EDAP TMS (EDAP) investor relations material

Executive summary

• Achieved 39% year-over-year revenue growth in core HIFU business, driven by record Focal One system sales and strong U.S. procedure growth, with placements up 69% year-over-year.

• U.S. market drove growth with record system placements and procedure volumes, expanding presence in leading academic and community hospitals.

• International expansion included first Focal One placements in India and Argentina, and continued growth in Europe and South America.

• Received FDA clearance for next-generation Focal One robotic HIFU with advanced imaging and planning capabilities.

• Strategic priorities for 2026 focus on commercial execution, clinical indication expansion, and technology innovation.

Financial highlights

• Full year 2025 HIFU revenue reached €33.1 million ($37.4 million), up 39% from €23.8 million in 2024.

• Total 2025 revenue was €62.4 million ($70.5 million), down 3% year-over-year due to a 27% decline in non-core businesses.

• Q4 2025 HIFU revenue was €11.7 million ($13.5 million), up 34% year-over-year; total Q4 revenue was €18.9 million, down 7%.

• Gross margin for Q4 was 42.6%, down from 44.8% in Q4 2024, impacted by tariffs and inventory reserves; adjusted gross margin would have been 46.9%.

• Q4 net loss was €8.2 million ($9.5 million), or (€0.22) per share, compared to €1.9 million in Q4 2024; full-year net loss was €25.9 million ($29.2 million), or (€0.69) per share.

Outlook and guidance

• 2026 core HIFU revenue expected between $50 million and $54 million, representing 34%-45% growth over 2025.

• Non-core revenue projected at $22 million-$26 million for 2026.

• 2026 total revenue guidance reiterated at $72.0–$80.0 million.

• Q4 anticipated to be the strongest quarter in 2026, with less than 50% of business in the first half and a seasonal dip in Q3.

• Continued focus on cash sales as primary sales model, with average selling prices stable or slightly increasing.