Quarterly Activities Report and Appendix 4C
Released
Released
Announcement PDF
ASX Announcement
July 25th, 2024
Quarterly Activity Report Q4 FY24
Highlights
•
Continued Growth across Atomo’s HIV Self-Test business:
o
~400k units sold during the quarter.
o
The Australian Federal Government announces two years of funding for HIV
self-test procurement across a number of programs.
o
Newfoundland launch their branded version of the Atomo HIV Self-Test in
Boots – the UK’s leading health and pharmacy retail chain.
•
Funded Development Programs secured: Further purchase orders received from the
Burnet Institute related to the development of two programs utilising the Pascal cassette
for next-generation rapid test assays developed by Burnet.
•
Revenue: $1.64m (unaudited) revenue in Q4 FY24, consisting of HIV test sales, OEM
Pascal sales and Development fees, bringing unaudited YTD revenue to $4.09m.
•
Cash receipts: Cash receipts from customers during the quarter of $1.08m. Atomo
finished the quarter debt-free, with cash on hand at quarter-end of $3.69m.
SYDNEY Australia, 25 July 2024 – Atomo Diagnostics Limited (ASX: AT1) (Atomo) is
pleased to release its Appendix 4C and quarterly activity report for the three months ended 30
June 2024 (Q4 FY24).
HIV Self-Test Business
Atomo has in the last six months received sales orders totalling over 520k units from its global
health partner, Viatris, for supply into several international markets. This represents a marked
increase in demand for the HIV self-test in global health markets and reflects the increased
significance of Atomo’s product as the only WHO prequalified self-test manufactured in Africa.
In Australia, the Federal Government committed in the May budget, to funding for the
expansion of the NAPWHA run HIV Self-Test via mail-out program. Atomo is budgeting
revenues of $1.3m over the next two years from this program and continues to work with
NAPWHA and Grindr to promote awareness and access to HIV Self-Testing via the program.
Atomo continues to support the Federal Government funded vending machine program
national scale up which is anticipated to generate additional demand for tests in the coming
months. Additionally, following South Australia Health, New South Wales Health’s MyTest
vending machine program was officially launched in June with Atomo supplying HIV self-tests
for the project.
My Test Program – NSW Health
Newfoundland Diagnostics have now launched their branded version of the Atomo HIV SelfTest in Boots stores across the UK. Boots is the UK’s leading health and pharmacy chain
operating around 2000 stores nationally. Launch in Boots stores follows the product launch in
Tesco Supermarkets across the UK earlier this year and sees the Atomo product establish
itself as the leading HIV Self-Test in the growing UK pharmacy retail market.
https://www.boots.com/newfoundland-hiv-test-10347963
Additional registrations of the Newfoundland-branded product variants have progressed with
Switzerland added to the existing approval during the quarter and a submission made to
Atomo’s Notified Body to add an Eastern European language variant of the Newfoundlandbranded product, further expanding the territories where the product will be actively promoted
through Atomo’s channel partners.
Blood-Based Pregnancy Testing
Atomo’s application to TGA to sponsor NG Biotech’s Blood Pregnancy Tests for inclusion on
the Australian Register of Therapeutic Goods (ARTG) has been unsuccessful. NGB’s Blood
Pregnancy Tests are currently authorised for commercial supply in Europe, the UK and Brazil,
and we note that NGB have supplied several hundred tests into international markets without
any reported performance issues or incidents.
We are currently reviewing with NGB the feedback received from the TGA, including
assessing requirements to generate the additional clinical data required for Australian
compliance, and to establish a timeline for NG Biotech as manufacturer to provide Atomo with
a revised Technical File that supports ARTG listing.
Funded Development Programs
Active Syphilis Test- Syphilis rates have significantly increased in the past decade globally,
with syphilis seen as a growing public health problem. The Burnet Institute has developed an
active syphilis rapid test that is specific to detection of current active syphilis infections.
Available rapid tests in the market cannot discriminate between current active cases of syphilis
and past treated cases of syphilis. The Burnet Institute Active Syphilis test has been optimised
in the Atomo Pascal cassette and Atomo and Burnet are discussing commercialisation options
with a view to formalising plans in a commercial agreement.
Liver function test (ALT) - Atomo is collaborating with the Burnet Institute on the
development of tests for monitoring Liver function (ALT) and the detection of active syphilis.
The agreement will see Burnet Diagnostics using Atomo’s Pascal cassette, with Atomo has
receiving an additional purchase order related to the optimisation of its Pascal cassette.
Other Opportunities: Atomo has had several inbound enquiries for Atomo products and
technology post US FDA 510(k) clearance of Lumos’s FebriDx test on the Atomo Pascal
platform. This combined with evidenced traction in retail channels and demonstrated user
preference in independent evaluations provides a compelling value proposition to industry
players increasingly focused on the transition to decentralised testing.
Financials
Total revenue (unaudited) of $1.64m for Q4 FY24, comprising $1.4m for HIV test sales, and
Pascal (OEM) sales of $234k and the remaining amount from development fees, bringing
revenue for FY24 to approximately $4.09m, an increase of 61% on FY23 YOY.
Operating costs for Q4 FY24 were $1.4m (unaudited) compared to equivalent costs of $2.3m
for Q4 FY23, representing a reduction of 38% in Operating costs for the quarter.
Cash receipts from customers during the quarter were $1.08m, and Atomo finished the quarter
debt-free and with cash on hand of $3.69m.
In accordance with ASX Listing Rule 4.7C.3, Atomo advises that an amount of $195k 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 into new markets including New Zealand, and Eastern
Europe, as well as a focus on promoting and scaling emergent public health-funded
programs in Australia and assessing public health funded opportunities in Europe and
the US.
•
Support existing OEM partners Lumos and NG Biotech as they focus on expanding
the marketing and sales of their rapid test products in Europe, Australia, the US and
South America.
•
Attending the ADLM conference and the Next Generation Dx Summit in Q1 FY 25 in
the US, to continue to raise levels of awareness and engagement related to the
company and its unique easy to use rapid solutions.
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.
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of Entity
Atomo Diagnostics Limited
ABN
Quarter Ended ("current quarter")
37 142 925 684
30 June 2024
Consolidated statement of cash flows
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
Year to date
(12months)
A$'000
Current Quarter
A$'000
1,079
3,807
( 51)
( 218)
( 1,286)
( 3,110)
(c) advertising and marketing
( 17)
( 114)
(d) leased assets
-
-
(e) staff costs
( 884)
( 4,126)
(f) administration and corporate costs
( 367)
( 1,835)
-
-
(a) research and development
(b) product manufacturing and operating costs
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
761
1.8
Other (provide details if material)
1.9
Net cash from / (used in) operating activities
( 1,494)
( 4,683)
2.
Cash flows from investing activities
2.1
Payments to acquire or for:
(a) entities
-
-
(b) businesses
-
-
(c) property, plant and equipment
64
32
152
34
(d) investments
-
-
(e) intellectual property
( 68)
( 48)
(f) other non-current assets
-
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 1
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
2.2
Year to date
(12months)
A$'000
Current Quarter
A$'000
Proceeds from disposal of:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments
(e) intellectual property
(f) other non-current assets
-
-
2.3
Cash flows from loans to other entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash from / (used in) investing activities
( 4)
( 14)
3.
Cash flows from financing activities
3.1
Proceeds from issues of equity securities
(excluding convertible debt securities)
-
2,259
3.2
Proceeds from issue of convertible debt
securities
-
-
3.3
Proceeds from exercise of options
-
3.4
Transaction costs related to issues of equity
securities or convertible debt securities
-
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
Transaction costs related to loans and
borrowings
( 46)
( 181)
3.8
Dividends paid
-
3.9
Other (provide details if material)
-
3.7
3.10 Net cash from / (used in) financing activities
4.
( 209)
-
( 46)
1,869
Net increase / (decrease) in cash and
cash equivalents for the period
4.1
Cash and cash equivalents at beginning of
period
5,208
6,470
4.2
Net cash from / (used in) operating activities
(item 1.9 above)
( 1,494)
( 4,683)
4.3
Net cash from / (used in) investing activities
(item 2.6 above)
( 4)
( 14)
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 2
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Year to date
(12months)
A$'000
Current Quarter
A$'000
4.4
Net cash from / (used in) financing activities
(item 3.10 above)
( 46)
1,869
4.5
Effect of movement in exchange rates on cash
held
25
46
4.6
Cash and cash equivalents at end of
period
3,688
3,688
5.
Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current Quarter
A$'000
Previous Quarter
A$'000
5.1
Bank balances
3,688
5,208
5.2
Term deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of quarter
(should equal item 4.6 above)
3,688
5,208
6.
Payments to related parties of the entity and their
associates
Current Quarter
A$'000
6.1
Aggregate amount of payments to related parties and their
associates included in item 1
195
6.2
Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 3
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
7.
Financing facilities
Note: the term "facility" includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
Total facility
amount at quarter
end
A$'000
Amount drawn at
quarter
end
A$'000
sources of finance available to the entity
7.1
Loan facilities
-
-
7.2
Credit standby arrangement
-
-
7.3
Other (please specify)
-
-
7.4
Total financing facilities
-
-
7.5
Unused financing facilities available at quarter end
7.6
Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
8.
Estimated cash available for future operating activities
8.1
Net cash from / (used in) operating activities (Item 1.9)
( 1,494)
8.2
Cash and cash equivalents at quarter end (Item 4.6)
3,688
8.3
Unused finance facilities available at quarter end (Item 7.5)
8.4
Total available funding (Item 8.2 + Item 8.3)
3,688
8.5
Estimated quarters of funding available (item 8.4 divided by
2.50
-
A$'000
-
item 8.1)
8.6
If Item 8.5 is less than 2 quarters, please provide answers to the following questions:
1. Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer: Not applicable.
2. Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer: Not applicable.
3. Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer: Not applicable.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 4
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
1
2
This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
This statement gives a true and fair view of the matters disclosed.
Date: 25 July 2024
Authorised by: ..........The Board
(Name of body or officer authorising release see note 4)
Notes
1.
This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s
activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes
to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so.
2.
If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and
provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in
accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard
applies to this report.
3.
Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4.
If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has
been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board
committee – eg Audit and Risk Committee] ”. If it has been authorised for release to the market by a disclosure committee, you can
insert here: “By the Disclosure Committee”.
5.
If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records
of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true
and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk
management and internal control which is operating effectively.
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Page 5
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