EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (February 2022)
21 slides from EBR Systems's investor presentation, Feb 2, 2022
Slide 1: Investor Presentation February 2022
For personal use only Investor Presentation February 2022 1
Slide 2: Investment highlights
Investment highlights For personal use only Unique novel Large addressable De-risked clinical Rapid path to Value upside technology market profile commercialisation potential EBR’s WiSE® is the Initially targeting Currently in final stage WiSE® has been WiSE® can be extended world’s smallest inside-
Slide 3: CRM is constrained by leads
CRM is constrained by leads There are many problems from using leads (wires) to deliver energy to the heart For personal use only Coronary Sinus limits Can migrate and LV lead placement sometimes fracture locations RIGHT ATRIUM LEAD Pathway for pathogens to Difficult to place myocardium LEFT VENTRIC
Slide 4: The world is going leadless
The world is going leadless EBR has a leadless solution for heart failure patients For personal use only • Heart Failure is a major medical and economic Leadless CRM Landscape problem • Many patients with heart failure require a treatment Bradycardia Defibrillation CRT called Cardiac Resynchronisati
Slide 5: Advantages of WiSE
Advantages of WiSE® For personal use only EBR’s WiSE® leadless pacemaker addresses the shortcomings of traditional pacemakers Wireless Eliminates lead complications such as placement difficulty, blood clots, unintended nerve stimulation, dislodgement, extraction and repositioning. Endocardial Delive
Slide 6: WiSE is the only leadless solution for CRT
WiSE® is the only leadless solution for CRT Other leadless pacemakers are too large for CRT and left ventricular (LV) pacing For personal use only WiSE® fills the gap RV Pacing only LV Pacing Currently the only leadless solution globally for LV pacing including CRT Other leadless pacemakers are too
Slide 7: Large initial addressable market
Large initial addressable market At commercial launch, EBR estimates to have an addressable market of ~US$2.1bn initially For personal use only Estimated Market Size Estimated Addressable Market 26,000,000+ $267m People worldwide affected by heart failure1 $1,068m EBR initially targeting patients un
Slide 8: Extensive clinical experience in multiple trials
Extensive clinical experience in multiple trials Over 350 patients have been treated with WiSE® to date For personal use only Study Year published Patients Key Findings WiSE®-CRT1 2014 17 Proof-of concept - providing CRT using WiSE® is feasible Select-LV2 2017 35 WiSE® provided clinical benefit in m
Slide 9: SOLVE Pivotal Study | Currently underway
SOLVE Pivotal Study | Currently underway EBR is in the final phase of their pivotal SOLVE study, with the aim of FDA submission in H1 2023 For personal use only COMPLETED ENROLLING Randomised Phase Single-arm Phase Complete enrolment H1 20221 FDA submission H1 2023 Purpose Assess the safety and effe
Slide 10: Endpoints achieved previously
Endpoints achieved previously Previous studies have exceeded the pre-specified Performance Goals (Endpoints) set for the SOLVE trial For personal use only Efficacy Results Safety Results Left Ventricular End Systolic Volume Type I Complication Reduction in end systolic volume indicates Device or pro
Slide 11: Commercialisation strategy
Commercialisation strategy EBR is executing on a clear and targeted plan with near term catalysts Expansion For personal use only 2024+ Initial Commercial Pre-Commercial H2 2023 2022 • Expand use of WiSE® beyond initial target of Lead Failure and High-Risk Upgrade patients • Initial focus on sites w
Slide 12: US sales and distribution platform
US sales and distribution platform EBR will leverage its established partnerships and infrastructure in the US to drive initial sales growth For personal use only Clinical trial sites to drive sales Unmet need and strong data • Targeting ~45 US sites that have Increase market awareness in key market
Slide 13: Experienced Board
Experienced Board Experienced board team with a proven track record For personal use only Allan Will John McCutcheon Trevor Moody Bronwyn Evans, Executive Chairman President & CEO Independent Non- PhD AM exec Director Independent Non- exec Director Dr. Evans is an experienced leader and Mr. Will is
Slide 14: Senior management team
Senior management team Highly qualified senior management team to drive commercial strategy For personal use only Frank Hettmann Parker Willis, PhD Michael Hendricksen Steve Sandweg Chief Financial Chief Technology Chief Operating Chief Commercial Officer Officer Officer Officer Mr. Hettmann has ove
Slide 15: Market expansion opportunity
Market expansion opportunity The WiSE ® technology platform can be expanded for use into other patient groups, increasing EBR’s For personal use only market opportunity and underpinning future growth Rapid adoption of leadless devices supports strong market growth Initial Addressable Market US$2.1bn
Slide 16: Other studies
Other studies EBR is currently progressing planning activities for studies in expanded indications For personal use only Totally Leadless CRT Study (TLC) ACCESS-CRT Study • TLC pairs WiSE® with a leadless RV pacemaker, • Conduction system pacing or left bundle branch area which has demonstrated stro
Slide 17: Near term catalysts
Near term catalysts EBR has several upcoming catalysts including pivotal trial readout expected in H2 2022 use only H1 2022 H2 2022 H1 2023 H2 2023 Trial Enrolment Complete Headline results SOLVE 6 month follow up Data analysis For personal Commercial Germany permanent US FDA approval & reimbursemen
Slide 18: Appendix
For personal use only Appendix
Slide 19: Corporate Overview
Corporate Overview For personal use only Financial Information Share Price Performance (since IPO) ASX Code EBR A$ 000‘ Shares on issue 267.9m 1.2 12000 Share price1 A$0.66 Market capitalisation ~A$178.8m 1 10000 Cash at bank (31 Dec A$107.8m 2021) 0.8 8000 Options & Rights 31.08m 0.6 6000 Sharehold
Slide 20: Disclaimer
Disclaimer The material contained in this document is a presentation of general information about may differ materially from what is expressed in this presentation. For personal use only the activities of EBR Systems, Inc. (ASX:EBR) (ARBN 654 147 127) and its subsidiaries (“EBR”) current as at the d
Slide 21: Contact Us
For personal use only Contact Us Company John McCutcheon President & CEO P: +1 408 720 1906 E: [email protected] Investors Joel Seah Vesparum Capital P: +61 3 8582 4800 E: [email protected] 21