4dmedical Ltd. · ASX:4DX
4dmedical — Investor Presentation (December 2023)
55 slides from 4dmedical's investor presentation, Dec 11, 2023
Slide 1: The future of lung health
The future of lung health 4DMedical Limited (ASX:4DX) Acquisition & Capital Raising Presentation December 2023
Slide 2: Executive Summary
Executive Summary 4DMedical is making significant progress in executing on its commercialisation strategy, with particular progress made in the US • Granted US$299 reimbursement benefit for XV LVAS® from the US Centers for Medicare and Medicaid Services (CMS), accelerating the utilisation of XV LV
Slide 3: 4DMedical Update
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Slide 4: XV Technology advantages
XV Technology® advantages New medical insights Improved safety Superior results Functional insight of Comparable radiation High-detail resolution spirometry at a regional level dose to X-ray of a CT scan Patient outcomes Time efficient Low cost Improved clinical Faster, more efficient Competitive pr
Slide 5: Material acceleration in commercialisation across 2Q FY2024
Material acceleration in commercialisation across 2Q FY2024, with Imbio acquisition a step change Objective: Become the standard of care for lung diagnosis across both ventilation and perfusion Imbio Acquisition Recent developments validate Focus on structure commercialisation strategy: Philips Mo
Slide 6: FY24 target catalysts
FY24 target catalysts Commercialisation • VA funded trial • 2nd Authority to Operate awarded enabling National Authority to Operate • Extend Department of Defense engagement • Execution of commercial agreement with US based academic medical center • Expansion in ANZ • Rapid expansion of Philips part
Slide 7: Transaction Overview
Transaction Overview
Slide 8: AI solutions that span lung and heart conditions
AI solutions that span lung and heart conditions affecting 1 in every 5 adults Lung Density Aortic Aneurysm Analysis Incl. patented VDM COPD, Asthma, FDA - TBD CE - TBD Pneumonia, BOS FDA CE Lung Texture Analysis CAC Scoring ILA’s, ILD/IPF CAD/Heart Disease drug-induced fibrosis FDA CE 2023 FDA 2024
Slide 9: Imbio today
Imbio today Two major channels for ‘Go-to-market’ • Partnerships to grow therapeutic franchises through imaging-based Companion screening & qualification of patients • Recognised leader in Lung & Diagnostics • Business model: per-patient or per-site fees paid by device/pharma Cardiothoracic imaging
Slide 10: Acquisition Highlights
Acquisition Highlights Function + Structure Commercialisation Growth opportunity ‘Owning the lung’ Deliver XV Technology® into Potential to provide screening Additional 4 lung diagnostic established Imbio contracts, program offerings across COPD, products, resulting in a full suite accelerating US h
Slide 11: Transaction summary
Transaction summary Binding agreement to acquire Imbio Inc. for a mix of upfront cash consideration and contingent consideration Transaction details • 4DMedical to acquire Imbio Inc. (Imbio), a recognised leader in lung imaging AI, for an upfront consideration of US$25 million and up to US$20 millio
Slide 12: Strategic Rationale
Strategic Rationale
Slide 13: Strategic rationale
Strategic rationale Accessing capabilities in lung structure to build compelling offer and ‘owning the lung’ Significant growth opportunities in place 1 • Established contracts allows acceleration with device and pharma companies needing lung imaging analysis • Complementary products allow for both
Slide 14: Combined software suite
Combined software suite Imbio brings increased breadth of product offering to CT modality Functional diagnosis Structural diagnosis software offering Lung 4DMedical Density Automated RV/LV and Lung XV LVAS® CT LVAS ™ CT:VQ Analysis ILD UIP PAH CAC Scoring Nodules (ventilation) (ventilation) (ventila
Slide 15: Growth opportunity: clinical conundrum
Growth opportunity: Solving the clinical conundrum for doctors across multiple care areas Clinical conundrum in COPD lung Heart Clinical tools needed Disease to solve Lung Cancer Applications for technologies in clinical practice assessment the conundrum A mismatch between clinical tests and imagi
Slide 16: Growth opportunity: Extending Screening Solutions
Growth opportunity: Extending Screening Solutions in multiple care areas Prior CT Scan in hospital COPD Assessment of cohort Drill down to triage Heart Disease Patient diagnosis and Lung Cancer database with Imbio algorithm appropriate care treatment accelerated COPD: #4 cause of death in the U.S.1,
Slide 17: Imbio: Detailed View
Imbio: Detailed View
Slide 18: Imbio at a glance
Imbio at a glance AI capabilities to detect, diagnose, and treat cardiothoracic conditions preemptively Automated, condition detection, quantification and Up to 50% of patients that Imbio identifies are not under active visualisation care 1 System-wide Standard lung CT Imbio AI Analysis Patient Imag
Slide 19: Imbio Technology sophisticated and scalable
Imbio Technology sophisticated and scalable Clinical Algorithms – core products Imaging Platform INSPIRATION ANALYSIS (LDAi) Physician Portal + Patient Navigation for rapid detection & diagnosis of emphysema • Fully-automated assessment of areas of low attenuation (LAA, indicative of emphysema) and
Slide 20: Companion Diagnostics (CDx)
Companion Diagnostics (CDx) Why Pharma and Med Device needs Imaging AI Companion imaging can grow device & pharma businesses by impacting clinical decisions across the entire course of patient care. SCREENING DIAGNOSIS PLANNING TREATMENT FOLLOW-UP Patient A Patient B 45% 40% 15% Find more patients I
Slide 21: Imbio performance and network
Imbio performance and network Strong revenue growth from established contracts plus expanding General Radiology network Revenue1,2 Gross Margin1 $ Network – sites3 +115% US$M +112% US$M Gross Margin % 5.4 127 6.5 6.3 5.5 85 90 84 6.0 5.0 80 80 5.5 4.5 5.0 70 4.0 4.5 60 4.0 3.5 +20% +27% 73 3.5 3.0 5
Slide 22: Transaction Funding and Outlook
Transaction Funding and Outlook
Slide 23: Transaction Funding
Transaction Funding Transaction Funding Details Upfront consideration • US$25 million (A$38.5 million) in cash will be payable upfront on completion of the acquisition by 4DMedical to the Sellers. Contingent • Contingent consideration of up to US$20 million to be paid on achievement of key milestone
Slide 24: Equity Raising Timetable
Equity Raising Timetable Trading halt Thursday, 7 December 2023 Placement opens Thursday, 7 December 2023 Placement closes Friday, 8 December 2023 Capital raising results announced and trading halt lifted Monday, 11 December 2023 Settlement of Placement Thursday, 14 December 2023 Allotment of New Sh
Slide 25: Equity Raising Details
Equity Raising Details A placement to sophisticated and professional investors of A$35.0 million. Placement • The issue of 44.3 million new, ordinary fully paid 4DMedical Shares (New Shares) under ASX Listing Rule 7.1 • Offer Price of A$0.79 per New Share represents a: • -17.3% discount to the last
Slide 26: Board of Directors Key advisors
Board of Directors Key advisors Significant medical and commercial sector experience Medical experts Dr SAM HUPERT MBBS Advisory Board Member Co-founder and Chief Executive Officer of Pro Medicus Ltd (ASX:PME) which develops and markets health imaging software primarily for radiologists in the U.S.,
Slide 27: Summary
Summary Rapid and substantial progress across key dimensions of commercialisation: • Reimbursement of XV: • Ahead of schedule with increased payment • Removes largest barrier to commercialisation in US • 2 new US sites signed up under payment • FDA approval of CT LVAS™ • Expansion into US, following
Slide 28: Summary
Summary Imbio acquisition synergistically interacts with all facets of commercialisation: • Function combined with structure for a comprehensive offering • Sales synergies into over 200 sites across USA • Population health opportunities including lung cancer screening • Expands and accelerates VA op
Slide 29: Appendix A Transaction Details
Appendix A Transaction Details
Slide 30: Transaction summary
Transaction summary Upfront consideration of US$25 million (approximately A$38.5 million) in cash and contingent consideration of up to US$20 million Transaction details • 4DMedical has entered into a binding agreement to acquire Imbio Inc. (Imbio) for a mix of upfront cash consideration and conting
Slide 31: Transaction summary – acquisition terms
Transaction summary – acquisition terms Escrow of contingent • Insofar as any contingent consideration is satisfied via the issue of new shares in 4DMedical (Earnout Shares), each tranche of Earnout Shares issued to the Sellers will be held in escrow for consideration shares a period of (a) 45 days
Slide 32: Financial impact of acquisition
Financial impact of acquisition Following completion of the acquisition, 4DMedical will be well funded to continue investment in growth Pro Forma as at Upfront Capital Raise Acquisition 30 September • Capital raise of $35.0m, at an offer AUD $'000 4DX Equity Raising1 consideration2 Costs Costs 2023
Slide 33: Appendix B Key Risks
Appendix B Key Risks OaHARQoOo QOCAD En a{ 4DMedical__.-
Slide 34: Key risks
Key risks Acquisition Transaction due 4DMedical has undertaken financial, operational, business and other analysis in respect of Imbio in order to determine its attractiveness to 4DMedical and whether to pursue the diligence and reliance acquisition. on information Risks may exist in relation to Imb
Slide 35: Key risks
Key risks Acquisition Transition risk The transition of ownership brings with it a range of risks that need to be managed. These risks include: • possible loss of key Imbio personnel or corporate knowledge; • reduced employee productivity due to uncertainty arising as a result of the proposed acquis
Slide 36: Key risks
Key risks Acquisition Personnel risks Pursuant to a consulting agreement (Consulting Agreement) between Imbio and Invenshure LLC (Invenshure), Invenshure provides certain consulting services to Imbio and certain office management and equipment. Those consulting services include executive / infrastru
Slide 37: Key risks
Key risks General The Directors consider that, on receipt of funds under the Offer, 4DMedical will have sufficient working capital to carry out its objectives. However, financial resources are limited and there is a risk that 4DMedical may never achieve profitability. 4DMedical may be required to ra
Slide 38: Key risks
Key risks General There is a risk that regulatory bodies will not grant the Group regulatory clearance to market its products or will significantly delay the grant of such clearances. Failure to receive regulatory Regulatory risk clearance will have a negative impact on the Group’s future revenue st
Slide 39: Key risks
Key risks General The performance of 4DMedical will continue to be influenced by the overall condition of the economy in Australia and the jurisdictions in which it has operations and any deterioration in employment or economic growth could adversely affect 4DMedical’s business. In light of recent A
Slide 40: Appendix C 4DMedical Overview
Appendix C 4DMedical Overview
Slide 41: Software offering and applications
Software offering and applications 4DMedical Current product XV LVAS® CT LVAS™ CT:VQ Currently in software offering release (ventilation) (ventilation) (ventilation / perfusion) development Image acquisition modality X-ray XV Scanner CT Existing hospital & 4DMedical hardware utilising Existing hospi
Slide 42: XV Technology advantages
XV Technology® advantages New medical insights Improved safety Superior results Functional insight of Comparable radiation High-detail resolution spirometry at a regional level dose to X-ray of a CT scan Patient outcomes Time efficient Low cost Improved clinical Faster, more efficient Competitive pr
Slide 43: Global market revenue opportunity
Global market revenue opportunity Market opportunity by country1 Country Spend (US) Procedures US 13,716M 73.5M Others 4,964M 59.8M Germany 2,678M 20.3M Japan 1,905M 22.8M China 1,851M 101.6M UK 1,351M 8.9M France 1,191M 10.2M Spain 780M 8.4M Italy 681M 8.5M Canada 606M 8.0M The global respiratory d
Slide 44: Global market disruption opportunity
Global market disruption opportunity Four existing lung diagnostic technologies: CT, X-ray, Nuclear Medicine, Pulmonary Function Tests Expenditure (US$bn) 17.5 X-ray Technology Computed 15.0 Tomography (CT) Imbio acquisition provides greater 12.5 reach into the CT market; TAM worth Procedures 253m ~
Slide 45: US reimbursement approved – XV LVAS
US reimbursement approved – XV LVASTM We addressed three key components … and engaged stakeholders across … which paved the way to U.S of reimbursement ... multiple bodies ... reimbursement • American Medical Association CPT Panel and 1 Code – describing the procedure Advisors Cat III CPT Code1 •
Slide 46: 4DMedical and Philips sign Memorandum of Understanding
4DMedical and Philips sign Memorandum of Understanding Key points: Initial focus of the partnership will be to offer 4D lung imaging as a critical screening solution for Veterans exposed to burn pits. 4DMedical’s XV Technology® will be added to Philips’ product catalogue and offered as a third-
Slide 47: Appendix D Imbio Product Suite
Appendix D Imbio Product Suite
Slide 48: Attractive product portfolio
Attractive product portfolio AI solutions that span lung and heart conditions affecting 1 in every 5 adults Lung Density Aortic Aneurysm Analysis Incl. patented VDM COPD, Asthma, FDA - TBD CE - TBD Pneumonia, BOS FDA CE Lung Texture Analysis CAC Scoring ILA’s, ILD/IPF CAD/Heart Disease drug-induced
Slide 49: Product suite has 4 FDA cleared products with a significant pipeline
Imbio product suite: in detail Product suite has 4 FDA cleared products with a significant pipeline Product Name Description Regulatory clearance Lung Density Analysis • Provides results based on a standard inspiratory chest CT. Inspiration (LDAi) • Fully-automated detection, visualization and quant
Slide 50: Disclaimer
Disclaimer This presentation has been prepared by 4DMedical Limited (ABN 31 161 684 831) (Company or 4DMedical) in connection with 4DMedical’s acquisition of Imbio Inc. (Imbio) and an offer of new ordinary shares in the Company (New Shares) and options to acquire shares in the Company (Options) by w
Slide 51: Disclaimer
Disclaimer Distribution of presentation The distribution of this presentation in jurisdictions outside of Australia may be restricted by law and you should observe any such restrictions. Any failure to comply with such restrictions may constitute a violation of applicable securities laws (see “Inter
Slide 52: Disclaimer
Disclaimer The Specified Persons make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this presentation and take no responsibility for any part of this presentation or the Offer. The Specified Persons make no recommendati
Slide 53: Disclaimer
Disclaimer 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 (New Zealand) (the FMC Act). The New Securities are not being offered or sold in New Zealand (or allotted with a view to being off
Slide 54: Disclaimer
Disclaimer United Kingdom (Cont.) Any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) received in connection with the issue or sale of the New Shares and Options has only been communicated or caused to be communicated and will only be communic
Slide 55: 4DMedical Limited (ASX:4DX) Investor Presentation December 2023
4DMedical Limited (ASX:4DX) Investor Presentation December 2023 Copyright ©4DMedical Limited 2023 Level 7, Melbourne Connect 700 Swanston Street Melbourne, Victoria 3053 Australia www.4dmedical.com ABN 31 161 684 831