ANI Pharmaceuticals, Inc. Q4 FY2025 earnings call

• 2025 was a year of outstanding execution and growth, with record performance across business lines. - 2026 priorities:
  • Transformation into a leading rare disease company: Maximize growth opportunity for cortofan gel by addressing unmet needs across indications, build and deploy a 90-person organization for acute gouty arthritis flares, focus on returning Alluvian to growth.
  • Continued execution in generics business: Leverage R&D, operational execution, U.S.-based manufacturing tools, and business development expertise, maintain 10 to 15 launches annually.
  • Disciplined capital allocation strategy: Invest in organic growth for cortofan gel in gout and generics R&D, explore inorganic growth for rare disease business

In 2025, the company delivered record revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS. Total company revenues grew 44% year-over-year, and adjusted non-GAAP EBITDA grew 47% year-over-year. The lead rare disease asset, quercrofen, had full-year revenues up 76% year-over-year. The generics business grew 28% year-over-year. Fourth quarter revenues were $247.1 million, full-year 2025 revenues were $883.4 million. Cortofan gel fourth quarter revenues were $111.4 million, full-year 2025 revenues were $347.8 million. Alluvian fourth quarter revenues were $19.8 million, full-year 2025 revenues were $74.9 million. Generics fourth quarter revenues were $100.8 million, full-year 2025 revenues were $384.1 million

2026 expected net revenue of $1.055 billion to $1.115 billion, 19%-26% growth year-over-year. Cortofan gel net revenue $540 million to $575 million, 55%-65% growth year-over-year. Alluvian net revenue $78 million to $83 million, ~4%-11% growth year-over-year. Adjusted non-GAAP EBITDA $275 million to $290 million, ~20%-26% growth year-over-year. Adjusted non-GAAP earnings per share between $8.83 and $9.34, ~12%-18% growth year-over-year

Q: Glenn Santangelo from Barclays asked about the multi-year opportunity for cortofan and Merck royalty.

A: Nikhil Alwani said there's a significant multi-year growth opportunity for cortofan due to under-penetrated patient populations, and Stephen Carey mentioned the royalty stepped up in 2025 and the blended royalty rate in 2026.

Q: David Anselm with Piper Sandler asked about operating leverage for the gout indication and duration of treatment across indications.

A: Nikhil Alwani discussed operating leverage with the 90-person organization for gout having partial impact in 2026 and full impact in 2027, and that duration of treatment varies across indications like sarcoidosis having longer use than acute gouty arthritis flares.

Q: Vamil Devon from Guggenheim Securities asked about the use of the 90-person organization and business development financing.

A: Nikhil Alwani said the 90-person organization for gout can be leveraged for other indications and appropriate patients, and on business development financing, details were discussed regarding leveraging and options for financing potential deals