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]

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]