ANI Pharmaceuticals (ANIP) 8 Nov 24 2024 Q3 Earnings call transcript
ANI Pharmaceuticals, Inc. (ANI) recently held its third quarter 2024 earnings call, highlighting a record-breaking performance for its lead rare disease asset, Cortrophin Gel, and its generics business. The company also shared updates on the integration of Alimera and its ophthalmology franchise, as well as its strategic plans for the future.
Strong Performance and Strategic Acquisitions
ANI reported total revenues of $148.3 million for the third quarter of 2024, a 13% increase over the same period last year, driven by accelerating demand for Cortrophin Gel and continued growth in its generics business. The company's strong performance was underpinned by its strategic acquisitions, including the acquisition of Alimera, which is highly synergistic to ANI's rare disease business. The acquisition is expected to create substantial shareholder value, with estimated EBITDA of $35 million to $38 million in 2025.
Cortrophin Gel's Multiyear Growth Trajectory
ANI's lead rare disease asset, Cortrophin Gel, showed impressive growth, with revenues increasing by 77% over the third quarter of 2023. The company's focus on target specialties, including neurology, rheumatology, nephrology, pulmonology, and ophthalmology, has contributed to Cortrophin's continued momentum, with the highest number of quarterly new patient starts and unique prescribers since its launch in January 2022. The ACTH category, which has returned to growth, is expected to deliver more than 20% year-over-year growth in 2024.
Generics Business and New Launches
ANI's generics business also performed well, with revenues increasing by 11% over the third quarter of 2023, driven by strong sales volumes and contributions from new product launches. The company plans to continue its cadence of new launches, with one new generic already launched in Q4 2024 and several new ANDAs submitted in the fourth quarter. ANI expects its generics business to grow in the high single-digit to low double-digit range going forward.
Ophthalmology Franchise and Alimera Integration
The integration of Alimera has been a key focus for ANI, with a combined ophthalmology sales force of 45 dedicated representatives now promoting all three products, Cortrophin Gel, ILUVIEN, and YUTIQ. The acquisition is expected to drive growth for all three products, with ANI's proven commercial execution capabilities expected to unlock the potential for ILUVIEN and YUTIQ. The company also highlighted its commitment to improving patient and physician experience and convenience through the development of a prefilled syringe offering for Cortrophin Gel, which is expected to launch in the first half of 2025.
Looking Ahead
ANI's outlook for the future is positive, with a focus on leveraging its rare disease business to drive growth. The company expects its rare disease business to be its largest business unit and the largest driver of growth in 2025, with strong multiyear growth trajectories for Cortrophin Gel and its ophthalmology franchise. ANI remains committed to investing in scientific research and development, with several new product launches and clinical studies underway.
Analyst Questions and Answers
During the Q&A session, analysts asked questions about the payer landscape for Cortrophin Gel, the growth drivers for Cortrophin, the impact of the Alimera acquisition on ILUVIEN and YUTIQ, and ANI's plans for future M&A activities. The company provided detailed responses, highlighting its confidence in the growth trajectory of its rare disease business and its commitment to delivering shareholder value.
Conclusion
ANI Pharmaceuticals' third quarter 2024 earnings call painted a positive picture of the company's financial health and strategic direction. With a focus on its rare disease business and strategic acquisitions, ANI is well-positioned for continued growth and shareholder value creation. The company's commitment to improving patient and physician experience and convenience, as well as its investment in scientific research and development, bodes well for its future prospects.