All right, welcome to Optomed Q4 and financial year 2022 investor call. My name is Sakari Knuutti, and I'm CFO of Optomed. We have also Juho Himberg on the line, and Juho is our CEO. Our release came out this morning, and the presentation that we go through in this session is available on our IR website. Please note that everyone can unmute themselves by pressing star six. All right, Juho, please go ahead. Good morning, everybody. It's 11:00 A.M. Finnish time to this our review of full year 2023 and the Q4 results. Let's move to the slide number two. The highlights of the quarter were basically relatively soft Q4. But if we look, you know, the full year results, we had a solid 3% growth over the year 2023. Optomed is waiting to receive FDA feedback regarding the additional data of the Aurora AEYE. And thirdly, Optomed expects its full year 2024 revenue to grow compared to 2023. Now, let's look the figures of to the last quarter 2023. Revenue for the Optomed declined 8.8%. Adjusted EBITDA was roughly EUR 400,000 lower than the year before. Cash flow from operating activities was roughly EUR 350,000 below previous year. Here, we would like to also highlight that last year, we didn't have any extraordinary items in Q4, but that's not the case for the full year. Now, if we look the full year results, we grew 4%. Adjusted EBITDA was 24% better for the full year than year before. And then if we look, you know, the cash flow from operating activities, improved over the full year significantly. Here, we need to also, when we are looking at these numbers, we need to take into the consideration that 2022 we received waiver for one loan of EUR 857,000, and then we had also grant in last year EUR 49,000. Taking that into the consideration, especially looking at our cash flow figures and also our adjusted EBITDA numbers, the improvement for the full year was significant. Now, we are moving into the slide, number 6. We look at the results by the segment. In device segment, for the quarter, decline was 90.8%. EBITDA was, there was a decline, roughly, EUR 320,000. And, also there is, this belongs to the normal fluctuation. This nature of device business in the past has been that there has been a fluctuation between the quarters. The highlights were that revenue continued to grow in global distributor sales and in the USA. So those areas where we are selling, or taking destiny to our own hands, we were able to grow. If we look at the comparison period-over-period, gross margin was supported by project work for an OEM client, and that's why the gross margin numbers. We were selling that with 100% gross margin. That's why there is a difference between these quarters. If we exclude that one, the numbers would be roughly the same. As you remember from the Q3 last year, we got the two relatively big deals there, which boosted our sales in Q3, and those were missing in the last quarter last year. For the full year, device segment declined 7.2%. EBITDA, the gross margins were roughly the same if we exclude these project sales. EBITDA declined, but here we need to also take into the consideration in 2022 this EUR 841,000 waiver, which we got last year. Excluding that one, the numbers would look a bit positive. Moving on to slide number 8. Software segment declined at 3.7%, and then here is what we need to highlight here is that if we compare 2021, 2022 software segment grew 23%. So that one was extremely strong Q4 for software segment, but in 2022. So comparables were unfavorable for us. Large agreements subject to the public procurement in case the company fails to win the new contract. This is what we talked in our last quarter as well, that has been postponed, and now we are expecting that the risk on the top line would be between EUR 0.5 million-EUR 1 million if we fail to win the contract for the next years. Now, if we move to the software segment for the full year, revenue grew 8.9%, gross profit grew 16%, and EBITDA had a very good growth 26.4%. Moving on to cash flow and slide number 10. So for the quarter, the net cash from operating activities was a bit minus EUR 500,000. And perhaps the key highlight for the quarter was that we wanted to respond to the evolving interest rate conditions, and that we decided to pay back a term loan in the amount of EUR 1 million, and that was paid during the quarter. So you can see that affecting the net cash from financing activities for the quarter. But looking at the full year cash flow profile, we would like to highlight the trend that has been going on, and it's clearly visible on the full year numbers. If you look at the full year numbers, in 2022, our cash flow from net cash from operating activities was EUR 2.4 million, and now in 2023, it was only EUR 600,000. The trend is positive, and we aim to keep it that way in the future as well. Here we move to the next slide. This is our business model. We have been talking already several times, and this is subject to the FDA clearance for Aurora AEYE system. So how this works is that quite often, when the companies are going and they are looking for a clearance or approval for their devices in the USA, they don't necessarily have this CPT reimbursement code. The reimbursement code is already ready for this our solution. We are targeting roughly 300,000 clinics, so slash customers, and this is due to the fact that we are not targeting only ophthalmologists, but we are expanding this business into the primary healthcare. In the next 5-10 years, there will be at least 50,000-100,000 AI-connected fundus cameras in the U.S. market. This is the estimate we are currently having. We are offering a complete solution, our portable camera plus then portal, which is then connected to the artificial intelligence, which is giving you then the results using artificial intelligence. We are having a recurring, or going to have a recurring revenue, revenue model, where we are giving all the solution to our clients, and there will be fixed annual subscription price or monthly, that has not been locked yet. It will have a high revenue share on Optomed sales. This is very, very effective sales model as it is recurring, recurring, revenue model. Customer is benefiting from this one, that they have a really low entry level to make a purchase, since it's a monthly or annual fees. They don't need to make a capital investments on that one. This provides excellent clinical results. There is this reimbursement, which is on average, at the moment, $55 per diabetic patient. The profit for the clinics with the low screening volumes. Since we are going with a fixed price or more, more you screen, more you will make money on this one. Then also what happens is that it improves your HEDIS score. It's a Medicare star rating, so when you are using artificial intelligence. So this is our new business model, which is waiting FDA clearance that we can kick this off. In summary, it was a challenging Q4, but it was satisfactory. If we look the long-term trend, there was no any significant major things happening, so it is the full year still follows the good trend where we are. Aurora AEYE is still waiting to receive FDA feedback, and Optomed it expects 2024 revenue to grow compared to 2023. Thank you. We are happy to take questions now. You can unmute yourself by pressing star and six. Hi, it's Pia Rosqvist calling from Carnegie. Hi. I hope you can hear me. Yes, we can. Very good. Good, thank you. I've got a few questions. If I start with the FDA approval process. So, you're working together with AEYE Health and AEYE Health is also working together with Topcon. And if I recall correctly, Topcon already received their FDA approval for the AEYE Health algorithm more than a year ago. So, can you take us back to why the process for you now is taking so much longer than, for example, for Topcon? Mainly it is due to the fact that the Topcon camera is like a tabletop camera. And to bring this one into the market, the handheld, so they will look most probably more in details into this process before approving it. Further to that, Topcon device has also been cleared with other devices. I mean, other AI algorithms, and that's that Topcon device is the first device being cleared by the FDA in the de novo process, way back in several years ago. Okay. And, now you say that you are awaiting FDA comments for the additional, additional data you sent in. Can you shed any light on now the timetable, we should be looking at? We have not sent it in to be so the project is basically AEYE Health project. So it is not Optomed who is directly in contact with the FDA. So this is to make this clear. And to comment on timeline, it's very tough, you know, to comment on the timeline of FDA. Those ones who has been following the FDA processes knows that it's really really difficult to give you any prediction on when it will come. But we are still expecting it to come still during this spring. And the answer can be yes, no, more information. Okay. And just reflecting upon I think Seppo's comments earlier, my understanding is that the ambition now for the additional data gathering was to ensure that you have so much data that there will not be a need to gather more information. Am I correct? That's correct, yes. Okay. But, but- And still if- I need to give you a disclaimer for this one. You never know. We- Mm. We believed that, you know? Yeah. All right, good. And then please, can you still estimate or assess the risk that you will not be granted the marketing approval? So, how confident are you that you will be granted it? ... how confident I am. I'm, I'm positive- Yeah. Optimistic, but cautious. Okay. Okay, right. Then to your business now in the fourth quarter, and maybe also looking ahead. So, what kind of sales pipeline do you have for larger projects in software and devices? Earlier in 2023, we saw some of these larger projects materializing, but what's kind of the outlook now into this year? So, the outlook for the year is that we expect to grow this over the last year. That's the expectation, and it includes in that also some big deals. Okay. Right. Then maybe into the OEM sales, if I still can continue. So, are there any changes to the declining trend? Is the trend of declining sales accelerating, or is it kind of stabilizing? Or, how, what kind of understanding should we have on the OEM sales? OEM sales, it will, in some point it will, stabilize. But when we are looking this, in the longer run, that we don't necessarily want to be OEM manufacturer. We want to brand Optomed, and we want to be Optomed and not to producing, not to produce, cameras to the third parties. So we want to... I enjoy personally much more, that we sell the products with Optomed brand, and that's what we need to do as a relatively small, relatively new medical device company, that we need to brand Optomed, and not to support, you know, basically our competitors', products. So we need to move beyond that one. But of course- Okay, thank you. And then- Of course, you know, we need to look this case by case, but in the future, I see that we would not be OEM manufacturer. Okay, thanks. Then finally, if I still may, on devices, sales in Q4 declined by close to 20%. How much of that decline is explained by declining OEM sales, or how can it be explained? So, can you repeat the question? So I, there was a- Sorry. So device sales declined by 19% year-on-year in the fourth quarter. What were the largest drivers behind the declining sales, and how much is declining OEM sales impacting? The decline comes mainly from OEM. It comes also maybe a little bit also from China. I don't know, I was not in the company in 2022 in Q4, but I recall that it was Chinese sales. But then if we look our own sales, like the global distributor sales and our direct U.S. sales, those increased. But it is mainly. It comes mainly from stock orders or big, larger deals with towards OEMs. Yeah, if you think about that, we have our sales funnels in the device segment. They include global distributor sales, the U.S. sales, China sales, and OEM. Now, we said in the release that we continued our growth in the U.S. and in the global distributor sales. So, so we didn't comment on China, but that hasn't been... Well, we didn't comment on that, but you can, you can basically derive from that, that OEM sales were definitely a factor. And, there All right, If you recall that in Q4, sorry, Q3, we shipped a big or we did a big shipment to China, so and that didn't come in Q4. So, there is also how these big shipments are distributed over the quarter. So it has a lot of impact. That's clear. Thank you. That's all for me now. Thank you, Pia. We are happy to take more questions and, you can unmute yourself by pressing star six. Hi, this is Gustaf Meyer from Redeye. Some my questions has already been answered, but could you talk more about the operating expenses during 2024? How do you think that they will develop? ... So operating expenses, they will—it depends a lot, you know, on how what happens with the clearance when it comes, because- Yeah, of course. But if we- Because then- You get the clearance. Yes. Then we will continue heavily investing into our U.S. operation. So that is, it follows there is a correlation between operating expenses and top line. Okay, great. And also about the additional data that have been submitted. When more exactly was it submitted? When it was exactly submitted? What? Yeah. The additional data. Uh. To the FDA. I can't comment, sorry, that. Okay. And also, if I remember correctly, you can't sign any agreements with U.S. clinics before the approval, but could you tell us something about how many clinics that you have a dialogue with? We have dialogue with many clinics currently. I cannot say with how many clinics, but we have already placed cameras with the anticipation receiving FDA clearance. So but, we definitely... At least I have spent the past quarter focusing on the U.S. market. So, we really have allocated quite a significant amount of time to be prepared for the clearance. Okay, thank you. And also about the large contract and the risk that you failed to win it in the software segment, how big is this risk? Or do you believe that this is a high risk or just something that you believe that it's important to mention for investors? That is something also, because these are quite often binaries. You win it, you don't win it. And since there is this tender, and it's been part of our business already for some years, and there is a risk, of course, we don't know what size of the risk it is, but we needed to highlight that one, that there is this probability. Yeah, and for the sake of clarity, this hasn't, this is the first public procurement in terms of this contract. And previously, we have actually won it, but it is definitely something that we wanted to highlight to the investors as well, that there is a public procurement- Yeah ... that may be lost. Okay, great. Yeah, that probably my last question. Thank you very much, and also thank you very much for the presentation. Thank you. Thank you very much. Feel free to take further questions and star six for unmuting. Hello, gentlemen, this is Joel from Inderes. Hello, Joel. One question related to earlier, well, pattern of questions. Could you comment on the level of OEM general sales? What is current level? I'm just wondering about what kind of sales are needed to offset this, if you are going to leave and only focus on Optomed brand. We have not opened those numbers, and that is, I need to little bit clarify what I said, is that that we are not currently that actively looking OEM partners. So of course, you know, we keep and value the contracts what we are having currently. And but we... It, like in the past, it was more in our focus to do these OEM contracts, but now this, we are fully focusing currently to the US market. So we are determined to get the clearance, and that is where our focus will be. It becomes a secondary priority for us, and what we want to do is to make Optomed brand towards our clients more visible. Yeah, that's completely understandable. But, I'm just wondering, you know, if you could give us any ballpark figure, then it would be useful when we are looking in, years ahead. But- Yeah, if you can, when you look at the numbers, you can get a rough estimation of that one, when you compare the previous year's figures, and you know that our distribution sales and our U.S. sales has increased. ... All right, fair enough. I will try to do that. Also, could you comment on the margins when you sell with Optomed brand versus OEM channel? There must be a difference. Yes, we have better margins in when we sell and we can ask, we can set the price. We are more flexible with the pricing when we are selling directly. All right. Final question for me. I will just try to clarify this large public procurement that is in jeopardy. And have you included or excluded this revenue EUR 0.5 million or EUR 1.0 million from your guidance? I'm just wondering if you have included or excluded this, and whether we could maybe make some assumptions based on your belief then. Well, like you have pointed out, we have several large deals, and this in kind of the revenue consists of large part of the revenue consisting of large deals. Now, none of them have been implemented in full to the guidance that we gave out. All right. So it's kind of like one large deal. And so some of them will come, and maybe will some still be in the guidance, and that's that. Yeah, what we said, that the revenue at risk is from EUR 500,000-EUR 1 million in terms of that deal. Yeah. Understood. Thank you very much. Thank you. Any further questions? If not, thank you very much, and we hope to see you again, at the latest, in our Q1 investor call. Thank you all. Thank you very much.