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. 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.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has successfully completed its underwritten public offering, selling 1,500,000 shares at $50.00 each, generating gross proceeds of $75 million. Underwriters have a 30-day option to buy an additional 225,000 shares. Guggenheim Securities and Raymond James served as book-running managers. The offering was made under a shelf registration statement filed with the SEC. ANI focuses on developing high-quality branded and generic pharmaceuticals, particularly in niche areas such as oncology and controlled substances.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced a public offering of 1,500,000 shares of common stock priced at $50.00 per share, aiming to raise $75 million in gross proceeds. Underwriters have a 30-day option to buy an additional 225,000 shares. The offering is expected to close around November 8, 2021, pending customary conditions. The offering is made under a shelf registration statement filed with the SEC. Guggenheim Securities leads the offering, with additional involvement from Raymond James and H.C. Wainwright & Co.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced an underwritten public offering of its common stock, subject to market conditions. The company intends to use the net proceeds for Cortrophin commercialization efforts, including sales and marketing, and for general corporate purposes, which may include acquiring or investing in additional businesses and technologies. Guggenheim Securities is acting as the book-running manager. The offering is part of a shelf registration statement with the SEC effective since July 17, 2020.
ANI Pharmaceuticals reported Q3 2021 net revenues of $52.1 million, a slight decrease from $53.0 million in Q3 2020. The company faced a net loss of $4.4 million with a diluted loss per share of ($0.37). Adjusted non-GAAP EBITDA was $16.6 million with adjusted diluted EPS at $1.01. The FDA approved the Purified Cortrophin™ Gel for chronic autoimmune disorders, with a launch planned for Q1 2022. Additionally, the acquisition of Novitium Pharma LLC is set to close in November 2021, and the company launched Nebivolol Tablets from two sites.
ANI Pharmaceuticals announced FDA approval for Cortrophin Gel, a critical treatment for chronic autoimmune disorders such as multiple sclerosis and rheumatoid arthritis. This approval restores much-needed options for patients and physicians in the U.S. market. ANI plans a full-scale launch in early Q1 2022, following a significant investment in manufacturing. The gel offers alternatives for patients intolerant to corticosteroids, marking a pivotal return to a long-standing treatment option first approved in 1954.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced it will release its third quarter 2021 financial results on November 1, 2021, at 8:30 a.m. ET. The call will be hosted by President and CEO Nikhil Lalwani and Senior VP and CFO Stephen P. Carey. Investors can access the live webcast at www.anipharmaceuticals.com, where a replay will also be available. The company focuses on developing, manufacturing, and marketing both branded and generic pharmaceuticals, aiming for sustainable growth through various initiatives in the bio-pharmaceutical sector.
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