• 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.

• Warning! GuruFocus has detected 4 Warning Signs with EDAP.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Edap TMS SA (NASDAQ:EDAP) 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 (NASDAQ: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 (NASDAQ: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.

Q & A Highlights

Q: Can you provide more detail on the expected growth in HIFU sales for 2025, particularly regarding system placements and procedure growth? A: We anticipate continued demand for Focal One, with strong sales both in the US and international markets. Our pipeline is robust, and we expect increased Focal One system sales, procedure growth, and service revenue from our installed base to drive our projected growth in 2025. - Ryan Rhodes, Chief Executive Officer

Q: What is the strategy for the non-core ESWL and distribution business, and how quickly do you expect these to decline? A: We are transitioning away from legacy regional agreements and relationships, focusing more on our high-growth HIFU business. While I can't predict if these will go to zero, we are winding down some of this business to focus on HIFU. The lithotripsy business will continue as a service business, which is margin accretive. - Ryan Rhodes, Chief Executive Officer and Ken Mobeck, Chief Financial Officer

Q: How are capital equipment purchase patterns from hospitals evolving in 2025, and are decision-making processes still elongated? A: Sales cycle times remain consistent, and we've adapted our strategy to be more effective in navigating these processes. Our pipeline is growing, and we are confident in our ability to close deals timely, given the strategic importance of prostate cancer treatment to hospitals. - Ryan Rhodes, Chief Executive Officer

Q: Has the recent CMS reimbursement increase led to more interest from hospitals in adopting Focal One? A: Yes, the 5.4% increase in reimbursement helps in pro forma analyses with hospitals, making the prostate cancer patient a valuable addition to their services. This increase allows more patients access to our technology and strengthens our reimbursement position. - Ryan Rhodes, Chief Executive Officer

Q: What is the strategy for commercializing Focal One for Endometriosis following the CE Mark approval? A: With the CE Mark, we are expanding efforts with Endometriosis experts and key thought leaders to refine and expand clinical development. We are in the early phase of a controlled market entry in CE Mark countries, working with expert physicians to advance this treatment. - Ryan Rhodes, Chief Executive Officer

For the complete transcript of the earnings call, please refer to the full earnings call transcript.