EDAP TMS S.A. reported Q1 2025 earnings, with management highlighting strategic decisions to transform the company into a global leader in HIFU focal therapy. The company announced several achievements, including the launch of a new product and expansion into new markets. The CFO, Ken Mobeck, will discuss financial results. Analysts from Jefferies and H.C. Wainwright will also participate in the Q&A session.
EDAP TMS S.A. (Nasdaq: EDAP), a leading developer of robotic energy-based therapies, reported its first-quarter 2025 financial results, highlighting a strategic pivot towards high-frequency ultrasound (HIFU) focal therapy. The company's CEO, Ryan Rhodes, announced strong performance in the HIFU segment, with a 6.8% increase in revenue to €6.2 million, despite a 9.1% decrease in total revenue to €13.6 million. The net loss for the quarter stood at €7.1 million, compared to €4.5 million in the same period last year, reflecting increased investment in HIFU development and commercialization [1].
Key achievements include the CE Mark approval for the Focal One® Robotic HIFU System in treating deep infiltrating endometriosis and the positive final results from the FARP randomized trial showing non-inferiority to radical prostatectomy. The company also launched the new Focal One i Robotic HIFU System, which incorporates enhanced features and expanded compatibility with multimodal imaging data [1].
The strategic shift is evident in the company's Q1 performance, with nine Focal One systems installed, the highest number of placements for any first quarter in EDAP's history. This momentum is driven by two critical clinical developments: the FARP trial results and the launch of the Focal One i system. The FARP trial, presented at the AUA 2025 meeting, demonstrated non-inferiority between focal ablation and radical prostatectomy for early-stage prostate cancer, providing Level 1 evidence supporting HIFU focal therapy as a viable first-line treatment option [1].
EDAP's cash position stood at €22.8 million as of March 31, 2025, indicating the company's financial stability as it executes its strategic pivot. The company maintains its 2025 guidance of 16-25% growth in core HIFU business and expects revenue declines between 20 and 25% in its non-core businesses (ESWL and Distribution) [1].
The CFO, Ken Mobeck, will discuss the financial results during a conference call scheduled for Thursday, May 15th, at 8:30 AM Eastern Time. Analysts from Jefferies and H.C. Wainwright will also participate in the Q&A session.
References:
[1] https://www.stocktitan.net/news/EDAP/edap-reports-first-quarter-2025-financial-9xmdyvrstikz.html
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