Here's How ANIP's Rare Disease Portfolio Is Driving Top-line Growth

ANI Pharmaceuticals’ ANIP rare disease franchise has emerged as a major growth catalyst in 2025, with segment revenues more than doubling year over year to $291 million in the first nine months. The company now expects the segment to contribute nearly half of its full-year revenues, highlighting its rising strategic importance.

The growth in this franchise is largely attributed to ANI Pharmaceuticals’ ACTH-based injection Cortrophin Gel, whose sales have surged 70% year over year to $236 million in the first nine months of 2025. This upside was attributed to increased demand across all specialties — neurology, rheumatology, nephrology and ophthalmology — aided by an expanded sales force and broader prescriber adoption. ANIP expects this momentum to continue, further supported by new clinical studies (including a phase IV study in acute gouty arthritis) and ongoing efforts to deepen specialty penetration. For the full year 2025, Cortrophin Gel sales are expected to reach $347-$352 million, reflecting a 75-78% increase from last year.

This strong performance is helping offset softer contributions from ANIP’s newly acquired ophthalmology assets — Iluvien and Yutiq — which were added following the September 2024 acquisition of Alimera Sciences. The company revised its 2025 sales outlook for these products to $73-$77 million (down from $87-$93 million), citing reimbursement challenges and continued utilization of existing inventory at physician offices. Still, ANIP expects the franchise to return to growth in 2026, supported by expanded field efforts, improved patient access and a significantly larger addressable patient population — nearly 10x current usage levels.

ANIP’s Competition in the Space

ANI Pharmaceuticals faces competition across its rare disease portfolio, particularly for Iluvien and Yutiq, where several pharma bigwigs, like AbbVie ABBV and Regeneron REGN, market well-established products. AbbVie is a key rival, with Ozurdex competing directly with Iluvien in diabetic macular edema (DME) and with Yutiq in non-infectious uveitis of the posterior segment (NIU-PS). Regeneron remains another major competitor through its Eylea franchise, one of the most widely used therapies in DME.

The primary competitor to Cortrophin Gel is Acthar Gel, which is marketed by Keenova Therapeutics (formerly Mallinckrodt Pharmaceuticals). Like ANIP, Keenova recently raised the sales outlook for Acthar Gel, now expecting full-year 2025 sales growth of 30-35%, up from the prior 20-30% range.

ANIP’s Price Performance, Valuation and Estimates

Shares of ANI Pharmaceuticals have outperformed the industry year to date, as seen in the chart below.

From a valuation standpoint, ANIP is trading at a discount to the industry. Going by the price/sales (P/S) ratio, the stock currently trades at 2.00 times trailing 12-month sales value, lower than 2.41 times for the industry.

EPS estimates for 2025 and 2026 have increased over the last 30 days.

ANI Pharmaceuticals currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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