ANI Pharmaceuticals (ANIP) 47th Annual Raymond James Institutional Investor Conference summary

Strategic transformation and growth outlook

• Projecting over $1 billion in sales for 2026, with rare disease expected to represent 60% of revenues and a 23% growth rate from 2025 to 2026.

• Rare disease business, led by Cortrophin Gel, is the primary growth driver, with 84% top-line growth in 2025 and expected 51% growth in 2026.

• Generics business delivers strong cash flows, 28% year-over-year growth in 2025, and supports investment in rare disease transformation.

• Disciplined capital allocation and a focus on both organic and inorganic expansion in rare disease are key 2026 priorities.

• Entering 2026 with $286 million in cash and a net leverage of 1.5x, supporting continued deleveraging.

Rare disease and product portfolio initiatives

• Cortrophin Gel targets multiple under-penetrated indications, including neurology, nephrology, rheumatology, ophthalmology, and pulmonology.

• ACTH market, where Cortrophin competes, grew 45% in 2025 and is protected by high regulatory and IP barriers.

• A new 90-person commercial team will focus on acute gouty arthritis flares, targeting a 285,000-patient addressable market.

• ILUVIEN, the second asset, is positioned for growth in diabetic macular edema and chronic non-infectious uveitis, with less than 5,000 annual patient starts and significant headroom.

• Strategic investments in clinical trials, commercial initiatives, and patient access are expected to drive multi-year growth.

Generics business performance and operational excellence

• Generics business achieved 28% growth in 2025, with a robust pipeline targeting 10-15 new launches annually.

• Portfolio includes 125 product families, with low revenue concentration and strong U.S.-based manufacturing.

• Over 2.5 billion doses manufactured in the last 12 months, with 90% of revenues from U.S.-made goods and minimal reliance on China.

• High single-digit percentage of Generics revenue reinvested into R&D to sustain growth and innovation.

• Operational efficiencies and cost reductions are ongoing to maintain competitiveness.