EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (June 2023)
40 slides from EBR Systems's investor presentation, Jun 23, 2023
Slide 1: Capital Raising Presentation
For personal use only Capital Raising Presentation EBR funded into commercialisation June 2023 1
Slide 2: Disclaimer
Disclaimer For personal use only This document has been prepared and authorised by EBR Systems, Inc. (ASX:EBR) (ARBN Forward-looking statements 654 147 127) (“EBR”) in connection with EBR’s proposed capital raising (the “Capital Raise”), Certain statements in this presentation may constitute forward
Slide 3: Disclaimer
Disclaimer For personal use only Not an offer This document is for information purposes only and is not a prospectus, disclosure document, under the US Securities Act of 1933, as amended, and in accordance with the procedures product disclosure statement or other offering document under Australian l
Slide 4: Disclaimer
Disclaimer For personal use only Disclaimer Neither Bell Potter Securities Limited (ACN 006 390 772, AFSL 243480), Wilsons Corporate To the maximum extent permitted by law, you agree to release and indemnify EBR, the Joint Finance Limited (ACN 057 547 323, AFSL 238383) nor Morgans Corporate Limited
Slide 5: Executive Summary
Executive Summary For personal use only • 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) technology • There are no direct competitors for the WiSE CRT System, the technol
Slide 6: 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 Can migrate and Left Ventricle (LV) lead sometimes fracture placement locations RIGHT ATRIUM LEAD Pathway for pa
Slide 7: No direct competitors
No direct competitors For personal use only EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy Wireless cardiac rhythm management landscape1 • There are several wireless cardiac rhythm management products in the CRT Bradycardia Defibrillation market
Slide 8: 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 and other leadless pacemakers are complementary Left ventricle Right ventricle/atrium WiSE CRT System fills the gap Currently the only leadless solution globally for LV pacing including CRT. EBR System
Slide 9: 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 10: Broad support from patients and KOLs
Broad support from patients and KOLs For personal use only Positive data welcomed by key industry leaders, patients and the industry Professor Prash Sanders Clinical coverage Director of Cardiac Electrophysiology and Pacing at the Coverage by major healthcare publications and conferences1 Royal Adel
Slide 11: Clear regulatory pathway
Clear regulatory pathway For personal use only EBR’s track record of successful engagement underpins confidence for FDA approval process 2019 2020 2022 2023+ FDA granted FDA approved trial re- FDA approved Clear pathway to Breakthrough Device design of pivotal leadless pacemakers approval with modul
Slide 12: Focused commercialisation strategy
Focused commercialisation strategy For personal use only EBR will leverage its established partnerships and presence in the US to drive initial sales growth, targeting initial sales in H1 2025 Clinical trial sites to drive initial sales Specialist sales force established • CRT market is concentrated
Slide 13: Strategy enhanced by market factors
Strategy enhanced by market factors For personal use only EBR’s commercialisation strategy is underpinned by 3 distinctive features Low hospital adoption barriers Reimbursement & High ASP Unmet need & strong data • Low barrier for opening new • New Technology Add-on Payment • Unmet need underscored
Slide 14: Product development
Product development For personal use only EBR is developing a new rechargeable battery that will support WiSE CRT System in becoming a first- line therapy option and treat a broader suite of patients Background EBR is developing a rechargeable battery and wireless charging system based on feedback f
Slide 15: Clinical development: totally leadless CRT
Clinical development: totally leadless CRT For personal use only EBR is currently progressing planning activities for studies to expand indications Totally leadless CRT • WiSE CRT System can pair with a leadless RV pacemaker to achieve totally leadless CRT • Increased adoption of leadless pacemakers
Slide 16: 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 17: 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 Upgrading dual chamber leadless TLC as first-line therapy WiSE CRT System used in conjunction with the WiSE CRT System used in conjunction with $0.4
Slide 18: 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 19: Upcoming milestones
Upcoming milestones For personal use only EBR continues to achieve significant value catalysts and pave the way to future value creation 2023 2024 2025+ ✓ SOLVE-CRT 6 Month follow up ❑ Submit Final PMA Module including transmitter upgrades ❑ Commercial launch in the US completed for final patient in
Slide 20: 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 21: Capital raise
For personal use only Capital raise
Slide 22: Capital raising overview
Capital raising overview For personal use only Institutional Placement to raise ~A$30 million and Security Purchase Plan to raise up to ~A$5 million • Placement to raise approximately A$30 million through the issue of ~33.0 million new CHESS depositary interests over shares of common stock (“New CDI
Slide 23: Indicative timetable
Indicative timetable For personal use only Event Date Trading halt Thursday, 22 June 2023 Institutional Placement bookbuild conducted Thursday, 22 June 2023 Record date for SPP 7:00pm (AEST) Thursday, 22 June 2023 Trading halt lifted, announce Completion of Institutional Placement Friday, 23 June 20
Slide 24: Sources and Use of funds
Sources and Use of funds For personal use only Funds raised will be used to advance EBR’s progress towards commercialisation and strengthen EBR’s balance sheet Sources A$m Uses A$m Equity Raising 30.0 Manufacturing (capital expenditures and operations) 6.6 Sales and marketing 8.2 Regulatory and clin
Slide 25: Appendix
For personal use only Appendix
Slide 26: Growth capital facility with Runway Growth Capital
Growth capital facility with Runway Growth Capital For personal use only EBR has unlocked the second tranche of up to US$20m following positive SOLVE-CRT results Key facility terms Financier: Runway Growth Finance Corp. (Runway) Facility size: Up to US$50,000,000 Tranche 1: US$20,000,000 available i
Slide 27: Experienced Board
Experienced Board For personal use only Experienced board with a proven track record 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 an op
Slide 28: Senior management team
Senior management team For personal use only Highly qualified senior management team to drive commercial strategy Frank Hettmann Parker Willis, PhD Michael Hendricksen Chief Financial Chief Technology Chief Operating Officer Officer Officer Mr. Hettmann has over 25 years of experience in senior Dr.
Slide 29: 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 30: Key risk factors
Key risk factors For personal use only Market adoption of WiSE® CRT System EBR's business model depends on hospitals and clinics in markets where it obtains the required regulatory approvals adopting WiSE® CRT System for the treatment of heart failure with CRT. However, there can be no guarantee tha
Slide 31: Key risk factors
Key risk factors For personal use only Reliance on key suppliers for product components EBR's products include components that are manufactured and supplied by third parties. The products are then assembled, validated and tested by these third parties or at the Company's headquarters in California.
Slide 32: Key risk factors
Key risk factors For personal use only Transition to commercialisation phase EBR is currently at the pre-commercialisation phase. The Company intends to move into the initial commercial phase after it receives FDA approval of WiSE® CRT System, which is currently expected in the H2 of 2024, subject t
Slide 33: Key risk factors
Key risk factors For personal use only Physician training The success of EBR's products depends in part on hospitals' and physicians' adherence to appropriate patient selection and proper techniques provided in training sessions conducted by the Company. However, physicians rely on their previous me
Slide 34: Key risk factors
Key risk factors For personal use only Regulatory requirements for manufacturing facilities The manufacturing facilities for EBR's products must meet stringent quality standards. Any failure to comply with the applicable regulatory requirements could result in, among other things, temporary manufact
Slide 35: Key risk factors
Key risk factors For personal use only Regulatory registrations or market approvals The manufacture, testing, labelling, sale and marketing of medical devices are subject to extensive regulation in the U.S., Europe, UK, Australia and other countries. Regulatory registrations or market approval of pr
Slide 36: Key risk factors
Key risk factors For personal use only Healthcare policy changes Many countries have instituted healthcare policy changes in an attempt to bring increasing spending on healthcare under control. Various healthcare reform proposals have also been proposed by U.S. federal and state governments and othe
Slide 37: 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 38: Foreign offer restrictions
Foreign offer restrictions For personal use only International Offer Restrictions This document does not constitute an offer of CDIs of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the CDIs may not be offered or
Slide 39: Foreign offer restrictions
Foreign offer restrictions For personal use only New Zealand 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 or sold in New Zealand (or allotted with a v
Slide 40: Contact Us
For personal use only Contact Us Company Andrew Shute Sr. VP Global Business Development P: +1 408 720 1906 E: [email protected] Investors Dean Dribbin Vesparum Capital P: +61 3 8582 4800 E: [email protected] 40