Imricor Medical Systems, Inc. · ASX:IMR
Imricor Medical Systems — H1 2024 Earnings Presentation
36 slides from Imricor Medical Systems's earnings presentation, August 2024
Slide 1: 1H 2024 Investor Presentation
rsonal use only 1H 2024 Investor Presentation August 2024 Imricor's vision is to bring iCMR to every cardiac centre in the world IMRICOR MEDICAL SYSTEMS, INC (ASX:IMR) WWW.IMRICOR.COM
Slide 2: Disclaimer
Disclaimer The material contained in this document is a presentation of general background developments and their potential effect upon Imricor. There can be no assurance that future information on Imricor Medical Systems, Inc. (Imricor) and its activities current as of the date developments will be
Slide 3: Investment Highlights
Investment Highlights Vision-MR Ablation Catheter (Consumable Revenue) rsonal use only Strong Over US$105m World’s First & Active or FDA Approval Competitive invested to date Only Pending in 15 trial underway Position Technology MRI Compatible Hospitals Similar to Only MRI developed over Ablation Ac
Slide 4: Executive Summary
Executive Summary World’s first and only MRI compatible platform of devices for cardiac ablations rsonal use only Two global pivotal trials in Europe and the US in 2024 to open new markets and further indications Hospital activation momentum re-established Balance sheet well funded to deliver on maj
Slide 5: Cardiac Arrhythmias – A growing problem globally
Cardiac Arrhythmias – A growing problem globally rsonal use only When electrical impulses that maintain a regular heart rhythm are disturbed, a patient develops an arrhythmia. They largely present as three indications, atrial flutter (AFL), atrial fibrillation (Afib) or ventricular tachycardia (VT)
Slide 6: Treatment options
Treatment options 1 Ablation rsonal use only • Catheter ablations have become first-line therapy for curing arrhythmias • Ablations can permanently restore the heart to normal rhythm • Minimally invasive surgery where a catheter is guided into the heart and energy is applied to destroy the heart cel
Slide 7: Catheter Ablation
Catheter Ablation rsonal use only A catheter is guided into the heart and the physician will apply energy (radiofrequency, cryo, pulse field) through the catheter with the purpose of forming scars/lesions that destroy the heart cells responsible for causing the electrical misfiring. If the right amo
Slide 8: X-Ray as an imaging modality
X-Ray as an imaging modality rsonal use only X-rays are particularly good for visualizing bones and detecting fractures, dislocations, and bone density issues LIMITATIONS Soft Tissue Visualization X-rays are not as effective at visualizing soft tissues like muscles, ligaments, and organs. Radiation
Slide 9: X-Ray guided cardiac ablation in conventional EP Lab
X-Ray guided cardiac ablation in conventional EP Lab In the past, doctors had to rely on X-Ray guidance as the only imaging modality available rsonal use only CHALLENGES OF X-RAY Cannot visualize soft Cannot confirm lesions tissue of the heart created are durable Drives additional tool usage like Da
Slide 10: MRI as an imaging modality
MRI as an imaging modality rsonal use only MRI is highly sensitive in detecting a variety of conditions, including tumours, brain disorders, spinal cord injuries, joint abnormalities, and vascular diseases. Detail MRI provides excellent contrast between different types of soft tissues, making it ide
Slide 11: Bringing the superior imaging of MRI to cardiac ablations
Bringing the superior imaging of MRI to cardiac ablations rsonal use only Higher first-time success1 VISION-MR ABLATION NAVTRAC-MR NORTHSTAR CATHETER – GEN 2 TRANSSEPTAL KIT MAPPING SYSTEM Faster procedures2 Lower cost3 Radiation free 1 100% effective at 3 months for Vision-MR Ablation Catheter in C
Slide 12: Imricor has pioneered this new approach over years
Imricor has pioneered this new approach over 18 years BENEFITS OF MRI rsonal use only Superior soft tissue Lower cost, no need for ICE visualization in 3D catheter to guide septal crossing Faster procedures, no need Lower overall cost burden to map out the heart with on health system and expensive m
Slide 13: Partners, Hospitals we Provide into and KOL Validation
Partners, Hospitals we Provide into and KOL Validation Our Partners PROF. GERHARD HINDRICKS DR. MARCO GÖTTE German Heart Center Amsterdam University rsonal use only of the Charité Medical Center “With MRI-guided treatment of heart conditions, we are working “We are extremely excited to towards fewer
Slide 14: Key Achievements in 1H 2024
rsonal use only Key Achievements in 1H 2024
Slide 15: 1H Highlights
1H Highlights • Saudi FDA Approval for Imricor Capital Equipment and Consumables rsonal use only • CE Mark approval for Vision-MR Diagnostic Catheter • Amsterdam UMC recommences commercial cases in April • Dubrava University Hospital performs first iCMR procedures in Croatia • Cardiovascular Institu
Slide 16: Financial Performance
Financial Performance rsonal use only
Slide 17: Profit and loss - Costs well contained as revenue starts to grow
Profit and loss - Costs well contained as revenue starts to grow US$’000 HY24 HY23 Commentary Revenue 408 199 • Revenue growth of 105% on pcp driven by capital sales and rsonal use only new site activations. Costs and non-R&D expenses (4,454) (5,194) • Costs and non-R&D expenses decreased 14% primar
Slide 18: Balance Sheet
Balance Sheet US$’000 Jun-24 Dec-23 Cash and cash equivalents 1,503 832 Accounts receivable 312 393 Commentary rsonal use only Inventory 1,860 1,681 • Accounts payable increase driven by 3rd party equipment Other current assets 448 1,034 inventory and regulatory compliance/submission fees. Total cur
Slide 19: Cashflow
Cashflow US$’000 HY24 HY23 Commentary rsonal use only Net loss (6,858) (9,220) • Other non-cash adjustments were down vs. prior Other non-cash adjustments (685) 1,020 comparative period primarily due to decreases in the change in fair value charges and stock-based Change in other assets and liabilit
Slide 20: Pro Forma Balance Sheet: Post July Capital Raising
Pro Forma Balance Sheet: Post July Capital Raising June Pro US$’000 Jun-24 Tranche 1 Tranche 2 Forma * Cash and cash equivalents 1,503 16,993 6,292 24,788 Commentary Accounts receivable 312 - - 312 rsonal use only Inventory 1,860 - - 1,860 • As announced on July 18, secured firm commitments for Othe
Slide 21: Business update and Outlook
Business update and rsonal use only Outlook
Slide 22: Key priorities
Key priorities 1. Complete VISABL-AFL trial for US FDA approval rsonal use only 2. Commence VISABL-VT trial at Amsterdam UMC 3. Reactivate European hospitals 4. Geographic expansion & prepare for US launch 5. Accelerate pipeline with new talent hires Investor Presentation, September 2024 1H 2021 Res
Slide 23: FDA Trial VISABL-AFL underway
FDA Trial VISABL-AFL underway Priority – Gain FDA approval for Atrial Flutter - US launch in 2025 rsonal use only • Reimbursement in US is about 4x higher than in Germany • US cardiac ablation market is approximately half of the global US$8 billion market • * Amsterdam UMC currently focused on first
Slide 24: FDA Global Pivotal Trial
FDA Global Pivotal Trial VISABL-AFL Trial – FDA Approval pathway Trial details rsonal use only • Treatment of type 1 atrial flutter • Patients : 91 with possibility to end at 76 if primary endpoints are met (e.g. 80% acute success) • Participating hospitals : 4 • Expected completion : Q4 2024 • Expe
Slide 25: Scaling in the US Market with AFL Ablations
Scaling in the US Market with AFL Ablations AFL Ablation Devices X-ray Lab iCMR Lab rsonal use only World’s largest market, representing approximately 50% of global US$8bn Ablation Catheter ✓ ✓ market Diagnostic (CS) Catheter ✓ ✓ Favorable reimbursement of $22,653 per procedure1 Cost per procedure $
Slide 26: MRI guided VT ablation - the most significant event in Imricor's history
MRI guided VT ablation - the most significant event in Imricor's history rsonal use only VISABL-VT Trial – CE Mark Approval Pathway for 2nd Indication Trial details • Treatment of Ventricular Tachycardia • Patients : 64 • Participating hospitals : 2 • Expected completion : Q3 2025 • Expected CE Mark
Slide 27: Scaling in the US Market with VT Ablations
Scaling in the US Market with VT Ablations VT Ablation Devices X-ray Lab iCMR Lab rsonal use only Ablation Catheter ✓ ✓ World’s largest market, representing approximately 50% of global US$8bn Mapping Catheter ✓ market Steerable Sheath ✓ ✓ Favorable reimbursement of $22,653 per Transseptal Needle ✓ ✓
Slide 28: Pipeline progress
Pipeline progress Priority - Activate European sites rsonal use only Hospital Dec 30th April 30th June 30th Aug 28th Leipzig Heart Centre Active Active Active Active Amsterdam UMC Pending Active Active Active Dubrava University Hospital Pending Active Active Active Cardiovascular Institute Paris Sud
Slide 29: Modern iCMR lab vendors – bringing it all together
Modern iCMR lab vendors – bringing it all together MRI COMPATIBLE EQUIPMENT NEEDED DEVELOPER REVENUE TYPE rsonal use only Ablation catheter Imricor Consumable Diagnostic catheter Imricor Consumable Transseptal puncture kit Imricor Consumable Dispersive electrode Imricor Consumable NorthStar 3D Mappi
Slide 30: Major milestones right ahead
Major milestones right ahead 2024 2025 2026 rsonal use only • Complete VISABL-AFL Trial to • FDA approval and US • FDA clinical trial for VT/AF in support FDA approval market launch US • First in human VT ablation in • VISABL VT trial completion • New site activations the iCMR • Pulsed Field Ablatio
Slide 31: Imricor Leadership: Management
Imricor Leadership: Management rsonal use only STEVE WEDAN JONATHON GUT GREGG STENZEL JENNIFER WEISZ NICK TWOHY President and Chief Executive Officer, Vice President of Finance and Chief Chief Operating Officer Vice President of Regulatory Vice President of Marketing and Board Chair Financial Office
Slide 32: Imricor Leadership: Board of Directors
Imricor Leadership: Board of Directors rsonal use only STEVE WEDAN MARK TIBBLES PETER MCGREGOR ANITA MESSAL President and Chief Executive Deputy Chair and Lead Non-executive Director Non-executive Director Officer, and Board Chair Independent Director Designed MRI and ultrasound Entrepreneur, busine
Slide 33: Appendices
rsonal use only Appendices
Slide 34: A strong intellectual property portfolio
A strong intellectual property portfolio Imricor’s patents protect technology that allows Imricor to rsonal use only manufacture medical devices that are uniquely MRI compatible. Trade secrets, 3rd party relationships and difficult regulatory environment leave a deep moat behind Imricor. 19 issued U
Slide 35: Appendix 1) Three Procedures Imricor is targeting
Appendix 1) Three Procedures Imricor is targeting AFL (Atrial Flutter) VT (Ventricular Tachycardia) AFIB (Atrial Fibrillation) • Atrial Flutter is a condition in which the heart's • Ventricular Tachycardia is a condition in which • Atrial Fibrillation is a condition heart's upper upper chambers (atr
Slide 36: Contact Information
Contact Information Investors & Australian Media: rsonal use only Simon Hinsley NWR Communications simon@nwrcommunications.com.au +61 401 809 653 Investors: Steve Wedan Executive Chair, President & CEO Email: steve.wedan@imricor.com Nick Corkill Vice President, Corporate Strategy Email: nick.corkill
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