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. (NASDAQ: ANIP) will announce its first quarter 2023 financial results on May 8, 2023. The results will be shared before market opening, followed by a conference call at 8:30 a.m. ET, hosted by President and CEO Nikhil Lalwani and CFO Stephen P. Carey. Investors can participate by calling 800-245-3047 or via a live webcast on the company’s website. A replay of the call will be available shortly after and last for two weeks. ANI Pharmaceuticals focuses on providing high-quality branded and generic pharmaceuticals, particularly for conditions with significant unmet medical needs. The company aims for sustainable growth through its Purified Cortrophin® Gel franchise and enhancing its generics portfolio.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has announced that CEO Nikhil Lalwani and CFO Stephen Carey will present at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 12:00 p.m. ET in New York City. The event will be available via webcast.
Investors can access the live presentation by clicking here. The recorded version will be available on demand starting May 3, 2023, at 7:00 a.m. ET for 90 days.
ANI Pharmaceuticals focuses on developing, manufacturing, and marketing high-quality pharmaceutical products, including those for unmet medical needs.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for its Nitrofurantoin Oral Suspension (25 mg/5 ml), a generic version of Furadantin®, addressing a market worth approximately $55.5 million annually. This approval aligns with ANI's strategy to expand its generics portfolio by providing limited-competition products to benefit patient populations in need. CEO Nikhil Lalwani emphasized the company's commitment to launching new products as a priority for growth.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for its Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g, a generic version of Colestid®.
This market is valued at approximately $81.3 million annually in the U.S., according to IQVIA/IMS Health. CEO Nikhil Lalwani noted the launch expands their generics portfolio, emphasizing the limited suppliers for this product.
ANI aims to enhance its growth through access to high-quality medicines and strengthening its generics business.
ANI Pharmaceuticals (ANIP) reported a strong performance in Q4 2022, achieving net revenues of $94.2 million—a 54.7% increase year-over-year. However, the company incurred a net loss of $(4.7) million, translating to a diluted GAAP loss per share of $(0.28). For full-year 2022, total net revenues reached $316.4 million, alongside a net loss of $(49.5) million. The company anticipates 2023 net revenue guidance of $360 million to $385 million, with adjusted EBITDA expected between $78 million and $88 million. ANI is focusing on its Rare Disease segment, particularly the Cortrophin Gel, and projects substantial revenue growth in this area.
Cosette Pharmaceuticals has announced the acquisition of US marketing rights for Betaine Anhydrous for Oral Solution from ANI Pharmaceuticals (ANIP), beginning immediate shipping to customers. This product provides an important treatment option for patients suffering from homocystinuria, a rare genetic disorder. The CEO of Cosette,
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