ANI Pharmaceuticals (ANIP) investor relations material

Business overview and strategy

• Accelerating transformation into a leading rare disease company, with rare disease business projected to reach 60% of sales by 2026.

• Lead assets include Purified Cortrophin Gel and ILUVIEN, both with significant growth potential and barriers to genericization.

• Generics business remains strong, with 10–15 new launches annually and 95% of sales from US-manufactured products.

• Capital allocation is focused on rare disease, while generics provide EBITDA and cash flow for reinvestment.

Cortrophin Gel growth drivers and market opportunity

• Addressable market for Cortrophin Gel is about 1 million patients across multiple autoimmune indications.

• Growth depends on reaching more patients and prescribers, especially in late-line therapy settings.

• Recent 60-rep sales force expansion targets acute gouty arthritis, with strong early demand and refills observed.

• Q4 expected to benefit from increased rep productivity, typical year-end prescription dynamics, and continued specialty momentum.

Financial performance and guidance

• Initial 2026 revenue guidance was revised from $540–$575M to $520–$540M due to Q1 insurance reverification and weather delays.

• Q2 saw 53% quarter-on-quarter growth, with $117M in revenue and strong momentum expected to continue.

• Operating leverage anticipated in 2027 as investments in sales force yield higher returns.