ANI Pharmaceuticals (ANIP) investor relations material

Executive summary

• Net revenues for Q1 2026 increased 20.5% year-over-year to $237.5 million, driven by Rare Disease and Generics, especially Cortrophin Gel and ILUVIEN, and a $15 million upfront payment from a new IP license agreement.

• Adjusted non-GAAP EBITDA grew 24.1% to $63.0 million year-over-year, with strategic investments in Rare Disease to accelerate growth.

• Net income rose to $29.5 million from $15.7 million in Q1 2025, reflecting higher sales and improved operating leverage.

• Board authorized a $100 million share repurchase program.

• The company completed the acquisition of Alimera, expanding its Rare Disease portfolio and international footprint.

Financial highlights

• Rare Disease and Brands net revenues grew 36.3% to $128.2 million, with Cortrophin Gel up 42.1% and ILUVIEN up 19.5%.

• Generics net revenues increased 6.8% to $105.4 million, driven by new product launches.

• Adjusted non-GAAP EPS was $2.05, up from $1.70 prior year; GAAP diluted EPS was $1.28.

• Gross margin was 60.6%, down from 62.9% year-over-year due to higher royalty-bearing sales.

• Cash and cash equivalents totaled $311.2 million at quarter-end; cash flow from operations was $58.4 million.

Outlook and guidance

• 2026 net revenue guidance raised to $1.08B–$1.14B; adjusted EBITDA guidance increased to $285M–$300M.

• Adjusted non-GAAP diluted EPS guidance raised to $9.19–$9.69.

• Cortrophin Gel net revenue guidance reaffirmed at $540M–$575M; ILUVIEN guidance $78M–$83M.

• Rare Disease expected to comprise ~60% of 2026 revenues; Cortrophin Gel growth projected at 55–65% year-over-year.

• Full-year adjusted non-GAAP gross margin expected between 59.9% and 60.9%.