StockWatch
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Biotechnology: Electromedical & Electrotherapeutic Apparatus
Quarterly ResultMay 7, 2026, 07:33 AM

EDAP Q1 HIFU Revenue +78% to $11.6M; Total Revenue $17.8M

AI Summary

EDAP TMS SA reported strong financial results for the first quarter of 2026, with record HIFU revenue of $11.6 million, representing a 78% year-over-year increase. U.S. Focal One procedure volumes grew 53%, and Focal One system shipments increased 83%. Total worldwide revenue reached $17.8 million, up from $14.3 million in Q1 2025, with gross profit margin improving to 45.7%. The company also highlighted positive results from the landmark HIFI-2 study. However, operating loss increased to $7.4 million and net loss to $9.1 million, or ($0.24) per share. EDAP reiterated its 2026 HIFU revenue guidance of $50.0 million to $54.0 million.

Key Highlights

  • Q1 2026 HIFU revenue increased 78% year-over-year to $11.6 million.
  • U.S. Focal One procedures grew 53% year-over-year.
  • Eleven Focal One systems were sold, an 83% increase from Q1 2025.
  • Total worldwide revenue for Q1 2026 was $17.8 million, up from $14.3 million in Q1 2025.
  • Gross profit margin improved to 45.7% from 42.0% in Q1 2025.
  • Net loss for Q1 2026 was $9.1 million, or ($0.24) per share, compared to $7.4 million, or ($0.20) per share, in Q1 2025.
  • Reiterated 2026 HIFU revenue guidance of $50.0 million to $54.0 million.
  • Cash, cash equivalents and short-term investments were $15.0 million as of March 31, 2026.