EDAP TMS (EDAP) Q1 2026 earnings summary

Executive summary

• Achieved record first quarter revenue of $17.8 million, up 24.8% year-over-year, driven by a 78% surge in HIFU segment growth and global expansion of Focal One placements.

• U.S. procedure volumes for Focal One increased 53% year-over-year, with shipments up 83%, reflecting rising adoption in academic and community hospitals.

• Net loss widened to $9.1 million ($0.24/share), compared to $7.4 million ($0.20/share) in Q1 2025, due to higher operating expenses and financial costs.

• Expanded clinical indications for Focal One, including prostate cancer, deep infiltrating endometriosis, and ongoing studies in benign prostatic hyperplasia (BPH).

• Hosted and participated in major scientific and educational events, reinforcing clinical leadership and market presence.

Financial highlights

• Gross profit increased to $8.1 million, with gross margin improving to 45.7% from 42% year-over-year.

• Operating expenses rose to $15.5 million, mainly due to higher marketing, sales, and administrative costs.

• Operating loss was $7.4 million, up from $6.3 million in Q1 2025.

• Cash and cash equivalents were $15 million at quarter-end, down $5.4 million from year-end 2025.

• Net financial expense was $1.7 million, primarily from warrant fair value changes and loan interest.

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 sustained growth.

• Strategic focus remains on expanding HIFU activities and de-emphasizing legacy ESWL and Distribution businesses.