ATOMO DIAGNOSTICS LIMITED — Interim / Quarterly Report 2021

Mar 9, 2021

This announcement was authorised by John Kelly, Managing Director

Atomo Diagnostics Limited 701 – 703 Parramatta Road Leichhardt NSW 2040 Australia

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MARKET UPDATE
10 March 2021
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
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DISCLAIMER

This presentation has been prepared by Atomo Diagnostics Limited (ACN 142 925 684) (the Company ). It contains general background information only which is current at the date of this presentation unless otherwise specified. It contains selected summary information and does not purport to be all-inclusive, comprehensive or to contain all of the information that may be relevant, or which a prospective investor may require in evaluations for a possible investment in the Company. Prospective investors should not rely on the information contained in this presentation, and must satisfy themselves as to the accuracy of all such information. This presentation has been prepared based on information available at the time of preparation and is subject to change without notice. In receiving this presentation, each recipient agrees to the foregoing terms and conditions, including any modifications to them. No person is under any obligation to update this presentation at any time after its release.

This presentation is provided for general information purposes only. This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of securities in the Company in any jurisdiction. It is not a prospectus, product disclosure statement, pathfinder document or any other type of public offer disclosure document for the purposes of the Corporations Act 2001 (Cth) ( Corporations Act ) and has not been, and is not required to be, lodged with the Australian Securities and Investments Commission. It should not be relied upon by the recipient in considering the merits of the Company or the acquisition of shares in the Company.

This presentation does not constitute investment or financial product advice. It is not intended to be used as the basis for making a financial decision, nor is it intended to constitute legal, tax, accounting or other advice. This presentation has been prepared without taking into account any person's individual investment objectives, financial situation or particular needs. Before making an investment decision, the recipient should consider its own financial situation, objectives and needs, and conduct its own independent investigation and assessment of the contents of this presentation, including obtaining investment, legal, tax, accounting and such other advice as it considers necessary or appropriate. Any references to or explanations of legislation, regulatory issues, benefits or any other legal commentary (if any) are indicative only, do not summarise all relevant issues and are not intended to be a full explanation of a particular matter. The information in this presentation has been obtained from and based on sources believed by the Company to be reliable. Past performance is not an indication of future performance.

This presentation may contain forward-looking statements, guidance, forecasts, estimates, prospects, projections or statements in relation to future matters that may involve risks or uncertainties and may involve significant items of subjective judgement and assumptions of future events that may or may not eventuate ( Forward Statements ). Forward Statements can generally be identified by the use of forward looking words such as "anticipate", "estimates", "will", "should", "could", "may", "expects", "plans", "forecast", "target" or similar expressions. Forward Statements including indications, guidance or outlook on future revenues, distributions or financial position and performance or return or growth in underlying investments are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. To the extent that certain statements contained in this presentation may constitute Forward Statements or statements about forward looking matters, then the information reflects the Company's (and no other party's) intent, belief or expectations as at the date of this presentation. No independent third party has reviewed the reasonableness of any such statements or assumptions. None of the Company, its related bodies corporate and their respective officers, directors, employees, advisers, partners, affiliates and agents (together, the Company Parties ) represent or warrant that such Forward Statements will be achieved or will prove to be correct or gives any warranty, express or implied, as to the accuracy,

completeness, likelihood of achievement or reasonableness of any Forward Statement contained in this presentation. Except as required by law or regulation, the Company assumes no obligation to release updates or revisions to Forward Statements to reflect any changes. Recipients should form their own views as to these matters and any assumptions on which any of the Forward Statements are based and not place reliance on such statements.

An investment in the Company's securities is subject to known and unknown risks, many of which are beyond the control of the Company, including factors and risks specific to the industry in which the Company operates as well as general economic conditions, prevailing exchange rates and interest rates and conditions in the financial markets. The Company does not guarantee any particular rate of return or the performance of the Company, nor does it guarantee any particular tax treatment. Prospective investors should make their own enquiries and investigations regarding all information in this presentation, including the assumptions, uncertainties and contingencies which may affect future operations of the Company and the impact that different future outcomes may have on the Company.

By accepting this presentation the recipient agrees to keep permanently confidential all information that it contains. It should not be made available to any other third party without the prior written approval of the Company. Furthermore, no contact should be made with the Company or any of the aforementioned companies’ customers, suppliers or shareholders without the express permission of the Company.

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No party other than the Company has authorised, permitted or caused the issue, submission, dispatch or provision of this presentation, or takes any responsibility for, or makes or purports to make any statement, representation or undertaking in this presentation and there is no statement in this presentation that is based on any statement by any other party. No person, either as a director, partner of or in the employment of the Company has any authority to make, imply, or give any representation or warranty whatsoever in relation to the information contained in this presentation. None of the Company Parties take any responsibility for any information in this presentation or any action taken by you on the basis of such information.

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• exclude and disclaim all liability, including (without limitation) any liability for fraud or negligence, for any expenses, losses, damages or costs incurred either as a result of the information in this presentation being inaccurate or incomplete in any way for any reason, or otherwise arising in connection with this presentation; and

• make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this presentation.

All dollar values are in Australian dollars ($ or A$) unless otherwise stated.

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INTRODUCTION

Atomo Diagnostics Limited (“Atomo”) (ASX: AT1) is a medical company supplying unique, integrated rapid diagnostic test (RDT) devices to the global diagnostic market

• Headquartered in Australia, Atomo develops and manufactures innovative patented devices that simplify testing and reduce errors

• Significant proven market traction selling approved Atomo finished products to healthcare distributors and Atomo devices to diagnostic customers (OEM) across global markets and multiple clinical applications

• Well capitalised balance sheet with $24.7m cash (no debt)

• Unique ‘all in one’ rapid test devices that have the ability to disrupt the global point of care (POC) rapid test market

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3
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PATENT PROTECTED UNIQUE SOLUTIONS

Traditional ‘bits in a box’ kits

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Atomo’s fully integrated user-friendly solutions
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Standard lateral flow ‘bits in a box’ test kits
typically contain multiple components
adding complexity with user errors common
and regulatory challenges for self testing
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Atomo has developed a range of
unique, integrated devices that deliver
blood-based rapid diagnostic testing
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The test process can be completed
in just three simple user steps, with
the result provided after 15 minutes
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* The Atomo Elion device shown above is designed and developed, and is currently being commercialised 4
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COMPANY TIMELINE

Pre‐commercialisation

• 2010: Founded, with initial focus on R&D and usability trials

• 2014: AtomoRapid RDT awarded ‘Best in Show’ at Medical Design Excellence Awards (MDEA)

• 2015 : US$6m investment from Global Health Investment Fund (GHIF) to support business scale‐up

• 2016 : US$2.6m grant from Bill & Melinda Gates Foundation (BMGF) to develop HIV self‐test

• 2016 : GHIF leads follow‐on equity round investment totalling A$4.3m

• 2017: Atomo secures HIV Self Test approval in Europe

• 2017: Atomo secures first HIV approval from WHO (ERP)

Atomo HIV Self Atomo HIV Self Test Viatris (ex: Mylan) Atomo pivots to Atomo secures first Test approved approved by the launches the Atomo COVID‐19[2] : NG/ large US contract – for CE marking Australian TGA as HIV Self Test in Europe (sales of 2m unit COVID‐19 by European the first and only LMIC[1] markets 1.9m units) take or pay; Access regulators self test for sale in Bio Australia 2018 2020 2021 2019 Atomo announces Atomo expands its Atomo completes Atomo successfully Atomo records H1 partnership for HIV OEM business via pre‐IPO raise for lists on ASX: AT1 FY21 cash receipts self‐testing with partnership with $16M during pandemic of $5.8m Viatris (ex: Mylan) Lumos/ FebriDx covering more than 100 countries

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1LMIC refers to Lower and Middle Income Countries
2 COVID‐19 rapid testing detects SARS‐COV2, the virus that causes COVID‐19 5
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- KEY FINANCIAL METRICS FOR 1H FY21[1] Strong top-line growth

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Revenue Gross Profit GP Margin Drivers
Revenue:
• COVID-19: Sales to NG Biotech &
$4.58m $2.52m 55%
direct to the Australian market
• HIV: Viatris (ex: Mylan) sales into
388% 278% 1,300bps South Africa & other countries, plus
direct in the Australian market
• OEM: Sales to Lumos to support
global FebriDx rollout
Net Op. Gross Profit & Margin:
EBITDA Net Cash
Cashflow • Continued expansion of higher
margins as the business scales
($2.12m) $24.7m Net Op. Cashflow:
($193k)
• Benefit of volume gains, decline in
68% 91% Debt free unit costs, lower funding costs and
increase in R&D grant
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1. Percentage changes show the relative change since 1H FY20, being the previous corresponding 6
period (unless otherwise stated)
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UNDERLYING P/L & CASHFLOW – Scale benefits materialising

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• Overall Gross Profit margin increased from 42% to 55% as new higher margin contracts delivered improved performance and scale benefits allowed the business to drive down COGS

• Overheads increased as the company and increased capability across management, technical and sales functions, plus public company expenses

• EBITDA loss of $2.12 million as gross margins continued to improve and expenses were managed

• Strong cash conversion on sales with cash receipts totalling $5.8m

• Net Operating Cashflow improvement to near break-even ($193k)

• Significant revenue growth of 389% generated by:

• $2.61 million from continued customer demand for COVID-19 point of care antibody testing devices, including sales of Atomo devices to NG Biotech and sales of finished products by Atomo in the Australian market

• $0.77 million from HIV related sales, as sales were made into South Africa, directly in Australia and in other markets via Viatris (ex: Mylan).

• $1.11 million from OEM business as Lumos in particular continued to ramp up its FebriDX roll out

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KEY MEDIUM TERM STRATEGIC FOCUS

COVID business	HIV business	Leveraging existing platforms	Leveraging existing platforms
		Commercialising new Atomo
COVID – an ongoing test market Atomo building a global COVID test business	Anticipating strong growth - upgraded facility ready to support large tenders from Global Health and rollout of PrEP drugs	• • •	and OEM products: Neutralizing COVID-19 Antibody* Coeliac disease Hepatitis C
		•	Liver disease
Expanding in-house	International		Build brand
capabilities	expansion		awareness
Investing in Atomo in-house capability for assay development and commercialisation of new	Atomo products to be launched in the US and establishment of a US business		Increasing focus on building Atomo brand and product awareness in the global
finished test products	Pushing into new large markets		diagnostic market

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* Neutralizing COVID-19 antibody tests detect antibodies that bind to a specific part of the virus SARS-COV2, that have been observed to decrease
SARS-COV2 viral infection in cells (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test- 8
detects-neutralizing-antibodies-recent-or)
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COVID-19 – AN ONGOING TEST MARKET – BROAD TRENDS

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Source: Atomo. The COVID-19 Rapid Testing Landscape is conceptual in nature and seeks to broadly outline trends in testing demand experienced by
Atomo, Atomo customers and through dialogue with industry participants. The chart is not a forecast and outlines the potential evolution of the market for 9
rapid testing
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ATOMO’S COVID BUSINESS – EMERGING GLOBAL COVERAGE*

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• 1.9m units sold to NG Biotech for France
• NG Biotech Self test CE Mark target mid CY21 • Atomo in discussions with
• Other partner discussions in progress large Chinese global player
• Considering antigen test market opportunities for antibody and
neutralizing antibody tests
on Atomo platform. Online
and self-test channels in
China subject to regulatory
approval
• Access Bio launch
~Q4FY21 post FDA
EUA. • Atomo launch Q2 FY21
Min 2m take or pay – revenue to date $560k
• Self/At-home Test FDA • Antibody test primary
EUA targeted end of driver, antigen test
CY21 gaining traction
• Neutralising antibody • Neutralizing antibody
discussions • Local distribution deal in test partnership in
commenced negotiation with leading
place ‐ regulatory
local institute
approval to be sought
• Negotiations under post FDA EUA for Access
way with potential Bio/Atomo test
partner for Brazil for all • Consideration being
COVID-19 products, given to expand into
large and significantly neutralising antibody and
impacted population self ‐test applications
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There is no guarantee that negotiations will result in a binding distribution agreement and/or that necessary regulatory approvals will
1 0
be obtained
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HIV SELF-TESTING: A GLOBAL OPPORTUNITY

Global Health Markets

Private Sector Markets

Strategic Companion Dx Partnership with Viatris (ex: Mylan)

• Atomo has partnered with the leading global HIV drug business through an exclusive agreement covering more than 100 countries

• With WHO prequalification, the Atomo test is one of only 4 products eligible for procurement in the global health tender market

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Focus on increasing partnerships with PrEP providers in developed markets

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• Selling in Australia, UK, Germany and across LMIC markets

• Atomo is looking at options to expand its Companion Dx. business via PrEP delivery and is piloting this channel in Australia where there are currently 50,000 patients on PrEP, each of which requiring multiple HIV tests annually

• Atomo estimates the global private sector HIV Self Test market to be ~7M units in FY22

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J ohnson C et al (2020). HIV self‐testing market forecasting. World Health Organization ‐ Diagnostic Manufacturer
1 1
Meeting. Power Point presentation (virtual meeting). 20th October 2020.
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LEVERAGING EXISTING PLATFORMS

Atomo has developed innovative integrated rapid test platforms which offer improved functionality and reliability for a broad range of clinical applications

The company is focused on commercialising a range of RDT products on its existing platforms. Products in the pipeline or under consideration include:

• Neutralising COVID Antibody, Hepatitis C, liver disease, Coeliac disease

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To support the launch of new test products in the field Atomo is well advanced with the commercialisation of eHealth solutions that deliver results interpretation and traceability

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The images illustrate Atomo’s digital reader and app currently under development

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GROWING ATOMO’S CAPABILITIES AND OPERATIONS

Atomo is expanding its development and manufacturing capabilities to expedite the commercialisation of finished products

Assay development and pilot test strip manufacturing to enable Atomo to deliver key clinical applications and opportunities

Next gen blister manufacturing

Completed redesign and commenced build for additional next generation automated blister machines to support the expansion of Pascal and Elion in OEM markets, as well as providing ‘best in class’ platforms for new Atomo finished products

Increased decentralised supply chain redundancy

• North American made product for US customers and government contracts

• Continued expansion of manufacturing capacity in South Africa for HIV tenders

• Australian onshoring of development & commercialisation capabilities and offering a proven channel to market for the development of innovative Australian institute research

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INTERNATIONAL EXPANSION*

US MARKET

Increased focus on securing additional US partners (both OEM customers and channel partners for Atomo products)

Launching Atomo based products in the US market:

• First suite of Atomo based approvals in process via the FDA EUA path for COVID-19 antibody test (Access Bio) and FebriDx via FDA 510(k) (Lumos) – CY21

• Targeting rapid tests currently being sold in the US market for OEM - CY21

• Atomo to bring own finished products to US market - CY22

NEW MARKET ENTRY

The opportunity for Atomo’s products is global with a focus on entering new large markets

• Atomo is in discussions with a large Chinese global player for products related to COVID, Hepatitis and various other products regarding possible launch in China and certain LMIC markets

• Atomo is in discussions with a Brazilian healthcare company regarding launch of Atomo COVID products into Brazil

Europe

Continued focus on securing additional European business through the launch of COVID tests (neutralising antibody and self-test products) and the commercialisation of new Atomo tests via distributor and OEM channels

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There is no guarantee that negotiations will result in a binding distribution agreement and/or that necessary regulatory approvals will
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be obtained
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INVESTMENT CASE

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A proven innovator – commercialised the world’s first fully integrated, blood-based rapid tests

Emerging market participant with more than 3.5m units sold globally to date and a further 2m units contracted

‘Best in class’ solutions based on Atomo’s award winning technology now increasingly recognised in market

Flexible, convenient rapid test platform that can be quickly and effectively adapted to launch new tests across a broad range of clinical applications

Large & growing global rapid test market - the global lateral testing market accounted for US$5.4 billion in 2020*

Scalable production with a cost-effective supply chain capacity of 1.6m total devices per month, based on a family of Robust Intellectual property and significant proprietary know-how on design and manufacturing Well capitalised balance sheet with $24.7m cash and no debt

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* https://www.globenewswire.com/fr/news-release/2020/06/04/2043819/0/en/Global-Lateral-Testing-Market-is-Estimated-to-be-USD-7-9-Billion-by-
2029-with-a-CAGR-of-4-3-During-the-Forecast-Period.html 1 5
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John Kelly Managing Director john.kelly@atomodiagnostics.com +61 401 922 279

atomodiagnostics.com