EDAP TMS (EDAP) Q4 2024 Earnings Call March 27, 2025 08:30 AM ET Company Participants John Fraunces - DirectorRyan Rhodes - CEO & DirectorKen Mobeck - Chief Financial Officer Conference Call Participants Michael Sarcone - AnalystNone - AnalystSwayampakula Ramakanth - Managing Director & Senior Equity Analyst Operator and welcome to today's EDAP TMS Fourth Quarter and Full Year twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. Later, you will have the oppo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 27, 2025 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [x] Form 40-F [ ] 1 SIGNATURES Pursuant to th ...

Core Insights - EDAP TMS SA reported strong financial results for Q4 and full-year 2024, highlighting significant growth in its Focal One Robotic HIFU business, particularly in the prostate cancer treatment market [1][5][20]. Business Performance - Full-year 2024 HIFU revenue reached USD 25.7 million, a 15.3% increase from 2023 [5]. - Q4 2024 HIFU revenue was USD 9.3 million, reflecting a 15.0% increase compared to Q4 2023 [5]. - The number of Focal One HIFU procedures in the U.S. grew by 51% year-over-year in 2024 [5]. Clinical Developments - The Focal One system received CE Mark certification for treating deep infiltrating endometriosis [5][6]. - The landmark HIFI study published in European Urology demonstrated positive outcomes for Focal One Robotic HIFU compared to surgery for prostate cancer management [2][7]. - The first patients were treated in a Phase I/II study evaluating Focal One Robotic HIFU for Benign Prostatic Hyperplasia (BPH) [5][10]. Financial Overview - Total worldwide revenue for Q4 2024 was EUR 20.3 million (USD 21.5 million), a 3.6% increase from Q4 2023 [13]. - Gross profit for Q4 2024 was EUR 9.1 million (USD 9.6 million), with a gross profit margin of 44.8% [17]. - The net loss for Q4 2024 was EUR 1.9 million (USD 2.1 million), an improvement from a net loss of EUR 5.0 million (USD 5.5 million) in Q4 2023 [19]. Strategic Focus - The company aims to expand its core Focal One business while reducing investments in non-core products, targeting high-growth opportunities in therapeutic HIFU [3]. - EDAP TMS is positioned to create significant value for patients and shareholders as it advances clinical development programs in various conditions beyond prostate cancer [3]. Upcoming Events - EDAP TMS will have a significant presence at the American Urology Association (AUA) Meeting from April 26-29, 2025, in Las Vegas, Nevada [11].

Group 1 - The company, EDAP TMS SA, will release its financial results for Q4 and the full year ended December 31, 2024, on March 27, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer [2] - The conference call is scheduled for March 27 at 8:30 am EDT, with specific dial-in information provided for domestic and international participants [3] Group 2 - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [4] - The company has introduced the Focal One® system, which is a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [4]

Core Insights - EDAP TMS SA has appointed Glen French to its Board of Directors, enhancing its leadership with his extensive experience in medical devices and technology [1][2][4] - Glen French emphasizes the transformative potential of EDAP's Focal One technology in treating prostate cancer and its applicability to other medical conditions [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [5] - The Focal One platform is recognized as a leading prostate focal therapy, with potential expansion into other therapeutic areas [5] Leadership Background - Glen French has over 25 years of experience in the medical device industry, having co-founded and sold three companies and taken another public [2][3] - He served as CEO of Pulmonx Corporation, achieving over 20% compound annual revenue growth and successfully executing an IPO that raised $218.5 million [2][3] Strategic Direction - The addition of Glen French to the Board is expected to guide EDAP's strategic decision-making as it aims to establish Focal One as the premier robotic HIFU technology platform [2] - French believes that the technology can address significant unmet medical needs across various patient populations, indicating a broad market potential [2][3]

Core Insights - Cortechs.ai and EDAP TMS SA have successfully completed the world's first OnQ Prostate-assisted Focal One® Robotic HIFU procedure, marking a significant milestone in prostate cancer care [1][6] - OnQ Prostate's patented RSI technology enhances lesion localization and targeting, providing urologists with more detailed information for patient selection and treatment planning [2][6] Company Developments - Cortechs.ai is positioned as a leader in AI applications in radiology, focusing on advanced imaging technologies to improve disease screening and early detection, particularly in prostate cancer [5] - EDAP TMS SA is recognized for its innovative robotic energy-based therapies, with the Focal One platform being a leading solution for prostate focal therapy [8] Clinical Impact - The integration of OnQ Prostate with Focal One Robotic HIFU is expected to improve the precision and personalization of prostate cancer treatments, potentially leading to better patient outcomes [3][4] - The successful application of OnQ Prostate technology at UCSF demonstrates its capability to enhance the standardization of prostate MRI interpretation, which is crucial for effective treatment [3][6]

Core Insights - Cortechs.ai and EDAP TMS SA have successfully completed the world's first OnQ Prostate-assisted Focal One® Robotic HIFU procedure at UCSF, marking a significant milestone in prostate cancer treatment [1][6] - OnQ Prostate is the only FDA-cleared solution for RSI-MRI, providing detailed tissue microstructure information to help urologists identify suitable candidates for focal therapy [2][6] - The integration of OnQ Prostate with Focal One enhances lesion localization and targeting, improving the precision of prostate cancer treatments [3][6] Company Overview - Cortechs.ai specializes in AI applications in radiology, focusing on advanced medical imaging technologies to enhance disease screening and early detection [5] - The company develops innovative medical device software for tracking neurodegeneration and prostate cancer, offering cost-effective solutions for assessing prostate health [5] - EDAP TMS SA is recognized for its robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology, with Focal One being a leading platform for prostate focal therapy [7] Industry Context - Focal therapy is an emerging approach in prostate cancer care aimed at ablating significant disease while preserving healthy tissue, thus reducing side effects associated with whole-gland treatments [3][4] - The ability to precisely localize lesions is critical for urologists to achieve successful oncologic control while minimizing damage to surrounding healthy tissue [3][4] - As focal therapy becomes more integrated into prostate cancer care, companies like Cortechs.ai are at the forefront of developing solutions that support effective, evidence-based, and minimally invasive treatment strategies [4]

Core Insights - EDAP TMS SA reported preliminary record sales of 11 Focal One Systems in the fourth quarter of 2024, indicating strong demand for its robotic HIFU technology [2] - The number of Focal One procedures in the U.S. grew by 30% year-over-year, reflecting the increasing adoption of this treatment for prostate cancer [2] - The company anticipates that the recent publication of the HIFI study in European Urology will further enhance awareness and adoption of the Focal One technology [2] Company Overview - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [3] - The Focal One system is positioned as a leading prostate focal therapy, with potential applications extending beyond prostate cancer [3]

Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [3] - The company has introduced the Focal One platform, which is recognized as the leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [3] Leadership Appointment - Joshua H. Levine has been appointed to the Board of Directors of EDAP TMS, bringing extensive executive experience in the medical technology sector [1] - Levine's previous roles include President and CEO of Accuray Incorporated, where he led a turnaround that restored consistent growth and profitability [1][2] - He has also served as President and CEO of Immucor, Inc., overseeing its transition to a private entity in a $2 billion acquisition [1][2] Strategic Vision - Levine's appointment is expected to enhance EDAP's strategic vision and execution as the company expands its leadership in advanced HIFU technology applications [1] - The Focal One platform is noted for transforming treatment paradigms in prostate cancer and has potential applications in other therapeutic areas such as endometriosis and BPH [1] Market Position - EDAP TMS has made significant progress in establishing the Focal One platform as the dominant technology for robotic HIFU over the past two years [1] - The company aims to leverage Levine's expertise in portfolio transformation and strategic business development to drive shareholder value [1][2]

Core Insights - EDAP TMS SA has initiated a phase I/II PULS Trial to evaluate High Intensity Focused Ultrasound (HIFU) technology for treating pancreatic tumors, marking a significant milestone in addressing this challenging disease [1][2] - The trial aims to assess the tolerance and preliminary efficacy of HIFU in patients with locally advanced and unresectable pancreatic tumors, highlighting the urgent need for new treatment options in this area [2][3] Company Overview - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices utilizing ultrasound technology [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device, and is exploring its potential for multiple indications beyond prostate cancer [4] Industry Context - Pancreatic cancer has a five-year survival rate of only 11.5%, with an estimated 62,210 new cases and 49,830 deaths projected in the U.S. for 2022, making it one of the most difficult cancers to treat [3] - Despite a 5.5% improvement in the relative five-year survival rate over the past decade, pancreatic cancer remains the third leading cause of cancer deaths, underscoring the critical need for innovative treatment solutions [3]