Onward Medical N.v. · EURONEXT:ONWD
Onward Medical — H1 2024 Earnings Presentation
40 slides from Onward Medical's earnings presentation, Sep 10, 2024
Slide 1: Investor Webcast: 2024 Half-Year Results and Business Update
Investor Webcast 2024 Half-Year Results and Business Update September 10, 2024
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, inclu
Slide 3: Speaking Today
Speaking Today Amori Fraser Finance Director Sarah Moore Sales & Marketing Leader Dave Marver CEO September 2024 Webcast 3
Slide 4: Introduction
Introduction September 2024 Webcast 4
Slide 5: ONWARD Medical at a Glance
ONWARD® Medical at a Glance Key Facts o Founded in 2015 Technology: 3 purpose-built neuromodulation platforms o ARCEX® delivers ARC Therapy externally through the skin o ~100 FTEs o ARCIM® delivers ARC Therapy via a fully implanted system o HQ in the Netherlands o ARCBCI pairs ARCIM with an implante
Slide 6: Vision
Vision Empowered by independence, people with spinal cord injury will enjoy life in the ways that matter to them September 2024 Webcast 6
Slide 7: Our Technology
Targeted, programmed electrical stimulation of the Our Technology spinal cord to restore movement, function, and independence in people with spinal cord injury Note: Investigational devices, not available for commercial use. The ARCBCI graphical representation includes ONWARD Medical’s ARCIM with CE
Slide 8: Company Focus
Reach commercial stage by year-end, then expand labeling and platforms Company Focus Short Term Medium Term Long Term 2024 2026/2027 2026/2027+ Commercialize external platform (ARCEX) Commercialize implantable platform (ARCIM) Expand labeling and platforms First indication: Upper Limb First indicati
Slide 9: Current Pipeline
9 indications under clinical or pre-clinical evaluation, with 3 in current roadmap Current Pipeline Short and medium term focus Funded primarily through grants and research partners Clinical Platform Indication FDA BDD1 Pre-clinical Human PoC Pivotal Feasibility2 ARCEX Upper Limb Study expected to A
Slide 10: 1H 2024 Update
1H 2024 Update September 2024 Webcast 10
Slide 11: 1H Business Update
Important achievements disclosed in first half of 2024, including successful FDA De Novo 1H Business Update submission for ARCEX System, capital raise and debt financing January February February March March Clinical Corporate Clinical Clinical Corporate Announced expansion KBC Securities Awarded 10
Slide 12: ARCEX FDA De Novo Submission
Regulatory submission to allow marketing of ARCEX in the US for ARCEX FDA De Novo upper limb indication Submission o ARCEX is an investigational breakthrough therapy - First spinal cord stimulation therapy to restore hand and arm function after SCI - First commercial product for ONWARD Medical o Sub
Slide 13: Pivotal Trial Results for ARCEX Therapy
Met all primary and secondary endpoints, demonstrating safety and effectiveness in Pivotal Trial Results for improving upper limb function after SCI (n=65, 14 trial sites globally) ARCEX Therapy 90% Improved in at least one primary strength or function assessment Improved hand function Improved qual
Slide 14: Strong shareholder base and access to capital
Strong shareholder base and access to capital Shareholder Country % of capital Financial Profile INKEF Capital BV Netherlands 11.5% Listing venue LSP Advisory BV Netherlands 10.8% shareholders Gimv (Private Equity) Belgium 9.2% Pre-IPO Wellington Partners GmbH Germany 7.6% Brussels, primary listing
Slide 15: 2024 Half Year Results
2024 Half Year Results September 2024 Webcast 15
Slide 16: Half-Year 2024 Financial Review
Half-Year 2024 Financial Review EUR Million For the six-month period ended, 30 June 2024 2023 Total Revenues & Other Incomes 0.2 0.9 Research & Development Expenses (6.1) (7.6) Clinical & Regulatory Expenses (2.7) (2.2) Marketing & Market Access Expenses (1.4) (1.6) Patent Fees & Related Expenses (0
Slide 17: Half Year 2024 Cash Update
Expect current cash position to fuel Half Year 2024 Cash operations through spring 2025 Update H2 2023 Q1 2024 Q2 2024 Ending Balance €14.0M used €6.8M used €9.9M used €32.1M net cash1 (including as of 30 Jun 2024 transaction and seasonal costs) 1 Net cash is defined as the sum of cash and cash equi
Slide 18: 2024 YTD Business Update
2024 YTD Business Update September 2024 Webcast 18
Slide 19: YTD Business Update
Year to date achievements since end of first half YTD Business Update July July September Science Corporate Corporate Announced Announced Awarded Christopher & publication publication of annual Dana Reeve highlighting evidence- sustainability Foundation grant to based programming summary for full ye
Slide 20: Sustainability Update
Published annual sustainability summary for full year 2023 Sustainability Update Highlights Performance o Rated in the top 40% in the industry for our sustainability performance by EcoVadis, the world’s 88% largest provider of business sustainability ratings of purchased electricity from renewable s
Slide 21: Reeve Foundation BCI Grant
ONWARD Medical and partners awarded $1.1M grant from Christopher & Dana Reeve Foundation Reeve Foundation Grant to further study ARC-BCITM System BCI Grant o ONWARD Medical, CEA-Clinatec, and .NeuroRestore awarded $1.1M grant to support expansion of ongoing early clinical feasibility study to explor
Slide 22: Outlook
Outlook September 2024 Webcast 22
Slide 23: Upcoming Milestones and News Flow
Several important catalysts expected in the next 12 months Upcoming Milestones and News Flow ARCEX ARCEX Regulatory clearance Up-LIFT pivotal study ARCEX ARCEX submission manuscript publication FDA clearance First commercial sale (US) Upper limb Upper limb Upper limb Upper limb COMPLETED COMPLETED A
Slide 24: ARCEX Commercial Plans
ARCEX Commercial Plans (to be initiated post-market clearance) September 2024 Webcast 24
Slide 25: Customer Targeting and Sales Deployment
Customer Targeting and Sales Deployment September 2024 Webcast 25
Slide 26: Rehabilitation Clinic Importance
Following regulatory clearance, SCI rehabilitation clinics will be at the core of Rehabilitation Clinic ONWARD’s commercialization strategy Importance clinic o Clinics to purchase ARCEX devices for in-clinic use and bill for therapy sessions o Opportunity to re-engage chronic patients not currently
Slide 27: Targeting and Channel Strategy
Build enduring relationships with priority target customers; high customer concentration Targeting and Channel Strategy Call Points US Europe ~500 Northeast Mid Atlantic Southeast UK France Germany North Central Netherlands South Central Switzerland West Geographical focus US and select European mar
Slide 28: US Clinic Targeting and Salesforce Ramp
Initial focus will be VA SCI hubs, Up- LIFT study sites, and other high US Clinic Targeting volume, influential SCI clinics and Salesforce Ramp Initial Focus At Scale Total ~75 ~375 accounts Account o Up-Lift and KOL sites (~10-15) o VA spokes (~135) types o VA hubs (~25) o Other rehabilitation cent
Slide 29: Initial Sales Hiring Status
Initial hires on board, with additional hires in the queue Initial Sales Hiring Status Blake Pokress Area VP Sales Initial hires in progress − Area VP (hired) − Inside Sales & Customer Advocacy Director (hired) − Sales Rep (expected by Oct 01) Additional staff in the hiring queue Sarah Montana − 5 a
Slide 30: VA Commercial Partnership
Forged partnership with US SDVOSB VA Commercial Partnership Service-Disabled Veteran-Owned Small Business will serve as our Veterans Administration (VA) contracting and logistics partner o ONWARD promotes therapy and maintains customer relationship (sales and training), Lovell executes government co
Slide 31: Customer Training
Customer Training September 2024 Webcast 31
Slide 32: Training and New Clinic Customer Activation
Professional education program designed to initiate ARC-EX use at clinics Training and New Clinic efficiently and effectively, while building brand-affinity and engagement Customer Activation Program components Digital Includes video modules to accelerate start-up process starter kit Hands-on 3-4 ho
Slide 33: Home Use Activation and Support
Training for home use will be delivered by clinicians, with support from Home Use Activation ONWARD as needed and Support Evolution of home use support Clinicians play a key part At launch o Prescription 6-12 months ONWARD field team & staffed helpdesk o Product training Clinics o Therapy adjustment
Slide 34: Value
Value September 2024 Webcast 34
Slide 35: Positioning
Competitive benchmarking vs. rehab devices widely available in the US and Positioning Western Europe FES & other electrical stimulation devices Exoskeletons & FES bikes <$1k <$5k $10k $20k $45k $60k $120k Basic electrical FES for gait Multichannel FES FES bikes Upper extremity Exoskeletons stimulati
Slide 36: Market Access
Market Access September 2024 Webcast 36
Slide 37: Home Market Access Landscape and Evolution
Success in clinics will drive home use, which will generate data required for Home Market Access broad reimbursement; access to Landscape and Evolution ~30% of market shortly after launch Years 1-3 Years 3 and 4 Years 5+ No new reimbursement code required for clinic Expect Medicare and private Rest
Slide 38: Q&A
Q&A September 2024 Webcast 38
Slide 39: Thank you!
Thank you! September 2024 Webcast 39
Slide 40: Slide 40