ANI Pharmaceuticals (ANIP) investor relations material

Business segment overview

• Focus on rare disease therapeutics, generics, and brands, with rare disease as the main growth driver.

• Rare disease segment, led by Cortrosyn and ILUVIEN, projected to contribute about 50% of 2025 revenues.

• Generics business benefits from strong R&D, new product launches, and U.S.-based manufacturing.

• Brands segment provides high margins and cash flow, supporting rare disease expansion.

• 2025 revenue guidance is $818M–$843M, with adjusted EBITDA of $213M–$223M, reflecting 33%–37% and 34%–41% growth, respectively.

Rare disease and Cortrosyn performance

• Cortrosyn and ILUVIEN expected to generate $409M–$422M in 2025, up from zero in 2022 for Cortrosyn.

• Expanded sales force and new prefilled syringe presentation accelerated Cortrosyn adoption.

• Acute gouty arthritis indication exclusive to Cortrosyn, driving further growth.

• Market growth for ACTH therapies rebounded, with 27% growth in 2024 and 39% projected in 2025.

• Multi-year growth expected, supported by new prescribers and broad specialty adoption.

Generics and brands segment dynamics

• Generics segment guided to mid-teens growth for 2025, outperforming industry trends.

• Success driven by operational excellence, U.S. manufacturing, and consistent new product launches.

• Prucalopride launch secured 180-day exclusivity, highlighting R&D strength.

• Strategy focuses on pipeline selection, lesser competition, and leveraging scale.

• Brands segment continues to deliver high margins and cash flow.