Financial Data and Key Metrics Changes - The company reported total revenue for the full year 2024 of EUR64.1 million, an increase of 6.1% compared to EUR60.4 million in 2023 [51] - Fourth quarter revenue for 2024 was EUR20.3 million, a 3.6% increase from EUR19.6 million in the same period in 2023 [53] - HIFU revenue for the full year 2024 was EUR23.8 million, reflecting a year-over-year growth of 15.7% [52] - Gross profit for Q4 2024 was EUR9.1 million, with a gross profit margin of 44.8%, up from 43.7% in the previous year [56] Business Line Data and Key Metrics Changes - HIFU business revenue for Q4 2024 was EUR8.8 million, compared to EUR7.5 million in Q4 2023, driven by 11 Focal One systems sold [54] - Disposable revenues in the HIFU segment grew by 28.5% year-over-year [54] - The ESWL division reported revenue of EUR2.4 million for Q4 2024, a slight increase from EUR2.3 million in Q4 2023, while distribution revenue decreased to EUR9.1 million from EUR9.9 million [55] Market Data and Key Metrics Changes - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [13] - Focal One procedures in the U.S. grew approximately 31% year-over-year in Q4 2024, with total procedures growing about 51% over 2023 [15] Company Strategy and Development Direction - The company aims to focus on high-growth market opportunities, particularly in the HIFU segment, while reducing investments in lower-growth, low-margin businesses [45] - The recent CE Mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry [7][9] - The company plans to phase down its non-core ESWL and distribution business to concentrate on the HIFU growth strategy [63] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16% to 25% year-over-year for 2025 [62] - The positive reception of the landmark HIFI study is expected to drive demand for Focal One in 2025 and beyond [64] - The company is committed to expanding its HIFU technology into new indications, including BPH and pancreatic tumors [24][44] Other Important Information - The company reported a net loss of EUR1.9 million for Q4 2024, an improvement from a net loss of EUR5 million in the same period in 2023 [58] - Total cash and cash equivalents at the end of Q4 were EUR29.8 million, up from EUR25.5 million at the end of Q3 2024 [59] Q&A Session Summary Question: Guidance on HIFU sales growth - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [67][69] Question: Non-core ESWL and distribution business phase down - The company is transitioning away from non-core distribution products, focusing on high-growth HIFU business, but cannot project if it will phase down to zero [70][72] Question: Capital equipment purchase patterns from hospitals - The sales cycle remains elongated, but the company has adapted its strategy to close deals more effectively, emphasizing the clinical necessity of its offerings [79][81] Question: Impact of increased reimbursement on hospital interest - The recent increase in CMS reimbursement is expected to enhance interest from hospitals in adopting Focal One, as it allows more patients access to the technology [84][86] Question: Strategy on endometriosis commercialization - The company is in the early stages of expanding clinical development efforts following the CE Mark for treating deep infiltrating endometriosis [93][95] Question: Data from the pancreatic tumor study - The PULS trial is in its early stages, being conducted locally in France, with patient recruitment ongoing [97][99] Question: Revenue growth expectations related to reimbursement - The revenue growth guidance is primarily based on the core business of prostate cancer treatment, with additional potential from new indications not factored in [102][105]