Welcome to the presentation of Sedana Medical Q3 report. 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. Now, I will hand the conference over to CEO, Johannes Doll; CFO, Johan Spetz; and CMO, Peter Sackey. Please go ahead. Thank you very much. Welcome, everybody, to our Q3 report. We will follow the same structure today that we always use for these calls. I will kick us off by presenting the performance during the third quarter and the progress we have made against our three strategic priorities. Then Peter Sackey, our Chief Medical Officer, will talk about where we are with our clinical trials in the United States, and our CFO, Johan Spetz, will go a little deeper into the financials. Then I will wrap it up, and we will take time to discuss your questions. So let's get started. On page three, please. As many of you know, we have the whole company fully focused on three strategic priorities. These priorities are, first, to achieve profitable growth in our current business after having left the COVID-19 aftermath behind. Second, to reach breakeven in our ex-U.S. business during next year already. And thirdly, simultaneously getting closer towards an approval of our inhaled sedation therapy in the United States, and to prepare for the launch in our future largest potential markets. During the third quarter, we have seen some good progress on all of these three priorities. First of all, I'm quite happy that after the COVID-19 rollercoaster, we have reached some level of consistency in our sales growth. We are now looking at the third quarter in a row with quite robust growth, especially in our direct markets, so where we have our own sales forces and therefore more control of the performance. Sales growth in the quarter was 29% in Swedish krona and 16% in local currency. So we continue to benefit from quite strong currency tailwind here. I will come back to the performance in the individual markets, but what you see already stand out very positively is the growth in our so-called other direct markets, which includes Spain, France, U.K., Nordics, and the Benelux countries, where we had a growth of 87%, or 69% in local currencies. And this represents another great step forward in our journey to reach scale outside our main market at Germany. After the quarter, we also had two very positive milestones, both of them we have waited for, for a very long time. In the U.K., we have finally received an MHRA approval, so regulatory approval. And in Spain, the Ministry of Health has now officially confirmed pricing and reimbursement approval. Both of these milestones could be quite important triggers for future growth in these markets. From a P&L perspective, we are seeing quite good progress as well. Our gross margin was at 70%, and we have been able to reduce our operating expenses by 17%. In this case, exchange rates are working a little bit against us, as a big part of our cost is in euros, not in SEK. And without that effect, the savings would even have been at 21%. So I'm quite proud of the fact that we have been able to achieve this level of cost saving in an inflationary environment, and at the same time, also showing robust growth on the top line. You can see the result on the EBITDA line. We've been able to cut our EBITDA loss in half compared to last year, so I see us quite well on track to meet our big goal of reaching EBITDA breakeven in our ex-U.S. business during 2024, so next year. With SEK 450 million or a little bit more on the bank account, we continue to be financed to execute on our plan, including the clinical trials in the US and also the launch in the United States. Speaking of the U.S., we're seeing a very good progress in the U.S. as well. Both phase III trials, INSPiRE-ICU 1 and 2, have enrolled the majority of patients. The study is in full swing. We have 27 clinical trial sites actively recruiting now. What we're currently seeing is an acceleration of enrollment after the summer months. The summer in the ICU is typically a bit slow. That acceleration has come a little bit later than we had planned for, which is mostly a function of how many patients that you have in the ICU that need to be mechanically ventilated. So we currently expect that both trials will run into the early part of 2024. But importantly, there is no change to the overall timeline. So our estimate is still that we will be able to submit the NDA, so the file, to the FDA in the first quarter of 2025. And as you probably remember, we did receive FDA Fast Track designation. So while there's, of course, no guarantee for that, we will try to work with the FDA to get a shorter review period than the standard, which is 10 months. If we then move to page four, please. What you see here is a brief recap of our view on the market potential and our short-term financial targets, which we have introduced in the last quarterly report in the summer. Based on that, we see that in our current direct markets in Europe, so again, Germany, Spain, France, U.K., Nordics, and Benelux, a bit less than 1 million patients are mechanically ventilated and sedated per year. And that translates into a market potential for our current products between SEK 3 billion and SEK 4 billion. And in the U.S., based on the same analysis. That more than 2 million adult patients per year are mechanically ventilated in ICUs, which translates into a market potential between SEK 10 billion-SEK 12 billion. So very clearly, the U.S., once we get there, will be our largest potential market, even though we have not assumed a significant price premium versus Europe. It is, however, quite important to note that other sedation products, most notably propofol, which is the standard of care, have a net price of 2x, 3x, sometimes 4x the European price level, depending on the hospital. So there might be some upside. We have defined two important financial targets for the shorter term: a sales level of SEK 145 million-SEK 155 million for this year, and also to reach break-even ex-U.S. during next year. Sales-wise, we are now at SEK 109 million after Q3. Typically, the fourth quarter is a bit stronger for us compared to the summer quarters. That is because you have more patients in ICU during the winter months, as you tend to have more respiratory infections in the winter, of course. So I see the company well on track to end up within that range for the full year and also for the profitability target. You have seen that we have cut the EBITDA loss in half. So it's, of course, still very much early to declare victory here, but with continued sales growth and continued discipline on the cost side, which we have been quite successful with so far, I'm confident that we will get there during next year as well. Then on the next page, page five, we see the longer-term sales development with the sharp increase during COVID-19, and the following drop in 2022. Year to date, we see a growth of 26%, or still 15% in local currencies, and a sales level that is both more than double of that in the last pre-COVID year, 2019. And also already higher than 2020, which was quite heavily influenced by COVID patients. So overall, a very positive picture. On page six, the next page, you see the sales bridge for the third quarter, year-over-year. In absolute numbers, Germany has contributed the most to our sales growth, 9% growth in EUR during the quarter, which corresponds to 21% in SEK. A little bit less than the very strong second quarter, where we were comparing to the weakest quarter in 2022, but still a solid 16% growth in EUR year to date. In Germany, we have less possibilities to grow from new customers, as we do have the majority of German intensive care units as our customers already. So our focus is very much on high potential accounts, where we want to increase the penetration of inhaled sedation. And in order to do that, we have launched a field force effectiveness program several quarters ago, which is focused on spending more time with our key customers and help them identify more patients who are likely to benefit from the clinically proven advantages of inhaled sedation. Really strong growth in our other direct markets. Spain stands out here as the main growth engine. And remember, the pricing and reimbursement approval only came after the end of the quarter, so this is only based on device sales. 69% growth, or 87% in SEK. And also here, this result is not a coincidence, but very much in line with our strategy of creating more Germanys. So to reach scale in these markets by investing in a very targeted way and profitable growth opportunities, while at the same time also be very disciplined to streamline the organization where we don't see profitable growth. And that very focused approach is showing results. On the distributor side, so the countries where we don't have our own teams on the ground, but have partners selling the product on our behalf, we had a weaker quarter, a of -11% or 20% in local currencies. That is partly explained by timing effects. Many of our partners only order once a year, and depending on where these orders fall, we see a stronger or sometimes a weaker quarter. But also we do still see quite high stock levels in some of the countries, which are delaying new orders. What we're doing is implementing a quite similar approach, and that has worked very well in our direct market. So, a very focused approach, where we work very closely with our key distributors, where we see the highest potential, and at the same time, find a quite efficient support model for our smaller partners. Then let us move on to page seven. Finally, I'm able to present a map that is completely green here. We have received regulatory approval in the U.K. after submitting our file, I think 2.5 years ago. That's very great news, as we have now received approval in all of the 18 countries where we have applied for marketing authorization. So we did not get a single no anywhere, which speaks very strongly for the quality of our clinical data and the meaningful benefits that we're bringing to intensive care patients with this therapy. On page eight, you see that the U.K. was not the only good news, but let us stay with the U.K. for a second. We are planning to launch our pharmaceutical, Sedaconda isoflurane, when we have the supply available. Now that we have the approval, we could place that order with our supplier, and that is going to take a few months. What this means for us is that finally, inhaled sedation is an on-label therapy also in the U.K., and our team can actively promote it. And let's not forget, this finally allows us to fully benefit from the very positive NICE guidance that we have received already back in 2021. Which recommends inhaled sedation and confirms a saving of GBP 3,800 approximately per patient. If a hospital uses our product instead of intravenous sedatives. So we are hoping for increased demand from customers in the U.K. as a consequence of this regulatory approval. In Spain, we cannot complain at all about a lack of demand, but we have been growing very fast already. But now we have also received pricing and reimbursement approval. You probably know that that has taken a bit of back and forth with the Ministry of Health, but now we are allowed to sell the drug from December onwards. But as in all countries, I should also say that the drug as such is not going to be the main driver of sales and margin growth. Our main business is and will be the medical devices, and we hope we will see an acceleration of devices sales, as a consequence. The reason for believing that is that we have quite a few customers in Spain that have delayed the implementation of our therapy because they were waiting for the drug to be available, so they did not have to use an off-label treatment. And so quite a few reasons to be optimistic about the further development in these two key markets. If we can move on to page nine. This page shows how we are doing on our quest towards profitability outside the U.S., during 2024. And all of these are year-to-date numbers. In short, sales are up, gross margin is up, and we have taken out a significant share of operating expenses, 10% down in OpEx year to date, if you exclude the currency effects, and as you've heard, more than 20% in the quarter. And the result is an EBITDA loss that is still negative, but it's half of last year. So very good trend. I've highlighted on this slide the ex-U.S. portion that the darker blue here. And as you can see, the U.S.-related operating expenses are quite minor as for now, because the big cost in the U.S. is currently clinical trial related, and those are capitalized to the balance sheet. Yes. So again, how will we get to turn the remaining EBITDA loss into a positive number sometime during next year? It will continue to be a mix of further sales growth, again, in a very focused and targeted approach, and further spending discipline across the organization. Then let's switch gears and talk about the U.S.. This is page ten. Our strategy is to build up a Sedana U.S. organization and launch our inhaled sedation products ourselves. What makes us confident that this is the right strategy for the U.S. is the fact that we see by far the largest commercial opportunity in the U.S., and at the same time, we are also dealing with a manageable target population. And therefore, the investment level is realistic also for a company that does not have limitless resources available. Strategically, I think, having our destiny in our own hands, and planning for a stand alone launch is worth a lot. But of course, when the time comes and we feel that complementing our own commercial presence with a partner that can maybe help us achieve faster growth or broaden our reach, we would of course consider that as well. But before we can talk about a successful U.S. launch, which of course I'm very much looking forward to, we have to complete the clinical trial, and with this, I'll hand it over to Peter Sackey, our Chief Medical Officer, who will give an update on that. Thank you. Yes, so as you may have heard before, we have the two phase III studies, INSPiRE-ICU 1 and INSPiRE-ICU 2, that are ongoing, and we've added more active study sites with both trials enrolling. I think having enrolled more than half the patients and with a good trajectory on the enrollment side. We will, however, expect to see some of the enrollment running to 2024. With that said, we are still counting on submitting our NDA to the FDA in Q1 2025, and where the standard review time is 10 months. And as we've communicated before, we have received a Fast Track Designation by the FDA early this year. If we move over to slide 11, please. The Fast Track Designation that the FDA has granted, our clinical development program is purposed to generally give the new therapies a faster approval if the data are appropriate. And that in itself confirms the FDA sees our therapy as an important potential addition to what's available today. And the potential benefits with the Fast Track designation includes frequent communication and an accelerated approval, priority or rolling review. And we hope that one of these will be applicable, however, we will not know that until the time of submission or at our pre-NDA meeting. This is what we'll be discussing with the FDA, if any of these options would be possible to utilize. If we move over to slide 12. Good news when it comes to the investigator-initiated trial. So the SESAR trial, as we communicated earlier, has completed enrollment of 700 patients. This is the largest randomized medical trial of inhaled sedation to date, and obviously, this will be very interesting to follow the outcome of this study in ARDS patients. And the investigators are independent from Sedana, despite sponsoring of devices and some training from our side. But they have communicated that they expect to see the data or present the data in the second half year of 2024. The other study that is investigator-initiated and that we have played a role in facilitating is the INASEC study, also in France. This study is currently enrolling and has reached 165 patients to date. Then we move to next slide. So slide number 13. In the last months, we have had a number of activities in different parts of the world, by either led by Sedana or by our distributors. And the most notable one was earlier this week the European Society of Intensive Care Medicine, where we held an evening symposium, and inhalation was also on the regular program, and was presented by one of the known guideline writers for sedation globally. And with that, I'd like to move on to slide 14 and hand over to you, Johan Spetz. Thank you, Peter. Yes, so next up is the financial section. So in general, on this slide, what you can see is very much what Johannes has talked about. The fact that we are seeing good progress over the past couple of or several quarters, in terms of the financial development of the company, where we are continuously growing sales, and at the same time, we're able to lower our cost base, despite the generally inflationary environment that we're seeing in most of our markets. But let's dive into some of the details here. So net sales in the quarter, we report SEK 34 million, that's up 29% year-over-year, or 16% if we adjust for the positive currency effect that we are experiencing. Of course, most of our sales is in euros, as you know. As Johannes described already, we are growing in Germany, driven mainly by increased penetration in existing accounts, and also growing strongly in our other direct markets, where it's mainly driven by new accounts opening up. We are seeing steady, robust growth also in Q3, overall. If we look at the gross profit, we report SEK 24 million for the third quarter. That's equivalent to a gross margin of 70%, which is in line with what we had in the same period of last year. We are experiencing cost increases in the supply chain, for things like materials and components. We are, of course, in ongoing dialogue with our main suppliers. Sequentially, as you can see, we are reporting a slightly lower gross margin in Q3 compared to Q2, where we had 71%. So this is something that we are, of course, working on maintaining a good gross margin. Looking at EBITDA for the quarter, we report SEK -13 million, and that's essentially a reduction in the EBITDA loss by 50% compared to a year ago. And really, what's coming through in that number is, of course, the sales growth, but also the fact that we are able to reduce our OpEx, so looking at selling, admin, and R&D costs for the company. So we report a reduction of those type of costs of 17% in Q3 this year compared to last year. And at fixed exchange rates, the reduction is actually slightly more pronounced. So 21% reduction when adjusting for currency effects. So what we're doing here is very much continuing on the various efforts that we've initiated. So we're continuing to streamline our headquarters functions, things like HR, investor relations, accounting, controlling. We're also continuously trying to reduce external spending on consultants and other vendors, as well as conferences. So we have done quite a bit in this regard, as you see in our numbers, and we aim to do more going forward as well. Of course, you know, our target for next year is to break even ex-U.S. in terms of EBITDA. So that's what we're going for. In terms of our organization, we have 92 employees and consultants at the end of Q3. That's down from 95 at the beginning of the year. So that's of course also in line with us streamlining, in particular, the headquarters functions of the company. Next slide, please. So the next slide, slide 15, you can see our cash flow and the development of our cash balance. So looking at both cash and our short-term deposits in combination, you can see that balance stood at SEK 453 million at the end of Q3, compared to SEK 504 million at the beginning of the quarter. And the reduction here of SEK 51 million is primarily driven by the investment in the U.S. clinical program. So cash flow from operations for the quarter was SEK -4 million. Should be noted there that for accounting reasons, that line includes interest received on our short-term deposits of SEK 6 million. So that's why it's boosted in a way by that. Cash flow from investments in capitalized development expenditures was SEK -42 million. So that's primarily the investments in the U.S. clinical program, as just mentioned. When you look at the total cash flow from investments for the quarter, that's a positive number, SEK 111 million. What's important to highlight there is that that also takes into account the fact that we have had deposits that expired in Q3. So we have a reallocation of cash from short-term deposits back to the cash line in the balance sheet, which then has this effect on cash flow from investments. But really, what's important to highlight here is that the actual change in the cash plus short-term deposits balance, which is what really matters, to look at that, it's much more relevant to look at what's been invested in the capitalized development expenditures. Similarly, for total cash flow in the quarter, there, when we again adjust for the allocation from deposits to cash, the total cash flow was SEK -47 million for the quarter, and that's really what provides a fair picture of what's happened in the quarter. But again, the reported total cash flow is then a positive number of 106 million SEK. But again, that captures the reallocation back to cash from short-term deposits. So liquidity management, of course, remains very important for us. As you know, if you follow us, a lot of our expenses over the coming years will be in the U.S. So we have already now around 75% of our available funds in U.S. dollars. And as I said, during the third quarter, we reinvested part of our dollars in new short-term deposits to optimize our interest rates that we're earning on our cash. And again, as a reminder, we expect to be fully financed until break even, with the cash and short-term deposits that we have, and to be able to execute on our strategic plan. And also as a reminder, we have no long-term debts in the company. And then if we turn to the next slide, here you can see our largest shareholders at the end of the quarter, and we continue to be grateful of the support from this group of investors, of course, as we continue on our growth journey with Sedana Medical. With that, I will hand back to Johannes. Yeah. Thank you, Johan. That brings us to our last page, page 17. To wrap it up, let's take a step back again and recap why we think Sedana Medical is worth a look as an investment. Our business model lend itself to attractive profitability over time, and that is for two reasons. We continue to see healthy growth margins of 70% and up. So by definition, we can become quite profitable as a business when we reach scale. So that's one. And at the same time, secondly, our customers are intensive care units, so not a very large target population. So we can cover these intensive care units with a relatively small operating expense level on a local level. And 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, the team is generating very attractive EBITDA margins on a local level already. And while we are not at the same scale yet, other countries like Spain, for example, are operating with nice profitability on a local level already as well. So we have the proof of concept. It can be done. So then the real question is: Will we reach enough scale and convince enough hospitals to use inhaled sedation more broadly? And here we have convincing clinical data on our side, showing that patients really benefit from inhaled sedation. And equally importantly, we can also show that hospitals do save money with inhaled sedation versus the previous standard of care, which was intravenous sedation. We have lots of places to grow and to create new Germanies, as I had just said before. Again, regulatory approval in now 18 countries in Europe, and the largest commercial opportunity, the U.S., is still completely untapped, with the FDA having given us Fast Track Designation. And let's not forget, very important these days, a strong balance sheet and the commitment to get profitability outside the U.S. already next year. So we can hopefully soon launch in the U.S. out of a position of strength, with a stable and profitable platform in Europe. And as we've talked about, we have. I think we have a pretty exciting time ahead with a potential break-even next year outside the United States, and also clinical trial data coming in. So we are very much looking forward to that next year. That concludes our presentation. Thank you very much again for listening, and we will now 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 there. Thanks for taking my questions. I have three connected to the U.S. to begin with. The first one relates to the comment around patient recruitment being slower than expected, or let's say, the acceleration of the summer months, at least. So yeah, what gives you confidence that you can still submit the application to the FDA Q1 2025 based on this? Just some elaboration there would be good. Yes, so maybe, maybe that at first glance a little confusing. So first of all, we are, we are, of course, not talking about a massive delay, and sometimes a bit difficult, difficult to predict exactly how many patients we will have in the ICU. Now, after the summer, it picked up, slightly, more slowly than we, than we thought. The reason it does not impact overall timelines, and that's the important part here, is that after the last patient is recruited, we still have this, this long-term follow-up, so the, the three and six-month follow-up. And that gives us the opportunity to do a few things in parallel, as opposed to doing them sequentially. So that allows us to keep the timeline under control, even if maybe the recruitment takes a little bit longer. But again, now we've very recently had some of the best enrolling weeks that we've ever had in the study. So if we continue like that, then things look pretty good. But again, the important thing is that the overall timeline does not change. I appreciate the flavor there. And, you know, when do you expect to be able to show some kind of headline data from these studies? I appreciate you said studies will recruit until early 2024, but, how long after final recruitment, so to speak, does it take before we can see any headline data? Maybe not the follow-up, but the headline data. Yes, so we have, as we've done for previous trials, we are planning to publish when the top-line data are available. Typically, that's the primary endpoint. It depends a little bit on what the data looks like. Of course, if you have very clear results, it usually goes a bit faster. If it's a more tricky situation, then it might take a little bit longer. What you can typically expect is that there's a couple of months of data cleaning, getting the data in the right format and so forth, until you can do a database lock, so then the data don't move anymore, and you can analyze them. But I'd expect to be able to see something in around mid-next year. Perfect, the answer. The last one connected to the U.S. is, you know, as I've asked before, any comment on where you expect CapEx connected to the study and OpEx related to the US next year? You know, that's very helpful, if you can share some thoughts on this. Yeah, sure. So, with regards to the overall spending in the U.S., if you think sort of pre-launch spending, so including both CapEx for the clinical program and also building up the U.S. organization commercially ahead of launch, what we said is based on the equity raise we did in late 2021, and that's still the case today. We are fully funded to execute on that plan. So, then, what's always been the case is in terms of the clinical trial, 2023 is the big spending year, just based on the shape of the expected recruitment plan. But then, of course, now with the slight change in the timeline, that might change somewhat, but 2023 is still the main year for investments in the U.S. in terms of the clinical trial. We have not guided specifically on any OpEx number for the U.S. next year. So there we would need to refer back to the fact that we do think that we have enough cash in the bank to execute on the plan of launching ourselves in the U.S. in 2026. Yeah, and just from a timing perspective so if you're looking at a launch now, I will assume that there's no benefit from the Fast Track Designation, which of course I'm hoping that there will be. If you then look at a launch, for example, in early 2026, then you will typically see the bulk of the investment from an OpEx perspective, so building up the organization, preparing for the launch really intensively, that you would see in maybe the year leading up to the launch. So 2024 will still be comparatively minor in comparison to what it will be after and before launch. Perfect. I appreciate these comments. Then two more. The first one is, you know, on demand. I mean, we're almost into November now, so could you share any indication on what seasonality you expect going into Q4 in terms of, you know, more patients at the ICU due to flu and so on? What do you see out there? Hello, can you hear us? I can hear you. I can hear you. Sorry, we had a short disconnect there. Can you repeat the question? So the question, I think if w e got cut off here in the middle, but I think your question was around whether we see any patterns in Q4 here in terms of how many patients we have in the ICU. So, of course, you know, from a seasonality perspective, Q4 tends to be one of the stronger quarters that we see. The reason for that is that ICUs typically fill up during the winter months because you have more respiratory infections, not just COVID, but also just the flu, and pneumonia, things like that. So you always have more patients, at least in the countries where we are mostly active in the winter compared to the summer months. October was in a sense of a little bit the typical October where you see a bit of a mix geographically. So in Germany, for example, we're seeing that some regions the ICUs are already quite full, in others, that's not yet the case, and that's not so atypical. So after the summer, October is oftentimes a transition month. And then in November and December, you see more patients. So far, there's no reason to believe that we would have an unusual Q4 from a patient number perspective. Were you perhaps referring to the study or to sales? I think that answers my question. Okay, thanks. Can you hear me good now, by the way? Yes, yes. Sorry. Okay, good. The last one was just on Germany, you know, a bit slower here in Q3 versus a very strong Q2. Of course, there was an easier comp in Q2, and the comparison should be more normal in Q3, let's say. But, you know, in Germany, the 9% here, is that something you're satisfied with? Or, you know, would you want to see that increase in terms of percentage growth year on year going forward? Or, yeah, how do you look upon Germany? Yes. So I mean, overall, I'm satisfied. So if you look at the company, 16% growth, while at the same time, reducing OpEx at 21%, that's, I think, nothing to be ashamed of. 9% in Germany, in euros, is less than we had last quarter. But as you rightly say, there's also a bit of a comparator effect in here because last Q2 in last year was the trough in terms of demand and sales in Germany. And then there was a little bit of a catch up effect in Q3 after a very weak Q2 last year. So we had a weak comparator in Q2, and now a slightly stronger comparator in Q3. I think over time, that will equal out. The year-to-date number, 16%, is I think one that we are quite pleased with. Again, in Germany, we have the majority of ICUs already as our customers. So where the growth needs to come from is convincing our customers to use inhaled sedation in more patients, and we are succeeding with that as we continue to take share. So overall, well on track. Thanks for all the answers. Welcome. The next question comes from Niklas Johansson, from Private Investor. Please go ahead. Yes, hello. I have a follow-up question on Germany. Would you say that you have reached some kind of market saturation, or at least that you have picked the lowest hanging fruits, looking at the clinics that still are not on your client list? Yes. So, if you have, s o in 2022, we had a market penetration of 10%. And now that number is a little bit higher, but still, there's lots of places, for us to grow, because intravenous sedation is still being used in almost 90% of sedation days in Germany. So I don't see us anywhere close to a saturation. What you say is true, that there's not so many big hospitals left that don't do inhaled sedation at all. So, where the growth is coming from, if you look at the sources of growth, is a little bit less new accounts, but where there's still plenty of opportunity to grow is in the penetration of the accounts that we have. And that's very much the executional focus that we have. So we have prioritized the hospitals that have a lot of sedation days, so a lot of potential, and are not using inhaled sedation as much as we think patients would benefit from it. And that's where our teams spend a lot of time and try to work with the customers, also connect them with other customers that are maybe more comfortable using inhaled sedation in different patient indications. That is showing good results. It's not going to skyrocket overnight. As always, in clinical practice, it takes time to change behavior, but we are not close to the limit in terms of growth. And we see that also, if you look at our best-performing sales territories, the penetration is more than 20%, so double of the national average. There are some individual hospitals that use inhaled sedation by far in the majority of their patients, so there is definitely room upwards still. Okay, thank you. And just a final question: In your quest to create, as you say, new Germanies, how do you see, for instance, Spain and France, if you benchmark those markets to your earlier years in Germany? Do you see reasons for optimism or pessimism if you compare to where you were in Germany for, say, five years ago? Yes. No, I'm very optimistic. So the truth is that Germany still represents 70% of our sales, so it's the main market, but that has not happened overnight. So there's more than 15 years of history and a slow build to get to the penetration that we see today. And if I compare the momentum that we, for example, see in Spain today and compare that with the momentum we had in the early years in Germany, Spain is growing much faster. But that's also not a total surprise. It should be like that, because in the early Germany days it was a much smaller company, much less support. Let's not forget, at the time, it was an off-label therapy, so we couldn't, or the company could not, promote the device as actively as we can do that today. Of course, there's an advantage that countries like Spain and France have. But we also don't have the luxury of taking 15 years of building more Germanys. That has to grow much more quickly. I'm as I said, I'm especially pleased with the development in Spain, where we are seeing very rapid growth right now and a lot of demand, and a lot of support from key opinion leaders. The treatment guidelines from both the anesthesiology and intensivist associations have been or will be updated in favor of inhaled sedation. So there's a lot of good momentum. France, not growing as fast as Spain, but we also are on a very good growth track. What helps is that there's quite a few leading key opinion leaders from France that are very, very supportive and are also speaking internationally about inhaled sedation very positively. We have the investigator trials in France, which draw a lot of attention to the concept. And now with the drug being available, that opens the doors to some tenders that are quite important in France, like AGEPS and UniHA and so forth. So I'm very optimistic about these two countries and specifically. Okay, that's very helpful. Thank you. The next question comes from Oscar Bergman from Redeye. Please go ahead. Hi, guys. I've got a few questions, and I think I just start one by one. So the first one, how long do you expect it to take now until the first U.K. sales of Sedaconda could be recorded? Yes. So by Sedaconda, I assume you mean Sedaconda isoflurane, so the pharmaceutical. We are already selling the devices, and now we will add the pharmaceutical to it. Now we have gotten the regulatory approval. You have to, at least as a small company, wait until you have that regulatory approval until you produce the products, because the label could still have small changes and so forth. So, we have now placed that order with our supplier, and there's usually a lead time of round about three-four months. That's very much in line with what we have seen at the time when the first markets like Germany, France, and so forth were getting approval. So that's what I would expect in the U.K. as well. So somewhere in the earlier part of next year, we will start making the product available. But also, as I said before, the pharmaceutical will always be the smaller part of our sales. Our main business is the devices, and the main impact also from the regulatory approval that we're expecting is that we see the value from accelerated demand for the therapy as such, and the lion's share of that is the medical devices. Thanks. And, if you look at your other direct markets, now that you have reimbursement in Spain and the full approval and, especially the NICE guidelines, could you give some sort of insights on your expectations for these markets during 2024? Yeah. No, I would, of course, expect a continued growth. Now, we've had very nice growth rates already in these markets. I think Spain, with the updated treatment guidelines, with the pricing and reimbursement approval, with the good momentum that we have in the market, I see no reason why we should slow down. So that I expect to continue. France has picked up the sales growth as well. There's, as I said, a couple of really promising tenders upcoming. We've started up a few new university hospitals, which the team have been working on for a very long time. So, I'm expecting good growth from there as well. And then with the U.K., the U.K. has been operating a little bit with a handbrake on, if you like, because unlike the other countries, we didn't have the regulatory approval yet, so we couldn't push the therapy as actively as we could in other markets. And that also had the disadvantage that we couldn't fully utilize the NICE guidance that we got. It's a very unusual situation that you get a NICE guidance before you get the therapy approved. Usually, it's the other way around. And the NICE guidance as such was incredibly positive. It's a recommendation to use our therapy, which the NICE doesn't give out recommendations very lightly. It also confirms a pretty sizable health economic benefit, which also is not easy to get from NICE. So it was a bit of a shame that the NICE guidance applied to a therapy that was off-label, and now finally it is on-label, and we can go ahead full steam. So I'm very optimistic about the momentum in these markets. It's, of course, also important for us strategically, that we decrease the dependency a bit on Germany. As I said, I see Germany as a growth engine still, and as you've seen in absolute terms, Germany still has contributed most during the quarter to our year-over-year growth. But of course, we depend on these other direct markets to continue to show good growth rates. It's quite interesting that the NICE guidelines came ahead of on-label, of course. But, how do you view that possibility also for the U.S. market? Sorry, I'm not sure I understand the question. The opportunity in general of- No, no, no. To the NICE guide? The possibility of getting clinical guidelines on the U.S. market ahead of your eventual or potential launch there. Yeah. So just to be clear, the NICE guidance is not the same thing as a treatment guideline. A treatment guideline is typically given out by guideline committees, which typically consist of KOLs, and they cover a topic, say, sedation and pain management in the ICU, and then they give you instructions of what to use first line, what to use second line, what to use third line. But NICE guidance is not that. A NICE guidance is a recommendation to health care practitioners to use a certain therapy, and it primarily looks at a therapy from a cost-effectiveness perspective. And that's where NICE has said that if you use that use our products instead of intravenous sedation, then you will have a benefit. What you say, however, is true. Treatment guidelines do make a big difference. Now in the U.S., the situation is different, right? Because we don't have the device available yet, so there is no off-label sales. We will only see that once we have the approval. And then what you typically see if new products are approved, then those approvals also do get reflected in the treatment guidelines. Of course, you, there's a limit to how much you can influence that, but of course, you should also make sure that your clinical data are known to the relevant people, and that the relevant inputs are given. Because we do see that has helped in Germany, that is helping now in Spain, it's helping in other places as well. That if inhaled sedation is in a prominent place in treatment guidelines, that makes it easier for physicians to choose our therapy, and we usually see increased demand as well. Okay. Just to summarize your answer then, any eventual clinical guidelines on the U.S. market is not to expect until you have launched on that market? No, that is correct. And we are not. They wouldn't help us much before launch because we don't have products on the market yet. And the guideline committees are usually looking at clinical data, and in the U.S. case, they would, of course, want to see U.S.-generated data, and those may not exist until our study is done, and hopefully, the therapy is approved. Yeah. And then, if we suppose that you launch on the U.S. market by the end of 2025 or early 2026. If you play with the scenario of you guys deciding to go with a partner for the US launch, how far ahead could you make that decision without so to say make things difficult for you in that launch? So there's always a balance here, of course, which is why it's very important for us to prepare for the scenario A, which is to be fully ready to launch by ourselves. So we don't mentally depend on a partner and then run out of time in the end. So that's why I think that strategic independence is very important, and we are preparing the launch as if there is no partner, which, by the way, might also be a scenario. But now you're asking for that scenario where we do go with a partner. Now, it would be too early to talk about that because there's still from a partner perspective, we are too far away from launch. So of course, once you have shown clinical data that is hopefully positive, once you've shown that maybe the FDA is open to give some benefits from a Fast Track Designation perspective, once you maybe have a better sense of how likely it is to get approval, then the value of the business financially speaking, will of course increase. So it's better to wait with the potential collaboration until closer to launch. So now it's too early, but of course, you wouldn't wanna make that decision two weeks before launch either. Somewhere, I guess, in the year leading up to the launch. Okay. Well, thank you very much, Hannes. I'll head back into the queue. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments. Yes. We got one question in the chat that is just coming through. I'm just gonna read it, not seen it before. "Hi, given that everything goes as planned with the approval in the U.S., do you foresee being able to grow that geography in a profitable manner immediately? Or is it more realistic to assume it will be eating the profit from Europe, which will hopefully be profitable by that time, and if more cash is needed to expand in the U.S., how long do you believe that will take before being profitable on a stand-alone basis? Yeah, so that's a good question. So, we've talked about our efforts of turning the European business profitable, because in a way, that will provide the oxygen that we will need to climb the U.S. mountain. Doing business in the U.S. is quite expensive, of course, and I would expect that it takes some investment, so we would not be profitable immediately. At the same time, we will also be going for a very targeted launch. So we would not do the good old-fashioned biotech approach, where you hire 100 reps and cover the country right away. You would be more targeted. A smart way for us would be to build geographies, sales geographies around the clinical trial sites that we already have, where we already do have a lot of support, where some of our best key opinion leaders sit and using those as lighthouse accounts and building from there, I think is a smart way to grow. Because also in the U.S., as in pretty much all all major markets worldwide, there is a certain period that it takes after approval until you get a new therapy listed, until you've been through all the P&T committees, until you've spoken to the purchasing departments in the hospital for both the device and the pharmaceutical. And it can actually start getting used. So we will, of course, be prudent with the expense until we see the pickup. And according to our financial planning, long-term financial planning, we will not depend on taking on new money. At least, we will not be forced to do that if everything works out as planned. Of course, if we feel like if we invested much more and we believe that we could create more value that way, then we would consider that, but I don't want to be in a situation where we are forced to take on new money. Good. So I hope that answers the question. If not, then feel free to reach out to us. There's no other questions in the chat. Thank you very much for listening again. Thank you very much for the good discussion, and I'm wishing you a nice day.