Atomo Diagnostics Limited (ASX:AT1)
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Apr 28, 2026, 3:57 PM AEST
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Earnings Call: Q3 2024

Apr 30, 2024

John Kelly
CEO, Atomo Diagnostics

Good morning. My name is John Kelly. I'm the Managing Director and CEO of Atomo Diagnostics, and welcome to the Atomo Diagnostics FY 2024 Third Quarter Results Presentation Webinar. I would just like to share our release, and we can go through it. Firstly, HIV. We've obviously seen strong growth in the HIV business over the last couple of months, and that reflects a number of trends within the market, both with regard to the emergence of retail pharmacy sales, as well as the adoption of self-testing by public health to support expanded testing outside of primary health clinics. We announced a number of sizable orders from our global health partner, Viatris, and that, I think, represents a marked increase in demand within global health.

And that, I think, also reflects the increasing recognition that we're getting for being the only listed manufacturer that has a manufacturing facility certified in Africa, for Africa, with global health products. And we're, I think, bullish about the opportunities that that unique position we have in the market within global health offers. And Viatris certainly have been very active in the promotion of that and activities related to a number of ongoing tenders in global health, not just in Africa, but largely volume-wise based in Africa. So we do expect that growth to continue over the medium term, as HIV testing in global health becomes a bigger segment of the market relative to professional testing and Atomo's unique performance and ability to make in Africa becomes increasingly recognized.

Outside of global health, we announced at the very end of quarter two, another sizable order for HIV self-test for our partner in Europe, Newfoundland. We manufactured and supplied and invoiced the first tranche of 50,000, and we'll be looking to manufacture the remaining quantity once we complete the orders for Viatris, which came with a reasonably tight requested delivery date from those countries in Africa. So we've prioritized them, and we'll start to see the revenue from those Viatris orders come through in this fourth quarter with the Newfoundland business to follow. We're very encouraged by Newfoundland's continued ordering, obviously, but as well as that, their continued expansion into the market. They announced that they had, in the quarter, received approval from INVIMA, which is the Colombian regulator, and that product's now registered for supply into Colombia.

Newfoundland were the first company, we believe, in the world, to set up a self-test pop-up shop in Bogotá, in Colombia, and now they're able to start supplying that HIV self-test into that channel. We've continued to work with them on a number of other markets, and we'll talk a little bit about the expansion of our relationship with them in the wrap-up. Back here in Australia, we continue to see growth in our HIV business through both the pharmacy rollout, we're now in more than 300 pharmacies across the country, but also increasingly through public health. We've worked with NAPWHA and Grindr to promote awareness of pilot opportunities to access self-testing in the market.

We've seen that pilot generate very significant demand, and we're engaged with the government now in the run-in to the budget to see what level of funding support can be made available to expand that access, now that we've been able to show the utility of the channel and also the inherent demand for HIV self-testing in the community. Outside of that pilot, we also continue to work with state governments to promote and implement a number of vending machine pilot programs, and we're expecting to see those opportunities also scale. There's actually, for those that are interested, an article out in today's Australian that Atomo, NAPWHA and Grindr were part of, and that talks, I think, to the growing awareness of the need for self-testing and our ability to really help drive impact through that channel.

Outside of our HIV business, we continue to see a lot of increased demand for the technology through inbound inquiries, and that is, I think, a recognition of a number of things, one being the approval of the Lumos FebriDx test in the U.S. through 510(k). Obviously, that product is supported on the Atomo Pascal platform, and that's allowed us to really expand our ability to engage with and offer a proven pathway for U.S. partners who are interested in accessing our technology. I think also the success that we've had in entering the market in the U.K. for pharmacy retail with Newfoundland shows that not only is our platform, the ideal platform for blood home self-test, but that that channel is now becoming a mainstream ranged item in not just pharmacies, but in a number of markets in supermarkets.

That's, I think, where diagnostics is going, and we're seeing a lot of companies now, post-COVID, starting to recognize that transition and looking at how they can adapt their tests in a increasingly consumer-focused market. I think our technology is now very well recognized as offering that bridge into a consumer channel. That's now starting to show through a number of funded development programs. We announced that we were part of a consortium that was awarded a AUD 3 million federal government grant to develop a very novel rapid test for Group B Strep, which is a very significant issue for women in later stages of pregnancy. And that program is one that we hope to get underway shortly. We're in the process of finalizing our agreement with Nannk to support that. That would see us-...

Run a sizable portion of the development, particularly around the integration of the Atomo Curie swab device, which offers a number of usability and performance enhancements over standard swab-based applications. We're also encouraged by that development program because it offers a number of potential opportunities for vaginal swab testing beyond Strep B, and we have a sexual health business that we think would be ideally expanded to include chlamydia and gonorrhea, which is a very large, as yet unmet home test opportunity in global markets. We continue to work also with long-term partner, the Burnet Institute, to support them on the development of a number of very novel assays that they've developed.

One is a liver function test that is currently being used to support a large clinical study in the U.S., a large pharmaceutical stage III trial. But beyond that trial, we have discussed with, with Burnet the, the various areas of the market where liver function screening offers some potential commercial interest, and we see that as an ongoing opportunity beyond that clinical trial. Outside of liver function, we've been working also with Burnet on a very, novel syphilis test. Most syphilis tests, well, in fact, all syphilis rapid tests on the market at the moment do not distinguish between current active infection and prior treated infection, because they typically just measure antibodies that are present post, treatment.

This new test is much more specific at distinguishing between active and past infection, making it, potentially a much more useful test to use in the diagnosis of active infection in the community, and we think that leads to potential opportunities for at-home testing as well as obviously in clinic professional testing. We note that syphilis rates have increased very dramatically in the last 10 years across most developed and developing markets. So that's a product that obviously lends itself to a sizable, global health opportunity, subject to cost and funding. Outside of those programs, we continue to, as I mentioned, receive inbound interest in the platforms that we have, Pascal being the, the FDA, cleared one through the FebriDx test, but our interest, extends beyond Pascal, and we're seeing interest now across a range of platforms.

We're seeing some development fees being secured by the business. I think that's an important milestone for us to be able to announce. Even though the revenue in this quarter for development fees is reasonably modest, we do expect that to increase fairly significantly over the next two or three years, and that references, I think, a new level of confidence that we have in charging for development services to get access to our platform. In the past, Atomo shareholders have funded development at risk on the understanding that the technology would be able to generate downstream commercial interest, such as we secured from NG Biotech and Lumos, as well as supporting our own finished products in the market.

But I think the success of those products in the market and the success we've shown in being a leader in self-testing, has allowed us to be a lot more bullish now in those commercial agreements. And we now expect to see ongoing development fee revenue coming into the business as we start to develop custom solutions for partners, as well as obviously, optimizing the current platforms that we have for those partners. And that's an exciting, new business for us, because not only does it generate revenue over the coming years, but it then locks in those partners for ongoing licensing and/or supply of the product once we get through that development phase, and successfully help them get into the market with a regulatory approval. The other area of the business that we've spoken of late is pregnancy testing.

We continue to support NG Biotech as they register the product here in Australia. They are the listed manufacturer. It's their application to TGA. We are the sponsor supporting that process. We've been working with NG Biotech to address a number of requests from TGA. That work was completed last week, and that submission has now gone back into TGA. And we await their feedback once they've had time to review that response. We'll obviously provide updates as we receive them on that program. Outside of the Australian registration, we continue to support the NG Biotech expansion of their finished product business in markets where Atomo is not the listed manufacturer or the sponsor.

They have, as we announced in the last quarter, had success in expanding their relationship into a number of European markets, so we continue to see demand for the cassettes outside of our own needs. So that's encouraging that they're, I think, actively scaling up their market entry post-COVID. If we talk about the financials for the quarter, we received a revenue unaudited of just over AUD 500,000, which was primarily made up of HIV sales. It's probably worth noting that the bulk of the sales that we received in the quarter via Viatris have not as yet been invoiced and booked as revenue. So we do expect to see a very sizable uptick in HIV sales for quarter four, which we'll report, obviously, at the next quarterly for our end-of-year total.

Outside of that, we continue to see ordering from NG and Lumos, and as I mentioned, some initial development fees, modest at this stage, but we do expect them to grow, you know, fairly materially over the coming years as we start to continue to book development programs, particularly with some larger companies that are looking to expand into home testing. Cash receipts for the quarter, just over AUD 750,000, and that left us with cash on hand of just over AUD 5 million at the end of the quarter, debt-free and with a strong revenue pipeline for quarter four. We do expect to close out the FY 2024 period in good stead in relation to available cash on hand to run the business.

In terms of the priorities moving forward, obviously continuing to grow and optimize and maximize revenue from our HIV business, we will be looking to support entry into new markets with regard to Newfoundland, obviously, entry into the Colombian market post that approval. We're looking to work with our authorized representative in Europe to add Switzerland to the CE mark, so that we can move into product launch with Newfoundland there as well as supporting an application to BSI to expand into a second product variant that covers Eastern Europe. Newfoundland, we understand, are seeing good demand from a number of countries in Eastern Europe for the product.

Then back here in the Australia region, we're using the TGA approval to look to launch into New Zealand in the coming quarters with the HIV product and also potentially the pregnancy product as well. In addition to those retail channels, we're seeing strong interest, as we noted from public health. We do expect to see some funding or hopeful of seeing some funding in the budget moving forward for self-testing now that that's part of the federal government's policy to manage HIV. We have had very strong success and from the pilot programs, particularly the NAPWHA study, I think that success is now well-recognized by all participants in the study, as well as by government, both state and federal.

So we are very bullish about the opportunities to expand those programs and expect to see revenue, obviously, growing as we roll through FY 2025 and into 2026 through public health. And I think that reflects more broadly a recognition by public health providers globally that diagnostics in the home and diagnostics outside of clinics is a valid, cost-effective, and convenient way for people to test. And I think that's a remnant of the recognition of the success of antigen testing during COVID, the HIV self-test adoption by public health, a further example of that. We continue to be very optimistic that those programs will expand into other applications. The one I think that we're most interested in is sexual health.

We think that there are key, opportunities across a range of sexual health tests to start to transition testing into the home, and we're looking to develop, obviously, products that are ideally placed for those markets, HIV, we mentioned syphilis. We're interested in using the swab platform for chlamydia and gonorrhea, so that's a real area of strategic focus for the business to be a leader in home sexual health testing. We continue to see, as I mentioned, inbound interest from partners on the platform. We expect to continue to execute agreements over the coming months and quarters with new partners for optimization of their tests for Atomo platforms, as well as for a number of partners, the development of custom solutions for, their own applications, particularly for clip and reader applications.

We're very excited to get started in the coming months with Nannk on the development of that swab device for Strep B, and we'll be expecting to make announcements as those programs move forward, as well as obviously keeping the market informed of progress with the pregnancy product as well, as it works through registration processes in Australia and New Zealand, and we continue to talk to partners about the opportunities for the product in the U.S. market as well. So that's the presentation complete. I'm just gonna jump back to the main screen to see whether there's been any questions. We did have a couple in overnight. The first one was: Any insight into FebriDx uptake by Lumos in the U.S.?

I will say that we have seen, orders from Lumos in quarters two and three, so we are seeing regular demand. We are more bullish about the, overall demand for the cassette for FebriDx over the next 18-24 months versus the last period coming out of COVID. But with regard to the specifics around market entry in the U.S., I think that's, that's really, a question for, for Lumos to answer. Second question was: The company has received two HIV orders of size from Viatris in as many months. Is this ordering pattern seasonal or expected to continue? That's a really good question.

There are ongoing regular tenders in global health that Viatris are obviously very active in, in tendering for, so there are opportunities for us to win regular orders, but obviously, our success in those tenders is, is typically binary, so we're never sure which tenders we're gonna win. So there is a slight level of lumpiness to the tenders being secured, so we can't say that we're gonna win tenders every quarter. But we are very encouraged by the fact that Viatris have had success recently in being the chosen blood test for those tenders, and we think that's in large part due to the good work that Viatris are doing. They're a very respected global partner, having also, you know, provided for many years, HIV drug treatment to global health.

But it also reflects, I think, the increasing recognition our test performs very well and that the ability to offer made-in-Africa product with shorter lead times than most of our non-African based competitors, I think is starting to resonate, and we're hopeful of continuing to see good growth in that channel. The third question relates to pregnancy, as when does AT1 anticipate approval in Australia for the pregnancy test? Like I said, we've helped NG submit last week a response to TGA. They'll be going through that response. I'm not gonna preempt when they're gonna make their determination or how quickly that's gonna happen, but we'll certainly keep the market informed of any material developments with regard to that product.

I think that seems to be the only three questions we've received, so I would like to conclude by saying that we are in a good position with regard to growth of HIV. We're excited about new product opportunities on the platform. We're very excited about the ability to start engaging with larger companies and charging development fees to secure access to our platforms moving forward. We are obviously expecting a very solid quarter four based on all the orders in the pipeline. So I look forward to welcoming you back for the quarter four end-of-year wrap-up, where we think we'll be able to talk to revenue growth, margin growth, as well as a number of new exciting development pipelines. Until then, thank you for your time. It's been a pleasure.

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