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 third-quarter 2022 net revenues of $83.8 million, marking a 61% year-over-year growth. However, the net loss available to common shareholders stood at $(9.0 million), with a diluted GAAP loss per share of $(0.55). Adjusted non-GAAP EBITDA reached $19.6 million. The company reiterated its full-year 2022 guidance for net revenues between $295 million and $315 million. Key product Cortrophin generated $12.6 million in sales, with substantial gains in patient cases initiated and prescriber engagement.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its third quarter 2022 financial results on November 9, 2022, before market opening. The Company aims to discuss these results on a conference call at 8:00 a.m. ET. Interested parties can access the call via toll-free number 800-245-3047 or through a live webcast available on their website. A replay will be available shortly after the call. ANI focuses on developing, manufacturing, and marketing branded and generic pharmaceuticals to meet high medical needs.
ANI Pharmaceuticals, Inc. announced the appointment of Krista L. Davis as Chief Human Resources Officer, effective September 12. With over 20 years of executive leadership experience, including a significant role at Novartis, Davis aims to enhance organizational effectiveness during a crucial growth phase for the company. Nikhil Lalwani, President and CEO, emphasized her strategic contribution to priority people and organizational issues, aligning with ANI's goals to deliver life-changing therapeutics.
ANI Pharmaceuticals will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 12:30 PM ET. CEO Nikhil Lalwani and CFO Stephen Carey will represent the company during the event. A webcast of the presentation will be accessible on the company’s website in the Investors section. Additionally, ANI will hold 1x1 meetings on the same day, which can be requested through H.C. Wainwright. ANI Pharmaceuticals focuses on developing high-quality branded and generic pharmaceutical products.
ANI Pharmaceuticals announced the launch of Prochlorperazine Maleate Tablets USP in 5 mg and 10 mg dosages, a generic version of Compazine®. Developed with Biophore India Pharmaceuticals, this product addresses a U.S. market worth approximately $30 million. ANI aims to enhance patient access to high-quality generics, with CEO Nikhil Lalwani emphasizing the importance of limited competition products. The launch reflects ANI's strategy of providing affordable medication options, contributing to their sustainable growth.
ANI Pharmaceuticals, Inc. received FDA approval for its Dexamethasone Tablets USP in 1.5mg, 4mg, and 6mg dosages, entering a market valued at approximately
ANI Pharmaceuticals reported record net revenues of $73.9 million for Q2 2022, a 52% increase year-over-year. Despite this growth, the company faced a net loss of $(15.3) million and a diluted GAAP loss per share of $(0.94). Sales from Cortrophin reached $10.2 million, contributing to the positive trajectory of the recently launched product. Guidance for full-year revenue is maintained at $295 million to $315 million, with adjusted EBITDA expectations of $54 million to $60 million. Steps in business operations include consolidating manufacturing and enhancing generic product offerings.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has launched Acebutolol Hydrochloride Capsules, the generic equivalent of Sectral®. The U.S. market for this medication is valued at approximately $10 million annually, according to IQVIA/IMS Health. CEO Nikhil Lalwani emphasized the company's focus on addressing patient needs and its successful track record in reintroducing older ANDAs. The firm aims for growth through innovation in generics and branded products while navigating potential risks such as competition and regulatory approvals.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced the acquisition of four abbreviated new drug applications (ANDAs) from Oakrum Pharma, LLC. This move is expected to enhance ANI's generics product portfolio and unlock value in 2023. CEO Nikhil Lalwani emphasized the acquisition's alignment with ANI's strategic focus on business development and in-house research efforts, aimed at providing essential medications. The transaction was facilitated by Bourne Partners, who served as exclusive financial advisor to Oakrum Pharma.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its second quarter 2022 financial results on August 8, 2022, before market open. A conference call will be hosted by President Nikhil Lalwani and CFO Stephen P. Carey at 8:00 a.m. ET. Investors can join the call by dialing 800-225-9448 or via webcast at www.anipharmaceuticals.com. A replay will be available shortly after the call for two weeks. ANI focuses on developing and marketing prescription pharmaceutical products addressing high unmet medical needs.
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