Ani Pharmaceutic Stock Price, News & Analysis

ANI Pharmaceuticals (Nasdaq: ANIP) reported record Q3 2025 net revenues of $227.8M, a 53.6% year‑over‑year increase, driven by Purified Cortrophin Gel $101.9M (up 93.8%). The company reported record adjusted non‑GAAP EBITDA of $59.6M and adjusted non‑GAAP diluted EPS of $2.04, with GAAP diluted EPS of $1.13.

ANI raised full‑year 2025 guidance to $854M–$873M total net revenue, adjusted non‑GAAP EBITDA of $221M–$228M, and adjusted non‑GAAP diluted EPS of $7.37–$7.64. Rare Disease is expected to represent about 50% of 2025 net revenues, including revised Cortrophin Gel guidance of $347M–$352M (≈75%–78% growth).

ANI Pharmaceuticals (Nasdaq: ANIP) will release its third quarter 2025 financial results on Friday, November 7, 2025 prior to market open.

A conference call with Nikhil Lalwani (CEO), Stephen P. Carey (CFO) and Chris Mutz (Head of Rare Disease) will be held on November 7, 2025 at 8:30 a.m. ET. Investors can join by dialing the U.S. toll-free number 800-267-6316 using conference ID 5120265 or via live webcast at www.anipharmaceuticals.com under the Investors section.

A replay will be available about two hours after the call and remain accessible for two weeks by dialing 800-839-2391 and entering access code 5120265.

ANI Pharmaceuticals (Nasdaq: ANIP) announced that results from the NEW DAY clinical trial of ILUVIEN (fluocinolone acetonide 0.19 mg) for diabetic macular edema will be presented in a late-breaking oral session at the American Academy of Ophthalmology (AAO) 2025 Retina Subspecialty Day on October 17, 2025 at 4:39 pm ET.

The release reiterates that NEW DAY results were previously reported and will be further disseminated at multiple meetings; it also restates ILUVIEN's indication for DME in patients previously treated with corticosteroids who did not have a clinically significant intraocular pressure rise, and summarizes key safety data including intraocular pressure and cataract incidence from the trials.

ANI Pharmaceuticals (NASDAQ:ANIP) has announced its participation in two upcoming investor conferences. CEO Nikhil Lalwani and the executive team will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 9:00 AM ET, and the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 1:50 PM ET.

Investors can access both live and archived webcasts through the company's website at www.anipharmaceuticals.com in the Investors section under Events and Presentations. The webcast replays will remain available for 90 days.

ANI Pharmaceuticals (NASDAQ:ANIP) reported exceptional Q2 2025 results with record-breaking performance across key metrics. The company achieved total net revenues of $211.4 million, representing 53.1% year-over-year growth. Their Rare Disease segment, led by Cortrophin Gel with $81.6 million in revenue (66% YoY growth), was a major contributor.

The company's Generics business generated $90.3 million in revenue, up 22.1% YoY. ANI delivered record quarterly adjusted EBITDA of $54.1 million, a 62.8% increase, and achieved adjusted non-GAAP diluted EPS of $1.80.

Based on strong performance, ANI raised its 2025 guidance, now expecting total revenues of $818-843 million and adjusted non-GAAP EBITDA of $213-223 million. Rare Disease revenues are projected to represent approximately 50% of total company revenues in 2025.

ANI Pharmaceuticals (NASDAQ: ANIP) has scheduled its second quarter 2025 financial results announcement for Friday, August 8, 2025, before market open. The company will host a conference call at 8:30 a.m. ET to discuss the results.

Key executives participating in the call include CEO Nikhil Lalwani, CFO Stephen P. Carey, Head of Rare Disease Chris Mutz, and Chief Medical Officer Mary Pao, M.D., Ph.D. Investors can access the call via toll-free number 800-343-4136 using conference ID 5034065. A webcast will be available on the company's website under the Investors section.

ANI Pharmaceuticals (NASDAQ:ANIP) announced results from the NEW DAY clinical trial evaluating ILUVIEN® for diabetic macular edema (DME) treatment. The study compared ILUVIEN to aflibercept in treatment-naïve patients.

The trial's primary endpoint of reducing supplemental aflibercept injections was not met in the intent-to-treat population (2.4 vs 2.5 injections, p=0.756). However, a secondary endpoint showed significantly longer time between treatments with ILUVIEN (185.4 vs 132.8 days, p<0.001). A post-hoc analysis of patients without protocol deviations showed significant reduction in supplemental injections for the ILUVIEN group (1.8 vs 2.5, p=0.029).

Safety data showed ILUVIEN was well-tolerated but had higher treatment-related adverse events (41%) compared to aflibercept (3%), mainly related to cataracts and increased intraocular pressure.

ANI Pharmaceuticals (NASDAQ:ANIP) announced its participation in the upcoming Leerink Partners Therapeutics Forum, focusing on I&I and Metabolism. The company's President and CEO, Nikhil Lalwani, will be conducting one-on-one meetings with investors during the event, which takes place on July 8, 2025, in Boston, MA.

ANI Pharmaceuticals presented new preclinical data for Purified Cortrophin Gel at EULAR 2025 Congress, demonstrating promising results in treating murine collagen-induced arthritis. The study showed that repository corticotropin injection (RCI) significantly reduced joint swelling and inflammatory cytokine response in mice, particularly at the 400 U/kg dose, without causing additional bone loss. The research, led by experts from UC San Diego and UC Davis, supports ANI's commitment to understanding their product's mechanism of action. Cortrophin Gel is currently indicated for short-term administration as adjunctive therapy in rheumatoid arthritis, including juvenile rheumatoid arthritis.