Announcement PDF H1 FY2025 RESULTS PRESENTATION ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) PRIVATE AND CONFIDENTIAL 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. 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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 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). 2 WHO IS ATOMO AND WHAT DO WE DO? WHO IS ATOMO? • Headquartered in Australia, with a low-cost certified facility in Atomo develops solutions that transform the user experience and minimize errors South Africa, we develop, manufacture and supply innovative common in rapid blood test environments: user-centric rapid tests and test functionality to the Point-of-Care Test market. • WHAT DO WE DO? Atomo solutions increasingly recognized as delivering best-in- Point of Care Rapid Test Products with a focus on Sexual Health and Female Health: • class usability, accuracy and product differentiation and facilitating self-test approvals for blood-based applications • Sexual Health: HIV (commercialized) and Active Syphilis (in development), and; • Women’s Health: blood pregnancy (commercialized) and iron deficiency (in development) Proven performance in the hands of users, with existing product approvals in key developed markets offers Atomo potential as leading solution in CLIA-waived and self-test markets in the US • Point of Care Test Cassette Technologies: • Atomo’s unique development capabilities offer significant strategic value in a market increasingly driven by the need to deliver low-cost reliability in decentralized point of care settings ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Integrated test cassettes and accessories that significantly improve usability and precision in rapid test procedures • Solutions addressing blood-based testing, swab-based testing, salivabased testing and blood sample transfer 3 SOLUTIONS THAT DELIVER Initial solutions focused on transforming usability in the lateral flow market Issues with Standard Multi-Component Test Kits “The lancet would not be out of place in a Christmas cracker” Home allergy test kit feedback – Boots, UK ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Advantages of Atomo Devices “Simple to use! Brilliant! I would rather pay for this test in future if it means it is this easy – Thank you” Self-test user feedback – Feefo, UK 4 INVESTMENT HIGHLIGHTS • Opportunity to invest in a disruptive innovator with unique user focused solutions • Potential to disintermediate lateral flow point of care diagnostics. • Strong FY24 revenue growth (>80% pcp) • Access to multiple large, growing global diagnostic markets in Infectious Disease and Women’s Health – HIV US$4B (2026), Syphilis US$1.4B (2026), Women’s Health (blood pregnancy & Ferritin) US$2b (2026) • Integrated user-friendly OEM device solutions for blood and swab based decentralised testing • Multiple modalities established – enables multiple channels to market - pharmacy/retail, public health in-clinic and at-home, and critical supplier of technology to other diagnostic manufacturers Innovating novel and disruptive lateral flow solutions in point of care and self-testing • Leading user-centric design, device engineering, usability and regulatory capabilities • Successful approvals of integrated test devices with regulatory clearances in the US, UK, Europe, Australia, Brazil and other Global Health markets • International market footprint - opportunity for entry into selected global markets/channels utilising existing approval, including the UK & Europe, Australia, Brazil and other Global Health markets • Commercially validated technology with more than 7 million units supplied to market and more than $30M in aggregate sales • Opportunity for significant margin growth at scale • Extensive IP Portfolio with more than forty registered patents (5 in the US) • Numerous trade secrets and development expertise • Exciting pipeline of finished tests and test devices in development ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Private and Confidential 5 ATOMO H1 FY2025 FINANCIAL RESULTS H1 FY25 – PROFIT & LOSS AUD H1 FY25($m) H1 FY24($m) (%) Revenue 2.05 1.92 Cost of sales (1.12) (1.05) Gross Profit 0.93 0.87 Gross Margin 45% 45% Other income 0.55 0.58 5% Employee benefits expense (1.73) (2.33) (26%) Foreign exchanges gains/(losses) (0.01) 0.01 Research and development costs (0.28) (0.11) 155% Professional fees expense (0.43) (0.34) 26% Inventory obsolescence expense (0.02) (0.02) 0% Other expenses (0.95) (0.96) (1%) Underlying EBITDA (1.94) (2.30) (16%) ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 7% 7% • Total customer revenue increased 7% in comparative periods, with gross margin maintained at 45% • Revenue of $2.05m includes $1.33m relating to POC test sales and $465k relating to sales of POC technology and remaining $250k relating to development and other revenue fees • Atomo’s overall OPEX has continued to moderate whilst continuing to increase revenue. Overall operating expenditure reduced ~$345k in comparative H1 periods. Bringing monthly average operating expenditure from $630k p.m. to below $570k p.m. • Key focus remains in investing in expanding the patented technology portfolio platform, as well as continuing to invest in core revenue generating activities of the business • Additionally, included in other income during the H1 FY25 period, Atomo recognised ~$40k for grant income for activities commencing for the CRC-P Active Syphilis grant awarded to Atomo in October 2024, $2.44m. The first milestone grant payment receipted in December 2024 for $485k Private and Confidential 7 H1 FY25 – BALANCE SHEET H1 FY25 FY24 • Cash balance of $2.9m at 31 December 24 and debt free AUD ($m) ($m) • Capitalised expenditure relating to R&D and PPE was insignificant Cash and cash equivalents 2.90 3.69 during the period. With investment in infrastructure completed Trade and other receivables 1.24 2.06 previously, movement largely driven by depreciation/amortisation Inventories 1.79 1.84 in line with useful life assessments of assets Property, plant and equipment 1.28 1.64 • Included in other liabilities is deferred income from grant funds Intangible assets 1.86 2.07 receipted in December 2024 for $485k, of which $40k was Other assets 0.19 0.08 recognised as other income for grant activities undertaken Total assets 9.26 11.38 • Ongoing targeted investment continues to focus on expanding Trade and other payables 0.74 0.77 finished products and OEM cassette business utilising Atomo’s Other liabilities 1.10 0.52 existing technologies and IP Total liabilities 1.84 1.29 Net Assets 7.42 10.09 ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Private and Confidential 8 H1 FY25 – CASH FLOW H1 FY25 Cashflow activities ($'m) • Cash receipts of ~$2.6m from customers 8.00 • An additional $761k received from the R&D tax rebate and $485k first milestone payment received for CRC-P Active Syphilis grant awarded 7.00 6.00 • Cash payments for stock of ~$1.1m 5.00 • Opex, capex and R&D activities totalling ~$3.5m 4.00 • Total Cash outflow for the H1 period was ~$132k p.m., an improvement monthly cash burn from prior period average of $333k p.m. excluding prior period capital raise 3.00 2.00 1.00 0.00 Cash @ June 2024 Cash receipts R&D Rebate ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Gov't Grants Payments for stock Operating costs CAPEX Cash @ Dec 2024 Private and Confidential 9 FUNDAMENTALS & TRENDS Core Revenue (FY22 to date) Operating Expenditure (FY22 to date) 2.5 6 2 5 4 A$ (m) A$ (M) 1.5 1 3 2 0.5 0 1 H1 FY22 H2 FY22 HIV H1 FY23 OEM H2 FY23 H1 FY24 H2 FY24 0 H1 FY25 H1 FY22 H2 FY22 H1 FY23 H2 FY23 H1 FY24 H2 FY24 H1 FY25 Development fees/other • Both Revenue (excld COVID-19 sales) and Gross Margin (GM) has continued to steadily grow and improve over the last 2 years • Given prior periods investment made in building Atomo business infrastructure and core IP, focus is being directed towards market facing and revenue generating activities and continuing to diversify the portfolio for new product tests/technology and development program revenue • OPEX has continue to reduce significantly over the period. Average OPEX reduced from ~$630k p.m. to less than $570k p.m • Through on-going measures, OPEX is expected to further reduce and moderate for business overhead costs, whilst investing in revenue generating activities *Operating expenses and EBITDA prior to one-off stock obsolescence H1 FY23 for COVID Stock $1m & impairment of assets $798k H2 FY24 ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Private and Confidential 10 ATOMO PRODUCTS • FINISHED LFA TESTS • TEST DEVICES • DEVELOPMENT PIPELINE ATOMO PRODUCT PLATFORM & PIPELINE | SUMMARY HIV Self-Test • The only HIV self-test approved in Australia, also approved for sale in the UK and supplied through Boots and Tesco’s and in Europe. Registered in more than twenty countries in developing markets. Prequalified by the WHO, making it a global solution for HIV testing Pascal Cassette • Commercialized as the world’s first all in one rapid for lateral flow blood testing, Pascal provides long term agreements as critical supplier to diagnostic companies, including NG Biotech and Lumos. Supports test approvals for both professional use and self-test use and delivers tests registered in Europe, the US (510k), Canada, Australia and Brazil • Usability Accessory: Atomo knowhow and IP reconfigured to support Blood testing using Standard LFA Test Cassettes Florey Cassette (Blood Tests) Active Syphilis Test (PU and Self-Test) • Under development, retaining key usability from Atomo’s Pascal platform, the Blood Test device is an accessory cane that can be integrated with existing regulatory-approved test cassettes, ensuring minimal regulatory hurdles • Developed on Atomo’s Pascal platform. Proof of concept performance for active syphilis established. Australian Government Grant for $2.44m awarded to complete clinical trials and product dossier. Clinical trails commencing late 2025 • Opportunity to be first in market with a rapid POCT test that is specific for Active Syphilis infection and also user compatible for self-test approvals Curie Cassette (Swab Tests) • Usability Accessory: Atomo knowhow and IP reconfigured to support Swab testing using Standard LFA Test Cassettes Ferritin Test • Developed in Atomo’s Galileo platform with Analytical verification complete and Usability supported by the HIV Self-Test • Small clinical trial to complete Dossier: Ferritin is a key biomarker in diagnosing conditions such as iron deficiency Atomo Blood Pregnancy test • Commercial rights to register and market the Pascal Blood based pregnancy test in the US and Australia Indicates products are commercialised with regulatory approval and revenues ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Products Under Development 12 CURRENT PRODUCT REGISTRATIONS Product Registrations – Atomo as Listed Manufacturer HIV Self Test | US$4bn (2026) [Source] • TGA | Australia • WHO PQ | LMICs • CE Mark | UK & Europe COVID-19 Antibody Test (Discontinued) • TGA | Australia Product Registrations – Atomo Partners Pregnancy Test | US$2.1bn (2026) [Source] • CE Mark | UK & Europe • ANVISA| Brazil FebriDx | US$5.2bn (2026) [Source] • FDA (510k) | USA • CE Mark | UK & Europe • TGA | Australia • Health Canada | Canada TGA WHO PQ FDA CE MARK ANVISA HEALTH CANADA ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 13 ATOMO HIV SELF TEST ATOMO IS SEEING TWO KEY DRIVERS OF LONG-TERM GROWTH: o Expansion of Markets in Pharmacy/Retail post COVID o Emergence of Public Health Procurement for Self-Testing • HIV revenues more than double from $1.56m in FY23 to US$3.3m in FY24 • Australian Federal Government adopts HIV Self-Testing in national policy and commits to SelfTest product procurement for the first time. Similar trends in other developed healthcare markets such as US and UK • Atomo received order for $440,000 from Government funds to support promotion of tests to users of Grindr in Australia directly through Grindr’s APP • New South Wales State Health launches the ‘MyTest’ Vending Machine program in NSW across NSW Health HIV Vending Machine 30 machines state-wide for launch; with more than 200 machines now operational nationally and expanding • Atomo’s Test launched in leading UK retailers, Tesco Supermarkets and Boots Pharmacies as COMMERCIALISATION STATUS: well as in pharmacy chains in Germany and Australia • Atomo announces 5-year agreement with Newfoundland for UK & Europe, worth more than • Only registered HIV self-test approved for sale in Australia $5.4m, and ensuring continued supply into key European retail channels • Atomo HIV self test now registered in over 30 countries with more than 4 million tests supplied to market to date ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 14 ATOMO HIV SELF TEST FUTURE OUTLOOK o HIV self-testing is expected to grow to US$531m by 2026 at a CAGR of 30% [Source]. High growth rate driven by convenience and privacy offered by self-testing, as well as growing adoption of self-test policy and procurement of self-tests by public health bodies o Anticipated roll out commencing May 2025 of a National Vending Machine Program funded directly by Australian Federal Government o Launch of the Atomo HIV Self-Test in the leading New Zealand pharmacy channel in April 2025 o Potential for pathway to US FDA approval (CLIA waiver and OTC/self-test) o Evaluating opportunity to develop, with a partner funding, a 4th Generation HIV Self-Test on Pascal for the POCT market (CLIA waiver) o Lobbying for policy changes to allow HIV self-testing at home for PrEP users to reduce burden to test in clinic every 12 weeks o Planned expansion into new markets in Europe and South America ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 15 45° PASCAL CASSETTE IQ2 360° Pascal delivers unmatched performance and best in-class usability in point-of-care and self-test settings. Platform fully developed and commercialised for OEM Built-In Safety Lancet 70° • Eliminates the risk of hazardous sharps injuries by locking the needle inside the device after use Accurate Blood Collection and Delivery • Blood collection unit designed to collect and deliver the correct sample 140° volume to the test strip Integrated Buffer Delivery • In-built buffer storage blister allows for button activated delivery of the IQ1 Y required quantity of buffer to the test strip Interlocked User Steps • Devices design forces correct sequence of user steps improving reliability and compliance ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 16 CURRENT OEM CUSTOMERS PASCAL IS THE IDEAL SOLUTION FOR PARTNERS DEVELOPING RAPID BLOOD TESTS REQUIRING USABILITY AND RELIBILITY IN DEVELOPMENT Lumos Diagnostics is a US company specialising in rapid, cost- NG Biotech is a French diagnostics company focusing on the Atomo has supplied the Burnet Institute effective point-of-care test solutions development and manufacture of novel in-vitro diagnostics with a batch of 20,000 Pascal units to be products used to deliver a rapid test to monitor liver function (ALT) in a US clinical trial being Utilising Atomo’s Pascal product, Lumos’ FebriDx platform is registered in leading healthcare markets, most recently with Utilising Atomo’s Pascal platform, NG’s blood-based Precision+ conducted by a large Pharmaceutical FDA 510(k) clearance in the US and CLIA waiver in process pregnancy test offers results in 5 minutes company. [Source] Pregnancy can be detected earlier in blood than in urine; and The test assists with the identification and differentiation of with blood, hCG levels do not drop off after first morning flow viral and bacterial acute respiratory infections Registered and launched over the last 24 months in France, FebriDx has secured attractive reinbursement for use in the the UK, Spain, Italy, Portugal, the UAE and Brazil [Source] Atomo continues to work with Burnet to explore the larger market opportunities for an easy to use rapid for liver health monitoring US market ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 17 ATOMO SYPHILIS TEST In Development ATOMO IS SEEKING TO BE FIRST TO MARKET WITH A RAPID TEST THAT CAN DISTINGUISH BETWEEN ACTIVE AND PRIOR TREATED SYPHILIS INFECTION: • Syphilis, has re-emerged as a significant global public health threat . Syphilis testing market is expected to be worth around US$1.4bn by 2026 [Source] • Syphilis, has re-emerged as a significant global public health threat with an estimated 7m new cases in 2022, according to WHO • Existing rapid tests cannot distinguish between current active and past treated infections and are unsuited to test people that have had Syphilis previously with Lab tests required to detect active syphilis and take days to return a confirmatory result • Proof of Concept for Active Syphilis Complete. Product Development and Dossier Test Specificity funded via an Australian Government Grant for $2.44m, awarded November 2024 Atomo Active Syphilis 92% Abbott Bioline 3.0 41% Abbott Determine 33% Significantly Improved Specificity * Preliminary Atomo Active Syphilis performance data ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 18 IN DEVELOPMENT FLOREY CASSETTE (BLOOD) x DESIGNED TO MINIMIZE ADOPTION BARRIERS WITH EXISTING STANDARD TESTS APPROVED AND IN-MARKET Regulatory Burden - Florey is a usability accessory with lower barriers to • introduction as the approved test assay /cassette IVD does not change Operations impact – existing manufacturing operations for the approved test • strip, cassette and pouching remain unchanged Wide-Ranging Compatibility • Integrates with Standard lateral flow cassettes, including those validated for use with IVD desktop readers Accurate Blood Collection and Delivery - Blood collection unit designed to collect and deliver the correct sample volume to the test strip, utilizing patented technology developed in Pascal Integrated Buffer Delivery - In-built buffer blister allows for button activated delivery of the required reagent quantity to the test ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 19 IN DEVELOPMENT CURIE CASSETTE (SWAB) INTERNAL CHAMBER CAN BE RESIZED & OPTOMIZED FOR NASAL, ORAL AND VAGINAL SWABS 360° Compatible With Existing Swab-Based LF Strip Tests, Curie simplifies workflow complexity, improves inter-operator variability and strengthens assay signal intensity IQ2 Improved Sample Delivery Process • Proprietary process and a controlled volume of buffer delivered to improve sample concentration line intensity IQ1 The Atomo Curie Y device delivers higher test line intensity than standard swab test formats ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 20 BUSINESS PRIORITIES FOR 2025 1. EXPAND HIV SALES REVENUE: • • • • 2. PROGRESS ACTIVE SYPHILIS PRODUCT: Continue support for existing HIV • • Sign Commercialisation Agreement • Continue support for existing distributors internationally with Burnet early February – Sign up new distributors (ex: NFLD) for key supports channels partner markets in Europe discussions in key markets for Pascal – US focus with Pascal Complete Syphilis product FebriDx CLIA waiver pending Continued expansion of Australian • Pascal customers • Secure new customer demand Pharmacy rollout development next 3 months and Launch HIV test in New Zealand through a commence clinicals in early FY26 Florey Blood device and develop Secure funding to progress clinicals interested customer pipeline for Commence supply into Gov. funded to support registration in markets custom Florey solutions Vending Machine National scale up outside of ANZ & EU – targeting the Continue to supply into the Gov. funding US (Gov. Grant / B2B partner) & in Atomo finished test products; NAPWHA free-to-user mailout program LMIC (Gates Grant) HIV ST, Active Syphilis ST and leading Pharmacy chain • • 3. GROW US CUSTOMER BASE • Lobby for HIVST- PrEP confirmation testing • • Establish performance for Explore US commercial interest Syphilis Professional Use in Australia (channel worth up to A$2m in revenue annually) ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) Private and Confidential 21