EDAP TMS(EDAP) - 2025 Q1 - Quarterly Report

EDAP Reports First Quarter 2025 Financial Results Management Commentary & Business Highlights In Q1 2025, EDAP's management highlighted a record number of nine Focal One system placements, underscoring strong market adoption. This growth is supported by positive clinical data from the FARP trial, which provided Level 1 evidence for focal ablation. Key strategic developments include the launch of the advanced Focal One i system, receiving CE Mark approval for endometriosis treatment, and strengthening the Board of Directors with experienced executives - Achieved a record nine Focal One system placements, the highest for any first quarter in the company's history, indicating strong growth and adoption[8] - Launched the new Focal One i Robotic HIFU System, which includes enhanced capabilities like expanded compatibility with PSMA PET scans and streamlined workflows[8][11][12] - Final results from the FARP randomized controlled trial demonstrated that focal ablation was non-inferior to radical prostatectomy for early-stage prostate cancer, providing Level 1 evidence supporting its use[9][11][12] - Received CE Mark designation for the Focal One system for the treatment of deep infiltrating endometriosis, expanding its clinical applications[11][13] - Successfully performed the world's first remote transcontinental Focal One Robotic HIFU procedure[11][13] - Appointed Glen French and Joshua H. Levine, executives with extensive experience in the medical device industry, to its Board of Directors[13] Financial Performance For Q1 2025, total revenue decreased 9.1% year-over-year to €13.6 million, primarily due to a strategic de-emphasis on non-core businesses. The core HIFU business grew 6.8%, while non-core revenue declined as planned. The company reported a wider operating loss of €6.0 million and a net loss of €7.1 million, reflecting increased investments in the HIFU segment. EDAP reiterated its full-year 2025 guidance, anticipating 16-25% revenue growth in its core HIFU business 2025 Financial Guidance The company reaffirmed its full-year 2025 financial guidance, projecting strong double-digit revenue growth in its core HIFU business while anticipating a planned contraction in its non-core segments as it focuses on focal therapy - Expects year-over-year revenue growth of 16% to 25% in the core HIFU business[15] - Expects revenue declines between 20% and 25% in its non-core businesses (ESWL and Distribution)[15] First Quarter 2025 Results In Q1 2025, total revenue declined 9.1% YoY to €13.6 million, driven by a planned reduction in the non-core business. The core HIFU segment's revenue grew 6.8% to €6.2 million. Gross margin contracted slightly to 42.0% from 42.8%. The operating loss increased to €6.0 million from €4.8 million in Q1 2024, due to focused investments in the HIFU business. Net loss was €7.1 million, or €(0.19) per share Q1 2025 Key Financial Results (vs. Q1 2024, in EUR) | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | €13.6 million | €14.9 million | -9.1% | | HIFU Revenue | €6.2 million | €5.8 million | +6.8% | | Non-core Revenue | €7.4 million | €9.1 million | -18.7% | | Gross Profit | €5.7 million | €6.4 million | -10.9% | | Gross Margin | 42.0% | 42.8% | -0.8 p.p. | | Operating Loss | (€6.0 million) | (€4.8 million) | +25.0% | | Net Loss | (€7.1 million) | (€4.5 million) | +57.8% | | EPS (EUR) | (€0.19) | (€0.12) | N/A | Cash Position (in EUR) | Metric | Mar 31, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash & Cash Equivalents | €22.8 million | €29.8 million | Financial Statements This section provides the unaudited condensed consolidated financial statements for the quarter ended March 31, 2025. It includes the Statement of Operations, Balance Sheet, Statement of Cash Flows, and a divisional breakdown of operations, offering a detailed view of the company's financial position and performance - The Unaudited Condensed Consolidated Statement of Operations shows a net loss of €7,074 thousand for Q1 2025, compared to a net loss of €4,546 thousand in Q1 2024[29] - The Unaudited Condensed Consolidated Balance Sheet reports total assets of €74,976 thousand and total shareholders' equity of €34,458 thousand as of March 31, 2025[31] - The Unaudited Condensed Consolidated Statement of Cash Flows indicates net cash used in operating activities was €5,076 thousand for Q1 2025[33] - The divisional breakdown for Q1 2025 shows the HIFU division generated €6,177 thousand in revenue with an operating loss of €5,361 thousand, reflecting significant investment in this core area[35]