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 ...

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 Insights - EDAP TMS SA reported record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and increasing procedure growth [1][2] - The company anticipates 36% to 38% annual year-over-year growth in HIFU revenue for 2026, with initial revenue guidance set between $50.0 million and $54.0 million [1][5] Financial Performance - For Q4 2025, worldwide HIFU revenue is projected to be between $12.9 million and $13.3 million, marking the highest quarterly revenue in the company's history [2] - Annual 2025 HIFU revenue is expected to range from $36.7 million to $37.2 million, also the highest annual revenue recorded [2] - Non-core revenue for Q4 2025 is estimated between $7.9 million and $8.3 million, with annual non-core revenue expected between $32.7 million and $33.1 million [3] Operational Highlights - A record 15 Focal One system placements occurred in Q4 2025, indicating strong global demand from hospitals and urology centers [2] - The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, showcasing growing utilization [2] Strategic Outlook - The CEO emphasized that the growth in HIFU revenue now represents over half of the company's expected annual revenue, validating the execution strategy [4] - Increasing clinical validation and data from key trials are driving broader adoption of focal therapy for prostate cancer, with more hospital networks recognizing Focal One as a strategic investment [4] - The company is confident in its ability to deliver continued revenue growth and shareholder value creation in 2026, supported by a strong global pipeline and customer engagement [4]

Summary of EDAP Conference Call Company Overview - **Company**: EDAP - **Industry**: MedTech, specifically focused on prostate cancer treatment through Focal therapy Key Points Capital Environment - The capital demand and spending environment for hospitals is under pressure, leading to strategic investments in clinically necessary equipment like Focal One, which addresses prostate cancer, the most diagnosed cancer in men [4][5] - EDAP reported a **167% growth** in capital sales for Focal One last quarter, indicating strong momentum in the capital equipment space [5] Market Dynamics - The U.S. market is characterized by a strategic approach to capital investments, while the international (OUS) market varies by region, with notable sales increases in Western Europe [6][7] - Focal therapy is emerging as the fastest-growing treatment category for prostate cancer, with hospitals increasingly recognizing its clinical value [6][7] Sales Process and Customer Engagement - The sales process is heavily influenced by clinical efficacy and economic arguments, with hospitals showing a preference for outpatient procedures that are economically viable [9][10] - EDAP is present in nearly **50 academic centers** in the U.S., including top institutions like Memorial Sloan Kettering and Mayo Clinic, with some hospitals acquiring multiple Focal One systems [10] Clinical Evidence and Adoption - The HIFI Study, involving **3,200 patients**, supports the efficacy of Focal therapy, showing oncologic control and better patient outcomes compared to radical treatments [17][21] - EDAP is in the early adopter phase of the market adoption lifecycle, with ongoing efforts to educate hospitals on the value of Focal therapy [18][19] Financial Performance - EDAP expects HIFU revenue to grow by **26-34%**, while non-core business is projected to decline by **25-30%** [46] - Gross margins for HIFU are trending in the high forties, with an increase from **39% to 42%** in Q3 2024, indicating a positive financial trajectory [47] Product Development and Future Outlook - The launch of Focal One Eye, a new platform, is expected to enhance performance and gross margins, with an average selling price of around **$650,000** in the U.S. [49] - EDAP is actively pursuing additional indications for HIFU technology, including studies for benign prostatic hyperplasia (BPH) and women's health applications [34][42][28] Strategic Focus - The company is transitioning away from non-core businesses to concentrate on HIFU, which is seen as the growth engine for the future [46][51] - EDAP is working with strategic suppliers to improve cost structures and optimize margins, aiming for mid-single-digit improvements in gross margins [54] Additional Insights - The company is leveraging its legacy in urology to expand its market presence and capitalize on the growing demand for targeted robotic HIFU therapy [22][23] - The potential for HIFU technology extends beyond prostate cancer, with applications being explored in various medical fields, indicating a broad growth opportunity [25][28]

Summary of EDAP TMS Conference Call Company Overview - **Company**: EDAP TMS (NasdaqGM:EDAP) - **Industry**: MedTech, specifically focused on therapeutic ultrasound for cancer treatment Core Technology and Product - **Focal One**: A robotic High-Intensity Focused Ultrasound (HIFU) platform designed for urologists to perform focal ablation of prostate tissue, launched in May 2025 as an improvement over the previous platform [2][3] - **Key Features**: - Combines imaging, robotics, and HIFU technologies for precision [3] - Real-time imaging and dynamic focusing technology for accurate treatment [3][4] - Outpatient procedure with minimal recovery time [5] Market Opportunity - **Prostate Cancer Statistics**: Nearly 1.5 million patients annually, projected to double to 2.9 million by 2040 [6] - **Treatment Gap**: Focal One addresses the gap in treatment for favorable intermediate-risk prostate cancer, which is not adequately served by existing therapies [7] - **Market Growth**: HIFU is experiencing growth while traditional treatments like surgery and radiation are stagnating or declining [9] Clinical Evidence and Studies - **HIFY Study**: Largest study of its kind, showing positive outcomes in oncologic control and preservation of sexual function and urinary control [11][12] - **FARP Study**: Randomized control trial comparing HIFU and radical prostatectomy, expected to publish results soon [12] - **Comparative Study**: HIFU showed lower mortality rates compared to external beam radiation therapy over 10 years [13] Sales and Adoption - **Current Install Base**: Nearly 80 systems placed in top cancer hospitals and academic institutions [13] - **Procedure Growth**: 67% CAGR in procedures, with a 15% quarter-over-quarter growth from Q2 to Q3 2025 [14] - **Adoption Curve**: Currently in the early adoption phase, with increasing sales and reimbursement support [16][17] Expansion into New Indications - **BPH (Benign Prostatic Hyperplasia)**: Initiating studies to treat BPH, leveraging the existing technology [15][21] - **Endometriosis**: Limited launch in Europe for treating stage four endometriosis, with promising initial results [15][22] Financial Performance - **Margin Improvement**: Gross margins increased from 39.4% to 43%, focusing on higher-margin HIFU business [27] - **Strategic Focus**: Transitioning away from non-core businesses to enhance profitability in the HIFU segment [27][28] Conclusion - **Future Outlook**: Strong potential for continued growth in the HIFU market, with ongoing clinical trials and expanding applications in urology and women's health [20][23]

Core Points - EDAP TMS SA will announce its third quarter financial results for 2025 on November 6, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer on the same day at 8:30 am EST [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology for various medical conditions [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device controlled by urologists, with potential applications beyond prostate cancer [4]

Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [2] - The company has developed the Focal One system, which is recognized as a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [2] Upcoming Events - Ryan Rhodes, the CEO of EDAP TMS, will participate in a fireside chat and host one-on-one investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference [1] - The conference is scheduled for September 8-10, 2025, in New York City, with Rhodes' presentation set for September 9 from 8:30-9:00 AM ET [1]