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 reported first quarter 2022 net revenues of $64.5 million, a 17.6% increase from Q1 2021. However, the company faced a net loss of $(20.1) million, equating to a diluted GAAP loss per share of $(1.27). Adjusted non-GAAP EBITDA was $4.3 million. The company provided revenue guidance for Cortrophin Gel of $35 million to $40 million and total net revenue guidance of $295 million to $315 million for 2022. Strong physician demand for Cortrophin Gel has resulted in over 250 new cases initiated. ANI's ongoing R&D efforts led to several new product launches and six new ANDA applications.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its Q1 2022 financial results on May 10, 2022. A conference call will follow at 8:30 a.m. ET to discuss these results. The call can be accessed via a toll-free number and a webcast available on their website. ANI focuses on developing, manufacturing, and marketing high-quality branded and generic pharmaceuticals, aiming for sustainable growth through its Purified Cortrophin™ Gel franchise and enhanced generics business.
ANI Pharmaceuticals has launched Misoprostol Tablets in 100 mcg and 200 mcg strengths, positioned as the generic counterpart to Cytotec®.
The U.S. market for these tablets is valued at approximately $15.3 million. The product holds an AB rating, ensuring its bioequivalence to the reference drug, which enhances its competitive edge amidst a recent market shortage.
ANI aims to fulfill the demand for limited market competition in generics, emphasizing its commitment to patient needs and sustainable growth.
ANI Pharmaceuticals has appointed Renee P. Tannenbaum, Pharm.D., MBA, to its Board of Directors, increasing the board size to nine members. Dr. Tannenbaum brings over 35 years of experience in the pharmaceutical sector and will enhance the company's strategy as it launches Purified Cortrophin Gel. She has held senior roles at major firms like AbbVie and Elan Pharmaceuticals and looks forward to contributing to ANI's growth trajectory, especially post the recent acquisition of Novitium Pharma LLC.
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.
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