H1 FY26 Results Presentation
Released
Released
Announcement PDF
ATOMO DIAGNOSTICS
H1 FY26 RESULTS PRESENTATION
26th February 2026
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
WHO IS ATOMO? WHAT BUSINESSESTOWE HAVE?
• We develop, manufacture and supply innovative rapid
diagnostic tests and best-in-class rapid test technologies for
professional and self-test point-of-care test (POCT) markets
• Atomo solutions increasingly recognised as delivering
unmatched user simplicity and reliability, and facilitating
hard to get approvals where accuracy is critical
• Atomo’s unique solutions offer a significant growth
opportunity as the market continues to shift to
decentralised testing and growing interest in home testing
post-pandemic
Our unique portfolio of patented rapid tests and technologies allows people to test reliability, putting healthcare in the hands of the user
Point of Care Test (POCT) Diagnostic Products:
• Supply of diagnostic rapid tests into professional use and
self-test market channels
• Initial focus on Sexual / Female Health, being high growth
segments in the POCT market, with use in both channels
Point of Care Test Technologies (OEM Supply):
• Integrated proprietry cassette supplied to partners that require
usability and precision at the point-of-care
• Custom cassettes (blood and swab based) for partners seeking
improved usability for standard cassettes (POC clip-in)
WHO IS ATOMO AND WHAT DO WE DO?
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• Atomo signs exclusive global licensing agreement to commercialise a novel Liver function test on Pascal; the first
commercial application targeted is monitoring drugs with known liver injury risk; the test is already under evaluation for this
purpose with a large multinational pharmaceutical company in an US drug trial commenced 2025
• Revenue generated during H1 FY26 was $2.2m: over the period the company received $2m in customer receipts and a
further $1.2m in government grants and tax incentives, bringing cash on hand at 31 December 2025 to $3.51m, with no debt
H1 FY26 – ACTIVITY SUMMARY
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
• Atomo receives Pascal orders for FebriDx totaling ~A$1.5 million
• Pascal performance proven in US clinical studies; delivering greater than 99%
usability and supporting submission to US FDA for FebriDx CLIA waiver
• Atomo secures two new customers for Pascal
• Detection of Iron deficiency (Chromacare, Canada) – order for 43,000 Pascal
cassettes; ~A$170k in Pascal revenues and development fees
• Detection of Stroke (UK company) – order for 20,000 Pascal cassettes
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ASX: AT1 CORPORATE SNAPSHOT
Market Cap.
$30.79M
Year low – high
$0.014 - $0.048
Shares on issue
810,175,282
H1 FY26 FINANCIAL
PERFORMANCE
AUD
H1
FY26 ($m)
H1
FY25 ($m)
(%)
Revenue 2.18 2.05 6%
Cost of sales (1.33) (1.12)
Gross Profit 0.85 0.93 (9%)
Gross Margin 39% 45%
Product sales Gross Margin 37% 37%
Other income 1.11 0.55 102%
Employee benefits expense
(1.36) (1.73) 21%
Research and development costs (0.32) (0.28) (14%)
Professional fees expense (0.21) (0.43) 51%
Inventory obsolescence expense (0.01) (0.02) 50%
Other expenses (1.05) (0.96) (9%)
Underlying EBITDA (0.99) (1.94) 49%
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
HY1 - FY26 PROFIT & LOSS
• Sales increased 6% compared H1 FY25,
bringing total revenue to $2.18m for the
period.
• Gross margin reduced by 6%, primarily driven
by the HIV Global Health LMIC segment,
which represented a meaningful share of
sales and carries lower operating margins.
• With revenue remaining stable, and costs
tightly managed, underlying EBITDA loss
effectively halved for the period to ~$1.0
million.
H1 FY26 FY25
AUD ($m) ($m)
Cash and cash equivalents 3.51 3.22
Trade and other receivables 1.86 1.69
Inventories 1.61 1.65
Property, plant and equipment 0.58 0.89
Intangible assets 1.43 1.64
Other assets 0.49 0.18
Total assets 9.48 9.27
Trade and other payables 1.38 1.03
Other liabilities 1.46 1.28
Total liabilities 2.84 2.31
Net Assets 6.64 6.98
• Atomo had a cash balance of $3.51m as of 31
December 2025, and the company remains debt
free
• Capitalised expenditure relating to R&D and PPE
for the period was not significant
• Ongoing activities continues to focus on
expanding HIV sales, bringing to market new
Atomo finished tests and increasing the Pascal
supply volumes to support increasing demand
from existing customers and new customer
acquisition.
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
HY1 - FY26 BALANCE SHEET
• Total Cash Receipts: $4.5 million
• ~$2m from product sales
• $875k from R&D tax rebate
• ~$330k from CRC-P Grant for Active Syphilis
test development
• ~$1.3m from capital raised in July 2025 (net
of transaction costs)
• Total Cash Payments: $4.2 million
• ~$1.3 million in stock purchases
• ~$2.9m in operating expenses
• Overall OpEx and CapEx remained in line
expectations, supported by ongoing cost
saving initiatives aimed at achieving
breakeven
• Year-end cash balance of $3.5 million, no debt
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
HY1 - FY26 CASHFLOW
A$(m)
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
Cashflow activities
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
Revenue momentum increasing, with
diversification across core revenue channels:
• Strong, established position in the HIV market
• Increasing demand for Pascal for FebriDx
• Growing pipeline of Pascal customers and
pipeline
OpEx stable across H1 FY26, supported by a
focus on costs without constraining revenue
growth from core business
• Additional non-dilutive funding used to get
new products to market, further reduced
operating expenditure by approximately $1
million in H1 FY26 from graph above
FUNDAMENTALS
(2.5)
(2.0)
(1.5)
(1.0)
(0.5)
0.0
H1 FY24 H2 FY24 H1 FY25 H2 FY25 H1 FY26
A$(m)
Underlying EBITDA Loss*
0
0.5
1
1.5
2
2.5
H1 FY24 H2 FY24 H1 FY25 H2 FY25 H1 FY26
A$(m)
Revenue
POC Tests POC Technology Development fees/other
-
1.0
2.0
3.0
4.0
H1 FY24 H2 FY24 H1 FY25 H2 FY25 H1 FY26
A$
(m)
OpEx
(excl. grants & rebate offsets)
• EBITDA Losses reducing, representing a
material improvement over time
• Improvement underpinned by revenue
growth, disciplined operating
expenditure management, and the
successful non- dilutive funding of new
Atomo products
ATOMO’S
DIAGNOSTIC TEST
BUSINESS
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ATOMO’S HIV SELF-TEST BUSINESS
• Continued growth for HIV Self-Test with H1 FY26 revenues of $1.1m and orders
received in Q3 worth a further ~$1.6 million
• Australian Government reaffirms continued federal funding for Australia’s key
HIV Self-Test distribution programs established with support from Atomo
• Atomo secures an experienced commercial resource with an immediate focus on
growing HIV revenues in Australia and expanding international channel
partnerships with initial focus on Europe and Asia
ATOMO IS SEEING TWO KEY DRIVERS OF LONG-TERM GROWTH IN HIV:
o Increasing demand in Retail markets post COVID
o Emerging Public Health Procurement for Infectious Disease Self-Testing
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
HIV SELF-TEST SALES MOMENTUM
Atomo Secures an A$500k Order for HIV Self-Test; 15th Jan 2026
https://investors.atomodiagnostics.com/announcements/7325306
Atomo Secures an A$416k Order for HIV Self-Test; 30th Jan 2026
https://investors.atomodiagnostics.com/announcements/7333123
Atomo Secures an A$630k Order for HIV Self-Test; 6th Feb 2026
https://investors.atomodiagnostics.com/announcements/7333123
Federal Government funded and NAPWHA operated: https://hivtest.au/order-your-test/
• https://www.futuremarketreport.com/industry-report/hiv-pointofcare-testing-market
HIV Rapid Test market estimated at US$1.75 billion, growing at a CARG of 10% *
High growth rate in Self-Testing driven by privacy and convenience, and a growing
adoption of self-test policy and procurement of self-tests by public health bodies
Atomo and NAPWHA collaborate at Mardi Gras Fair Day
UNIQUE ACTIVE SYPHILIS TEST
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
An Increasing Public Health Challenge and Commercial Opportunity:
• The global syphilis testing market was valued at $1.1 billion in 2020, and is projected
to reach $1.9 billion by 2030 #
• Data suggests the UK performed ~1.8 million syphilis tests in 2024, including
~350,000 tests supported through at-home blood sample collection / mail to lab ^
• There is currently no rapid test available that can be reliably used at the point-of-care
to distinguish active infection from prior treated infections
• Product Development complete with preliminary verification offering unmatched
specificity distinguishing active infections (Atomo 86% vs Current tests <45%) *
• Positive engagement with clinicians, regulators and public health
# https://www.alliedmarketresearch.com/syphilis-testing-market
^ https://sti.bmj.com/content/101/4/242
* Atomo Specificity compared to rapid Syphilis test on the market
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
ATOMO’S LIVER TEST – DERISKED DEVELOPMENT PATHWAY
Atomo secures an exclusive worldwide license to commercialise
Burnet Institute’s proven ALT / Liver test assay *
• Atomo will be the listed manufacturer and supplier of the
finished test supplied to market
• Delivered using Atomo’s proven Pascal cassette at the
point-of-care and at-home, the test provides rapid
detection of liver injury through measurement of ALT
(key indicator of liver inflammation and damage)
• Product development substantively complete, diagnostic
performance established and a pharmaceutical company
now evaluating the test to monitor for drug induced liver
injury (DILI) in a US clinical trial
* https://investors.atomodiagnostics.com/announcements/7326658
Test Performance:
Test shows good correlation (R2 = 0.9089) between
fingerprick blood and venous blood (see graph below)
ROC curve analysis conducted using a threshold of 40 IU/L
for normal vs abnormal. Validation set gave AUC 0.94
(indicating very strong accuracy in distinguishing between
normal and abnormal ALT levels)
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
LIVER TEST – BROAD COMMERCIAL UTILITY
• Monitoring for drug-induced liver injury (DILI) – common drug types where ALT
monitoring is recommended; TB Drugs, Methotrexate, Leflunomide & Azathioprine
(Immunology and Rheumatology), Valporoate (Neurology), Amiodarone
(Cardiovascular) and long-term Diclofenac use (Analgesic and Anto-inflammatory)
• Diagnosis and treatment management of Hepatitis B and C – evaluation trial planned
for later in year for commencement of Hepatitis B drug treatment based on ALT level.
• Screening for Fatty Liver disease risk – high level of correlation between elevated ALT
and Fatty Liver disease; a condition affecting more than 1.5 billion people globally. An
opportunity for a home screening test for at-risk populations, as well as home
monitoring of diagnosed patients receiving treatment
• Screening for Alcoholic Liver disease risk – correlation between elevated ALT and liver
damage allows for an immediate screening test to detect liver cell injury or
inflammation; impacting around 300 million people globally
ATOMO’S
OEM CASSETTE
BUSINESS
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
• Atomo receives H1 FY26 orders for FebriDx totaling ~A$1.5m, representing a ~1600% increase
in Pascal FebriDx orders when compared to H1 FY25
• Lumos signs a six-year agreement with PHASE Scientific for supply of FebriDx® in US - Lumos
anticipates FebriDx product revenues of up to US$313 million over the term, assuming CLIA
waiver is granted and contracted MOQ’s achieved
• FebriDx® submitted to US FDA for CLIA wavier, based on Pascal performance - validated in US
trials as delivering greater than 99% concordance between trained and untrained users
• Atomo anticipates a significant increase in demand from FebriDx in the coming years, noting
that a Lumos anticipates a decision from US FDA on FebriDx CLIA waiver during Q3 FY26
• 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
PASCAL OEM BUSINESS – H1 FY26 HIGHLIGHTS
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
NEW PASCAL OEM BUSINESS – CHROMACARE
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
• 43,000 Pascal units now being manufactured to support product
validation and registrations – long term commercial supply
agreement for Pascal anticipated in Q4 FY26
• Chromacare interest in a US CLIA waiver submission supported by
Pascal and utilising Pascal FebriDx as a predicate *
* Assumes FebriDx secures CLIA waiver approval from US FDA (Currently pending)
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
NEW PASCAL BUSINESS – PIPELINE
New 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 Q4 FY26
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
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ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
OPERATIONAL EXPANSION
Atomo has commenced an Operational expansion to support the growth of the
company’s OEM Pascal businesses and Atomo Diagnostic Test products
• 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
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• Pascal orders for FebriDx growing significantly, with a decision by US FDA on CLIA waiver anticipated. (Lumos has
previously disclosed significant contract demand for FebriDx , subject to securing CLIA waiver)
• Onboarding new customers on the Pascal platform, with best-in-class Pascal performance increasingly recognised and
valued in the market, as is the ability to enable CLIA waiver status (pending)
• Continued organic growth in the HIV business, with more than A$1.6m in orders received during Q3 FY26
• Active Syphilis performance demonstrates best-in-class diagnostic specificity - preliminary engagement with
clinicians, regulators and government is encouraging and clinical trials anticipated to commence mid-year
• Exclusive license secured to commercialise a novel liver test. Large addressable markets across several applications
and an evaluation by a potential multinational Pharma partner for Drug Injury Risk monitoring already underway
• Revenue increasing & underlying losses for the H1 FY26 below $1 million, representing a near halving of losses
compared to the prior comparable period, and demonstrating a pathway to profitability given potential revenue growth
ATOMO DIAGNOSTICS LIMITED | (ASX: AT1)
INVESTOR HIGHLIGHTS
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