ANI Pharmaceuticals (ANIP) Morgan Stanley 24th Annual Global Healthcare Conference summary

Strategic transformation and business evolution

• Transitioned from a business development-focused generics company to a dual-engine model with high-performing Rare Disease and generics businesses, anchored by the successful launch of Cortrophin Gel and the acquisition of Novitium.

• Rare Disease revenues are projected to approach 60% of total revenues by 2026, with overall revenues growing from $200 million to over $1 billion in six years.

• Generics business delivers 10–15 new product launches annually, supported by strong U.S.-based manufacturing and R&D investment.

• Generics EBITDA and cash flows are reinvested to accelerate Rare Disease growth.

Rare Disease franchise and Cortrophin Gel expansion

• Cortrophin Gel addresses multiple autoimmune indications with an addressable market of about 1 million patients, but current market penetration remains low.

• Recent expansion targets primary care and podiatry for acute gouty arthritis flares, with a 60-person sales force added in May and June, showing strong early demand and prescription depth.

• Gout expansion leverages a unique indication not held by competitors, expected to drive significant sales growth in late 2026 and 2027.

• 2026 sales guidance for Cortrophin Gel is $520–$540 million, with most growth from existing specialties and additional contribution from the new expansion.

Ophthalmology and ILUVIEN developments

• ILUVIEN's SYNCHRONICITY study data for chronic non-infectious uveitis will be presented in Q4, providing new efficacy and safety insights to clinicians.

• Data aims to support ILUVIEN as a durable, reduced treatment burden option for uveitis, potentially driving future growth.