Impedimed Limited · ASX:IPD
Impedimed — Investor Presentation (October 2021)
49 slides from Impedimed's investor presentation, Oct 27, 2021
Slide 1: Capital Raising Presentation
CAPITAL RAISING PRESENTATION ® SOZO Digital Health OCTOBER 2021 Platform Technology Transformation Adoption Affirmation Growth
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer Important Notice and Disclaimer This document is dated 27 October 2021 and has been prepared and authorised by ImpediMed Limited (ABN 65 089 705 144) (“ImpediMed”) in connection with ImpediMed’s proposed capital raising (the “Capital Raise”), comprising: • a placement
Slide 3: Important Notice and Disclaimer
Important Notice and Disclaimer Not an offer This document is for information purposes only and is not a prospectus, disclosure document, product disclosure statement or other offering document under Australian law or any other law (and will not be lodged with the Australian Securities and Investmen
Slide 4: Important Notice and Disclaimer
Important Notice and Disclaimer Forward Looking Statements 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. Forward-looking statements can generally be identified by t
Slide 5: Important Notice and Disclaimer
Important Notice and Disclaimer Disclaimer Neither Canaccord Genuity Limited nor Wilsons Corporate Finance Limited (together, the “Joint Lead Managers”), nor any of their or ImpediMed’s respective advisers nor any of their respective affiliates or related bodies corporate, nor any of their respectiv
Slide 6: Table of contents
Table of contents Section Page number Executive summary 7 Company overview 8 Quarterly results update 26 Offer details 30 Key risks 34 Foreign selling restrictions 47 Contact details 49 Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. 6
Slide 7: Executive summary
Executive summary • PREVENT Trial results released on medRxiv.org in October 2021: https://www.medrxiv.org/content/10.1101/2021.10.12.21264773v1 PREVENT Trial • PREVENT Trial met primary end point and reached statistical and clinical significance summary • Results demonstrate that BIS screening shou
Slide 8: Company overview
Company overview impedimed
Slide 9: Our Transformation: Medical Device to Connected Digital Health Platform
Our Transformation Medical Device Connected Digital Health Platform U400 BIS Device SOZO Platform U400 Cancer Population^ SOZO® Cancer Population^ • ~20 Minute Test • Less than 30 Second Test • Trained Nurse/Therapist • Medical Assistant • Standalone Device • Connected Device • Gel Backed Electrodes
Slide 10: ImpediMed's Technology
ImpediMed’s Technology . Using Bioimpedance Spectroscopy (BIS), SOZO non-invasively measures, monitors and manages fluid status and tissue composition Inferred Measures of Fluid SOZO Directly Measures Fluid Bioimpedance Spectroscopy (BIS) Imaging Low Frequency Current passes around cells Implantable
Slide 11: Comprehensive Data
Comprehensive Data SOZO® measures and tracks critical patient data • L-Dex® lymphoedema index • HF-DexTM heart failure index • Total body water • Protein and minerals • Extracellular fluid • Basal metabolic rate • Intracellular fluid • Phase angle • Skeletal muscle mass • Body mass index • Fat mass
Slide 12: Connected Digital Health Platform
Connected Digital Health Platform Test patients at any location and allows data access and sharing across the entire healthcare system Cloud Access Scalable Test patients at any location Add and move test locations and immediately review without any additional software results online setup Trends Se
Slide 13: SOZO Digital Health Platform
® SOZO Digital Health Platform 1 Device, Multiple Applications Lymphoedema FDA Clearance, CE Mark Heart Failure FDA Clearance, CE Mark End Stage Renal Disease** CE Mark Protein Calorie Malnutrition FDA Clearance, CE Mark Body Composition FDA Clearance, CE Mark Bone Density^ Venus Insufficiency^^ * R
Slide 14: $2.0+ Billion Annual Addressable Market
Platform Technology, Transforming Care: Initial Focus on Three Large Addressable Markets Oncology Heart Failure Lymphoedema Protein Calorie Malnutrition^ Fluid Overload Dehydration Protein Calorie Malnutrition^ A$700+ million A$1+ billion Renal Failure Fluid Overload Protein Energy Wasting^ $2.0+ Bi
Slide 15: Markets Significantly Overlap
Markets Significantly Overlap • Cardiovascular disease is the leading cause of death among people on dialysis with kidney disease • Dialysis patients experience high rates of mortality, driven largely by an exceptionally high rate of cardiovascular related mortality Heart • Common for people with ch
Slide 16: Strong Adoption, Validated Technology
Strong Adoption, Validated Technology 810+ 375+ SOZO Devices in SOZO Devices in Core Business Clinical Business 35 2 international drug studies involving 375+ sites in 28 countries evaluating fluid volumes (heart failure & renal failure patients) Proprietary, do not reproduce, distribute, or excerpt
Slide 17: Oncology: $1.4 Billion
Oncology • 1.8m newly diagnosed cancer cases per year in the US • 1 in 3 at risk cancer survivors will develop secondary lymphoedema • Lymphoedema costs the US healthcare system ~$7 bn p.a. Stage 1 – Pitting Edema Stage 2 - Irreversible Stage 3 - Elephantiasis 30 - 85% at risk of 55% at risk of Prot
Slide 18: PREVENT Trial Successful, Statistically Significant
PREVENT Trial Successful, Statistically Significant Key to a significant acceleration of near-term results Consistent Reduction in Lymphoedema Progression Study after Study • PREVENT Trial met primary end point and reached statistical significance • Results demonstrate that BIS screening should be a
Slide 19: Growth Drivers: Reimbursement & NCCN Guidelines
Growth Drivers: Reimbursement & NCCN Guidelines® Reimbursement NCCN® • PREVENT randomised control trial the key to reimbursement • NCCN Submission upon PREVENT publication and accelerating growth • Current NCCN submission covering the Meta-Analysis and • PREVENT delivers clear path to reimbursement
Slide 20: Heart Failure: $700+ Million
Heart Failure HF Patients by Classification • Affecting at least 26 million people worldwide 6.5 Million • Costs US healthcare system estimated $31 billion annually Class I Class IV 5% 35% • Estimated 6.5 million Americans live with heart failure • 1 in 5 people over the age of 40 will develop heart
Slide 21: HF-Dex Fluid Analysis for Heart Failure
HF-Dex™ Fluid Analysis for Heart Failure SOZO® Heart Failure Patient Output • Assessment of fluid burden is critical to the management of Heart Failure patients • Current methods of determining fluid levels are either inaccurate or invasive and expensive • SOZO gives clinicians an objective measure
Slide 22: Renal Failure $300+ Million
Renal Failure CE Mark obtained, US Regulatory strategy currently being formulated • There are in excess of 450,000 US dialysis patients receiving treatment three times a week for about four hours • Unhealthy kidneys are no longer properly removing wastes and extra fluid from the body • Centers for M
Slide 23: Renal Failure Market: Attractive Market Dynamics
Renal Failure Market: Attractive Market Dynamics • Very attractive concentrated market • Two companies caring for 85% of ESRD patients • Both operate more than 2,500 dialysis clinics each and together treat in excess of 400,000 ESRD patients • ImpediMed received FDA Breakthrough Designation for SOZO
Slide 24: SOZO and Dry Weight for Renal Failure
® SOZO and Dry Weight for Renal Failure ImpediMed believes SOZO can provide a reliable scientific way of calculating dry weight Breakthrough Designation • ImpediMed received FDA Breakthrough Device Designation for Renal Application • To be granted breakthrough designation, you must demonstrate the f
Slide 25: Key Highlights and Takeaways
Key Highlights and Takeaways • Transformation to Connected Digital Health Platform complete • $10m annual revenue run rate with strong growth despite COVID-19 headwinds • Multiple applications addressing significant health care needs • Inflection point, with 3 focus areas set to accelerate adoption:
Slide 26: Quarterly Results Update
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Slide 27: Q1 FY'22 Overall Business Results
Q1 FY’22 OVERALL BUSINESS RESULTS TOTAL REVENUE $2.6m $2.5m TOTAL REVENUE SOZO Business + 71% $2.6m ✓ RECORD QUARTER YOY^ • SaaS Revenue from Q1FY’22 Core Business $15.4m • SaaS Revenue from + 71% Clinical Business $0.1m YOY (AstraZeneca) • New SOZO contracts CASH ON HAND Legacy signed and device Bu
Slide 28: Land and Expand Strategy: Q1 FY'22 ARR and CRP
Q1 FY’22 ARR AND CRP LAND EXPAND EXPAND ACCOUNTS TESTING PROGRAMS • AstraZeneca expanding and extending one trial, estimated value of $500k 51 36,500+ • 1 additional unit and 3 $9.0m ^ Units Sold Globally Additional Patient Tests contract renewals for NCCN Member Institutions The Land and ARRi Q1 FY
Slide 29: Q1 FY'22 SOZO Revenue and Patient Tests
Q1 FY’22 SOZO REVENUE AND PATIENT TESTS SOZO Revenue Patient Tests To-Date (Excluding Legacy) (310,000+ on File) $10m+ $2,500,000 38,000 Annual Revenue Run Rate $2,000,000 30,400 $2.5m $1,500,000 22,800 SOZO Revenue +76% YOY $1,000,000 15,200 ✓ RECORD QUARTER $500,000 7,600 36,500+ $- COVID-19 + D v
Slide 30: Offer details
Offer details 30
Slide 31: Offer overview
Offer overview • ~A$40 million Offer comprising: ‒ an Institutional Placement to raise approximately A$35 million; and Offer size and structure ‒ a Share Purchase Plan under which eligible shareholders have an opportunity to subscribe for up to A$30,000 of New Shares up to a cap of approximately $5
Slide 32: Use of funds
Use of funds Use of funds Category A$m • General working capital (sufficient to achieve breakeven) including Working capital 18.5 advance inventory purchases to address growth, current global chip shortages, COVID related supply chain issues and transition to SOZO II Product enhancements 3.0 • SOZO
Slide 33: Offer timetable
Offer timetable Event Date (AEDT) Trading halt Monday, 25 October 2021 Institutional Placement bookbuild opens 11:00am (AEDT) on Monday, 25 October 2021 Institutional Placement bookbuild closes 10:30am (AEDT) on Tuesday, 26 October 2021 Record date for SPP 7:00pm (AEDT) on Tuesday, 26 October 2021 T
Slide 34: Key risks
Key risks impedimed
Slide 35: Risk Factors: Company Specific Risks
Risk Factors This section identifies what the Directors regard as major risks, which may materially and adversely affect the future operating and financial position of ImpediMed Limited (ImpediMed or Company) and its subsidiaries (together, the Group) and the value of shares in the capital of the Co
Slide 36: Risk Factors (cont.)
Risk Factors (cont.) The commercial success of ImpediMed’s products is substantially dependent on achieving acceptable payment levels to medical providers to support pricing strategies for L-Dex and additional indications and uses for SOZO. Whether acceptable third-party payments and reimbursement l
Slide 37: Risk Factors (cont.)
Risk Factors (cont.) The Company is relying on additional data from clinical trials and real-world data utilising SOZO to drive the commercial expansion and market adoption of SOZO in Heart Failure (HF), Renal Failure, protein calorie malnutrition (PCM) and other indications. Although early results
Slide 38: Risk Factors (cont.)
Risk Factors (cont.) ImpediMed’s business and the business of the third parties with which it operates are subject to the laws and regulations in a number of jurisdictions. Unforeseen changes in laws and government policy in the U.S., the EU, Australia and elsewhere, including material and unforesee
Slide 39: Risk Factors (cont.)
Risk Factors (cont.) The Group relies on third party suppliers, manufacturers and distributors for the development and distribution of its products, which carries the risk of delay and disruption. In assessing the effective management of ImpediMed’s supply chain and manufacturing capability, ImpediM
Slide 40: Reliance on third party technology
Risk Factors (cont.) ImpediMed relies on a range of third-party cloud computing and other information technology systems to facilitate the use of the platform and deliver services to customers, Reliance on third especially for SOZO. This includes software licenced from third parties and open-source
Slide 41: Risk Factors (cont.)
Risk Factors (cont.) ImpediMed has transitioned to a SaaS subscription business model, which presents a number of potential risks. The key risks are described below. • ImpediMed must devote significant resources to developing and deploying the subscription model and this may create working capital c
Slide 42: Risk Factors (cont.)
Risk Factors (cont.) ImpediMed faces product liability exposure with respect to its products. This exposure is likely to increase as commercial sales increase. ImpediMed conducts extensive safety and penetration testing of new and current technology and regularly reviews customer complaints. However
Slide 43: Risk Factors (cont.)
Risk Factors (cont.) Third parties may own or control patents or patent applications that ImpediMed may be required to license in order to commercialise its product, which ImpediMed may infringe, or that could result in litigation that would be costly and time consuming. As a result of intellectual
Slide 44: Capital requirements
Risk Factors (cont.) ImpediMed may require substantial additional funds which may be dilutive or that may not be available to ImpediMed on favourable terms, or at all. If ImpediMed is unable to obtain additional funds when required, ImpediMed may be forced to: • delay; Capital • reduce the scope of;
Slide 45: Risk Factors: General Risks
Risk Factors (cont.) 2. General Risks There are risks associated with any share market investment. Some of these risks are listed below. ImpediMed’s financial statements are presented in Australian dollars. A substantial portion of current sales revenue and costs are denominated in currencies other
Slide 46: Risk Factors: Other
Risk Factors (cont.) 3. Other Other risks include those normally found in conducting business, including litigation resulting from breach of agreements or in relation to employees or any other cause. The above list of risk factors should not be taken as exhaustive of the risks faced by ImpediMed or
Slide 47: Foreign selling restrictions
Foreign selling restrictions 47
Slide 48: Foreign selling restrictions
Foreign selling restrictions 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 (the "FMC Act"). The Shares are not being offered or sold in New Zealand (or allotted with a view to being offer
Slide 49: Contact Details
Contact Details Investor Relations: Mike Bassett SVP Corporate and Strategic Development mbassett@impedimed.com +61 407 431 432 www.impedimed.com