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 ...

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, while total worldwide revenues for 2024 were $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, with disposable revenues growing by 28.5% [39] - The ESWL division saw nominal growth, with revenues of €2.4 million compared to €2.3 million in the previous year [40] Market Data and Key Metrics Changes - The number of Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in the HIFU segment, while reducing investments in lower growth, low margin businesses [34] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry and further clinical development [6][25] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [46] - The company anticipates that the landmark Hi Fi study will drive demand for Focal One, positioning it as a mainstream treatment option for prostate cancer [47] Other Important Information - The company has entered into clinical studies for the treatment of BPH and pancreatic tumors, indicating a commitment to expanding its HIFU technology into new indications [20][21] - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] Q&A Session Summary Question: Can you provide more detail on HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [49][50] Question: What is the intent for the non-core ESWL and distribution business? - The company is transitioning away from non-core distribution products, focusing on high growth HIFU business, but cannot project if it will phase down to zero [51][52] Question: How is the capital equipment purchase pattern from hospitals in 2025? - The sales cycle remains consistent, but the company has adapted its strategy to close deals more effectively, expecting notable growth throughout 2025 [58][60] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - The reimbursement increase has positively impacted hospital interest in adopting Focal One, as it enhances the financial analysis for adding this treatment to their services [62][64] Question: What is the strategy for endometriosis commercialization? - The company is working with experts to refine clinical development efforts following the CE mark, with plans for a Phase one launch in CE mark countries [71][72] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is early in patient recruitment, being conducted locally in France, with no specific data timeline provided yet [73][74]

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, with total worldwide revenues of $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, driven by 11 Focal One systems sold [39][40] - The ESWL division saw nominal growth with revenues of €2.4 million in the fourth quarter, while the distribution business revenue decreased to €9.1 million from €9.9 million [41][42] Market Data and Key Metrics Changes - Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year in the fourth quarter [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] - Notable sales were made in international markets, including Germany, Portugal, and Turkey [12] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in prostate cancer, endometriosis, and BPH, leveraging the Focal One platform [32] - Plans to reduce investments in lower growth, low margin businesses, including the discontinuation of the ZONALIB iMOVE lithotripsy product line [33][34] - The company is committed to transforming into a more agile organization, with new board members bringing expertise in medical device commercialization [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [47] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant milestone, allowing for controlled market entry [6] - The company anticipates that the Hi Fi study publication will drive further adoption of Focal One as a treatment option for prostate cancer [15][48] Other Important Information - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] - The company is actively working on clinical studies for BPH and pancreatic tumors, demonstrating its commitment to expanding the applications of HIFU technology [19][20] Q&A Session Summary Question: Can you provide more detail on the HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [50][52] Question: Is the intent to phase down the non-core ESWL and distribution business to zero? - Management indicated that while they are winding down some non-core businesses, they cannot project if it will go to zero, but focus will shift to high growth HIFU business [53][54] Question: How is the capital equipment purchase pattern from hospitals in 2025? - Management noted that the sales cycle remains consistent, but they have adjusted strategies to close deals more effectively, with a growing active pipeline [60][62] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - Management confirmed that the reimbursement increase has positively impacted hospital interest in adopting Focal One technology [64][66] Question: What is the strategy for commercializing the endometriosis treatment? - The company is in the early stages of expanding clinical development efforts following the CE mark approval for treating deep infiltrating endometriosis [73][74] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is in the early recruitment phase, with the study being conducted in France [75][76]

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 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 - 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]