4DMedical Limited (4DX) Earnings Call Transcript & Summary

Thank you for standing by, and welcome to the 4DMedical Investor Webinar. [Operator Instructions] I would now like to hand the conference over to Dr. Andreas Fouras, Managing Director and Chief Executive Officer of 4DMedical. Please go ahead.

Thank you, and thanks, everyone, for joining today at this exciting moment in 4DMedical's journey. Take all of that as read, and it's been. So today, obviously, we're here to talk about VQ and the impact we feel that's going to have on 4DMedical. But I'll just take a moment to set the scene and remind everybody about where 4D is at, at the moment in our journey. We have an incredible opportunity whereby existing lung diagnostics are failing us, whether that's in the space that we've typically talked about these three spaces of lung health screening, unexplained dyspnea and burn pits. And we've also talked about the journey 4DMedical has gone on to grow our portfolio of products to grow ourselves up to a $6 million to $7 million run rate of revenue to have peak costs well and truly behind us. And as part of the learnings that we've made, we've learned that there's a fair amount of friction for a customer to bring in these solutions. And so we've been able to put together a toolbox rather than individual tools here to solve these problems. And you can see here this incredibly comprehensive portfolio where we focus here on the U.S. typically, but you can see with those clearances across the U.S., Canada, Europe and Australia, really burgeoning portfolio that puts us in the position of having the biggest cardiovascular -- sorry, the biggest cardiopulmonary portfolio of any company, big or small. But as I said, here we are today to talk about CT:VQ. And I'm incredibly excited. This is a once-in-a-generation opportunity for us to make an impact on health care. And so today, we'll be talking about CT:VQ. We'll be talking about the landscape. We'll be talking about our 510(k) submission, what that means, the time lines around that. And we'll be talking about -- we're really excited about the evidence we have to support the growth and the market entry of the technology as well. So we start with CT:VQ is being designed and built to solve the logistical and technical challenges of nuclear VQ imaging. Nuclear VQ is slow, logistically complex, expensive and generates images of low resolution. And this is a multibillion-dollar procedure. So the challenges and large market share equal opportunity for disruption. And so as I said, we'll go through here. Nuclear VQ is a high-cost procedure, poor resolution outputs. It's time consuming. So for example, compared to a CT scan, which is typically a 2-minute imaging procedure on a 10- to 15-minute appointment. A nuclear VQ scan is typically a 45-minute procedure on a 1-hour appointment. There's a lot for the patient to do and to listen and to sit still, for example, for a long period of time. Equipment is expensive and the procedure is complex. And we have really three key goals here to be successful, reducing costs and increased productivity for health care providers, improve the patient experience and increasing equity through greater health care accessibility. And of course, the core pathway for that accessibility is through the fact that we are delivering this technology on routine CT imaging. And so there are around the world, vastly more CT scanners than there are facilities capable of delivering a nuclear VQ, which delivers that increased experience, increased patient and care and also, of course, solving this issue of radioactive materials and contrast injections. And in that space, by solving this problem, we have an immediate opportunity to displace what is currently right now a $1 billion opportunity in the United States and a $2.5 billion to $3 billion opportunity globally. Now I'll just take a minute to briefly talk about -- when I keep talking about nuclear VQ, what is it that I mean? What procedure am I talking about? And how is it delivered? However, we will focus typically on the U.S., which is, of course, we've just made an FDA submission. And the U.S. is our first market and of course, the largest globally as well. So there's three platforms that a nuclear VQ test is typically delivered on. That is planar scintigraphy. So that's where you have a single camera taking images of the patient to create these flat images, somewhat grainy and flat images here that you see. SPECT, which is a 3-dimensional image where -- which uses the same kind of ideas as CT to take images from around the patient and to use them to construct them together into a 3-dimensional image. And then SPECT CT, where that is then embedded in that same SPECT instrument is also a CT scanner that can take the CT image. So you can see the difference here between images in the middle and images on the right, where there's now a CT. The SPECT images are floating in space. On the right-hand side, those images are wrapped up in the CT scan of the patient. Now it's important to understand that the overwhelming majority in the United States, about 2/3 of all nuclear VQ is delivered with planar scintigraphy, the less sophisticated version here on the left. And what is CT:VQ and how is it delivered? CT:VQ is a software layer applied to non-contrast CT scan of the lungs. So we use what's called a HR CT or an inspiratory expiratory paired CT, where effectively, there is CT captured at both the peak of inspiration and the peak of expiration. Our analysis is mathematical in nature. There's no AI or learn component, and that delivers an image measuring both ventilation and perfusion. So delivering functionally the same outputs as the SPECT VQ image, which delivers the V and the Q components. And so -- and on top of that, we have as I said, there's -- as you likely know, there's 1 million VQ scans done a year in the United States. And we -- as we said in our announcement yesterday, and I'll talk you through today, we intend to capture all of those, every one of them. And in addition, beyond displacing existing nuclear VQ, there are additional growth opportunities. And so that is to facilities that do not currently offer nuclear imaging to facilities where they have some form of effective cap or some form of maximum number of nuclear VQs that can be performed and to CT departments where contrast enhancement or CT perfusion is not available. And layered on top of all of those opportunities is our alignment to the CT LVAS CPT code at USD 650, which is really going to be an additional key driver of adoption upon regulatory clearance. So if I'm actually -- just going to back up just a moment. And so the -- I'm going to talk just briefly -- just backing up slightly to talk briefly about I've had a personal experience of having received a nuclear VQ scan, right? And in that process, radiology tends to be quite close to where health care is delivered in the hospital. Nuclear imaging is often for good reasons, separated out from that space. You travel to NucMed. And then there are -- you have two stages of the scan. It's effectively two scans, right? You have a ventilation scan and a perfusion scan, the V and the Q components. And for the V component, this is delivered by inhaling material effectively some kind of powder or dust, which contains the -- depending on which contrast agent is used, contains that agent, which then travels up into your lungs and sticks to the lining of your lungs. You then have that imaging procedure performed. And you then have a second procedure where you're now injected with the radioactive contrast and the perfusion or the blood flow component of the image is conducted. So you have those two tests happening at once. And as I said, that's, on average, a 45-minute test. It's logistically complex. I'm not aware of any other test at the hospital that requires inhaled radioactive contrast. And so there's infrastructure and so on that needs to be wrapped up around that. And when SPECT, in particular, on the right-hand side here, when SPECT VQ is working well, you get some really great images, you get 3-dimensional data, you get the ability to do quantification. But all the way over here on the left, these planar images are pretty grainy. They're flat, not 3-dimensional in nature and don't allow quantification or quantitative data to be extracted. And so we've talked about that -- those practicalities and the reasons -- and this is here for us, the first time that 4DMedical is bringing to market a product where the existing work practices and existing workflows form a tailwind for the uptake of our technology. And we don't have to push through that as a headwind via an education process. And then when you stack on top of that, really attractive reimbursement code gives me -- it's just one of the many, many reasons why I am and the rest of 4DMedical is so excited about this. Now so in order to be FDA cleared, we've gone down the pathway of demonstrating that we have equivalents to nuclear imaging to the nuclear VQ. And we have validated that in a multicenter clinical evaluation. And you can see here just one of the many case studies where you note that you can see really very similar things on both the SPECT and the CT:VQ, both in the perfusion layer and in the ventilation layer. Now that assessment that we've done in terms of -- has three components to it. So we've done what's called a stand-alone device performance, which you can think of as a quantitative or a numerical assessment. We've performed a reader performance, which I think is good to think of as a clinical assessment. So the first part, the quantitative is what are the numbers if you look into the scan and pull the numbers out, do you get similar numbers out of both tests. And then a clinical assessment or the reader performance is when you ask a range of experienced readers to look at both a nuclear image and our images, do they see the same things? Would they make the same decisions. And then also, we have a case-based review, which allows us and the physicians and FDA and in fact, all of you just to see for your own eyes with a qualitative assessment to do that comparison. So if we start with the quantitative assessment, you can see that when using standard methodology for comparing technologies like this, you can see the data clusters very neatly along that line. So in fact, there is really very good agreement between those modalities. we have an R of 0.872 with the perfusion. So effectively saying that it's 87% the same and high statistical significance. So the [ teachers ] test p-value of 0.001 really is saying that there's no doubt that those two technologies are linked. Now we had a very experienced panel of readers spanning both radiologists, nuclear medicine specialists and lung doctors who reviewed and assessed these patients. And here, we can see an example of the type of process that those folks went through where you can see the blue arrows showing where they're identifying defects or where they're identifying values of low perfusion on the bottom left or low ventilation on the bottom right. So those blue arrows are pointing to regions of defect or low lung function. And you can see that those regions match really very well. And for what it's worth, I will also point out that you do on a -- obviously, not on every scan, of course, not. But on a regular basis, you do get typically contrast generated artifacts where so these red arrows are pointing to things that really shouldn't be -- features that really shouldn't be in the images. They're not really, for example, the esophagus lighting up as a region of high lung perfusion is not appropriate or the clumpiness that you see up in the ventilation image that's typically generated by very poor airflow as a result of folks who have, for example, COPD, but also need this test. So really, the sort of the simple version of my view of that is that where there's real things happening in the body that both technologies see them both. But where you have those artifacts, they only appear or occur in the nuclear imaging because CTVQ doesn't require contrast and isn't prone to those problems. Here, you can see another example really where you can -- also very interesting -- these examples are more of the classic wedged defects. So that's where the perfusion is a defect looks like a wedge that -- where the wedge spreads out from the core of the body where it smallest out to being largest at the rips, you can really clearly see those wedge defects in both the SPECT and the CT:VQ. And then here, we take all of that data from the six readers, which between them had over 150 years' experience of reading these types of data. And we met the very highest level of agreement for this, scoring a Kendall's tau of in excess of 0.71, which is a really very, very strong level of agreement between those. And the FDA target for us was 0.4, so a whole level back down at strong to moderate, but we exceeded that and in fact, received a score of greater than very strong. So we were incredibly pleased with the outcome of this, the reader study effectively saying that when doctors look at the two scans, they see pretty much the same thing. So -- once again, I think these are all in the document, which has been lodged with the ASX, and so you can take your time and have a look at these. But the short version here once again is where there is a defect, where there is a dark spot in the SET, we also have a dark spot that comes up in the CT:VQ. And of course, you would expect to see that, as I said, the readers found that to be the same. A really strong wedge defect here, again, in this case. And most likely, this is caused from a PE, strong defect in the perfusion, not present in the ventilation image, but once again, great matching between CT:VQ and nuclear imaging. A more detailed view here looking to identify regions of defect shown on in more detail specifically here on just the perfusion layer only. And in the interest of time, I might just step through these because we have some more data that I'd like to share. So DLCO is an important functional assessment. It stands for diffusing capacity of the lungs for carbon monoxide, utilizes delivery of small -- very small amounts of carbon monoxide during pulmonary function test. And it's used as a surrogate measure of total lung function. The rest of a pulmonary function test tends to measure how your lungs move air. But of course, your lungs need to move air and get that perfused by the blood for complete function. So in fact, DLCO is a pretty close surrogate, at least to my mind, of a VQ test. So we thought we'd dip into this DLCO compared to SPECT. We looked at the heterogeneity or the variability measured by a statistical measure called the coefficient of variation. And you can see that there is a relationship between the CV of SPECT, perfusion and DLCO. You can see there is an agreement there and an R square of 0.38, so indicating a weak statistical relationship. We did the same test again using CT:VQ. And you can see now the data tightens up quite considerably. So we went from 0.38 to 0.605 here. So a substantial increase in the statistical relationship, but you can just see that with your own eyes without needing a statistician. So we have a higher correlation between our data and the actual physiology what's happening in the body than is measured with SPECT. At least as demonstrated here by this data. So we decided to do another analysis and said, okay, well, let's look at the CVs for both and plot them one against the other. And I know this is a little bit a bit technical, but the key thing to see here is if there was equal heterogeneity or equal variability in both the SPECT signal and the CT signal, the data would lie along this dotted line, the gray dotted line. And in fact, the data lies much higher than that around that red dash line. And what that's telling us is in every case, except for one, there was greater variability in the SPECT signal than there is in the CT:VQ signal, which is when all taken together in combination is really strongly suggestive that there is lower noise in the CT:VQ data than there is in the SPECT data. So we've filed with FDA. We're very excited. And we -- as we announced yesterday, we received our day 7 acknowledgment letter back from FDA. So we have the -- we're on the clock, and we're moving towards this day 90 and final decision. But for -- as many of you may know that when FDA writes back to you and asks you for additional information that the clock stops. And so it's 90 days while it's on their clock. And the FDA goal for this year is 112 days of total time. So they call that a shared outcome. So they'll do -- they'll aim to do less than 90, and we'll aim to do less than 22 days with the ball in our court. And so we'd be very excited should this hit that shared outcome. And we have a good degree of confidence that we'll be able to stick our part of the bargain there. So I think the key takeaways from this position that we're in is we have, for the first time, in the history of building up our portfolio, building up our sales of our technologies, working very hard to do that to getting ourselves to the point where we've more than doubled over the last year and are now at a run rate between $6 million and $7 million per year run rate of revenue. And we've done that flying into the headwind of workflow. And in this case, we're very confident this is the first time that we only need to meet equivalents. We only need to be equally as good as SPECT imaging to win that market because we have incredible tailwinds of better economics and substantially improved workflows. And can't underestimate just how important that is to hospitals, to doctors and to CEOs of hospitals about having better economics and having improved workflows drives decisions every single day. And so -- but we have, as you've seen in the data that I presented, at least demonstrated equivalence in quantitative stand-alone comparison, demonstrated equivalence in the clinical reader study. And additionally, we have some areas where we show -- we believe we show superiority through the absence of contrast-related artifacts and also through a demonstrated lower noise. But it's also just while we're talking about that comparison, all of that comparison has been done with SPECT CT with the most sophisticated version of nuclear imaging available in the market in the U.S. And as I said earlier, 2/3 of all SPECT imaging -- SPECT VQ -- sorry, nuclear VQ in the United States is performed down at the planar at the scintigraphy level. And so sitting in our corner is no need for radiopharmaceuticals. Clearer, faster diagnostic capability, access, greater accessibility through existing -- the wide network of existing CT scanners in every emergency room and in every hospital around the U.S. and an improved patient experience. You don't have to go often come back for outpatients, come back at a later time for a different imaging test to a different location, inhale radioactive materials, have them injected into you licensed still for 45 minutes or more. And so incredibly excited about this and then headed with just to ATS, just as this was unfolding, and having the opportunity to talk to doctors about the potential should this be FDA approved, what their level of interest might be. And we had dozens and dozens of conversations with key opinion leaders, leading doctors across the United States. And really, we boiled down those into sort of into three stories, three conversations that we had with them. And so -- and the story number one is I can't get Nuc VQ scans for all my patients because for some reason or another, there's a maximum number of scans or VQ slots that I can get available. I want to have this for more of my patients. I'm already getting CT scans, combining these would really help me deliver health care to my patients. Another story, SPECT VQ is not available in our hospital, and we're still reliant on using planar scintigraphy. So that grainier nonquantitative data to the left, but we have multiple CT scanners I can access, shifting from planar scintigraphy to CT:VQ is a no-brainer. And then the third story is -- and this was really interesting to hear this. My facility has patients waiting for Nuclear VQ outpatient scans for 2 to 3 weeks before I can schedule procedures for me to deliver on those. And often, this requires a whole separate trip for them to come back. I could add CT:VQ to the CT done as part of their regular clinical workup. And so it was really sitting in these -- soaking in those conversations, having those conversations with doctors that really gave us the confidence to come out and to make the bold claim that there are 1 million scans that we can displace, and we are coming for every single one of them, not 15% market share or 27.5% market share. We think we can displace each and every single one of them. And the conversations we've had with doctors to date completely supports that. And then to give you an exact quote, a very specific quote of one of the leading doctors in this space in the United States, Professor Kyle Hogarth, and I'll read it out. So I am excited about being able to image perfusion in my patients without the delays and logistical challenges of nuclear imaging. I'm already ordering a non-contrast CT on these patients. I want to maximize the data from each scan, and this allows me to do that. So it's extraordinary to have a leader such as Professor Hogarth come out and express such strong support for the technology at the stage that we are right now. And you can see incredibly well credentialed leader in this space. So we've built the fundamentals. We have over 360 sites delivering our technology. We have revenue growing quarter-on-quarter, costs of running the business reducing quarter-on-quarter. We have that infrastructure that we have fought hard for and that Matt and the sales team have built through that combat of building and educating and changing clinical practice. And then laid in on top of that is a 25x of 25x increased sales coverage from -- through the Philips partnership. Continue to get -- I could give a whole presentation about Philips and how excited I am about them and where that's going. The current agreement is incredibly exciting. And then stack on top of that, the conversation that we've had today, a greater than USD $1 billion opportunity for us to deliver something that is more convenient for the doctor, it's more convenient for the patient, delivers at least as good when it's at the technology at the top level, but for 2/3 of sites delivers something which is clearly substantially superior as doctors have been saying to us, a no-brainer. So really, we're at an incredibly exciting moment in the history of 4D. We've worked hard to get ourselves to this position. I'm incredibly excited about where this is going to take us. And really, there's no limit to where this can go. So thank you very much for listening to that. And I know we're over time. I apologize. I guess I got pretty excited just talking through it all, but I'll certainly be staying around for questions.

[Operator Instructions] Your first question comes from Nicolas Boston from Numbers Executive, who asks, you've said 4DMedical expects to capture 100% of the 1 million nuclear ventilation perfusion scans performed annually. What's the expectation based on? How quickly do you think that shift could happen? How many CT scanners are already running your software? And how do you plan to overcome the usual pushback from hospitals already set up with nuclear workflows?

Yes. Look, thanks for your question. And what gives me the confidence is conversations I've been having with doctors specifically in the last week, but really that we've been having with them for several years now. Many folks see this as a problematic part of their workflow. And doctors and hospitals don't like to be inconvenienced. Difficult workflows cost them time and money and make it more difficult for them to deliver the care they want for their patients. And we've been doing a great job of building the revenue that we have where it has been a change to their workflow. It has been better care for their patients, but for the cost of a minor inconvenience. And this is the first time that we have something that is better economics and better workflow and great for their patients all at once. So all of the forces align in the same direction. And that's an incredibly rare circumstance in health care. And it's exactly the type of situation that allows for really rapid change.

Your next question comes from [ Dean Egan ], a private investor, who asks, 4Dx's CT:VQ scans seem to have much greater definition than SPECTs. Will someone familiar with SPECT be more easily able to interpret CT:VQ scans?

Yes. I mean -- and great question. And the short answer is yes. And so -- and that's exactly why we designed that reader study and had six incredibly experienced readers look through and say, would they come to the same conclusion? Would they find the same -- would they make the same decisions based on the use of the two technologies? And there was really -- as I said, there was that really very strong agreement. So we -- the short answer is you don't have to trust me to saying that. We've given it to six incredibly experienced doctors and the data has come back and the data is yes. They can read it easily and they get the right answers from it.

Your next question comes from [indiscernible], a private investor who asks -- what is the progress and update with DoD in their trial CT:VQ? And will -- sorry, and CT:VQ, will it need another CPT code?

Thanks. So I'll take the first question first. So actually, again, at ATS, the Department of Defense presented their research on -- or the research they've done to date using VQ, and it was really very positive outcome. So I think the DoD is enjoying using the technology. They're already publishing the results. And I think that's a really very positive sign. And the short answer is, if I switch over to the second part of your question around reimbursement, this technology aligns with the same reimbursement code that we've already won for CT LVAS. So that's USD 650 per test. We'll be able to claim and hospitals will be able to claim, sorry, against that exact same code. And that really is incredibly helpful. To just to quickly talk about economics, every time a nuclear imaging department loses doing a nuclear VQ test, almost certainly going to be replaced with a test that has higher reimbursement than that nuclear than nuclear VQ. So all of the rest of the things in that pipeline to fill in to replace it are higher reimbursement, whereas the reimbursement for a CT scan is about the $150 mark. And so that means the total reimbursement coming in for a CT plus a CT:VQ analysis is $800, which is much larger than the average reimbursement that happens in a radiology department. So you have, at the same time, this unusual thing where something moving from somewhere to somewhere else isn't one place losing and the other place winning. In fact, both locations win, which is really why we hear more and more about sites effectively throttling back or capping limiting the number of VQ tests that they can do. But great questions. Thank you.

Your next question comes from Chris [indiscernible], a private investor, who asks, what is the radiation dose from a typical CT:VQ scan?

Right. Well, so I think that I'll give the kind of cute answer first, which is 4DMedical delivers software. We take a CT scan that someone was already given by a hospital. And so VQ per se is no radiation. But the underlying HR CT is -- and of course, at every site, it's completely different, and you have to rely on published data to make these types of assessments. But high-resolution CT dose is around about 1.2 to 2.5 millisieverts of radiation and a VQ SPECT is in the range of 2 to 9 millisieverts. So I think, broadly speaking, you could say that they're similar. In some cases, you may have one higher than the other. On average, you'd probably have that happen, but you have less radiation for the VQ than for the nuclear imaging.

Your next question comes from [ Craig Hutchinson ], a private investor, who asks, any details on the scanner to test young children and incentives to manufacture in the U.S.

Look, I think the I think you're talking about the XV scanner project. That project continues to progress quite well. We now have two scanners installed and very active in the United States and continue to progress with pediatrics. But I'd love to talk about that quite a bit more. But I think today, I want to really focus us on VQ and the VQ opportunity is just 100 days away, and I think that makes it much more worthy of our time today.

Your next question comes from Chris [indiscernible], a private investor who asks -- apologies your next question comes from Tom Godfrey. I'm so sorry, apologies. Your next question comes from [ Craig Hutchinson ] who asks, will 4DX need another capital raising before reaching profitability?

4D is progressing really well down this pathway. So we have well and truly put peak expenditure behind us. So we expect for several quarters in a row to have a reduction in quarterly OpEx quarter-on-quarter. We have rapidly growing revenues that we've realized over the last few quarters, and we expect that to continue to happen. And additionally, it's worth mentioning just not very far into our future in the next quarter, at least $5 million of R&D tax credits to flow into the bank account as well.

Your next question is from Tom Godfrey from Ord Minnett who asks, does VQ change your strategy with the VA?

Thanks for the question, Tom. Look, VQ is incredibly exciting opportunity with the VA. And once again, it comes down at least in part from the economics. There's really not that many sites in the -- of the 176 VA medical centers and thousands of clinics. On a small proportion of them have the capacity, the equipment and the staffing to deliver nuclear imaging. And when they have the need to send folks out to what's called community care, so they send someone across the street or down the road or in fact, sometimes to the next town to get imaging, they pay USD 3,000 per nuclear VQ through community care network billing. And so it's a really significant opportunity for them to deliver better patient care at about 1/5 of the cost. So we're excited about what that can do for getting our foot further in the door with the VA and side by side with having Philips there working with us talking to the VA every single day, I'm really excited about where we're going to go with the VA over the next year.

Unfortunately, that does conclude our time for questions. I'll now hand back for closing remarks.

Look, I'm really incredibly excited about where we're at. We have all of these factors that we've typically been having to fight against now at our back. We have the first opportunity for our sales team to sell a replacement product. We can do that side-by-side with Philips. We have more customers than we've ever had, costs reducing strongly across the business. We're an incredibly exciting moment, and I really appreciate you being on the call today to hear a bit more about it. Thank you so much.