[EDAP Reports First Quarter 2025 Financial Results](index=3&type=section&id=EDAP%20Reports%20First%20Quarter%202025%20Financial%20Results) [Management Commentary & Business Highlights](index=3&type=section&id=Management%20Commentary%20%26%20Business%20Highlights) 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](index=8&type=chunk) - Launched the new **Focal One i Robotic HIFU System**, which includes enhanced capabilities like expanded compatibility with PSMA PET scans and streamlined workflows[8](index=8&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - 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](index=9&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - Received **CE Mark designation** for the Focal One system for the treatment of deep infiltrating endometriosis, expanding its clinical applications[11](index=11&type=chunk)[13](index=13&type=chunk) - Successfully performed the world's first **remote transcontinental Focal One Robotic HIFU procedure**[11](index=11&type=chunk)[13](index=13&type=chunk) - Appointed **Glen French and Joshua H. Levine**, executives with extensive experience in the medical device industry, to its Board of Directors[13](index=13&type=chunk) [Financial Performance](index=5&type=section&id=Financial%20Performance) 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](index=5&type=section&id=2025%20Financial%20Guidance) 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](index=15&type=chunk) - Expects revenue declines between **20% and 25%** in its non-core businesses (ESWL and Distribution)[15](index=15&type=chunk) [First Quarter 2025 Results](index=5&type=section&id=First%20Quarter%202025%20Results) 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](index=7&type=section&id=Financial%20Statements) 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](index=29&type=chunk) - 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](index=31&type=chunk) - The Unaudited Condensed Consolidated Statement of Cash Flows indicates net cash used in operating activities was **€5,076 thousand** for Q1 2025[33](index=33&type=chunk) - 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](index=35&type=chunk)

Core Insights - EDAP TMS SA reported strong growth in the adoption of its Focal One robotic HIFU system, achieving a record nine system placements in Q1 2025, the highest in the company's history [2][5] - The company launched the new Focal One i Robotic HIFU System, which includes enhanced features aimed at improving treatment efficiency and expanding its market leadership in focal therapy [2][6] - Positive clinical data from the FARP randomized controlled trial supports the use of HIFU for early-stage prostate cancer, indicating non-inferiority compared to traditional robotic radical prostatectomy [3][6] Business Update - The company achieved a record number of Focal One system placements and received CE Mark designation for the treatment of deep infiltrating endometriosis [5][7] - The FARP trial results were presented at the AUA 2025 meeting, marking a significant milestone in clinical evidence for ultrasound-based focal ablation therapy [6][5] - The Focal One i system features new capabilities, including compatibility with advanced imaging technologies and improved treatment workflows [6][5] Financial Performance - Total HIFU revenue for Q1 2025 was EUR 6.2 million (USD 6.5 million), a 6.8% increase from EUR 5.8 million (USD 6.3 million) in Q1 2024, driven by increased system sales [10] - Total revenue for the non-core business declined to EUR 7.4 million (USD 7.8 million) from EUR 9.1 million (USD 9.9 million) in the previous year, reflecting the company's strategic focus on high-growth opportunities in focal therapy [11] - The company's total worldwide revenue for Q1 2025 was EUR 13.6 million (USD 14.3 million), down 9.1% from EUR 14.9 million (USD 16.1 million) in Q1 2024 [13] Operating Metrics - Gross profit for Q1 2025 was EUR 5.7 million (USD 6.0 million), with a gross profit margin of 42.0%, slightly down from 42.8% in Q1 2024 [14] - Operating expenses increased to EUR 11.7 million (USD 12.3 million) from EUR 11.2 million (USD 12.1 million) in the same period last year, primarily due to investments in the HIFU business [15] - The net loss for Q1 2025 was EUR 7.1 million (USD 7.5 million), compared to a net loss of EUR 4.5 million (USD 4.9 million) in Q1 2024 [16] Cash Position - As of March 31, 2025, the company held cash and cash equivalents of EUR 22.8 million (USD 24.6 million), down from EUR 29.8 million (USD 30.9 million) at the end of 2024 [16]

Core Viewpoint - EDAP TMS SA will release its financial results for Q1 2025 on May 15, 2025, before market opening [1] Group 1: Conference Call Details - A conference call and webcast will be held on May 15, 2025, at 8:30 am EDT [2] - The call will feature CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch [2] - Dial-in numbers include 1-800-267-6316 for domestic and 1-203-518-9783 for international calls, with the passcode "EDAP" [3] Group 2: Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices using ultrasound technology [3] - The company has introduced the Focal One® system for prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

Core Insights - EDAP TMS SA announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) Study, demonstrating non-inferiority of focal ablation compared to robotic prostatectomy in treating localized prostate cancer [1][6] Study Results - The FARP study achieved its primary endpoint, showing a treatment failure rate of 5.6% in the Focal Ablation (FA) group versus 7.9% in the Radical Prostatectomy (RP) group, indicating a statistical difference of 2.3% in favor of Focal Ablation [7] - A total of 213 patients were enrolled, with 107 randomized to FA and 106 to RP, and 25% of RP patients crossed over to FA [7] Clinical Implications - The study provides significant evidence supporting the use of ultrasound energy-based focal ablation for organ-localized prostate cancer, particularly High-Intensity Focused Ultrasound (HIFU) [2][4] - The positive results from the FARP trial, along with the HIFI Study, are expected to accelerate the adoption of Focal One Robotic HIFU in clinical practice [4] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing minimally invasive medical devices utilizing ultrasound technology for various conditions [5] - The Focal One® system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]

About EDAP TMS SA AUSTIN, Texas, April 24, 2025 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy- based therapies, announced the launch of the new Focal One i system at the upcoming 120th American Urological Association (AUA) Annual Meeting being held in Las Vegas, Nevada from April 26-29, 2025. The Focal One i system incorporates important new features and enhanced capabilities including: "The new features and design of the Focal One i system are based directly on the feedback from our cust ...

Core Insights - EDAP TMS SA will have its largest presence at the 120th American Urological Association (AUA) Annual Meeting, showcasing the Focal One Robotic HIFU platform [1][2] - The meeting will highlight the growing acceptance of robotic HIFU technology in the urology community, with numerous hands-on simulations and live demonstrations planned [2][5] Company Activities - The Focal One Robotic HIFU Masterclass will take place at the Keck School of Medicine of USC on April 24-25, featuring lectures and live procedures [5][6] - Expert-led demonstrations and semi-live procedures will be part of the AUA activities, emphasizing the advanced capabilities of the Focal One technology [5][9] Scientific Presentations - The AUA meeting will include the final results of the FARP study, the first randomized controlled trial comparing ultrasound-based focal ablation to robotic prostatectomy for early-stage prostate cancer [3][6] - A notable increase in scientific presentations on focal therapy and ablation for prostate cancer management is expected, indicating a growing interest in this area [5][9] Notable Presentations - Dr. Ruben Olivares will present the first remote transatlantic Focal One Robotic HIFU procedure, showcasing the technology's remote capabilities [3][6] - The FARP study results will be presented by Eduard Baco, providing level-1 evidence to support the use of focal ablation with Focal One [6]

Table of Contents As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMP ...

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]

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, while total worldwide revenues for 2024 were $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, with disposable revenues growing by 28.5% [39] - The ESWL division saw nominal growth, with revenues of €2.4 million compared to €2.3 million in the previous year [40] Market Data and Key Metrics Changes - The number of Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] 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 [34] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry and further clinical development [6][25] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [46] - The company anticipates that the landmark Hi Fi study will drive demand for Focal One, positioning it as a mainstream treatment option for prostate cancer [47] Other Important Information - The company has entered into clinical studies for the treatment of BPH and pancreatic tumors, indicating a commitment to expanding its HIFU technology into new indications [20][21] - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] Q&A Session Summary Question: Can you provide more detail on HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [49][50] Question: What is the intent for the non-core ESWL and distribution business? - 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 [51][52] Question: How is the capital equipment purchase pattern from hospitals in 2025? - The sales cycle remains consistent, but the company has adapted its strategy to close deals more effectively, expecting notable growth throughout 2025 [58][60] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - The reimbursement increase has positively impacted hospital interest in adopting Focal One, as it enhances the financial analysis for adding this treatment to their services [62][64] Question: What is the strategy for endometriosis commercialization? - The company is working with experts to refine clinical development efforts following the CE mark, with plans for a Phase one launch in CE mark countries [71][72] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is early in patient recruitment, being conducted locally in France, with no specific data timeline provided yet [73][74]

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, with total worldwide revenues of $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, driven by 11 Focal One systems sold [39][40] - The ESWL division saw nominal growth with revenues of €2.4 million in the fourth quarter, while the distribution business revenue decreased to €9.1 million from €9.9 million [41][42] Market Data and Key Metrics Changes - Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year in the fourth quarter [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] - Notable sales were made in international markets, including Germany, Portugal, and Turkey [12] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in prostate cancer, endometriosis, and BPH, leveraging the Focal One platform [32] - Plans to reduce investments in lower growth, low margin businesses, including the discontinuation of the ZONALIB iMOVE lithotripsy product line [33][34] - The company is committed to transforming into a more agile organization, with new board members bringing expertise in medical device commercialization [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [47] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant milestone, allowing for controlled market entry [6] - The company anticipates that the Hi Fi study publication will drive further adoption of Focal One as a treatment option for prostate cancer [15][48] Other Important Information - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] - The company is actively working on clinical studies for BPH and pancreatic tumors, demonstrating its commitment to expanding the applications of HIFU technology [19][20] Q&A Session Summary Question: Can you provide more detail on the HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [50][52] Question: Is the intent to phase down the non-core ESWL and distribution business to zero? - Management indicated that while they are winding down some non-core businesses, they cannot project if it will go to zero, but focus will shift to high growth HIFU business [53][54] Question: How is the capital equipment purchase pattern from hospitals in 2025? - Management noted that the sales cycle remains consistent, but they have adjusted strategies to close deals more effectively, with a growing active pipeline [60][62] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - Management confirmed that the reimbursement increase has positively impacted hospital interest in adopting Focal One technology [64][66] Question: What is the strategy for commercializing the endometriosis treatment? - The company is in the early stages of expanding clinical development efforts following the CE mark approval for treating deep infiltrating endometriosis [73][74] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is in the early recruitment phase, with the study being conducted in France [75][76]