Welcome to our dedicated page for Ani Pharmaceutic news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on Ani Pharmaceutic stock.
ANI Pharmaceuticals Inc. (ANIP) delivers innovative solutions in specialty generics and complex drug formulations, focusing on therapeutic areas with high barriers to entry. This page provides investors and healthcare professionals with timely updates on regulatory milestones, manufacturing developments, and strategic initiatives within controlled substances, oncology, and rare disease therapies.
Discover official press releases covering ANIP’s FDA submissions, product launches, and financial results alongside analysis of its Minnesota-based manufacturing capabilities. Our repository includes updates on niche segments like hormonal therapies and extended-release formulations, reflecting the company’s commitment to addressing unmet medical needs.
Bookmark this page for direct access to ANIP’s latest corporate announcements, partnership details, and therapeutic pipeline progress. Stay informed about developments in cGMP-compliant production and market expansions through verified, up-to-date reporting.
ANI Pharmaceuticals (ANIP) has received FDA approval for an expanded label of ILUVIEN (fluocinolone acetonide intravitreal implant) to include treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS), in addition to its existing diabetic macular edema (DME) indication.
The company plans to market ILUVIEN for both indications in the U.S. later this year. The treatment is already approved for both DME and NIU-PS in seventeen European countries. ANI has extended its supply agreement with Siegfried through 2029, including plans to upgrade equipment and expand manufacturing capacity.
ILUVIEN is specifically indicated for DME patients previously treated with corticosteroids without significant intraocular pressure rise, and for chronic NIU-PS treatment. The treatment carries important safety considerations, including risks of infection, increased intraocular pressure, cataracts, and delayed wound healing.
ANI Pharmaceuticals (ANIP) has received FDA approval for a new prefilled syringe format of Purified Cortrophin® Gel, a repository corticotropin injection. The new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through established specialty pharmacy networks.
The prefilled syringe format simplifies administration for patients while maintaining the existing vial options. The product launch is scheduled for the second quarter of 2025. Cortrophin Gel is indicated for various conditions including acute gouty arthritis, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, severe psoriasis, and acute exacerbations of multiple sclerosis.
ANI Pharmaceuticals (ANIP) reported record Q4 2024 results with net revenues of $190.6 million, up 44.8% year-over-year. The company's Rare Disease segment generated $87.0 million, including $59.4 million from Cortrophin Gel (up 42.3%) and $27.6 million from ILUVIEN and YUTIQ.
Key financial metrics include adjusted non-GAAP EBITDA of $50.0 million (up 65.7%) and adjusted non-GAAP diluted EPS of $1.63. The company raised its 2025 guidance, projecting net revenues of $756.0-776.0 million and adjusted non-GAAP EBITDA of $190.0-200.0 million.
The Generics segment showed 9.4% growth to $78.6 million, with five new product launches in Q4. The company ended 2024 with $144.9 million in cash and $639.2 million in outstanding debt.
ANI Pharmaceuticals (ANIP) has announced its participation in two major healthcare investor conferences in March 2025. The company's President and CEO, Nikhil Lalwani, along with senior management members, will present at the Raymond James & Associates' 46th Annual Institutional Investors Conference on March 4 at 1:40 PM ET and the Leerink Partners Global Healthcare Conference on March 11 at 3:40 PM ET.
Both presentations will be available via live and archived webcasts on ANI's website (www.anipharmaceuticals.com) under the Investors section's Events and Presentations area. The webcast replays will remain accessible for 90 days following the events.
ANI Pharmaceuticals (NASDAQ: ANIP) has scheduled its fourth quarter and full year 2024 financial results announcement for February 28, 2025, before market open. The company will host a conference call at 8:00 a.m. ET to discuss the results.
Key executives participating in the call include President and CEO Nikhil Lalwani, CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz. Investors can access the call toll-free at 800-579-2543 using Conference ID 4860276. A webcast will be available on the company's website under the Investors section, with a replay accessible for two weeks after the call.
ANI Pharmaceuticals (ANIP) has announced its participation in the upcoming Guggenheim Biotech Conference in New York City. The company's President and CEO Nikhil Lalwani and CFO Stephen Carey will conduct a fireside chat on Wednesday, February 5, 2025, at 2:00pm EST.
The presentation will be available through a live webcast, which can be accessed through ANI Pharmaceuticals' website under the Investors section's Events and Presentations area. For those unable to attend, the webcast recording will remain accessible for 60 days following the event.
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.
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