Atomo Diagnostics Limited (AT1) Earnings Call Transcript & Summary

[Audio gap] Q1 for FY '26, and welcome to today's presentation. As you know, we finished FY '25 with a bit of a refresh. We repaired the balance sheet. We had a Board refresh and also continued with some cost out in the business. That's also into FY '26. And since then, we've seen some significant momentum in the business through the early phase of this FY. And that momentum in the business has transferred through to some momentum in the market. So that's based off a number of deliverables over strategic areas, and we'll go through them today in the quarterly. And then we'll move on to a Q&A section. We actually have more questions than normal, which I think reflects increased interest in Atomo and in the opportunities that lie ahead. So in terms of a summary of where we are with our review of business for Q1, obviously, there's been a number of material deliverables related to the FebriDx product that we support with Pascal and also with other new product development opportunities, including Syphilis and the Lumos agreement and also with Florey. And we'll go through them all in some detail, and there's room for questions at the end. So let's first go to OEM Pascal supply business. Obviously, we're very pleased to see that Pascal has performed excellently in the FebriDx clinical studies that were conducted over the last year in the U.S. And that performance, which is greater than 99% concordance in the studies between trained and untrained users really does deliver what we feel is a best-in-class level of ease of use and usability in blood testing in the U.S. market. We understand that off the back of that usability as well as the diagnostic performance of the FebriDx test that Lumos submitted to FDA for CLIA waiver approval in August, and we understand that there's hopes that, that will come to a positive conclusion at some point in the coming months. We're very excited about that opportunity because it not only helps support the agreement that Lumos had with PHASE Scientific for supply of FebriDx to the U.S. market, but also beyond that, the ability for Atomo to demonstrate that Pascal has delivered that level of performance and that, that performance was deemed acceptable by the FDA for CLIA waiver. I think, stands the platform in really good stead for subsequent agreements in other areas outside of the area that Lumos is focused on. And we do believe over the coming years, it's entirely feasible that we have a number of FebriDx style supply agreements for Pascal as Pascal becomes increasingly recognized as the go-to solution for CLIA waiver type applications and markets, as well as we believe the ability to get into OTC approval for self-test in the U.S. That's our ultimate goal. Now Pascal already has self-test approval in markets outside of the U.S. and we feel that CLIA waiver of a test with Pascal is the next step in the U.S. to that much sought after OTC approval that opens up that home test market in the U.S. We are now seeing an increase in interest in the platform more broadly, and I'll talk to some of the conferences that we've been to in recent months where we've been able to showcase both Pascal and Florey. If we come back to the FebriDx product, obviously, we're starting to now see orders coming through from Lumos off the back of that agreement, approximately $1 million worth of orders already received, and we are now actively looking to scale up our production capabilities. We do have obviously validated capacity on hand. We're now bringing that online and getting production scaled up as we move forward into what we expect to be increased demand for Pascal for FebriDx in the coming years, and we do believe that, that will expand beyond FebriDx into other tests over time. Outside of that, FebriDx and Pascal momentum, we continue to see new channels being opened up in HIV self-testing. We're very pleased that we've now launched very recently through the Chemist Warehouse e-commerce website in Australia, which is one of the leading, if not the leading pharmacy retail online portal in Australia. And we're very excited to see the product now being offered extensively online as well as continue to expand in the pharmacy chains in bricks-and-mortar sites. And that reflects obviously the fact that we launched in New Zealand through Chemist Warehouse stores earlier in the year. We were very pleased and proud to announce an order of HIV self-test destined for Ukraine, a country with a decimated health care system, and that's a [ U.S. Aid-funded ] order, and we'll be looking to manufacture and supply that as a priority in the coming months. We also very recently received an order just under $150,000 worth of stock from our partner in the U.K. Newfoundland, who successfully launched the product into leading retail channels in the U.K. being [ Boots pharmacies ] and Tesco supermarkets. And we received overnight a very positive feedback from them that the tests have very low levels of user complaints compared to other bits and box tests for other applications that Boots and Tesco's retail. And that, I think, reflects the usability that our devices deliver, the ease of use that they deliver and that, I think, reflects also the type of performance that we showed in the Lumos FebriDx CLIA waiver study. So the products are continuing to work very well in the market and both our customers and end users are recognizing that, and we believe we'll be rewarding that over time with increased orders as we've seen from Newfoundland as well as new product opportunities. Beyond HIV, we continue to look to focus on expanding our finished test menu. We are very focused on an Active Syphilis test. You may recall that we've secured a [ CRCP ] grant from the Commonwealth government back in February of '24. We've been working very diligently with the Burnet Institute on the commercialization of that assay on Pascal. We've done preliminary testing now, or should I say, Burnet have done analytical testing, and we're very happy with the performance that the test now demonstrates. There's 2 distinct benefits, I think, to this test over what's existing in the market in Australia and other markets. The first one is that there is no rapid test currently that can distinguish between active syphilis infection and patients who've been treated previously for prior infections and still have antibodies. And that means that while those current generation of tests are sensitive to syphilis, they are not specific for active users, and they do have a very significant false positive rate, and they send through a large number of people for further confirmatory testing that are not positive. The test that's been developed between Atomo and Burnet is much more specific for distinguishing between those 2 cohorts. Preliminary results suggest 83% specificity. We believe we can get better performance than that in the final validated claims, and that compares to a range of specificities between 0% and 55% of those types of cohort tests. So this is a material improvement to what's on the market. Important to note that specificity with never infected patients is 99%. So there is no false positivity rate with people who never had any exposure to syphilis. I think the other important factor is that on the Atomo Pascal platform with the usability, with the ease of use, with the reliability, we're also very confident of being able to deliver a leading self-test to market. There isn't a self-test approved in Australia. The only one approved in the U.S. does not distinguish between active and prior treated infections. So we can really deliver something pretty unique. And that's coming into a clinical need that is only increasing. Syphilis rates are increasing very significantly, 300% in the last 10 years in Australia, I believe nearly 500% in the U.S. over the last decade. And in fact, the Australian government declared syphilis very recently to be a communicable disease of national significance. So that says that there is a lot of public health focus on syphilis testing. We've proven with our HIV business that access to easy-to-use self-test really makes a significant impact on the diagnosis and management of disease. And we believe that there is enormous opportunity for the syphilis test in the market. We will now be engaging with regulators following some positive feedback that we've received on the test and its benefits from both U.S. and Australian key opinion leaders, active in sexual health, and we'll be taking that key opinion leader feedback and the performance to regulators, including the Australian TGA and the U.S. FDA by way of a pre-sub in the coming months to finalize clinical validation pathways and look to commence our clinical trials early in calendar year '26. We will keep the market informed of developments there, but we do think that, that really is a very unique and valuable opportunity for the business. We disclosed earlier in our quarterlies, the arrival of Florey as a solution to market that we're very excited about. We've been to a number of conferences in the U.S. and presented Florey to potential partners. I can confirm that our thoughts on the benefits of that test being able to be delivered to standard cassettes has been well received. It is a solution that adds the Atomo functionality to a standard cassette. And the benefit there is that if there is an existing test in the market where they've gone through regulatory and clinical, they're in manufacturing, they have existing approvals, we believe that the introduction of an accessory to the usability is a reduced material burden for reapproval than putting the whole new strip into a new test and having to revalidate from the start. And that means that there is less barriers to adoption. And more importantly, that cassette remaining unchanged makes it compatible with any downstream readers that it is required to be used against. And that's typically required in the U.S. where a reader-based result is often required for reimbursement and traceability. So our ability to provide the front end Atomo usability without having any impact on downstream readability of that standard cassette, I think, is a very significant feature that the partners we've spoken to initially are excited about and we'll be looking to continue to expand engagement, commercial engagement around Florey with a view to announcing some initial customers as we move through the FY. In terms of financials -- no, firstly, Board changes. As you know, there were a number of Board restructuring appointments in May of 2025, I came on to the Chair and interim capacity while those new directors joined the Board. We now have Mr. Patrick Cook appointed as the Chairman of the company, and that has allowed me to transition back to full-time focus on my executive responsibilities, and I think that's in everybody's interest. So glad that we were able to get that done before the AGM. In terms of our financials for the quarter, unaudited revenues are just under $700,000, primarily HIV sales, and we have had a number of sales attached to the OEM Pascal business. We do expect those Pascal sales to increase fairly materially through the coming quarters as we roll out with FebriDx supply as well as new customers joining the platform over time. Operating costs were $1.3 million, again, unaudited, and that reflects a continuing focus on management to reduce operating costs. And we also continue to receive CRCP income from the government to support ongoing development activities for the active syphilis test. Cash receipts from the quarter were just under $2.3 million, over $800,000 from customers, $1.3 million in capital. That is essentially the inflows of capital arising out of the Placement and SPP programs that were completed at the end of FY '25. And as I mentioned, some small payments from CRCP grant. That left Atomo at the end of the Q1 period, 30 September, debt-free with cash on hand of approximately $3.4 million. And it's worth noting that we have an R&D tax rebate due in this quarter, just under $900,000, which will obviously further build on the cash on hand balance. In terms of our key priorities moving forward, I think it's really a continued focus as we set out for our FY '25 wrap-up. We continue to focus on growing short-term revenues. The easiest way for us to do that is to expand HIV sales channels. We're looking to restructure a number of regional agreements to provide us with flexibility to enter into some country-specific new channel partners, and that includes activities in Europe, South America and Southeast Asia, primarily. We have an experienced commercial manager who joined this week and his -- one of his key focuses in the early phase will be to execute that HIV sales scale up as well as looking for new channel partners in areas where we're not seeing significant business from our current channel partners. Beyond that, we're continuing to focus on OEM customer capture, and we have 2 real drivers of that. One is the arrival of Florey, which allows us to offer a solution for tests already in market as well as the expansion of the proven attractiveness and performance of Pascal that's now been delivered out of the FebriDx clinical results. And we hope [ subsequently waiver ] to really demonstrate to the market the value that Pascal delivers in testing performance because I think that is critical to further expansion into OEM channels with CLIA waiver and then we, as I said, ultimately, OTC home test approvals. We're very focused also on operational scale-up of Pascal, which I think is obvious to everyone as to why that would be. We are going to continue to focus on operational scale-up of our ability to make product. We have in South Africa facility for manufacture of HIV. That's ideally suited to also allow us to manufacture syphilis moving forward, and we're in the process of a tech transfer over to South Africa from Burnet for scale-up of syphilis manufacturing to support the clinical trials and downstream manufacturing. We continue to focus on operating costs, and very excited about the opportunities for both Pascal in the international markets as well as Florey and ongoing scale-up of our HIV business, introduction of syphilis, and we also continue to look at other pipeline opportunities, and there'll be more, I think, on that in the coming quarters as we look to partner with companies who have identified opportunities for tests that we can deliver to them on Pascal in markets where we can add significant value. I'd like to thank you for taking time to listen to the quarterly report. I am going to now stop sharing, and we will jump into a Q&A session.

I'd like to thank everyone for taking the time to put in some questions. I'll just run through them in no particular order. First question says, the question is about Florey device reusability. If there were 2 strips/cassettes, could they be swapped out in the same Florey? The answer is no for 2 reasons. One, once the blood is transferred from Florey to the cassette, that Florey device is essentially contaminated with blood. If it was the same person using it, then in theory, that blood tube could be reused. However, the blister that sits inside Florey is test specific and is delivered to run the test. So Florey is, in effect, a single-use disposable. It replaces the need for the pipette and the bottle buffer, but it is a single-use device. How is AI going to affect the business? I think the answer is over time, it will increasingly affect the business. We have had a review of internal systems that we've been able to optimize with some AI support. We're looking at options for an in-house closed-loop system where we can use AI to help streamline operations. But in terms of the use of AI on the product side, we're not looking at significant upgrades to the product with AI. Our tests are generally visually [ read or read ] in a reader. We don't have sophisticated reader-based systems. So AI is not really applicable to the product itself in the short term. But obviously, we are focused on how AI can be used as a business to make things more efficient, and we'll advise of anything material that comes along. Next question says this test is well known in the U.S., the U.K. and other markets. Why is it not accepted by other companies? I think my answer to that would be that it's really only just now that the test and the performance of our tests are really becoming recognized by the market. I think that's a lot to do with the results that FebriDx have delivered in their clinical studies, the fact that it has supported a very high level of usability on Pascal, the fact that the CLIA waiver has now been submitted. I would argue that, that's really generated a lot of visibility for the platform and the benefits of the platform, and we're now starting to see an inbound level of interest. And from that, I expect to see follow-on opportunities being executed with other partners for other applications. But is the test really well known? I think it's increasingly being made aware, but there's work to go there. And I think the FebriDx visibility has been very helpful in that regard. What strategies are being considered to boost revenues, merger, complementary product, identify ways to enhance earnings? So as I mentioned, there is a short-term focus on the increase of HIV self-test business through our existing approvals. That's the quickest way to generate additional revenue. Over the medium term, there's expectations of -- and obviously, I'll say in the short term, a scale-up of Pascal to support any demand coming from FebriDx. Beyond that, the launch of Syphilis is an obvious step change for us in terms of revenue expectations. New customers coming to market on Pascal, ideally on the other side of a CLIA waiver would be a further step-up in revenue expectations and then customers coming through on Florey adds further OEM momentum to the business. Beyond Syphilis, we are looking at a number of tests and potential opportunities. We do have the partnership with NG for blood pregnancy. So that's still under consideration. And through our distributor networks, we're getting feedback on the types of tests that our partners would like to see available on the Atomo platforms. And there may be some announcements around what those types of tests would look like, who those partners might be as we roll forward. Another question, any plans to develop a point-of-care test for fecal specimens. The short answer is no. We have a [ full dance card ] in terms of applications on blood-based application platforms being Florey and Pascal. There is a final question that says, what's the situation with the swab test. We do have a swab device that we've developed and demoed, and we've shown some good usability and diagnostic improvements versus a standard kit. The reality is that any test that we commercialize with that swab device has to be optimized for a specific swab size and for a specific diagnostic application. So the status is currently that we are offering the swab device to potential partners as a concept, and we will be looking to have a partner take that on and go to market with an existing application tied to that development. We don't want to spend time, money and effort bringing forward a custom application for a test that we don't have to commercialize. So we are looking for partners to essentially take that platform through with a specific test as the end output. That are all the questions I've received. I'd like to thank everyone for joining today. I'd like to thank everyone for their continued support. We're very excited about the opportunities ahead for the coming year. We've seen good momentum in the business, good momentum in the market. We have a lot of opportunities for our OEM business. We have a lot of opportunities to grow Atomo platforms in the market as well as Atomo finished tests on those platforms, HIV and syphilis being the first, we believe, of many. I'd like to thank you for joining me, and have a very good day.