ANI Pharmaceuticals (ANIP) Wells Fargo 21st Annual Healthcare Conference summary

Strategic transformation and business focus

• Focused on transforming into a leading rare disease company, leveraging assets Cortrophin and ILUVIEN, both with significant multi-year growth potential and high barriers to genericization.

• Expansion of rare disease business through business development (BD) and M&A, targeting commercial or near-commercial assets that fit existing infrastructure.

• Generics business remains strong, with ongoing investment in R&D and cash flows supporting rare disease expansion.

• Key decisions included acquiring Novitium Pharma to build internal R&D and talent acquisition from leading rare disease organizations.

• Company culture of collaboration has supported growth from 200 to 1,300 employees.

Financial performance and guidance

• Achieved record Q2 revenues of $266 million, with Cortrophin growing 43% and non-GAAP EBITDA reaching $71.6 million.

• Full-year 2026 guidance: revenues of $1.08–$1.14 billion, adjusted non-GAAP EBITDA of $285–$300 million.

• Cortrophin guidance for 2026 is $520–$540 million, representing about 50% growth at midpoint.

• Generics expected to return to high single-digit or low double-digit growth after a flattish year.

• ILUVIEN guidance for 2026 is $78–$84 million.

Product expansion and market opportunity

• Cortrophin Gel targets multiple autoimmune indications, with a large addressable market of about 1 million patients across six or seven priority indications.

• Significant growth achieved by reaching new prescribers, especially those previously naive to ACTH therapy.

• Recent expansion into primary care and podiatry for acute gouty arthritis flares, adding 64 reps to reach 7,000 targeted physicians.

• Leading indicators from the expansion are positive, with most reps and prescribers initiating multiple cases and early refills observed.

• Market growth is prioritized over share capture, with both the company and competitor addressing unmet patient needs.