Core Insights - EDAP TMS SA reported record revenue for its High-Intensity Focused Ultrasound (HIFU) business in Q4 and full-year 2025, driven by strong demand for the Focal One Robotic HIFU system [1][4][10]. Financial Performance - Total revenue for the HIFU business in Q4 2025 was €11.7 million ($13.5 million), a 34% increase from €8.8 million ($9.4 million) in Q4 2024 [4]. - Full-year 2025 HIFU revenue reached €33.1 million ($37.4 million), marking a 39% increase compared to €23.8 million ($25.8 million) in 2024 [10]. - Total worldwide revenue for Q4 2025 was €18.9 million ($21.9 million), a slight decrease of 7% from €20.3 million ($21.8 million) in Q4 2024 [6]. - For the full year 2025, total worldwide revenue was €62.4 million ($70.5 million), down 3% from €64.1 million ($69.4 million) in 2024 [12]. System Sales and Growth - In Q4 2025, the company achieved a record of 15 net system placements for the Focal One, with 14 being cash sales and one an operating lease [2]. - Full-year 2025 saw a 69% year-over-year growth in Focal One system placements [8]. - The number of Focal One procedures in the U.S. grew by 28% year-over-year in Q4, indicating a growing adoption of focal therapy among urologists [4][8]. Revenue Guidance - The company reiterated its 2026 revenue guidance of $72.0 million to $80.0 million, with core HIFU business revenue expected to grow between 34% and 45% year-over-year [3][8]. Operating Performance - Gross margin for Q4 2025 was 42.6%, down from 44.8% in Q4 2024, primarily due to tariffs on imports and inventory reserves [7]. - Operating loss for Q4 2025 was €5.2 million ($6.0 million), compared to €3.7 million ($4.0 million) in Q4 2024 [9]. - Full-year 2025 operating loss was €21.9 million ($24.7 million), slightly higher than the €20.5 million ($22.2 million) loss in 2024 [14]. Cash Position - As of December 31, 2025, the company held cash and cash equivalents of €17.4 million ($20.5 million), a decrease from €29.8 million ($31.0 million) at the end of 2024 [15].

Core Insights - EDAP TMS SA will participate in the UBS Global Healthcare Conference, hosting 1x1 investor meetings on November 10, 2025 [1][2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced the Focal One® system, a leading prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]