Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [2] - The company has developed the Focal One system, which is recognized as a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [2] Upcoming Events - Ryan Rhodes, the CEO of EDAP TMS, will participate in a fireside chat and host one-on-one investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference [1] - The conference is scheduled for September 8-10, 2025, in New York City, with Rhodes' presentation set for September 9 from 8:30-9:00 AM ET [1]

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 [12][25] - 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 [13][26] - 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 [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 [28] 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 [5][8] - U.S. procedures grew approximately 4% over Q1 2024, indicating strong demand for Focal One among the U.S. urology community [13][14] - The decline in non-core revenue was expected due to the strategic decision to focus on high-growth opportunities in HIFU [13][26] Market Data and Key Metrics Changes - In international markets, four cash sales of Focal One were completed outside the U.S. in Q1 2025, indicating growing momentum [12] - Major placements included hospitals in competitive environments, such as Baylor Scott and White Health and Methodist Charleston Medical Center [9][10] Company Strategy and Development Direction - The company aims to become the global leader in HIFU focal therapy, with significant strategic decisions made to support this transformation [5] - The launch of the new Focal One I robotic HIFU system represents a significant advancement, incorporating cutting-edge technology and feedback from customers [23][33] - The company is focusing on expanding its presence in the management of prostate cancer and exploring new indications for its technology [19][33] Management's Comments on Operating Environment and Future Outlook - Management noted challenges in the payer landscape, particularly with longer review times for Medicare Advantage patients, but emphasized ongoing efforts to improve market access [14][36] - The company reiterated its 2025 revenue guidance, expecting HIFU revenue to grow between 16% and 25% year-over-year, while non-core segments are expected to decline [32][33] Other Important Information - The company received CE Mark approval for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone [15][16] - The first remote transatlantic Focal One robotic HIFU procedure was successfully conducted, showcasing technological advancements [17][19] Q&A Session Summary Question: Can you elaborate on the changing trends in the payer landscape? - Management indicated that the trends are primarily relevant to Medicare Advantage Plan patients, with ongoing efforts to work closely with payers and improve reimbursement processes [36][37] Question: Has the trend continued into Q2, and are procedures ultimately getting approved? - Management acknowledged the risk of denials but noted significant progress in appeals, with a majority of appeals being successful [39][40] Question: What are the next steps for marketing Focal One for endometriosis in Europe? - The company is working on a controlled market entry in CE Mark countries, with plans for a broader launch following initial efforts [45][46]

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, April 22, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that Focal One will have its largest presence ever at the upcoming 120th American Urological Association (AUA) Annual Meeting. "This year's AUA meeting promises to be the most significant scientific meeting to date highlighting the growing acceptance and utilization of the Focal One Robotic HIFU platform by the global urology community," said Ryan Rhodes, Chief Executive Officer o ...