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of Contents](#id93db5ee702e4e9d8da25580f80f13e1_7)\n\nUNITED STATES\n\nSECURITIES AND EXCHANGE COMMISSION\n\nWashington, D.C. 20549\n\nFORM 10-K\n\nxANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934\n\nFor the fiscal year ended December 31, 2025\n\noTRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934\n\nFor the transition period from _______ to _______.\n\nCommission file number 001-31812\n\nANI PHARMACEUTICALS, INC.\n\n(Exact name of registrant as specified in its charter)\n\nDelaware58-2301143\n\n(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)\n\n210 Main Street West\n\nBaudette, Minnesota\n\n56623\n\n(Address of principal executive offices)(Zip Code)\n\n(218) 634-3500\n\n(Registrant’s telephone number, including area code)\n\nSecurities registered pursuant to Section 12(b) of the Act:\n\nTitle of each classTrading SymbolName of each exchange on which registered\n\nCommon Stock, par value $0.0001 per share\nANIPThe Nasdaq Global Market\n\nSecurities registered pursuant to Section 12(g) of the Act:\n\nNone\n\nIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o\n\nIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x\n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o\n\nIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o\n\nIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):\n\nLarge accelerated filer\nx\n\nAccelerated filer\n\no\n\nNon-accelerated filer\no\n\nSmaller reporting company\n\no\n\nEmerging growth company\n\no\n\nIf an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o\n\nIndicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. x\n\nIf securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements o\n\nIndicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o\n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x\n\nThe aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of June 30, 2025 was $1.3 billion (based upon the last reported sale price of $65.25 per share on June 30, 2025 on The Nasdaq Global Market).\n\nAs of February 20, 2026, 22,414,104 shares of common stock and 10,864 shares of Class C special stock of the registrant were outstanding.\n\nDOCUMENTS INCORPORATED BY REFERENCE\n\nPortions of the definitive proxy statement for the registrant’s 2026 annual meeting of stockholders to be filed within 120 days after the end of the period covered by this Annual Report on Form 10-K are incorporated by reference into Part III of this Annual Report on Form 10-K.\n\n[Table of Contents](#id93db5ee702e4e9d8da25580f80f13e1_7)\n\nANI PHARMACEUTICALS, INC.\n\nANNUAL REPORT ON FORM 10-K\n\nFor the Year Ended December 31, 2025\n\nTABLE OF CONTENTS\n\nPage\n\n[PART I](#id93db5ee702e4e9d8da25580f80f13e1_13)\n\n[Item 1.](#id93db5ee702e4e9d8da25580f80f13e1_16)\n\n[Business](#id93db5ee702e4e9d8da25580f80f13e1_16)\n\n[3](#id93db5ee702e4e9d8da25580f80f13e1_16)\n\n[Item 1A.](#id93db5ee702e4e9d8da25580f80f13e1_19)\n\n[Risk Factors](#id93db5ee702e4e9d8da25580f80f13e1_19)\n\n[21](#id93db5ee702e4e9d8da25580f80f13e1_19)\n\n[Item 1B.](#id93db5ee702e4e9d8da25580f80f13e1_22)\n\n[Unresolved Staff Comments](#id93db5ee702e4e9d8da25580f80f13e1_22)\n\n[56](#id93db5ee702e4e9d8da25580f80f13e1_22)\n\n[Item 1C.](#id93db5ee702e4e9d8da25580f80f13e1_25)\n\n[Cybersecurity](#id93db5ee702e4e9d8da25580f80f13e1_25)\n\n[57](#id93db5ee702e4e9d8da25580f80f13e1_25)\n\n[Item 2.](#id93db5ee702e4e9d8da25580f80f13e1_28)\n\n[Properties](#id93db5ee702e4e9d8da25580f80f13e1_28)\n\n[58](#id93db5ee702e4e9d8da25580f80f13e1_28)\n\n[Item 3.](#id93db5ee702e4e9d8da25580f80f13e1_31)\n\n[Legal Proceedings](#id93db5ee702e4e9d8da25580f80f13e1_31)\n\n[58](#id93db5ee702e4e9d8da25580f80f13e1_31)\n\n[Item 4.](#id93db5ee702e4e9d8da25580f80f13e1_34)\n\n[Mine Safety Disclosures](#id93db5ee702e4e9d8da25580f80f13e1_34)\n\n[58](#id93db5ee702e4e9d8da25580f80f13e1_34)\n\n[PART II](#id93db5ee702e4e9d8da25580f80f13e1_37)\n\n[Item 5.](#id93db5ee702e4e9d8da25580f80f13e1_40)\n\n[Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](#id93db5ee702e4e9d8da25580f80f13e1_40)\n\n[59](#id93db5ee702e4e9d8da25580f80f13e1_40)\n\n[Item 6.](#id93db5ee702e4e9d8da25580f80f13e1_43)\n\n[Reserved](#id93db5ee702e4e9d8da25580f80f13e1_43)\n\n[61](#id93db5ee702e4e9d8da25580f80f13e1_43)\n\n[Item 7.](#id93db5ee702e4e9d8da25580f80f13e1_46)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#id93db5ee702e4e9d8da25580f80f13e1_46)\n\n[62](#id93db5ee702e4e9d8da25580f80f13e1_46)\n\n[Item 7A.](#id93db5ee702e4e9d8da25580f80f13e1_70)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#id93db5ee702e4e9d8da25580f80f13e1_70)\n\n[81](#id93db5ee702e4e9d8da25580f80f13e1_70)\n\n[Item 8.](#id93db5ee702e4e9d8da25580f80f13e1_73)\n\n[Financial Statements and Supplementary Data](#id93db5ee702e4e9d8da25580f80f13e1_73)\n\n[82](#id93db5ee702e4e9d8da25580f80f13e1_73)\n\n[Item 9.](#id93db5ee702e4e9d8da25580f80f13e1_157)\n\n[Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](#id93db5ee702e4e9d8da25580f80f13e1_157)\n\n[143](#id93db5ee702e4e9d8da25580f80f13e1_157)\n\n[Item 9A.](#id93db5ee702e4e9d8da25580f80f13e1_160)\n\n[Controls and Procedures](#id93db5ee702e4e9d8da25580f80f13e1_160)\n\n[143](#id93db5ee702e4e9d8da25580f80f13e1_160)\n\n[Item 9B.](#id93db5ee702e4e9d8da25580f80f13e1_163)\n\n[Other Information](#id93db5ee702e4e9d8da25580f80f13e1_163)\n\n[144](#id93db5ee702e4e9d8da25580f80f13e1_163)\n\n[Item 9C.](#id93db5ee702e4e9d8da25580f80f13e1_169)\n\n[Disclosures Regarding Foreign Jurisdictions that Prevent Inspections](#id93db5ee702e4e9d8da25580f80f13e1_169)\n\n[144](#id93db5ee702e4e9d8da25580f80f13e1_169)\n\n[PART III](#id93db5ee702e4e9d8da25580f80f13e1_172)\n\n[Item 10.](#id93db5ee702e4e9d8da25580f80f13e1_175)\n\n[Directors, Executive Officers and Corporate Governance](#id93db5ee702e4e9d8da25580f80f13e1_175)\n\n[144](#id93db5ee702e4e9d8da25580f80f13e1_175)\n\n[Item 11.](#id93db5ee702e4e9d8da25580f80f13e1_178)\n\n[Executive Compensation](#id93db5ee702e4e9d8da25580f80f13e1_178)\n\n[144](#id93db5ee702e4e9d8da25580f80f13e1_178)\n\n[Item 12.](#id93db5ee702e4e9d8da25580f80f13e1_181)\n\n[Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](#id93db5ee702e4e9d8da25580f80f13e1_181)\n\n[144](#id93db5ee702e4e9d8da25580f80f13e1_181)\n\n[Item 13.](#id93db5ee702e4e9d8da25580f80f13e1_184)\n\n[Certain Relationships and Related Transactions, and Director Independence](#id93db5ee702e4e9d8da25580f80f13e1_184)\n\n[145](#id93db5ee702e4e9d8da25580f80f13e1_184)\n\n[Item 14.](#id93db5ee702e4e9d8da25580f80f13e1_187)\n\n[Principal Accountant Fees and Services](#id93db5ee702e4e9d8da25580f80f13e1_187)\n\n[145](#id93db5ee702e4e9d8da25580f80f13e1_187)\n\n[PART IV](#id93db5ee702e4e9d8da25580f80f13e1_190)\n\n[Item 15.](#id93db5ee702e4e9d8da25580f80f13e1_193)\n\n[Exhibits and Financial Statement Schedules](#id93db5ee702e4e9d8da25580f80f13e1_193)\n\n[145](#id93db5ee702e4e9d8da25580f80f13e1_193)\n\n[Item 16.](#id93db5ee702e4e9d8da25580f80f13e1_196)\n\n[Form 10-K Summary](#id93db5ee702e4e9d8da25580f80f13e1_196)\n\n[149](#id93db5ee702e4e9d8da25580f80f13e1_196)\n\n[Signatures](#id93db5ee702e4e9d8da25580f80f13e1_199)\n\n[150](#id93db5ee702e4e9d8da25580f80f13e1_199)\n\n[Table of Contents](#id93db5ee702e4e9d8da25580f80f13e1_7)\n\nIn this annual report, references to “ANI Pharmaceuticals,” “ANI,” the “Company,” “we,” “us,” and “our” refer, unless the context requires otherwise, to ANI Pharmaceuticals, Inc., a Delaware corporation, and its consolidated subsidiaries.\n\nCAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS\n\nThis Annual Report on Form 10-K and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “may,” “will,” “should,” “could,” “expects,” “estimates,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words, and the use of future dates. Such forward-looking statements include, but are not limited to, statements concerning the following:\n\n•our planned future operations, strategies and growth potential;\n\n•our financial performance, including our estimates of our expenses and capital requirements, and our expectations regarding our revenue potential (including revenue from licensing, royalties and sales) of our products;\n\n•our development pipeline, including the structure, focus, success, cost and timing of our development activities, including nonclinical studies and clinical trials, and the reporting of data from those activities;\n\n•expected timeframes for the submission of new drug applications, abbreviated new drug applications, or supplemental new drug applications to the U.S. Food and Drug Administration (the “FDA”);\n\n•our expectations regarding the size of patient populations, market acceptance and clinical utility of our products and product candidates, if approved;\n\n•our manufacturing capabilities and our ability to comply with significant regulations with respect to the manufacture of our products or, where applicable, our reliance on third parties to do the same;\n\n•supply chain and inventory expectations, and our and our partners’ ability to meet anticipated demand;\n\n•selling and marketing strategies and associated costs to support the sales of our branded products, including Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (“Cortrophin Gel”) and ILUVIEN® (\"ILUVIEN\");\n\n•the success of competing therapies that are or may become available;\n\n•our strategic initiatives, including acquisitions, strategic alliances and collaborations, and our ability to realize the intended benefits of such initiatives;\n\n•our ability to attract and retain key personnel;\n\n•our expectations and uncertainties regarding future pricing, coverage and reimbursement for our products;\n\n•the impact of new or modified laws or regulations, and the application or implementation thereof, including the One Big Beautiful Bill Act (the “Act”), and tax, healthcare and pharmaceutical laws and regulations in the U.S. and foreign jurisdictions;\n\n•our ability to obtain, protect and enforce our intellectual property; and\n\n•general economic, industry, geopolitical and market conditions, such as military conflict or war, inflation and financial institution instability, or the impact of global pandemics on our business.\n\nAny forward-looking statements in this Annual Report on Form 10-K are based on the reasonable beliefs of our management as well as assumptions made by and information currently available to our management. Forward-looking statements are inherently subject to known and unknown risks, uncertainties and other factors, some of which cannot be predicted or quantified, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed under Part I, Item 1A, “Risk Factors” and elsewhere in this Annual Report on Form 10-K, as well as in our other periodic reports filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”). Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.\n\n1\n\n[Table of Contents](#id93db5ee702e4e9d8da25580f80f13e1_7)\n\nNOTE REGARDING TRADEMARKS\n\nCortenema®, Purified Cortrophin® Gel, Inderal® LA, ILUVIEN®, Inderal® XL, InnoPran XL®, Inzirqo®, Kionex®, Lithobid®, Reglan®, SOVUNA®, Tezruly®, Vancocin®, Veregen®, and YUTIQ® are registered trademarks subject to trademark protection and are owned by ANI Pharmaceuticals. Cortrophin-ZincTM is a trademark owned by ANI Pharmaceuticals pending registration. Atacand® and Atacand HCT® are the property of AstraZeneca AB and are licensed to ANI Pharmaceuticals, Inc. for U.S. sales of those products. Arimidex® and Casodex® are the property of AstraZeneca UK Limited and are licensed to ANI Pharmaceuticals, Inc. for U.S. sales of those products. Oxistat® is the property of Fougera Pharmaceuticals Inc. and is licensed to ANI Pharmaceuticals for U.S. sales of Oxistat® Lotion. Solely for convenience, trademarks referred to in this Annual Report on Form 10-K may appear without the ® or ™ symbols, but any such references are not intended to indicate, in any way, that we will not assert our rights or the right of the applicable licensor to these trademarks to the fullest extent under applicable law. This Annual Report on Form 10-K may also contain trademarks or trade names of other parties, and we do not intend our use or display of other parties’ trademarks or trade names to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.\n\n2\n\n[Table of Contents](#id93db5ee702e4e9d8da25580f80f13e1_7)\n\nPART I"}