Market Opportunity & Growth - The company is a global leader in therapeutic ultrasound for cancer and benign diseases, with a strong growth opportunity in urology and prostate cancer[4,6] - Prostate cancer is the most common cancer among men in the US, with 33 million American men living with it in 2025, and 313780 new cases diagnosed[14,15] - Globally, there are approximately 15 million new prostate cancer cases per year as of 2022, with Europe accounting for 473011 cases, Asia for 386424 cases, and North America for 255782 cases[19,20] - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470000 globally, including 165000 in Europe, 130000 in Asia, and 100000 in North America[25] Clinical Evidence & Technology - Over 1000 peer-reviewed publications support HIFU in the treatment of prostate cancer[36] - A comparative study (HIFI) showed comparable cancer control with HIFU (90% STFS) versus radical prostatectomy (86% STFS), with superior functional outcomes for HIFU[41,45] - A randomized controlled trial (FARP) demonstrated equivalent oncologic control at 3 years (935% TFF for Focal Ablation vs 915% for Radical Prostatectomy) and superior functional outcomes after focal ablation[54] - The company's Focal One system has 11 systems in the NY/NJ MSA at the end of 2024 and 67 systems in the US at the end of Q1 2025[104,107] Reimbursement & Expansion - Medicare reimbursement for HIFU is $9247 in 2025, a 54% increase, and physician payment is $951[70,73] - The company is targeting large incidence cancer and benign conditions, including 15 million prostate cancer cases, 113 million BPH cases, and 205 million rectal endometriosis cases[89]

Core Points - EDAP TMS SA will transition to U.S. reporting status effective January 1, 2026, ceasing to qualify as a foreign private issuer under SEC rules [1] - This change reflects the company's commitment to transparency and regulatory best practices, aiming to strengthen relationships with shareholders and attract institutional investors [2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [2] - The company has introduced the Focal One® system, a leading prostate focal therapy, with potential applications beyond prostate cancer [2]

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 ...

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 developed the Focal One®, a leading prostate focal therapy device, which is controlled by urologists and has potential applications beyond prostate cancer [3] Upcoming Event - Ryan Rhodes, the CEO of EDAP TMS, will present and host one-on-one investor meetings at the Jefferies Global Healthcare Conference from June 3-5, 2025, in New York City [1] - The presentation is scheduled for June 5th from 4:20 to 4:50 PM ET, and it will be available via a live and archived webcast [2]

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]

Core Insights - EDAP TMS SA reported strong growth in the adoption of its Focal One robotic HIFU system, achieving a record nine system placements in Q1 2025, the highest in the company's history [2][5] - The company launched the new Focal One i Robotic HIFU System, which includes enhanced features aimed at improving treatment efficiency and expanding its market leadership in focal therapy [2][6] - Positive clinical data from the FARP randomized controlled trial supports the use of HIFU for early-stage prostate cancer, indicating non-inferiority compared to traditional robotic radical prostatectomy [3][6] Business Update - The company achieved a record number of Focal One system placements and received CE Mark designation for the treatment of deep infiltrating endometriosis [5][7] - The FARP trial results were presented at the AUA 2025 meeting, marking a significant milestone in clinical evidence for ultrasound-based focal ablation therapy [6][5] - The Focal One i system features new capabilities, including compatibility with advanced imaging technologies and improved treatment workflows [6][5] Financial Performance - Total HIFU revenue for Q1 2025 was EUR 6.2 million (USD 6.5 million), a 6.8% increase from EUR 5.8 million (USD 6.3 million) in Q1 2024, driven by increased system sales [10] - Total revenue for the non-core business declined to EUR 7.4 million (USD 7.8 million) from EUR 9.1 million (USD 9.9 million) in the previous year, reflecting the company's strategic focus on high-growth opportunities in focal therapy [11] - The company's total worldwide revenue for Q1 2025 was EUR 13.6 million (USD 14.3 million), down 9.1% from EUR 14.9 million (USD 16.1 million) in Q1 2024 [13] Operating Metrics - Gross profit for Q1 2025 was EUR 5.7 million (USD 6.0 million), with a gross profit margin of 42.0%, slightly down from 42.8% in Q1 2024 [14] - Operating expenses increased to EUR 11.7 million (USD 12.3 million) from EUR 11.2 million (USD 12.1 million) in the same period last year, primarily due to investments in the HIFU business [15] - The net loss for Q1 2025 was EUR 7.1 million (USD 7.5 million), compared to a net loss of EUR 4.5 million (USD 4.9 million) in Q1 2024 [16] Cash Position - As of March 31, 2025, the company held cash and cash equivalents of EUR 22.8 million (USD 24.6 million), down from EUR 29.8 million (USD 30.9 million) at the end of 2024 [16]

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]

Core Insights - EDAP TMS SA announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) Study, demonstrating non-inferiority of focal ablation compared to robotic prostatectomy in treating localized prostate cancer [1][6] Study Results - The FARP study achieved its primary endpoint, showing a treatment failure rate of 5.6% in the Focal Ablation (FA) group versus 7.9% in the Radical Prostatectomy (RP) group, indicating a statistical difference of 2.3% in favor of Focal Ablation [7] - A total of 213 patients were enrolled, with 107 randomized to FA and 106 to RP, and 25% of RP patients crossed over to FA [7] Clinical Implications - The study provides significant evidence supporting the use of ultrasound energy-based focal ablation for organ-localized prostate cancer, particularly High-Intensity Focused Ultrasound (HIFU) [2][4] - The positive results from the FARP trial, along with the HIFI Study, are expected to accelerate the adoption of Focal One Robotic HIFU in clinical practice [4] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing minimally invasive medical devices utilizing ultrasound technology for various conditions [5] - The Focal One® system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]

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 ...