Investor Presentation

Made public by

sourced by PitchSend

2 of 40

Creator

4DMedical logo
4DMedical

Category

Technology

Published

No date provided

Slides

Transcriptions

#14DMedical FORMERLY 4DX TM Investor Presentation Goldman Sachs Healthcare Forum 8 October 2020 ASX: 4DX 4DMedical Limited | ABN 31 161 684 831 wwwww wwwwwwww H#2Important Notice and Disclaimer This presentation has been prepared by 4DMedical Limited (ACN 161 684 831) (Company or 4DMedical). This presentation contains summary information about the Company, its subsidiaries and the entities, businesses and assets they own and operate (Group) and their activities current as at 8 October 2020 unless otherwise stated and the information remains subject to change without notice. This presentation contains general background information and does not purport to be complete. No attempt has been made to independently verify the information contained in this presentation. Not an offer or financial product advice The Company is not licensed to provide financial product advice. This presentation is not and should not be considered, and does not contain or purport to contain, an offer or an invitation to sell, or a solicitation of an offer to buy, directly or indirectly any securities, to any person in any jurisdiction to whom or in which such offer or solicitation is unlawful nor shall it (or any part of it), or the fact of its distribution, form the basis of, or be relied on in connection with or act as any inducement or recommendation to enter into, any contract whatsoever relating to any securities. This presentation is for information purposes only and is not a prospectus, product disclosure statement, pathfinder document for the purposes of section 734(9) of the Australian Corporations Act 2001 (Cth) (Corporations Act) or other offer document under Australian law or the law of any other jurisdiction. This presentation does not constitute an invitation to apply for or purchase Securities and does not include any application form for Securities. This presentation does not constitute an advertisement for an offer or proposed offer of Securities. Neither this presentation nor anything contained in it shall form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in, or refrain from engaging in, any transaction. Nothing in this presentation constitutes legal, financial, tax or other advice. Recipients of the presentation should conduct their own investigation, evaluation and analysis of the business and other data and information set out in the presentation. Financial data All dollar values are in Australian dollars ($ or A$) unless otherwise stated. Any financial data in this presentation is unaudited. Past performance The operating and historical financial information given in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of the Company's views on its future performance or condition. Actual results could differ materially from those referred to in this presentation. You should note that past performance of the Group is not and cannot be relied upon as an indicator of (and provides no guidance as to) future Group performance. Future performance This presentation contains certain "forward-looking statements". The words "expect", "anticipate", "estimate", "intend", "believe", "guidance", "propose", "goals", "targets", "aims", "outlook", "forecasts", "should", "could", "would", "may", "will", "predict", "plan" and other similar expressions are intended to identify forward-looking statements. Any indications of, and guidance on, future operating performance, earnings and financial position and performance are also forward-looking statements. Forward-looking statements in this presentation include statements regarding the Company's future growth options, strategies and new products. Forward-looking statements, opinions and estimates provided in this presentation are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current market conditions. Forward-looking statements, including projections, guidance on future operations, earnings and estimates (if any), are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. No representation is given that the assumptions upon which forward looking statements may be based are reasonable. This presentation contains statements that are subject to risk factors associated with the Group's industry. These forward-looking statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to earnings, capital expenditure, cash flow and capital structure risks and general business risks. No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including the Company). In particular, but without limitation, no representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward looking statements in this presentation will actually occur. Actual operations, results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Any forward-looking statements in this presentation speak only as of the date of this presentation. Subject to any continuing obligations under applicable law, the Company disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in this presentation will under any circumstances create an implication that there has been no change in the affairs of the Group since the date of this presentation. Pg 2 | Investor presentation 4DMedical™ FORMERLY 4D#3• • Introduction to 4DMedical • • • Founded in 2012, 4DMedical Limited is a Melbourne-based software technology company focused on creating a step change in the capacity of physicians to diagnose and manage patients with diseases of the lung The respiratory diagnostic sector represents a global market of over US$31 billion per annum, with over 377 million respiratory diagnostics tests performed each year 4DMedical is focused on commercialising its four-dimensional XV lung imaging technology, which utilises proven, patented algorithms to convert X-ray images into quantitative scan data Unlike existing respiratory diagnostic procedures, 4DMedical's proprietary XV technology provides a non-invasive way of understanding regional lung motion and airflow in real-time With FDA clearance in place, 4DMedical's major focus is on US market commercialisation of its XV Technology Australian TGA approval for XV Lung Ventilation Analysis Software (LVAS) allows 4DMedical to gain local traction quickly through leveraging existing industry knowledge and relationships The SaaS business model offers hospitals access to the technology without the traditional issues of hardware integration, capex, additional staff or re-training 4DMedical's advancement in respiratory diagnostic technology is expected to result in improved patient experiences, earlier intervention leading to improved healthcare outcomes, with reduced costs of care > Pg 3 Investor presentation Vereni 4DMedical 4DMedical#44DMedical™ FORMERLY 4DX Respiratory Diagnostics Market Overview#5Respiratory Diagnostics Market Overview Global Lung Diagnostic Market Opportunity 4DMedical's core initial focus is rapid penetration of the US market. Given the large market size, even low market penetration could see substantial revenue generation with high gross margin. Respiratory Diagnostics Spend Worldwide demand (Thoracic X-ray, Thoracic CT scans, Nuclear scans, PFTs) Frost & Sullivan Report 2020 GLOBALLY > US $31 BILLION SPEND 377 MILLION PROCEDURES REST OF WORLD GERMANY $2.7 B $4.9 B 735 MILLION PROCEDURES JAPAN $1.9 B Israel $69 Million Country US Spend Procedures 13,716M 73.5M Switzerland $197 Million Others 4,964M 59.8M Germany 2,678M 20.3M Japan 1,905M 22.8M India $276 Million China 1,851M 101.6M UK 1,351M 8.9M France 1,191M 10.2M Australia $285 Million Spain 780M 8.4M Italy 681M 8.5M Canada 606M 8.0M Turkey $346 Million South Korea 450M 6.8M Turkey 346M 16.1M Australia 285M 5.3M South Korea $346 Million India 276M 25.3M Switzerland 197M 1.2M Israel 69M 1.1M UNITED STATES OF AMERICA. $13.7 B 73.5 MILLION PROCEDURES Candad $606 Million Italy $681 Million. CHINA $1.8 B FRANCE Spain $780 Million $1.2 B UK $1.3 B 4DMedical#61 1816 RENE LAENNEC INVENTS THE STETHOSCOPE 2 1846 JOHN HUTCHINSON DEVELOPS THE WATER SPIROMETER MEASURING VITAL CAPACITY Respiratory Diagnostics Market Overview Existing Lung Diagnostics. are Failing Us Over the last 200 years, advances in medical diagnostic technology have delivered dramatic benefits for mankind whilst advancements in lung diagnostics have stagnated. The current gold standard modality to diagnose lung dysfunction (Spirometry) was invented in the 1860s. The most recent significant advance in lung diagnostics, the CT, is 50 years old next year. Billions in R&D has been poured into cancer, heart and brain diagnostics, but lung health research has not increased at the rate of lung disease. 99% of all lung diagnostics globally are made up of these four tests: Spirometry X-ray 3 1895 ROENTGEN DISCOVERS THE USE OF X-RAYS IN MEDICAL IMAGING •VAGA 1903 WILLEM EINTHOVEN DISCOVERS ELECTROCARDIOGRAPHY (ECG/EKG) 1929 - HANS BERGER DISCOVERS HUMAN ELECTROENCEPHALOGRAPHY 1953-MEDICAL ULTRASONOGRAPHY - INGE EDLER 1960 - ECHOCARDIOGRAM - EDLER AND HERTZ 1965 FIRST COMMERCIAL ULTRASOUND 1971 SIR GODFREY HOUNSFIELD INVENTS THE FIRST COMMERCIAL CT SCANNER 1971 MAGNETIC RESONANCE IMAGING - RAYMOND VAHAN DAMADIAN 1976-FIRST COMMERCIAL PET SCANNER 9 10 11 12 1979 DEVELOPMENT OF SPECT 13 1990 - SEIJI OGAWA DEMONSTRATES THE FIRST fMRI • CT • Nuclear Medicine All trade off accuracy, sensitivity, cost and radiation exposure, while failing to provide a comprehensive insight into both the form and function of the patient's lungs. Existing lung diagnostics are decades out of date, are not fit for purpose and are ripe for displacement. Pg 6 Investor presentation 3 1800 1850 1900 1950 2000 13 4DMedical#7Respiratory Diagnostics Market Overview Pulmonary Function Test Accurate, but insensitive Overview First invented in 1846, the advancement of the spirometer facilitated the early detection of pulmonary disease in humans. The number two lung diagnostic in the USA with 12.2m tests performed in 2019 (16.5% of all lung diagnostic procedures). Average Estimated Cost* Spirometry: US$72 Complete PFT: US$750 Advantages: • . • • • Functional Accurate Zero dose Non-invasive Low cost (Spirometry) O Limitations: TM Volume Smyt Pre Tri Pre Trial Post T 800 Pred Insensitive as it quantifies the whole of lung as one averaged measure Non-specific: requires 20% variance to be clinically significant diagnosis ←--- late Complete PFT is expensive and time consuming Effort dependent --->> significant repeatability issues Some patient cohorts have significant issues with compliance X-ray Technology Inexpensive, but tells us very little Overview Invented in 1895, the X-ray is widely used in clinics to determine changes in lung structure. The number one lung diagnostic in USA with 49.6m tests performed in 2019 (66.9% of all lung diagnostic procedures). Average Estimated Cost* US$120 • • ÖR Advantages: 2D image Ubiquitous Relatively inexpensive Low radiation dosage (0.1 mSv) Limitations: Structural, not functional Of limited clinical value 2D image and overlapping anatomy means features can be hidden and be missed Poor record in screening applications (e.g. lung cancer, and occupational diseases) *Frost & Sullivan 2020. Pg 7 Investor presentation 4DMedical#8Respiratory Diagnostics Market Overview CT Technology Sensitive, but expensive and high radiation dose Overview Invented in 1971, computed tomography (CT) technology is considered the current gold standard in lung diagnostic testing. The number three lung diagnostic in the USA with 10.9m tests performed in 2019 (14.7% of all lung diagnostic procedures). Average Estimated Cost* US$525 Advantages: . • 3D image can't miss features Sensitive = High-resolution detail of images Limitations: • • • • • 100 Hight Cost: 4x an X-ray High radiation dose: 70x an X-ray (7 mSv; real cancer risk) High rate of false positives (~95% in NLCST vs 3% mortality for surgery) Structural only Requires highly skilled radiologist to infer function from lung structure Very high rate of utilization (low rate of availability) Nuclear Medicine Capability to measure ventilation and perfusion, but significant limitations Overview Invented in 1963, the ventilation- perfusion scan is a nuclear medicine scan that uses dual radioactive agents (radiopharmaceuticals) to examine airflow (ventilation) and blood flow (perfusion) in the lungs. The number four lung diagnostic in USA with 780k tests performed in 2019 (1.1% of all lung diagnostic procedures). Average Estimated Cost* VQ Scan: US$1,503 Advantages: • Perfusion analysis capability Only modality that can identify ventilation/ perfusion mismatch Importance in treating pulmonary embolism & pulmonary hypertension 25-26 27-28 29-30 31-32 45-46 Sagittal 47-48 49-50 51-52 Limitations: High cost, poor resolution of outputs Testing takes 1 hour to complete Use of dual radioactive particulate contrast agents raises toxicity concerns especially for those with pulmonary hypertension Expensive testing equipment needed Complex to administer, requires expert analysis, onerous safety precautions *Frost & Sullivan 2020. Pg 8 Investor presentation 4DMedical#9Introduction to XV Technology TM 4DMedical™ FORMERLY 4DX#10Introduction to XV Technology XV Technology Overview • • • • XV Technology allows physicians to understand regional air flow within the lung, and to identify respiratory deficiencies earlier and with greater sensitivity, creating a step change in the capacity of physicians to diagnose and manage patients with diseases of the lung Utilising proven mathematical models and algorithms, XV technology converts sequences of X-ray images into four-dimensional quantitative data (three dimensional + time) Leveraging existing hardware and software in hospitals allows 4DMedical to deliver its XV Technology quicker and at a lower cost base to existing procedures while simultaneously delivering high gross margin to the company 4DMedical's proprietary XV Technology operates through a cloud-based SaaS platform that fully integrates with existing X-ray equipment, alleviating the requirement for hospitals and clinics to make a capital investment The XV Technology platform allows 4DMedical to rapidly and efficiently deploy a suite of respiratory diagnostic products across its network of clinics and hospitals, providing a strong ability to defend market share from future competitors Pg 10 | Investor presentation XV Technology TM 4DMedical#11Introduction to XV Technology XV Technology Demonstration Uniform ventilation Pg 11 | Investor presentation Healthy Lung Subtle defect Diseased Lung Defect TM XV Technology Compensation 4DMedical FORMERLY A#12Introduction to XV Technology XV Technology Advantages of existing modalities, in a single platform Functional insight of spirometry at a regional level Comparable radiation dose to X-ray High-detail resolution of a CT scan XV Technology™ Improved clinical outcomes Faster, more efficient testing using existing hardware Competitive pricing below incumbent technologies $ Pg 12 | Investor presentation TM 4DMedical#13"There is a global need for a higher quality and more cost effective respiratory diagnostic solution. 4DMedical's technology has the potential to revolutionise lung imaging and, if successful, can win a large market share" Dr. Sam Hupert 4DMedical Advisory Board CEO & Co-Founder, Pro Medicus 4DMedical > Executive Summary How to Read Report Guide Scan Details XVLVAS Axial Slices Coronal Slices Contact 4Dx Ventilation Animation Ventilation Report - Detailed Result Video: Regional ventilation visualizations (through the breath phase) 0.0 Less R Select View L R 0.1 0.2 0.3 Specific Ventilation 0.4 More 0.0 Less Select View Coronal Axial 0.1 0.2 Specific Ventilatie Pg 13 | Investor presentation Coronal Axial Select Slice Back Phase Point Middle Front < II < Select Slice Back Volume-Time Curve Ideatores phase of bath Middle Front Phase Point II 4D Medical FORMERLY ADX#14Company Overview 4DMedical™ FORMERLY 4DX#15Company Overview 4DMedical origins & history A fifteen year journey from conception to commercialisation First commercial agreement to collaborate with major US hospital signed with Cedars Sinari Andreas Fouras conceptualises 4D imaging using X-rays Andreas Fouras and colleagues receive an American Asthma Foundation Research Grant First clinical studies using XV Technology begin 510(k) FDA submission made First major order received for a preclinical scanner Imaging complete for first phase of clinical trial Australian TGA Approval for XV LVAS 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Pg 15 | Investor presentation First patent for XV Technology is filed 4DMedical commences operations Agreement signed with two more major US hospitals Clinical trial completed Clinical Advisory Board is formed, comprising of leaders in respiratory diagnostics First in human data released at the 2017 International Workshop on Pulmonary Imaging FDA clearance received for XV LVAS 4DMedical™ FORMERLY 4D#16Company Overview SaaS Business Model Designed For Rapid Uptake Our business model is designed for rapid penetration of the lung diagnostics market, with no upfront costs borne by hospitals for installation and a 'pay as you go model' which avoids the capital budgets of the hospital system. Remote deployment allows for exponential roll out • • • 4DMedical's products leverage the existing imaging software systems present in US hospitals Hospitals are brought online to the XV platform remotely - through 3rd party supplier, ability to deploy software in 6 days The XV platform is expected to be compatible with majority of X-ray machines within 12 months No upfront costs borne by hospitals for installation . • • • Initial software configuration is paid by 4DMedical to the software provider for each new hospital Payback period expected to be approximately 50 days on initial hospitals, with volume discounts being negotiated with the software provider expected to rapidly reduce this towards 10 days as rollout increases No capital expenditure required by hospitals removes potential hurdles and delays caused by VACS (budget approval committees), and provides a clear step change in lung diagnostic capabilities in a cost- effective manner with no lock-ins 'Pay per use' model, with no minimum volume required and scan cost strategically priced to be less than a CT scan (US$175 per XV LVAS test) Immediate deployment of additional products • Once installed within the hospital, ability to deploy new product offering and functionality by leveraging the XV Technology platform Ability to scale rapidly . Use of third-party cloud providers and automated processing of scans allows for the rapid scale up with minimal additional expenditure O SaaS Pg 16 | Investor presentation 4DMedical™ FORMERLY 4D#17Company Overview 4DMedical Cloud Based Workflow 4DMedical imaging protocol is agnostic to hospital X-ray hardware • • X-ray equipment transmits image to PACS (Picture Archive and Communication System) as per industry standard Fully automated workflow from PACS to PACS via 3rd party partner, initially USA's industry standard software provider - Laurel Bridge • Cloud based 4DMedical software analyses images using patented technology Radiologist reads ventilation report as per standard hospital workflow, then sends to referring clinician & Bo PATIENT DOCTOR Pg 17 | Investor presentation HOSPITAL OR PRIVATE CLINIC RADIOLOGIST 10 Bo PATIENT PACS од TECHNICIAN IMAGE SEQUENCE Using existing hospital X-ray equipment 4DMEDICAL REPORTS 3RD PARTY HIPAA PACS COMPLIANT TRANSFER 4DMedical 4DMEDICAL ANALYTICAL SOFTWARE Processed locally within regulatory jurisdiction 3RD PARTY HIPAA COMPLIANT TRANSFER 4DMedical#18Company Overview XV Platform Product Pipeline The XV Technology platform provides for the rapid deployment of product for various indications. XV Lung Ventilation Analysis Software (LVAS) - FDA Clearance obtained & Australian TGA approved • The XV LVAS provides physicians a patient's regional measurements of ventilation at each phase of the breath - a key measurement offering physicians functional data on lung health at unprecedented levels of detail. • • FDA approved with wide indication for use provides for broad use by physicians Australian TGA approval for inclusion in the Australian Register of Therapeutics Goods allows for local commercial sales Ventilation Perfusion (VQ) - Clinical trials begin 2021 • VQ is a combination diagnostic, designed to compete with the Nuclear Medicine V/Q scan and measure both ventilation and perfusion. However, unlike the Nuclear Medicine V/Q scan, the XV Technology VQ report is completely contrast free. Ventilation is measured using the XV LVAS and perfusion is measured using a precursor to 4DMedical's CFPA technology. Contrast free Pulmonary Angiography (CFPA) - Clinical trials begin 2021 CFPA is a novel, non-invasive imaging technique that provides regional measurements of the pulmonary vasculature - the blood vessels which carry oxygen from the lungs to the heart - enabling the evaluation of lung health through the blood network. Expected Commercialisation Milestones ENGINEERING USA CLINICAL TRIALS USA ANZ APPROVAL USA ANZ COMMERCIALISATION USA ANZ Pg 18 Investor presentation |2020 2021 VQ CFPA XV XV XV 2022 2023 VQ CFPA VQ CFPA VQ CF VQ CF VQ CFPA XV 4DMedical™ FORMERLY 4D#19Company Overview Significant Barriers to Entry First mover advantage, comprehensive patent protection and strong product pipeline provide significant barriers to entry for 4DMedical's target market using XV technology • First mover advantage First mover advantage allows for 4DMedical to deploy further products across the XV Technology platform to defend market position and differentiate from future competition Comprehensive patent protection • In-house patent attorney Ten patent families with filings made in eight, for a total of 43 patents with 15 granted • Patents covering: XV Technology (core patent) | Heart Imaging Low Dose Scan Pulmonary Vascular Imaging | Novel implementation of motion Clinical Validation • 70+ peer reviewed publications across extensive network of KOL research partners • Clinical trials and regulatory clearance Future product pipeline • . Future product suite targeting additional respiratory indications expected to provide 'whole of market' solution Ability to deploy further incremental functionality to existing products at minimal costs allows for additional enhancements to be deployed quickly and efficiently measurements Pg 19 | Investor presentation PATENT STREAMS 4DMedical GLOBAL EXCLUSIVE LICENSE AGREEMENT SIGNED WITH MONASH UNIVERSITY MONASH University COUNTRIES WITH LIVE PATENTS AND PATENT APPLICATIONS TOTAL PATENTS: 45 15 GRANTED 20 YEARS FROM FILING MONOPOLY PROVIDED BY A PATENT 4DMedical™ FORMERLY 4D#204DMedical™ FORMERLY 4DX Board and Management Team#21Board and Management 4DMedical Board of Directors Advisory Board BRUCE RATHIE Non-Executive Chairman Experienced lawyer, Investment Banker and Company Director as current Non-Executive Director of PolyNovo Limited (PNV.ASX) and current Non-Executive Director of Netlinkz Limited (NET.ASX). ANDREAS FOURAS, PhD Managing Director & CEO Award-winning aerospace engineer and innovator responsible for the conception and development of 4DMedical's core technologies. LIL BIANCHI Non-Executive Director, Chair of the Audit & Risk Committee Experienced contributor of business transformations for US- listed technology companies with a beneficial technology product expertise in Al and SaaS offerings. DR. ROBERT A. FIGLIN, MD Non-Executive Director Globally recognised leader in genitourinary and thoracic oncology, as well as Editor of the Kidney Cancer Journal and Spielberg Family Chair in Hematology/Oncology at Cedars Sinai. DR. SAM HUPERT Advisory Board Member Co-founder and Chief Executive Officer of Pro Medicus Ltd (PME.ASX) which develops and markets health imaging software primarily for radiologist in the US, Europe and Australia. DR. RAYMOND CASCIARI, MD Advisory Board Member Former Chief Medical Officer at St. Joseph Hospital in Orange, CA with over 40 years' experience in Pulmonary Disease, Internal Medicine and Intensive Care Medicine. LUSIA GUTHRIE Non-Executive Director Experienced executive and med- tech entrepreneur, former CEO of ASX listed LBT Innovations (LBT.ASX) and Chair of the BioMelbourne Network. JULIAN SUTTON Non-Executive Director Chartered Financial Analyst who began his career as an actuarial analyst in Melbourne before moving into funds management with Schroders and Credit Suisse in London. JOHN LIVINGSTON Non-Executive Director, Chair of the Remuneration & Nomination Committees Founding partner of ASX listed Integral Diagnostics (IDX.ASX) and an industry leader in the implementation of PACS and RIS in radiological settings. HEATH LEE Executive Director & CFO Qualified Chartered Accountant and a Fellow of the Financial Services Institute of Australasia, as well as a graduate of the Australian Institute of Company Directors. PROF. BRUCE THOMPSON Advisory Board Member President of the Thoracic Society ANZ, Dean of the School of Health Sciences at Swinburne University, previously head of Physiology Services at the Alfred Hospital. Pg 21 | Investor presentation 4DMedical™ FORMERLY 4D#22Board and Management 4DMedical Executive Team ANDREAS FOURAS, PhD Managing Director & CEO Award-winning aerospace engineer and innovator responsible for the conception and development of 4DMedical's core technologies. HEATH LEE Executive Director & CFO Qualified Chartered Accountant and a Fellow of the Financial Services Institute of Australasia, as well as a graduate of the Australian Institute of Company Directors. PAUL COOKE Senior Vice President, Sales & Marketing Executive and thirty-year veteran in business development, marketing, international commercialisation and market-entry. R. AIDAN JAMISON, PhD Senior Vice President, Engineering Monash University graduate with 10 years' experience in the biomedical research and intellectual property sectors. Aidan drives 4DMedical's research and development activities. RACHAEL TENKATEN Vice President, Product Aerospace Engineer with over 12 years' experience working on cutting-edge Biomedical, Aerospace Automotive and Defence projects. RICHARD CARNIBELLA, MBBS, PhD Director, Research Multi-disciplinary researcher with degrees in medicine and mechatronics engineering, as well as an industry expert in phase contrast lung X-ray imaging. JONATHAN DUSTING, PhD Director, Innovation Monash University graduate with over 15 years' experience in applied biological engineering research, translating ambitious research projects into disruptive biotech products and services CHARLENE STAHR Company Secretary Master of Engineering Science with experience in operations, finance, international research programs and technology development. Pg 22 | Investor presentation 4DMedical™ FORMERLY 4D#23Corporate Capital Structure Ticker Share Price (7 October 2020) Shares on Issue (m) Options on Issue (m) Market Capitalisation 4DX Substantial Shareholders¹ Andreas Fouras 24.49% $1.665 Perennial Value Management Limited 5.49% 264.76 20.67 Senior Management Team $441m Andreas Fouras Heath Lee Managing Director & CEO CFO Board of Directors Bruce Rathie Andreas Fouras Heath Lee Lil Bianchi John Livingston Robert Figlin Lusia Guthrie Julian Sutton Non-Executive Director & Chairman Managing Director & CEO Executive Director CFO Non-Executive Director Non-Executive Director Non-Executive Director Non-Executive Director Non-Executive Director Paul Cooke Aidan Jamison Jason Kirkness Rachael Tenkaten Jon Dusting Richard Carnibella Terence Walsh Michael Curtis Ming Lam Charlene Stahr SVP, Sales & Marketing SVP, Engineering VP, Medical & Clinical Affairs VP, Product Director of Innovation Director of Research Director of Quality & Regulatory Affairs Chief Software Architect Financial Controller Company Secretary Notes: 1) As at 7 September 2020. Pg 23 | Investor presentation 4DMedical™ FORMERLY 4D#24Commercialisation Strategy 4DMedical™ FORMERLY 4DX#25Commercialisation Strategy Compelling Value Proposition For USA Healthcare System Improved Patient Experience • Non-invasive and fast imaging protocol - with simple to understand report outputs No patient compliance required - both lying and sitting options are possible Radiation dose is low allowing for more frequent lung assessments Earlier diagnosis provides improved patient outcomes at lower cost Improved Patient Outcomes • Technology has FDA Clearance for all lung conditions to maximize societal benefit • ICU bed & ventilator value multiplier in a pandemic or other emergency event • Novel end-point for clinical trials to support faster therapy development • Earlier diagnosis leads to earlier treatment and healthier population Superior patient monitoring capability Pg 25 Investor presentation Reduced Cost of Care Earlier diagnosis delivers earlier intervention and less cost for chronic disease management • Acute patient readmissions accounts for disproportionate costs (38% of COPD patients have 4-10 ER visits per year) • No additional hospital CapEx or OpEx required • • Fully automated production to deliver low cost/high value proposition vs other lung diagnostics Change in standard of care will reduce overall diagnostic costs H . Easy to Implement • • Seamless integration with standard radiology workstreams Rapid integration (possible 6 days, offsite) Leverages existing X-ray equipment/ infrastructure with no CapEx 4DMedical™ FORMERLY 4D#26Commercialisation Strategy US Lung Diagnostic Market Opportunity • • . . 4DMedical's initial core focus is the rapid penetration of the US market. FDA Clearance of XV LVAS product allows 4DMedical to market for a wide range of applications and an experienced in-house sales force has already been recruited. XV LVAS provides a cost-effective and rapid path to market, while SaaS platform allows for ability to scale up quickly. Market strategy to target large hospitals operating at scale to drive take up and market adoption Department of Veterans Affairs (VA) is US largest healthcare provider and directly funds costs (no requirement for reimbursement) Clinical trial partner hospitals present high value revenue opportunity with existing presence and acceptance of technology Given the large market size, even low market penetration could see substantial revenue generation with high gross margin 73 million respiratory diagnostic tests undertaken each year in the US ✓ 6,176 hospitals, each with an average of ~150 hospital beds 4DMedical's initial target hospitals average ~500 hospital beds ✓ 2% of US lung diagnostic market represents ~US$250M revenue per annum Thoracic X-ray Thoracic CT scans PFT Nuclear Medicine Total US Procedures 49,590,000 10,888,664 12,200,000 778,000 73,456,664 US Spend (US$) $5.95 billion $5.76 billon $878 million $1.17 billion $13.76 billion % share of US Lung diagnostic procedures Ave. price per Diagnostic (US$) 4DMedical Revenue Opportunity @ 2% Market Share, US$175/scan 66.9% 14.7% 16.5% 1.1% 99.2% $120 $525 $50-$2,500 $1,503 $50-$2,500 US$173.56m US$38.12m US$42.70m US$2.72m $257.10m Pg 26 | Investor presentation 4DMedical#27Commercialisation Strategy USA Commercialisation Strategy Stage 1 Stage 2 Clinical Trials at Flagship US sites Pilot Solution and Launch 1st Product Stage Stage 4 National Expansion Accelerate Adoption Already installed and used at 6 of the highest rating hospitals in USA • Build KOL advocates to educate market • Publication strategy to amplify use cases • • Pre-launch pilot 4DMedical direct sales force recruited • Priority targets VA, KOL Hospitals and IDNS • Virtual Launch of • product & EOI issued VA launch to one VISN . Expand sales team to increase conversion • Network roll outs at VA & IDNS Health economics reports & novel use cases published • Med society support for CPT code obtained • Obtain reimbursement ⚫ Network-wide contracts Expand sales team to increase conversion • Increase utilization at hospitals • New products/variants introduced Stage 1 complete ~13 Hospitals (Direct Sales Force) ~169 Hospitals (Direct Sales Force/ Distributors/Channel Partners) 300+ Hospitals (Direct Sales Force/ Distributors/Channel Partners) Pg 27 | Investor presentation 4DMedical™ FORMERLY 4D#28Commercialisation Strategy US Clinical Trial Partners • • • 4DMedical has existing partnerships with some of the largest and most prestigious hospitals in the US Existing eight clinical trial partners represent approximately 1% of US hospitals beds, and 1% of the US market revenue opportunity Core focus is to continue commercialisation in these hospitals delivering key opinion leader (KOL) support and immediate revenue opportunities KOLs have a strong understanding of the benefits of the technology, with XV Technology platform already in use • The scale of these initial hospitals presents significant revenue potential in the immediate term Clinical Trial Partner Name Top 10 Rank Pre-FDA revenue City Patient Beds 1 Est. Respiratory Potential Revenue Opportunity² Diagnostics p.a. (US$m, p.a.) Cleveland Clinic 4 Y Cleveland 1,283 119,319 $ 20.9 UAB Hospital Birmingham 1,201 111,693 $ 19.5 Vanderbilt University Hospital Massachusetts General Hospital Nashville 1,033 96,069 $ 16.8 2 Boston 1,011 94,023 $ 16.5 The Johns Hopkins Hospital Duke University Hospital Cedars-Sinai Health System Temple University Hospital 3 Baltimore 1,007 93,651 $ 16.4 Durham 972 90,396 $ 15.8 8 Y Los Angeles 880 81,840 $ 14.3 Philadelphia 732 68,076 $ 11.9 8,119 755,067 $ 132.1 1: Estimated by approximate annual diagnostic / patient bed ratio of Cleveland Clinic 2: Estimated respiratory diagnostic tests per annum, charged at US$175/test Pg 28 Investor presentation 4DMedical™ FORMERLY 4D#29• Commercialisation Strategy TGA Approval for XV LVAS received September 2020 4DMedical's XV LVAS approved by the TGA for inclusion in Australian Register of Therapeutics Goods (ARTG) • TGA approval was received 6 months ahead of schedule ● 4DMedical intends to clearly define a path for immediate adoption of its SaaS product and supply of the software across Australia, with a sales and marketing team being established to deliver Australian customers in 2021 • 4DMedical is now well positioned to progress the global rollout of XV LVAS having also received FDA 510(k) clearance in May 2020 Investments made in 4DMedical's core US market will have positive flow on effects in Australia "4DMedical lung imaging technology provides a rare and exciting opportunity to improve lung health outcomes for patients globally" Professor Greg Snell Head of Lung Transplant Service, Alfred Hospital Australian Market Opportunity A$400m Total Spend 5.3m Procedures Annually Pg 29 | Investor presentation 4DMedical#30Future Growth Avenues 4DMedical™ FORMERLY 4DX#31Future Growth Avenues Increased Functionality, Indications and Regions Increased functionality of existing XV LVAS product Ability to provide additional functionality to the existing XV product post deployment allows for greater ability to command a pricing premium • Ability to increase average revenue per test at little to no additional cost to the business Deployment of new products on the XV Technology platform • • • Utilise XV Technology platform to deploy new products to market, including CFPA (Vasculature) and premium combination product VQ SaaS business model allows new products to be immediately launched to existing hospitals on the XV Technology platform, enabling increased market penetration and immediate hospital take up Preparation for relevant FDA Clearances has already commenced, commercialisation of new products expected from 2021 US reimbursement • US reimbursement in the future has potential to supercharge growth Expansion of global presence . . SaaS business model allows for global scale up throughout major respiratory diagnostic markets globally FDA Clearance de-risks and/or fast-tracks approvals in other jurisdictions Utilisation of distribution agents in additional countries provides vast network of future sales opportunities via a capital light model Leverage the experience and expertise of in-house sales team to ensure optimal expansion strategy with third party distribution agents 4DMedical XVLVAS 0.24 L 55.9 2 Hospital Pg 31 | Investor presentation 4DMedical™ FORMERLY 4D#32Future Growth Avenues COVID-19-A Fundamental Tailwind • The COVID-19 pandemic has created a significant increase in demand for global demand for lung health technology In particular, the US has been one of the hardest-hit countries with ~7.5m confirmed cases and ~211k deaths, representing ~20% of the total deaths caused by COVID-19 globally* 4DMedical is currently working with leading US and Australians hospitals and clinics to potentially provide COVID-19 relevant assessment scans for the monitoring of the lungs using its XV Technology COVID-19 will substantially increase the demand for lung health assessments XV Technology clinical use cases • Emergency screening support (overflow) • • Improved patient triage: • As a diagnostic aid XV Technology provides lung function quantification to help determine initial treatment: home rest, admission to a ward or immediate admission to ICU As a surveillance tool: XV Technology provides faster feedback on treatment efficacy. This enables clinicians to make faster decisions in the type/level of patient care (alter treatment plan), and resourcing (e.g. move from ICU to ward) Accelerated therapy research . More sensitive than other tests / scans. Up to 6x faster feedback on changes in lung function Patient lung health monitoring post COVID-19 Reported Cases 0 to 1,000 5,001 to 10,000 1,001 to 5,000 10,001 to 20,000 40,001 or more AS GU MH FM MP PW PR VI Note: John Hopkins University & Medicine (as at 7 October 2020) Pg 32 Investor presentation 20,001 to 40,000 Image Source: National Centre for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases 4DMedical™ FORMERLY 4D#33Future Growth Avenues Future Catalysts & Milestones Beta site (soft product launch) to de-risk market entry Commence CE Mark process for XV Ventilation product Ongoing sale of XV LVAS, CFPA & VQ products in the US XV LVAS launched in US & Australian markets Customer contracts secured with leading hospitals and clinics Clinical trials for VQ and CFPA products (US & ANZ) FDA clearance of VQ and CFPA products Appoint third-party distributor for the US market Launch of XV LVAS in Europe Pg 33 | Investor presentation Indication specific clinical trial results for up to four trials (incl @Johns Hopkins and Cleveland Clinic) FY21 FY22 FY23+ 4DMedical™ FORMERLY 4D#34Investment Summary 1 Clinically validated, FDA Clearance technology offering superior outcomes at lower costs compared with incumbent technologies 2 Significant global market with attractive growth drivers in core geographic regions, Australian TGA approval and FDA 510(k). clearance received 3 Capital light sales model underpinned by plug-and-play SaaS delivery leveraging existing X-ray infrastructure, delivering 90%+ gross margin 4 XV Technology platform allows for rapid and efficient deployment of product to healthcare providers 5 Established relationships with some of the world's most recognized and acclaimed medical institutions 6 Significant barriers to entry, including first mover advantage, strong IP portfolio and a strong product pipeline 7 Significant operating leverage with the ability to scale rapidly 8 Highly experienced Board of Directors and senior management team Pg 34 | Investor presentation#35Appendix 4DMedical™ FORMERLY 4DX#36Appendix Technology Comparison Compared to incumbent technology, XV Technology benefits from: Cost efficiency, being significantly cheaper than both a Pulmonary Function Test (PFT) and a thoracic CT scan Higher level of detail and accuracy ✓ 4D output, showing regional lung function and airflow in real-time Low radiation dose, in line with that of a regular X-ray and substantially less than nuclear medicine (10x) or thoracic CT scan (35x) ✓ Better patient experience and quicker testing time than full PFT, nuclear medicine and thoracic CT scan PFT Thoracic X-ray Nuclear Medicine Thoracic CT scans XV Technology Year Technology Invented 1846 # of Procedures (US, p.a.) 12,200,000 1895 49,590,000 1963 778,000 1971 10,888,664 2012 $ on Procedures (US, p.a) US$878 million US$5.95 billion US$1.17 billion US$5.76 billon % share of US Lung diagnostic procedures 16.5% 66.9% 1.1% 14.7% Ave. price per diagnostic Spirometry: US$72 Full PFT: US$750 US$175 US$120 US$1,503 US$525 + imaging <US$120 Resolution/Detail Low Low Moderate High High Level of Accuracy High Low Moderate High High Output 1D 2D 2D/3D 3D 4D Radiation Dose Time to Complete Spirometry: 10 mins Full PFT: 1-2hrs None Low (0.1mSv) Moderate (2.0mSv) High (7.0mSv) Low (0.2mSv) 5 mins 1-2 hrs 20 mins 5 mins Pg 36 | Investor presentation 4DMedical™ FORMERLY 4D#37Contacts Corporate Charlene Stahr Company Secretary 4DMedical™ FORMERLY 4DX Investor Relations Simon Hinsley +61 401 809 653 [email protected] Media Matthew Wright +61 451 896 420 [email protected] [email protected] For more information please visit www.4DMedical.com

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

1st Quarter 2021 Earnings Presentation image

1st Quarter 2021 Earnings Presentation

Technology

Rackspace Technology Q4 2022 Earnings Presentation image

Rackspace Technology Q4 2022 Earnings Presentation

Technology

CBAK Energy Technology Investor Presentation image

CBAK Energy Technology Investor Presentation

Technology

Jianpu Technology Inc 23Q1 Presentation image

Jianpu Technology Inc 23Q1 Presentation

Technology

High Performance Computing Capabilities image

High Performance Computing Capabilities

Technology

SOLOMON Deep Learning Case Studies image

SOLOMON Deep Learning Case Studies

Technology

1Q20 Earnings image

1Q20 Earnings

Technology

Nutanix Corporate Overview image

Nutanix Corporate Overview

Technology