EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (September 2024)
50 slides from EBR Systems's investor presentation, Sep 18, 2024
Slide 1: Capital Raising Presentation
For personal use only Capital Raising Presentation Through FDA approval & into Commercialisation September 2024
Slide 2: Important Notices and Disclaimer
Important Notices and Disclaimer Introduction due care, but the EBR does not make any representation or warranty, express or For personal use only implied, as to the fairness, accuracy, correctness, reliability or completeness of the • THIS DOCUMENT IS NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED i
Slide 3: Important Notices and Disclaimer
Important Notices and Disclaimer Forward-looking statements or agents. For personal use only • Certain statements in this presentation may constitute forward-looking statements or Past performance statements about future matters that are based on management’s current expectations and beliefs (being
Slide 4: Important Notices and Disclaimer
Important Notices and Disclaimer • The retail component of the Entitlement Offer will be made on the basis of the S under the US Securities Act of 1933, as amended, and in accordance with the For personal use only information contained in the Retail Offer Booklet (“Retail Offer Booklet”) to be prepa
Slide 5: Important Notices and Disclaimer
Important Notices and Disclaimer • The JLM Parties take no responsibility for the Capital Raise and make no Managers (and their respective related bodies corporate, affiliates, officers, directors, For personal use only recommendations as to whether any person should participate in the Capital Raise
Slide 6: Executive Summary
Executive Summary • The WiSE® CRT System is the world’s smallest inside-the-heart wireless cardiac pacing device, and the only way to provide leadless Novel Cardiac Resynchronization Therapy (CRT) For personal use only technology • There are no direct competitors for the WiSE CRT System, the technol
Slide 7: Investment highlights
Investment highlights For personal use only Developer of the world’s first and only leadless pacemaker for heart failure High value market opportunity Pathways to market Defined Strategy Clear pathway to FDA Clear commercial Unique solution Large markets Positive results approval strategy in place N
Slide 8: Cardiac Rhythm Management Market
Cardiac Rhythm Management Market For personal use only Three key segments driving growth in the global cardiac rhythm management market Worldwide CRM Market (~US$13.6bn)1 Implantable Pulse Generator $4.8bn $4.7bn Right atrium lead $4.0bn Left ventricle lead Right ventricle lead Cardiac Resynchronisa
Slide 9: Traditional CRT systems are suboptimal
Traditional CRT systems are suboptimal For personal use only Traditional CRT systems use wires or leads to deliver energy to the heart, which can lead to many problems. Leads can migrate and LV lead must be placed sometimes fracture outside the heart to avoid blood clots Leads can become a way for C
Slide 10: EBR has a wireless solution for the heart
EBR has a wireless solution for the heart For personal use only EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy Left ventricle1 Right ventricle / atrium1 WiSE CRT System fills the gap The only leadless solution for left ventricle (LV) pacing Other
Slide 11: WiSE CRT Technology Overview
WiSE CRT Technology Overview For personal use only EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy 11 (narrated video)
Slide 12: Pivotal SOLVE-CRT Study met all endpoints
Pivotal SOLVE-CRT Study met all endpoints Positive results confirm WiSE CRT System as a highly effective treatment option for patients with heart failure1 For personal use only Primary efficacy endpoint met Primary safety endpoint met Decrease in left ventricular end systolic volume -16.4% (vs. -9.3
Slide 13: Strong Support from Global Key Opinion Leaders
Strong Support from Global Key Opinion Leaders For personal use only Jagmeet P. Singh M.D., Ph.D. Prash Sanders, MBBS, PhD, Timothy Betts, MD, MBChB, FRCP Cardiologist & Electrophysiologist, FHRS Cardiologist & Electrophysiologist Harvard Medical School, Cardiologist & Electrophysiologist, Oxford Un
Slide 14: Commercialisation pathway
Commercialisation pathway For personal use only Positive pivotal trial results and strong track record with the FDA provide a clear pathway to approval and commercialisation Drive adoption and growth FDA approval process underpinned by positive pivotal trial results and a track record of successful
Slide 15: 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 • CRT market is highly concentrated - targeting high
Slide 16: 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 Clinical trial sites to Direct, specialist sales Manufacturing capabilities drive initial sales force • 2025: Targeting US sites that have • Ex
Slide 17: US$3.6bn initial addressable market
US$3.6bn initial addressable market At commercial launch, EBR estimates an initial addressable market of ~US$3.6bn For personal use only Leadless Upgrades • Patients with a leadless right Acute Lead Failure ventricle pacemaker can only $773m $413m Unable to implant CRT wire in a new upgrade with WiS
Slide 18: Totally Leadless CRT grows the market
Totally Leadless CRT grows the market For personal use only Continued global growth and adoption of leadless RV pacemakers significantly expands EBR’s market opportunity Global Leadless RV Pacemaker Market Revenue and Unit Growth (US$m) (thousands) $1,400 1H 2025: Boston Scientific EMPOWER expected
Slide 19: 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 Launch in select OUS1 markets as indica
Slide 20: Clinical development: Totally Leadless CRT
Clinical development: Totally Leadless CRT For personal use only EBR is actively progressing activities to initiate studies to support expanded indication Commercial benefits • Increased adoption of leadless pacemakers expands the need for WiSE, including upgrading dual chamber leadless pacemakers •
Slide 21: 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 Commercial benefits • Drives higher uptake by removing barriers to adoption
Slide 22: 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 SOLVE-CRT 6 Month follow up completed FDA approval in the US Expand manufacturing facility for final patient Commercial laun
Slide 23: Experienced Board
Experienced Board Experienced board with a proven track record For personal use only Allan Will John McCutcheon Trevor Moody Bronwyn Evans, Executive Chairman President & CEO Independent Non-exec PhD AM Director Independent Non- exec Director Dr. Evans is an experienced leader and CEO Mr. Will is an
Slide 24: Senior Management Team
Senior Management Team Highly qualified senior management team to drive commercial strategy For personal use only Gary Doherty Parker Willis, PhD Michael Hendricksen Chief Financial Officer Chief Technology Chief Operating Officer Officer Mr. Doherty has over 30-years of experience across Dr. Willis
Slide 25: Summary
Summary For personal use only EBR remains 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 tec
Slide 26: Capital Raise
For personal use only Capital Raise 26
Slide 27: Offer Summary
Offer Summary Fully Underwritten Institutional Placement to raise ~A$37.4 million and an Entitlement Offer to raise up to ~$12.6m For personal use only A fully underwritten Offer of approximately A$50.0 million which comprises: ▪ A 1 for 20 pro-rata accelerated non-renounceable Entitlement Offer to
Slide 28: Indicative timetable
Indicative timetable For personal use only Event Date Trading halt and announcement of underwritten offer (including release of ASX announcement, Appendix 3B, cleansing notice and Wednesday, 18 September 2024 investor presentation) Complete Institutional Offer (Placement and Institutional Entitlemen
Slide 29: Sources & Uses of Funds
Sources & Uses of Funds Funding to support the commercialisation, manufacturing scale up, R&D, and general For personal use only working capital Sources AU$m US$m • Post completion of the capital raise, EBR will have a pro forma cash balance of Placement 37.4 25.4 ~US$88.1m / ~AUD$129.6m(1) ANREO 12
Slide 30: Appendix
For personal use only Appendix
Slide 31: 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 On-set of heart failure Post-WiSE CRT implant US Marine and Vietnam war veteran who Heart failure materially impacted Po
Slide 32: Randomised sub-study supports primary results
Randomised sub-study 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 = 0.002†
Slide 33: Key risk factors
Key risk factors For personal use only 1. Company Specific Risks 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 include, but are not limited to, those risks referred to below. Regulatory ap
Slide 34: Key risk factors
Key risk factors For personal use only Further, payers continually review new technologies for possible coverage and can, without notice, deny coverage for products and procedures or delay coverage approval until further clinical data is available. As a result, the coverage determination process is
Slide 35: Key risk factors
Key risk factors 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 procedure-based information and legally protected health information, insuranc
Slide 36: Key risk factors
Key risk factors For personal use only New or competing technologies or products EBR expects to generate the vast majority of its revenue going-forward from the sale of WiSE® CRT System. The medical device industry is competitive, subject to rapid change and significantly affected by new product int
Slide 37: Key risk factors
Key risk factors For personal use only Relationships with physicians The research, development, marketing and sale of EBR's products and potential new and improved products depend upon EBR maintaining working relationships with physicians. EBR relies on these professionals to provide it with conside
Slide 38: Key risk factors
Key risk factors For personal use only Pricing and margins The Company can give no assurance that it will be able to achieve satisfactory prices for its products or maintain prices at the initial levels it achieves. Any decline in the amount that payors reimburse EBR's customers for procedures invol
Slide 39: Key risk factors
Key risk factors For personal use only Third party intellectual property rights disputes EBR does not believe that its activities infringe any third party's intellectual property rights. However, in the future the Company may be subjected to infringement claims or litigation arising out of patents a
Slide 40: Key risk factors
Key risk factors For personal use only Healthcare fraud and abuse laws and other healthcare laws and regulations Healthcare providers, including physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any products for wh
Slide 41: Key risk factors
Key risk factors Defects or failures, and product liability claims For personal use only EBR’s business is subject to significant risks associated with the manufacture, distribution and use of medical devices that are placed inside the human body, including the risk that patients may be severely inj
Slide 42: Key risk factors
Key risk factors For personal use only Changes in U.S. and non-U.S. tax laws The rules dealing with U.S. and non-U.S. tax matters are constantly under review by persons involved in the legislative, judicial, administrative, regulatory and related governmental processes and authorities. Changes to ta
Slide 43: Key risk factors
Key risk factors For personal use only 2. General risks There are risks associated with any stock market investment. Some of these risks are listed below. Stock market fluctuations Stock market fluctuations in Australia and other stock markets around the world may negatively impact the CDI price. Fa
Slide 44: Foreign offer restrictions
Foreign offer restrictions For personal use only International Offer Restrictions This document does not constitute an offer of Chess Depositary Interests (“CDIs”) representing shares of common stock of the Company in any jurisdiction in which it would be unlawful. In particular, this document may n
Slide 45: Foreign offer restrictions
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”). The CDIs are not being offered to the public within New Zealand other than
Slide 46: Foreign offer restrictions
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 no prospectus (within the meaning of section 85 of the Financial Services an
Slide 47: Summary of Underwriting Agreement
Summary of Underwriting Agreement Underwriting Agreement For personal use only EBR entered into an underwriting agreement with Bell Potter Securities Limited (Bell Potter), Morgans Corporate Limited and E&P Capital Pty Ltd (the Joint Lead Managers) in respect of the Capital Raise on 18 September 202
Slide 48: Summary of Underwriting Agreement
Summary of Underwriting Agreement • EBR or a group member is insolvent or there is an act or omission which may result in EBR or a group member becoming insolvent; For personal use only • other than as permitted by the Underwriting Agreement, EBR alters its capital structure or constituent documents
Slide 49: Summary of Underwriting Agreement
Summary of Underwriting Agreement The ability of a Joint Lead Manager to terminate the Underwriting Agreement in respect of some events will depend on whether the Joint Lead Manager has reasonable grounds to believe that the event: For personal use only • has, or is likely to have, a material advers
Slide 50: Contact us
For personal use only Contact us Company Investors John McCutcheon Joel Seah President & CEO Vesparum Capital P: +1 408 720 1906 P: +61 3 8582 4800 E: info@ebrsystemsinc.com E: EBRSystems@vesparum.com