EDAP TMS (FOCL) Q3 2026 earnings summary

Executive summary

• Q3 continuing-operations revenue rose 25.5% YoY to $9.828M; U.S. Focal One procedures grew 32% and seven systems were sold.

• Strategic realignment centers on robotic focal therapy and Focal One; ESWL and Distribution are classified as discontinued operations, with disposal expected within one year of held-for-sale classification.

Financial highlights

• Q3 revenue was $9.828M vs. $7.828M; 9M revenue was $34.624M vs. $23.838M.

• Q3 gross margin increased to 51.4% from 46.6%; operating expenses rose to $12.829M from $10.316M and operating loss widened to $7.777M from $6.669M.

• Consolidated Q3 net loss narrowed to $4.462M, or $0.10/share, from $5.940M, or $0.16/share; 9M net loss widened to $28.032M from $19.790M.

• Q3 net financial income of $2.038M included a $2.6M EIB warrant fair-value gain, partly offset by interest expense.

Outlook and guidance

• FY 2026 revenue guidance narrowed from $50M–$54M to $50M–$52M, representing stated growth of 34%–39% over 2025.

• Three systems expected in Q3 were forecast to generate Q4 revenue; by the call, one sale had closed and two purchase orders were signed.

• HIFUSA, a Phase III randomized trial with 14 centers and 108 patients, is expected to publish data in early 2027 after final-patient follow-up in Q1.