Revenio Group Oyj (REG1V) Earnings Call Transcript & Summary
November 30, 2023
Earnings Call Speaker Segments
Erkki Tala
executiveGood afternoon, everyone, from snowy Finland, and welcome to Revenio Group's Capital Markets Day 2023. Live audience here in Sanomatalo, in Helsinki and you who are watching the live stream from this event. You're all warmly welcome. My name is Erkki Tala. I joined Revenio 6 months ago from international optical retail business with 20 years background in GrandVision and Specsavers. Today, I'm hosting this event for all of you. Our previous Capital Markets Day was in 2021. From today's perspective, the world was in pretty balanced order. Last few years have been time for global crisis and financial instability. Revenio hasn't been immune to all these challenges. And this year, we have faced some headwind from the market. However, our fundamental business strengths remain, and we have refreshed our strategy for the period of 2024 to '26 to respond to changes in the market. And today, we are excited to tell you the best part of all that. We have got an excellent lineup of presenters today. First on stage will be our CEO, Jouni Toijala. Jouni will start by presenting a short flashback from the last CMD. What have been the key business deliverables since that? And what's the pulse of the business now? He will then raise the eye level to the future, frame the refreshed strategy and explain the rationale for choices made. Jouni will hand over to Kate Taylor, our Vice President for Strategy and Business Development, and Kate will present you some key insights on the current clinical trends and their chains, delivering strong basis for revenue products and solutions and impacting strongly on our product strategy. Tomi Karvo, our Vice President for products, brand and marketing will then take the baton from Kate and give you a solid view of our evolving product strategy. How we are structuring our offering? What is the ecosystem we are building to connect our devices and solutions seamlessly together? How do we differentiate ourselves in the marketplace? After Tomi's presentation, we have got time for a short break. As we are then fresh back from the break, John Floyd, our VP for sales will lead us to the market and customers. What is Revenio's market? What is the U.S. -- what are the USPs we are having? Who are our key customers? And how we make sure we reach them? Where do we see potential for growth? Finally, John will then hand over to Robin Pulkkinen, our CFO, for the last presentation of the day. Robin will present some key elements of our rather unique business model from a financial perspective, talk about our growth pathways and review the guidance for this year. And when Robin has finished, CEO Jouni Toijala will be back on stage summarizing the presentations. Before we move on to the Q&A, where presenters are ready to answer all your questions. [Operator Instructions] Please notice the disclaimer since today's presentations include forward-looking statements. And now with this note, Jouni, please welcome to start.
Jouni Toijala
executiveSo nice to see you all here. And then, of course, behind the web. My name is Jouni Toijala, and I'm the group CEO. And the plan, as Erkki said today. So I'm going to recap a bit before going to the future part. I'm going to look back a bit at the start because it's actually 2.5 years when we last time had the CMD. Feels kind of a short time, but time flies really, really fast. So if looking at the time March 2021. So at the time, we had our tonometer business. We had the fundus imaging business, we had the perimeter business. We didn't have software assets at the time. And if you recall back, so the April 2021, we closed the Oculo acquisition. With that acquisition, we got assets, IP, an excellent team related to the eye care specific software solutions. So that was kind of a key changed in our strategic path, which we covered during the 2021 CMD. Then if looking back and looking the growth in revenue. So we have been able to grow quite fast. But under the hood, we have been actually doing a lot of things not only on sales, but we have been scaling up our operations globally. We have been hiring even the head of the HR, Head of the IT. So we have been putting a global processes in place in addition to operations in HR, in IT. And then at the same time, we have also renewed our whole product creation process. But I come back to that one in the coming slides. Then 2021, CMD, we laid out down 5 key cornerstones. So the first one was to have a full focus on eye care. If you go back the early 2021, so we have been -- sticked with that plan. So all capital has been allocated to the eye care related business. And at the time, we divested the Cutica and Ventica businesses. Then secondly, we said that we are going to improve the quality of clinical diagnostics with targeted product innovations. So if we look back and we look what we have been able to get into the markets in the last 2.5 years, so new home products or the HOME2 approved across the globe has the FDA approval. In addition to that one, we launched the EIDON Ultra-Widefield function via our EIDON family. A quick measure for the IC200. So you can test it actually here, if you are live here, so you are able to test it. And then lots of various software releases for the different products, whether they are perimeters, whether they are fundus imaging devices. And the latest actually from this month, so we launched a new software version 4.0 for our COMPASS perimeter product. Then like I said, so we laid down 2021. So we laid down a cornerstone related to the -- being present in the eye care pathways and optimizing the eye care pathways in the future. And for that one, we managed to close the Oculo acquisition and based on the Oculo assets a bit more than a year ago, we then launched the iCare ILLUME software platform. So that's a combination of the DRSplus device, then the ILLUME cloud and through the ILLUME cloud, we are also able to include the different AI players part of the package. Then fourthly, we said that we are going to build on the eye care brand awareness and then the customer experience. And Tomi is going to cover a bit more details on this one, but we have been able to grow the aided brand awareness and we have been able to elevate our brand position. But I'll let Tomi to go those ones, those things through. And then we said 2.5 years ago, if we do these 4 things well, we are able to then grow in a profitable manner. And if we look the past years, and we look at the average growth rate of the market compared to our growth rate on the sales side. So we have been able to grow in last couple of years, roughly 5 to 6x faster than the market, i.e., we have been able to take the market share in all our segments where we operate. But let's start to look for the future. So a couple of things here. So the bottom line is that we are in a growth industry. So that is just a fact. So all the macro drivers are backing that one up. And the need of eye care, so that's growing globally. There's a couple of drivers on that one. I think everybody knows, at least time 2.5 years older than I was in the last CMD, so the people are aging. Then secondly, lots of lifestyle-related diseases like diabetes, so they are starting to pick up. So really, the amount of the patients, they are really, really growing. Then on the hindsight, then if you look at the resources of the health care professionals, eye care nurses, doctors, I mean the workforce is static, even the patient amounts are increasing. The workforce remains static, and we are going to have a big gap on these ones. And Kate is actually going to cover in her presentation, the more clinical view on this one. And then Kate is also going to touch more -- in more detail the dynamics of the workforce. So really looking forward to that one. So to overcome this unbalanced situation, we just have to find a ways of working so that we work way, way smarter. So if we then start to look and put the lens towards the future. So our future looks like that we are planning to keep the wonderful word visible for all with a developing connected and predictive eye care pathways. So I go that one in a detailed a bit more later. So if we look past, so we had revolutional technologies and products tonometers, fundus imaging and the perimeters. If we are on the present state, so we basically have the same set of products, new versions and others. But then we have enhanced that one with the software solutions. So what we now have part of our portfolio, so we also have the innovative ophthalmic solutions. And then when looking at the future. So the next phase for us in the next 3 years is to build and bring more connectivity to our solution. So what does that mean in practice? So in practice, that means that we are going to connect the devices. We are going to connect the data, we are going to connect the patients and then the health care providers in a one package. And Tomi is actually going to cover this one in more detail, and we have a slightly new news on this one as well in the future. Then in many, many occasions, whether it's investor calls, whether is it analyst calls, we have been constantly -- we have got the question that are you able to define the new markets outside of the ophthalmic diagnostic device market? So here we are. So traditionally, if you look for past, we look to present, we look for the future. So we have been playing in an ophthalmic diagnostic device market, which 2.5 years was USD 3.3 billion. Now it's USD 3.4 billion, USD 3.5 billion. We roughly have a 1/3, a bit more than USD 1 billion. So that's tonometers, that's fundus imaging, that's perimeters. Then in addition to that, with the ILLUME, we expanded the market to the DR screening business. And based on our assumption based on our calculation, by 2030, that market is USD 1 billion. And how we actually got there? So Kate is going to go through in her clinical part that. Then for glaucoma home monitoring solution. So that's a new thing. If you go back in years, I have been working for Revenio 3.5 years, roughly. So it's a constant question that we get. So now we have a figure for that one. So glaucoma home monitoring solution market, based on our assumption and calculations, roughly USD 750 million by 2030. For that one, we need to get the same way than in the DR screening, we have to get the reimbursement in place in selected markets. Then if we go to the nonorganic growth area. So we have been doing extensive study. So we actually asked the question from ourselves that how big is the eye care market? What growth pockets we have in eye care market? And we covered through the vision care. So there, you have spectacle frames, lenses, contact lenses, et cetera. So we said that that's not where do we want to focus. Then we went through the ophthalmic diagnostic device market and identified that we have plenty of growth pockets in that one. So that's going to be one of the core areas where we want to focus in the long run. Then the next big part is actually the surgery IOLs, et cetera, we said that that's not in our focus. So there's really, really big established players in there. So not for us. Then same for drugs. So not going to go there. And then the last part is actually the eye care-related software solutions. And that one, we also identified as one of our growth areas for the future. And then we roughly screened out about 800 to 900 companies and built up a short list. And based on that short list, we started to compare that one to the areas, which we don't have from the ophthalmic diagnostic device market. And we ended up that those which are interesting for us. They are the other -- kind of the other third. And this is the area that where we are spending time also in the future. But I want to point out that, that's not currently the market where we are operating. So in order to be growing -- in order to be scaling towards the connected and predictive eye care pathways, we have a following cornerstones for the next 3 years. Number 1, in product quality of clinical diagnostics with the targeted product innovation. So that's exactly the same what we had 2.5 years ago. So the goal is really to keep investing to the R&D, bring competitive products out, bring new software solutions out, and that hasn't changed. So that's a core of our success. Then we are going to continue to optimize the clinical care pathways with the connected and predictive solutions. So that's more or less the same, but there's a kind of a small spin around which is different. And the difference is connectivity and then it's the predictive part of it. And on the predictive part, the data and the AI is going to play a significant role. Then third one, enhance customer focus in operations and sales. That's the third one. I'm going to cover that one through in more detail in a later phase. And then people and culture. We didn't have a people and culture last time, I say, foundational strength. And I'll come back to that one why we actually elevated that one up. And then again, the same thing. If we do all these 4 things right, we are sure we are able to continue our profitable growth. But let's jump to the specific areas. So let's start with the improve the quality of clinical diagnostics with targeted product innovation. So a couple of examples here. And the plan is to keep innovate even further. So this links back to our continuous investment. So roughly 10% out from the revenue goes to the R&D. But under the hood, we have done many things in the past 1.5 years. So we have renewed, as I said, our whole product creation process. We have renewed our ways of doing the research, identifying forthcoming technologies. Then we have a research projects on those ones. We have been heavily working on the IP landscaping side. And then, of course, to kind of find out what's the right process to actually combine the hardware and the software. And the ILLUME being the one prime example. So specific software in a device and then we have a cloud software and the functionality and the seamless interaction between them. And then, of course, if looking for the future, so we have a compelling road map for all the products when going forward. Then the second area to optimize clinical care pathways with connected and predictive solutions. So the Phase #1 for us was to actually finalize the Oculo acquisition. So we got the cloud-based asset for eye care specific software. We got an excellent team, and that was kind of a start. So if you look at the other industries, whether is it industrial Internet, whether is it automotive, consumer electronics, you just name it, so there has been the slogan for a long time that the software is going to eat the world. So the software is going to eat the med tech world. It's just going to happen slowly because we have a tighter regulation in place. So that was the phase #1. So we really needed a team. We needed all the IP. We needed the platform assets. So we got those all through the Oculo acquisition. And then on the Phase II, based on that team based on all those assets, we actually build up in really fast manner the iCare ILLUME platform. So the Italian team did lots of good work and build up features and functionalities into a device that with the single press of the button, images go to the ILLUME cloud. Then the cloud takes care that we circle them around. And then we have a report in really rapid manner. And if we have a Phase I here, then we have a Phase II here. So we have a Phase III as well. And Tomi is actually going to cover what's to be expected in a Phase III. And kind of a prehint on that one. So that's related to data. And that's going to be related to connectivity and predictive ways of doing things. So -- but I'll let Tomi to go through that one. Then enhance customer focus and operation -- in operations and sales. So as everybody knows, our business model is extremely scalable. We don't have a manufacturing. If we want to ramp up as an example, R&D projects and have more products on the pipeline so we can quite flexibly fix that we do core things by ourselves, and then we subcontract the other parts. So this is going to be a key for our future as well. So we want to work. We want to grow with all the players who are our partners. So that's going to be kind of a close to our heart in the long run. So it gives us agility, it gives us speed in the long run. Then throughout the whole supply chain, we are going to be committed to global supplier code of conduct. So I'll come to the ESG part a bit later, but that's the target. Then moving to sales side. So John is, of course, going to do the deep dive to the sales. But we are going to invest on the iCare brand and customer experience. Then we have been constantly doing the distributor channel choices. We keep doing that one. But one of the main new things here is really to have a focus and start building the new non-ophthalmic distributors -- the distribution channels for our screening business. So this is a new thing we have been already, of course because of the ILLUME. So we have been building this one, but this is new, and this is an important thing to get here. And then, of course, manage to continue working with our key opinion leaders, whether it's the product development, whether is it a bit like the videos that you are going to see today. So that's going to be high on our agenda also in the future. Then people and culture. So why we picked this one up. And I want to spend a bit of time on this one. So I think if you look back not to our CMD, we will look back to early 2020 when we got the COVID. So I mean, at least for me, difficult time to start at Revenio. So I was kind of -- I started May 2020. But in overall, the uncertainty of COVID, where it's going to go, what's going to happen. Okay, we thought COVID is over. We got the Ukraine war. We got the unstable geopolitical situation. After that one, we got high inflation. After that one, we got high interest rates. And if you think that one from the people perspective, if you think that one from the team perspective, then there's also increased load of delivering and executing at work. So at least that's what I have been feeling is really thinking this one. So we have been spending quite a lot of effort internally to actually helping people to realize that they even have to sleep every now and then. They perhaps need to exercise. They perhaps have to eat healthy food and so far don't take care of their well-being. That's going to be high in our agenda in a long run, and that's one of the fundamental things why we wanted to also elevate the people and culture part as a foundational strength when going forward. Then we have to guarantee, of course, in order to be able to execute the strategy. So we have to be sure that we have the right people, right competencies in place. Then the plan is to further strengthen our positive employee experience and also the employer image. So we have been able to get really well the people in, but of course, more work to be done. And then the plan is continue cultivating the values, the culture and the ways of working. And here, really the key is that how do we combine the ways of doing hardware, the ways of doing the software is going to be crucial for us in a long run. ESG. So we have been working with that one for a longer time already. So no big changes there for key items here. So we improve the quality of life. That's as it was before. We are going to grow and develop together at least, of course, links to our internal team, but it links to our external partners as well. And we nurture the environment. So here, again, the plan is to have a compliance on environmental conscious design standard when going forward. And then we act -- responsibility -- in the responsible way and transparent way, so we have a code of conduct or we have had it for years. And when you join the Revenio, you have to read the code of conduct. You have to sign it in our HR system, so going to be high on our agenda as well in the future. But let's start to summing the first part up and really looking forward to get Kate on stage because that's a new thing to get the more clinical view. But I'll summarize here. So in the long run, the plan is to scale towards connected and predictive eye care pathways. So we do this one by improving the quality of clinical diagnostics with targeted product innovations so still continue to invest, both in device development and on the software platform development. Then we are going to optimize the clinical care pathways with connected and predictive software solutions. Here, Oculo acquisition was Phase I. Retina screening solution ILLUME Phase II. Tomi is going to have a bit more information where we are going in a Phase III. And then enhancing the customer focus in operational -- in operations and sales, and then as I said, so we are going to elevate the people as the foundational strength when going forward. And we do these ones, right? So we are able to grow in a profitable manner. Thank you on my behalf. And with these words, I would like to let Kate to the stage.
Kate Taylor
executiveThank you, Jouni. It's a pleasure to be here today. My name is Kate Taylor. I'm the Vice President of Strategy and Business Development. I started live training as an ophthalmologist and then worked with McKinsey & Company when I left clinical practice. And I've spent the last 20 years working in global health innovation, including as the founder of Oculo, a clinical communications and referral platform that was acquired by Revenio 2.5 years ago. So it's my pleasure today to talk to you about the clinical context underpinning our growth strategy. I think the first thing to be really clear about is that we are addressing a big and important problem. The numbers of people affected by eye diseases are huge and growing. This is because, as Jouni said, populations are aging, and lifestyle diseases are growing. Most of them, many of them have eye-related complications. If we look at some of these leading causes of blindness and vision loss around the world, we see 80 million people with glaucoma, 0.5 million -- sorry, 0.5 billion people with diabetes, of whom 100 million have diabetic retinopathy sight threatening blinding eye disease due to their diabetes. Nearly 200 million people with age-related macular degeneration and over 1 billion people with myopia or shortsightedness, and these numbers are growing. But there's hope. Globally, 90% of vision loss is either preventable or treatable. This is such an important challenge to overcome because of all of these diseases in all of them, an unacceptably high proportion of patients are either undiagnosed or untreated. So there's a lot of work to be done. And at the same time, these diseases are all chronic and progressive. And this explains why it's so important to think about them in terms of care pathways. So that you have the data for the treatment and the care of the patient at every step of the time when you're looking after that patient. So let's look at these key care pathways and how they can be changed and improved, including through our products and strategy. Before we do that, though, let's look at what Jouni was talking about, these limitations in our ability to care for our patients. This is some American data. And on the left, it's historical data from 2012 to 2020. And what you'll see is the blue line is the number of American ophthalmologists. And the red line is the number of ophthalmologists that would be required to care for the patient demand. That's the graph on the left, and you see the gap is widening over time. On the right side, we're looking into the future, and this is looking at the numbers of ophthalmologists in the coming years, which are predicted to decrease. This is because, according to the American Ophthalmologist Association, the average age of an ophthalmologist in the U.S. is 54 years. So even as we're graduating new ophthalmologists, the replenishment is too slow to refill the pool. At the same time, as we said, the demand of patients is due to increase by about 1/4. And so we have this progressive workforce inadequacy reaching about 30%. About 1 in 3 patients, we don't have enough doctors for. Despite the optometric workforce, which is clinically competent and active in the U.S., which doesn't exist in many, many parts of the world. So if we put this American example in context, worldwide, there are 212,000 ophthalmologists, but over 2 billion patients. So what are the eye diseases that we're going to struggle to face? Well, let me start with the glaucoma care pathway. Glaucoma is an optic neuropathy, a disease of the optic nerve. It's a diverse group of diseases. And people with glaucoma suffer from a progressive loss of the nerve cells that take a visual signal and transmit it back to the brain where we -- it gets interpreted as vision. Glaucoma typically occurs in people over the age of 40 and its prevalence increases with age. Genetics are really important. And so if you have a first degree relative with glaucoma, you have an eightfold risk of having glaucoma yourself. And also, things like African and Asian ancestry are also risk factors as are chronic diseases like hypertension and are diseases on the rise, like myopia. Unfortunately, in high-income countries like Finland or my country, Australia, about half of people with glaucoma will be undiagnosed and the numbers are much, much higher in low and middle-income settings. Diagnosis and treatment are really important because vision loss that occurs with glaucoma is associated with increased morbidity, reduced quality of life, reduced independence and increased health care costs. Now the way you care for glaucoma is you manage intraocular pressure, the pressure inside the eye or IOP. And that's the major modifiable risk factor. So when you're looking to treat it with drops or with surgery, that's what you're trying to change. So a lot of attention is paid to what's the highest or the maximum IOP. And fluctuations were just changes and the amount and the degree of changes in IOP are an independent risk factor additionally. So why does it matter to know IOP? As I said, glaucoma is a chronic disease. This diagram from a clever professor from Moorfields [indiscernible] from the Lancet shows the changes that happened. On the left side of the graph, you've got a normal patient. On the right side, you've got the eye from a patient who is blind from glaucoma. And although it's a little bit small, what you can see is the optic -- if you look at the arrow sign, the optic nerve, which has started as a lovely yellow, healthy circle there, progressively becomes paler and paler and it ends up looking like a white dot as the nerve cells die. If you look at the next middle row, these are the visual fields that we can measure with perimetry. And where it's white, that means the patient is perceiving light, and where it blacks out, that's where the patient has stopped seeing light. And what you'll see is this progressive loss from the periphery into the center of vision of the patient's ability to perceive light. What's extraordinary is if you look at the bottom row, you'll see the patient's perception. And this is really important because the brain is so good at filling in the blank that even with really severe vision loss, patients don't necessarily perceive how little they are now seeing. And that means that they aren't presenting to say, I need help. And so screening for glaucoma, is really important because that's how you find patients. Screening is complicated, however, because half of patients with glaucoma may have normal intraocular pressures when tested. And so it's important to be able to see the back of the eye and look for those changes in the back of the eye. And this is where we're so excited about the opportunity for AI supported screening to be able to get screening to more patients in more convenient places. And they become all sorts of opportunities as well beyond screening, but in treatment for predictive AI so that we better tailor treatment. Once we diagnosed a patient with glaucoma, the main stay of treatment, as I said, is to manage their intraocular pressure. And let me just talk for a minute why remote patient monitoring or ambulatory monitoring or home monitoring of intraocular pressure is so important. Because of the chronicity and progressiveness of glaucoma, you have to monitor the patient over time. And you usually do that by bringing the patient into a clinic and checking their pressure and taking their fields and having a look at the back of the eye. But every time you're going to make a decision based on their intraocular pressure, you actually want to know what the real intraocular pressure is. And as I said, intraocular pressure like blood pressure or like blood sugars will go up and down throughout the day. And if you're simply taking one measurement in clinic, you don't know if you caught the highest measurement, the lowest measurement, an average measurement, you don't know from a single point what those trends and fluctuations look like. And so you can't actually make a fully informed judgment on the patient's management. So at each step of the management pathway, if you truly want to understand the patient's IOP, you need to understand their ambulatory or their home IOP. And that's where we're seeing the changes in the traditional understanding of routing glaucoma management to include ambulatory or home monitoring. Home IOP monitoring is one of a number of clinical trends that are rapidly changing in glaucoma management. And I have to say it's quite fun because glaucoma has been a really boring part of ophthalmology for a long time, and there's a lot of new science and a lot of new hope that's coming forward. So we talked about some of these, the increased availability of screening, the wonderful changes that are happening in the options for treatment, things that are much less invasive than traditional surgical treatments and much more effective often than the traditional eye drops. As these new treatments are coming to market as they're under development, we need new methods for monitoring glaucoma. And again, what we're seeing is this is also translating into increased reimbursement for remote patient monitoring, which of course, is a wider trend in health care across all diseases. So as Jouni said, how do we see the market opportunity for home IOP monitoring? Our internal business modeling builds on the disease projections that I've just covered, for the coming years and the huge numbers of patients under management and moving through glaucoma care pathways as described on the previous slide. We've looked and conducted detailed assessments of the markets, looking at the dynamics of the glaucoma patient population, the patterns of medical and surgical treatment, the values of the markets for eye drops and therapeutics, surgeries and clinical services and the projected growth in these categories. We've looked at the added medical costs of glaucoma treatment and vision loss and the trends in ambulatory patient monitoring. And so what we see over time is with progressive reimbursement for the market for home IOP monitoring will grow from being [ EUR 150 million to EUR 750 million ] by 2030. As I mentioned, it's critical as we unlock more reimbursement so that more patients have access to this and more clinicians are using it freely. All right. Changing gears slightly, let's move to the retina related care pathways, and I'm going to start by focusing on age-related macular degeneration or AMD. Now AMD is the leading cause of blindness in patients over the age of 65, and it affects up to half of people aged over 80. This is about 200 million people today, growing to nearly 300 million people by 2040. And increasingly, these patients will be living in low and middle-income countries as those populations also age. AMD is a really hard disease if you get it. If you imagine putting a fist in front of your eye and looking through it, you can't. You've lost your high-acuity central vision that enables you to see faces and to read and to drive, for example. And so AMDs are associated with a significant reduction in your quality of life, in your independence and mobility, and it's associated with greater risk of falls, isolation and depression. There are 2 major kinds of AMD. There's the dry atrophic kind and a wet or fluid in generating kind. And there are different diseases but can cross over. Now geographic atrophy or the dry AMD has been a terrible disease because if someone has it, essentially, we have had nothing we could do, except say, I'm very sorry, you're going to progressively go blind. But this year has been extraordinary because we've had the first 2 therapies cleared to be able to treat dry AMD or geographic atrophy. So the first time there's something that we can offer patients to slow their vision loss. With wet AMD, we've had some groundbreaking treatments now for a number of you, many years, but they rely on monthly injections into the eye to stay on top of the disease. And this is a heavy burden of treatment for patients. Excitingly, what's happening in wet AMD is a number of new therapies from gene therapies to longer-acting agents so that you can delay the periods between treatment and personalized treatment regimens better for patients. These therapies increase the need -- both for dry AMD and wet AMD increase the need for personalization of treatment, which means we need better home monitoring. We need to be able to detect geographic atrophy by optometry and general ophthalmology because they're not yet patients who are under the care of specialists -- ophthalmologists. We need technologies to support treatment personalization, and we need better technologies to monitor the very many trials and to support the implementation of novel treatments as they come to market. So this translates to a growing need for microperimetry like the MAIA, for tools for detection and screening like the EIDON and DRSplus and ILLUME, for home monitoring with OCT with visual fields and with home and IOP monitoring and in future for clinical decision support tools. Still focusing on our retina care pathways and linking our screening care pathway. Let's look a little bit at diabetic eye disease. Now diabetes is frankly a global disaster with about 100 million people developing diabetes between now and 2030. Diabetic eye disease is already the leading cause of vision loss in working-age people. This is a tragedy because it doesn't have to be like this. Diabetic retinopathy occurs in 30% to 40% of people with diabetes, but 100% of people with diabetes are at risk over time. 95% of the vision loss from diabetes can be prevented if people are detected and treated early. It's an incredible opportunity to save sight. However, half of the people in the developed world in the high-income settings with diabetes don't get their recommended eye tests, and it's much worse in the middle- and low-income countries where 80% of people with diabetes live. So telemedicine screening programs are proven to increase patient attendance, adherence and to reduce the proportion of patients who get vision threatening diabetic retinopathy. And so there's a real logic to the trend that reimbursement for AI-based screening should gain traction. So given the economic and growing -- the enormous and growing burden of disease, the static workforce screening for diabetic eye disease clearly needs these new ways of working. And this includes moving screening from outside of eye care clinics because too few patients get to them, moving screening to where the patients are, sometimes retail settings, sometimes emergency departments, sometimes endocrinology or diabetes clinics, sometimes primary care, wherever the patients are. And to succeed in doing that, it's really important that when you take the picture that's going to be graded, it works that you actually get a gradable image. And what we see in the literature is that with many cameras, only about 60% of those photos can actually be graded. And that's a fantastic comparison to the DRSplus, which has image ability, which means if you take an image, you can actually grade it, well over 95% in the literature. So we're excited about that. We see that as creating a really significant market opportunity for ILLUME and for the DRSplus and for our screening pathway. We have modeled where we see that to be, taking into account the numbers of patients with diabetes, the patterns of patients with diabetes in contact with health systems and other care points, the dynamics of screening reimbursement in the U.S. and elsewhere around the world, where we're seeing more reimbursement. We looked at the large markets that exist for the medical and surgical treatment of diabetic retinopathy. And we looked at the health system costs that can be avoided by avoiding vision loss from diabetes. So putting that together, we see the market for diabetic retinopathy screening as $700 million in 2024, growing to $1 billion in 2030, with additional opportunities for device sales. So to summarize for the last minute, the key points. The growing burden of eye disease and the static workforce, increased the need for new diagnostics, better connectivity and data-driven solutions. The critical eye disease that we face globally are chronic and progressive. And so for continuity of care, we need to have data throughout care pathways. It needs to be available whenever it's needed. There are new therapies that are coming on board that are changing the need for a number of diagnostics devices and data solutions. This includes microperimetry, autofluorescence and photography and imaging, predictive personalization and remote patient monitoring to manage glaucoma and retina care pathways. The evidence base around the role of intraocular pressure in glaucoma progression and management as an independent risk factor with understanding that not only the maximum, but fluctuations is growing. And so that translates to an increased need for home IOP monitoring. There is a surprisingly fast acceptance of AI as a screening tool and for clinical decision to support, and I say surprisingly fast if you think about the conservative rate of technology adoption that often is present in clinical medicine. And there are tremendously exciting advances in clinical practice and technology that really align with growth opportunities for Revenio. And with that, let me hand over to Tomi, who will talk to you about how the Revenio product portfolio is going to address these growth opportunities. Tomi?
Tomi Karvo
executiveGood afternoon, ladies and gentlemen. So my name is Tomi Karvo. I'm responsible for the products, brand and marketing. Now 8 years in eye care. My earlier background, my work experience is from selling and marketing medical devices for almost close to 30 years, so a long time. But it's really great to be here today. So I'm going to spend the next 20 minutes looking at how we have built our product strategy and how does our vision for our extended portfolio of products look like in the future. So the major things that we have taken into account when building the new product strategy are related to the global factors that Jouni and Kate have been going through there. So the demands for the care systems, the burdens of eye disease is growing and all that. Then we have taken a careful look on what are the strengths of eye care. So what have we done really, really well in the past? And what can we utilize out of that in the future. Then taking a careful look at the competitive differentiation. So we definitely don't want to do the same thing what the competitors are doing, but we want to find our own niche. And so what are the products that go -- solution products that go in there. Then one of our core competencies is understanding the customer. And now in -- at this phase, we have taken a careful look at what are the workflow efficiency needs and clinical decision-making needs that are needed so that we can succeed in the future. And like Jouni mentioned, we have done quite an extensive analysis on any defined growth opportunities within the iCare diagnostic area. So if we start from the high-level top story, vision, strategy nothing has actually really changed like you have seen. So we -- our aspiration is still to keep the wonderful world visible for all. We aim to be the leader in patient-centric, ophthalmic screening, diagnostics and monitoring. And there, you already see the difference. So here's the word screening, which we will be focusing on in the future. And I would like to emphasize the word patient-centric, which is really 1 of our core competencies. And what it means now going forward is that we build solutions around the patient, also for the patient, but around the patients because data is becoming extremely important. So everything that we do is easy to use high quality around the patient and then data available for care pathways and decision-making. So our innovative solutions bridge devices with the software to improve diagnostic confidence, workflow efficiency seamless connectivity in glaucoma and retinal diagnostics. So here, a couple of points, solutions. We may have been focusing a little bit on selling devices in the past. Now we focus on creating solutions. And we focus on glaucoma and retinal care pathways. So a busy slide, but if we take a look at the customer segments where we work on, so all of these customer segments that you see there are segments where we today work on. So from traditional optometry, ophthalmology to non-ophthalmic segments, patients and pharmaceuticals. They all share certain requirements that on the bottom, so efficiencies, access to data, clinical confidence. And this we have in built into all of our products. But I think that our success factor has been that we have been able to take into account the specific needs of different segments and then build solutions for different segments. And that naturally in the past, has been mainly -- or the growth has come from the traditional segments. Now we have solutions in each of the new segments. So taking as an example, the non-ophthalmic segment, where we have now had ILLUME solution for about a year on the market. And it is proven to be a very, very fast-growing business. And we have examples from many, many countries in Europe where screening programs are taking place. It's also south in Africa, in Arabic countries, in the U.S., so all over the world, this business area is growing, and we believe that it's going to be one of the fastest growing for us in the future. Patients we have been working with for a long time with remote monitoring and home solutions. And like now mentioned already many times here, depending on the reimbursement successes or cycles in different countries. It's going to keep on being one of the most speedy or most fast-growing segments for us in the future. Research universities, pharma, Kate was talking about the new treatments, new drugs coming to the market, which require certain devices to be clinically proven and we have been on this segment. And next year, we are introducing the new MAIA, and we believe that with that, we are actually going to also get to a very nice growth path. So focusing on growing faster than the market in the traditional segments and then having some high-growth areas in the new segments. And maybe I'll just mention the bottom part, which is becoming more and more important. So the connectivity and integrations to all the places. So building an ecosystem in the future, we need to be able to integrate and interface with everybody, so be open. So a couple of words on where we are today, where they're coming from. Where do we want to go. So 20 years ago, we got to the market with the tonometer technology that has proven to be fantastic, and we are #1 tonometer company in the world with our tonometers. About 5 years ago, integrating with Centervue imaging technologies, the same thing. So I would claim that we have the best high-quality, high-resolution imaging devices in the world. So we have had really, really good unique technology that we have brought to the market. But we have been working in kind of niche segments, selling devices. And then with the acquisition of Oculo taking the assets, taking the knowledge from software, we have been now -- we have included or integrated clinical communication solutions and we have been able to create the ILLUME solution for screening. So we are already now able to offer some of the solutions. And this will continue in the future. So this is our path. We want to continue adding new diagnostic devices, hopefully, with similar success stories than in the past, and we want to invest in software. So adding data solutions so that we can really collect the data, view the data, provide the data for different caregivers. And then working together with AI, so working together with partners like we do today and create AI-assisted solutions, no matter what it could be because already today, there are new approvals for AI as the solutions for, for example, systemic diseases being detected by AI, for example, cardiovascular diseases. So this could be one of the new segments for us in the future, that will be a growth area for us. So where do we start when we start now going towards building care pathways, what do we have today? So if we want to go towards managing and creating a good glaucoma pathway. So like you've heard the glaucoma detection is including main 3 measurements or main 3 types. So IOP measurements, evaluation of the optic nerve head and visual field testing. And I strongly believe that we have a unique solution already today. Nobody else has the same. So we basically have all the devices that do it. They are high quality. They have the special benefits for the customers, how it's done related to our rebound technologies, related to the new combos that we brought to the market just now the automated track perimetry and the software that we are able to provide to the patients and to the clinicians to actually to do long-term monitoring. So already today, we have a solution that is unique. And the next things are going to be related to data and data management. But hey, let's take a look at the -- one of the technologies so that we don't forget where we're coming from the IC200 in the short video. [Presentation]
Tomi Karvo
executiveIC200, and this year we introduced a new version of the product with a quick mission, making it even easier to use with complicated cases. Next year, we are going to be adding products to our glaucoma portfolio. So it will be even a more versatile offering in glaucoma. So if we do the same thing with the retinal side, what do we actually already have today and how do we start building the care pathway system. So here, we also have a unique offering. So with the best image quality and the ease of use and the automated ways of working. I mean it is a wonderful place to start from. So there are true colors, the high resolution, the ultrawide field images. We actually give tools to the doctors that they can detect, they should be able to detect most of the pathologies from our images. They are easy -- really, really easy to use. And I think that you will hear from our KOLs during the break, what kind of experience that they have had with the product. And one of the big benefits related to resources is that they are so easy to use it that they don't always need high level -- highly skilled technicians, but they can be used by almost anybody, like myself even. And this is especially true with the DRSplus that together with the ILLUME software has made it possible to enter the retinopathy -- diabetic retinopathy screening. And I will let now video explain to you how versatile the ILLUME is and where it can be used, how does the workflow work outside -- or also outside of the ophthalmic area. [Presentation]
Tomi Karvo
executiveSo as you have seen there, the ILLUME and the DRSplus can be used outside of the ophthalmology or in any hospital setting. Then referrals are included and specialists will be taking care of, if needed, the treatment of the patient. So how does the full portfolio or strategy? How does it look like? So here you -- hopefully, everybody can see the 2 care pathways consisting of different phases, starting with the screening going into examination and going into follow-up and monitoring so divided into diagnostic and management parts, and the blue boxes in the picture are the products that we already have today. So we can quite well cover most of the needs that are related to diagnosing, retinal pathologies and glaucoma. However, there are certain areas that we have identified and the extensive work that Jouni was talking about, this is where we want to add. So we have identified a few very interesting product areas. And if we are able to do that, that would double our addressable market size from EUR 1 billion to EUR 2 billion. So adding new diagnostic products. And critical here are the software. So we already know today have the part of the clinical communications that it needed to connect the iCare professionals and the patients and the data. We have a screening solution. But what might be missing is the data management. So I actually have the great pleasure to show you the world premiere of the eye care data management system that is not yet available but it is a very important part of our solution. So you will be the first people to get a sneak peek of the product to be launched in 2024. [Presentation]
Tomi Karvo
executiveSo critical product coming to the market next year. And I just want to emphasize the importance here with this slide. So we are building a 1 platform, which is uniting patients data professionals for enhanced diagnosis and treatment. This will enable us to start creating collaborative care models by utilizing the data and doing clinical communications on top of the data management. It will enable us also to create or at least participate in creating efficient and effective care pathways. And this also is the road to assisted clinical decision-making. So by having the data available from different sources, we will assist the eye care professionals in making clinical decisions. AI can be added so that it can be another tool in making predictive clinical decision-making. All of this on a secure level, of course, because we are talking about a patient information. And as mentioned in the video, it's going to be 1 of the drivers for our device sales first, which we have now already seen with the ILLUM, so we have had great successes by selling a lot of devices because of having an excellent screening solution. Recurring software revenues will follow. So that has already started. But of course, in the beginning, it's smaller than the hardware sales. So summarizing here what do we aim to do. So we aim to be the leader in patient-centric ophthalmic screening, diagnostics and monitoring. We believe that our competencies in building devices and solutions are going to create a diagnostic confidence that nobody else can do. We do it in a patient-centric way by providing easy-to-use solutions which are safe, high quality for the patient. We create seamless connectivity so that we can actually take first steps towards being part of the ecosystem. And we will be able to start managing and creating efficient workforce. So our focus is going to be in traditional eye care segments, but finding new opportunities in new ones. Then the 2 care pathways, we will fill them with the solution made out of devices, tonometers, perimeters, funders imaging and new diagnostic devices and we focus on creating software solutions that connect the data patients and health care professionals. So this all, we package under the iCare brand and we worked through different customer touch points in the world, and this work has been going on for quite some time. And we have been quite successful. So we have been able to increase our aided brand awareness from 81% to 90%, so by 9 percentage points in the last 3 years, and we have become #3 within all the diagnostic device manufacturers measured by the Net Promoter Score. This work will naturally continue. But so far, so good. So key takeaways from my part. So we'll focus on building solutions for glaucoma, retina pathologies and screening. The base for our success is continued innovation in diagnostic devices and a sizable investment in building connectivity and seamless data solutions. We will expand our portfolio to include new diagnostic devices, and we will keep on focusing on creating superior customer experience and a strong brand. Thank you very much. I think it is time for a break. During the break, we will place some interesting KOL videos. So please don't go too far. And we'll be seeing you in about 15 minutes. [Break]
Erkki Tala
executiveSo welcome back from a short break. Hopefully, you have refreshed yourself and our full of energy for the next session. So we'll continue with the presentations, and we'll next go to sales. Welcome, John Floyd, to the stage.
John Floyd
executiveGood afternoon. Thank you all for joining us today. My name is John Floyd. I'm the Vice President of Sales. Give you a little bit of background on me. I've been in medical sales for a little over 25 years, almost -- actually almost 30 years, been in diagnostic ophthalmic sales for over 20 years in the last 13 of those 20 years I've been with iCare. So let's first talk about where it is that we are playing on, where our footprint is and our global sales, where we're delivering our products, and selling directly to customers. We're in over 100 countries across the globe with 5 sales offices in multiple regions. The regions we have sales offices are in Finland, Italy, Australia, China and the United States where I'm based. The United States is a little bit of a unique area for us or market for us because we use the only area in the world that we use direct sales force that work primarily or we have some that are independent and some that are direct employees of the company, but they all work together for iCare directly. We also use 130 distributors across the globe and those other 99 countries to cover the other regions of APAC, EMEA, Latin America and Canada. As Jouni mentioned earlier, the total global market for diagnostic instruments is approximately $3.5 billion, just under $3.5 billion in total revenue opportunity. There are obviously, it's not a balanced market across the globe. There are some larger areas. The top 10 areas include the United States, Japan, China, India, Germany, the U.K., Italy, France, Brazil and Canada. That top 10 segment of the market is representing 73% of the total global market for ophthalmic diagnostic equipment. If we extend that a little further and look at the top 20 market share, it represents about 88% of the total revenue opportunity in diagnostics. If we take it 1 step further and look at just the top 30, it represents 93% of the total global market opportunity and ophthalmic diagnostics. I find that important to illustrate because as you can see, it's a very compressed market, the top 30 markets represent north of 90% of the opportunities, so a very compressed market. So we talked about where we play. We talked about what the market opportunity is. Now let's talk about how we -- who our key customers are. We have broken this down into a couple of different segments. And 1 of our strengths in our portfolio of products is that we have a broad relevance across multiple different customer segments. In ophthalmology, for instance, that segment can vary significantly between not only different parts of the world, but also within country. What I mean by that is the settings for diagnostics can range from multiple specialties such as retina or glaucoma specialists. It can also extend into private practices into large clinics and into hospitals. What this translates into is that it -- these different segments within ophthalmology or have different requirements for different types of diagnostics. Example of that would be the EIDON AF or the EIDON FA. There's a primarily found -- on a global scale, they're primarily found in specialty clinics and large hospitals. Whereas if you look at our tonometers, our tonometers are available or you can find tonometers in any 1 of these different segments in ophthalmology. Optometry, again, on a global scale, can really be described in 2 different subsegments. The 2 subsegments are the clinical optometrists or medical model optometrists as we sometimes call them. These doctors are -- these optometry store focused not only on refractive care, but they also are managing some early stage and sometimes diagnosing for the first time, early-stage pathologies and patients and managing those patients for a period of time until it is needed to pass them off to a specialist. The other type of optometrist is the retail optical optometrists primarily focused on refractive care or lens care or selling glasses and contact lenses. Though we're seeing that market change over the last 5 to 10 years, they are beginning to expand with their services to provide more care for patients using screening technology, such as our tonometers and our DRSplus and being able to screen and diagnose patients earlier. Within some of these larger markets as well, there is the large retail chains, and they are becoming a very substantial segment of some of our bigger markets in the United States, for instance, they're quickly taking over double digits percentage of ownership and optical -- excuse me, well, optical or optometry market. And with these larger institute or larger groups, they are really needing or demanding reliable, reproducible, accurate fast and easy-to-use products in order to keep up with the demand that we keep hearing as the patient population continues to age and grow. Our newest customer is the screening segment the retinal screening segment, often happening outside of settings where your traditional iCare is taking place. As Kate discussed earlier, diabetic retinopathy is a common complication for diabetes. And it is imperative, imperative that these patients are seen screened or have full retina exam on an annual basis. It is for the -- it's imperative to protect your vision. The highly automated and easy-to-use DRSplus along with ILLUME is a great package for these types of offices to be able to provide this service in an effective way. And examples of these types of clinics is they've been touched on diabetes clinics, primary care clinics. But the beautiful part about this, as Tomi mentioned earlier, our products are extremely easy to use, so they don't take a lot of training or specialized technicians to be able to run these because you're not going to find them in those types of markets. The ILLUME platform that we've talked about as well connects the best-in-class AI, for example, the AI technologies and similar partners like Thirona, OphtAI and [indiscernible] just as a couple of examples. The AI takes the image data. It analyzes that data and then hands it over to the ILLUME platform that supports continuity of care for referrals when necessary. This combination gives the best-in-class image capability with fantastic AI technology, which we believe is going to set the standard of care and set the bar for what our customers are going to expect. We're already seeing very high interest in the market, though it is going to be a slow market to grow. We are seeing a high interest in the market, and we look forward to the adoption and the growth in the coming years. So we've talked about the market size, we've talked about where we're playing. We talked about the different segments. Now what makes people buy from iCare? Obviously, we're not the only tonometer company in town. We're not the only imaging device on the market, what makes them buy from us? The -- we'll start this and we'll break it down to the 3 segments again. With tonometry, it's reliability. Again, these clinics are seeing dozens of patients, in some cases, 100 patients a day. They have to have reliable equipment that is durable and will hold up. The other great thing about tonometers is the very low maintenance. There's very little maintenance. There's no calibration that's required. The minimal maintenance is required, it can be done by non-engineer nonspecific technician type of -- can be done by the customer, quite frankly. The other thing is reproducibility. And this is going to go across the board for everything I talk about on diagnostic reproducibility. I know we've talked about that a couple of times on some other slides, but the key to reproducibility in diagnostics is we're seeing these patients sometimes 1 year apart, sometimes 2 and 3 years apart. If you do not have reproducibility from 1 patient to the next or from 1 technician to the next it is very difficult to pick up on subtle changes in pathology. If it's not reproducible, you can't -- you have no benchmark to work from. So reproducibility is key. Our tonometers are highly reproducible, which as we have our reception after if you all are able to join us, more than happy to demonstrate the iCare tonometer on myself, and we'll show you just how we reproducible it is on myself. Patient friendliness. We talk about no anesthetics and no air puff. That was, I believe, where we started from with this technology. But I think really expanded as we got to grow and as we got to know our market even better 10, 12 years ago, obviously, this tonometer started with the idea in pediatrics to eliminate or reduce the need for exams zone or anesthesia in small children, and it has done that beautifully. We are beloved by pediatric ophthalmologists all over the world and their staff. But in addition to that, we've learned that it's as patient-friendly in many different areas that we probably didn't know about in the early stages. Another example would be a cataract specialist. Cataract specialists when they diagnose a patient or when they come to surgical conclusion with a patient to remove a cataract, there is a test they have to do called biometry. They're measuring the focal length or the distance or the measurement of the actual eye and in traditional ways of doing tonometry in the old days, they would use applanation tonometry, which is still around today, but what that does is it flattens the cornea is pressing the cornea. It disrupts the shape of the eye for a temporary period of time. But what that causes is after they've done applanation tonometry, they cannot do the biometry test. So they have to bring these patients back sometimes from hours away, these patients many times are elderly. They live 2, 3 hours away, and they're having to come back and they also disrupt the flow of the practice. Because the rebound tonometer, as you saw on the IC200 demo is so light to the touch and measures quickly. It does not disrupt the cornea and the patients can have that test done on the same day as the primary visit. I see that as extremely patient friendly, but it's also highly efficient. And then, of course, portability would be in a handheld device it's very portable. The imaging technology, we've talked about the outstanding image quality. That is, we can't say that enough. It is world-class second to none, and I know we're biased and I'm a sales guy. I'm telling you it is true. There's many, many different examples that you can find online, but we're also more than happy to show you our photos against anyone's photos in the industry. The ultrawide field lens that we have talked about briefly has really revolutionized the EIDON product that came out about 2 years ago. We call it an option for the EIDON. I will tell you that it is -- it's more of an option to not buy EIDON with an ultrawide field lens. It has just become the standard of care for the larger markets in optometry and ophthalmology. And not everybody in the imaging business can do ultrawide imaging. We're one of the few. And again, with phenomenal image quality on that. There's a photo we'll show in a second that will better explain that. Patient-friendly, the device is comfortable to use with the patient, as you will see in some of the videos from our KOLs. But it's also we use a true white light, LED light. And because of the technology, the confocality that we use we don't have to put as much energy into the eye. Any camera has to have a flash. But this were -- every camera puts energy into the eye and with the EIDON we're able to use a lower volume of lower intensity of energy to capture a high-quality image. That's very comforting to the patient. And it also requires -- it can be done in a very small pupil with no dilation, which makes it extremely patient-friendly. The automation. Automation sounds very generic. Automation is incredibly important to reproducibility because you have just as everyone in this audience has different skill sets. With automation, we all can take the same level of quality of image from the lease experience operator to the most experienced rather operator. And what that really means to me as well, and one of the things that we've talked to our doctors about is, now you can take your least experienced staff member and they become much more valuable resource to the practice and your more experienced staff member then can go around the practice and do other more say, sophisticated testing or take care of other issues that the doctor needs, which really increases efficiency, which is desperately needed today. Then we talk about screening. This one is easy because it relates back to imaging, all of the same reasons I talked about the image quality, the ease of use, the automation, but also the speed on this DRSplus is amazing. It will take a photo on the right eye, left eye, get back to its resting position in 30 seconds. And it doesn't matter who's running it. It will do it that quickly, as well as with all of our imaging equipment can easily go through corneal opacities as well as cataracts. Also bundled together with accurate and pretty reproducible AI technology. It really enhances the screening capabilities, and it's why people are looking at the DRSplus to be the next leader in screening. So I'll quickly talk about this image. The center ring represents the 45-degree field of view, which is standard, what has been the standard for decades in retinal screening versus retinal photography. That is also what our DRSplus captures. The next ring is the 120-degree shot. That is the single shot from the EIDON Ultra-Widefield. The entire images you see there is multiple shots that the EIDON Ultra-Widefield is using and then stitching together with a proprietary algorithm that we use to give a beautiful 200-degree field of view. But let's see also from Dr. Sada, who is a world-renowned retina specialist. Let's see what he has to say, why this advanced technology assist him in some of his diagnosis. [Presentation]
John Floyd
executiveSo one thing I will point to that he said earlier is the image that he sees coming from the EIDON and the DRSplus is the same image that he sees when he's looking through his slit lamp or microscope. So it is real color, true fundus imaging. It's not anything else, anybody else can do. I know people claim it, this is reality. So while we have a broad range of products suitable for many different customer segments. It's a great asset for the company, but it also means that distribution channels are not necessarily the perfect fit for all markets and all segments. It works in some regions, but not in all. During the new strategy period, we're going to focus on developing our current distribution structure. We're going to be reviewing the full market potential for all of our products, focusing on developing areas where new skills and new resource partners or resources or partners may be needed to expand our reach to all customer segments. In the U.S., we have -- we've got the ability, we have the scalability to go direct to market on our own with our own sales force in most areas. However, we need to continuously monitor the trends in the market to make sure we learn from our customers where we need to strengthen our skills where we need to strengthen our knowledge, we always can learn and where we need to improve our operations. Expanding our reach to advanced ophthalmology, such as retina specialists is one with our fantastic products is one of the key development areas we need to focus on in the U.S. For the rest of the world, we are using selected distribution partners, as I mentioned, to take our products to market. This will still be a model of choice for us proving the high degree of flexibility, scalability and speed to market. We're committed to continuous development of our distribution partners. We are working with them and helping them and they are helping us to scale both of our businesses. We are reviewing potential in all market segments systematically, monitoring the performance and setting new targets and goals according to those systematic analysis. Together with our distribution partners, we will focus even more on strengthening a holistic eye care brand covering all product lines with meaningful marketing activities. Our screening business built on the combination of the DRSplus and the ILLUME platform has gotten off to a very promising start. The big thing for our new strategy period will be to look for channel development for this new business. Our focus in the first phase is going to be on the non-ophthalmic channels for diabetic screening. This will not happen overnight. It's not that we're going to be moving slow necessarily. It's -- the market is going to be slow to adapt. Things like this don't happen overnight. It's going to take time for the acceptance and the adoption of AI being used in screening and medicine. And in different markets, it will be accepted or adapted or adopted a different -- completely different rates. With that as well, different markets are going to require a little bit different technology or a little bit of tweaking in our technology, we'll be able to do that. It will take a little bit of time as well, but we'll focus on the large markets first, of course. And then lastly, regulatory requirements. Regulatory requirements are always a hurdle. And when you're in 100 different countries, it takes time as well. So I run a little over my time, but I want to share a quick success story that will kind of shed a little bit of light on our technology. We were invited several months ago by one of the -- this was in the U.S. market, by one of the largest medical care providers in the country and the United States. They have dozens and dozens of hospitals and hundreds of clinics across the country. They were looking to expand their diabetic retinopathy screening program. So they asked us to come in, and do an evaluation side by side with some of our competitors. These competitors were much larger than us. They've been in the market much longer than us. They've been in retinal photography longer than us. But we were excited for the challenge. So what they did is they actually brought real patients in from ophthalmology and optometry using staff. They brought them in, and they brought in different types of patients with different ages, different ethnicities, different pathologies to make it a real-world test. They did a really nice job. To abbreviate the story, we were able to photograph everyone that came through where not every patient was able to be photographed by the other technologies. One particular case, it was a cataract patient, and the staff member didn't even believe in the beginning that, that was the image that came from the patient that we just photographed. So we had to take it again, which we allowed her to do. Then we were contacted by this group 2 weeks later for a follow-up. And they told us -- we don't usually give the information like this away, but you were voted by staff, optometry and ophthalmology unanimously selected your technology for this project. Pretty amazing. But it gets better. They said, not only were they so excited about how -- what great technology this is. They now want to replace our nonmydriatic cameras in those departments with this technology. Even better, they said, we hadn't -- I don't think they had considered, but they said we actually would like to expand this even into our emergency departments. And they've now bought dozens of devices, not only for their screening markets not only for their optometry and ophthalmology clinics, but now for their emergency departments and they are using this technology across the board, and it will be a great client for us for years to come. So key takeaways. We have a broad product offering to really attack different market segments. We have clear, clear unique selling benefits to all of our technologies. We can adapt to our sales channel and building on our existing strengths, as Tomi was talking about. And our superior customer service builds the brand forward. We are very, very focused on the customer. That's how you build a strong brand, and that's how you build a strong company. Retinal screening in non-ophthalmic eye care settings is going to be imperative and it's going to be a great opportunity. It's a new frontier for everyone that's in the game, and lastly, our global footprint enables our growth and our ability to grasp and understand the market and develop the correct products that the market is asking for. Thank you.
Robin Pulkkinen
executiveHello, everybody. I hope you've enjoyed the great presentations we've hear and seeing here today. My name is Robin Pulkkinen, I'm the Group CFO, been with the company a little bit more than 8 years. So if we start with the growth, I see that many people have been commenting that already today. going back to '21 in March. Back then, we looked at the historical organic growth. We said that from 2016 to 2020, our organic growth has been slightly faster or slightly above 13%, and back then, we committed that we would try to accelerate that growth in the coming years. It's -- I'm happy to be able to say that actually, we've been able to deliver on those promises. And today here, we're coming back and saying that we're targeting to reach a growth rate of 3x faster than the ophthalmic diagnostic device market '25 onwards. There's been some misunderstanding where that means 300% faster or whether it's 3x the speed, it's 3x the speed of the market. The next 6 months still look challenging due to the macroeconomic outlook, but we do expect to see and start seeing the market to normalize towards the end of next year. So just going through a bit the business model. We've touched a bit different parts of this today. Our business model has really played out well for us over the last decade. So we're fully focused on iCare nowadays. It hasn't always been the case. I'll come back to that a bit more later on. All our outsourcing is fully -- manufacturing is fully outsourced. So we do our tonometers and the probes in Finland, probes are done on fully automatic production lines and the imaging devices are manufactured in Italy in a couple of different factories. All our critical suppliers are backed up with double supplier principle. We invest in R&D. We've increased the investments in euros on a continuous basis annually. But we do also use outsourcing for some of the varying demands on different projects what we have in hand. And then finally, like John covered in his presentation, we do have a direct sales operation in the U.S., and then we cover the remaining other 100 countries through distribution channels. So growing faster than the market. So looking at the last 7 years, revenue has been able to grow roughly 27% on average on annual growth basis. As you remember, in 2019, we acquired a Centervue. So that's not fully organic growth that we've been reporting. Looking at how the growth has been when you kind of eliminate the impact of the Centervue acquisition. The tonometer business over a 7-year period has been growing slightly above 16%, and the imaging slightly above 18% during that 7-year period. We've indexed here on the right, you can see the imaging and tonometry business kind of split it both starting at 100 at 2016 and then kind of showing how the share of the revenue has developed. They are not kind of represented a true split between the businesses as you maybe remember from 2019 when we acquired Centervue, their revenue was smaller than the tonometer revenue we had at the iCare. Software revenue continues to increase, especially now around the screening business. We've seen that already happen this year. Going through the plans for next year, it's pretty evident that, that is going to be one of the growth drivers for us. It's also important to understand that these solutions are not necessarily going to be software revenue only. That's actually most likely going to be driving more of the hardware sales. So looking at the total revenue related to that is going to be more on the hardware side instead of software alone. This year, like we've heard before, we've had some headwinds in the growth. There are some unfortunate things maybe this year that we kind of ran out of stock for some of our products. But like Tomi said, we are coming out with the new MAIA, microperimeter next year. And kind of looking at this year, how we've done, excluding the perimetry business, the growth has been almost 9% FX adjusted. So the balance sheet, it's in a really strong and good condition. We've actually -- our equity ratio went above 72% now at the end of Q3. Profitability has remained pretty stable over the last 4 years, and the return on investment has been getting slightly better. On the kind of what's behind the numbers on the balance sheet, there's been quite a bit more changes there. So looking at the average invested capital in 2019 to 2022. It's actually doubled during that time. We opened the -- looking at the equity at the opening balance sheet in 2019. It's actually EUR 18 million. Now at the end of '22, it's over EUR 90 million. So it's actually 5x over the 4-year period. There's a couple of things, the retained earnings and then the equity issue in 2019, which have been increasing that over the years. Basically, the net debt-free company, net gearing being minus 13% at the end of last year. Cash generation, very much in line with the top line. So over 25% combined annual growth rate over 7 years. It looks pretty steady. Within the year, there is quite a bit of variance. So when you look at the quarterly splits, the bars don't look so smooth. So the first half typically generates less cash for us than the second half. And looking at the last couple of years. The last quarter of the year has been actually representing more than 50% of the whole year operating cash flow. There's no change here. So we aim to continue on this path and continue to generate positive cash flows. The M&A side is something that may have an impact on the investment side of the cash flow. But we end up on the operating side. Continuously investing into R&D. So this year, we are reaching this year, looking at the right bar here, the first 3 quarters, we've actually spent a little bit more than 10% of revenue on R&D. Looking at our guidance. we're kind of -- in order to keep our guidance, we're looking at a really strong Q4. So that most likely is going to be that percentage dropping when we come to the end of the year. Kind of looking at the euros from 2019 to '22. We've -- in euros doubled our R&D spend over that time. We have a little bit more than 210 employees in the company, 1/4 or 25% of those work in R&D function. So we are heavily investing there. Roughly 2/3 of our R&D investments go into hardware development and embedded software and then the remaining 1/3 goes into the software development. So the M&A pathway. Many of you know, over a decade ago, the revenue was involved in a number of different businesses, 2012, our Board decided to focus on health technology, and we started divesting all the noncore businesses. There was quite a bit of stuff there. By 2015, we sold the last non-core businesses out. The RIB boats being the last. And starting from 2016, it's been a healthy company back then. We had the tonometers and we had the Cutica, Ventica, Oscar products. Kind of like we've heard today, the tonometer market is roughly EUR 200 million annually. So it was rather small. We had a great product still have, we're still considered kind of a one-trick pony and kind of it was obvious to us back then that we need to start expanding the portfolio in 2019 after 2 years of negotiation with the Centervue owners, we were able to close the transaction where we got access to the fundus imaging and the perimetry. 2021, we added also Oculo group like we've heard today and we were we got access to the software assets, platform and team. So currently, looking at the portfolio. So we have the tonometers, fundus imaging and perimeters, it's roughly 1/3 of the ophthalmic diagnostic device market where we have an offering like we heard from Tomi today earlier Jouni as well. Out of that 2/3 that we don't have, maybe half of that, so 1/3 of the total market is that interest for us. We have been doing quite heavy studying and investigating about the opportunities that there may be, but it's something that we are continuing to work on. And then at this time, I think the last 1/3 of the market is something that is not in our focus as of today. It might change in the future, but not at this stage. So kind of quite actively looking for product portfolio expansion. We're quite well geared to move on potential M&A opportunities. So we do have a 10% share issue right from the AGM, and then, of course, the balance sheet is very healthy, where there's plenty of room for using leverage as well. So a little bit summarizing the organic growth, screening, a totally new opportunity in the non-ophthalmic setting where the growth and the opportunity these are pretty obvious to us. We've seen that happen this year. We see that planning for next year. Our fundus imaging and the market share is still rather low, below single digits. Our level of automation and the quality of the picture is second to none. So we do believe that there are growth opportunities there. Tonometry, our market share is approaching 40%. It is going to be challenging on the professional side to maintain double-digit growth forever. I think there, the home and the related reimbursements are going to be a key driver to invade that growth. On the M&A side, we've covered a few times, so we carefully are assessing those opportunities and looking if there are anything that we could consider, and I think the distribution channel change probably then comes once or if we have a wider portfolio of products to cover and sell then the distribution channel structure comes on table, whether we have enough breadth or wide enough portfolio to consider going direct in some other markets than the U.S. only. So larger Western countries. And the profitability outlook, it's stable, but I'll actually jump to the next slide where you can see kind of the M&A potential impact on the kind of the profitability kind of outlook for the company. So when we screen the markets that it's very obvious that there is no other revenues around our profitability and growth is very unique for the industry. So we've collected some of the kind of the relevant competition profitability levels with internally, not disclosing what those companies are, but it's pretty obvious that the profitability levels in general are lower. This was actually the same case when we acquired Centervue. So their gross margins were in the low 60s, EBITs in the low 20s, but we've been able to significantly improve those over the years. And of course, we would plan to try to do dissimilar with any other acquisitions. The strong financial development has enabled a steadily increasing dividend combined with lowering payout ratio. So the EPS has been growing nicely like we kind of P&L in general for many years in a row. Our dividend has been increasing on average EUR 0.02 per year for a number of years now. I think all the way from 2016, maybe 2016 to '17 was EUR 0.01 increase, but other than that, it's EUR 0.02 increases. The payout ratio has come down. This was also kind of what I mentioned earlier in the balance sheet structure, the equity ratio has increased, and of course, the payout ratio has a strong play there. We are a growth company. So we do see -- I've been asking actually over the last 7 years, a number of different investors, how they see revenue from a dividend point of view and how they value the dividend payments. 9 times out of 10 investors feel that if we can use that money to accelerate the growth, they would rather do that, then let us pay the dividend out. And that is also something that we think internally similar way inside revenue inside the Board. So if there are opportunities where we could use the money better than paying out dividends, then that's something that is on the table. So our guidance was updated in August. So still unchanged. The exchange rate adjusted net sales is estimated to be between 1% and 5% compared to the previous year. Like everybody is being able to calculate, it looks like we need a really good Q4 to keep that. They're still on track. So profitability, excluding nonrecurring items, is estimated to remain at a good level. So takeaways. So we are geared up for strong and profitable growth. We have had some headwinds this year, but we have some potentially challenging beginning of the year, but I think we have really good new products and solutions in the pipeline that are coming out also next year, but also in further in the future. They are the home side, the reimbursement, which we are working on, which is going to be a pivotal part of actually getting that market to grow to what we've been discussing today. So from EUR 150 million to over EUR 700 million in 6 years, it really means that the reimbursements need to start going through in different countries, starting with the U.S. We still continued in searching for the potential M&A opportunities, especially -- and partnerships, especially to expand the ophthalmic diagnostic device market reach and portfolio. We're in a good financial position, and the operating model is really robust, has really served us well and is geared for value creation also in the future. And the R&D investments, we do -- will continue those to build the future based on key differentiators and the needs of our customers. Good. With those words, I'll invite Jouni back on stage.
Jouni Toijala
executiveThank you, Robin. Excellent. So let's start to conclude the day. So key takeaways from the day. So I'll actually start where Robin finished up. So we are going to continue to invest in the R&D roughly 10% from the sales also when going for the future. So that means new exciting products and solutions also. So not only the hardware but the combination of the hardware, software and the solutions. Then I also mentioned this is a key thing. So we are going to expand our offering to nontraditional iCare settings by connecting the care pathways and having a holistic offering both from devices and then the cloud-based software. So that's a key thing. Then still as before, so we are going to develop the customer experience, brand and do the continuous improvement on the way that how do we sell and also the sales channel configuration. Then we are going to continue the search for the M&A and focused partnerships in a long run balance sheet in extremely good condition, and we are really geared up to do that one. And then of course, ESG is going to be higher now at agenda as it has been for the years. So we are maturing that one and being then ready when we had to report that one across. Even across the financial reporting. So on track with that one. And with these words, I think we are done but not all things are done. So we go for the Q&A.
Erkki Tala
executiveAll right. It has been pretty packed afternoon. Thanks for all the great presentations and now is the exciting Q&A part still left. As I said earlier, the live audience here can just kind of raise their hand and we'll bring the mic, our assistants will bring the mic to you. And we have already got some questions from chat box as well. So we'll pick them from there as we go. But let's start with the live audience here in Sanomatalo. So let's start from here.
Pia Rosqvist-Heinsalmi
analystPia Rosqvist from Carnegie. If I start with a few financial questions, and I look at Robin, a big guidance for this year. So you seem quite confident even though Q4 will need to be a good one. So what could go wrong?
Robin Pulkkinen
executiveWe -- what is it now. We're now starting to sell in December already. So -- but we haven't sold for like second half of December much at yet. So our delivery times are really fast. So our backlog is 1 to 2 weeks on average maybe. We're -- tonometers in the U.S. leave the door in 24 hours. So of course, there's still a lot to be done, but we are on the right track. I think the nothing has changed in regards to the keep in the guidance so far. Fingers crossed, of course, the last week of the year is the best week in the U.S. every year. So I think John is going to be busy after Christmas. But yes, everything is kind of in order.
Pia Rosqvist-Heinsalmi
analystAll right. Then looking at next year, you say that the next 6 months, they still look difficult. What specific sectors, where are your concerns? And what do you expect to happen then after, say, the summer next year?
Erkki Tala
executiveWould you, Jouni, take this one, start with this one?
Jouni Toijala
executiveYes. Yes, I could pick up this one. So if we go back to the Q2 this year. So we actually said at the time that we have had the challenges on the PE-driven optometric. So I think that has been the reason earlier on the Q2. Now if we look where we are currently, so we have been able to kind of back up and fill up that hole. And then really looking for the first half, so we are having still pretty tough comparables for the Q1. So we grew roughly 15% on the top line. But I mean, we are now -- I mean, sticking with the guidance and seems to be like houses in order. But the next year, as we told on the Q3 report, so we still share the same view. And then for -- sorry, for the 2024, we are going to give the guidance in roughly a bit more 2.5 months, so not too much time to wait on that. So the exact guidance for the next year is going to be given beginning of February.
Pia Rosqvist-Heinsalmi
analystThen finally, regarding the growth from 2024. Can you separate the elements behind this speeding up? How much do you expect from devices? How much of the growth do you expect from software?
Jouni Toijala
executiveRelated to '25 beyond. We see that the -- if we first start from the tonometer. So we see that there's room to grow on tonometers then we are working on the reimbursement for the home in the U.S.A. So hopefully, we are wiser on that 1 towards the end of the next year. So that would then, of course, help 2025. Then if we go back to the fundus imaging, so a bit what John said. So products are extremely competitive. We don't see that trend changing at all. And then the market share is less than 10% still. So that's a clear growth driver. Then if we go for perimeters, we could divide that 1 in 2 buckets. So the 1 is the Compass product. So we just launched a new software version for that one. So we are looking forward, that's going to also start to gain more traction. And then we are going to have a new version of the MAIA next year. So that's also really good. So that's kind of a second half next year. Then if we go for the software part of the business. So extremely good traction on the ILLUME, that's going to help us to sell the devices. We have a quite heavy angle growth rate of course, also for the actual recurring revenue from the AI and from the ILLUME, but we start from the small parts, so the big opportunity next year and then the coming is still to enable and boost up the device sales as well. So I think those are kind of the main drivers. And then, of course, new products coming. So we have been during the last couple of years putting effort to actually bring the new products into the market. So on that time horizon, kind of -- I'm committed that there's something new coming as well in the kind of next 1 to 2 years. Did I miss anything?
Erkki Tala
executiveThere's a related -- thanks for questions. So there's a related question in chatbox. I think we could take this here. This is from Juha Kinnunen, Inderes. Regarding tonometers, again, I understand this is a bit kind of longer term, so for the strategy period. So we have got dominant market share in tonometers and market growth is maturing or what he kind of guess is the case. What's the revenue -- share of the revenue you expect from probes in mature state in tonometer market?
Robin Pulkkinen
executiveBeginning the probe sales hasn't been -- we haven't been seeing similar slowdown the on the device side. So I think the probe side will continue to grow. The installed base is increasing all the time quite fast. So we are selling a lot of devices, even though the growth may be slowing down slightly. But the probe sales are still growing well. And of course, the home is the wild card there that we don't have really much -- we have sales, but the opportunity is huge if we work our player cards with regards to the reimbursement.
Erkki Tala
executiveAnd once we have got to the tonometers before getting back to the audience here in Sanomatalo, there's a question regarding new market entrants in RPT technology, I guess, in this case, do we see currently price erosion in tonometers given the new entrants? Jouni, would you like to...
Jouni Toijala
executiveNo.
Erkki Tala
executiveYes. Clear answer. So who had a question next?
Daniel Lepistö
analystDaniel Lepistö from Danske Bank. So I have a few questions. Maybe first one, still on the midterm growth guidance, taking 3x the market growth from 2025 and beyond. I think can you sort of reiterate whether you expect the imaging device growth to still be the sort of the majority from the growth contribution in the future? Or has the sort of -- I think the outlook with the home and the potential with the home, maybe change the tonometer growth estimates a bit?
Robin Pulkkinen
executiveYes, I think the imaging has been growing faster for 7 years in a row. The organic growth has been over 18%. I think the market share being below 10% versus tonometers, 40%. So definitely, I think there is more room in the imaging side and the market is almost 3x bigger than the tonometer market. So definitely, the imaging is going to be key in the delivering those growth numbers. But of course, the home, it's -- maybe it's still a bit difficult to estimate. We see how the reimbursement work goes through and what the conclusions are from there before we're able to really do any good estimations ourselves either how it's going to play.
Daniel Lepistö
analystOkay. And the natural follow-up question here is the -- regarding profitability, I don't think you discussed your sort of margin expectations too much on the forward-looking guidance. What about as the imaging devices that tend to have a structurally lower gross margin than the tonometers. Are you seeing any sort of structural pressure on the margin side going forward?
Robin Pulkkinen
executiveThere's many different things that have a role, whether if we sell an imaging device in the U.S., the gross margin is actually really good. We're going through distribution channels, it's a bit lower because we leave more than 40% of the money on the table. But in general, I think the imaging devices, we have been coming out with in the Ultra-Widefield, the DRSplus. They're all -- all have a better margin than historically we've seen in this interview times for their products. So there's many different elements to the profitability. I think the general outlook for the profitability is stable. I think there's not really any major scripts there when it comes to the margin.
Daniel Lepistö
analystThe final question about time lines. Maybe first about the much talked AI and DRSplus maybe especially for the U.S. market, the FDA approval. Is this something that you would expect any announcements maybe next year, year after? And the second question about -- same about the HOME2 and the reimbursement that you see, any sort of time line do wait for here?
Jouni Toijala
executiveI might take that one. So for the AI for the FDA, we are driving with 2 lanes. So the first lane is that -- we want to ensure that we are selling devices and we sell the devices also with the other with other AI players and not only with ILLUME. So that's 1 track but which we have been driving already for a long time. So I would be really disappointed that if we won't have our DRSplus FDA approved with the AI player next year. Then we have a second lane, which we are now driving. And that's a whole solution kind of drive. So that includes DRSplus. It includes ILLUME. It includes Thirona AI. So having that one package and clear that one with the FDA that enables us to have also the recurring revenue from the AI and then with -- and from the ILLUME. So those are 2 tracks that we are driving and kind of I would be disappointed that if we don't have a positive news next year on the -- for the track #1. And for the Home2. Yes. I recall that one. So I think the time line and Kate, you correct me if I'm wrong, but there's certain days that you are able to do the submissions prepared paperwork for the payers and so forth and kind of we are pretty good shape on that one. So that would be then perhaps towards the end of the next year. But do you want to open a bit the process, Kate?
Kate Taylor
executiveNo. Essentially, there is a submission deadline early next year that we're working towards.
Nikko Ruokangas
analystAll right. Nikko Ruokangas from SEB. First of all, I'll also go back to financial targets. And about your growth target after 2025, so -- or '24. So it's a bit different wording compared to your earlier target of accelerating from 13% rate. So what were the reasons to change this wording? And does this growth target also include acquisitions or are possible acquisitions and extra addition to that, I mean that the previous target referred to organic growth?
Erkki Tala
executiveWill you take over this?
Robin Pulkkinen
executiveYes. I think the -- we've been kind of wanting to move a little slightly towards the our guidance in relation to the market growth. I know that we've use objectives in the past. Some people like numbers more with the range. We've kind of taken out the approach with comparing to the market growth. I think it's still slightly in the year, how the '24 guidance obviously is going to be given where there's going to be objective number relative to the market growth. [indiscernible] we'll see that in February, how that plays out that part. The growth it's not betting on us closing successful M&A to reach that growth. Maybe basically, that's fair to say. So potentially, we would need to reiterate that if there are M&A.
Nikko Ruokangas
analystYes. So it is -- you see that it's realistic to reach without M&A?
Robin Pulkkinen
executiveYes.
Nikko Ruokangas
analystAll right. Great. Then about maybe continuing on this a bit and next year. So as you already discussed that H1 looks still challenging given the environment and also the tough comps. But do you see that when we go to H2 next year that you could be able to reach those financial targets or these growth targets?
Robin Pulkkinen
executiveWell, we're in the right way at least that point I think we have new products coming out. We have the new MAIA coming out hopefully there. So we are kind of filling the gaps in the portfolio. So we're a bit limited now without the micro parameter, and there is a good demand for it. But unfortunately, we are out of parts and are not able to deliver the old version. So there are other things also like the home reimbursement, the screening opportunities that are definitely on the second half time frame rather than the first half. So there are many drivers and different releases that are coming out, hopefully, on the product side as well.
Nikko Ruokangas
analystAll right. I understand. Then moving onwards from the financial questions. So you discussed about the market growth depending on timing of these reimbursements and you also already discussed about the home reimbursement time line and possibility and so on. But do you see trends that reimbursing coming in Europe also in the AI space?
Jouni Toijala
executiveYes. So let's hope that's the case because we have certain areas where we have so if we go check, we already have reimbursement, and that's a kind of a continuing trend. But as an example, in Czech, there's already reimbursement in place.
Nikko Ruokangas
analystGreat. Then about the data management tool you introduced. So will this work only with your iCare devices? Or do you aim to expand this so that it could be used with other devices as well?
Tomi Karvo
executiveYes, we are going to be able to connect other main manufacturers devices as well.
Nikko Ruokangas
analystAll right. Great. Then one last from me. So how well are your potential clients aware of these kind of screening options regarding, for example, ILLUME. So that are you getting inbound questions? Are your clients aware that this kind of AI can be used and they ask about you? Or is it that you have to be proactive to introduce these kind of options? So could you describe how this kind of discussions have started and have there been any changes during this 1.5 years?
John Floyd
executiveI'd say yes. We do have inbound, but it is -- we do have inbound requests for information on the technology we were just another large hospital organization just yesterday or day before, I apologize, jetlag is setting in a little bit. I think it was yesterday that we had another successful demonstration with another very large hospital organization or chain, not chain but organization. That's also looking to expand their diabetic screening opportunities. We feel that it went extremely well. We feel that it will be a repeat story to the story I told earlier today. But then we also have some channel partners in the U.S. that are actively going out and working and they are being they're receiving a tremendous amount of interest in the technology that our DRSplus is built into. So -- but then, of course, we are -- we don't sit and wait for the phone. That's not sales. So we are also actively going out and marketing, participating in trade shows and calling on potential clients. So it's good.
Erkki Tala
executiveDo you want to...
Jouni Toijala
executiveOn top of what John said. So I think it's good to recognize the 2 things here. So when we launched it was April last year when we launched the ILLUME, our capabilities related to the screening, whether it's capabilities for DRSplus, a screening device or then the fully blown into software platform. So we have seen 2 trends here happening after that one. So the clients are asking more, of course, end-to-end solution. But the clients have realized as well that okay. So the DRSplus is an excellent screening device. So we have had also the cases that they come. And okay, so we use as an example, human grading of [indiscernible]. But you seem to have the best device and the most automatic device and the best image quality. So we have had also the cases as an example in the U.S.A. that for the screening purposes, they want to have a DRSplus and that goes for the human screening and so forth. So just wanting to summarize, John, that we have kind of 2 trends. So kind of asking for the whole package and asking the single device. And then, of course, in the long run, we are happy to plug in the whole software solution at the end. But of course, the goal is to also boost the digital marketing and do active promotion and then across the geographies that where we have regulatory approvals for the whole system.
Erkki Tala
executiveThank you. Let's take a couple of questions from chat box, actually related to the previous question, there was a question that should we think screening as one of the key areas now as it was presented in presentations pretty heavily, I guess. And then kind of another question on that is primary care going to be the key market for screening?
Jouni Toijala
executiveTomi, do you want to comment on the product strategy point of view, the screening, the retina kind of -- and glaucoma pathway. So I think that kind of tells the story a bit?
Tomi Karvo
executiveYes. I think the screening is a very fast developing market and the segments are it's not yet present in all the markets, but they are screening programs already started in many of the markets. So -- but it's -- I mean, the screening is done through the eye. So it can be done in different setups. It can be done in different places. And then in the end, it will be part of 1 of the care pathways. So I think it's -- now it's really difficult to say. I mean I think the question was related, that is it a really, really important segment. And I would say that the answer is yes, it is a very, very important segment for us because it is going to bring us a lot of device sales. And eventually, it will also start piling up our software sales. So hopefully, that answers the question there.
Erkki Tala
executiveHopefully that answers your question.
Jouni Toijala
executiveThe only building on top of that one. So that doesn't mean that the other segments where we are playing are not important for us. So I think that's good, too.
Erkki Tala
executiveYes. And one more question from Chatbox related to this topic, I think, what kind of income do you expect from AI or your own software in the coming years? Is it possible to reach significant revenue without U.S. and FDA approval? So few your questions in there. So what do we expect is FDA and U.S. mandatory for success?
Jouni Toijala
executiveLet's start with the FDA and U.S. mandatory for success in a long run and really scale the business. And also, if we think our presence in the U.S.A. So we have the direct operations in the U.S.A. So we can drive that business. And if you look at the overall market, so usually on the med tech, roughly 1/3 of the potentials come from the U.S.A., like John said, and we roughly 50% come from us. So we have to be top of that game, so we have to get into the U.S.A. and the plan for that one is good. Then when it comes to the getting the revenue from the software. So of course, the growth rates are looking good, but we start from the small number. So we are looking for the future to grow that one. And if we are able to grow that one. So there's going to be in years to come positive impact to our gross margin development. So that's a plan. But if we look at the near term, really, the key is with the software is to push additional device sales, especially in the segments where we currently are not in. And now I'm referring not the other segments in optometry or standard or premium ophthalmology. So I hope that clarifies the logic.
Erkki Tala
executiveThen very last question probably for this topic from here from the chat box. Could you comment on ILLUM key figures so far? So when can the audience expect to see some numbers?
Jouni Toijala
executiveWe don't split the different -- and I know that it would be highly valuable. But for the competition reasons, we don't give the detailed numbers, but the -- if we -- actually, with the [indiscernible] who is here at the audience, so we actually look to the amount of the reports that we are generating. So it's a good growth on the generated report point of view month by month.
Erkki Tala
executiveThanks for that. Any questions from the live audience here? Mikael.
Mikael Rautanen
analystIt's Mikael Rautanen from Inderes. In the strategy you outlined shifting from selling devices into selling solutions and iCare pathways supported by software. But I assume, and this is my assumption is that your sales partners and sales channels are motivated and driven to cell devices. So does this new strategy imply changes in your partner and sales channel strategy?
Jouni Toijala
executiveI might start with that one, then John compliance, excellent question. So let's look first the channels where we have been playing a lot. So that's optometric standard ophthalmology and the premium ophthalmology. So of course, our -- if you look at the distribution, U.S. is the difference. But if you look at our distribution partners. So those partners, so we have been now training them in order to sell the solutions. So there's there are capabilities that for the existing channels, even our current distributor network is able to sell the fully blown solution. Then where they are not currently focusing is the nontraditional iCare segments. And there, we have to work more. And I think that hopefully clarifies but we have a channel guru and direct sales guru here. So anything, John, that you would like to...
John Floyd
executiveYes. I mean it yes, it depends on the market. It depends on the distributor. But in general, we are evaluating if there are better channel partners, specifically for screening going into this primary care. The distributors we use, as Jouni, was alluding to, they've focused most times for decades on the ophthalmic industry. And stepping out of that arena and going into primary care will be a stretch. So we would be evaluating each 1 of those markets and the commitment that those distributors are able to provide.
Jouni Toijala
executiveAnd then I think for the traditional distributors, we have a [ carrot ], and that one we have to figure out, but we have a chance for [ carrot ]. It's a bit like on the tonometer side of the business. So they sell the probe. So that's a recurring revenue element for them. And then depending how do we want to play this thing with the distributors. So we might have a similar type of recurring [ carrot ] for them, which is then getting certain share of the regular software revenue. So that might be the [ carrot ] that might be interesting for them in a long run.
John Floyd
executiveRemember, too, one of the byproducts, just the story I told earlier, if we do choose a different channel partner in a specific region to sell into primary care, those primary care doctors are not going to be managing these pathologies. They are going to be identifying pathologies and referring them to ophthalmologists. That data will be coming through our platform with our image quality. And that will open up opportunities for those distribution partners that are working in those channels to sell additional equipment. So one hand works with the other. So it's not mutually exclusive.
Kate Taylor
executiveAnd also that the ophthalmologists are really important decision-makers in any screening program. And so is this complementarity that John's describing from both sides.
Erkki Tala
executiveAny more questions? I think there were in the front line.
Joni Sandvall
analystJoni Sandvall from Nordea. Maybe I'm starting with the easy one. I think Jouni you mentioned that you will get some support from the new MAIA in H2. So should we read this as the product is quite ready already and are you able to maybe sell on clinical purposes already during the H1?
Jouni Toijala
executiveNot the H1, I would say. It depends on all the labeling because it's also going to be research use. But we are shooting for the second half.
Joni Sandvall
analystOkay. Then a question about the investment needs and maybe it goes on the R&D side. So you have been roughly 1/3 has been going on, on the software side. And now when the focus is shifting a bit on that side. So should we expect a larger part of the R&D spending on software during this strategy period?
Jouni Toijala
executiveI would say that no. And so we have 2/3 going for the hardware 1/3 going for the kind of back-end software solutions. And why I'm saying this one is that in the future, also the amount of the software, which is going to be embedded into a device. So we already have plenty of deep learning algorithms in the imaging devices and so forth. So I think that's one part of the answer. Then the second part is that if we look the dynamics where next year, the year after, where the money comes, we have to build the best possible devices that we can build in order to add the clinical value, and that comes to data. So if we -- now I'm referring to John's comment related image quality. So if you move towards the predictive AI assist that clinical decision-making. So if you put c*** into the algorithm, c*** comes out. So the data features and functions, what we have to have in the devices, so those needs to be top notch, top quality. So we have to keep investing on the devices. And then I have been in the software businesses for the last 20 years. And usually, the tendency is that it's always overinvested, and the money comes next quarter. and it's kind of not coming. So the goal is that we run and we still keep running the software investment in tight leash and trying to do the things differently in order to stay competitive and find a small niches where we are able to connect the device plus the software like the ILLUME. I think that's a prime example. And it didn't take too long time to get it out and with quite small amount of people. But that's -- anybody would like to add anything on this one.
Joni Sandvall
analystOkay. Last question from my side. If you think your competition currently how you believe that they will use software going forward and you are building in-house now. Is there possibilities for competition to came on the same play maybe through outsourced deals or stuff like this?
Jouni Toijala
executiveShould I -- Tomi, do you want to...
Tomi Karvo
executiveMaybe I'll take the other one.
Jouni Toijala
executiveYes, yes. So I think we have a competition already playing, so there's several players. So I mean, choice extremely strong software, but they go really on the high end with the forum solutions. So that's a premium ophthalmology handling the whole care pathways for the different parts. So that's kind of where we have directed our offering to the different segment. So we recognize that requires an investment that for us, it doesn't make sense to do if you go for topcon then the Harmony product. So again, a bit more different segment. So I think it comes back to the understanding the segment and the customer and what segment to pick and what customer to pick and then doing superior end-to-end experiences. So that it's a combination of device to software, and then we nail it down to do kind of be a fit for purpose tool for certain parts. But I mean, Kate, John, anything, Tomi, you would like to add on this one?
John Floyd
executiveNo, I agree with you. I think the open -- the largest open opportunity is in the lower-end segment, not going after hospitals and those are extremely expensive and would take a long time. They're very long sales cycles. There's -- because of all the diagnostic technology that's being released not only by us but by others in the market, it just continues to drive the need for data management even in smaller offices. It's not uncommon to see in optometry offices in the U.S., 3, 4, 5 different diagnostic devices. A lot of it is pumping out a lot of important data and having all that data streamlined in 1 platform would be extremely valuable.
Kate Taylor
executiveAnd I think there's a global trend where in countries where there is optometry, but in countries where there is not optometry where there's optical retail, for example, of more and more clinical service provision. And so therefore, the needs -- the platform needs the device needs continue to grow in less typical markets.
Erkki Tala
executiveOkay. let's take a couple of questions from Chad before moving to the audience again, related to M&A. So how do you see the valuations currently in the M&A market, given the interest environment? And then a couple of following questions. Has the importance of M&A changed in the new strategy period versus the previous one?
Robin Pulkkinen
executiveMaybe I'll start with the valuations. They definitely haven't come down as fast as the public companies. So we do see there that the prices are stickier almost not even changing in some cases. So it is steadily putting a challenge on that side of the process. So -- we'll see how the road changes, but at least like once we've been talking to the valuation is not the same than it was like 2 years ago, at least it has gone up, but they haven't come down for the private.
Jouni Toijala
executive[indiscernible]. So no change. I mean if you look at the revenues history, -- so starting from, I mean, many, many years before the Centervue acquisition, I think Centervue acquisition took 2 years to negotiate and kind of finalize so no change. So we go with exactly the same strategy that we have been going kind of since 2017, '16, roughly.
Robin Pulkkinen
executiveYes, there's not that many good candidates. So it's not that you can just dump one and walk to the next door. There's maybe less than 10 doors to go to. So you really have to be successful.
Erkki Tala
executiveGood. And then this next one was probably to Tomi, I think, as it talks about the kind of potential M&A targets or the kind of product category segments we want to feel is OCD still the most natural target? Or are there other potential kind of interesting areas?
Tomi Karvo
executiveJouni, maybe you want to take this because you have answered this before.
Jouni Toijala
executiveOkay. Thank you, Tomi. No, I think that -- as Tomi said, so if you look the retina care pathways. And I think we have discussed this 1 in quite many times. So that's 1 interesting area for us in the long run on the M&A side. Then if we look others. So there's also other interesting parts, which are kind of under the EUR 1 billion bucket if we talk about the ophthalmic diagnostic device market. But that's -- I mean, it's an interesting for us.
Erkki Tala
executiveAny further questions from the audience? Here, Pia.
Pia Rosqvist-Heinsalmi
analystIt's Pia from Carnegie. Still staying with the M&A topic. So what kind of leverage would you be comfortable as you're currently net debt free, but how much could you increase the leverage?
Robin Pulkkinen
executiveWe haven't really decided on any maximum level. But I think personally, I would sleep worse if we were 3x EBITDA or more. So -- but we haven't really cast anything in stone and even in the board level. So we haven't really, but definitely there is room for leverage would have been easier with the lower interest rate times, but yes, world has changed a bit.
Jouni Toijala
executiveWe also about to say the same that if you have asked, Pia, this question 3 years ago, so we have given higher EBITDA kind of a multiplier on the debt, but...
Pia Rosqvist-Heinsalmi
analystThen to the presentations, I'm not sure if I understood correctly, but are you already selling kind of the imaging devices to emergency rooms -- you are?
John Floyd
executiveYes.
Pia Rosqvist-Heinsalmi
analystOkay. And they are using them without artificial intelligence -- and what do they use them for in an emergency room setting.
John Floyd
executiveWell, it's interesting. And I'm glad I have a clinical expert beside me, but many patients that come in presenting with things like headaches, nausea, dizziness, which emergency rooms probably seeing 85% of their patients to walk through the door. Those are actually many times red flags for ocular issues such as angle closure glaucoma. Interestingly, this large hospital group, I told the story about earlier when they implemented their very first DRSplus, one of our -- actually as our Vice President of Sales, went in to do the installation because he wanted to learn more about the opportunity as well, and he's a super sharp guy and understands the marketing very, very well. And they actually identified during that day 2 patients that had papilledema, believe yes, that they were actually moved into the stroke program, which is either extremely costly or extremely lucrative, whichever way you want to look at it. But it's a very, very serious -- or a very serious pathology and disease. Could it have been picked up with other technology? Yes, an MRI, but talking about a multimillion dollar. I mean, the service contract on an MRI is probably more expensive than what they paid in the DRSplus. But then, of course, they are able to leverage that technology, ophthalmologists are on call around the clock for ocular issues and being able to feed that data to the doctors on call is vital to keeping good care for patients. So interestingly, it's still a new market. I'm not saying that we have many but this is a big success story for us then, and we're able to take that story and go out and build it. But I will tell you, about 8 to 10 years ago, we didn't have any tonometers in emergency departments in the U.S. either. Now we have hundreds and has become the wanted tonometers, the one that everybody wants because of the ease of use and now with the IC200 in the supine position, everybody wants it. It's actually quite a fun market because it's fairly untapped.
Kate Taylor
executiveAnd if I can just add, for example, in emergency department system, U.S. data, 1 out of 4 adults who present to an emergency department have diabetes. All of these hospital systems have their HEDIS score, their quality measures. If you aren't doing adequate diabetic retinopathy screening, you don't get your HEDIS multiplier. So just being able to do that essentially opportunistically as people walk through the door is really important. Then about 3-or-so percent of patients who come to an emergency department have an ophthalmic complication and about 4% come with a headache. And as John is saying, every person with a headache, you want to know, is it a headache and a migraine, or is it a brain tumor. And so getting a photo of the back of the eye is really important. And most emergency doctors are not good at it. And we've seen a similar pattern, for example, in neurology clinics, where, again, neurologists, junior neurologist, senior neurologist, it's often hard to get a view in the back of the eye. But given the eyes an outgrowth of the brain as a neurologist, it's really can get really useful information by looking at the back of the eye because it's your window into the brain. And so it's effective and it's in the literature, it's cost effective to stick a camera to be able to look at the back of the eye in a neurology clinic. It's another example of a sort of nontraditional eye care setting.
Erkki Tala
executiveAnd now I have to say that all good comes to an end at some point, and we have got time for one more question from the live audience, if you have got any.
Pia Rosqvist-Heinsalmi
analystI have many questions, but I'll choose now carefully. Regarding your customer segments, you showed a picture with your customer segments and also the new screening part. So can you help us analysts in any way how much of -- how should we look -- how is the sales split by segment today and say, in 5 years, how has it changed?
Jouni Toijala
executiveThat's a difficult question, Pia. So I tried to break it certain parts. So -- and John, you correct me if I'm wrong with these numbers. So if we start from the U.S.A. where we operate directly, and we have the best data because we go direct. So roughly 50% to 55% out from sales comes from the optometry, roughly EUR 30 million to EUR 35 million comes from ophthalmology, and then we have a rest. So that one, we know pretty well. I think the numbers are kind of a correction.
John Floyd
executiveIt's close enough that -- give or take.
Jouni Toijala
executiveThen if we go then to watch the other parts, so we go APAC, we go EMEA and so forth. So we worked through the distributors. So we don't have exactly the same split. And then it depends country by country. So if we go for France, no optometry, right? So everything goes to the ophthalmology side of the business. So for the rest of the world, it's difficult to say. Then I think the question is that how it's going to look in couple of years' time. I think it's hard to say, but the goal is to increase our presence on non-ophthalmic channels.
John Floyd
executiveIt will be higher. From the sales part it will be higher.
Jouni Toijala
executiveAnd Kate, I think you have the certain figures related to the kind of amount of the practices and the sites if you want to...
Kate Taylor
executiveYes. I mean, for example, if you look at primary care sites, sort of a 10x compared to ophthalmology sites. And so -- and if you think about the dynamics of screening programs, they're public health programs. So they've done it of a national regional scale. It's a totally different order of magnitude than a single device at a time. And I think that's why we're so excited about the opportunity because it really is a breakout opportunity. Although as I think we were talking -- Robin was talking, the uncertainty is some of it is going to be lumpy because it's big. And it's sort of national tenders at times as opposed to those direct sales. So that's where I think the opportunity is exciting and the uncertainty is.
Erkki Tala
executiveSo the last question comes from the chat and then goes properly for -- to Jouni to answer. That kind of wraps up all the kind of afternoon. So how we are measuring success, so to speak, with the new strategy period. So what are the key elements and deliverables, we need to see that we can dictate the strategy period being successful?
Jouni Toijala
executiveI would say that let's start from the devices that we are able to slice and dice. So we have to be successful in order to be delivering our compelling road map. So we have a good road map. So we have to come up and in the next 3 years, to bring all the products that we have in the pipeline to the market. Then if we go to the software solution part. So data management to get that one through FDA approval. So work is ongoing on that one because as you saw the software is on good shape. Then, of course, build more features, functionality around the ILLUME [indiscernible] AI part flying also in the U.S.A. So that's clear. And then I think brand customer experience, optimizing that one. And really, what John has been saying many times today, so get the channel right for the existing areas where we are operating and getting the non-ophthalmic channel in good order. And then I still want to come back to the people and the team. So we have been living pretty exceptional times. So we really have to take care that the team is kind of up and running, still after 3 years. So I have to take care of everybody's health and well-being and competencies and training. So I think those are the recipes for the long-term sustainable growth. But anything there that I was missing.
Erkki Tala
executiveGood closure. So now Revenio Group's Capital Markets Day 2023 is coming to an end. And thanks for presenters, panelists, thanks for the live audience here in Sanomatalo, in Helsinki and you who watch the live stream from this event for your active participation throughout this afternoon. Thank you.
Jouni Toijala
executiveThank you.
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