EDAP TMS(US:EDAP)2025-03-27 13:32Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, while total worldwide revenues for 2024 were $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, with disposable revenues growing by 28.5% [39] - The ESWL division saw nominal growth, with revenues of €2.4 million compared to €2.3 million in the previous year [40] Market Data and Key Metrics Changes - The number of Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in the HIFU segment, while reducing investments in lower growth, low margin businesses [34] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry and further clinical development [6][25] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [46] - The company anticipates that the landmark Hi Fi study will drive demand for Focal One, positioning it as a mainstream treatment option for prostate cancer [47] Other Important Information - The company has entered into clinical studies for the treatment of BPH and pancreatic tumors, indicating a commitment to expanding its HIFU technology into new indications [20][21] - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] Q&A Session Summary Question: Can you provide more detail on HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [49][50] Question: What is the intent for the non-core ESWL and distribution business? - The company is transitioning away from non-core distribution products, focusing on high growth HIFU business, but cannot project if it will phase down to zero [51][52] Question: How is the capital equipment purchase pattern from hospitals in 2025? - The sales cycle remains consistent, but the company has adapted its strategy to close deals more effectively, expecting notable growth throughout 2025 [58][60] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - The reimbursement increase has positively impacted hospital interest in adopting Focal One, as it enhances the financial analysis for adding this treatment to their services [62][64] Question: What is the strategy for endometriosis commercialization? - The company is working with experts to refine clinical development efforts following the CE mark, with plans for a Phase one launch in CE mark countries [71][72] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is early in patient recruitment, being conducted locally in France, with no specific data timeline provided yet [73][74]