ANI PHARMACEUTICALS INC

ANI PHARMACEUTICALS, INC.

FORM 10-Q — Quarterly Report

For the Quarterly Period Ended September 30, 2026

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q 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 Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “may,” “might,” “will,” “should,” “could,” “expects,” “estimates,” “forecasts,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” “seeks,” and “targets,” and 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:

•statements concerning the timing and impact of our proposed acquisition of Egetis Therapeutics AB (“Egetis”);

•the ability to close our proposed acquisition of Egetis on a timely basis or at all;

•our planned future operations, strategies and growth potential;

•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;

•our expectations regarding the sufficiency of our cash and other financial resources, our liquidity, and our ability to fund our operations, satisfy our debt obligations, and, if necessary, obtain additional financing;

•our plans with respect to the timing and amount of any repurchases of our common stock under our share repurchase program;

•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;

•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”);

•our expectations regarding the size of patient populations, market acceptance and clinical utility of our products and product candidates, if approved;

•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;

•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 products, including Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (“Cortrophin Gel”), ILUVIEN® (“ILUVIEN”), and EMCITATE® if we complete our acquisition of Egetis;

•the success of competing therapies that are or may become available;

•our strategic initiatives, including acquisitions, strategic alliances and collaborations, such as our proposed acquisition of Egetis, and our ability to realize the intended benefits of such initiatives;

•our ability to attract and retain key personnel;

•our expectations and uncertainties regarding future pricing, coverage and reimbursement for our products;

•the impact of new or modified laws or regulations, and the application or implementation thereof, including the One Big Beautiful Bill Act, and tax, healthcare and pharmaceutical laws and regulations in the U.S. and foreign jurisdictions;

•our ability to obtain, protect and enforce our intellectual property; and

•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, and the risks of fluctuations in foreign currency exchange rates.

Any forward-looking statements in this Quarterly Report on Form 10-Q 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” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) on February 27, 2026 and elsewhere in this Quarterly Report on Form 10-Q. 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.

We may use our investor relations website as a distribution channel of material company information. Financial and other important information regarding the Company is routinely posted on and accessible through our investor relations website. We encourage investors and others interested in our Company to review the information we post on our investor relations website in addition to our filings with the SEC, press releases, public conference calls and webcasts. Information contained on the Company’s website is not included as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.