Nitazoxanide

PRINCETON, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Nitazoxanide Tablets, 500 mg. ANI’s Nitazoxanide Tablets are the generic version of the reference listed drug (RLD) Alinia®. "The market launch of Nitazoxanide Tablets, another niche limited competition product, underscores our purpose of ‘Serving Patients, Improving Lives’,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "We share ANI’s commitment to providing affordable, high-quality medicines for the patients who depend on them and are pleased to partner on the launch of this limited competition product,” stated Dr. Jagadeesh Rangisetty, Chief Executive Officer of Biophore. U.S. annual sales for Nitazoxanide Tablets total approximately $36.1 million, based on December 2024 moving annual total (MAT) IQVIA data. About ANI Pharmaceuticals, Inc.ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com. About Biophore India Pharmaceuticals Pvt. Ltd.Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche, high quality pharmaceutical products for the generic industry. Since its inception in 2007, Biophore has emerged as a trusted partner for niche and complex products in the generic industry across US, Europe and other regulated markets. For more information, please visit our website, http://www.biophore.com/. Forward-Looking StatementsThis press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the recent acquisition of Alimera; the risks that our acquisitions and investments, including the recent acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com Source: ANI Pharmaceuticals, Inc.

In conjunction with the royalty financing deal with HealthCare Royalty (HCRx) announced on January 30, 2025, GENFIT will request the consent of the holders of 2025 OCEANEs and proposes: to repurchase the 2025 OCEANEs at EUR 32.00 per bond from interested bondholders, or alternativelyto pay a consent fee of EUR 0.60 per bond still outstanding after the upcoming bondholder meeting and cancellation of the repurchased 2025 OCEANEs Both proposals are subject to approval of the royalty financing by the 2025 OCEANEs bondholders at the upcoming bondholders meeting and closing of the royalty financing Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 10, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the final terms of the 2025 OCEANEs repurchase proposal and the consent fee that would be paid to the holders of 2025 OCEANEs still outstanding after cancellation of repurchased 2025 OCEANEs. Context On January 30, 2025, GENFIT announced that it has entered into a non-dilutive capped royalty financing agreement (the “Royalty Financing”) with HealthCare Royalty (HCRx) for up to €185 million. This transaction significantly extends GENFIT’s cash runway, including after the repayment of its bonds convertible into new shares and/or exchangeable into existing shares due October 16, 2025 (the “2025 OCEANEs”). GENFIT also announced that it intended to offer to interested bondholders to repurchase their 2025 OCEANEs. In the Royalty Financing, HCRx will be compensated and repaid out of a portion of the royalties which GENFIT is eligible to receive on sales of Iqirvo® (elafibranor) pursuant to its long-term strategic partnership with Ipsen. To secure its obligations under the Royalty Financing, GENFIT will transfer the corresponding royalty receivables to a French law trust (fiducie-sûreté) for the benefit of the holders of the royalty financing bonds. The terms and conditions of the 2025 OCEANEs contain a negative pledge clause which limits GENFIT’s ability to grant security interests to its creditors on its present or future assets or revenues. Granting the fiducie-sûreté is not permitted under this clause. The closing of the Royalty Financing (i.e. the payment of the first €130 million under the Royalty Financing) is thus conditioned upon the holders of the 2025 OCEANEs approving an amendment to the negative pledge clause (the “Amendment of Terms”). If the Amendment of Terms is approved1, and the closing of the royalty financing is completed, GENFIT will pay a consent fee (the “Consent Fee”) to the holders of 2025 OCEANEs still outstanding after cancellation of the repurchased 2025 OCEANEs. Concurrently with the Amendment of Terms, GENFIT is proposing to repurchase the 2025 OCEANEs of any interested holder (the “Repurchase” and, together with the Amendment of Terms, the “Transaction”). Dual Proposal to the 2025 OCEANEs holders GENFIT and Natixis, its Solicitation Advisor, have collected feedback from the 2025 OCEANEs holders in order to set the definitive terms of the Transaction. GENFIT proposes: to repurchase 2025 OCEANEs at a price of EUR 32.00 per bond, or alternativelyto pay a Consent Fee of EUR 0.60 per 2025 OCEANE In the coming days, GENFIT will propose to all of the 2025 OCEANEs holders to enter into a Put Option Agreement, pursuant to which GENFIT will unconditionally and irrevocably undertake to repurchase the 2025 OCEANEs of such holder, subject to approval by the general meeting of the 2025 OCEANEs holders of the Amendment of Terms and the closing of the Royalty Financing. After execution of the Put Option Agreement, the holder will have until several days after the closing of the Royalty Financing to exercise its option under the Agreement. Holders of the 2025 OCEANEs who have not entered into the Put Option Agreement or who do not exercise their option will receive the Consent Fee. As stated above, both the Repurchase and the payment of the Consent Fee are subject to (i) the approval by the general meeting of the 2025 OCEANEs holders of the Amendment of Terms, and (ii) the closing of the Royalty Financing. 2025 OCEANEs holders interested in the Repurchase are invited to contact (i) with respect to qualified investors, GENFIT at investors@genfit.com or their usual sales contact at Natixis (the “Solicitation Advisor”), or at ld-m-equityflowsalescb@natixis.com or at ld-secm-syndicateteam@natixis.com, and (ii) with respect to retail holders, the 2025 OCEANEs Bondholders Representative (Représentant de la Masse) at genfit@aetherfs.com. The Consent Fee will only be paid after the Repurchase has taken place. 2025 OCEANEs that have been bought back by GENFIT as part of the Repurchase (or that have been converted prior to 5:00 p.m. (Paris time) on the date falling 2 business days prior to the date of payment of the Consent Fee) will thus not receive the Consent Fee. The terms and conditions of the 2025 OCEANEs contain a clean-up call option at par if the total number of 2025 OCEANEs still outstanding represents 15% or less of the number of 2025 OCEANEs originally issued (that is 912,162 2025 OCEANEs or less, compared to 1,902,698 2025 OCEANEs outstanding as of today). GENFIT undertakes that, following the Repurchase, it will not exercise this clean-up call option until the 2025 OCEANEs reach maturity. In the coming days, GENFIT will convene a general meeting of the 2025 OCEANEs holders, which is expected to be held in early March. A Consent Solicitation Memorandum will be published, together with the documents required by French law. The results of the general meeting and the closing of the Royalty Financing will be announced in two subsequent press releases. Natixis is acting as sole solicitation advisor to assist GENFIT to seek the consent of the holders of the 2025 OCEANEs and in the repurchase of the 2025 OCEANEs. CMS Francis Lefebvre is acting as legal advisor to GENFIT. ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor2) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about the completion of the royalty financing and the timing of and the vote of the bondholders at the 2025 OCEANEs general meeting. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2023 Universal Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024, the Half-Year Business and Financial Report dated September 19, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com GENFIT | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 The required quorum is 1/4 of the outstanding 2025 OCEANEs and the required majority is 2/3 of the 2025 OCEANEs holders present or represented.2 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®. Attachment GENFIT Announces Final Terms for Dual Proposal to the 2025 OCEANEs Holders