EBR SYSTEMS INC. — Investor Presentation 2022

Feb 1, 2022

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Investor Presentation February 2022

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Investment highlights

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Unique novel Large addressable De-risked clinical technology market profile

Rapid path to commercialisation

Value upside potential

EBR’s WiSE[®] is the Initially targeting Currently in final stage WiSE[®] has been WiSE[®] can be extended world’s smallest insidepatients who cannot of pivotal SOLVE trial. awarded FDA into other patients, the heart wireless receive CRT from Breakthrough Device expanding addressable Extensive clinical cardiac pacing device existing devices or are at Designation[1] . market to ~US$7.1bn. experience with >350 and the only leadless high risk for patients treated to date. EBR is targeting FDA Increasing adoption of CRT solution. conventional upgrades. approval and US leadless RV pacemakers Previous studies have Strong competitive Represents an commercial launch in H2 creates a new market – exceeded endpoints that protection with 97 addressable market of 2023 with initial adoption WiSE[®] is the only device have been set for the issued patents globally. ~US$2.1bn. from sites participating which can upgrade pivotal trial. in clinical trials. leadless RV pacemakers to leadless CRT.

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CRT: Cardiac Resynchronisation Therapy, RV: Right ventricle 1 Breakthrough Device Designation provides greater access to the FDA and initial multi-year payment coverage

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CRM is constrained by leads

There are many problems from using leads (wires) to deliver energy to the heart

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Coronary Sinus limits
Can migrate and
LV lead placement
sometimes fracture
locations
RIGHT ATRIUM
LEAD
Pathway for
pathogens to Difficult to place
myocardium LEFT VENTRICLE
(CS) LEAD
RIGHT LV lead must be
Associated with
VENTRICLE placed outside the
phrenic nerve
LEAD heart to avoid blood
stimulation
clots
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CRM: Cardiac Rhythm Management

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The world is going leadless

EBR has a leadless solution for heart failure patients

Leadless CRM Landscape

• Heart Failure is a major medical and economic problem

• Many patients with heart failure require a treatment called Cardiac Resynchronisation Therapy (CRT)

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Bradycardia Defibrillation CRT
Helps maintain cardiac Helps manage Restores ventricular
contraction during tachycardia or dyssynchrony in patients
bradycardia fibrillation with heart failure
Medtronic Boston Boston Scientific
Micra [®] Scientific Emblem [®]
Empower [®] EBR Systems
WiSE [®]
Abbott Medtronic
Aveir [®] EV ICD [®]
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• CRT uses cardiac pacing devices to coordinate the left and right sides of the heart

• CRT has been shown to significantly improve the health and quality of life for heart failure patients

• Many patients are unable to receive CRT because their anatomy or disease condition prevents placing a lead to stimulate the left side of the heart

• EBR‘s WiSE[® ] can be used in these patients to stimulate the left side of the heart, and with a rightside pacer, deliver CRT

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CRT: Cardiac Resynchronisation Therapy, RV: Right ventricle

1 The Impact of Cardiac Resynchonisation Therapy in the Treatment of Heart Failure, February 2017, Takashi Murashita

• 2 MarketAndMarkets: Cardiac Resynchronisation Therapy Market (2019), Global Forecast to 2024

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Advantages of WiSE[®]

EBR’s WiSE[®] leadless pacemaker addresses the shortcomings of traditional pacemakers

Wireless

Eliminates lead complications such as placement difficulty, blood clots, unintended nerve stimulation, dislodgement, extraction and repositioning.

Endocardial

Delivers pacing directly to the inside of the left ventricle – considered to be more physiologic.

Customised

Tailored therapy – endocardial pacing provides a greater selection of stimulation sites which may lead to better patient outcomes.

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WiSE[® ] is the only leadless solution for CRT

Other leadless pacemakers are too large for CRT and left ventricular (LV) pacing

WiSE[®] fills the gap

Currently the only leadless solution globally for LV pacing including CRT

Other leadless pacemakers are too big for LV pacing Leading to increased risk of blood clots, restricting their use to RV and right atrium pacing only

No direct competitors

Currently no other players known to be developing leadless LV pacing technology for CRT

Strong competitive protection WiSE [®] is protected by over 97 issued patents globally

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RV Pacing only LV Pacing
Medtronic Abbott Boston Scientific EBR Systems
Micra [®] Aveir [®] Empower [®] WiSE [®]
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Dr. Jeffrey Alison, Monash Hospital, Melbourne. Micra on the left, WiSE[®] held by tweezers on the right.

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Large initial addressable market

At commercial launch, EBR estimates to have an addressable market of ~US$2.1bn initially

Estimated Market Size

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26,000,000+

People worldwide affected by heart failure[1]

EBR initially targeting patients unable to receive CRT from existing devices and those at high risk from conventional upgrades

Without effective CRT, these patients have poor clinical prognosis, poor quality of life and reduced life expectancy

Estimated Addressable Market

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$267m
$1,068m
$801m
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US$2.1bn

Acute Lead Failure High Risk Upgrades Chronic Lead Failure

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1 Savarese, G., & Lund, L. H. (2017). Global Public Health Burden of Heart Failure. Cardiac failure review , 3 (1), 7–11. Notes: Acute lead failures: Unable to implant CRT lead in a new patient, Chronic lead failures: CRT system implanted but has ceased providing clinically effective CRT, High-risk upgrades: Patient has another implanted device but has developed heart failure and requires CRT. These patients are at high risk from a standard lead-based upgrade.

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Extensive clinical experience in multiple trials

Over 350 patients have been treated with WiSE[®] to date

Study Year published	Patients Key Findings
WiSE®-CRT1 2014	17 Proof-of concept - providing CRT using WiSE® is feasible
Select-LV2 2017	35 WiSE® provided clinical benefit in majority of patients
Investigator study3 2020	22* Patients previously classified as non-responders were able to achieve CRT with WiSE®
Registry4 2020	90 WiSE® can provide CRT in a real world setting to previously untreated non-responders and high-risk upgrade patients
Investigator study5 2020	8 Micra® and WiSE can operate together to deliver totally leadless CRT to patients
SOLVE-CRT Roll-in Study6 2021	31 Run-in open-label study that showed high success rate, reduction in heart failure symptoms and reversal of remodeling
SOLVE-CRT Pivotal Study In progress	Randomised - 108 Completed, remains blinded
	Single-arm - 75 Single arm, treatment only trial in progress

• *Note: 22 Patients were part of Registry

• Auricchio A, Delnoy PP, Butter C, et al. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study. Europace 2014 May; 16(5): 681-8.

• Reddy VY, Miller MA, Neuzil P, et al. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129.

• Sidhu BS, Porter B, Gould J, et.al. Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy. PACE 2020;43(9):966-973.

• Sieniewicz BJ, Betts TR, James S, et.al. Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system. Heart Rhythm 2020;17(8):1291-1297.

• Carabelli A, Jabeur M, Jacon P, et.al. European experience with a first totally leadless cardiac resynchronization therapy pacemaker system. EP Europace 2020; euaa342.

• Carabelli A, Jabeur M, Jacon P, et.al. European experience with a first totally leadless cardiac resynchronization therapy pacemaker system. EP Europace 2020; euaa342. 6. Okabe T, Hummel JD, Bank AJ, Niazi IK, McGrew FA, Kindsvater S, Oza SR, Scherschel JA, Walsh MN, Singh JP. Leadless left ventricular stimulation with WiSE-CRT System – Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase). Heart Rhythm. 2021 Jul 23:S1547-5271(21)01808-7.

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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

COMPLETED ENROLLING

Randomised Phase

Single-arm Phase

Complete enrolment H1 2022[1] FDA submission H1 2023

Purpose

Assess the safety and effectiveness of the WiSE[®] System

Design

Population

International, multi-center study in follow-up to initial 31-patient US roll-in study (completed and published)[2] Acute lead failures, chronic lead failures, high risk upgrades

Single-arm Phase

Single arm, open label targeting enrolment complete H1 2022 and headline data H2 2022

Primary Efficacy Endpoint >9.3 % improvement in heart function measured by reduction in left ventricular end systolic volume

Primary Safety Endpoint <30% patients with device or procedure-related complications

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• 1 Early-stopping, interim analysis enrolment

• 2 Modified design of Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy (SOLVE-CRT) in non-responders, previously untreatable and high-risk upgrade patients trial, J.P. Singh et al (2021), Am. Heart J. 235:158-162

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Endpoints achieved previously

Previous studies have exceeded the pre-specified Performance Goals (Endpoints) set for the SOLVE trial

Efficacy Results

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Safety Results

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Left Ventricular End Systolic Volume

Reduction in end systolic volume indicates improvement in heart failure

Type I Complication

Device or procedure-related complications

Clinical Trials

End Systolic Volume (% change in sub-group[1] )

Safety

Freedom from Type I Complications Rate

Select-LV	-19.9%
Registry	-20.9%
SOLVE-CRT Roll-in study	-18.5%
Combined Clinical Trials	-20.2%
SOLVE Performance Goal	-9.3%

SOLVE-CRT Roll-in (N = 31, all patients relevant for safety 90.3% evaluation) SOLVE Performance Goal 70.0%

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1 Sub-group analysis conducted by EBR on relevant patients (i.e., acute lead failures, chronic lead failures and high-risk upgrade patients) that will be assessed in the SOLVE clinical trial for the US PMA application

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Commercialisation strategy

EBR is executing on a clear and targeted plan with near term catalysts

Expansion

2024+

Initial Commercial

Pre-Commercial

2022

• Complete SOLVE pivotal trial enrolment in H1 2022

• Support clinical sites and patient implants

• Presentations at cardiology conferences; Publications in medical and scientific journals

H2 2023

• Initial focus on sites with WiSE[®] experience (through clinical trials)

• Targeting top 200 to 250 sites that account for ~50% of US CRT market

• Launch in select OUS[1] markets as reimbursement coverage is secured

• Initial focus on key opinion leaders at high volume sites in each market

• Expand use of WiSE[® ] beyond initial target of Lead Failure and High-Risk Upgrade patients

• Leverage growth opportunities from increasing adoption of leadless pacemakers (WiSE[®] upgrades RV leadless pacemakers to CRT)

• Geographic expansion into other markets using distributors

• Expand WiSE[®] ’s payment and reimbursement coverage

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1 OUS: Outside the US

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US sales and distribution platform

EBR will leverage its established partnerships and infrastructure in the US to drive initial sales growth

Clinical trial sites to drive sales

• Targeting ~45 US sites that have participated in previous clinical trials

• Capitalise on existing partnerships with top CRT sites

• Target top 200 to 250 clinical sites, representing > 50% US CRT market

Specialist sales force established

• Execution of commercial launch supported by specialised direct sales force

• SOLVE team in place with clinical and technical expertise of WiSE[®] system

• Target growth to 35 sales territories by end of 2025

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Unmet need and strong data

Increase market awareness in key markets:

• Unmet need underscored by FDA Breakthrough Device designation for WiSE[®]

• Leverage extensive body of clinical evidence

• Support of Key Opinion Leaders (KOLs)

Reimbursement & High ASP

• New Technology Add-on Payment (NTAP) expected post FDA approval

• US WiSE® ASP: US$35,000[1]

• OUS WiSE® ASP: US$20,000[2]

Low hospital adoption barriers

• Low barrier for opening new accounts – no capital equipment required and reimbursement available post-approval

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Note: ASP: Average Selling Price,

• 1 U.S. pricing with New Technology Add-on Payment (NTAP) post-approval

• 2 Initial Phase “OUS Markets” limited to AU, UK, Germany, France, BeNSca

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Experienced Board

Experienced board team with a proven track record

Allan Will John McCutcheon Executive Chairman President & CEO

Mr. McCutcheon has over 35 years of sales, marketing, and general management experience in medical devices. Previously he served as the President and CEO of Ceterix Orthopaedics Inc. He has also held CEO roles at Ventus Medical and Emphasys Medical.

Mr. Will is an operating executive with extensive experience founding, funding, operating, and selling medical device companies. Prior to EBR, as chairman of Ardian, he led negotiation of the company’s acquisition by Medtronic for over US$800m.

Mr. Will was also founding Managing Director of Split Rock Partners’ Silicon Valley office, focusing on therapeutic medical devices. He was founder, chair and CEO of the Foundry, co-founding 11 companies there, including:

David Steinhaus, MD Independent Nonexec Director

• Evalve Inc., which was acquired by Abbott Laboratories for US$450m

Dr. Steinhaus was formerly VP and GM of the Heart Failure Business for the Cardiac Rhythm and Heart Failure Division at Medtronic plc, after 20 years of cardiology (electrophysiology) practice. He is currently the Executive Chairman of the board of Enopace Biomedical Ltd.

• Concentric Medical Inc., which was acquired by Stryker Corp for US$135m

Mr. Will is an inventor on more than 30 issued patents.

Trevor Moody Independent Nonexec Director

Mr. Moody currently serves as Medical Device Partner at M.H. Carnegie & Co, where he makes investments in medical device companies. He was previously General Partner at Frazier Healthcare Ventures, a large U.S. based venture capital and private equity firm.

Karen Drexler Independent Nonexec Director

Ms. Drexler currently serves on the boards of two other public companies, Resmed, Inc., where she serves on the compensation and nominating and governance committees, and Outset Medical Inc, where she chairs the compensation committee.

Bronwyn Evans, PhD AM Independent Nonexec Director

Dr. Evans is an experienced leader and CEO with a broad technical background across multiple sectors including medical technology, manufacturing, power generation, and technical regulation & standards. She is currently CEO of Engineers Australia and Director at GME.

Christopher Nave, PhD Non-exec Director

Dr. Nave is a Founder and Managing Director of Brandon Capital Partners and the CEO of the Medical Research Commercialisation Fund. Dr Nave previously served as the Director of Commercialisation at the Baker Heart Research Institute.

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Senior management team

Highly qualified senior management team to drive commercial strategy

Frank Hettmann Chief Financial Officer

Mr. Hettmann has over 25 years of experience in senior and executive positions in finance, operations and administration within medical device and technology companies. He was previously CFO of Avenu Medical Inc. and Neology Inc.

Madhuri Bhat Chief Regulatory Officer

Ms. Bhat has over 20 years of experience in public affairs, public policy, clinical, quality assurance and regulatory roles. She led several successful pivotal clinical trials and secured regulatory approvals in the US and internationally for Class II and III cardiovascular systems.

Parker Willis, PhD Chief Technology Officer

Dr. Willis is an electrical engineer and has worked in medical devices for over 25 years, all in technical leadership capacities for the development of novel technologies in cardiac electrophysiology. He previously held a senior position at Boston Scientific Corporation (NYSE: BSX).

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Spencer Kubo, MD
Chief Medical
Officer
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Dr. Kubo has extensive experience developing innovative cardiovascular devices including neuromodulation, mitral regurgitation and cardiac support.

Michael Hendricksen Chief Operating Officer

Mr. Hendricksen has over 25 years of medical device product development and manufacturing experience. He was previously COO at Ceterix Orthopaedics. Prior to Ceterix, he was VP of R&D at Foundry NewCo XI.

Andrew Shute Senior VP of Global Field Operations

Mr. Shute has over 20 years of medical device experience and has led the successful commercialisation of new technologies and products working in corporate start-up and distributor settings.

Steve Sandweg Chief Commercial Officer

Mr. Sandweg has 30 years of sales experience in Fortune 500 medical technology companies, primarily within cardiovascular and structural heart space. Previously he served as General Manager for Keystone Heart, a Venus Medtech Company.

John Sam VP of Engineering and Operations

Mr. Sam has over 15 years of medical device experience and has managed, supported and transferred many different technologies and products from concept to commercialisation.

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Market expansion opportunity

The WiSE [®] technology platform can be expanded for use into other patient groups, increasing EBR’s market opportunity and underpinning future growth

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Rapid adoption of leadless devices
supports strong market growth
Initial Addressable Market US$2.1bn
New Patient Groups, Indications &
Geographies
• First-line CRT treatment
•
De novo implants for bradycardia
Expansion Opportunity US$7.1bn •
International expansion
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Note: Expanding into any additional clinical indications and/or patient groups may require supporting data from clinical studies, additional regulatory approvals, and establishing payment coverage or reimbursement.

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Other studies

EBR is currently progressing planning activities for studies in expanded indications

Totally Leadless CRT Study (TLC)

ACCESS-CRT Study

Trial

• TLC pairs WiSE[®] with a leadless RV pacemaker, which has demonstrated strong safety and efficacy results in a previous study

• Increased adoption of leadless RV pacemakers is creating a need for WiSE[® ] and approximately 30% of these patients will need CRT within 4 years

• WiSE[®] is the only device that can upgrade a leadless RV pacemaker to totally leadless CRT

• Conduction system pacing or left bundle branch area pacing (LBBAP) provides physiological activation of the left ventricle using the heart’s native conduction system.

• By utilising these faster conduction pathways, it has the potential to improve outcomes in patients eligible for CRT.

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Purpose

Demonstrate the safety and efficacy of the coimplantation of the WiSE[®] -CRT System with an intracardiac pacemaker to provide totally leadless CRT.

Demonstrate the feasibility, safety and outcomes of leadless LBBAP using the WiSE[®] -CRT System

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Design

Single arm, prospective, multicentre, observational study enrolling up to 40 patients.

Multicentre, prospective, non-randomised, observational study enrolling up to 45 patients.

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Near term catalysts

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EBR has several upcoming catalysts including pivotal trial readout expected in H2 2022
H1 2022 H2 2022 H1 2023 H2 2023
Trial Enrolment Complete Headline results
6 month follow up
Data analysis
Germany permanent US FDA approval &
reimbursement commercial launch
US filing for regulatory approval & commercial
launch preprations
Australia inclusion on
Australian and European Totally Leadless Study (TLC) prosthesis list
Australian and European ACCESS-CRT Study s
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SOLVE
Commercial
Other
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Appendix

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Corporate Overview

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Financial Information Share Price Performance (since IPO)
ASX Code EBR
A$ 000‘
Shares on issue 267.9m
1.2 12000
Share price [1] A$0.66
Market capitalisation ~A$178.8m 1 10000
Cash at bank (31 Dec
A$107.8m
2021) 0.8 8000
Options & Rights 31.08m
0.6 6000
Shareholder distribution
0.4 4000
Substantial shareholders 0.2 2000
Other 0 0
Nov-21 Dec-21 Jan-22 Jan-22
Allan Will Volume Close Price
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1Share Price as at close on 31 January 2022. IPO Share Price of $1.08 in November 2021

Substantial shareholders are MRCF3 Services (H) Pty Ltd ATF MRCF3 (H) Trust, MRCF3 Services (HP) Pty Ltd ATF MRCF3 (HP) Trust and MRCF3 (HP) Pty Ltd ATF MRCF3 Part C Trust, Brandon Capital Partners, Carnegie Healthcare Fund LP, Carnegie Innovation Fund No.2 LP and Split Rock Partners LP

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Disclaimer

The material contained in this document is a presentation of general information about the activities of EBR Systems, Inc. (ASX:EBR) (ARBN 654 147 127) and its subsidiaries (“EBR”) current as at the date of this presentation. It should be read in conjunction with EBR’s periodic and continuous disclosure announcements filed with the Australian Securities Exchange, available at www.asx.com.au.

The information in this presentation is provided in a summary form, does not purport to be complete and should not be relied upon as advice for investment purposes. This presentation is for information purposes only and is not financial product advice or a recommendation to acquire EBR securities. This presentation does not take into account the investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.

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 to the fairness, accuracy, correctness or completeness of the information, opinions or conclusions contained in this presentation. The information in this presentation is subject to change without notice and unless required by law, EBR assumes no obligation to update this presentation or its contents for any matter arising or coming to EBR’s notice after the date of this presentation.

Certain statements in this presentation may constitute forward-looking statements or statements about future matters that are based on management’s current expectations and beliefs. Such statements are typically identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘expects’, ‘anticipates’, ‘intends’ and other similar words. These statements are subject to risks and uncertainties that are difficult to predict and are based on assumptions as to future events that may not prove accurate. Actual results

may differ materially from what is expressed in this presentation.

To the maximum extent permitted by law, no responsibility for any loss arising in any way (including by way of negligence) from anyone acting or refraining to act as a result of this presentation or its contents is accepted by EBR or any of its officers, employees or agents.

The distribution of this presentation outside of Australia may be restricted by law and any such restrictions should be observed. This presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in Australia, the United States or any other jurisdiction.

Investors should note that this presentation may contain unaudited financial information that has been prepared by EBR’s management. EBR’s results are reported under US GAAP. Certain financial data in this presentation is “non-IFRS financial information” under Regulatory Guide 230 (Disclosing non-IFRS financial information) published by ASIC. All values are stated in U.S. dollars unless otherwise stated.

EBR’s CHESS Depositary Interests (“CDIs”) are traded on ASX in reliance on the safe harbour provisions of Regulation S under the US Securities Act of 1933, as amended, and in accordance with the procedures established pursuant to the provisions of a noaction letter dated 7 January 2000 given to ASX by the staff at the US Securities and Exchange Commission. The relief was given subject to certain procedures and conditions described in the no-action letter. One of the conditions is that the issuer provides notification of the Regulation S status of its securities in communications such as this presentation.

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Contact Us

Company

John McCutcheon President & CEO P: +1 408 720 1906 E: info@ebrsystemsinc.com

Investors

Joel Seah Vesparum Capital P: +61 3 8582 4800

E: EBRSystems@vesparum.com

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