EDAP TMS (EDAP) investor relations material

Executive summary

• Achieved record Q1 2026 revenue of $17.8 million, up 24.8% year-over-year, driven by a 78% surge in HIFU segment revenue and robust global demand for Focal One technology.

• Seven consecutive quarters of HIFU segment growth, with expanding adoption in both U.S. and international markets, and Focal One recognized as a leading multi-indication focal therapy platform.

• Significant clinical milestones, including publication of the HIFI-2 study and expansion into endometriosis and BPH indications.

• Net loss widened to $9.1 million ($0.24 per share), reflecting higher operating expenses and financial costs.

• U.S. HIFU procedures grew 53% year-over-year, with Focal One system shipments up 83% and new placements in prestigious centers.

Financial highlights

• HIFU revenue grew 78% year-over-year to $11.6 million, with 11 capital sales and a 30% increase in treatment-driven revenue.

• Non-core ESWL and Distribution revenue declined to $6.2 million, as part of a strategic shift.

• Gross profit rose to $8.1 million (45.7% margin), up from $6.0 million (42.0%) year-over-year.

• Operating expenses increased to $15.5 million, resulting in an operating loss of $7.4 million.

• Cash and cash equivalents at quarter-end were $15 million, with a subsequent $14 million credit facility drawdown post-quarter.

Outlook and guidance

• Reiterated full-year 2026 guidance: core HIFU revenue expected at $50–$54 million (34–45% growth), non-core revenue at $22–$26 million.

• Management expects continued losses in the foreseeable future and may require additional financing to support operations until profitability is achieved.

• Continued focus on commercial execution, indication expansion, and technology innovation for 2026.