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 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]