ANI Trims Cortrophin Gel Outlook After Gout Launch

The Tip Desk · August 7, 2026 · 4 min read

The company now sees $520 million to $540 million of Cortrophin Gel sales in 2026, implying 50% to 55% growth, after a $117.1 million second-quarter result.

ANI Pharmaceuticals (ANIP) cut its 2026 Cortrophin Gel net revenue outlook to $520 million to $540 million, implying 50% to 55% growth, from the $540 million to $575 million range it had reaffirmed after the first quarter. Full-year total net revenue guidance of $1,080 million to $1,140 million and adjusted non-GAAP EBITDA of $285 million to $300 million were left unchanged.

The rare-disease specialist said the modest Cortrophin Gel adjustment reflected first-half results. Cortrophin Gel net revenues were $117.1 million in the second quarter ended June 30, 2026, up 43.5% from a year earlier, after $75.1 million and 42.1% growth in the first quarter. Year-over-year growth in the second quarter was driven primarily by existing specialty areas of Nephrology, Neurology, Ophthalmology, Pulmonology and Rheumatology, and momentum continued into the third quarter with a record number of new cases initiated in July.

Total net revenues were $266.0 million, up 25.9% from a year earlier, accelerating from 20.5% growth in the first quarter. Rare Disease total net revenues, which include Cortrophin Gel and ILUVIEN, rose 30.7% to $135.8 million. Adjusted non-GAAP EBITDA was $71.6 million, up 32.4% from a year earlier, after $63.0 million and 24.1% growth in the first quarter. GAAP net income available to common shareholders was $24.7 million, or $1.05 a share. Adjusted non-GAAP diluted earnings per share were $2.21.

ILUVIEN net revenues were $18.7 million, down 16.1% from a year earlier, reversing a 19.5% year-over-year increase in the first quarter. The decline was primarily due to the timing of international shipments. There were no sales of YUTIQ in the quarter, as promotional efforts in the U.S. had shifted to ILUVIEN, which carries a combined label of DME and NIU-PS. ANI announced six-month topline data from the Phase 4 SYNCHRONICITY trial in chronic non-infectious uveitis affecting the posterior segment and anticipates announcing detailed results at a retina-specialist conference in the fourth quarter of 2026. Full-year ILUVIEN guidance was left at $78 million to $83 million.

Generics net revenues were $99.1 million, up 9.7% from a year earlier, after $100.8 million and 28.2% growth in the fourth quarter of 2025. The increase was driven by new product launches, including a partnered generic launch that commenced in the third quarter of 2025. ANI launched 12 new Generics products year-to-date and is on track for at least 15 new product launches in 2026.

Brands net revenues were $11.8 million, down 10.5% from a year earlier, reflecting a normalization in demand for certain products. Brand royalties and other revenues were $17.7 million, comprising $9.7 million of royalties on net sales of pitolisant-based products under the Harmony Agreement and $8.0 million of development-milestone revenue. Remaining development work is expected to be completed in the third quarter of 2026, at which time an additional $2.0 million in development-milestone revenue will be recognized, and low single-digit royalties on pitolisant-based products will continue.

GAAP gross margin decreased from 64.7% to 62.4%, and non-GAAP gross margin from 64.9% to 62.6%. Both decreases were primarily due to higher sales of royalty-bearing products, including Cortrophin Gel and the partnered generic product, and the non-recurrence of prior-year Prucalopride revenues, effects somewhat tempered by Harmony Agreement revenue. GAAP selling, general, and administrative expenses increased 12.1% to $91.7 million; non-GAAP SG&A increased 20.2% to $80.7 million. Both comparisons included incremental expense related to initial marketing and recruitment for the Rare Disease team expansion targeting acute gouty arthritis.

The Rare Disease sales-force expansion to reach podiatrists and primary care physicians for Cortrophin Gel in acute gouty arthritis flares was fully operational as of the end of June, as planned. The expansion targets an estimated addressable market of approximately 285,000 patients, the majority of whom are treated by podiatrists and primary care physicians, and more than 95% of reps generated multiple new patient cases while more than a third of prescribers initiated two or more cases. President and CEO Nikhil Lalwani said leading indicators from the gout expansion were very positive and that encouraging initial trends, together with continued momentum in existing specialties, further support the company’s conviction in Cortrophin Gel’s multi-year growth opportunity.

As of June 30, 2026, the company had $360.2 million in unrestricted cash and cash equivalents and $620.9 million in principal value of outstanding debt. Cash flow from operations was $115.0 million on a year-to-date basis. Effective May 8, 2026, the board authorized a share repurchase program of up to $100.0 million in common stock through May 2029.