Welcome to Sedana Medical Q1 Report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to CEO, Johannes Doll, CFO, Johan Spetz, and CMO, Peter Sackey. Please go ahead. Good afternoon, everybody. Welcome to Sedana Medical's Q1 report. Thanks for taking the time with us. We know there's a lot of reports coming out today, we are happy to have you with us. With me, I have our Chief Medical Officer, Peter Sackey, and our CFO, Johan Spetz. I will kick us off by talking you through our performance and progress in Q1. Peter will give an update about our INSPiRE-ICU trials, which we have running in the U.S. Johan will go through our numbers in a bit more depth before I will wrap it up. We can discuss your questions. As always, there are some predictions we're making about the future. When you have a minute, please give our disclaimer on page two a quick read. Let's start on page three, please, with the highlights for the quarter. For this year, 2023, we have set ourselves three main priorities. First, we want to grow again. Now that we are gradually entering more normal market conditions in the post-COVID-19 period, we want to show that Sedana Medical is indeed a growth company. Secondly, for me, it is of real strategic importance that we will be able to enter the U.S. based on a stable base business that is profitable. We want to break even outside the U.S. before we launch in the U.S. For this year, this means that we have to make credible steps towards break-even ex-US. Thirdly, we want to make real headway towards being able to launch in the U.S. For this year, this means that we want to complete enrollment of our INSPiRE-ICU trials. I'm very happy this time to report that we have made good progress against all these three priorities during the quarter. This is, in a way, a very special report for us. After a long 2022 with lots of different post-COVID headwinds, we report growth again. Sales were up 12%, 5% in local currencies. I'm even more pleased that every single one of our direct markets, so the countries where we have our own teams in place, have grown versus last year. At the same time, we saw another quarter with sales decline in our distributor markets, which I will get back to. Great milestone in Spain, which has been one of the strongest performing markets for a while. In April, the Ministry of Health has approved pricing and reimbursement for our drug, Sedaconda isoflurane, we're looking forward to launching it soon. Also during the quarter, we received regulatory approval and pricing and reimbursement approval in Italy, meaning that there's only one country missing out of the 18 countries where we have applied for regulatory approval, which is the U.K., which I will also come back to. On the profitability side, we've grown our gross margin again, 73% versus 68% last year, which is, of course, very good to see. Even better to see that our EBITDA loss is 35% lower than a year ago. We continue to have a strong balance sheet with SEK 560 million in cash and short-term deposits, which we use to optimize interest rate income. We are financed to execute on our plan, and we don't foresee that we will need to go to the market to ask for more money. Exciting times also in the US. Our trials, which as you know, have gotten Fast Tracked by the FDA, are running full steam. We are still working towards completion before the year-end. If we are successful with that and have a swift and successful review by FDA, we will have US patients benefit from enhanced sedation in early 2025. On page four, you see our sales development over time. Of course, you know that especially 2020 and 2021 were heavily influenced by COVID-19, meaning a trend break in our longer-term sales development. Also, Q1 of last year was still affected by the tail of the last COVID-19 wave hitting the ICUs. After that, we saw a significant reset in sales during 2022, which was explained by the fact that we saw a drastic decline of ventilated patients in intensive care, pretty much in all countries. While Q1 of this year, still has less patients than last year, 2022, we do show growth on a company level again. If you have a look at this picture, not just against last year, but also versus the first COVID quarter in 2020. You then go to the next page, on page five, you see how the growth breaks down into our regions. Germany was up 6% in EUR, against the effect of still less patients in the ICU. Including exchange rate, that meant a growth of 13%. Very pleased with our other direct markets as well. These are Spain, France, UK, Nordics, and the Benelux countries. Not just with the overall growth of 61%, or 52% in local currencies, but also that every single one of them has grown versus last year, which is good to see. We still see the same story about distributor markets, a heavy decline year-over-year of 43%. Still with the same explanation, that we still don't have new orders from our previously largest distributor in South America because they are working through a big stock that has been built during COVID-19. Q2 of last year, by the way, is the last quarter where we have received a sizable order from them. After Q2 of this year, at least, this effect should go away. If you take a glass full view on distributor markets, we did have growth for the other distributors. If you take out the South America effect, we grew in the rest in Q1. We also had quarter-over-quarter growth for the third time in a row now. At some point, of course, we will see sales from South America again once the stock has normalized because it continues to be a high potential region for us. Let's move on to page six, please. We've talked a lot about the negative market influences that have plagued us in 2022, and we've also talked a lot about how things should gradually normalize during 2023. Here's a bit of an update of what we can see after the first quarter and whether things actually do improve. The largest impact, of course, on last year's performance was the lower number of ventilated ICU patients, which for parts of the year were down 40%, 50% according to our analysis. In Q1 of this year, we had even less patients than Q1 last year. That is because last year was still influenced by the tail of the last COVID-19 wave. The good news is that the gap is narrowing. We will hopefully soon start comparing apples with apples when we look at year-over-year comparisons. We've talked a lot also about staff shortages and how they affect ICUs because they have to run at lower capacity. With the staff shortages also came quality issues as well because the vacancies had to be filled sometimes with nurses from the normal wards that maybe didn't have the same intensive care background or temp workers or nurses from abroad with different education and experience. That is still an issue, and it will be an issue for a while for sure. It has eased a bit though in Q1. It's still quite rare that you would find an ICU that will tell you that they are sufficiently staffed. On the positive side, access to the hospitals in the sense of getting in, getting access to our customers, doing trainings, et cetera, is much, much easier than during COVID-19. A slightly more new development that we're seeing are strikes of healthcare staff, especially in UK and France. There have of course also been regional strikes last year, less widespread and rarely affecting the ICU. Now we do see nurses and doctors go on larger strikes, and also walking out of ICUs, primarily again, U.K. and France, of course related to inflation and the resulting pay demands, but also for improved work conditions and to address the staff shortages. The impact on us is that we had a few accounts where we had to postpone starting them up, postpone trainings and so forth. We are hoping these strikes get resolved reasonably soon. Overall, are we in a market environment that is the same as before COVID? No. Those times will also not come back, in my view. We have to deal with these new challenges. We continue to believe that we will have a more friendly market environment than last year for sure, or at least a comparable one. That's what really counts for us for our goal to grow the sales. On page seven, just to show you what I've already talked about, these are the statistics for Germany in Q1. As we said before, there are no perfect data when it comes to ventilated and sedated patients in intensive care. We have to triangulate a bit. On the left, you see the total numbers of ICU patients that were in a ventilator bed. As we said before, that does not mean that they were actually ventilated or sedated. In fact, we typically see that around 40% of these patients are ventilated. That number decreased by 5% on average year-over-year. On the right side, you have ventilated COVID-19 patients. Here we know that they were ventilated, but it does not capture all patients as there are of course, other reasons for being ventilated in an ICU apart from COVID. What we do see here is that the number is down 74%. We know from experience that the left side underestimates what's going on, and the right side overestimates the decline. Our best estimate, not hard data, but our best estimate is that in Germany we still had 20% less ventilated patients than a year ago. The really good news here is as you see on the slide, the gaps are getting narrower and narrower. Going forward, it will be easier to calibrate our performance versus last year. On page eight, as already mentioned, we saw a slight easing of the situation when it comes to whether or not ICUs were operating under normal conditions. It is still two-thirds of all ICUs in Germany that report restricted or at least partly restricted operations, which is almost always a function of staff shortages. If we then go to page nine, you see our progress with regards to the drug launch. There are several steps to take here. The first one is the regulatory approval. We have secured that in 17 out of the 18 countries where we have applied. The one that is still missing is the U.K., w e were promised an update on the timeline a while ago, but unfortunately have not received one. If you want to find anything positive in this very slow process, remember we submitted more than two years ago, it is that we've received a few questions from MHRA, so at least we know that someone is working on the case. They are also not very critical questions in our view, so we still think that the likelihood of getting approval like in the other 17 countries is very, very high. Unfortunately, we still can't make any predictions regarding the timeline. Once you have regulatory approval, you need to go through a process to make sure your products get paid for, a fact that is sometimes a bit underestimated by smaller companies. You need pricing and reimbursement approval, which we have in place for all the major markets now apart for the U.K., of course. During Q1, we received approval in Italy, and after the quarter, we had great news from Spain, where the Ministry of Health, as I said, has approved pricing and reimbursement for Sedaconda. Now we're looking forward to launching the drug in Spain in the next couple of months, and also in Italy, where from our perspective, things should be ready for launch soon. Of course, here should mention that we're working with the distributor, so don't have the timelines under control as much as we have for our direct markets. On Page 10, you see a little deep dive on Spain. Spain has been one of our strongest growing markets already since a while. Now since the beginning of the year, we've received two really great news that might mean a further acceleration of the sales. I already mentioned pricing and reimbursement. The decision is already published, but there's still a little bit of paperwork to finish before we can launch the drug. What's also helping a lot is the Spanish Intensive Care Society has updated their treatment recommendations for sedation in the ICU, and now they recommend isoflurane as the first-line therapy on the same level as propofol for moderate and severe sedation. Of course, Sedana Medical is, as in the other countries as well, the only company that has an approved isoflurane for the ICU. That, of course, helps us a lot. Both of these news are very important milestones because what you see in Spain a lot is that ICUs have sedation reference as they call it, usually a senior nurse who have the special task to make a local protocol for how sedation is done in this ICU or hospital. Both pricing, reimbursement, and treatment guidelines are things they look at very closely for making their decisions whether a drug gets listed or not. Now we can tick both boxes for Sedaconda, which we hope will get us on the protocol for even more hospitals in Spain. On Page 11, I've already mentioned we want to be profitable ex U.S. before we launch in the US. I can't or we can't have a situation where we are still losing money in Europe. We have to finance a US launch. We're putting a lot of focus on improving our P&L, and you can see here that that is starting to have an impact. These numbers are for the whole company, so it includes the US cost as well. Gross margins have reached 73%, which is great. The one word of caution, I would say is that the price increases we have given our customers tend to have immediate effect in the P&L. The increase in COGS that we've also had take a bit longer accounting-wise until they show in the P&L. We might not always have this level from now on, but we still have a target to keep gross margins above 70%. 2022 was a tough year, of course, in many ways, we have also used the time to hopefully build a stronger and healthier Sedana Medical. We've streamlined our headquarters, especially in admin and overhead functions, and shifted more resources into the countries and driving sales. That is starting to also show an effect on the OpEx side, where quarter-over-quarter, you see a nice decline. Of course, higher sales, higher gross margin, and lower OpEx together contribute to a lower EBITDA loss, roughly 35% lower than last year. We will of course, continue to work on the P&L to reach the goal of again, breaking even ex-US before US launch. With that, let's go to Page 12, and I will hand it over to Peter to take us through the US update. Yes. When it comes to the U.S., we have had interaction with the FDA and received in January this year a Fast Track designation for our development program, which is very positive. The purpose of this Fast Track designation is to get important new therapies to U.S. patients earlier. This is a confirmation that the FDA sees our therapy as potentially meeting a clinical medical need that's unmet, and also it means that we potentially can have a swifter review and a more focused review from the FDA when we submit our NDA. The potential benefits include accelerated approval prior to review or rolling review. Should we move to the next slide, please? Slide 13. The two trials that we're running in the U.S. are progressing according to plan. We're adding on new study sites and seeing a decent recruitment rate. We still aim to complete these trials by the end of this year so that we can have a launch early 2025. Next slide, 14. In parallel, we have some investigator-initiated trials that we've been supporting in different ways, and you've heard it before. Maybe the most important one is the INASED study, which is a study comparing isoflurane with propofol for up to 14 days. The primary endpoint there is delirium incidence after end of treatment, also delirium duration and long-term cognitive outcomes. The study is progressing with 145 patients recruited to date. We also have another study in France. That's the SESAR in ARDS study, the CESAR study. That is not our study, but we are supporting the investigators in 30 ICUs across France. In this study, over 600 patients have been recruited to date, and the plan is to have 700 at the end before the analysis. This enrollment is expected to be completed by the end of this year. We had a study that we supported, a retrospective cohort study in ARDS patients, the ISCA study, that was a multinational retrospective data collection study that was published in January 2023. This study then showed that inhaled sedation was feasible and safe and reduced the requirements for other sedatives. There were no significant differences with regards to long-term clinical outcomes. As stated, it was concluded that the inhaled sedation was a useful sedative in this patient population. Next slide, please. That's 15. As we've also communicated in this press release, we have completed the enrollment in our pediatric study in Europe, the IsoCOMFORT study. This was a study that was conducted in Sweden, Germany, France, Spain, and the U.K. The study compares the efficacy and safety of Sedaconda versus IV midazolam for sedation of mechanically ventilated children from age 3 to 17. The purpose of this study was to obtain market authorization for children and also to secure the data exclusivity and market protection for the adult indication until 2031. We expect to present high-level results from the study in this quarter. If we have a successful review, we expect to get the pediatric approval in the first half year of 2024. Regardless of the outcome of the study, and this is important, the data exclusivity extension to 2031 will be approved as long as we have the study report to the authorities. Of course, we are hoping and anticipating to get pediatric approval as well. Another important aspect of this study being completed is that it's included as part of the approved US Pediatric Study Plan together with the ongoing juvenile non-clinical studies. That's important because that's a prerequisite for our NDA. Next slide, please. Just a few places we've been in the first quarter of 2023, so in different congresses and symposia across Europe, and also in South America and in the U.S., with a presentation in the program for the Society of Critical Care Medicine about inhaled sedation. With that, I hand over to CFO, Johan Spetz. Slide 17. Thank you, Peter. Yes. If we now turn to slide 17 and take a look at the financials in a bit more detail. Our sales, as you've seen in Q1, was 38 million SEK. That's up 12% compared to a year ago. At constant exchange rates, our sales increased by 5%. As Johannes has already showed, Germany is back to growth. We see strong growth in our other direct markets, while our South American distributor continued to pose some headwinds for our distributor segment. Overall, of course, good to be back and growing sales again. Our gross margin was 73% in Q1, and that can be compared to 68% in Q1 2022, and 72% in Q4 of 2022. A continuation of the positive trend for the gross margin that we've seen in recent quarters. Now in Q1, it was mainly an effect of, and Johannes mentioned this as well, higher prices that we've that we get from our customers. We also had a mix effect coming from the fact that we have a slightly lower share of distributor sales, and then we also have lower allocated central costs contributing to the gross margin. If we look at OpEx, we've been disciplined in general on the cost side in the quarter, and we can report a slight OpEx reduction relative to a year ago. This is, of course, despite the inflationary environment that we're seeing. We continue in general to implement various cost efficiency measures that we have set out for ourselves. As Johannes mentioned as well, we are streamlining headquarter and admin functions while we continue to invest in our customer-facing teams. This shows in our EBITDA, where we see a clear improvement year-over-year. Now for Q1, we report minus SEK 11 million in EBITDA, and that can be compared to minus SEK 16 million in Q1 of last year. If we turn to the next slide 18, please, where we show our cash flow and available funds. One important point to make related to our cash position is that we now split our available funds between our regular bank accounts and what we have placed in short-term deposits for better interest rates. The deposits are now reported in the balance sheet as you have seen as short-term investments. Importantly, both of these are to be considered available funds for us. The cash balance, including these short-term deposits at the end of Q1, was SEK 560 million. That can be compared to SEK 608 million at the beginning of the quarter. If we look at the cash flow in the quarter, cash flow from operations was minus seven million SEK, of which we had cash flow from working capital of positive three million SEK, mainly related to payments from customers. We report cash flow from investments in Q1 of minus 346 million SEK. Importantly here, we have this allocation from cash to short-term deposits, making up 306 million SEK of this change. Similarly, for the total cash flow for Q1, we report minus 354 million SEK. Again, adjusted for the allocation of cash to deposits, the total cash flow in Q1 was minus 48 million SEK, that can be compared to minus 61 million SEK in Q1 last year. We expect to be fully financed until break even and to execute on our strategic plan. As a reminder, we have no long-term debt in the company. If we turn to slide 19, here you can see our top shareholders at the end of the quarter. We thank our shareholders for their continued support, of course. With that, I will hand the call back to Johannes. Yes. Thank you, guys. Let's go to the, let's go to the last page to wrap it up. Let's take a step back from all the information we've thrown at you during the last, 25 minutes and remind ourselves what Sedana Medical is about from an investment perspective. We continue to see, as we've heard multiple times, we've continued to see very good gross margins of 70% and up, especially good this quarter, as you've seen. So by definition, we can become quite profitable as a business when we reach scale. We already have proof of concept for that in our main market, Germany, where the majority of intensive care units are already our customers today, and where the team is generating very attractive EBITDA margins on a local level. While we're not at the same scale yet to other countries like Spain, for example, are also operating with nice profits on a local level already. We have the proof of concept it can be done. Will we reach enough scale and convince enough hospitals to use inhaled sedation as a standard therapy? We have all the arguments that we need, in my opinion. We have convincing clinical data on our side showing that patients really benefit from inhaled sedation, which is important, as only good medicine will translate into good business. Equally important, we can also show that hospitals actually save money with inhaled sedation versus the previous standard of care, intravenous sedation. We have lots of places to grow, as you've heard, and to create new Germanys. Again, regulatory approval in 17 countries in Europe, hopefully soon 18 when the U.K. finally comes around. The largest opportunity, U.S., is still fully untapped with FDA giving us Fast Track designation in January. That is also coming closer. Let's not forget, very important these days, a strong balance sheet. As you've heard from Johan as well, a continued commitment to keep working on the OpEx side to get closer to profitability outside the U.S. so we can launch from a stable platform. That concludes our presentation. Thank you very much for listening, and we'll be very happy to take your questions. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Mattias Vadsten from SEB. Please go ahead. Hi, guys. I have a few questions. I'll probably take them one by one. You have, in my opinion, a strong development in direct markets this quarter. If you could give any more details as to which country or countries that were particularly good. Then to that, you know, Spain that has been performing quite well. If you expect any major effects from Spain, from Q 2f now with the price reimbursement approval in place. That would be the first one. Thank you, Mattias. As you know, we report the regions, Germany, the direct markets in aggregate, and then the distributor market separate. We're always a bit shy in talking about individual markets specifically. What I'm very happy about in this report is that every one of our direct markets, Spain, France, U.K., Nordics, and the Benelux countries, all of them have contributed positively to in terms of growth. Looking at the growth of more than 50% in local currencies. Of course, you can imagine that all of these growth rates look pretty healthy. I have called out Spain, which indeed is currently the strongest contributor within that group of countries. We've seen very, very strong growth for a while. Just as a reminder, of course, you know that is with the device only, because we didn't have the pricing and reimbursement approval yet. That was also without, at least until beginning of the year, without the new treatment guidelines recommending inhaled sedation. Now we've reached these additional trigger points, if you like, in Spain, which of course, we hope that will lead to a further acceleration. Will it be a dramatic difference if you have a country that's already growing very, very fast? Of course, we hope that we can accelerate a bit more, but I'm already very happy with where we are today. That's good. You know, maybe a difficult question, but if you could talk a little bit about what share of hospitals in each of the major markets in Europe, like, yeah, let's say U.K., Spain, France maybe, what share of hospitals that are purchasing your therapy. I know, you know, the penetration at current customers probably is high on your priority list. Anyways, just to get a feel maybe versus, yeah, Germany. Yeah. I'll again say a little more wake than maybe you would wish because, of course, we don't disclose these kind of details. In Germany, I think you know that more than half of the ICUs are our customers today. The ones that we have as customers tend to be the larger hospitals. We cover more than the potential, more, a higher share of the potential. We're not at that same level in any other country yet. It's also a little bit misleading only to look at how many hospitals have bought from us, because of course, we are quite targeted in which hospitals we pursue. We are trying to be much smarter in terms of where the potential sits. We want to fish where the fish are. We have a pretty good idea in most countries now where the potential sits. How many, for example, ventilator beds does a certain hospital have? How many ICUs do they have? And also, what's our likelihood of getting in? Do we have advocates, do we have the arguments on our side that make it likely that we can implement the therapy? I will not be able to give you a percentage number. It's lower than in Germany. The good news is that the number is steadily increasing. We still open new accounts on a continuous basis, and as we've discussed in a previous report, are quite successful in also keeping the customers on board that once we have them, they typically stay with us. That of course speaks to the quality of the therapy because hospitals don't tend to stay with a therapy that doesn't work. Once they do see that it really makes a difference for these patients, they do wake up faster, they need less opioids, they are clearer when they wake up, they have a faster recovery, more spontaneous breathing, all these things that they see in their everyday practice. That, of course, is the best loyalty program that you can have. I think, yeah, that's a good answer. Just to understand correctly, I guess you're happy with the coverage on high potential ICUs, let's say. It's just, it's about the penetration on those now ahead. Are there any important ones in the specific countries that are really after right now? No, that's. That's. The answer depends on the country. In Germany. Mm-hmm I think that of course, there's very few large potential hospitals that are not using inhaled sedation, at least to some extent. Here the growth will partly come from new accounts, but mostly we have to work on making sure that inhaled sedation, now that we have the fantastic clinical data, is used on a broader base. That looks different in the other countries where we don't have that same penetration in the or the same number of customers yet. The priority is to find the right balance between opening new accounts and also making sure we increase the penetration in existing accounts. If the question is where the growth is coming from, of course, Germany mostly increasing penetration, other markets, mostly opening new accounts. I think that's good. I will jump back to the queue. As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. There are no more questions at this time, I hand the conference back to the speakers for any closing comments. Yeah. Thank you very much. Not much, not much to say. Thanks a lot for joining us, and we're looking forward to updating you on our continued progress. You all have a nice day. Bye-bye