EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance

Core Insights - EDAP TMS SA reported record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and increasing procedure growth [1][2] - The company anticipates 36% to 38% annual year-over-year growth in HIFU revenue for 2026, with initial revenue guidance set between $50.0 million and $54.0 million [1][5] Financial Performance - For Q4 2025, worldwide HIFU revenue is projected to be between $12.9 million and $13.3 million, marking the highest quarterly revenue in the company's history [2] - Annual 2025 HIFU revenue is expected to range from $36.7 million to $37.2 million, also the highest annual revenue recorded [2] - Non-core revenue for Q4 2025 is estimated between $7.9 million and $8.3 million, with annual non-core revenue expected between $32.7 million and $33.1 million [3] Operational Highlights - A record 15 Focal One system placements occurred in Q4 2025, indicating strong global demand from hospitals and urology centers [2] - The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, showcasing growing utilization [2] Strategic Outlook - The CEO emphasized that the growth in HIFU revenue now represents over half of the company's expected annual revenue, validating the execution strategy [4] - Increasing clinical validation and data from key trials are driving broader adoption of focal therapy for prostate cancer, with more hospital networks recognizing Focal One as a strategic investment [4] - The company is confident in its ability to deliver continued revenue growth and shareholder value creation in 2026, supported by a strong global pipeline and customer engagement [4]