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]

Summary of EDAP Focal One Conference Call Company Overview - **Company**: EDAP Focal One - **Industry**: Medical Devices, specifically in therapeutic ultrasound for cancer treatment - **Key Technology**: Focal One robotic High-Intensity Focused Ultrasound (HIFU) Core Points and Arguments 1. **Market Opportunity**: EDAP Focal One identifies a significant growth opportunity in the urology and prostate cancer markets, with prostate cancer being the most commonly diagnosed cancer among men, with over 313,000 new cases expected in 2025 in the US alone [3][6][41] 2. **Clinical Need**: The company addresses an unmet clinical need in cancer treatment, particularly for patients with intermediate-risk prostate cancer who have limited options after radiation therapy failure [4][9] 3. **Patient Demographics**: There are approximately 3.3 million men living with prostate cancer in the US, with a potential market of over 470,000 patients globally who could benefit from Focal One's technology [6][9] 4. **Emerging Market Shift**: The market is shifting from traditional treatments (surgery, radiation) to emerging focal therapy driven by HIFU, which is expected to grow significantly [10][12] 5. **Clinical Evidence**: Strong clinical evidence supports HIFU's effectiveness, with studies showing superior functional outcomes compared to traditional surgery, particularly in preserving urinary control and sexual function [15][18][50] 6. **Reimbursement Landscape**: The company benefits from favorable reimbursement conditions, with a 90% increase in CMS reimbursement rates for HIFU treatments in 2023 [24][27] 7. **Technological Advancements**: Focal One's technology leverages advanced imaging, robotics, and AI, allowing for precise treatment delivery and integration with various imaging modalities [27][28] 8. **Expansion into New Indications**: EDAP is exploring new indications for its technology, including benign prostatic hyperplasia (BPH) and endometriosis, with significant market potential [32][34] 9. **Global Presence**: The company has a growing global footprint with over 350 clinical sites and is expanding its market presence in key regions such as the US, Germany, and Japan [5][41] Additional Important Insights 1. **Strategic Shift**: The company is transitioning from a legacy business focused on kidney stone treatments to a concentrated focus on HIFU technology, aiming to become a market leader in this domain [44][45] 2. **Impact of Tariffs**: EDAP anticipates a 10% impact from tariffs on goods entering the US but believes its manufacturing base in France will help mitigate costs [56][57] 3. **Capital Equipment Market**: The Focal One I platform was well-received at major conferences, indicating strong interest from hospitals in investing in advanced cancer treatment technologies [59][61] 4. **Guideline Changes**: There is potential for changes in treatment guidelines as more data becomes available, which could accelerate the adoption of HIFU therapies [55] This summary encapsulates the key points discussed during the conference call, highlighting EDAP Focal One's strategic positioning, market opportunities, and technological advancements in the medical device industry.

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]

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]

[EDAP Reports First Quarter 2025 Financial Results](index=3&type=section&id=EDAP%20Reports%20First%20Quarter%202025%20Financial%20Results) [Management Commentary & Business Highlights](index=3&type=section&id=Management%20Commentary%20%26%20Business%20Highlights) In Q1 2025, EDAP's management highlighted a record number of nine Focal One system placements, underscoring strong market adoption. This growth is supported by positive clinical data from the FARP trial, which provided Level 1 evidence for focal ablation. Key strategic developments include the launch of the advanced Focal One i system, receiving CE Mark approval for endometriosis treatment, and strengthening the Board of Directors with experienced executives - Achieved a **record nine Focal One system placements**, the highest for any first quarter in the company's history, indicating strong growth and adoption[8](index=8&type=chunk) - Launched the new **Focal One i Robotic HIFU System**, which includes enhanced capabilities like expanded compatibility with PSMA PET scans and streamlined workflows[8](index=8&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - Final results from the FARP randomized controlled trial demonstrated that focal ablation was non-inferior to radical prostatectomy for early-stage prostate cancer, providing **Level 1 evidence** supporting its use[9](index=9&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - Received **CE Mark designation** for the Focal One system for the treatment of deep infiltrating endometriosis, expanding its clinical applications[11](index=11&type=chunk)[13](index=13&type=chunk) - Successfully performed the world's first **remote transcontinental Focal One Robotic HIFU procedure**[11](index=11&type=chunk)[13](index=13&type=chunk) - Appointed **Glen French and Joshua H. Levine**, executives with extensive experience in the medical device industry, to its Board of Directors[13](index=13&type=chunk) [Financial Performance](index=5&type=section&id=Financial%20Performance) For Q1 2025, total revenue decreased 9.1% year-over-year to €13.6 million, primarily due to a strategic de-emphasis on non-core businesses. The core HIFU business grew 6.8%, while non-core revenue declined as planned. The company reported a wider operating loss of €6.0 million and a net loss of €7.1 million, reflecting increased investments in the HIFU segment. EDAP reiterated its full-year 2025 guidance, anticipating 16-25% revenue growth in its core HIFU business [2025 Financial Guidance](index=5&type=section&id=2025%20Financial%20Guidance) The company reaffirmed its full-year 2025 financial guidance, projecting strong double-digit revenue growth in its core HIFU business while anticipating a planned contraction in its non-core segments as it focuses on focal therapy - Expects year-over-year revenue growth of **16% to 25%** in the core HIFU business[15](index=15&type=chunk) - Expects revenue declines between **20% and 25%** in its non-core businesses (ESWL and Distribution)[15](index=15&type=chunk) [First Quarter 2025 Results](index=5&type=section&id=First%20Quarter%202025%20Results) In Q1 2025, total revenue declined 9.1% YoY to €13.6 million, driven by a planned reduction in the non-core business. The core HIFU segment's revenue grew 6.8% to €6.2 million. Gross margin contracted slightly to 42.0% from 42.8%. The operating loss increased to €6.0 million from €4.8 million in Q1 2024, due to focused investments in the HIFU business. Net loss was €7.1 million, or €(0.19) per share Q1 2025 Key Financial Results (vs. Q1 2024, in EUR) | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | **Total Revenue** | **€13.6 million** | **€14.9 million** | **-9.1%** | | HIFU Revenue | €6.2 million | €5.8 million | +6.8% | | Non-core Revenue | €7.4 million | €9.1 million | -18.7% | | **Gross Profit** | **€5.7 million** | **€6.4 million** | **-10.9%** | | Gross Margin | 42.0% | 42.8% | -0.8 p.p. | | **Operating Loss** | **(€6.0 million)** | **(€4.8 million)** | **+25.0%** | | **Net Loss** | **(€7.1 million)** | **(€4.5 million)** | **+57.8%** | | EPS (EUR) | (€0.19) | (€0.12) | N/A | Cash Position (in EUR) | Metric | Mar 31, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash & Cash Equivalents | €22.8 million | €29.8 million | [Financial Statements](index=7&type=section&id=Financial%20Statements) This section provides the unaudited condensed consolidated financial statements for the quarter ended March 31, 2025. It includes the Statement of Operations, Balance Sheet, Statement of Cash Flows, and a divisional breakdown of operations, offering a detailed view of the company's financial position and performance - The Unaudited Condensed Consolidated Statement of Operations shows a net loss of **€7,074 thousand** for Q1 2025, compared to a net loss of **€4,546 thousand** in Q1 2024[29](index=29&type=chunk) - The Unaudited Condensed Consolidated Balance Sheet reports total assets of **€74,976 thousand** and total shareholders' equity of **€34,458 thousand** as of March 31, 2025[31](index=31&type=chunk) - The Unaudited Condensed Consolidated Statement of Cash Flows indicates net cash used in operating activities was **€5,076 thousand** for Q1 2025[33](index=33&type=chunk) - The divisional breakdown for Q1 2025 shows the HIFU division generated **€6,177 thousand** in revenue with an operating loss of **€5,361 thousand**, reflecting significant investment in this core area[35](index=35&type=chunk)

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]