Welcome, everyone, to the Artrya Investor Call for the June 2025 Quarterly. My name is David Allen from Hawkesbury Partners, and I'll be moderating the call today. The presenters on today's call from Artrya are Bernie Ridgeway, Executive Chairman, John Konstantopoulos, CEO, and Harvey Farrington, Acting CFO.
This call is being recorded, and all participants are in a listen-only mode. A recording of this call will also be placed on Artrya's website shortly. The presentation will be followed by a question and answer session, and if you wish to ask a question, please type it into the Zoom Q&A section. I'll now hand the call over to Bernie Ridgeway, Executive Chairman of Artrya.
Thanks, David. Good morning and welcome, everyone, to Artrya's Quarterly Investor Call. Joining me on the call today from Perth is our Acting CFO, Harvey Farrington, and on the line in New York is our CEO, John Konstantopoulos . Today, we'll be providing listeners with an update of our commercial and operational achievements for the quarter-ending 30th of June 2025, as outlined in our Appendix 4C filed with the ASX yesterday.
We'll also use this as an opportunity to touch on our recent U.S. commercial launch and the progress of our SAPPHIRE study, which is part of the reason John is in the U.S. right now. Before we move into our business and financial progress for the quarter, I would like to add a few comments about our recent leadership transition.
As shareholders may be aware, John was co-founder of Artrya, and in addition to being one of the initial innovators driving our Salix technology, he has spent the last few years driving our strategy and commercial engagement, most particularly in the network of hospital partners we now have in the U.S. and Australia.
So, as we move into a new financial year with the Salix platform in its commercial growth phase, we felt it was the right time for John to take the reins and really drive that commercial launch. With this more commercial focus, Harvey will retain his commercial role and support John in driving our finance function going forward. Now, I'd like to hand over to our CEO, John Konstantopoulos, for a review of the quarter. John?
Thanks, Bernie, and good morning to everybody on the call, and as Bernie mentioned, I'm in the U.S. at the moment in New York, and I've been here for the last couple of weeks, where I really started at the Society of Cardiovascular Computed Tomography's annual conference, which happened about 10 days ago, and since then, I've really been working my way through the U.S., meeting a number of different doctors and hospital systems across the country.
There's been a lot of interest in our software, and many of the systems that I've met are really keen on being part of our upcoming SAPPHIRE study, and I'll talk about that in a little bit, but firstly, I just want to say how excited I am to be leading Artrya at this point in time, especially at this key moment as we transition from an R&D company to this commercial company.
I genuinely believe that we have a great opportunity to bring software to doctors and hospital systems that are fighting on the front lines to combat coronary artery disease, and many of these doctors don't have the solutions or tools to properly identify or treat patients at risk of coronary artery disease. And this has really been accentuated through some of the conversations I've had over the last 10 days with a lot of these hospital systems and doctors that have reinforced that opinion of mine.
Everyone I meet sees the real potential for the Salix platform in their system. I also look forward to announcing some of these doctors and well-known centers as part of our SAPPHIRE study in the near future while we finalize the protocol as well as the launch timing of it.
As many of you know, SAPPHIRE is our chance to show that we can better predict cardiovascular risk, not by just only using our Salix cardiac plaque software, but we also have a brand new novel plaque dispersion score, which was recently peer-reviewed and published in a leading publication, and it's designed to flag those patients who don't show the usual risk factors but still end up having heart attacks or, worst case, or unfortunately, pass away.
If we can somehow risk-assess these patients, we can also save their lives. In parallel to the study, we're also aiming to fast-track the adoption of Salix Coronary Anatomy and Salix Coronary Plaque when it's cleared through the use of both these modules during the SAPPHIRE study, and that really helps our commercialization approach in the near future.
All in all, it's been a transformational quarter for us here at Artrya, and we've started to really shift from being a purely R&D-focused company to be a commercially driven and revenue-generating company. It's really exciting, and I'm personally very excited about where we're going, but it's only just getting started. So let me just talk a little bit about what we're doing in the U.S. and our U.S. commercial launch.
Just after the end of the quarter, we hit an exciting milestone with our first U.S. commercial launch of the Salix Coronary Anatomy platform. And this came after completing a fair amount of rigorous technical integration work and also securing the regulatory clearance of our Salix Coronary Anatomy platform. And in early July, we signed a five-year commercial agreement with Tanner Health. This also marks the beginning of our first U.S. commercial revenues.
The agreement is worth a minimum of $600,000 and it's spread over a five-year period. And this further potential upside through per scan revenues with the additional modules that we're busy working on, such as Salix Coronary Plaque, which is with the FDA under review at the moment, as well as Salix Coronary Flow, and when we receive FDA clearance for that. Tanner has been a very close and supportive partner throughout the whole testing integration process, and they continue to be that. And this launch is a real validation of the work our technical and our commercial teams, as well as their teams, have done to bring Salix into a live clinical and IT environment. What is important, though, is that this deal shows that our platform is both scalable and brings clinical value.
It sets a strong foundation for expanding into other U.S. health systems, the ones we already have partnerships with, such as Northeast Georgia Health System and Cone Health, but it also helps us bring more of the Salix modules to market so that we can generate additional revenue through that per scan fee that I mentioned earlier. And both of those additional modules that we're developing are supported by strong reimbursement codes in the U.S.
Secondly, in June, we filed our 510(k) submission with the FDA for our Salix Coronary Plaque module. This is our next-generation AI solution that detects and quantifies high-risk plaque. It's that type of plaque that is actually the key indicator for heart attacks and potential death, and this module allows us to access that existing CPT code, the Category 1 CPT code of $950 per plaque analysis. It's currently in transition from a Category 3 code to Category 1, and it will be fully transitioned by the end of this year.
For us, this means that the FDA clearance of the plaque module remains our nearest-term priority, and as it significantly increases our revenue opportunity and our value proposition, and as such, we're targeting to really push that for clearance and aiming for a Q3 calendar year 2025 clearance by the FDA. In addition to Tanner Health, we're also working very closely to the other hospital systems in the U.S. that I mentioned, Northeast Georgia Health System and Cone Health, and we're preparing to integrate and go live with them both with using Salix in the near term. So more local to home in Australia, we're also working with two key partners, Sonic Healthcare and Lumus Imaging , to onboard their different sites.
And this also expands our footprint in a market where regulatory clearance for Salix Coronary Anatomy and Salix Coronary Plaque is already in place. And it's a testament to our offering that we have two of the largest imaging providers in the Australian marketplace working very, very closely with us. Before I go on, I just want to take a quick step back and also talk about some of the customer success developments that we've been working on, because these are really important for us as a company as we go forward and transition into this commercial company that I mentioned earlier. When you launch a new software into a busy, complex hospital environment, there's a lot that needs to be done and take place so that it works smoothly and can be a success.
We've put a significant amount of time into creating training programs, user protocols, and other things to support the doctors who report on CCTA scans and also care for their patients. We've set up a multilevel support team at our new call center in West Perth, and it means by doing it ourselves, we're able to keep costs down and also gain a better understanding of some of the common questions and issues that come up. This insight really helps us improve on how Salix is integrated, how it's trained on, and how it's enhanced over time.
We're also working closely with a number of people across the world around our reimbursement materials to help smooth the pathway with payers and insurers. Everything we're doing at the moment is focused on making adoption easier, making the user experience beyond just the software great, and keeping our customers happy. I'd like to now hand over to Harvey to discuss the financial results of this quarter. Thanks, Harvey.
Thanks, John. I'll now run you through the financial activities for the quarter, as we've reported in the Appendix 4C, lodged with the ASX on the 28th of July. The numbers I'll be referring to are all in Australian dollars, and in accordance with the ASX listing rules, these are not audited. So for the quarter ended 30 June, cash outflows from operating activities were AUD 5.4 million, which is consistent with our scaling up for the U.S. commercial launch as well as the filing of our plaque 510(k) application with the FDA.
Our key areas of operating cash flow were AUD 1.7 million for project and operational costs, which were mainly the U.S. commercial launch of Salix Coronary Anatomy, our pre-launch activities in Australia, as John mentioned, as well as customer support infrastructure in West Perth that will benefit our future customers. Also, we spent AUD 1.7 million for research and development, which was for our FDA submission of the plaque module and the development of the flow module.
We also had inflows of AUD 400,000 as an additional R&D rebate for the FY 2024 year and AUD 9.4 million as a net amount from the placement in February. So as at 30 June, we had a cash balance of AUD 11.3 million, and I would also like to add that we expect to receive our R&D rebate for FY 2025 by the end of this calendar year, which will be in the range of AUD 4.5 million-AUD 5 million, subject to ATO and audit verification. So looking ahead, average monthly cash outflows are expected to return to pre-June quarter levels, and target investment will continue to support preparations for the FDA submission of the flow module. We remain committed to prudent cash management with spending focused on high-priority commercial and regulatory milestones. I'll now hand back to John to discuss our outlook and priorities. John.
Thanks, Harvey. And before we move into the Q&A, I want to take this time and opportunity to provide the listeners with my near-term priorities for the business. I would add that we are also working through a complete top-to-bottom review of our commercial readiness and U.S. execution strategy to make sure we are well placed and best placed to execute on the opportunities that are in front of us. And I'll update the shareholders more on this at the AGM in the future.
So in summary, we have four key objectives. The first one is we want to expand the expansion of our commercial operations by going live with our U.S. and Australian partners, which will bring us additional subscription and per-scan revenues. The second one is FDA clearance and then the launch of Salix Coronary Plaque module. This will increase our revenue potential significantly as those scans are already reimbursed in the U.S. at $950. We're finalizing the plans to launch our SAPPHIRE study with high-quality clinical sites. And lastly, completing our Salix Coronary Flow module to be ready for submission to the FDA in the fourth quarter of this calendar year.
We really see a clear pathway for sustained growth backed by strong commercial foundations we laid over the last few quarters and ones we'll continue to be laying going forward as well. And I also want to just end this by saying that this is a strong opportunity for us to go forward, and we're all very excited as we try and launch into the U.S. And we thank the shareholders for their backing, and I'd like to now conclude for this formal presentation and also happy to take questions now.
Thank you, John. We have some questions coming through, and just a reminder for listeners, if you'd like to ask a question, please type it into the Q&A window in Zoom. Your first question comes from Matthew Dowling. What is the estimated completion date of the SAPPHIRE study?
Thanks, Matthew. Yes, we're busy working through the protocol development at the moment, and we plan to kick that off early in the new year, and because there are two major phases of that study, the first phase, we expect to have the first results in the first six to eight months of the calendar year next year, and that will be finalized probably closer to the end of next year, and then which will kick off the second phase of the study.
Okay, your next question. Since the FDA clearance and the commercial launch in the U.S., what's been the response from potential new hospitals? And are you seeing any increase in inbound activity or inquiry?
Yeah, it's been a pretty exciting couple of weeks now here in the U.S. We're getting a lot of interest on our software, predominantly because of the point-of-care real-time approach that we have compared to our competitors. So we are seeing a lot of interest in the software because of the value proposition that it brings. We are very focused on making sure that we're targeting the right customers and bringing them into the SAPPHIRE study as our pathway forward to getting them all into commercial agreements.
The next question. Now the company's moved to be more commercial. What other infrastructure are you likely to need in the next year? And does that include more sales and commercial people either here or in the United States? And if so, how do you plan to recruit those people?
Yeah, so what we're trying to do from a sales perspective is leverage SAPPHIRE as our pipeline generation, and that will be ongoing, and then we feel that that is a key way for us to get a large number of quality sites that generate a large number of scans per year for us, and that will lead us into a lot of opportunity going forward. We don't believe we need a large sales force because we've got a very focused sales strategy. What we will need is account management to manage those accounts, as well as customer support and customer success, and that goes back to us bringing that great customer experience and user experience to each of the different sites that we engage with, and we're starting to look into that at the moment as part of our U.S. execution plan.
Thank you. We have a follow-on question. Is key management relocating to the United States given the significant nature of the pathway there?
That's a good question. For the time being, I'm very much focused on building the right team in the U.S. And personally, I'll be commuting back and forth there to help guide and set up that team in the U.S. as we go forward based on the different teams that I mentioned earlier and what we need around account management and customer support.
Thank you. We have a question, a multi-part one from Andrew Wilkinson. I might just pick up part of it. And that is, who's going to take over your previous responsibilities, John, during your transition to CEO, in particular driving commercial agreements, FDA approvals, and SAPPHIRE?
So Harvey's taken on the commercial side of things. So that's partly the combination of the CFO and the commercial piece. So that Harvey's taken on a lot of that. I'm still very much engaged in driving the clinical relationships as well as the commercial opportunity in the U.S. and those partnerships as well. The regulatory side, we've got a strong team in the U.S. with Richard Stewart, Dr. Richard Stewart, who's based in San Francisco, our head of regulatory, as well as Ryan Athearn , who's based in Seattle, who leads our clinical operations.
We've got a number of questions around SAPPHIRE. So one of those is, can you provide any updates on the six to eight groups that you reported were interested in being involved in the SAPPHIRE study?
Yeah. So we're very close to solidifying most of those, and we'll start looking at providing shareholders more certainty on who those are as we go forward in the coming weeks. But yes, we are working very closely with three very, very large systems in the U.S. One of them is very much focused on coronary artery disease in women for us as part of SAPPHIRE. But to put those into perspective, the six to eight, they perform roughly about 400,000 CCTA scans per year. So listeners can easily see that just by focusing on those, we have a substantial pipeline going forward with those different groups.
So John, I think it's fair to say as we bring those partners on, we'll make the necessary ASX announcement.
Correct.
Yeah. Just taking that a step further, Andrew Wilkinson asks, along with the SAPPHIRE study negotiations, will you be progressing commercial discussions with U.S. groups who are not involved in the study?
Yes. Yeah. So as I mentioned earlier, Northeast Georgia and Cone Health are the immediate ones that we're focusing on, and those are the two that we'll be definitely pushing forward as we progress through the rest of this year.
We've got another question, follow-up from Matthew Dowling. How many scans do Tanner Health complete each year that will be eligible for the per-scan rebate? And if you'd like to comment perhaps on Northeast Georgia and Cone Health.
I can't give the number that they each do because it's confidential from their side, but they roughly perform about 14,000-15,000 scans in combination between the three of those groups. As we've mentioned before, all 15,000 patients will move through the Salix Coronary Anatomy platform and be charged roughly about AUD 50 per scan. About 70% of the 15,000 will have plaque in their coronary arteries and will go for a Salix Coronary Plaque analysis. We'll charge roughly about AUD 750 for that to split some of the reimbursement back with the system. About 35% of the patients that go through a system of those 15,000 will incur a Salix Coronary Flow analysis. Similarly, we'll charge about AUD 800 and share in the reimbursement for that.
You picked up a lot of that in the next question, John. It is, what is the projected split of the AUD 950 rebate that you mentioned per scan? And in other words, how much will Artrya keep and how much will the hospital system receive?
Yeah. So roughly about AUD 750 we'll charge, and the hospital system will take about AUD 200 of that.
So John, just further to your comments in relation to that sort of those healthcare or the healthcare group in Tanner Health, Northeast Georgia Health System, and Cone Health, they're relatively small systems in the U.S. and we've deliberately chosen those smaller systems to basically use as a training ground for the integration into their systems, the commercial aspects that really form a blueprint for scaling up in relation to the SAPPHIRE partners.
And I think one thing that John may have admitted to say, he did say that around 400,000 scans in that SAPPHIRE group, during the first phase of that study, we expect to bring them on as commercial partners. So we don't have to sort of run through the completion of the study before we bring them on as commercial partners. So once we've integrated into their system, I mean, that's the plan. And to use the learnings from that small Tanner, Northeast Georgia, Cone group to then scale up into the SAPPHIRE partners with all of our learnings.
That's correct. Yeah.
The next question is from Tanu Petra . Congratulations on all the progress. Could you elaborate on the key aspects of your commercial strategy that position you for success in the U.S.? And is that different to competitors like HeartFlow who are still struggling to gain market share? Thank you.
It'd be worthwhile just mentioning the biggest value proposition we have as a company is our near real-time and point-of-care approach. The reason that many of the competitors struggle is because of the approach they take, which is they send a scan off for processing, and that takes about 24 hours for results to come back. It costs quite a lot of money. In fact, it basically costs more than reimbursement code.
Many of the systems that I've been speaking to, and this is over the years, not just this trip, they don't like the fact that they are not able to control the results of that report. Our strong value proposition is around that point-of-care controllable real-time report that they can edit and is less than the reimbursement code. So our approach into the U.S. has been to focus on the three partners that we have, Northeast Georgia, Cone, and Tanner, as Bernie mentioned, to really show traction and then use SAPPHIRE as a mechanism to keep on expanding and not have this land and expand approach that HeartFlow had early on, as an example, and burn through a lot of capital. And unfortunately, we're unable to gain traction because of their business model. Well, fortunately for us, not unfortunately.
Thank you. The next question relates to the FDA clearance of your plaque module. It's the nearest major milestone. What can you tell us about the process and the likely timing?
So as I mentioned earlier, we're in the review with the FDA. The 60-day clock stop is in August. Roughly mid to third week of August, we expect them to stop the clock and potentially come back with questions. We've done a lot of work pre that stop to make sure that we've covered everything that they may ask and continue to do a lot of the working up of some of those questions and brainstorm what those questions may be.
So assuming they come back with questions, we'll go back to them with answers. That will be submitted back to the FDA as a second report back to them. And then the clock starts again. And 30 days later, we anticipate clearance post us giving the answers back to them, which is, as I mentioned, still anticipating into the third quarter of this year.
We have a follow-up question from Andrew Wilkinson. Does the Tanner Health contract include per-scan fees for SCA? The quarterly specifically mentions the per-scan fees for SCP, but not SCA.
Yeah, we price SCA on a subscription basis. So it bundles the monthly scans that perform into a volume-based pricing. And that is set as a subscription for each of the sites that we sell SCA to a nd SCP, the module, will be charged on a per-scan fee, which is, as I mentioned earlier, charged at AUD 750.
Yeah. John, the SCA is a platform, right?
Right.
That's what attracts a subscription model. And then as the SCP or the plaque scans go through there, Andrew, we charge it, as John said, AUD 750 for us and AUD 200 for the maintenance for the health system retains AUD 200 of that reimbursement.
Correct. Yeah.
The next question, looking forward, how's the development of your flow module tracking? Is it on schedule for this year? And can you give us a little more color on the features that make it more compelling than some of the existing products?
Yeah, this is a really exciting one for us as well. We've had a lot of great feedback over the last two weeks. The major difference between us and HeartFlow, as an example, is that it provides a real-time blood flow assessment. It's in that same eight minutes that we process the CCTA scan report as well as the plaque report. The additional value proposition is that they can resimulate blood flow or FFR in almost near real-time by just editing a wall, and why that's important in a lot of the hospital systems and the excitement we're getting from it is because it allows a lot of the interventional cardiologists to start planning their procedures using our software instead of either A, having to ask for another HeartFlow report or go to another system.
So we're getting a lot of exciting feedback as well as excitement on that product. We're in the final throes of the development of that and planning the study for that at the moment, and our goal is to still submit in the fourth quarter of this calendar year.
Thank you, and just a reminder, if anybody has any final questions, please type it into the Q&A window in the Zoom. We have one final question at the moment, which we've touched on to some extent, and that is, are you on track to launch the SAPPHIRE study? And when do you believe that launch date might be?
Yeah. As mentioned a little earlier, we're finalizing the protocol development and the agreements with all the different sites at the moment and planning to launch that early in the new year.
Thank you. I can see we don't have any further questions. So I'm now going to hand back to you, John, for closing remarks.
Thank you, David. And thank you, everyone, for participating on this call and for all your questions. We're very pleased with the progress we've made to this point. And now, as we move into 2026 financial year, we must really focus on executing commercially and to also build our capabilities in the areas that we need to build. And we look forward to keeping you updated. And also, thank you for all your support and continued support. Thank you, David.
Thank you. That concludes our call for today. This will be placed on the company's website shortly, and we thank you for participating. You may now disconnect.