Quarterly Activity Report - 31 December 2023
Released
Released
Announcement PDF
ASX Announcement
29 January 2024
Quarterly Activity Report Q2 FY24
Highlights
Strong growth in revenue and margins across Atomo’s HIV Self-Test business:
o
Over 130k units sold during the quarter, primarily into high value developed
markets in Europe and Australia.
o
HIV Self-Test successfully launched across TESCO supermarkets in the UK
and launching in pharmacies across Germany.
o
Order received from UK partner Newfoundland for an additional 220k units to
support product expansion in the UK and Germany and launch into new
European markets.
o
Significant Australian revenue growth in December following the formal
adoption of HIV Self-Testing into government policy on World AIDS Day.
Re-emerging POC Technology (OEM) demand post COVID:
o
Over 50k units sold during the period to existing customers, with a further order
over 50k units received in January.
o
Increased inbound enquiries for Atomo products and technology post US FDA
510k approval for Pascal and traction in OTC channels earlier in FY24.
o
An inaugural purchase order received recently from a global diagnostic
company relating to assessment of Atomo cassettes for potential use with a
diagnostic reader system.
Continued progress with Pregnancy Testing:
o
Atomo and NG Biotech (NGB) have progressed generating additional data
requested by TGA, with a response to TGA imminent.
o
NGB secured a significant contract covering Italy, Spain and Portugal with
multinational TOWA Pharmaceutical.
o
Atomo and NGB held a pre-sub meeting with US FDA in December and are
now updating clinical plans to support US product approvals.
Revenue: $710k (unaudited) in Q2 FY24 revenue during the quarter, making product
sales revenue for H1 FY24 of $1.9m, compared with product revenues of $1m (excluding
COVID) for H1 FY23, representing half year over half year growth of 98%.
Cash receipts: Cash receipts of $1.9m during the quarter, made up of $1.1m in receipts
from customers and $761k received from Government R&D rebate. H1 cash receipts of
$2.8m. Atomo finished the quarter debt-free, with cash on hand at quarter-end of $6.5m.
SYDNEY Australia, 29 January 2024 – Atomo Diagnostics Limited (ASX: AT1) (Atomo) is
pleased to release its Appendix 4C and quarterly activity report for the three-months ended
31 December 2024 (Q2 FY24).
HIV Self-Test
Newfoundland Diagnostics took delivery of the remaining shipment of their initial order for the
UK and European markets and launched the product in Tesco, the largest supermarket chain
in the UK. A launch campaign is now underway across the UK to raise awareness about HIV
in general and the availability of the Newfoundland HIV Self-Test in particular, with further UK
national media anticipated to coincide with UK National HIV Testing Week in February.
December saw the launch of the HIV Self-Test in Germany through pharmacy chain MePro
FH-Handels GmbH, with display stands now in pharmacies across the country. Further
expansion into other retail outlets and across other markets in the EU will roll out in 2024.
To support continued growth in the European market, Newfoundland placed an order for an
additional 220k tests, with the first tranche of 50k units under manufacture. As a result of
meeting their volume obligations for CY2024, the contract with Newfoundland remains
exclusive and will be extended for a further five years.
During the period, Atomo assisted Newfoundland to submit for registration with the Colombian
regulator, with approval anticipated in the coming months. In parallel, Newfoundland have
opened the world’s first retail store dedicated solely to rapid self-testing in Bogota, Colombia.
Newfoundland’s new innovative consumer self-test store in Bogota, Colombia
In Australia, Atomo has been working with NAPWHA and Grindr to promote awareness and
access to HIV Self-Tests. Atomo also continues to support existing vending machine programs
as well as working with State governments implementing larger vending machine programs in
the coming months. Vending machine roll out to a wider public audience allows further grass
roots awareness of our brand and product, so anchoring possible interest in other test products
as these become available in Australia.
As the graph below shows, HIV sales continue to grow strongly in the Australian market, with
recent policy changes that went into effect 1st December driving government adoption of selftesting policy and delivering immediate growth in December sales, with continued growth is
anticipated over the coming year.
Engagement with State and Federal Governments is accelerating post this policy change,
suggesting the potential for broader adoption of HIV Self-Testing across public health
channels during 2024 and beyond.
POC Technology (OEM)
Atomo sold over 50k units during the period to existing customers, with a further order over
50k units received in January. The company anticipates regular ordering from its two existing
customers as they continue to focus on the commercial rollout of their blood tests post COVID.
The company has seen an increase in inbound enquiries for Atomo products and technology
post US FDA 510k approval for Pascal and evidenced traction in OTC channels earlier in
FY24. This combined with demonstrated overwhelming user preference and error reduction
in independent evaluations provides a compelling value proposition to industry players
increasingly focused on the transition to decentralised testing.
Atomo has collaborations now in place with new diagnostic companies interested in accessing
Atomo technology, having recently received a purchase order relating to assessment of its
Elion cassette for use with a reader system. The company also anticipates executing
agreements in the coming months with two Australian entities related to Atomo devices
supporting commercialisation of a blood-based rapid test and a swab based rapid test.
Blood Based Pregnancy Testing
Atomo received a detailed response from the TGA relating to the application to register
professional use and self-test variants of the Atomo blood pregnancy test in Australia. Atomo
and NG Biotech (NGB) have progressed generating additional data requested by TGA, with
a response to TGA imminent. The company remains hopeful that both versions of the
product will receive regulatory approval for Australia and be launched nationally during 2024.
NGB secured a strategic partnership agreement with multinational TOWA Pharmaceutical
covering NGB’s version of the Pascal based blood pregnancy self-test.
Atomo and NGB participated in a pre-sub meeting with US FDA in December with a followup meeting with FDA is scheduled for early March.
Financials
Total revenue (unaudited) of $710k for Q2 FY24, comprising $624k for HIV sales, and OEM
sales of $86k, bringing total revenue for the half year FY24 to approximately $1.9m.
HIV revenues increased during the period with expectations of growth to continue into H2
FY24 for reasons noted above. The increasing mix of HIV sales in developed healthcare
markets with better pricing when compared to Atomo’s traditional global health channels is
reflected in improving gross margin. Overall GM for the company improved to 46% when
compared to 39% (excld Covid) for the corresponding period in H1 FY23.
Cash receipts from customers during the quarter were $1.1m with a further $761k received
from the Government R&D rebate program. Atomo finished the quarter debt-free and with
cash on hand of $6.5m.
In accordance with ASX Listing Rule 4.7C.3, Atomo advises that an amount of $208k was
paid during the quarter to Atomo Directors in salary and director’s fees.
Key Priorities and Use of Funds
Continued growth of HIV sales in Australia with a focus on scaling emergent public
health funded programs and an expansion of global HIV commercial relationships.
Secure new OEM customers for Pascal following FDA approval, in addition to
executing agreements with partners related to other Atomo platforms.
Continued market engagement through active attendance at key conferences and
events focusing on new test development and commercialisation.
Securing regulatory approval and launch in Australia for Atomo’s pregnancy tests, and
completion of FDA submission plans and a go-to-market strategy.
For more information, please contact:
John Kelly
Atomo Diagnostics
john.kelly@atomodiagnostics.com
Phone: +61 401 922 279
This announcement was authorised by the Board of Directors.
About Atomo
Atomo is an Australian medical device company supplying unique, integrated rapid diagnostic test
(RDT) devices to the global diagnostic market. Atomo’s patented devices simplify testing procedures
and enhance usability for professional users and untrained self-testers. The Company has supply
agreements in place for tests targeting infectious diseases including COVID-19, HIV, viral vs bacterial
differentiation and female health.
See more at www.atomodiagnostics.com.
Forward looking statements
This announcement may contain forward looking statements which may be identified by words such
as “believes”, “considers”, “could”, “estimates”, “expects”, “intends”, “may”, and other similar words
that involve risks and uncertainties. Such statements are not guarantees of future performance and
involve known and unknown risks, uncertainties, assumptions and other important factors, many of
which are beyond the control of Atomo or its Directors and management and could cause Atomo’s
actual results and circumstances to differ materially from the results and circumstances expressed or
anticipated in these statements. The Directors cannot and do not give any assurance that the results,
performance or achievements expressed or implied by the forward-looking statements contained in
this announcement will actually occur and investors are cautioned not to place undue reliance on
these forward-looking statements.
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