Sedana Medical AB (publ)

Hello and welcome to today's webcast with Stana Medical. We see you Johannes Doll, CFO Johan Spets and CMO Peter Säcki will present the report for the first quarter of 2025. After the presentation, there will be a Q&A. So if you're calling in and want to ask a question, please press star nine to raise your hand and then star six to unmute yourself when handed the word. You can also send in questions via the form to the right. And with that said, a hand over the word to you guys.

Thank you. Welcome to our Q1 report 2025. Thank you very much for joining us today. Let's jump straight into the highlights on page three. This is a quarterly report that I'm very happy with as we have made strong progress across all of our three priorities. On the top line, we have come out of the gate strong with a new record in quarterly sales of 57.5 million SEC, which is the first quarter ever above 50 million SEC and a year over year growth of 18%. 15% of that is organic and the rest is contract manufacturing revenue from our newly acquired manufacturing plant in Malaysia. What's behind the growth is a good quarter in Germany with 8% growth and continued very strong performance in our other direct markets outside Germany with 50% growth. What's also worth mentioning here is that the publication of the CESAR study on March 18th has not affected our growth trajectory. That is true for March, as you can see in the numbers in this report. And I can also confirm that is true for April as well, which you cannot see in this report. We are tracking daily orders and also all conversations our field force has with customers about CESAR. And as I said, do not see a change in our growth trajectory. Dice progress also on the profitability side. Gross margins are stable at 71%. In the second half of the year, we are anticipating a further improvement of the gross margins as a consequence of the acquisition of our Malaysian supplier. But even without that future positive gross margin effect, we can report an ex-US EBITDA of positive 7% in the first quarter. It's slightly negative on a group level, which includes US related operating expenses. But if you correct for exchange rate headwinds we've had during the quarter, also our group level EBITDA in Q1 was slightly positive. We also had positive operating cashflow. So we are progressing just in line with our strategy, which is to grow sales so we can deliver profitability and positive cash flows from Europe that we can then reinvest in our future launch in the US. Speaking of the US, we had great news recently with the FDA approving our early access program or expanded access program as the FDA would usually refer to it. This means that eligible patients will be able to get access to our therapy already before the official market authorization. And this is of course great news for us in many ways. First of all, the FDA only approves programs like this if they believe that you are bringing a solution to a situation where there are no goods alternatives. In this case for difficult to sedate patients, which is a very good sign. We will also have hospitals and key opinion leaders trained and using the therapy before approval, which could potentially accelerate our commercial launch and is also a great way for us to test processes and gain insights ahead of launch that would be very valuable for the actual launch further down the line. As you probably remember, we had positive high-level results for both our US trials and the FDA has previously granted us fast track designation. So things are progressing full steam towards submission in the early part of next year. And let's move to the next page, page four, please, which shows the longer term sales development. We've shown that slide for a while now as it shows nicely our progression over time. As you know already, we've set a new all-time high in sales for the full year of 2024, which finally exceeded the outlier years during COVID-19. And we have now followed up on that new all-time high in yearly sales with a new all-time high and quarterly sales with 57.5 million SEC. If you have followed us for a while, you know that this is the result of a fundamental transformation of the company, starting with a streamlining of all our non-customer facing functions to free up cash to invest into the frontline and commercial execution, especially in countries where we have good probability and momentum. Let's go to page five. The sales growth combined with a simultaneous focus on driving the cost down has resulted in a significant improvement of our profitability situation. 2022, that you see on the left side of this slide was the year with the biggest EBITDA loss in Senana's history. And over time, you can nicely see the improvement of our EBITDA. For Q1 of this year, you can now see a positive 4 million SEC ex-US, which corresponds to an EBITDA margin of 7% or 8% excluding exchange rate effects. And on the group level, so including the US, you still have a small negative, but adjusting for some exchange rate effects during the quarter, we would actually have delivered just slightly positive EBITDA also on a group level. And this is of course a development that I'm very pleased with. If we then go to page six, I see ourselves very well on track to deliver on our financial target for the full year. We've guided for positive full year EBITDA ex-US in the low to mid single digits. And now we've started the year with positive 8%. And we're now entering the summer quarters, which are typically a bit lower sales for us, but then we're also anticipating some gross margin improvement in the second half from the Malaysian acquisition. So overall, I think we're very well on track and we're confident that we will deliver on our guidance. Good, so let's do a double click on our sales performance and look at the individual regions. On page seven, you will see that Germany is back to growth. You may remember that we had flat sales development in Q4 of last year. The reason for that was mostly that we had some turnover in the field for us, leading to temporary vacancies and some time that was needed to onboard new colleagues. And our therapy is quite sensitive to promotional activities and presence with customers. So these kinds of disruptions can easily impact the growth in a given quarter. Good news is that now the team is fully staffed again and we've been rolling out a sales acceleration plan, which the team is implementing with a lot of motivation working on maximizing the time in the field. So the time we spend with customers and also finding ways to broaden use of our therapy across patient segments in high potential accounts. Now we've had 8% growth in Q1, which is good, especially since we are comparing to a strong Q1 of last year. And it's very important to keep growing in our main market. Of course, we had 13% market penetration in 2024, which is not bad, but we still have room to grow in light of the clinical and health economic benefits that our products bring to patients and intensive care units. We know that in our best performing sales territories in Germany, we had average penetration levels of quite a bit more than 20%. And those are still growing. So there's still lots of room for us to grow. Then let's turn to the next page, page eight and our other direct markets. So the direct markets or the markets where we have our own field force outside Germany. In the first quarter, this group of countries delivered a growth rate of 50% and they now represent a bit more than a third, 37% of our core business. And that for me is a very nice success story as only three years ago, these countries contributed 17% to our business. So today it's 37, which really helps reduce our historical vulnerability from being too dependent on just one main market. Spain continues to be our strongest market outside Germany. The team there is very successful in making more and more hospitals use our therapy and more and more patients. That sounds very simple, but that element establishing broad use in a lot of patients in a given hospital is actually at the core of our commercial focus. And for several years now, we followed a very disciplined investment approach where we extend teams that show profitable growth, but also go the opposite way and cut back investments where this is not yet the case. And in Spain, of course, we have increased the team size last year to keep up with the strong demand and further accelerate it. And that continues to have an impact. In the UK, we've also seen a significant increase in demand during 2024, and also see a continued growth into 2025. We've just added another key account manager to strengthen that momentum. And in France, you know that we've had some flat development for a while, mostly related to lack of stability in the sales team, which made it unnecessary to restructure the team and have a new territory structure. But now we've seen two quarters in a row with growth and are working on making that permanent. So then let's go to the next page, our distributor business, which is the smallest part of our core business. Of course, our strategic focus is on our direct markets, given the share they represent in our sales, but the distributor business is still a nice add-on. We are pursuing a very focused approach here with a lot of emphasis on a few key partners and high potential opportunities. That business is inherently more volatile as ordering cycles are longer and inventory levels kept at distributors tend to be much higher than at a hospital. And for Q1, you can see a significant decline in sales year over year, minus 39%. The explanation is that last Q1, we had the only order from our South American partner during 2024, which was worth 1.4 million SEC, and we did not have an order from South America this quarter. So that explains most of the difference. Based on the in-market demand we see in countries like Mexico, Colombia, Brazil, we are still expecting growth for South America for the full year, but these orders will materialize only in the later part of this year. Distributors outside South America are also down somewhat in Q1, which has mostly to do with the timing of orders coming in. Then we move to the next page, and I'm handing over to Peter, who has some exciting news to share regarding our largest future potential market,

the US. Thank you, Johannes. So as Johannes mentioned earlier, and we also press release, the FDA approved our Expand Access Program. Just a few weeks ago, and this is a great opportunity in many ways, both for patients and for us as a company. And just to share, Expand Access Programs are typically granted by the FDA specifically for patients that have serious life-threatening disease or conditions, and for treatments with investigational medical products outside clinical trials and before marketing authorization, and when there's no comparable or satisfactory alternative available. When it comes to inhaled sedation with isoprene, the patient group that we've been granted the Expand Access Program for are the difficult to sedate patients. And these are patients that are receiving intravenous sedatives in appropriate combinations, maximum tolerated doses, and still cannot be kept at a targeted sedation level. And they exhibit recurring agitation with risk of self-harm, or have escalating sedative doses, or there may be clinical concerns for side effects of ongoing IV sedatives. And that's the greed sort of criterion for inclusion in this program. And the program as such is open for any interested hospitals in the US that have critical care facilities that are sort of up to standard. And we will be giving the device, scavenging and isoprene for free to these hospitals for these patients. And looking at the benefits of this, as I mentioned, this of course is a way to manage patients that are difficult to sedate, and they are at high risk for complications for critical care. So we believe that will bring benefits to those patients, and also to the units. These patients often require high level of staffing, and as I said, they have complications, and they stay longer time in the ICU. For us, it means that inhaled isoprene sedation will be available and be used in the US in the years until we have an approval. And that means that the hospitals and key opinion leaders that will choose to use this therapy will continue growing their expertise and proficiency in the use of inhaled sedation. And that's of course is very valuable for us because that means we will have hospitals and clinics and healthcare professionals that are able to speak about this therapy and who can be experts that we can refer to when we launch. And the EAP also includes a slightly broader range of conditions than the actual trials. So that's also valuable for us. And finally, it's also an opportunity for us to develop and test our implementation, training, supply chain, et cetera, so that we are up to speed at the time of launch. And it's also an opportunity for us to map hospital processes and have discussions on reimbursement and so on before we have the approval in our hands. Next slide, please. The basis for our NDA submission are the two pivotal US studies that we've spoken out previously. This is by ICU trials. They are two identical phase three trials that confirmed the sedation efficacy of inhaled isofrine and which shared the high level results with you previously. And they compare inhaled isofrine with intravenous propful in adult mechanically ventilated ICU patients. And these studies had a number of run-in patients and then they had 235 randomized patients in each study with the primary endpoint being the percentage of time at which patients were kept at Richmond agitation sedation scale between minus one and minus four. And the key secondary endpoints in falling priority are number one is the opioid dosing during sedation. We're also looking at time to wake up after end of sedation, cognitive recovery after end of sedation and the proportion of time with spontaneous breathing. And both studies have demonstrated a non-inferiority with regards to the primary endpoint. And we've also had a look at the high level safety results and share them with you. And they indicate durability of our therapy and no new safety concerns. So all of this is promising I would say. Next slide please. And the studies were conducted across the US at 31 clinical trial sites that you see listed here from East to West, from North to South. And this of course for us is a great platform to start off as we now move into EAP phase and then gradually looking forward to hopefully an approval and a launch in the US with these places. Some of these places we believe will be as of centers of excellence as we launch. Next slide please. And now I hand over to back to you, Johannes. Yes,

thank you, Peter. So we're now on page 13. As you know, the US is our largest growth opportunity. We 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, which is because of a high number of ventilator beds, medical practice that favors intubation and medical ventilation more than in Europe and also an overall higher price level. We see a very good product market fit, which I will get back to on the next page. And on top of that, Peter and his team have really done an excellent job in building a network of key opinion leaders in all these clinical trial sites that you have just seen. And you've seen that some of these are the premier names in the US hospital landscape. And those people are very, very supportive of our therapy and Sedana Medical as a company already today. So we have high market potential, a good product market fit, a KOL network that is ready to get started. And we have positive high level results and now also an approved early access program. So therefore we continue to believe that we can create the most value if we launch ourselves in the US, capture more of the upside, generate the proof that this therapy can be successful in the US. While then over time, keeping the option if necessary or wanted to compliment our presence with a partnership if we deem that to create even more value. I've mentioned the product market fit. So let's have a closer look at that on the next page, page 14. We know that inhaled sedation with isoflurane has fantastic clinical benefits for patients. We've seen that for several hundred thousands of patients and more than a thousand hospitals around the world. But the truth is clinical benefits alone are no guarantee for a product to be successful on the US market. And the commercial success very much also depends on how well the product fits with the healthcare system. The different payment mechanism for hospitals in the US, but by far the most predominant one for mechanically ventilated patients in the ICU is diagnosis related codes, so-called DRGs. That means that the hospital gets paid a fixed rate for a given patient depending on what diagnosis and partly also what procedures that patient will have. This means that from a hospital PNL perspective, the revenue side is fixed and the cost is dependent on how long a patient is in the ICU. So a therapy that could help a patient wake up faster or spend less time on the ventilator, recover faster, leave the ICU earlier, all these would be benefits that help the hospital's financials. And now of course I cannot say that Sedana will be able to provide those benefits in the US because we have to await the approved label. But we have shown all of these things in our European trial. What we also know from our European trial is that in-haste sedation patients need less opioids. If you treat them with isoflurane, 30% less in Z001 and even 50% less in the pediatric trial, isocomfort, without these patients actually having more pain. And the US is as you know, extremely sensitive to avoid opioids because of the terrible opioid addiction epidemic that is going on in the US. And if there's one regulatory authority that is very sensitive about opioids, then it's of course the FDA. So bringing a therapy that might reduce the use of opioids as we have shown in Europe in a vulnerable patient population is a major plus on the US market, especially since there's very good evidence now that the dose of opioids you receive in the hospital is actually very closely correlated with how much opioids you will be leaving the hospital with. And that's of course is a big driver of addiction risk. And thirdly, we know from Europe that treatment guidelines, treatment recommendations can play a crucial role in facilitating the uptake of our products as we have seen for example in Spain. And then if you read the CDC's wake up and breathe document, it reads very much like the benefits that incidation with isofluring has shown. It's about getting patients off the ventilator sooner, improving recovery time, having them interact with families faster, shortening ICU stays and so forth. So if we manage to confirm the results in our US study, we'd be fitting right in and would be well positioned to get into the treatment guidelines. Then let's move to page 15, please. Yes, thanks. Another good news from a growth perspective is that we have now received national approval in 11 countries in Europe for our pediatric indication. This means that our products can now also be used on label for kids between the age of three and 17. That is not a huge patient group, but it's a very vulnerable one. And so far only Midazolam was approved. There's a sedation in the ICU for these kids, which comes with a lot of complications. So that's really, really good news. And as a very positive side effect, the group that is working with EMA that is responsible for these things granted us an additional year of market protection. So we now have the maximum that you can get, 11 years in total, which will last until 2020, 2032. And market protection means that during that period, no company can launch a generic for inhaled sedation in the ICU in the countries where we have approval. Let me now hand over to Johan to do a deep dive into our numbers.

Thank you, Johannes. Yes, if we spend a bit more time on our financial result for the first quarter of 2025, just as a reminder, Johan has already mentioned, of course, the sales development, but just to reiterate, so we report net sales for the first quarter of 57 million or 57 and a half, to be a bit more precise, which is an increase of 18 percent compared to the previous year, both in reported currency and also in local currencies. And this robust growth is driven, as Johannes also pointed out, by a re-acceleration of growth in Germany and also continued strong performance by our other direct markets, in particular, Spain, while distributor markets saw a sales decline, to a large extent explained by the fact that the comparator period included a large order from our South American distributor, 1.4 million SEC. And then in addition to our core operations, we now also report contract manufacturing revenue, which amounted to 1.7 million for the first quarter of 2025. We report a stable and robust gross margin of 71 percent for the quarter, which means then that the fact that we have growing sales means that we have an increasing gross profit, now amounting to 41 million SEC for the quarter. That's also up compared to the same period of last year. In terms of EBITDA, we show really good progress as well. So EBITDA for the group for the first quarter of 2025, minus 1 million SEC, that's an improvement from minus 4 million in the same period of 2024. And also very important for us as a metric is, as you know, the EBITDA excluding US, and there we see an improvement to positive 4 million SEC for the first quarter of 2025, up from minus 1 million SEC last year. And as Johannes also pointed out earlier, there is some FX headwind there as well. So adjusted for that, it would be even slightly better, EBITDA XUS in the first quarter. So very good to see that type of profitability development over time. If we look at the OpEx side, there we see a slight increase in the first quarter of this year compared to the same period of last year, mainly driven by consultants in admin functions, our paediatric approval and preparations for the US market. But as you can see, just looking at the improving gross profit and the fact that we're not growing OpEx nearly at the same rate, of course, that leads to this improvement in EBITDA. So we very much expect this to continue going forward, driven by continued sales growth and cost discipline, which very much remains in focus for us. In terms of our organization, as you know, with the acquisition of InvaTiff Sekel, we've grown the number of colleagues in Sedona Medical quite substantially at the end of or during Q4 of last year when the acquisition was completed. So now at the end of March 2025, we have a total staff, including consultants of 126 people. That's up from 90 at the same time last year. But again, this addition is related to the staff in Malaysia at our new manufacturing site there. Then on the next slide, we can take a closer look at our cash flow and cash position. So starting with the cash position, at the end of the quarter, we had 165 million SEC of cash in the bank. That's compared to 194 at the start of the year. And if you look at that change in the cash position of minus 29 million SEC, that's driven by two things, really. It's capex, mainly in the US of 17 million SEC. And then there's a negative currency effect of 16 million SEC coming from the fact that we have most of our cash now in US dollars. And of course, with the strengthening Swedish Krona that we've seen that comes through as a negative cash effect there. These two negative items, so the capex and the currency effect, those are offset by positive cash flow from operations and changes in working capital. So that's with regards to the change in the cash position. But then if we look at the actual cash flow as such, we have cash flow from operations in the quarter of positive six million SEC. And that's driven by positive operating cash flow from our ex-US business, a reduction in inventory and also increased short term liabilities. And then cash flow from investments in the quarter, as I said, negative 17 million. And that is driven by our clinical program and registration preparation work in the US. And what's important to highlight here is, of course, that it is a significant decrease in the quarterly capex level that you can see now coming through in the first quarter of this year compared to compared to the past couple of years, really. But if you compare it to the direct comparator period, it was 52 million SEC in the first quarter of last year, now down to 17 million this quarter. And that very much reflect the fact that, as you know, last year, we concluded our US clinical trials. So we expect now capex to remain markedly lower in 2025 relative to recent years. And what that all adds up to in terms of total cash flow during the quarter was now negative 12 million SEC, which again is quite a significant reduction in terms of cash outflow for the company as a whole compared to recent quarters and years. In terms of liquidity management, we continue to have roughly three quarters of our available funds in US dollars, since that is where we will have our spending going forward, related, of course, to the US submission and eventually preparations or the commercial launch activities coming up in the US, if all goes according to plan. And again, with this cash position of 165 million SEC that we have now, we expect to be fully financed to execute on our strategic plans for the company. Next slide shows our shareholder list as of the end of the quarter 2025. And it's great, of course, to see that we continue to have support from our main shareholders, some of which have increased their shareholdings during the quarter. So thank you very much, of course, for your continued support. And with that, I will hand the word back over

to Johannes. Yes. And this is our last page, recapping the investment in the quarter. And this is the second case for Sedana Medical. Our business model lends itself to attractive profitability over time because we continue to see good gross margins of 70% and up. And as you said, anticipating a further improvement in the second half from the Malaysian acquisition. So by definition, we can become quite profitable as a business when we reach scale. And at the same time, our customers are intensive care units, so a relatively concentrated target group that can be covered with a reasonable operating expense level on a local level. We already have proof of concept that that works in our main market, Germany, where the majority of ICUs are already our customers. The team is generating very attractive EBITDA margins on a local level. We also see growth momentum, great growth momentum outside Germany. And while we are not at the same scale yet, most of our countries contribute positively with local profitability by now. So we have the proof of concept, and now it's all about reaching more scale, convincing enough hospitals to use inhaled sedation with isoburine more broadly and achieving profitable growth. And here we have, of course, convincing clinical and health economic data on our side, as we've seen, showing that our patients really benefit from inhaled sedation and that hospitals save money with inhaled sedation with isoburine versus the previous standard of care. And we have lots of places to grow in Europe and also hopefully soon also in the US, where we have positive trial results, fast-track designation and now also an approval for the early access program. And all of this still with a solid balance sheet with no debt, and 165 million in cash. So you saw a good reduction in the cash burn rate already this quarter, and we will see the same also ahead. So we continue to be financed to execute in our strategic plan. This concludes the presentation. Thank you again for taking the time to listen to us today, and we'll be very happy to take your questions.

Thank you so much for the presentation. And as you mentioned, now we'll carry on with Q&A. So if you're calling in and want to ask a question, please press star nine to raise your hand and then star six to unmute yourself when handed the word. And the first caller here is Mattias Wallsten from SEB. You're welcome. You have the word.

Sorry, can you hear me now?

Yes, now we can hear you.

Good afternoon, and thank you for taking my questions. First one was trying to get a bit more flavor on customer behaviors post the CSER trial readout and how the discussions have been with customers. And perhaps particularly interested also in France, of course. So that's the first one. Then I have a few more.

Yes, I'm happy to share some more granularity. So as I said, the CSER was published on March 18th. And since then, we've been tracking the impact very, very closely. So, of course, we have done what we always do, which is to track daily orders on a daily basis, country by country. But we've also asked the field force to report back every conversation they have about CSER with customers. So we have a pretty good picture of where everybody stands. The most important news first is that on the highest level, on a company level, we do not see a change in the growth trajectories or growth momentum is very much intact. So if somebody was concerned about the CSER study having an impact on our commercial performance, we don't see that at least in March and April. Then when it comes to the discussions we're having with customers, the vast majority of feedback is that there's not going to be any impact on the use in these hospitals. These are typical isoflurane users who have used isoflurane for a long time, have seen the benefits and now don't change the behavior because of a seborrheicane study. So that's the majority of feedback. And then we, of course, have some customers that have raised questions. That is not surprising. And those we need to manage. There's also some customers where they are reassessing whether inhaled sedation, especially with seborrheicane, should be continued in ARDS patients. Nobody has so far stopped inhaled sedation completely. But we might see a little bit of reduction in some accounts that predominantly those that use isoflurane and don't want to switch for iso. But then on the other end of the spectrum, we also have several customers who have switched from off label to iso use to our drug as a consequence of CSAR. And that's a very positive development because when that happens, we quickly see an uptick in sales, first of all, because we sell the gas and we don't sell isoflurane, of course. But we usually also see an increased use of the therapy because people start getting better results and the therapy becomes cheaper because isoflurane is at a lower price point than isoflurane. France, specifically to your question, we are seeing a little bit the same picture overall. So we've quite a few, a few isoflurane customers. And there's more isoflurane customers than in other countries. We've seen quite a few of those switch to iso already. Including several hospitals that have participated in the CSAR trial. So seeing the results firsthand, a lot of them have now switched to iso. But we still have a bit more work in France than in other places, simply because the starting base is a higher share of off label isoflurane use. But overall, as I said, growth momentum very much intact. And that's, of course, what we wanted to see.

I could just add to what Johannes was saying, that we've had a lot of we've been relatively proactive in our interactions from the medical department. So we've arranged webinars in the different markets, allowing both customers and others who would like to discuss to have an open discussion. We've also interacted with both the first author and the last author of the CSAR paper. And the picture that is shared independently of Sedana's proactivity is that this is a use of isoflurane that is quite different from the standard use of inhaled sedation and certainly different from the use of isoflurane. And that there are also specificities related to isoflurane and side effects, mainly renal side effects that are contributors to the findings of the CSAR trial. So it's I mean, it's of course, it's we are happy to see that there is an organic academic or scientific discussion about these kind of papers. And to be honest, I think that might actually be beneficial in a way, because inhaled sedation is something that's being discussed. And we have in a way maybe been fortunate to have chosen the drug that seems to be the safer drug. So there will also be a number of letters to the editor that will be responded to by the main authors. And I can mention that the last author of the CSAR paper is Professor Jean-Michel Constantin, who is from Paris, Labetit Saint-Petrier, and who was the sort of the mentor of Mathilde Badon. He moved to Paris for, I think, four or five years ago. And three years ago, they decided to change from C-Bufferane to isoflurane for because they were seeing problems with renal dysfunction and polyuria. That was already when CSAR was halfway through and they didn't have any interim analysis in place until the end of the study. So that's why the study continued. But he was already, for him, it was already clear that iso was the preferred drug a few years ago. And so he's switched. And of course, that's something that's a story we share because that says something about sort of the clinical preference among one of the believers of C-Bufferane once upon a time.

Thanks. I think this is a good answer. You partly answered my question, but my follow up question to this was, you know, how established would you say it is currently with regards to what went wrong in the CSAR study? And why the response was so weak or the results were so weak? So I can share.

Yeah. So last week, we had an investigator meeting here for the US trial investigators. And Rommie Constantine was invited from Paris to come and talk about inhaled sedation because he's a user since over 15 years. And also to talk about the ideas in the CSAR trial. And and that they have done also they have done a retrospective chart review of C-Bufferane treated patients. That's not yet published, but that's in review. And they see a lot of poluria and his own his own speculation, although they don't have the data to support it, is that a combination of probably higher dosing than than than than than typical. Combined with the poluria, which leads to which can lead to hypovolemia was probably detrimental for a number of patients in this trial. Once again, that's his that's his speculation. That's also our speculation. That's what what has happened. And that would sort of be very much in line with with the data that they did actually collect, namely they suppress the use and and causes of excess mortality where where therapy factory shock was the was the driving cause of excess mortality. So it makes it makes a lot of sense if you if you have poluria that's not corrected and you give a high dose of all phalanesthetics, you will certainly end up with high base of presbyosis and a risk of of of shock. And you don't see we don't see this with isophrase. There's no report of any poluria. We don't see that in any of our studies that poluria and it's not been described in a case case report. So at least for me, it's it's quite quite clear that differences both in in the drugs and in the way that patients were treated during covered 19 and the CSR study as it was initiated under the very I would say war zone circumstances.

Perfect. Thank you very much for that. Good answer. I will try to not take up too much time, but I have a few questions around the early access program as well. And so hope you can catch them all. But the first of all, you know, what support has the FDA had to be able to allow something like this? I guess I would guess it is top line in the US trials and the European data and then follow up questions. How many hospitals will you try to approach? Also, you know, what share of patients do assess are difficult to sedate patients and therefore are eligible to treat and also can't hear what kind of costs you anticipate to to deal with this in the US.

So I could talk about the medical parts and then you like to talk about the costs when it comes to the approval of the this is the IC frame by the second ACD is still an investigation product. So this is not this is not a pre approval of therapy. I think it's important to point out. We need to put together the adults here and make a strong case. I believe we have the data to to support a future approval, but that will be the FDA's call. Of course, they do have the top line results from the US studies. They do not have our other results so far from the US. They have the extensive literature available where you have over 200 publications of inhaled isoflurane to date among those 200. You have several publications on various different various patient patient populations. Isoflurane once you remember isoflurane is a drug that's been used for difficult to say patients previously publications on that. It's also a drug that is known to in a sufficient dose lead to general anesthesia. So it lends itself the data lends itself to to sort of support its use of isoflurane in patients that are not well managed with IV sedatives. We are obliged to collect safety data, so that is, of course, an obligation for us. But it also is an opportunity to show that that this therapy is safe also for these patients. When it comes to approaching hospitals, typically within the AP, this is not something you markets. You you announce it on your home page, which we have done. There are many of our investigators in in our US trials that have have been asking about the possibility of using isoflurane in these type of patients. A few of the patients in the trial were difficult to date as they joined the trial, especially among the run in patients. This was a favorite patient category to to use this on. So they know it works and we've received almost two digit number of requests for the AP. So we we we are we need to find ways to to to set up this whole supply chain and make this available as we've as we've communicated the second half of this year. And I think that will be that will have plenty of work to to meet meet the demand when it comes to AP. We do have people in the US already who were part of the trial educators and also myself and others from our medical team will be supporting in the AP. I don't know if you'd like to say anything more, Johannes, when it comes to costs.

Yes, so we I mean, it's quite obvious, I think that we have to strike a balance here, right? Because we will be providing this is not commercial sales. We will providing the products for free as a customary in these in these early access programs. Of course, the FDA would not like you to make a profit off of the early access programs. So we have to strike a balance. As Peter says, we will not be actively marketing this. So we will have to be a bit selective given the the the limited resources we have on our end. What we want is having hospitals fully trained up and running and bought into the therapy when when we launch for real. What we want is to test our processes and gain insights about how the hospital processes work. But at the same time, what we do not want is for this to become such a an expensive investment that we are putting our our cash position at risk. So we will, of course, balance that very, very carefully. The cost on us is mostly the products as such. So, of course, those are cheaper to us than they would be to a to a customer. But it's still still the cost and the logistics of getting it, getting it to customers. We are not planning to hire any new colleagues for this program. So, as Peter said, it will be done with existing resources. So overall, without giving you a specific number now, because we've got guided on that, it's we will make sure that it works out in the end.

Thank you very much.

Thank you so much. We will now carry on to the next question here. And it's Filip Viber from Pareto. You have the word.

Hi,

and I think that's covered a lot of ground, but I just have a few more here. So perhaps starting with what you just talked about here, the cost for the early access program. So I'm just like a technical question. Will that end up as extra costs sort of lowering the overall gross margin or where will that end up?

Yeah, no, we will we will take that as the OPEX, because it's not something that we that we sell technically. So it will be an OPEX under selling selling cost. And you

as you as OPEX. So it will it would not affect the XUS EBITDA, but you would see that the cost in the in the overall. OK, OK. Thanks for that.

And just sort of a question out of Kiro's Q&A. Curiosity. So I know it's going to be a small amount, but will you have to pay tariffs on the product that you import for the early access program?

Yeah, we're doing that analysis right now. It's as you know, a lot of uncertainty around around that at this point and even more so when we look to the predicting what it will look like in the second half of the year. It's is an analysis that is ongoing, so I cannot give you a definite answer on that. If it was so that we have to have to pay tariffs, it's of course not not a showstopper, because it's going to be very, very small amounts in comparison. Yeah, all right.

OK, perhaps just a bit on the on Germany here. So this sales acceleration plan that you have been doing now, just if you could give some more details on this, has it been mostly about hiring the new sales team and getting them up to speed, or have there been other measures taken as well? And then just following that, so 8% growth now in Q1. Have you seen any difference in the momentum now in start of April?

Yeah, so this is the sales acceleration plan we have put in place because we were not happy with the performance last year, especially in Q4, where the sales was flat. And part of the explanation was these turnover in a few districts and the fact that it takes time to get people up to speed. But it was not only focused on getting the team stable, it has several elements, including making sure we spent as much time with customers as possible. So there's a lot to do with account planning, making sure you minimize distractions for the for the field for so they can really spend their time selling and not not administrating things. It is about selling approaches, how we make sure that hospitals use our therapy as a routine treatment. So across patient populations as opposed to just individual patient population. And of course, there's also always in these programs, there's an element around performance management and how you set the incentives and so forth. And all of that combined, sometimes a bit tricky to say what exactly had the impact, but the combination of these things very clearly has an impact. So we had a strong Q1 last year already and now 8% higher than that. So that's a pretty good result. And then hopefully we will see that performance continue into the next quarters.

Yeah, because I think you wrote about it and you talked about it also that you've been tracking the orders quite closely now and you haven't seen the change in April. So I'm interpreting that as that you still have a very good momentum in April. Is that what you say? That's a fair assumption or?

Yes, I've said that on the on the company level. So and Germany is a big part of the company. So I will of course not disclose the Germany performance for April. But for the company, we've not seen a CESA impact in April.

OK, and then just lastly, perhaps to you one here. So in the capital side, investments in TANGBO, it has come down significantly, as you said before. So just wondering about the expectations now going forward. So will it continue to be at this level? Is this a stable level going forward or will it continue going down?

Yeah, no, it's overall it will it will remain at a significantly lower level than it's been in in recent years. There will be, of course, capex remaining as we continue to prepare the dossier for submission and all the work that's involved with that. What we've said previously is that it will gradually come down during during the year. Now we saw perhaps a bit more of a reduction already in Q1. So you might not get as much of a continued reduction during the remainder of the year. But but it's definitely as a new and lower level now relative to last year and should be expected to remain at this newer level.

Yeah, all right. Yeah, I think that was all the questions from my end. Thanks a lot. Thank you.

Thank you so much. And we have received one question as well here. Any news update on the FDA request regarding polling of data from the EU and US trials?

Yeah, so no update from the from the FDA's perspective. But what we have done in the meantime is we have completed a feasibility study. We've looked into whether that's technically feasible to pull the US and the European study. The result of that was positive. So all the endpoints that we want to pull will be possible to be pulled. So the sequence of things now is that first the two US studies will read out in isolation. So we will get the secondary endpoints and the long term follow up for each of these studies individually. Then the next step is to pull the two US studies. That has nothing to do with the recent FDA input that was always planned. So we run analysis across both studies. And then the next step will be once that is done is to pull the two US studies and the European study together. And all of these things will then be compiled in the dossier and the timeline. For that it still very much stands compared to what we said previously. So we're expecting to submit the file to the FDA in the early part of 2026.

Thank you so much. Those are all the questions we had. So thank you so much for presenting here today. And thank you for all for the questions and we wish you a pleasant week.

Thank you very much. Have a nice day.