Onward Medical N.v. · EURONEXT:ONWD

Onward Medical — Onward Med — H1 2025 Earnings Presentation

35 slides from Onward Medical's earnings presentation, Sep 2, 2025

  1. Slide 1: Investor Webcast: 2025 Half Year Results

    Investor Webcast 2025 Half Year Results September 02, 2025

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements This Presentation may include statements, including the Company’s financial and operational medium-term objectives, that may be deemed to be “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, includin

  3. Slide 3: Speaking Today

    Speaking Today Dave Marver Amori Fraser Gretchen Nelson Chief Executive Officer Senior Finance Director Senior Director Clinical Operations September 2025 Webcast 3

  4. Slide 4: Introduction

    Introduction September 2025 Webcast 4

  5. Slide 5: Company Overview

    Pioneering therapies to restore movement, function, and independence in people with spinal Company Overview cord injuries and other movement disabilities 3 purpose-built neuromodulation platforms o Problem: ~9M people worldwide living o ARCEX® delivers ARC Therapy externally through the skin with SC

  6. Slide 6: Growth Strategy

    Focus first on near-term indications and path to profitability, then unlock multiple additional Growth Strategy indications and populations Phase 1 Phase 2 Focus ARCEX hand sensation & strength and Label and platform expansion ARCIM blood pressure instability Expected o1 Drive commercial uptake for

  7. Slide 7: YTD Highlights

    YTD Highlights September 2025 Webcast 7

  8. Slide 8: YTD Highlights

    Met commercial objectives, received IDE approval for ARCIM pivotal study, and advanced science and YTD Highlights technology leadership, including BCI platform Commercial traction Met objectives for initial phase of US launch of ARCEX, including selling 30 units in 1H 20251 Regulatory milestones o A

  9. Slide 9: ARCEX Launch & Commercial Traction

    1 ARC Launch EX & Commercial Traction September 2025 Webcast 9

  10. Slide 10: ARCEX Demand Indications

    As of Aug 31, 2025 Strong demand since FDA clearance with many inbound requests for information and ARCEX Demand engagement Indications 2,600+ 340+ US leads US clinic leads collected1 collected Confidential Note: Leads defined as unsolicited inbound requests September 2025 Webcast 10 1 Lead figures

  11. Slide 11: ARCEX 2025 Sales Acceleration

    Sales expected to increase every quarter in line with analyst consensus thanks to broader US ARCEX 2025 Sales clinic launch and emerging OUS opportunities Acceleration Done On track Analyst consensus sales1, cumulative # of units sold 150+ units sold1 150 100 60+ units sold 30 units sold3 50 10 unit

  12. Slide 12: ARCEX US Clinic Sales Pipeline

    As of Aug 31, 2025 110+ incremental units are already in current probability-weighted pipeline, in addition to units ARCEX US Clinic sold to date Sales Pipeline Late-stage Stage Process Demo Validated1 Committed2 initiated scheduled Totals # of opportunities ~90 ~60 ~80 ~18 ~250 Probability of sale

  13. Slide 13: ARCEX Market Expansion

    Upside opportunities: Regulatory applications filed in June 2025 and authorizations expected ARCEX Market in Q4 2025 Expansion US home use application CE mark application Average time for FDA 510(k) decision is ~150 days1 FDA 510(k) application submitted to allow CE Mark application filed to enable

  14. Slide 14: EMPOWER BP Design

    2 EMPOWER BP Design September 2025 Webcast 14

  15. Slide 15: Addressing Blood Pressure Instability

    Addressing Blood Pressure Instability Testimonials reflect individual experiences and outcomes, which may vary. For investigational use only. September 2025 Webcast 15

  16. Slide 16: Unmet Need

    Symptomatic blood pressure instability is an underappreciated Unmet Need and unmet need after SCI Orthostatic Hypotension (OH) Autonomic Dysreflexia (AD) Low blood pressure tied to posture or postural Sudden, often dangerous rise in blood pressure in response to a changes, for example when moving fr

  17. Slide 17: EMPOWER BP Study Design

    Prospective, randomized, sham-controlled and double-blinded EMPOWER BP Up to 22 sites | Up to 112 subjects Study Design (2) Therapy 2:1 Randomization Programming Surgery 6 months 24 months Primary Screening Crossover safety endpoint (1) Sham 3 months Primary effectiveness endpoint Primary effectiven

  18. Slide 18: ARCIM Blood Pressure Roadmap

    Commercial launch anticipated in 2H 2028; upside possible based on interim ARCIM Blood Pressure analysis Roadmap Key milestone Commercial launch 2025 2026 2027 2028 2029 Pivotal Enrollment and primary endpoint completion Follow-up study Submission & approval IDE approval Interim analysis (base case)

  19. Slide 19: Clinical Pipeline

    3 Clinical Pipeline September 2025 Webcast 19

  20. Slide 20: Pipeline Strategy

    Advancing pipeline with grant funding and investigator-initiated studies to ensure focus on Pipeline Strategy two initial indications and targeted use of capital Investigator-initiated studies Grant-funded studies Opportunities for cost-effective 9 indications expected to be under evaluation in 2025

  21. Slide 21: Pipeline Overview

    Option to commercialize new indications and unlock additional value in the future as Pipeline Overview business grows; opportunities include label, population, and platform expansion FDA Potential launch Eligible population Platform Indication BDD1 Current stage date (est.) in US & Europe2 A Bladder

  22. Slide 22: A & F Bladder

    Aiming to address high-priority need for A & F Bladder SCI patients using both ARCEX and ARCIM Eligible population Clinical studies ~310’000 (ARCEX); 450’000 (ARCIM)1 ARCEX Investigator-initiated studies to explore use of Unmet need ARCEX for bladder and bowel control o Bladder control is a high pri

  23. Slide 23: B & I Stroke

    Opportunity to leverage ARCEX and ARCBCI to address unmet needs for stroke patients B& I Stroke Unmet need Clinical studies Upper limb ARCEX o Stroke is the leading cause of long-term Investigator-initiated study pending to neurological disability worldwide and explore use of ARCEX System for lower

  24. Slide 24: C SCI Mobility

    Promising clinical feasibility study results for C SCI Mobility enabling the ability to stand and walk in 9 participants with chronic spinal cord injuries Eligible population Key achievements to date Illustrative timeline ~240’0001 Published data in Nature 2025-2028 demonstrating the Conduct ongoing

  25. Slide 25: D Parkinson's Mobility

    Opportunity to leverage ARCIM Therapy D Parkinson’s to address mobility challenges (not tremor) in Parkinson’s disease Mobility Eligible population Key achievements to date Illustrative timeline ~1’100’0002 2025-2028 Results of first-in-human proof- Conduct ongoing feasibility Unmet need of-concept

  26. Slide 26: E Parkinson's Blood Pressure

    Opportunity to leverage ARCIM Therapy to address blood pressure instability E Parkinson’s Blood challenges in Parkinson’s disease Pressure Eligible population Key achievements to date Illustrative timeline ~830’0001 Implanted three Parkinson’s 2025+ patients with ARCIM Therapy Conduct clinical feasi

  27. Slide 27: G & H BCI Mobility & Upper Limb

    Enabling thought-driven movement for SCI and stroke patients; already 5 G&H BCI Mobility & humans implanted1 Upper Limb Illustrative timeline Eligible population Key achievements to date for mobility Expected first indication: 2025-2029 First-in-human implant for Mobility2 ~420’000 mobility SCI in 2

  28. Slide 28: 2025 Half Year Results

    2025 Half Year Results September 2025 Webcast 28

  29. Slide 29: Half Year 2025 Financial Review

    Revenue growth following commercial launch of ARCEX Half Year 2025 Financial Review EUR Million For the six-month period ended, 30 June HY 2025 HY 2024 Total Revenues & Other Incomes 1.21 0.2 Cost of Goods Sold (0.2) - Gross Profit 1.0 0.2 Research & Development Expenses (5.2) (6.1) Clinical & Regul

  30. Slide 30: Half Year 2025 Cash Update

    Cash position of €40.9M as of June 30, 2025, supported by initial sales Half Year 2025 traction and disciplined expense Cash Update management Burn Ending Balance €19.1M used €40.9M net cash1 during 1H 2025 as of 30 June 2025 1 Net cash is defined as the sum of cash and cash equivalents and fixed te

  31. Slide 31: 2025 Outlook

    2025 Outlook September 2025 Webcast 31

  32. Slide 32: Upcoming Milestones and News Flow

    Several important catalysts expected in the next 12 months Upcoming Milestones ARCEX ARCIM ARCBCI and News Flow ARCEX ARCEX ARCEX ARCEX ARCEX FDA authorization (US) First commercial sale Home use authorization CE mark (EU) First commercial sale Hand sensation & strength (US) (US) Hand sensation & st

  33. Slide 33: Q&A

    Q&A September 2025 Webcast 33

  34. Slide 34: Thank you!

    Thank you! September 2025 Webcast 34

  35. Slide 35: Slide 35

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