EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (March 2022)
20 slides from EBR Systems's investor presentation, Mar 14, 2022
Slide 1: Investor Presentation March 2022
For personal use only Investor Presentation March 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 Targeting initial Currently in final stage of WiSE® has been WiSE® can be extended world’s smallest inside
Slide 3: Traditional pacemakers are suboptimal
Traditional pacemakers are suboptimal Traditional pacemakers use wires to deliver energy to the heart, which can lead to many problems 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 pl
Slide 4: EBR has a wireless solution for heart failure patients
EBR has a wireless solution for heart failure patients WiSE® is the only wireless device that can deliver cardiac resynchronisation therapy (CRT) For personal use only Wireless Cardiac Rhythm Management Landscape1 • Many patients with heart failure require a treatment called Cardiac Resynchronisatio
Slide 5: Advantages of WiSE
Advantages of WiSE® WiSE® addresses the shortcomings of traditional For personal use only pacemakers Wireless Eliminates lead complications such as placement difficulty, blood clots, unintended nerve stimulation, dislodgement, extraction and repositioning. Endocardial Delivers pacing directly to the
Slide 6: No direct competitors
No direct competitors No other players are known to be developing wireless left ventricular (LV) pacing technology for CRT For personal use only Right ventricle/Right atrium Left ventricle WiSE® fills the gap Currently the only leadless solution globally for LV pacing including CRT Medtronic Abbott
Slide 7: Large initial addressable market
Large initial addressable market At commercial launch, EBR estimates to have an addressable market of ~US$2.1bn initially For personal use only Initial Addressable Market (US$) EBR is initially targeting patients unable to receive CRT from existing devices and those at high risk from conventional up
Slide 8: Extensive engagement with the FDA
Extensive engagement with the FDA EBR has received approval from the FDA with regards to the modified trial design for SOLVE-CRT pivotal For personal use only study – underpinned by extensive clinical experience with over 350 patients* treated with WiSE® to date 2016: FDA granted an Investigational
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 Primary Efficacy Endpoint Primary Safety Endpoint Reduction in Left Ventricular End Systolic Volume Freedom from Type 1 Complications 9.3% (indic
Slide 11: Commercialisation strategy
Commercialisation strategy EBR is executing on a clear and targeted plan with near term catalysts For personal use only Expansion Initial Commercial 2024+ Pre-Commercial • Expand use of WiSE® beyond initial H2 2023 target of Lead Failure and High-Risk Upgrade patients 2022 Refer to next slide for de
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 Specialist sales force established • Targeting ~45 US sites that have participated in previous • Exec
Slide 13: Senior leadership team
Senior leadership team Highly qualified senior leadership team to drive clinical development and commercialisation strategy For personal use only John McCutcheon Spencer Kubo, MD Steve Sandweg President & CEO Chief Medical Officer Chief Commercial Officer Mr. McCutcheon has over 35 years of industry
Slide 14: 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 New Patient Groups, Indications & Geographies • First-line CRT treatment Initial Addressable Expansio
Slide 15: 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 16: Outlook for 2022
Outlook for 2022 EBR has several upcoming catalysts including pivotal trial readout expected in Q4 2022 use only Q1 2022 Q2 2022 Q3 2022 Q4 2022 Trial Enrolment Headline Complete results 6 month follow up SOLVE personal Data analysis Heart Rhythm Society Clinical Australian and European Totally Lead
Slide 17: Appendix
For personal use only Appendix
Slide 18: Corporate Overview
Corporate Overview For personal use only Financial Information Board ASX Code EBR Karen Drexler John McCutcheon Independent Non-exec Shares on issue ~257m President & CEO Director Share price1 A$0.65 Allan Will Mr. McCutcheon previously served as Ms. Drexler currently serves on the Market capitalisa
Slide 19: 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 20: 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] 20