Edap TMS SA: Q4 FY2025 earnings call
What management said about Q4 FY2025, from the documents filed with the SEC on 25 March 2026: press release. Guidance figures: 2 kept. The quarter’s numbers.
Key takeaways
- Full-year HIFU revenue rose 39%: HIFU business revenue for 2025 was €33.1 million ($37.4 million), up from €23.8 million ($25.8 million) in 2024. Source
- Full-year total revenue down 3%: Worldwide revenue for 2025 was €62.4 million ($70.5 million), down 3% from €64.1 million ($69.4 million) in 2024, with lower non-core revenue. Source
- Full-year net loss widened: Net loss was €25.9 million ($29.2 million), or €(0.69) per share, against €19.0 million ($20.6 million), or €(0.51), in 2024. Source
- Record fourth-quarter system placements: Net system placements in the fourth quarter were 15, described as a quarterly record: 14 cash sales and one operating lease. Source
- U.S. procedures up 28% in Q4: U.S. Focal One procedures rose 28% year over year in the fourth quarter, the second consecutive quarter of double-digit procedure growth. Source
- Q4 gross margin fell on tariffs: Fourth-quarter gross margin was 42.6%, against 44.8%. Management attributed the drop to tariffs on goods imported from France and an inventory reserve; excluding these, it was about 46.9%. Source
- Year-end cash down to €17.4 million: Cash, cash equivalents and short-term investments were €17.4 million at 31 December 2025, against €29.8 million a year earlier. Source
“We experienced strong global demand for Focal One Robotic HIFU as demonstrated by our 2025 results,”
Ryan Rhodes, Chief Executive Officer
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Total revenue Source | 2026 | $72.0 million to $80.0 million | Kept |
| Core HIFU revenue Source | 2026 | $50.0 million to $54.0 million | Kept |
What changed from last quarter
- Guidance kept: 2026 total revenue guidance of $72.0 million to $80.0 million was reiterated, with no change to the range. Source
Full-year and fourth-quarter results
- Full-year HIFU revenue rose 39%: HIFU business revenue for 2025 was €33.1 million ($37.4 million), up from €23.8 million ($25.8 million) in 2024. Source
- Full-year HIFU above January range: The $37.4 million full-year HIFU figure is above the preliminary range of $36.7 million to $37.2 million given on 12 January 2026.
- Full-year total revenue down 3%: Worldwide revenue for 2025 was €62.4 million ($70.5 million), down 3% from €64.1 million ($69.4 million) in 2024, with lower non-core revenue. Source
- Full-year net loss widened: Net loss was €25.9 million ($29.2 million), or €(0.69) per share, against €19.0 million ($20.6 million), or €(0.51), in 2024. Source
- Fourth-quarter revenue down 7%: Fourth-quarter worldwide revenue was €18.9 million ($21.9 million), against €20.3 million ($21.8 million) a year earlier. Source
HIFU and non-core segments
- Non-core revenue down 27%: Non-core businesses (ESWL and Distribution) brought in €29.4 million ($33.2 million) in 2025, down 27% from €40.3 million ($43.6 million) in 2024. Source
- Fourth-quarter non-core revenue lower: Non-core revenue in the fourth quarter was €7.2 million ($8.4 million), against €11.5 million ($12.3 million) a year earlier. Source
- Non-core decline tied to HIFU focus: Management attributed the lower non-core revenue to the company continuing to prioritize its HIFU business. Source
- Division gross margins differ: 2025 gross margins on net sales were 48.1% for HIFU, 46.2% for ESWL and 33.4% for Distribution. HIFU recorded an operating loss of €18.3 million; ESWL an operating profit of €1.9 million. Source
“Looking ahead, we believe the adoption of focal therapy will continue to expand globally, and we remain well positioned to meet this growing demand from urologists and their patients.”
Ryan Rhodes, Chief Executive Officer
Focal One systems and procedures
- Record fourth-quarter system placements: Net system placements in the fourth quarter were 15, described as a quarterly record: 14 cash sales and one operating lease. Source
- Full-year placements up 69%: Focal One system placements rose 69% for the full year 2025. Source
- U.S. procedures up 28% in Q4: U.S. Focal One procedures rose 28% year over year in the fourth quarter, the second consecutive quarter of double-digit procedure growth. Source
- Disposables revenue up 43%: Worldwide disposables revenue grew 43% in the fourth quarter, which management linked mainly to 28% growth in U.S. procedures. Source
- Large networks buying multiple systems: Management said large integrated healthcare networks have begun buying multiple Focal One systems. Source
Gross margin, tariffs and costs
- Q4 gross margin fell on tariffs: Fourth-quarter gross margin was 42.6%, against 44.8%. Management attributed the drop to tariffs on goods imported from France and an inventory reserve; excluding these, it was about 46.9%. Source
- Full-year gross margin up to 42.5%: Gross profit margin on net sales was 42.5% for 2025, up from 41.4%. Gross profit was €26.6 million in both years. Source
- Operating expenses higher year over year: Operating expenses were €48.4 million for 2025, against €47.1 million in 2024. Fourth-quarter operating expenses were €13.2 million, against €12.8 million. Source
- Q4 net loss widened: Fourth-quarter net loss was €8.2 million, or €(0.22) per share, against €1.9 million, or €(0.05), a year earlier. Operating loss was €5.2 million. Source
“Entering 2026, our pipeline continues to build, and demand for Focal One remains well balanced across both academic and community treatment centers.”
Ryan Rhodes, Chief Executive Officer
Cash, debt and equity
- Year-end cash down to €17.4 million: Cash, cash equivalents and short-term investments were €17.4 million at 31 December 2025, against €29.8 million a year earlier. Source
- Operating cash outflow €14.5 million: Net cash used in operating activities was €14.5 million in 2025, against €13.6 million in 2024. Capital spending was €5.1 million. Source
- Non-current debt rose to €13.5 million: Non-current long-term debt was €13.5 million at year-end, against €2.2 million. Short-term borrowing was €5.1 million, against €6.2 million. Source
- Shareholders' equity fell to €16.5 million: Total shareholders’ equity was €16.5 million at 31 December 2025, against €40.9 million a year earlier. Source
Demand and strategy
- Pipeline continues to build: Management said the pipeline keeps building into 2026, with demand balanced across academic and community treatment centers. Source
- Drivers of Focal One demand: Management attributed demand to growing clinical data, the platform's versatility and adaptability, and patient interest in a non-invasive option. Source
- Focal therapy adoption expected to expand: Management expects focal therapy adoption to keep expanding globally, and says the company is positioned to meet demand from urologists and patients. Source
Leadership and results call
- Executives hosted results call: Ryan Rhodes, Ken Mobeck and François Dietsch hosted the results call on March 25, 2026, at 8:30 a.m. Eastern Time. Source
- Completed results replace preliminary figures: The January release said its figures were preliminary and subject to completion of quarter-end reporting. This release gives the completed full-year figures.
Coming up, as management said on 25 March 2026
- AUA annual meeting in May: Listed as an upcoming meeting: the American Urological Association annual meeting in Washington, D.C., May 15 to 18, 2026. Source
- Investor Day on June 1: Investor Day is listed for June 1, 2026, at Nasdaq MarketSite in New York City. Source
- Jefferies healthcare conference in June: Listed as an upcoming event: the Jefferies Global Healthcare Conference, June 2 to 4, 2026, in New York City. Source
Figures management reported
| Figure | Reported |
|---|---|
| Focal One net system placements, Q4 2025 Source | 15 (14 cash sales, one operating lease) |
| Focal One systems sold, Q4 2025 Source | 14, against 11 in Q4 2024 |
| Focal One system placements, full year 2025 Source | up 69% year over year |
| U.S. Focal One procedures, Q4 2025 Source | up 28% year over year |
| Worldwide disposables revenue, Q4 2025 Source | up 43% year over year |
Risks management discussed
- External: Management said tariffs on imports of finished goods from France reduced fourth-quarter gross margin. Source
- Operational: An inventory reserve related to legacy parts also reduced fourth-quarter gross margin. Source
- Demand: Non-core revenue declined as the company prioritizes growth in its HIFU business. Source
Earlier plans management reported on
- Not stated: The company said it reiterates revenue guidance issued earlier. No status term is used for it. Source
- Not stated: The January release said completed annual results would be released in March 2026. The current release is dated March 25, 2026.
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.