Thank you for standing by, and welcome to the Nanosonics Limited 2021 Full Year results and Investor Call. All participants are on listen only mode. There will be a presentation followed by question and answer session. If you wish to ask a question you will need to press star key followed by the number one on your telephone keypad. I would now like to hand the conference over to Mr. Michael Kavanagh, Managing Director and CEO. Please go ahead. Thank you very much, a very good morning, everybody, and thank you all for joining the call this morning. I am joined remotely by McGregor Grant, our CFO. Well, by now you will have seen the FY 2021 results announcements, which I believe demonstrate how the company has successfully adapted to the challenges of COVID-19 and overall delivered an excellent set of results, and particularly in the second half of the year as the market conditions improved. There are really three key takeaway messages I'd like to convey from the comprehensive set of results and information contained in the release, you'll find the investor presentation, annual report, and sustainability report, which were all posted this morning. The first message really is around how the organization did experience a significant recovery in the second half of the year over the first half as market conditions improved. This recovery was experienced across all key measures of the business, including installed base growth, total revenue growth, capital revenue growth, and consumables and service revenue growth. That revenue growth was even more pronounced when you look at it on a constant currency basis. The second message I want to leave you with is that there is still a significant opportunity for growth in the trophon business. Indeed, the opportunity in North America is larger than our original estimate, with the total addressable market in that market now estimated to have increased by 50% to 60,000 units. In addition, the fundamentals for adoption in Europe have strengthened, where coupled with our investment in the region, we witnessed excellent growth for the year, despite the region essentially being in lockdown for the full year. That's very encouraging for the future. The third message is, in addition to the significant trophon opportunity, Nanosonics has an exciting pipeline of new products. We've just launched AuditPro, which brings significant benefits to customers as well as opportunity for Nanosonics as we enter the new and important space of digital connectivity and data in infection prevention. Of course, in addition, this morning, we announced the next platform technology that the company's working on, which is addressing what is probably recognized as the most significant issue in instrument reprocessing today, and that's endoscope reprocessing, and in particular, addressing the significant technical challenges associated with the cleaning phase of endoscope reprocessing that I'll talk about a little bit later. What I'd like to do is just provide a bit more detail on each of these three areas, and then I'll hand over for questions. As I mentioned, the first key message is really around the significant recovery achieved in the second half of the year. As you will have seen, full-year revenue for the year was AUD 103.1 million. That was up 3% on prior corresponding periods. In constant currency, however, total revenue was up 12%. More importantly, looking at the revenue outcome in both halves, it does provide very important insights. As market conditions improved in the second half, and particularly in North America, where access to hospitals improved and ultrasound procedure volumes trended back to pre-COVID-19 levels, we saw revenue grow 39% over the first half to AUD 60 million. If you look at that on a constant currency basis, that growth was actually up 50%. As you all know, installed base is probably one of the most important metrics for the business. Despite the impacts of COVID-19, the global installed base increased 13% to 26,750 units. That's an increase of over 3,000 units for the year, with all regions, I might say, performing very well in that growth. Again, the second half of the year saw a significant recovery in new installed base adoption as the market conditions did improve, and particularly in North America, with 1,650 new units installed. That was a growth of 20% on the first half. Back to a very positive growth momentum trend indeed in the second half. If I look at that by region, in North America, the installed base increased 12%, or just under 2,500 units for the year, where we now have nearly 23,500 units installed across over 5,000 institutions. The second half installed base was up 20% over the first half, with 1,360 units installed in that second half. That second half run rate annualized is just over 2,700 units, which is getting back close to the pre-COVID annual installations we've always been aiming for, which as you know is between 2,700 and 3,000 units per annum. Indeed, when I look at the second half installed base in FY 2021, it was actually greater than the first half of FY 2020, where there was no COVID impact. Again, demonstrating the underlying strong fundamentals for adoption in the North American market. In our European region, our EMEA region, despite COVID-related restrictions really prevailing for the full financial year, the installed base grew 35% for the year, where the total installed base now reaching just over 1,500 units across the region. This growth, I believe, reflects the strengthening fundamentals for adoption of Trophon across the region. In the investor presentation, you'll actually find some details around all those guidelines that now exist. We're supporting automated high-level disinfection, and they continue to emerge. Obviously, there's now a growing understanding of the risks of cross-contamination. Of course, we're continuing to increase our investment in our infrastructure across the region. Both halves actually, not just H2 over H1, both halves of the year in the EMEA region demonstrated excellent growth compared to prior corresponding periods, where H1, the first half, for example, was up 54% on the PCP, and H2 was actually up 73% on PCP. Certainly, we're beginning to gain a fair amount of very positive traction over in the European region. In Asia Pacific, despite the Australian and New Zealand market being highly penetrated, we still had installed base grew by 9% or 150 units for the year. In that region now, there is 1,760 units installed. A majority of that growth was actually experienced in Australia, New Zealand, as Japan was effectively in a state of emergency and lockdown for the majority of the year. Back to revenue for a moment, and if I split the total revenue down to capital and consumables, despite a 13% increase in new installed base, the actual capital revenue for the year was down 11% to AUD 26.7 million. This reduction was primarily associated with a reduction in the number of units sold to GE HealthCare in the first half of the financial year, which we recorded during our first half results. From that, you'll remember that reduction was really just due to a decrease in the installed base growth as a result of COVID-19, particularly in Q4 of FY 2020 and Q1 of FY 2021, and then the corresponding impact that had on GE's inventory levels. They didn't need to purchase capital when the amount going out to customers was down. Importantly, the capital revenue increased 84% in H2 compared with H1. As market conditions improved, the installed base growth recovered, and of course then GE resumed their normal capital purchasing patterns. That was really a one-off impact due to inventory, and we saw a nice return to normal patterns of purchase in the second half. Of course, this impact of GE capital purchases was only felt in our North American region. For Europe and Middle East, total capital revenue for the year was up 91% to AUD 2.7 million. What's important to note here is, as the majority of units placed in the U.K., which is our largest market in the European region, are under the Managed Equipment Service model, where no capital revenue is actually recognized. This increase in capital revenue in EMEA does reflect a growth in the markets outside of the U.K. Again, strong indications for very positive growth momentum emerging in our European region. Of course, in the Asia Pacific, the total capital revenue for the year was up 143% to AUD 2.7 million. Now, if I exclude the capital revenue that was associated with upgrades, the overall capital revenue for the year in Asia Pacific was up 36%. Of course, upgrades are an important part of our capital revenue growth moving forward, so it was good to see upgrades come through in Nanosonics AuditPro in the last financial year. From a consumables and service perspective, revenue increased 9% to AUD 76.4 million. Here, I think it's really important to look at this on a constant currency basis as it better reflects the actual volume growth. In constant currency, that revenue would actually have been AUD 84 million or up 20%, which I think is important to understand. As you all know, the first half consumable sales, they were impacted due to the effect of COVID on ultrasound procedure volumes. However, the second half saw a positive trend towards pre-COVID procedure levels with revenue for the consumable and service up 27% in H2 compared with H1, or that would be 39% in constant currency. What is important, I guess also, is that towards the end of the financial year, all indications for that ultrasound procedure volumes. We're definitely approaching pre-COVID levels across most markets. Details on all the regional splits with respect to those revenue numbers are provided in the release and in the investor presentation. Moving on to the second key takeaway or message, and that is there's a significant opportunity, an ongoing opportunity for growth in the Trophon business. Indeed, the opportunity is larger than our original estimates. At the half year, we said that we were going to examine the North American market to get a better understanding of the total addressable market. For many years we've been quoting a 40,000 unit opportunity, which is certainly out of date. The ultrasound market has not stood still and indeed has grown strongly. We did commission work in the U.S. to better understand the current state of ultrasound installed base in the U.S. As a result of that work, the estimated total addressable market for trophon units in North America has been revised up from 40,000 units to 60,000 units. This takes into account the growth in the ultrasound market over really the last eight years or so, since we've been quoting that 40,000 unit number. What this means, of course, is there's an opportunity for strong ongoing growth in North America. Indeed, rather than being 59% penetrated, if we were still quoting 40,000 units, we are only 39% penetrated, which provides excellent runway for ongoing growth. We've not done a similar exercise for Europe and Asia Pacific at this stage, as the same level of granular detail is not readily available. We do acknowledge that the 40,000 unit opportunity in each of these regions is out of date and is likely higher, just like in the US, as ultrasounds has certainly grown in those markets as well. Getting to a specific number, to be honest, is not a big priority for us at the moment, as you all know that there's still a large runway to go, even with the 40,000 opportunity. We'll look at that at a later date. Speaking of growth in these regions, you've seen the growth being experienced in Europe, and certainly we aim to continue to invest in that market to further stimulate growth on the back of the strengthening fundamentals. We know from our North American business that Trophon can be a very successful business, delivering significant contribution margin. Our aim is to replicate what we have achieved in North America, in the other two regions. In Asia Pacific, despite the challenges associated with Japan being in a state of emergency for the majority of the year, we did continue our market development work there with virtual education and training with relevant specialist societies and, of course, our distributors. We did expand our local infrastructure over there. We continue with our market development activities, in partnership with our distributors, including GE HealthCare. We are currently finalizing, actually, it may be finalized, the registration of our wholly foreign-owned enterprise in China, or would be in China. We are now preparing for regulatory submission, to approve Trophon 2 for commercialization in that market. I think it'll probably be in FY 2023 market introduction, but there's a lot of work going on behind the scenes as we prepare for that. Of course, growth in capital equipment is only one dimension. There's also the opportunity for growth in consumables. I mean, we did see, especially on a constant currency basis, very, very strong growth in consumables this year. Also in the investor presentation, there's a slide in there that I think is quite informative and that highlights that there is over 150 different types of procedures that use ultrasound probes across many departments that risk contact with mucous membranes, non-intact skin or sterile tissue, therefore necessitating the requirement for high-level disinfection. As education on this creates greater awareness, there's certainly the possibility that the usage of trophons will also increase, driving increases in consumable usage. Of course, another important aspect related to the significant growth opportunity for Trophon is upgrades. For obvious reasons, upgrades weren't a big focus in FY 2021 because where we did have hospital access, we were very much focused on new installed base. Now that hospital access is back, there will be more of a focus, in FY 2022 on upgrades. Customers have been notified at the end of life notifications for the original Trophon EPR, which is just a normal part of the product life cycle. There are now over 6,500 Trophon EPRs, I believe, that are seven years and older in the market. Considering the value proposition of T2, the Trophon 2 over the EPR, the original device, together with, I believe, is a solid economic rationale. We'll certainly be informing customers of the upgrade opportunity over the next 12 months. Just a note here. As upgrades do kick in, so will the mix between capital and consumables, which, of course, then can have an impact on gross margin, depending on the volumes of upgrades we get in FY 2022. We expect the gross margin to rebalance closer to the historical levels of about 75%+ that was experienced in the prior years. That's important to note. Considering there then the increased TAM in North America, the Europe growth kicking in as fundamentals have improved, opportunities through our expansion in Asia Pacific, the potential for increased usage of each trophon due to a wide range of ultrasound procedures and of course, upgrades, I think that there is definitely a significant opportunity for the trophon business alone looking forward. Of course, this leads to the third and final key message I wanted everybody to leave with, and that is that Nanosonics, we have an exciting pipeline, really, of new products. As you all know, product expansion is a core aspect of our strategic growth agenda. In FY 2021, the company invested AUD 17.2 million in R&D, so that's up 11% on the prior year. In June, we announced the launch of Nanosonics AuditPro, which is an infection control workflow compliance management system. It's a result of a number of years of research and development and really opens up a significant opportunity to market a unique solution that really integrates infection prevention decision-making, track and trace, and compliance into a single digital solution. That product now is being rolled out in the U.S. with plans to introduce it into other regions over time. The AuditPro solution, it comprises of a mobile scanning device coupled with a subscription to a browser-based application for users. The first application focuses on ultrasound procedures, where the new handheld scanning device is actually designed to be coupled with every ultrasound console at point of care. With over 270,000 ultrasound units in the U.S. alone, you can imagine that AuditPro represents a significant new opportunity for Nanosonics. One takeaway on this is important that some people were thinking about AuditPro, the ratio of AuditPro would be associated with the ratio of trophon. We're very much looking at AuditPro as a ratio to ultrasound consoles, not as a ratio to the number of trophon units that are out in the marketplace. Over time, we're not expecting significant revenue. It's like a service model, a subscription model that will generate revenue over a five-year subscription model and recognize that revenue over the 5-year period. Obviously, as the install base grows with AuditPro, then the revenue can become quite significant. In addition to AuditPro, there is our next new technology platform, the Nanosonics Coris platform. This new technology platform is directed at solving what is probably the most important and significant problem in instrument reprocessing today, and that's the cleaning of flexible endoscopes. Indeed, more healthcare-associated outbreaks have been linked to contaminated endoscopes than any other medical device. It's a highly complex problem to solve that has existed for many years. A bit of detail around this, if I may. First of all, reusable flexible endoscopes, and there's a range of types of flexible endoscopes. They are highly sophisticated medical devices that enable advanced diagnostic and therapeutic interventions across a range of conditions. These reusable endoscopes, they incorporate advanced technologies that give physicians really a sophisticated level of control in carrying out very complex and minimally invasive procedures and the ability to navigate challenging anatomical situations to deliver the highest level of patient care. As I mentioned, there are many types of flexible endoscopes, including colonoscopes and gastroscopes, duodenoscopes, bronchoscopes, et cetera. From a reprocessing or a decontamination perspective, the cleaning stage of the reprocessing or decontamination process, it's a critical step, and has significant implications for the outcomes of the subsequent high-level disinfection stage of the process. Indeed, the father of decontamination, Earle Spaulding, a famous quote from him is, "You can clean without disinfecting, but you cannot disinfect without cleaning." People talk a lot about moving towards sterilization, but even still, without very effective cleaning, that won't make as much of a difference. There are lots of challenges associated with manual cleaning, combined with reports of persistent contamination from biofilm, which is really a very difficult contaminant to remove despite that routine cleaning. This does represent a significant unmet need that's well recognized by regulators and customers. Now, addressing this problem, which has existed for many years. It's a very, very complex issue. You are dealing with trying to automate what today has anywhere between 50 and 200 manual cleaning steps. You're dealing with sophisticated endoscope design and architecture that has multiple interconnected channels and complex ports. You're dealing with channels with diameters that can be less than a millimeter. Of course, you're dealing with very complex and difficult soils to remove, such as biofilm. As you can imagine, it is a very, very complex technology development program. The Nanosonics team, they focused on the significant technical challenges for a number of years now with the aim of developing a novel automated technology designed to really revolutionize the cleaning process of flexible endoscopes. Our new Nanosonics Coris platform technology, like trophon, it will comprise both capital equipment and consumables. In testing to date, this new automated platform has demonstrated the ability to deliver significant superiority in cleaning efficacy over the requirements of the current standards, including those moves. There are some new recent standards that are even stricter, and we can significant superiority even over those. Testing demonstrates superior efficacy over manual cleaning against these difficult biofilm contamination, including in the smallest channels of an endoscope, down to less than a millimeter in diameter. A big technical challenge to overcome, the R&D team have done an absolutely amazing job there. The potential to address this, of course, represents a significant opportunity for the company. There are over 60 million flexible endoscope procedures being conducted across the U.S. and the largest 5 markets in Europe alone every year, that number is growing at about 6% per annum. We're very pleased with our progress in the product's development. There's still some more development work to do, which will be followed by external clinical assessments to support the regulatory submission. We continue to engage with the FDA, to determine the necessary requirements to support a successful regulatory submission. All of that is going well. The timing for initial commercial launch previously indicated, that is being revised and will be determined in due course, dependent on, of course, those technical, regulatory, and operational milestones being met. At the moment, we're currently targeting the first commercial launch in calendar 2023. There are some impacts of COVID-19 at the moment with lockdowns here in Australia, but we're doing our best to try and manage those. We'll keep the market informed as material new information becomes available. Needless to say, it's a very exciting development, and we remain highly confident in bringing what we believe can be a transformational product to market that does address the most significant unmet need in instrument reprocessing today. Indeed, we believe, like Trophon, can become a new standard of care. All around, some very, very exciting things ahead for the business from a product portfolio perspective. In terms of outlook for 2022, first of all, we do have to acknowledge that there is still uncertainty in the marketplace, especially with the Delta variant of COVID-19. However, assuming that positive market recovery trends do continue, and we're seeing that with vaccinations increasing around the world, et cetera, we do anticipate a return to double-digit growth. I think you saw what our second half number was of AUD 60 million. We're expecting double-digit growth in total revenue in FY 2022, and that will be driven by ongoing increase in the installed base globally, increased usage of consumables across all regions as ultrasound procedures return to pre-COVID-19 levels. In addition, of course, it's anticipated we'll see new capital revenue coming in from upgrades from Trophon EPR to Trophon 2 during FY 2022 as well. I did mention earlier on, just depending on the upgrades in capital and the growth now in capital in the second half or in this year, from new IP and upgrades, that the mix between capital revenue consumables will likely change, and that will result in gross profit margin more aligned to what it was in FY 2020. Our estimates are remaining above 75%. With the exciting growth opportunities outlined for the Trophon franchise, as well as opportunities in the broader infection prevention markets, we are maintaining our commitment to continue to invest in the long-term strategic growth agenda, with an emphasis, of course, on continuing investments growth in our regional operations and R&D. The operating expenses in FY 2021 in the fourth quarter were AUD 20.3 million. The business returns to its intended investment run rate, as you know, we originally, at the beginning of the year, were guiding towards AUD 75 million-AUD 78 million. Of course, with impacts of COVID-19, et cetera, that had come down. In the fourth quarter, we got back to that intended run rate of AUD 20.3 million. That annualized alone is about AUD 82 million, and of course, we expect some growth on top of that. We're expecting our investment in the ongoing growth of the business to approximate AUD 90 million for the year. With that overview, I'm happy to hand over for any questions. Thank you. Your first question comes from Josh Kannourakis with Barrenjoey. Please go ahead. Hi, Michael and McGregor. Can you hear me okay? Yes. Good morning, Josh. Good morning. Well done on the results. Firstly, just a question about the core trophon business and with regard to your outlook. Can we talk a little bit about what you're seeing in terms of trends for the start of the year, in terms of access into hospitals, and just how that's been tracking in terms of your workforce and sales funnel? Yeah. Look, a good question. It's obviously something we're monitoring very closely. In the U.S., what we're seeing is access to hospitals has certainly improved a lot as vaccinations have increased. There's pockets in North America, in the southern states like Florida and Texas, where the Delta strain and hospitals are under a bit of strain, where access is more limited. We still are getting in there. Our service people are getting in, our clinical applications people are getting in. Even in those southern states at the moment, we're still seeing the ultrasound procedural levels back towards pre-COVID levels. We're not seeing those big drops that we had seen originally. Ultimately I think what's happening as vaccines are rolling out, there's also an acknowledgment that there are many other healthcare issues over and above COVID that have to be addressed. The hospitals are, I believe, better equipped. I mean, this time last year was all around getting access to PPE and ventilators. They are a lot better equipped to manage it at the moment. With that in mind, our access has certainly improved a lot. It's similar sort of story in Europe. Our German field force are out there now. Our U.K. field force are out there. Yes, there are new guidelines with respect to visiting hospitals, but these guys are able to get into the hospitals now. Got it. No, that's great. Just in terms of upgrades, and you mentioned you do expect some of those to start happening into FY 2022 and some good granularity there. Can you just talk a little bit through the implementation of the EPR end-of-life strategy, and also how AuditPro could potentially play into accelerating that upgrade cycle? Yeah. Normal part of product life cycle when you are always going to, at some stage, obsolete products. When you do go through an obsolescence strategy, you notify customers with respect to an end-of-life notification. We did notify customers some period time ago about the end of manufacturing, more recently notifying them with respect to end of life. What end of life means is not that we're no longer going to support customers who have EPRs, but there could be limitations for older devices in terms of being able to service devices because of obsolete parts and things. That's the normal process medical device companies follow. Customers have been notified. I think when we look at the upgrades, the EPR, the T2 over EPR is certainly some very strong value proposition there. Economically as well, I think it makes sense to upgrade. Remember, many of these EPRs are under service contract. When they get a new T2, that's warranted for the first year. It's almost like they've got a discount to the value of one year of service contract from the T2 already. To your point on AuditPro, I think AuditPro can, even though it's a discrete product in of itself, but its first application is in ultrasound. The connectivity, AuditPro does not connect with the EPR, but it does with the T2. It can certainly be a driver for upgrades as well when the teams are out there talking to existing customers about AuditPro. Not just a driver for the upgrades. I would say the other aspect that AuditPro could potentially impact over time is that this product, it has inbuilt in the product, in that handheld, is it almost ensures that as part of the clinical workflow, that the customer is taking on board the necessary infection prevention requirements. It educates them and helps them understand what they need to be doing with the probe and whether or not it requires high-level disinfection, et cetera. I think it can continue to drive that education. Of course, with over 150 different types of procedures, ultrasound procedures that require high-level disinfection, there's the possibility that AuditPro could actually drive increased consumable usage as well, as well as upgrades over time. Great. Extremely quick one, in the essence of time on the new product. Can we assume that because you've released or discussed it now that the major technical challenges are overcome? I know you've mentioned there's a couple of additional product enhancements to come, but are the major technical issues that you've dealt with, can we assume they're overcome? Yeah. The big thing here, in one sense it sounds easy, the cleaning of flexible endoscopes. When you look at the architecture of endoscopes, and it's a purposeful architecture that enables the physician to have extreme control and be able to navigate internally into very, very small areas. That complex architecture is actually required. You're dealing with endoscopes that have many different channels, and those channels have different diameters, and there's bifurcations in there and connectors and over nine different ports and all of these sort of things. You can imagine the process, and that's why the current cleaning process can have anywhere from 50 to 200 different steps. You can imagine trying to automate that. All our testing to date now consistently demonstrating that we are achieving significant superiority over the required standards today. Very, very importantly, the ability to very, very effectively clean those very small lumens, which are considered to be the most difficult aspect of the cleaning and potentially one of the biggest contributors to the contamination. Our ability to be able to get rid of biofilm in those channels has proven to be very, very successful. We're feeling very, very comfortable. Yes, there's some more work to do. Not in the product. You remember, a product like this then got to be introduced into manufacturing. There's many test systems that have to be developed, et cetera. There's a whole suite of elements associated with the development over and above just the product itself. We feel very comfortable with the product that we have and that indeed it can be transformational when launched. Great. Well done, guys. Thank you. Thank you. Your next question comes from Martin Jacobs with Canaccord Genuity. Please go ahead. Morning, guys. Congratulations on a strong result. I thought I'd just start this, just asking, what percent of sales are represented by GE now? If you can share that with us. That I don't have it off the top of my head. I think it's probably in the order of about 55%, 60%. You'll find that in the annual report under the significant customers. What I will say, though, when thinking about that, is remember the consumables. That we now effectively sell the consumables close to the ASP of what we sell directly to customers. GE, they continue to provide consumables to their customers. In one sense, you almost have to discount that percentage by the volume of consumables, because if they were not selling those consumables, we would be selling those consumables to those customers. Ultimately today, including consumables, it would be in the order of about 60%. Right. Thank you. On the OpEx, you're foreshadowing quite a big jump in the cost there. I was just wondering if you can split that out between SG&A and R&D, firstly. Secondly, you've notified a 9% increase in staff, and can you just talk to sort of where that's being attributed? Yeah. That's a good question. As I say, originally for FY 2021, even with the COVID-19, we were looking to invest upwards of AUD 75 million-AUD 78 million. Obviously, we came in underneath that. Importantly, in the fourth quarter, we were able to get back on track as markets began to open up and with our investment strategy and exceeded the fourth quarter on a run rate of about AUD 20.5 million. Annualize that, you're at AUD 82 million straight away. Going into this year, we are looking to continue to invest out in the regions. There's more investment going out into the U.S. There's more investment going into the European region. We're doing investments as we're expanding our Asia Pacific infrastructure. Yes, there is more going to go into R&D as well this year over last year. The other thing I'll flag is we will very likely move to a new premises. We're close to signing a new lease on a new premises that is a larger premises that will support the next phase of the growth, giving us a lot more capacity from a laboratory perspective and an office perspective as well. That will start coming in from an accounting perspective in FY 2022 as well. Okay. On the upsize for the market, so it is good to see you have adjusted that. You also noted that pre-COVID-19, your units were sort of 2,700-3,000 units. That is what you want to get back to. In the past, you have talked about 3,000 as a sort of a, I guess, a baseline that you can go a year in, year out. Is there a subtle softening in your expectations going forward, or is that just being casual with us? No, I think we'd like to think I've always said, there's not many pieces of medical technology getting out there with about annually 3,000 new units going in and then generating annual revenue from it. We'd like to think in North America that we'll be able to get back to that run rate of 3,000, and then we start seeing an accelerated growth in Europe. Really what the 60,000 shows is there's still good run rate for ongoing growth as opposed to we're getting now automatically a shift in growth from 3,000 to 3,500 or 4,000 units. Okay. Just finally from me, in terms of the new endoscope product. Yeah. Pleased to see that you're acknowledging the problem of biofilm as a factor in infections. I was just wondering, if someone had developed a biofilm disrupting agent and could coat it on endoscopes, et cetera, would that have an impact on your potential, and have you thought about that technology? I'm sure many people are thinking about those types of technology. biofilm, we could go into hours of lectures on biofilm and the intricacies of biofilm, but coating products to minimize biofilm formation, I think, nobody's been able to crack that. It's a big, big area. At the moment, I think, Martin, we feel very, very comfortable in the opportunity and the technology that we have going, and feel very comfortable that it will become a new standard of care. Okay. Thanks very much, guys. Thank you. Thank you. Your next question comes from Chris Cooper with Goldman Sachs. Please go ahead. Hi. Morning. Thanks very much. Michael, if you don't mind just first on the revenue guidance for double-digit. I don't know whether you can help steer us a little bit here. Clearly the second half, there's a recovery that's played out as foreshadowed. For the year as a whole, I think it's fair to say that it's still a little bit below where you'd normally expect to be. A double-digit revenue growth wouldn't necessarily be a big surprise for people. Could you help to just narrow that slightly? Clearly it's a very broad range. The consensus, I believe, is currently something in the high 20s. Is that something you feel comfortable with at this stage? Yeah. Look, Chris, we've traditionally not given any guidance with respect to revenue. I think a lot of companies actually at the moment are not giving much guidance with respect to revenue with the uncertainties that are out there. What we'd like to think is that everybody's seen what our second half revenue has been, and we would like to think that that's the run rate going into FY 2022. As long as the conditions continue to improve based on what I've covered this morning with respect to the opportunities that are out there for trophon, we would like to think that that run rate is certainly achievable, which gives some indication of what the first digit is on that double-digit growth. Really with the uncertainties out there, I can't give any more granular information than that. Just to clarify that comment, approximate doubling of the exit rate in FY 2021 wouldn't be a bad starting point when we're thinking about 2022? Yeah. Okay. Thank you. Look, on the relationship with GE, there's a couple of sort of smaller questions within this. Up to 60% of revenue now, it's a fairly big increase in the amount of revenue generated through that relationship. Is that now the new normal, or does that begin to fall back down again as the rest of the customer base continues to recover through FY 2022? The reason I ask is, it doesn't appear as though there's been a material sort of pricing impact, negative, as we've seen those GE orders come back through the second half. Yeah, the orders came back in the second half. I want people to GE are, and continue to be a very important partner for Nanosonics, and we've got a close working relationship with all our colleagues with GE. I don't want people to get fixated on this 60% associated with GE. Remember, a lot of that is associated with consumables. As you know, the contract with GE a number of years ago changed, where effectively we were taking the consumables back. GE decided that they would continue to provide the consumables to their customers, so they can offer the holistic solution and it'd be easier from a customer experience perspective, et cetera. What we sell the consumables to GE at close to the price of what we would sell them to the customer. In one sense, you've got to discount the consumable volume when you look at that 60% being associated with GE. Without a doubt, as our direct business continues to grow, but more importantly, how we look at things moving forward, and particularly in North America, internally, we talk about our demand generation strategy. We've got a field force that are out there that are generating a lot of demand that can either be filled through us direct. If we notice that it is a customer that's predominantly using GE equipment, we'll make sure that that customer is aware. They'll always have the choice, but we'll make sure that the customer is aware that they can get the equipment through GE because they may be able to bundle it into a contract they already have with GE, et cetera. We're more focused on ensuring that the market install base grows, as opposed to whether it grows directly or indirectly, because ultimately the consumables flows through to Nanosonics. Okay. Is the plan at this stage for GE to help with the commercialization of Coris? We've made no statements around the commercialization model that we're going to go forward with the Coris technology. As you can imagine, GE don't have anything to do with endoscopy. Okay. Very final question, just to knock back quickly. The AUD 90 million that you're guiding to for FY 2022, it sounds as though, from your comments earlier, that maybe we should be assuming this to be sort of a new base run rate, with perhaps a little bit of growth year-over-year from 2022. Would that be reasonable? Yeah, I think so. When you look at it, Chris, the opportunities for growth in the business and infection prevention alone are really great. At this stage, we're still going to continue to invest for growth. Obviously, when you've got markets like North America now that are well established, and whilst we haven't broken it down out here for the market, we're delivering excellent contribution margin out of North America in the trophon business and demonstrating excellent operating leverage in North America as well. That's where We believe we can get to that in the other markets as well. A lot of those other markets are highly under-penetrated. We're not going to stop with AuditPro and Nanosonics Coris. Our growth is underpinned by continuing to invest in R&D and bring more and more new infection prevention products to market over time as well. Without a doubt, I would say, yes, it is a new baseline, and there will be growth year on year on that baseline. Got it. Thanks very much. Thank you. Your next question comes from Lyanne Harrison with Bank of America. Please go ahead. Hello, Michael. Hello, McGregor, and congratulations on a good second half recovery. Thank you. I might start with the total addressable market for the trophon. We had an estimate of about 60,000 units, the 60,000 units are obviously 20% higher than our estimate. Can you give us some color on the assumptions you used to, or the assumptions that were used in the study, to arrive at that number? Yeah. The foundation was looking at the total number of ultrasounds that are out in the marketplace. In North America, it's in the order of greater than 270,000 ultrasounds out in the marketplace. We cut the data in a number of ways, looking at by type of ultrasound. Is it console? Is it compact? Is it handheld? Et cetera. Then we looked at ratios of trophon to the different types of ultrasound, and those ratios were based on our experience in hospitals and other segments of the market. All of that came to a number that probably conservatively is in the order of about 60,000 units. Okay. Thank you very much. If I think about, obviously the new Coris product. With the work that you've done to date on looking at the market there, can you give us a sense of how large do you think that the market demand might be for the Coris? In the announcement, we did give a bit of a flavor as to the number of endoscopy procedures. Up over AUD 16 million or so annually, that's just the U.S. and Europe top five. If you include other parts of the world, in Japan, et cetera, obviously it'll be a lot higher. It will be a capital and consumable model, so very, very similar to trophon where we expect to get similar sorts of margins, et cetera, on consumables, et cetera, that we're looking to generate potentially. I think the overall opportunity is very significant. The other thing that's probably worth mentioning is, unlike trophon, where you've got a lot of markets now that are still in the early phase, all in terms of adopting necessary guidelines for high-level disinfection. Certainly in the majority of markets globally, for endoscopy, the reprocessing of endoscopes are mandated, and of course, the cleaning stage. There's elements like that that could have a positive impact for us in terms of stage and rate of adoption internationally as well. Okay. Obviously, you mentioned the capital and consumables model. Yeah. Just so that we could probably get a sense of estimating the market size. Is the capital likely to be priced higher or lower than the Trophon 2? Really today we're not going into any details. Okay On commercialization. Yeah. Okay. In fullness of time, we'll come out with more details around all of that sort of information, which I know it's one step to now announce where the technology is. Yeah. Of course, that leads to your next questions, which are all very valid questions. In the interest, I guess in the fullness of time, we'll come out with a lot more information about it. Okay. Absolutely. Understand that. Then on the consumables for the Coris, are they likely to use same or similar consumables to the Trophon? Oh, no. One thing I will emphasize, this is a totally new product platform. New capital, new consumable. Okay. Final question I have is on the Trophon in terms of the install or the new install base. Based on our calculations, the average ASP jumps up significantly in second half 2021. Can you give us some color on what might be the reason for that? I'm not sure what your calculations would be based on, on the capital, but I don't think there has been significant increases in the capital ASPs in the second half. It was primarily driven by volume. Okay. Is there any mix in terms of more Trophon 2 versus the EPR? 100% of all Trophons that we're selling now and have been. Got you. for the last couple of year are all Trophon 2. Okay. Thank you very much. I'll take one more question, just in the interest of time, and I'm sure I'll be talking to many people who are on this call, in more detail over the coming days. Thank you. Your final question is from John Deakin-Bell with Citi. Please go ahead. Thank you, Michael. Just to clarify on the Coris product, I know you appreciate, you've given us a bit more detail. Can you just tell us where the patent position is currently for this product? John, we've been filing a lot of patents in a lot of areas, and we fully expect that we will have strong patent protection like we have for Trophon, for the system, when it's launched. They're not granted at this point? Some patents we have are granted, others are going through the process. Okay. Thank you. Just finally, I'm just intrigued really. You're talking about the patents are going through the process. You haven't started the clinical trials. You're talking about not launching the product for two years. Why have you decided today to talk more about it? I think obviously there's been a lot of questions around this new product. I think it's just timely that we inform the market as to one of the key areas we are focused on in our R&D spend. There's been a lot of speculation out there and, by virtue of the fact that we've told the market today of what the product is, even its brand name that's registered, people should feel comfortable in the fact that we believe we can bring a transformational product to market. Great. Thank you. Just finally, perhaps for me, maybe also for you, the R&D spend in actually doing the clinical trials for this, is that going to be a material one-off step up or is it you can cover that within the current percent of sales that you're spending? Yeah, we'd be able to cover it. Yep. Great. Okay. Thanks very much. Thank you very much. All right. Thank you. There are no further- With that, I'd like to thank you everybody again for joining the call this morning. Hopefully, you now have a better understanding of the results that have come out and understand the importance of what was achieved in the second half of the year with that very strong growth, the fact that we've got excellent ongoing opportunity for growth, which is probably even bigger than for Trophon than originally anticipated, and an exciting new product pipeline. With that, I'll leave you all, and thank you for your participation, and undoubtedly, I'll be speaking to many of you over the coming days. Thanks very much. Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.
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