ANI Pharmaceuticals reported third‑quarter 2025 results that far exceeded analyst expectations, with net revenue climbing 53.6% to $227.8 million and adjusted non‑GAAP diluted earnings per share rising to $2.04—$0.30 above the consensus of $1.74. The earnings beat was driven by a 109.9% jump in the Rare Disease and Brands segment, largely powered by a 93.8% increase in Cortrophin Gel revenue, and a 20.6% rise in the Generics and Other segment, which includes a 20.6% increase in generics revenue to $94.4 million. The company’s cost‑control program and efficient operating leverage helped maintain a 15.9% operating margin, up 29.7 percentage points YoY, while the GAAP gross margin improved to 59.0% from 57.5% in the prior year.
The Rare Disease and Brands segment generated $118.5 million, a 109.9% increase from $53.5 million in Q3 2024, reflecting strong demand for Cortrophin Gel and the continued uptake of ILUVIEN and YUTIQ following the Alimera acquisition. Cortrophin Gel alone contributed $101.9 million, up 93.8% YoY, driven by expanded sales force activity and new patient starts across multiple specialties. The Generics and Other segment’s 20.6% growth to $94.4 million was supported by the launch of a new partnered generic product and sustained performance of the core portfolio, offsetting a modest decline in the other segment’s revenue.
Product‑level detail shows that ILUVIEN added $16.6 million in Q3 2025, while YUTIQ’s contribution was modest, reflecting the early stage of its commercialization. The company’s strategic focus on rare‑disease therapeutics is evident in the near‑doubling of Cortrophin Gel revenue compared to Q3 2024, and the management’s emphasis on expanding the ophthalmology sales force has translated into tangible top‑line growth.
Management raised the full‑year 2025 guidance to $854 million–$873 million in revenue, $221 million–$228 million in adjusted EBITDA, and $7.37 to $7.64 in adjusted non‑GAAP diluted EPS, up from the prior guidance of $768 million–$793 million, $195 million–$205 million, and $6.27 to $6.62, respectively. The updated gross‑margin outlook of 61.0%–62.0% reflects the company’s pricing power in the rare‑disease space and the cost savings from the Alimera acquisition. The guidance increase signals management’s confidence in sustained demand growth and continued operational efficiency.
Liquidity remains robust, with $262.6 million in unrestricted cash and $252.6 million in accounts receivable as of September 30, 2025, against $633.1 million of debt. The strong cash position supports ongoing R&D investment and potential future acquisitions, while the debt level remains manageable relative to the company’s cash flow generation.
CEO Nikhil Lalwani highlighted the quarter as a “turn‑key” performance, citing the near‑doubling of Cortrophin Gel revenue and a 70% rise in adjusted EBITDA YoY. He emphasized the company’s focus on rare diseases as a primary growth driver and the strategic benefits of the Alimera acquisition. The market reaction was mixed, with some analysts noting the strong earnings beat but also cautioning that the company’s valuation remains high relative to peers. Overall, the results reinforce ANI’s trajectory as a leading specialty pharmaceutical player with a clear focus on high‑margin rare‑disease therapeutics.
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