EDAP TMS (EDAP) Q2 2025 earnings summary

Executive summary

• Achieved record Q2 HIFU revenue of $9.7M, up 89% year-over-year, driven by 12 Focal One system placements, including major hospital networks and international sites.

• Focal One net placements grew 140% year-over-year; HIFU revenue up 76.8% year-over-year in Q2 2025.

• Focal One i, the next-gen robotic HIFU platform, delivered its first U.S. system and performed several procedures, supporting broader adoption.

• Expanded clinical indications with CE Mark for endometriosis and initiated commercialization in Europe, positioning the platform for multi-application growth.

• Entered a €36M ($42M) strategic financing facility with the European Investment Bank to support commercial expansion and R&D.

Financial highlights

• Q2 2025 total revenue was €16M, up 1.6% year-over-year, with HIFU revenue up 76.8% to €8.5M.

• Gross margin improved to 42.5% from 37.5% year-over-year, driven by focus on high-margin HIFU.

• Operating loss for Q2 was €5.8M, slightly improved from €6.1M in Q2 2024; net loss was €5.6M (€0.15/share) vs. €6.1M (€0.16/share) prior year.

• Cash and cash equivalents at Q2 end were €16.3M, down from €22.8M in Q1, reflecting investment in HIFU growth.

• Inventory decreased to €15.5M due to improved management and higher turnover.

Outlook and guidance

• Raised 2025 HIFU revenue growth guidance to 26–34% year-over-year (from 16–25%); non-core ESWL/distribution expected to decline 25–30%.

• Confident in strong pipeline and continued HIFU adoption, supported by expanded sales team and clinical data.