
Given the global nature of pharmaceutical supply chains, any changes to historically prevailing tariff requirements could impact us and our industry (i.e. increase costs, product availability, and supply chain disruptions). The Company is closely monitoring these tariff and trade developments and will take actions to reduce or minimize any material negative impact.
30
Results of Operations
Consolidated Results
The following table sets forth our summarized, consolidated results of operations for the three months ended March 31, 2025 and 2024 (in thousands):
Three Months Ended March 31,
Change
2025
2024
$
%
Net revenue
$
695,420
$
659,191
$
36,229
5.5
%
Cost of goods sold
439,529
421,131
18,398
4.4
%
Gross profit
255,891
238,060
17,831
7.5
%
Selling, general and administrative
118,288
112,595
5,693
5.1
%
Research and development
40,040
39,298
742
1.9
%
Intellectual property legal development expenses
1,767
984
783
79.6
%
Restructuring and other charges
571
1,470
(899)
(61.2)
%
Charges related to legal matters, net
—
94,359
(94,359)
(100.0)
%
Other operating (income) expense
(5,122)
100
(5,222)
nm
Operating income (loss)
100,347
(10,746)
111,093
nm
Total other expense, net
(62,861)
(64,776)
1,915
(3.0)
%
Income (loss) before income taxes
37,486
(75,522)
113,008
nm
Provision for income taxes
12,868
6,156
6,712
109.0
%
Net income (loss)
$
24,618
$
(81,678)
$
106,296
nm
nm - not meaningful
Net Revenue
Net revenue for the three months ended March 31, 2025 increased 5.5% from the prior year period primarily due to:
•
Growth in our Affordable Medicines segment net revenue of $23.4 million, primarily due to new products launched in 2025 and 2024, which contributed $40.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
•
Growth in our AvKARE segment net revenue of $9.8 million, primarily driven by
growth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel.
•
Growth in our Specialty segment net revenue of $3.1 million, primarily driven by increases of $9.1 million and $4.0 million in sales of CREXONT® and UNITHROID®, respectively, partially offset by a $5.1 million decline in sales of RYTARY®. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
Cost of Goods Sold and Gross Profit
Cost of goods sold increased 4.4%
for the three months ended March 31, 2025 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased
Affordable Medicines and
AvKARE volume, increased amortization related to CREXONT
® and
increased plant and freight costs, partially offset by manufacturing efficiencies.
Gross profit as a percentage of net revenue increased to 36.8% for the three months ended March 31, 2025 from 36.1% in the prior year period, primarily as a result of the factors noted above.
Selling, General, and Administrative
SG&A expenses for the three months ended March 31, 2025 increased 5.1% as compared to the prior year period, primarily due to increases in employee compensation and launch costs associated with CREXONT®, partially offset by a reduction in legal expenses primarily resulting from insurance coverage for certain legal fees.
31
Research and Development
R&D expenses for the three months ended March 31, 2025 increased 1.9% as compared to the prior year period, primarily due to increases in employee compensation.
Charges Related to Legal Matters, Net
For the three months ended March 31, 2024, charges related to legal matters, net of
$94.4 million
were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to
Note 16. Commitments and Contingencies
for additional information.
Other Operating Income
Other operating income for the three months ended March 31, 2025 was comprised of income earned from the
India Production Linked Incentive Scheme for the Pharmaceutical Sector (the “PLI Scheme”).
Total Other Expense, Net
Total other expense, net for the three months ended March 31, 2025 decreased 3.0% as compared to the prior year period. The decrease was primarily driven by an $8.8 million decrease in interest expense as a result of lower rates and lower amounts outstanding on our variable-rate debt and the favorable impact of foreign exchange, partially offset by an $8.7 million period-over-period increase in our tax receivable agreement liability.
Provision For Income Taxes
For the three months ended March 31, 2025, our provision for income taxes and effective tax rate were
$12.9 million
and
34.3%
, respectively, as compared to
$6.2 million
and
(8.2)%, respectively,
for the three months ended March 31, 2024. T
he period-over-period changes in the provision for income taxes and effective tax rate primarily
related to differences in jurisdictional mix of income, the utilization of net operating losses in the prior period and discrete items related to share-based compensation in the current period.
Affordable Medicines
The following table sets forth results of operations for our Affordable Medicines segment for the three months ended March 31, 2025 and 2024 (in thousands):
Three Months Ended March 31,
Change
2025
2024
$
%
Net revenue
$
414,708
$
391,294
$
23,414
6.0
%
Cost of goods sold
242,633
239,922
2,711
1.1
%
Gross profit
172,075
151,372
20,703
13.7
%
Selling, general and administrative
33,715
33,085
630
1.9
%
Research and development
30,980
34,371
(3,391)
(9.9)
%
Intellectual property legal development expenses
1,713
960
753
78.4
%
Charges related to legal matters, net
—
94,359
(94,359)
(100.0)
%
Other operating income
(5,122)
—
(5,122)
nm
Operating income (loss)
$
110,789
$
(11,403)
$
122,192
nm
nm - not meaningful
Net Revenue
Affordable Medicines net revenue for the three months ended March 31, 2025 increased 6.0% as compared to the prior year period, primarily due to new products launched in 2025 and 2024, which contributed $40.8 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
32
Cost of Goods Sold and Gross Profit
Affordable Medicines cost of goods sold for the three months ended March 31, 2025 increased 1.1% as compared to the prior year period, primarily due to costs associated with increased sales volume and
increased plant and freight costs, partially offset by manufacturing efficiencies.
Affordable Medicines gross profit as a percentage of net revenue increased to 41.5% for the three months ended March 31, 2025 from 38.7% in the prior year period, primarily as a result of the factors noted above.
Selling, General, and Administrative
Affordable Medicines SG&A expense for the three months ended March 31, 2025 increased 1.9% as compared to the prior year period, primarily due to increases in employee compensation and shipping costs.
Research and Development
Affordable Medicines R&D expenses for the three months ended March 31, 2025 decreased 9.9% as compared to the prior year period, primarily due to a decrease in in-licensing and upfront milestone payments of $3.3 million and reduced project spend, partially offset by increases in employee compensation.
Charges Related to Legal Matters, Net
For the three months ended March 31, 2024, charges related to legal matters, net of $94.4 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to
Note 16. Commitments and Contingencies
for additional information.
Other Operating Income
Other operating income for the three months ended March 31, 2025 was comprised of income earned from the
PLI Scheme.
Specialty
The following table sets forth results of operations for our Specialty segment for the three months ended March 31, 2025 and 2024 (in thousands):
Three Months Ended March 31,
Change
2025
2024
$
%
Net revenue
$
108,297
$
105,234
$
3,063
2.9
%
Cost of goods sold
53,083
44,800
8,283
18.5
%
Gross profit
55,214
60,434
(5,220)
(8.6)
%
Selling, general and administrative
30,978
25,196
5,782
22.9
%
Research and development
9,060
4,927
4,133
83.9
%
Intellectual property legal development expenses
54
24
30
nm
Restructuring and other charges
130
946
(816)
(86.3)
%
Other operating expense
—
100
(100)
(100.0)
%
Operating income
$
14,992
$
29,241
$
(14,249)
(48.7)
%
nm - not meaningful
Net Revenue
Specialty net revenue for the three months ended March 31, 2025 increased 2.9% as compared to the prior year period, primarily driven by increases of $9.1 million and $4.0 million in sales of CREXONT® and UNITHROID®, respectively, partially offset by a $5.1 million decline in sales of RYTARY®. In addition, the prior year period included $4.5 million of out-licensing revenue associated with IPX203.
33
Cost of Goods Sold and Gross Profit
Specialty cost of goods sold for the three months ended March 31, 2025 increased 18.5% as compared to the prior year period, primarily due to increases in amortization related to CREXONT® and sales volume.
Specialty gross profit as a percentage of net revenue decreased to 51.0% for the three months ended March 31, 2025 as compared to 57.4% in the prior year period due to the impact of increased amortization related to CREXONT®.
Selling, General, and Administrative
Specialty SG&A expense for the three months ended March 31, 2025 increased 22.9% as compared to the prior year period, primarily due to launch costs associated with CREXONT® and increases in employee compensation.
Research and Development
Specialty R&D expenses for the three months ended March 31, 2025 increased 83.9% as compared to the prior year period, primarily due to increased in-licensing and upfront milestone payments of $3.0 million and higher project spend.
AvKARE
The following table sets forth results of operations for our AvKARE segment for the three months ended March 31, 2025 and 2024 (in thousands):
Three Months Ended March 31,
Change
2025
2024
$
%
Net revenue
$
172,415
$
162,663
$
9,752
6.0
%
Cost of goods sold
143,813
136,409
7,404
5.4
%
Gross profit
28,602
26,254
2,348
8.9
%
Selling, general and administrative
15,694
14,907
787
5.3
%
Operating income
$
12,908
$
11,347
$
1,561
13.8
%
Net Revenue
AvKARE net revenue for the three months ended March 31, 2025 increased 6.0% as compared to the prior year period primarily driven by
growth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel.
Cost of Goods Sold and Gross Profit
AvKARE cost of goods sold for the three months ended March 31, 2025 increased 5.4% as compared to the prior year period primarily due to an increased inventory provision and higher sales in our government label channel, partially offset by decreased sales in our lower margin distribution channel.
Gross profit as a percentage of net revenue increased to 16.6% for the three months ended March 31, 2025 from 16.1% in the prior year period, primarily as a result of the factors noted above.
Selling, General and Administrative
AvKARE SG&A expense for the three months ended March 31, 2025 increased 5.3% as compared to the prior year period, primarily due to increases in employee compensation and higher sales-related expenses.
Liquidity and Capital Resources
Our primary source of liquidity is cash generated from operations, available cash on hand, and borrowings under debt financing arrangements (as defined and discussed in
Note 15. Debt
in our 2024 Annual Report on Form 10-K). As of March 31, 2025, we had access to
$305.2 million
of available capacity under the Amended New Revolving Credit Facility and
$28.0 million of available capacity under the Amended Rondo Revolving Credit Facility
. On April 9, 2025, the Company executed an amendment to the Amended Rondo Revolving Credit Facility to increase (i) the borrowing capacity from $70 million to $125.0 million and (ii) the letter of credit commitment from $60 million to $90 million, and extend the maturity to April 9, 2030. We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations,
34
including acquisitions, and provide sufficient liquidity over the next 12 months from the date of filing of this Quarterly Report on Form 10-Q.
However, our ability to satisfy our working capital requirements and debt obligations will depend upon economic conditions, the impact of international trade policy, including tariffs, our ability to negotiate and maintain satisfactory terms under our borrowing and debt facilities in the future, and demand for our products, which are factors that may be out of our control. Our primary uses of capital resources are to fund operating activities, including R&D expenses associated with new product filings, and pharmaceutical product manufacturing expenses, license payments, spending on production facility expansions, capital equipment, acquisitions, and legal settlements.
We estimate that we will invest approximately $120.0 million during 2025 for capital expenditures to support and grow our existing operations, primarily related to investments in manufacturing equipment, information technology, and facilities. Our 2025 estimate includes capital expenditures for our collaboration and supply agreement with Metsera, Inc. (“Metsera”), of which we expect Metsera to reimburse us approximately $20.0 million. We expect such reimbursements to primarily be included in our cash flows from financing activities.
Debt Instruments
Over the next 12 months, we expect to make substantial payments, including
mo
nthly interest and quarterly principal amounts due for our Term Loan Due 2028, monthly interest on our Amended New Credit Facility, and contractual payments for leased premises. Refer to
Note 12. Debt
in this Quarterly Report on Form 10-Q and
Note 15.
Debt
,
Note 17. Leases,
and
Commitments and Contractual Obligations under Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
in our 2024 Annual Report on Form 10-K for additional information.
Settlement in Principle on Nationwide Civil Prescription Opioid Litigation
In late April 2024, we reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed by Attorneys General, political subdivisions and Native American tribes. Refer to
Note 16. Commitments and Contingencies
for additional information.
Tax Receivable Agreement
As part of the Reorganization (as defined in
Note 1. Nature of Operations
in our 2024 Annual Report on Form 10-K), the tax receivable agreement (“TRA”) was amended to reduce our future obligation to pay 85% of the realized tax benefits subject to the TRA to 75% of such realized benefits. As of March 31, 2025, the contingent TRA liability, including the impact of the amendment, was approximately $123.1 million. During the three months ended March 31, 2025, the Company made payments of $3.0 million associated with the TRA.
The timing and amount of any payments under the TRA may vary, depending upon a number of factors including the timing and amount of our taxable income, and the corporate tax rate in effect at the time of realization of our taxable income. The timing and amount of payments may also be accelerated under certain conditions, such as a change of control or other early termination event, which could give rise to our obligation to make TRA payments in advance of tax benefits being realized. For further information, including our recognized current and long-term liabilities for the TRA, refer to
Note 4. Income Taxes
in this Quarterly Report on Form 10-Q and
Item 1A. Risk Factors
and
Note 6. Income Taxes
in our 2024 Annual Report on Form 10-K.
Tax-Related Distributions
In 2020, we acquired a 65.1% controlling interest in both AvKARE Inc., a Tennessee corporation, now a limited liability company (“AvKARE, LLC”), and Dixon-Shane, LLC d/b/a R&S Northeast LLC, a Kentucky limited liability company (“R&S”). The sellers of AvKARE, LLC and R&S (the “AvKARE Sellers”) hold the remaining 34.9% interest in the holding company that directly owns the acquired companies (“Rondo”). We attribute 34.9% of the net income or loss associated with Rondo to redeemable non-controlling interests. During the three months ended March 31, 2025 and 2024, we made cash tax distributions of $0.1 million and $0.6 million, respectively, to the AvKARE Sellers. During April 2025, we made cash tax distributions of $4.8 million to the AvKARE Sellers.
Development and Supply Agreement
Pursuant to a development and supply agreement with Kashiv Biosciences LLC (“Kashiv”) for a long-acting injectable, we paid Kashiv $10.0 million in February 2025 for the achievement of a regulatory milestone, which was accrued as of December 31, 2024. Refer to
Note 23. Related Party Transactions
in our Annual Report on Form 10-K for additional information.
35
Acquisition of Land From Related Parties
During the second quarter of 2025, we executed an agreement to acquire parcels of land in India from two family members of the Co-Chief Executive Officers. We plan to utilize this land to construct two new greenfield peptide manufacturing facilities. The total purchase price for this acquisition was $11.4 million, of which $10.9 million was paid to the sellers. The remaining payment of $0.5 million will be deferred until three years following the acquisition date as partial security for the sellers’ indemnity obligations. It is anticipated that the facilities will be used to manufacture products for us, as well as support our collaboration agreement with Metsera, Inc. For additional information related to our agreement with Metsera, Inc., refer to
Note 3. Alliance and Collaboration
in this Quarterly Report on Form 10-Q and
Note 5. Alliance and Collaboration
in our 2024 Annual Report on Form 10-K.
Cash Balances
As of March 31, 2025, our cash and cash equivalents consist of cash on deposit and highly liquid investments. A portion of our cash flows are derived outside the U.S. As a result, we are subject to market risk associated with changes in foreign exchange rates. We maintain cash balances at both U.S. based and foreign country based commercial banks. At various times during the year, our cash balances held in the U.S. may exceed amounts that are insured by the Federal Deposit Insurance Corporation (FDIC). We make our investments in accordance with our investment policy. The primary objectives of our investment policy are liquidity and safety of principal.
Cash Flows
The following table sets forth our summarized, consolidated cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
Three Months Ended
March 31,
Change
2025
2024
$
%
Net cash provided by (used in):
Operating activities
$
7,408
$
(4,410)
$
11,818
nm
Investing activities
(17,798)
(19,760)
1,962
(9.9)
%
Financing activities
(39,166)
(23,155)
(16,011)
69.1
%
Effect of exchange rate changes on cash
(470)
(165)
(305)
184.8
%
Net decrease in cash, cash equivalents, and restricted cash
$
(50,026)
$
(47,490)
$
(2,536)
5.3
%
nm - not meaningful
Cash Flows from Operating Activities
Net cash provided by operating activities was $7.4 million for the three months ended March 31, 2025 as compared to net cash used in operating activities of $4.4 million in the prior year period.
The period-over-period increase was primarily driven by (i) payment of $52.4 million associated with the
Opana ER® antitrust litigation settlement during the three months ended March 31, 2024, (ii) higher period-over-period collections of outstanding receivables, and
(iii)
increased profitability adjusted for non-cash items, partially offset by
a decrease in accounts payables due to timing
.
Cash Flows from Investing Activities
Net cash used in investing activities for the three months ended March 31, 2025 was $17.8 million as compared to $19.8 million in the prior year period
. The period-over-period decrease in net cash used in investing activities was primarily due to a decrease in acquired intangible assets primarily driven by the payment of a sales-based milestone related to a licensing and supply agreement in the prior year period, partially offset by higher capital expenditures.
Cash Flows from Financing Activities
Net cash used in financing activities was $39.2 million for the three months ended March 31, 2025 as compared to $23.2 million in the prior year period. The period-over-period increase in net cash used in financing activities was primarily due to an increase in employee payroll tax withholding on restricted stock unit and performance stock unit vesting.
36
Commitments and Contractual Obligations
Our contractual obligations are
set forth in
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
contained in our 2024 Annual Report on Form 10-K. As of March 31, 2025, there have been no material changes to the disclosure presented in our 2024 Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of March 31, 2025.
Critical Accounting Policies and Estimates
For a discussion of our critical accounting policies and estimates, see
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
in our 2024 Annual Report on Form 10-K. There have been no material changes to the disclosures presented in our 2024 Annual Report on Form 10-K.
Recently Issued Accounting Standards
Recently issued accounting standards are discussed in
Note 1. Summary of Significant Accounting Policies
.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There has not been any material change in our assessment of market risk as set forth in
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
, in our 2024 Annual Report on Form 10-K.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Co-Chief Executive Officers and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our Co-Chief Executive Officers and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, our Co-Chief Executive Officers and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2025.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2025, there were no changes in our internal control over financial reporting which materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Management, including our Co-Chief Executive Officers and Chief Financial Officer, does not expect that our disclosure controls and procedures or our system of internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed or operated, can provide only reasonable, but not absolute, assurance that the objectives of the system of internal control are met. The design of our control system reflects the fact that there are resource constraints, and that the benefits of such control system must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control failures and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the intentional acts of individuals, by collusion of two or more people, or by management override of the controls. The design of any system of controls is also based in part on certain assumptions about the likelihood of future events, and there can be no assurance that the design of any particular control will always succeed in achieving its objective under all potential future conditions.
37
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.
39
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: May 7, 2025
Amneal Pharmaceuticals, Inc.
(Registrant)
By:
/s/ Anastasios Konidaris
Anastasios Konidaris
Executive Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
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