ANI Pharmaceuticals, Inc. (ANIP) reported preliminary full‑year 2025 results that surpassed guidance and positioned the company for a record‑breaking 2026. Net revenues rose 39‑42% to $854‑$873 million, driven largely by the Rare Disease and Brands segment, which generated $129 million in revenue and $41 million in operating income. The company’s flagship product, Cortrophin Gel, contributed $347‑$352 million, while the ILUVIEN/YUTIQ retina franchise added roughly $74.9 million in net sales.
Adjusted non‑GAAP EBITDA climbed 42‑45% to $221‑$228 million, reflecting disciplined cost management and a favorable mix shift toward higher‑margin specialty products. Diluted earnings per share fell slightly below consensus at $7.37‑$7.64, but the figure still represents a robust operating performance, especially given the company’s aggressive investment in the Rare Disease pipeline and the expansion of its manufacturing footprint.
CEO Nikhil Lalwani highlighted that 2025 was a pivotal year, noting that the company “entered 2026 in a position of strength” and that the Rare Disease business now accounts for roughly 60% of total revenue. He emphasized that the continued growth of Cortrophin Gel, now in a 90‑person expansion of the Rare Disease team, is a key driver of the company’s transformation from a generics‑centric manufacturer to a specialty‑pharma leader.
For 2026, ANI projected total net revenues of $1.055‑$1.115 billion, a 20‑25% increase from 2025, and a gross margin of 59.3‑60.3%. Adjusted non‑GAAP EBITDA guidance rose to $275‑$290 million, while diluted EPS guidance was $8.83‑$9.34. The company expects Cortrophin Gel revenue to reach $540‑$575 million, underscoring the product’s central role in the 2026 outlook.
Analysts remain bullish, maintaining a strong‑buy consensus and price targets ranging from $90 to $121. The guidance signals confidence in sustained demand for the Rare Disease portfolio and a continued focus on cash generation to fund future growth.
The results and forward guidance reinforce ANI’s strategic pivot toward high‑growth specialty products, strengthen its balance sheet with $285 million in unrestricted cash, and position the company for a significant expansion of its Rare Disease pipeline.
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