EDAP TMS (EDAP) Q1 2025 earnings summary

Executive summary

• Achieved record first-quarter placements of nine Focal One Robotic HIFU systems, including major U.S. hospital networks and international markets, the highest in company history.

• Launched the new Focal One i Robotic HIFU system with enhanced features and received CE mark for treating deep infiltrating endometriosis.

• Conducted the world's first remote transatlantic Focal One Robotic HIFU procedure, marking a significant clinical and technological milestone.

• Presented positive final results from the FARP randomized controlled trial, supporting HIFU as a first-line prostate cancer treatment.

• Hosted first-ever Robotic Focal HIFU masterclass and had largest presence at AUA meeting, with multiple clinical presentations and hands-on demonstrations.

Financial highlights

• HIFU revenue rose 6.8% year-over-year to EUR 6.2 million, driven by increased system sales and service revenue.

• Total worldwide revenue declined 9.1% year-over-year to EUR 13.6 million, reflecting expected decreases in non-core segments.

• Gross profit was EUR 5.7 million with a margin of 42%, down from 42.8% in the prior year.

• Net loss widened to EUR 7.1 million (EUR 0.19 per share), compared to EUR 4.5 million in Q1 2024.

• Cash and cash equivalents at quarter-end were EUR 22.8 million, down from EUR 29.8 million at year-end.

Outlook and guidance

• Reiterated 2025 guidance: HIFU revenue expected to grow 16%-25% year-over-year; non-core businesses to decline 20%-25%.

• Confident in achieving HIFU growth targets despite payer challenges and lumpy capital equipment environment.