ANI PHARMACEUTICALS INC Q4 FY2024 earnings call

Management Statement and Operational Highlights

• Record fourth quarter and full year 2024 results with upward revision of 2025 guidance for total revenues and adjusted non-GAAP EBITDA.
• Rare Disease was the primary growth driver in 2024, with Cortrophin Gel generating ~$200 million in sales in 2024. Generics business had 12% revenue growth in 2024.
• Acquired Alimera Sciences in September 2024 to broaden rare disease presence. Refinanced debt to establish more efficient capital structure.
• Strong Q4 2024 revenues driven by accelerating demand for Cortrophin Gel, continued growth for generics, full quarter contribution from ILUVIEN and YUTIQ, and higher demand for brands.
• Initiatives for ILUVIEN and YUTIQ include extending manufacturing partnership with Siegfried, clinical trials (NEW DAY and SYNCHRONICITY), and plans to transition commercialization to a single product (ILUVIEN) post-PAS approval.
• Generics business had 17 new product approvals in 2024, including Prucalopride tablets launched with 180-day exclusivity.

Segment Performance

• Rare Disease: In Q4 2024, rare disease revenues more than doubled to $87 million. Cortrophin Gel generated $59.4 million in Q4, up 42% from Q4 2023. Revenues from new ophthalmology products ILUVIEN and YUTIQ were $27.6 million, representing their first full quarter post-Alimera acquisition.
• Brands & Generics and Other: Generics and Other segment had revenues of $83.7 million, up 8% year-over-year. Brands segment had revenues of $19.8 million, an increase of 59% over the prior year period.

Guidance

• 2025 revenue expected to be $756 million to $776 million, representing 23%-26% growth over 2024.
• Adjusted non-GAAP EBITDA expected to be $190 million to $200 million, reflecting 22%-28% growth over 2024.
• Cortrophin Gel revenue forecasted to be $265 million to $274 million, a 34%-38% growth from 2024.
• Combined ILUVIEN and YUTIQ net revenues expected to be $97 million to $103 million, accounting for market access dynamics and commercial transitions.
• Generics business expected to have low double-digit revenue growth driven by base business strength and new launches.
• Brands expected to see normalized performance after Q1 surge, with demand returning to a more normalized run-rate in quarters 2-4.

Risks

• Market access issues for ILUVIEN and YUTIQ, particularly affecting Medicare patients for ILUVIEN's DME indication.
• Potential disruptions in supply chain or manufacturing transitions for ILUVIEN and YUTIQ, including the shift from EyePoint to Siegfried.
• Competitive landscape in the ACTH market, with potential challenges from existing and new competitors.
• Regulatory challenges related to clinical trial results and label approvals for ILUVIEN and YUTIQ.

Question and Answer

• Q: David Amsellem on BD/M&A and Cortrophin gout mix A: Nikhil Lalwani stated ANI is thoughtful about leverage, intends to pursue BD/M&A while maintaining balance sheet health, rare disease will be primary growth driver, and 15% of Cortrophin volume is from gout with gout serving as a gateway for new prescribers.
• Q: Vamil Divan on ILUVIEN/YUTIQ access and Cortrophin seasonality A: Nikhil Lalwani mentioned market access programs for ILUVIEN/YUTIQ not receiving adequate funding in 2025, and Cortrophin has typical Q4 to Q1 sales dynamic with sequential growth building from there.
• Q: Gary Nachman on ILUVIEN/YUTIQ supply transition and Cortrophin sales force A: Nikhil Lalwani discussed commercial, clinical, and operational initiatives for ILUVIEN/YUTIQ, supply transition from EyePoint to Siegfried, and added sales force for Cortrophin across specialties with focus on ROI.
• Q: Oren Livnat on YUTIQ/ILUVIEN transition and procedure A: Nikhil Lalwani explained transition to ILUVIEN with PAS approval expected in Q2, minimal procedural differences for physicians, and value-add of simplifying to one product for customers.
• Q: Jeevan Larson on Cortrophin market disruptions A: Nikhil Lalwani noted ACTH market growth, significant addressable market for ACTH therapy, and competitive landscape with focus on building awareness for appropriate patients.
• Q: Glen Santangelo on Generics growth algorithm A: Nikhil Lalwani discussed Generics growth from new product launches, Prucalopride launch with 180-day exclusivity, and balance of new launches and erosion from competition.