ANI Pharmaceuticals Inc 2026年季度报告

Nasdaq Global Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. YesNo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required tosubmit such files). YesNo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YesNo As of May1, 2026, there were 22,734,618 shares of common stock and 10,864 shares of class C special stock of the registrantoutstanding. ANI PHARMACEUTICALS, INC.FORM 10-Q — Quarterly ReportFor the Quarterly Period Ended March 31, 2026 PART I — FINANCIAL INFORMATION Item 1.Condensed Consolidated Financial Statements (unaudited)4Condensed Consolidated Balance Sheets (unaudited) — As of March 31, 2026 and December 31, 20255Condensed Consolidated Statements of Operations(unaudited) — For the Three Months EndedMarch 31, 2026and 20256Condensed Consolidated Statements of Comprehensive Income (unaudited) — For the Three Months EndedMarch 31, 2026 and 20257Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity(unaudited) —For the Three Months EndedMarch 31, 2026 and 20258Condensed Consolidated Statements of Cash Flows(unaudited)— For the Three Months EndedMarch 31,2026 and 20259Notes to Condensed Consolidated Financial Statements(unaudited)10Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations33Item 3.Quantitative and Qualitative Disclosures About Market Risk41Item 4.Controls and Procedures41PART II — OTHER INFORMATIONItem 1.Legal Proceedings42Item 1A.Risk Factors42Item 2.Unregistered Sales of Equity Securities and Use of Proceeds42Item 3.Defaults upon Senior Securities42Item 4.Mine Safety Disclosures42Item 5.Other Information43Item 6.Exhibits43Signatures44 Table of Contents CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q and certain information incorporated herein by reference contain forward-looking statementswithin the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the SecuritiesExchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact contained in thisQuarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by termssuch 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 statementsinclude, but are not limited to, statements concerning the following: •our planned future operations, strategies and growth potential;•our financial performance, including our estimates of our expenses and capital requirements, and our expectations regardingour revenue potential (including revenue from licensing, royalties and sales) of our products;•our development pipeline, including the structure, focus, success, cost and timing of our development activities, includingnonclinical studies and clinical trials, and the reporting of data from those activities;•expected timeframes for the submission of new drug applications, abbreviated new drug applications, or supplemental newdrug applications to the U.S. Food and Drug Administration (the “FDA”);•our expectations regarding the size of patient populations, market acceptance and clinical utility of our products and productcandidates, if approved;•our manufacturing capabilities and our ability to comply with significant regulations with respect to the manufacture of ourproducts or, where applicable, our reliance on third parties to do the same;•supply chain and inventory expectations, and our and our partners’ ability to meet anticipated demand;•selling and marketing strategies and associated costs to support the sales of our branded produc