ANI Pharmaceuticals (ANIP) investor relations material

Business overview and growth strategy

• Focus on rare disease, generics, and brands creates a virtuous cycle of growth, with rare disease as the primary driver.

• Rare disease assets, Purified Cortrophin Gel and ILUVIEN, target large, addressable patient populations.

• Generics business leverages R&D, operational excellence, and U.S.-based manufacturing for sustained growth.

• EBITDA and cash flows from generics and brands are reinvested to fuel rare disease expansion.

• 2025 guidance: $854M–$873M revenue, 39%–42% YoY growth; $221M–$228M adjusted EBITDA, 42%–46% YoY growth.

Rare disease franchise and Cortrophin Gel

• Strategic shift to rare disease began with acquisition and launch of Cortrophin Gel, now a $347M–$354M asset in 2024.

• Cortrophin Gel addresses multiple autoimmune indications as a late-line therapy, including RA, nephrotic syndrome, MS, gout, sarcoidosis, and uveitis.

• Growth driven by large addressable patient populations and expanded Salesforce targeting new prescribers.

• Clinical evidence generation and new product formats (1ml vial, prefilled syringe) enhance adoption and convenience.

• Multi-year growth opportunity supported by ongoing R&D, commercial investment, and market expansion.

Market dynamics and access

• Category growth validated by both company and competitor performance, with combined guidance nearing previous market peaks.

• Addressable patient population remains significantly underpenetrated, supporting long-term growth.

• Access initiatives include payer partnerships, field support for physicians, and a robust Patient Assistance Program.

• Clinical evidence and education efforts aim to improve payer confidence and reduce prior authorization fatigue.

• Medicare Part D redesign provided a moderate tailwind in 2025; minimal impact expected for 2026.