$ANIP earnings report

ANI reported third-quarter net revenues of $290.8 million, up 27.6% year over year, led by Rare Disease. Cortrophin Gel revenue was $138.7 million, up 36.1%, while ILUVIEN revenue was $22.3 million, up 34.1%. Generics revenue of $104.5 million increased 10.7%, supported by existing-product demand and new launches. Brand royalties and other revenue added $11.5 million, including $2.0 million of development milestones and approximately $9.5 million of Harmony Agreement royalties.

Profitability improved with mix. GAAP gross margin rose to 61.6% from 59.0%, and non-GAAP gross margin rose to 61.8% from 59.2%. ANI attributed both increases primarily to favorable product mix and Harmony Agreement revenue, partly offset by more sales of products that bear a royalty payable. GAAP operating income was $52.4 million, GAAP net income available to common shareholders was $35.1 million, and diluted GAAP income per share was $1.51. Adjusted non-GAAP EBITDA increased 39.8% to $83.3 million, while adjusted non-GAAP diluted EPS was $2.70.

The key operating constraint is Cortrophin Gel conversion. ANI said demand indicators in gout remained strong, with new patient cases doubling quarter over quarter and new prescribers up approximately 67%, but conversion was slower than expected in gout and existing specialties because of specialty-pharmacy network capacity constraints. The company is expanding that network and patient-support capabilities. It simultaneously reduced the Cortrophin Gel full-year revenue range to $480 million - $500 million from $520 million - $540 million, despite describing a target of approximately 40% year-over-year Cortrophin growth in 2026.

Full-year total company revenue guidance was narrowed to $1,085 million - $1,125 million from $1,080 million - $1,140 million. ILUVIEN revenue guidance was revised to $80 million - $85 million from $78 million - $83 million. ANI raised adjusted non-GAAP EBITDA guidance to $290 million - $300 million from $285 million - $300 million and adjusted non-GAAP diluted EPS guidance to $9.37 - $9.71 from $9.19 - $9.69. The guidance framework also calls for total company adjusted non-GAAP gross margin of 60.3% to 61.0%.

Capital allocation included approximately $20.0 million of share repurchases through November 2 under the $100.0 million authorization. At September 30, ANI reported $420.8 million of unrestricted cash and cash equivalents, $616.9 million of principal value of outstanding debt, and $198.8 million of year-to-date cash flow from operations. The company also announced an offer to acquire Egetis for SEK 11.25 per share, with the offer value including outstanding incentive programs stated as approximately SEK 5.6 billion or approximately $560 million. The proposed transaction adds execution, financing, regulatory, and acceptance-condition milestones to monitor.

ANI reported record second-quarter total net revenues of $266.0 million, up 25.9% year-over-year. Rare Disease was the principal growth engine, with total net revenues increasing 30.7% to $135.8 million and Cortrophin Gel increasing 43.5% to $117.1 million. Generics also contributed, with generic pharmaceutical products increasing 9.7% to $99.1 million. Brand royalties and other revenues added $17.7 million, including development-milestone revenue and pitolisant-product royalties under the Harmony Agreement.

Cortrophin Gel demand remained broad across the existing specialties of Nephrology, Neurology, Ophthalmology, Pulmonology and Rheumatology. The company stated that its acute gouty arthritis expansion was fully operational by the end of June and reported favorable early demand indicators, including over 95% of reps generating multiple new patient cases and over a third of prescribers initiating two or more cases. Generics performance was supported by the partnered generic launch begun in the third quarter of 2025, additional product launches, and commercial and operational outperformance. Offsetting factors included a 16.1% decline in ILUVIEN and YUTIQ revenue due primarily to international shipment timing and a 10.5% decline in Brands revenue due to normalized demand for certain products.

Profitability improved in absolute terms despite lower gross margins. GAAP net income attributable to common shareholders was $24.7 million, compared with $8.1 million in the prior-year period, and GAAP diluted income per share was $1.05 versus $0.36. Adjusted non-GAAP EBITDA increased 32.4% to $71.6 million and adjusted non-GAAP diluted earnings per share rose to $2.21 from $1.80. However, GAAP gross margin declined from 64.7% to 62.4% and non-GAAP gross margin declined from 64.9% to 62.6%, primarily reflecting a greater mix of royalty-bearing products and the absence of prior-year Prucalopride revenue. Higher selling, general, and administrative expense included costs for the Rare Disease sales-force expansion.

ANI reaffirmed total company net revenue guidance of $1,080 million - $1,140 million, adjusted non-GAAP EBITDA guidance of $285 million - $300 million, and adjusted non-GAAP diluted EPS guidance of $9.19 - $9.69. It retained ILUVIEN guidance of $78 million - $83 million but revised Cortrophin Gel net revenue guidance to $520 million - $540 million from $540 million - $575 million. Liquidity included $360.2 million of unrestricted cash and cash equivalents, while principal debt outstanding was $620.9 million. The company generated $115.0 million of year-to-date operating cash flow and authorized a program to repurchase up to $100.0 million of common stock through May 2029.