EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (January 2023)
18 slides from EBR Systems's investor presentation, Jan 30, 2023
Slide 1: Investor Presentation January 2023
For personal use only Investor Presentation January 2023 1
Slide 2: Attractive investment opportunity
Attractive investment opportunity EBR is a de-risked investment case with material upside potential For personal use only High value market opportunity De-risked pathways to market Value upside Large initial De-risked De-risked 17x Average addressable No competition commercial clinical pathway EV/Re
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 Pathway for LEAD 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 • There are a few wireless products in the market CRT Bradycardia Defibrillation • Pat
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: US$2.5bn initial addressable market
US$2.5bn initial addressable market At commercial launch, EBR estimates to have an addressable market of ~US$2.5bn initially For personal use only Target Patient Groups Initial Addressable Market (US$) Acute Lead Failure $0.3bn Unable to implant CRT wire in a new CRT patient $0.4bn Chronic Lead Fail
Slide 7: 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. Other wireless p
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 2016 2019 2020 FDA granted FDA granted FDA approved trial re- Investigational Device Breakthrough Device design of pivotal study Exempt
Slide 9: Completed SOLVE pivotal study
Completed SOLVE pivotal study EBR completed interim enrolment in its pivotal SOLVE study, with headline results expected in H1 2023 For personal use only COMPLETED COMPLETED1 Next Steps • Complete 6 month follow up and data analysis • Headline results released Single-arm at Heart Rhythm Society Rand
Slide 10: De-risked clinical pathway
De-risked clinical pathway 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% (indicate
Slide 11: Patient success story
Patient success story EBR has allowed the patient to once again partake in all the activities he used enjoy before his heart failure For personal use only Pre heart failure Onset of heart failure Post WiSE CRT Implant US Marine and Vietnam war veteran who Heart failure materially impact the patient’
Slide 12: WiSE device update
WiSE® device update EBR has identified a potential increased rate of battery depletion in some WiSE® systems For personal use only WiSE® transmitter update Solution No impact to SOLVE trial • Ongoing technical assessments have ✓ EBR is working closely with clinical sites ✓ Does not affect timing of
Slide 13: US sales and distribution platform
US sales and distribution platform EBR will leverage its established partnerships and presence in the US to drive initial sales growth For personal use only Clinical trial sites to drive initial sales Specialist sales force established • Targeting ~45 US sites that have participated in previous • Ex
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: Growth capital facility with Runway Growth Capital
Growth capital facility with Runway Growth Capital For personal use only Flexibility Capital risk mitigation If the macroeconomy and EBR‘s Well funded through to first few valuation rebounds, subsequent years of commercialisation and tranches can be forgone in favour debt is easier to obtain when th
Slide 16: Approaching value inflection
Approaching value inflection 2023 aims to be a pivotal year for EBR, as the company achieves significant value catalysts and paves For personal use only the way to future value creation Future value Value catalysts 2024+ Milestones achieved ❑ FDA approval in the US 2023 ❑ Commercial launch in the US
Slide 17: 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 18: Contact Us
For personal use only Contact Us Company John McCutcheon President & CEO P: +1 408 720 1906 E: [email protected] Investors Dean Dribbin Vesparum Capital P: +61 3 8582 4800 E: [email protected] 18