Will ANIP's Rare Disease Franchise Maintain Momentum in 2026?

ANI Pharmaceuticals’ ANIP rare disease franchise spearheaded its growth in 2025. This robust growth was fueled by the strong performance of its ACTH-based injection Cortrophin Gel.

Cortrophin Gel sales jumped 70% year over year to $236 million in the first nine months of 2025, witnessing broad-based growth across all targeted specialties, supported by an expanded sales force in neurology, rheumatology, and nephrology, as well as synergies from the integrated ophthalmology sales team.

During the third quarter, the company reported continued growth in prescriptions for the prefilled syringe, which represented approximately 70% of newly initiated cases. Prescriptions for acute gouty arthritis flares — an indication in which Cortrophin Gel is the only approved ACTH-based therapy — continued to be a key growth contributor, accounting for more than 15% of overall Cortrophin Gel utilization.

A phase IV study evaluating Cortrophin Gel in acute gouty arthritis flares is ongoing.

ANIP expects this momentum to continue in 2026 as well. ANIP expects its rare disease business to represent half of its total net revenues in 2025. For full-year 2025, Cortrophin Gel sales are projected to reach $347-$352 million, representing growth of 75-78% year over year.

The strong performance of the rare disease franchise is helping offset weaker-than-expected contributions from ANI’s recently acquired ophthalmology products, Iluvien and Yutiq, which were added through the September 2024 acquisition of Alimera Sciences.

ANIP’s Competition in the Space

ANI Pharmaceuticals’ ophthalmology products, Iluvien and Yutiq, face competition from several pharma bigwigs, like AbbVie ABBV and Regeneron REGN.

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 is also a formidable competitor, led by its industry top ophthalmology franchise comprising Eylea, one of the most widely used therapies in DME.

The prime 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

ANIP’s shares have gained 42.3% in a year compared with the industry’s growth of 17.6%.

From a valuation standpoint, ANIP is trading at a premium to the industry. Going by the price/sales (P/S) ratio, the stock currently trades at 2.04X trailing 12-month sales value, higher than 1.92x for the industry.

EPS estimates for 2025 and 2026 have increased over the last 60 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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