EDAP TMS (EDAP) Q4 2024 earnings summary

Executive summary

• Achieved record revenue in 2024, driven by strong growth in the HIFU segment and increased adoption of Focal One for prostate cancer treatment, with U.S. Focal One HIFU procedures up 51% year-over-year.

• Focal One received CE Mark for deep infiltrating endometriosis, expanding addressable markets, and first patients treated in BPH and pancreatic cancer HIFU studies.

• Strategic focus is shifting to high-growth HIFU business, with reduced investment in legacy ESWL and distribution segments.

• Added two experienced board members, Glen French and Joshua H. Levine, to support growth and transformation.

• Favorable reimbursement for HIFU procedures in the U.S. continues, with a 5.4% increase in Medicare payment for 2025.

Financial highlights

• Full-year 2024 revenue reached EUR 64.1 million ($69.2M), up 6.1% year-over-year; HIFU revenue grew 15.7% to EUR 23.8 million ($25.7M).

• Q4 2024 revenue was EUR 20.3 million ($21.5M), up 3.6% year-over-year; HIFU segment up 17.9%.

• Gross profit margin improved to 44.8% in Q4 2024 from 43.7% in Q4 2023; full-year gross margin was 41.4%.

• Q4 2024 net loss was EUR 1.9 million ($2.1M), a significant improvement from EUR 5 million ($5.5M) loss in Q4 2023; full-year net loss was $20.5M, improved from $22.9M in 2023.

• Cash and cash equivalents at year-end 2024 were EUR 29.8 million ($30.9M), up from EUR 25.5 million in Q3 but down from $48.1M at year-end 2023.

Outlook and guidance

• HIFU revenue expected to grow 16%-25% year-over-year in 2025.

• Non-core ESWL and distribution business projected to decline 20%-25% in 2025.

• OpEx anticipated to increase in the mid-single digits, with labor cost reallocation to HIFU growth.

• Management expects continued momentum in Focal One HIFU adoption, with expansion into new indications and geographies.

• Largest presence planned at the American Urology Association Meeting in Q2 2025.