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IMPEDIMED LIMITED Capital/Financing Update 2023

May 18, 2023

65135_rns_2023-05-18_bd49b3c9-e4dc-4c70-b43d-abe3e2ce3382.pdf

Capital/Financing Update

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Capital Raising Investor Presentation

May 2023

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ASX: IPD

Approved for release by the Board of ImpediMed Limited

Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. ©2023 ImpediMed Limited.

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Im ortant Notice and Disclaimer p

Important Notice and Disclaimer

This document is dated 19 May 2023 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 of new fully paid ordinary shares in ImpediMed (“ New Shares ”) to certain intuitional and sophisticated investors (the “ Placement ”); and

  • an offer of New Shares under a share purchase plan to eligible shareholders in Australia and New Zealand (“ Share Purchase Plan ” or “ SPP ”).

By accepting this Document, you acknowledge and agree to the terms set out below.

Not for release or distribution in the United States

This document and the information contained herein does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States or any other jurisdiction in which such an offer would be illegal. The securities referred to in this document have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (“ US Securities Act ”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold, directly or indirectly, in the United States or to any person acting for the account or benefit of any person in the United States unless the securities have been registered under the US Securities Act (which ImpediMed has no obligation to do or procure) or are offered or sold pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act and applicable securities laws of any state or other jurisdiction of the United States.

Summary information

The material contained in this document is a presentation of general information about the activities of ImpediMed and its subsidiaries (the “ Group ”) which is current as at the date of this presentation. The information is provided in a summary form, does not purport to be complete and does not purport to contain all information which a prospective investor may require in evaluating a possible investment in ImpediMed or that would be required in a prospectus, product disclosure statement or other disclosure document prepared in accordance with the requirements of the Corporations Act 2001 (Cth) (the “ Corporations Act ”). This document must be read in conjunction with ImpediMed’s other periodic and continuous disclosure information lodged with the ASX, which are available at www.asx.com.au. This presentation does not take into account the investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.

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 ImpediMed’s products and their suitability for you, as well as the regulatory approval or clearance status of such products in your country.

Market and Industry data

Certain market and industry data used in connection with this document may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. None of ImpediMed, its representatives or advisers have independently verified any such market or industry data provided by third parties or industry or general publications.

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Im ortant Notice and Disclaimer p

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 Investments Commission (“ ASIC ”)). This document is not and should not be considered an offer or an invitation to acquire the New Shares or any other financial products and does not and will not form any part of any contract for the acquisition of the New Shares.

The Share Purchase Plan Offer will be made on the basis of the information contained in the SPP offer booklet (“ SPP Offer Booklet ”) to be prepared for eligible shareholders in Australia and New Zealand and made available following its lodgement with ASX. Any eligible shareholder in Australia or New Zealand who wishes to participate in the SPP should consider the SPP Offer Booklet before deciding whether to apply for New Shares under the SPP. Anyone who wishes to apply for New Shares under the SPP will need to apply in accordance with the instructions contained in the SPP Offer Booklet.

Not financial product advice

This document does not constitute financial product or investment advice or any recommendation to acquire New Shares or accounting, legal or tax advice. Each recipient of this document should make its own enquiries and investigations regarding all information in this document including but not limited to the assumptions, uncertainties and contingencies which may affect future operations of the Group and the impact that different future outcomes might have on the Group. Information in this document is not intended to be relied upon as advice to investors or potential investors and has been prepared without taking account of any person’s individual investment objectives, financial situation or particular needs. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own investment objectives, financial situation and needs and seek legal, accounting and taxation advice appropriate to their jurisdiction. ImpediMed is not licensed to provide financial product advice in respect of the New Shares. Cooling off rights do not apply to the acquisition of New Shares under the Capital Raise.

Investment risk

An investment in New Shares is subject to known and unknown risks, some of which are beyond the control of the Group. ImpediMed does not guarantee any particular rate of return or the performance of the Group, nor does it guarantee any particular tax treatment. Persons should have regard to the Risk Factors set out in pages 32 to 43 of this document.

Financial data

All references to dollars, cents or $ in this document are to Australian currency, unless otherwise stated. Several figures, amounts, percentages, estimates and calculations of value in this document are subject to the effect of rounding.

Investment risk

Past performance, including past price performance of ImpediMed’s shares and pro forma financial information given in this document, is given for illustrative purposes only and should not be relied upon as (and is not) an indication of ImpediMed’s views on its future financial performance or condition. Past performance of ImpediMed cannot be relied upon as an indicator of (and provides no guidance as to) the future performance of ImpediMed. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee, whether as to the past, present or future.

Past performance

Past performance, including past price performance of ImpediMed’s shares and pro forma financial information given in this document, is given for illustrative purposes only and should not be relied upon as (and is not) an indication of ImpediMed’s views on its future financial performance or condition. Past performance of ImpediMed cannot be relied upon as an indicator of (and provides no guidance as to) the future performance of ImpediMed. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee, whether as to the past, present or future.

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Im ortant Notice and Disclaimer p

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 the use of forward-looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions within the meaning of securities laws of applicable jurisdictions. 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 predict and are based on assumptions as to future events that may not prove accurate. Actual results may differ materially from what is expressed in this presentation.

Any such statements, opinions and estimates in this document speak only as of the date hereof and are based on assumptions and contingencies subject to change without notice, as are statements about market and industry trends, projections, guidance and estimates. Forward-looking statements are provided as a general guide only. The forward-looking statements contained in this document are not indications, guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of the Group, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. Forward-looking statements may also assume the success of the Group's business strategies. The success of any of these strategies is subject to uncertainties and contingencies beyond ImpediMed's control, and no assurance can be given that any of the strategies will be effective or that the anticipated benefits from the strategies will be realised in the period for which the forward-looking statements may have been prepared or otherwise. Refer to the Risk Factors set out in pages 32 to 43 of this document for a non-exhaustive summary of certain key business, offer and general risk factors that may affect the Group.

There can be no assurance that any existing or future regulatory filings will satisfy the relevant authorities’ requirements regarding SOZO nor can there be any assurance that SOZO will be 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 revenues, costs, profitability and financial performance could be 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 vary materially from those described herein as anticipated, believed, estimated or expected.

No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including ImpediMed or any of its advisers). In particular, no representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward-looking statements in this document will actually occur. Actual operations, results, performance, production targets or achievements may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Except as required by law or regulation (including the ASX Listing Rules), ImpediMed disclaims any obligation or undertaking to update forward-looking statements in this document to reflect any changes in expectations in relation to any forward-looking statement or change in events, circumstances or conditions on which any statement is based.

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Im ortant Notice and Disclaimer p

Disclaimer

Neither Canaccord Genuity Limited, Wilsons Corporate Finance Limited nor Jarden Australia Pty Ltd (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 respective directors, officers, partners, employees or agents (together, the “ Beneficiaries ”), have authorised, permitted or caused the issue, submission, dispatch or provision of this document and, except to the extent referred to in this document, none of them makes or purports to make any statement in this document and there is no statement in this document which is based on any statement by any of them.

To the maximum extent permitted by law, ImpediMed, the Joint Lead Managers and their respective advisers, and each of their respective Beneficiaries exclude and disclaim all responsibility and liability, including, without limitation, for negligence or for any expenses, losses, damages or costs incurred by you as a result of the information in this document being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise.

To the maximum extent permitted by law, ImpediMed, the Joint Lead Managers and their respective advisers, and each of their respective Beneficiaries make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this document and, with regards to the Joint Lead Managers, it and its advisers, and each of their respective Beneficiaries take no responsibility for any part of this document or the Capital Raise.

The Joint Lead Manager and their advisers, and each of their respective Beneficiaries make no recommendations as to whether you or your related parties should participate in the Capital Raise nor do they make any representations or warranties to you concerning the Capital Raise. You represent, warrant and agree that you have not relied on any statements made by the Joint Lead Managers, their advisers, or any of their respective Beneficiaries in relation to the Capital Raise. You further expressly disclaim that you are in a fiduciary relationship with any of ImpediMed, the Joint Lead Managers or their advisers or any of their respective Beneficiaries.

To the maximum extent permitted by law, you agree to release and indemnify ImpediMed, the Joint Lead Managers and their respective advisers from and against all claims, actions, damages, remedies or other matters, whether in tort, contract or under law or otherwise, arising from or which may arise from or in connection with the provision of, or any purported reliance on, this document and you covenant that no claim or allegations will be made against any of the them in relation to this document.

You acknowledge and agree that determination and eligibility of investors for the purposes of the Capital Raise is determined by reference to several matters, including legal and regulatory requirements and the discretion of ImpediMed and the Joint Lead Managers. You further acknowledge and agree that ImpediMed and the Joint Lead Managers and their respective Beneficiaries exclude and expressly disclaim any duty or liability (including for negligence) in respect of the exercise of that discretion, to the maximum extent permitted by law.

Acknowledgement and representation and warranty

By receiving this document you acknowledge and agree that you understand the contents of this notice and that you agree to abide by its terms and conditions. By receiving this document you further agree, irrevocably and unconditionally, to submit to the non-exclusive jurisdiction of the courts of New South Wales, in respect of any disputes, actions, suits or proceedings arising out of, or relating to, this document.

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Table of Contents

Section Page number
Executive Summary 7
Market Opportunity 8
Offer Details 18
Company Overview 23
Key Risks 32
Foreign Selling Restrictions 44

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Executive Summar y

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NCCN Guidelines [®] inclusion
to accelerate ImpediMed’s
reimbursement strategy
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ImpediMed strongly
positioned to capture
significantly expanded TAM
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Capital raising to advance
Private Payor and Provider
onboarding as ImpediMed
scales
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  • NCCN Guidelines[®] updated 24 March 2023 to recommend regular screening for Lymphoedema, including with bioimpedance spectroscopy (BIS).

  • Inclusion of BIS in the NCCN Guidelines[®] assists in establishing BIS as a standard of care and accelerates adoption by Private Payors and Providers.

  • Expected timeline of published policies brought in by six months, with nearly 50% of Private Payors now projected to publish policies by the end of calendar year 2023.

  • Written confirmation from first Regional Payor that it will be publishing its policy to include BIS by end of May.

  • In addition to Breast Cancer survivors, NCCN Guidelines[®] now recommend regular screening for all cancer survivors at risk of Lymphoedema.

  • $1b+ TAM for Breast Cancer Related Lymphoedema ($600m prior to NCCN inclusion)

  • $2b+ TAM for all cancer survivors at risk of Lymphoedema .

  • SOZO is the only FDA cleared BIS device for Lymphoedema[1] .

  • 24,000+ Sites of Service for SOZO , with Private Payor reimbursement unlocking access to sell in 10,000+ of these sites under existing agreements.

  • $20m Placement.

  • $5m Share Purchase Plan (SPP).

  • Offer Price of $0.130 per share, representing a 16% discount to the last close price on Wednesday, 17 May 2023.

  • Proceeds used to accelerate the Private Payor opportunity post inclusion in NCCN Guidelines[®] and enable the scaled roll-out of SOZO systems in the U.S.

Note: NCCN Guidelines refers to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Survivorship V.1.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed March 24, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

  1. ImpediMed’s U400 is also an FDA Cleared BIS Device for Lymphoedema. Since the launch of SOZO®, SOZO® is the only commercially available FDA Cleared BIS Device for Lymphoedema.

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7

Market Opportunity

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MARKET OPPORTUNITY

Ke U dates y p

Highly Achieving Expanded Transformative Significant Total Addressable Moment for Momentum with Market (TAM) Company Private Payors NCCN Guidelines[®] Nearly 50% of Health Plans More than doubling of TAM updated to recommend BIS expected to publish in Oncology related to all for all cancer patients at risk coverage[1] by end of the U.S. cancer patients at risk of limb lymphoedema. calendar year on the back of of limb lymphoedema. the guidelines updates.

  1. Projected timing based on a combination of direct correspondence with private payors by ImpediMed or our provider partners and publicly available BIS medical policy publishing updates.

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MARKET OPPORTUNITY

NCCN Guidelines[®] U dated to Recommend BIS p

NCCN Guidelines®
updated 24 March
2023 to recommend
regular screening for
lymphoedema,
including with BIS1.
Recommends
Regular Screening
Names BIS as an
objective measurement
tool to identify early
signs of lymphoedema.
SOZO is the only FDA
cleared BIS device for
Lymphoedema2.
Specifically
Names BIS
All At-Risk Cancer
Survivors
The NCCN Guidelines®
now recommend
regular screening for all
cancer survivors at risk
of lymphoedema.
The recommendations
made by the NCCN
Survivorship Panel
were Category 2A,
which means that there
was uniform NCCN
consensus for this new
recommendation.
Uniform
Consensus
The inclusion of BIS in
the NCCN Guidelines®
will help establish BIS
as standard of care
and accelerate
adoption by Private
Payors and Providers.
Helps Establish New
Standard of Care

BIS = Bioimpedance Spectroscopy

  1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines[®] ) for Survivorship V.1.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed March 24, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
  1. ImpediMed’s U400 is also an FDA Cleared BIS Device for Lymphoedema. Since the launch of SOZO, SOZO is the only commercially available FDA Cleared BIS Device for Lymphoedema.

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MARKET OPPORTUNITY

Coverin All Patients At Risk of Limb L m hoedema g y p

Annual cancer diagnoses in the US by cancer type[1]

  • Addressable market in Oncology significantly expanded.

  • .

  • There are 1.9 million new cancer diagnoses in the US each year[1]

  • The Breast Cancer Related Lymphoedema market represents approximately 300,000 new cancer diagnoses in the US each year, or 15%[1 ] of total.

  • ImpediMed’s current technology is capable of addressing over 1.1 million new cancer diagnoses, or 58%[1] of total.

  • These 1.1 million cancer diagnoses cover over 5,600 facilities (inpatient .

  • and outpatient), equating to over 24,000 relevant sites of service[2]

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Breast 290,560
Colorectal 160,470
15%
42% Genital 395,600
8%
Skin 99,780
21%
Urinary 164,190
9% 5%
Not at risk of limb
lymphoedema
807,430
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  1. National Cancer Institute: https://seer.cancer.gov/statfacts/html/common.html

  2. Based on data from Definitive Healthcare.

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MARKET OPPORTUNITY

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Annual Cost of
Lymphoedema [2]
Treatment Market
$10B+
$600M+

$1B+
$2B+
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$2B+ Addressable Market for ~~Lymphoedema in U.S. Alone~~

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Previous Serviceable Market [1]
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  • Prior to NCCN Guidelines[®] inclusion

  • Total Addressable Market[1]

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Breast Cancer Patients
Total Addressable Market

All At-Risk Cancers
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Total Addressable Market[1]

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Addressable Market values stated in AUD.

  1. Based on a range of USD $1,500 - $5,500 per month license fee for the respective markets, dependent on the number of relevant sites of service and patient populations seen for each cancer type.

  2. Based on 1+ million cancer related lymphoedema patients treated annually.

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MARKET OPPORTUNITY

Substantial Growth O ortunit with Reimbursement pp y

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Private Payor reimbursement strategy unlocks access to 10,000+
Sites of Service [^^]
accessible under
existing agreements
A D D R E S S A B L E
M A R K E T
~500
Sites of Service currently
24,000+
achieved in the U.S [] (prior to
NCCN Guidelines [®] inclusion)
Sites of Service
in the U.S.
13,500+
additional addressable
Sites of Service in the U.S.
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Current U.S. SOZO Footprint*

NCCN INSTITUTIONS[^]

  • 22 of 33 NCCN Customers

TOP 25 INTEGRATED DELIVERY NETWORKS[^^]

  • 17 of 25 IDN Customers

Top U.S. Cancer Centres[^^^]

  • 150+ of 500 Cancer Centre Customers

  • Achieved prior to NCCN Guidelines inclusion or Private Payors coming on board.

  • ^ Based on data from the NCCN website: https://www.nccn.org/home/member-institutions.

  • ^^ Based on data compiled from IQVIA Market Insights Reports and Definitive Healthcare. Accessible Sites of Service indicate a signed Master Agreement, Business Associate Agreement, Legal clearance and/or IT clearance at a Corporate level.

  • ^^^ Based on data from Definitive Healthcare.

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MARKET OPPORTUNITY

World Renowned Customer Base

1,000+ SOZO Systems deployed globally in Core and Clinical Businesses[1] 100+ SOZOs in Europe[2] ~500 SOZOs in U.S. 400+ SOZOs in Australia and Asia-Pacific region

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  1. The Core Business relates primarily to the Group’s Oncology business. The Clinical Business refers to revenue generating contracts from research contracts such as AstraZeneca.

  2. SOZOs in Europe predominantly relate to the AstraZeneca Clinical Trials.

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MARKET OPPORTUNITY

U.S. Private Payor Landscape

Complex network of regional and national private health insurers

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  • Payors in the health care industry are organisations which set service rates, collect payments, process claims, and pay provider claims (such as private health plans, Medicare, and Medicaid). This compares to Providers who offer health care services (such as hospitals or clinics). Payors and Providers are typically not the same entity but can be in some instances.

  • The top 5 national payors in the U.S. are UnitedHealthcare, Anthem Blue Cross, and Aetna, Cigna and Humana.

  • The top 5 regional payors are Kaiser, HCSC, Molina, Highmark, BCBS Michigan.

  • Private payors are both national and regional in scope, but there are more regional payors among the top individual health insurers by state.

  • Therefore, even though the top national payors have significant national market share, they are not necessarily the most influential in any given market or state.

  • The largest private payors have complex and time-consuming processes to change medical policy. Smaller regional payors prefer to follow the lead of their larger peers before changing medical policy. The mid to large regional private payors are the quickest to make medical policy changes.

Source: https://healthcareinsider.com/top-individual-health-insurance-companies-mapped-367121

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MARKET OPPORTUNITY

Reimbursement Strate and U dates gy p

First Regional Payor Policy Publication

Written confirmation from Regional Payor that policy will be published to include BIS as medically necessary for lymphoedema evaluation in the setting . of breast cancer by end of May[1] Once published, the Company will make a further announcement to the ASX.

Expecting First State Immediate Response with Critical Mass from Private Payors Expecting critical mass Nearly 50% of Private Payors (>80% covered lives) in a key now projected to publish target state this quarter[1] . coverage[1] by end of 2023 calendar year.

BIS = Bioimpedance Spectroscopy

  • 1.Projected timing based on a combination of direct correspondence from private payors to ImpediMed or to our provider partners, as well as publicly available BIS medical policy publishing updates.

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MARKET OPPORTUNITY

Immediate Im act of NCCN Guidelines[®] on Reimbursement Strate p gy

Further, material progress since April 2023 update:

Continued acceleration of Payor timelines

3 to 12

months

  • Initially reported 3 to 18 months for Private Payors to review their current medical policies.

  • • Now expecting 3 to 12 months for Payors to publish their updated policies.

Brought in by ~6 months Moved from “policy review” to “published policy”

Today

Dec 2023

Jun 2024

Reimbursement Strategy

  • Focus on key Regional Payors to start a domino effect

  • Top 5 Payors likely to accelerate with Regional Payor momentum

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50%

Nearly 50% are now projected to publish coverage by the end of calendar year 2023[1]

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95%+ Nearly all projected to publish coverage by the end of our fiscal year 2024[1]

• Unlocks substantial growth opportunity with reimbursement

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  1. Projected timing based on a combination of direct correspondence with private payors by ImpediMed or our provider partners and publicly available BIS medical policy publishing updates.

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Offer Details

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18

OFFER DETAILS

Offer overview

• Institutional Placement to raise approximately A$20 million through the issue of approximately 153.8 million shares (representing ~8.6% of shares currently on issue).
Offer size and
structure
• SPP to eligible shareholders in Australia and New Zealand, under which eligible shareholders have an opportunity to subscribe for up to A$30,000 of new shares
• The SPP will be capped at A$5 million, which means eligible applicants may be subject to scale back
• Offer price of A$0.130 per new share under the Institutional Placement and SPP (“Offer Price”), which represents a:
Offer price
16.1% discount to the last closing price of A$0.155 on Wednesday, 17 May 2023;

24.4% discount to the 5-day volume weighted average price (“VWAP”) of A$0.172 to Wednesday, 17 May 2023; and

25.7% discount to the 10-day VWAP of A$0.175 to Wednesday, 17 May 2023
Institutional
Placement
• The Institutional Placement was conducted on Thursday, 18 May 2023
Share Purchase • ImpediMed intends to offer eligible shareholders an opportunity to subscribe for up to A$30,000 of new shares under the SPP at a price per share equal to the Offer Price
Plan • It is intended that the SPP will be capped at approximately A$5 million
Director • A number of directors have indicated an intention to acquire securities in the secondary market on ASX during 2023, given they are prohibited from participating in the
Involvement Institutional Placement without shareholder approval under ASX Listing Rule 10.11
Ranking • New shares issued under the Offer will rank pari passu with existing shares from their date of issue
Joint Lead
Managers
• Canaccord Genuity (Australia) Limited, Wilsons Corporate Finance Limited and Jarden Australia Pty Ltd are acting as the Joint Lead Managers to the Offer

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OFFER DETAILS

Use of Funds

Proceeds used to accelerate the Private Payor opportunity post inclusion in NCCN Guidelines[®] and enable the scaled roll-out of SOZO systems in the U.S.

Use of funds1
Category A$m
Market Access and Customer Success 6.0
Sales and Marketing 7.0
Medical Affairs and Software Development 2.5
Manufacturing 3.0
Offer costs 1.5
Total 20.0

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2% - 4% 5% - 10% 10% - 30%
Targeted Market Targeted Market Targeted Market TAM
Share^ based on Share^ with initial Share^ at Scale
previous B/E model^^ investment
$1bn
~A$25m A$35m - A$40m Full deployment BCRL
cost basis cost basis of funding
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  • Use of funds is expected to fund ImpediMed’s initial accelerated oncology growth plan, with a targeted market share of 10 – 30% at scale.

  • Gradually deploy funds now to prepare Company for scale.

  • Accelerate investment as growth opportunities present.

  • Targeted Market Share and Revenue at profitability significantly increased .

  • compared to prior break-even modeling[^^]

  • Excludes capital raised under the Share Purchase Plan (SPP), which would cover general working capital requirements.

  • ^ Market share refers to percentage of Total Addressable Market for Breast Cancer patients at risk of Breast Cancer Related Lymphoedema (BCRL).

  • ^^ Break-even modelling refers to the modeling and focus the Company has been operating under prior to inclusion on NCCN Guidelines[®] .

  • BCRL = Breast Cancer Related Lymphoedema market

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OFFER DETAILS

Further Details on Use of Funds[1]

Market Access and Reimbursement + Customer Success

  • Reimbursement Field Support team for onboarding of Private Payors and Providers, including building workflows, training and payor contracting support.

  • Integrated customer success team to build repeatable processes for scale and customer retention.

  • Patient Advocacy Programs.

  • Payor outreach and Key Opinion Leader (KOL) support for additional cancer types.

$6.0m

Sales and Marketing

  • Chief Commercial Officer and Sales Operations team, experienced in commercial scaling in US.

  • Currently 6 Sales Reps, initially growing to 10-15, with longerterm expectation of 25-35.

  • Capital to be deployed over next 6-12 months in advance of key Payor wins.

  • Lead Generation and data analytics.

$7.0m

Medical Affairs and Software Development

  • Chief Medical Officer to build out Medical Affairs team.

  • Evidence generation to capture expanded market opportunity beyond Breast Cancer.

  • Key ongoing software enhancements to promote customer usage, maintain customer retention rates and consolidate first mover advantage.

  • Metrics development and tracking capabilities.

$2.5m

Manufacturing

  • Critical investment in manufacturing capability to meet anticipated demand.

  • Increased inventory levels to meet step-change in orders over the coming 12 months.

  • Advanced inventory purchasing to begin covering the ~30% long-lead time componentry to reduce build lead times.

  • Calibration units for manufacturing product at scale.

$3.0m

  1. Excludes costs related to the offer.

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OFFER DETAILS

Offer timetable

Event Date
Trading halt Thursday, 18 May 2023
Institutional Placement bookbuild conducted Thursday, 18 May 2023
Record date for SPP 7:00pm (Sydney time) on Thursday, 18 May 2023
Trading halt lifted, announce Completion of Institutional Placement Friday, 19 May 2023
Settlement of new shares issued under the Institutional Placement Friday, 26 May 2023
Allotment and trading of new shares issued under the Institutional Placement Monday, 29 May 2023
SPP offer booklet dispatched, SPP offer period opens Tuesday, 30 May 2023
SPP offer period closes Friday, 16 June 2023
SPP completion announcement Monday, 19 June 2023
Allotment of new shares issued under the SPP Wednesday, 21 June 2023
Commencement of normal trading in new shares issued under the SPP Thursday, 22 June 2023

NOTE: The above timetable is indicative only. The Company or Joint Lead Managers may vary any of the above dates without notice, subject to the Corporations Act, the ASX Listing Rules and other applicable law.

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22

Company Overview

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COMPANY OVERVIEW

Cor orate Overview p

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A$277M Share Register
ASX Listed
Market Cap Institutional: 53%
IPD.AX
Private: 44%
as at 17 May 2023
October 2007 Board/Management: 3%
A$21.4M A$45.0M [^] Debt: Nil
Cash on Hand Proforma Cash to No borrowings
as at 31 March 2023 fund growth from banks
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^ Estimated based on a cash balance as at 31 March 2023 of A$21.4 million, plus a Placement of A$20 million and SPP of ~A$5 million, net of costs. All figures are stated in Australian dollars (AUD) unless otherwise notated.

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COMPANY OVERVIEW

Hi h Mar in SaaS Model Poised for Com oundin Growth g g p g

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$9.2m 90%+
ARR [^] GROSS MARGINS
in AUD on ARR and SaaS Revenue
33% ↑
28% ↑
CORE SaaS BUSINESS
In ARR YoY [^]
GROWTH YoY [^]
(+15% CC [^] )
(+26% CC [^] )
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  • Results to date are prior to impact of NCCN Guidelines[®] inclusion or Private Payors coming on board

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SOZO Revenue
(Excluding Legacy)
$2,700,000
$2,025,000
90%+ Gross
Margins on
SaaS Revenue
$1,350,000
$675,000
$-
SaaS - Core Business^^ Device and Contract Fees SaaS - Clinical Business^^
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 Q2'23 Q3'23
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  • ^ ARR denotes Annual Recurring Revenue. YoY denotes Year-over-Year change in metric. CC denotes Constant Currency.

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^^ The Core Business relates primarily to the Group’s Oncology business. The Clinical Business refers to revenue generating contracts from research contracts such as AstraZeneca.

All FY’23 revenue and cash flow numbers are unaudited.

25

All figures are stated in Australian dollars (AUD) unless otherwise notated.

COMPANY OVERVIEW

Stron Underl in Fundamentals g y g

  • 33% Average Monthly License Fee increase across U.S. renewal contracts

  • Four (4) consecutive quarters with 30%+ increase in renewal license fees.

  • Achieved prior to the NCCN Guidelines[®] inclusion and Private Payors.

  • With the NCCN Guidelines[®] inclusion, these increases will accelerate as private payors now come on board.

  • $9.2m ARR[i] , of which $8.7m relates to the Core Business, +28% YoY^ (+15% CC)

  • $3.2m TCV[ii] signed in Q3 FY’23 in the Core Business, +44% YoY (+34% CC)

  • Stair step pricing model locks in growth before additional unit sales:

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$10.2M+
Core Business ARR
as at 31 March 2024
17%+ growth before
another unit is sold
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$8.7M
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Core Business ARR
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as at 31 March 2023

+15% growth YoY CC

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33%+ ↑
AVERAGE MONTHLY LICENSE
FEES ON U.S. SOZO RENEWAL
CONTRACTS
in constant currency (CC)
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< 2%
CHURN RATE
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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.

^ YoY denotes Year-over-Year change in metric. CC denotes Constant Currency.

i Annual Recurring Revenue (ARR): The amount of revenue reasonably expected to be booked for the next 12-month period based on existing signed contracts, and assuming installation upon sale.

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ii Total Contract Value (TCV): Total value of customer contracts including one-time and recurring revenue

Proprietary, do not reproduce, distribute, or excerpt without written permission from ImpediMed. ©2023 ImpediMed Limited.

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COMPANY OVERVIEW

Connected Di ital Health Platform g

SOZO Platform

SOZO

  • Less than 30 Second Test

  • Medical Assistant

  • Connected Device

  • Cloud-based SaaS* Pricing Model

  • On Device, Online or via EHR**

  • Multiple Applications

Scalable

Add and move test locations without any additional software setup

Secure

Control who accesses the SOZO network and establish unique security settings

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  • SaaS = Software-as-a-Service

  • ** EHR = Electronic Health Records

  • ^ The bubbles depicting Cancer Population sizes are for illustrative purposes only and not reflective of actual market sizes. 1. Bone analysis and FDA clearance is in development.

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COMPANY OVERVIEW

Im ediMed’s Technolo p gy

Using Bioimpedance Spectroscopy (BIS), SOZO non-invasively measures, monitors and manages fluid status and tissue composition

Subjective and Time Consuming

BIS is Objective and Fast

Imaging

Implantables

Weight

Volume

Observation

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Low Frequency
Current passes
around cells
Fluid
256 frequencies
Fat
High Frequency
Current passes
through cells
Muscle
Bone
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COMPANY OVERVIEW

SOZO Di ital Health Platform g

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Lymphoedema
FDA Clearance, CE Mark,
NCCN Guidelines [®]
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^^^
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  • ^ kidneyfund.org: Kidney failure is the last and most severe stage of chronic kidney disease and is also referred to as End-Stage Renal Disease (ESRD).

  • ^^ Algorithm has been developed and preliminary discussions have been held with FDA.

  • ^^^ Proof of concept studies undertaken; no regulatory applications submitted to date.

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COMPANY OVERVIEW

SOZO is the Onl FDA Cleared BIS Device for L m hoedema^ y y p

Tape Measure / Arm
Volume
Water Displacement Perometry Tissue Dielectric
Constant
MoistureMeter D
LymphScanner
Bioimpedance
Spectroscopy
(BIS L-Dex)
SOZO, U400
Specified for Screening in
NCCN Guidelines®
No No No No Yes
Detects Subclinical
Lymphoedema as per ASBrS
Working Group Publication1
No No No No Yes
Level I Randomised Data with
Early Intervention in Breast
Cancer Patients2
Yes No No No Yes
FDA Clearance for
Lymphoedema Assessment3
No No No Yes Yes
  • ^ ImpediMed’s U400 is also an FDA Cleared BIS Device for Lymphoedema. Since the launch of SOZO, SOZO is the only commercially available FDA Cleared BIS Device for Lymphoedema.

  • McEvoy MP, et al. The prevention and treatment of breast cancer- related lymphedema: A review. Frontiers in Oncology 2022.

  • Ridner SH, et al. A Randomized Clinical Trial of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphatic Research & Biology 2022.

  • BIS FDA 510(k) Clearance K180126, April 2018.

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COMPANY OVERVIEW

Business Si nificantl De-Risked in Oncolo g y gy

Key Accomplishments to Date

Key Initiatives Underway

  • ✓ Largest Level I randomised controlled trial for detection of subclinical lymphoedema

  • ✓ NCCN Guidelines[®] inclusion for all cancer survivors at risk of lymphoedema

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  • Evidence generation for additional cancer types

  • Guideline support to specify PREVENT protocols

  • ✓ Medicare coverage and Case Assistance Program claims data

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  • Broad private payor reimbursement coverage

  • ✓ SOZO Pro FDA Clearance

  • ✓ IP Protection: Technical, Clinical and Commercial layers of protection

  • ✓ Disruptive Change to previous Standard of Care

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  • Prepare for manufacturing and operational scale

  • Significant acceleration of commercialisation efforts to affirm first mover advantage

  • Establish BIS as Standard of Care

  • Potential changes to the board to enhance our evolving strategic needs, including oncology expertise

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Key Risks

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KEY 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 Company ( Shares ). You should carefully consider the following risk factors, as well as the other information contained in this Presentation and ImpediMed’s ASX announcements, before making an investment decision.

The Directors assessment of risks was based on their knowledge as at the date of this Presentation and there is no assurance that the relative importance of the various risks will not change.

1. Company Specific Risks

In addition to the general risks noted in this Presentation, investors should be aware of the specific risks of an investment in ImpediMed. These specific risks include, but are not limited to, those risks referred to below.

The Group is focused on developing a model for practice integration of L-Dex® and other applications, for existing and new accounts. This, together with acceptance of a Software as a Service (SaaS)
subscription business model, evaluating the cost of the technology, the fit of the technology, the inclusion in guidelines, and reimbursement/payment levels for the technology, will all play a part in determining
the future growth of the business.
ImpediMed is at an early stage in the commercialisation of SOZO® and its various software applications, including L-Dex. ImpediMed’s ability to generate sufficient revenue in the future depends on a number
of factors, including:

the acceptance and rate of adoption by hospitals and clinicians of SOZO and its various software applications, particularly in the U.S.;
1.1 Adoption of the
Group’s technology

acceptance by U.S. healthcare payors of the reimbursement of ImpediMed’s technology, including private health insurers’ payment of claims;

progress in completing clinical trials and expanding the use of SOZO technology to other indications; and

the ability to manufacture sufficient quantities of SOZO devices to the required standard and at acceptable cost levels.
There is a risk that ImpediMed will continue to incur losses from its operations and may not achieve sustained profitability.
Other factors that will determine ImpediMed’s profitability are its ability to manage its costs, its ability to execute its development and growth strategies, economic conditions in the markets in which it operates,
competitive factors and regulatory developments. Accordingly, the extent of future profitability, and the time required to achieve sustained profitability are uncertain. Moreover, the sustainability of any
profitability cannot be predicted.

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KEY RISKS

Risk factors (cont.)

The commercial success of ImpediMed’s products is substantially dependent on achieving estimated payment levels to medical providers to support pricing strategies for L-Dex and additional indications and uses for SOZO.

Pricing and 1.2 reimbursement

A Category I CPT[®] code for L-Dex has been in effect in the U.S. market since 1 January 2015. A CPT Code is assigned by the American Medical Association and is a prerequisite for reimbursement in the U.S. The current 2023 Medicare National Average payment for each medically necessary test under CPT Code 93702 is US$145. Medicare is a U.S. government agency that makes payment information public. Private payor payments are privately negotiated between the payor and the provider and varies dramatically by state but are typically higher than the Medicare reimbursement rate. However, levels of reimbursement are subject to periodic review and payors, including U.S. Medicare, can, without notice, deny or reverse reimbursement coverage and payments.

Whilst the Company expects that the recent inclusion of BIS in the NCCN Guidelines[®] should help to accelerate adoption of coverage by private payors, no assurance can be given that reimbursement will be provided by private payors or that any coverage will be established quickly or without substantial delay. If reimbursement is provided by private payors, there is the risk that private payors will not provide coverage at the levels projected by the Company. The level of reimbursement will impact the Company’s pricing and marketing strategy and may impact overall demand for SOZO. If reimbursement amounts are lower than the Company has projected, the total addressable market for SOZO will be reduced and the Company may be unable to sell SOZO systems and subscription services on a profitable basis.

There is a risk that ImpediMed’s sales and marketing efforts may not be successful. ImpediMed sells its products by using a mix of employed sales representatives and independent distributors. In the U.S. market, ImpediMed employs a sales force that focuses on the sale of the SOZO system and its associated subscription services.

1.3 Sales and marketing

ImpediMed’s future success depends in part on its ability to sell an increasing number of subscriptions for SOZO covering further medical indications (as and when regulatory clearances for additional indications are obtained) and additional features and services. If ImpediMed’s sales force fails to adequately promote, market and sell SOZO and its associated subscription services to new customers and fails to adequately promote and expand its product and service offerings within existing customer accounts, sales may be lower than expected.

ImpediMed’s future success also depends in part on its ability to hire and retain a qualified sales force. If ImpediMed is unsuccessful in adequately hiring and retaining a qualified sales force, sales may be lower than expected.

In addition, ImpediMed’s sales and marketing efforts often require physical access to customer sites, which are predominantly within large hospital systems. Material adverse changes in public health and safety may cause delays or an inability of ImpediMed’s employees to access customer sites, which may result in sales being lower than expected.

There is a risk that L-Dex or other indications and/or uses for SOZO and future products may not gain adequate market acceptance. The degree of market acceptance could depend on a variety of factors, including:

  • regulatory clearances;

  • the clinical trial outcomes;

Market acceptance of 1.4 products and patient population

  • peer-review of clinical data;

  • the level of support from target markets;

  • the level of reimbursement coverage and payment;

  • • clinical profile of competitive products; and

  • the success of marketing and sales efforts in existing and new accounts.

Additionally, there is a risk that market estimates do not accurately reflect the number of patients in the target markets.

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KEY RISKS

Risk factors (cont.)

1.5 Resources

ImpediMed’s ability to successfully transform into a high growth medical technology company relies on being able to retain and attract specialised talents, including skilled information technology personnel and executive talent. ImpediMed faces intense competition for key personnel, especially in the information technology sector in the U.S., and may not be able to attract, retain and motivate such individuals. The loss of services of one or more members of key personnel or the inability to recruit and retain high calibre staff could delay or compromise the successful commercialisation of ImpediMed’s products.

To achieve its commercialisation goals, ImpediMed will need to attract suitably qualified personnel with commercialisation experience. It may also need to increase the number of employees and consultants and may experience difficulties in managing growth.

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, ImpediMed must assess the risk of not having enough product to meet demand due to product shortages or supply chain issues.

ImpediMed, or its contract manufacturers and suppliers, may fail to achieve and maintain required manufacturing standards which could result in device recalls or withdrawals, product shortages, delays or failures in product testing or delivery or other problems that could seriously harm ImpediMed’s business.

Manufacturing and 1.6 supply chain

ImpediMed may be affected by industrial action. Operating equipment and facilities may not operate as intended or be available as a result of unanticipated failures or other events outside of ImpediMed’s control (e.g. fires, catastrophic breakdowns or deliberate acts of destruction).

ImpediMed and its contract manufacturers may not be able to obtain and maintain all licenses and approvals required to maintain manufacturing operations.

In addition, ImpediMed and its contract manufacturers may face changing macroeconomic conditions that could lead to an inability to source materials required in product builds or severe delays in the time required to manufacture product. Any interruption to ImpediMed’s supply chain or manufacturing capability could result in the cancellation of shipments and loss of product, resulting in delays, decrease in revenues and additional costs.

Developing software and technology, particularly in the medical sector, is expensive and often involves an extended period of time to achieve a return on investment. An important aspect of ImpediMed’s business is to continue to invest in innovation and related product development opportunities. ImpediMed believes that it must continue to dedicate resources to ImpediMed’s innovation efforts to develop ImpediMed’s product offering and to maintain ImpediMed’s competitive position. If ImpediMed is unsuccessful in its innovation efforts, sales may be lower than expected.

Product and software 1.7 development

The Group also runs the risk of not meeting timelines or not making the right product that addresses customer and market needs. The Group follows a defined design control process and monitors projects to ensure that they are staffed correctly, while also conducting usability studies to determine customer and patient needs.

The Group must also assess the risk related to failing to achieve and maintain software products, which could result in recalls or withdrawals, product shortages, delays or failures in software delivery or other problems that could seriously harm ImpediMed’s business.

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KEY RISKS

Risk factors (cont.)

Software, data and 1.8 cloud management

The use of information technology is critical to ImpediMed’s ability to deliver its products and services to customers.

ImpediMed, or its contracted software developers or data hosts, may fail to develop and maintain software products which could result in recalls or withdrawals, product shortages, delays or failures in software delivery or other problems that could seriously harm ImpediMed’s business, including its reputation, and operating and financial performance.

ImpediMed’s products and services rely on the performance, reliability and availability of data centres and communications systems (including servers, the internet, hosting services and the cloud systems). There is a risk that these systems may be adversely affected by disruption, failure, service outages, improper configuration, maintenance error, data corruption (as a result of computer viruses, “bugs” or “worms”, malware, internal or external misuse by websites, cyber attacks) or other disruptions including natural disasters and power outages.

Disruption or failure 1.8.1 of technology and software systems

These disruptions may be caused by events outside of the Group’s control, and may lead to prolonged disruption to the Group’s platforms, or operational or business delays and damage to ImpediMed’s reputation. This could potentially lead to a loss of customers, legal claims by customers, and an inability to attract new customers, any of which could adversely impact the Company’s operating and financial performance.

Further, some of the Company’s systems incorporate and are dependent on the use and development of ‘open source’ software, which gives rise to greater risks to ImpediMed than if it used internally developed code or commercial third-party software. These risks include potential security issues from malicious capability built into the software or consequential issues to ImpediMed’s platform, or components thereof, if this software becomes unavailable or unreliable. In addition, if an author or other third party that uses or distributes such open-source software was to allege that the Company had not complied with the legal terms and conditions of an OSS licence, the Company could incur significant legal expenses and could be subject to significant damages.

These in turn may lead to reputational damage and adversely impact the Company’s operating and financial performance.

Reliance on third 1.8.2 party technology

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, especially for SOZO. This includes software licenced from third parties and open-source software.

Interruption, compromise to or failure of these systems and software could lead to a disruption of ImpediMed’s ability to service its customers effectively. This could lead to potential loss in revenues, as well as adversely affecting ImpediMed’s reputation, financial position and performance.

ImpediMed’s products involve the storage of sensitive data and proprietary information. ImpediMed is vulnerable to data breaches by employees and others with both permitted and unauthorised access which poses a risk that such sensitive data and proprietary information may be exposed to the public or be permanently lost.

Cyber security and 1.8.3 data breaches

Although processes are in place to combat cyber security risk (including firewalls, encryption of client data, a privacy policy and policies to restrict unauthorised access), there is a risk that the measures ImpediMed takes to prevent data breaches may prove to be inadequate which may result in cyber attacks, unauthorised access to or used of data, exposure or loss of data, and disruption to the Group’s services.

Any accidental or deliberate data breaches or other unauthorised access to ImpediMed’s information technology systems or sensitive data may result in reputational damage, a loss of confidence in the services the Company provides, loss of information integrity, a disruption of services or breaches of ImpediMed’s obligations under applicable laws or agreements. ImpediMed may also incur costs as a result of rectifying system vulnerabilities or introducing additional safeguards to minimise the risk of future data breaches.

A breach in security of, or a significant disruption in, ImpediMed’s information technology systems could adversely affect ImpediMed’s operating results, financial condition, reputation and brand.

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KEY RISKS

Risk factors (cont.)

The Company is relying on additional data from clinical trials and real-world data utilising SOZO to drive the future commercial opportunities and market adoption of SOZO in Heart Failure ( HF ), Renal Failure, Protein Calorie Malnutrition (PCM ) and other indications. Although early results from studies and real-world data have been promising, the outcome of studies is uncertain and there is a risk that they may not demonstrate the effectiveness of SOZO in patient management in these additional indications.

Adoption of SOZO for 1.9 other indications

If the results from the studies do not support the adoption of the Company’s technology, this may limit future markets for SOZO and adversely affect the Company’s potential revenues. Even if the studies support the use of the Company’s technology, there is no assurance that the commercial rollout of SOZO will succeed or that SOZO will replace current monitoring methods.

In addition, if the Company is unable to obtain clearance for removal of SOZO contraindications for implantable pacing and cardioverter defibrillators devices, the adoption of the Company’s technology in HF and other indications may be adversely impacted.

The full commercialisation effort for HF, Renal Failure, PCM and other potential indications will likely require additional capital (in addition to the funds raised in the Placement and SPP), which the Company may be unable to raise in a timely manner.

  • 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 unforeseen changes in relation to: • licensing and clearance requirements; • regulations relating to clinical trials;

  • 1.10 Change in laws and • data privacy, security, and storage laws; healthcare policy • manufacturing; • product clearance; and • pricing (including any tariffs and/or taxes), could materially impact ImpediMed’s operations, assets, contracts and profitability.

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KEY RISKS

Risk factors (cont.)

Although ImpediMed’s current products have received key regulatory clearances, ImpediMed may still face developmental and ongoing regulatory compliance difficulties, or challenges in respect of future regulatory clearances. Regulatory agencies subject a marketed device, its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. Potentially costly follow-ups or post-marketing clinical studies may be required and previously unknown problems may result in restrictions on the marketing of the device and could include product withdrawal.

If ImpediMed fails to comply with applicable regulatory requirements, a regulatory agency may:

  • issue warning letters;

  • impose civil or criminal penalties;

Ongoing regulatory 1.11 issues

  • suspend ImpediMed’s regulatory clearances or restrict or change the cleared indications for use or impose additional safety reporting requirements;

  • suspend any of ImpediMed’s ongoing clinical trials;

  • refuse to approve pending applications or supplements to approved applications filed;


impose restrictions on ImpediMed’s operations, including closing ImpediMed’s or its contract manufacturers’ facilities or terminating its licenses to manufacture ‘Good Manufacturing Practice’; or

seize or detain devices or require a product recall.
In addition, the law or regulatory policies governing medical devices may change. New regulatory requirements or additional regulations may be enacted that could prevent or delay regulatory clearances of
ImpediMed’s products or that may otherwise impact ImpediMed’s ability to market, distribute and sell devices and or consumables. ImpediMed cannot predict the likelihood, nature or extent of adverse
government regulation that may arise.
Privacy laws around the world continue to develop and impose greater burdens on businesses when dealing with personally identifiable information. The laws are designed to give greater protections to data
owners, improve transparency and require businesses to develop better privacy practices and security processes. Failure to do so can result in pecuniary penalties, negative publicity, damage to brand and a
requirement to improve processes and controls, each of which, if they were to happen, could adversely affect ImpediMed’s operating results, financial condition, reputation and brand.
1.12 Privacy laws Additionally, ImpediMed’s business model is heavily dependent on hosting and accessing protected health information (PHI) and electronic protected health information (ePHI). In the U.S., the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) establishes national standards for the protection of certain PHI and ePHI. ImpediMed’s customer base often requires ImpediMed to enter into a
Business Associate Agreement (BAA), primarily to ensure that as a third-party service provider, ImpediMed is subject to the same obligations relating to the security of PHI/ePHI as those that apply directly to
covered entities under the HIPAA. While ImpediMed seeks to mitigate the risk of an inadvertent disclosure of PHI and ePHI or a breach of privacy relating to PHI/ePHI by its employees or contractors by
putting in place appropriate internal security measures, training and taking out insurance cover, if a breach were to arise and ImpediMed is found to be liable and subject to a payment of damages, this could
adversely affect ImpediMed’s operating results, financial condition, reputation and brand.
The medical technology industry is highly competitive, and there are a number of well-established companies that could develop products and services that compete with ImpediMed’s devices and
technologies. ImpediMed’s success depends, in part, upon its ability to maintain a competitive position in the assessment and monitoring of lymphoedema as well as other applications. Although there are no
1.13 Competition cleared competitive bioimpedance products in the U.S. lymphoedema clinical assessment market at present, the Company expects the inclusion of BIS in the NCCN Guidelines® will motivate other companies
to pursue products in this market. Accordingly, there can be no assurances that the Company’s current market leading position will continue, or that ImpediMed will be able to compete with new competing
products.

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KEY RISKS

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, the risk is present that ImpediMed’s products could:

  • cause harm or injury to users;

  • be used off label or not in accordance with instructions for use;

  • be used in a manner contrary to defined clinical guidelines and/or protocols;

  • require a recall; or

  • result in a breach of digital assets such as cyber security data.

Regardless of the merits or eventual outcome, liability claims may result in:

  • Product liability

  • 1.14 • decreased demand for ImpediMed’s products; claims and insurance • injury to ImpediMed’s brand and reputation; • withdrawal of clinical trial participants;

  • costly litigation;

  • • substantial monetary awards to physicians or patients and others;

Patents and 1.15 trademarks

  • loss of revenues; and

  • • an inability to sell ImpediMed’s products. ImpediMed may not be able to maintain insurance coverage at a reasonable cost or obtain suitable or reasonable insurance coverage in respect of any liability that may arise. Any claim for damages could be substantial. The value of ImpediMed’s products is partly dependent on ImpediMed’s ability to protect its intellectual property. ImpediMed uses patents, trademarks and copyright to protect its technology and applications from unauthorised use by third parties. There is a risk that ImpediMed may be unable to detect the unauthorised use of its intellectual property rights in all instances. Further, actions that ImpediMed takes to protect its intellectual property may not be adequate or enforceable and thus may not prevent the misappropriation of, or copying or circumvention of, ImpediMed’s intellectual property and proprietary information. For example, the term of patents may expire or may be challenged, invalidated or circumvented. ImpediMed is relying on its patents for commercial protection for its devices and technology.

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KEY RISKS

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 property infringement claims, or to avoid potential claims, ImpediMed might be:

Enforcement and 1.16 infringement of intellectual property

  • prohibited from selling or licensing a product;

  • required to expend considerable amounts of money in defending the claim;

  • required to pay substantial royalties or licence fees;

  • required to pay substantial monetary damages; or

  • required to redesign a product so it does not infringe, which may not be possible or could require substantial funds and time.

1.17 Brand and reputation

The reputation and brand of ImpediMed and its products are important in attracting hospitals, medical clinics, large companies, strategic partners and healthcare professionals to use ImpediMed’s products. Any reputational damage or negative publicity around ImpediMed or its products could adversely affect ImpediMed’s customer relationships, general business and ultimately its financial performance (see also above regarding “Product liability claims and insurance”). The action of ImpediMed’s employees, including any breaches of any regulations to which ImpediMed is subject, or any negligence in the provision of data, may damage ImpediMed’s brand.

There has been substantial litigation and other proceedings in the biotechnology and medical technology industries.

1.18 Litigation

If ImpediMed was forced to defend litigation or other third-party claims, it could be costly, time consuming and divert management’s attention from the business. This could lead to delays in ImpediMed’s development or commercialisation efforts.

If third parties are successful in their claims, ImpediMed might have to pay substantial damages or take other actions that are adverse to the ImpediMed business.

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KEY RISKS

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;

  • reduce the scope of; or

1.19 Capital requirements

  • eliminate,

one or more clinical trials, product and software development or commercialisation efforts.

ImpediMed is also potentially vulnerable to changes in investor sentiment pertaining to ImpediMed, overall sector or market volatility, or general macroeconomic conditions. Material adverse changes in investor sentiment could affect ImpediMed’s ability to raise additional funds if or when required.

If ImpediMed brings new products to market for new clinical applications, it will require regulatory clearances for the commercial sale of such products. ImpediMed must complete pre-clinical development and clinical trials to demonstrate safety and efficacy of the device on humans. Clinical trials are expensive, time consuming, subject to delay and their outcome uncertain. There are numerous factors that could affect the timing of the commencement, continuation and completion of clinical trials that may delay the clinical trials or prevent ImpediMed from completing these trials successfully.

Clinical trials and 1.20 clinical development

Due to ImpediMed’s reliance on contract research organisations, hospitals and investigators to conduct clinical trials, it is unable to directly control the timing, conduct and expense of clinical trials. Ongoing and future clinical trials may not show sufficient safety or efficacy to obtain regulatory and reimbursement acceptance.

Success in pre-clinical and early clinical trials is not a guarantee of future results nor does it ensure that later large-scale trials will be successful. The outcome of these trials is uncertain and there is a risk that they may not be successful and may not demonstrate sufficient safety or efficacy to obtain regulatory clearance.

Future regulatory 1.21 clearances

New products for new clinical applications will also require clinical development, testing, manufacturing, sales and marketing all of which are subject to extensive regulation by regulatory authorities in the U.S., the EU, Australia and elsewhere. The process of obtaining regulatory clearance is expensive, complex, lengthy and the outcomes uncertain. ImpediMed may not be able to obtain marketing authorisations for all its targeted claims, including any necessary clearances of next generation devices.

Another possibility is that the targeted claims may be delayed or subject to significant limitations (narrower claims), warnings, precautions or contra-indications with respect to conditions of use.

1.22 Dividends

ImpediMed has never paid a dividend and does not intend on paying dividends in the foreseeable future, which means that holders of Shares may not receive any return on their investment from dividends in the short to medium term.

International 1.24 operations

ImpediMed has operations in Australia, the U.S. and Europe and sells or distributes its technology globally. Consequently, ImpediMed faces complex legal and regulatory requirements in multiple jurisdictions, which exposes ImpediMed to certain financial and other risks.

In some jurisdictions there can be high costs associated with compliance with the laws, rules and regulations, and failure to comply with any applicable law or regulatory requirement could result in penalties and enforcement action.

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KEY RISKS

Risk factors (cont.)

2. General Risks

There are risks associated with any share market investment. Some of these risks are listed below.

2.1 Foreign exchange ImpediMed’s financial statements are presented in Australian dollars. A substantial portion of current sales revenue and costs are denominated in currencies other than Australian dollars, particularly U.S.
dollars. Future changes in the exchange rates in the jurisdictions in which ImpediMed operates may adversely impact ImpediMed’s financial performance.
There are risks associated with any securities investment. The prices at which the securities trade may fluctuate in response to a number of factors, including recommendations by brokers and analysts, the
Securities general economic climate and other factors described in paragraphs 2.3 and 1.1 below, and investor perceptions.
2.2 investments and
share market
Furthermore, the share market may experience extreme price and volume fluctuations that may be unrelated or disproportionate to the operating performance of the companies listed on the market. These
factors may materially adversely affect the market price of Shares regardless of ImpediMed’s operational performance.
conditions In addition, there is a risk that inadequate trading liquidity of ImpediMed’s Shares may adversely affect your ability to realise your investment in ImpediMed.
Neither ImpediMed nor the Directors warrant the future performance of ImpediMed, or any return of an investment in ImpediMed.
Material adverse changes in the general domestic and international economic climate may have an adverse effect on ImpediMed’s performance. These factors may include fluctuations in inflation, interest
2.3 General economic
factors
rates, rate of economic growth, taxation laws (and the application of existing laws by the courts or taxation authorities), consumer spending, unemployment rates, government fiscal, monetary and regulatory
policies and consumer and business sentiment. Other factors include acts of terrorism, cyber hostilities, pandemics (including COVID-19), outbreaks of international hostilities, fire, floods, earthquakes, labour
strikes, natural disasters, outbreaks of disease or other natural or manmade events or occurrences that may have an adverse demand for ImpediMed’s products or ImpediMed’s ability to conduct business.
Any of these factors have the potential to cause costs to increase or revenues to decline.

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KEY RISKS

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 by investors in ImpediMed. The above factors, and others not specifically referred to above, may in the future materially affect the financial performance of ImpediMed and the value of the Shares.

Therefore, the Shares to be issued pursuant to the Placement carry no guarantee with respect to the payment of dividends, returns of capital or the market value of those Shares.

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Foreign Selling Restrictions

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FOREIGN SELLING RESTRICTIONS

International Offer Restrictions

This document does not constitute an offer of New Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any country outside Australia except to the extent permitted below.

Hong Kong

WARNING: This document has not been, and will not be, registered as a prospectus under the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong, nor has it been authorised by the Securities and Futures Commission in Hong Kong pursuant to the Securities and Futures Ordinance (Cap. 571) of the Laws of Hong Kong (the “SFO”). Accordingly, this document may not be distributed, and the New Shares may not be offered or sold, in Hong Kong other than to “professional investors” (as defined in the SFO and any rules made under that ordinance).

No advertisement, invitation or document relating to the New Shares has been or will be issued, or has been or will be in the possession of any person for the purpose of issue, in Hong Kong or elsewhere that is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to New Shares that are or are intended to be disposed of only to persons outside Hong Kong or only to professional investors. No person allotted New Shares may sell, or offer to sell, such securities in circumstances that amount to an offer to the public in Hong Kong within six months following the date of issue of such securities.

The contents of this document have not been reviewed by any Hong Kong regulatory authority. You are advised to exercise caution in relation to the offer. If you are in doubt about any contents of this document, you should obtain independent professional advice.

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 New Shares are not being offered or sold in New Zealand (or allotted with a view to being offered for sale in New Zealand) other than to a person who:

  • is an investment business within the meaning of clause 37 of Schedule 1 of the FMC Act;

  • meets the investment activity criteria specified in clause 38 of Schedule 1 of the FMC Act;

  • is large within the meaning of clause 39 of Schedule 1 of the FMC Act;

  • is a government agency within the meaning of clause 40 of Schedule 1 of the FMC Act; or

  • is an eligible investor within the meaning of clause 41 of Schedule 1 of the FMC Act.

Singapore

This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in connection with the offer or sale, or invitation for subscription or purchase, of New Shares, may not be issued, circulated or distributed, nor may the New Shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore except pursuant to and in accordance with exemptions in Subdivision (4) Division 1, Part 13 of the Securities and Futures Act 2001 of Singapore (the “SFA”) or another exemption under the SFA.

This document has been given to you on the basis that you are an “institutional investor” or an “accredited investor” (as such terms are defined in the SFA). If you are not such an investor, please return this document immediately. You may not forward or circulate this document to any other person in Singapore.

Any offer is not made to you with a view to the New Shares being subsequently offered for sale to any other party in Singapore. On-sale restrictions in Singapore may be applicable to investors who acquire New Shares. As such, investors are advised to acquaint themselves with the SFA provisions relating to resale restrictions in Singapore and comply accordingly.

United Kingdom

Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)) has been published or is intended to be published in respect of the New Shares.

The New Shares may not be offered or sold in the United Kingdom by means of this document or any other document, except in circumstances that do not require the publication of a prospectus under section 86(1) of the FSMA. This document is issued on a confidential basis in the United Kingdom to “qualified investors” within the meaning of Article 2(e) of the UK Prospectus Regulation. This document may not be distributed or reproduced, in whole or in part, nor may its contents be disclosed by recipients, to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) received in connection with the issue or sale of the New Shares has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of the FSMA does not apply to the Company.

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (“relevant persons”). The investment to which this document relates is available only to relevant persons. Any person who is not a relevant person should not act or rely on this document.

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