Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [3][4] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year to €8.5 million [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [23] Business Line Data and Key Metrics Changes - The HIFU business saw a 76.8% increase in revenue, driven by nine capital sales compared to three in the prior year, and a 16.1% increase in treatment-driven revenue [21][22] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [9][10] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [11] Company Strategy and Development Direction - The company is expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis, which is expected to drive incremental sales growth [13][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [5][29] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [28] Other Important Information - The company will transition to a U.S. domestic filer starting January 1, 2026, which is expected to enhance transparency and attract new institutional investors [18][20] - Inventory decreased to $15.5 million in Q2 2025, reflecting efficient inventory management and higher turnover due to increased demand for Focal One [25][26] Q&A Session Summary Question: Can you provide details on the payer issues and improvements? - Management noted solid growth in the HIFU business despite challenges with Medicare Advantage plans, with early signs of improvement in procedure approvals [32][34] Question: What factors does CMS consider for reimbursement rate increases? - CMS considers service value, clinical value ratios, procedure volume, and costs associated with services when determining reimbursement rates [43][45] Question: How much effort is placed on multi-unit purchases? - Significant effort is placed on every sale, with recent sales indicating strong validation of the technology's value [48][50] Question: Update on the endometriosis trial? - The phase three study is ongoing, with over 80% of sham arm patients opting for Focal One treatment post-unblinding, and a limited European launch is underway [55][56] Question: Status of the €36 million financing? - No funds have been received yet, as the company is finalizing terms with the European Investment Bank [58][59]

Core Insights - EDAP TMS SA reported its strongest second quarter performance in company history, with a net total of 12 Focal One Robotic HIFU Systems placed, driven by increased customer demand from both U.S. and international markets [2][6] - The company executed a letter of intent with the European Investment Bank for a credit facility of 36 million Euros to support the expansion of its Focal One platform and focused ultrasound technologies [2][8] - The company anticipates continued growth in demand for Focal One treatments as more prostate cancer patients recognize its advantages, supported by recent clinical studies [2][6] Financial Performance - Total revenue in the HIFU business for Q2 2025 was EUR 8.5 million (USD 9.7 million), a 76.8% increase from EUR 4.8 million (USD 5.2 million) in Q2 2024 [6][9] - The company recorded a 23.9% year-over-year growth in worldwide disposable revenue, with Focal One procedures growing 4.8% in the U.S. [6][9] - Total worldwide revenue for Q2 2025 was EUR 16.0 million (USD 18.4 million), a slight increase of 1.6% compared to EUR 15.8 million (USD 17.0 million) in Q2 2024 [9] Business Segments - The non-core business (ESWL and Distribution) revenue for Q2 2025 was EUR 7.6 million (USD 8.7 million), down from EUR 11.0 million (USD 11.8 million) in Q2 2024, reflecting a strategic focus on the high-growth HIFU opportunity [7][9] - For the first half of 2025, total revenue in the HIFU business was EUR 14.7 million (USD 16.1 million), a 38.5% increase from EUR 10.6 million (USD 11.4 million) in the same period of 2024 [13] - The non-core business revenue for the first half of 2025 was EUR 15.0 million (USD 16.5 million), a 25.7% decrease compared to EUR 20.1 million (USD 21.7 million) in the first half of 2024 [14] Profitability Metrics - Gross profit for Q2 2025 was EUR 6.8 million (USD 7.8 million), with a gross profit margin of 42.5%, up from 37.5% in Q2 2024 [10] - Operating loss for Q2 2025 was EUR 5.8 million (USD 6.6 million), an improvement from an operating loss of EUR 6.1 million (USD 6.6 million) in Q2 2024 [11] - Net loss for Q2 2025 was EUR 5.6 million (USD 6.4 million), or EUR (0.15) per share, compared to a net loss of EUR 6.1 million (USD 6.6 million), or EUR (0.16) per share in Q2 2024 [12] Future Outlook - The company updated its 2025 financial guidance, expecting core HIFU business revenue growth to be between 26% and 34% year-over-year, up from the previous range of 16% to 25% [5][7] - The combined non-core ESWL and Distribution business revenue is expected to decline between 25% and 30% year-over-year [5][7] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8-10, 2025 [4]

Core Insights - EDAP TMS SA has announced a letter of intent for a EUR 36 million credit facility with the European Investment Bank (EIB) to support the growth of Focal One Robotic HIFU in the treatment of early-stage prostate cancer [1][2] - The financing will enhance the company's balance sheet and provide low-interest funding accessible in tranches as needed [2] - The credit facility is expected to close by the end of Calendar Year 2025, pending final legal documentation [1] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced Focal One as a leading prostate focal therapy, with potential applications beyond prostate cancer [3]

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]

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]