EDAP TMS (EDAP) Q3 2024 earnings summary

Executive summary

• Achieved worldwide revenue of $14.4 million (EUR 13.1 million) in Q3 2024, up 11.6% year-over-year, driven by strong Focal One HIFU adoption and procedure growth, especially in the U.S.

• HIFU revenue grew 48.2% year-over-year, with U.S. Focal One procedures up 34% and three Focal One systems sold in Q3, all cash sales.

• Strategic collaborations, including with Avenda Health for AI-assisted HIFU, and strong presence at major urology conferences, are supporting market leadership.

• Clinical programs advanced, with first BPH patients treated in Phase I/II study and positive extension data from Phase 3 endometriosis trial.

• Board changes included the appointment of an interim chair and a new board member.

Financial highlights

• Q3 gross profit was EUR 5.2 million (USD 5.7 million), up from EUR 4.2 million (USD 4.5 million) last year; gross margin improved to 39.4% from 35.5%.

• Q3 net loss widened to EUR 6.4 million (USD 7.0 million), or EUR (0.17) per share, from EUR 3.9 million (USD 4.3 million), or EUR (0.11) per share, in Q3 2023.

• Operating expenses rose to EUR 11 million, mainly due to global Focal One commercial investments.

• Cash and cash equivalents at September 30, 2024, were EUR 25.5 million (USD 28.4 million), down from EUR 43.5 million (USD 48.1 million) at year-end 2023.

• Year-to-date revenue grew 7.3% to EUR 43.8 million (USD 47.6 million); net loss for nine months was EUR 17.1 million (USD 18.5 million), or EUR (0.46) per share.

Outlook and guidance

• Several customer purchasing decisions extended into Q4; management expects a strong finish to 2024 and a robust Focal One pipeline entering 2025.

• CMS finalized a 5.4% increase in Medicare Hospital Outpatient payment for Focal One HIFU procedures effective January 2025, supporting hospital adoption.

• Anticipate continued growth in Focal One adoption, supported by favorable reimbursement and increasing clinical data.

• U.S. BPH clinical trial planned for next year, building on ongoing French phase I/II study.

• Company plans to meet with FDA by year-end to discuss endometriosis program data and next steps.