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. 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.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announces the appointment of Meredith W. Cook as SVP, General Counsel, and Corporate Secretary, effective July 18. With over 20 years of experience in the pharmaceutical sector, Ms. Cook's expertise includes corporate governance and mergers and acquisitions. Nikhil Lalwani, President and CEO, expressed confidence in her ability to significantly contribute to the company's growth, especially in launching the Purified Cortrophin® Gel. Ms. Cook previously held key legal roles at Amneal Pharmaceuticals and Dr. Reddy’s Laboratories.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Clorazepate Dipotassium Tablets, a generic version of Tranxene®. The U.S. market for this product is approximately $25.8 million, as reported by IQVIA/IMS Health. CEO Nikhil Lalwani highlighted this launch as part of ANI's commitment to expanding access to essential therapeutics. The Company continues to focus on sustainable growth through new product launches and strengthening its generics portfolio.
ANI Pharmaceuticals and Veeva Systems have partnered to enhance commercial strategies for ANI's Rare Disease Business Unit, utilizing Veeva's data-driven tools. This collaboration aims to launch ANI's first product, Purified Cortrophin Gel, in the U.S. The companies emphasize agility and precision in addressing rare disease patients' needs. ANI has adopted Veeva Commercial Cloud solutions to strengthen its sales and marketing capabilities. This partnership is expected to refine customer engagement and optimize sales interactions, marking a significant step in ANI's mission to improve patient access.
ANI Pharmaceuticals plans to cease operations at its Oakville, Ontario manufacturing plant by Q1 2023 as part of cost-competitiveness efforts following its acquisition of Novitium Pharma in November 2021. This move is expected to enhance profitability and cash flow by $7 million to $8 million annually. Products from the Oakville site will be transitioned to U.S. facilities, ensuring supply continuity. The company remains committed to treating employees respectfully and is exploring potential buyers for the Oakville site.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Abbreviated New Drug Application (ANDA) for Fludrocortisone Acetate Tablets USP, 0.1 mg, a generic version of Florinef®. The U.S. market for these tablets is valued at approximately
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