EDAP TMS (FOCL) 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 growing 51% year-over-year and a record number of system sales globally.

• 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 toward high-growth HIFU business, with a wind-down of non-core ESWL and distribution segments.

• Clinical and regulatory milestones, including new reimbursement codes, positive clinical trial data, and a 5.4% increase in Medicare payment for 2025, support future growth.

• Net loss for 2024 was $20.5M, an improvement from $22.9M in 2023.

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 grew 17.9% in Q4.

• Gross profit margin improved to 44.8% in Q4 2024 from 43.7% in Q4 2023; 2024 gross profit was $28.7M (41.4% margin).

• Q4 net loss narrowed to EUR 1.9 million ($2.1M) from EUR 5 million ($5.5M) a year ago.

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

Outlook and guidance

• HIFU revenue expected to grow 16%-25% year-over-year in 2025, driven by system placements, procedure growth, and service revenue.

• 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 support 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.