Atomo Diagnostics (AT1) 2024年年度報告「ASX」.pdf

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1、Annual Report2024Leading the Future of Medical DiagnosticsContentsAtomo Diagnostics LimitedACN 142 925 01Who We Are02 Chairmans Letter04CEOs Report06 Diagnostic Landscape08Unique Solutions09Key Metrics10Technology12Market/Products14Commercial Pipeline15Operational Capabilities16People and Culture17E

2、SG20Directors Report35Financial Statements36Statement of Profit or Loss and Other Comprehensive Income37Statement of Financial Position38Statement of Changes in Equity39Statement of Cash Flows40Notes to Financial Statements65Consolidated Entity Disclosure Statement66Directors Declaration67Independen

3、t Auditors Report72Shareholder Information74Corporate DirectoryATOMO ANNUAL REPORT 202401Increasingly recognised as a provider of user-friendly medical diagnostic devices.We are committed to driving innovation and enhancing patient outcomes through rapid,accurate point-of-care testing with less room

4、 for error.Atomos mission is to ensure equitable and affordable access to accurate diagnoses in decentralised settings offering a seamless pathway to treatment.Point-of-Care Finished Test ProductsTests for infectious diseases across point-of-care and self-test settings,distributed through an expandi

5、ng global network.Point-of-Care OEM TechnologyUnique blood and swab test devices and components,supplied to partners with capability to incorporate their own test assays into Atomo devices.Who We AreWe are an innovative diagnostics company supplying novel,integrated rapid diagnostic test devices and

6、 finished point-of-care rapid tests to global partners and increasingly direct to consumers.Atomos strategic focus is on two drivers of growth:ATOMO ANNUAL REPORT 2024Chairmans LetterDear Shareholders,I write to thank you for your continued support of Atomo Diagnostics(Atomo)and to introduce our Ann

7、ual Report.During the year the market saw continued growth in decentralised testing across both pharmacy retail and public health channels.Our continuing participation and advocacy of rapid testing to the benefit of community health aligns with the broader adoption of rapid testing within public hea

8、lth policy,as evidenced by the Australian Federal Government announcing funding for HIV self-tests as a key pillar of HIV health policy.Throughout the financial year,we saw continuing consumer adoption of rapid testing and the establishment of rapid tests as a ranged category across pharmacy retail

9、in developed healthcare markets.The material change in revenue mix and magnitude from the extreme demands for COVID tests during the pandemic has shifted to longer term demand for an increasing breadth of rapid diagnostic tests.The benefits of frequent,convenient testing reduce demands on facilities

10、-based testing resources.We are seeing a growing desire amongst people to exercise a greater level of control over their health.Self-testing allows individuals to conveniently,discretely and accurately assess and act based on their condition.Our partners continue to increase in number,reflecting gro

11、wing demand across products and markets and marking a new level of acceptance from regulators and public health of the merits of rapid testing in decentralised settings.John Keith Chair,Atomo BoardATOMO ANNUAL REPORT 202402a tool for broader community health management.We see this change in the cont

12、inued popularity and adoption of telehealth consultations and corresponding validation by health authorities,insurers and clinicians of the use of diagnostics in the home.Our Financial Management Atomos change year-on-year in revenue and sales mix reflected the absolute shift in demand with the pand

13、emic passing.This change allowed Atomo to prioritise the production and delivery of its existing patented products.The replenishment of Global Health budgets for HIV that were previously deployed for COVID testing and the widening demand for different types of rapid tests in consumer retail settings

14、 enable increased utilisation of our established production capacity.Making full use of this capacity to deliver growing sales remains our priority.During this period the company has had a focus on cost management with operational expenditure reducing year on year since FY22.You,Our ShareholdersThe

15、capital raised in early FY23 supports the commercial scale up of our HIV Self-Test business across international markets,supporting new customers seeking access to our products and an expanding pipeline opportunities for future business.We welcomed a number of new shareholders on to our register and

16、 their interest in and engagement with the company.Our People The people who make up Atomo-its executives,management and board-are working tirelessly on the opportunities for rapid diagnostic testing.Our management team have led with care and insight throughout the year,navigating conditions that ha

17、ve offered changing opportunities and different risks.On behalf of shareholders,the board warmly recognises these considerable efforts.Atomo continues to deliver on its objective to be a global leader in rapid diagnostics.Adoption of rapid diagnostics during the pandemic has changed users behaviours

18、 and expectations of testing.Atomo continues to meet this demand.We welcome your continuing support and hope that you share in our excitement.John Keith Chair,Atomo BoardOur Business Atomo develops and supplies integrated test devices and finished test products for use by healthcare professionals as

19、 well as patient self-testing.Atomo has a long-term strategic focus in three key areas:1.Sexual Health TestingThe development,commercialisation,and sale of finished rapid test products,such as Atomos HIV Self-Test.Demand for Atomos HIV Self-Test spans participation in Global Health programmes and,in

20、creasingly,in developed markets including in Australia and the UK.Atomos HIV Self-Test remains the only ARTG-listed self-test,and Australian distribution channels are ever widening to include an increasing number of pharmacies,vending machines in university campuses and licensed sex-on premises and

21、through online mail out channels.Outside of Australia,our partnerships with Viatris for global health markets and Newfoundland Diagnostics across Europe and the UK,see Atomos HIV Self-Test actively promoted.2.OEM+Devices Atomo partners in developing and supplying integrated test platforms that deliv

22、er our partners finished rapid tests to end users.The extent of our involvement in this process sees us describe the Original Equipment Manufacturer activity as OEM+,reflecting the fact that Atomo is increasingly supporting with product approvals and commercialisation well beyond simply supplying as

23、sembled cassettes.Tests include Lumos Diagnostics FebriDx bacterial detection test and NG Biotechs early pregnancy test.We celebrated Lumos 510(k)clearance from the FDA for its FebriDx test,representing the first 510(k)approved test from the US FDA on Atomos Pascal platform.Atomos partnership with N

24、G Biotech in pregnancy testing involves our option to distribute in new markets,including the US,Australia and New Zealand,subject to regulatory approvals.3.Consumer Health and WellnessResponding to decentralising health services and increasing demand from consumers for greater convenience and owner

25、ship of the healthcare experience,Atomos user-centric solutions allow end users timely and accurate rapid test results.This change is visible in discussions with rapid test development companies looking to partner with Atomo by using our platforms to house their tests.The adoption of rapid testing e

26、nables the decentralisation of screening diagnostics,and the widespread acceptance by regulators and by public health authorities who increasingly see its value as ATOMO ANNUAL REPORT 202403The performance of Atomos integrated blood test products positions the company as an increasingly recognised p

27、rovider of leading user-friendly rapid test solutions.This has facilitated our securing agreements with new commercial partners that supported the successful launch of our HIV Self-Test products into leading retail chains in a number of developed markets.This included leading UK channel partners Tes

28、co supermarkets and Boots pharmacies and Blooms the Chemist among others in Australia.The ranging of HIV self-tests in mainstream pharmacy retail channels further highlights the structural changes in the diagnostic market and speaks to the opportunity for Atomo to expand test menu in this growing se

29、gment.This valuable experience of launching in consumer and self-test focused channels in Australia and in the UK assists us in providing possible pathways to enter other markets,including in the US.Our strategic goal of expanding the HIV test business across key international markets is supported b

30、y success during the year entering both consumer and public health focused channels.CEOs ReportJohn Kelly Chief Executive OfficerThe point-of-care-test diagnostic market continues to move beyond the impact of a COVID-19 pandemic which brought significant changes to the testing landscape.This include

31、d how public health agencies think about large scale testing,especially in the home and increased consumer acceptance of and interest in self-testing.Post-pandemic,diagnostic companies saw reduced revenues and market valuations as large scale COVID testing disappeared.Atomo is pleased to now see rev

32、enues start to improve from this post-pandemic low,as opportunities created by the transition to decentralised testing now start to show momentum delivering an improvement in non-COVID business fundamentals.Atomo has,over the course of the financial year,continued to penetrate in the Australian phar

33、macy market with more than 100 new pharmacies now stocking the HIV test.This year also saw public health funding for procurement and supply of HIV self-tests free to users in Australia for the first time.A milestone that reflects a larger transition to the use of at-home self-testing as a key tool f

34、or the diagnosis and management of infectious and chronic disease in the community.During the year we supplied more than 250,000 tests to Newfoundland Diagnostics to support product launches in a number of European countries and Colombia,and we also recently secured registration for a six language E

35、astern European product variant.We supplied more than half a million tests to our global health partner Viatris to date during 2024,who continue to supply our test into a number of African and Asian markets.During the year,Atomo started working closely with Burnet Diagnostics on the development and

36、commercialisation of novel rapid test assays being ATOMO ANNUAL REPORT 202404 1 CLIA Waiver typically increases by 500%the number of locations where a POCT test can be used,compared with 510(k)only2 OpEx excluding one off inventory write offs&impairment of intangibles in comparative periods.Our busi

37、ness priorities for the coming year are clear:Progress go-to-market pathways to support entry into CLIA Waived and over the counter(OTC)channels in the key US market Continue restructuring of Atomos operational footprint to continued targeted reduction in Cost of Goods and OpEx Complete strategic pa

38、rtnership agreement with Burnet Diagnostics for development and commercialisation of further Pascal-based finished tests Secure new customers for Atomo cassette development/supply Establish pipeline of development services programs that generate near term services fee revenues with a goal of convert

39、ing to long-term supply agreements for cassette supply Deliver customer proprietary technology solutions beyond lateral flow,where workflows remain a challenge that Atomos patented modular technology can address.optimised on our Pascal cassette.This partnership includes a test that screens for activ

40、e syphilis infection in both professional and self-test settings,reflecting our continued focus on sexual health.A second test measures liver function and appears to have significant clinical utility across a range of therapeutic areas where liver function is an important marker of health,as well as

41、 having utility in clinical trials where there is a risk of liver toxicity.Initial production orders for Pascal cassettes to support an initial trial have recently been received.We were pleased to see an increase in overall demand for Pascal from customers.Regulatory approval for Lumos Diagnostics F

42、ebriDx test on our Pascal platform in the important US market was secured during the year,with CLIA Waiver now underway.This is the next step towards ensuring that Pascal has established regulatory pathways that supports a broad range of test applications and use settings in the US.Securing CLIA Wai

43、ver would significantly expand the number of healthcare and community settings in the US where the FebriDx test can be used1,and further increases the attractiveness of Pascal to a broader range of US market participants.There has been a focus on raising awareness of Atomos technology solutions in t

44、he diagnostics market with the company attending two US conferences in recent months.Attention is also now being turned to opportunities to adapt Atomos core functionality from the current formats used to support lateral flow testing towards solutions optimised for POC reader and rapid molecular for

45、mats.These increasingly important diagnostic formats seek to address a number of the limitations with lateral flow,but typically still suffer from user workflow challenges and complexities that limit adoption in decentralised and at-home settings.The patented functionality developed by Atomo support

46、s a range of diagnostic formats and we are excited about the opportunity to expand the areas of the market where we can deliver solutions and provide meaningful performance improvements moving forward.The company has worked hard over the period to reduce operating expenses across the business with a

47、pproximately$2 million removed from OpEx2 during FY24.This follows an OpEx reduction of$1.5 million for FY23 and cost continues to remain an area of management focus moving forward.This cost out strategy positions the business for scale and provides a lower fixed cost of goods and services moving fo

48、rward.As we move through FY25,we look forward to continued expansion of our core HIV test business and to supporting commercialisation of new customers and solutions utilising Atomos integrated test solutions across point-of-care and at-home channels.We also look forward to an expanded regulatory an

49、d commercial pathway to support market expansion by way of having a CLIA Waived test on Pascal in the US market.John Kelly Chief Executive OfficerThis prudent cash management saw the company close out the FY24 period with$3.69 million cash on hand,remaining debt free.ATOMO ANNUAL REPORT 202405The Em

50、ergence of Home TestingThe global point-of-care diagnostics market is projected to exceed US$75 billion by 20303 highlighting increasing demand for decentralised testing solutions more broadly and reflecting acceptance of rapid testing at home.Among the factors driving this growth is the simplicity

51、and cost effectiveness of lateral flow assays(LFA).LFAs are a core segment of point-of-care testing which is gaining traction in a market traditionally dominated by laboratory testing.The COVID-19 pandemic accelerated this shift and changed the testing landscape,highlighting the utility of testing a

52、way from clinical settings and creating a more favourable regulatory and clinical environment for decentralised testing.This shift is evident in the widespread availability of rapid tests in the market,which have become standard ranged items in pharmacy retail channels.Major retailers like Tesco and

53、 Boots in the UK and CVS in the US are increasingly ranging this product category,signalling a changed market landscape and growing consumer demand.Diagnostic LandscapeThe Shift Towards Decentralised TestingWithin public health,there is a growing recognition on the importance of self-testing,especia

54、lly for infectious diseases.Decentralised delivery improves the efficiency of healthcare services and in the case of sexual health,also helps to address social and cultural barriers to testing.It also delivers a level of convenience and discretion not available with facility-based testing services.T

55、he economic benefits of public health funded at-home testing as part of wider healthcare initiatives are also becoming increasingly clear.As the healthcare landscape continues to evolve,the rise of at-home testing,including OTC purchased and physician prescribed,represents a fundamental expansion of

56、 the POCT market.The convergence of technology,consumer demand,and supportive regulatory environments is paving the way for a future where at-home testing is not only a viable alternative,but a preferred choice for many aspects of healthcare.3 BusinessWire ATOMO ANNUAL REPORT 202406Emergence of Publ

57、ic Health Support in AustraliaIn the 2024 Federal Budget released in May,the Australian Federal Government announced a commitment of A$43.9 million to HIV services,marking a significant investment in the fight against HIV.This funding included for the first time a commitment to procurement and scale

58、 up of HIV self-testing nationally.National Association of People With HIV Australia x GrindrOne key initiative now directly funded by the government is the free to user test mailout program implemented by the National Association of People with HIV Australia(NAPWHA).This program,set up in late 2023

59、 by NAPWHA and supported by Atomo,enables individuals to receive two free HIV self-tests every six months via an internet portal and home delivery.The initiative has been extremely successful in reaching key populations through direct awareness via the Grindr for Equality program,which provides free

60、 advertising and promotion to the LGBTQ+dating community utilising the Grindr App.Data from the pilot phase of the program indicated that the program has been helpful in supporting testing among harder to reach groups,with more than 40%of testers never having tested or not having tested in the last

61、two years.National Vending Machine ProgramsVending machine programs have also been a pivotal component of expanding access to HIV testing,particularly among cohorts not usually testing through existing facilities-based services.Atomo has worked with SAMESH to support the Connect program which pionee

62、red delivery of HIV self-tests via vending machines in South Australia,as well as working with Queensland Positive People to establish and upscale the RAPID program,with vending machines placed in locations throughout Brisbane.National scale up of this model for test distribution has now been funded

63、 by Federal Government in the recent budget,with Thorne Harbour selected to implement the scale up phase over the next two years.The New South Wales Ministry of Health supported by Atomo,established a statewide vending machine program in New South Wales earlier this year.Branded MyTest,vending machi

64、nes have been strategically placed on university campuses and in other venues across the state,with more installations across the state planned for the coming year.Atomo is extremely proud to have been instrumental in supporting the set up and validation of these novel channels that improve access t

65、o free-to-user testing,and the company looks forward to working with all levels of government and community organisation to continue to see these initiatives expanded nationally to reflect the growing demand for reliable and convenient self-testing across Australia.ATOMO ANNUAL REPORT 202407Unique S

66、olutionsAtomos solutions to improve the ease and reliability of rapid testing have been developed with the user at the centre of the development process.The functionality integrated into our products simplifies the steps of use to run a test and have been proven to deliver reduced errors in use.This

67、 best-in-class usability also supports very high levels of user preference over multi-component test kit formats.Features such as a built-in safety lancet,accurate controlled blood collection and delivery,button activated buffer reagent delivery,and interlock features ensure critical steps of use ha

68、ppen in the correct sequence and remove or minimise common causes of error.The exceptional usability and user preference delivered by the Atomo Pascal Platform has enabled Atomo to enter into long term supply agreements with diagnostic companies looking to integrate their own tests with Atomos techn

69、ology.Notably,NG Biotech and Lumos Diagnostics have developed specialised tests on the Pascal platform and utilised Pascals usability performance to secure regulatory approvals for their tests across international markets.At the start of financial year 2024,Lumos secured US FDA 510(k)clearance of it

70、s FebriDx test on Pascal Platform and more recently announced a funded CLIA Waiver process for their FebriDx test in the US.CLIA Waiver of the FebriDx test assists in the differentiation of viral and bacterial acute respiratory infections.NG Biotech is a French diagnostics company focusing on the de

71、velopment and manufacture of novel in-vitro diagnostics products for therapy monitoring at the point-of-care.Utilising Atomos Pascal platform,NGs blood-based Precision+Pregnancy Test offers results in 5 minutes.Pregnancy levels build up earlier in blood than in urine and unlike urine,hCG levels do n

72、ot decrease in blood after first morning flow.Registered and launched over the last 18 months in France,the UK,Spain,Italy,Portugal,the UAE and Brazil,NG continues to expand its commercial rollout across key international markets.ATOMOs PASCAL DEVICEGreater than 90%reduction in blood delivery errors

73、90%REDUCTIONSimple to use products providing reliability and usability in decentralised settings1.EASY TO USE100%reduction in buffer delivery errors100%REDUCTIONAlmost 3 minutes faster40%FASTER90%of participants indicated Pascal was easier to use90%EASIERUnique solutions provided in Atomo platforms

74、for Future of POC&at-home testingThree key competitive advantages of Pascal Platform over Standard CassettesRapid results with a high degree of accuracyAccessibility online and increasingly through retail and via healthcare professionals2.SPEED OF RESULTS3.EASY TO OBTAIN&AFFORDABLEATOMO ANNUAL REPOR

75、T 202408*as of end of Aug 2024ATOMO ANNUAL REPORT 202409Key MetricsWith runs on the board,Atomo is making an impact in the rapid test marketAPPLICATIONSNumber of clinical applications successfully verified on Atomo cassettesPATENTSNumber of individual granted patents across various countriesPASCAL U

76、SER PREFERENCEUsers prefer Atomos testsPRODUCTIONAnnual production capacity for cassettesREGISTRATIONSNumber of countries with Atomo products successfully registeredOEMNumber of Atomo cassettes supplied to OEM market*ATOMO TESTSNumber of rapid tests manufactured and supplied*CAPACITYValidated approv

77、ed HIV Self-Test capacity17.7m90%454.5m4m3.6m965TechnologyAtomo is dedicated to empowering individuals to lead healthier,more informed lives through fast and accurate testing solutions.By reimagining diagnostics,we prioritise the user experience,ensuring that our devices are both intuitive and relia

78、ble.In the rapidly advancing field of point-of-care diagnostics,Atomo has emerged as an innovator in usability,developing integrated technologies that simplify workflows while enhancing the accuracy of rapid testing.Our commitment to reducing errors and minimising complexity is central to our missio

79、n of making diagnostic testing more accessible for all.ATOMO ANNUAL REPORT 202410Digital Health:Digital Reader and Mobile applications for error free semi-quantitative results through image recognitionElion:Optimised Workflow for Lateral Flow TestsCurie:All in One Sample Pre-mixing and Delivery Solu

80、tionATOMO ANNUAL REPORT 202411Market/ProductsHIVAtomos HIV business continues to gain traction across Australia,with significant growth in the retail pharmacy sector seen over the last year.Currently,more than 300 pharmacies in Australia are retailing the Atomo HIV Self-Test,a number that is growing

81、 significantly year on year.This expansion reflects the increasing demand for convenient,accessible HIV testing solutions and highlights growing awareness of the ability for people to be able to purchase a HIV self-test in Australia.Blooms The Chemist recently adopted the Atomo HIV Self-Test as a co

82、re product.This designation means that the test is now automatically distributed by Blooms Head Office to all Blooms retail outlets across Australia,significantly increasing its availability outside of urban areas where access to facility-based testing is reduced.Looking ahead,Atomo is poised for fu

83、rther expansion in the Australian market.A deal with the Independent Pharmacies of Australia Group(IPAG)has been signed by both Atomo and IPAG.IPAG is currently in the process of disseminating information to individual retailers that fall under its umbrella,which will make the Atomo HIV Self-Test av

84、ailable in up to potentially 2,500 pharmacies nationwide.Atomo is planning to launch the Atomo HIV Self-Test in New Zealand during FY25 after successful discussions with retail and wholesale groups.These developments highlight Atomos ongoing focus on expanding access to HIV testing in Australia&New

85、Zealand across private and public channels.(For information on the progress in the Public Health market in Australia,please refer to the Diagnostic Landscape Section,Pages 6 and 7).Outside of Australia,the World Health Organization(WHO)estimates that the HIV self-testing market in low-and middle-inc

86、ome countries(LMICs)could reach a value of$US58 million by 20254.In this market,Atomo is positioned as the only manufacturer currently offering an African-made,prequalified HIV self-test.Viatris has purchased 540,000 HIV self-tests so far during 2024 and we are encouraged by progress in this market

87、over the last year.In Europe,the trend post COVID,of consumer self-tests gaining popularity in mainstream retail channels such as pharmacies,supermarkets,and via e-commerce platforms is further accelerating adoption.In 2022,around half a million at-home HIV tests were supplied in the UK5,showcasing

88、the growing demand for convenient and accessible health solutions.Atomo has supplied 250,000 tests to Newfoundland Diagnostics over the last 18 months to support product launch in a number of European markets and in Colombia.The product is now stocked by Boots Pharmacies and Tescos Supermarkets in t

89、he UK,as well as in pharmacy chains in Germany and the Netherlands.Atomo recently received a new CE Mark approval from BSI for a Newfoundland Eastern European language.ATOMO ANNUAL REPORT 202412SyphilisSyphilis is a sexually transmitted infection(STI)that progresses through different stages and can

90、cause a wide range of symptoms over time if left untreated.Currently,diagnosing syphilis requires two separate tests.The first to detect the presence of antibodies to syphilis infection and the second,a test in the laboratory,to distinguish between an active infection and antibodies present from a p

91、ast-treated infection.This two-step process can cause delays,unnecessary anxiety and loss of follow-up opportunities.In resource limited settings where treatment is often commenced after a positive result from an antibody test,the result is significant over-treatment of patients with no active syphi

92、lis and increased risk surrounding antibiotic resistance.Atomo is working with Burnet Diagnostics Initiative,part of the Burnet Institute on co-development of a lateral flow test on Pascal to diagnose active syphilis.This test offers a significant advancement by distinguishing active syphilis infect

93、ions from past-treated infections as well as providing unmatched usability on an Atomo cassette.Syphilis is a growing public health challenge and represents a significant market opportunity across both public and consumer health channels.Globally,8 million new syphilis cases were reported in 2022,ca

94、using an estimated 220,000 neonates deaths and stillbirths6.The USA has also seen a dramatic rise,with 203,500 recorded cases,the highest number since 1950,and a 78.9%increase over five years7.4 Unitaid5 UK Government6 World Health Organization7 Center for Disease Control and PreventionATOMO ANNUAL

95、REPORT 202413Commercial Pipeline Other applicationsIn our efforts to expand and diversify our product offerings,Atomo is developing a range of innovative solutions across several critical healthcare areas.First,we are expanding our existing offerings within the sexual health market.In addition,we ar

96、e working with partners on diagnostic tests for monitoring chronic conditions such as ALT(alanine aminotransferase),which helps to monitor liver health,particularly for patients managing conditions like fatty liver disease or those taking medications that affect liver function.We are also focused on

97、 developing integrated digital health solutions by creating app-connected diagnostic devices.These devices will provide users with real-time data,historical health trends,and telehealth connectivity.Furthermore,we aim to incorporate AI-enhanced interpretation into these apps,delivering personalised

98、health insights and actionable recommendations based on test results.Our technology can also be applied to POC molecular and microfluidic based diagnostics platforms.This includes lab-on-a-chip solutions that perform intricate biochemical assays within a compact format,making them ideal for multiple

99、x testing and real-time analysis.Additionally,these platforms will automate sample processing,streamlining diagnostics for both point-of-care and home use.Lastly,we are adapting our Pascal platform to be compatible with traditional lateral flow cassette formats.This re-engineering broadens its appli

100、cation potential,allowing for seamless integration with existing lateral flow diagnostics and making Atomo solutions more attractive to potential customers.These initiatives position Atomo at the forefront of self-testing and chronic disease management,while leveraging cutting-edge microfluidic tech

101、nologies to remain a leader in the diagnostic industry.ATOMO ANNUAL REPORT 202414Operational Capabilities Currently,Atomo operates a certified manufacturing facility in Cape Town,South Africa,producing the only prequalified HIV self-test made on the continent for global health use,with a current cap

102、acity to produce up to 3 million self-tests annually.Atomos South African facility is prepared to meet the growing demand for HIV self-tests,which is projected to grow to US$531m by 2026 at a CAGR of 30%8.This very high growth rate is driven by convenience and privacy offered by self-testing kits as

103、 well as growing initiatives by public health to promote HIV testing.Atomos Cape Town facility currently employs around 20 staff.Local manufacturing of diagnostics in Africa promotes job creation,skills development,and significantly reduces logistics costs and the environmental impact of test distri

104、bution within the region.The US Presidents Emergency Plan for AIDS Relief(PEPFAR)plans to procure 15 million HIV tests from African manufacturers by 2025,with a budget of approximately$20 million allocated9.PEPFAR alone allocates around$750 million annually on HIV-related products,including tests an

105、d antiretroviral treatments.Key facility features:Fully validated and verified equipment and processes Audited and certified by WHO,TGA,BSI(ISO 13485:2016),and SAHPRA Supports large batch production with flexibility for smaller batches during scale-up Production capacity supporting up to 3 million f

106、inished tests annually.8 Verified Market Research9 PEPFARATOMO ANNUAL REPORT 202415People and CultureOver the past year,our focus on engagement and employee wellbeing has led to the introduction and enhancement of several key initiatives.Our recent employee wellbeing survey results have provided val

107、uable insights into our workplace environment,underscoring our strengths and guiding our efforts for continuous improvement.It was pleasing to see that key survey findings show our team has a strong sense of purpose and meaning in their work,highlighting our success in aligning individual roles with

108、 organisational goals related to delivering improved health outcomes globally.There is a clear understanding of roles and responsibilities,and employees appreciate the flexibility they are given in how they approach their tasks,which enhances overall efficiency.To build on these positive results,we

109、have introduced several initiatives,including an Employee Assistance Program(EAP)offering our team 24/7 access to support,resources and tools to help manage their wellbeing.Our people are looking for more opportunities to connect,recharge and give back.To strengthen workplace relationships and enhan

110、ce connection we shared self-introductory videos at weekly meetings across the global team.The act of working together as a team to give back through volunteering is a reminder of the power of connection and shared purpose.It strengthens bonds and helps foster a sense of community and collective ach

111、ievement that extends beyond the workplace.These initiatives reflect our commitment to fostering a supportive and positive work environment.We are dedicated to continually improving our workplace practices,based on employee feedback and emerging needs.What are you most passionate about?“Im most pass

112、ionate about World peace,the suffering of people around the globe hurts me enormously.I dream of seeing our planet full of peace worldwide”Dr Mohammed Imran Senior Product Development Engineer Melbourne,AustraliaWhat do you like most about working at Atomo?“Having the opportunity to learn and gain d

113、eeper knowledge in the finance and manufacturing processes”Susan Evi Supply Chain and Finance Coordinator Sydney,AustraliaTell us an interesting fact about yourself“I wanted to be a professional footballer,I reached 1st Division,unfortunately due to an injury I couldnt continue.”Moereed David Materi

114、als Handler Cape Town,South AfricaOur South African team preparing food for an orphanage in Cape Town,South Africa Connection:Some excerpts from our Self introductory videoCorporate responsibility Giving backVolunteering at Banish-our team sorted through 146 parcels and recycled 159 kg!ATOMO ANNUAL

115、REPORT 202416Environmental,Social&GovernanceSAFE&HEALTHY EMPLOYMENTEnsuring our employees work in a safe environment with opportunities for training and growth,addressing health and safety concerns as they arise and mitigating the risk of re-occurrence of incidentsThe following sustainability issues

116、 are most material to our business and are important to key stakeholders such as investors,consumers,customers,suppliers,governments and employees.PRODUCT QUALITY&SAFETYChoosing materials from quality sources,complying with ISO 13485 Medical Devices Quality Management,and delivering safe products to

117、 customers and investigating all concerns to ensure our products maintain the highest qualityCORRUPTION&BRIBERYEthical business practices relate to every aspect of Atomos business,from identifying product sources,through the development of diagnostics,transactions with regulatory bodies and sale to

118、customersRESOURCE USE&WASTE MANAGEMENTIncludes energy usage during manufacture and logistics,water usage and waste as a by-product of manufacture,with particular consideration given to the fact that the products are classified as medical waste upon useETHICAL PURCHASING&HUMAN RIGHTS IN THE SUPPLY CH

119、AINResponsibility to partners to ensure our product line is free from human rights concerns such as forced labour and trafficking,unsafe labour standards and unfair treatmentENVIRONMENTAL REGULATIONFocused on meeting or exceeding environmental regulation across its operations globallyPRODUCT PRICING

120、&ACCESSIBILITYStrategies and initiatives designed to provide more affordable diagnostic pricing and accessibility to products for patients through development,manufacture and marketing of high-quality generic and branded products,with a particular focus on accessible diagnostics for the global healt

121、h and Lower and Middle Income marketsCOMPLIANCEResponsibility to drive compliance with legal and regulatory requirements applicable to our global business.Includes development of policies and controls,communication and training,oversight and continuous improvementATOMO ANNUAL REPORT 202417ATOMO ANNU

122、AL REPORT 202418ATOMO ANNUAL REPORT 202419Financial Report2024Atomo Diagnostics LimitedABN 37 142 925 684Annual Report 30 June 2024Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Principal activities The principal activities of the group during the course of the year wer

123、e the development and sale of medical devices.There were no significant changes in the nature of the activities of the group during the year.Review of operations The loss for the group after providing for income tax amounted to AUD6,847,803(30 June 2023:AUD9,957,632).Revenue of approximately$4.1m co

124、mprised$3.2m for HIV sales,$730k for OEM sales and remaining$120k for development fees and other revenue.Overall revenue increased by 61%when compared to FY23 revenue results,driven by the growing demand for Atomos HIV Self-Tests globally.Cash and cash equivalents at 30 June 2024 amounted to$3.69m c

125、ompared to$6.47m as at 30 June 2023.Ongoing measures continued to be undertaken during the period to reduce operating expenditure for the group.Overall operating expenses reduced year on year by$2m,equivalent to 19%when compared to the prior period(excluding one-off inventory write offs&impairment o

126、f intangibles in comparative periods).With investment already made in the development and commercialisation of Atomos novel patent-protected technology,and with manufacturing capacity installed and validated,capital expenditure has reduced very significantly.We continue to focus on investing prudent

127、ly in key areas of the business to support market facing and revenue generating activities.The business is in a prime position to materially increase sales revenue without requiring corresponding increases in underlying operating costs.Business development activities continue to focus on re-establis

128、hing and growing our OEM customer base,with particular focus on the US market following Lumos Diagnostics successfully obtaining a 510(k)clearance for its FebriDx test on the Atomo Pascal device.NG Biotech have launched their blood pregnancy self-test in a number of European countries and in Brazil,

129、further validating the regulatory scope of important existing markets where Pascal supports clearance for self-testing.Significant changes in the state of affairs There were no significant changes in the state of affairs of the group during the financial period.Matters subsequent to the end of the f

130、inancial period No matter or circumstance has arisen since 30 June 2024 that has significantly affected,or may significantly affect the groups operations,the results of those operations,or the groups state of affairs in future financial years.Likely developments and expected results of operations Wi

131、th approximately$3.69m of cash at bank and no debt,Atomo continues to pursue its key priorities while remaining focused on conserving capital over the medium term.Continued rollout of HIV self-testing globally,including the UK where the test is now available in Boots and Tescos and into Eastern Euro

132、pe,as well supporting national scale up of HIV self-testing via government funded programs.Focus on the expansion of Atomos point-of-care(POC)cassette supply business,especially in the US market where the recent FDA 510(k)clearance obtained by Lumos Diagnostics for their test on the Atomo Pascal dev

133、ice opens a pathway for Atomo product and for new Diagnostics partners seeking improved user-friendly solution for POC and self-test markets.Growing the emerging development services business where Atomo is being paid to develop products and custom solutions for partners seeking access to Atomo tech

134、nology and products.Business risk The group has identified the following material business risks that may cause its revenue and profitability to decline and are important to key stakeholders such as investors,consumers,customers,supplier,governments and employees.Regulatory risk:The group sells medi

135、cal devices and finished products that require regulatory approvals to bemaintained(for existing approved products),and to be obtained(for new products)in multiple jurisdictions.Thisincludes obtaining and maintaining product approvals from the TGA in Australia,the FDA in the US,Health Canada inCanad

136、a,comparable bodies in Asia and South America,the World Health Organisation for LMIC global health markets,and compliance with the IVDD and IVDR regimes in Europe.There are risks associated with these regulatory approvalsthat may impact on the business should approvals be withdrawn for existing prod

137、ucts or not obtained for new products.Product quality and safety:Should quality or safety issues arise with Atomos products,there is the potential for negative financial and or reputational impacts.To mitigate this risk Atomo sources materials from quality suppliers,complies with ISO 13485 Medical D

138、evices Quality Management,and delivers safe products to customers.Atomo aims to adhere to or exceed strict regulatory standards in all jurisdictions that it serves,and investigates all concerns to ATOMO ANNUAL REPORT 202420Atomo Diagnostics Limited Directors report For the period ended 30 June 2024

139、ensure our products maintain the highest quality.We are frequently inspected by independent regulatory authorities auditing compliance with these standards.Compliance:Responsibility to drive compliance with legal and regulatory requirements applicable to our global business.Includes development of p

140、olicies and controls,communication and training,oversight and continuous improvement.Consequently,compliance affects every aspect of what we do,to deliver quality products to consumers.Supply chain:Responsibility to partners to ensure our product line is free from human rights concerns such as force

141、d labour and trafficking,unsafe labour standards and unfair treatment.Atomo relies on third party manufacturers in certain areas and as such has potential exposure to supply chain disruption risks.The company takes steps to stay closely engaged with its supply chain and ensures sufficient stock on h

142、and to mitigate this risk.Employees and skilled labour:Atomos business relies on key qualified personnel.Ensuring our employees are appropriately remunerated and work in a safe environment,which meets or exceeds relevant regulatory expectations,addresses health and safety concerns as they arise and

143、mitigates the risk of reoccurrence of incidents.Operational risk:Atomo has international operations,including a manufacturing facility in South Africa and as such is potentially exposed to additional risk from political,legal,economic and regulatory risk specific to those locations.Atomo operates in

144、 a competitive industry:Strategies and initiatives designed to provide diagnostics at competitive prices to ensure it can develop,manufacture and market high-quality generic and branded products,with a particular focus on accessible diagnostics for the global health and Lower and Middle Income marke

145、ts.Corruption and bribery:Business must be conducted with transparency,and free from unethical persuasion.Ethical business practices relate to every aspect of Atomos business,from identifying product sources,through the development of diagnostics,transactions with regulatory bodies and sale to custo

146、mers.Resource use and waste management:Includes energy usage during manufacture and logistics,water usage and waste as a by-product of manufacture,with particular consideration given to the fact that the products are classified as medical waste upon use.Climate risk:The board is considering on an on

147、going basis the potential response to climate risk and considering potential implementation of a formal review and policy response in future years.The Board believes that the group has adequate systems in place for the management of its exposure to business risk.The groups operations are not subject

148、 to any significant environmental regulation under Australian Commonwealth or State law.Information on directors Name:John Keith Title:Non-Executive Chair Experience and expertise:John Keith has served as a Non-Executive Director of Atomo since December 2011 and became Chair in 2014.Mr Keith is one

149、of the Managing Directors at BNP Paribas,establishing and leading its financial institutions coverage team.Prior to joining BNP Paribas in 2011,Mr Keith held country management and senior business and coverage positions for Nomura Securities in Sydney and Hong Kong.His career comprises working with

150、supranational,sovereign and institutional clients across all areas of investment and institutional banking.Mr Keith holds a Bachelor of Arts(Hons)majoring in Economic History from the Victoria University of Wellington,a Master of Applied Finance from Macquarie University and a Global Executive MBA f

151、rom the University of Sydney.Other current directorships:Nil Former directorships(last 3 years):Nil Special responsibilities:Member of the Audit and Risk Committee and Member of the People,Culture Nomination&Remuneration Committee.Interests in shares:3,261,056 Interests in options:Nil Contractual ri

152、ghts to shares:Nil ATOMO ANNUAL REPORT 202421Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Name:John Kelly Title:Managing Director and CEO Experience and expertise:John Kelly is the Managing Director and CEO of Atomo.For 25 years Mr Kelly has focused on developing and

153、commercialising innovative healthcare products that enhance usability and performance,having started with CR Bard in Europe developing Class III implantable cardiology products.Prior to co-founding Atomo in 2010,Mr Kelly acted as the Chief Operating Officer(COO)of Unilife Corporation,which was previ

154、ously an ASX-listed company(ASX:UNS)and subsequent to his departure,a Nasdaq listed company(NASDAQ:UNIS).At Unilife Corporation,he led the global operations team from 2005 to 2008,developing Unifill,the worlds first glass prefilled drug delivery device with integrated auto retract safety feature,and

155、 this technology was successfully licensed to Sanofi Aventis.Prior to joining Unilife in 2005,Mr Kelly spent five years at ResMed where he led the New Product Implementation Group and managed the development of the ground-breaking Mirage Swift and Activa mask systems.Mr Kelly holds an Honours degree

156、 in Mechanical Engineering from the University of Liverpool,a Masters degree in Manufacturing Systems Engineering from Queens University Belfast,and an Executive MBA from the University of Sydney,where he was awarded the Business Schools inaugural Excellence in Leadership scholarship.Other current d

157、irectorships:Nil Former directorships(last 3 years):Nil Special responsibilities:Nil Interests in shares:72,490,248 Interests in options:666,666 Contractual rights to shares:Nil Name:Paul Kasian Title:Non-Executive Director Experience and expertise:Dr Kasian is an experienced executive director with

158、 demonstrated success in both domestic and international companies encompassing senior leadership,strategy,investment and risk roles.His other roles have included Chief Investment Officer and Head of Global Financials at HSBC Asset Management,Founding Director of Accordius and Founding Director of W

159、allara Asset Management.He holds a PhD in Microbiology and a Master of Business Administration,both from the University of Melbourne,and is a Graduate Member of the Australian Institute of Company Directors.Other current directorships:Dr Kasian is currently Non-Executive Director(appointed 31 August

160、 2016)and Chair(appointed 15 September 2018)of IODM Limited(ASX:IOD).He was appointed a Non Executive Chairman of Diamond Key International on 7 December 2022.He is also Non Executive Chairman of Sedarex(appointed July 2023).Former directorships(last 3 years):Non-Executive Director of Eco Systems Lt

161、d Special responsibilities:Chair of the Audit and Risk Committee and member of the People,Culture,Nomination&Remuneration Committee.Interests in shares:100,000 Interests in options:Nil Contractual rights to shares:Nil ATOMO ANNUAL REPORT 202422Atomo Diagnostics Limited Directors report For the perio

162、d ended 30 June 2024 Name:Deborah Neff Title:Non-Executive Director Experience and expertise:A veteran of the life sciences industry,Deborah has spent most of her career building market-leading global businesses.As principal of DJN Consulting,LLC based in the San Francisco Bay Area,Deborah currently

163、 works with several privately held healthcare start-up companies providing strategic business advice and mentoring to the executive management teams.Previously was CEO of Evanostics,LLC,Pathwork Diagnostics Inc,and COO at Complete Genomics following a 15 year career with Becton Dickinson,where she l

164、ast served as President of BD Biosciences,a major global business unit of the company.She is an executive Trustee and Chair of the Foundation Board at the University of California,Davis.She serves as an independent Director and member of the Governance committee for Guide Dogs for the Blind,Inc.a no

165、n-profit organisation.Deborah holds a Bachelor in Science degree from the University of California,Davis.Other current directorships:Non-Executive Director and a member of the audit and nominating/governance committees at Cytek Biosciences,Inc.Former directorships(last 3 years):Nil Special responsib

166、ilities:Chair of the People,Culture,Nomination&Remuneration Committee and member of the Audit and Risk Committee Interests in shares:Nil Interests in options:Nil Contractual rights to shares:Nil Name:Cheri Walker Title:Non-Executive Director Experience and expertise:Dr.Walker is an executive with mo

167、re than twenty-five years of experience working with life science and diagnostic companies.Dr.Walker is currently the Chief Executive Officer of Zeta Corporation.She has previously held senior executive positions at Abcam;Charles River Labs;Qiagen,and Life Technologies,now part of ThermoFisher.Dr.Wa

168、lker holds a BA in Biology from Swarthmore College and a Ph.D.in Human and Molecular Genetics from Baylor College.Other current directorships:Nil Former directorships(last 3 years):Director CellIDx,Director BrickBio,Director of Rhinostics Special responsibilities:Member of the Audit and Risk Committ

169、ee Interests in shares:Nil Interests in options:Nil Contractual rights to shares:Nil ATOMO ANNUAL REPORT 202423Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Name:Curt LaBelle Title:Non-Executive Director (Resigned on 20 December 2023)Experience and expertise:Curt LaBel

170、le has served as a Non-Executive Director of Atomo since October 2016.Dr LaBelle has been actively involved in the healthcare industry for over 20 years,both operationally and as an investor.Previously,Dr LaBelle was President at the Global Health Investment Fund(GHIF),a social impact investment fun

171、d,which manages approximately US$108 million backed by the Gates Foundation,JP Morgan and others.He also serves as a director on the boards of Z Optics,Revelation Bio and Atticus Medical.Prior to joining GHIF,Dr LaBelle was Managing Director at Tullis Health Investors andVice President at Investor G

172、rowth Capital.He is a former chairman of Impulse Monitoring(acquired by Nuvasive),Exagen Inc.(NASDAQ:XGN)and a former director of Sirion Therapeutics(products acquired by Alcon and Bausch),SafeOp Surgical(acquired by AlphaTec)and KAI Pharmaceuticals(acquired by Amgen).As Dr LaBelle is President at G

173、HIF,a substantial shareholder of Atomo,Dr LaBelle is not considered to be an independent Director.Dr LaBelle holds a Bachelor of Economics from Brigham Young University,and MD and MBA degrees from Columbia University.Other current directorships:Director of Eyenovia Inc.(NASDAQ:EYEN)Former directorsh

174、ips(last 3 years):Former chairman of Exagen Inc.(NASDAQ:XGN)Special responsibilities:Nil Interests in shares:Nil Interests in options:Nil Contractual rights to shares:Nil Other current directorships quoted above are current directorships for listed entities only and excludes directorships of all oth

175、er types of entities,unless otherwise stated.Company Secretary Mr Watkins is a highly qualified company secretary and member of global financial and corporate services provider,Vistra(Australia)Pty Ltd.He has more than a decade of experience,specialising in the provision of services to ASX-listed an

176、d unlisted public companies operating in the mining,biotechnology,and industrial sectors.Mr Watkins is also a member of the Institute of Chartered Accountants of Australia and New Zealand and possesses a Bachelor of Business from Swinburne University of Technology.Mr Watkins was appointed as Atomos

177、Company Secretary on 9 June 2024.(Maria Clemente held the position from 1 March 2023 to 4 March 2024 and Sally McDow held the position from 5 March 2024 to 8 June 2024).Meetings of directors The number of meetings of the companys Board of Directors(the Board)and of each Board committee held during t

178、he period ended 30 June 2024,and the number of meetings attended by each director were:Full Board People,Culture,Nomination and Remuneration Committee Audit and Risk Committee Attended Held2 Attended Held2 Attended Held2 John Keith 7 7 3 3 3 3 John Kelly 7 7-Paul Kasian 7 7 3 3 3 3 Deborah Neff 6 7

179、3 3 3 3 Cheri Walker 7 7-2 3 Curt LaBelle1 1 4-1 Resigned on 20 December 2023 2 Represents the number of meetings when the director was eligible to attend as a member of the relevant committee.ATOMO ANNUAL REPORT 202424Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Remu

180、neration report(audited)The remuneration report details the key management personnel remuneration arrangements for the group,in accordance with the requirements of the Corporations Act 2001 and its Regulations.Key management personnel are those persons having authority and responsibility for plannin

181、g,directing and controlling the activities of the entity,directly or indirectly,including all directors.The key management personnel of the group during the financial year consisted of the following Directors of the Company:John Keith Non-Executive ChairJohn Kelly Managing Director and CEOPaul Kasia

182、n Non-Executive DirectorDeborah Neff Non-Executive DirectorCheri Walker Non-Executive DirectorCurt LaBelle Non-Executive Director(Resigned on 20 December 2023)And the following executives:William Souter Chief Financial Officer(Resigned on 13 December 2023)Chandra Sukumar Chief Operating OfficerThe r

183、emuneration report is set out under the following main headings:Remuneration GovernancePrinciples used to determine the nature and amount of remunerationDetails of remunerationService agreementsShare-based compensationAdditional disclosures relating to key management personnelStatutory performance i

184、ndicatorsRemuneration Governance To assist the Board in fulfilling its responsibilities in respect of remuneration and nomination related matters,the Board established a People,Culture,Nomination and Remuneration Committee to monitor and make recommendations to the Board in relation to:(i)recruitmen

185、t,retention and termination policies and practices for Executive Directors and direct reports to the ManagingDirector and the alignment of the policies and practices with the promotion and sustainment of a culture aligned withAtomos values,the promotion of long term sustainable success and the achie

186、vement of the companys business objectives;(ii)people strategies and practices which will instil and reinforce the Companys purpose and values,ensure health and wellbeing(physical and mental)and support the achievement of the companys long term business objectives;(iii)the development of,and progres

187、s in meeting,the Companys diversity objectives;and(iv)the Companys performance appraisal processes for the Managing Director and the Managing Directors direct reports,the Board,Board Committees and individual Non-Executive Directors.During the prior financial year,this Committee was renamed into the

188、 People,Culture,Nomination and Remuneration Committee(PCNRC)and the Committee Charter was amended to formally delegate the following Boards nomination responsibilities to PCNRC.The members of the PCNRC at the date of this report are:Deborah Neff(Chair)John KeithPaul KasianThe role and responsibiliti

189、es,composition,structure and membership requirements of the PCNRC are documented in the People,Culture,Nomination and Remuneration Committee Charter which is available on Atomos website at:https:/ Committee Charter provides that the Committee should comprise at least three members,all of whom are No

190、n-Executive Directors and a majority of whom are independent Directors and the Chair of the Committee should be an independent Director who is not Chair of the Board.All of the current members of the PCNRC have been assessed by the Board as being independent Non-Executive Directors and the Chair of

191、the Committee is not Chair of the Board.ATOMO ANNUAL REPORT 202425Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Principles used to determine the nature and amount of remuneration Non-executive directors remuneration Each of the Non-Executive Directors has entered into

192、appointment letters with Atomo confirming the terms of their appointment and their roles and responsibilities.The appointment letters are on standard commercial terms.The Chair,John Keith,receives an annual fee of$130,000 and each Non-Executive Director receives an annual fee of$50,000.Each Chair of

193、 a Board Committee receives an additional amount of$20,000 per annum.The Chair of the Audit and Risk Committee is Paul Kasian.The Chair of the People,Culture Nomination and Remuneration Committee is Deborah Neff.Deborah Neff is also director of Atomo US,Inc effective 30 March 2022,for which she rece

194、ives an annual fee of$20,000.Directors may also be reimbursed for expenses properly incurred by them in dealing with the Companys business or in carrying out their duties as a Director.Under the Constitution,the Board decides the amount paid to each Non-Executive Director as remuneration for their s

195、ervices as a Director.However,under the ASX Listing Rules,the total amount of fees paid to all Non-Executive Directors for their services must not exceed in aggregate in any financial year the amount fixed by the Companys shareholders in general meeting.This amount has been fixed initially in the Co

196、mpanys Constitution at$500,000 per annum in aggregate and may be varied by ordinary resolution in a general meeting.Executive remuneration The group aims to reward executives based on their position and responsibility,with a level and mix of remuneration which has both fixed and variable components.

197、The executive remuneration and reward framework has four components:base payshort-term performance incentivesshare-based paymentsother remuneration such as superannuation and long service leaveThe combination of these comprises the executives total remuneration.Fixed remuneration,consisting of base

198、salary,superannuation and non-monetary benefits,are reviewed annually by the People,Culture,Nomination and Remuneration Committee based on individual and business unit performance,the overall performance of the group and comparable market remunerations.Executives may receive their fixed remuneration

199、 in the form of cash or other benefits where it does not create any additional costs to the group and provides additional value to the executive.The short-term incentives(STI)program is designed to align the targets of the business units with the performance hurdles of executives.STI payments are gr

200、anted to executives based on specific annual targets and key performance indicators(KPIs)being achieved.Details of STIs paid to executives during the year can be found under the heading Amounts of remuneration below.The long-term incentives(LTI)include long service leave and share-based payments.Fur

201、ther details in relation to Atomos Employee Share Option Plan(ESOP)can be found under the heading“Share-based compensation”below.Voting and comments made at the companys 2 November 2023 Annual General Meeting(AGM)At the 2 November 2023 AGM,32.63%of the votes received supported the adoption of the re

202、muneration report for the year ended 30 June 2023.As such the Company received its first strike in relation to its remuneration report.The Board acknowledges that it received its first strike at its 2023 Annual General Meeting of shareholders.In response to this strike received from shareholders(whi

203、le there was no specific feedback received in relation to remuneration)the Company advises it has taken the following steps.The Company has not materially increased remuneration of its KMPs(or larger employee base)during the period.It applied relevant CPI increases to remuneration to reflecting infl

204、ation.Non Executive Director fees remain unchanged from when the Company listed.The Company is not intending to issue any LTIs to KMPs for the financial year 2025.ATOMO ANNUAL REPORT 202426Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 The Directors fully acknowledge la

205、st years strike and would like to confirm to its shareholders that the Companys remuneration practices remain a focus for the Board in light of the Companys performance,while continuing to consider market benchmarking.The Company welcomes engagement from shareholders on the remuneration of the Direc

206、tors and KMPs.Details of remuneration Amounts of remuneration Details of the remuneration of key management personnel of the group are set out in the following tables.Short-term benefits Post-employment benefits Long-term benefits Share-based payments Cash salary Cash Non-Super-Long service Equity-a

207、nd fees bonus monetary annuation leave settled Total 30 June 2024 AUD AUD AUD AUD AUD AUD AUD Non-Executive Directors:John Keith 130,000-130,000Paul Kasian 63,063-6,937-70,000Deborah Neff 90,000-90,000Cheri Walker 50,000-50,000Curt LaBelle1 25,000-25,000Executive Directors:John Kelly 406,056 35,000-

208、27,3998,022-476,477Other Key Management Personnel:William Souter2 143,679-12,285-5,858161,822 Chandra Sukumar 243,395 25,000-27,3992,636 5,492303,922 1,151,193 60,000-74,02010,658 11,350 1,307,221 1 Resigned on 20 December 2023 2 Resigned on 13 December 2023 ATOMO ANNUAL REPORT 202427Atomo Diagnosti

209、cs Limited Directors report For the period ended 30 June 2024 Short-term benefits Post-employment benefits Long-term benefits Share-based payments Cash salary Cash Non-Super-Long service Equity-and fees bonus monetary annuation leave settled Total 30 June 2023 AUD AUD AUD AUD AUD AUD AUD Non-Executi

210、ve Directors:John Keith 130,000-130,000Paul Kasian 63,348-6,652-70,000Deborah Neff 88,330-88,330Cheri Walker 31,250-31,250Curt LaBelle1 50,000-50,000Executive Directors:John Kelly 417,050 79,200-25,2925,614 14,861 542,017 Other Key Management Personnel:Chandra Sukumar 243,197 49,250-25,2926,553-324,

211、292William Souter2 290,411 57,600-25,2921,585 11,889 386,7771,313,586 186,050-82,52813,752 26,750 1,622,666 1 Resigned on 20 December 2023 2 Resigned on 13 December 2023 The proportion of remuneration linked to performance and the fixed proportion are as follows:Fixed remuneration At risk-STI At ris

212、k-LTI Name 30 June 2024 30 June 2023 30 June 2024 30 June 2023 30 June 2024 30 June 2023 Non-Executive Directors:John Keith 100%100%-Paul Kasian 100%100%-Deborah Neff 100%100%-Cheri Walker 100%100%-Curt LaBelle1 100%100%-Executive Directors:John Kelly 93%82%7%15%-3%Other Key Management Personnel:Cha

213、ndra Sukumar 90%85%8%15%2%-William Souter2 96%82%-15%4%3%1 Resigned on 20 December 2023 2 Resigned on 13 December 2023 Cash bonuses are dependent on meeting defined performance measures.The maximum bonus values are established at the start of each financial year and amounts payable to KMPs are deter

214、mined by the Board in consultation with the People,Culture,Nomination and Remuneration Committee.ATOMO ANNUAL REPORT 202428Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 The proportion of the cash bonus paid/payable or forfeited is as follows:Cash bonus paid/payable Cas

215、h bonus forfeited Name 30 June 2024 30 June 2023 30 June 2024 30 June 2023 Non-Executive Directors:John Keith-Paul Kasian-Deborah Neff-Cheri Walker-Curt LaBelle1-Executive Directors:John Kelly 27%60%73%40%Other Key Management Personnel:Chandra Sukumar 33%60%67%40%William Souter2-60%-40%1 Resigned on

216、 20 December 2023 2 Resigned on 13 December 2023 Service agreements Remuneration and other terms of employment for key management personnel are formalised in service agreements.Details of these agreements are as follows:Name:John Kelly Title:Managing Director Agreement commenced:1 October 2011 Term

217、of agreement:Not specified-agreement has been revised since commencement date of service Details:Annual salary of$440,000(including superannuation).The fixed remuneration will alter by any changes in the compulsory superannuation contribution that Atomo Diagnostics Limited is required to make.Plus a

218、 cash bonus of up to 30%of gross salary(subject to the satisfaction of performance criteria),to be reviewed annually by the People,Culture,Nomination&Remuneration Committee.John Kelly is entitled to participate in the Companys share and option plans.Please refer to the section titled“Share-based com

219、pensation”for further details.Ten(10)week termination notice by either party however this notice period does not apply if the employment is terminated for serious and wilful misconduct or any conduct by John Kelly that amounts to fraud,theft,violence,harassment,gross negligence or any other action t

220、hat may otherwise bring the Company into disrepute.Name:Chandra Sukumar Title:Chief Operating Officer Agreement commenced:31 October 2016 Term of agreement:Not specified-agreement has been revised since commencement date of service Details:Annual salary of$250,000(excluding superannuation).The fixed

221、 remuneration will alter by any changes in the compulsory superannuation contribution that Atomo Diagnostics Limited is required to make.Plus a cash bonus of up to 30%of base salary(subject to the satisfaction of performance criteria),to be reviewed annually by the People,Culture&Remuneration Commit

222、tee.Chandra Sukumar is entitled to participate in the Companys share and option plans.Please refer to the section titled“Share-based compensation”for further details.Ten(10)week termination notice by either party however this notice period does not apply if the employment is terminated for serious a

223、nd wilful misconduct or any conduct by Chandra Sukumar that amounts to fraud,theft,violence,harassment,gross negligence or any other action that may otherwise bring the Company into disrepute.ATOMO ANNUAL REPORT 202429Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Name:

224、William Souter Title:Chief Financial Officer Agreement commenced:10 March 2020(Resigned on 13 December 2023)Term of agreement:Not specified-agreement has been revised since commencement date of service Details:Annual salary of$320,000(including superannuation).The fixed remuneration will alter by an

225、y changes in the compulsory superannuation contribution that Atomo Diagnostics Limited is required to make.Plus a cash bonus of up to 30%of gross salary(subject to the satisfaction of performance criteria),to be reviewed annually by the People,Culture&Remuneration Committee.William Souter is entitle

226、d to participate in the Companys share and option plans.Please refer to the section titled“Share-based compensation”for further details.Sixteen(16)week termination notice by either party however this notice period does not apply if the employment is terminated for serious and wilful misconduct or an

227、y conduct by William Souter that amounts to fraud,theft,violence,harassment,gross negligence or any other action that may otherwise bring the Company into disrepute.Share-based compensation Option plan details The Board has exercised its discretion to allocate the following options to management in

228、prior periods as part of the Companys remuneration scheme to reward the diligent execution of the corporate strategy and to ensure retention of the key talent needed to deliver strategic outcome in the interest of shareholders.As at the date of this report,the Company had on issue 941,666 options to

229、 KMPs under the post-IPO option plan.The terms and conditions of each grant of options over ordinary shares affecting remuneration of directors and other key management personnel in this financial period or future reporting years are as follows:Number of Fair value options Vesting date and per optio

230、n Name granted Grant date exercisable date Expiry date Exercise price at grant date John Kelly 666,666 25 August 2022 25 August 2022 14 April 2025 AUD0.250 AUD0.073 Chandra Sukumar 275,000 22 August 2023 22 August 2023 22 August 2026 AUD0.047 AUD0.030 All options were granted over unissued fully pai

231、d ordinary shares in the Company.Options granted carry no dividend or voting rights.Additional disclosures relating to key management personnel Shareholding The number of shares in the company held during the financial period by each director and other members of key management personnel of the grou

232、p,including their personally related parties,is set out below:Balance at Received Balance at the start of as part of(Disposals)/the end of the period remuneration Additions other the period Ordinary shares John Keith 3,261,056-3,261,056 John Kelly 72,490,248-72,490,248 Paul Kasian 100,000-100,000 De

233、borah Neff-Cheri Walker-Curt LaBelle1&2 65,051,280-(65,051,280)-Chandra Sukumar 170,000-170,000 William Souter3&4 250,000-(250,000)-141,322,584-(65,301,280)76,021,304 ATOMO ANNUAL REPORT 202430Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 1 Includes shares held by Glob

234、al Health Investment Fund LLC.Curt LaBelle resigned on 20 December 2023 2 Curt LaBelle resigned on 20 December 2023.To this effect,shares held by Mr LaBelle and Global Health Investment Fund LLC is no longer considered related party share holdings in the company at 30 June 2024.Shares are included i

235、n Disposals/Other 3 Resigned on 13 December 2023 4 William Souter resigned on 13 December 2023.To this effect,shares held by Mr Souter is no longer considered related party shares holdings in the company at 30 June 2024.Shares are included in Disposals/Other Option holding The number of options over

236、 ordinary shares in the company held during the financial period by each director and other members of key management personnel of the group,including their personally related parties,is set out below:Balance at Expired/Balance at the start of forfeited/the end of the period Granted Exercised other

237、the period Options over ordinary shares John Kelly 999,999-(333,333)666,666 Curt LaBelle1-Paul Kasian-Deborah Neff-Cheri Walker-William Souter2 1,066,667 293,333-(1,360,000)-Chandra Sukumar-275,000-275,000 2,066,666 568,333-(1,693,333)941,666 1 Includes shares held by Global Health Investment Fund L

238、LC.Curt LaBelle resigned on 20 December 2023 2 Resigned on 13 December 2023 3 William Souter resigned on 13 December 2023.To this effect options,held by Mr Souter are no longer considered related party options holdings in the company at 30 June 2024.Options are included in Disposals/Other Statutory

239、performance indicators The group aims to align its executive remuneration to its strategic and business objectives and the creation of shareholder wealth.The table below shows measures of the groups financial performance over the last three years as required by the Corporations Act 2001.However,thes

240、e are not necessarily consistent with the measures used in determining the variable amounts of remuneration to be awarded to KMPs.As a consequence,there may not always be a direct correlation between the statutory key performance measures and the variable remuneration awarded.Measure 2024 2023 2022

241、Loss for the year attributable to the Company($)(6,847,803)(9,957,632)(5,706,854)Basic earnings per share(cents)(1.08)(1.74)(1.00)Dividend payments -Dividend payout ratio -Increase/(decrease)in share price 14%(61%)(70%)Total KMP incentives as a percentage of profit/(loss)for the year (19.1%)(16.3%)(

242、28.8%)This concludes the remuneration report,which has been audited.ATOMO ANNUAL REPORT 202431Atomo Diagnostics Limited Directors report For the period ended 30 June 2024 Shares under option Unissued ordinary shares of Atomo Diagnostics Limited under option at the date of this report are as follows:

243、Exercise Number Options Expiry date price under option Post-IPO options 14 April 2025 AUD0.250 1,733,332 Post-IPO options 14 April 2026 AUD0.250 533,334 Employee share options 22 August 2026 AUD0.047 818,333 Employee share options 1 July 2026 AUD0.035 2,120,000 Employee share options 1 July 2027 AUD

244、0.035 3,180,000 8,384,999 No person entitled to exercise the options had or has any right by virtue of the option to participate in any share issue of the Company or of any other body corporate.Shares issued on the exercise of options There were no ordinary shares of Atomo Diagnostics Limited issued

245、 on the exercise of options during the period ended 30 June 2024 and up to the date of this report.Indemnity and insurance of officers The company has indemnified the directors and executives of the company for costs incurred,in their capacity as a director or executive,for which they may be held pe

246、rsonally liable,except where there is a lack of good faith.During the financial period,the company paid a premium in respect of a contract to insure the directors and executives of the company against a liability to the extent permitted by the Corporations Act 2001.The contract of insurance prohibit

247、s disclosure of the nature of the liability and the amount of the premium.Indemnity and insurance of auditor The company has not,during or since the end of the financial period,indemnified or agreed to indemnify the auditor of the company or any related entity against a liability incurred by the aud

248、itor.During the financial period,the company has not paid a premium in respect of a contract to insure the auditor of the company or any related entity.Proceedings on behalf of the company No person has applied to the Court under section 237 of the Corporations Act 2001 for leave to bring proceeding

249、s on behalf of the company,or to intervene in any proceedings to which the company is a party for the purpose of taking responsibility on behalf of the company for all or part of those proceedings.Non-audit services Details of the amounts paid or payable to the auditor for non-audit services provide

250、d during the financial year by the auditor are outlined in note 22 to the financial statements.The directors are satisfied that the provision of non-audit services during the financial period,by the auditor(or by another person or firm on the auditors behalf),is compatible with the general standard

251、of independence for auditors imposed by the Corporations Act 2001.The directors are of the opinion that the services as disclosed in note 22 to the financial statements do not compromise the external auditors independence requirements of the Corporations Act 2001 for the following reasons:all non-au

252、dit services have been reviewed and approved to ensure that they do not impact the integrity and objectivityof the auditor;andnone of the services undermine the general principles relating to auditor independence as set out in APES 110 Code of Ethics for Professional Accountants issued by the Accoun

253、ting Professional and Ethical Standards Board,includingreviewing or auditing the auditors own work,acting in a management or decision-making capacity for the company,acting as advocate for the company or jointly sharing economic risks and rewards.ATOMO ANNUAL REPORT 202432Atomo Diagnostics Limited D

254、irectors report For the period ended 30 June 2024 Officers of the company who are former partners of BDO There are no officers of the company who are former partners of BDO.Rounding of Amounts The group is of a kind referred to in Corporations Instrument 2016/191,issued by the Australian Securities

255、and Investments Commission,relating to rounding-off.Amounts in this report have been rounded off in accordance with that Corporations Instrument to the nearest dollar.Auditors independence declaration A copy of the auditors independence declaration as required under section 307C of the Corporations

256、Act 2001 is set out immediately after this directors report.Auditor BDO Audit Pty Ltd continues in office in accordance with section 327 of the Corporations Act 2001.This report is made in accordance with a resolution of directors,pursuant to section 298(2)(a)of the Corporations Act 2001.On behalf o

257、f the directors _ John Keith Chair 29 August 2024 Sydney ATOMO ANNUAL REPORT 202433Level 11,1 Margaret St Sydney NSW 2000 Australia Tel:+61 2 9251 4100 Fax:+61 2 9240 9821 .au BDO Audit Pty Ltd ABN 33 134 022 870 is a member of a national association of independent entities which are all members of

258、BDO Australia Ltd ABN 77 050 110 275,an Australian company limited by guarantee.BDO Audit Pty Ltd and BDO Australia Ltd are members of BDO International Ltd,a UK company limited by guarantee,and form part of the international BDO network of independent member firms.Liability limited by a scheme appr

259、oved under Professional Standards Legislation.DECLARATION OF INDEPENDENCE BY GARETH FEW TO THE DIRECTORS OF ATOMO DIAGNOSTICS LIMITED As lead auditor of Atomo Diagnostics Limited for the year ended 30 June 2024,I declare that,to the best of my knowledge and belief,there have been:1.No contraventions

260、 of the auditor independence requirements of the Corporations Act 2001 inrelation to the audit;and2.No contraventions of any applicable code of professional conduct in relation to the audit.This declaration is in respect of Atomo Diagnostics Limited and the entities it controlled during the period.B

261、DO Audit Pty Ltd Gareth Few Director Sydney,29 August 2024 ATOMO ANNUAL REPORT 202434363738394065666772Atomo Diagnostics Limited Contents For the period ended 30 June 2024 Statement of Profit or Loss and Other Comprehensive Income Statement of Financial Position Statement of Changes in Equity Statem

262、ent of Cash Flows Notes to the Financial Statements Consolidated Entity Disclosure Statement Directors declaration Independent auditors report to the members of Atomo Diagnostics Limited Shareholder information General informationThe financial statements cover Atomo Diagnostics Limited as a group co

263、nsisting of Atomo Diagnostics Limited and the entities it controlled at the end of,or during,the period.The financial statements are presented in Australian dollars,which is Atomo Diagnostics Limiteds functional and presentation currency.Atomo Diagnostics Limited is a listed public company limited b

264、y shares,incorporated and domiciled in Australia.Its registered office and principal place of business are:Registered office Principal place of businessLevel 1 Level 13-5 George Street 3-5 George StreetLeichhardt NSW 2040 Leichhardt NSW 2040A description of the nature of the groups operations and it

265、s principal activities is included in the directors report,which is not part of the financial statements.The financial statements were authorised for issue,in accordance with a resolution of directors,on 29 August 2024.The directors have the power to amend and reissue the financial statements.ATOMO

266、ANNUAL REPORT 202435Atomo Diagnostics Limited Statement of Profit or Loss and Other Comprehensive Income For the period ended 30 June 2024 Consolidated Note 30 June 2024 30 June 2023 AUD AUD The above statement of profit or loss and other comprehensive income should be read in conjunction with the a

267、ccompanying notes Revenue 3 4,086,535 2,543,716 Costs of sales(2,480,532)(1,876,247)Gross profit 1,606,003 667,469 Other Income 4 1,096,216 1,157,705 Employee benefits expense 5(4,037,165)(4,853,433)Foreign exchange gains 25,170 107,548 Depreciation and amortisation expense 5(1,659,270)(1,891,787)Im

268、pairment of assets 12(798,990)-Research and development expenses(236,423)(604,719)Insurance (321,331)(402,950)Inventory obsolescence expense(169,298)(1,168,832)IT expenses(191,082)(197,600)Occupancy expenses(18,834)(9,497)Professional and consulting fee expenses(633,167)(822,793)Regulatory expenses(

269、654,011)(555,559)Travel expenses(97,315)(279,125)Other expenses(748,786)(1,089,072)Finance costs 5(9,520)(14,987)Loss before income tax expense(6,847,803)(9,957,632)Income tax expense 6-Loss after income tax expense for the period attributable to the owners of Atomo Diagnostics Limited(6,847,803)(9,

270、957,632)Other comprehensive income Items that may be reclassified subsequently to profit or loss Foreign currency translation 57,086(112,330)Other comprehensive income for the period,net of tax 57,086(112,330)Total comprehensive income for the period attributable to the owners of Atomo Diagnostics L

271、imited(6,790,717)(10,069,962)AUD Cents AUD Cents Basic earnings per share 28(1.079)(1.744)Diluted earnings per share 28(1.079)(1.744)ATOMO ANNUAL REPORT 202436Atomo Diagnostics Limited Statement of Financial Position As at 30 June 2024 Consolidated Note 30 June 2024 30 June 2023 AUD AUD The above st

272、atement of financial position should be read in conjunction with the accompanying notes Assets Current assets Cash and cash equivalents 7 3,687,990 6,470,318 Trade and other receivables 8 2,063,259 1,823,824 Inventories 9 1,838,757 2,136,666 Total current assets 7,590,006 10,430,808 Non-current asse

273、ts Property,plant and equipment 10 1,641,519 2,509,488 Right-of-use assets 11 75,567 233,732 Intangible assets 12 2,071,920 3,299,531 Total non-current assets 3,789,006 6,042,751 Total assets 11,379,012 16,473,559 Liabilities Current liabilities Trade and other payables 13 774,176 861,631 Lease liab

274、ilities 14 84,670 170,701 Provisions 15 279,191 277,155 Deferred Revenue 16 49,841 185,074 Total current liabilities 1,187,878 1,494,561 Non-current liabilities Lease liabilities 17-84,176Provisions 18 106,515 104,611Total non-current liabilities 106,515 188,787 Total liabilities 1,294,393 1,683,348

275、 Net assets 10,084,619 14,790,211 Equity Issued capital 19 70,086,549 68,036,837 Reserves 20 88,405 303,125 Accumulated losses(60,090,335)(53,549,751)Total equity 10,084,619 14,790,211 ATOMO ANNUAL REPORT 202437Atomo Diagnostics Limited Statement of Changes in Equity For the period ended 30 June 202

276、4 The above statement of changes in equity should be read in conjunction with the accompanying notes Issued Foreign Currency Translation Share Based Payment Accumulated Total Equity Capital Reserve Reserve Losses Consolidated AUD AUD AUD AUD AUD Balance at 1 July 2022 68,036,837(63,078)866,426(44,02

277、6,471)24,813,714 Loss after income tax expense for the period-(9,957,632)(9,957,632)Other comprehensive income for the period,net of tax-(112,330)-(112,330)Total comprehensive income for the period-(112,330)-(9,957,632)(10,069,962)Transactions with owners in their capacity as owners:Equity-settled s

278、hare based payments-(387,893)434,352 46,459 Balance at 30 June 2023 68,036,837(175,408)478,533(53,549,751)14,790,211 Issued Foreign Currency Translation Share Based Payment Accumulated Total Equity Capital Reserve Reserve Losses Consolidated AUD AUD AUD AUD AUD Balance at 1 July 2023 68,036,837(175,

279、408)478,533(53,549,751)14,790,211 Loss after income tax expense for the period-(6,847,803)(6,847,803)Other comprehensive income for the period,net of tax-57,086-57,086 Total comprehensive income for the period-57,086-(6,847,803)(6,790,717)Transactions with owners in their capacity as owners:Equity-s

280、ettled share based payments-(271,806)307,219 35,413 Issue of shares 2,259,206-2,259,206 Issue costs(209,494)-(209,494)Balance at 30 June 2024 70,086,549(118,322)206,727(60,090,335)10,084,619 ATOMO ANNUAL REPORT 202438Atomo Diagnostics Limited Statement of Cash Flows For the period ended 30 June 2024

281、 Consolidated Note 30 June 2024 30 June 2023 AUD AUD The above statement of cash flows should be read in conjunction with the accompanying notes Cash flows from operating activities Receipts from customers(inc.of GST)3,806,870 3,300,514 Payments to suppliers and employees(inc.of GST)(9,406,018)(10,4

282、30,849)(5,599,148)(7,130,335)Interest received 152,080 74,109 R&D and other government incentives received 760,964 1,208,555 Net cash used in operating activities 27(4,686,104)(5,847,671)Cash flows from investing activities Payments for property,plant and equipment(16,084)(59,976)Payments for intang

283、ibles assets-(341,300)Net cash used in investing activities(16,084)(401,276)Cash flows from financing activities Net proceeds form issue of share capital(net of costs)2,049,712-Repayment of leases(182,712)(170,752)Net cash from/(used in)financing activities 1,867,000(170,752)Net decrease in cash and

284、 cash equivalents(2,835,188)(6,419,699)Cash and cash equivalents at the beginning of the financial period 6,470,318 12,966,400 Effects of exchange rate changes on cash and cash equivalents 52,860(76,383)Cash and cash equivalents at the end of the financial period 7 3,687,990 6,470,318 ATOMO ANNUAL R

285、EPORT 202439Atomo Diagnostics Limited Notes to the Financial Statements For the period ended 30 June 2024 Note 1.Material accounting policy information New or amended Accounting Standards and Interpretations adopted The group has adopted all of the new or amended Accounting Standards and Interpretat

286、ions issued by the Australian Accounting Standards Board(AASB)that are mandatory for the current reporting period.Any new or amended Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.The Directors have reviewed all of the new and revised accounting standa

287、rds and interpretations issued by the Australian Accounting Standards Board for annual reporting periods beginning or after 1 July 2023.It has been determined that there is no impact,material or otherwise,of any other new or revised accounting standards and interpretations.Basis of preparation These

288、 general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board(AASB)and the Corporations Act 2001,as appropriate for for-profit oriented entities.These financial statements also compl

289、y with International Financial Reporting Standards as issued by the International Accounting Standards Board(IASB).Historical cost convention The financial statements have been prepared under the historical cost convention,except for,where applicable,the revaluation of financial assets and liabiliti

290、es at fair value through profit or loss,financial assets at fair value through other comprehensive income,investment properties,certain classes of property,plant and equipment and derivative financial instruments.Critical accounting estimates The preparation of the financial statements requires the

291、use of certain critical accounting estimates.It also requires management to exercise its judgement in the process of applying the groups accounting policies.The areas involving a higher degree of judgement or complexity,or areas where assumptions and estimates are significant to the financial statem

292、ents,are disclosed in note 2.Going concern The annual report has been prepared on the going concern basis,which assumes continuity of normal business activities and the realisation of the assets and the settlement of liabilities in the ordinary course of business.As disclosed in the financial statem

293、ents,the group incurred a loss of$6,847,803(2023:$9,957,632)and had net cash outflows from operating activities of$4,686,104(2023:$5,847,671)for the year ended 30 June 2024.The group had a surplus between current assets and current liabilities of$6,402,128(2023:$8,936,247 surplus)and a cash balance

294、of$3,687,990(2023:$6,470,318)as at 30 June 2024.As a result of these matters,there is a material uncertainty related to events or conditions that may cast significant doubt on whether the company will continue as a going concern and,therefore,whether it will realise its assets and settle its liabili

295、ties and commitments in the normal course of business and at the amounts stated in the financial report.The continuing viability of the group and its ability to continue as a going concern and meet its debts and commitments as they fall due are dependent upon the group being successful with the foll

296、owing factors:The ability of the group to raise additional funds from shareholders,new investors and or debt markets.The group has successfully conducted a number of capital raises in the recent years.When taking these into account,there is areasonable expectation that alternative sources of funding

297、 can be sourced,as and when required.Further,the groupunderstands it will require further funding to continue to execute its growth strategy as planned.In its determination on going concern,the Board placed significant reliance upon the representations of its Corporate Advisor with respect to its co

298、nfidence in its ability to continue raising capital on behalf of the group;Increased revenue from opportunities with existing and new customers and sales arrangements as they are realised into sales revenue;andEffective monitoring and reduction of the groups overhead expenditures,including the conti

299、nued realisation of head office cost reductions.In the event that the group is unable to achieve the matters detailed above,it may not be able to continue as a going concern and therefore the group may not be able to realise its assets and extinguish its liabilities in the ordinary course of operati

300、ons and at the amounts stated in the financial statements.ATOMO ANNUAL REPORT 202440Atomo Diagnostics Limited Notes to the Financial Statements For the period ended 30 June 2024 Note 1.Material accounting policy information(continued)No adjustments have been made to the recoverability and classifica

301、tion of recorded asset values and the amount and classification of liabilities that might be necessary should the consolidated entity and the company not continue as going concerns.Reclassification of prior year amounts and balances When required by Accounting standards,comparative figures have been

302、 adjusted to conform to changes in presentation for the current financial year.Parent entity information In accordance with the Corporations Act 2001,these financial statements present the results of the group only.Supplementary information about the parent entity is disclosed in note 24.Principles

303、of consolidation The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Atomo Diagnostics Limited(company or parent entity)as at 30 June 2024 and the results of all subsidiaries for the period then ended.Atomo Diagnostics Limited and its subsidiaries toge

304、ther are referred to in these financial statements as the group.Subsidiaries are all those entities over which the group has control.The group controls an entity when the group is exposed to,or has rights to,variable returns from its involvement with the entity and has the ability to affect those re

305、turns through its power to direct the activities of the entity.Subsidiaries are fully consolidated from the date on which control is transferred to the group.They are de-consolidated from the date that control ceases.Intercompany transactions,balances and unrealised gains on transactions between ent

306、ities in the group are eliminated.Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred.Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the group.The acquisiti

307、on of subsidiaries is accounted for using the acquisition method of accounting.A change in ownership interest,without the loss of control,is accounted for as an equity transaction,where the difference between the consideration transferred and the book value of the share of the non-controlling intere

308、st acquired is recognised directly in equity attributable to the parent.Non-controlling interest in the results and equity of subsidiaries are shown separately in the statement of profit or loss and other comprehensive income,statement of financial position and statement of changes in equity of the

309、group.Losses incurred by the group are attributed to the non-controlling interest in full,even if that results in a deficit balance.Where the group loses control over a subsidiary,it derecognises the assets including goodwill,liabilities and non-controlling interest in the subsidiary together with a

310、ny cumulative translation differences recognised in equity.The group recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss.Operating segments The group manages its operations as a single business operati

311、on and there are no parts of the group that qualify as operating segments under AASB 8 Operating Segments.The CEO(Chief Operating Decision Maker or“CODM”)assesses the financial performance of the group in an integrated basis only and accordingly,the group is managed on the basis of a single segment,

312、being medical device research and development.Information presented to the CODM on a monthly basis is categorised by type of expenditure.Foreign currency translation The financial statements are presented in Australian dollars,which is Atomo Diagnostics Limiteds functional and presentation currency.

313、Foreign currency transactions Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions.Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial period-en

314、d exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.ATOMO ANNUAL REPORT 202441Atomo Diagnostics Limited Notes to the Financial Statements For the period ended 30 June 2024 Note 1.Material accounting policy information(continued)Forei

315、gn operations The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date.The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates,which approximate the rates at

316、the dates of the transactions,for the period.All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is disposed of

317、.Revenue recognition The consolidated entity recognises revenue as follows:Revenue from contracts with customers and sale of goods and services Revenue is measured based on the consideration specified in a contract with a customer.The group recognises revenue when it transfers control over a good or

318、 service to a customer as per agreement arranged.This varies between:Goods are ready and released by Quality Assurance(QA)Goods are made available at collection point ex-worksGoods are delivered to customer at the arranged delivery pointGoods have been dispatched from manufacturing warehouse ex-work

319、sServices is recognised over time as the services rendered are based on either an hourly rate or a fixed priceWhere ex-works is agreed,the customer is responsible to make necessary arrangements for freight and the collection of goods from the groups warehouse.Invoices are usually payable within 30 t

320、o 75 days,dependent on the contracted agreement.The contracts do not allow the customers to return the goods as the testing kits have a set shelf-life and have gone through vigorous testing prior to delivery.Since none of the contracts permit the customer to return an item,revenue is recognised for

321、all the goods once the goods have been released by QA and are available for collection at the groups warehouse.Interest Interest revenue is recognised as interest accrues using the effective interest method.This is a method of calculating the amortised cost of a financial asset and allocating the in

322、terest income over the relevant period using the effective interest rate,which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.Other revenue Other revenue is recognised when it is rec

323、eived or when the right to receive payment is established.Income tax Income tax expense comprises current and deferred tax.It is recognised in profit or loss except to the extent that it relates to a business combination,or items recognised directly in equity or in other comprehensive income.Current

324、 tax:Current tax comprises the expected tax payable or receivable on the taxable income or loss for the year and any adjustment to tax payable or receivable in respect of previous years.It is measured using tax rates enacted or substantively enacted at the reporting date.Current tax also includes an

325、y tax liability arising from dividends.Current tax assets and liabilities are offset only if certain criteria are met.Deferred tax:Deferred tax is recognised in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts us

326、ed for taxation purposes.Deferred tax is not recognised for temporary differences on the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss,or on taxable temporary differences arising on the

327、initial recognition of goodwill.ATOMO ANNUAL REPORT 202442Atomo Diagnostics Limited Notes to the Financial Statements For the period ended 30 June 2024 Note 1.Material accounting policy information(continued)Deferred tax assets are recognised for unused tax losses,tax credits and deductible temporar

328、y differences,to the extent that it is probable that future taxable profits will be available against which they can be utilised.Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realised;such redu

329、ctions are reversed when the probability of future taxable profits improves.Unrecognised deferred tax assets are reassessed at each reporting date and recognised to the extent that it has become probable that future taxable profits will be available against which they can be used.Deferred tax is mea

330、sured at the tax rates that are expected to be applied to temporary differences when they reverse,using tax rates enacted or substantively enacted at the reporting date.The measurement of deferred tax reflects the tax consequences that could follow the manner in which the group expects,at the report

331、ing date,to recover or settle the carrying amount of its assets and liabilities.Deferred tax assets and liabilities are offset only if certain criteria are met.R&D tax incentives:R&D tax incentives received by the group are recognised as other income over the periods necessary to match the benefit o

332、f the incentive with the cost for which it is intended to compensate(associated cost).Such periods will depend on whether the associated costs are capitalised or expensed as incurred.Under this policy,for that portion of associated costs which are expensed during the period,the proportional incentiv

333、e is recognised in other income in full during the same period.For that portion of associated costs which are capitalised during the period,the proportional incentive is initially offset against the capitalised associated costs and recognised against amortisation expense on a systematic basis matching the useful life of the capitalised asset.Current and non-current classification Assets and liabil