EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (May 2025)
47 slides from EBR Systems's investor presentation, May 22, 2025
Slide 1: Capital Raising Presentation: Pathway to Commercialisation
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY US PERSON For personal use only Capital Raising Presentation Pathway to Commercialisation May 2025 ASX:EBR NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON
Slide 2: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer Introduction • The information in this presentation has been prepared by EBR in good faith and with due care, but the EBR does not make any representation or warranty, express or implied, as t
Slide 3: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer • Refer to “Risk factors” on pages 30 to 40 of this presentation for a non-exhaustive summary of • Any such statements, opinions and estimates in this presentation speak only as of the date ce
Slide 4: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer • Past performance is not necessarily a guide to future performance and no representation or any person to whom, it would not be lawful to make such an offer. The offer and sale of the warrant
Slide 5: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer Restrictions under Regulation S under the US Securities Act “FOR US” designation. This designation effectively prevents New CDIs from being sold on ASX to U.S. Persons during the Distribution
Slide 6: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer d) the ASX will advise ASX Participating Organisations that, during the Distribution Compliance ii. disclaim any obligations or undertaking to release any updates or revision to the Period, no
Slide 7: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer • The JLM Parties take no responsibility for the Capital Raise and make no recommendations as • Each of the Joint Lead Managers and their respective related bodies corporate and affiliates to
Slide 8: Important Notices and disclaimer
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Important Notices and disclaimer • In connection with the Placement, one or more investors may elect to acquire an economic interest in the New Securities (“Economic Interest”), instead of subscribing for or acquiring the For
Slide 9: Executive summary
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Executive summary Institutional Placement of A$55.9 million and Security Purchase Plan For personal use only • The WiSE® CRT System is the world’s smallest inside-the-heart wireless cardiac pacing device, and the only leadles
Slide 10: Investment highlights
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Investment highlights Developer of the world’s first and only leadless pacemaker for heart failure For personal use only High value market opportunity Pathways to market Defined Strategy FDA approval Multiple pathways Clear c
Slide 11: Traditional CRT systems are suboptimal
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Traditional CRT systems are suboptimal Traditional CRT systems use wires or leads to deliver energy to the heart, which can lead to many problems. For personal use only Leads can migrate and Left Ventricle (LV) lead must some
Slide 12: EBR has a leadless solution for the heart
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON EBR has a leadless solution for the heart EBR’s WiSE CRT System is the only leadless device that can deliver cardiac resynchronisation therapy For personal use only Left ventricle1 Right ventricle / atrium1 WiSE CRT System fi
Slide 13: Targeting a US$3.6bn initial addressable market
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Targeting a US$3.6bn initial addressable market At commercial launch, EBR estimates an initial addressable market of ~US$3.6bn For personal use only Worldwide CRM Market Initial Addressable market (~US$3.6bn)2 (~US$13.6bn)1 A
Slide 14: Approved Indications Support US$3.6bn TAM
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Approved Indications Support US$3.6bn TAM The FDA has approved the WiSE CRT System with the expected indications For personal use only The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are
Slide 15: Clear commercialisation strategy in place
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Clear commercialisation strategy in place Breakthrough device designation provides multiple pathways for reimbursement For personal use only ✓ Eligibility for inpatient add-on payments has been confirmed by CMS (NTAP1). Outpa
Slide 16: Manufacturing facilities in place to support commercialisation objectives
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Manufacturing facilities in place to support commercialisation objectives For personal use only EBR has secured a new state-of-the-art facility at favourable terms to support long-term commercial growth and scale Significant
Slide 17: Strong Support from Global Key Opinion Leaders
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Strong Support from Global Key Opinion Leaders For personal use only Niraj Varma, MD, PhD, FRCP Prash Sanders, MBBS, PhD, FHRS Timothy Betts, MD, MBChB, FRCP Professor of Medicine, Cardiologist & Electrophysiologist, Cardiolo
Slide 18: Reimbursement System
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Reimbursement System The reimbursement system in the US is a function of coding and coverage to determine the amount paid for a procedure For personal use only Coding Coverage Payment Coding allows uniformity in claims submis
Slide 19: WiSE Reimbursement
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON WiSE Reimbursement EBR has multiple pathways for WiSE Reimbursement For personal use only Medicare Coverage Medicare In-patient Payment Medicare Out-patient Payment Transitional Coverage of Emerging New Technology Add-On Paym
Slide 20: Favourable US market dynamics
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Favourable US market dynamics Market dynamics in the US support initial adoption of the WiSE CRT System For personal use only Market validation • Support of Key Opinion Leaders (KOLs) • Unmet need underscored by FDA breakthro
Slide 21: Long term growth strategy
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Long term growth strategy Long term growth opportunity targeting new patient groups, indications and geographies For personal use only Pursue new indications Product development Expand internationally Progress clinical studie
Slide 22: Clinical development: Totally Leadless CRT
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Clinical development: Totally Leadless CRT EBR is actively progressing activities to initiate studies to support expanded indication For personal use only Commercial benefits • Increased adoption of leadless pacemakers expand
Slide 23: Upcoming milestones
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Upcoming milestones EBR continues to achieve significant value catalysts and pave the way to future value creation For personal use only Delivered Near term (2025- 2026) Next steps (2026 +) ✓ Headline data released at Heart R
Slide 24: Summary
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Summary EBR remains driven to deliver superior treatment for patients suffering from cardiac rhythm diseases For personal use only Developer of the world’s first and only leadless pacemaker for heart failure EBR’s WiSE® CRT S
Slide 25: Capital Raise
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY US PERSON For personal use only Capital Raise 25 NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON
Slide 26: Offer summary
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Offer summary Institutional Placement to raise A$55.9 million and Security Purchase Plan For personal use only • A fully underwritten Institutional Placement (“Placement”) to raise A$55.9 million Placement size • 55.9 million
Slide 27: Indicative timetable
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Indicative timetable Event Date For personal use only Record date for SPP (7:00pm AEST) Wednesday, 21 May 2025 Trading halt lifted, announce Completion of Placement Thursday, 22 May 2025 Settlement of new CDIs issued under th
Slide 28: Sources & uses of funds
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Sources & uses of funds Funding to support the commercialisation ramp, manufacturing scale up, R&D, general / administrative and working capital For personal use only Sources A$m US$m • Post completion of the Placement, EBR w
Slide 29: Appendix
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY US PERSON For personal use only Appendix 29 NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON
Slide 30: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1. Company Specific Risks For personal use only In addition to the general risks noted in in this Presentation, investors should be aware of the specific risks of an investment in EBR. These specific risks in
Slide 31: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.3 Reliance on key suppliers for product components For personal use only EBR's products include components that are manufactured and supplied by third parties, some of which are single-source suppliers. The
Slide 32: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.6 Cyber security breaches, loss of data and other disruptions For personal use only In the ordinary course of the Company's business, it may become exposed to, or collect and store sensitive data, including
Slide 33: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.10 New or competing technologies or products For personal use only EBR expects to generate the vast majority of its revenue going-forward from the sale of WiSE® CRT System. The medical device industry is co
Slide 34: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.13 Pricing and margins For personal use only The Company can give no assurance that it will be able to achieve satisfactory prices for the WiSE® CRT System or maintain prices at the initial levels it achiev
Slide 35: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.16 Third party intellectual property rights disputes For personal use only EBR does not believe that its activities infringe any third party's intellectual property rights. However, in the future the Compan
Slide 36: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.19 Regulatory requirements for manufacturing facility For personal use only The manufacturing facility for EBR's products must meet stringent quality standards. Any failure to comply with the applicable reg
Slide 37: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.22 FCPA and similar worldwide anti bribery laws and any investigation For personal use only The U.S. Foreign Corrupt Practices Act (FCPA) and similar worldwide anti-bribery laws prohibit companies and their
Slide 38: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.25 The impact of the E.U. Medical Device Regulation For personal use only In 2017, the new E.U. Medical Device Regulation (MDR) came into force, which replaced the E.U.'s Medical Device Directive. EBR will
Slide 39: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 1.27 Transition to commercialisation phase For personal use only As is common with companies with a limited operating history, EBR has incurred net losses since its inception, has never been profitable and ca
Slide 40: Key risk factors
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Key risk factors 2. General risks For personal use only There are risks associated with any stock market investment. Some of these risks are listed below. 2.1 Stock market fluctuations Stock market fluctuations in Australia a
Slide 41: Foreign offer restrictions
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Foreign offer restrictions International Offer Restrictions For personal use only This document does not constitute an offer of new CHESS Depositary Interests (“New CDIs”) representing shares of common stock of the Company in
Slide 42: Foreign offer restrictions
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Foreign offer restrictions New Zealand For personal use only This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (the “FMC Act”).
Slide 43: Foreign offer restrictions
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Foreign offer restrictions Switzerland For personal use only The New CDIs may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange or on any other stock exchange or regulated trading facilit
Slide 44: Foreign offer restrictions
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Foreign offer restrictions United Kingdom For personal use only Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and n
Slide 45: Placement Agreement summary
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Placement Agreement summary Placement Agreement For personal use only EBR entered into a placement agreement with J.P. Morgan Securities Australia Limited (“J.P. Morgan”), Morgans Corporate Limited (“Morgans”), Wilsons Corpor
Slide 46: Placement Agreement summary
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON Placement Agreement summary • EBR fails to perform or observe any of its obligations under the Placement Agreement; • a representation or warranty made or given by EBR under the Placement Agreement proves to be, or has been,
Slide 47: Thank you
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY US PERSON For personal use only Thank you 47 NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO ANY U.S. PERSON