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What changed in Amneal Pharmaceuticals, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Amneal Pharmaceuticals, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+342 added−340 removedSource: 10-K (2026-02-27) vs 10-K (2025-02-28)

Top changes in Amneal Pharmaceuticals, Inc.'s 2025 10-K

342 paragraphs added · 340 removed · 275 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

39 edited+24 added−18 removed2 unchanged
Biggest changeNotwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations and may adversely impact our operating results in future periods. 54 Results of Operations Consolidated Results The following table sets forth our summarized, consolidated results of operations (dollars in thousands): Years Ended December 31, Change 2024 2023 $ % Net revenue $ 2,793,957 $ 2,393,607 $ 400,350 16.7% Cost of goods sold 1,773,519 1,573,042 200,477 12.7% Gross profit 1,020,438 820,565 199,873 24.4% Selling, general and administrative 476,436 429,675 46,761 10.9% Research and development 190,714 163,950 26,764 16.3% In-process research and development impairment charges — 30,800 (30,800) (100.0)% Intellectual property legal development expenses 5,845 3,828 2,017 52.7% Restructuring and other charges 2,355 1,749 606 34.6% Change in fair value of contingent consideration (930) (14,497) 13,567 (93.6)% Charges related to legal matters, net 96,692 1,824 94,868 nm Other operating income — (1,138) 1,138 (100.0)% Operating income 249,326 204,374 44,952 22.0% Total other expense, net (304,339) (244,644) (59,695) 24.4% Loss before income taxes (55,013) (40,270) (14,743) 36.6% Provision for income taxes 18,863 8,452 10,411 123.2% Net loss $ (73,876) $ (48,722) $ (25,154) 51.6% nm - not meaningful Net Revenue Net revenue for the year ended December 31, 2024 increased 16.7% from the prior year primarily due to: • Growth in our Affordable Medicines segment of $213.9 million, primarily due to new products launched in 2024 and 2023, which included biosimilars that contributed $59.7 million of year-over-year growth and other new products that contributed $144.1 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
Biggest changeThese provisions resulted in a reduction of the Company’s current income tax liabilities of $7.8 million during the year ended December 31, 2025. 55 Results of Operations Consolidated Results The following table sets forth our summarized, consolidated results of operations (dollars in thousands): Years Ended December 31, Change 2025 2024 $ % Net revenue $ 3,018,760 $ 2,793,957 $ 224,803 8.0 % Cost of goods sold 1,905,452 1,773,519 131,933 7.4 % Gross profit 1,113,308 1,020,438 92,870 9.1 % Selling, general and administrative 526,827 476,436 50,391 10.6 % Research and development 186,175 190,714 (4,539) (2.4) % Intellectual property legal development expenses 7,632 5,845 1,787 30.6 % Restructuring and other charges 4,208 2,355 1,853 78.7 % (Credit) charges related to legal matters, net (390) 96,692 (97,082) (100.4) % Other operating income (5,240) (930) (4,310) nm Operating income 394,096 249,326 144,770 58.1 % Total other expense, net (254,887) (304,339) 49,452 (16.2) % Income (loss) before income taxes 139,209 (55,013) 194,222 nm Provision for income taxes 11,276 18,863 (7,587) (40.2) % Net income (loss) $ 127,933 $ (73,876) $ 201,809 nm nm - not meaningful Net Revenue Net revenue for the year ended December 31, 2025 increased 8.0% from the prior year primarily due to: • Growth in our Affordable Medicines segment of $60.3 million, primarily due to new products launched in 2025 and 2024, which contributed $122.6 million of year-over-year growth, and strong volume growth, partially offset by price erosion. • Growth in our Specialty segment of $82.8 million, primarily driven by increases of $58.1 million and $23.7 million of CREXONT ® and UNITHROID ® , respectively, and growth in our non-promoted products.
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.
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.
Charges Related to Legal Matters, Net For the year ended December 31, 2024, charges related to legal matters, net of $96.7 million were primarily associated with an Affordable Medicines 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.
(Credit) Charges Related to Legal Matters, Net For the year ended December 31, 2024, (credit) charges related to legal matters, net of $96.7 million were primarily associated with an Affordable Medicines 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.
Item 1. Business and Item 1A. Risk Factors in this Form 10-K. Inflation While it is difficult to accurately measure the impact of inflation, we estimate our business did not experience a material increase in costs due to inflation for the year ended December 31, 2024.
Item 1. Business and Item 1A. Risk Factors in this Form 10-K. Inflation While it is difficult to accurately measure the impact of inflation, we estimate our business did not experience a material increase in costs due to inflation for the year ended December 31, 2025.
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, refer to Item 1A. Risk Factors and Note 6. Income Taxes .
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, refer to Part I., Item 1A. Risk Factors and Note 5. Income Taxes .
Liquidity and Capital Resources Our primary source of liquidity is cash generated from operations, available cash and borrowings under debt financing arrangements (as defined and described in Note 15.
Liquidity and Capital Resources Our primary source of liquidity is cash generated from operations, available cash and borrowings under debt financing arrangements (as defined and described in Note 14.
Refer to Note 20. Commitments and Contingencies for additional information.
Refer to Note 19. Commitments and Contingencies for additional information.
Provision For Income Taxes The provision for income taxes was $18.9 million and $8.5 million for the years ended December 31, 2024 and 2023 , respectively. The effective tax rates for the years ended December 31, 2024 and 2023 were (34.3)% and (21.0)% , respectively.
Provision For Income Taxes The provision for income taxes was $11.3 million and $18.9 million for the years ended December 31, 2025 and 2024 , respectively. The effective tax rates for the years ended December 31, 2025 and 2024 were 8.1% and (34.3)%, respectively.
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.
These payments had been fully accrued as a liability as of December 31, 2025. 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.
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. We make our investments in accordance with our investment policy.
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.
In-Process Research and Development Impairment Charges Affordable Medicines IPR&D impairment charges for the year ended December 31, 2023 were related to one asset that experienced adverse clinical trials results in the fourth quarter of 2023 and resulted in significantly lower than expected future cash flows. 57 Charges (Credit) Related to Legal Matters, Net For the year ended December 31, 2024, Affordable Medicines charges related to legal matters, net of $96.7 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.
(Credit) Charges Related to Legal Matters, Net For the year ended December 31, 2024, the Affordable Medicines charges related to legal matters, net of $96.7 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.
The primary objectives of our investment policy are liquidity and safety of principal. Cash Flows For a discussion comparing of our cash flows for the fiscal years 2023 to 2022, see Cash Flows under
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 For a discussio n comparing our cash flows for the fiscal years 2024 to 2023, see Cash Flows under
Selling, General, and Administrative Specialty SG&A expense for the year ended December 31, 2024 increased 24.4% as compared to the prior year primarily due to increases in promotional costs associated with ONGENTYS ® and CREXONT ® .
Selling, General, and Administrative Specialty SG&A expense for the year ended December 31, 2025 increased 23.8% as compared to the prior year primarily due to launch costs associated with CREXONT ® and the Brekiya ® autoinjector and increases in employee compensation.
Cost of Goods Sold and Gross Profit Affordable Medicines cost of goods sold for the year ended December 31, 2024 increased 10.7% compared to the prior year primarily due to costs associated with increased sales volume and increased plant and freight costs and an increased inventory provision, partially offset by efficiencies in our supply costs.
Cost of Goods Sold and Gross Profit Affordable Medicines cost of goods sold for the year ended December 31, 2025 increased 5.0% compared to the prior year primarily due to increased sales volume and increased plant and freight costs, partially offset by manufacturing efficiencies.
Refer to Note 20. Commitments and Contingencies for additional information. Refer to Note 20. Commitments and Contingencies for additional information. Tax Receivable Agreement As part of the Reorganization, our existing 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.
Tax Receivable Agreement As part of the Reorganization (as defined in Note 1. Nature of Operations ), our existing 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.
Selling, General, and Administrative AvKARE SG&A expense for the year ended December 31, 2024 increased 9.7% as compared to the prior year primarily due to higher sales-related expenses, increases in employee compensation and higher professional fees.
Selling, General, and Administrative AvKARE SG&A expense for the year ended December 31, 2025 increased 4.1% as compared to the prior year primarily due to increases in employee compensation and shipping costs.
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, IT and facilities. Our 2025 estimate includes capital expenditures for our collaboration and supply agreement with Metsera, of which we expect Metsera to reimburse us approximately $20.0 million.
We estimate that we will invest approximately $110.0 million during 2026 for capital expenditures to support and grow our existing operations, primarily related to investments in manufacturing equipment, IT and facilities. Our 2026 estimate is net of expected contributions from Metsera, Inc. under our collaboration and supply agreement.
Cost of Goods Sold and Gross Profit AvKARE cost of goods sold for the year ended December 31, 2024 increased 25.7% as compared to the prior year, and gross profit as a percentage of net revenue decreased to 15.6% for the year ended December 31, 2024 from 16.3% in the prior year primarily due to the increase in sales through our lower margin distribution channel and an increased inventory provision.
Cost of Goods Sold and Gross Profit AvKARE cost of goods sold for the year ended December 31, 2025 increased 6.9% as compared to the prior year primarily due to higher sales in our government label channel and an increase in our inventory provision, partially offset by decreased sales in our lower margin distribution channel.
Specialty gross profit as a percentage of net revenue increased to 54.5% for the year ended December 31, 2024 as compared to 45.1% in the prior year as a result of the factors described above.
Goodwill and Other Intangible Assets for additional information) and increased sales volume and product mix. Specialty gross profit as a percentage of net revenue decreased to 53.5% for the year ended December 31, 2025 as compared to 54.5% in the prior year as a result of the factors described above.
Income Taxes for additional information. 56 Affordable Medicines The following table sets forth the results of operations for our Affordable Medicines segment (dollars in thousands): Years Ended December 31, Change 2024 2023 $ % Net revenue $ 1,685,263 $ 1,471,401 $ 213,862 14.5% Cost of goods sold 1,011,363 913,869 97,494 10.7% Gross profit 673,900 557,532 116,368 20.9% Selling, general and administrative 129,578 119,912 9,666 8.1% Research and development 171,771 132,233 39,538 29.9% In-process research and development impairment charges — 26,500 (26,500) (100.0)% Intellectual property legal development expenses 5,685 3,708 1,977 53.3% Restructuring and other charges 70 211 (141) (66.8)% Charges (credit) related to legal matters, net 96,692 (64) 96,756 nm Other operating income — (1,138) 1,138 (100.0)% Operating income $ 270,104 $ 276,170 $ (6,066) (2.2)% nm - not meaningful Net Revenue Affordable Medicines net revenue for the year ended December 31, 2024 increased 14.5% as compared to the prior year, primarily due to new products launched in 2024 and 2023, which included biosimilars that contributed $59.7 million of year-over-year growth and other new products that contributed $144.1 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
Income Taxes for additional information. 57 Affordable Medicines The following table sets forth the results of operations for our Affordable Medicines segment (dollars in thousands): Years Ended December 31, Change 2025 2024 $ % Net revenue $ 1,745,524 $ 1,685,263 $ 60,261 3.6 % Cost of goods sold 1,061,600 1,011,363 50,237 5.0 % Gross profit 683,924 673,900 10,024 1.5 % Selling, general and administrative 142,383 129,578 12,805 9.9 % Research and development 156,013 171,771 (15,758) (9.2) % Intellectual property legal development expenses 7,389 5,685 1,704 30.0 % Restructuring and other charges 2,971 70 2,901 nm (Credit) charges related to legal matters, net (390) 96,692 (97,082) (100.4) % Other operating income (5,240) — (5,240) nm Operating income $ 380,798 $ 270,104 $ 110,694 41.0 % nm - not meaningful Net Revenue Affordable Medicines net revenue for the year ended December 31, 2025 increased 3.6% as compared to the prior year, primarily due to new products launched in 2025 and 2024, which contributed $122.6 million of year-over-year growth, and strong volume growth, partially offset by price erosion.
We expect such reimbursements to primarily be included in our financing cash flows. Debt Instruments Over the next 12 months, we expect to make substantial payments for monthly interest and quarterly principal amounts due for our Term Loan Due 2028, monthly interest on our Amended New Credit Facility, and contractual payments for leased premises.
Debt Instruments Over the next 12 months, we expect to make substantial payments for monthly interest and quarterly principal amounts due for our Term Loan Due 2032, semi-annual interest payments on our Senior Notes Due 2032, and contractual payments for leased premises. Refer to Note 14. Debt , Note 16.
There was no liability for tax distributions payable to the AvKARE Sellers as of December 31, 2024 or 2023.
During the years ended December 31, 2025, 2024 and 2023, we made cash tax and other distributions of $43.8 million, $19.8 million and $14.2 million, respectively, to the AvKARE Sellers. There was no liability for tax and other distributions payable to the AvKARE Sellers as of December 31, 2025 or 2024.
Cost of goods sold for the year ended December 31, 2023 included $11.0 million associated with the non-recurring customer order discussed above. Affordable Medicines gross profit as a percentage of net revenue increased to 40.0% for the year ended December 31, 2024 from 37.9% in the prior year as a result of the factors described above.
Affordable Medicines gross profit as a percentage of net revenue decreased to 39.2% for the year ended December 31, 2025 from 40.0% in the prior year as a result of the factors described above.
Annually, we are also required to calculate the amount of excess cash flow payments, as defined in our term loan agreements. Based on the results of the excess cash flows calculation for the years ended December 31, 2024, 2023 and 2022, no excess cash flows principal payments were required.
Based on the results of the excess cash flows calculations for the years ended December 31, 2025, 2024 and 2023, no excess cash flows principal payments were required.
Tax-related Distributions In 2020, we acquired a 65.1% controlling interest in both AvKARE Inc., a Tennessee corporation, now a limited liability company, and 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”).
Tax-related and Other 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”).
Debt ), including $495.2 million of available capacity on our Amended New Revolving Credit Facility and $28.0 million of available capacity under the Amended Rondo Revolving Credit Facility as of December 31, 2024 . We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations and provide sufficient liquidity over the next 12 months.
We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations and provide sufficient liquidity over the next 12 months.
The increase in cost of goods sold was primarily due to increased AvKARE and Affordable Medicines volume, increased plant and freight costs, and an increased inventory provision, partially offset by efficiencies in our supply costs.
The increase in cost of goods sold was primarily due to increased sales volume from all segments, impairment charges related to non-promoted products of $22.8 million, and increased plant and freight costs, partially offset by manufacturing efficiencies.
Research and Development Affordable Medicines R&D expense for the year ended December 31, 2024 increased 29.9% as compared to the prior year primarily due to an increase in in-licensing and upfront milestone payments of $30.0 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 23.
Research and Development Affordable Medicines R&D expense for the year ended December 31, 2025 decreased 9.2% as compared to the prior year primarily due to decreases in in-licensing and upfront milestone payments of $13.5 million and reduced project spend, partially offset by increased employee compensation.
Additionally, growth in our promoted endocrinology portfolio of $20.8 million was partially offset by declines in our non-promoted products. Cost of Goods Sold and Gross Profit Cost of goods sold increased 12.7% for the year ended December 31, 2024 as compared to the prior year.
Cost of Goods Sold and Gross Profit Cost of goods sold increased 7.4% for the year ended December 31, 2025 as compared to the prior year.
Cash Balances At December 31, 2024, 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.
As of December 31, 2025, no conditions have been met that would make redemption probable or otherwise certain. Cash Balances At December 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.
Cost of Goods Sold and Gross Profit Specialty cost of goods sold for the year ended December 31, 2024 decreased 5.3% as compared to the prior year due to a marketed product intangible asset impairment charge of $34.1 million in 2023 related to reduced promotional focus on LYVISPAH ® , partially offset by increased sales in our promoted products.
Cost of Goods Sold and Gross Profit Specialty cost of goods sold for the year ended December 31, 2025 increased 21.2% as compared to the prior year primarily due to an impairment charge related to a non-promoted product of $22.1 million (r efer to Note 11.
Selling, General, and Administrative Affordable Medicines SG&A for the year ended December 31, 2024 increased by 8.1% compared to the prior year primarily due to increases in employee compensation driven by infrastructure expansion and promotion associated with our biosimilar launches and the annual fees assessed on branded prescription drug manufacturers, which are also applicable to certain of our affordable medicine products, partially offset by reduced legal fees.
Selling, General, and Administrative Affordable Medicines SG&A for the year ended December 31, 2025 increased by 9.9% compared to the prior year primarily due to increases in employee compensation, costs of our international expansion, and shipping costs.
Specialty The following table sets forth the results of operations for our Specialty segment (dollars in thousands): Years Ended December 31, Change 2024 2023 $ % Net revenue $ 445,749 $ 390,457 $ 55,292 14.2% Cost of goods sold 202,821 214,277 (11,456) (5.3)% Gross profit 242,928 176,180 66,748 37.9% Selling, general and administrative 109,658 88,137 21,521 24.4% Research and development 18,943 31,717 (12,774) (40.3)% In-process research and development impairment charges — 4,300 (4,300) (100.0)% Intellectual property legal development expenses 160 120 40 33.3% Restructuring and other charges 1,517 1,105 412 37.3% Change in fair value of contingent consideration (930) (14,497) 13,567 (93.6)% Operating income $ 113,580 $ 65,298 $ 48,282 73.9% Net Revenue Specialty net revenue for the year ended December 31, 2024 increased 14.2% as compared to the prior year, primarily driven by a $44.7 million increase in our promoted Parkinson’s franchise, of which $16.6 million was comprised of sales of ONGENTYS ® , which launched in January 2024, and initial sales of CREXONT ® , which launched in September 2024.
Other Operating Income Other operating income for the year ended December 31, 2025 was primarily comprised of income earned from the PLI Scheme. 58 Specialty The following table sets forth the results of operations for our Specialty segment (dollars in thousands): Years Ended December 31, Change 2025 2024 $ % Net revenue $ 528,508 $ 445,749 $ 82,759 18.6 % Cost of goods sold 245,915 202,821 43,094 21.2 % Gross profit 282,593 242,928 39,665 16.3 % Selling, general and administrative 135,715 109,658 26,057 23.8 % Research and development 30,162 18,943 11,219 59.2 % Intellectual property legal development expenses 243 160 83 51.9 % Restructuring and other charges 471 1,517 (1,046) (69.0) % Other operating income — (930) 930 nm Operating income $ 116,002 $ 113,580 $ 2,422 2.1 % nm - not meaningful Net Revenue Specialty net revenue for the year ended December 31, 2025 increased 18.6% as compared to the prior year, primarily driven by increases of $58.1 million and $23.7 million of CREXONT ® and UNITHROID ® , respectively, and growth in our non-promoted products.
AvKARE The following table sets forth the results of operations for our AvKARE segment (dollars in thousands): Years Ended December, 31 Change 2024 2023 $ % Net revenue $ 662,945 $ 531,749 $ 131,196 24.7% Cost of goods sold 559,335 444,896 114,439 25.7% Gross profit 103,610 86,853 16,757 19.3% Selling, general and administrative 60,709 55,341 5,368 9.7% Operating income $ 42,901 $ 31,512 $ 11,389 36.1% Net Revenue AvKARE net revenue for the year ended December 31, 2024 increased 24.7% as compared to the prior year primarily driven by growth in our distribution and government channels resulting from new product introductions.
Research and Development Specialty R&D expense for the year ended December 31, 2025 increased 59.2% as compared to the prior year primarily due to increased in-licensing and upfront milestone payments of $6.0 million and higher project spend. 59 AvKARE The following table sets forth the results of operations for our AvKARE segment (dollars in thousands): Years Ended December, 31 Change 2025 2024 $ % Net revenue $ 744,728 $ 662,945 $ 81,783 12.3 % Cost of goods sold 597,937 559,335 38,602 6.9 % Gross profit 146,791 103,610 43,181 41.7 % Selling, general and administrative 63,176 60,709 2,467 4.1 % Operating income $ 83,615 $ 42,901 $ 40,714 94.9 % Net Revenue AvKARE net revenue for the year ended December 31, 2025 increased 12.3% as compared to the prior year primarily driven by g rowth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel .
Research and Development Research and development (“R&D”) expenses for the year ended December 31, 2024 increased 16.3% from the prior year primarily due to an increase in in-licensing and upfront milestone payments of $30.0 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 23.
Selling, General and Administrative Selling, general and administrative (“SG&A”) expenses for the year ended December 31, 2025 increased 10.6% as compared to the prior year primarily due to increases in employee compensation and launch costs associated with CREXONT ® and the Brekiya ® autoinjector. 56 Research and Development Research and development (“R&D”) expenses for the year ended December 31, 2025 decreased 2.4% from the prior year primarily due to a decrease in in-licensing and upfront milestone payments of $7.5 million, partially offset by an increase in employee compensation.
As of December 31, 2024, the unrecorded contingent TRA liability, including the impact of the amendment, was $133.8 million.
As of December 31, 2025, the unrecorded contingent TRA liability, including the impact of the amendment, was $129.1 million. During the year ended December 31, 2025, we made payments of $3.0 million, associated with the TRA. Subsequent to year‑end, in January 2026, we made TRA payments totaling $38.8 million.
We do not expect a material impact related to inflation for the year ending December 31, 2025.
We do not expect a material impact related to inflation for the year ending December 31, 2026. Notwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations and may adversely impact our operating results in future periods.
Gross profit as a percentage of net revenue increased to 36.5% for the year ended December 31, 2024 from 34.3% in the prior year, primarily as a result of the factors noted above. 55 Selling, General and Administrative Selling, general and administrative (“SG&A”) expenses for the year ended December 31, 2024 increased 10.9% as compared to the prior year primarily due to increases in employee compensation, promotion associated with ONGENTYS ® and CREXONT ® , increased expenses associated with our growing biosimilars, and annual fees assessed on branded prescription drug manufacturers, which are also applicable to certain of our Affordable Medicines products.
Gross profit as a percentage of net revenue increased to 36.9% for the year ended December 31, 2025 from 36.5% in the prior year, primarily as a result of the factors noted above and favorable product mix, as low margin distribution sales decreased.
For additional information, refer to Note 20. Commitments and Contingencies. Total Other Expense, Net Total other expense, net increased 24.4% for the year ended December 31, 2024.
Refer to Note 19. Commitments and Contingencies for additional information . Other Operating Income Other operating income for the year ended December 31, 2025 was primarily comprised of income earned from the India Production Linked Incentive Scheme for the Pharmaceutical Sector (the “PLI Scheme”).
Removed
Net revenue for the year ended December 31, 2023 included a non-recurring customer order of $21.0 million. • Growth in our AvKARE segment of $131.2 million primarily driven by growth in our distribution and government channels resulting from new product introductions. • Growth in our Specialty segment of $55.3 million primarily driven by a $44.7 million increase in our promoted Parkinson’s franchise, of which $16.6 million was comprised of sales of ONGENTYS ® , which launched in January 2024, and initial sales of CREXONT ® , which launched in September 2024.
Added
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 FDF or 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.
Removed
Cost of goods sold for the year ended December 31, 2023 included $11.0 million associated with the non-recurring customer order in our Affordable Medicines segment discussed above and a marketed product intangible asset impairment charge of $34.1 million in our Specialty segment related to a reduction in the promotional focus on LYVISPAH ® .
Added
Since taking office in 2025, President Trump has announced a number of tariff actions, and while there are currently no reciprocal tariffs on pharmaceutical products imported into the U.S., this can change at any moment.
Removed
Related Party Transactions for additional information), partially offset by operating efficiencies in our infrastructure.
Added
On February 1, 2025, the Administration imposed a 10% tariff on all products from China under the International Emergency Economic Powers Act , (50 U.S.C. 1701 et seq) (the “IEEPA”), and related authorities as announced in the Federal Register Notice and Executive Order 14195 dated February 1, 2025 (as amended).
Removed
In-Process Research and Development Impairment Charges In process research and development (“IPR&D”) impairment charges of $30.8 million for the year ended December 31, 2023 were related to one Affordable Medicines asset and one Specialty asset, both of which experienced adverse clinical trials results in the fourth quarter of 2023 and resulted in significantly lower than expected future cash flows.
Added
On February 20, 2026, the Supreme Court of the United States issued an opinion 54 ruling that President Trump’s tariffs exceeded presidential authority under the IEEPA, which had the effect of invalidating the tariffs imposed thereunder to date.
Removed
Change in Fair Value of Contingent Consideration The year-over-year variance of $13.6 million in change in fair value of contingent consideration for the year ended December 31, 2024 as compared to the prior year was primarily related to a reduction in promotional focus on LYVISPAH TM during the year ended December 31, 2023. Refer to Note 18.
Added
On April 14, 2025, the Department of Commerce Bureau of Industry and Security (“DOCBIS”) 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.
Removed
For the year ended December 31, 2023, charges related to legal matters, net of $1.8 million were comprised of $3.9 million in charges associated with Affordable Medicines civil prescription opioid litigation, a $3.0 million charge for the settlement of an Affordable Medicines customer claim, a $3.0 million charge for the settlement of Affordable Medicines commercial antitrust litigation, and a $1.9 million charge for the settlement of a corporate stockholder derivative lawsuit, partially offset by $10.0 million from the settlement of Affordable Medicines patent infringement matters.
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FDF, API, key starting materials, derivatives, and medical countermeasures), including whether trade remedies such as tariffs should be imposed. This investigation covers both generic and brand products.
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The increase was primarily driven by a $48.0 million increase in net interest expense as a result of higher rates on our variable rate debt and an increase in the average amount outstanding on our revolving credit facility throughout 2024, and a $47.6 million increase in our tax receivable agreement liability (refer to Note 6.
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On September 26, 2025, DOCBIS announced that it had initiated, as of September 2, 2025, a separate Section 232 national security investigation of imports of personal protective equipment, medical consumables (including syringes and intravenous bags), and medical equipment (including devices). These Section 232 investigations are ongoing.
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Income Taxes for additional information), partially offset by a $40.8 million loss on refinancing the Term Loan Due 2025 and amending the New Revolving Credit Facility in 2023 (refer to Note 15. Debt for additional information).
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On February 20, 2026, President Trump imposed a 10% global tariff for 150 days under Section 122 of the Trade Act of 1974 . FDF and API are exempt from the Section 122 tariff as of the date of this filing.
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The change in the effective income tax rate for the year ended December 31, 2024 as compared to the prior year was primarily due to the timing and jurisdictional mix of income and the Reorganization, which resulted in allocating all of Amneal’s income to the Company. Refer to Note 6.
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Given the global nature of pharmaceutical supply chains, any changes to historically prevailing tariff requirements could impact us and our industry by increasing costs, affecting product availability, and/or disrupting supply chains. The Company is closely monitoring these tariff and trade developments and will take actions to reduce or minimize any material negative impact.
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Net revenue for the year ended December 31, 2023 included a non-recurring customer order of $21.0 million.
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One Big Beautiful Bill Act On July 4, 2025, President Trump signed OBBBA, which includes a broad range of tax reform provisions affecting businesses, including, but not limited to, extending or making permanent certain business and international tax measures initially established under the 2017 Tax Cuts and Jobs Act and eliminating the requirement to capitalize and amortize U.S.-based research and experimental expenditures over five years, making these expenditures fully deductible in the period incurred.
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Related Party Transactions for additional information), partially offset by operating efficiencies.
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This growth was partially offset by a year-over-year decrease of $6.0 million in out-licensing revenue associated with IPX203. • Growth in our AvKARE segment of $81.8 million, primarily driven by g rowth in our government label channel resulting from new product introductions, partially offset by a decline in our lower margin distribution channel .
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For the year ended December 31, 2023, the Affordable Medicines credit related to legal matters, net was $(0.1) million , comprised of $10.0 million received from the settlement of patent infringement matters, net of $3.9 million in charges associated with civil prescription opioid litigation, a $3.0 million charge for the settlement of a customer claim, and a $3.0 million charge for the settlement of commercial antitrust litigation.
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Total Other Expense, Net Total other expense, net decreased 16.2% for the year ended December 31, 2025. The decrease was primarily driven by a $44.1 million favorable year‑over‑year change in tax receivable agreement liability during the year (see Note 5.
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Additionally, growth in our promoted endocrinology portfolio of $20.8 million was partially offset by declines in our non-promoted products.
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Income Taxes ), a $17.5 million decrease in interest expense due to lower interest rates and lower outstanding balances on our variable‑rate debt, and favorable foreign currency movements, primarily related to the Euro, partially offset by a $31.4 million loss recognized in connection with the refinancing of our debt in August 2025 (see Note 14. Debt ).
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Research and Development Specialty R&D expense for the year ended December 31, 2024 decreased 40.3% as compared to the prior year primarily due to reduced project spend of $8.6 million and reduced infrastructure costs. 58 Change in Fair Value of Contingent Consideration The year-over-year variance of $13.6 million in change in fair value of contingent consideration for the year ended December 31, 2024 as compared to the prior year was primarily related to a reduction in promotional focus on LYVISPAH TM during the year ended December 31, 2023.
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The year-over-year changes in the provision for income taxes and effective tax rate primarily reflected differences in income by jurisdiction, the impact of OBBBA, and items related to share based compensation in the current year. Refer to Note 5.
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Refer to Note 18. Fair Value Measurements for additional information.
Added
This growth was partially offset by a year-over-year decrease of $6.0 million in out-licensing revenue associated with IPX203.
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In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term 59 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.
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Gross profit as a percentage of net revenue increased to 19.7% for the year ended December 31, 2025 from 15.6% in the prior year primarily as a result of the factors noted above.
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We attribute 34.9% of the net income or loss associated with Rondo to redeemable non-controlling interests. During the year ended December 31, 2024, 2023 and 2022, we made cash tax distributions of $19.8 million, $14.2 million and $6.9 million, respectively, to the AvKARE Sellers.
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Debt ), including $595.2 million of available capacity under our 2025 Revolving Credit Facility and $83.0 million of available capacity under the Amended and Restated Rondo Revolving Credit Facility as of December 31, 2025 .
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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 for additional information.
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Leases, and Commitments and Contractual Obligations under Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations for additional information. 60 Annually, we are also required to calculate the amount of excess cash flow payments, as defined in our term loan agreements.
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During July 2025, we deposited an aggregate of $24.2 million into dedicated accounts as a step in the process to finalize a definitive settlement agreement. These deposits remained our property until a definitive settlement agreement was reached and no amounts were disbursed in 2025.
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On January 23, 2026, we determined that we will make effective our nationwide agreement to settle a substantial majority of the opioids-related claims brought against us by various states and subdivisions (the “Nationwide Opioids Settlement Agreement”), having previously secured sufficient participation by those states and subdivisions, including all eligible state and territorial Attorneys General and all subdivisions that previously sued us.
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The Nationwide Opioids Settlement Agreement was effective on January 29, 2026 and we made our first installment payment of $23.8 million to the trust administrator on that date. An additional installment payment of $12.1 million was made on February 26, 2026. Refer to Note 19. Commitments and Contingencies and Note 25. Subsequent Events for additional information.
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The sellers of AvKARE, LLC and R&S (the “AvKARE Sellers”) hold the remaining 34.9% interest (the “Rondo Class B Units”) 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.
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Biosimilar Licensing and Supply Agreement - Denosumab Pursuant to a licensing and supply agreement with mAbxience S.L. (“mAbxience”) for two denosumab biosimilars referencing Prolia ® and XGEVA ® , the Company paid mAbxience $7.5 million in February 2026 upon the achievement of regulatory milestones. These amounts had been accrued as of December 31, 2025. Refer to Note 4.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThrough its control of a majority of our voting power and the provisions set forth in our charter, bylaws and our Third Amended and Restated Stockholders Agreement, dated November 7, 2023 (as amended to date, the “Stockholders Agreement”), the Amneal Group has the ability to designate and elect a majority of our board of directors.
Biggest changePursuant to the Third Amended and Restated Stockholders Agreement, dated November 7, 2023 (as amended to date, the “Stockholders Agreement”), the Amneal Group has the ability to designate and elect a number of directors to our board of directors (the “Board of Directors”) equal to the to the product of (x) the percentage of the shares of our common stock beneficially owned by Amneal Group and (y) the total number of directors comprising the Board of Directors, rounded up to the nearest whole number, provided, that such rounding shall not result in the Amneal Group having the right to designate a majority of the total number of directors comprising the Board of Directors when the Amneal Group beneficially owns 50% or less of the outstanding shares of our common stock.
If we receive less than one year’s termination notice from a sole-source supplier that intends to cease supplying raw materials, it could result in disruption of our ability to produce the drug involved. Any significant supply interruption could have a material adverse effect on our business, condition (financial and otherwise), prospects and results of operations.
If we receive less than one year’s notice of termination from a sole-source supplier that intends to cease supplying raw materials, it could result in disruption of our ability to produce the drug involved. Any significant supply interruption could have a material adverse effect on our business, condition (financial and otherwise), prospects and results of operations.
If we fail to comply with AI laws and regulations, we may be subject to sanctions, fines, and reputational damage, orders to stop certain processing of personal data, orders to delete certain data or destroy AI algorithms derived from data collects, legal action on behalf of impacted individuals or other enforcement or other actions.
If we fail to comply with AI laws and regulations, we may be subject to sanctions, fines, and reputational damage, orders to stop certain processing of personal data, orders to delete certain data or destroy AI algorithms derived from data collects, legal action on behalf of impacted individuals or other enforcement or actions.
A catastrophic event that results in the destruction or disruption of any of our or our third-party partners’ business centers, manufacturing facilities, data centers, R&D or manufacturing facilities, or our critical business or IT systems could severely affect our ability to conduct normal business operations and, as a result, our future operating results could be adversely affected.
A catastrophic event that results in the destruction or disruption of any of our or our third-party partners’ business centers, manufacturing facilities, data centers, R&D facilities, or our critical business or IT systems could severely affect our ability to conduct normal business operations and, as a result, our future operating results could be adversely affected.
Any changes in FDA requirements may make it more difficult for us to file ANDAs or obtain approval of our ANDAs and generate revenues and thus have a material adverse effect on our business, results of operations and financial condition.
Any changes in FDA requirements may make it more difficult for us to file ANDAs or obtain approval of our ANDAs and generate revenues and thus may have a material adverse effect on our business, results of operations and financial condition.
A disruption, infiltration or failure of these systems, facilities or third-party hosted services in the event of a hurricane, tsunami, tornado, earthquake, wildfire or flooding or other weather event, power loss, telecommunications failure, software or hardware malfunctions, pandemics, cyber-attack, war, terrorist attack or other catastrophic event that our disaster recovery plans do not adequately address, could cause system interruptions, reputational harm, loss of IP, delays in our product development, lengthy interruptions in our services, breaches of data security and loss of critical data.
A disruption, infiltration or failure of these systems, facilities or third-party hosted services in the event of a hurricane, tsunami, tornado, 32 earthquake, wildfire or flooding or other weather event, power loss, telecommunications failure, software or hardware malfunctions, pandemics, cyber-attack, war, terrorist attack or other catastrophic event that our disaster recovery plans do not adequately address, could cause system interruptions, reputational harm, loss of IP, delays in our product development, lengthy interruptions in our services, breaches of data security and loss of critical data.
Our international operations may be adversely affected by general economic conditions (including inflation, expropriation and other government actions), economic and fiscal policy (including changes in exchange rates and controls, interest rates and taxation policies), changes in IP protections and remedies, trade regulations, tax laws, and increased government regulation (including those affecting approval, production, pricing, and marketing of, reimbursement for and access to our products).
Our international operations may be adversely affected by general economic conditions (including inflation, expropriation and other government actions), economic and fiscal policy (including changes in exchange rates and controls, tariffs, interest rates and taxation policies), changes in IP protections and remedies, trade regulations, tax laws, and increased government regulation (including those affecting approval, production, pricing, and marketing of, reimbursement for and access to our products).
We rely particularly on trade secrets, trademarks, unpatented proprietary expertise and continuing innovation that we seek to protect, in part, by registering and using marks; and by entering into confidentiality agreements with licensees, suppliers, employees, consultants and other parties. We use this 35 approach to protecting our IP in large part because few of our products are protected by patents.
We rely particularly on trade secrets, trademarks, unpatented proprietary expertise and continuing innovation that we seek to protect, in part, by registering and using marks; and by entering into confidentiality agreements with licensees, suppliers, employees, consultants and other parties. We use this approach to protecting our IP in large part because few of our products are protected by patents.
We cannot guarantee that any investment we make in developing, marketing or licensing products will be recouped, even if we are successful in commercializing those products. 23 We face intense competition in the pharmaceutical industry from both brand and generic drug product companies, which could significantly limit our growth and materially adversely affect our financial results.
We cannot guarantee that any investment we make in developing, marketing or licensing products will be recouped, even if we are successful in commercializing those products. We face intense competition in the pharmaceutical industry from both brand and generic drug product companies, which could significantly limit our growth and materially adversely affect our financial results.
If, due to capital constraints, we require financing, we cannot provide any assurance that we will be able to obtain such financing when needed on acceptable terms or at all. Global economic conditions could harm us. Global efforts to contain health care costs continue to exert pressure on product pricing and market access to pharmaceutical products.
If, due to capital constraints, we require financing, we cannot provide any assurance that we will be able to obtain such financing when needed on acceptable terms or at all. 42 Global economic conditions could harm us. Global efforts to contain health care costs continue to exert pressure on product pricing and market access to pharmaceutical products.
Clinical trials are often conducted with patients having advanced stages of disease and, as a result, during the course of treatment these patients can die or suffer adverse medical effects for reasons that may not be related to the pharmaceutical agents being tested, but which nevertheless affect the clinical trial results.
Clinical trials are often conducted with patients having advanced stages of disease and, as a result, during the course of treatment these patients can die or suffer adverse medical effects for reasons that may not be related 29 to the pharmaceutical agents being tested, but which nevertheless affect the clinical trial results.
Although 43 we believe our liabilities are adequate as of the date of this report, we cannot provide assurances that our reserves will ultimately prove to be adequate. Increases in sales allowances may exceed our estimates for a variety of reasons, including unanticipated competition or an unexpected change in one or more of our contractual relationships.
Although we believe our liabilities are adequate as of the date of this report, we cannot provide assurances that our reserves will ultimately prove to be adequate. Increases in sales allowances may exceed our estimates for a variety of reasons, including unanticipated competition or an unexpected change in one or more of our contractual relationships.
Continued concerns about the systemic 42 impact of potential geopolitical issues and economic policy uncertainty, particularly in areas in which we operate, could potentially cause economic and market instability in the future and could adversely affect our business, including our financial performance. These conditions may also result in decreased consumer spending, including spending on our products.
Continued concerns about the systemic impact of potential geopolitical issues and economic policy uncertainty, particularly in areas in which we operate, could potentially cause economic and market instability in the future and could adversely affect our business, including our financial performance. These conditions may also result in decreased consumer spending, including spending on our products.
Our principal competitors in the U.S. generic/biosimilar pharmaceutical products market, where we primarily compete, are Teva Pharmaceutical Industries Ltd., Viatris Inc., Sandoz Group, Pfizer Inc., Fresenius Kabi KGaA, Hikma Pharmaceuticals PLC, Dr. Reddy’s Laboratories Ltd., Amphastar Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Zydus Pharmaceuticals USA Inc., and Aurobindo Pharma Limited.
Our principal competitors in the U.S. generic and biosimilar pharmaceutical market, where we primarily compete, are Teva Pharmaceutical Industries Ltd., Viatris Inc., Sandoz Group, Pfizer Inc., Fresenius Kabi KGaA, Hikma Pharmaceuticals PLC, Dr. Reddy’s Laboratories Ltd., Amphastar Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Zydus Pharmaceuticals USA Inc., and Aurobindo Pharma Limited.
However, to distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product. It is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to the authentic product.
However, to distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product. It is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to 25 the authentic product.
A significant 32 disruption at any of these facilities or otherwise within our supply chain, even on a short-term basis, could impair our ability to produce and ship products to the market on a timely basis or at all, which could have a material adverse effect on our business, financial position and results of operations.
A significant disruption at any of these facilities or otherwise within our supply chain, even on a short-term basis, could impair our ability to produce and ship products to the market on a timely basis or at all, which could have a material adverse effect on our business, financial position and results of operations.
Furthermore, should there be ambiguity with respect to how to properly calculate and report payments, and even in the absence of any such ambiguity, a governmental authority may take a position contrary to a position that we have taken and may impose civil and/or criminal sanctions on us.
Furthermore, should there be ambiguity with respect to how to properly calculate and report payments, and even in the absence of any such ambiguity, a governmental authority may 39 take a position contrary to a position that we have taken and may impose civil and/or criminal sanctions on us.
As a result, payments could be made under the TRA in excess of the tax savings that we ultimately realize in respect of the tax attributes with respect to the Members or their permitted transferees. Risks Related to Our Class A Common Stock The Amneal Group owns a majority of our outstanding Class A Common Stock.
As a result, payments could be made under the TRA in excess of the tax savings that we ultimately realize in respect of the tax attributes with respect to the Members or their permitted transferees. Risks Related to Our Class A Common Stock The Amneal Group owns nearly a majority of our outstanding Class A Common Stock.
Our principal competitors in the specialty pharmaceutical products market include Supernus Pharmaceuticals, Inc., Jazz Pharmaceuticals PLC, AbbVie Inc. and Alkermes PLC. Our competitors in the AvKARE segment are other wholesalers, including Cardinal Health, Inc., Cencora, Inc., McKesson Drug Co., and manufacturers / re-packagers such as Golden State Medical Supply.
Our principal competitors in the specialty pharmaceutical market include Supernus Pharmaceuticals, Inc., Jazz Pharmaceuticals PLC, AbbVie Inc. and Alkermes PLC. Our competitors in the AvKARE segment are other wholesalers, including Cardinal Health, Inc., Cencora, Inc., McKesson Drug Co., and manufacturers / re-packagers such as Golden State Medical Supply.
At the same time, regulators and legislators have increasingly expressed or pursued opposing views, legislation and investment expectations with respect to sustainability initiatives, including the enactment or proposal of “anti-ESG” legislation or policies. These opposing views may also be adopted by our investors.
At the same time, regulators and legislators have increasingly expressed or pursued opposing views, legislation and investment expectations with respect to sustainability initiatives, including the enactment or proposal of “anti-ESG” legislation or policies. These opposing views may also be adopted by certain of our investors.
The FDA or foreign regulatory authorities may require us to conduct unanticipated additional clinical trials, which could result in additional expense and delays in bringing our product candidates to market. Any failure or delay in completing clinical trials 30 for our product candidates would prevent or delay the commercialization of our product candidates.
The FDA or foreign regulatory authorities may require us to conduct unanticipated additional clinical trials, which could result in additional expense and delays in bringing our product candidates to market. Any failure or delay in completing clinical trials for our product candidates would prevent or delay the commercialization of our product candidates.
In the event our lenders accelerated the repayment of the borrowings, we and our subsidiaries may not have sufficient assets to repay that indebtedness. Any acceleration of amounts due under the credit agreements would 41 likely have a material adverse effect on us.
In the event our lenders accelerated the repayment of the borrowings, we and our subsidiaries may not have sufficient assets to repay that indebtedness. Any acceleration of amounts due under the credit agreements would likely have a material adverse effect on us.
We cannot provide assurance that these agreements will not be breached or circumvented. We also cannot be certain that we will have recourse to adequate remedies in the event of a breach of such agreements. Disputes may arise concerning the ownership of IP or the applicability of confidentiality agreements.
We cannot provide assurance that these agreements will not be breached or circumvented. We also cannot be certain that we will have recourse to adequate remedies in the event of a breach of such agreements. Disputes may arise concerning the ownership of IP or the applicability of 35 confidentiality agreements.
Any such penalties, sanctions, or exclusion from federal health care programs could have a material adverse effect on our business, financial position and results of operations. From time to time we conduct routine reviews of our government pricing 39 calculations.
Any such penalties, sanctions, or exclusion from federal health care programs could have a material adverse effect on our business, financial position and results of operations. From time to time we conduct routine reviews of our government pricing calculations.
The payment of future cash dividends, if any, will be at the discretion of our Board of Directors and will be dependent upon our earnings, financial condition, capital requirements and other factors as our Board of Directors may deem relevant. Item 1B. Unresolved Staff Comments None.
The payment of future cash dividends, if any, will be at the discretion of our Board of Directors and will be dependent upon our earnings, financial condition, capital requirements and other factors as our Board of Directors may deem relevant. Item 1B. Unresolved Staff Comments None. 46
There are substantial filing fees for NDAs that are not refundable if FDA approval is not obtained. There are a number of risks and uncertainties associated with clinical trials. The results of clinical trials may not be indicative of results that would be obtained from large scale testing.
There are substantial filing fees for NDAs that are not refundable if FDA approval is not obtained. There are a number of risks and uncertainties associated with clinical trials. The results of clinical trials may not be indicative of results from large scale testing.
As the patent(s) for a brand name product 25 or the statutory marketing exclusivity period (if any) expires, the first generic manufacturer to receive regulatory approval for a generic equivalent of the product is often able to capture a substantial share of the market.
As the patent(s) for a brand name product or the statutory marketing exclusivity period (if any) expires, the first generic manufacturer to receive regulatory approval for a generic equivalent of the product is often able to capture a substantial share of the market.
The failure of one of our facilities, or a facility of one of our third-party suppliers, to comply with applicable laws and regulations may lead to breach of representations made to our customers or to regulatory or government action against us related to products made in that facility.
The failure of one of our facilities, or a facility of one of our third-party suppliers, to comply with applicable laws or regulations may lead to breach of representations made to our customers or to regulatory or government action against us related to products made in that facility.
In particular, the FDA, the DOJ and other agencies have increased their enforcement activities with respect to the sales, marketing, research and similar activities of pharmaceutical companies in recent years, and many pharmaceutical companies have been subject to government investigations related to these practices.
In particular, the FDA, the DOJ, the FTC, and other agencies have increased their enforcement activities with respect to the sales, marketing, research and similar activities of pharmaceutical companies in recent years, and many pharmaceutical companies have been subject to government investigations related to these practices.
Additionally, continuing and increasingly sophisticated studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by the industry, government agencies and others which can call into question the utilization, safety and efficacy of products currently or previously marketed by us.
Additionally, increasingly sophisticated studies of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by the industry, government agencies and others which can call into question the utilization, safety and efficacy of products currently or previously marketed by us.
The Amneal Group may have different interests than our other stockholders and may make decisions adverse to such interests. 45 In the ordinary course of their business activities, the Amneal Group may engage in activities where their interests conflict with our interests or those of our other stockholders.
The Amneal Group may have different interests than our other stockholders and may make decisions adverse to such interests. In the ordinary course of their business activities, the Amneal Group may engage in activities where their interests conflict with our interests or those of our other stockholders.
As a result of these restrictions, we may be limited in how we conduct business, unable to raise additional financing and unable to compete effectively. These restrictions may affect our ability to grow in accordance with our strategy.
As a result of these restrictions, we may be limited in how we conduct business, 41 unable to raise additional financing and unable to compete effectively. These restrictions may affect our ability to grow in accordance with our strategy.
These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.
These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, uncertainty, increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.
We continually assess these threats and make investments to increase internal protection, detection, and response 31 capabilities, as well as ensure our third-party providers have required capabilities and controls, to mitigate these risks.
We continually assess these threats and make investments to increase internal protection, detection, and response capabilities, as well as ensure our third-party providers have required capabilities and controls, to mitigate these risks.
For example, it could: • increase our vulnerability to adverse economic and industry conditions; • limit our ability to obtain additional financing for future working capital, capital expenditures, raw materials, strategic acquisitions and other general corporate requirements; • expose us to unhedged interest rate fluctuations (such as recent increases in interest rates from 2022 through 2023) because the interest on certain debt under the credit facilities is imposed at variable rates; 40 • require us to dedicate a substantial portion of our cash flow from operations to payments on our debt (including interest payments), thereby reducing the availability of cash flow for operations and other purposes; • make it more difficult for us to satisfy our obligations to our lenders, resulting in possible defaults on and acceleration of such indebtedness; • limit our ability to refinance indebtedness or increase the associated costs; • require us to sell assets to reduce debt or influence the decision about whether to do so; • limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate or prevent us from carrying out capital spending that is necessary or important to our growth strategy and efforts to improve operating margins or our business; and • place us at a competitive disadvantage compared to any competitors that have less debt or comparable debt at more favorable interest rates and that, as a result, may be better positioned to withstand economic downturn.
For example, it could: • increase our vulnerability to adverse economic and industry conditions; • limit our ability to obtain additional financing for future working capital, capital expenditures, raw materials, strategic acquisitions and other general corporate requirements; • expose us to unhedged interest rate fluctuations because the interest on certain debt under the credit facilities is imposed at variable rates; 40 • require us to dedicate a substantial portion of our cash flow from operations to payments on our debt (including interest payments), thereby reducing the availability of cash flow for operations and other purposes; • make it more difficult for us to satisfy our obligations to our lenders, resulting in possible defaults on and acceleration of such indebtedness; • limit our ability to refinance indebtedness or increase the associated costs; • require us to sell assets to reduce debt or influence the decision about whether to do so; • limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate or prevent us from carrying out capital spending that is necessary or important to our growth strategy and efforts to improve operating margins or our business; and • place us at a competitive disadvantage compared to any competitors that have less debt or comparable debt at more favorable interest rates and that, as a result, may be better positioned to withstand economic downturn.
If such laws or regulations are more stringent than current legal or regulatory obligations, we may experience disruption in, or an increase in the costs associated with sourcing, manufacturing and distribution of our products, as well as an increase in costs associated with monitoring, tracking and reporting ESG related information to regulatory bodies, which may adversely affect our business, results of operations or financial condition.
If such laws or regulations are more stringent than current legal or regulatory obligations, we may experience disruption in, or an increase in the costs associated with sourcing, manufacturing and distribution of our products, as well as an increase in costs associated with monitoring, tracking and reporting sustainability-related information to regulatory bodies, which may adversely affect our business, results of operations or financial condition.
Accompanying the press and media coverage of pharmaceutical pricing practices and public complaints about the same, has been increasing U.S. federal and state legislative and enforcement interest with respect to drug pricing. For instance, the DOJ issued subpoenas to pharmaceutical companies, including us, seeking information about the sales, marketing and pricing of certain generic drugs. See Note 20.
Accompanying the press and media coverage of pharmaceutical pricing practices and public complaints about the same, has been increasing U.S. federal and state legislative and enforcement interest with respect to drug pricing. For instance, the DOJ issued subpoenas to pharmaceutical companies, including us, seeking information about the sales, marketing and pricing of certain generic drugs. See Note 19.
“First filers” are often able to price the applicable generic drug to yield relatively high gross margins during this 180-day marketing exclusivity period. With respect to our generic products, ANDAs containing Paragraph IV certifications generally become the subject of patent litigation that can be both lengthy and costly.
“First filers” are often able to price the applicable generic drug to yield relatively high gross margins during this 180-day marketing exclusivity period. With respect to our generic products, ANDAs containing Paragraph IV certifications often become subject to patent litigation that can be both lengthy and costly.
Levels of market acceptance for our new products could be affected by several factors, including: • the availability of alternative products from our competitors; • the prices of our products relative to those of our competitors; • the timing of our market entry; • the ability to market our products effectively at the retail level; • the perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits of our drug products compared to those of competing products; • the healthcare providers’ willingness to prescribe medication based on perceptions, training, personal experiences and guidelines; • the willingness of payers and insurance companies to cover or add products to their formularies; • the willingness of hospitals and integrated delivery systems to stock or approve products on their formularies; and • the acceptance of our products by government and private formularies.
Levels of market acceptance for our new products could be affected by several factors, including: • the availability and pricing of alternative products from our competitors; • the timing of our market entry; • the ability to market our products effectively at the retail level; • the perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits of our drug products compared to those of competing products; • the healthcare providers’ willingness to prescribe medication based on perceptions, training, personal experiences and guidelines; • the willingness of payers and insurance companies to cover or add products to their formularies; 26 • the willingness of hospitals and integrated delivery systems to stock or approve products on their formularies; and • the acceptance of our products by government and private formularies.
Furthermore, we may not be able to (i) differentiate our products from those of our competitors, (ii) successfully develop or introduce new products, on a timely basis or at all, that are less costly than those of our competitors, (iii) integrate new systems or technology, such as AI, as quickly or successfully as our competitors, or (iv) offer customers payment and other commercial terms as favorable as those offered by our competitors.
Furthermore, we may not be able to (i) differentiate our products, (ii) successfully develop or introduce new products, on a timely basis or at all, that are less costly, (iii) integrate new systems or technology, such as AI, as quickly or successfully, or (iv) offer customers payment and other commercial terms as favorable as those offered by our competitors.
Our four largest customers, Cencora, Inc., McKesson Drug Co., Cardinal Health, Inc. and CVS Health Corporation, accounted for approximately 70%, 70% and 71% of total net sales of products for the years ended December 31, 2024, 2023 and 2022, respectively.
Our four largest customers, Cencora, Inc., McKesson Drug Co., Cardinal Health, Inc. and CVS Health Corporation, accounted for approximately 71%, 70% and 70% of total net sales of products for the years ended December 31, 2025, 2024 and 2023, respectively.
In addition, changes in our raw material suppliers could result in significant delays in production, higher raw material costs and loss of sales and customers, because regulatory authorities must generally approve raw material sources for pharmaceutical products, which may be time consuming. For example, we may need as long as 18 months to find and qualify a new sole-source supplier.
In addition, changes in our raw material suppliers could result in significant delays in production, higher raw material costs and loss of sales and customers, because regulatory authorities must generally approve raw material sources for pharmaceutical products, which may be time consuming. For example, we may need as long as 24-30 months to find and qualify a new sole-source supplier.
State governments have also taken steps to impose surcharges or taxes on opioid manufacturer s or distributors. Any new or stricter regulations imposed by governmental authorities such as the DEA related to opioid products, as well as a potential increase in opioid-related litigation involving us, could result in material adverse effects on our business and results of operations.
State governments have also taken steps to impose surcharges or taxes on opioid manufacturers or distributors. Any new or stricter regulations imposed by governmental authorities such as the DEA related to opioid products, as well as a potential increase in opioid-related litigation involving us, could result in material adverse effects on our business and results of operations.
The Amneal Group has control over all matters submitted to our stockholders for approval, including changes in capital structure, transactions requiring stockholder approval under Delaware law and corporate governance, subject to the terms of the Stockholders Agreement relating to the Amneal Group's agreement to vote in favor of directors not designated by the Amneal Group and such other matters that are set forth in the Stockholders Agreement.
The Amneal Group has significant influence over all matters submitted to our stockholders for approval, including changes in capital structure, transactions requiring stockholder approval under Delaware law and corporate governance, subject to the terms of the Stockholders Agreement relating to the Amneal Group's agreement to vote in favor of directors not designated by the Amneal Group and such other matters that are set forth in the Stockholders Agreement.
Third parties could illegally distribute and sell counterfeit versions of our products, which do not meet the rigorous manufacturing and testing standards that our products undergo. Counterfeit products are frequently unsafe or ineffective and can be life-threatening. Counterfeit medicines may contain harmful substances, the wrong dose of the API or no API at all.
Third parties could illegally distribute and sell counterfeit versions of our products, which do not meet the rigorous manufacturing and testing standards that our products undergo. Counterfeit products are frequently unsafe or ineffective and can be life-threatening because they may contain harmful substances, the wrong dose of the API or no API at all.
Any of these events could prevent us from conducting our day-to-day activities and could disrupt the operation of our supply chain. For example, we source some of our APIs from the Middle East region, and the armed conflicts that have escalated in the area since October 2023 could threaten our ability to obtain these important inp uts.
Any of these events could prevent us from conducting our day-to-day activities and could disrupt the operation of our supply chain. For example, we source some of our APIs from the Middle East region, and the armed conflicts that have escalated in the area since October 2023 could threaten our ability to obtain these important inputs.
We have been and are currently involved in private antitrust actions involving certain settlement agreements as described in Note 20. Commitments and Contingencies — Other Litigation Related to the Company’s Business.
We have been and are currently involved in private antitrust actions involving certain settlement agreements as described in Note 19. Commitments and Contingencies — Other Litigation Related to the Company’s Business.
For the year ended December 31, 2024, our significant product families (defined as our top five products by annual revenue 26 including both our Affordable Medicines and Specialty segments) accounted for 25% of our consolidated net revenue. The sale of our products may be significantly influenced by market conditions, as well as regulatory actions.
For the year ended December 31, 2025, our significant product families (defined as our top five products by annual revenue including both our Affordable Medicines and Specialty segments) accounted for 25% of our consolidated net revenue. The sale of our products may be significantly influenced by market conditions, as well as regulatory actions.
Further, statements about our ESG-related initiatives and goals, and progress against those goals, may be based on standards for measuring progress that are still developing, internal controls and processes that continue to evolve, and assumptions that are 33 subject to change in the future.
Further, statements about our sustainability-related initiatives and goals, and progress against those goals, may be based on standards for measuring progress that are still developing, internal controls and processes that continue to evolve, and assumptions that are subject to change in the future.
These initiatives and goals within the scope of ESG could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not advance at a sufficient pace, and we could be criticized for the accuracy, adequacy or completeness of the disclosure.
These initiatives and goals could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not advance at a sufficient pace, and we could be criticized for the accuracy, adequacy or completeness of the disclosure.
Because there is a high rate of failure inherent in the R&D process of new products, there is a significant risk that funds invested in R&D will not generate financial returns. We cannot be certain when or whether any of our products currently under development will be approved or launched or whether, once launched, such products will be commercially successful.
Because of a high rate of failure in the R&D process of new products, a significant risk exists that funds invested in R&D will not generate financial returns. We cannot be certain when or whether any of our products currently under development will be approved or launched or whether, once launched, such products will be commercially successful.
For example, we have been the victim of phishing attempts, some of which have been successful in evading detection and blocking. While we have experienced threats to our data and systems, to date, we are not aware that we have experienced a material cyber-security breach. Over time, however, the sophistication of these threats continues to increase.
For example, we have been the victim of attempted phishing email attacks, some of which have been successful in evading detection and blocking. While we have experienced threats to our data and systems, to date, we are not aware that we have experienced a material cyber-security breach. Over time, however, the sophistication of these threats continues to increase.
For example, in 2025, we expect to lose exclusivity for RYTARY ® , an extended-release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease. As our competitors introduce their own generic equivalents of our generic drug products, our revenues and gross margin from such products generally decline, often rapidly.
For example, in 2025, we lost exclusivity for RYTARY ® , an extended-release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease. As our competitors introduce their own generic equivalents of our generic drug products, our revenues and gross margin from such products generally decline, often rapidly.
Therefore, under the TRA, we will be required to make cash payments to the Members and their permitted transferees equal to 75% of certain attributed tax benefits, if any, that we actually realize. The amount of cash payments that we will be required to make under the TRA may be significant.
Therefore, under the TRA, we will be required to make cash payments to the Members and their permitted transferees equal to 75% of certain attributed tax benefits, if any, that we actually realize.
In addition, we could be criticized for the scope or nature of such initiatives or goals, or for any revisions to these goals.
In addition, we could be criticized for the scope or nature of such initiatives or goals, for any revisions to these goals, or for failure to achieve such goals.
Further, if we are unable to realize synergies or other benefits expected to result from any acquisitions, joint ventures or other business combinations, or to generate additional revenue to offset any unanticipated inability to realize these expected synergies or benefits, our growth and ability to compete may be impaired, which would require us to focus additional resources on the integration of operations rather than other profitable areas of our business, and may otherwise cause a material adverse effect on our business, results of operations and financial condition.
Further, if we are unable to realize synergies or other benefits expected to result from any such transactions, or to generate additional revenue to offset any unanticipated inability to realize these expected synergies or benefits, our growth and ability to compete may be impaired, which would require us to focus additional resources on the integration of operations rather than other profitable areas of our business, and may otherwise cause a material adverse effect on our business, results of operations and financial condition.
Any failure by us to comply with applicable laws and regulations and/or any actions by the FDA and other agencies as described above could have a material adverse effect on our business, financial position and results of operations. Our profitability depends on our major customers.
Any failure by us to comply with applicable laws and regulations and/or any actions by the FDA and other agencies as described above could have a material adverse effect on our business and financial results. 27 Our profitability depends on our major customers.
Our business interruption plans may be insufficient to mitigate these, and any other, catastrophic events. Our business is subject to evolving corporate governance and public disclosure regulations and expectations, including with respect to environmental, social and governance matters, that could expose us to numerous risks.
Our business interruption plans may be insufficient to mitigate these, and any other, catastrophic events. Our business is subject to evolving corporate governance and public disclosure regulations and expectations, including with respect to governance and sustainability-related matters, that could expose us to numerous risks.
Our branded pharmaceutical products are or may become subject to competition from generic equivalents because there is no proprietary protection for some of the branded pharmaceutical products we sell, because our patent protection expired or because our patent protection is not sufficiently broad or enforceable.
Our branded pharmaceutical products are or may become subject to competition from generic equivalents because either (i) there is no proprietary protection for some of the branded pharmaceutical products we sell, (ii) our patent protection expired or (iii) our patent protection is not sufficiently broad or enforceable.
We must register our facilities, whether located in the U.S. or elsewhere, with the FDA as well as regulators outside the U.S., and our products must 27 be made in a manner consistent with cGMP, or similar standards in each territory in which we manufacture.
We must register our facilities, whether located in the U.S. or elsewhere, with the FDA as well as regulatory authorities outside the U.S., and our products must be made in a manner consistent with cGMP, or similar standards in each territory in which we manufacture.
Products that do reach the market may ultimately be subject to recalls or other suspensions in sales. Delays and uncertainties in the FDA approval process and the approval processes in other countries can result in delays in product launches and lost market opportunity.
Products that do reach the market may ultimately be subject to recalls or other suspensions in sales. Delays and uncertainties in the FDA or foreign regulatory approval processes can result in delays in product launches and lost market opportunity.
Failure to address AI risks will reduce our ability to deliver strategic objectives. Also, investments in AI may not realize the benefits that were anticipated.
Investments in AI may not realize the benefits that were anticipated. Failure to address AI risks could reduce our ability to deliver strategic objectives.
We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. Significant disruptions to our IT systems or breaches of information security could adversely affect our business.
We depend on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. Significant disruptions to our IT systems or breaches of information security could adversely affect our business.
The majority of our Class A common stock is held by the Amneal Group and is eligible for sale or transfer (subject to certain continuing restrictions). The Amneal Group may elect to sell their shares.
The significant amount of our Class A common stock held by the Amneal Group is eligible for sale or transfer (subject to certain continuing restrictions). The Amneal Group may elect to sell their shares.
In the ordinary course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such information.
We regularly collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such information.
The sale of authorized generics adversely impacts the market share of a generic drug product that has been granted 180 days of marketing exclusivity. This is a significant source of competition for us, because an authorized generic drug product can materially decrease the profits that we could receive as an otherwise exclusive marketer of a generic drug product.
The sale of authorized generics adversely impacts the market share of a generic drug product that has been granted 180 days of marketing exclusivity. Authorized generic drug products present a significant source of competition for us and can materially decrease the profits that we could receive as an otherwise exclusive marketer of a generic drug product.
The principal competitive factors in the pharmaceutical market include: • introduction of other generic drug manufacturers’ products in direct competition with our generic drug products; • introduction of authorized generic drug products in direct competition with our generic or branded products, particularly during exclusivity periods; • the ability of generic drug product competitors to quickly enter the market after the expiration of patents or exclusivity periods of our branded products, diminishing the amount and duration of significant profits; • consolidation among distribution outlets through mergers and acquisitions and the formation of buying groups; • the willingness of generic drug customers, including wholesale and retail customers, to switch among products of different pharmaceutical manufacturers; • pricing pressures by competitors and customers, even if similar price savings are not passed on to consumers; • a company’s reputation as a manufacturer and distributor of quality products; • a company’s level of service (including maintaining sufficient inventory levels for timely deliveries); • a company’s ability to use and integrate artificial intelligence (“AI”); • product appearance and labeling; and • a company’s breadth of product offerings.
The principal competitive factors in the pharmaceutical market include: • introduction of other generic drug manufacturers’ products in direct competition with our generic drug products; • introduction of authorized generic drug products in direct competition with our generic or branded products, particularly during exclusivity periods; • the ability of generic drug product competitors to quickly enter the market after the expiration of patents or exclusivity periods of our branded products, diminishing the amount and duration of significant profits; • consolidation among distribution outlets through mergers and acquisitions and the formation of buying groups; • the willingness of generic drug customers, including wholesale and retail customers, to switch among products of different pharmaceutical manufacturers; • pricing pressures by competitors and customers, even if similar price savings are not passed on to consumers; • a company’s reputation as a manufacturer and distributor of quality products; • a company’s level of service (including maintaining sufficient inventory levels for timely deliveries); • a company’s ability to use and integrate artificial intelligence; • product appearance and labeling; and • a company’s breadth of product offerings. 23 Many of our competitors have longer operating histories and greater financial, R&D, marketing and other resources than we do.
The amount of time required for the FDA to qualify a new supplier and confirm that our manufacturing processes meet the necessary standards could cause delays in the manufacturing and marketing of one or more of our products and could, depending on the particular product, have a material adverse effect on our results of operations and financial condition.
The amount of time required for the FDA to qualify a new supplier and confirm that our manufacturing processes meet the necessary standards could cause delays and could, depending on the particular product, have a material adverse effect on our results of operations and financial condition.
After the introduction of a competing generic product, a significant percentage of the prescriptions previously written for the branded product are often written for the generic version.
After the introduction of a competing generic product, a significant percentage of the prescriptions previously written for the branded product often switch to the generic version.
The drug pricing reforms in the IRA have impacted, and may impact in the future, the prices of certain of our products. For example, rebates related to the IRA reduced our net revenue for the years ended December 31, 2024 and 2023 by $8.0 million and $7.9 million, respectively.
The drug pricing reforms in the IRA have impacted, and may impact in the future, the prices of certain of our products. For example, rebates related to the IRA reduced our net revenue for each of the years ended December 31, 2025 and 2024 by $8.0 million.
The Amneal Group also may pursue business opportunities with any of our clients, customers or vendors that may be complementary to our business and, as a result, those acquisition opportunities may not be available to us. The Amneal Group could also transfer control of us to a third-party by transferring its shares.
The Amneal Group also may pursue business opportunities with any of our clients, customers or vendors that may be com plementary to our business and, as a result, those acquisition opportunities may not be available to us. The Amneal Group could also transfer its significant holdings in us to a third-party by transferring its shares.
In addition, Part D plan sponsors are permitted and encouraged to negotiate rebates with manufacturers. The Medicare Part D program, which went into effect January 1, 2006, is administered by the CMS within the Department of Health and Human Services.
In addition, Part D plan sponsors are permitted and encouraged to negotiate rebates with manufacturers. The Medicare Part D program, which went into effect January 1, 2006, is administered by the CMS within HHS.
Catastrophic events, including severe weather events, war and terrorist attacks, may negatively affect our business and results of operations. We rely on our network infrastructure and enterprise applications, internal technology systems and websites to run our business as well as our or our third-party partners’ physical facilities, such as our R&D or manufacturing premises.
Catastrophic events, including severe weather events, war and terrorist attacks, may negatively affect our business and results of operations. We rely on our internal technology systems and websites to run our business as well as our or our third-party partners’ physical facilities, such as our R&D or manufacturing premises. In addition, we rely on third-party hosted services.
The size and complexity of our IT systems, and those of our third-party vendors, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners or vendors.
The size and complexity of our IT systems, and those of our third-party vendors, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners, vendors, or malicious third parties using phishing or ransomware attacks.
If utilization of our DTAs becomes more-likely-than-not in the future, at such time, we could incur obligations approximating the $133.8 million unrecorded contingent TRA liability as of December 31, 2024.
If utilization of our DTAs becomes more-likely-than-not in the future, at such time, we could incur obligations approximating the $129.1 million unrecorded contingent TRA liability as of December 31, 2025.
To grow and achieve success in our branded product business, we must continually identify, develop, acquire and license new products that we can ultimately market. There are many difficulties and uncertainties inherent in pharmaceutical R&D, and there is a high rate of failure inherent in new drug discovery and development.
To grow and achieve success in our branded product business, we must continually identify, develop, acquire and license new products that we can ultimately market. Difficulties and uncertainties inherently exist in pharmaceutical R&D, resulting in a high rate of failure in new drug discovery and development.
The interests of the Amneal Group may differ from the interests of our other stockholders. As of December 31, 2024, the Amneal Group controlled the majority of the voting power of all of our outstanding shares of common stock.
The interests of the Amneal Group may differ from the interests of our other stockholders. As of December 31, 2025, the Amneal Group controlled approximately 48% of the voting power of all of our outstanding shares of common stock.
For instance, the DEA has recently increased its scrutiny and regulation over the manufacture, distribution and sale of opioid products, which may require us to incur significant expenses to comply with such regulations.
For instance, the DEA has recently increased its scrutiny and regulation over the manufacture, distribution and sale of opioid products, which may require us to incur significant expenses to comply with such regulations. As discussed in further detail in Note 19.
If any of our products or similar products that other companies distribute are subject to market withdrawal or recall or are proven to be, or are claimed to be, harmful to consumers, then this could have a material adverse effect on our business, results of operations and financial condition.
If any of our products or similar products that other companies distribute are subject to market withdrawal or recall or misused or are proven to be, or are claimed to be, harmful to consumers, and if any negative publicity associated with any of the foregoing occurs, then this could have a material adverse effect on our reputation, business, results of operations, and financial condition.
Developing and acting on initiatives within the scope of ESG, and collecting, measuring and reporting ESG related information and metrics can be costly, difficult and time consuming and is subject to evolving reporting standards and similar proposals by other international regulatory bodies.
Developing and acting on initiatives within the scope of sustainability, and collecting, measuring and reporting sustainability-related information and metrics can be costly, difficult and time consuming and is subject to evolving reporting standards and differing proposals offered by various regulatory bodies.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeIn addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity. Specific cybersecurity incidents are tracked by a third-party service provider through a ticketing system. Should cybersecurity issues arise throughout the quarter, management would determine whether a cybersecurity incident was material and decide on appropriate reporting and mitigation measures.
Biggest changeSpecific cybersecurity incidents are tracked by a third-party service provider through a ticketing system. 48 Should cybersecurity issues arise throughout the quarter, management would determine whether a cybersecurity incident was material and decide on appropriate reporting and mitigation measures. Following this determination, management would promptly schedule a meeting with the Audit Committee.
We also conduct periodic phishing attack simulations to evaluate users’ vulnerability to emerging email threats. We conduct remediation training where failures occur. On a quarterly basis, our cybersecurity team also conducts scenario - based tabletop exercises with critical business teams to simulate disasters and cyberattacks. The tabletop exercises test and fine-tune our business continuity plans and incident response procedures.
We also conduct periodic phishing attack simulations to evaluate users’ vulnerability to emerging email threats. We conduct remediation training where failures occur. On a periodic basis, our cybersecurity team also conducts scenario - based tabletop exercises with critical business teams to simulate disasters and cyberattacks. The tabletop exercises test and fine-tune our business continuity plans and incident response procedures.
We prioritize our mitigation of cybersecurity risks based on relative likelihood and severity (e.g., critical risk, high risk, low risk) and document a mitigation plan that details a resolution timeline.
We prioritize our mitigation of cybersecurity risks based on relative likelihood and severity (e.g., critical risk, high risk, medium risk, low risk) and document a mitigation plan that details a resolution timeline.
Incident response emphasizes rapid containment following detection of a range of threats including: • suspicious repeated login failures; • suspicious network traffic; • malware detection; and • other threats as prioritized through a combination of industry threat intelligence via the Healthcare Information Sharing and Analysis Center and the Company’s security operation center.
Incident response emphasizes rapid containment following detection of a range of threats including: • suspicious repeated login failures; • unusual login patterns; • suspicious network traffic; • malware detection; and • other threats as prioritized through a combination of industry threat intelligence via the Healthcare Information Sharing and Analysis Center and the Company’s security operation center.
However, a significant cybersecurity incident may materially impact our 47 business strategy, results of operations and financial condition.
However, a significant cybersecurity incident may materially impact our business strategy, results of operations, and financial condition.
Program Assessments Our cybersecurity processes are evaluated as part of an ongoing assessment of our internal control environment, which are informed by the five pillars of the NIST Cybersecurity Framework (“NIST CSF”). We employ a third-party service provider to conduct periodic penetration tests and scan different parts of our IT environment for potential vulnerabilities.
Program Assessments Our cybersecurity processes are evaluated as part of an ongoing assessment of our internal control environment, which are informed by the five pillars of the NIST Cybersecurity Framework (“NIST CSF”). We employ a third-party service provider to conduct periodic penetration tests and scan different parts of our information technology (“IT”) environment for potential vulnerabilities.
As discussed more fully under Part 1, Item 1A, Risk Factors, “We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks, ” the sophistication of cybersecurity threats continues to increase, and the preventative actions we take to reduce the risk of cybersecurity incidents and protect our systems and information may be insufficient.
As discussed more fully under Part 1, Item 1A, Risk Factors, “We depend on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks, ” the sophistication of cybersecurity threats continues to increase, and the preventative actions we take to reduce the risk of cybersecurity incidents and protect our systems and information may be insufficient.
Additionally, we use a variety of detective and preventive technologies, including: 46 • email threat detection; • endpoint detection and response; • a 24 hours a day, 7 days a week security operations center that monitors system log telemetry and threat intelligence via a security incident and event management platform; • vulnerability scanning on both internal and externally - facing infrastructure; • next-generation firewalls with geographic access restriction for sensitive externally - facing systems; • multi-factor authentication for remote access and certain internal systems; • data loss prevention for email traffic containing sensitive information; • domain name service threat detection; and • internal incident response procedures based on NIST Special Publication 800-61.
Additionally, we use a variety of detective and preventive technologies, including: • email threat detection; • endpoint detection and response; • a 24 hours a day, 7 days a week security operations center that monitors system log telemetry and threat intelligence via a security incident and event management platform; • vulnerability scanning on both internal and externally - facing infrastructure; • next-generation firewalls with geographic access restriction for sensitive externally - facing systems; • multi-factor authentication for remote access and certain internal systems; • data loss prevention for email traffic containing sensitive information; • mobile device security control for company-owned and personally-owned devices accessing certain systems; • domain name service threat detection; and • internal incident response procedures based on NIST Special Publication 800-61.
Following the onboarding phase, the cybersecurity team continuously monitors risks related to the vendor, partner and/or system. All third-party cybersecurity incidents are tracked though the third-party service provider and are communicated to our cybersecurity team upon discovery.
Following the onboarding phase, the cybersecurity team continuously monitors risks related to the vendor, partner and/or system. Identified third-party cybersecurity incidents are tracked through the third-party service provider and are communicated to our cybersecurity team upon discovery.
As of the date of this report, we do not believe that any risks from any cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition.
As of the date of this report, we do not believe that any risks from any cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business, financial position, results of operations and/or cash flow.
The Audit Committee receives cybersecurity updates from IT leadership at least twice a year. When meeting with the Audit Committee, the IT leadership team highlights significant accomplishments and issues related to our IT infrastructure, including cybersecurity incidents, risks, industry trends, notable incidents facing other companies, incident preparedness and other developments.
The Audit Committee receives cybersecurity updates from IT leadership periodically. When meeting with the Audit Committee, the IT leadership team highlights significant accomplishments and issues related to our IT infrastructure, including cybersecurity incidents, risks, industry trends, notable incidents facing other companies, incident preparedness and other developments.
During the onboarding phase, our cybersecurity team under the direction of the Sr. Director Information Security, Compliance, and Privacy, performs a technological risk assessment on, and utilizes certain tools to detect external risk posed by, the vendor, partner and/or system. Vendors identified as posing elevated risk are escalated to senior management for informed risk tolerance determination.
During the onboarding phase, our cybersecurity team under the direction of the Vice President, Global 47 IT Security, performs a technological risk assessment on, and utilizes certain tools to detect external risk posed by, the vendor, partner and/or system. Vendors identified as posing elevated risk are escalated to senior management for informed risk tolerance determination.
Management Oversight Our IT department, in conjunction with the compliance department, assess and manage risks related to cybersecurity. The Senior Director of Global Information Security, Compliance and Privacy, is the primary management personnel responsible for our cybersecurity program.
Management Oversight Our IT department, in conjunction with the compliance department, assess and manage risks related to cybersecurity. The Vice President, Global IT Security is the primary management personnel responsible for our cybersecurity program.
We prioritize critical or high vulnerabilities for swift remediation. Additionally, we employ a third-party service provider for continuous cybersecurity risk and vulnerability monitoring. We make continuous adjustments to system and network configurations to mitigate or remediate identified vulnerabilities. Incident Response Cybersecurity incident response procedures are informed by NIST Special Publication 800-61, and continuously improved following periodic exercises and live incidents.
We prioritize critical or high vulnerabilities for swift remediation. Additionally, we employ a third-party service provider for continuous cybersecurity risk and vulnerability monitoring. We make continuous adjustments to system and network configurations to mitigate or remediate identified vulnerabilities and emerging threats.
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Following this determination, management would promptly schedule a meeting with the Audit Committee.
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Incident Response Cybersecurity incident response procedures are informed by NIST Special Publication 800-61, and continuously improved following periodic exercises and live incidents.
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In addition, the department heads for IT and internal audit have industry recognized credentials and extensive experience in the area of cybersecurity.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOur properties are generally used to support the operations of our Affordable Medicines, Specialty and AvKARE segments. 48 Our significant properties are as follows: Property Address Legal Status Purpose Bridgewater, New Jersey Leased Executive Office Glasgow, Kentucky Leased Administrative, Distribution and Warehouse Glasgow, Kentucky Leased Warehouse Yaphank, New York Leased Warehouse Glasgow, Kentucky Owned Warehouse Glasgow, Kentucky Owned Warehouse Glasgow, Kentucky Leased Warehouse Piscataway, New Jersey Leased Warehouse Piscataway, New Jersey Leased Manufacturing Piscataway, New Jersey Leased R&D, Manufacturing Branchburg, New Jersey Leased Manufacturing Branchburg, New Jersey Leased Manufacturing Piscataway, New Jersey Leased Manufacturing Branchburg, New Jersey Leased Warehouse East Hanover, New Jersey Leased Warehouse Bridgewater, New Jersey Leased R&D Yaphank, New York Leased Manufacturing, R&D, Quality and Regulatory Pulaski, Tennessee Leased Warehouse and office space Philadelphia, Pennsylvania Leased Warehouse and office space Fountain Run, Kentucky Leased Warehouse and office space Cashel Co, Tipperary, Ireland Owned R&D, Manufacturing Ahmedabad, Gujarat, India Owned Oral Solids Manufacturing and R&D Matoda, Gujarat, India Leased Oral Solids and Injectables Manufacturing and R&D Ahmedabad, Gujarat, India Leased R&D (Injectables), Corporate Office Ahmedabad, Gujarat, India Leased Corporate Office Mahabubnagar, Telangana, India Leased Oncology R&D and Manufacturing Visakhapatam, Apandhra Pradesh, India Owned API Manufacturing and R&D Bharuch, Gujarat, India Leased API Manufacturing Ahmedabad, Gujarat, India Leased R&D Mehsana, Gujarat, India Owned Injectables Manufacturing Ahmedabad, Gujarat, India Leased Office space Ahmedabad, Gujarat, India Owned Injectables Manufacturing and R&D Mumbai, Maharashtra, India Leased Office Space Ahmedabad, Gujarat, India Leased Warehouse Item 3.
Biggest changeOur significant properties are as follows: Property Address Legal Status Purpose Bridgewater, New Jersey Leased Executive Office Glasgow, Kentucky Leased Administrative, Distribution and Warehouse Glasgow, Kentucky Leased Warehouse Yaphank, New York Leased Warehouse Glasgow, Kentucky Owned Warehouse Glasgow, Kentucky Owned Warehouse Glasgow, Kentucky Leased Warehouse Piscataway, New Jersey Leased Warehouse Piscataway, New Jersey Leased Manufacturing Piscataway, New Jersey Leased R&D, Manufacturing Branchburg, New Jersey Leased Manufacturing Branchburg, New Jersey Leased Manufacturing Piscataway, New Jersey Leased Manufacturing Branchburg, New Jersey Leased Warehouse East Hanover, New Jersey Leased Warehouse Brookhaven, New York Leased Manufacturing, R&D, Quality and Regulatory Pulaski, Tennessee Leased Warehouse and office space Philadelphia, Pennsylvania Leased Warehouse and office space Fountain Run, Kentucky Leased Warehouse and office space Cashel Co, Tipperary, Ireland Owned R&D, Manufacturing Ahmedabad, Gujarat, India Owned Oral Solids Manufacturing and R&D Matoda, Gujarat, India Leased Oral Solids and Injectables Manufacturing and R&D Ahmedabad, Gujarat, India Leased R&D (Injectables), Corporate Office Ahmedabad, Gujarat, India Leased Corporate Office Mahabubnagar, Telangana, India Leased Oncology R&D and Manufacturing Visakhapatam, Andhra Pradesh, India Owned API Manufacturing and R&D Bharuch, Gujarat, India Leased API Manufacturing Ahmedabad, Gujarat, India Leased R&D Mehsana, Gujarat, India Owned Injectables Manufacturing Ahmedabad, Gujarat, India Leased Office space Ahmedabad, Gujarat, India Owned Injectables Manufacturing and R&D Mumbai, Maharashtra, India Leased Office Space Ahmedabad, Gujarat, India Leased Warehouse Ahmedabad, Gujarat, India Leased Corporate Office
Item 2. Properties Amneal owns or leases numerous properties in domestic and foreign locations. Amneal’s principal properties include manufacturing facilities, R&D laboratories, warehouses, and corporate offices.
Item 2. Properties Amneal owns or leases numerous properties in domestic and foreign locations. Amneal’s principal properties include manufacturing facilities, R&D laboratories, warehouses, and corporate offices. Our properties are generally used to support the operations of our Affordable Medicines, Specialty and AvKARE segments.
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Legal Proceedings Information pertaining to legal proceedings can be found in Note 20. Commitments and Contingencies and is incorporated by reference herein. Item 4. Mine Safety Disclosures Not applicable. 49 PART II.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeIn the U.S., when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. AvKARE Our AvKARE segment provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, predominantly focused on the U.S. Department of Defense and the U.S.
Biggest changeFor Specialty products, the majority of such products’ commercial value is usually realized during the period in which the product has market exclusivity. In the U.S., when market exclusivity expires and generic versions of a product are approved and marketed, there can often be substantial and rapid declines in the branded product’s sales.
In September 2024, we began selling CREXONT ® , which is indicated for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
In September 2024, we began selling CREXONT ® , which is indicated for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese 53 poisoning in adults.
For the years ended December 31, 2024 and December 31, 2023, we utilized the Russell 2000 Index as a broad equity market index for purposes of meeting the disclosure requirements of Regulation S-K Item 201(e)(1)(i) and the Dow Jones U.S. Select Pharmaceuticals Index as a published industry index for purposes of meeting the disclosure requirements of Regulation S-K Item 201(e)(1)(ii)(A).
For the years ended December 31, 2025 and December 31, 2024, we utilized the Russell 2000 Index as a broad equity market index for purposes of meeting the disclosure requirements of Regulation S-K Item 201(e)(1)(i) and the Dow Jones U.S. Select Pharmaceuticals Index as a published industry index for purposes of meeting the disclosure requirements of Regulation S-K Item 201(e)(1)(ii)(A).
The Class A common stock price performance shown on the graph only reflects the change in our Class A common stock price relative to the noted indices and is not necessarily indicative of future price performance. 50 Dividends We have never paid cash dividends on any class of our common stock and have no present plans to do so.
The Class A common stock price performance shown on the graph only reflects the change in our Class A common stock price relative to the noted indices and is not necessarily indicative of future price performance. 51 Dividends We have never paid cash dividends on any class of our common stock and have no present plans to do so.
As of September 30, 2023, we held 50.4% of the Amneal Common Units and the group, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Members” or the “Amneal Group”) held the remaining 49.6%.
As of September 30, 2023, we held 50.4% of the Amneal Common Units and the group, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Amneal Group”) held the remaining 49.6%.
Our current policy is to retain all earnings, if any, for use in the operation of our business or to reduce our debt. Issuer Purchases of Equity Securities We did not purchase any shares of our Class A common stock during the three months ended December 31, 2024. 51 Item 6. Reserved 52 Item 7.
Our current policy is to retain all earnings, if any, for use in the operation of our business or to reduce our debt. Issuer Purchases of Equity Securities We did not purchase any shares of our Class A common stock during the three months ended December 31, 2025. Item 6. Reserved 52 Item 7.
For a discussion of our financial condition and results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022, see “Results of Operations” and “Liquidity and Capital Resources” under Part II, Item 7.
For a discussion of our financial condition and results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023, see “Results of Operations” and “Liquidity and Capital Resources” under Part II, Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Amneal Pharmaceuticals, Inc. (the “Company”, “we,” “us,” or “our”) is a global pharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines. Our Affordable Medicines segment includes retail generics, injectables, and biosimilars.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Amneal Pharmaceuticals, Inc. (the “Company”, “we,” “us,” or “our”) is a diversified, 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.
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 U.S., India, and Ireland .
Affordable Medicines Our Affordable Medicines segment includes approximately 270 product families covering an extensive range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches and topicals.
Affordable Medicines Our Affordable Medicines segment includes over 280 product families covering an extensive range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches and topicals.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information and Holders Our Class A common stock trades under the symbol “AMRX” on the Nasdaq. According to the records of our transfer agent, we had 154 holders of record of our Class A common stock as of February 14, 2025.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information and Holders Our Class A common stock trades under the symbol “AMRX” on the Nasdaq. According to the records of our transfer agent, we had 159 holders of record of our Class A common stock as of February 13, 2026.
Refer to the section “Segments” below for an overview of our segments, including the change in name of the Affordable Medicines segment. Prior to the Reorganization (as defined herein), we were a holding company, whose principal assets were common units (the “Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”).
Refer to the section “Segments” below for an overview of our segments. Prior to the Reorganization (as defined herein), we were a holding company, whose principal assets were common units (the “Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”).
Select Pharmaceuticals Index for the period from December 31, 2019 to December 31, 2024, assuming the investment of $100 on December 31, 2019, and the reinvestment of dividends.
Select Pharmaceuticals Index for the period from December 31, 2020 to December 31, 2025, assuming the investment of $100 on December 31, 2020, and the reinvestment of dividends.
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission on March 14, 2024. Overview Segments We have three reportable segments: Affordable Medicines (formerly known as Generics), Specialty, and AvKARE.
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission on February 28, 2025. Overview Segments We have three reportable segments: Affordable Medicines, Specialty, and AvKARE.
As such, the timing of new product introductions can have a significant impact on our financial results. The entrance into the market of additional competition generally has a negative impact on the volume and/or pricing of the affected products.
As such, the timing of new product introductions can have a significant impact on our financial results. The entrance into the market of additional competition generally has a negative impact on the volume and/or pricing of the affected products. Additionally, pricing is determined by market place dynamics and is often affected by factors outside of our control.
Effective with the Reorganization, we hold 100% of the Amneal Common Units and consolidate the financial statements of Amneal and its subsidiaries. Refer to Note 1. Nature of Operations in our consolidated financial statements for additional information about the Reorganization.
Effective with the Reorganization, we hold 100% of the Amneal Common Units and consolidate the financial statements of Amneal and its subsidiaries. Refer to Note 1. Nature of Operations in our consolidated financial statements for additional information about the Reorganization. The following discussion and analysis contains forward-looking statements that involve risks and uncertainties.
Risk Factors and under the heading Forward-Looking Statements in this Annual Report on Form 10-K. The following discussion and analysis, as well as other sections in this report, should be read in conjunction with the consolidated financial statements and related notes to consolidated financial statements included elsewhere herein.
The following discussion and analysis, as well as other sections in this report, should be read in conjunction with the consolidated financial statements and related notes to consolidated financial statements included elsewhere herein.
Additionally, pricing is determined by market place dynamics and is often affected by factors outside of our control. 53 Specialty Our Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease, and endocrine disorders.
Specialty Our Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease, and endocrine disorders.
AvKARE is also a wholesale distributor of pharmaceuticals, over the counter drugs and medical supplies to its retail and institutional customers that are located throughout the U.S. focused primarily on entities that provide care to low-income and uninsured patients. Operating results for the sale of Amneal products by AvKARE are included in our Affordable Medicines reportable segment.
AvKARE is also a re-packager of bottle and unit dose pharmaceuticals and vitamins under the registered names of AvKARE and AvPAK. AvKARE is also a wholesale distributor of pharmaceuticals, over the counter drugs and medical supplies to its retail and institutional customers that are located throughout the U.S. focused primarily on entities that provide care to low-income and uninsured patients.
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
Operating results for the sale of Amneal products by AvKARE are included in our Affordable Medicines reportable segment. Certain Market, Industry, and Geopolitical Factors 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.
UNITHROID ® , indicated for the treatment of hypothyroidism, is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc. Our Specialty products are marketed through skilled specialty sales and marketing teams, who call on neurologists, movement disorder specialists, endocrinologists and primary care physicians in key markets throughout the U.S.
Our Specialty products are marketed through skilled specialty sales and marketing teams, who call on neurologists, movement disorder specialists, endocrinologists and primary care physicians throughout the U.S. Our Specialty segment also has other product candidates that are in varying stages of development.
We recorded non-controlling interests for the portion of Amneal’s economic interests that we did not hold prior to the Reorganization. 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.
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 and under the heading Forward-Looking Statements in this Annual Report on Form 10-K.
RYTARY ® is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. ONGENTYS ® is an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes, which we commenced selling in early 2024 under a license agreement with BIAL-Portela & Ca., S.A.
RYTARY ® is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. UNITHROID ® , indicated for the treatment of hypothyroidism, is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc. New product launches are an important growth driver.
Our portfolio of products includes CREXONT ® (combination of carbidopa and levodopa extended release capsules), RYTARY ® (extended release oral capsule formulation of carbidopa-levodopa), UNITHROID ® (levothyroxine sodium), and ONGENTYS ® (opicapone). On August 7, 2024, the FDA approved our new drug application (“NDA”) for CREXONT ® , previously referred to as IPX203.
Significant products within our Specialty segment include CREXONT ® (combination of carbidopa and levodopa extended release capsules), RYTARY ® (extended release oral capsule formulation of carbidopa-levodopa), UNITHROID ® (levothyroxine sodium), and Brekiya ® (dihydroergotamine mesylate) injection.
Removed
Although we had a minority economic interest in Amneal prior to March 31, 2023, we were Amneal’s sole managing member, having the sole voting power to make all of Amneal’s business decisions and control its management. Therefore, we consolidated the financial statements of Amneal and its subsidiaries prior to the Reorganization.
Added
Brekiya ® autoinjector, approved by the FDA in May 2025 and launched in the U.S. in October 2025, is the first and only ready-to-use autoinjector formulation of dihydroergotamine mesylate indicated for the acute treatment of migraine, with or without aura, and for the acute treatment of cluster headache in adults.
Removed
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 segment name change did not result in any change to the composition of our reportable segments and, therefore, did not result in any changes to our historical segment results.
Added
In 2025, an authorized generic version of RYTARY ® was launched, and the Company anticipates multiple generic versions of RYTARY ® to be introduced in the future. In 2025, CREXONT ® continued to grow within our Specialty segment.
Removed
Our Specialty segment also has a number of product candidates that are in varying stages of development. For Specialty products, the majority of the product’s commercial value is usually realized during the period in which the product has market exclusivity.
Added
CREXONT ® was added to three large national formularies, which expanded total U.S. insurance coverage from about 30% of covered lives at the end of 2024 to over 50% at the end of 2025.
Removed
Department of Veterans Affairs. AvKARE is a re-packager of bottle and unit dose pharmaceuticals under the registered names of AvKARE and AvPAK.
Added
In December 2025, we announced new positive interim results from our ongoing Phase 4 ELEVATE-PD study, including significant increases in daily “Good On” time and reductions in “Off” time. AvKARE Our AvKARE segment provides pharmaceuticals primarily to governmental agencies, predominantly focused on serving the U.S. Department of Defense and the U.S. Department of Veterans Affairs.
Added
For a more detailed explanation of our business and its risks, refer to

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeCash Flows from Financing Activities Net cash used in financing activities of $211.8 million for the year ended December 31, 2024 was relatively flat compared to the prior year as a decrease in payments associated with refinancing our Term Loan Due 2025 in the prior year of $162.3 million and a reduction in tax distributions paid to non-controlling interests of $51.1 million were offset by a year-over-year decrease in net debt and financing leases of $207.8 million and an increase in employee payroll tax withholding on restricted stock unit vesting of $5.6 million.
Biggest changeCash Flows from Financing Activities Net cash used in financing activities of $31.5 million for the year ended December 31, 2025 as compared to $211.8 million for the prior year.
Included within these policies are certain policies which contain critical accounting estimates and, therefore, have been deemed to be “critical accounting policies.” Critical accounting estimates are those which require management to make assumptions about matters that were uncertain at the time the estimate was made and for which the use of different estimates, which 62 reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur from period to period could have a material impact on our financial condition or results of operations.
Included within these policies are certain policies which contain critical accounting estimates and, therefore, have been deemed to be “critical accounting policies.” Critical accounting estimates are those which require management to make assumptions about matters that were uncertain at the time the estimate was made and for which the use of different estimates, which reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur from period to period could have a material impact on our financial condition or results of operations.
This evidence 64 includes, but is not limited to, prior earnings history, projected future earnings, carryback and carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a DTA. The weight given to the positive and negative evidence is commensurate with the extent the evidence may be objectively verified.
This evidence includes, but is not limited to, prior earnings history, projected future earnings, carryback and carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a DTA. The weight given to the positive and negative evidence is commensurate with the extent the evidence may be objectively verified.
Goodwill is allocated and evaluated for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment. Our reportable segments are the same as the respective operating segments and reporting 63 units.
Goodwill is allocated and evaluated for impairment at the reporting unit level, which is defined as an operating segment or one level below the operating segment level. Our reportable segments are the same as the respective operating segments and reporting units.
As of December 31, 2024, based upon all available objective and verifiable evidence both positive and negative, including historical levels of pre-tax loss and income both on a consolidated basis and tax reporting entity basis, legislative developments, expectations and risks associated with estimates of future pre-tax income, and prudent and feasible tax planning strategies, we determined that it is more likely than not that we will not realize the benefits of our gross DTAs.
As of December 31, 2025, based upon all available objective and verifiable evidence both positive and negative, including historical levels of pre-tax loss and income both on a consolidated basis and tax reporting entity basis, legislative developments, expectations and risks associated with estimates of future pre-tax income, and prudent and feasible tax planning strategies, we determined that it is more likely than not that we will not realize the benefits of our gross DTAs.
As noted above, we have determined it is more-likely-than-not we will be unable to utilize all of our DTAs subject to the TRA; and, as of December 31, 2024 and 2023, we had not recognized the entire contingent liability under the TRA related to the tax savings we may realize from Amneal Common Units sold or exchanged.
As noted above, we have determined it is more-likely-than-not we will be unable to utilize all of our DTAs subject to the TRA; and, as of December 31, 2025 and 2024, we had not recognized the entire contingent liability under the TRA related to the tax savings we may realize from Amneal Common Units sold or exchanged.
The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from our estimates and could have a material adverse effect on our results of operations and/or cash flows in any given accounting period, or on our overall financial condition. For further details, refer to Note 20.
The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from our estimates and could have a material adverse effect on our results of operations and/or cash flows in any given accounting period, or on our overall financial condition. For further details, refer to Note 19.
While we believe we have valid claims and/or defenses for the matters described in Note 20. Commitments and Contingencies, the nature of litigation is unpredictable and the outcome of the proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, we accrue for a potential loss.
While we believe we have valid claims and/or defenses for the matters described in Note 19. Commitments and Contingencies, the nature of litigation is unpredictable and the outcome of the proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, we accrue for a potential loss.
Commitments and Contingencies . 65 Recently Issued Accounting Standards Recently issued accounting standards are discussed in Note 2. Summary of Significant Accounting Policies .
Commitments and Contingencies . Recently Issued Accounting Standards Recently issued accounting standards are discussed in Note 2. Summary of Significant Accounting Policies .
Income Taxes in our consolidated financial statements, we are a party to a TRA under which we are generally required to pay to the Amneal Group 75% of the applicable tax savings, if any, in U.S. federal and state income tax that we are deemed to realize and that are created as a result of tax benefits attributable to payments made under the TRA.
Income Taxes , we are a party to a TRA under which we are generally required to pay to the Amneal Group 75% of the applicable tax savings, if any, in U.S. federal and state income tax that we are deemed to realize and that are created as a result of tax benefits attributable to payments made under the TRA.
Such payments are dependent upon the occurrence of specific and contingent events, and not the passage of time. A discussion of our significant contingent milestones is contained in Note 5. Alliance and Collaboration and Note 23. Related Party Transactions. Off-Balance Sheet Arrangements We did not have any off-balance sheet arrangements as of December 31, 2024.
Such payments are dependent upon the occurrence of specific and contingent events, and not the passage of time. A discussion of our significant contingent milestones is contained in Note 4. Alliance and Collaboration and Note 22. Related Party Transactions. Off-Balance Sheet Arrangements We did not have any off-balance sheet arrangements as of December 31, 2025.
If utilization of these DTAs becomes more-likely-than-not in the future, at such time, these TRA liabilities (which amount to approximately $133.8 million as of December 31, 2024, as a result of basis adjustments under Internal Revenue Code Section 754) will be recorded through charges to our statements of operations.
If utilization of these DTAs becomes more-likely-than-not in the future, at such time, these contingent TRA liabilities (which amount to approximately $129.1 million as of December 31, 2025, as a result of basis adjustments under Internal Revenue Code Section 754) will be recorded through charges to our statements of operations.
Accordingly, as of December 31, 2024, this valuation allowance was $590.3 million and reduced the carrying value of these gross DTAs, net of the impact of the reversal of taxable temporary differences, to zero. As described in Item 1A. Risk Factors and Note 6.
Accordingly, as of December 31, 2025, this valuation allowance was $586.6 million and reduced the carrying value of these gross DTAs, net of the impact of the reversal of taxable temporary differences, to zero. 65 As described in Item 1A. Risk Factors and Note 5.
However, if the tax attributes are not utilized in future years, it is reasonably possible no amounts would be paid under the TRA in excess of the $53.9 million accrued as of December 31, 2024.
However, if the tax attributes are not utilized in future years, it is reasonably possible no amounts would be paid under the TRA in excess of the $57.5 million accrued as of December 31, 2025.
(5) Represents the tax receivable agreement liability as of December 31, 2024. A discussion on our tax receivable agreement is contained in Note 6. Income Taxes . (6) Represents minimum sales and marketing spending obligations and a minimum royalty obligation. The foregoing table does not include milestone payments potentially payable by us under our collaboration agreements.
A discussion of our tax receivable agreement, including the unrecorded contingent liability, is contained in Note 5. Income Taxes . (5) Represents minimum sales and marketing spending obligations, a minimum royalty obligation, and a minimum purchase obligation. The foregoing table does not include milestone payments potentially payable by us under our collaboration agreements.
If the net book value of the reporting unit exceeds its fair value, we recognize a goodwill impairment charge for the reporting unit equal to the lesser of (i) the total goodwill allocated to that reporting unit and (ii) the amount by which that reporting unit’s carrying amount exceeds its fair value.
If the reporting unit’s carrying amount exceeds its fair value, we record a goodwill impairment charge equal to the lesser of (i) the total amount of goodwill allocated to that reporting unit or (ii) the amount by which the reporting unit’s carrying amount exceeds its fair value.
Cash Flows from Investing Activities Net cash used in investing activities was $63.0 million for the year ended December 31, 2024 as compared to $69.2 million for the prior year.
Cash Flows from Investing Activities Net cash used in investing activities was $112.3 million for the year ended December 31, 2025 as compared to $63.0 million for the prior year.
Historically, our changes of estimates reflecting actual results or updated expectations have not been material to our overall business. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location.
If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location.
If a quantitative assessment is required, we determine the fair value of our reporting unit using a combination of the income and market approaches.
When a quantitative test is required, we estimate the fair value of each reporting unit using a combination of income and market approaches.
A discussion of our operating lease obligations is contained in Note 17. Leases . (4) Amounts primarily represent future minimum rental payments under a non-cancelable financing lease obligation for a production facility in New York. A discussion of our financing lease obligations is contained in Note 17. Leases .
(3) Amounts primarily represent future minimum rental payments under a non-cancelable financing lease obligation for a production facility in New York. A discussion of our financing lease obligations is contained in Note 16. Leases . (4) Represents the tax receivable agreement liability as of December 31, 2025.
As of December 31, 2024, $366.3 million, $161.7 million, and $69.5 million of goodwill was allocated to our Specialty, Affordable Medicines, and AvKARE segments, respectively. During the fourth quarter of 2024, we tested each of our reporting units for impairment using a quantitative assessment.
As of December 31, 2025, $366.3 million, $159.7 million, and $69.5 million of goodwill was allocated to our Specialty, Affordable Medicines, and AvKARE segments, respectively. During the fourth quarter of 2025, we performed a qualitative assessment for each reporting unit. There was no impairment of goodwill in any reporting unit for the year ended December 31, 2025.
Certain deductions represent estimates of rebates related to gross sales for the reporting period and, as such, knowledge and judgment of market conditions and practice are required when estimating the impact of these revenue deductions on gross sales for a reporting period.
Certain deductions represent estimates of rebates related to gross sales for the reporting period and, as such, knowledge and judgment of market conditions and practice are required when estimating the impact of these revenue deductions on gross sales for a reporting period. 63 Historically, our changes of estimates reflecting actual results or updated expectations have not been material to our overall business.
Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that a reporting unit’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required.
If, based on this assessment, we conclude that it is more likely than not that a reporting unit’s fair value exceeds its carrying amount, no further testing is required. If the qualitative assessment does not support that conclusion, we proceed to perform a quantitative impairment test.
Impairment of Goodwill and Intangible Assets Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value based test.
Impairment of Goodwill and Intangible Assets Goodwill Goodwill, which represents the excess of the purchase price over the fair value of net assets acquired, is carried at cost.
Income Taxes We record valuation allowances against our DTAs when it is more likely than not that all or a portion of a DTA will not be realized.
Food and Drug Administration regarding a supplemental new drug application. For the year ended December 31, 2024, intangible asset impairment charges were not material. Income Taxes We record valuation allowances against our DTAs when it is more likely than not that all or a portion of a DTA will not be realized.
The determination of fair value in the quantitative assessment required us to make significant estimates and assumptions. These estimates and assumptions primarily included, but were not limited to: the selection of appropriate peer group companies, the discount rate, terminal growth rates, forecasts of revenue, operating income, depreciation and amortization, restructuring charges and capital expenditures.
These estimates and assumptions primarily include but are not limited to: the selection of appropriate peer group companies, the discount rate, terminal growth rates, forecasts of revenue, operating income, depreciation and amortization, restructuring charges and capital expenditures. 64 Significant judgment is used in determining these assumptions, and changes in any of these assumptions could have a material impact on our consolidated results of operations.
Accordingly, any changes in assumptions described above could have a material impact on our consolidated results of operations. Additionally, for each of our reporting units, there are a number of future events and factors that may impact future results and the outcome of subsequent goodwill impairment testing. For a list of these factors, see Item 1A. Risk Factors .
Additionally, future events and factors may impact future results and the outcome of subsequent goodwill impairment testing. For a list of these factors, see Item 1A. Risk Factors .
Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Annual Report on Form 10-K. 60 The following table sets forth our summarized, consolidated cash flows for the years ended December 31, 2024 and 2023 (in thousands): Years Ended December 31, Change 2024 2023 $ % Cash provided by (used in): Operating activities $ 295,099 $ 345,577 $ (50,478) (14.6) % Investing activities (62,996) (69,189) 6,193 (9.0) % Financing activities (211,791) (212,573) 782 (0.4) % Effect of exchange rate changes on cash (999) 65 (1,064) nm Net increase (decrease) in cash, cash equivalents, and restricted cash $ 19,313 $ 63,880 $ (44,567) (69.8) % nm - not meaningful Cash Flows from Operating Activities Net cash provided by operating activities was $295.1 million for the year ended December 31, 2024 as compared to $345.6 million for the prior year.
The following table sets forth our summarized, consolidated cash flows for the years ended December 31, 2025 and 2024 (in thousands): Years Ended December 31, Change 2025 2024 $ % Cash provided by (used in): Operating activities $ 339,992 $ 295,099 $ 44,893 15.2 % Investing activities (112,263) (62,996) (49,267) 78.2 % Financing activities (31,530) (211,791) 180,261 (85.1) % Effect of exchange rate changes on cash (1,680) (999) (681) 68.2 % Net increase in cash, cash equivalents, and restricted cash $ 194,519 $ 19,313 $ 175,206 nm nm - not meaningful Cash Flows from Operating Activities Net cash provided by operating activities was $340.0 million for the year ended December 31, 2025 as compared to $295.1 million for the prior year.
Debt. Interest on our Term Loan Due 2025 and Term Loan Due 2028 was calculated based on applicable rates at December 31, 2024, excluding the impact of our interest rate swap.
Debt. Interest on our Term Loan Due 2032 and Senior Notes Due 2032 was calculated based on applicable rates at December 31, 2025, excluding the impact of our interest rate swap. (2) Amounts represent future minimum rental payments under non-cancelable facility leases. A discussion of our operating lease obligations is contained in Note 16. Leases .
The year-over-year decrease in net cash used in investing activities was primarily due to $12.0 million in proceeds from the sale of a subsidiary in India to a subsidiary of Kashiv in April 2024 (refer to Note 23.
The year-over-year decrease in net cash used in financing activities was primarily due to a net increase in cash inflows from debt of $167.3 million, primarily as a result of the refinancing of our debt in the current year (refer to Note 14.
For more information about goodwill, including our interim impairment test, see Note 12. Goodwill and Other Intangible Assets . There was no impairment of goodwill in any reporting unit for the year ended December 31, 2024. Significant judgment is used in determining the assumptions utilized in our quantitative assessment.
For more information about goodwill, including our annual impairment test, see Note 11. Goodwill and Other Intangible Assets . The determination of fair value in a quantitative assessment would require us to make significant estimates and assumptions.
We test goodwill for possible impairment annually during the fourth quarter, or whenever events or circumstances indicate that the carrying amount may not be recoverable. In order to test goodwill for impairment, an entity is permitted to first assess qualitative factors to determine whether a quantitative assessment of goodwill is necessary.
Goodwill is not amortized; rather, it is subject to annual impairment testing during the fourth quarter of each year, or more frequent testing if events or circumstances indicate that the carrying amount may not be recoverable.
The qualitative factors that we consider may include, but are not limited to, general economic conditions, our outlook, market performance of our industry and recent and forecasted financial performance.
We may first perform a qualitative assessment to determine whether it is more likely than not that a reporting unit’s fair value is less than its carrying amount. In performing this assessment, we consider a range of qualitative factors, which may include general economic conditions, industry performance, our operating outlook, and recent and projected financial performance, among others.
Removed
The year-over-year decrease in net operating cash flows for the year ended December 31, 2024 as compared to the prior year period was primarily driven by (i) lower collections of outstanding accounts receivable due to timing of sales in the quarter ended December 31, 2022, which benefited the year ended December 31, 2023 and (ii) receipt of a $21.4 million upfront payment associated with the license agreement with Orion Corporation during the year ended December 31, 2023, partially offset by (i) increased profitability adjusted for non-cash items, (ii) lower period over period payments associated with the Opana ER ® antitrust litigation settlement and (iii) favorable working capital movements, most notably an increase in days payables outstanding.
Added
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K.
Removed
Related Party Transactions for additional information) and a year-over-year decrease in cash paid for intangible assets associated with marketed product licenses, partially offset by higher capital expenditures.
Added
Excluding the $52.4 million Opana ER ® antitrust litigation settlement payment made in the prior year, net cash from operating activities decreased year-over-year as increases in cash earnings and lower interest rates in the current year were more than offset by changes in working capital.
Removed
Refer to Note 15. Debt for additional information about the refinancing our Term Loan Due 2025. The decrease in tax distributions was the result of the Reorganization (refer to Note 21.
Added
The year-over-year increase in net cash used in investing activities was primarily due to an increase in capital expenditures and deposits for future acquisition of property, plant, and equipment in the current year, partially offset by proceeds from the sale of a subsidiary in the prior year.
Removed
Stockholders’ (Deficiency) Equity for additional information). 61 Commitments and Contractual Obligations Our contractual obligations as of December 31, 2024 were as follows (in thousands): Payments Due by Period Total Less Than 1 Year 1-3 Years 3-5 Years More Than 5 Years Term Loan Due 2025 (1) $ 191,979 $ 191,979 $ — $ — $ — Interest payments on Term Loan Due 2025 (1) 5,271 5,271 — — — Term Loan Due 2028 (1) 2,292,856 58,791 117,582 2,116,483 — Interest payments on Term Loan Due 2028 (1) 735,460 226,929 436,230 72,301 — Amended New Revolving Credit Facility (2) 100,000 100,000 — — — Operating lease obligations (3) 58,754 16,914 24,059 14,762 3,019 Financing lease obligation (4) 105,632 7,508 12,897 11,320 73,907 Tax receivable agreement liability (5) 53,885 2,985 50,900 — — Non-cancelable marketing and royalty obligations (6) 17,068 10,159 6,909 — — Total $ 3,560,905 $ 620,536 $ 648,577 $ 2,214,866 $ 76,926 (1) A description of our Term Loan Due 2025 and Term Loan Due 2028, and related debt service and interest requirements is contained in Note 15.
Added
Debt ), repayment of notes payable - related party of $44.2 million in the prior year, and cash received from an alliance party of $6.4 million in the current year, partially offset by an increase of $24.0 million in tax and other cash and other distributions to non-controlling interests and an increase in employee payroll tax withholdings on restricted stock unit and performance stock unit vesting of $14.3 million. 62 Commitments and Contractual Obligations Our contractual obligations as of December 31, 2025 were as follows (in thousands): Payments Due by Period Total Less Than 1 Year 1-3 Years 3-5 Years More Than 5 Years Principal payments on Term Loan Due 2032 (1) $ 2,094,750 $ 21,000 $ 42,000 $ 42,000 $ 1,989,750 Interest payments on Term Loan Due 2032 (1) 977,334 152,679 301,160 294,603 228,892 Principal payments on Senior Notes Due 2032 (1) 600,000 — — — 600,000 Interest payments on Senior Notes Due 2032 (1) 288,750 41,250 82,500 82,500 82,500 Operating lease obligations (2) 79,204 16,941 27,832 18,430 16,001 Financing lease obligation (3) 99,826 7,585 12,565 11,429 68,247 Tax receivable agreement liability (4) 57,488 38,832 18,656 — — Non-cancelable marketing and royalty obligations (5) 21,077 15,677 5,400 — — Total $ 4,218,429 $ 293,964 $ 490,113 $ 448,962 $ 2,985,390 (1) A description of our Term Loan Due 2032 and Senior Notes Due 2032, and related debt service and interest requirements is contained in Note 14.
Removed
In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. (2) A description of our Amended New Revolving Credit Facility is contained in Note 15.
Added
For the year ended December 31, 2025, we recognized $22.8 million of intangible asset impairment charges in cost of goods sold. The charges primarily related to a Specialty segment product right for which the Company significantly reduced the cash flow forecast after receipt of a complete response letter dated July 22, 2025 from the U.S.
Removed
Debt . The table assumes the balance outstanding as of December 31, 2024 will be repaid or refinanced by December 31, 2025. The actual balance outstanding may fluctuate significantly in future periods. The interest rate on borrowings under the Amended New Revolving Credit Facility resets every 30, 90 or 180 days based on the term that we select.
Removed
In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. (3) Amounts represent future minimum rental payments under non-cancelable facility leases.
Removed
For the year ended December 31, 2024, intangible asset impairment charges were not material. For the year ended December 31, 2023, we recognized $66.9 million of intangible asset impairment charges, of which $36.1 million was recognized in cost of goods sold and $30.8 million was recognized in in-process research and development impairment charges.
Removed
Cost of sales impairment charges for the year ended December 31, 2023 of $36.1 million primarily related to a reduction in promotional focus on LYVISPAH™ in our Specialty segment, resulting in significantly lower than expected future cash flows.
Removed
IPR&D impairment charges for the year ended December 31, 2023 of $30.8 million were related to one Affordable Medicines asset and one Specialty asset, both of which experienced adverse clinical trials results in the fourth quarter of 2023 and resulted in significantly lower than expected future cash flows.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

16 edited+3 added−9 removed3 unchanged
Biggest changeOur transactional exposure arises from the purchase and sale of goods and services in currencies other than the functional currency of our operational units. We also have exposure related to the translation of financial statements of our foreign divisions into U.S. dollars, our functional currency.
Biggest changeWe also have exposure related to the translation of financial statements of our foreign divisions into U.S. dollars, our functional currency. The financial statements of our operations outside the U.S. are measured using the local currency as the functional currency.
Such foreign currency transaction gains and losses include fluctuations related to long term intercompany loans that are payable in the foreseeable future. While it is difficult to accurately measure the impact of inflation, we estimate our business did not experience a material increase in costs due to inflation for the year ended December 31, 2024.
Such foreign currency transaction gains and losses include fluctuations related to long term intercompany loans that are payable in the foreseeable future. While it is difficult to accurately measure the impact of inflation, we estimate our business did not experience a material increase in costs due to inflation for the year ended December 31, 2025.
We do not expect a material impact related to inflation for the year ending December 31, 2025. However, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations and may adversely impact our operating results in future periods.
We do not expect a material impact related to inflation for the year ending December 31, 2026. However, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations and may adversely impact our operating results in future periods.
We limit our credit risk associated with cash equivalents by placing investments with high credit quality securities, including U.S. government securities, treasury bills, corporate debt, short-term commercial paper and highly rated money market funds. As discussed in Note 15.
We limit our credit risk associated with cash equivalents by placing investments with high credit quality securities, including U.S. government securities, treasury bills, corporate debt, short-term commercial paper and highly rated money market funds. As discussed in Note 14.
We had no short-term investments as of December 31, 2024 and December 31, 2023. Financial instruments that potentially subject us to concentrations of credit risk consist principally of cash equivalents and accounts receivable.
We had no short-term investments as of December 31, 2025 and December 31, 2024. Financial instruments that potentially subject us to concentrations of credit risk consist principally of cash equivalents and accounts receivable.
We estimated the fair values of the Term Loan Due 2028 and Term Loan Due 2025 using quoted prices in active markets and yields for the same or similar types of borrowings, taking into account the underlying terms of the debt instruments.
We estimated the fair values of the Term Loan Due 2032, Senior Notes Due 2032, Term Loan Due 2028, and Term Loan Due 2025 using quoted prices in active markets and yields for the same or similar types of borrowings, taking into account the underlying terms of the debt instruments.
The financial statements of our operations outside the U.S. are measured using the local currency as the functional currency. Adjustments to translate the assets and liabilities of these foreign operations into U.S. dollars are accumulated as a component of other comprehensive loss. Transaction gains and losses are included in the determination of our net loss in our statements of operations.
Adjustments to translate the assets and liabilities of these foreign operations into U.S. dollars are accumulated as a component of other comprehensive loss. Transaction gains and losses are included in the determination of our net loss in our statements of operations.
Exhibits, Financial Statement Schedules are filed as part of this Annual Report on Form 10-K and incorporated by reference herein. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Not applicable.
Financial Statements and Supplementary Data The consolidated financial statements listed in Item 15. Exhibits, Financial Statement Schedules are filed as part of this Annual Report on Form 10-K and incorporated by reference herein. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Not applicable.
Based on the principal amount of the Term Loan Due 2028 outstanding as of December 31, 2024, a hypothetical 100 basis point increase or decrease in interest rates would have affected our annual interest expense by approximately $22.9 million, before the impact of the interest rate lock agreement discussed above.
Based on the principal amount of the Term Loan Due 2032 outstanding as of December 31, 2025, a hypothetical 100 basis point increase or decrease in interest rates would have affected our annual interest expense by approximately $20.9 million, before the impact of the interest rate lock agreement discussed above. 67 Item 8.
At December 31, 2024 and 2023, we estimated the fair value of the Term Loan Due 2025 to be $192.6 million and $190.8 million, respectively. At December 31, 2024 and 2023, we estimated the fair value of the Term Loan Due 2028 to be $2.36 billion and $2.33 billion, respectively.
At December 31, 2025, we estimated the fair value of the Term Loan Due 2032 and Senior Notes Due 2032 to be $2.12 billion and $633.0 million, respectively. At December 31, 2024 we estimated the fair value of the Term Loan Due 2028 and Term Loan Due 2025 to be $2.36 billion and $192.6 million, respectively.
We estimated that a hypothetical 100 basis point decrease in the forward one-month SOFR curve would potentially decrease the fair value of the variable-to fixed interest rate swap asset by $28.2 million as of December 31, 2024. Increases or decreases in interest rates would affect our annual interest expense.
We estimated that a hypothetical 100 basis point decrease in the forward one-month SOFR curve would potentially decrease the fair value of this interest rate swap asset by $24.4 million as of December 31, 2025. Refer to Note 18. Financial Instruments for additional information. Increases or decreases in interest rates would affect our annual interest expense.
The fair value of the variable-to-fixed interest rate swap was an asset of $35.9 million as of December 31, 2024. We estimated that a hypothetical 100 basis point increase in the forward one-month SOFR curve would potentially increase the fair value of the variable-to-fixed interest rate swap asset by $27.0 million as of December 31, 2024.
We estimated that a hypothetical 100 basis point increase in the forward one-month SOFR curve would potentially increase the fair value of this interest rate swap asset by $24.6 million as of December 31, 2025.
At December 31, 2024 and 2023, we had $2.48 billion and $2.54 billion, respectively, of variable rate debt. Our debt as of December 31, 2024 comprised of our Term Loan Due 2028 with principal outstanding of $2.29 billion and our Term Loan Due 2025 with principal outstanding of $192.0 million.
At December 31, 2025 and 2024, we had $2.09 billion and $2.48 billion, respectively, of variable rate debt. Our total debt of $2.69 billion as of December 31, 2025 was comprised of our Term Loan Due 2032 with principal outstanding of $2.09 billion and our Senior Notes Due 2032 with principal outstanding of $600.0 million.
Debt , we are party to term loans with an aggregate principal amount of $2.5 billion, the Amended New Revolving Credit Facility and the Amended Rondo Revolving Credit Facility under which loans and letters of credit up to a principal amount of $495.2 million and $28.0 million are available as of December 31, 2024, respectively (principal amount of up to $20.2 million and $18.0 million remain available for letters of credit, respectively).
Debt , we are party to the Term Loan Due 2032 and Senior Notes Due 2032 with 66 an aggregate principal amount of $2.7 billion, as well as the 2025 Revolving Credit Facility and the Amended and Restated Rondo Revolving Credit Facility under which loans and letters of credit up to a principal amount of $595.2 million and $83.0 million are available as of December 31, 2025, respectively (principal amount of up to $20.2 million and $48.0 million remain available for letters of credit, respectively).
These exposures are transactional and translational in nature. Since we manufacture and sell our products throughout the world, we believe our foreign currency risk is diversified. Principal drivers of this diversified foreign exchange exposure include the European Euro and the Indian Rupee.
By the nature of our global operations, we are exposed to cash flow and earnings fluctuations resulting from foreign exchange rate variation. These exposures are transactional and translational in nature. Since we manufacture and sell our products throughout the world, we believe our foreign currency risk is diversified.
The proceeds for any loans made under our asset backed revolving credit facility are available for capital expenditures, acquisitions, working capital needs and other general corporate purposes.
The proceeds for any loans made under our asset backed revolving credit facility are available for capital expenditures, acquisitions, working capital needs and other general corporate purposes. We limit our credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary. We do not require collateral to secure amounts owed to us by our customers.
Removed
In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand.
Added
Principal drivers of this diversified foreign exchange exposure include the European Euro and the Indian Rupee. Our transactional exposure arises from the purchase and sale of goods and services in currencies other than the functional currency of our operational units.
Removed
We limit our credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary. We do not require collateral to secure amounts owed to us by our customers. By the nature of our global operations, we are exposed to cash flow and earnings fluctuations resulting from foreign exchange rate variation.
Added
In August 2025, we terminated our then existing interest rate swap and entered into a new interest rate lock agreement (the “August 2025 Swap”) by blending and extending the remaining asset position from the prior swap into the new arrangement.
Removed
In October 2019, we entered into an interest rate lock agreement for a total notional amount of $1.3 billion whereby we exchanged floating for fixed rate interest payments for our LIBOR based borrowing under our Term Loan Due 2025 (the 66 “October 2019 Swap”).
Added
The August 2025 Swap has a notional value of $650.0 million associated with the Term Loan Due 2032 and requires us to pay a fixed interest rate of 3.1636% while receiving one‑month SOFR (subject to a 0.50% floor) through May 6, 2030. At December 31, 2025, the fair value of the swap asset was $5.8 million.
Removed
On May 31, 2023, we executed an amendment to the interest rate swap that changed the reference rate from LIBOR to the one-month secured overnight financing rate (“SOFR”). On November 14, 2023, in connection with our refinancing of the Term Loan Due 2025 and the New Credit Facility, as defined in Note 15.
Removed
Debt , we novated the October 2019 Swap to another counterparty and, in connection with such novation, amended the October 2019 Swap.
Removed
Specifically, the amendments modified (i) the fixed rate payable by the counterparty from 1.3660% to a new fixed rate of 2.7877% and (ii) extended the termination date through May 4, 2027 (i.e., one year before the Term Loan Due 2028 matures). The amendments did not change the notional amount of $1.3 billion. Refer to Note 19.
Removed
Financial Instruments for additional information. At inception and at year end, we assessed hedge effectiveness and determined it to continue to be highly effective. We also reviewed the credit standing of the counterparty at year end and deemed the counterparties to have the ability to honor their obligations.
Removed
Based on the principal amount of the Term Loan Due 2025 outstanding as of December 31, 2024, a hypothetical 100 basis point increase or decrease in interest rates would have affected our annual interest expense by approximately $1.9 million.
Removed
In January 2025, the Company paid the entire remaining principal balance of $192.0 million outstanding on its Term Loan Due 2025, plus accrued interest thereon of $0.7 million, with $190.0 million of new borrowings under the Amended New Revolving Credit Facility and cash on hand. Item 8. Financial Statements and Supplementary Data The consolidated financial statements listed in Item 15.

Other AMRX 10-K year-over-year comparisons