EDAP Reports Record Q2 Revenue, Driven by Focal One Robotic HIFU System Demand

EDAP reported Q2 revenue of $18.431 million, surpassing analyst expectations, driven by strong demand for Focal One Robotic HIFU Systems. The company plans to expand its Focal One platform and has signed a letter of intent with the European Investment Bank for low-interest capital. Looking ahead, EDAP expects its Focal One pipeline to strengthen as awareness of its benefits grows among prostate cancer patients. EDAP's financial health presents a mixed picture, with a modest revenue growth rate, negative margins, and a conservative approach to leverage. However, its valuation metrics suggest potential undervaluation.

EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, reported its second-quarter 2025 financial results, showcasing a robust performance driven by increased demand for its Focal One Robotic HIFU Systems. The company's revenue for the period reached EUR 16.0 million (USD 18.4 million), exceeding analyst expectations and marking a 1.6% increase compared to the same period last year [1].

The second quarter saw a significant increase in the HIFU business, with total revenue growing by +76.8% year over year, driven by nine Focal One capital sales compared to three systems sales in the previous year. The company's core HIFU business revenue is now expected to grow within the range of 26% to 34% year over year, up from the prior range of 16% to 25% [1].

EDAP has also secured a significant financial boost with the signing of a letter of intent for a 36 million Euro credit facility with the European Investment Bank (EIB). This low-interest capital will support the acceleration of the HIFU growth and strategic expansion of the Focal One platform [1].

Despite the positive financial results, EDAP's financial health presents a mixed picture. The company reported a net loss of EUR 5.6 million (USD 6.4 million) for the second quarter, with gross profit margin increasing to 42.5% from 37.5% in the comparable period last year. The increase in gross profit margin was primarily due to the strategic focus on the core HIFU business segment [1].

Looking ahead, EDAP expects its Focal One pipeline to strengthen as awareness of its benefits grows among prostate cancer patients. The company is also planning to attend and present at the upcoming H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8-10, 2025 [1].

References:
[1] https://investor.focalone.com/news-releases/news-release-details/edap-reports-strong-second-quarter-2025-hifu-results