Presentation - Wilsons Advisory Drug & Device Conference
Released
Released
Announcement PDF
ImpediMed Limited
1/50 Parker Court
Pinkenba, QLD, 4008
Australia
E: investorrelations@impedimed.com
W : impedimed.com
24 October 2024
Companies Announcements Office
Australian Securities Exchange
Presentation – Wilsons Advisory Drug & Device Conference
ImpediMed Limited (ASX:IPD) releases the attached presentation to be delivered today at the
Wilsons Advisory Drug & Device 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
Wilsons Advisory Drug & Device 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
SOZO® Digital Health
Platform with Multiple FDA
Cleared Applications
with Primary Focus on Breast
Cancer Related Lymphoedema
(BCRL) Prevention
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
A single SOZO
measurement provides:
•
•
•
•
L-Dex® lymphoedema analysis
HF-Dex® heart failure analysis
Body CompTM
Hy-Dex® hydration analysis
3
Improving
Survivorship for
US Breast Cancer
Patients
310k
82%
Newly diagnosed US breast
cancer patients every year1
Breast cancer patients are at
risk of arm lymphedema due to
their treatment5
• There are 4+ million breast
cancer survivors1
1 in 5
Breast cancer patients will
develop lymphedema2 resulting in
•
Isolation and depression3
• Hospitalisation risk4
• Economic burden4
• 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
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.
4
SOZO® BIS: Critical elements in place to forge the new Standard of Care
to capture $600M BCRL TAM
Positive Global Clinical Trial
1200 patient trial: Statistically Significant
Lower Progression to Chronic
Lymphoedema1
FDA cleared
application
Widespread and Increasing US Payor
Coverage
146.6M Covered Lives across the US
p=0.016
Absolute reduction: 11.3%
Relative reduction: 59%
19.2%
• 16 states now at Critical Mass (>80% covered lives)
• 18 private payors providing positive coverage
• 39 private payors providing silent coverage
7.9%
Multiple Guidelines and Standards
Support Early Detection
Tape measure
(23/100)
BIS in updated
NAPBC Standards
NCCN
L-Dex
(7/89)
PREVENT trial: n=1,200 10 US and
international centers including Vanderbilt
University, Mayo Clinic and MD Anderson
5
1. Published in Lymphatic Research & Biology https://www.liebertpub.com/doi/10.1089/lrb.2021.0084
ImpediMed’s Bioimpedance Spectroscopy (BIS) technology replaces time
consuming SOC with early, objective & fast detection technology
Current Standard of Care (SOC)
Subjective or Time-Consuming
Bioimpedance Spectroscopy (BIS) – FDA-cleared, Clinically Validated,
Guideline Supported, Reimbursed, Early, Objective & Fast Detection
L-Dex Score
Examination
Volume
Captures Sub-Clinical, Stage 0 lymphedema that can be treated
Optical Scanning
Lymphography
Stage 0,
Subclinical
Stage 1, Pitting
Oedema
Stage 2,
Irreversible
Stage 3,
Elephantiasis
100%
resolution
88%
resolution
0%
Resolution
0%
Resolution
6
SAAS Business with growing Global Installed Base and Annual Recurring
Revenue
SOZO Annual Recurring Revenue1
Global Installed Base
ROW Installed Base
Units
• Low churn, 3% annualized
US Installed base
A$ millions
•
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 exchange rate used for Q1 FY25 ARR calculation was 0.67497 (Q4 FY24: 0.66699).
7
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
•
6 networks contracted with 2-3 devices
$2.7 million
$11.6 million
•
Renewed a top 5 customer
7% vs Q4 FY24
5% vs Q4 FY24
•
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.
8
Key forward looking metrics improving
Q1 FY25 Metrics
Opportunity Pipeline Units
585
34% increase vs Q4 FY24
1 new NCCN Center
Covered Lives1
146.6M
5% vs Q4 FY24
3 additional payors providing coverage
16 States now at Critical Mass2
SOZO at 23/33
19 Private payors providing positive coverage3
New! - NAPBC Accredited Centers
39 Private payors providing silent coverage4
SOZO at 143/570 Institutions
1.Covered Lives: represents the number of people nationally covered by Medicare or private insurance payors.
2.Critical Mass: 80% or more of the population in a State is covered by Medicare or private insurance payors (includes Medicare and the top 5 payors with covered lives within the state).
3.Positive coverage: Insurance payor has a publicly available medical policy stating that BIS is medically necessary.
4.Silent coverage: Insurance payor has not explicitly included or excluded BIS for lymphedema assessment in their medical policy. CPT 93702 was removed from their
experimental/investigational medical policy but the payer has not developed a BIS specific medical policy.
9
Immediate priority is focused sales, marketing and clinical execution in BCRL,
with 2-year strategy looking at adjacent markets
ImpediMed 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
Expand reach in
oncology
Develop new markets
• Continued focus on sales execution with urgency
• Manage cash burn
• ROW Growth
• Support LPP implementation and patient utilisation
• Progress towards
break even
• Oncology body
composition
• Execute IDNs on system-wide implementation
• Leg lymphoedema
• Continued progress to towards payor coverage
target 85% through support of Academic Societies
and KOLs
• Complete new
product roadmap
and implement
Ensure everything we do is underpinned by quality and integrity
10
Building a sustainable business
New Executive Team and new Board
Expanded commercial focus on lead generation for targeted US BCRL
customers
More efficient cost management
Building a pathway to future growth
Share your feedback
Discover