EDAP TMS (NasdaqGM:EDAP) Q4 2025 Earnings call March 25, 2026 08:30 AM ET Company ParticipantsKen Mobeck - CFOLouisa Smith - PrincipalRyan Rhodes - CEOSwayampakula Ramakanth - Managing Director of Equity ResearchConference Call ParticipantsJoseph Downing - AnalystMichael Sarcone - AnalystOperatorGreetings, and welcome to the EDAP TMS fourth quarter and year-end 2025 conference call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin G ...

EDAP TMS (NasdaqGM:EDAP) Q4 2025 Earnings call March 25, 2026 08:30 AM ET Company ParticipantsKen Mobeck - CFOLouisa Smith - PrincipalRyan Rhodes - CEOSwayampakula Ramakanth - Managing Director of Equity ResearchConference Call ParticipantsJoseph Downing - AnalystMichael Sarcone - AnalystOperatorGreetings, and welcome to the EDAP TMS fourth quarter and year-end 2025 conference call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin G ...

EDAP TMS (NasdaqGM:EDAP) Q4 2025 Earnings call March 25, 2026 08:30 AM ET Speaker4Greetings, and welcome to the EDAP TMS fourth quarter and year-end 2025 conference call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin Group. Thank you. You may begin.Speaker2Good morning. Thank you for joining us for the EDAP TMS fourth quarter and full year 2025 financial and operating results conference call. Joining me on today's call are Ryan R ...

EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue 39% Full-Year YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in the Number of U.S. Focal One Procedures69% Full-Year YoY Growth in Focal One System Placements28% Q4 YoY Growth in U.S. Procedures, Marking the Second Consecutive Quarter of Double-Digit Procedure GrowthDemand for Focal One Systems Remains Strong with System Placements in Academic Cancer Centers, Community Hospitals, and Larg ...

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Summary of EDAP TMS FY Conference Call Company Overview - **Company**: EDAP TMS (NasdaqGM:EDAP) - **Focus**: Global leader in therapeutic ultrasound, specifically for the treatment of cancer and benign diseases, with a strong emphasis on prostate cancer treatment using Focal One technology [2][3] Industry Insights - **Market Opportunity**: - Nearly 1.5 million newly diagnosed prostate cancer cases annually, projected to double to 2.9 million by 2040 [2] - Significant unmet needs in prostate cancer treatment, particularly for patients with intermediate risk [3] Core Product Insights - **Focal One Technology**: - Robotic High-Intensity Focused Ultrasound (HIFU) as a first-line treatment for prostate cancer, addressing a gap between active surveillance and radical treatments [3][4] - Focal One is positioned as a desirable treatment option, already included in guidelines for salvage therapy [4] Clinical Evidence - **Efficacy and Outcomes**: - Focal One demonstrates comparable cancer control to traditional treatments (surgery and radiation) while offering superior functional outcomes, such as preservation of urinary continence and erectile function [10][11] - Landmark studies (HIFI and FARP) show that HIFU has lower complication rates and better functional outcomes compared to surgery [10][11][12] Market Dynamics - **Growth Trends**: - HIFU is experiencing exponential growth, while traditional surgery and radiation therapies are stagnating or declining [6] - The company reported a 52% growth in Focal One installations and a 44% increase in procedures from 2021 to 2025 [19] Reimbursement Landscape - **Payment Mechanisms**: - New Medicare payment mechanisms have increased reimbursement rates for HIFU, making it competitive with traditional surgical payments [12][13] Adoption and Expansion - **Installed Base**: - As of December 31, 2025, 87 Focal One systems installed across 42 academic and 45 community hospitals in the U.S., including top-rated cancer hospitals [13][14] - Growing presence in Europe with 41 systems and 254 treatment sites [16] Future Opportunities - **Additional Markets**: - Potential expansion into treating Benign Prostatic Hyperplasia (BPH) and endometriosis, with significant market sizes identified [16][18] - The U.S. endometriosis market includes 66.5 million diagnosed women, with a focus on providing non-invasive treatment options [18] Competitive Landscape - **Comparison with Other Therapies**: - Discussion on Aquablation therapy for BPH, highlighting concerns about its efficacy and safety compared to HIFU [29][31] Management and Strategy - **Leadership Team**: - Proven management team with experience from leading med tech companies, positioning EDAP for continued growth and innovation in the therapeutic ultrasound market [20] Conclusion - **Outlook**: - EDAP TMS is well-positioned for growth in both men's and women's health markets, with a strong clinical evidence base and favorable reimbursement landscape supporting its innovative HIFU technology [20]

Core Viewpoint - EDAP TMS SA, a leader in robotic energy-based therapies, will present at the Oppenheimer 36th Annual Healthcare MedTech & Services Conference and host one-on-one investor meetings on March 18, 2026 [1]. Group 1: Event Details - The presentation is scheduled for March 18, 2026, from 12:00 to 12:30 PM ET [2]. - The format will include a virtual presentation and one-on-one investor meetings [2]. - A live and archived webcast of the presentation will be available on the Company's website [2]. Group 2: Company Overview - EDAP TMS SA specializes in developing, manufacturing, promoting, and distributing minimally invasive medical devices using ultrasound technology [3]. - The company is recognized for its Focal One system, which is a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [3].

Core Viewpoint - EDAP TMS SA will announce its financial results for the fourth quarter and full year of 2025 on March 25, 2026, before market opening [1]. Group 1: Financial Results Announcement - The financial results will be released on March 25, 2026, before market open [1]. - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer [2]. Group 2: Conference Call Details - The conference call is scheduled for March 25 at 8:30 a.m. EDT [3]. - Domestic and international dial-in numbers are provided, along with a passcode for access [3]. Group 3: Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices using ultrasound technology [4]. - The company has developed the Focal One® system for prostate focal therapy, with potential applications beyond prostate cancer [4].

Core Viewpoint - EDAP TMS S.A. has appointed David Horn to its Board of Directors, effective February 11, 2026, enhancing the board's expertise in strategic growth and transformation [1][2]. Group 1: Appointment Details - David Horn brings extensive experience in capital markets and the medical device industry, having served as President and CFO of Seer, Inc. since 2023 and previously at Morgan Stanley for over 20 years [3]. - Horn will be a member of the Audit Committee and Nominations Committee, contributing to strategic planning and execution [2][3]. Group 2: Company Leadership and Strategy - The Chairman of the Board, Lance Willsey, expressed confidence in Horn's ability to support EDAP's growth strategy and enhance shareholder value [3]. - Horn emphasized the importance of EDAP's innovation in focal therapy technology and its potential to expand clinical indications [4]. Group 3: Board Changes - Glen French has stepped down from the Board of Directors effective February 10, 2026, with appreciation expressed for his contributions [4][5].

Prostate Cancer Statistics - 3.3 million American men are living with prostate cancer, with 313,780 new cases diagnosed in the U.S. annually [7] - The global market for prostate cancer treatment includes 1.5 million new cases per year, with Europe accounting for 473,011 cases and Asia for 386,424 cases [8] HIFU Treatment Insights - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470,000, with Europe contributing 165,000 and Asia 130,000 [10] - HIFU demonstrates a 90% cancer control rate compared to 86% for radical prostatectomy, indicating superior functional outcomes [18] - A multicentric study shows that HIFU has equivalent 10-year survival rates compared to external beam radiation therapy (EBRT), with lower mortality rates [20] Financial Performance - Revenue for the three months ended September 30, 2025, was $16.1 million, a 12% increase from $14.4 million in the same period of 2024 [45] - Gross profit for the same period was $6.9 million, with a gross margin of 43.0%, up from 39.4% in 2024 [45] - For the nine months ended September 30, 2025, revenue reached $48.8 million, a slight increase from $47.6 million in 2024 [46] - The company reported a net loss of $19.8 million for the nine months ended September 30, 2025, compared to a net loss of $18.5 million in 2024 [46] - HIFU revenue for the nine months ended September 30, 2025, was $23.9 million, reflecting a 46% increase from $16.3 million in 2024 [46] Market Expansion and Technology - The reimbursement for HIFU procedures has increased by 90% in 2023, with a projected payment of $9,671 under the CMS Hospital Outpatient Prospective Payment System [22][23] - The physician payment for HIFU in 2026 is set at $1,087, making it a competitive option compared to other treatments [24] - The company is positioned to expand into the benign prostatic hyperplasia (BPH) market, which affects 15 million U.S. men annually [32] - The Focal One technology is integrated with advanced imaging and AI capabilities, enhancing treatment precision and efficiency [28] - The company is actively recruiting for a Phase I-II clinical study on HIFU for BPH, confirming safety and potential symptom improvement [33] Installation and Adoption Rates - Focal One systems installed in U.S. hospitals reached 87 as of December 31, 2025, with a compounded annual growth rate (CAGR) of 52% in installations [41] - Focal One procedures experienced a CAGR of 44% from 2021 to 2025, indicating strong adoption in the market [41] - The company has a growing global install base, with 254 Focal One treatment clinical sites as of December 31, 2025 [39] Cash Position - Cash and cash equivalents decreased to $12.4 million as of September 30, 2025, down from $28.4 million in 2024 [47] Regulatory Approvals - The company received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum on March 25, 2025 [35]