Prostate Cancer Statistics - 3.3 million American men are living with prostate cancer, with 313,780 new cases diagnosed in the U.S. annually [7] - The global market for prostate cancer treatment includes 1.5 million new cases per year, with Europe accounting for 473,011 cases and Asia for 386,424 cases [8] HIFU Treatment Insights - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470,000, with Europe contributing 165,000 and Asia 130,000 [10] - HIFU demonstrates a 90% cancer control rate compared to 86% for radical prostatectomy, indicating superior functional outcomes [18] - A multicentric study shows that HIFU has equivalent 10-year survival rates compared to external beam radiation therapy (EBRT), with lower mortality rates [20] Financial Performance - Revenue for the three months ended September 30, 2025, was $16.1 million, a 12% increase from $14.4 million in the same period of 2024 [45] - Gross profit for the same period was $6.9 million, with a gross margin of 43.0%, up from 39.4% in 2024 [45] - For the nine months ended September 30, 2025, revenue reached $48.8 million, a slight increase from $47.6 million in 2024 [46] - The company reported a net loss of $19.8 million for the nine months ended September 30, 2025, compared to a net loss of $18.5 million in 2024 [46] - HIFU revenue for the nine months ended September 30, 2025, was $23.9 million, reflecting a 46% increase from $16.3 million in 2024 [46] Market Expansion and Technology - The reimbursement for HIFU procedures has increased by 90% in 2023, with a projected payment of $9,671 under the CMS Hospital Outpatient Prospective Payment System [22][23] - The physician payment for HIFU in 2026 is set at $1,087, making it a competitive option compared to other treatments [24] - The company is positioned to expand into the benign prostatic hyperplasia (BPH) market, which affects 15 million U.S. men annually [32] - The Focal One technology is integrated with advanced imaging and AI capabilities, enhancing treatment precision and efficiency [28] - The company is actively recruiting for a Phase I-II clinical study on HIFU for BPH, confirming safety and potential symptom improvement [33] Installation and Adoption Rates - Focal One systems installed in U.S. hospitals reached 87 as of December 31, 2025, with a compounded annual growth rate (CAGR) of 52% in installations [41] - Focal One procedures experienced a CAGR of 44% from 2021 to 2025, indicating strong adoption in the market [41] - The company has a growing global install base, with 254 Focal One treatment clinical sites as of December 31, 2025 [39] Cash Position - Cash and cash equivalents decreased to $12.4 million as of September 30, 2025, down from $28.4 million in 2024 [47] Regulatory Approvals - The company received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum on March 25, 2025 [35]

Core Insights - EDAP TMS SA reported record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and increasing procedure growth [1][2] - The company anticipates 36% to 38% annual year-over-year growth in HIFU revenue for 2026, with initial revenue guidance set between $50.0 million and $54.0 million [1][5] Financial Performance - For Q4 2025, worldwide HIFU revenue is projected to be between $12.9 million and $13.3 million, marking the highest quarterly revenue in the company's history [2] - Annual 2025 HIFU revenue is expected to range from $36.7 million to $37.2 million, also the highest annual revenue recorded [2] - Non-core revenue for Q4 2025 is estimated between $7.9 million and $8.3 million, with annual non-core revenue expected between $32.7 million and $33.1 million [3] Operational Highlights - A record 15 Focal One system placements occurred in Q4 2025, indicating strong global demand from hospitals and urology centers [2] - The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, showcasing growing utilization [2] Strategic Outlook - The CEO emphasized that the growth in HIFU revenue now represents over half of the company's expected annual revenue, validating the execution strategy [4] - Increasing clinical validation and data from key trials are driving broader adoption of focal therapy for prostate cancer, with more hospital networks recognizing Focal One as a strategic investment [4] - The company is confident in its ability to deliver continued revenue growth and shareholder value creation in 2026, supported by a strong global pipeline and customer engagement [4]

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]

Core Insights - EDAP TMS SA has received FDA 510(k) clearance for enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, reinforcing its leadership in robotic focal therapy for prostate cancer [1][2][3] Product Enhancements - The new clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface to the Focal One i system [2] - The next-generation ultrasound imaging engine offers real-time visualization and supports the development of AI-driven algorithms for tissue ablation visualization and treatment evaluation [2] Company Commitment - The CEO of EDAP TMS expressed pride in the new FDA clearance, highlighting it as a significant technical milestone and a testament to the company's commitment to innovation in focal therapy [3] - EDAP TMS is recognized as a leader in robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology [3]

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 Insights - EDAP TMS SA will present at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, with CEO Ryan Rhodes and CFO Ken Mobeck hosting 1x1 investor meetings [1][2] 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 the Focal One® system, a leading prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

Financial Data and Key Metrics Changes - The company reported global revenues of $16.1 million for Q3 2025, marking the second consecutive quarter of record overall quarterly revenue [2] - HIFU revenue reached $7.7 million, a 57% increase compared to Q3 2024 [2] - Total revenue for Q3 2025 was EUR 13.9 million, a 6% increase from EUR 13.1 million in Q3 2024 [11] - Gross profit for Q3 2025 was EUR 6 million, with a gross margin of 43%, up from 39.4% in the same period last year [12][14] - Net loss for Q3 2025 was EUR 5 million, an improvement from a net loss of EUR 6.4 million in Q3 2024 [15] Business Line Data and Key Metrics Changes - HIFU business grew 49% year-over-year, driven by six capital sales in Q3 2025 compared to three in the prior year [11][12] - Focal One placements increased by 167% year-over-year, with eight placements in Q3 2025 [3] - Focal One procedures in the US grew more than 15% year-over-year, indicating a return to double-digit growth [3][4] Market Data and Key Metrics Changes - The company is seeing meaningful progress in reimbursement coverage, particularly among Medicare Advantage providers [4] - The latest hospital and physician payment rules from CMS reinforce the use case of HIFU, providing a clear reimbursement pathway [5] Company Strategy and Development Direction - The company aims to make Focal One the standard of care for localized prostate cancer, focusing on expanding clinical adoption and market access [2][18] - Plans to expand into new clinical indications, including benign prostatic hyperplasia (BPH) and endometriosis, are underway [6][8] - The company maintains financial guidance for 2025, expecting core HIFU business revenue growth of 26%-34% [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, supported by strong clinical evidence and expanding market access [18] - The company is focused on accelerating adoption and utilization across its Focal One install base while maintaining a disciplined investment approach [18] Other Important Information - The company received the first tranche of EUR 11 million from the European Investment Bank, aimed at supporting strategic investments in HIFU [16][22] - The company is monitoring the impact of US tariff policies, estimating a full-year impact of EUR 900,000 [17] Q&A Session Summary Question: Details on the EIB deal and its use - Management indicated that proceeds from the EIB deal will be used for product development, clinical development, and commercial growth, primarily focused on the HIFU core business [22] Question: Coverage of US Focal One procedures and expected growth - Management noted that the procedure mix includes Medicare patients, Medicare Advantage plan patients, and commercial patients, with positive trends in Medicare Advantage coverage expected to drive volume growth [23] Question: Expectations for Q4 given typical seasonal softness - Management reiterated guidance for 2025, confident that Q4 numbers will align with year-end targets of $58 million to $62 million [24]

Revenue Performance - Third quarter 2025 total revenue was €13.9 million (US $16.1 million), a 6% increase compared to €13.1 million (US $14.4 million) in Q3 2024[15] - HIFU business revenue for Q3 2025 was €6.7 million (US $7.7 million), representing a 49% year-over-year increase from €4.5 million (US $4.9 million) in Q3 2024[13] - Non-core business revenue for Q3 2025 was €7.2 million (US $8.4 million), a decline from €8.6 million (US $9.8 million) in Q3 2024, reflecting a strategic focus on HIFU[14] - Year-to-date HIFU revenue for the nine months ended September 30, 2025, was €21.3 million (US $23.9 million), a 42% increase from €15.1 million (US $16.3 million) in the same period of 2024[19] - For the nine months ended September 30, 2025, total revenues were €43,480 thousand, slightly down from €43,797 thousand in the same period of 2024[31] Profitability and Loss - Gross profit for Q3 2025 was €6.0 million (US $6.9 million), with a gross profit margin of 43%, up from 39% in Q3 2024[16] - Gross profit for Q3 2025 was €5,972 thousand, up 16% from €5,154 thousand in Q3 2024, resulting in a gross margin of 43%[30] - Net loss for Q3 2025 was €5.0 million (US $5.8 million), or (€0.13) per share, an improvement from a net loss of €6.4 million (US $7.0 million), or (€0.17) per share, in Q3 2024[18] - Net loss for Q3 2025 decreased to €5,014 thousand from €6,399 thousand in Q3 2024, reflecting a 22% improvement[30] - Operating loss for the nine months ended September 30, 2025 was €16,691 thousand, compared to €16,796 thousand in the same period of 2024, indicating a marginal improvement[31] Operational Metrics - Focal One system placements increased by 167% year-over-year, with six systems sold in Q3 2025 compared to three in Q3 2024[7][13] - U.S. Focal One HIFU procedures grew by 15% year-over-year, indicating a return to double-digit growth[9][13] - The company expects core HIFU business revenue to grow between 26% to 34% year-over-year for 2025[12] Financial Position - Cash and cash equivalents decreased to €10,567 thousand as of September 30, 2025, down from €29,836 thousand at the end of 2024[33] - Total assets as of September 30, 2025 were €61,464 thousand, a significant decrease from €86,063 thousand at the end of 2024[33] - Research and development expenses for the nine months ended September 30, 2025 were €6,749 thousand, an increase from €5,862 thousand in the same period of 2024[31] Financing - The company secured a €36 million credit facility from the European Investment Bank to support the expansion of the Focal One platform[8][10] Share Information - The average number of shares used in the computation of basic and diluted EPS for Q3 2025 was 37,438,630, compared to 37,233,406 in Q3 2024[30] - The company reported a net cash used in operating activities of €12,473 thousand for the nine months ended September 30, 2025, compared to €13,584 thousand in the same period of 2024[34]

Core Insights - EDAP TMS SA reported record-breaking revenue performance in Q3 2025, driven by a 167% year-over-year increase in Focal One system placements and a 49% growth in HIFU revenue [2][7][9] - The company is experiencing a paradigm shift in prostate cancer management, with increasing demand for non-invasive treatment options among urologists [2] - A €36 million credit facility agreement with the European Investment Bank was finalized to support the expansion of the Focal One platform [3][8] Financial Performance - Total revenue for Q3 2025 was €13.9 million (US $16.1 million), a 6% increase from €13.1 million (US $14.4 million) in Q3 2024 [11] - HIFU business revenue reached €6.7 million (US $7.7 million), up 49% from €4.5 million (US $4.9 million) in the same period last year [9] - Non-core business revenue declined to €7.2 million (US $8.4 million) from €8.6 million (US $9.8 million) year-over-year, reflecting a strategic focus on high-growth opportunities in Focal Therapy [10] Operational Highlights - The company sold six Focal One systems in Q3 2025, compared to three in Q3 2024, indicating strong market adoption [9] - Gross profit for Q3 2025 was €6.0 million (US $6.9 million), with a gross profit margin of 43%, up from 39% in Q3 2024 [12] - Operating loss for Q3 2025 was €4.9 million (US $5.7 million), an improvement from a loss of €5.8 million (US $6.4 million) in the same period last year [13][14] Year-to-Date Results - For the nine months ended September 30, 2025, total revenue was €43.5 million (US $48.8 million), a slight decrease of 0.7% compared to €43.8 million (US $47.6 million) in the same period of 2024 [16] - HIFU business revenue for the nine months was €21.3 million (US $23.9 million), a 42% increase from €15.1 million (US $16.3 million) in 2024 [14] - The net loss for the nine months was €17.7 million (US $19.8 million), or (€0.47) per share, compared to €17.1 million (US $18.5 million), or (€0.46) per share, in the same period of 2024 [18] Future Outlook - The company expects core HIFU business revenue to grow between 26% to 34% year-over-year for 2025, while non-core ESWL and Distribution business revenue is anticipated to decline by 25% to 30% [5] - The Focal One pipeline continues to expand, reflecting growing demand and effective execution by the commercial and clinical teams [3]

Core Points - EDAP TMS SA, a leader in robotic energy-based therapies, will present at the Jefferies Global Healthcare Conference in London on November 18, 2025 [1] - The presentation will be led by CEO Ryan Rhodes and will include 1x1 investor meetings [1] - The conference will take place from November 18-20, 2025, at the Waldorf – Aldwych [2] Company Overview - EDAP TMS SA specializes in developing, manufacturing, promoting, and distributing minimally invasive medical devices using ultrasound technology [3] - The company is known for its Focal One® system, which is a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [3] - EDAP TMS aims to combine advanced imaging, robotics, and precise non-invasive energy delivery in its medical devices [3]