EDAP TMS (EDAP, Financial) is set to unveil its cutting-edge Focal One i system at the 120th American Urological Association Annual Meeting in Las Vegas, Nevada, from April 26-29, 2025. This innovative system introduces a suite of enhanced features aimed at revolutionizing urological procedures.
The Focal One i system is designed to integrate seamlessly with expanded HIFUsion technologies, now including Prostate-Specific Membrane Antigen PET scans and ExactVu Micro-Ultrasound. Additionally, it offers extended support for Koelis 3D biopsy maps and DynaCAD Urology datasets, enriching diagnostic and treatment capabilities.
Improvements in workflow efficiency are achieved through streamlined HIFUsion and treatment processes, guided by step-by-step procedures. This enhancement is expected to significantly boost operational efficiency for medical professionals.
To foster knowledge sharing and best practices, the system includes onboard video libraries. Furthermore, it supports the streaming and recording of Focal One i treatments, facilitating remote proctoring and collaborative medical procedures.
This launch marks a significant step forward in urological treatment technology, promising to enhance both the precision and efficiency of procedures conducted by healthcare providers.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 2 analysts, the average target price for Edap TMS SA (EDAP, Financial) is $3.23 with a high estimate of $4.47 and a low estimate of $1.99. The average target implies an upside of 98.18% from the current price of $1.63. More detailed estimate data can be found on the Edap TMS SA (EDAP) Forecast page.
Based on the consensus recommendation from 3 brokerage firms, Edap TMS SA's (EDAP, Financial) average brokerage recommendation is currently 2.3, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Edap TMS SA (EDAP, Financial) in one year is $8.01, suggesting a upside of 391.41% from the current price of $1.63. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Edap TMS SA (EDAP) Summary page.
EDAP Key Business Developments
Release Date: March 27, 2025
- HIFU Revenue (Q4 2024): $9.3 million, a 15% increase year-over-year.
- Total Worldwide Revenue (Q4 2024): $21.5 million, a 1.1% growth year-over-year.
- Full Year 2024 Worldwide Revenue: $69.2 million, a 5.7% increase over 2023.
- Focal One System Sales (Q4 2024): 11 systems, including 7 in the US.
- Focal One Procedures Growth (2024): Approximately 51% increase over 2023.
- Gross Profit (Q4 2024): EUR9.1 million, with a gross margin of 44.8%.
- Operating Loss (Q4 2024): EUR3.7 million.
- Net Loss (Q4 2024): EUR1.9 million or EUR0.05 per diluted share.
- Cash and Cash Equivalents (End of Q4 2024): EUR29.8 million.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Edap TMS SA (EDAP, Financial) reported a strong fourth quarter performance with a 15% year-over-year increase in HIFU revenues, reflecting continued Focal One adoption.
- Focal One Robotic HIFU received CE Mark for the treatment of deep infiltrating Endometriosis, marking a significant regulatory milestone.
- The company recorded a record global number of Focal One system sales in the fourth quarter, including notable sales in the US and new markets like Portugal and Turkey.
- The publication of the HIFI study in European neurology is expected to drive additional Focal One procedure growth and potentially expand robotic HIFU into the first line treatment setting.
- Edap TMS SA (EDAP) is making significant progress in expanding Focal One robotic HIFU beyond prostate cancer, with clinical trials for pancreatic tumors and BPH underway.
Negative Points
- Despite revenue growth, Edap TMS SA (EDAP) reported an operating loss of EUR3.7 million for the fourth quarter of 2024.
- The company's non-core ESWL and distribution business is expected to decline between 20% and 25% in 2025, impacting overall revenue.
- Operating expenses increased to EUR12.8 million in the fourth quarter of 2024, primarily due to focused investments and variable compensation.
- The transition away from lower growth, low margin businesses like the Sonoli IMU lithotripsy product line may lead to short-term revenue declines.
- The company faces uncertainties related to potential changes in US tariff policies, although no material issues are currently anticipated.
