ANI Pharmaceuticals (ANIP) investor relations material

Strategic transformation and business overview

• Focused on accelerating transformation into a leading rare disease company by 2026, with rare disease assets now accounting for about 60% of revenues based on recent guidance.

• 2024 revenue guidance is $1.08–$1.14 billion, with adjusted non-GAAP EBITDA of $285–$300 million.

• Two key rare disease assets, Cortrophin Gel and ILUVIEN, both have strong multi-year growth prospects and are difficult to genericize.

• Generics and smaller brands create a virtuous cycle, generating cash flow to reinvest in rare disease expansion.

• Capital allocation priorities include organic growth, M&A in rare disease, and continued investment in generics R&D for 10–15 new launches annually.

Cortrophin Gel growth and expansion

• Cortrophin Gel guidance for 2024 is $540–$575 million, with Q2 implied at $118–$128 million, reflecting a significant step-up from Q1.

• Growth is driven by large, under-penetrated patient populations across multiple indications, with recent momentum in new patient starts and dispensed volumes.

• Expanded sales force by 50% (adding 64 reps) to target 7,000 primary care and podiatrist HCPs for severe acute gouty arthritis flares.

• Early feedback from the expanded team is positive, with strong momentum continuing into Q2 and expectations for a significant sales bump in the second half of the year.

• Market fundamentals remain strong, with the ACTH market expected to grow about 30% combined for both players.

Gout expansion and physician engagement

• Targeting a subset of 285,000 addressable severe acute gouty arthritis patients through 7,000 identified HCPs using claims data.

• Cortrophin Gel is positioned as a late-line treatment for patients not controlled by other therapies, with support provided to offices for complex enrollment and access processes.

• Expansion aims to reach more patients beyond those already served by nephrologists and rheumatologists.

• Access varies by payer channel but is generally at parity with the main competitor; prior authorization and step-through criteria apply across channels.

• Confidence in second-half acceleration and achieving full-year guidance, with historical trends supporting a back-half sales ramp.