EDAP TMS(US:EDAP)2025-03-27 12:30Financial 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, with total worldwide revenues of $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, driven by 11 Focal One systems sold [39][40] - The ESWL division saw nominal growth with revenues of €2.4 million in the fourth quarter, while the distribution business revenue decreased to €9.1 million from €9.9 million [41][42] Market Data and Key Metrics Changes - Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year in the fourth quarter [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] - Notable sales were made in international markets, including Germany, Portugal, and Turkey [12] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in prostate cancer, endometriosis, and BPH, leveraging the Focal One platform [32] - Plans to reduce investments in lower growth, low margin businesses, including the discontinuation of the ZONALIB iMOVE lithotripsy product line [33][34] - The company is committed to transforming into a more agile organization, with new board members bringing expertise in medical device commercialization [34][35] Management's 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 [47] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant milestone, allowing for controlled market entry [6] - The company anticipates that the Hi Fi study publication will drive further adoption of Focal One as a treatment option for prostate cancer [15][48] Other Important Information - 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] - The company is actively working on clinical studies for BPH and pancreatic tumors, demonstrating its commitment to expanding the applications of HIFU technology [19][20] Q&A Session Summary Question: Can you provide more detail on the 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 [50][52] Question: Is the intent to phase down the non-core ESWL and distribution business to zero? - Management indicated that while they are winding down some non-core businesses, they cannot project if it will go to zero, but focus will shift to high growth HIFU business [53][54] Question: How is the capital equipment purchase pattern from hospitals in 2025? - Management noted that the sales cycle remains consistent, but they have adjusted strategies to close deals more effectively, with a growing active pipeline [60][62] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - Management confirmed that the reimbursement increase has positively impacted hospital interest in adopting Focal One technology [64][66] Question: What is the strategy for commercializing the endometriosis treatment? - The company is in the early stages of expanding clinical development efforts following the CE mark approval for treating deep infiltrating endometriosis [73][74] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is in the early recruitment phase, with the study being conducted in France [75][76]