EDAP TMS S.A. reported record high‑intensity focused ultrasound (HIFU) revenue for both the fourth quarter and the full year of 2025. Fourth‑quarter HIFU sales reached €11.7 million, a 34 % year‑over‑year increase, while full‑year HIFU revenue climbed to €33.1 million, up 39 % from the previous year.
Gross margin for the quarter fell to 42.6 % from 44.8 % in 2024, largely because of tariff impacts on finished goods imported from France and a reserve for legacy inventory. Operating loss widened to €5.2 million from €3.7 million, and net loss expanded to €8.2 million. The company’s 15 Focal One robotic platform placements in the quarter—14 cash sales and one lease—underscored strong demand for the system.
Total revenue for the quarter was €18.9 million, down 7 % from €20.3 million in Q4 2024, and full‑year total revenue fell 3 % to €62.4 million from €64.1 million. Non‑core ESWL and distribution sales declined 27 % to €29.4 million. Cash and cash equivalents at the end of Q4 were €17.4 million, a drop from €29.8 million at the end of 2024. Management reiterated 2026 revenue guidance of $72.0 million to $80.0 million, with core HIFU revenue expected to be $50.0 million to $54.0 million.
Earnings per share missed consensus estimates, reporting $-0.22 versus an expected $-0.16, a miss of $0.06. Revenue beat expectations, with $21.88 million reported against an estimate of $21.32 million. The margin compression was driven by tariffs and the legacy inventory reserve; excluding those items, gross margin would have been approximately 46.9 %. The widening net loss was largely due to a €2.5 million non‑cash charge related to warrants and interest expense on the European Investment Bank (EIB) Tranche A drawdown, and a €2 million negative currency impact versus the prior‑year period.
CEO Ryan Rhodes said, "We experienced strong global demand for Focal One Robotic HIFU as demonstrated by our 2025 results." CFO Ken Mobeck added, "The decline in gross margin was primarily due to the impact of tariffs on imports of finished goods from France and an inventory reserve related to legacy parts. Excluding these items, gross margin would have been approximately 46.9 %." Mobeck also explained the net loss increase: "The increase was driven by two items below the operating line. A €2.5 million non‑cash charge related to warrants and interest expense on the European Investment Bank (EIB) Tranche A drawdown, and a €2 million negative currency impact versus the prior‑year period." Rhodes noted, "Entering 2026, our pipeline continues to build, and demand for Focal One remains well balanced across both academic and community treatment centers. Importantly, we are also beginning to see large, integrated healthcare networks purchase multiple Focal One systems, signifying that Focal One is increasingly being adopted as an important technology platform for addressing early‑stage prostate cancer." He added, "2025 was a transformative year for our company, highlighted by 39 % revenue growth in our core HIFU business and record commercial performance for Focal One. Importantly, much of this growth was driven by accelerated adoption in the U.S., where we delivered record system placements and strong procedure growth."
Investors reacted negatively to the earnings release, focusing on the EPS miss and the widening net loss. The revenue beat and strong HIFU growth were offset by concerns about margin compression, cash runway, and the company’s continued net losses, leading to a cautious market stance.
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