EDAP TMS (EDAP) 2025 Conference June 05, 2025 04:20 PM ET Speaker0 Okay. Alright. Good afternoon. My name is Michael Sarcone. I'm an analyst on the US Medical Supplies and Devices team, this is day two of the Jefferies twenty twenty five New York Healthcare Conference. This is a session with EDAP Focal One. And with us from the company, we've got Ryan Rhodes, CEO Ken Moback, CFO and John Francis who heads the IR function. Ryan Rhodes is going to give a presentation, some prepared commentary and then we'll o ...

The live and archived webcast of the presentation can be accessed in the Investors section of the Company's website here. About EDAP TMS SA A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and in the U.S. as th ...

EDAP TMS (EDAP) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants John Fraunces - DirectorRyan Rhodes - CEO & DirectorKen Mobeck - Chief Financial OfficerSean Lee - VP - Equity Research Conference Call Participants Michael Sarcone - Analyst Operator Day. I would like to welcome everyone to EDAP TMS First Quarter twenty twenty five Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer se ...

Financial Data and Key Metrics Changes - HIFU revenues for Q1 2025 were EUR 6.2 million, an increase of 6.8% compared to EUR 5.8 million in Q1 2024 [11][24] - Total worldwide revenue for Q1 2025 was EUR 13.6 million, a decrease of 9.1% from EUR 14.9 million in the same period in 2024 [12][25] - Gross profit for Q1 2025 was EUR 5.7 million, down from EUR 6.4 million in Q1 2024, with a gross profit margin of 42% compared to 42.8% year-over-year [25][26] - Net loss for Q1 2025 was EUR 7.1 million or EUR 0.19 per diluted share, compared to a net loss of EUR 4.5 million or EUR 0.12 per diluted share in the prior year [27] Business Line Data and Key Metrics Changes - The company placed nine Focal One systems in Q1 2025, a record for any first quarter, including six cash sales and three operating leases [4][6] - U.S. procedures grew approximately 4% over Q1 2024, despite longer review and approval times for Medicare Advantage patients [12][13] Market Data and Key Metrics Changes - Four cash sales of Focal One systems were completed outside the U.S. in Q1 2025, indicating growing international demand [11] - The company noted that over half of the National Comprehensive Cancer Network (NCCN) member institutions now have access to the Focal One platform [10] Company Strategy and Development Direction - The company aims to become the global leader in HIFU focal therapy, focusing on growing its core HIFU business and expanding clinical data support [4][6] - The launch of the new Focal One I robotic HIFU system is expected to enhance technological leadership and meet future needs of surgeons [22][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the payer landscape, particularly with Medicare Advantage plans, but noted progress in appeals and approvals [35][38] - The company reiterated its 2025 revenue guidance, expecting HIFU revenue growth between 16% and 25% year-over-year, while non-core segments are projected to decline [30][41] Other Important Information - The company received CE Mark approval for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone [14][15] - A landmark remote transatlantic Focal One robotic HIFU procedure was successfully conducted, showcasing technological advancements [17][18] Q&A Session Summary Question: Changes in payer landscape and procedure approvals - Management noted that the trends are primarily relevant to Medicare Advantage Plan patients, with ongoing efforts to improve market access and reimbursement [35][36] Question: Continued challenges in Q2 and approval processes - Management confirmed that while there is a risk of denials, notable progress in appeals is being made, with a majority of appeals resulting in approvals [38][39] Question: HIFU sales growth guidance assumptions - The guidance incorporates expected procedure growth and assumes that payer challenges may recede in the second half of the year [40][41] Question: Marketing plans for endometriosis after CE Mark approval - The company is in a controlled market entry phase in CE Mark countries and is preparing for broader launch based on clinical data [44][46]

AUSTIN, Texas, May 15, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the first quarter of 2025. "Demand for Focal One remains on a solid growth trajectory, as demonstrated by our strong first quarter system placements. We placed a record number of nine Focal One systems, which is the highest number of placements for any first quarter in our company's history," said Ryan Rhodes, Chief Executive Officer of ED ...

Core Viewpoint - EDAP TMS SA will release its financial results for Q1 2025 on May 15, 2025, before market opening [1] Group 1: Conference Call Details - A conference call and webcast will be held on May 15, 2025, at 8:30 am EDT [2] - The call will feature CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch [2] - Dial-in numbers include 1-800-267-6316 for domestic and 1-203-518-9783 for international calls, with the passcode "EDAP" [3] Group 2: Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices using ultrasound technology [3] - The company has introduced the Focal One® system for prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

"The positive results from the FARP randomized controlled trial further validate the role of robotic focal ablation with ultrasound energy in the management of prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "Focal One Robotic HIFU was used for the vast majority of the patients treated with focal ablation in this study. This demonstrates Focal One's leadership position in the rapidly growing treatment category of focal therapy for prostate cancer. We anticipate that the positive dat ...

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 ...

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 ...