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
Alcami , a leading contract development and manufacturing organization (CDMO), has announced a leadership transition with Chairman of the Board Patrick Walsh stepping in as Interim CEO following Bill Humphries' resignation. Walsh, who previously served as CEO of Alcami on two occasions and has been Chairman for the past four years, will ensure operational continuity and maintain the company's client-focused approach.
During his two-year tenure, Humphries led Alcami through a period of facilities expansion and global supply chain realignment. Walsh currently holds several leadership positions, including Chairman of ANI Pharmaceuticals (NASDAQ: ANIP), Chairman of MedPharm, and Operating Partner at Ampersand Capital Partners.
ANI Pharmaceuticals (ANIP) has announced preliminary financial results for Q4 and full-year 2024, along with its 2025 outlook. Based on unaudited results, the company expects to meet or exceed its previously provided guidance ranges for 2024. The Rare Disease Segment performed as expected, with Purified Cortrophin Gel generating net revenues of $197.8-198.4 million for 2024.
The newly acquired ILUVIEN and YUTIQ products contributed $30.4-31.0 million in net revenues from September 16 to December 31, 2024. Looking ahead to 2025, ANI projects total net revenues between $739-759 million, representing 24-27% growth compared to 2024 guidance midpoint, and adjusted non-GAAP EBITDA of $182-192 million.
The company will provide complete 2024 results and full 2025 financial guidance during its Q4 2024 earnings call in late February.
ANI Pharmaceuticals (Nasdaq: ANIP) has received FDA approval and launched Prucalopride Tablets, the first generic version of Motegrity®. The company secured a Competitive Generic Therapy (CGT) designation with 180-day exclusivity for this product. This achievement reinforces ANI's position as the holder of the second-highest number of CGT approvals in the U.S. Generics market. According to IQVIA data from October 2024, the U.S. annual market for Prucalopride Tablets is approximately $168.0 million.
ANI Pharmaceuticals (ANIP) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, January 14, 2025, at 2:15pm PST/5:15pm EST in San Francisco. Key executives presenting include President and CEO Nikhil Lalwani, CFO Stephen Carey, and CMO Dr. Mary Pao.
The presentation will be available via live webcast and can be accessed through the company's website at www.anipharmaceuticals.com under the Investors section's Events and Presentations area. An archived version of the webcast will remain accessible for 90 days following the event.
ANI Pharmaceuticals (Nasdaq: ANIP) announced its participation in the 36th Annual Piper Sandler Healthcare Conference. President and CEO Nikhil Lalwani and CFO Stephen Carey will host a fireside chat on Wednesday, December 4, 2024, at 3pm EST in New York City.
The event will be available via live webcast and can be accessed through the company's website at www.anipharmaceuticals.com in the Investors section under Events and Presentations. A replay will remain accessible for 90 days following the presentation.
ANI Pharmaceuticals (ANIP) reported record Q3 2024 results with net revenues of $148.3 million, up 12.5% year-over-year. The company's lead product, Cortrophin Gel, achieved record revenues of $52.6 million, growing 76.8%. Despite posting a net loss of $(24.2) million, ANI raised its 2024 guidance, expecting revenues between $594-602 million. The company completed the acquisition of Alimera Sciences, adding ILUVIEN and YUTIQ to its portfolio, and implemented a new capital structure expected to reduce annual interest expenses by $39 million.
ANI Pharmaceuticals (Nasdaq: ANIP) has announced its participation in two major healthcare conferences this November. Nikhil Lalwani, President and CEO, and Stephen Carey, CFO, will present at the Guggenheim Inaugural Healthcare Innovation Conference on November 13, 2024, at 10:00am ET, and the Jefferies London Healthcare Conference on November 20, 2024, at 2:30pm GMT/9:30am ET.
Live and archived webcasts will be available on ANI's website under the Investors section, with replays accessible for 90 days.
ANI Pharmaceuticals (NASDAQ: ANIP) has scheduled its third quarter 2024 financial results announcement for November 8, 2024, before market open. The company will host a conference call at 8:00 a.m. ET featuring CEO Nikhil Lalwani, CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz. Investors can access the call toll-free at 800-445-7795 using Conference ID 4757982. A webcast will be available on the company's website under the Investors section, with a replay accessible for two weeks by calling 800-839-8389.
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) and launched Estradiol Gel, 0.06%, a generic version of EstroGel® Gel, 0.06%. The product enters a market with annual sales of approximately $16.7 million, according to August 2024 IQVIA data. This launch represents another -competition product in ANI's portfolio, aimed at ensuring accessibility for patients and customers.
ANI Pharmaceuticals (ANIP) announced its upcoming presentation of new pre-clinical data on membranous nephropathy (MN) research at the American Society of Nephrology Kidney Week 2024 in San Diego, October 23-27. The company will showcase two poster presentations focusing on THSD7A-associated membranous nephropathy and melanocortin therapy's protective effects.
Chief Medical Officer Dr. Mary Pao highlighted the significance of their research in understanding melanocortin receptors' role in nephrotic syndrome. The presentations will be delivered by lead author Jing Liu, with sessions scheduled for October 25 and 26.
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