Table of Contents As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMP ...

EDAP TMS S.A. (NASDAQ:EDAP) Q4 2024 Earnings Conference Call March 27, 2025 8:30 AM ET Company Participants John Fraunces - IR, LifeSci Advisors Ryan Rhodes - CEO Ken Mobeck - CFO Conference Call Participants Michael Sarcone - Jefferies Swayampakula Ramakanth - H.C. Wainwright Operator Good day, everyone, and welcome to today's EDAP TMS Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, you will have the opportunity to ask questions du ...

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].

Company to host conference call and webcast on Thursday, March 27th at 8:30am EDT AUSTIN, Texas, March 6, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that it will release its financial results for the fourth quarter and full year ended December 31, 2024, before the markets open on Thursday, March 27th, 2025. An accompanying conference call and webcast will be conducted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Fin ...

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]

First Focal One® procedure utilizing Cortechs.ai's advanced MRI-imaging technology, OnQ Prostate, successfully performed at the University of California, San Francisco Prostate Cancer CenterOnQ Prostate's Restriction Spectrum Imaging (RSI) technology improves lesion localization and targeting for urologists performing Focal One Robotic High Intensity Focused Ultrasound (HIFU) ablation Reflects EDAP's continued commitment to innovation and further validates Focal One as the leading focal therapy platform con ...

First Focal One® procedure utilizing Cortechs.ai’s advanced MRI-imaging technology, OnQ Prostate, successfully performed at the University of California, San Francisco Prostate Cancer CenterOnQ Prostate’s Restriction Spectrum Imaging (RSI) technology improves lesion localization and targeting for urologists performing Focal One Robotic High Intensity Focused Ultrasound (HIFU) ablation Reflects EDAP’s continued commitment to innovation and further validates Focal One as the leading focal therapy platform con ...

Company Reports Preliminary Worldwide Record Fourth Quarter Sales of 11 Focal One Systems Record U.S. Fourth Quarter Focal One System Sales Record Number of U.S. Focal One Procedures, with Year-Over-Year Growth of 30% PDF Version AUSTIN, Texas, January 13, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced preliminary record Focal One System sales for the fourth quarter of calendar year 2024. The Company experienced robust dem ...

PDF Version AUSTIN, Texas, January 10, 2025 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced the appointment of Joshua H. Levine to its Board of Directors. “We are pleased to welcome Josh Levine to our Board of Directors," said Dr. Lance Willsey, Interim Chairman of the Board of EDAP TMS. “Josh brings a wealth of executive experience and a track record of growing shareholder value by focusing on transformative, high growth busines ...

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]