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IMPEDIMED LIMITED — AGM Information 2022
Oct 25, 2022
65135_rns_2022-10-25_46db04e5-9df4-4f65-b2c6-38269c2ba9e9.pdf
AGM Information
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26 October 2022
ASX ANNOUNCEMENT
2022 Annual General Meeting – Interim CEO’s Presentation
ImpediMed Limited ( ImpediMed ) (ASX:IPD) provides the attached Interim CEO’s presentation to be delivered at today’s Annual General Meeting commencing at 9.00am AEDT.
Authorised for release by the Company Secretary of ImpediMed Limited.
Contact Details
Investor relations Contact:
Mike Bassett, ImpediMed T: +61 407 431 432 E: [email protected]
About ImpediMed
Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS).
ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO[®] for multiple indications including heart failure, lymphoedema, and protein calorie malnutrition, sold in select markets globally.
For more information, visit www.impedimed.com.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on 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 forward-looking 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.
Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the
date when made. ImpediMed does not assume any obligation to publicly update or revise any forwardlooking 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.
ANNUAL GENERAL MEETING
26 October 2022
ASX:IPD
Disclaimer
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The material contained in this document is a presentation of general information about the activities of ImpediMed Limited (“ImpediMed”) current as at the date of this presentation. The information is provided in a summary form, does not purport to be complete and should not be relied upon as advice for investment This does not take into account the
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purposes. presentation investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.
• To the extent permitted by law, no responsibility for any loss in of from arising any way (including by way negligence) anyone acting or refraining to act as a result of this presentation or its contents is accepted by ImpediMed or any of its officers, employees or agents. • The information in this presentation is subject to change and unless assumes no to required by law, ImpediMed obligation update this presentation or its contents for any matter arising or coming to ImpediMed’s notice after the date of this presentation.
• SOZO[®] is intended only for use in countries in which it has received regulatory approval or clearance. Inclusion of products and information does not imply any official medical advice, recommendation or warranty. The information provided is not a substitute for the advice of an appropriate health professional. This website can be accessed from countries around the world and may contain references to products that have not been granted regulatory approval or clearance in your country. You should consult your health professional for detailed information regarding and their for as well as the ImpediMed’s products suitability you, regulatory approval or clearance status of such products in your country.
Forward Looking Statements
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Certain statements in this presentation may constitute forwardlooking statements or statements about future matters that are based on management’s current expectations and beliefs. The forward-looking statements in this release include statements regarding the next generation product, the ability of the new features to broaden the appeal of the product, and the ability of new product to meet the needs of the customer base, among others. These statements are subject to risks and uncertainties that are difficult to and are based on as to predict assumptions
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future events that not accurate. Actual results may prove may
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differ materially from what is expressed in this presentation.
• There can be no assurance that any existing or future regulatory filings will satisfy the relevant authorities’ requirements regarding SOZO nor can there be assurance that SOZO will be any approved or cleared for all applications by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding ImpediMed’s ability to commercialise SOZO, including its estimates of potential and financial could be revenues, costs, profitability performance affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; its ability to maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may from those described herein as vary materially anticipated, believed, estimated or expected.
FOCUS AREAS
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Dave Anderson Background
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Dave Anderson, Interim CEO and Director
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• Board Member since April 2020
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• 30-year background in healthcare and insurance
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Past CEO and President of Blue Cross Blue Shield of Western and Northeastern New York
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• Broad experience in healthcare with an expertise in reimbursement
Reimbursement Critical to Success
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CAP program delivering results that position us for coverage discussions
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• Achieved interim coverage and pilot programs ahead of first policy determinations
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First coverage determinations expected this quarter (Q2 FY’23)
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• NCCN outcomes expected to be known this quarter
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Sales strategy targeting areas of coverage
Sound Financial Position through to Break-even
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Sound financial position, with $34.9 million Cash on Hand as at 30 September 2022
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10+ quarters of operating cashflow^
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• Measured cost control to align cash outflow with break-even targets
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• Starting 2nd Half of FY’23, Net Operating Cash Outflow expected to be <$(3.0) million per quarter^^
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^ Estimated quarters of funding available as calculated based on the Company’s estimate of normalised, recurring cash flows. The estimated quarters of funding available as calculated in note 8 of the Appendix 4C, Quarterly cash flow report is 6 quarters of funding, based on the temporary increase in spend in Q1 FY’23 for annual administrative costs and fees related to the change in management. All Rights Reserved | Confidential ^^ Based on an estimated foreign currency of $1.00:$0.66 AUD:USD. Continued foreign currency rates below this amount will have a positive impact on cash receipts and a negative impact on cash expenditures for reporting purposes.
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FY’22 & Q1 FY’23 SOZO BUSINESS PERFORMANCE
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SOZO Revenue
(Excluding Legacy)
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Revenue Metrics
$2,700,000
- Incremental growth continues prior to full reimbursement
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$2,025,000
$1,350,000
$675,000
$-
SaaS^ Device and Contract Fees
Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23
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Record results for Total Revenue, SOZO Revenue and SOZO SaaS Revenue
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Total Revenue for FY’22 of $10.6 million, an increase of 26% YOY*
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Total Revenue for Q1 FY’23 of $2.9 million, +17% YOY
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$2,025,000
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- ~900 SOZO units sold in Core Business to date
SaaS Metrics
- $9.2m ARR[i] at 30 September 2022, +20% YOY
$1,350,000
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$19.1m CRP[ii] at 30 September 2022, +32% YOY
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90%+ SaaS Gross Margins on CRP
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Churn Rate negligible, 1% across all SOZO contracts
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95% Renewal Rate on SOZO contracts up for renewal in FY’22
i Annual Recurring Revenue (ARR): The amount of revenue reasonably expected to be booked for the next 12month period based on existing signed contracts, and assuming installation upon sale. ii Contracted Revenue Pipeline (CRP): Future period revenue amounts related to TCV[iii] that are yet to be reported as recognised revenue.
^The values shown are for SaaS Revenue are across all lines of business, including the Core Business and Clinical Business.
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iii Total Contract Value (TCV): Total value of customer contracts including one-time and recurring revenue. * YOY denotes Year-over-Year change in metric.
All FY’23 revenue and cash flow numbers are unaudited.
All Rights Reserved | Confidential
All figures are stated in Australian dollars (AUD) unless otherwise notated.
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SOZO BUSINESS PERFORMANCE
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Strength of renewals and low churn helping to drive growth
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38% Average Monthly License Fee increase across US renewal contracts in Q1 FY’23
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• This is up from the 34% increase achieved in Q4 FY’22
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Expectation for continued renewal increases for this financial year and into FY’24
Leveraging the power of our business model
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Stair step pricing model locks in growth before additional unit sales - Agreed price increases for years 2 and 3 for stair stepped contracts
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- ~$2.7 million additional ARR over the next 12 months inherent in current SOZO contracts $10.9M Core Business ARR
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as at 30 September 2023 +33% growth before another unit is sold
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Core Business ARR $8.2M
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as at 30 September 2022 +20% growth YoY^
All Rights Reserved | Confidential
38%+ ↑ Average Monthly License Fees on SOZO US renewals contracts in Q1 FY’23 33%+ ↑ Growth in ARR for 30 September 2023 before another SOZO unit sold
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All FY’23 revenue and cash flow numbers are unaudited. All figures are stated in Australian dollars (AUD) unless otherwise notated.
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^ YOY denotes Year-over-Year change in metric.
FOCUS ON LARGE CORPORATE ACCOUNTS
Assembling the tools to accelerate growth
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IDN, Corporate Account and NCCN Institution client base expanding: • In 19 of 31 NCCN Institutions
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In 16 of the Top 25 IDNs^
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• Agreements in place to allow rapid acceleration post reimbursement/coverage
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Around a quarter of US SOZO devices are with IDNs or Corporate Accounts
Growing the number of key account agreements
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In Q1 FY’23, signed a Global Strategic Commercial Partnership and pilot program with Genesis Care: • Initial rollout of five (5) SOZO units to establish lymphoedema screening services for breast cancer patients
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• Scope within agreement to expand roll out globally upon successful completion of the pilot program
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Renewed or expanded agreements with Integrated Delivery Networks (IDNs) such as City of Hope, UPMC, Sutter Health, and Trinity Health
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Renewed or expanded agreements with NCCN Institutions such as City of Hope, Mayo Clinic, UT Southwestern, and Fred Hutchinson Cancer Center
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Key IDNs, NCCN Institutions or Corporate Accounts added or extended in past 2 quarters:
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All Rights Reserved | Confidential
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^ Based on data compiled from IQVIA Market Insights Reports and Definitive Healthcare.
REIMBURSEMENT THE KEY - DUAL PATH APPROACH
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1. Private Payor Reimbursement / Coverage
2. NCCN Guidelines[® ]
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Case Assistance Program (CAP) continuing to deliver results
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CAP produces the appeal wins needed to obtain coverage policies with health plans
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• Strategy is focused on commercial coverage, initially through regional health plans
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Payor meetings have commenced
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3 of 10 initial Private Payor meetings have occurred
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First 2 payor meetings successful based on initial payments
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Third still in ongoing discussions
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4 additional meetings in November and 2 meetings in December
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Engaged in discussions with 4 regional health plans for commercial coverage policies
- 2 Health Plans are now paying under a pilot program of coverage, prior to us obtaining commercial coverage
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NCCN Guidelines inclusion would establish BIS L-Dex as standard of care and significantly accelerate adoption by Private Payors and Providers
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The two independent submissions presented at the Annual Breast Cancer Panel meeting, held on 25 and 26 August, 2022, have been reviewed
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Additional independent submission to the NCCN Survivorship Panel for review at their annual Panel Meeting on 19 and 26 October, 2022, increasing the possibility of a positive outcome
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Expectation remains that any changes will be published by the end of the calendar year
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2 additional Health Plans actively engaged in medical policy discussions for commercial coverage
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Focusing sales team resources in key areas that can leverage traction gained with regional health plans
Path to obtaining Standard of Care
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All Rights Reserved | Confidential
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