Announcement PDF ImpediMed Limited 1/50 Parker Court Pinkenba, QLD, 4008 Australia E: investorrelations@impedimed.com W : impedimed.com 18 November 2024 Companies Announcements Office Australian Securities Exchange Presentation – Bell Potter Conference ImpediMed Limited (ASX:IPD) releases the attached presentation to be delivered today at the Bell Potter Conference. Approved for release by Dr Parmjot Bains, Managing Director and CEO of ImpediMed Limited. For more information, contact Leanne Ralph, Company Secretary, at leanne.ralph@bellev.com.au ImpediMed Limited Forging a new Standard of Care Bell Potter Conference, 2024 Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. ©2024 ImpediMed Limited. 1 Forward Looking Statements This presentation contains or may contain forward-looking statements that are based on ImpediMed Limited (ImpediMed) management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forwardlooking statements, including without limitation our expectations with respect to our ability to expand sales and market acceptance in the US and Australia including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialise new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Any forward-looking statements, including projections, guidance on future revenues, earnings and estimates, are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. While management has prepared this information based on its current knowledge and understanding and in good faith, there are risks and uncertainties involved which could cause actual results to differ from projections. You should not place undue reliance on forward-looking statements which speak only as of the date when made. Except as required by law, ImpediMed does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ImpediMed may not actually achieve the plans, projections or expectations disclosed in forward-looking statements. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements and no representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including ImpediMed Limited). 2 Agenda ImpediMed – Forging a new standard of care Platform Technology with multiple applications Strategy - Focus on accelerating sales and controlling costs First Application - Breast Cancer Related Lymphoedema New Team to execute - New Board & New Executive Team Financials - Key Metrics & Q1 FY25 Results Value Proposition 3 Platform Technology SOZO® Digital HealthPlatform One device - Multiple FDA cleared applications • • • • • Lymphoedema – FDA clearance, CE Mark Body composition – FDA clearance, CE Mark Heart failure – FDA clearance, CE Mark Protein calorie malnutrition – FDA clearance, CE Mark Renal Failure – CE Mark Single measurement - Multiple outputs • • • • L-Dex® lymphoedema analysis HF-Dex® heart failure analysis Body CompTM Hy-Dex® hydration analysis Initial Focus: Breast Cancer Related Lymphoedema (BCRL) 4 Immediate strategy Execute to breakeven with a focus of sales, marketing and clinical execution in BCRL 12-Month Priorities Next 12 months: Execute towards break even July 2025 Next 1-2 years: Innovate and expand GOAL 1 GOAL 2 GOAL 3 GOAL 4 GOAL 5 BCRL sales execution World-class customer experience Progress to break even Broaden Oncology Survivorship Develop new markets • Continued focus on sales execution with urgency • Manage cash burn • Support LPP implementation and patient utilisation • Progress towards break even • Oncology body composition • ROW Strategy in progress • Leg lymphoedema • Completed new product roadmap at Board for review • Execute on discussions with large IDNs on systemwide implementation • Continued progress to towards payor coverage target 85% through support of Academic Societies and KOLs • Deliver actionable insights at the point of care Ensure everything we do is underpinned by quality and integrity 5 SOZO BIS: All elements in place to forge the new Standard of Care Positive Global Clinical Trial 1200 patient trial: Statistically Significant Lower Progression to Chronic Lymphoedema1 p=0.016 Absolute reduction: 11.3% Relative reduction: 59% 19.2% 7.9% $600m BCRL TAM Widespread & Increasing US Payor Coverage FDA cleared 1mil patient tests conducted • 23 US States now at Critical Mass (>80% covered lives) • 255m Covered Lives across the US • 73% US population now covered 1,000 Devices deployed globally Multiple Guidelines and Standards Support Early Detection Tape measure (23/100) BIS in updated NAPBC Standards NCCN L-Dex (7/89) PREVENT trial: n=1,200 10 US and international centers including Vanderbilt University, Mayo Clinic and MD Anderson 6 1. Published in Lymphatic Research & Biology https://www.liebertpub.com/doi/10.1089/lrb.2021.0084 Forging a new standard of care for Breast Cancer Survivorship 4M+ • US breast cancer survivors1 310k Newly diagnosed US breast cancer patients every year1 1 in 5 Breast cancer patients will develop lymphedema2 resulting in • Isolation and depression3 • Hospitalisation risk4 • Economic burden4 1. Breast Cancer.org 2024 American Cancer Society, Inc. 2. Gillespie TC, et al. Breast cancer-related lymphedema: risk factors, precautionary measures, and treatments. Gland Surg. 2018 Aug; doi: 10.21037/gs.2017.11.04. 3. Teo I, et al. Examining pain, body image, and depressive symptoms in patients with lymphedema secondary to breast cancer. Psychooncology. 2015 Nov;24(11):1377-83. Doi:10.1002/pon.3745. Epub 2015 Jan 20. PMID: 25601235. 4. Dean LT, et al. “It still affects our economic situation.” A long-term economic burden of breast cancer and lymphedema. Supp Care Canc 2017; https://doi.org/10.1007/s00520-018-4418-4. 5. American Cancer Society. Cancer Treatment & Survivorship Facts & Figures 2019-2021. Atlanta: American Cancer Society; 2019. 6. Ridner SH, et al. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphatic Research and Biology 2022. 82% Breast cancer patients are at risk of arm lymphedema due to their treatment over their 5-year survivorship journey5 • Lymph node surgery​ • Radiation therapy​ • Taxane-based chemotherapy Preventing Breast CancerRelated Lymphedema 92% Of patients did not progress to chronic lymphedema with early detection using L-Dex and intervention through 3 years6 7 SOZO BCRL: Replaces time consuming SOC with early, objective & fast detection for Breast Cancer Related Lymphoedema Current Standard of Care (SOC) Subjective or Time-Consuming Bioimpedance Spectroscopy (BIS) – FDA-cleared, Clinically Validated, Guideline Supported, Reimbursed, Early, Objective & Fast Detection L-Dex Score Examination Volume Captures Sub-Clinical, Stage 0 lymphedema that can be treated Optical Scanning Lymphography Stage 0, Subclinical Stage 1, Pitting Oedema Stage 2, Irreversible Stage 3, Elephantiasis 100% resolution 88% resolution 0% Resolution 0% Resolution 8 ImpediMed Board – New Team with Global Experience  Governance  Project delivery  Culture  Performance Non-Executive Directors Executive Directors Global Company Experience Christine EmmanuelDonnelly Janelle Delaney Fiona Bones Andrew Grant Dr Parmjot Bains McGregor Grant Non-Executive Director Non-Executive Director Non-Executive Director CEO / Managing Director CF&OO / Executive Director Non-Executive Chair • Appointed 28 September 2023. • 30 years in IP expertise through commercialisation and strategic in-house intellectual property roles. • 4+ years in Board / healthcare governance experience. • Appointed 28 September 2023. • 30 years of project management and execution at IBM, with responsibility for the quality of delivery across Asia Pacific’s portfolio of several thousand projects. • Appointed 7 June 2024. • 20+ years global experience in finance, corporate governance and systems transformation. • Vice President of Finance, International Controller of Google • Appointed 28 • Appointed January September 2023 2024. • 20+ years working with • Medical doctor, exkey US customers and Pfizer and McKinsey, across global with 30+ years healthcare markets. global healthcare • Global Strategic experience across planning and delivery the US, Asia, Middle in healthcare globally, East and Australia. including McKinsey • 6 years Board / and ResMed. governance experience. • Appointed Director September 2023 and CFO November 2023. • Ex-Nanosonics CFO. • Experience with Board administration, governance and investor relations. • • • • Pfizer Google IBM McKinsey Australian MedTech Experience • • • ResMed Polynovo Nanosonics New World Class Executive team  US healthcare market  Medtech commercialisation  Sales execution  Creating long-term value Executive Directors Executives Dr Parmjot Bains McGregor Grant Dr Steven Chen Tim Benkovic Julie Kuhlken Aaron Ogilvie Ashley Munoz Dennis Schlaht CEO / Managing Director CF&OO / Executive Director Chief Medical Officer SVP, Sales & Customer Success Senior Director, Marketing Senior Director, Product Development Director of Human Resources SVP, R&D and Technology • Appointed January 2024. • Medical doctor, exPfizer and McKinsey, with 30+ years global healthcare experience across the US, Asia, Middle East and Australia. • 6 years Board / governance experience. • Appointed Director September 2023 and CFO November 2023. • Ex-Nanosonics CFO, 13 years. • Experience with Board administration, governance and investor relations. • Appointed September 2023. • Former American Society of Breast Cancer Surgeons (ASBS) President • Surgical oncologist/ breast surgeon with 10+ years’ industry experience in drug and device product development. • Appointed April 2024. • Ex-Nanosonics 6 years, ex Head of US Sales • 30+ years' experience in medical device, SaaS, and distribution industries. • Proven history of building top performing sales teams. • Appointed October 2023. • Ex-Becton Dickenson • 25+ years’ experience in marketing and leadership. • Appointed on Exec October 2024. • Ex-Johnson and Johnson • 25+ years experience of product development leadership. • Appointed on Exec July 2024. • Broad expertise across diverse human resource functions. • Appointed June 2007. • Accomplished senior technology executive. • Broad areas of expertise including strategic planning and leadership, R&D and global technology implementations. Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. ©2023 ImpediMed Limited. 10 Key forward looking metrics improving Q1 FY25 Pipeline Metrics and New Payor Coverage Metrics FY25 Q1 Sales Pipeline Updated Mid Q2 FY 25 585 devices Critical Mass States1 34% increase vs Q4 FY24 23 States +7 vs Q1 FY25 Q1 FY 25 NAPBC Standard Inclusion Updated Mid Q2 FY 25 SOZO at 143/570 254.7m Accredited NAPBC Institutions Covered Lives2 1 new NCCN Center SOZO at 23/33 1.Critical Mass: 80% or more of the population in a State is covered by Medicare, Medicaid or private insurance payors. 2.Covered Lives: represents the number of people nationally covered by Medicare, Medicaid or private insurance payors. 82% increase vs FY24 11 Financial momentum continues with record quarterly increase in TCV1 SOZO Core Business Quarterly TCV Q1 FY25 Financial Highlights # SOZO units sold U.S. SOZO Core Business TCV 28 $4.8 million1 22% vs Q4 FY24 40% vs Q4 FY24 Total revenue SOZO Core Business ARR $2.7 million $11.6 million 7% vs Q4 FY24 5% vs Q4 FY24 • 6 networks contracted with 2-3 devices • Renewed a top 5 customer • Price of renewed contracts increased 19% on average 1.Total Contracted Value (TCV) relates to new and renewed contracts and includes any consideration for the sale of SOZO units as well as the total licence fees for the duration of the signed contracts. Typically, these contracts are for a period of three years. 12 SAAS Business with a Global Installed Base and ARR growth Global Installed Base SOZO Annual Recurring Revenue1 Units ROW Installed Base US Installed base Low churn 3% annualized ARR up 21% vs Q1 FY24 1.Annual Recurring Revenue (ARR) represents the amount of revenue reasonably expected to be recognised for the next 12-month period based on existing contracts, assuming installation upon sale and no churn. The amounts shown are as reported. The exchange rate used for Q1 FY25 ARR calculation was 0.67497 (Q4 FY24: 0.66699). 13 The Value Proposition Multiple Regulatory Clearances Lymphoedema Heart Failure Renal Failure Body Comp Reimbursement 73% of US Insured Lives covered Critical mass coverage in 23 US States Lymphoedema prevention Initial TAM $600M Guideline and Standard Inclusion NCCN & NAPBC Successful Global RCT ~$110M Market Cap Platform Technology Lymphoedema Body Comp Heart Failure Renal Failure Multi-Application TAM significantly larger 1000+ Devices deployed Globally Growing Pipeline exceeds required devices to breakeven 14 Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. ©2024 ImpediMed Limited.