Good morning, and thank you for joining Volpara Health's webinar, which will be hosted this morning by Ralph Highnam, CEO of Volpara Health, and Chris Wood, CEO of RevealDx. This morning's webinar will provide an overview of Volpara's recent partnerships and expansion into the lung cancer screening using AI market in the U.S. and other regions of strategic importance. If you wish to ask a question, please do so using the Q&A facility at the bottom of your screen, and all questions will be addressed at the conclusion of the presentation. I will now hand over to Ralph Highnam to begin this webinar. Thank you very much. Cool. Thank you, Hannah, welcome everyone. Thank you for your time today to hear about how we're positioning for growth in lung cancer screening. Very warm welcome as well to Chris Wood, CEO of RevealDx, who's joined us on the call and who will be talking for a few minutes later, just telling us about their product, and so on. Look, we obviously are very focused on breast cancer. We'll touch on that in a minute, but we are increasingly getting involved in lung cancer screening, as we'll come to during this talk. With the announcements we've made over the last few weeks, we have had lots of questions from investors and other people across Australia and New Zealand asking us about lung cancer, what is lung cancer screening, and so on. Really, we wanted to capture today some of the essence of what the danger lung cancer problem actually gives to the world, how it's being dealt with screening, and so on, to answer some of those background questions while setting it up, really, and showing how Volpara is going to play a major part in this going forward. With that background, let me move on a bit and just try and move that off the screen. Okay. As we said, Volpara is on a mission to save families from cancer. We're going to achieve that mission by being a leader in cancer prevention software. We're well on the way of doing that in breast cancer, covering now 33% of all U.S. women screened for breast cancer. I do want to add here, breast cancer very much remains our main commercial focus, whilst we're really developing and waiting for the opportunity to really to progress in lung. The lung cancer opportunity in the U.S. is at least equal to breast. The number of cases is pretty similar, but the number of women actually dying from lung cancer is actually more than it is in breast cancer. That's 60,000 versus 42,000, obviously one of the key reasons for that is breast cancer screening is very successful at reducing mortality. Lung cancer screening programs are coming through now, the papers are coming out really proving the benefits, that's leading to expansion globally, again, we'll touch on that as we go through. Volpara is well-positioned then to enter that market, given that in 2019, we acquired MRS Systems Inc. MRS had a patient hub product, which is about patient tracking and patient reporting, specifically for breast, but also for lung. When we acquired that product in 2019, we actually got 8% of the U.S. lung cancer screening market. Now, as that screening uptake grows, and we'll touch on how that's going to develop, we really believe that the market for lung AI will approach the same as for breast, if not exceed it, at NZD 400 million of ARR. Our approach in lung, as in breast, is going to be to innovate or partner to really bring in that deep AI expertise to build out a comprehensive, secure software platform built around our patient hub product. Let's talk a little bit about some of that background information then. Lung cancer today then is very sadly often caught far too late. Something like 42% then of lung cancers are caught in stage IV, which means they're well spread throughout the body, which means that the prognosis is not good. Compare that to breast, where 43%, thanks to screening, are actually caught in stage I. These are the two main types of lung cancer, you'll see the survival rates are pretty poor, especially for when they're distantly spread like the stage IV cancers often are. Compare that to stage I breast cancer or even stage II breast cancer, where survival is over five years, is 95%-99% now. Not only does this take a big personal cost on people throughout the U.S. and throughout the world, but also it's very expensive, and that's just one set. $21 billion a year is lost in productivity in the U.S. by wages alone, there's similar numbers for Europe. Those costs there do not include things like treatment costs and so on. That's purely wages. Most of us know then that smoking is the main risk factor for lung cancer. One of the things that I've been learning a lot about recently is, as well, that even though many people grew up smoking because it used to be fashionable years ago, and then they stop, fact is, nearly 40% of lung cancers in former smokers occur more than 15 years after smoking. Also then 10%-20% of lung cancers are in people that never, ever smoked. That's secondary smoke pollution, radon, and other causes coming through there. Although smoking is the main risk factor, there's lots of people developing lung cancer who basically gave up smoking many years ago. There's been two excellent papers from the U.S., which is the NLST one, and then from Europe, which is the NELSON study, showing that if you do a low-dose CT of the chest, you can reduce mortality of lung cancer by 20% or so. Obviously, as we know in breast cancer screening, all screening generates false positives. All screening requires looking at lots and lots of images. And to work out who to get back for assessment, which ones you can safely recall a year or two further down the road. There's a lot of time and expense taking place in there, which is exactly where AI really comes in. Lung cancer screening in the U.S., it used to be 8 million people eligible. The U.S. has just doubled that now to 15 million people are eligible each year for lung cancer screening. That's as it says there, all people between the ages of 50 and 80 with 20 pack years of smoking get invited in. Uptake remains low, but has grown as the benefits become better known. For us as a company, it's very exciting now to be kind of looking more and more into this market because it's a very strong growing market. If you look back at how breast cancer screening grew, it started off at about the same levels as lung cancer, 10%- 15%. As the benefits of breast screening really took hold, it went all the way up to 70% compliance. We expect that to happen in lung as well. It's going to take time, but that's kind of the overall effect that we expect to see. Sadly, then coming back to the causes of lung cancer, with 34 million adult smokers in the U.S. and actually in Australia as well, where it's about that kind of 10%-14% of the population smoking, and those cancers appearing many years afterwards, and smoking, plus the worsening air pollution and so on around the world, lung cancer very much is not going away. Let's talk about lung cancer screening. We just talked about those two studies. There was a big U.K. one that came out about four weeks ago as well, again, really stressing the benefits and not just in terms of-- the interesting thing that's on the lung cancer trials is they're coming out not just talking about catching cancers early, they've actually gone right the way through to actually prove that the mortality rate comes down. That's pretty exciting, and this is an article from The Guardian recently covering one of the big U.K. trials. This is leading then to the U.S. doubling the number of people eligible for lung cancer screening, but also the U.K. actively trialing lung cancer screening now. That report up there on the top right, this is the Australian Lung Cancer Screening Inquiry, which was published in May 2021. The Australian government is putting AUD 7 million into scoping out what a lung cancer screening program would be like. Down here as well, obviously, we're based in New Zealand, there's a big Māori-led trial of lung cancer screening as well, which was announced in May. The exciting thing for us here obviously is using our technology, using our skills, using the deep AI skills from groups like RevealDx to really come in at the start of these trials to really influence how they're set up and how they kind of run from day one to help ensure low false positives, lots of cancers being caught and lots of lives being saved. Let's talk a bit about lung cancer screening, and we'll compare breast and lung in a minute. High-risk patients are invited into screening, that's obviously done using patient management tools and risk assessment tools. Well, when Volpara brought CRA Risk in February of this year, we are one of the world's leading companies in terms of providing risk scoring to patients at referring doctors or GPs to actually help people enter screening. Low-dose CT is done, this is quite a modern CT unit, computed tomography unit, which is effectively a 3D X-ray. The X-rays then or the CTs then come up, a radiologist then looks for signs of cancer. The radiologist will, while they're doing this, then find lots of nodules, which we'll show you an example of that in a second or two. It's their job then at that point to work out are those nodules benign, malignant? Should we have a follow-up in a year's time or two years' time? Actually, do we need to head straight for biopsy? Indeed, is it just benign and we can just ignore it for a while? That task, that nodule diagnosis is one of the big differences between breast and lung and one of the big opportunities that we see for our partnership with RevealDx. Sitting beneath here then, you see the patient management tool then, and we talked about CRA Risk. computer-aided detection to help detection of nodules to reduce the false negatives. Well, that's where our partnership with Riverain and MeVis comes in. 25% of all these people will have nodules found. 95% of those are likely to be benign. This is where RevealDx's technology really comes into play, and Chris will talk about that in a minute. Sitting beneath all this workflow process is what we've come to term quality management system. That's kind of where our Volpara Patient Hub product comes in, and that's where things like Volpara Analytics really come into play as well. We don't do it for lung today, but there's no reason why we shouldn't do. Is the lung CT positioned well enough? Is that good enough for the radiologist to read? Can we flag up while the person is here that it needs to be retaken? Right the way through to measuring and monitoring radiation dose to make sure we're not inducing any cancers while screening for cancer. It is a big market. We talked just now about how much lung cancer screening is costing the U.S. economy in lost earnings each year. If you look at the number of people eligible to screen and you assume that all those people go on for screening, with insurers paying $250 per screen, you're approaching a $4 billion business just for the screening component of lung CT. You've got these people going off for diagnosis again, if you assume that 20%-30%, so that's somewhere between 3 million and 4 million people go on to have diagnoses done or workup done. If you assume an average cost of $3,000 per person, that's up to $10 billion in diagnostic workup costs. That cost there obviously varies massively from those who can just come back in three to six months' time and get another CT done, right the way through to someone who needs maybe a PET-CT, maybe lung biopsy, and so on. One of the big things that we've really been learning about lung cancer screening compared to breast cancer screening is that the breast is relatively easy to biopsy, the lung is not. You really want to try to avoid those lung biopsies, if at all you can. Just as per the previous slide, you can see how lung cancer screening software using AI can help with quality control and automation of processes, can help faster, more accurate results with significantly fewer missed nodules. Right the way through to making sure those nodules that are found are diagnosed properly and worked up properly. The way we look at the total potential of the market is if we can save 20% of those costs, that NZD 10 billion cost, that would be saving payers over NZD 2 billion per year. If you look at other models of reimbursement in the U.S., you could expect the opportunity here to be in excess of $400 million or so. Again, that is equal to or in excess of what we expect the breast AI market to develop into. Let's have a look at products before we get Chris to talk about RevealDx. This is Volpara Patient Hub product. In here then you can enter all the patient information, all the patient risk factors, have they smoked, have they not smoked, generate risk scores. The radiologist can come in here at the end and mark up, say, "Yep, there's a nodule. It was solid. It was this big," and so on, and then put in what they recommend to happen. Obviously, we can start to auto-fill this with Riverain or MeVis technology, in the future, we'll be auto-filling this in as well with the output from RevealDx and so on. This then goes all the way through from that initial patient entry all the way through to patient reporting, generating the patient letters, and helping inform the patient about what they should do next. This is the MeVis product. This is very much a dedicated lung cancer imaging workstation. It's really geared for volume reading. Not just doing one case an hour, for example, but really geared towards doing 10 cases or more per hour. That kind of volume reading, batch reading, is a real key component of any screening program. MeVis actually include a computer-aided detection product and a nodule measurement product. Both MeVis and Riverain produce nodule measurements, volumetric analysis to say they are this big, this wide, and so on. What we're going to hear from Chris is they go beyond those volumetric measurements to use the overall characteristic of the images and the nodule and some very fancy AI and big databases to produce a better characterization. This is an output from Riverain. They have a couple of tools for lung cancer. One is image enhancer to help visual detection of nodules. The other one, which we're kind of more interested in, is that CAD, and you see over here that they've automatically marked on this report where nodules are, and then they've characterized each of those nodules over here for the radiologist to look at as they go through the process. You can see here from Riverain's webpage that they've got some very strong claims about how much they help radiologists save time reading these big CTs while ensuring fewer missed nodules. Also providing a lot of peace of mind and confidence in the results. Breast cancer screening always involves two readers. A lung cancer screening, at least initially now, is involving one reader and CAD, at least in the U.S. With that, let me introduce Chris. Chris, fantastic to have you here, and the slide is yours. All right. Thanks, Ralph. Great to be here today. Thanks for the opportunity to talk about RevealAI-Lung. Our software is integrated into the workflow after detection of a lung nodule. This nodule can be detected by one of the commercially available tools Ralph was just talking about or by the radiologist themselves. With a single click, the software mines the CT data around the nodule and produces what we call a Malignancy Similarity Index or MSI. That can impact clinical decision-making. For example, in the case here, additional workup like imaging, biopsy, or even surgery might be performed. Our MSI shows the five-year likelihood of this nodule developing into cancer to be less than 1%. Especially in the case where intervention may be dangerous to the patient, the proper course of action would be to allow this patient to simply continue to get imaged according to their normal screening interval. Our studies, soon to be published, will show a reduction in these false positives, which will have a significant impact on the overall cost of lung cancer screening programs that Ralph was outlining earlier. The MSI can also influence decision-making the other way around. A high MSI can result in an accelerated treatment of malignant nodules, which will have a positive impact on patient outcomes and costs as well. Our software improves both sensitivity and specificity. It's not a simple trade-off between the two. We spent five years in the development of the algorithm, specifically designing it to be robust. In other words, we can deploy in institutions with different vendor scanners, imaging protocols, et cetera. We've even validated our algorithm will produce the same results on ultra-low dose CT scanners, which are new scanners that have different reconstruction techniques. Building robust algorithms has been one of the major challenges of commercial deployment of AI into radiology. Through our sort of development effort, we've produced something that's not a black box. We know what our algorithm is looking at and how to QA our system. We believe we've developed something truly unique in the market. RevealAI is patented, CE marked, and will be obtaining TGA and FDA clearances in the near future. Our partnership with Volpara allows us to integrate seamlessly into the lung cancer screening programs so we can improve clinical operations while simultaneously impacting clinical outcomes. This is why we're so excited about this partnership. Okay, Ralph, that's our brief introduction. Back to you. Awesome. Thank you, Chris. Obviously, you can go to the RevealDx website to learn more about some of the technology. As Chris said, there are papers on the way, and we will be talking about those papers as they come out to you to make sure you keep up to date with developments in this space. Chris, I'm just going to touch on one of those points there. Just for the wider audience here, Chris has been in medical imaging for many years, was a co-founder of a very successful breast MRI company, Confirma, and then did a unified worklist for reading radiology, Clario, which was also very successful. Now Chris has come across into the RevealDx and lung cancer screening world. He is based in Seattle, which is where our main U.S. office is based. Just going back to Chris's comment there about AI, you'll see some of the cultural similarities. With the partnerships, we're always looking for people that share the values. This also then, the reason Volpara has been successful in breast is the AI we do. It's not black box, it's explainable, it's repeatable, it's multi-vendor. As Chris said, if you look in the AI literature around radiology, you'll see lots of questions around the ability to generalize across different X-ray systems or CT systems in this case, or across different populations. What's impressed us about RevealDx and some of their technology is they've done exactly kind of what we've done in breast in patenting ways of making these things robust across systems. That really is the key to getting AI into clinical implementation across the world. That's all good, and we can come back to that maybe in some questions. All right. Let's just compare and contrast a little bit there. Volpara is famous then for offering a full breast imaging stack, and that's kind of what we've depicted down the left-hand here, from those patient management systems all the way down to the quality management system. Empowering tools, this is empowering patients, is something we've been talking a lot about over the last year, and you're going to see stuff coming out on that for breast, in particular during Breast Cancer Awareness Month. We've talked about that to the market. The one thing I'm going to touch on, though, down the bottom here is stacks are very similar between breast and lung. One of the key differences is breast biopsies are relatively easy to do. Of course, you don't want to do them, but they are relatively easy to do compared to lung. There's some big percentage of those lung biopsies actually cause complications, which then start to generate a huge amount of cost and pain, obviously, for the patient. We've seen there's a much bigger market in lung for those diagnostic tools as compared to the breast tools. We are also then committed to kind of the platform approach with smooth integration, but also then allows our salespeople to go on-site and sell a full stack of products, which makes it much more cost-efficient, compared to just trying to sell any one product. The other thing which is almost every day now has become more and more part of our world is security consciousness. Volpara as a company is ISO 27001, and we've got some SOC 2 compliance on the way as well. Those certificates around information security are becoming more and more critical to do deals in the U.S. and elsewhere around the world. Again, walk in the door, one software tech stack with this platform of security consciousness will really be much more compelling compared to any rivals that are walking in the door. As we've done in breast, experience shows that these stacks are great and Volpara can do most of it, but really you need to partner to bring in those deep AI skills to really focus on particular organs, in this case lung. As at the bottom, getting in early at the start of these screening programs is much easier than later on when they're established and more rigid. Many of you have seen us do 10-year randomized control trials now with certain screening programs around the world. We are getting traction, but it's all moving slowly. If we're getting early, getting the start, it should be far easier. Growth strategy and competition with potential partners. There are a lot of players in this space. None of them are really taking the platform approach, which we've just kind of outlined. We are going to leverage our install base. Obviously, if we've got a big deal already with one big radiology group or one big hospital chain, then we can use those T's and C's and the contracts and information security to try and push through our lung platform work as well. A key difference here as well between breast and lung is, although to start with, as Chris said, we're going to target people that provide and pay. We will be targeting, or Chris will be targeting with his team, reimbursement for the diagnostic tool in due course. That will be an interesting marker for us to follow as a company, and again, we'll be keeping you informed on that as it progresses. I'm just going to leave you then and open up the floor for Q&A. Just going back to the start, we're on a mission for saving families from breast cancer, but we've now changed that to saving families from cancer. Lung cancer really is a natural expansion for us. Just for me personally, we got into breast cancer because of Mike Brady's mother-in-law, and then various people that I've known over the years have died of breast cancer. Also it's the same in lung. A lot of the generation above me, three of those, one of my favorite uncle died of lung cancer. This is a natural kind of expansion. It's kind of a bit of a personal mission to get on this one as well, to really try and reduce that mortality. Again, we believe it's a huge opportunity kind of opening up in the U.S. and elsewhere around the world. This is theimagingwire.com. It's a kind of a newsletter. They covered our lung cancer push last week and talked about Riverain, RevealDx, and so on. It's just a great takeaway message that they wrote up there. Lung cancer screening is starting to significantly increase in the U.S. and globally. There's new workflow constraints coming in, and there's real opportunities for the platform approach to come in at the start to really help mold these screening programs as they develop and start up. With that, very open to questions for myself or Chris. Thanks, Ralph. We do have a few questions from the floor. If anybody else does have a question, please feel free to ask. You can do so using the button, the Q&A button at the bottom of your screen. The questions we have, what is the expected timeline for FDA approval? That's a great question. I'll let Chris answer that one. Obviously, they've already got CE marking, obviously Volpara's got a lot of experience with the FDA. Chris, do you want to answer that one? Maybe include the TGA as well. Sure. TGA will come first. Because of the CE mark, that's something that we anticipate being able to get in 90 days or so. FDA is a little harder to predict. We anticipate we'll be submitting early next year, and it is a 90-day review process because it is a 510(k). It's not a PMA-level product or something like that. Our target is next year, hopefully early next year, but that'll be up to the government to a certain extent. Cool. Thank you. Thank you. Another question from the floor. Will Volpara breast AI and Reveal AI enhance each other? That's a great question. Certainly the underlying philosophy of the two companies around AI and make it explainable and robust, I'm certain we'll be sharing some technology tips around that. I think more interestingly is once we get to know these guys, success in our industry usually comes from focus. Once we work with these guys on focus, it'll be interesting to bring some of their technology back into the breast world. We do have one of the biggest databases in the world, for example, of breast images, and certainly searching them for similar cases, which is kind of similar to what RevealDx is doing, is challenging and would be of interest. There will be complementary things, and we'll be looking into those as we go. Certainly initially, there'll be a lot of focusing just on getting going in lung, just as we've done in breast. Thank you. How does your technology compare with 4DMedical lung screening? Yeah, that's a great question. 4DMedical is obviously a pretty exciting company down there in Melbourne. Obviously, all the trials are coming out. It's all about lung CT in the U.S. Some of these are very long trials, 10-year trials or so, randomized controlled trials to prove the benefit of lung CT for actually reducing mortality. Those trials actually come after people were using just 2D X-ray, which was not proven to reduce mortality. Given that experience, they did the big trials on lung CT and actually showed reduction in mortality. As far as I'm aware, 4DMedical are very much more focused on the function of the lung and other diseases of the lung other than lung cancer CT. Sorry, other than lung cancer detection. At some point you could imagine some of the functional results coming out of 4DMedical might actually say, "Hey, look, this lung's not performing properly. Maybe you want to get onto a screening program," for example. Yeah, we see them potentially as being more complementary than competitive technologies. Okay. Can you please outline the expected financial impact from the investment in RevealDx for Volpara over the next few years? That is in reference to revenues and operating expenses. Well, let's talk a bit about that. At the moment, Volpara's already got a lung cancer screening team built up. We've got two excellent salespeople, dedicated salespeople in the U.S. We've got an engineering team already built up for Patient Hub Lung, and we've got all the support and servicing things in place to support lung cancer. We certainly don't see us ramping up any operational expenses in relation to this deal. Indeed, part of the reason for partnering is to reduce some of those operational hits until revenue builds up further. Obviously, revenue impact is going to depend on when TGA, which is the Australian regulatory, gets clearance and when the FDA gets clearance, it's hard to predict. We don't really expect over next year, certainly, the percentage of our ARR, annual recurring revenue, to change that much between breast and lung, because we're seeing good growth, as we've given guidance on already, good guidance on breast. As the lung ramps up, we don't see it this year, but certainly the year after, we expect to start seeing some ramping of lung as those regulatory clearances come through. Okay. Thank you. We do have some other questions that were sent through on the email prior to today. One being, will your lung venture require you to raise additional capital? Yep. Again, Hannah, that's a great question. Again, we've got the lung cancer team in place. We've got the dedicated salespeople in the U.S. already, and in Australia, focused onto lung, and we've got all the support people in place. Remember, as a company, over the last year or 18 months in particular, we've been doing a huge amount of work to make us more scalable. That involves setting up world-class structures and IT platforms to deal with support service so that we can bring in partner products and we can deal with them without really having to ramp up costs. At this point, no, we don't need to do any more capital raising. Again, one of the reasons for partnering is to let other groups deal with the complexities of the FDA and expense of the FDA, for example. Okay. Are you looking at any additional cancer screening markets? We are not at the moment. Obviously, breast and lung are the two big ones that we're looking at. Really you're starting to see, and this has been developing over the last few years, Volpara's sweet spot is cancer imaging or cancer screening, and where it involves data and images. The big two for that is breast and lung. Although we are watching areas such as prostate, for example, where prostate MR is looking like a very promising screening tool as compared to blood tests. Nothing on the immediate horizon, but breast and lung are plenty big enough for us to be focusing on at the moment. Okay. We have a final question, I believe, from the floor. Who do you view as your major competitors in the U.S. and globally, specifically in the lung cancer space? That's, again, a great question. We listed down a pile of smaller companies who do. They might do computer-aided detection or they might do. There's one other company doing diagnosis of nodules, for example. There's no one doing that whole platform. Yeah. As of yet, we don't see a major competitor coming in at a big enough scale that can really deal with some of these very big screening programs with a whole platform of products. Now, it doesn't mean one won't come in, but certainly at the bigger level, we don't see anyone at the moment. Although I'm sure any of those companies we listed might be looking towards what we're doing because it's an obvious route to start combining a bigger technology stack for the sales teams to sell. Thank you very much. If there are no other questions, we will conclude the webinar today. Thank you everybody for joining us. If you do have anything further to add or want to speak to Ralph, please do send me an email. My email address is in the ASX announcement that went out. Thank you, everyone. Thank you, Ralph and Chris. Much appreciated. Thank you. Thank you.