Announcement PDF ASX Announcement 2 November 2023 2023 Annual General Meeting – MD & CEO’s Address In accordance with ASX Listing Rule 3.13.3, Atomo Diagnostics Limited (Atomo) attaches the Managing Director & CEO’s Address to be delivered at Atomo’s 2023 Annual General Meeting. For more information, please contact: John Kelly Atomo Diagnostics john.kelly@atomodiagnostics.com Phone: +61 401 922 279 This announcement was authorised by the Managing Director & CEO. Atomo Diagnostics Limited ACN 142 925 684 Level 1, 3-5 George St Leichhardt NSW 2040 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. ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 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). PRIVATE AND CONFIDENTIAL 5 WHO IS ATOMO AND WHAT WE DO? Our unique portfolio of integrated tests and technologies allows people to test early and test often, putting healthcare in the hands of the consumer WHO IS ATOMO? WHAT DO WE DO? Headquartered in Australia, we develop, manufacture and supply innovative rapid Atomo focuses on two revenue channels: tests and unique test solutions into point of care and self-test consumer markets Our solutions recognised as delivering best-in-class usability & accuracy and facilitating OTC/consumer approval for blood-based commercial applications Proven usability and existing blood-based self-test approvals in key markets gives Point of Care Rapid Test Products for Infectious Disease and Female Health: • Supply of commercialised rapid tests for HIV, blood pregnancy and iron deficiency - POC and self-test • Clinical applications in pipeline across wellness and sexual health Atomo potential to achieve and defend first mover success in the US OTC market Expanding globally with products registered in more than thirty countries and dedicated commercial resources covering the US, UK & Europe and S.E.Asia Atomo’s products offer a significant growth opportunity as the market continues to Point of Care Test Platform Technology: • Cassette solutions supplied to partners requiring improved usability and user preference, or seeking self-test / OTC channel access • shift to decentralised and expanded interest in at-home testing post-pandemic ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) Custom cassette solutions (blood and swab based) for partners seeking improved usability for POC reader solutions 6 ACHIEVEMENTS IN FY24 Atomo entered into a number of new HIV distribution agreements to focus on emerging opportunities in consumer retail channels post COVID-19, and access markets where are products are not yet registered. First 510(k) approval secured for a Pascal rapid test in the valuable US market, supporting Atomo tests and other OEM customers to bring further tests to market Atomo HIV Self-Test, CE Marked under the Newfoundland brand and launched in Tesco Supermarkets across the UK Recommencement and expansion of OEM business from existing customers following a hiatus in blood-testing during the COVID pandemic Growth of our HIV Self-Test business in Australia through the rollout of the product in pharmacy channels, as we expand the pharmacy network, and increase engagement with government. Renegotiation of our strategic relationship with NG Biotech to give Atomo exclusive commercial rights for the NG Biotech blood pregnancy test on the Atomo Pascal device for the US, Canada, Australia and New Zealand. Subsequent submission engagement with TGA in Australia and FDA in the US. Securing a number of reseller commercialisation agreements with companies in the US and Europe that develop new rapid test assays for the market Reduction in Operating expenditure of the business with cost reduction across the year of approximately $1.5m ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) AtomoNOW pregnancy test submitted for approval to TGA in April 2023 7 FINANCIAL PERFORMANCE FY24 AUD FY23($m) FY22($m) Quarterly Revenue (excl COVID-19) (%) Revenue 2.54 12.34 Cost of sales (1.88) (8.09) Gross Profit 0.66 4.25 Gross Margin 26% 34% Less COVID RAT sales 0.39 10.42 Normalised Revenue 2.15 1.92 Normalised Gross Margin 37% 27% Other income 1.15 2.70 (57%) Employee benefits expense (4.85) (4.10) (18%) Foreign exchanges gains/(losses) 0.11 0.09 (22%) Research and development costs (0.60) (1.41) 57% Professional fees expense (0.82) (2.33) 65% Inventory obsolescence expense (1.17) (0.36) (225%) Other expenses (2.54) (2.50) (2%) Underlying EBITDA (8.06) (3.66) (120%) s (79%) (84%) 12% • After normalising for COVID-19 sales, revenue grew by 12% and gross margins improved to 37% • Return to Quarterly revenue growth post-COVID as customers refocus, with Q1 FY24 reflecting improved non-COVID-19 sales in HIV and OEM • Cash on hand at end of Q1 FY24: $6.9 million • Opex continues to reduce through FY23 and into FY24 ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 8 AN IMPROVED DIAGNOSTIC TEST LANDSCAPE The landscape for diagnostic testing continues to transition away from hospitals and clinics post COVID-19. Key stakeholders in the healthcare eco-system, some previously resistant to decentralised rapid testing, lower costs, are increasingly acknowledging the convenience and proven efficacy of at-home diagnosis and treatment PUBLIC HEALTH BODIES CLINICIANS AND PHARMACISTS “Almost everyone has done a The healthcare ecosystem has rapid diagnostic permanently changed as a result test” experienced accelerated growth during the pandemic Speed of results, ease of use and ease of access are increasingly important to healthcare professionals USERS AND CONSUMERS Growing demand for reliable, rapid and decentralised diagnostic testing 1 Delivery of healthcare in the home now commonly accepted Consumer demand is quickly growing KEY STAKEHOLDERS REGULATORS RETAIL AND FMCG Regulators now understand and accept the role of point-of-care diagnostics in the overall healthcare landscape Low-cost, high volume, easy to use diagnostic products with the ability to meet the demands of consumers are now on the shelves in mainstream retailers 1 ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) McKinsey & Co. Telehealth: A quarter-trillion-dollar post COVID-19 reality May, 2022 9 ATOMO LEADS USABILITY INNOVATION IN RAPID TESTING Pascal ‘all in one’ test Standard multi component test kit “The lancet would not be out of place in a joke Christmas cracker” Home allergy test - Boots feedback page, UK COMPLEX: Multiple components, too many steps, requires expertise HIGH ERROR RATES: Difficult to secure regulatory approvals, “I would rather pay for this test in future (than use a free test) if it means it is this easy” Atomo HIV Self Test user - Feefo, UK SIMPLE & RELIABLE: UNIQUE: Surveyed US clinicians believe three things are necessary to drive continued rapid test adoption: Intuitive to use, delivering accurate performance for untrained users The only commercialized fully integrated blood test solution Pascal Performance Standard test kit formats deliver quick results and affordability, but only Atomo’s Pascal solution delivers inherent ease of use and simplicity for blood applications Recent 510k approval by FDA for a US manufactured test on Pascal provides predicate for future products – CLIA waiver pending. OTC to follow. 1 https://www.ipsos.com/sites/default/files/ct/news/documents/2022-03/Ipsos_Future%20of%20POC%20and%20Rapid%20Testing_March%202022.pdf ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 10 ATOMO’S HIV SELF TEST INCREASINGLY SUPPLIED GLOBALLY Atomo saw momentum in its HIV business over the last year developed. The Atomo HIV Self-Test is now registered in more than 40 countries with nearly three million HIV Tests sold globally With Tier 1 regulatory approvals including CE Mark for Europe, Australian TGA and prequalification by the World Health Organization, the company's HIV business is growing rapidly post COVID Atomo’s latest HIV contract is with UK based Newfoundland Diagnostics. Initial order for 200k self-tests supporting recent launch across Tesco supermarket stores in in October, with a further 210k tests to be ordered by end of 2023 to support launch in Europe during FY24 Finished product assembly is carried out at the company’s certified facility in South Africa, reducing the product cost of goods and logistics effort to supply volume into key global health markets, where Atomo’s HIV Self test is registered in 39 LMIC markets ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) HIV self-testing increasingly being adopted by public health bodies around the world to scale up testing among key atrisk cohorts Atomo has programs underway in Australia, the UK and discussions with US CDC pending Atomo is now focused on further expansion of its HIV business and is seeking partners to support launch in remaining key markets, including the US and China, as well as assessing opportunities to expand the menu to include a HIV/Syphilis combo product 11 FIRST BLOOD BASED OTC PREGNANCY TEST TO MARKET* The AtomoNOW rapid pregnancy test is a unique solution in a very large addressable market. This bloodbased pregnancy test offers a number of significant advantages over traditional urine based rapid tests: • Earlier detection of pregnancy and more reliable in the early phases of pregnancy • Can perform the test at any time of day (rather than needing first flow with urine) We consistently see that approximately 1 in 5 pregnancy test purchasers would buy AtomoNOWTM # This matches the proportion who feel very positive about the concept, the proportion who express that they are very interested in purchasing it (unpriced) and the proportion who say they will buy it at US$20. * Developed in partnership with NG Biotech, the product is launched in France, the UK and Brazil, with Australian TGA approval anticipated in the coming months. US Pre-sub to FDA lodged in September 2023 # Independent survey of 300 women aged 18-45 in Australia who bought a pregnancy test in the last 12 months ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 12 ATOMO’S OEM TECHNOLOGY BUSINESS Atomo offers partners a broad range of unique products that fundamentally improve rapid testing BLISTER SOLUTIONS DIGITAL HEALTH OFFERINGS BLOOD TEST SOLUTIONS SWAB TEST SOLUTIONS A range of proprietary integrated blood test Portfolio of patents and device development Direct supply opportunity to OEM device Video of user steps. Image Recognition to devices proven to reduce common errors that improve swab and saliva rapid testing partners and POC cassette developers interpret results (removes user errors and with rapid testing and improve usability, especially with untrained self-test users Commercialised across an increasing range of clinical applications improves precision) Supports a broad range of swabs with Frangible seal delivers best in class precision multiple test applications and multi-stage reagent delivery Semi-Quantitative results. Patented Blood delivery QC algorithm Compatible with existing standard cassettes Co-commercialisation/license in market • • Atomo’s existing blood cassette partners have recommenced ordering Pascal after a hiatus during the COVID pandemic The Pascal device is now approved through a US FDA 510k in the US market providing a predicate for other potential partners to bring further tests to market in the US ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 13 MAKING AN IMPACT With experience in rapid testing technology, Atomo has runs on the board ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 14 STRATEGIC FOCUS FOR FY24 & FY25 The overarching focus of the business is to grow revenues over the next two years so that the company can accelerate the next phase of its journey to become a leader in the commercialisation of consumer self tests, via a number of emerging revenue streams Continued growth of the HIV Self-Test business, through a focus on: • Continued support of recently opened up pharmacy / retail channels in key developed markets • Deployment into public health in developed markets, such as Australia and Europe • Securing commercial arrangements to support US ‘go to market’ launch • Taking control of more private sector markets in middle income countries, such as Columbia & Mexico, and securing better placed in-country commercial partners Expanding the portfolio of finished tests that Atomo is able to market directly or supply to strategic channel partners: • Launching the AtomoNOW pregnancy test in ANZ and progressing the regulatory submission in the US • Securing regulatory approval and launching the AtomoNow iron deficiency (Ferritin test) • Seeking to develop and commercialise tests to home monitor levels of Testosterone and of Vitamin D Expanding the OEM supply business for Pascal and other platforms through: • Support of existing partners rolling out Pascal supported tests globally • Securing supply agreements for new partners and products on the back of recent regulatory approvals, entry into mainstream retail channels driving increased market awareness ATOMO DIAGNOSTICS LIMITED | (ASX:AT1) 15