Atomo Diagnostics Limited (ASX:AT1)
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Apr 28, 2026, 3:57 PM AEST
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Earnings Call: Q4 2024

Jul 25, 2024

John Kelly
Managing Firector and CEO, Atomo Diagnostics

Good morning, and welcome to the fourth quarter FY 2024 Atomo Diagnostics report. I'm just gonna pull up the quarterly report that we put out to market today and run through that. I'm John Kelly, I'm the Managing Director and CEO of Atomo Diagnostics. In terms of our quarterly performance, we are pleased to announce obviously approximately 400,000 units of HIV self-test sold during the quarter. The majority of that to our partner, Viatris and Global Health, as well as an increasing volume going into the local Australian market. And that's been driven and continues to be driven by the adoption of self-test in public policy for the Australian Federal Government. And we see now committed funding for a number of years through a number of programs that we've been working to get implemented over the last year or two.

We're also continuing to see Newfoundland expand their market reach in HIV self-testing in Europe, and we're very pleased to see that in addition to the progress they made earlier this year in reaching markets in the U.K. through Tesco supermarkets, we also now see that they're selling into Boots, which is, obviously a very exciting development. Boots being the leading, U.K. retailer for healthcare and pharmacy by quite a margin. So that's a very critical pharmacy retail contract to be able to move into. Outside of HIV growth, we're continuing to see interest in the platform, in particular, some work that we've been doing with the Burnet Institute down in Melbourne.

They've developed two very exciting novel, rapid test assays, and those assays have been optimized on our Pascal device, and we're looking to move forward with some commercial-related engagement with them and other partners offshore. Particularly excited about the test they've developed for syphilis, and we'll talk a little bit later in the report around that. We also continue now to start to see increases in our revenue. We had unaudited revenue for the quarter of AUD 1.64 million, which takes our unaudited year-to-date total to just over AUD 4.09 million, which is a significant step-up in revenue compared to the FY 2023 period, and that comes against a backdrop of reduced business costs. So that's obviously pleasing to see, and we'll talk a little bit more about that as well.

In terms of cash receipts for the quarter, just over AUD 1 million in cash coming into the business, and that leaves us with debt-free and cash on hand for the 30 June closeout of approximately AUD 3.7 million. So if we jump into HIV business in more detail, obviously, we announced in May in the federal budget, a significant commitment from the Australian Government to the adoption of HIV self-test. That's the first time that the Australian government really has looked to bring self-testing into public policy for infectious disease testing HIV. We have expectations of around about AUD 1.3 million worth of revenue from the funding and scale-up of an at-home mail program run by NAPWHA, which was set up with Atomo and NAPWHA, and recently promoted through Grindr.

We've seen off the back of the Grindr promotion, significant upticks in demand for the product. That now can continue and scale through FY 2025 and 2026 with this government funding. We're very excited to see that happen, and we think that is a program and a channel that will continue, we believe, to be funded beyond that initial two-year period, once the infrastructure has been set up and the evidence comes in to support the use of the test through that channel. We also have support from government through a number of vending machine programs. We helped set up some vending machine pilots in Queensland and in South Australia over the last two years, and they've proven very successful in reaching people that aren't typically testing in facilities.

That's now been expanded by federal government support across all states, except for, I understand, New South Wales, and that's because New South Wales has been developing and launching its own MyTest vending machine program, and that was launched in June, and we supplied the first batch of products into those machines, and we do expect that pilot to also scale over the period. So very excited about the public health engagement we've got now for self-test, but also pleased to be able to report that we continue to bring on new pharmacies at a good clip. And we're seeing that private sector pharmacy model scale, and we expect to bring on, I think, over 100 pharmacies in the next first half of this FY 2025 period. So that's good long-term growth for HIV in Australia.

In Europe, our partner, Boots, as I mentioned, has expanded beyond the largest supermarket chain. Tesco now into Boots, which is the largest pharmacy chain, and that, I think, gives us a really good position with them in terms of being the leading test in that private sector pharmacy market, which in the UK is substantial. We've seen obviously significant purchasing from Newfoundland over the last 15 months for the support of that launch in Europe.

We announced that they had, earlier in the year, got approval for Colombia, which we added to the agreement, and more recently, they've been able to, with our support, get registration of the product in Switzerland, and they have an application in for a new product variant that we supported for Eastern Europe, and they do have some firm demands in place for when that test gets, that variant gets approved. So we do expect to see their market reach expand across, across Europe. I'm very excited about that. We're also talking to them about other potential applications beyond HIV. They do have interest in consumer health testing more broadly. They're very impressed with the level of performance that the Atomo platform delivers, and we're in discussions around other blood-based applications that could be added to that partnership.

In terms of blood-based pregnancy testing, we were disappointed to announce that our application to sponsor NG Biotech's blood-based pregnancy test in Australia has been unsuccessful. We do note that that test has been registered in a number of other jurisdictions with the clinical data that NG has provided in their dossier. That, that clinical data was not considered by TGA to be sufficient for registration in Australia. We've been asked in the Q&A session around our plans to resubmit for that. We are currently in the process of working through the requirements for Australian registration that we've got now from TGA with NG. They are the listed manufacturer of the product. It's their dossier.

They need to deliver that dossier back to TGA through us to meet that requirement, and we're working with them to understand the time and effort needed to do that. And once we have a determination on that, we will certainly update the market. We do note that NG continue to expand their product outside of Australia and the U.S. under their own brand. They've supplied several hundred thousand tests into the market, and they are expanding, particularly into Southern Europe. They signed an agreement with Towa Pharmaceutical for Italy, Spain, and Portugal, and we've been seeing an uptick in demand from them for that contract.

I think that talks to the ability for them to get market traction in markets where there has been promotion from a sizable pharma partner that has the ability to raise the awareness and provide the market reach needed to convert, I think, the market from urine to blood testing. And we're very excited to see that that's been done well because that provides a case study for us in other markets. We have been asked some of the questions to confirm what or reiterate what our relationship is with NG, so I'll just reiterate that.

We supply NG with our assembled Pascal device for their Precision+ pregnancy test, and they have the rights to make that test and supply it to market as the listed manufacturer in all markets, except for Australia, New Zealand, and the U.S., where Atomo has the right to launch its own branded version of their product as the sponsor, but then the NG still being the listed manufacturer. And we have obviously been working with them to support the process for scale-up in those markets. So hopefully that clarifies the commercial relationship. In terms of funded development programs, I mentioned that we have two active programs moving forward. The first, and I put it first because it's probably the biggest market opportunity of the two, is a rapid syphilis test that could be used for both professional and self-test use.

It's a very unique opportunity because currently, the only rapid syphilis tests on the market detect antibodies for syphilis, so you will detect positive if you have syphilis, but you will also, with those tests, detect positive if you've had and been treated for syphilis, in the last, you know, 12-15 months, which is quite a significant problem in terms of the specificity of the test for actually detecting active syphilis. Burnet have been very successful in developing a test that only detects active syphilis, and that test strip has been optimized on our cassette, and we've had significant interest from a number of partners around the world to see what that test could do as a self-test in the market. It is a very large unmet need.

Syphilis rates are growing much more rapidly than HIV, and it's becoming a very significant global challenge, particularly with transmission of syphilis in natal situations. So we believe there's a really good opportunity for that product. Our commercial partners overseas have expressed interest in that product, and we're working with Burnet to try to close out some commercial arrangements that would allow us to take that product forward on the Pascal device. They've also developed a liver function test, and that liver function test is being assessed for a number of different applications for liver screening. One of them is to help with pharmaceutical trials and to shortcut the time for large phase III trials, where any sort of liver toxicity risk is a challenge.

We know that they've made very good progress with a couple of large pharmaceutical companies around opportunities for that, or at least we know of one. That, I think, gives us some confidence that that product will have product sales attached to the product beyond the development phase that we've got. But exactly what that market looks like, it depends, I think, on what applications the liver screening is ultimately dedicated to. But we have expressed interest with Burnet in commercializing jointly with them, that product as well as syphilis. Other opportunities, more broadly, we continue to see inbound interest for the platform. A lot of that's coming off the back of the 510(k) clearance that the FebriDx test secured about 12 months ago, and obviously transition across into CLIA waiver.

And hopefully, we believe with the right test, OTC home approval will make the Pascal platform a leading go-to-market solution in the U.S. market, and a lot of the inbound interest that we've got sits in that area. I'll be heading over to the U.S. next week for the ADLM, which was the old AACC conference, one of the leading diagnostic conferences in the U.S., and then going back there a couple of weeks later for the NextGen Dx conference in Washington. They're the two conferences where a lot of the new products get demonstrated and where a lot of researchers come to find technology for bringing new applications to market.

So they're the conferences, certainly, that we have got increased visibility at now, and we'll be looking to progress some of those pipeline discussions as well as, you know, fill that hopper with new inbound interest as well. One of the questions we got relates to the pipeline. Do we have a pipeline, and when do we expect to announce some further deals? I think we'll be in a much better position to answer that post those two conferences. So the next quarterly, we do expect to be able to provide some better granularity on what those what those pipeline agreements might mean for us. If we turn to the actual financial performance for the quarter, as I mentioned at the start, AUD 1.64 million of revenue on audit. That's primarily HIV sales in global health markets and in Australia.

We continue to see orders from our OEM customers, about AUD 250,000 in product Pascal sales, and we're now starting to see some fairly modest development fees, companies looking to access our technology, proof of concept programs, samples, some concept development work. While modest at the moment, we do believe that is a very encouraging sign. Before the pandemic, before we had 510(k) clearance, we weren't getting anyone prepared to pay for development. We were having to do that development at risk. So I think now that we're seeing that development interest, we do expect that to scale over time.

What that means for the FY 2024 period is revenue of approximately AUD 4.1 million, which represents a very pleasing increase on the FY 2023 number, and I think that's been referencing and reflecting the reestablishment of our business post the post-COVID hangover that Atomo and other diagnostics companies suffered when COVID sales fell away. We do believe that revenue growth will continue into FY 2025, and we're also pleased to be able to report that our operating costs through the period have come down materially, which means we're delivering more revenue with a lower cost base, and that's been a result of a significant focus on managing operating costs and running the business as lean as we can.

We had cash coming in for the quarter of just over AUD 1 million, and that leaves the business with AUD 3.69 million cash on hand as of 30 June. So that's the quarterly summary. In terms of some of the other questions that we've received that I'm gonna go through, someone's asked, in the absence of TGA approval for pregnancy test, what, apart from the HIV and Burnet development fees, are we expecting in terms of revenue growth? We are expecting to see an uptick in sales from our existing OEM customers, and we are expecting to be able to launch new customers onto the platform over the coming period, as well as continuing to see significant growth in the HIV business over the longer term.

Are we still going to reapply for pregnancy with TGA? We'll be able to answer that once we've had the appropriate discussions with NG. NG ultimately has to upgrade their dossier to support that resubmission, so we'll be talking to them about the requirements to do that, and then we'll be in a much better position to advise the market on our position and subsequent timing. Will Atomo share costs for further clinical trials with NG? Well, that's part of, obviously, the discussion. Some of the clinical work that we're asking them or looking for them to do may also be required for their IVDR transition. So there's obviously some of that work that they would need to do over a period of time in any event. So that's obviously part of our conversation.

Are there any new OEM contracts in the pipeline? Yes, there are. When will they come to fruition? As I mentioned earlier, we will be in a much better position to provide some clarity on that after we follow up with the engagements in the U.S. over the next couple of months. I'd like to thank everyone for joining me today. I'd like to thank you for your continued support, and we look forward to putting our end-of-year results out and updating the market post our engagement at conferences in the U.S. Thank you for your time.

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