Core Insights - ANI Pharmaceuticals, Inc. reported significant growth in 2025, with total net revenues increasing by at least 39% and adjusted non-GAAP EBITDA growing by at least 42% [2] - The company anticipates generating over $1 billion in total net revenues for 2026, with approximately 60% coming from its Rare Disease business [2] - ANI plans to expand its Rare Disease organization to capture opportunities in acute gouty arthritis flares, a unique indication for Cortrophin Gel [2][12] Financial Performance - Preliminary results indicate Cortrophin Gel net revenues of approximately $111.4 million for Q4 2025, an 88% increase year-over-year, and approximately $347.8 million for the full year 2025, a 76% increase year-over-year [3] - Full year 2025 total net revenues are expected to be between $854 million and $873 million, with adjusted non-GAAP EBITDA between $221 million and $228 million [4][7] - The company expects full year 2026 total net revenues of $1,055 million to $1,115 million, with Cortrophin Gel net revenues projected at $540 million to $575 million [7][8] Strategic Priorities - ANI aims to maximize the growth opportunity for Cortrophin Gel by addressing unmet medical needs across various indications [12] - The company will focus on expanding its Rare Disease organization and advancing a Phase 4 clinical trial for Cortrophin Gel in acute gouty arthritis flares [12] - Continued execution in the Generics business is expected to support cash generation for the Rare Disease segment [2][12]

Core Insights - ANI Pharmaceuticals, Inc. will have its CEO, Nikhil Lalwani, participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025 [1] - The live and archived chat will be available on the company's website for 90 days [2] Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [3] - The company aims for sustainable growth through its Rare Disease business, Generics business, and Brands business, targeting areas such as ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3]

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2] - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business [2] Recent Developments - Nikhil Lalwani, President and CEO of ANI Pharmaceuticals, will host 1x1 meetings at the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8, 2025, in Boston, MA [1]

Core Viewpoint - ANI Pharmaceuticals, Inc. has received FDA approval for a new prefilled syringe format of Purified Cortrophin® Gel, enhancing patient administration convenience and reflecting the company's commitment to rare disease therapies [1][2]. Product Details - The new prefilled syringe will be available in two single-dose options: 40 USP units/0.5 mL and 80 USP units/mL, alongside existing vial formats of 5 mL and 1 mL [1]. - Cortrophin Gel is indicated for various conditions, including acute gouty arthritis, rheumatoid arthritis, systemic lupus erythematosus, and severe allergic and inflammatory conditions [4]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [6]. - The company aims for sustainable growth through its Rare Disease business, Generics business, and Brands business [6].