ANI Pharmaceuticals (ANIP) investor relations material

Strategic priorities and business overview

• Focus on rare disease, generics, and brands segments, with rare disease expected to account for about half of 2025 revenues.

• EBITDA and cash flows from generics and brands are reinvested to expand rare disease assets, especially Cortrophin Gel and ILUVIEN.

• 2025 revenue guidance is $854M–$873M, representing 39%–42% growth, with organic growth at 34%–37%.

• Adjusted non-GAAP EBITDA guidance for 2025 is $221M–$228M, up 42%–46% year-over-year.

• Top priority is expanding the rare disease business while maintaining a strong balance sheet and leveraging R&D investment.

M&A and growth strategy

• Significant organic growth potential exists, especially for Cortrophin Gel and ILUVIEN, with addressable patient populations over 10x current treatment levels.

• M&A targets are commercial rare disease assets that add scale without excessive leverage or clinical risk.

• Future acquisitions may not require synergy with Cortrophin Gel but should leverage rare disease infrastructure.

• Confident in deploying new sales forces for rare patient populations if needed.

Cortrophin Gel market and uptake

• ACTH market projected at nearly $1B in 2025, with large untapped patient populations across multiple indications.

• About half of Cortrophin Gel prescribers are new to ACTH, with growth across rheumatology, neurology, nephrology, pulmonology, and ophthalmology.

• Acute gouty arthritis represents 15% of volume, with significant opportunity due to lack of competitor indication.

• Pulmonology, especially sarcoidosis, is a growth area with longer therapy duration per patient.

• Ongoing phase 4 study in acute gouty arthritis to generate further clinical evidence.