Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (June 2019)
39 slides from Impedimed's investor presentation, Jun 19, 2019
Slide 1: Investor Presentation
For personal use only Investor Presentation ASX:IPD June 2019
Slide 2: Disclaimer
Disclaimer • The material contained in this document is a presentation of • To the extent permitted by law, no responsibility for any loss For personal use only general information about the activities of ImpediMed Limited arising in any way (including by way of negligence) from anyone (“ImpediMed”)
Slide 3: Forward Looking Statements
Forward Looking Statements • Certain statements in this presentation may constitute forward- • There can be no assurance that any existing or future regulatory For personal use only looking statements or statements about future matters that are filings will satisfy the relevant authorities’ requirem
Slide 4: Corporate Overview
Corporate Overview ImpediMed develops, manufactures and sells bioimpedance spectroscopy devices with For personal use only a focus on the early detection of lymphoedema and heart failure • ASX listed (October 2007) • Operations in US (San Diego), Australia (Brisbane) and Europe (Greece) (68 total st
Slide 5: Investment Highlights and Technology Adoption
For personal use only Investment Highlights Technology Adoption FY by Quarter (direct sales channel) 15,000 Highly Disruptive Technology 48,000+ Patient Tests Proprietary Digital Health Platform on File with Robust Patent Portfolio 11,250 Large, Attractive, and Growing Markets Regulatory Clearances
Slide 6: SaaS Business Model Now Well Established in Lymphoedema
SaaS Business Model Now Well Established in Lymphoedema Contracted Revenue Pipeline (CRP) and For personal use only Annual Recurring Revenue (ARR) by FY Quarter (in AU$ millions) Software as a Service (SaaS) Business Model • SOZO devices sold to hospitals and clinics $10.0 • SaaS monthly subscriptio
Slide 7: SaaS Business Model Accelerating Revenue in Lymphoedema
SaaS Business Model Accelerating Revenue in Lymphoedema Growth Drivers FY’20 • Aggressively drive National Lymphoedema Prevention For personal use only Guidance Program in new key centres and build out in existing centres Midrange Low Midrange High Growth vs. (increases device and subscription sales
Slide 8: Transition to SaaS Business Model Complete and Revenue now Accelerating
Transition to SaaS Business Model Complete and Revenue now Accelerating Expecting 2X - 3X Revenue Growth in FY’20 For personal use only SOZO Replaces Legacy Revenue Crossover Complete and Revenue Now Accelerating Reported Medical Revenue Legacy and SOZO Total Reported Medical Revenue (in A$ millions
Slide 9: Connected Digital Health Platform
Connected Digital Health Platform Key Centers Connected Digital Health Platform For personal use only Cloud • Comprehensive patient data (Business Associate Agreement compliant) • Access to information across the care continuum • Manage large patient populations • Integrates seamlessly into hospital
Slide 10: Platform Technology with Multiple Applications
Platform Technology with Multiple Applications 2 Key Focus Areas – Lymphoedema and Heart Failure For personal use only Traditional FDA Submissions Lymphoedema Heart Failure Real World Evidence for FDA Submissions Malnutrition Bone Density Dehydration Renal Failure R&D Clinical FDA Submission FDA Cle
Slide 11: Large, Attractive and Growing Markets
Large, Attractive and Growing Markets FDA Clearance and CE Mark for both Indications For personal use only Newly Diagnosed Cancer Cases Heart Failure Patients by Classification 1.8 Million per Year 6.5 Million Class I Class IV 35% 5% All Others At Risk of Limb Lymphoedema Class III 45% 55% 25% Class
Slide 12: ImpediMed's Proprietary Technology Directly Measures Fluid in the Body
ImpediMed’s Proprietary Technology Directly Measures Fluid in the Body For personal use only Indirect Measure of Fluid Direct Measure of Fluid Bioimpedance Spectroscopy (BIS) • Imaging Low Frequency Current passes around cells Fluid • Implantables 256 frequencies Fat • Weight High Frequency Current
Slide 13: For personal use only
For personal use only • Up to 60% of the of the human body is made up of water • Fluid balance is critical to a healthy body • Small variations between intracellular and extracellular fluid can have dire consequences • Until now there has not been an easy, fast, accurate and non-invasive way for cli
Slide 14: SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform
SOZO - Next Generation Bioimpedance Spectroscopy Digital Health Platform For personal use only • L-Dex® for assessing subclinical unilateral Lymphoedema • Sensitive detection of small changes in body fluid: FPO • L-Dex for assessing subclinical • Intracellular bilateral Lymphoedema • Extracellular •
Slide 15: Game Changing Technology - Lymphoedema
Game Changing Technology - Lymphoedema For personal use only Annual Cost of Lymphoedema Reduction in Lymphoedema Lymphoedema is a leading post-surgical complication for many Cancer Related Lymphoedema Data from the PREVENT Trial, the largest randomised cancer patients Lymphoedema clinical study ~$7
Slide 16: ImpediMed is Well Positioned to Capitalise on Lymphoedema Prevention
ImpediMed is Well Positioned to Capitalise on Lymphoedema Prevention For personal use only Old Perceptions Old Perceptions New Realty New Reality ImpediMedLeadership ImpediMed LeadershipPosition Position • Lymphoedema is an unavoidable • 1 in 3 at-risk cancer survivors will • Extensive clinical data
Slide 17: SOZO for Cancer Survivors
SOZO FOR CANCER SURVIVORS For personal use only • Over 15.5 million cancer survivors in the U.S. • 1 in 3 will develop Lymphoedema • More than 5.5 million U.S. patients suffering from persistent cancer-related Lymphoedema • Lymphoedema usually presents within first 36 months • Lymphoedema is one of
Slide 18: Lymphoedema is a Common Consequence of Cancer Treatment
Lymphoedema is a Common Consequence of Cancer Treatment Prevalence by Cancer and Treatment For personal use only Melanoma + Irradiation 50% SLNB + Whole Breast & Regional Lymph Node Irradiation 41% Gynecologic + Irradiation 34% ALND + Whole Breast Irradiation 32% Vulvar 30% Gynecologic Misc. 27% ALN
Slide 19: Current State of Lymphoedema Detection and Treatment
Current State of Lymphoedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected capacity is fluid and protein consistency, limb becomes reduced, setting causing tissue fibrosis very large and the stage for an swelling; pitting causing misshapen, and overload of the
Slide 20: The Future of Lymphoedema Detection and Treatment
The Future of Lymphoedema Detection and Treatment • Transport • Accumulation of • Spongy tissue • The affected capacity is fluid and protein consistency, limb becomes reduced, setting causing tissue fibrosis very large and the stage for an swelling; pitting causing misshapen, and overload of the oed
Slide 21: Subclinical Detection of Lymphoedema Optimises Patient Outcomes
Subclinical Detection of Lymphoedema Optimises Patient Outcomes For personal use only Resolution of Lymphoedema based on Stage at the Time of Detection1 Lymphoedema Total Stage when Patients Resolved Chronic Detected (N=49) (n=40) (n=9) Subclinical 25 25 0 Stage 1 17 15 2 Simple and inexpensive Stag
Slide 22: Demonstrated Real World Outcomes
Demonstrated Real World Outcomes Nashville Breast Center, TN, USA Macquarie University, NSW, AUS Breast Care Specialists, NY, USA (n=596, F/U 17 months) (n=188, F/U 8 months) (n=206, F/U 25.9 months) For personal use only 80 50 30 • Compelling clinical data 60 -75% 38 23 • Medically meaningful resul
Slide 23: L-Dex Increasingly Recommended in Clinical Practice Guidelines
L-Dex Increasingly Recommended in Clinical Practice Guidelines Lymphatic Education & Research Network Centers of Excellence 2019 For personal use only BIS recommended as risk assessment tool eviCore Clinical Guidelines for Physical and Occupational Therapy Services 2019 BIS is a validated clinical t
Slide 24: Practice-Changing Results - PREVENT Trial Interim Results
Practice-Changing Results - PREVENT Trial Interim Results • “These preliminary results are important and support the use of subclinical detection 12 Month Interim Results Publication: For personal use only with BIS and early intervention for patients with breast cancer at risk for lymphedema”. Annal
Slide 25: Reimbursement Strategy
Reimbursement Strategy For personal use only NCCN Guidelines® Commercial Payors • Requesting inclusion of formalised testing • Currently in discussions protocol and BIS technology for • Series of meetings to take place over the Lymphoedema prevention coming months • Joint application • Tools: • Nati
Slide 26: Lymphoedema Prevention Program
Lymphoedema Prevention Program Transforming Patient Care through the Prevention of Cancer-Related Lymphoedema For personal use only • Complete solution for cancer- related lymphoedema prevention • Incorporates “Best Practices” of our top cancer centres • Consultative sales approach: • Maximises pati
Slide 27: Game Changing Technology - Heart Failure
Game Changing Technology - Heart Failure For personal use only Number of Adults with Heart Failure Annual Cost of Heart Failure The number of people diagnosed with heart failure is increasing Cancer This total includes Related the cost of healthLymphoedema care services, medications and projected to
Slide 28: SOZO for Heart Failure
SOZO CA NCEfor R SHeart Failure UR VIVO RS • Global pandemic affecting at least 26 For personal use only million people worldwide • Estimated 6.5 million Americans live with heart failure • 1 in 5 over the age of 40 will develop heart failure • Most common cause of hospitalisation of people 65 years
Slide 29: Current Heart Failure Monitoring Methods are Inadequate
Current Heart Failure Monitoring Methods are Inadequate • Current practice is to monitor HF patients daily for fluid burden both in-clinic and at-home For personal use only • Substantial opportunity to improve on existing monitoring methods Device Method Benefit Shortcomings Inaccurate and Weight Sc
Slide 30: SOZO Non-invasively Monitors Signs of Heart Failure as well as CardioMEMS
SOZO Non-invasively Monitors Signs of Heart Failure as well as CardioMEMS at a Fraction of the Cost For personal use only Case Study • Advanced heart failure patient with implanted CardioMEMS device ™ • Changes made in diuretic medication to keep fluid balance stable ™ • SOZO fluid measurements take
Slide 31: Early Detection of Fluid Build-up Critical to Reducing Heart Failure Readmissions
Early Detection of Fluid Build-up Critical to Reducing Heart Failure Readmissions For personal use only Progression to Heart Failure Hospitalization • After a single heart failure hospitalisation • Nearly 25% of patients are readmitted in 30 days1 ImpediMed Focus • Nearly 50% of patients are readmit
Slide 32: US Heart Failure Business Model
US Heart Failure Business Model For personal use only Initial Focus on Class III HF Patients • Estimated at 25% of US 6.5 million HF patients • Monitor and manage the disease progression for Class III patients Preliminary Estimate of Initial US Addressable Market SOZO HF Usage Model Estimated initia
Slide 33: Heart Failure Action Plan
Heart Failure Action Plan Clinical Data for Widespread Adoption For personal use only • Working with world leading institutions on HF trials • First data presented at 23rd World Congress on Heart Disease July 2018 • Correlation case study and clinical utility of SOZO to monitor HF patients presented
Slide 34: Expected Milestones and Upcoming News Flow
Expected Milestones and Upcoming News Flow • Continued strong growth in SOZO SaaS subscription based business For personal use only • PREVENT Trial 2-year data published • PREVENT Trial — additional publications • Cost of treating lymphoedema publication • NCCN Guidelines® — The addition of a formal
Slide 35: Appendix
Annual General October 2018 Meeting For personal use only Appendix
Slide 36: Management Team
Management Team For personal use only Deep and Broad Commercialization Experience Richard Carreon Frank Vicini, MD Morten Vigeland Catherine Kingsford Managing Director and Chief Medical Officer Chief Financial Officer SVP Medical Affairs Chief Executive Officer • Joined September 2014 • Joined Apri
Slide 37: Board of Directors
For personal use only Board of Directors Scott R. Ward Gary Goetzke Robert M. Graham Richard Carreon Judith Downes Donald A. Williams Amit R. Patel MS, BSc Juris Doctorate AO, FAA, FAHMS, MBBS, MD, Managing Director and Non-Executive Director BAcy, CPA MBA, BME Non-Executive Director Non-Executive D
Slide 38: SOZO Delivers Compelling Healthcare Cost Savings
SOZO Delivers Compelling Healthcare Cost Savings Complicated Lymphoedema Costs the Healthcare System ~$120k per patient over 2 years For personal use only Implementing a prospective model of care for cancer patients has the potential to: • Reduce Lymphoedema rates by as much as 95% • Reduce the heal
Slide 39: BIS Offers the Best Option for Managing Heart Failure Patients
BIS Offers the Best Option for Managing Heart Failure Patients 5 papers, including 3 from Aachen University / BIS differentiates between healthy and For personal use only Philips Research Technologies unhealthy patients • 242 patients Findings: • Peripheral edema detected with a sensitivity of 100%