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]
EDAP TMS(EDAP) - 2025 Q3 - Quarterly Report