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]

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 [4][5] - 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 [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 [24] Business Line Data and Key Metrics Changes - HIFU business revenue for Q2 2025 was €8.5 million, compared to €4.8 million in Q2 2024, driven by nine capital sales versus three in the prior year [22][23] - 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 [10][11] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [12] Company Strategy and Development Direction - The company is focusing on expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis [14][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] - Transitioning to a U.S. domestic filer starting January 1, 2026, to comply with SEC reporting rules and attract new institutional investors [18][20] 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 [30] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [29] Other Important Information - Inventory decreased to $15.5 million in Q2 2025 from €18 million at the end of Q1 2025, attributed to efficient inventory management [26] - The company is actively working with market access partners to improve pre-authorizations for Focal One procedures [11] Q&A Session Summary Question: Can you provide details on the payer issues and reimbursement situation? - Management noted improvements in reimbursement efforts, with strong collaboration with market access partners to accelerate pre-authorizations for Focal One procedures [33][34] Question: What factors does CMS consider for higher reimbursement rates? - CMS evaluates average payments, cost of service, volume of procedures, and clinical value when determining reimbursement rates [43][44] Question: Can you provide an update on the endometriosis trial? - The phase three study showed over 80% of sham arm patients opted for Focal One treatment post-unblinding, with a limited European launch currently underway [53][54] Question: How is the €36 million from the EIB intended to be used? - The funds are earmarked for accelerated commercial growth in the HIFU business and investment in clinical indications and new technologies [56][59]

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]