My name's David Allen from Hawkesbury Partners, and I'll be your host for the call today. The Artrya host for today's call is John Konstantopoulos, CEO and co-founder. He's also joined today by Bernie Ridgeway, Executive Chairman, and Richard Jarvis, Chief Financial Officer. This call's also being recorded, and participants are in a listen-only mode. There'll be a question-and-answer session following the presentation, and if you'd like to ask a question at that time, then please type it into the Zoom Q&A section. A recording of today's call will also be on Artrya's website shortly. I'll now hand over the call to John Konstantopoulos, CEO of Artrya. Please go ahead.
Thanks, David, and good morning, everybody. It's great to be speaking with listeners again after what's been a really very busy quarter for us. The momentum that began with our commercial launch at Tanner Health continued to build with our expanded customer base of Cone Health and Northeast Georgia, as well as our Salix Coronary Plaque module, which is now live alongside our Salix Coronary Anatomy platform. As we highlighted at the AGM last November, the December quarter was a key focus for us to put the right commercial and operational foundations in place so that we can expand and grow in 2026. With that in mind, one of our key objectives was to successfully complete, which we successfully completed last quarter, was to convert all three of our U.S. foundation partners into full commercial customers.
As we've previously discussed, all these three customers have now been contracted for subscription-based access to the Salix Coronary Anatomy platform and will pay us a fee per scan for the Salix Coronary Plaque module. Just to recap quickly on these new customers, Northeast Georgia entered into a three-year contract with a minimum $300,000 agreement. Cone Health has signed a five-year agreement with a $450,000 minimum, and Tanner Health a five-year contract with a minimum of $600,000. I'm pleased to report that following the signing of these latest contracts, the rollout of Salix has now progressed and is progressing well across Northeast Georgia's five hospitals, as well as the Georgia Heart Institute, alongside now with Cone Health's hospitals and across all their physician practices in North Carolina.
From an opportunity perspective, these minimum contracted amounts pay for each of their access to the Coronary Anatomy platform and allow them to report now off a single solution that helps them be more efficient in their reading of CCTA scans. But we really see the real commercial opportunity coming through the Plaque module, which has a much larger fee per scan opportunity and allows them to perform Plaque assessments and risk stratify patients. This is also now supported by the fully transitioned Category 1 reimbursement code. As shareholders are aware, these revenues will expand when we further add the Flow module to the offering after its regulatory clearance. To support our Plaque revenue, we successfully integrated the Salix Coronary Plaque module and went live with Tanner at their first facility in the last quarter of last year. This marked the generation of our first Plaque fee per scan revenue.
The integration at Tanner was seamless, and early feedback that we've had from the clinicians and the broader user group has been extremely positive. Users have highlighted the ease of reviewing scans on a single screen, the efficiency in how quickly they can read the CCTAs now compared to how it was in the past, and now the opportunity that they have to assess patient risk beyond just the narrowing, which is really why we built Salix and Salix Coronary Plaque in the first place. As we've started to commercialize with our first customers in the U.S., we've also focused on building an on-the-ground customer success team. I am pleased to report that we now have recruited and trained several highly skilled and experienced Artrya field personnel.
The team is now fully operational, and as an Australian-based provider, it's really important for us that we have an on-the-ground team in the U.S. so that we can support our customers over there. Some examples of the help and support that they provide include working with the hospital IT team to make sure that data's flowing seamlessly between the picture archiving and communication system, the PACS , as well as the electronic medical record system, the EMR, as well as making sure that workflow is optimized so that we're continuously providing benefits to the doctors. The team also works very closely with the imaging lab technicians or radiographers who support the clinicians and provide them with training and customer support.
In the background, we've also helped the administrative team as well as the reimbursement team optimize their patient reporting as well as make sure that the reimbursement processes are set up well within their systems so they can access the Plaque reimbursement code now. We feel this team is now well established, and we will further expand this team in line with our needs as well as how our customer, our commercial customers, the needs that they require, and when we bring further SAPPHIRE partners on board. As shareholders are aware, a focus for us in 2026 is to FDA clear the Salix Coronary Flow module, which is the next expansion of our Coronary Anatomy platform.
While our current technology gives clinicians a detailed view of the Salix Coronary Anatomy and Plaque, the Flow module really gives an additional physiological or functional assessment of a patient to better understand how blood is moving through the coronary arteries and the impact of a narrowing, and if that impact is severe enough for a patient to go for an invasive procedure. During the December quarter, we had a formal Q-S ubmission meeting with the FDA to clarify their expectations before entering the application process. It was a very good meeting and productive meeting with the FDA, and the key takeaways are that the FDA confirmed our 510(k) approach, and they gave us clear guidance on the data we need to compare ourselves to as well as the performance thresholds that we need to meet.
While we targeted to lodge our FDA submission in late 2025, we've expanded our calibration and study work to make sure that we're providing a very robust submission to the FDA so that we meet all their expectations and go above and beyond that to make sure that it clears a lot faster after submission. To do this, there are a number of activities underway, and one of the two main ones are, as I mentioned, making sure that the calibration against invasive procedures is done well as well as expanding our study, which I'll talk about a little later, to make sure that we're giving a very robust submission back into the FDA. We are guiding the market around an end of June 2026 FDA clearance and remain comfortable with that outcome.
We've also learned from the past that a detailed and compliant FDA submission is much more likely to be cleared faster and have a successful outcome if we do that well upfront. Turning now to some of our other key initiatives and developments, and SAPPHIRE's study being one of them, we've made strong progress this quarter, and we've secured all the participating sites ahead of the launch now in 2026. We're very pleased to announce that the Huntsville Hospital Heart Center, Mass General Brigham, and Ascension St. Vincent's agreed to be participants joining Piedmont Healthcare. As listeners would have seen late last week, we announced HCA Healthcare and this morning Dignity Health, who is a part of the CommonSpirit group who have joined the SAPPHIRE study.
Some of these names may not be very familiar to everybody, but they are very widely known within the U.S. healthcare sector and really bring significant scale, quality, and expertise to the study, especially some of the research capability that some of these centers have within the cardiology space. Just some facts and figures to share on some of these systems: the Huntsville Heart Center performs 420,000 emergency visits per year. They have 1,200,000 outpatient procedures each year. Mass General Brigham is one of the largest hospital-based research centers in the U.S. and has over 3,700 clinical trials. Ascension is the sixth largest nonprofit system in the U.S. HCA is the largest for-profit system, and Dignity Health, together with CommonSpirit, form the fifth largest hospital system in the U.S.
All of these are substantial systems that form part of the SAPPHIRE study and comprise these six high-volume centers now and allow us to set a firm foundation for 2026. The study is designed as a retrospective multi-center real-world trial that will look at the clinical utility of using Salix Coronary Plaque as well as our Plaque dispersion score to see whether we could better risk stratify or predict whether a patient would have risk earlier than what they currently have. We've also announced Dr. Ron Blankstein out of Mass General Brigham, who's agreed to be the principal investigator for the study, and he brings a huge amount of experience and expertise to us as well as reputation in leading a study like this for Artrya.
In terms of the next steps with SAPPHIRE, our clinical team is now progressing the contracting and ethics submissions across all centers, and this will enable us to start accessing those retrospective scans around the middle of this year as we've originally planned. Before I hand over to Richard, I would also like to quickly mention a few other activities for the quarter and also our ongoing steps to expand our leadership team. As we announced last week, we have a search underway for an experienced Chief Financial Officer that has global commercial expertise as well as ASX public company expertise and experience. As we transition that role, Richard Jarvis to my left has taken on the interim CFO role, and he brings an extensive background of ASX experience, and it's great to have him on board here and with us today.
It's also worth mentioning that in late December, Artrya was included in the S&P/ASX All Technology Index. This comprises 48 of Australia's leading and emerging technology companies and is widely used as a benchmark for the sector performance. Artrya is also only one of four healthcare companies in this index, and the total market capitalization for the entire index is roughly AUD 4 billion. It's really, really good for us to be included with so many other notable technology companies. Our investor engagement was very active last quarter, in addition to many of the roadshows that we were on to meet some of the institutional and retail investors across Australia and the U.S..
I was fortunate enough to be able to present at a number of investor conferences, including the Canaccord Genuity Conference in New York, the Bell Potter Healthcare Conference in Sydney, and looking ahead, we'll be presenting at the Euroz Hartleys Healthcare Forum early in February, as well as the ASX Small and Mid-Cap Conference with Bell Potter and Barrenjoey Conferences coming up in March. With that, I'll now hand over to Richard to take you through some of the financial results. Thank you, Richard.
Great. Thank you, John, and it's a pleasure to be here with everyone today. I'll now take you through the key financial activities for the quarter as reported in our Appendix 4C that was lodged with the ASX on Friday. Please note that all figures are in Australian dollars and they're also unaudited.
Firstly, I wanted to highlight that the quarter was marked by two key events: the completion of the capital raise that was completed at the beginning of the quarter, and as John also noted, the commencement of scalable revenue. As announced on the 31st of October, the company successfully completed an AUD 18 million capital raise, which comprised two components. Firstly, AUD 5 million in respect to the share purchase plan, and secondly, AUD 14.7 million was received in respect to the second tranche of the placement net of share issue costs. Therefore, with AUD 76.5 million in cash and liquid assets and zero debt at 31 December, the company now holds an exceptionally strong balance sheet. This strong position provides a robust financial runway to execute on our commercial strategy and to accelerate our go-to-market priorities.
Importantly, this capital position allows us to invest with discipline while also scaling revenue, marking a decisive shift from pure R&D to commercial execution. Turning to operations, this quarter represented a critical inflection point for the company with the commencement of scalable revenue. As per the 4C, we recorded customer receipts of $60,000, and while modest, this does validate the technology and its commercial readiness and also demonstrates market adoption in its early stages. Again, as John noted, we've now got three engaged customers positioning the company to scale revenue in the coming quarters. Other operating cash inflows included $400,000 of interest income, and this from funds held on term deposit. On the cost side, total operating outflows were $5.4 million. This is down from $6.1 million in the prior quarter, which included significant one-off costs.
Headcount has increased to 49 personnel at 31 December, and this is up from 41 at the prior quarter end. This includes five U.S.-based hires to support the company's commercial expansion. R&D expenditure for the quarter focused on refining the Coronary Flow module while operational investment centered on onboarding U.S. customers and supporting market entry. In respect to financing activities, AUD 18.8 million was received from the completion of the placement, as mentioned in the introduction. I should also note that we have lodged our FY 2025 tax return and expect to receive an R&D rebate of AUD 5.6 million in the March quarter. Therefore, in total, as at 31 December, we held AUD 46.5 million in cash and a further AUD 30 million was held in term deposits, providing a total pro forma cash position of AUD 76.5 million.
In summary, with our capital base now secured and revenue generation underway, we're ideally positioned to deliver our strategic goals and drive commercial outcomes in 2026 and beyond. I'll now hand back to John to discuss our outlook and the next phase of growth. Thank you.
Thanks, Richard. I appreciate that. Before we move into the question and answers, I'd like to touch a little bit on the outlook and near-term priorities for us as a company. These priorities really are the FDA clearance of the Salix Coronary Flow module.
We're busy finalizing the calibration work as well as the study work for the FDA submission, and we expect to have that module cleared by the FDA in the new financial year, starting the new financial year, so that we can really start ramping up with the foundation customers with the use of both Salix Coronary Anatomy, Plaque, and the Flow module. We're also looking to launch the SAPPHIRE study, and now that we have the six high-volume centers we've agreed to participate, we're now moving through all the respective ethics approvals and contracting processes so that we can start getting those scans coming in and start performing some of the study work.
We're also looking to fully integrate all three of our U.S. customers with both Salix, with both the Salix Coronary Anatomy platform as well as the Plaque module, and this will then look to expand that as we launch into FY 2027 to use all of these at full volume with all three of these different centers. Additionally, as we put our focus on the U.S., we're also building a large network of key opinion leaders like Dr. Blankstein, and we'll build on that as we plan to expand to other customers in the foreseeable future, as well as help prepare some of the planned publications and presentations we have at the upcoming industry meetings. This two-pronged approach really helps us build awareness for Artrya as well as Salix more broadly.
I would also add that this year is very much on building what we started in 2025, and we will continue to establish ourselves and operationally build ourselves into the U.S. this calendar year and start launching our revenue growth as we go into FY 2027. That now ends our formal presentation, and we are happy to take questions. Thank you, David.
Yeah, thank you, John. We have a few questions coming through, and just a reminder, if you'd like to ask a question, just please type it into the Q&A window in your Zoom. Okay, your first question relates to the SAPPHIRE partner. If we look at the partners signed under the study, what are the total scans and what does the revenue opportunity equate to over time for Plaque and for Flow?
Thank you. That's a great question.
As we've mentioned in the past, the combination of the SAPPHIRE partners that we now have signed up all lead into up to about 400,000 CCTA scans per year, and at a blended rate across all three modules of about $850, it equates to roughly about $350 million in revenue opportunity from these SAPPHIRE partners, which is really why we focused on bringing these core groups with the expertise and the credibility that they have into the study.
A follow-on question, John. What's the likely date of the SAPPHIRE study commencing?
Yeah, effectively, we've already started that. As I mentioned, we're now engaging with questionnaires at the different hospital centers that we've really brought on so that questionnaire really gets them to go find the scans, bring those scans into our registry.
In parallel, we started the ethics process, which gets us the approval to get, as a company, to get access to those scans so we can start processing them. But the true statistical work really starts in the second half of this year, and we expect to have some preliminary results by the end of this year.
Another question relating to SAPPHIRE, John. Given it's a key part of your plans to build the data and the customers, what can you tell us in relation to a ballpark of the costs once you start running the study?
Yeah, we've budgeted a little bit of money for each of the centers to come on board, and that varies between $100,000-$200,000 for each center.
If you think of that as our commercial approach as well, it's a really cheap way of building significant credibility with the study, but also having it as a separate business development person that we can expand a pipeline of up to the 400,000 scans I mentioned per year.
Following on from that, John, when do you think, or how long do you think it might take to convert a SAPPHIRE partner into a commercial agreement?
Look, because we've already engaged with them, our pipeline is built. We've very much focused on the study and getting the foundation customers up and running. We've guided the market that in FY 2027, we'll get all foundation customers running up to full ramp, which is roughly about the 15,000 scans per year, and then get the SAPPHIRE partners running into FY 2028.
It takes about the same time that is taken with the other partners like Tanner Health and Cone Northeast Georgia, where you pilot early on for about 30-60 days, and then from that, the contractual process starts and an integration process starts. It's roughly about four to five months post them agreeing post the pilot to really move into commercial agreement with us.
We've got a few questions in relation to the SCF or Flow module and the submission. The question is, last year you told us that the submission we made before the end of the year and approval around the May to March timetable, now you're suggesting that FDA approval by the 30th of June. Are you concerned about a delay, and does this delay your plan rollout and your future revenue opportunities?
I'll answer that in two ways. We're not concerned about the delay.
As we've always said, getting the Flow module cleared by the end of this financial year is really the goal so that we can lead into FY 2027 with all three platform modules and the two modules, Plaque and Flow, ramping at our foundation customers. When we had the Q-S ubmission meeting with the FDA last year, they really focused on, and we talked to them on two major things. One, the data we need to compare ourselves to, as well as the accuracy that we need to hit. From an accuracy perspective, when we get good images and good quality data, we're beyond the accuracy that the FDA has given us. What's really taken time for us to work this through is one of two things. One, as I mentioned earlier, we're really putting a lot of effort up front around the study to get a robust submission in.
We've added an additional study beyond the two that we've discussed with the FDA, and that third study is getting clinicians and technologists in a clinical setting to use our SCF module and run the study so that we can present that data to the FDA as well. The second piece is we need good image quality data. When we've approached a number of centers in the U.S. over the last six to eight months to get the data, they all present that they have good quality data, but when we get the data, not all of it is the quality we need. We've had to push out some of it and then go to other centers and bring in more images to bulk up the good quality data. That's really where the two major points of focus for us have been.
I will reiterate, though, when we run it on the data that we need and based on what the FDA said, the accuracy that we have is beyond the limit that the FDA has set us.
We've got a couple of questions around the timing of the SCF submission. One of them is just in relation to the actual timing that you're expecting. Related to that, are you seeing any impact or distractions given that the FDA does seem to have a number of changes going on, and can you assure us that there won't be any further delays? Two questions, one around the timeline, and can you make some assurances around no further delays?
Look, on the FDA itself, we can't control the FDA. We need to focus on what we do and what we do well and can control. It's similar to what we did with SCP.
Back then, the whole COVID event and circumstances were happening. We didn't focus on that. We focused on adding extra studies, making sure we had a robust submission, and we got cleared a lot faster than the 90 days. That's exactly what we're doing now. We're focusing up front on a quality study and submission so that we expect to get cleared a lot faster at the back end once we've submitted. We can't control the FDA, but we're doing everything we can from our side to control that and do what the FDA has told us to do.
The next question comes from Andrew Wilkinson of Venn Brown. Some of these points you've already touched on. One of them is, has the product development of the Flow module been completed?
Also, can you give a little bit more reasoning around the delay and any further delays, which you've just touched on?
Yeah. Around the delays I've spoken, it's more around us making sure we've got a quality submission with the right data and we're getting the right submission in. With regards to the product, the product's already completed. It's now in the testing phase with the scans that we're getting for the study so that we can start getting that study really ramping and accelerating and closing quickly.
A follow-on from Andrew Wilkinson, are you talking to other potential partners in relation to the SAPPHIRE study, or are you planning to just cap it at the six that you've already announced?
Look, we are capping it at the six we've already announced. Dr. Blankstein, as I mentioned, being the primary investigator, is also heavily engaged in making sure that we have at least 10,000-12,000 scans for the SAPPHIRE study, which will be the largest study of its sort globally. To be able to get to that cohort of scans, we may need to access others in the future, but as it stands currently, the 6 that we have have more than enough scans for us to start building a registry, but we don't discount Dr. Blankstein talking to others to just bulk up those scans in the future.
A question that was emailed in, as part of the study, are you pursuing that Salix is going to be included in ACC or AHA clinical guidelines as a way of first-step triage of chest pain? If not now, when might you be thinking about doing that?
Yeah, we're not doing that now because CCTA and Plaque and FFR are already in the guidelines within ACC as well as AHA. The SAPPHIRE study, as many of the listeners know, also has a component called the Plaque dispersion score, which is a very novel approach of trying to predict future risk of patients. As we go through the study and as we get the results, that may then help us guide whether we start approaching the AHA and ACC to try to shift the guidelines to include something like the Plaque dispersion score as well.
Your next question comes from Tanu Jain, analyst at Petra. Thanks for taking my question. Could you please provide some more detailed feedback from Tanner on their first use of the SCA and SCP and the differences that they are seeing versus some of the existing tools?
Yeah, it's a really good question, and it's one of those questions where I was on a call with Dr. Khawaja from Tanner, who leads all of cardiology for the Tanner Health group. What we're trying to do is run a small economic study with them to show that they're a lot more efficient using Salix and also can generate a lot more money just using the coronary anatomy platform for now. What he said to me when I spoke to him late last week was that in the past, using his existing tools, it would take him about 25 minutes per scan to read a CCTA scan. He would come home after his rounds at, let's say, 10:00 P.M. at night, and he would read trying to read those scans because he'd probably do about five to six scans a night.
He says, using Salix, at worst, it takes him about five minutes to read a scan now, which makes it a lot easier for him because he can now read the scans while he's on his rounds, and he's able to get through the scans a lot faster and focus on his patients more. That's live feedback that we got as late as of late last week.
There's a related question, John, and that is, when do you expect to see some of the other centers as part of Tanner Health using the module? Would that then relate to some meaningful uptick in usage and some Plaque revenues?
Yeah, we're busy finalizing the onboarding of the remaining centers on Tanner now, and we expect that to start moving forward into their full volume in the next quarter and leading into FY 2027.
Yes, we've already started seeing more clicks on Plaque as well, and we're working closely with them to make sure that they're also using the Plaque tool as it's needed for them to better assess their patients.
There's a couple of questions in around the number of scans. The first is, based on the scans that you've already done in the December quarter, will the business have KPIs for completed scans moving forward, say under 10 minutes, for example?
We will have KPIs, and we're busy working on what that looks like for FY 2027, and that would predominantly be on revenue per customer as well as scans performed per customer, both on the volume for Salix Coronary Anatomy as well as Plaque clicks and in the future Flow as well.
Looking forward, there's a question around, are you able to give any color around the number of scans you've done in January from the three foundational customers and any other feedback you might give versus their use of other products such as the HeartFlow or Cleerly products?
Yeah, we're working closely with Tanner now in their volumes, getting that up. Northeast Georgia and Cone, we're busy onboarding them, and we expect that to lead into this next quarter and then start getting them ramping up going into the end of this quarter, the next quarter as well as FY 2027 at full volume. The usage of other tools, look, many of the listeners would have been on a call with Dr. Wesley O'Neal from Cone Health, who's used both Cleerly and HeartFlow in the past.
The general feedback for us is that they are really excited about using Salix because they are currently at full capacity. They are performing over 6,000- 7,000, 8,000 scans per year, CCTA, growing at about 20%-25% year-on-year. Their doctors are not growing with that expansion, which means they are at full capacity. Using our competitors, they are having to shift their workflow and delay their workflow because of the turnaround times. What really excites them about our software is that they can perform that in almost real time now, both using the platform as well as the Plaque module and then Flow in the future.
We have a corporate question here. The comment is, the stock is down about 17% over the past three days.
Given the company's quarterly fundamentals actually look quite strong, has there been some feedback from interactions with investors that you think might be driving this?
I'll give a view, Bernie, you can give yours as well. I think the sector as a whole, tech and healthcare, has been heavily impacted probably over the last week or so, and we're being included with many others in the space. We continue to do what we do, and nothing has changed from our side. We're accelerating where we need to accelerate, and we're running where we need to run. Why it's down 17% is more than likely because the sector's down.
We have a question moving forward around insurance. Have you been talking to any of the insurance companies to potentially gain coverage in their plans for your product?
We have not.
However, many of the listeners would have probably heard that last year when for Plaque at least, Humana, Cigna, EviCore, and Blue Cross Blue Shield were all activated for Plaque clearance. As a start of this year, Aetna has come on board, and it looks like Anthem is about to come on board, and that really pulls the lives covered to over 85% as we go forward. We're starting to see some of the other smaller singular insurers like Florida Blue that covers the whole of the state of Florida also coming on board now. The momentum is really starting to drive, and what we're trying to do with our reimbursement team is just making sure that we've got coverage with those insurers.
When I say coverage, I don't mean Plaque coverage, but that we're interacting with those insurers to be aware when they are covering Plaque for those that have not yet covered.
Okay. Just a reminder, listeners, if anyone does have a question, just please type it into the Q&A function, and we'll get to that. Your next question, John, comes from Andrew Wilkinson of Venn Brown. Given the size of these SAPPHIRE partners, if they all become commercial customers, how long do you think it might take to roll it out across all of their centers and the estimated 400,000 scans that they perform each year?
Let me say it, that's a really happy problem to have.
I will say that if we start focusing on the smaller ones first, like Huntsville that perform roughly about 10,000 scans a year, they are similar size to Conan, so that will take that, let's say, four to five, six months of getting them signed up, integrated, and started onboard and onboarded. That's roughly where we started first with the smaller ones, the Huntsville, and then the Piedmont's, and then shifting to the Mass Generals and some of the other larger ones that we have. We expect the groups like Ascension, HCA, Dignity/Common Spirit, the large ones, will really start onboarding either on a state-by-state basis or an integration point, integration point basis, and we probably expect that ramp-up to be a little longer compared to some of the singular centers.
We have another question here in relation to the Australian customers.
What feedback could you give us? A bit of an update on our Australian customers?
Yeah. As we've mentioned in the past, The Cardiac Centre in Wollongong is fully using the software. They're very keen to be our voice of Plaque here in Australia. Sonic Healthcare, we're finalizing that work now. We slowed that down just a little bit so that we could make sure that the FDA and some of our U.S. customers have been onboarded. Sonic has also asked for an additional small feature, which we've now brought in, but we expect that to start growing as we lead into this next quarter.
Okay. John, that's all of the questions we have today. I might just pass it back if you've got any closing remarks.
No, look, it's been a great quarter, this December quarter.
We are very much aware of the process that we need to go forward into 2026. We're excited about it. There's real growth opportunity for us, and it's now really making sure we put the fundamentals in place for us to execute on everything I've just said over the last half an hour.
Thank you, everyone, for joining the call today. We very much appreciate from the company's perspective the engagement and the numbers of listeners that are here and the progress as we move into 2026. That concludes the call. You may now disconnect.
Thank you.