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ATOMO DIAGNOSTICS LIMITED Interim / Quarterly Report 2021

Feb 22, 2021

64440_rns_2021-02-22_0a99cb02-6849-4b41-81c4-65da24d05c26.pdf

Interim / Quarterly Report

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Managing Director

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

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FY21 Interim Results Presentation
23 February 2021
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
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DISCLAIMER

This presentation has been prepared by Atomo Diagnostics Limited (“Atomo”) based on information available as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessary to make an investment decision. Reliance should not be placed on the information or opinions contained in this presentation. An investor must not act on the basis of any matter contained in this presentation but should make its own assessment of Atomo as part of its own investigations.

This presentation has been provided for general information purposes only. It does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Atomo, nor does it constitute financial product advice or take into account any individual’s investment objectives, taxation situation, financial situation or needs.

Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, neither Atomo, nor any of its officers, directors, employees and agents, nor any other person, accepts any responsibility or liability for the content of this presentation including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of or reliance on any of the information contained in this presentation or otherwise arising in connection with it. This disclaimer also extends to all and any information and opinions contained in, and any omissions from, any other written or oral communications transmitted or otherwise made available to the recipient in connection with

the opportunity outlined in this presentation and no representation or warranty is made in respect of such information.

The information presented in this presentation is subject to change without notice and Atomo does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this presentation, which may affect any matter referred to in this presentation. The cover image is illustrative only.

This presentation may contains certain forward looking statements that are based on Atomo’s beliefs, assumptions and expectations and on information currently available to Atomo management. Such forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results or performance of Atomo to be materially different from the results or performance expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding present and future business strategies and the business, economic and competitive environment in which they operate in the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward looking statements or other forecast. To the full extent permitted by law, Atomo and its directors, officers, employees, advisers, agents and intermediaries disclaim any obligation or undertaking to release any updates or revisions to information to reflect any change in any of the information contained in this presentation (including, but not limited to, any assumptions or expectations set out in the presentation).

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2
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INVESTMENT CASE

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

Emerging market participant with 3.5m devices sold globally and a further 2m contracted

‘Best in class’ solutions based on Atomo’s award winning rapid test devices now increasingly recognised

Large global market - The global lateral testing market accounted for US$5.4 billion in 2020*

Flexible rapid test platform that can be quickly and effectively adapted to support new products across a range of clinical applications

Scalable production with a cost-effective supply chain capacity of 1.6m total devices per month, based on Robust IP and significant proprietary design and process know-how

Extensive Pipeline of next generation RDT devices and applications to drive growth into the future

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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 3
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- KEY FINANCIAL METRICS[1.] Strong top-line growth

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Revenue Gross Profit GP Margin
$4.58m $2.52m 55%
389% 278% 1,300bps
Net Op.
EBITDA Net Cash
Cashflow
($2.12m) $24.7m
($193k)
68% Debt free
91%
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Drivers
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Revenue:

  • COVID-19: Sales to NG Biotech & direct to the Australian market

  • HIV: Mylan sales into S. Africa &other countries, plus direct in the Australian market

  • OEM: Sales to Lumos to support global FebriDx rollout

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Gross Profit & Margin:

  • Continued expansion of higher margins as the business scales

Net Op. Cashflow:

  • Benefit of volume gains, decline in unit costs, lower funding costs and increase in R&D grant

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1. Compared to previous corresponding period(unless otherwise stated) 4
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KEY BUSINESS HIGHLIGHTS – G rowi ng international recognition

Access Bio Australian COVIDHIV facility Partnership 19 progress certified Agreement to supply 2m COVID-19 antibody test COVID-19 Antibody RDT South African HIV sales commenced. devices into US (take or facility certified and fully Initial sales of the COVIDpay), with first shipments operational 19 antigen test[1.] delivered to the US HIV self-test OEM demand Increased device demand growing accelerates capacity Expanding approvals Production ramp up to Rated capacity supporting increased meet demand for OEM increased during H.1 sales opportunities, with devices, with additional FY21, from 750k to increased demand automated blister 1.6m total devices per anticipated over the machines being month commissioned

Agreement to supply 2m COVID-19 Antibody RDT devices into US (take or pay), with first shipments delivered to the US HIV self-test demand growing

Expanding approvals supporting increased sales opportunities, with increased demand anticipated over the coming 12 months

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Atomo’s second generation proprietary blister manufacturing machine

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1. The TGA approved Atomo Antigen Test Manufactured by Access Bio in the US on behalf of Atomo. COVID-19 5
rapid testing detects SARS-COV-2, the virus that causes COVID-19
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BUSINESS UNITS SUMMARY

COVID-19

HIV

OEM

Revenue - $2.61m

  • Access Bio – agreement signed to supply 2m devices by 30 Sept 2021 (take or pay). FDA submission finalised early January.

  • First shipment of 259k units delivered

  • Australia

  • Commercial traction secured for the AtomoRapid Antibody test.- Sales of $394k achieved.

  • Initial launch of the Atomo rapid antigen test – manufactured by Access Bio on behalf of Atomo.

  • NG Biotech – 1.9m devices sold to 31 Dec 20. Minimum orders not met, move to nonexclusive basis.

  • Europe – Atomo re-engaging with other interested parties to discuss potential commercial arrangements

Revenue - $0.77m

  • PrEP Health agreement - signed for distribution of the Atomo HIV Self-Test in Australia

  • Independent validation - Atomo HIV SelfTest demonstrated excellent usability in a recent evaluation, with 100% of untrained, first-time self-test users judging it ‘easy to use’.

  • International demand – demand growing in global markets

  • South African HIV facility - now fully operational following certification by BSI, TGA and WHO

  • Professional use test – TGA approval. Aust commercial launch planned in the coming months

Revenue - $1.10m

  • Production increase – responding to growing demand. eg: Lumos Diagnostics commercialising a rapid blood test to detect viral vs bacterial infections

  • OEM opportunities – continue to seek new OEM opportunities across Pascal and Galileo devices. Elion device anticipated to launch during CY2021

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1. Compared to PCP 6
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UNDERLYING P/L & CASHFLOW – S c a l e b e n e f i t s m a t e r i a l i s i n g

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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 product 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 Mylan.

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

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BALANCE SHEET – Wel l c a p i t a l i s e d

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  • Cash of $24.69 million as at 31 December 2020 and no debt, putting the company in a strong position to continue to invest in growth

  • Product manufacturing and build up of inventory in anticipation of continued strong growth of COVID-19 rapid test sales and HIV global tender opportunities

  • An investment of $2.29m million in R&D was made over the half year period including:

  • $1.81 million capitalised to the balance sheet as Intangible development, primarily related to investment in the next generation blister machines

  • $0.48 million expenditure expensed through the P&L on new product development and other R&D activities

  • A further investment of $0.65 million capital investment in PPE to support and scale production capabilities, process improvements and capacity

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2H21 – KEY PRIORITIES

  • Following delivery of two containers to-date, ramp up supply of Atomo devices to Access Bio under the take or pay contract for rapid antibody tests to the US market.

  • FDA Emergency Use Authorisation approval of Access Bio’s COVID-19 rapid antibody tests to support sales beyond the contracted minimum 2 million tests

  • Atomo driving continued growth of direct sales channels for COVID-19 antibody and antigen rapid testing in Australian, as well as seeking new opportunities in international markets

  • Support Mylan (now Viatris) to scale up the HIV Self-Test tender business

  • Commercialisation agreements for new finished products

  • Continuing investment in development of digitisation to support the use of Atomo products; especially in home settings and via telehealth services

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COVID-19 – HERE TO STAY?

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John Kelly Managing Director [email protected] +61 401 922 279

atomodiagnostics.com