Edap Tms SA · NASDAQ:FOCL

Edap Tms SA — Investor Presentation (January 2026)

49 slides from Edap Tms SA's investor presentation, Jan 12, 2026

  1. Slide 1: The Global Leader in Therapeutic Ultrasound

    1 The Global Leader in Therapeutic Ultrasound ​

  2. Slide 2: Statements & Disclaimer

    2 Statements & Disclaimer FORWARD - LOOKING ​ ​ ​ ​ ​ ​

  3. Slide 3: Company Overview

    edap | Focal-‘One Company Overview

  4. Slide 4: Strategic Company Focus

    4 Strategic Company Focus ​ Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease

  5. Slide 5: Investment Thesis: Strong Growth Opportunity

    5 5 Investment Thesis: Strong Growth Opportunity x Large and Growing Market Opportunity: Urology and Prostate Cancer x Solves an Important Unmet Clinical Need in Cancer x Proven Compelling Clinical Evidence x Increasing Patient and Physician Demand x Strong Hospital and Physician Reimbursement x Lev

  6. Slide 6: Large and Growing Market Opportunity In Urology and Prostate Cancer

    6 Large and Growing Market Opportunity In Urology and Prostate Cancer

  7. Slide 7: Prostate Cancer is the Most Common Cancer Amongst Men in the U.S.

    7 3.3 Million American Men Living with Prostate Cancer in the U.S. (1) 313,780 New Cases Diagnosed in the U.S. (1) 35,770 U.S. Deaths from Prostate Cancer (1) U.S. PROSTATE CANCER MARKET Prostate Cancer is the Most Common Cancer Amongst Men In the U.S. (1) 2025 estimates from the American Cancer Soc

  8. Slide 8: Prostate Cancer Market Opportunity

    8 8 Prostate Cancer Market Opportunity Number of New Prostate Cancer Cases Region 473,011 Europe 386,424 Asia 255,782 North America 225,985 Latin America 103,050 Africa 23,602 Oceania 1,467,854 Total LARGE GLOBAL MARKET 1.5 Million New Prostate Cancer Cases Per Year Data Source: Cases refers to Diag

  9. Slide 9: Focal One Answers an Unmet Need for a Large Underserved Patient Population

    9 9 Focal One Answers an Unmet Need for a Large Underserved Patient Population PROSTATE CANCER Focal One HIFU Focal One HIFU ​ First - Line Treatment ​ Progression from Active Surveillance ​ Salvage Treatment

  10. Slide 10: Focal One HIFU Prostate Cancer Annual Procedure Opportunity

    10 10 470,000 Based on 2023 Internal Company Estimates 165,000 130,000 100,000 75,000 Europe Asia North America South America Focal One HIFU Prostate Cancer Annual Procedure Opportunity Global Addressable Market FOCAL ONE ROBOTIC HIFU

  11. Slide 11: Prostate Cancer Patient Value Equation

    11 Prostate Cancer Patient Value Equation FOCAL ONE ® ROBOTIC HIFU PROVEN EFFICACY QUALITY OF LIFE PRESERVATION HIGH LOW HIGH Radiation (Urinary and Sexual Function Outcomes) Focal One Robotic HIFU Active Surveillance Surgery (Cancer Control)

  12. Slide 12: Treatment Comparison: Optimal Organ-Preserving Patient Treatment

    12 Low - 1 Session, Same Day Outpatient Procedure Focal One ® Robotic HIFU 95% (1) ORGAN - PRESERVING STRATEGY WHOLE - GLAND RADICAL TREATMENT STRATEGY CANCER CONTROL QUALITY OF LIFE PATIENT BURDEN Treatment Comparison Focal One HIFU Provides the Optimal Organ - Preserving Patient Treatment FUNCTION

  13. Slide 13: Focal Therapy | The New Emerging Market

    13 13 Focal Therapy | The New Emerging Market DRIVING A PARADIGM SHIFT IN PROSTATE CANCER (1) As of 2013. Chen et al. National trends in the management of localized prostate cancer: A population - based analysis 2004 - 2013. Prostate. (2) Source: Internal company estimates Active Surveillance Radica

  14. Slide 14: HIFU | The Fastest Growing Treatment Option

    14 HIFU | The Fastest Growing Treatment Option DRIVING A PARADIGM SHIFT IN PROSTATE CANCER Based on Medicare Claims reported by CMS on HOPPS Final Rule for FY24, FY25 and FY26 HIFU Cryo Brachytherapy Radical Prostatectomy

  15. Slide 15: Strong Supporting Clinical Evidence

    15 Strong Supporting Clinical Evidence

  16. Slide 16: Proven Clinical Evidence Supporting Focal One Robotic HIFU

    16 16 Proven Clinical Evidence Supporting Focal One Robotic HIFU ​ ​ 1000+ Peer - Reviewed Publications Supporting HIFU in the Treatment of Prostate Cancer (1) ​ 3. Preserve Sexual Function ​ 2. Maintain Urinary Control ​ 1. Cancer Control ​ Optimizing Trifecta Outcomes for Prostate Cancer (1) PubMe

  17. Slide 17: HIFI - Prospective Multicentric Comparative Study

    17 17 HIFI - Prospective Multicentric Comparative Study Focal One ® HIFU vs Radical Prostatectomy ​ Prospective, Comparative, Multicentric , non - inferiority clinical trial comparing HIFU to Radical Prostatectomy (RP) ​ 3,328 patients treated (1,967 HIFU - 1,361 RP) across 46 centers ​ 90% of HIFU

  18. Slide 18: HIFI Study Demonstrates Optimal Trifecta Outcomes

    18 18 HIFI Study Demonstrates Optimal Trifecta Outcomes ​ 1. Cancer Control Comparable Oncologic Outcomes ​ 3. Preserve Sexual Function ​ 2. Maintain Urinary Control Δ 11% Urinary Continence Erectile Function Pad - Free Continence at 12 months Decrease from baseline at 12 months ​ HIFU Provides Supe

  19. Slide 19: FARP - Randomized Controlled Trial

    19 19 FARP - Randomized Controlled Trial Focal Ablation vs Radical Prostatectomy ​ Randomized Controlled, Non - inferiority Clinical Trial comparing Focal Ablation (FA) to Robot - Assisted Radical Prostatectomy (RP) Equivalent Oncologic Control at 3 years (93.5% TFF vs 91.5%) Superior Functional Out

  20. Slide 20: HIFU Demonstrates Equivalent Survival to Radiation Therapy

    20 20 HIFU Demonstrates Equivalent 10 - year Survival to Radiation Therapy ​ 10 - year Oncological Outcomes of HIFU vs EBRT (1) • Lower Mortality at 10 years post HIFU (9.2%) compared to EBRT (16.7%) • Lower Cancer - Specific Mortality after HIFU (5.4%) compared to EBRT (9.2%) Yeh, HT., Liu, YY., Ch

  21. Slide 21: Strong Hospital and Physician Reimbursement

    21 Strong Hospital and Physician Reimbursement

  22. Slide 22: Creates Favorable Environment for Growth

    22 Creates Favorable Environment for Growth STRONG REIMBURSEMENT 1. APC Level 6 Under CMS for CY23, CY24 and CY25 2. 90% Increase in Reimbursement in 2023 3. APC Level 6 Maintained by CMS in 2026 Based on CMS Hospital Outpatient Prospective Payment System Final rule

  23. Slide 23: Hospital Outpatient Medicare Payment

    23 23 Hospital Outpatient Medicare Payment (Medicare Payment (National Average). From CMS Hospital Outpatient Prospective Payment System – CY25 and CY26 Final rule 2026 Payment CPT ® Code Procedure $5,478 55875 Prostate Brachytherapy $9,671 55873 Cryo Ablation $9,671 55880 HIFU $10,860 55866 Laparos

  24. Slide 24: Favorable Physician Payment

    24 24 Favorable Physician Payment Based on CMS Physician Fee Schedule – CY 2026 Final rule Physician Payment (Medicare - 2026) Work RVU (2026) CPT ® Code Procedure $693 13.12 55875 Prostate Brachytherapy $692 13.26 55873 Cryo $530 11.21 55882 MRI Transurethral Ultrasound Ablation $884 17.29 55880 HI

  25. Slide 25: Focal One Best-in-Class Technology

    25 Focal One ® Best - in - Class Technology

  26. Slide 26: The Leading Focal Therapy Technology

    26 Targeting and Imaging ​ Precise Robotic Delivered Ablation THE LEADING FOCAL THERAPY TECHNOLOGY ​ Image Guided Treatment Planning

  27. Slide 27: Focal One Core Technologies

    27 27 Robotics HIFU Advanced Imaging Focal One ® Core Technologies Artificial Intelligence (AI) Remote Connectivity

  28. Slide 28: The Most Advanced Robotic HIFU Platform Controlled by Urologists

    28 Integrated Workstation Compatible With Standard OR Beds MRI, PSMA PET Unfold AI* , OnQ Prostate* Koelis * and DynaCAD * 3D Biopsy HIFUsion ® Image - Guided Treatment Planning Dynamic Focusing Probe Precise Robotic Positioning Multi - Axis Sub - millimeter Robotic Movements Auto - Adjusting Pinpoi

  29. Slide 29: World's First Focal One Transcontinental Telecollaboration

    29 29 World’s First Focal One Robotic HIFU Transcontinental Telecollaboration ​ Cleveland, Ohio ​ Abu Dhabi ​ Cleveland, Ohio ​ Abu Dhabi

  30. Slide 30: BPH & Endometriosis Large Market Opportunities For Expansion

    30 BPH & Endometriosis Large Market Opportunities For Expansion

  31. Slide 31: HIFU Unlocks a Large Market Opportunity

    31 31 HIFU Unlocks a Large Market Opportunity (1) Newly Diagnosed Cases per year From World Health Organization – Globocan 2022 (2) From WHO and Habib N et al. Bowel Endometriosis: Current Perspectives on Diagnosis and Treatment. Int J Womens Health. 2020 (3) Xu et al.. Global, Regional, and Nationa

  32. Slide 32: Leveraging Expertise in Robotic HIFU and Prostate for BPH

    32 94 Million Global cases of BPH in 2019 (1) 15 Million U.S. men are affected by BPH/LUTS (2) 600,000 U.S. men aged 65+ newly diagnosed annually (3) Leveraging Expertise in Robotic HIFU and Prostate for BPH ​ 12.2 Million men actively managed for BPH/LUTS: • 55% under Drug Management (4) • 35% unde

  33. Slide 33: Building High-Level Evidence in the Treatment of BPH

    33 Building High - Level Evidence in the Treatment of Benign Prostate Hyperplasia BPH: FOCAL ONE CLINICAL STUDY PROGRESS Feasibility Study Completed Phase I - II Study Recruiting • Monocentric Feasibility Study (9 patients) • Confirmed Safety and potential for improvement of BPH - related symptoms •

  34. Slide 34: Leveraging Expertise in Robotic HIFU For Endometriosis

    34 6.5 Million US Women Have Endometriosis (1) 1.3 Million 20% of Cases are Deep Infiltrating Endometriosis (DIE) in the U.S. (2) 11% of U.S. Women are Affected by Endometriosis (2) Leveraging Expertise in Robotic HIFU For Endometriosis ​ Common symptoms of Rectal Endometriosis may include various c

  35. Slide 35: Building High-Level Evidence in Deep Infiltrating Rectal Endometriosis

    35 Building High - Level Evidence in the Treatment of Deep Infiltrating Rectal Endometriosis ENDOMETRIOSIS: FOCAL ONE CLINICAL STUDY PROGRESS Phase I Study Completed Phase II Study Completed Phase III Study Completed Enrollment • Feasibility (20 patients) • Published in the Journal of Ultrasound in

  36. Slide 36: Growing Global Install Base

    36 Growing Global Install Base

  37. Slide 37: Focal One Adoption Accelerating at Major U.S. Hospitals

    FOCAL ONE ADOPTION ACCELERATING At Major U.S. Hospitals ​ 87 Focal One Systems as of Dec. 31, 2025 (42 Academic – 45 Community)

  38. Slide 38: Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US

    38 38 Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US FOCAL ONE IS THE LEADING FOCAL THERAPY TECHNOLOGY 70% Best Hospitals for Urology 7 Out of 10 NCCN Member Institutions 55% 18 Out of 33 National Comprehensive Cancer Network® 63% SUO Approved Programs 22 Out of 35

  39. Slide 39: Focal One Adoption Accelerating at Major European Hospitals

    FOCAL ONE MOBILE SITES FOCAL ONE FIXED SITES ​ 41 Focal One Systems as of Dec. 31, 2025 254 Focal One Treatment Clinical Sites FOCAL ONE ADOPTION ACCELERATING At Major European Hospitals

  40. Slide 40: Key Business Trends

    edap | Focal-‘One Key Business Trends

  41. Slide 41: Focal One U.S. Momentum 2021-2025

    41 41 ​ Focal One U.S. Momentum 2021 - 2025 (Compounded Annual Growth Rates) Focal One Procedures CAGR Focal One Installations CAGR 44% 52% Focal One Procedures Focal One Installations (1) (1) Based on 2025 Preliminary, Unaudited Company Results

  42. Slide 42: Focal One HIFU Accelerated Revenue Growth

    42 42 2021 2022 2023 2024 2025 ​ Focal One HIFU Accelerated Revenue Growth Capital Sale + Recurring Revenue ​ Capital Sales ​ Service ​ Disposables & Treatment - Driven Revenue 2026 (1) ANNUAL HIFU REVENUE (1) Based on 2025 Preliminary, Unaudited Company Results (2) Source: Internal company estimate

  43. Slide 43: Positioned for Growth

    43 43 Positioned for Growth SUMMARY • Large Addressable Markets in Men’s and Women’s Health • Growing Install base of Leading Tier 1 Academic and Community Hospitals • Differentiated Non - Invasive Robotic HIFU Technology Solving Unmet Needs for Prostate Cancer, BPH and Endometriosis • Strong Clinic

  44. Slide 44: Appendix

    edap | Focal-‘One Appendix

  45. Slide 45: Financial Highlights as of September 30, 2025 (Three Months)

    45 45 THREE MONTHS ENDED SEPTEMBER 30TH 2025 2024 (in $Million USD except per share data) 16.1 14.4 Revenue 6.9 5.7 Gross Profit 43.0% 39.4% Gross Margin (5.7) (6.4) Operating Profit (Loss) (5.8) (7.0) Net Income (Loss) (0.16) (0.19) Earnings (Loss) Per Share NOTE: Translated for convenience of the

  46. Slide 46: Financial Highlights as of September 30, 2025 (Nine Months)

    46 46 NINE MONTHS ENDED SEPTEMBER 30TH 2025 2024 (in $Million USD except per share data) 48.8 47.6 Revenue 20.7 19.0 Gross Profit 42.5% 39.9% Gross Margin (18.7) (18.2) Operating Profit (Loss) (19.8) (18.5) Net Income (Loss) (0.53) (0.50) Earnings (Loss) Per Share NOTE: Translated for convenience of

  47. Slide 47: Balance Sheet Highlights as of September 30, 2025

    47 47 Balance Sheet Highlights as of September 30, 2025 Balance Sheet As Of: September 30 , 2024 September 30 , 2025 (in $Million USD) 28.4 12.4 Cash and Cash Equivalents 42.9 39.6 Other Current Assets 16.8 20.1 Fixed and Other N on - Current Assets 88.1 72.1 32.7 36.9 Current Liabilities 7.8 7.9 No

  48. Slide 48: Slide 48

  49. Slide 49: The Global Leader in Therapeutic Ultrasound

    49 The Global Leader in Therapeutic Ultrasound

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