ADDED
A s 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.
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.
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.
Moreover, we operate in a very competitive and rapidly changing environment.
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.
Cortrophin-Zinc TM is a trademark owned by ANI Pharmaceuticals pending registration.
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.
REMOVED
As of February 21, 2025, 21,762,646 shares of common stock and 10,864 shares of Class C Special stock of the registrant were outstanding.
Form 10-K Summary 160 Signatures 161 Ta b l e of Contents In 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.
Such statements include, but are not limited to, statements about future operations, strategies and growth potential, the revenue potential (licensing, royalty and sales) of products we sell, development timelines, expected timeframe for submission of new drug applications, abbreviated new drug applications, or supplemental new drug applications to the U.S.
Food and Drug Administration (the FDA ), pipeline or potential markets for our products, selling and marketing strategies a nd associated costs to support the sales of Purified Cortrophin Gel (Repository Corticotropin Injection USP) ( Cortrophin Gel ), the closing of the acquisition of Alimera Sciences, Inc.
( Alimera ), impact of accounting principle s, litigation expenses, liquidity and capital resources, the impact of global pandemics on our business, and other statements that are not historical in nature, particularly those that utilize terminology such as anticipates, will, expects, plans, potential, future, believes, intends, continue, other words of similar meaning, derivations of such words, and the use of future dates.
Readers should not put undue reliance on these forward-looking statements.
Factors that might cause such a difference include, but are not limited to, those discussed in our periodic reports filed with the U.S.
Securities and Exchange Commission (the SEC ), including those discussed in the Risk Factors section in Part I, Item 1A.of this Annual Report on Form 10-K, and the following factors: Our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, may not achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; Cortrophin Gel is our first rare disease pharmaceutical product.
Raising additional funds by entering into additional credit or other borrowing facilities or issuing debt may subject us to covenants and other requirements that may restrict our operations.
2 Ta b l e of Contents NOTE REGARDING TRADEMARKS Cortenema , Purified Cortrophin Gel, Inderal LA, ILUVIEN , Inderal XL, InnoPran XL , Kionex , Lithobid , Reglan , SOVUNA , Vancocin , Veregen , and YUTIQ are registered trademarks subject to trademark protection and are owned by ANI Pharmaceuticals, Inc.