ANI Cuts Cortrophin Gel Outlook After Specialty Pharmacy Bottleneck

The Tip Desk · November 6, 2026 · 4 min read

Third-quarter net revenues were $290.8 million as Cortrophin Gel reached $138.7 million, and the company narrowed 2026 revenue guidance to $1,085 million–$1,125 million.

ANI Pharmaceuticals (ANIP) reported third-quarter net revenues of $290.8 million, up 27.6% from a year earlier, as year-over-year growth accelerated from 25.9% in the second quarter.

The diversified biopharmaceutical company said Purified Cortrophin Gel net revenues were $138.7 million, up 36.1% from the year-ago quarter. That year-over-year rate slowed from 43.5% in the second quarter. The company attributed the third-quarter increase to momentum from the gout expansion and continued progress in Nephrology, Neurology, Rheumatology, Ophthalmology and Pulmonology. New gout patient cases doubled quarter-over-quarter and new prescribers rose about 67%, the company said. Revenue conversion was slower than expected in both existing specialties and gout because of capacity constraints in the specialty pharmacy network. ANI said it is expanding that network and patient-support capabilities to convert demand into patients on therapy.

ILUVIEN net revenues were $22.3 million, up 34.1% from a year earlier on increased volumes and the phasing of international shipments. Rare Disease total net revenues, which include both products, were $160.9 million. Generics net revenues were $104.5 million, up 10.7% from a year earlier, which the company said was driven by demand for existing products and new launches in 2025 and 2026. Brands net revenues were $10.0 million. Brand royalties and other revenues were $11.5 million, including $9.5 million of Harmony Agreement royalties and $2.0 million of development milestones, versus zero in the year-ago quarter.

GAAP net income available to common shareholders was $35.1 million, or $1.51 a share, compared with $26.3 million, or $1.13 a share, a year earlier. Adjusted non-GAAP diluted earnings per share were $2.70. Adjusted non-GAAP EBITDA was $83.3 million, up 39.8% from a year earlier. GAAP gross margin increased from 59.0% to 61.6% and non-GAAP gross margin from 59.2% to 61.8%, which the company said was primarily due to a favorable product-mix shift and Harmony Agreement revenue, tempered by higher sales of royalty-bearing products. GAAP selling, general and administrative expenses increased 23.8% to $94.9 million, including expansion of the Rare Disease team targeting acute gouty arthritis.

For full-year 2026, ANI narrowed total company revenue guidance to $1,085 million–$1,125 million from $1,080 million–$1,140 million. Cortrophin Gel revenue guidance was cut to $480 million–$500 million from $520 million–$540 million. Adjusted non-GAAP EBITDA guidance was raised to $290 million–$300 million from $285 million–$300 million, and adjusted non-GAAP diluted EPS guidance was raised to $9.37–$9.71 from $9.19–$9.69. ILUVIEN full-year net revenue guidance was raised to $80 million–$85 million from $78 million–$83 million. The company expects full-year adjusted non-GAAP gross margin between 60.3% and 61.0% and an annual U.S. GAAP effective tax rate of 27% to 29%. President and CEO Nikhil Lalwani said the company is executing initiatives to achieve approximately 40% year-over-year growth in 2026 for Cortrophin.

On November 5, ANI announced a recommended public offer to acquire Egetis Therapeutics for SEK 11.25 a share, a 27% premium to the 60-day VWAP, plus convertible debt and warrants. The offer value, including outstanding incentive programs, is approximately SEK 5.6 billion, or about $560 million. Adjusted for estimated net proceeds from Egetis’ sale of a rare pediatric disease priority review voucher for $190.0 million, enterprise value is approximately $434 million. If consummated, the deal would add EMCITATE (tiratricol), the only approved U.S. and European treatment for peripheral thyrotoxicosis associated with MCT8 deficiency, with Orphan Drug exclusivity and patent protection into 2045. The acceptance period is expected to run from about November 20 to about December 18, 2026. The offer is financed with cash on hand and new debt from JPMorgan Chase Bank, N.A.

Through November 2, ANI had repurchased 275,635 shares for about $20.0 million under a $100.0 million program authorized May 8, 2026, including 102,492 shares for about $7.5 million in the third quarter. As of September 30, the company had $420.8 million in unrestricted cash and cash equivalents and $616.9 million in principal value of outstanding debt.