Atomo Diagnostics Limited (AT1) Earnings Call Transcript & Summary

[Audio Gap] Increasingly commercialize the world's most user-friendly, reliable point-of-care blood tests on the market. And there are applications targeting both professional and self-test clinical use, and our solutions are increasingly being recognized as delivering best-in-class performance. And that unlocks, we believe, a number of significant growth opportunities in a market that's becoming not just more decentralized, but also 1 that's increasingly requiring reliability and precision. We have 2 businesses, and 1 of them is the initial business that we set up, which is the development commercialization and sale of finished diagnostic products. Our first product was HIV and we continue to focus on sexual health. We are also expanding the portfolio. But in that expansion, we really focus on applications where we can deliver tests that have used in both professional and self-test applications. Outside of our growing portfolio of Atomo diagnostic finished products, we also supply our award-winning cassettes and other test technology to partners who deliver their own test to market. And the benefit of that business is obviously that our clinical regulatory and go-to-market costs are covered by the partner. And Atomo provides that critical component that helps drive that usability and success. In terms of the half year milestones and critical activities, we've received orders for Pascal from FebriDx totaling $1.5 million for the half year. And through that period, Lumos announced that the FebriDx U.S. CLIA waiver study had met its endpoints. A large part of that was through the performance of Pascal in those studies, where we enabled FebriDx to deliver greater than 99% concordance between trained and untrained users. And that really is an important usability validation for the product that we think will support that CLIA waiver process. That success in the U.S. clinical studies is not only helped FebriDx with its process, but it's also validated the performance of Pascal for other potential partners. We have, during 2025, being engaged with a pipeline of potential new customers for Pascal and that performance being disclosed by Lumos has helped us secure some additional partners at Chromacare from Canada and U.K. company that are both now signed up for the platform, and we'll be hoping to finalize those longer-term supply agreements in Q4, and we'll talk a little bit more about our excitement there in those opportunities moving forward. During the period, we also expanded our partnership with Burnet to license from them a developed novel ALT liver function test that has enormous potential in several large clinical applications, and we'll talk at some length in this presentation about where that test is at and the performance of it, and we're looking to commercialize it. For the period, Suzy's going to step us through the financials, but we've delivered just over $2 million of revenue for the half year. And we finished the period 31 December with $3.5 million cash on hand, which is I think, represents a conservative use of our capital over the period, and the company has no debt. Before we jump into the financials, I just want to talk about the period from a corporate perspective. This is a graph to show kind of where the market has been for us since the FY '26 period started. We're very pleased with progress. We're pleased with the momentum for the year. We expect that momentum to continue. Our share price has comfortably doubled so we're also pleased to see there's more momentum in the business in terms of market engagement and interpreting volumes. So we think that all speaks to a journey to better fundamentals as we move forward, and we think the half year results start to paint that picture, and we expect to build on that moving forward.

Thanks, John. Hi all, and thank you for joining us again. And so it's a pleasure to present our financial results, and I'm pleased to share that the first half has delivered a solid performance for the business, we continued revenue growth, disciplined cost management and a significant improvement in our underlying EBITDA. So to start off with profit and loss. Top line revenue for the half year increased 6% and reaching just shy of $2.2 million. However, gross margin had reduced by 6%, bringing it to $850,000 in gross profit. It's important to note that 2 key factors here driving the overall margin mix. The first being [ pay ] included development and license fees, which have extremely high margins attached to us. So excluding these items, product revenue margin remained stable at 37% period-on-period as shown on the table on the left. Secondly, as well, additional margin softness was influenced by the Global Health LMIC segment, which represented a meaningful share of sales and actually carries lower yields there. Looking down the table to other income. Other income doubled to $1 million. This largely relates to our R&D rebate as well as non-diluted funding of the syphilis development grant program, for which activities were performed and also offset incurred during the period, largely for employee costs and R&D costs in particular. Furthermore, on the cost side, expenses remained under control with notable reductions in employee expenses and professional fees also having. Now turning to the underlying EBITDA, we are seeing fundamentals moving in the right direction. Underlying EBITDA essentially having with half year loss coming under $1 million there. So overall, our half year performance shows a business that is strengthening operationally, maintaining revenue momentum and improving financial efficiency. While margin pressures remain a focus, we have taken steps to manage these effectively moving forward in the short to medium term. So we're now looking at the balance sheet here, we ended the period with $3.5 million in the bank with no debt. Our balance sheet remains relatively clean and consistent with the prior period. Now jumping to the cash activities for the period. So excluding the capital funding, monthly cash burn average came under $170,000 a month. That's slightly up from prior period of roughly $130,000 per month, and that's reflective of the additional resources directed to the [ Alden ] pipeline opportunities and short- and medium-term revenue streams there. So overall, receipts for the period totaled $4.5 million, and that was made up of $2 million from customers, [ $875 million ] from R&D rebate, a further $330,000 from the CRC-P Grant and $1.3 million in capital raise funding were received in the beginning of the financial year in Q1. Total outflows on the other side amounted to $4.2 million for stock and operating expenses. So -- and taking a step back and looking at our financial trends, I would like to highlight the positive trends across EBITDA, revenue and operating expenses. So EBITDA loss over time has continued to reduce as shown on the first graph here. Since half 1 FY '24 losses have narrowed every period, improving from around $2.3 million to under $1 million this half year, with most of that reduction in losses picking up in the recent period. So that's a 57% reduction in EBITDA loss there. In looking at the graph in the middle, revenue momentum continues to grow but also diversify across HIV, OEM and development fees, whilst operating expenses to continue to moderate and further offset by non-dilutive funding. So as we move into the second half, our priorities are clear. We will continue to drive revenue growth, restore margin strength and maintain rigorous cost oversight. So the first half has laid a strong foundation, and we are confident in our trajectory for the remainder of the year from the current orders on hand and building demand, in particular for the Pascal casette platform.

Yes. And we'll talk a little bit more -- thank you, Suzy. We'll talk a little bit more about our plans for production operations, and that will also include some thoughts on margins moving forward. We've set the scene, I think, with kind of highlights over the half year. We've gone through the financials. We're talking about the trends we're seeing longer term on fundamentals. I want now to jump into some of the products and services in a little bit more detail, talk a little bit about normally the performance for the half year, but where we think some of those products and services go from here as we expand and some of the new opportunities that we're looking to bring to market. So our core revenue stream from the business was -- remains HIV self-testing, and we continue to see long-term changing opportunities for HIV. And that's driven by, as we've mentioned previously, a realignment of people's expectations on consumer testing in the home. And in the case of infectious diseases, in particular, an emerging acceptance and recognition from public health that at-home testing are much more cost effective and targeted way to reach people. And our tests are ideally set up to deliver that kind of performance. We've seen with HIV over $1 million in sales for half year 1, and we announced in this quarter the start of half year 2, a further $1.6 million worth of orders being received. So that shows steady ongoing growth in that business, and that's underpinned, as I've said by not just changes in consumer sentiment but also from funding programs in place. And we're very pleased to see that the Australian government has extended its funding of those programs that we were a party to establishing and validating and now scaling with partners in the Australian community. We also recognize the need to expand revenue beyond our current revenue streams. We brought on some additional commercial resources during the half year. And the focus there is twofold: one, to increased sales in current markets, particularly with a focus locally on ANZ, but also to expand distribution networks into markets outside of Europe with a particular focus in South America and Asia, where we have a product that has significant commercial opportunity, we expect over the coming quarters to announce new partner distribution opportunities and see a general growth in that HIV business over the longer term. We've seen some good announcement. We've seen some good awareness. We work very closely now with partners in Australia to increase the awareness of the government's free-to-user program. There's a picture of myself in the new commercial manager at the [ Mardy Graph Fair Day ] with NAPWHA publishing information on the product, also increasing awareness to the knowledge base of the community and providing access to those tests. So we think that's really important work, both from a community perspective, but also for generating awareness of the availability of the test, which ultimately drives sales revenue for Atomo. Beyond Atomo, we're actively focusing on building a really exciting portfolio. We've previously discussed active syphilis. We've made good progress during the half year. We see that becoming an increasingly important clinical need and with a commercial opportunity. Virtually every developed government has now said that syphilis is a major public health challenge for them. Rates are going up much more than they are for HIV, and there's a lot of testing now required to bring this under control. It's over $1 billion of market value. The U.K. performed nearly 2 million syphilis tests in 2024. Interestingly, 350,000 of them were done by at-home blood collection by way of a dry blood spot that's then mailed into a lab for a test. That's an expensive way to run a test. It's got logistics costs. It requires both an antibody test and an RPR test in the lab. And that is a market that this test, we believe the Atomo test is ideally designed to enter. At the moment, standard antibody tests are not used in the home for these types of programs because they don't provide the specificity required to distinguish between antibody positive prior treated cases and active cases. And that's what in the lab, the RPR test does. The Atomo test correlates very highly with RPR, and we're very confident that we can get this test into those at-home screening programs, not just in the U.K., but in Australia and in other markets. We have had some very good performance data of this period of work. We're now at 86% specificity for the test in the preliminary clinical verification work that was done by Burnet. We are hopeful that we can get the claims specificity over 90% in the final product, and that compares to the best-performing antibody test specificity of less than 50%, which is essentially not in as good as a coin toss. So we're very, very excited about that. We think it has both professional and self-test opportunities in developed markets, where it's needed as a test and treat in the field test as well as in markets like Australia and U.K. were going to be used as a self-test. And we're also actively working with NAPWHA and others to make sure that this test when it's available, can very easily dovetail into the existing distribution channels like the vending machine program, like the at-home mail program that we've already got set up for HIV. So we're very, very excited about this. More recent announcement we made to market at the start of this half year was the expansion of our partnership with Burnet to look to commercialize in partnership with them, the ALT liver test that they've already developed on Pascal. That's already in the market in a manner of form as a pilot evaluation in a clinical study with a pharmaceutical company, and we'll talk a little bit about that application more broadly. But I mentioned that because it shows that the test already has had extensive development. Burnet has spent several years bringing this asset to market the last year, that has been on Pascal. So we do have a very good starting point for taking this product line to market. We've got results that show good levels of correlation between fingerprick blood and lab generated whole blood from phlebotomy, which is obviously critical for any kind of validation against the gold standard in the lab. And we have good levels of early performance data to suggest a strong level of accuracy in distinguishing a 40 IU cutoff, which is the accepted level for abnormal and normal levels of ALT and screening programs. So we believe the building blocks have a really good product are here. And we're very excited about bringing that forward. We already have some work progressing in the first targeted market, which is drug and just liver injury. There are a number of commonly used drugs that metabolically impact deliver. And there are a number of commonly prescribed drugs where monitoring temporary or periodic monitoring of liver function is recommended and carried out. Drugs for TB, a number of immunology, neurology and cardiovascular drugs as well as long-term use of certain painkillers. That's a very big market. They are markets where currently now people are having to go into doctors' offices for liver function screening, and we feel a home test opens up an enormous opportunity for drug companies to not only streamline their Class III drug tirals, but to manage drug risks for liver toxicity that have in the past stopped drugs going to market. And obviously, if you can unlock market access for a drug, that's a very significant value add for a pharmaceutical company. And there's an awful lot of drugs that have this risk already in the market. They both patented drugs as well as a number of off-market generics. So we think there's a large list of potential customers for this application, and we're pleased that it's already been evaluated by a leading multinational pharmaceutical company for this application. And we think this really is a companion diagnostic of note in this space. Outside of that application, ALT liver function is widely recognized as being an important biomarker to measure other conditions. We've spoken with a leading key opinion leader in the U.K. who's looking to run a trial to see if this test could be used for in-field screening of people to determine their need to go on to hep B drug treatment and potentially to come off treatment when that drug has worked. We know from research and from some of the work done by Burnet before we license the assay that there's a very high correlation between ALT and fatty liver disease, which is an increasingly common chronic condition affecting over 1 billion people, and we see there are opportunities for use of the test, both for screening high-risk populations at home as well as the ongoing monitoring of patients who are receiving treatment or implementing lifestyle changes to reduce the impact of fatty liver disease on their health and test that can monitor that in the home. We believe is infinitely more scalable than a program where people have to go to a clinic and have a blood draw for that same application. So we think there's very exciting opportunities across multiple applications, but with just reinforcing with drug and just liver injury for pharma partners, being the priority application there. Beyond the Atomo finished test portfolio, we're actively growing our OEM supply business where we supply the device to other partners for their own tests. Atomo has had success in that industry, and we're seeing significant opportunities now growing from existing partners as well as we mentioned at the start, a number of new partners. If we look at highlights for this half year to date with regard to Pascal, we've seen a very significant increase in the orders for Pascal for FebriDx, orders received in the period totaling $1.5 million, and that's a 1,600% increase on orders received for the same product from the half year 12 months ago. So we're seeing very significant growth in demand for FebriDx-based Pascal, and we note that CLIA waiver decision is pending in the next couple of months, and we're expecting to see ongoing demand through that channel based of progress that has been made in terms of distribution of FebriDx into the U.S. We're very excited about that. We also note that Pascal has been a large part of that performance in those trials, and that's helped, I think, enormously with the success rate for the CLIA application. But beyond that, as mentioned at the start of the presentation, it's really allowed us to go back and showcase what Pascal can do to other partners who've been, I suppose, sitting on the side waiting to see whether we can deliver the kind of validated performance that we've said we think we can and now that that's been proven by a third party in a large U.S. study. And we believe our hope certainly supporting a case where we have approval that we can scale up that customer pipeline now quite aggressively with 2 customers already signed up and hopefully more to come. And to support that, we are very excited about the scale-up of our operations to meet that capacity demand in the coming years, and there's a slide later in the presentation that looks to do that. We have had a number of inquiries from shareholders just to clarify exactly what the relationship is between Pascal and FebriDx. So just to be clear, each FebriDx test sold requires a Pascal device to be supplied to make that test work. So it's a one-for-one relationship as we scale up in partnership with Lumos. Beyond FebriDx, as I mentioned, we're seeing new customers coming to the platform and very excited to be able to report that. We've been talking about this opportunity for a long time, and now we're starting to see it bear fruit. Chromacare is a Canadian company that's developing a range of tests. Some of them are not as developed as ferritin but have a very significant commercial opportunity, and we're looking to partner with them at a strategic level and be their essential provider of usability for all of their portfolio of tests with ferritin. We hope being the first. We're again excited because this is an application that has both professional and self-test use markets already established. They have placed an order for over $150,000 worth of devices and development support. That's a substantial commitment to go to market with the new test. They've ordered 43,000 cassettes to base all of their clinical and regulatory validation on. That's not a decision they make lightly, and that suggests that we are well locked in on them as a supply partner, but we will look to convert that into a long-term exclusive supply agreement in the coming months. And we'll certainly bring more updates to market as and when that's finalized. I'll just mention again that one of the interests that Chromacare had, obviously, is in the large U.S. market, particularly the market opened up by CLIA waiver, and they're very excited about the opportunity to be use FebriDx as a predicate subject to that getting approval, the usability of the device and device itself essentially remains unchanged across those applications. So we are confident that we can use a lot of that usability validation, confidence in supporting other partners. Beyond Chromacare, we have a U.K. partner that signed up for 20,000 cassettes. We're not disclosing the partner or the application in part because it's commercial in confidence and also because it's a very big opportunity, and we think can -- if it gets significant market uptake through clinical penetration could be a really substantial product for them and for us, and we'll certainly bring disclosure to the market when we get that agreement fully completed, and we hope to do that in the coming months as well. These new customers, I think, speak to the long-term value that we can deliver the type of revenue that we think we can generate with Pascal. We'll be looking to move beyond this with a awareness program, particularly in the U.S. where CLIA waiver adds real value to partners, and we're preparing some partnership opportunities, some co-promotion, some presentations and representation at key conferences to really just make sure that people are aware of the benefit of this device and its availability and its success in delivering good performance and good approvals to partners. And we're very excited about the long-term pipeline that we think we can build for Pascal customer base. To support all of that exciting opportunity, we are in the process since late last year of an operational -- expanding our operational capabilities and capacities. There are a number of impacts to the business that this will deliver, all positive, we believe. The first one, obviously, is increased capacity so that we can move beyond the current capacity limit, which is not -- has not yet been hit, but we can see with some of the growth opportunities that, that will be a point reached at some point moving forward. We want to obviously get capacity to increase in advance of that. So we are looking at improving our capacity. That will also have a number of impacts to the business beyond capacity. It will improve our margins quite materially because by bringing a number of steps in house and also by going to things like larger multi-cavity tools, we get better economies of scale, better component pricing. And we do think that will have a material measurable impact on our gross margins over time. It also allows us to have more control over processes by bringing them under our own quality management system, which we already have in place for HIV. And it will also reduce our lead time to deliver into customer orders because we can do that directly through our own control. There are 2 short-term steps that have been undertaken to immediately improve our operational capability. The first one is qualification high cavitation injection molding tool that will increase the amount of components we can mold and also reduce the cost of components at a component set basis. The second one is the qualification of the machine in your picture, which is [ MK2 ] blister machine that was built in Australia and has now been qualified at a facility in Sydney that we are running. We're doing the qualification that will be operational in the next couple of months. A couple of points to make clear there. Both the cavitation -- high-cavitation tooling and the blister machine are already built and they've already been paid for. So there's no additional CapEx required to get these assets operational, Atomo is directly validating them for the blisters that go through the machine to support our business. So that is the 2 new customers for Pascal, our own blisters for syphilis and liver testing. And also the ability to requalify existing customers like Lumos and [ ENGIE ] from machine 1 on to machine 2. So we're increasing capacity. We're adjusting costs. We're bringing these operations under our own control. And we are getting ahead of the curve in terms of the demand. Beyond that, there's opportunities for us, obviously, to scale. We will wait to see how longer-term forecasts are firmed up for existing customers and what new pipeline of customers start to sign up for the program, but we are making the steps necessary to make sure that capacity is not a barrier to growth and that our gross margins improve quite materially over the next 6 to 18 months. So I just want to wrap up by summarizing some of the investor highlights. Hopefully, these have become clear to the presentation. But for the avoidance of doubt, I'll just reiterate a couple of ones that I think are particularly important. Obviously, Pascal revenues are starting to grow significantly now. We've seen that over the last 6 months. We expect to see further growth in that channel, both from existing customers and new customers that are coming on to the platform. We think the customers we've got now, which is 4, we believe the 1 back in this in 5 years will be the first of a large number of people that come on to the platform. And I've always said, I think this Pascal device can be the gold standard for blood-based testing in developed markets. And I think we're one step closer to that now than we were months ago, so I'm very excited about that. Pleased to see that the HIV business is growing steady. We're seeing more orders in Australia where we get better margins. We're seeing our partner Newfoundland and the U.K. starting to make inroads into markets in Europe, and we'll look to be able to make some further announcements on that in the coming period. And we have our own buildup of capabilities internally to grow the distribution footprint for the business outside of Europe and Australia and bring more countries online. So I think over the medium and long term, we expect to see some solid growth in that core business. Very excited about the opportunity for bringing syphilis to market. We think that's a really important unmet need. It dovetails really well into our current customer access channels for HIV, which means we can really get additional sales, we believe without having to reinvent the wheel in terms of a go-to-market channel because we can really piggyback off what we've done over the last couple of years with HIV. Really excited about the opportunities for this liver test. There's a number of verticals, which ones really take this product and run with it. That's what we're going to find out over the coming period. We do think from the work that we've done with Burnet and the due diligence we've done reviewing this opportunity, the fatty liver disease and monitoring of drug risk for injury are 2 really, really big opportunities, both from a partnering opportunity with pharma companies that are in those spaces as well as obviously self-test and consumer applications for people who want to screen for their own health. So we're really excited about those, and we'll look to -- I think they have the market at the next quarterly on progress we've made now that we've got that program up and running. To close out on the fundamentals of the business from a financial perspective, Suzy has done a really get great job presenting where we're at. We think the fundamentals are clearly improving. Our losses for the half year down to below $1 million. Our OpEx is tight. Any expansion of OpEx will be focused on commercial capabilities to grow revenue, and that's where we want to be. And we think the growth underpinning the business now is heading in the right direction. So very excited about that. I'd like to thank everyone for taking time to listen to the 2 of us present where we're at. We're now going to have a few questions that we received.

One of the questions related to operations. I hope that's been answered in the slide around operations. There's another question say, HIV has been outstanding performer recently. What's the opportunities in the U.S.? Is there plans for an FDA submission? We have met with key opinion leaders in the U.S. The challenge in the U.S. is that HIV self-testing remains a [ PMA ], which is a very expensive process. There has been talk of FDA moving it down to a 510(k). That has not happened for self-testing. We believe that it will. But as to when, we don't know. We have also been in discussions with potential partners around the opportunity to put a Gen 4 HIV assay that's currently targeted at regular PrEP screening, HIV confirmed negative testing for PrEP screening on the platform, and we think there might be a big market opportunity for us for professional use Gen 4, particularly in the U.S. market, off the back of CLIA waiver for the platform. I think that would be something we look to progress subject to obviously having a commercial partner in the U.S. locked in. We've been asked what's up with the swab test? I'll take a step back and say where we're at with both the swab test, which is Curie as well as the clipping blood test, which is Florey. Both those designs have been completed to a point where we've got working prototypes, and we're confident that they can work as devices, and we're also confident that they add the cane usability and reliability that Atomo becoming increasingly recognized for. The difference between those test platforms and Pascal. Pascal we can develop through to its entirety and then go to market with finished products. And it's a standardized platform. The devices, Florey and Curie are customized for the cassettes that we partner with, which means we need to bring them to market with an actual finished end test, specific applications, specific cassette that we interface with. There are a lot of tests that are in the market already that are standard cassettes. We've proven with Pascal, that we have a platform that offers a vastly superior level of performance, usability, reliability and user preference. The challenge for existing tests in the market is how do I avail myself of the Atomo usability when I have a standard cassette that's already gone through clinical and regulatory, and I don't want to do that all again. And the answer from us was we have a device that easily clips onto your casette. It offers the same functionality and you get the same types of benefits. The benefit of Florey is that it's based off the exact same functionality as Pascal. We can now show partners what Pascal did for FebriDx. And the clip-in version, we believe, delivers the same level of usability, which in theory, can open up things like self-test approval and CLIA waiver, which are hugely valuable for partners. So we are looking to bring those products forward, but we will be doing it in partnership with customers that want to pay for us to do that, and we will do that on a finished test, and we're looking as a priority to find and lock in those initial customers to validate those devices. So stay tuned. We will be expecting to continue to progress with those. And that's one of the commercial goals that we set ourselves for the next 12 months is to find customers for those devices so we can finalize the go-to-market and launch them. They're all the questions that we've received as of today. So I'm going to thank everyone for their time. I hope what you've heard has been -- well, firstly, I hope it made sense. I secondly hope it is encouraging. We're certainly excited about the opportunity. We think the second half of the year will be really good, and we expect to push on into FY '27 with a lot of momentum, a lot of growth and a lot of good news. So please stay tuned, and thank you for your time.

Thank you.