Welcome to our dedicated page for ANI Pharmaceuticals news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on ANI Pharmaceuticals stock.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a US-based integrated specialty pharmaceutical company dedicated to developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals. The company's expertise lies in targeting niche and high-barrier markets such as controlled substances, anti-cancer treatments (oncolytics), hormones and steroids, and complex formulations. ANI operates two state-of-the-art manufacturing facilities in Baudette, Minnesota, capable of producing oral solid dose products, liquids, topicals, controlled substances, and other potent products in fully-contained environments.
In recent developments, ANI Pharmaceuticals has achieved significant milestones, including the FDA approval of the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension, USP, and the launch of Pentoxifylline Extended-Release Tablets. These initiatives highlight ANI's commitment to expanding access to high-quality generics for limited competition products.
The company's flagship product, Purified Cortrophin® Gel, drives its Rare Disease segment, which has shown remarkable growth. In the first quarter of 2024, ANI reported record net revenues of $137.4 million, marking a 28.7% year-over-year increase. The Rare Disease segment alone delivered Q1 net revenues of $36.9 million, a 126.2% year-over-year growth. ANI's generics business also continues to strengthen with multiple product launches, including Baclofen Oral Suspension and Kionex® (Sodium Polystyrene Sulfonate Suspension USP) for oral or rectal use.
Financially, ANI Pharmaceuticals is on a robust growth trajectory, with 2024 guidance projecting net revenues between $520 million and $542 million and adjusted non-GAAP EBITDA between $135 million and $145 million. The company’s success is underpinned by its strategic focus on innovation, enhanced R&D capabilities, and leveraging its North American manufacturing footprint to meet market demands.
ANI Pharmaceuticals remains dedicated to its mission of
ANI Pharmaceuticals, Inc. reported fourth quarter net revenues of $60.9 million, with a net loss of $24.1 million (diluted loss per share of $1.72). For the full year 2021, revenues reached $216.1 million, and the net loss stood at $42.6 million. The company launched Purified Cortrophin™ Gel for chronic autoimmune disorders and acquired Novitium Pharma, integrating it to enhance their generics business. ANI projects 2022 revenues between $260 million and $275 million, indicating a growth of 20%-27% year-over-year.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is set to release its fourth quarter and full year 2021 financial results on March 15, 2022, at 8:30 a.m. ET. The conference call will be hosted by CEO Nikhil Lalwani and CFO Stephen P. Carey. Investors can access the live and replay webcast on the company's website under the “Investors” section. ANI Pharmaceuticals focuses on developing high-quality branded and generic prescription drugs, aiming for sustainable growth through a strong Purified Cortrophin™ Gel franchise and enhanced generics.
ANI Pharmaceuticals (NASDAQ: ANIP) announces the appointments of Mary Pao, M.D., Ph.D., as Chief Medical Officer, and Elizabeth Powell, J.D., as Chief Compliance Officer and Head of Legal for its Rare Disease Business Unit. These executives bring over four decades of pharmaceutical experience, aiming to enhance the commercialization of Purified Cortrophin™ Gel. Dr. Pao joined in October 2021, focusing on clinical strategy, while Ms. Powell has been with ANI since February 2022, overseeing compliance and legal matters.
On February 14, 2022, ANI Pharmaceuticals (NASDAQ: ANIP) announced FDA approval for a generic version of Cystadane® (betaine anhydrous) powder, with shipments starting in early February. This approval grants ANI 180 days of exclusivity under Competitive Generic Therapy. CEO Nikhil Lalwani emphasized the company's commitment to serving underserved rare disease patients and expanding its product lineup, which includes seven additional ANDAs filed with the FDA. This marks ANI's third generic orphan drug launch, enhancing its position in the pharmaceutical market.
ANI Pharmaceuticals has announced the U.S. commercial launch of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) 80 U/mL, which treats chronic autoimmune disorders like multiple sclerosis and rheumatoid arthritis. This launch is driven by ANI's new rare disease business unit and represents a significant addition to the ACTH treatment category, which has lacked options for over 20 years. ANI aims to ensure access to Cortrophin Gel through support programs for patients, prescribers, and healthcare professionals.
ANI Pharmaceuticals will present virtually at the H.C. Wainwright Bioconnect Conference on January 10, 2022, at 7:00 a.m. ET. The presentation will feature CEO Nikhil Lalwani and CFO Stephen Carey. The webcast will be available on demand starting at the specified time and will remain archived for 90 days on ANI's website. ANI Pharmaceuticals focuses on providing high-quality branded and generic pharmaceutical products, particularly for diseases with unmet medical needs. For more details, visit www.anipharmaceuticals.com.
ANI Pharmaceuticals, Inc. announced FDA approval for its Rifabutin Capsules USP, 150 mg, a generic version of Mycobutin®. The U.S. market for this drug is valued at approximately $16.6 million annually, indicating strong commercial potential. CEO Nikhil Lalwani emphasized the company's robust R&D capabilities and commitment to addressing market needs with limited competition generics. This approval marks a significant step in ANI's strategy to enhance its generics portfolio and drive sustainable growth.
ANI Pharmaceuticals has completed the acquisition of Novitium Pharma, enhancing its generics pipeline and manufacturing capabilities. The combined entity boasts a robust product pipeline with over 20 planned launches in the next 18 months, focusing on Competitive Generic Therapy (CGT) and 505(b)(2) products. Pro-forma revenues for the year to date reached $202.5 million, and new capital structures, including a $75 million equity raise, position ANI for sustainable growth. The acquisition is expected to be immediately accretive to adjusted non-GAAP earnings per share.
ANI Pharmaceuticals will present at the Piper Sandler 33rd Annual Healthcare Conference on November 22, 2021, at 10:00 a.m. ET. CEO Nikhil Lalwani and CFO Stephen Carey will lead the presentation, which will also involve 1x1 meetings by request via Piper Sandler. The webcast will be available on demand for 90 days on the company's website. ANI is a diversified bio-pharmaceutical company focused on developing high-quality branded and generic prescription products for patients with unmet medical needs.
ANI Pharmaceuticals, Inc. announced the FTC's acceptance of the proposed consent order regarding its acquisition of Novitium Pharma. The FTC requires the divestiture of development rights to one generic drug and related assets of another, deemed immaterial to ANI's business. With this decision, ANI has cleared the necessary antitrust hurdles, proceeding to close the acquisition around November 18, 2021, subject to customary conditions. This acquisition is strategic, aiming to enhance ANI's portfolio in the pharmaceutical market.
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