EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (January 2024)
20 slides from EBR Systems's investor presentation, Jan 30, 2024
Slide 1: Investor Presentation January 2024
For personal use only Investor Presentation January 2024 1
Slide 2: EBR Systems at a glance
EBR Systems at a glance For personal use only Driven to deliver superior treatment for patients suffering from cardiac rhythm diseases Developer of the world’s first and only leadless pacemaker for heart failure EBR’s WiSE® CRT System has no direct competitors and is complementary to other pacemaker
Slide 3: Traditional pacemakers are suboptimal
Traditional pacemakers are suboptimal For personal use only Traditional pacemakers use wires or leads to deliver energy to the heart, which can lead to many problems Coronary Sinus limits Leads can migrate Left Ventricle (LV) lead and sometimes placement locations fracture RIGHT ATRIUM LEAD Leads ca
Slide 4: EBR has a wireless solution for heart failure patients
EBR has a wireless solution for heart failure patients For personal use only EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy Left ventricle Right ventricle/atrium WiSE CRT System fills the gap Currently the only leadless solution globally for LV p
Slide 5: Pivotal SOLVE-CRT Study meets all endpoints
Pivotal SOLVE-CRT Study meets all endpoints For personal use only Positive results confirm WiSE CRT System as a highly effective treatment option for patients with heart failure Primary efficacy endpoint met Primary safety endpoint met -16.4% Decrease in in left ventricular end systolic volume 80.9%
Slide 6: Randomised sub-analysis supports primary results
Randomised sub-analysis supports primary results For personal use only The WiSE CRT System demonstrates clinically and statistically significant evidence of reverse remodelling and electrical response within previously untreatable and high-risk patients LVESV (%) LVEDV (%) LVEF (%) QRS (ms) † ‡ † p
Slide 7: Commercialisation pathway
Commercialisation pathway For personal use only Positive pivotal trial results and strong track record with the FDA de-risk EBR’s regulatory approval process and underpin a clear pathway to commercialisation 1 Confidence in FDA approval process Drive adoption and growth underpinned by positive pivot
Slide 8: Favourable US market dynamics
Favourable US market dynamics For personal use only Market dynamics in the US support initial adoption of the WiSE CRT System Market validation • Support of Key Opinion Leaders (KOLs) • Unmet need underscored by FDA Breakthrough Device designation • Low barrier to transition to become first-line the
Slide 9: Initial commercialisation strategy
Initial commercialisation strategy For personal use only EBR will leverage its established partnerships and presence in the US to drive initial sales growth, targeting first sales during H1 2025 Clinical trial sites to drive Specialist sales force Scale manufacturing initial sales established capabi
Slide 10: Long term growth strategy
Long term growth strategy For personal use only Long term growth opportunity targeting new patient groups, indications and geographies Pursue new indications Product development Expand internationally Progress clinical studies to expand Grow addressable market through Launch in select OUS1 markets a
Slide 11: US$2.6bn initial addressable market
US$2.6bn initial addressable market For personal use only At commercial launch, EBR estimates to have an initial addressable market of ~US$2.6bn Leadless Upgrades Acute Lead Failure • Patients with a leadless right ventricle pacemaker can only upgrade with WiSE Unable to implant CRT wire in a new CR
Slide 12: Totally Leadless CRT is a growth market
Totally Leadless CRT is a growth market For personal use only The Totally Leadless CRT (TLC) market has the potential to grow by an additional US$4.2bn Dual Chamber Leadless Upgrades First-line treatment with TLC WiSE CRT System used in conjunction with the WiSE CRT System $0.4bn used in conjunction
Slide 13: Market expansion opportunity
Market expansion opportunity For personal use only The WiSE CRT System can be expanded for use in other patient groups, indications and geographies, increasing EBR’s market opportunity and underpinning future growth Initial addressable market • Acute Lead Failure US$2.6bn • Chronic Lead Failure • Hi
Slide 14: Product development: Rechargeable battery
Product development: Rechargeable battery For personal use only EBR is developing a new rechargeable battery that will support the WiSE CRT System in becoming a first-line therapy option and treat a broader suite of patients Charging unit Commercial benefits • Drives higher uptake by removing barrie
Slide 15: Upcoming milestones
Upcoming milestones For personal use only EBR continues to achieve significant value catalysts and pave the way to future value creation Delivered Near term Next steps ü SOLVE-CRT 6 Month follow up q Publication of manuscript in a peer q FDA approval in the US completed for final patient in February
Slide 16: Investment highlights
Investment highlights For personal use only EBR is focused on executing its clear and targeted commercialisation strategy to deliver shareholder value High value market opportunity De-risked pathways to market Expert leadership Unique solution Large markets Positive results Focused strategy Strong t
Slide 17: Appendix
For personal use only Appendix
Slide 18: Patient success story - Richard
Patient success story - Richard For personal use only EBR has allowed the patient to once again partake in all the activities he enjoyed before his heart failure Pre heart failure Onset of heart failure Post WiSE CRT Implant US Marine and Vietnam war veteran Heart failure materially impact the Post
Slide 19: Disclaimer
Disclaimer For personal use only The material contained in this document is a presentation of general information about may differ materially from what is expressed in this presentation. the activities of EBR Systems, Inc. (ASX:EBR) (ARBN 654 147 127) and its subsidiaries (“EBR”) current as at the d
Slide 20: Contact Us
For personal use only Contact Us Company John McCutcheon President & CEO P: +1 408 720 1906 E: info@ebrsystemsinc.com Investors Jed Pedersen Vesparum Capital P: +61 3 8582 4800 E: EBRSystems@vesparum.com 20