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Earnings Call: Q1 2025

Oct 29, 2024

John Kelly
Managing Director, Atomo Diagnostics

Good afternoon. My name is John Kelly. I'm the Managing Director of Atomo Diagnostics, and welcome to Atomo's first FY 2025 quarterly activity report. Thank you for joining me. I'd like to start by talking about some developments and progress on our core HIV self-test business. We have seen continued demand through this period from the step-up in demand that we saw going into the back end of FY 2024, and we noticed a significant pickup, specifically with regard to local demand in Australia, and that's come primarily through the NAPWHA Mail Home program, which is now being fully funded by the federal government, post that commitment in the May budget to fund HIV self-testing for the first time in government policy. That also includes some demand from New South Wales Health for their vending machine program, and we also...

Are pleased to report that progress has been made with regard to the expansion of the national vending machine program, and we've had updates with our partners there that confirm that a lot of the actual vending machine manufacturing and installation is now underway, which means we'll be expecting to see an uptick in demand through that vending machine scale-up as we move into early calendar 2025. Outside of Australia, we're also pleased to report for the first time a new variant coming to market in Europe and an order received for that Eastern European variant. We've manufactured that batch. It's gone to our partners in Europe to have batch release managed, and once that's completed, we will dispatch in November. That represents an expansion of the footprint we have for the product in Europe.

Over the last eighteen months, there's been a success in entering the pharmacy retail market, initially in the U.K., through channel access to Boots and Tesco, as well as a large pharmacy chain in Germany, recent launch activities in the Netherlands and now into Eastern Europe, particularly with the demand coming in the early stages out of Poland, so we're excited to see that footprint continue to expand, and we're looking at supporting partner discussions in a number of other markets, including some discussions related to the Iberian market, so that would be Spain, Portugal, and potentially also Italy. More broadly, we're mindful of the transition from IVDD to IVDR now underway in Europe, and we've been, for the last number of months, preparing for that transition.

We've had the completion of the first phase audit of the South African operation, and there'll be some follow-up audits here in Sydney later this year, and that will support a resubmission of our dossier to upgrade from IVDD to IVDR. As a Class D product, we were already compliant with a large portion of the IVDR requirements that have come in, but we'll be looking to do a gap analysis, plug any small gaps in terms of documentation, and have that submission in place by the deadline of May 2025, and that would then allow us to continue to supply the current product under IVDD while the IVDR dossier is under review. We're well prepared and well progressed in that process. Moving on to our next finished product to come to market.

We're very excited to be able to announce the successful securing of a sizable government grant, a CRC-P grant, that was applied for by Atomo as the lead recipient, with a number of partners to support that program. We had announced to market that we've been working with the Burnet Institute for a number of months on the optimization of a novel active syphilis biomarker on the Atomo Pascal device. By combining that very novel biomarker with the usability and performance of Pascal, we really will be able to deliver, we believe, a truly market-leading product. One that not only is suited to both professional and self-test use, but also one that can distinguish between active syphilis infection and prior treated infection. At the moment, that typically has to be done through lab testing.

Rapid tests on the market to date really only detect antibody presence, which can be present with an infection, but also will be present with prior infection, so that means that current tests on the market are not very specific for active infection, and people who have been screened positive on those tests typically have to wait up to a week for a confirmatory test before they get treated, or alternatively, before they get told they didn't have syphilis in the first place. We feel that a test that can be specific at the point of care is a significant step forward, and to our knowledge, it would be the first rapid screening test that is specific for active syphilis available globally. Added to our track record on self-test market development, we think that's a really compelling product opportunity.

We're very excited about the performance that Burnet's been able to demonstrate on the assay, and we're very excited about getting started with this, with this project. We will be looking to secure the agreement with the Commonwealth later this year, and we expect initial funds from that grant to come through in January, so we can fast track completion of the dossier, with a view to having a product dossier capable of supporting submission to Australian TGA as well as to IVDR for European marketing. Also, our intention is, at this stage, to deliver both a professional use and self-test variant, and we have, in the case of syphilis, significant demand, we believe, in both of those channels. We know syphilis is a very large growing problem. Rates in Australia have tripled in the last decade.

I believe they've more than tripled globally over that period, and there's now an estimated eight million people being infected with syphilis each year. We're noting a lot of interest in syphilis from the Australian public health system, and it is an unmet endemic situation that we think this test can go a long way to addressing. And the reason we're very interested in syphilis, not only the large unmet clinical need, but it is a product that offers two channels to market. One, public health demand, and two, over-the-counter pharmacy retail channel opportunities. And that's a market that we're particularly interested in because it fits very nicely with our current HIV business. We have a HIV test that has public health customers as well as private payer customers, and we feel that syphilis sits very nicely in that category.

It also sits next to HIV in terms of being a sexual health test, and we know that a lot of the people at risk of HIV are also at risk of syphilis. So we find it to be a very complementary product and one that our channel partners are very interested in accessing. If we move on to other partnerships with Burnet, we previously also announced that we had supported them on an ALT biomarker, which is a test for liver function screening. We'd previously received a small purchase order that we had delivered to them to support some U.S. drug trial support in the U.S. We have another batch that's coming through later this year for that program. I think that talks to a larger partnership opportunity that we have with Burnet. We have a very good working relationship with them.

They are a global leader in the development of very novel assays that impact large clinical markets, and they are very keen to work with Atomo, not only to access our platform, but also our capabilities around product development, product commercialization, regulatory approval, and increasingly, our access into professional and self-test markets. I think that talks to a larger opportunity that we can deliver for the business outside of those types of partnerships, and I think that, in many ways, will be expanded as our product continues to secure regulatory approvals globally. We've noted in market that Lumos are moving towards a CLIA waiver submission for their FebriDx test, which is on Pascal.

As many of you know, that will sizably increase, we believe, the demand for FebriDx as a product, but also increase the demand for Pascal as a U.S. compatible platform that has a de-risk pathway to market there through both 510(k) and CLIA waiver channels. That is, I think, being seen in terms of inbound inquiries. We have several detailed development discussions underway with partners across a range of applications. We're not at liberty at this stage to talk about specific partners and specific applications.

However, we can say that some of these, discussions are quite well advanced, and we do remain confident that we will be able to deliver a number of new customers onto, not just the Pascal platform, but variants of our technology as alternate platforms, and be able to secure the types of long-term supply agreements that we've already been able to deliver through partnerships with companies like Lumos and NG Biotech. In terms of the financials for the quarter, we announced, eight hundred and seventy-six thousand dollars worth of revenue for the quarter. The majority of that has come from HIV self-test sales, primarily sales in the Australian market, where we enjoy a much healthier margin as a direct distributor to market than we do when we go through distributors and other channels. So we're very excited to see that continued growth in the Australian business.

We do expect that business in Australia to continue to grow as the government continues to support self-testing and as the vending machine program starts to build scale as those new machines come online. Operating costs for the quarter were AUD 1.6 million unaudited. That is a sizable reduction on the equivalent cost for the quarter one year earlier, and I think that represents our continued focus on managing costs in the business. It's just under 20% cost reduction. That comes off the back of a larger reduction for FY 2023 to 2024. So we are looking to run the business in a cost-efficient manner, and we continue to remain focused on that as a core deliverable.

Cash receipts for the quarter were one point one six million, and we noted that we finished the quarter with two point six one million cash on hand and debt-free. Since that period, we also disclosed the securing of an ATO rebate for seven hundred and fifty thousand in this period, post the end of the quarter. That would then be added to as we see funds come through from the federal government in January for the commencement of syphilis. That will help further with the operating capital in the business. We have had a number of questions that I was going to address.

First question is, "Can you please provide us an update on any new OEM contracts in the U.S. that might be online in the near future?" I'm not able to talk about specifics because we do have, obviously, confidentiality obligations with counterparties. I can say that we do have some engagements with parties who have secured grant funding in the U.S. for products that we are looking to support through Pascal, and we do hope to be able to provide some further information on that particular opportunity and others. We are in discussions with a company in the U.K. that has a product that they've been looking to bring to market, but see the benefits in having more usability in their solution because of its deployment in an ambulance setting, where ease of use and reliability are critical.

And we've been able to obviously point to the 510(k) for the platform and the looming CLIA waiver as evidence that that regulatory pathway and commercial pathway is valid. So we have been making progress, and we do hope to be able to bring some specifics to market in the coming months. We had another question, and that relates to our cash on hand. So obviously, we're mindful of the cash balance in the business. We have been looking to manage costs accordingly. We note that since we closed out the end of quarter cash, we've received a sizable R&D rebate, as well as incoming grant funding. But we also are, you know, mindful of the ability for the business to look at capital more broadly on the market, you know, for applications and opportunities as they arise.

So it's something that the board are very focused on, cash management, and we will keep investors advised on developments in that area. The third question we have relates to revenue, and it says, "What are the prospects for revenue growth as we move forward?" As noted, HIV continues to grow. We're very happy with the opportunities both in Europe and Australia, in particular, for the growth of the business in high-margin environments. Outside of global health, we expect to see continued developments and progress in that market. Outside of HIV, obviously, when syphilis comes to market, we expect it to have a similar level of demand. It's a similarly impactful infectious disease and one that has not received the focus over the last twenty years that HIV does and has received.

In some ways, it probably provides more opportunity for us because it's a less managed, less treated condition. That also gives us an opportunity to play not only in the self-test market but in the syphilis market for professional use, which means we really cover a bigger addressable market there. So I think syphilis will be a solid performer, we believe, over the longer term, and sits very well beside HIV in terms of the end customer, both public health and pharmacy retail.

On the OEM side of the business, we expect to see some growth in our current business partner demand, particularly as they continue to roll out with new regulatory approvals like CLIA waiver, as well as in the case of NG Biotech, expansion into some other markets in Europe where they currently were not active, and I note that they announced a partnership with Towa Pharmaceutical, and they've been seeing good business in Italy, Spain, and Portugal. Beyond that, we do have expectations of new customer contracts coming into play off on Pascal, and we have been working on some other product concepts that reutilize and repurpose our existing core technology in areas where there may be, we believe, less barriers to adoption in terms of regulatory approval.

And in the coming months, we hope to be able to talk a little bit more about those technologies, the intended use of those, and what some of the applications and channel partners might be for those. In the meantime, I'd like to thank you for your time. We haven't any more questions come in, so I'd like to thank you for taking time to explain what we're doing for quarter one, and thank you for your support. Have a good day.

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