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 fourth quarter and full year 2022 financial results on March 9, 2023, before the market opens. The call will include insights from Nikhil Lalwani, CEO, and Stephen P. Carey, CFO, at 8:30 a.m. ET. Interested parties can participate via a conference call at 800-343-5172 or through a webcast available on the ANI website. Following the call, a replay will be accessible for two weeks. ANI Pharmaceuticals focuses on developing high-quality branded and generic pharmaceuticals, particularly in addressing high unmet medical needs.
ANI Pharmaceuticals (NASDAQ: ANIP) has received FDA approval for its Levocarnitine Tablets USP, 330 mg, a generic version of the branded drug Carnitor®. The U.S. market for Levocarnitine Tablets is valued at approximately $10 million annually. This launch aligns with ANI's mission to enhance patient access to affordable medicines and reinforces its commitment to limited-competition products. The company aims for sustainable growth through its generics and innovative product lines, leveraging its manufacturing capabilities.
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, 20 mg/5 mL, a generic version of Prozac®. This generic drug targets a U.S. market estimated at $14.6 million, according to IQVIA/IMS Health. CEO Nikhil Lalwani emphasized ongoing commitment to affordable generics, showcasing the company's focus on enhancing its generics business. The approval may potentially boost ANI's sales and market presence, reflecting its strategic growth in the pharmaceutical sector.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Abbreviated New Drug Application for Trimethoprim Tablets USP, 100 mg. This product is a generic version of the established Trimethoprim Tablets, targeting an annual U.S. market worth approximately $16.8 million according to IQVIA/IMS Health. CEO Nikhil Lalwani highlighted ANI's commitment to bringing niche products to market while expanding its generics portfolio.
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
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