Summary of EDAP Conference Call Company Overview - **Company**: EDAP - **Industry**: MedTech, specifically focused on prostate cancer treatment through Focal therapy Key Points Capital Environment - The capital demand and spending environment for hospitals is under pressure, leading to strategic investments in clinically necessary equipment like Focal One, which addresses prostate cancer, the most diagnosed cancer in men [4][5] - EDAP reported a **167% growth** in capital sales for Focal One last quarter, indicating strong momentum in the capital equipment space [5] Market Dynamics - The U.S. market is characterized by a strategic approach to capital investments, while the international (OUS) market varies by region, with notable sales increases in Western Europe [6][7] - Focal therapy is emerging as the fastest-growing treatment category for prostate cancer, with hospitals increasingly recognizing its clinical value [6][7] Sales Process and Customer Engagement - The sales process is heavily influenced by clinical efficacy and economic arguments, with hospitals showing a preference for outpatient procedures that are economically viable [9][10] - EDAP is present in nearly **50 academic centers** in the U.S., including top institutions like Memorial Sloan Kettering and Mayo Clinic, with some hospitals acquiring multiple Focal One systems [10] Clinical Evidence and Adoption - The HIFI Study, involving **3,200 patients**, supports the efficacy of Focal therapy, showing oncologic control and better patient outcomes compared to radical treatments [17][21] - EDAP is in the early adopter phase of the market adoption lifecycle, with ongoing efforts to educate hospitals on the value of Focal therapy [18][19] Financial Performance - EDAP expects HIFU revenue to grow by **26-34%**, while non-core business is projected to decline by **25-30%** [46] - Gross margins for HIFU are trending in the high forties, with an increase from **39% to 42%** in Q3 2024, indicating a positive financial trajectory [47] Product Development and Future Outlook - The launch of Focal One Eye, a new platform, is expected to enhance performance and gross margins, with an average selling price of around **$650,000** in the U.S. [49] - EDAP is actively pursuing additional indications for HIFU technology, including studies for benign prostatic hyperplasia (BPH) and women's health applications [34][42][28] Strategic Focus - The company is transitioning away from non-core businesses to concentrate on HIFU, which is seen as the growth engine for the future [46][51] - EDAP is working with strategic suppliers to improve cost structures and optimize margins, aiming for mid-single-digit improvements in gross margins [54] Additional Insights - The company is leveraging its legacy in urology to expand its market presence and capitalize on the growing demand for targeted robotic HIFU therapy [22][23] - The potential for HIFU technology extends beyond prostate cancer, with applications being explored in various medical fields, indicating a broad growth opportunity [25][28]

Summary of EDAP TMS Conference Call Company Overview - **Company**: EDAP TMS (NasdaqGM:EDAP) - **Industry**: MedTech, specifically focused on therapeutic ultrasound for cancer treatment Core Technology and Product - **Focal One**: A robotic High-Intensity Focused Ultrasound (HIFU) platform designed for urologists to perform focal ablation of prostate tissue, launched in May 2025 as an improvement over the previous platform [2][3] - **Key Features**: - Combines imaging, robotics, and HIFU technologies for precision [3] - Real-time imaging and dynamic focusing technology for accurate treatment [3][4] - Outpatient procedure with minimal recovery time [5] Market Opportunity - **Prostate Cancer Statistics**: Nearly 1.5 million patients annually, projected to double to 2.9 million by 2040 [6] - **Treatment Gap**: Focal One addresses the gap in treatment for favorable intermediate-risk prostate cancer, which is not adequately served by existing therapies [7] - **Market Growth**: HIFU is experiencing growth while traditional treatments like surgery and radiation are stagnating or declining [9] Clinical Evidence and Studies - **HIFY Study**: Largest study of its kind, showing positive outcomes in oncologic control and preservation of sexual function and urinary control [11][12] - **FARP Study**: Randomized control trial comparing HIFU and radical prostatectomy, expected to publish results soon [12] - **Comparative Study**: HIFU showed lower mortality rates compared to external beam radiation therapy over 10 years [13] Sales and Adoption - **Current Install Base**: Nearly 80 systems placed in top cancer hospitals and academic institutions [13] - **Procedure Growth**: 67% CAGR in procedures, with a 15% quarter-over-quarter growth from Q2 to Q3 2025 [14] - **Adoption Curve**: Currently in the early adoption phase, with increasing sales and reimbursement support [16][17] Expansion into New Indications - **BPH (Benign Prostatic Hyperplasia)**: Initiating studies to treat BPH, leveraging the existing technology [15][21] - **Endometriosis**: Limited launch in Europe for treating stage four endometriosis, with promising initial results [15][22] Financial Performance - **Margin Improvement**: Gross margins increased from 39.4% to 43%, focusing on higher-margin HIFU business [27] - **Strategic Focus**: Transitioning away from non-core businesses to enhance profitability in the HIFU segment [27][28] Conclusion - **Future Outlook**: Strong potential for continued growth in the HIFU market, with ongoing clinical trials and expanding applications in urology and women's health [20][23]

Core Points - EDAP TMS SA will announce its third quarter financial results for 2025 on November 6, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer on the same day at 8:30 am EST [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology for various medical conditions [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device controlled by urologists, with potential applications beyond prostate cancer [4]

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]

Core Insights - EDAP TMS SA will have its largest presence at the 120th American Urological Association (AUA) Annual Meeting, showcasing the Focal One Robotic HIFU platform [1][2] - The meeting will highlight the growing acceptance of robotic HIFU technology in the urology community, with numerous hands-on simulations and live demonstrations planned [2][5] Company Activities - The Focal One Robotic HIFU Masterclass will take place at the Keck School of Medicine of USC on April 24-25, featuring lectures and live procedures [5][6] - Expert-led demonstrations and semi-live procedures will be part of the AUA activities, emphasizing the advanced capabilities of the Focal One technology [5][9] Scientific Presentations - The AUA meeting will include the final results of the FARP study, the first randomized controlled trial comparing ultrasound-based focal ablation to robotic prostatectomy for early-stage prostate cancer [3][6] - A notable increase in scientific presentations on focal therapy and ablation for prostate cancer management is expected, indicating a growing interest in this area [5][9] Notable Presentations - Dr. Ruben Olivares will present the first remote transatlantic Focal One Robotic HIFU procedure, showcasing the technology's remote capabilities [3][6] - The FARP study results will be presented by Eduard Baco, providing level-1 evidence to support the use of focal ablation with Focal One [6]