FY26 Results and Strategy Presentation
Released
Released
Announcement PDF
ATOMO
DIAGNOSTICS
FY26 RESULTS OVERVIEW
24 SEPTEMBER 2026
2
This presentation has been prepared by Atomo Diagnostics Limited (“Atomo”) based on
information available as at the date of this presentation. The information in this presentation is
provided in summary form and does not contain all information necessary to make an investment
decision. Reliance should not be placed on the information or opinions contained in this
presentation. An investor must not act on the basis of any matter contained in this presentation
but should make its own assessment of Atomo as part of its own investigations.
This presentation has been provided for general information purposes only. It does not constitute
an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any
security in Atomo, nor does it constitute financial product advice or take into account any
individual’s investment objectives, taxation situation, financial situation or needs.
Although reasonable care has been taken to ensure that the facts stated in this presentation are
accurate and that the opinions expressed are fair and reasonable, no representation or warranty,
express or implied, is made as to the fairness, accuracy, completeness or correctness of the
information, opinions and conclusions contained in this presentation. To the maximum extent
permitted by law, neither Atomo, nor any of its officers, directors, employees and agents, nor any
other person, accepts any responsibility or liability for the content of this presentation including,
without limitation, any liability arising from fault or negligence, for any loss arising from the use of
or reliance on any of the information contained in this presentation or otherwise arising in
connection with it. This disclaimer also extends to all and any information and opinions contained
in, and any omissions from, any other written or oral communications transmitted or otherwise
made available to the recipient in connection with the opportunity outlined in this presentation and
no representation or warranty is made in respect of such information.
The information presented in this presentation is subject to change without notice and Atomo does
not have any responsibility or obligation to inform you of any matter arising or coming to their
notice, after the date of this presentation, which may affect any matter referred to in this
presentation. The cover image is illustrative only.
This presentation may contain certain forward-looking statements that are based on Atomo’s
beliefs, assumptions and expectations and on information currently available to Atomo
management. Such forward looking statements involve known and unknown risks, uncertainties,
and other factors which may cause the actual results or performance of Atomo to be materially
different from the results or performance expressed or implied by such forward looking
statements. Such forward looking statements are based on numerous assumptions regarding
present and future business strategies and the business, economic and competitive environment in
which they operate in the future, which are subject to change without notice. Past performance is
not necessarily a guide to future performance and no representation or warranty is made as to the
likelihood of achievement or reasonableness of any forward-looking statements or other forecast.
To the full extent permitted by law, Atomo and its directors, officers, employees, advisers, agents
and intermediaries disclaim any obligation or undertaking to release any updates or revisions to
information to reflect any change in any of the information contained in this presentation
(including, but not limited to, any assumptions or expectations set out in the presentation).
DISCLAIMER
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
3
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ATOMO DIAGNOSTICS - FY26 IN REVIEW
Financial Highlights
• Revenue growth of 41% bringing total revenue for the
FY26 of $5.3 million
• EBITDA improvement of 39% highlights increasing
operating leverage in the business
• Cash receipts for the period totaling $10.2 million
• Cash on hand of $3.7 million on 30 June 2026 and
the company remains debt free
• $4.6m from customer receipts
• $4.0m from capital raised during the period, net of
transaction costs
ASX: AT1
Business Highlights
• Strong growth in HIV franchise of 21% to $2.8 million
• OEM revenue grew 209% to $2.2 million, driven by Lumos
Diagnostics launch of CLIA-waived FebriDx
• Onboarded Pharmacies in Australia selling the Atomo HIV Self-
Test increases 56% during the year plus July 2026 (from 126 to
196 – more growth anticipated during FY27)
• Active syphilis technical product development completed,
commencing with analytical and clinical studies in FY27
• Successful completion of Pascal orders received Jan 2026 for two
new OEM customers – supports long-term supply agreements;
anticipated early in FY27
• Commencing development efforts for ATL Liver function test -
focus initially on liver function monitoring for patients prescribed
at-risk drugs and fatty liver disease screening
Transitioning to sustainable revenue growth with an expanding new product pipeline
4
NEW CHAPTER FOR ATOMO – FROM FOUNDATION TO GLOBAL SCALE
• Building on 15 years of innovation and
execution under founder and long-standing CEO
John Kelly
• A seamless leadership transition designed to
preserve institutional knowledge while bringing
global commercial focus
• Dr. Cheri Walker appointed Interim CEO, with
extensive experience across life sciences,
diagnostics and international commercialisation
• Leadership positioned closer to Atomo's key
growth markets, particularly the US and Europe
• Strategic priority shifts from foundation-
building to scale: accelerating adoption,
expanding partnerships and maximising the
value of Atomo's differentiated platform
Passing the baton from founder leadership to the next phase of commercial growth
5
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
REFLECTIONS ON FY26
Accelerating growth: 41% FY26 revenue growth, reflecting strong momentum across the business
Improving economics: Continued improvement in EBITDA (+39% YOY) as scale, mix and operational
discipline strengthen the underlying business
Capital discipline: Prudent cash management while maintaining the investment required for innovation
and to support growth
Multiple growth engines: Increasing contribution from core HIV, OEM/Pascal and emerging product
opportunities reduces reliance on any single revenue stream
Visible runway: Existing customer relationships, expanding distribution and new product launches
provide a foundation for continued FY27+ growth
Pipeline creates future optionality: New products expand the addressable market and create
additional platforms for future revenue
Long-term value creation: Building a growing, diversified revenue base that can fund innovation and
compound enterprise value over time
FY26 established the foundation for Atomo's next phase of value creation
6
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
WHO IS ATOMO? WHAT BUSINESSESDOWE HAVE?
• We are a commercial stage diagnostic company with a growing
revenue base from sales of approved professional and self-test
point-of-care tests (POCT) across global markets
• Atomo solutions deliver unmatched usability and reliability that
enable decentralised testing, a trend jump-started during the
pandemic and now driven by global changes in rapid testing
requirements and where timely centralized testing is not
available
• Atomo is poised for significant growth with proven products in
the market, a growing pipeline of products in development, and
established partners launching exciting new POCT products
across global markets
Diagnostic company with a growing portfolio of patented rapid tests with proven superior usability, reliability, and performance
Atomo Point of Care Test (POCT) Diagnostic Products:
• Blood-based rapid tests sold into professional use and self-test market
channels on a global basis
• Focus on growing our pipeline of high value, reimbursed diagnostic products
for decentralised professional testing
Point of Care Test Technologies (OEM Business):
• Growing partner sales driven by an FDA approved/CLIA waived test
positioned for professional use, decentralised testing
• Integrated proprietary all-in-one device for partners seeking improved
usability and performance for blood-based POCT
• Additional technologies that can integrate with the client’s own
cassette, turning it into a user-friendly system for blood-based POCT
WHO IS ATOMO AND WHAT DO WE DO?
ASX: AT1
Commercial-stage diagnostic products company with a growing a portfolio of innovative point-of-care rapid tests for global markets
ATOMO’S OWN DIAGNOSTIC PRODUCT PIPELINE ASX: AT1
Pipeline focused on global professional use markets disseminating rapid testing to urgent care and other decentralised opportunities
7
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
Product Indication Feasibility Development Validation Clinical Trials
TGA IVDR MENA USA Other AUS/NZ EU/UK Africa USA MENA Other
Atomo
Generation 3 HIV HIV Detection - Self Test
Generation 4 HIV HIV Detection - Professional Use
Generation 4 HIV HIV Detection - Self Test
Pregancy (HCG) Professional/Self Test
Active Syphilis Active Syphilis Detection 3Q27
Liver - ALT Liver Disease Monitoring 2H27
Hepatitis B- Virus (HBV) HBV Detection
Hepatitis C- Virus (HCV) Professional
Partner
Lumos FebriDx™ Professional/CLIA-waived
Chromacare Ferritin Proffesional/Self Test
Confidential UK Partner Professional
Complete
In Process
Regulatory Approvals Commercial Launch
ASX: AT1
Expanding sales from attractive OEM business with products ranging from launched to new ones entering the pipeline
ASX: A1
PARTNER PORTFOLIO UPDATES
UK Customer
• Atomo is partnering with a UK company on a novel rapid test that
addresses a large unmet clinical need in professional settings.
• In FY26, 20,000 Pascal units ordered to support validation and
registration requirements. Commercial supply agreement for
Pascal anticipated in early FY27.
Ferritin – New Product Opportunity
• Atomo has partnered with Chromacare to develop a rapid test
for measuring iron levels, with applications in both professional
and at home self test markets. Initial order received this year
from Chromacare worth ~A$170,000.
FebriDx Market Launch Continues
• Atomo partner Lumos Diagnostics received CLIA waiver of its
FebriDx product, which uses Atomo’s Pascal device for rapid,
blood-based testing to differentiate bacterial versus non-
bacterial infection. US clinical trials validated greater than 99%
concordance between trained and untrained users. The target
market includes urgent care and other reimbursed decentralised
professional use testing.
• Atomo received FY26 orders for FebriDx totaling ~A$1.9 million,
representing a nine-fold increase when compared to the prior
year.
8
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
9
FY26 – REVENUE SUMMARY
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
Strong sales growth across core activities in HIV Tests and Pascal OEM
Revenue growth across core activities
• HIV Growth 21% YoY, totaling $2.8 million
• OEM Growth 209% YoY, totaling $2.2 million
• Overall total revenue* growth 41% YoY bringing
total FY26 revenue to $5.3 million
-
0.50
1.00
1.50
2.00
2.50
3.00
HIV OEM
A$'m
Revenue YoY Growth
Jun-25 Jun-26
* Total revenue includes development and other income
HIV BUSINESS ACTIVITY ASX: AT1
NFLD (Europe)
Australian Pharmacy Growing Momentum
• 196 pharmacies active in Australia
• Target to grow 6x over the next 3 years
• 59 new pharmacies added in FY26
New Zealand – Expansion and foundation established
• 73 pharmacies activated since launch in FY25
• Target to grow 8x over the next 3 years
• CDC (Pharmacy Wholesaler) commenced ordering towards
end of FY26
Australia Government Program
• Rollover order from key government programs
• NAPWHA demand has grown 275% over the last 24 months
International HIV Business
Significant growth underway across European and LMIC markets
Viatris (LMIC)
Revenue up 69% YoY
Revenue up 74% YoY
Continued push on growing HIV sales is paying off in 21% YOY growth in HIV sales
10
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ACTIVE SYPHILIS – ADVANCING THROUGH THE PIPELINE
• no existing rapid test can reliably distinguish active & prior infection
• no current test format is optimised for easy, reliable self-testing
Channel Leverage — Similar users, public buyers and distribution
channels
Addressing significant unmet clinical and market needs
Efficiency — Lower cost of entry, faster time to launch and scale revenue
Established demand via existing HIV channels
Development & Commercial Readiness:
• Product Development & Initial Verification Complete
Strong product verification and preliminary clinical data supporting commercial
interest
Sensitivity greater than 85% for active syphilis detection is market leading
• Technology Transfer commenced for Manufacturing (Q4 FY26 and Q1 FY27)
Enabling product for formal clinical trials and reg. submissions and validating
manufacturing processes
• Clinical Trials commencing early CY27
Clinical validation planning underway and progressing toward commercialisation
• Initial engagement with Regulator successfully completed
Positive engagement with clinicians and key stakeholders to support market access
ASX: AT1
Successful completion of product development preparing for clinical trials in early CY27
11
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ALT LIVER TEST – ENTERS THE DEVELOPMENT PIPELINE
Commercial pathway: Confirming priority use case for
clinical-trials and doctor prescribed at-home liver
monitoring
Partner development: Engage with pharmaceutical, CRO
or commercial partners during FY27
KOL engagement: Engagement commenced with clinical
leaders in key channels – DILI / pharmaceutical
conferences and Fatty Liver disease KOLs
Partner development: Engage with Australian
clinical KOL’s and public health to assess use of a
screening test across high-risk cohorts for Fatty Liver
disease
Assess funding opportunities for this application:
Fatty Liver disease has a very large public health
cost globally generating interest from governments
Unique, large product opportunity for detecting liver damage
12
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
13
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
• Atomo received FY26 orders for FebriDx totaling ~A$1.9m, representing a nine-
fold increase in Pascal FebriDx orders when compared to FY25
• Lumos signed a six-year agreement with PHASE Scientific for supply of FebriDx®
in US - Lumos anticipates FebriDx product revenues of up to US$317 million over
the term, assuming CLIA waiver is granted and contracted MOQ’s achieved
• FebriDx® received CLIA waiver from the US FDA, based on Pascal performance -
validated in US trials as delivering greater than 99% concordance between trained
and untrained users
• Each FebriDx® test sold to Phase requires Lumos order a Pascal cassette, with
Atomo receiving a percentage portion of the proceeds based on the transfer price
of Pascal
FEBRIDx – FY26 HIGHLIGHTS
2026 and future revenue growth driven by Lumos Diagnostics CLIA waiver, sales focus, and distribution partnership
14
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
CHROMACARE – FERRITIN OPPORTUNITY
Rapid Test to screen for Iron Deficiency in Point-of-Care
Other Tests in active development
• Atomo has partnered with Canadian company Chromacare on a rapid test
that can measure iron levels (Ferritin), with applications in both
professional and at home self test markets. Initial order received this
quarter from Chromacare worth ~A$170,000
• Pascal units supplied to support product validation and registrations –
long term commercial supply agreement for Pascal anticipated in early
FY27
• Chromacare interest in a US CLIA waiver submission supported by Pascal
and utilising Pascal FebriDx as a predicate
Another high value product targeted to the professional use, decentralised testing market
15
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
UK Customer
• Atomo is partnering with a UK company on a novel rapid test that
addresses a large unmet clinical need in professional settings
• 20,000 Pascal units ordered to support validation and registration
requirements. Commercial supply agreement for Pascal anticipated
in early FY27
Promotion post CLIA waiver
• Atomo is implementing market engagement and partnering with a
number of US test development companies on promotion of Pascal
as a proven solution for rapid blood test assays seeking expanded
market access through CLIA waiver approval in the US* or launching
as a self test * CLIA waiver approval typically increases the addressable market for a rapid blood test >10-fold
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02979439-
2A1614136&v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6
Successful completion of manufacture of products for feasibility study
UK CLIENT – EXCITING NEW POCT PRODUCT CATEGORY
FY26 OPERATIONAL UPDATE ASX: AT1
Execution on important steps to increase resilient capacity and improve gross margins
Operational expansion initiated to support the growth of Atomo Diagnostic Products
and OEM Pascal units
• Increased production capacity and improved margins on supply of Pascal to
customers and for use in Atomo finished diagnostic tests
• Qualification underway of high cavitation injection mould tooling to increase
component capacity and reduce Cost of Goods (COGs)
• Qualification of the company’s proprietary high volume Blister Machine #2 –
now located in an Atomo operated facility in Sydney
• Expansion of Finished Test Assembly / Packaging accreditation at Atomo’s South
Africa beyond HIV to include supply of Active Syphilis tests
• Blister Machine 2 was successfully relocated to an Atomo-operated facility in
Sydney. The facility will be integrated into Atomo’s Quality Management System
(QMS) in the coming months
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1) 16
17
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
STRATEGIC INITIATIVES in FY27 AND BEYOND
Establish Atomo as a growing diagnostic company with a robust product pipeline
Increasing Focus on New Atomo Products: Successfully finish development and launch Active Syphilis
and Liver ALT marker while completing feasibility on additional pipeline products including Gen4 HIV and
evaluating HBV, HCV and other tests to complement the POCT, professional use portfolio.
Expand Partnership Activity on a Global Basis: Add more development partners to take Pascal platform
into more indications; support current OEM partners, identify commercial partners for Atomo products
in the US and other markets.
Increase Manufacturing Capacity, Capabilities and Efficiency: Complete current and future projects to
increase capacity and platform functionality while reducing manufacturing costs with a focus on
additional operating leverage and increased profitability.
Commercial Execution and Expansion: Grow the markets and sales for current HIV and pregnancy
products, sign additional development partners, build a sales and marketing platform with maximum
impact, and develop commercial launch and partnering activities for active syphilis, liver ALT, and other
Atomo products.
Long-Term Value Creation: Build a growing, diversified revenue base that can fund innovation and
compound enterprise value which will lead to increased market capitalization and stock price
appreciation.
FY 2026 FINANCIALS
19
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
FY26 PROFIT & LOSS
• Revenue up 41%, driven by strong volume demand across HIV
Global Health Market
• Gross margin lower due to product mix
• Prior including net ~$340k in one-off license fees,
impacting margin by 6% YoY
• Core product margin excluding licence and developments
fees was 35% vs 42% YoY.
• Shift driven by higher product demand from lower yielding
Global Health market segments
• Operational discipline with overall expense reducing YoY
$640k/+9%.
• Investment in R&D activities further offset eligible operational
costs during the period. Net improvement of $1.34m/+25% YoY.
• Underlying EBITDA improved 39% from a loss of $3.38m to a loss
of $2.06m, representing a meaningful step towards profitability
AUD
FY26
($m)
FY25
($m)
(%)
Revenue 5.33 3.79 41%
Cost of sales (3.45) (1.87)
Gross Profit 1.88 1.92 (2%)
Gross Margin 35% 51%
Other income 2.24 1.52 47%
Employee benefits expense
(2.88) (3.26) 12%
Foreign exchanges gains/(losses) (0.04) (0.01) (300%)
Research and development costs (0.76) (0.62) (23%)
Professional fees expense (0.49) (0.95) 48%
Inventory obsolescence expense (0.12) (0.13) 8%
Other expenses (1.89) (1.85) (2%)
Underlying EBITDA (2.06) (3.38) 39%
Strong revenue growth and improving EBITDA while investing in innovative R&D development and pipeline
• Cash and cash equivalents of $3.71m at 30 June 2026, and remaining
debt free
• During the year, the Atomo completed capital raisings of $4.0m net of
transaction costs, provide funding to support ongoing
commercialisation, product development and funding future growth
initiatives.
• Capitalised expenditure relating to R&D and PPE for the period was not
significant
• Atomo’s balance sheet supports ongoing investment in portfolio
expansion, pipeline development opportunities and cost of goods
reduction initiatives, aimed at driving future revenue growth and
improving margins.
20
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
FY26 BALANCE SHEET
AUD
FY26
($m)
FY25
($m)
Cash and cash equivalents 3.71 3.22
Trade and other receivables 3.22 1.69
Inventories 1.97 1.65
Property, plant and equipment 0.34 0.89
Intangible assets 1.22 1.64
Other assets 0.36 0.18
Total assets 10.82 9.27
Trade and other payables 1.68 1.02
Other liabilities 1.43 1.28
Total liabilities 3.11 2.30
Net Assets 7.71 6.97
Finishing the year with a solid cash position and no debt
• Total Cash receipts: $10.2m
• ~$4.6m from customer receipts
• $875k from R&D tax rebate
• $660k from CRC-P grant for Syphilis test
development
• ~4m from capital raised during the period,
net of transaction costs
• Total Cash payments: $9.7m
• $4.1m in stock purchases
• $5.6m in operating expenses
• Year-end cash balance of $3.7m, no debt
21
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
FY26 CASHFLOW
A$m
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
Strong cash generation from sales, grants, and fundraising activities
Revenue
Operating
Discipline
EBITDA
Productive
Assets
FY25 Revenue
A$3.8M
✓ Atomo is seeing strong momentum in its established revenue
channels including HIV Testing and Pascal OEM
✓ Expansion of customer base across new partners for Pascal and
an expanded Atomo test product pipeline
FY26 Revenue A$5.3M
+40% GROWTH
✓ Capital focus on new test portfolio
development / commercialisation – Syphilis and
Liver
✓ Non-dilutive funding grants (Syphilis) and
selective licensing of proven assets (Liver) used
to support lower-cost development and go to
market
-5
-4.5
-4
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
FY24 FY25 FY26
A$(m)
Historical EBITDA
✓ EBITDA – continued trend towards breakeven
as existing revenue channels grow and
product offerings expand
✓ Debt free balance sheet
✓ Atomo validating a second-generation
blister machine and high-cavity mould
tooling to support expansion of capacity
and improve economies of scale and
margins
ASX: AT1
FINANCIAL SUMMARY
22
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
FY2026 was a transitional year, showing strong and sustainable revenue growth with improving EBITDA
23
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
FY26: YEAR OF TRANSITION
Strong revenue momentum: FY26 revenue growth of 41%, demonstrates increasing demand across Atomo's
core business lines and emerging opportunities
Improving operating leverage: EBITDA performance continued to improve as revenue growth increasingly
flows through the business
A business increasingly positioned for scale: Revenue growth is becoming broader-based, with momentum
across HIV, OEM/Pascal and emerging diagnostic opportunities
Confidence in sustainable growth: We expect the underlying revenue trajectory to continue into FY27 and
beyond, supported by multiple complementary growth engines
Reinvesting growth into innovation: As revenue increases, it is expected to cover most non-research
operating costs, providing the opportunity to selectively reinvest in R&D and product development for an
attractive future return on investment
Expanding the product pipeline: Investment in new tests and applications can broaden Atomo's
addressable markets and create additional exciting and significant commercial opportunities
Creating a compounding value proposition: Revenue growth → improved operating leverage →
reinvestment in R&D → broader product portfolio → longer-term revenue growth and enterprise value
Building a platform for sustainable growth
: AT1
For further information, please contact:
Cheri Walker, Interim CEO and Executive Director
Cheri.Walker@atomodiagnostics.com
p. +61 2 9099 4750
Investor Queries investor
Investorqueries@atomodiagnostics.com
Atomo Strategy Update and FY26 Full Year Investor Webinar Presentation
Atomo Diagnostics Limited will hold its Strategy Update and FY26 Full Year Investor webinar on
Thursday 24th September 2026 at 11:00 AM.
To access Atomo’s Investor Hub please scan the QR code.
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
Share your feedback
Discover