ANI PHARMACEUTICALS INC

In addition to the other information set forth in this Quarterly Report on Form 10-Q, please carefully consider the factors described under the heading “Risk Factors” in our 2025 Form 10-K in Part I, Item 1A. The risks described are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.

The following are new material risk factors related to the pending acquisition of Egetis Therapeutics AB (“Egetis”) that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.

Risks Related to the Offer

The Offer is subject to a number of conditions beyond our control. Failure to complete the Offer within the expected time frame, or at all, could have a material adverse effect on our business, operating results, financial condition and our share price.

On November 5, 2026, the Company announced a recommended public offer to acquire the shares in Egetis Therapeutics AB (“Egetis”) for SEK 11.25 per share, representing a 27% premium to the 60-day VWAP, as well as the convertible debt and the warrants issued by Egetis (the “Offer”). The value of the Offer, including outstanding incentive programs, amounts to approximately SEK 5.6 billion or approximately $560.0 million (calculated utilizing 30 trading day average USD to SEK exchange rate of 9.9471 as of November 3, 2026).

The completion of the Offer is subject to certain customary closing conditions for an offer governed by the Swedish Takeover Rules, including holders of at least 90% of the outstanding Egetis shares (on a fully-diluted basis) tendering their shares into the Offer (the “Minimum Tender Condition”) and receipt of all necessary regulatory, governmental or similar clearances, approvals and decisions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and from foreign direct investment authorities. We reserve the right to withdraw the Offer in the event it becomes clear that any of the above conditions are not satisfied or cannot be satisfied. Other than with regard to the Minimum Tender Condition, however, such withdrawal will only be permitted if the non-satisfaction of such condition is of material importance to our acquisition of the shares in Egetis. We also reserve the right to waive, in whole or in part, any of the conditions to the Offer, including, with respect to the Minimum Tender Condition, to complete the Offer at a lower level of acceptance.

We cannot predict whether and when the conditions to the Offer will be satisfied. If one or more of these conditions are not satisfied, and as a result, we do not complete the Offer, we would remain liable for significant transaction costs, and the focus of our management would have been diverted from seeking other potential strategic opportunities, in each case without realizing any benefits of the Offer. Further, any disruptions to our business resulting from the announcement and pendency of the Offer, including any adverse changes in our relationships with our partners, suppliers and employees, could continue or accelerate in the event that we fail to consummate the Offer.

Our share price may also fluctuate significantly based on announcements by Egetis, other third parties, or us regarding the Offer or based on market perceptions of the likelihood of the satisfaction of the conditions to the consummation of the Offer. Such announcements may lead to perceptions in the market that the Offer may not be completed, which could cause our share price to fluctuate or decline. Other factors outside of our control, such as a governmental entity enacting legislation that prohibits the Offer, could cause us not to satisfy the governmental entity condition and thus the Offer would not be consummated.

If we do not consummate the Offer, the price of our common stock may decline significantly from the current market price, which may reflect a market assumption that the Offer will be consummated. Any of these events could have a material adverse effect on our business, operating results and financial condition and could cause a decline in the price of our common stock.

We have incurred, and will continue to incur, direct and indirect costs as a result of the Offer.

We have incurred, and will continue to incur, significant costs and expenses, including fees for professional services and other transaction costs, in connection with the Offer, including costs that we may not currently expect. We must pay substantially all of these costs and expenses whether or not the transaction is completed. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. To the extent these acquisition and integration expenses are higher than anticipated, we may experience liquidity or cash flow issues.

The obligations and liabilities of Egetis, some of which may be unanticipated or unknown, may be greater than we have anticipated, which may diminish the value of Egetis to us.

Egetis’ obligations and liabilities, some of which may not have been disclosed to us or may not be reflected or reserved for in Egetis’ historical financial statements, may be greater than we have anticipated. The obligations and liabilities of Egetis could have a material adverse effect on Egetis’ business or Egetis’ value to us or on our business, financial condition, or results of operations. In the event that we are responsible for liabilities substantially in excess of any amounts recovered through rights to indemnification or alternative remedies that might be available to us, or any applicable insurance, we could suffer severe consequences that would substantially reduce our earnings and cash flows or otherwise materially and adversely affect our business, financial condition, or results of operations.

We will incur substantial debt in order to satisfy our obligations in connection with the acquisition of Egetis.

In connection with the offer, we entered into a credit agreement (the “Credit Agreement”) relating to a 364-day senior bridge facility (the “Facility”), with the lenders named therein and JPMorgan Chase Bank, N.A., as administrative agent. The Facility provides for borrowings up to an aggregate principal amount of $676.0 million and matures 364 days after the initial day of funding, in each case, as further described in the Credit Agreement.

In order to service the debt we incur under the Credit Agreement, we will require a significant amount of cash. Our ability to make scheduled payments of principal and interest depends on our future performance, which is subject to economic, financial, competitive, and other factors beyond our control. Our business may not continue to generate cash flow from operations in the future sufficient to service our debt. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt, or obtaining additional debt or equity financing on terms that may not be favorable to us or available to us at all. Our ability to refinance any such debt will depend on the capital markets and our financial condition at that time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default under our current or future indebtedness. Any event of default or inability to otherwise satisfy our obligations could have a material adverse effect on our future operating results and financial condition.

If the acquisition of Egetis is consummated, the combined company may not perform as we or the market expects, which could have an adverse effect on the price of our common stock.

Even if the Offer is consummated, the combined company may not perform as we or the market expects. Risks associated with the combined company following the Offer include:

•integrating businesses is a difficult, expensive, and time-consuming process, and the failure to successfully integrate our businesses with the business of Egetis in the expected time frame would adversely affect our financial condition and results of operation;

•there may be inconsistencies in standards, controls, procedures and policies that will need to be reconciled;

•it is possible that our key employees or key employees of Egetis might decide not to remain with us after the Egetis acquisition is completed, and the loss of such personnel could have a material adverse effect on the financial condition, results of operations, and growth prospects of the combined company;

•the success of the combined company will also depend upon relationships with third parties and Egetis’ or our pre-existing customers, which relationships may be affected by customer preferences or public attitudes about the Offer. Any adverse changes in these relationships could adversely affect the combined company’s business, financial condition, and results of operations; and

•if government agencies or regulatory bodies impose requirements, limitations, costs, divestitures or restrictions on the consummation of the Offer, the combined company’s ability to realize the anticipated benefits of the acquisition may be impaired.

Further, we intend to enter into the Offer with the expectation that the acquisition will result in, among other things, benefits relating to enhanced revenues, a strengthened market position for the combined company and operating efficiencies. Achieving the benefits of the Offer is subject to a number of uncertainties, including whether we integrate Egetis in an efficient manner, and general competitive factors in the marketplace. The occurrence of any of these Offer-related events individually or in combination could materially and adversely affect our business, results of operations, financial condition and the market price of our common stock.

We may face exposure to adverse movements in foreign currency exchange rates in connection with the Offer.

In the Offer, we are offering SEK 11.25 in cash for each share of Egetis, as well as the convertible debt and the warrants. The value of the Offer, including outstanding incentive programs, amounts to approximately SEK 5.6 billion or approximately $560.0 million. We will be obligated to pay such amounts in Swedish krona upon consummation of the Offer. An increase in the value of Swedish krona compared to the US dollar could result in a higher effective purchase price payable by us due to currency exchange rate fluctuations. To date, we have not hedged against risks associated with foreign exchange rate exposure. Any hedging techniques we may implement in the future may not be successful, and our business, financial condition, and results of operations may be materially adversely affected by exchange rate fluctuations.