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Earnings Call: H2 2025

Sep 2, 2025

John Kelly
Founder, CEO, MD & Interim Chair, Atomo Diagnostics

Results presentation. Thank you for joining us. By way of an introduction for anyone who's new to Atomo or the story, I just wanted to take a moment to talk about who Atomo is and what we do. We're an innovator in point-of-care diagnostics, and we're an Australian-based company with low-cost operations overseas that allow us to be competitive in international point-of-care rapid test markets. We've developed a range of patented portfolio products that really move the dial in terms of usability and ease of use in point-of-care testing, primarily blood testing. Our technology is now increasingly recognized globally as delivering best-in-class performance in both the hands of untrained professional users as well as at-home lay users. That's an emerging market that we think our technology really is instrumental in helping to support.

In terms of that patented technology, how we make a business model with that technology, we've really got two arms to the business. One is the development and supply of finished end product tests to market, with a primary focus in sexual health. We'll talk a little bit about those products and that portfolio over the longer term. Outside of areas where Atomo is the listed manufacturer, we have proprietary technology devices, cassettes that we supply to other diagnostics companies for applications that they want to bring to market, and we're the critical supplier to them for those products.

We have a solution, Pascal, in market that has got enormous potential and has made some good strides this year in terms of its journey to becoming, we think, a gold standard for testing in international markets, as well as Flori, a new device that's been adapted from Pascal to address another unmet need in the market that we've identified. We'll talk a little bit about those in this presentation. In terms of corporate business activities, it's been a busy year. FY2025 for Atomo, we have gone through a period of board refresh. We have had two new directors join the board, both with significant IVD diagnostics industry experience, Anthony May and Patrick Cook. We've had a number of directors leave the board as part of a renewal process: our Chairman John Keith, Ms. Deborah Neff, and Dr. Paul Cassian, who've departed during the year.

I'd like to take this opportunity to thank them for their significant efforts over the last couple of years in helping getting Atomo to where it is today. I'd also like to thank Dr. Sherry Walker for stepping up from Non-Executive to chair the ARC Committee. As part of that refresh, I took on the role of Interim Chair. That's really been a journey to lean up the board, help with continued support of reduced OpEx, and to make the business a little bit more flexible. That's been a process that has been done in parallel with some capital activity to repair the balance sheet. We raised just under $3 million net of fees through the year. I was very pleased to report that that has been primarily supported by existing shareholders.

That shows a level of support on the current register for the direction of the business and the technology that we've developed. We've also continued to focus over the year on improving our burn rate. A large part of that has been continued focus on reducing costs within the business and a focus on improving our OpEx over the period as we scale up our revenue. You can see from the small graph down in the bottom corner that we have been making continual progress towards a break-even position. That's something that continues to be a very significant focus for the business moving forward. Outside of corporate activities during the year, there's been a number of, I think, quite material commercial deliverables for the business.

We'll talk in the presentation in a bit more detail around each of those assets, what they mean for the business, what stage of commercialization they're at, and what we think the future for those assets looks like moving forward. Certainly, with HIV, our core product, our initial product to market on the platform, we continue to see growth in the Australian and European markets. That's encouraging because they're the markets where we secure the best margin for HIV product supply. We've seen the emergence of a material public health procurement business in Australia funded by the government. That's really a recognition that self-testing now has a role, I think, a permanent and ever more important role to play in the delivery of public health diagnostics in the market and a transition away from laboratory-based testing.

We have also been making active progress on a syphilis test development based initially off an Australian government grant. We're very excited about that product. We will talk in the presentation in a little bit more detail around why we're excited. That fits very nicely alongside HIV. The two user groups in terms of testing for HIV and syphilis have a very significant overlap. The channels that we've developed for HIV delivery, both consumer health as well as public health, are ideally suited to leverage for the delivery of an active syphilis test, both professional use and self-test point of care. On the OEM development side of the business, obviously, Pascal has made significant progress over the last year or two as both Lumos and Engie Biotech have rolled their tests out after a bit of a hiatus through the COVID period where they focused on antigen COVID testing.

We are now seeing the fruits of that journey with the Lumos agreement with PHASE. We will talk a little bit about that moving forward. Pascal has been instrumental in providing the performance to underpin their CLIA waiver process. We are very proud of that. We think that not only opens up significant revenues through our partnership with Lumos, but more broadly, the ability for Pascal to support CLIA waiver tests in the U.S. is very material to us. Pascal, Febrex, being only one application out of potentially many, as well as Atomo being able to bring its own products to market in the U.S. off the back of the performance of the Pascal device in that CLIA waiver setting.

We also will talk a little bit about a new device, Flori, that we've developed, essentially a remodified Pascal that looks to address a market that we feel has enormous potential. We will talk a little bit about why we think Flori is a good solution for that market and what that market opportunity might look like moving forward. Before we jump into that, I wanted to hand over to Suzy, who's going to step us through this year's FY2025 financial numbers.

Suzy Elhlou
Financial Controller, Atomo Diagnostics

Thanks, John. Good morning, everyone. Thank you for joining us today. I'd like to take a few minutes to walk through our financial results for the period, starting off with our profit and loss statement for FY2025. To begin with, as shown in the P&L summary, revenue of $3.8 million was achieved. This was broadly in line with the prior year period. During the year, HIV sales totaled just shy of $2.5 million. Whilst this is comparatively lower than the prior period, this was mainly driven by a reduction in our global health funding from the U.S., which did impact our top-line revenue. As such, our efforts were redirected to growing momentum in Australia and the Europe market, which do yield significantly better margin and therefore largely sustained our gross margin from the HIV revenue stream.

On the Pascal technology side, OEM sales remain comparable with the prior period, totaling $700,000. Whilst a significant improvement in our development and license fees revenue sustained our top-line revenue, contributing more than half a million there. As a result, we're seeing meaningful progress in our margin, which increased from 39% to over 50% in FY2025. This reflects Atomo Diagnostics' growing revenue streams outside of HIV global health business, which contributes significantly higher margin. This is an encouraging trend and a key focus area for us and one that we see continuing as we enhance our operational leverage and scale. On the cost side, we're also continuing to deliver improvements here. Operating expenses were down compared to the prior year by approximately $650,000 as a result of our focus on cost management and ongoing efficiency initiatives. We're seeing the impact of these efforts now in our bottom line.

As a result of the improved margins and reduced operating costs, we narrowed our EBITDA loss for the period. The loss came down by approximately 23% to just shy under $3.5 million. That's marking a key step in the right direction towards our goal of achieving profitability. In summary, we're building a stronger financial foundation, improving our margins, our expenses are moderating, and significantly reducing our EBITDA. These are early but important indicators of the progress we are making. Now let's move on to the balance sheet. I'm pleased to report that our cash position remains stable over the period, supported by the capital raising efforts and non-dilutive grant funding that we received for the development of active syphilis. This financial stability gives us the ability to continue to execute on our strategy with a focus on expanding existing revenue channels and introducing new tests and platform offerings.

Cash on hand landed at $3.2 million as of 30 June. However, I do want to highlight that we received a further $1.3 million in capital net of transaction costs post year end as we closed out our capital raising activities in the July-August period. In line with what we shared earlier, EBITDA loss has reduced materially. We're seeing early returns from our efforts to drive margin improvements and cost efficiency, which is translating into better cash flow outcomes there. In summary, our balance sheet remains in a solid position. Cash is stable and no debt. Losses are narrowing. We're entering the next period with stronger financial footing and clearer momentum. Now turning to the cash flow. For the period, our cash receipts were slightly below our cash payments, reflecting a controlled use of our cash as we continue to invest in key areas of the business.

While this resulted in a net cash outflow, it is important to note that the variance was within our expectations and aligned with our budget and operating plan for that period. On the receipts side, total cash inflow was $8.7 million, while on the payments side, our cash totaled $9.1 million. Overall, we have been very deliberate in our cost management. We're seeing the impact of that discipline in reducing our EBITDA loss as previously discussed. While the net cash was an outflow, we remained in a stable financial position, supported by the capital raising during the period and the additional funding we received of the $1.3 million cash net of transaction costs. This gives us a clear runway to continue executing on our strategy with confidence. I'd now like to just take a moment and walk through the key trends supporting our company's performance and progress.

Over the last several years, we've seen consistent and sustained revenue. This trajectory reflects a strong market demand, deepening customer engagement across point-of-care, HIV sales tests, OEM technology, and broadening development revenue. At the same time, we've delivered improvements in margin. Margin expansion remains a core priority as we scale, and the positive trend that we're seeing gives us the confidence in the long-term economics of the business. Importantly, our revenue portfolio has also diversified, as you can see on the graph to the left. We're now seeing strong contribution across three key revenue streams. HIV sales have been primarily driven by our expanding Australia domestic market, which did grow 60% year on year and looks to continue to grow.

John Kelly
Founder, CEO, MD & Interim Chair, Atomo Diagnostics

OEM sales look to significantly grow as well in the coming period, as one of our key customers, Lumos, has secured a very significant contract with PHASE Scientific for the Pascal-housed Febrex test. We provide the market with some estimates on the potential impact for Atomo's Pascal revenue moving forward. Here we're now seeing growth in both the pharmacy retail channels as well as in public health funded channels. We were instrumental in the setting up of pilot programs that have now been scaled up nationally, utilizing our existing backend e-commerce infrastructure. That e-commerce infrastructure has now been used to support the NAPA at-home mail-out program, where we supply tests direct to end users' homes discreetly. Those tests are free to the user, paid for by the Australian federal government as part of their HIV diagnostics budget.

In addition to the Mail Home program, we worked with a number of partners, particularly SAMH in South Australia, initially to prove the concept of vending machine access for tests in high throughput areas where young people congregate, universities. That's been expanded to a number of other venues. That program has proven particularly successful in reaching people who haven't been testing regularly or, in many cases, never tested before. That is a key group that the government's trying to access with testing services. That program has also been funded by the government for national scale-up when we announced large orders through the period for both the NAPA and vending machine programs. We do expect to see both those programs continue to scale over the coming period.

We're working with our partners, particularly Newfoundland Diagnostics in the UK, to try to see if we can help them replicate that public health momentum in the National Health Service. They have started that engagement this year, but their primary focus was and remains pharmacy retail. They've been very successful in getting us onto the shelves in Tesco and Boots, two of the leading UK retailers in that market. It's interesting to note that, let alone Boots, certainly Tesco were not selling HIV self-tests before the COVID pandemic. There's been a clear transition to this acceptability of home-based diagnostics as mainstream retail channels. That's one that we think we can continue to leverage off, not only with HIV, but with syphilis and other tests over the coming years.

Outside of the UK, we're looking to expand our distributor network, particularly into Europe and other markets like Southeast Asia and South America, where we feel we can further optimize the distribution infrastructure that we can bring to bear. Having syphilis coming in behind HIV, I think, gives potential distribution partners some excitement around the portfolio that we can provide to them. We do continue to see long-term growth in the HIV self-test business. It's probably worth noting, we're also looking at opportunities to put a Gen4 HIV test onto Pascal with a view to really entering that professional use market, particularly with the management of PrEP in facilities-based treatment programs. We had some early discussions with a strip provider that has some interest in that area. I think HIV remains for us a core driver of long-term growth in the business and underpins the journey that we're on.

We've seen success in Europe. We've seen, obviously, some retraction in LMIC global health markets as a result of changes in U.S. federal government policy around global health support. As Suzy noted, that was the least profitable part of our business. We have, for a number of years, been focused on growing HIV revenues outside of global health to offset any decline in revenues in that channel. Europe still has significant potential for us. In the Australia-New Zealand market, we're the clear market leader. We'll note that during the year, we also successfully launched New Zealand through Chemist Warehouse. We'll turn now to active syphilis.

We're very excited about this opportunity, not only because it fits very nicely into our existing HIV channels for both public and consumer health supply, but because the test itself that we've developed in partnership with the Burnet Institute is incredibly novel in terms of not only its ability to be both a professional and self-test offering, but also because of the active syphilis component. With most, or actually with all, existing rapid syphilis tests on the market, they are traditionally antibody tests. That means that they will be reactive for someone that has syphilis, but they will also be reactive for someone that's had syphilis in the past and been successfully treated. That is a very significant clinical limitation in the use of rapid tests in a point-of-care setting, particularly for test and treat programs.

The reason for that is that as the amount of people that have had syphilis previously increases, the amount of people that are being incorrectly diagnosed as positive and sent through for expensive confirmatory processes becomes less and less efficient. We've heard cases of 75% to 80% of people being sent forward from screening programs actually being incorrectly diagnosed as syphilis-active patients, but really being patients who've had syphilis previously. That makes test and treat programs for rapid testing almost useless in certain high-risk cohorts where previous infections are quite common. Syphilis rates more broadly are increasing globally. We feel that a test that can actively distinguish between current infection and prior treated infection is a game changer, particularly on the Atomo Pascal device, given its proven ability to be used in CLIA waiver and at-home settings. The test exceeds the World Health Target Product Profile for active syphilis detection.

We believe it's the first test to actually meet, let alone exceed, those requirements. We're very excited about the opportunity globally for this test. The latest performance that we'll talk about in a second really underpins what we think the value of that opportunity is. Syphilis is a very... It's an emerging problem. Rates in the U.S. have nearly doubled over the last five years. Rates in Australia have more than doubled in the last 10 years. It is becoming an emerging public health crisis. We're now starting to see a lot more focus by government. I think that maybe reflects why Atomo was successful with the grant to develop this test. We are also seeing significant interest from global health providers around the access to a test that can be used to test and treat in a single visit accurately. We have done a lot of development this year.

We've worked with Burnet Institute to do some initial clinical validation. The performance has been, I'd say, met. It's actually, in some ways, exceeded our expectations, particularly in terms of what we think we can get regarding claim specificity. In terms of the performance of the test, if we compare it to the market leaders, we have less blood volume needed, which makes it more suitable for self-test users. It's on the Pascal platform, which we know adds significant user preference compared to multi-component kit formats, as well as obviously reducing errors and providing much better repeatability with untrained users. It makes it ideal for CLIA waiver applications as well as at-home applications. That is a real competitive advantage. These other tests are not approved for self-test use. We think the Pascal active syphilis test certainly can meet that standard.

We have competitive levels of sensitivity, that being the ability to detect active syphilis patients in screening. Where we add additional clinical benefit is our ability to distinguish between people who have syphilis, an active infection, versus people who've had a prior infection treated but still have antibodies to syphilis. It's that ability to distinguish between active versus prior treated that really gives this test its compelling market advantage in clinical benefits. You will see from the specificity results of the other tests that they are essentially unable to distinguish between those two groups. They will call all of those patients positive. They will send them all through for further testing, or they will be put on treatment erroneously. The Atomo Diagnostics test has much better levels of ability to distinguish between the two.

The encouraging feedback is that in our engagement, some extensive engagement we've had over the last couple of months with clinicians both in Australia and in the U.S., that is a very material clinical benefit. That is something that will make this test a preferred test in point-of-care testing programs, we believe, added to the fact that it can be delivered to the end user in the Pascal format. We believe that the opportunity for this test is very, very significant in a market where syphilis is becoming increasingly problematic for global health players as well as public health markets in high-value settings like Australia, like the UK, like the U.S. We're very excited about the opportunities. We will now be engaging with the TGA, BSI in Europe, and the U.S. by way of a pre-sub to finalize our clinical endpoints to then validate in a clinical study.

We'll be looking to get that product to market as a priority in Australia and Europe, and we'll be looking for a U.S. partner to help with the U.S. go-to-market commercialization as well. We'll obviously keep the market informed, but we're very excited about the opportunity this product gives to us as a product and also as part of a sexual health portfolio alongside HIV. I'll then talk about the OEM technology. I think Suzy made a point that our OEM technology revenues for FY2025 were broadly similar to FY2024. I think that reflects the fact that the recent agreement that Lumos has in place with PHASE Scientific has really yet, at least from an FY2025 perspective, impacted the business. We're going to see that now coming into FY2026. We've already disclosed an initial order from them.

We expect to see a significant ramp-up over the next couple of years on the basis that CLIA waiver is secured for Febrex. We're very proud of the performance that the Atomo Pascal device has delivered in enabling that CLIA waiver submission to go in with a high level of confidence. Greater than 99% concordance between trained and untrained users on the Pascal device is, in my opinion, market-leading performance for a blood-based test in a low-trained clinical setting. I think that is going to be material for the uptake of Febrex in the market. I think more broadly, beyond Febrex, we'll position Atomo and its Pascal platform as the gold standard solution in the U.S. CLIA waiver blood test market. That's a journey that we've been on for a while, and I think this CLIA waiver performance for Febrex takes us a further step towards that goal.

We do expect to see significant demand for Pascal in the near term through Febrex and the PHASE agreement, but over the medium term, more broadly, as Pascal gets acknowledged as being the gold standard solution for blood testing in clinical settings, pharmacy settings, decentralized settings, and ultimately in the home where the test was designed to be used. We're very proud of the performance that we've delivered. It's now increasingly recognized by clinicians and regulators as delivering precision and repeatability that just isn't available with standard multi-component kits. I think we've done a really good job of getting that product to market as a platform. Now we're starting to see the demand build up as the performance is validated, and the benefits of getting CLIA waiver are increasingly clear to diagnostic partners.

I think Lumos announced that that was a potential more than 10 times increase in addressable market with CLIA waiver. That's the kind of market growth benefits that this platform can provide. We think the demand for this platform is going to be substantial. That's really based off best-in-class usability. We reduce blood delivery errors down by more than 90%. We reduce buffer delivery errors almost completely. The steps are user interlocked so that they can't happen in the wrong sequence, and the time to do the test has been reduced because the steps are more straightforward. Importantly, the end user is not second-guessing whether they've done the steps correctly and they've got the right result. That's been proven now in a validated third-party study for CLIA waiver with Febrex, greater than 99% concordance.

I think that's an amazing level of performance that we're very proud of, and we think it really does support now a significant level of growth for Pascal as a platform and supply, not just to Lumos for Febrex, but we believe over time a large number of clinical applications on the platform. I'm going to talk a little bit about Flori and why we developed it. Pascal, as I've, I think, made clear over the last couple of minutes, is an excellent performing device. It's perfect for companies like Lumos that are developing a new test and bringing it to market. We provide a cassette that supports their clinical approvals, a dossier that supports their regulatory activities. Because it is the device that the test sits in, it becomes the device that gets regulatory approval.

While that's not a problem for a new test, it means that for existing tests in the market, to move to Pascal requires a partner to go back and do some revalidation and some clinical work to get a reapproved version of their product on the Pascal cassette. That turned out, particularly with bigger companies that were already in market at scale, to be a barrier to adoption, even though they really liked the usability that Pascal delivered. Over the last year, we've really thought, how can we deliver Pascal-type usability but minimize the operational and regulatory overheads that come with moving to an Atomo solution? We've come up with Flori, which essentially takes the blood collection and delivery and the buffer delivery from Pascal and optimizes it to be compatible with a standard cassette. The standard cassette clips in to our device. We deliver the blood.

We deliver the buffer. The cassette can be read as is, or it can be taken out and put into a desktop reader in a clinic if it needs to be read digitally for traceability, for quantification, for reimbursement purposes. What we really have done, we believe, with this solution is give the market a significant improvement in precision and usability, but to do it in a way where the standard cassette remains unchanged, the end cassette in the reader remains unchanged. Therefore, our device is essentially an accessory, a usability accessory rather than the finished test. That significantly reduces, we believe, the clinical and regulatory burden to move on to Atomo Pascal functionality. The initial reviews that we've had from some experts in regulatory affairs suggest that's the case. Certainly, the feedback we got from the market when we went to ADLM last month was hugely encouraging.

I think people see that it does deliver benefits but removes the barriers. I'm very excited about the opportunity of this product over the longer term because it can be retrospectively added into an existing product supply chain as an accessory, we believe, with minimal disruption and cost and effort for the partner company that wants to upgrade the usability. What we'll be looking to do is prove usability between Pascal and Flori so that that equivalency allows us to then leverage off the work we've done with Pascal. We think there's a significant market opportunity for this cassette. We'll be looking to tool it up and go into pilot manufacturing. We are confident that there are customers for this application. We'll keep investors aware of developments as they progress and disclosure becomes appropriate.

We also have the Curie Swab device, which delivers a similar level of usability and functional improvement, but for swab testing. That is still a platform that we think has enormous opportunity longer term. We are waiting for a customer to come along and help pay for the validation of that. We'll advise as and when that customer is secured. We do think that both swab and blood testing applications can be improved enormously with Atomo technology brought to bear. In terms of summary, we have a number of assets that are either in market and about to scale revenue or coming to market with very significant addressable markets. We believe some quite unique functionality that will allow us to be successful in those markets. In terms of investment highlights, we have a number of technologies that we think are proprietary. They're patented. They're proven.

We think the investment opportunity now in Atomo is significant as we move into FY2026. We have very unique functionality now proven. It's not just functionality for the sake of it. It's functionality that really impacts real-world performance. I think the study results from the clearest Febrex prove that. Greater than 99%. That's unmatched levels of performance that we can now point to in any commercial discussions with partners for other applications. The performance of Pascal underpins the fact that it's a very flexible platform. We have a number of different tests validated on it. Certainly, Febrex revenue is very material to Lumos. It's material to us as the supplier of Pascal into that test. For us, that partnership with Lumos is limited to one narrow clinical application.

We believe that there's multiple applications that are suitable and will be coming to market on this platform as its bona fides gets increasingly recognized in helping companies like Lumos deliver the kind of performance that Pascal has delivered in that study. We also have the ability to bring our own solutions forward in large addressable markets. We've done it with HIV. We've proved we can do it. We've proved we can compete with large multinationals on performance. We've validated a low-cost manufacturing facility that we run in South Africa that allows us to be cost-competitive, even though we're not at scale. As we scale, we're going to see continued improvements in margins. Now, with Pascal scaling up, we're very confident we can deliver improved margin improvements. We've gone from 39% to 51%. We think we can get into the high 50% with some volume.

That's across both the finished product and OEM businesses. We're focusing on sexual health for our own finished products. That's because we needed to pick an area where we could have meaningful impact commercially. HIV then sits very nicely alongside syphilis. We have channels in both private sector and public sector markets for HIV that are ideally suited to introduce syphilis and would also be ideally suited to introduce a HIV Gen4 as and when that product becomes closer to market. We think sexual health is an area where we can be a leading player. It is an exciting market for us because it has both over-the-counter consumer demand as well as increasing public health demand for pharmacy, facility, and at-home channels. They're now publicly funded in the way they weren't before COVID.

We're really focused on tests that can tick both those boxes, that can sell over the counter, but also have large bulk contracts from public health providers as well. With the OEM cassette device, obviously, Pascal, I think, has now proven itself as having enormous value to the market. We believe it's a journey towards becoming the gold standard for testing in CLIA waived and at-home markets. That's a very valuable place to be. It's been a long journey to get there. We'll talk a little bit, I think, now about what's taken some time. I think a new technology that's unproven is, by its nature, risky to larger companies.

Over time, we've been able to prove with our HIV performance, where we put 18 batches into Europe without any being rejected by the regulator after being tested, by the performance that we've delivered for Febrex, the device and the solutions that we offer are now increasingly validated. I think that makes it much easier for companies that are interested in usability to now look to partner with Atomo. I think being able to also offer the Flori device that allows them to do that without large-scale, expensive, time-consuming clinical and regulatory and operational impacts further de-risks that transition to Atomo usability. I'm fully convinced that in the next 5 to 10 years, Atomo technology will be the benchmark for performance in blood-based and I hope also swab-based rapid diagnostics. I'd like to thank everyone for joining us today. That's the end of the presentation.

We have had a number of questions that have come in. We will stop sharing the presentation. We will then just take a few questions. We'll also have a look and see if any have come in during our presentation. The first question, it's the company seems to be getting ready to deliver. Why has it taken so long? I think I've addressed that in some ways. New technology, particularly in health care, is there's a lot of inertia in health care. There's a lot of risk aversion. Obviously, technologies need to be well proven before they will be accepted. That's been a bit of a journey. I think also in the early stages of Atomo, there was risk around whether Atomo would be around to supply, whether it could scale, whether it was a reliable partner over the longer term. I think we've proven that we are here.

Our technology is scalable. I think that has helped. We also did, you know, we launched our HIV test in Australia and Europe in 2019. Our partner, Lumos, with Febrex and Engie Biotech with their blood precision pregnancy test were launching at the start of 2020. That's when COVID hit the market. Our partners pivoted into antigen-based COVID testing. Blood testing really took a back seat in both public health priorities as well as in our partners' go-to-market priorities. It's really only since COVID that we've seen now Lumos starting to re-engage the market, launch in the U.S., build that momentum. There has been a bit of a delay because of COVID. I think now we're starting to see with the success we're seeing in the HIV public-funded growth as well as with Febrex, that there are significant opportunities for our solutions.

Suzy Elhlou
Financial Controller, Atomo Diagnostics

I think we have caught up to where we want to be. I think the future for our technology is extremely encouraging. Another question was, it says here, gross margins in the business have improved over the year. Is that going to continue? I'll let Suzy talk to that one. Yeah. Thanks, John. In terms of gross margin, as we mentioned, we did see a significant improvement from prior. We do expect to be able to stay in that margin in the coming period. That really comes down to a couple of factors, really. Firstly, the mix of HIV business revenue. As we mentioned, global health business has slowed down during the period. However, we have been able to continue growing HIV revenue in the Australia and Europe market, which delivers significantly better margins when compared to the global health. Secondly, OEM.

I think for current margins, they are also reflective of the OEM business, which is also better than our HIV global health. We expect margins for the OEM to improve as we scale further and further optimize our supply chain. Thirdly, really, our development and license fee revenue is quite profitable for the business, as the revenue is based on patented technology and investment that we've already made into the business. That keeps our costs quite low for that revenue stream.

John Kelly
Founder, CEO, MD & Interim Chair, Atomo Diagnostics

Yeah. Thanks, Suzy. We have another question that's come in online. What's happened with the pregnancy test that's not been mentioned in the last couple of webinars? Engie still continues to buy Pascal cassettes for their blood pregnancy test. They sell it in France, a number of European markets, and Brazil. We did submit to the TGA with their dossier. Their dossier has now subsequently gone through IVDR and passed. The European regulator is happy with the clinical data that is available with that test. Without going into too many details, the TGA wanted to see additional clinical data. Some of that data, particularly early pregnancy validation, is very difficult to secure. We're talking the difference between being positive in the blood-based test versus a urine test might be three or four days. Finding somebody in a clinical study that's in that three-day window is exceptionally challenging.

There are practicalities around how we do that. We are still very interested in the market here. We've had some discussions around what a clinical study, maybe trying to leverage IVF, would be so that we've got more control on where people might be in their pregnancy cycle. We haven't forgotten the test. I think we also didn't have the capital really to fund a clinical study in Australia if that was needed. Now that we've raised some capital, our options are a little better than they were. As we continue to grow and see more revenue coming in from HIV, from syphilis, from Pascal, and Flori, then our ability to fund these other platform applications to market becomes a lot more viable. One other question was received earlier. Can you tell us more about the agreement with Lumos and Pascal revenues into that PHASE contract?

Listen, we've made some disclosures around what we think the opportunity might mean for us. Clearly, it's material to us in terms of revenue to Lumos. We're not going to talk any more about the details between the two businesses in terms of agreement. That's company confidential. What I can say is that we're hugely proud of the performance that Pascal has delivered into that contract in terms of opening up CLIA waiver for them. They require Pascal for that product. It's clear that the performance has supported the approval. We think that bodes really well, not only for supply of Pascal to Febrex as they scale it. We know they announced yesterday some funding from BARDA to expand the intended claims for CLIA waiver from down to two years of age.

I am much more likely to take my children to the doctor for a respiratory infection than I would to take myself. I think the expansion of applicability for that test down to two bodes very well for increased demand in the U.S. market. I think that only further gives us pause for confidence that this will be a big volume supply agreement for us. Beyond that, I think the CLIA waiver opens up the opportunity for us to bring our own test to market, particularly syphilis, which is on Pascal, as well as potentially the blood pregnancy test, which is on Pascal. Obviously, we're looking at other applications longer term where we think CLIA waiver and home-based approval provide significant market opportunity. That is my thoughts on that. We've not got any more questions in.

I'd like to take this opportunity to thank you, I suppose, for your patience through the last couple of years. I feel like we've got to a position now where we really can start to drive growth in the core business being HIV and Pascal, as well as bringing on complementary new solutions like syphilis, like Flori, that leverage off our existing infrastructure, leverage off our existing IP, but expand the business such that we can now start to rely on multiple revenue channels and be less dependent on global health volumes, which got us a start in the business. Really, we're challenging from a revenue and margin perspective. We think we're moving beyond those, which I think is helpful. I'd like to thank everyone for their time. We are very excited about the opportunities for FY26. We will certainly keep you in touch.

We'd encourage you to use Investor Hub as a go-to center for all things Atomo. We'll be certainly trying to improve our communication and visibility for investors over the coming year. Thank you for your time.

Suzy Elhlou
Financial Controller, Atomo Diagnostics

Thank you, everyone.

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