Core Insights - EDAP TMS SA reported record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and increasing procedure growth [1][2] - The company anticipates 36% to 38% annual year-over-year growth in HIFU revenue for 2026, with initial revenue guidance set between $50.0 million and $54.0 million [1][5] Financial Performance - For Q4 2025, worldwide HIFU revenue is projected to be between $12.9 million and $13.3 million, marking the highest quarterly revenue in the company's history [2] - Annual 2025 HIFU revenue is expected to range from $36.7 million to $37.2 million, also the highest annual revenue recorded [2] - Non-core revenue for Q4 2025 is estimated between $7.9 million and $8.3 million, with annual non-core revenue expected between $32.7 million and $33.1 million [3] Operational Highlights - A record 15 Focal One system placements occurred in Q4 2025, indicating strong global demand from hospitals and urology centers [2] - The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, showcasing growing utilization [2] Strategic Outlook - The CEO emphasized that the growth in HIFU revenue now represents over half of the company's expected annual revenue, validating the execution strategy [4] - Increasing clinical validation and data from key trials are driving broader adoption of focal therapy for prostate cancer, with more hospital networks recognizing Focal One as a strategic investment [4] - The company is confident in its ability to deliver continued revenue growth and shareholder value creation in 2026, supported by a strong global pipeline and customer engagement [4]

Core Insights - EDAP TMS SA reported its strongest second quarter performance in company history, with a net total of 12 Focal One Robotic HIFU Systems placed, driven by increased customer demand from both U.S. and international markets [2][6] - The company executed a letter of intent with the European Investment Bank for a credit facility of 36 million Euros to support the expansion of its Focal One platform and focused ultrasound technologies [2][8] - The company anticipates continued growth in demand for Focal One treatments as more prostate cancer patients recognize its advantages, supported by recent clinical studies [2][6] Financial Performance - Total revenue in the HIFU business for Q2 2025 was EUR 8.5 million (USD 9.7 million), a 76.8% increase from EUR 4.8 million (USD 5.2 million) in Q2 2024 [6][9] - The company recorded a 23.9% year-over-year growth in worldwide disposable revenue, with Focal One procedures growing 4.8% in the U.S. [6][9] - Total worldwide revenue for Q2 2025 was EUR 16.0 million (USD 18.4 million), a slight increase of 1.6% compared to EUR 15.8 million (USD 17.0 million) in Q2 2024 [9] Business Segments - The non-core business (ESWL and Distribution) revenue for Q2 2025 was EUR 7.6 million (USD 8.7 million), down from EUR 11.0 million (USD 11.8 million) in Q2 2024, reflecting a strategic focus on the high-growth HIFU opportunity [7][9] - For the first half of 2025, total revenue in the HIFU business was EUR 14.7 million (USD 16.1 million), a 38.5% increase from EUR 10.6 million (USD 11.4 million) in the same period of 2024 [13] - The non-core business revenue for the first half of 2025 was EUR 15.0 million (USD 16.5 million), a 25.7% decrease compared to EUR 20.1 million (USD 21.7 million) in the first half of 2024 [14] Profitability Metrics - Gross profit for Q2 2025 was EUR 6.8 million (USD 7.8 million), with a gross profit margin of 42.5%, up from 37.5% in Q2 2024 [10] - Operating loss for Q2 2025 was EUR 5.8 million (USD 6.6 million), an improvement from an operating loss of EUR 6.1 million (USD 6.6 million) in Q2 2024 [11] - Net loss for Q2 2025 was EUR 5.6 million (USD 6.4 million), or EUR (0.15) per share, compared to a net loss of EUR 6.1 million (USD 6.6 million), or EUR (0.16) per share in Q2 2024 [12] Future Outlook - The company updated its 2025 financial guidance, expecting core HIFU business revenue growth to be between 26% and 34% year-over-year, up from the previous range of 16% to 25% [5][7] - The combined non-core ESWL and Distribution business revenue is expected to decline between 25% and 30% year-over-year [5][7] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8-10, 2025 [4]

Core Insights - EDAP TMS SA has announced a letter of intent for a EUR 36 million credit facility with the European Investment Bank (EIB) to support the growth of Focal One Robotic HIFU in the treatment of early-stage prostate cancer [1][2] - The financing will enhance the company's balance sheet and provide low-interest funding accessible in tranches as needed [2] - The credit facility is expected to close by the end of Calendar Year 2025, pending final legal documentation [1] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced Focal One as a leading prostate focal therapy, with potential applications beyond prostate cancer [3]