Atomo Diagnostics Limited (AT1) Earnings Call Transcript & Summary

Good afternoon, everyone. My name is John Kelly. I'm the Managing Director of Atomo, and I'd like to welcome you this afternoon to our fourth and final quarterly presentation for FY '25 period. Quite a bit to get through today. So I'm going to just run through the highlights very quickly and then we can jump into a more detailed debrief on the more material matters that we're covering in today's presentation. Obviously, we are very pleased to see that Lumos has announced a very substantial and strategic partnership in the U.S. market for their FebriDx test, which is housed and delivered to market in the Pascal device. And we also note that they're making very good progress with the CLIA waiver study that underpins a sizable portion of the U.S. professional market for that test. We've also reported good growth in our Australian HIV self-test business, and we expect to see continued momentum as the government fully embraces self-testing as a key pillar of the HIV response. We have made very good progress with the development and clinical verification of the active syphilis test that we're developing in conjunction with the Burnet Institute and funded through a federal government grant. We have been very busy on the corporate side over the period. We've seen a renewal of Board with a reduction in the overall size of the Board, and with that, some restructuring of new capital into the business and a further focus on strategic goals moving forward. We reported for the period revenue of just over $1 million, which brings unaudited year-to-date for the 4 periods revenue to just over $4 million, and cash receipts also for the quarter were just slightly over $1 million as well. If we go now to the OEM announcement that Lumos made in relation to our Pascal business. Obviously, we were very pleased to see that. We know that FebriDx has enormous potential. It secured 510(k) approval some time ago. There's been very positive reimbursement attached to the product. And now we see a major player like PHASE Scientific are stepping up to be the exclusive distributor of that product in the U.S. Obviously, the volumes attached to that contract appear to be heavily weighted towards securing CLIA waiver for the product. But we do note that Lumos made some representations that they felt that study was wrapping up soon and that the submission to FDA for CLIA waiver would be fairly prompted in a matter of months. Obviously, that's all very positive. We are the exclusive supplier of the FebriDx Pascal device that underpins that to that approval and that product in the market. So we're working now quite closely with Lumos to understand what that scale up looks like for their supply into the U.S. market, and we're obviously very keen to see that happen as soon as possible. And we do expect, as a result of that, to see a sizable volume of demand for FebriDx and -- through FebriDx Pascal into the U.S. market over the coming years, and that is heavily weighted towards bigger volumes with CLIA waiver being secured. And that's obviously a very important milestone for both Lumos and Atomo in that process. We also do expect to start to see a strategic focus for Atomo on the development of new finished diagnostic products for the business. And that's an area of the business where we can have more control and a bigger share of the revenue. We have HIV in market. We're very focused on getting syphilis to market. And we have a pipeline of other applications that we'll be looking to prioritize and announce to market in the coming quarters. And a lot of that development and commercialization activities, we do expect to now be funded from working capital that comes out of the supply agreement on the OEM side for Pascal. But not only using the funding from the OEM Pascal agreements, but also using the CLIA waiver. We anticipate FebriDx receiving to support a U.S. product market entry for Pascal products more broadly. With regard to our HIV self-test business, we've reported a solid growth, more than 140% year-on-year growth in Australia, and that's been really the switching on of federal funding for HIV self-testing. Prior to the federal government policy change in February last year, the self-test market in Australia was essentially user pays over the counter or small not-for-profit projects. With the adoption of public health self-testing, and I think that comes off the back of an acknowledgment post COVID that at-home testing can really play a part in public health, we're starting to see a significant investment by the Australian government into HIV self-testing and continued expectations of growth in that segment as we roll out. Those programs are both running very well, being the vending machine program and the at-home mail program. We're working very closely with the implementation partners for those products to support not only the availability of product, but in the case of the at-home mailing program, we also take responsibility for the back-end delivery to the end user in their home. That's a model we think can be expanded beyond HIV, and we're certainly looking to replicate the HIV model both in terms of private access as well as public health access for the syphilis test once it becomes available as a self-test approved version of the product. The syphilis test, we're very excited about it. It's a very novel test. For those of you who aren't aware, current generation rapid syphilis test or antibody test, which means they will detect syphilis antibodies with a good level of sensitivity. That makes them accurate for screening to detect syphilis, but very inaccurate in being able to distinguish whether those antibodies are a result of an active infection or prior treated syphilis. With those current generation tests, someone who has had syphilis and been treated will still have antibodies and will still be reactive inaccurately to that test. The Atomo test that's been developed in partnership with the Burnet Institute has a different biomarker that is much more specific for determining active syphilis and is much better at screening out prior-treated syphilis infections from active infections. The improvement in specificity that we've been able to demonstrate in preliminary clinical data is very significant. That information has been presented by Burnet at a recent conference, and we'll be looking to bring some additional updates to the market in terms of not only that performance but also summarize the key opinion leader feedback as to what that means clinically for the use of the test in both screening programs through the confirmatory testing as well as in single test-and-treat scenarios where the specificity is critically important to accurate screening programs. We're very excited about that. We acknowledge that syphilis is a very substantial and growing issue, not just in Australia, but globally. We note that there is unmet demand for self-testing for syphilis globally, and we feel this novel test combined with the proven usability and performance of being delivered on Pascal will make it, we believe, the market leader in rapid syphilis screening and certainly gives us a number of distinct advantages, active distinct -- active detection of syphilis and delivery in a self-test format are both -- with low blood volumes compared to other tests are very compelling clinical and usability benefits that we think we can take advantage of. And we're very excited about the opportunities to bring that test to market in Australia and submit for Australian and European approval of the clinical work that we're doing later this year, but also looking to leverage that data to secure active interest from a U.S. partner for U.S. equivalent and some preparation for U.S. pre-sub meetings with FDA will be commenced later this year to support that. We have mentioned previously that we are looking to develop and have, in fact, completed the design work on an Atomo solution that mimics the functionality of Pascal but does not have the test strip inside the device. And we have done that to allow for Atomo to deliver a solution to market that can be used with standard cassettes that have already gone through their regulatory and clinical programs and to give partners the ability to use a device that offers better usability without having to go back and spend a lot of time and money and effort to clinically validate and approve a test again. And we feel that the device we've come up with does that well because it interfaces with a standard cassette. The standard cassette remains unchanged. The manufacturing of that cassette remains unchanged. And the reading of that cassette remains unchanged. In fact, it can be taken out of our device and put into a desktop reader for a standard read, and that makes it compatible with the very vast majority of blood-based desktop readers used in U.S. CLIA waiver settings. So we think there's a real market opportunity here to go out and address the existing tests that are at scale in market that have their regulatory approvals with a very easy to adopt and easy to adapt to device. And we've had some very interesting preliminary engagement with the small number of parties that we've involved in our kind of development cycle, and we're now actively engaged with them this week at a conference in the U.S. in terms of opportunities to move that forward. We'll obviously keep the market informed as those commercial discussions and technical validations progress. But I do think this is a device that adds a lot of value to a very big existing market that's underserved in terms of usability. And the best case we can use this device to help tests move from a 510(k) over to a CLIA-waived approval. That opens up very big market scaling for those partners. And obviously, if we're the technology that helps them unlock those markets, then there's certainly value for us as an enabling partner in that space. Outside of our product development and revenue activities, we have undergone a period of Board renewal. We've had a number of directors leave the Board, and I'd like to take this opportunity being the first quarterly since they resigned to thank Deborah Neff, Paul Kasian and John Keith for their many years of dedicated service to the company. I'd like to thank Dr. Cheri Walker for remaining on the Board, not only as a nonexec, but taking up the position of Chair of the AR Committee, Audit and Risk; and also to welcome Anthony May and Patrick Cook to the Board as nonexec directors. That now makes the Board a Board of 4. And I know that both Patrick and Anthony have very significant backgrounds on the commercial side of rapid test development and rapid test commercialization. They have a lot of connectivity in Asia Pac and also in Europe, and they brought to the Board a very solid level of commercial experience as well as an extensive network of potential distributors that we're now looking to engage with selectively in terms of how we can expand our current distribution network to better maximize opportunities in different markets where some of our existing distributors maybe don't have the level of access that we would like to see. So we're very pleased to have had that renewal completed, and looking forward to moving forward now with a renewed Board. In terms of the financials for the quarter, as I mentioned previously, revenue unaudited for the period was $1.07 million, and that's made up of test sales, primarily HIV as well as some other development efforts and grant income for directly funding the development activities on syphilis. Operating costs were $1.6 million for the quarter, although we do note that a large portion of that was covered under the CRC-P grant that we secured for the government. So in terms of working capital coverage of operating costs, we have had an improved quarter compared to prior periods. Cash proceeds of just over $1.5 million. And in addition to cash in from cash receipts and grant, we also undertook a number of capital activities to improve the balance sheet of the business and allow the business to deliver on these new product opportunities. We had a share placement where it was just over $1.6 million received net of costs. The reason that number is smaller than the placement size is because a large portion of that funding came through after 30 June. It's probably worth noting that the vast majority of that placement was subscribed for by existing shareholders, which I think shows a core ramp of shareholders in the business that are supportive of the direction of the business and the opportunities that lie ahead. We did bring in some new professional investors as part of that placement to a small degree. And some of those investors were part of the follow-on share purchase plan shortfall placement that we made 2 weeks ago. In addition to that, we had several hundred thousand dollars subscribed for by retail shareholders on the register by way of the SPP. So total funds that were brought into the company under this process, net of fees, has been about $2.6 million. And that obviously improves our balance sheet, added to the CRC-P grant and the revenue that we've generated gives us a good working capital through for the period. In terms of where we move to next, as we're entering into FY '26, we have, I think, a small number of key priorities that we really want to deliver on this year now that we've been able to renew the Board, bring in some capital and show where the opportunities now lie for the business. We have seen growth in our HIV business in Australia. We want to expand that growth outside of Australia. We'll be looking to expand our distribution network partners and bring on new partners in Europe as well as a select number of LMIC markets, particularly outside of Africa. And we are targeting Central, South America and Southeast Asia, where we do have some product registrations already through our partnership with Viatris, but also have the ability to register the Atomo version either through our existing TGA or CE Mark approvals. We're also very excited about the ability to scale up our supply to Lumos as they move through their contract with PHASE Scientific and hopefully, deliver in the near future, a CLIA waiver that would scale up those volumes. We continue to supply NG Biotech. And we are very hopeful of being able to secure new customers in the U.S., in particular, off the back of a CLIA waiver that would effectively derisk for new potential customers the effort to bring their test to market on Pascal [ with EHR ] by that stage, secured a CLIA waiver for the FebriDx test or helped secure a FebriDx test CLIA waiver. That pre-vetting of Pascal is CLIA waiver-ready. I think, also opens up the opportunity for Atomo to bring its own finished diagnostic products through in the U.S. with a more certain regulatory and clinical pathway, less commercial risk for a partner that wants to participate in that process and gives us a direct path to U.S. FDA engagement now that Pascal has some credentials through that initial process with FebriDx. Outside of our short-term growth on revenues, we have a number of products that we're looking to bring to market. I've talked extensively about syphilis. We'll talk to the market in more detail in the coming months around what that opportunity looks like both clinically and commercially. We are looking to develop both professional and self-test variants. I think it's probably important for investors to note that, that is a strategy that we're going to continue to focus on. That is delivering products to market that can count on some level of professional use demand and public health support, whether that's in clinic use or public health-funded at-home use, but also have then a consumer self-test market as well that we can access outside of professional programs. And that's as opposed to some tests in the consumer market that are essentially consumer only and don't really have a public health demand. We feel this ability to supply into both public health tenders as well as consumer pharmacy retail channels. It gives us maximum reach with products that we commercialize. We've seen that with HIV successfully. We believe the same dynamics apply to syphilis. And I think that, that dual approach will be one of the main criteria that we apply to any other applications that we look to commercialize under the Atomo brand as a finished product by Atomo. And we'll hopefully, in the coming months, be able to talk to what that pipeline looks like, what tests are in there, what stage of development they're at and what commercial opportunities we see for them and why we prioritize them. Outside of finished products, as I mentioned, we think Florey gives us an easy and pretty cost-effective way to enter the larger existing rapid test market where the requirement to revalidate and reapprove your test on Pascal is, for various reasons, overly onerous, and Florey offers an easier way to do that. So we do expect to see some new products getting commercialized in the next period. And with that, expectations of commercial partnerships that are underpinning those activities. Outside of new products, we continue to focus on the operational structure of the business. We've leaned on the board. We've leaned on the resourcing and overheads in the business over the last couple of years. We are looking to see how we can optimize our supply chain and operating activities to improve our margins, increase our capacity in particular with regard to requirements for Pascal demand over the period. And we expect to see with that obviously, greater control, better cost improvements and ultimately, better blended margins in the business that come from streamlined supply chain and economies of scale that we expect to see with Pascal. So that's the presentation. We didn't have any questions received before the meeting started or I do see that there may be one on the screen. Let me just see if I can access that. Let me see. Unfortunately, I don't think I can see that question. But I would just ask, if you could e-mail that to me, we're more than happy to address it. And if it's a material benefit, we're happy to include that in our next communication, which is going to be coming up quite shortly. I'd like to thank everyone for their support of Atomo through the year. As you can see, we've made significant commercial progress on our existing products. We have some very exciting new products coming to market. We have a leaner business, a new Board and additional capital to execute on those opportunities. We're very excited about where we find ourselves going into this FY, in particular, the growth in HIV, the opportunities for Lumos and the opportunity and potential of the syphilis test that we're actively looking to put into clinical trials later this year. I'd like to thank you for your time and say good afternoon.