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]