Sedana Medical AB (publ)

Hello and welcome to today's presentation with Sedona Medical. With us presenting today, we have the CEO Johannes Dahl and CFO Johan Spets. We'll do a Q&A after the presentation. You can either type in your question using the form that is located to the right, or if you're calling in and would like to ask a question, please press star 9 to raise your hand and then star 6 to unmute. We will then announce if it's your turn by saying the last four digits of your phone number. And with that said, please go ahead with your presentation.

Thank you. A warm welcome to Sedana Medical's Hathier Report 2024. I know that some of you are dialing in during your vacation, so I'm glad that you're taking the time with us today. Thank you very much for that. With me today, I have our CFO, Johan Spitz, who will take us through our financial update later on. Let's start with page three, please, with the highlights of the second quarter. Focus is very important for us. Of course, the three strategic priorities that we are steering the company towards have stayed the same. First, to bring Sedana back on a steady growth path in our ex-US business. Second, to reach breakeven in our ex-US business as a first important step towards our longer-term profitability aspirations. And these two together, a healthy growing business and the profits from it will form a stable platform for our third priority to make headway towards our U.S. approval, which could put Sedana on a different growth trajectory. Two significant milestones stand out for me this time, as they are both very important achievements in executing our strategy. We have completed enrollment of both our clinical trials in the U.S., which is a big step forward in bringing inhaled sedation to our largest potential market. And just yesterday, we have announced that we will acquire our main supplier, which will improve our bottom line by approximately two percentage points over time. And this is an important strategic move in building a long-term profitable company. We will come back to both of these achievements in more detail, of course. You know that profitable sales growth is a big focus area for us. During last year's restructuring of the company, we have turned Sedana Medical into a much more commercially oriented company by shifting resources from the corporate headquarters to the front line and implementing a very disciplined investment approach, focusing on countries with strong momentum and profitability. And this strategy has worked. We have returned to a solid growth path after the post-COVID-19 period, and we now operate almost all of our country organizations in a profitable way. When it comes to 2024, overall, I'm quite pleased where we stand after six months. In both Q1 and Q2, we have delivered the highest sales ever in the respective quarter. And after six months, we are 20% above last year, or 19% if you exclude the trend rate effects, which is above our sales growth guidance for the full year of 14% to 18%. But we also have to clearly state that a growth of 10% in the second quarter is not where we want to be. Part of the explanation here is that we are comparing to an unusually strong second quarter last year, but we also had a weak quarter in Germany, or specifically a weak June due to a very low number of mechanically ventilated patients in the ICUs. On the other hand, our performance in our other direct markets and our distributor business was again strong during the quarter. On the profitability side, we have a negative EBITDA of 14 million SEC and an ex-US EBITDA of negative 11 million SEC. On the surface, that ex-US EBITDA looks very similar to the year before, but it is important to note that we had a 2 million SEC negative exchange rate effect this time, whereas last year we had a positive exchange rate effect of 3 million SEC. So there's a 5 million FX swing here in the delta. The decline of the EBITDA versus the first quarter, where we showed break-even ex-US, is due to the seasonally lower sales level and also a bit higher admin costs, for example, legal costs related to the acquisition. On the US side, as I said, enrollment is completed, which is not just a great milestone to reach, but also very important from a cash perspective. The main driver of our cash out over the last quarters was payments to the hospitals participating in the trial for recruiting each patient. That's done now. There will be a little bit of a lag effect over a few months while the invoices are coming in, but we can then expect our burn rate to come down considerably. Apart from that achievement, we continue to be on track and keep our timeline intact. Then let's move to the next page, page four, please, and take a moment to talk through the acquisition that we have announced yesterday night. What will we do? Why is this a very good deal for us? And what will be the financial impact So we will acquire our main supplier, Innovative Sikal, based in a place called Klang, just outside Kuala Lumpur in Malaysia. Main supplier in that case means that they are not our only supplier, but they manufacture our main device, and also certain accessories, such as adapters. Therefore, they represent a very sizable part of the goods, and the purchase price of 34 million SEK 75% of that will be paid upon closing, which we expect in the second half, and 25% are deferred by two years. This means that the transaction has an EBITDA multiple of 4.3 and a PE multiple of 5.7, which is of course a very good deal. There are two important reasons why this is a good deal from a strategic perspective. Firstly, we gain control of the supply chain of our main products. We are less subject to price variations and are in control of future scale up of the capacity to meet our growth plans. And over time, we can also implement measures to further enhance the productivity. Secondly, and that's the obvious one, we are expecting to add two percentage points to our EBITDA once the existing stock is depleted. So I see this as a very logical next step in building a long-term profitable company. We will pay for the transaction out of existing cash. The deal will pay back quite quickly. We expect a positive impact on our operating cash flow already from 2025, and we should have a net positive cash flow from 2028. Importantly, we continue to be financed to execute on our plan, including bringing our products to the U.S. market. If we then move on to page five, please. You can see what I already touched upon, the restructuring of the company and especially the shift of investments towards the frontline teams and the future effectiveness measures we have implemented have led us back on a growth path after the quite negative year of 2022 after COVID. After six months in 2024, we are 20% above last year, again, 19% excluding FX. So we are on track to live up to our promise to deliver an all-time high in sales this year and meet or even exceed a little bit our growth guidance. If we then move on to the next page, page six, you can again see the impact of our work on the bottom line. You see some seasonality in the sales on the top part of the slide. But the trend is quite clear after the biggest EBITDA loss in the company's history in 2022. Q2 of this year specifically looks a little bit less nice than Q1, where XUS EBITDA was positive and the group EBITDA was almost in balance. Again, the explanation is the lower sales level, but also the fact that we had a 2 million SEC negative FX effect this time, whereas we had a 2 million positive FX effect in the first quarter. Of course, we continue to be fully focused on turning our business profitable so we can build a stable financial platform for our US launch. On page seven, I have already mentioned the discrepancy we see between the first two quarters when it comes to the growth rates. Q1 was excellent and compared to that, Q2 looked a little disappointing. So let's have a closer look at that. Our business is seasonal. Let patients require mechanical ventilation in the summer months simply because there are less respiratory infections when it's warm. People spend a lot of time outside. So what you can usually expect is that Q2 and also Q3 are at a lower sales level than Q1 and Q4. If you look back in history, that sales decline between the first and the second quarter was on average 10%. Last year was not normal as the quarters did not follow that typical seasonality, but Q1 and Q2 were almost on the same sales level. So we are comparing our 2024 Q2 numbers, again, the highest Q2 sales we've had so far, to a relatively strong Q2 last year. But it is also fair to say that the decline this year was more pronounced than average. We had 13% lower sales than Q1, if we correct for the South American order in Q1, which will not come back every quarter. And the explanation for that we will see on the next page, slide eight, please. We had a very weak quarter in our main market, Germany, where we even saw a slight sales decline year over year. If you were to double click on that, you would see that this is because of a very weak June, where sales declined by more than 20% year over year. April and May were positive, and also the first weeks of July are positive again, but June was not. Now to dig a little bit deeper in June, we made a survey with 40 of our top accounts and asked our key account managers to map how many mechanically ventilated patients these customers had relative to their number of ventilator beds. And we found that only 20% of beds were occupied by a ventilated patient at that point in time, which was very much in line with also the feedback we heard from our key account managers at the time who were telling us about empty ICUs. A normal range would be around 40%. So we had a temporary absence of patients, possibly because of the early onset of summer weather. So there's an explanation. But of course, I also have to state clearly that negative growth in our main market is not where we want to be. And of course, the team is fully focused on continuing to grow the German business. If we then go to page nine, please. Our other direct markets, again, delivered a strong quarter, even though we had some similar effects as in Germany when it comes to the number of patients in some countries. In the end, we had a growth rate in the mid 40s. Spain continues to perform very strongly. So the combination of strong execution, updated treatment guidelines and pricing and reimbursement approval continues to show an impact. And I'm very pleased also that UK sales have significantly accelerated after the NHRA approval end of last year. In percentage terms, the UK is actually our fastest growing market at this point. And again, things were a bit slower in France due to two vacancies we had on the team. Our sales are very sensitive to our activity level in the field and the time we spend with our customers. So, of course, we are addressing these vacancies. And I see good opportunities to accelerate that growth again here as well. On page 10. Let's have a look at the distributor business. We had a long period where it was less fun to look at the performance of our distributor business. We had declining sales for almost two years as a consequence of excessive stock building during COVID-19. We never let a good crisis go to waste, so we have used the time to restructure the team and implement a new approach, which focuses very much our support on key partners with high sales potential and a positive momentum. And this strategy, as you can see, is working. We now have the third quarter in a row with solid year-over-year growth. On the next page, page 11, just to sum it up, where does all of this put us with regards to our all-year guidance? We have promised 14% to 18% growth. We're now tracking at 19%, so I see ourselves fully on track. And we have guided for positive XUS EBITDA during the year. We have already achieved that in Q1, which proves that we are within striking range. So while we will continue to have some seasonal swings in the summer quarters, we of course continue to be focused on XUS probability of the main priority. You'll want to see it again in Q4. And if we then move to page 12 and switch gears to the United States, as you know, the US is our largest growth opportunity and one of the reasons why we are so focused on turning the ex-US business profitable as we want to be able to launch in the US based on a stable platform in Europe and a cash generating business, of course. We have estimated the US market potential for our products to 10 to 12 billion SEC, which is three times as much as in our current direct markets combined. This is because of a high number of ventilator beds, a A slightly different medical practice that favors intubation compared to Europe and also an overall higher price level. During the quarter, we have taken a big leap forward by completing enrollment of both our clinical phase three trials, which takes out a big part, at least of the execution risk related to the study. And it's also, as I said before, very, very good from a cash perspective because it will significantly reduce our cash burn. And it also brings us one step closer to hopefully approval and a successful launch. As a reminder, the study endpoints are almost the same as the ones we have had in Europe. And we all know that this was a very successful study. For example, we know from our European trials that our inhaled sedation patients needed less opioids, 30% less in Z001 and even 50% less in our kids trial, in our pediatric trial. without the patients experiencing more pain. Now that's a great clinical argument in our everyday life here in Europe as well. But if there's one country in the world that is most sensitive to avoiding opioids because of the opioid addiction epidemic and more than 100,000 drug overdose deaths every year, it's of course the U.S. And also the FDA is very, very much concerned about that. So bringing a therapy that will reduce the use of opioids in a vulnerable patient population would be a major plus on the U.S. market. Page 13 is still a slide that I like a lot because it shows the caliber of clinical trial sites that we have been working with. You will find the most prominent institutions in America on that list, including Harvard, Columbia, Mayo Clinic, Cleveland Clinic, Mass General, just to name a few. And that's not just great from an academic point of view, but seeing how some of the top key opinion leaders in that space gather around this novel way of sedating patients in the ICU is very, very encouraging and provides a great platform for future commercial success as well. So if we manage one day to turn that trial site list into our customer list, then of course we've made a big step forward. On the next page, page 14. So enrollment is completed, but of course the work towards submission is in full swing. I'm very pleased that all the parts that we have under our control are moving along nicely and on time. such as the three and six months follow-up of the study patients with the fully on track and also the work on the different parts of the dossier is progressing. As with every submission, we have now left a phase where most things were under our control, at least to the extent that you can control recruiting into an intensive care trial. And now we are entering a phase where we also depend on external factors to keep our timelines. The obvious one is that we will need positive data, which we are expecting in the second half. There's, of course, never a study without risk, but there are reasons to be very optimistic that the European trial worked out so well, and we're looking at the same inputs again. The other obvious dependency is the FDA itself. We are, to some extent, in their hands, and, of course, depend on them accepting our, for example, analysis and submission plans, etc. We are in frequent exchange with the agency, as we would like to confirm as much as possible and take out as much of the risk as possible before the submission so we can avoid surprises afterwards. Well, the feedback has been very positive for us, and we will, of course, stay with that strategy of seeking as much confirmation for what we are proposing as possible. And I have to say the pass-back designation really helps with that because that allows us quite frequent access to the agency. If we then look at page 15, please. The next month will be extremely exciting. We have several milestones upcoming, which each of them will bring us a step closer to the goal and also reduce the risk. One big milestone is already cleared. As I said, recruitment is done, meaning that the study execution risk is considerably reduced, which you typically find to be one of the bigger risks in trying to get a product to market. If as a next step, we will get positive top line data, that would again be an increase in the terms of all products on the US market. And then again, the more we can get upfront acceptance from the FDA about our plans, the more we can avoid surprises later on and have a better view of the timelines. And as we have said before, yes, the fast track designation could help. Right now, it helps in getting frequent access to the agency, as I said, but the decision around accelerated review times and others, which I know a lot of people are very interested in, will only be taken by the FDA once we put the data in front of them, so after the submission. From a commercial perspective, the attractive opportunity coincides with the fact that we are dealing with a very concentrated customer base. Less than 5,000 hospitals have intensive care units in the US. Less than 3,000 have units with more than 10 beds. Those tend to be in the larger cities, so you don't need a lot of frontline personnel to cover the key customers. And based on that high commercial opportunity and comparably low manageable investment we have taken the decision to build our own commercial company in the us to launch inhaled sedation onto the us market if we deliver the proof of concept on a standalone basis that would definitely increase the value of the us opportunity overall and we're quite confident about the strong support network we've already built in our clinical trial sites so we have a good starting base as i said before we of course also keep the flexibility to complement our own that a potential partner could help us get faster sales uptake, broaden our reach, leveraging existing customer relationships, et cetera, and we can create more value overall. With that, let's turn to the next page and I'll hand it over to Johan for some more detail on the financials. Thank you, Johannes.

Yes, so on the next slide, slide 16, as Johannes said, you have our financial results for the second quarter of 2024. report net sales for the quarter of 41 million SEC that's up 10% year-over-year in reported currency and also 10% up excluding currency effects so up from 37 million in the same period of last year and as Johannes has outlined well already we are seeing very strong growth continuing from our direct markets and in particular that's driven by Spain and UK so that segment combined saw growth of 47% year-over-year in reported currency 46% year-over-year excluding FX and we also saw strong growth from our distributor market segment growth of 30% year-over-year or 29% excluding FX and among the distributors we see In particular, strong growth from our prioritized European distributors. But as Johannes also said, the strong growth from these two segments is offset by a weaker quarter in Germany. And as Johannes already presented, it's driven by a decrease in demand. Ventilated patients in June in particular, the rest of the quarter was more robust in Germany. And as we've highlighted also in the report, we've seen a good start to July in Germany as well. So that's on the sales side. If we turn to gross profit, we report 29 million SEK for the quarter. That's up from 27 million in the same quarter of last year. And that results in a gross margin of 71%, which is relatively in line with the same period last year. This is rounded, of course, to 71%. So what that hides, to some extent, is a slight decrease in the gross margin this year compared to the same period last year. That's mainly related to the fact that we're now selling more of our pharmaceuticals, that are called isoflurane, which we do at a slightly lower gross margin than some of our other main products, in particular the ACD, the main device. EBITDA for the period at a group level was negative 14 million SEC that is compared to negative 11 million SEC in the same period of last year and if we just look at EBITDA ex-US that was negative 11 million in the second quarter this year compared to negative 10 million in the same quarter of last year and If we look at what goes into that EBITDA number, Johannes has already mentioned that we have an FX component in there. But if we start on the OPEX side, we see that that's relatively stable in the quarter compared to the same period last year. So 46 million SEC in OPEX. That is up slightly from Q1 of this year. So... We can see that that's driven by an increase in administrative costs mainly related to legal fees driven by the acquisition that was just announced and also our new long-term incentive program that was approved by the AGM in May and also some personnel costs. But if we look at those admin costs in total, we can see that around half of that overspend, if you will, or cost increase. So half of those 2 million, so 1 million is non-recurring in nature. And then just linking back to the EBITDA, where we see at the group level again, a slightly higher EBITDA loss this period compared to last year. As Johannes mentioned earlier, we are seeing an FX effect included there. So EBITDA in the second quarter this year includes a net negative FX effect of 2 million SEC. Whereas in the same period last year and also in the first quarter of 2024, that effect was positive to a similar magnitude. So the swing effect there is something to be aware of when looking at EBITDA and comparing to those other periods. In terms of the organization, we now have 89 people, including consultants at the end of the period. That's compared to 93 people at the end of the same period last year so next slide please on slide 17 you can see our cash flow and available funds so cash at the end of the period stood at 304 million sec that's compared to 361 million at the beginning of the quarter and this decrease is basically entirely driven by the investments that we are making in capitalized development expenditures currently which as you know, is mainly our US clinical study. So if we look at the breakdown of the cash flow, we have cash flow from operations during the period of actually slightly positive 2 million SEC, but that includes a working capital effect of 14 million SEC. And that is due to timing of payments, both payments from customers and also payments we make to our clients related to the US clinical study. So payments to hospitals and the CRO involved in the clinical study. Cash flow from investments, as you can see there from the number, that's the big driver of our cash flow at the moment. So negative 56 million for the period. And again, driven almost entirely by our US projects, both the US clinical study, of course, and also Now that's shifting, of course, relatively speaking to more US registration work as the recruitment phase is concluded. So in summary, on the cash flow side, so total cash flow for the second quarter of negative 54 million SEC and their just to explain how to think about that in relation to the change in the actual cash position. There is also an FX effect on the cash balance of minus 2 million SEK during the period. Just as an additional point to make when we look at the cash flow of the company, it's of course important to to highlight that with the patient recruitment now being completed in our US clinical study, CAPEX will gradually come down during the second half of this year. And in particular, as we go into 2025, we will see a substantially lower CAPEX level. So that's, of course, important to keep in mind when thinking about our cash flow outlook going forward, or sorry, cash balance outlook going forward, I should say. And as a reminder, in terms of our liquidity management, we have now around 80% of our cash already in US dollars. And also as a reminder, we continue to expect to be fully financed to reach breakeven, which of course we are close to already, and also to execute on our strategic plan, including reaching market approval in the US. And we have no long-term debts in the company. And then if we turn briefly to the next slide, you see our current largest shareholders or the largest shareholders as of the end of June, I should say. And of course, we continue to be very thankful for your support. And with that, I will hand the call back over to Johannes.

Let's turn to the last page, page 19. To wrap it up, as we do it usually, let's take a step back and recap the investment case for Sedana. Our business model lends itself to attractive probability over time, and that's for two reasons. A, we continue to see good gross margins of 70% and up. We've just made another step in that direction with the acquisition of our main supplier. So by definition, we can become quite profitable as the business reaches scale. And secondly, our customers are intensive care units, so a relatively small target group that can be covered with reasonable operating expense levels on a local level. And we already have a proper concept for that in our main market Germany, where the majority of our users are already using our products today. The team is generating attractive EBITDA margins on a local level, while we are not At the same scale, yet other countries like Spain, now also the UK, are operating with similar EBITDA margins on a local level already, as well as most of our countries contribute positively by now. So we have the proof of concept, and now it's all about reaching scale, convincing enough hospitals to use inhaled sedation more broadly, achieving profitable growth, and here we have convincing clinical data on our side, showing that patients really benefit from our therapy. And equally importantly, we can also show that hospitals save money with inhaled sedation versus the previous standard of care. And we have lots of places to grow, to create new Germanys. As we're starting to see, our other direct markets now represent 30% of our sales, 23 last year at the same point in time. Regulatory approval in 18 countries in Europe and the largest commercial opportunity U.S. is still untapped with FDA giving us aspect designation and FDA permitting, as I said, the launch coming up in 2026. And let's not forget, very important these days, still a strong balance sheet and the commitment to get to profitability outside the U.S. during this year. That concludes our presentation. Thank you again for listening. We'll be very happy to take your questions. be it on the phone or via the chat.

Thank you very much for that presentation. And like you said, now we'll jump into the Q&A section here. If you're calling in and have a question, you can press star nine to raise your hand and then star six to unmute. We'll then announce if it's your turn, but say unless for digits of your phone number. Got a person calling in with the phone number ending in 6771. Please go ahead. You have the word.

I think we can't hear you.

Okay, can you hear me now?

Yes, perfect.

Okay. Hi, it's Filipp here from Pareto. So my first question is just on the seasonality of sales and then what happened in Germany. And so you mentioned the capacity of these 40 key customers in Germany. So I was just wondering how representable you would say these are of your entire customer base in Germany.

Yes, so it's not going to give you a result that is exact by the percentage point. But of course, we have selected the customer such that we get a good picture of what's going on. And I think the directional message that we found out that the level of capacity utilization was very low in June and very much in line with also the subjective feedback we were getting from the economists for a couple of weeks. The ICUs were very empty. So I think it's a relatively good indicator for what was going on.

All right. And you also mentioned that July already shows improvement. So how confident would you say that you are that the outcome in June was just temporary?

The nature of our business is that we will have to live a little bit with the seasonal fluctuations. Broadly speaking, we always have stronger winter months than we have summer months because there's less respiratory infections in the summer when people are moving around outside. We don't spend as much time inside. We have a little bit more heart attacks and stuff in the summer, but directionally, the intensive care units are more empty. But apart from that broad seasonality, you will see deviations from that year over year, depending on when a flu season starts, what viruses and so forth. Also, the weather is playing a quite important role. So sometimes it's advisable to look at our progress over a slightly longer period of time. So you see the time compare quarters over quarter or even months over months, which sometimes can be a little bit But generally, I mean, now July has looked much more normal in that sense. We don't have a crystal ball and we're confident that we will stay on track. So probably June was temporary.

All right. Sounds all right. And if we look forward to Q3, which also tends to be one of the weaker quarters and often even weaker than Q2, would you expect sales to come down even further, or do you think that Q2 now was the bottom of this year?

Yeah, so what you can see directly, if you look at the historical years, and of course every year will be a little bit different. Yes, Q2 and Q3 are the quarters that are a bit weaker. Q1 and Q4 are the ones that are stronger. You sometimes saw Q3 being a bit weaker than Q2, but I will not make a prediction of whether we will come out weaker or stronger than Q2. Historically, it's often been the case that Q3 was a bit weaker than Q2, yes.

Okay, okay. And next question is just on the cost side. You talked a bit about it, but OPEX has remained fairly stable. with the exception of admin costs, which you mentioned due to these legal fees for the acquisition and also this incentive program. But do you expect the admin costs to stay a bit higher now until the transaction is closed? And then secondly, if you could give any sort of guidance on extra costs during the integration of this company.

Yes. Do you want to take that, Johan? Yes. So there are I think in general the admin costs should remain relatively stable from current levels going forward. And then we do not expect any material additional integration costs. What we will see is a bit of a facing situation where, of course, as we point out in the press release, we will benefit from a better gross margin by integrating this supplier. But of course, we need to work down the existing inventory of those products that we will be having at the time of closing. So in that sense, we will see a bit of a cost impact from integrating that new company basically before we see the benefits which will become more pronounced as we go into 2025 based on the current timeline. But those costs would be more related to our cost of goods, as opposed to admin costs.

All right. And I just have one last question now around investments into the US trials. We've talked about it a lot before, and it climbed quite high this quarter to 55 million, the investments in intangibles. um and and then we have some lag before it starts going down but is it possible to give any clarification on sort of how fast you expect the cost to come down and how large the reduction could be like what just roughly what are we talking about here yeah do you want to take this one as well

So what you see being reflected in the relatively high number for this quarter is, of course, that we had four... Part of the quarter, the trials are still going on in full swing and then there is this lag effect of payments to the sites coming oftentimes a couple of months after the patient has been in that particular hospital. So that's why it's been a high number all through the second quarter. It will likely remain relatively high also for another couple of months, but then it should start to come down. When it starts to come down, it will come down quite significantly. Going into 2025, the capex spent will be significantly lower. Basically, during the course of next year, of course, what we will have still is work related to the registration in the US, but not at all the same type of expenses related to clinical study, of course.

Okay, but is that like 20% of what it costs to do for the recruitment, or is that roughly correct?

We have not provided guidance on that, but it will come down substantially. That's clear.

That's everything from me.

Thanks. We'll move on with the written questions here. Starting with the first one. What strategies are in place to achieve the all-time high sales target for 2024?

Yeah, good question. It's the same strategies that we have applied since we have refocused the company to become much more commercially oriented. And also a big part of that is resource allocation. So we are pursuing an approach where if a country is profitable and growing, that's where we would like to invest. So we are adding more people as we come in. In Germany, as we've done in Spain, as we will do in the UK, now that the performance is really good. But at the same time, we also are not shy to cut back on countries that are not yet profitable or maybe not growing as much as we are. We would like to give countries a chance to become profitable before we scale them up. That's the resource allocation part, but then there's a lot of effectiveness measures that we have put in place that have to do with how do we make sure our key account managers spend as much time with customers as possible. We know that our therapy is very sensitive to how much time we spend in the fields and how often we visit our customers. It's also a big value driver in seeing the right customers, we have become much more sophisticated in figuring out which ones are where we have potential to grow. And then we double down on those. And of course, there's a big element also when we spend time and when we spend the time with the right customers, how are we as convincing as we can be? And here it is about Taking all the clinical arguments and all the health economic arguments that we have, so hospitals saving money by using our therapy and packaging them up in a way that is as convincing as possible, but also tailored to the accounts. We're dealing with very different ICUs. ICUs can have very different types depending on the patients that they see. So we need to have stories in place that play to individual patients and diagnosis as opposed to stay at the general level. So that combination of resource allocation and commercial excellence has worked well for us and we will continue to make that a key focus.

And a few words on the UK would be good to understand what is driving the strong growth there and also your expectancy of growth going forward for that market. Could momentum improve further also?

Yes. So the UK is kind of the tech thing now almost for the strategy that I've been describing. So before We got the NHRA approval in the UK. This was a market that was relatively flat from a sales development. So we have actually decreased the team to allow them to become profitable, then put a very focused targeting in place and a very clear strategy focusing on a few key accounts with a reduced team and that is bearing fruit. So now we've turned a relatively improbable country into a very profitable country and also one that is growing at high pace. So then the next phase of the strategy kicks in where we can consider extending the team because at some point you get to a point where the demand exceeds what the team can handle and we're getting quite close to that. Over the next quarters, we will probably extend the team in the UK. Of course, what helps also is that we have a... the NICE guidance in place in the UK, which tells customers that by using our therapy, they're not just doing something good for the patients, but they're also saving real money, 3,800 pounds per patient. So we have all the ingredients that We will continue to see a strong momentum, whether we can further accelerate the percentages that I see right now. And the sales are very, very good. I'm hoping that we can keep that. But of course, we're not yet at a scale that Spain already is or Germany already is. But I'm looking very, very pleased with the development in the UK.

And could you try to give any helping words on how much you expect the co-op picks to come down in the second half of the year? And also, to what extent would you add the U.S. OPEX for the coming quarters? What functions needs to be added?

Yes, so the CAPEX part, I feel like Johan has answered. So the biggest driver of CAPEX was the recruitment of patients. We're paying each hospital for every patient for several months until that invoice comes. which is why CapEx was quite high in Q2, because in the end of the 30, we were recruiting the most patients. We will still see some of that in the coming months. But then it really comes down to a fraction of what it used to be. On the OPEX side, We'll talk a little bit more about OPEX over time. The focus is more on medical activities. Right now, we don't have an approval yet. We can't, of course, go out there because there's no label yet. But medical activities and especially nurturing that network that we have built during the study, which I'm really happy about, is very valuable because these people give us very good advice and they also help us beat the drums for what would be a new therapy in the US. So you will see a little bit more of that. But also, of course, we have to be prudent and listen As long as we don't have data which tell us that we are likely to have the product on the market, we will not go overboard in terms of investing from an OPEX perspective. So the figure for next level funding a little more in the US from an OPEX perspective will be once we know that the top line data are positive and we're likely to have a product on the market. And then again, we will not immediately see a huge organization in place that focuses very much on medical roles. And the actual field force will come on board quite a bit later. So you have enough time to claim them and to map out their territories and so forth. But for a company like us, it makes no sense to hire a complete engineer or so before launch because there's not much value adding activity that they can do.

And how will the acquisition of Innovativ Sekal impact your long-term profitability and also your supply chain stability?

Yeah, those are the exact two reasons why we did the acquisition. So we are taking them over and taking control of the manufacturing of our main products ourselves. That will help us on the cost of goods. The impact of that initially seemed to be two percentage points on the EBITDA line once we have depleted the swap that is still there. From a cash perspective, we will benefit right away once we close the deal. But for the P&L, it will take a little bit of longer time. And then from a stability perspective, yes, of course, it's good to be in control of the supply chain. It makes us a little less subject to cost fluctuations. It makes it a little bit less vulnerable to risks related to supply disruptions. Plus, we are in control of the operations, so we can put efficiency measures in place, scale up the capacity as will be required if we meet our growth ambitions. So from that perspective, I think it's a very, very good deal for us. And also, if you looked at the financials, it will add much more value to Sedana than we will be paying for it.

Can you provide any more details on the current progress and your expected timelines for the U.S. market launch?

Yeah, I think I've talked during the presentation. So the enrollment of both trials is done, really good. And what's ongoing right now is the long-term follow-up. So there's a three and a six-month follow-up. That's fully on track. The three-month follow-up for the first trial is actually already done. The rest is also progressing as planned. Now there's a lot of work ongoing on putting together the dossier. So the timeline, we have not changed. We're still hoping to get frontline data during the second half and are aiming for a submission in the first half I'm sorry, first quarter of 2025. So that timeline is unchanged. And as I said, we're trying to keep very, very close with the FDA because a lot of things they need to accept from how we structure the analysis, how we structure the submission. There's thoughts about how to improve the data between food studies and so forth. So we're trying to de-risk by having as many of these discussions and submissions so we don't have to pass. The feedback has been positive so far. We are fully in the FDA's hands. We're trying to stay close and have an even better view of the timeline. The question that always comes in the context is, will we benefit from the FastTrack designation? We are benefiting today in so far that we have quite frequent access to the agency, which allows us to stay quite close to them, which I think is really important. Whether or not we will in the end have an impact on the client will be subject to an FDA's decision, so that's a little bit out of our hands. Of course, we will for the benefits that we think we are eligible to, but that will very much depend on the data. So once the FDA sees the data and hopefully they look good, then we have good chances it would maybe cut down the review time that we have under our control. That's something that the FDA would

Thank you for that answer. We'll move on with the next question here. How significant is the role of the German market in your overall sales performance and what strategies are being implemented to boost your sales in this region?

Of course, the German market is still our main market, 60% of our sales. which is also quite visible in this quarter if we have a weaker quarter in Germany than the overall growth rate of the company. But one of our strategies is, of course, that we're trying to create more Germanys. So we are very much focused on growing sales in Spain, in the UK, in France. So we become less dependent on Germany and have a more balanced portfolio of countries. It goes for the distributor markets, of course, as well. Naturally, if you have a market where the penetration is already at 12%, which is 10 million euros, then you will see lower growth rates in a country that's maybe at 1 or 2 million euro sale. That we will see for a while. I'm expecting that the share of other direct markets increase further but at the same time we have we have not reached the limits in germany at all yet if i look at the regional variations that we have in germany our overall penetration of the market is around 12 but we have territories and not just one where we are above 20 those are usually the ones where we have the longest customer relationship we have a very good salesperson we have continuity in the key account manager role with no changes i think these kind of things can contribute to a strong growth performance and so good headways to grow further in germany and why have you not raised any capital to finance the acquisition and why is the rollout in europe especially in germany so slow okay these are two slightly unrelated uh unrelated questions So why have we not financed the acquisition through external money? Because we don't have to. The price will be 34 million. Roughly 25 of those will be due in the fall when we close the deal. And then the rest is deferred by two years. If you were to look at our long-term cash direction, we will have a positive cash flow effect quite fast because we will be able to produce the products cheaper than we are buying them today. So some of that exhibition price we will earn back before we reach the trough of our long-term cash outlook. So from that perspective, the need for additional financing was not required. So we are still fully financed to what we're planning to do. And then the second question, why is the rollout in Europe so slow? I'm not going to agree it's slow. I think we've grown 20% year over year in the first six months. The model in Medtech is usually that you have to change behavior account by account. So typically, unless you have a cure for a very uncurable disease, the uptake is usually more gradual than explosive, I would say. So I'm quite happy with where we are. We've guided for... for a sales growth of 14% to 18%. We are at 19% after half of the year. So above that guidance corridor, we have really, really good growth in some of the markets in Spain and UK. And good upside also to come back to the growth also in Germany and countries like France. And the distributors are back on track. Overall, I think there's really good growth prospects also going forward.

Okay, and looking at the FDA fast track and the possible benefits of this designation, will they be announced in connection to the filing or could they come at any time during the process?

After the filing, yes. So the FDA will typically decide about that once they see the data, which is of course also understandable because if the data is not good, then the FDA will have less interest in fast tracking your product. But let's assume that the data is positive. We will of course apply for priority review. And then we are in the FDA's hands once that will come after submission when it is not possible for us to think.

Okay. And how confident are you that you will be able to pull off the U.S. commercialization with your own team rather than together with a partner?

Yeah, so we're looking at both scenarios, of course. As I've said, we are preparing for the launch as if it's only us, because I think if you're preparing for having a partner on board, you get a little sloppy in the launch preparation, and you increase the value of the whole opportunity if you're ready to launch yourself. I'm quite confident with the We have such prominent hospitals on board in the study. We have so much excitement from the different doctors. I think we have a very, very good starting base. So if we go for a targeted launch initially where we focus on our clinical trial side, the flight house accounts, and then build territories around them and get hospitals in the vicinity to follow the example of these very prominent hospitals, I think we can very quickly show a very good proof of concept, which would then again increase the value of the whole US operation. At the same time, as I've said before, we are of course quite visible in the space. It's a small pond. We are interacting with a lot of those companies naturally because we work and interact with other ventilator companies, pump manufacturers, the IPQ, ICU equipment manufacturers and so forth. So we know a lot of these companies now with the enrollment completion and definitely also once we have positive data, the interest is high. So we will look at those options to work together with partners. But at the end of the day, we will decide whatever creates more value for us. Strategic flexibility to do both. So we're preparing for our own launch. Even better than great.

And with the two trials now fully recruited, how will things impact your investments going forward?

Yeah, I think we've answered that question. So CapEx will come down. As we said, there will be a residual as there will still be as they will still be happening, but on a much lower level. So they take the company apart into three pieces. One is the US CapEx investments that will come down quite a bit. And that used to be, as you know, the biggest source of cash burn. The European or ex-US part of the business break even. Operating cash flows have been positive in some quarters already. So there will be very little cash burn and hopefully soon cash generation. And then the US part, we will, of course, have a launch, which initially will take some investments, but we're not at the same level as the money we've spent on the cloud.

Okay, and can you remind us about the reimbursement status on the UK market? Is it still not in place?

So in the UK, we now have the regulatory approval by MHRA for the drug. The device was approved even before. The way it works in the NHS is a DRG system, so it's basically a direct drug. negotiation with the with the hospital. So you don't have our product at least doesn't have to go through one of these centralized pricing reimbursement processes. It's a it's a direct negotiation price negotiation with the.

And we'll take one final question here. Looking at Innovative Secol and its other customers, will you suspend operations with that company?

No. So it's true that the Innovative Stakeholder has two customers. One is us, which was representing the larger share of sales. But there's another Nordic company. So we'll keep producing for them. It provides us with a, I mean, not a huge, but a probable cash flow from that company. So we will keep that as it is for now.

Okay, thank you very much, Johannes and Johan, for presenting today and answering all of our questions. And also, thank you everyone who either called in or typed in your questions and followed this presentation with Serana Medical. And I wish you a great rest of the summer. And until next time, thank you very much and goodbye, everyone.

Have a nice summer. Thanks for all the questions.