ANI Pharmaceuticals' Q4 2024: Contradictions Unveiled in Cortrophin Gel Growth, Reimbursement Challenges, and Seasonality Effects

These are the key contradictions discussed in ANI Pharmaceuticals' latest 2024Q4 earnings call, specifically including: Cortrophin Gel growth drivers, reimbursement changes for ILUVIEN and YUTIQ, Alimera integration and synergies, and seasonality impact on Cortrophin Gel:



Record 2024 Performance and 2025 Guidance:
- ANI Pharmaceuticals reported record fourth-quarter revenues of $190.6 million, marking a 45% increase from the prior year period, and raised its 2025 guidance to revenue of $756 million to $776 million, reflecting a 23% to 26% growth over 2024.
- The growth was driven by the strong performance of Cortrophin Gel, a new ophthalmology product portfolio, and increased demand for certain brands due to market dynamics.

Cortrophin Gel and ACTH Market Dynamics:
- Cortrophin Gel generated $59.4 million in revenues during Q4, up 42% year-over-year.
- The ACTH market is expected to grow approximately 25% to approximately $660 million in 2024, with significant growth potential as the number of patients on ACTH therapy remains below historical levels.
- Increased physician awareness and 15% of new prescribers using ACTH for the first time in gout patients contributed to the growth in Cortrophin Gel use.

Rare Disease Business and Ophthalmology Expansion:
- The company's Rare Disease business, including Cortrophin Gel and new ophthalmology products ILUVIEN and YUTIQ, generated $27.6 million in revenue in Q4.
- ANI Pharmaceuticals expects combined ILUVIEN and YUTIQ net revenues of $97 million to $103 million in 2025, with initiatives to enhance supply security and market penetration.
- The expansion of the ophthalmology sales team and strategic acquisitions, such as the acquisition of Alimera, have contributed to growth in this segment.

Generics Business and Product Launch:
- The Generics segment achieved revenues of $78.6 million, an increase of 9% over the prior year, with contributors including new product launches and an existing manufacturing footprint.
- The launch of Prucalopride tablets with 180 days of exclusivity is expected to drive growth in the first half of 2025.