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ATOMO DIAGNOSTICS LIMITED — Investor Presentation 2021
Nov 9, 2021
64440_rns_2021-11-09_088c9821-693c-46f3-aae8-e858159db7ea.pdf
Investor Presentation
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Atomo Diagnostics Limited 701 – 703 Parramatta Road Leichhardt NSW 2040 Australia
Authorised by John Kelly, Managing Director
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BELL POTTER HEALTHCARE CONFERENCE
Wednesday 10 November 2021
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
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 contain 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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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
INTRODUCTION
Atomo Diagnostics Limited (ASX: AT1) is an innovative medical device diagnostics company supplying unique, integrated rapid diagnostic test (RDT) devices and finished point-of-care tests to the global market
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Headquartered in Australia with international operations, Atomo develops, manufactures and sells innovative patented devices and rapid tests that address unmet user needs
Increasing market traction locally in Australia as well as the US, Europe and Global Health markets selling approved Atomo finished tests to healthcare distributors and Atomo devices to diagnostic partners(OEM)
Atomo has experienced strong growth since FY19, with demand for both rapid tests and home based self tests growing globally
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
STANDARD RAPID TEST KITS: OFF PATENT AND COMPLEX
Traditional incumbent ‘bits in a box’ Lateral Flow kits
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Rapid Lateral flow based technology was commercialised more than 30 years ago and is now broadly off patent
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This has resulted in low barriers to entry with many players entering the market across a broad range of clinical applications as seen most recently with COVID-19*
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This has led to the market experiencing significant commoditisation of RDT products, with little differentiation outside of the chemistry in the assay (itself largely unknown to end users)
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Prior to Atomo identifying a significant unmet need in the market, little real development effort and innovation had gone into improving usability, reliability and utility of the rapid test procedure itself
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These standard kits are not intuitive and user satisfaction is generally low, especially in consumer health - self test applications
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
* COVID-19 rapid testing detects SARS-COV-2, the virus that causes COVID-19
ATOMO’S SOLUTION – CONSUMER FOCUSED
Integrating key functionality directly into the cassette delivers significant benefits
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Usability delivers best in class user preference
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Established reliability and functionality in the field
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Removal of the need for add-on accessories
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Removing and/or simplifying steps of use
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Interlocking features to ensure correct sequencing of workflow
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Pascal Test – supports professional and self test applications
Elion Self Test – a user friendly consumer focused rapid blood test device
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DaVinci Combo Test – two strips in a single rapid test *
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- DaVinci can deliver different sample volumes to each test strip and also offers integrated blister reagent functionality
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ATOMO’S STRATEGIC FOCUS
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
UNIQUE CAPABILITIES IN POCT
The intersection between Consumer Medical Devices & Diagnostic Testing
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Less IP Intensive
More sales focused
Core Functionality Devices Finished Product Customer Delivery
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IP Intensive
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Atomo DNA Core Functionality
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Point-of-Care Self Testing
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Blood collection • Galileo
- Digital delivery
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HIV
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Design and engineering • Saliva & swab collection • Pascal
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• Patent generation • Buffer delivery • Elion
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Subscription models
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COVID
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Other
- White label brands -
Interlocks • Da Vinci
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Rapid Prototyping
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•
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• Manufacturing machinery Co-development
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• Regulatory processes and processes devices • User centric design • IFU’s
- Non-Blood
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Digital, App
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
EXISTING PRODUCTS AND CUSTOMERS
| P R O D U C T S | C U S T O M E R S / C H A N N E L S | |
|---|---|---|
| Infectious Diseases Tests |
HIV-Self Test and Professional | Iyeza, Owen Mumford (UK/EU) Mylan/Viatris (LMIC), Australia - Distributors |
| (HIV, COVID, Others) | COVID*-Antigen and Antibody Professional | Atomo branded Antigen tests (Australia) |
| OEM device for Antibody tests (NG and ABI) | ||
| Rapid Test Devices |
Blood Devices-Galileo, Pascal, Elion (pending) |
NG Bio, Lumos |
| (devices, components) | Non-Blood-Swab and Saliva (commenced) |
Development In process |
| Consumer Health | HIV-Direct to consumer Australia | Expansion to pharmacy and removal of |
| & Wellness (entering new markets) |
COVID-Emerging market in Australia | restrictions on advertising and promotion ST submission pending – eCommerce/ Pharmacy |
- COVID-19 rapid testing detects SARS-COV-2, the virus that causes COVID-19
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ATOMO’S INFECTIOUS DISEASE BUSINESS
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HIV COVID-19
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COVID Antigen - Australia Atomo has secured supply up to 20 million antigen tests during FY22 & 23. COVID OEM Devices With extended market life, we see some opportunity to supply custom cassettes to leading COVID antigen home tests Neutralising Antibody There is some prospect of neutralising antibody testing becoming a sizeable market channel
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HIVST = HIV Self-test
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
RAPID TESTING IN AUSTRALIA
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Change in public policy and regulatory positions
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Growing support for rapid testing, evidenced by changing public health position from Federal, NSW and VIC Governments and TGA regulations
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TGA has commenced process of approving at-home tests for COVID-19
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TGA has announced improved supply and advertising conditions for COVID-19 and HIV Self-Tests
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Improved ability for Atomo to communicate to market for HIV Self-Test, COVID-19 Rapid Antigen and COVID-19 Rapid Antibody tests
COVID-19 Rapid Antigen Testing
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Aged Care
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Transport and logistics
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Major retailers
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Construction Companies
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Film, TV, Opera crews
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FIFO resources companies
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Food preparation and factories
HIV Self-Testing
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Direct to consumer (now open to advertising and promotion)
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Clinics and community centres
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Partnerships incl. PrEP
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Grant funded programmes and Public Health
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Pharmacies (new channel)
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Government tenders
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
CO-DEVELOPMENT BUSINESS
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GOAL: To become the leading provider of integrated Rapid test devices by leveraging Atomo’s capabilities, IP and know-how by offering Co-Development partners access to Atomo’s platforms and proprietary components
Leverage existing platforms
Development beyond blood
Custom Development
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Accelerate roll-out of current technologies with existing approvals to existing markets (Europe, Australia) and new markets (US) with potential for partners to upgrade existing products to an Atomo platform
Atomo’s development & usability expertise, portfolio of patent protected technologies and proprietary knowhow to enhance a Partner’s portfolio of assets, products and sample types
Work with partners for bespoke solutions that leverage Atomo’s existing technology, that allow for cost-sharing new developments, and create locked in customer relationships through supply, licensing and royalties
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Elion: developed but not yet commercialised
Swab and saliva rapid test concepts in development
Technical discussions in process
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
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TELEHEALTH: OPENING NEW MARKETS
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COVID-19 has accelerated personalised, predictive and preventive medicine programs
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Consumer adoption and growth in Telehealth, POCT, OTC and at-home self-testing markets
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Telehealth consultations 38x higher than before the pandemic*
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Historical uncertainty from health care providers towards self-testing/at-home testing has been reduced
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Precedents have been set with regulatory authorities to approve self-testing technologies
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Usability, simplicity and accuracy are critical for diagnostics use in these settings
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In the US, telehealth as a share of medical consults went from 0.2% to 13% at the peak of the COVID-19 pandemic, and has stabilised at ~6% of all consults
CB Insight’s – 2021 Healthcare Digital Transformation Survey
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- [Source: McKinsey & Co, Telehealth: A quarter-trillion-dollar post-COVID-19 reality? July 2021]
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
CORPORATE PROFILE
| Key financial details | |
|---|---|
| ASX code | AT1 |
| Share price (05/11/21) | $0.25 |
| Shares on issue | 568.6m |
| Options on issue | 23.7m |
| Market cap* | $142m |
| Current cash (30/09/21) | $15.2m |
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Share price performance
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AT1 Share Price
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0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
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*Undiluted
| Board Member | Position |
|---|---|
| John Keith | Non-Executive Chairman |
| John Kelly | Founder and Managing Director |
| Dr Curt LaBelle | Non-Executive Director |
| Connie Carnabuci | Non-Executive Director |
| Dr Paul Kasian | Non-Executive Director |
| Deborah Neff | Non-Executive Director* |
| Major Shareholders | % (undiluted) |
|---|---|
| Dalraida Holdings Pty Ltd / John Kelly | 13.1% |
| Global Health Investment Fund I, LLC | 11.4% |
| Ellerston Capital Limited | 7.31% |
| Walker Group Holdings Pty Ltd | 6.70% |
As per substantial shareholder notices
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
*Appointed 15 September 2021
KEY HIGHLIGHTS - FY21
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Atomo COVID-19 rapid tests – Added by the TGA to the ARTG in H1 FY21 for supply in Australia. Tests launched in Q2 & Q3 FY21. Circa. 50k, primarily antibody test units sold in 2H FY21.
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Regulatory Approval – Atomo devices have now achieved broad regulatory approvals including FDA, CE Mark, TGA & WHO prequalification (Atomo and Customer Finished tests)
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HIV - Global health agreement signed between Mylan (Viatris)/Atomo and Unitaid in Q4 FY21 covering more than 135 countries. Initial orders commenced
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OEM/Co-development business – Ongoing technical and commercial engagement progressing with several leading multinational diagnostics companies seeking access to Atomo’s rapid blood test platforms and proprietary functionality for non-blood test applications
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US market entry – Business development/commercial resourcing and local entity infrastructure currently being established to support expanded engagement in the US
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New product development - Atomo commences development of first non-blood rapid test platform in Q4 FY21
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Financials – Sales growth of 25%, cash receipts of ~$8m and cash at bank of $18m at 30/6/21
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
KEY FINANCIAL METRICS
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FY21 Sales $6.72m Gross Margin ($m) $3.42m
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Q1 FY22 Sales $2.4m Cash receipts $2.2m
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Cash receipts and revenues: Cash receipts of $2.2m from customers during the quarter, and unaudited revenue of $2.4m
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COVID-19 rapid antigen test sales in Australia have significantly increased since 1 July 2021
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New arrangements with Access Bio: US$1.72m (A$2.4m) cash which was received post-quarter end and commitment to supply up to 20m COVID-19 rapid antigen tests to Atomo
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Completed initial Viatris order for 250,000 HIV Self-Test products to supply into the South African market as part of Unitaid agreement with subsequent orders received late in Q1 for India and two other countries
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Atomo finished the quarter debt-free and with cash on hand of $15.2m
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
PRIORITIES FOR FY22*
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Capitalising on expanding local COVID-19 opportunities, including launch of a self-test product (subject to TGA approval), and increasing resources to support growing demand across public health and private sector channels as Australia opens up to the world
Progressing strategic partnership opportunities with large diagnostics companies looking to improve the usability and marketability of their existing point-of-care testing products, and enter the rapidly growing home-based telehealth market
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Growing Atomo’s HIV business through the support of key partners rolling out Atomo’s HIV products globally, developing new markets and expanding Atomo’s domestic sales channels given recent supportive TGA changes enabling pharmacy sales and product advertising
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Ongoing development of a range of non-blood rapid test solutions, including for swab and saliva rapid testing and so significantly expand Atomo’s addressable market in point-of-care testing (POCT)
Establishing Atomo’s US business and upgrading the Company’s commercial and business resources, capabilities and infrastructure
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*The priorities above reflect the Company’s intentions in FY22 only. They have been provided as a general guide and should not be relied upon as an indication or guarantee of future performance. There is no guarantee that these priorities will eventuate
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)