Sedana Medical Aktie

Hello, and welcome to today's FINWIRE presentation with Sedana Medical. [Operator Instructions]

With that said, I'll hand the floor to you. Please go ahead.

Thank you for the introduction. A warm welcome to our Q2 reports 2026. I am here with our new CFO, Mikael Haag, who will introduce himself and speak about our financials in just a few minutes; Peter Sackey, our Chief Medical Officer, who's usually with us, is not here today as he is traveling in the U.S. onboarding the next large hospital into our early access program.

So let's talk about the second quarter. What stands out, of course, is the NDA submission in June, a huge milestone after years of work on our U.S. clinical and regulatory program, so our biggest growth opportunity, the United States, has moved another step closer.

At the same time, we managed to further improve profitability, even though sales on the group level were flat versus a very strong Q2 last year.

So let's jump right into the highlights on Page 3, thank you, structured around our 3 priorities. So growing sales in our core markets, reaching profitability and our exciting U.S. journey. Q2 net sales were SEK 49 million, which is flat compared to last year at constant exchange rates. If we look only at the core business, so excluding the contract manufacturing sales from our factory in Malaysia, sales were slightly up by 1%. We had a delayed shipment to our contract manufacturing customer that shifted from June into July. So it's actually the contract manufacturing business that pulls us down just slightly on the group level, but that's a pure timing effect.

Still, this flattish development looks a bit underwhelming probably at first glance, but we need to remember that we are comparing against a very strong Q2 last year when we had organic growth of 21%. Having said that, it is very clear where we have to improve. Germany had another very soft quarter. But the good news is that every other market outside Germany showed really good growth and also accelerated growth compared to the first quarter. I'll go through each region in a bit more detail in a moment.

Another very positive outcome of this quarter is that we -- despite the flat sales again improved our profitability, both our ex U.S. and group EBITDA are up. Ex U.S. EBITDA reached 2% in the quarter from 0 a year ago and 6% year-to-date, up from 3%. And at the group level, EBITDA improved to minus 4% in the quarter, up from minus 8%. As always, we have a bit of seasonality here. And we now stand at breakeven year-to-date, up from minus 4 last year.

Also, the gross margins improved nicely to 73% in the quarter, up from 70% last year, helped a little bit by the lower share of contract manufacturing revenue in the quarter, but more importantly, significantly lower cost of goods of our main device following the Innovatif Cekal acquisition. We ended the quarter with SEK 52 million in cash. Cash burn was a bit higher in the quarter due to the final spurt towards the submission and also affected by some temporary working capital effects, but now the work with the submission is done, so we expect the U.S. CapEx to decrease further. So we continue to believe that we are financed to execute on our plan and actually as an extra safety buffer given the cost uncertainty that sometimes comes with an FDA review.

We have also put in place a new loan facility with a local bank, giving us access to SEK 50 million in additional funds should it be needed. So we are not drawing down the amount at this point, but it is there in case we will need it. That in itself, I think, is good news as our profitable core business is now allowing us to be creditworthy with local banks and then get access to this kind of facility.

And then, of course, the big 1 in June, we submitted our new drug application to the FDA, slightly ahead of our public guidance. And together with the Fast Track designation, the positive pre-NDA meeting, the early access program that is now treating patients at several hospitals, we are step-by-step moving closer to our big goal of US approval.

The review clock has now formally started, and we expect to hear from the FDA in August or September with a decision on whether they will accept the file. If they accept the file, they will set a PDUFA date, so the date by which the FDA commits to completing the review and deciding on approval and also give us a decision on our request for priority review.

If we then move to the next page, Page 4, please, you see the same picture that we've shown you before of our multiyear turnaround now extended by 1 more data point for the first half of 2026. Just to recap the story coming out of COVID, we made it a priority to reach profitability outside the U.S. before launching there, and we ran a really disciplined turnaround program, cutting significantly into everything noncustomer facing. So our Swedish headquarters today runs with less than half of the people it used to have while reinvesting part of that freed-up cash into the frontline.

We've also become much more disciplined and differentiated in how we invest across countries, doubling down where we see profitable growth and pulling back where we don't see that. We also acquired our main supplier in Malaysia, as you know, and as a consequence, managed to reduce cost of goods of our main device, Sedaconda ACD quite significantly. And you can see the results on this slide, a consistent multiyear improvement in the bottom line. That has actually outpaced the sales growth, meaning we've always found ways to do more with less.

Page 5, next page, shows where this puts us against our financial targets for the year. We guided for a mid- to high single-digit EBITDA margin outside the U.S. And year-to-date, we stand at 6%, up from 3% in the first half of last year. And we guided that we would approach group level EBITDA breakeven. And year-to-date, we are actually exactly there at 0%, up from minus 4% last year.

As always, there will be some seasonality quarter-to-quarter, as we've also seen it between Q1 and Q2 here, but we're confident in delivering on our full year financial guidance.

Before I go region by region, I want to spend a moment on the next page on Page 6 to give you some context on how we are comparing ourselves against last year, which maybe helps calibrating the performance in the first half of 2026. Last year, we closed at an all-time high of SEK 200 million in sales, but the shape of the year was quite unusual. So we sold SEK 107 million in the first half and SEK 93 million in the second, so the first half was 15% higher than the second half of the year.

And in Germany, specifically, that pattern was even more pronounced with the first half, 22% higher than the second half, and that compares with a typical post-COVID split of roughly 49% in the first half and 51% in the second. So quite even. So this traces back to the shape of last year's flu season, where we had a very long and severe wave of ICU admissions early in the year, but then that faded out from around May onwards, and since then, has quite consistently been below the levels of the previous year. And the practical consequence of that, when we look at the performance this year is simply that we've been running into -- or running against a quite unusually high comparator in the first half of this year, simply because the first half of last year was stronger than usual.

If we then move to the next page, on Page 7, let's turn to Germany, which faced another difficult quarter. Sales declined 22% at constant exchange rates against Q2 last year when we had grown 19%. Year-to-date, we stand at 18% decline at constant exchange rates. And as I'll show you on the next page, the majority of this effect is explained by quite a lot fewer patients in German intensive care units than we had a year ago.

That said, we are, of course, not just waiting for the market to turn back in our favor, but we are fully focused on what we can control on the execution side, more than half of German intensive care units are already customers today representing over 2/3 of the addressable market. So our biggest growth opportunity is deepening penetration within existing accounts rather than opening new ones and to capture that.

We have now installed new sales leadership during the quarter. We are restructuring territories, so we can sharpen the focus on high potential accounts, even more, we're increasing visit frequency in high potential accounts. We are becoming even better at using data and analytics to steer our activities towards the highest potential opportunities, and we are rolling out sales training even more consistently to dip the effectiveness of our key account managers.

On Page 8, that shows you the data behind the market headwind I've talked about. This is data on weekly hospital admissions with severe acute respiratory infections, so a quite relevant group for us. You can see that this year's flu season, which is what you see in the dark blue is running consistently below the prior season in light blue. Year-to-date, hospitalizations were down 11%. And that's also very much in line with what the German National Intensive Care Registry, so DIVI reports. The share of free ICU beds is up 12% without the total number of beds changing.

The capacity for invasive ventilation is up and also the number of ICUs who report that they cannot -- but they don't have enough staff to deal with the patient volumes, has dropped by 20% compared to last year. So all of this is evidence for lower patient volumes in German ICUs this year.

So what does all of that mean? As a consequence, if there's less patients that require our products, customers will reorder a bit later, and they will also order smaller volumes, and that's what we've seen now for as long as we had lower patient volumes. But again, that should not distract us from our focus on execution. Even in this somewhat contracted market situation, which is hopefully temporary, there are still enough patients for us to go after, and that's what we need to be focused on.

We then move to the next page, Page 9, on to some more good news. All of our other direct markets, in which Spain, France, U.K. are the most important ones, accelerated broadly in the quarter, all of them were growing in the quarter, in total 41% at constant exchange rates. And as I said, every single 1 of them improved versus the first quarter. So that's really good to see. Year-to-date, these markets are now up 22% at constant exchange rates.

In Spain, the nationwide doctor strikes that had started in January are still ongoing. So there's still no agreement between the unions and the Ministry of Health. There's still 5-day strikes roughly once a month, so 1 week a month. But despite that, our growth has reaccelerated quite sharply in the quarter.

Our team has simply gotten better at working around the strike, so they're better at reaching the stakeholders even during the strike weeks, and we are also opening new doors in patient populations where we haven't traditionally been very strong, such as neurocritical care, where there's been an investigator-led study, pilot study published quotes in Neuro-Conda, which is now helping start conversations with neurocritical ICUs. That was a study that looked at mechanically ventilated neurocritical patients and specifically those without intracranial hypertension, so those that didn't have too high pressure in the brain. And what that showed was that early sedation with isoflurane is feasible and achieved reliable deep sedation without causing problems to the brain by affecting its blood supply or pressure. So a really good study for us, and that has helped in Spain and will help beyond Spain with neurocritical patients.

Also, France delivered solid growth this quarter, the APHP network of 38 university hospitals in and around Paris that we've been talking about where our pharmaceutical had been blocked until this year is now live, and we've already opened 8 new hospitals account there. We're still in the process of restructuring the French organization, and we expect a new country manager to be in place in the fall.

In the U.K., performance also improved versus Q1, even though it's a little bit from a low base. One issue we had to fix in the U.K. is that historically, there was maybe a little too much focus on accounts that are easy to convert. Those are oftentimes smaller hospitals, but that don't have enough long-term growth opportunities, and we've prioritized our or reprioritized our account focus towards higher potential accounts now, and we are seeing early encouraging signs that, that is working, even though it usually takes a bit of time to fully play out.

So if I take all of these markets together, our other direct markets now represent more than 40% of our core business, which I find a quite remarkable shift from just a few years ago when we essentially had just Germany and nothing else.

Page 10. The next page shows our distributor markets, which continued their solid trajectory, growing 26% at constant exchange rates in the quarter and 22% year-to-date. That is mostly driven by strong orders from Saudi and from South America, so -- and this progress really builds nicely on the groundwork that has been laid last year, which was about sharpening the focus on select few prioritized partners and at the same time also terminating distributors that weren't contributing meaningfully enough. And as always, this business is a bit more volatile quarter-by-quarter than maybe our direct markets, but the underlying trend is very, very encouraging.

So let's switch gears then and come to the U.S. on Page 11. As you know, this is our largest growth opportunity comparing the addressable market. And our direct markets today with the U.S. makes it very clear. We estimate the U.S. market potential for our products at roughly $1 billion or SEK 10 billion to SEK 12 billion, roughly 3x the potential in our current direct markets. So that the day we hopefully receive U.S. approval, our addressable market would essentially quadruple overnight. And that higher potential in the U.S. comes from a larger number of ventilator bids. It comes from a medical practice that favors intubation and mechanical ventilation more in Europe. And there's actually also a generally higher price level, even though we haven't factored that into this addressable market number yet. So there could be additional upside if we manage to get a higher price than in Europe.

And that's quite easy to see, I guess, how the U.S. market entry could change the shape of this company completely if we were to achieve market penetration levels that are at the level of where Germany is today, for instance, in the U.S., then we'd be looking at sales of SEK 1.5 billion, again, without any pricing upside.

On the next page, Page 12, that walks you through where we stand on the path to U.S. approval. So the big event of the quarter, as I mentioned, was submitting our new drug application in June, just a little bit before our public guidance. This follows 2 successful drug Phase III trials, which have both met their primary endpoint with no new safety findings, a productive pre-NDA meeting we had with the FDA in the fall last year, where we got good alignment on the content and format and expectations for the submission.

So now, the file is in the FDA's hands. We are in the so-called validation period. And when that validation period is over, we expect to hear from the agency, which is likely going to be in August or September, both on whether they will accept our file. If they accept the file, we will also get the PDUFA date, so the date by which the FDA commits to give us a decision. And at the same time, we will also hear back on our request for priority review. And if that were to happen, that would shorten the review time to 6 months, otherwise, the standard that we are working against this 10 months.

We've, of course, done a lot of preparatory work already to prepare for the FDA review. For instance, we've performed several mock audits where we have brought in from FDA inspectors inspecting our manufacturing site, our quality systems, our clinical trial oversight and documentation, select suppliers. So the areas that we know tend to draw the most FDA scrutiny.

On Page 13, a brief reminder of our launch strategy. So we continue to believe we will create the most value by launching in the U.S. ourselves, keeping control of our assets, capturing more of the upside while also keeping the option open to over time, bring in a partner later if that were to create even more value. And this works because -- despite its size, the U.S. market is fairly concentrated. So there's less than 5,000 hospitals with ICUs overall and even less with meaningful sizes so we can pursue a very targeted launch built around the network of key opinion leaders and trial sites that we've already established.

On the next page, Page 14, that -- there's a lot of detail on the slides that I'll go through it quickly. So it shows some of the secondary endpoint results from our trials, which we believe offer meaningful differentiation, subject, of course, to FDA review and labor decisions. We firstly saw that's very important, a substantially greater reduction in opioid use compared with propofol, roughly 31% and 37%, which matters because opioids drive real clinical problems in the ICU from constipation to respiratory depression to delirium, and of course, also because opioid exposure during ventilation is linked to opioid use after discharge and the related addiction risks.

We also saw a fast return to wakefulness, typically within an hour of stopping treatment, which supports more predictable extubation and avoids the complications that come with long unpredictable wake-up times on IV sedatives. On mortality, we saw a numerical advantage for isoflurane of 4% to 5% centage points, 30 days in both studies, not statistically significant, but reassuring nonetheless, and we also saw more ICU-free days 5, 6 patients, which is consistent with the findings we had in the European studies as well. And that's very meaningful for hospitals because every ICU day that you save saves the hospital up to $1,000.

And finally, another true differentiator, Isoflurane is eliminated almost entirely through excalation, so there's minimal metabolism, which is a real difference actually was IV sedation where you need functioning liver and kidneys to deal with the metabolization now in an ICU, half of the patients present with some kind of an organ failure. So there's lots of patients in the ICU with liver or kidney problems. So that is an attractive target segment for sedation as well.

Then, on Page 15 shows the network of clinical trial sites behind our 2 pivotal studies leading academic medical centers across the U.S., many of them, very well-known names. So you will see Cleveland Clinic, Mayo Clinic, Vanderbilt and a lot of others that you recognize. And these centers are already forming the foundation of our emerging KOL network in the U.S., and this will, of course, be very, very valuable to count on their support after approval and during launch.

Page 16, just a brief update on our early access program, which allows difficult to sedate patients, those who cannot achieve target sedation on IV sedative to access our therapy ahead of full approval already, and the program started, as we communicated with Vanderbilt earlier this year. We've now expanded to 3 hospitals step-by-step that are actively treating patients. We have another 4 lined up in the final stages of being onboarded. And as we move closer to launch, step by step, we will onboard more hospitals Beyond the direct patient benefit, which I guess is obvious. So patients that have an alternative to something that doesn't work today. This is also valuable for us commercially. So it means that hospitals and key opinion leaders are building real hands-on proficiency with our therapy, well ahead of launch, and we're learning a great deal about implementation processes, training, supply chain and so forth, which we think can apply once we launch for real in the U.S.

Then, if we move on to the financial section, I'll hand it over to Mikael to take you through the details here.

Thank you. My name is Mikael Haag. I'm the new CFO here. I've been here 1 month. In the last 8 years, I've been CFO of similar companies, listed and nonlisted tech focus and growth focus in Europe. And Europe and U.S.A. So the financial results, Bedorica, net sales amounted to SEK 49.1 million compared to SEK 49.8 million in second quarter last year. It is a decline of 1% year-over-year but flat excluding currency effects.

Germany declined 23% or 22% excluding currency effects. But as you heard, it was driven by lower ICU occupancy rate compared to the same period last year impacting the demand in our largest markets. In contrast, rather direct market delivered strong growth with over -- with 41% year-over-year, particularly strong performances in Spain and France, but also in the U.K.

Sales in our distributor markets increased by 23% year-over-year, corresponding to 26% excluding current specs, demonstrating continued momentum across several international markets. Finally, contract manufacturing amounted to SEK 1.9 million, down a bit from SEK 2.7 million, partly explained by timing effects where some of the shipments were late. And will then come in July.

Gross profit and gross margin. Gross profit was SEK 35.8 million compared to SEK 34.9 million in the second quarter. Gross margin improved to 73%, up from 70%. The margin improvement was mainly driven by lower cost goods for our main products, Sedaconda ACD following our supplier acquisition or a supplier in Malaysia.

In addition, the lower proportion of contract manufacturing sales also contributed positively to the gross margin development. Moving on to profitability. EBITDA improved to negative SEK 1.9 million compared to negative SEK 4.1 million in the second quarter. The EBITDA margin improved to negative 4% compared to 8% 1 year ago excluding U.S. operations, EBITDA was positive, almost SEK 1 million compared to negative SEK 0.2 million last year, corresponding to EBITDA margin of 2% compared to 0% in the same period last year.

Operating expenses were approximately SEK 46 million compared to SEK 45 million in the second quarter of 2025. And despite continued market headwinds during the quarter, we're pleased to see that EBITDA continued to improve, reflecting our focus on operational efficiency and profitability. Staff at the end of the quarter of 2026, we had 132 employees and consultants compared to 131 last year. Excluding Innovatif Cekal with the acquisition, the number of employees and consultants were 80 compared to 86 the prior year period, reflecting a continued focus on maintaining lean and efficient organization.

So, to summarize, with overall sales flat, excluding currency effects, Germany remained affected by lower ICU occupancy rates. There was strong growth in other direct markets and distributor markets, and at the same time, improved gross margins and continued cost discipline, resulting in an improved year-over-year EBITDA.

So cash and our financial position. At the end of the second quarter 2026, cash and cash equivalents amounted to SEK 52 million compared to SEK 81 million at the beginning of the quarter. The quarter's change in cash was negative SEK 29.5 million, primarily driven by intangible assets investments of SEK 20 million, mainly related to the U.S. program as well as a negative change in working capital of SEK 5 million.

On that, cash flow from operating activities amounted to negative SEK 8 million compared to negative SEK 12 million last year. Looking at working capital movements, Operating liabilities had a negative impact of SEK 13 million on a quarter while operating receivables contributed positively by SEK 8 million. Inventory changes had a positive impact of SEK 1 million. So there are quite big swings on both sides of working capital.

Going forward, we expect a bit less negative impact from working capital. And as you saw, we had -- did have an uptick in investments to the FDA submission as well. So expected going forward, slightly less, as Johannes mentioned before. Consequently, the total cash flow for the quarter was SEK 29.5 million. That was SEK 31.1 million 1 year ago. In addition to our cash position, we have secured a credit line with a local bank just recently for SEK 50 million, providing additional financial flexibility. This will provide an extra buffer for the review period. So based on our current plans and available financing, we expect to be fully funded to achieve the U.S. approval, which remains the most important value-creating milestone for the company.

Thank you. Good. Then, if we then move to Page 20 to wrap it up before we open it up for questions. I see 3 big reasons to believe in Sedana Medical's success. Number one, and the foundation of it all, is a therapy that makes a real difference for critically ill patients every day. We're helping them wake up faster, recover faster, leave the ICU sooner and with meaningful cost benefits for hospitals, too.

Number two, we have a profitable core business in Europe. We reached breakeven group EBITDA year-to-date, so we now have a solid financial platform to fund our U.S. launch.

And number 3, we are closer than ever to our biggest opportunity, the United States with 2 successful pivot trials, the FDA Fast Track designation, the positive pre-NDA meeting, the early access program that's underway and now our NDA submitted to the FDA. We have a lot of positive momentum, and we look forward to bringing in hesitation with isoflurane to U.S. patients in the very, very near future.

So thank you very much for now for listening, and we will now open it up for your questions.

[Operator Instructions] But now we can start with some written questions.

Yes. So we got written questions through the chat here. From Matthias, so your question, are you willing to give some color as to why the CapEx increases quarter-over-quarter what magnitude of CapEx is likely to remain coming quarters. .

Yes. And then there's another question. I'll take them 1 by one. So on the cash, as Mikael has just laid out, we did have a bit higher cash out this quarter, mostly driven by higher expenses into U.S. CapEx. That reflects the final spurt we had with everything needed to come together for the U.S. submission. And then we also had some negative working capital effects. Those are temporary. So they will not look like this every quarter and probably will have some positive effects from working capital going forward also.

If you zoom out a little bit from that, so we used to have the clinical trial as the biggest source of cash burn. So back then, we had SEK 50 million, SEK 60 million cash burn by quarter. When that was done, the CapEx decreased quite significantly for putting together the dossier, so paying statisticians, medical writers and so forth. So you saw CapEx of maybe SEK 10 million to SEK 20 million per quarter and now with a little bit of a mini peak in Q2 at the end of the submission period. So all else equal, the CapEx going forward should decrease further, and it should decrease quite significantly. So the cash burn should decrease.

The unknown here is what will happen in the review period. So once the file is accepted and the FDA will start asking questions. Some of that might drive extra work. They might ask for an additional statistical analysis. They might have questions that cost a little bit of money to address. That's a bit of an unknown. So it's difficult for us to quantify. We've done an analysis of what we can foresee. And I think I'm quite confidently say that the cash burn will come down compared to what you've seen now in the quarter.

Then, the next question is the post COVID profile of the year with almost 50-50 revenue split in the first half versus the second, would you say based on the market factors that it would apply to 2026.

And then there's a second part of the question, were there only particular orders that drive the improvement in other direct markets? So is it simply just better execution and penetration that is expected to be sustainable at? So on the shape of the revenue distribution at 2026, of course, I don't have a crystal ball. -- what makes the comparator period to 2025 a little bit unusual, as we said, that a lot of the sales were in the first half and much less in the second half, and that was a function of the flu seasons being very unequally distributed. So you always have a bit of seasonality last year that was a bit more pronounced because the flu season was really strong. First half of the year, and then this year, we had a much weaker one. So I would expect a more normal year this year. But of course, it's always a bit difficult to predict.

And also, we need to make ourselves a little bit independent from these seasonal swings. What we need to be focused on is the execution and that we are very much focused on, and we see good early signs of acceleration in our markets outside Germany. Also, Germany, we have a plan in place to end the softness and return to better numbers again. And even in this -- as I said, even in this market where we have less patients, there's still enough patients for us to grow. So even in Germany today, we have 1 in 7 patients that receive our therapy. So that means there's still a lot of patients that we can go after.

And then the last question, what's driving the improvement in other direct markets? I would almost say for Spain, it's a little bit of the return to normal. So Q1 was weaker because we got quite affected by the strikes. Now we have found ways to work around those things are more normal again, and we're also seeing better growth. And then U.K. and France have for a long time been lagging behind Spain a little bit. We've put measures in place to accelerate, and those are showing effect. So there's no like individual big orders that are affecting the results. But hopefully, we can sustain those growth numbers and accelerate them further when it comes to France and U.K. going forward.

Two more questions on the chat.

Could you share more details on the international expansion plans for Sedaconda in the second half of 2026? So I'm a big believer in focus. So we are very strict in where we invest and where we don't invest. We have defined our focus geography as Germany, Spain, France, U.K., where we primarily invest and want to grow, and there's still lots of growth opportunities. And then there's the U.S. as the 1 that could change the shape of the company.

There is a few candidates of countries where over time, we could establish direct sales, but since the question is specifically for the second half of 2026, our geographic focus will not change because we still have a lot to do and we still have a lot to grow in our existing geography.

And there was 1 more. Yes. I think that's...

And then there's 1 more. Could you provide more details on the expected time line for regulatory approval in the coming quarters? So I'm assuming that, that refers to the U.S. So again, we've submitted the file in mid-June. We are now in what's called the validation period. Typically, you'll hear back after 2 or 2.5 months from the FDA. So that's the next milestone, which is probably August, September. We will hear whether the file is accepted, we will hear what the PDUFA date is, and we will hear the outcome on the priority review request that we have put in.

And depending on that decision, we're looking at an overall review time of 10 months as a standard and 6 months if we get priority review. So in a best case scenario, we could be looking at approval around the turn of the year. The base case assumption is that it would be after 10 months, so somewhere in the first half of next year. But again, FDA review always has uncertainties, and it's not in our hands, it's in the FDA hands. We've done everything we could to prepare. But that's the textbook time lines.

Yes. If you don't have any other written questions, we can finish with questions that we have here at the phone with the number finishing with 771. Please unmute yourself.

This is [indiscernible]. Can you hear me?

Yes.

So I've got a few questions there. I'll take the first on Germany here. So it seems like the impact of lower hospitalization in was larger in Q1 that it was now in Q2. But now we had a bigger sales decline in this quarter. So I'm just wondering if there was anything else that also affected the growth rate now in Q2 other than the market situation with the lower hospitalization.

Yes. So the 1 thing to be said about this data is they are not perfect in the sense that our target patient is mechanically ventilated patients that are sedated in the and there's no external data that tracks exactly that patient population.

What you saw in the data in the graph that we've shown was hospital admissions with respiratory infections. So it's not a given that these patients end up in the ICU and it's also not -- and there's other patients in ICU as well beyond respiratory patients. And 1 effect that you see during the summer quarters is that the share of respiratory patients in ICU is lower simply because you have less pneumonia, you have less COVID, you have less flu. So that's why in the summer months, those respiratory infections are a little less good predictor than in the winter months where they represent a bigger share of the patients.

What also plays a role is that you have a little bit of a lag. So if I have less patients in the ICU today, that translates into lower orders, usually in a few weeks, so not immediately. So it's true that the delta in patients in that statistic was larger in Q1. But then, with the caveats of data quality, as I said, the patient number is still the biggest explanation for the lower sales as well. So there is no big other effects that we are seeing, but internally, as I've repeatedly said, we don't spend a lot of time staring at these graphs and feeling sorry about ourselves that the market is declining because there's still enough market to be captured and that we need to do by focusing on the execution. We've put new leadership in place. We are doubling down on the high growth opportunities and have good early signs that, that is starting to work, but it will take some time to fully play out.

Okay. Very clear. And then on the seasonality in Germany also, so Q3 tends to be lower sales than in Q2. So we say it's reasonable to assume the same this year. And I'm not talking about absolute sales numbers rather than a growth percentage.

In most years, of Sedana's history, yes, Q3 was the weakest quarter sales-wise, simply because you reach the lowest patient volumes. So again, less respiratory infections, then vacation also plays a role. So I, of course, don't have a crystal ball to foresee exactly the sales numbers in Q3. We're working on getting the best possible quarter in Q3, of course, historically, you're right in saying that Q3 tends to be a bit weaker than Q2.

I'm just thinking if we are at the same level in Q3 as well, that would imply negative growth, but you're also talking about easier comps in H2, which should enable growth or if there are any other factors to take into account?

No, that's correct. I mean, yes, you are a very good analyst, so you will figure this out. So...

All right. Okay. Then perhaps a question on other direct sales here. I suppose it was Spain that had the biggest effect or is it possible to quantify in any way, it was -- how much was Spain and how much was an acceleration in France, U.K., Benelux?

Yes. So we're not kind of disclosing the individual growth rates per country. It is true, and I think common knowledge that Spain is our largest market among those 3. So also, the growth is in absolute terms, making the biggest contribution. What's more important for me is if I think a few years back, when I started, then the company was mostly Germany and not much else. And we were talking about creating the next Germany. And that we managed to do with Spain, which is now really good underway. It will probably beat Germany penetration-wise in the near future.

And now, we need U.K. and France to also accelerate. Structurally, there's no reason why those countries would be smaller than Spain. And most med tech companies, you would see U.K. and France generating more sales than in Spain. And now it's about applying some of the recipes that have really worked well in Spain, also in these 2 other markets. And then hopefully, over time, those markets will be the additional growth engines for the group growth.

Then just lastly, a couple of questions regarding cash flow and the cash position. And also it declined quite a lot more than it has in prior quarters. So I know you don't usually like to give an exact guidance around what the investments are going to decline to. So you've talked about them going down significantly. But it was SEK 20 million in this quarter. Like are we talking single digit million already in Q3 or going forward? Or like is it possible to give any sort of quantification on that?

Yes. So the -- I mean the clinical trial cost is out of the system. So that's 0 now. The submission preparation cost has stopped. There's going to be a few invoices paid in July that relate to work in June, but then that's also going to 0. So what is left is costs that will emerge during the FDA review. So FDA questions that will cost money to address, and that is very difficult to predict. We've done a very thorough analysis of what questions can we foresee. That analysis points towards investment levels that are much lower than what you've seen so far. But there's some uncertainty related to every FDA review. So it would not be very professional, I think, to give you a concrete number because the -- we haven't received any FDA questions yet.

What we can say is we expect significantly lower cash out from all that we can see, and then, let's see what the FDA review brings. And as you've also seen, we've now put in place a loan facility just in case. So we've taken advantage of the fact that the profitable ex U.S. business now makes us creditworthy. So we have an additional SEK 50 million if we need it. We're not planning to draw on it, but should there be something unforeseen in the FDA review that requires more costs than we have seen, then that facility is there. So that's how we're thinking about the cash position right now.

Okay. Good. I think you kind of answered my last question, but that was around the credit facility. So that's mainly due to like unforeseen costs during the FDA review and not because the actual approval might be delayed that you're taking. Yes, I think if you understand my question.

No. So I mean we've submitted the file. We are in the validation period. We've not heard anything from the FDA yet, which is completely normal at this stage. So usually, the first meaningful feedback you get is in August, September. So there's 0 indications at all that the approval would be delayed, but the review period hasn't started yet or the substantiative review hasn't started yet. So that loan decision is completely independent from that. So I'm assuming that the file will be accepted. I'm assuming that we are reasonably well prepared as well as you can be for an FDA review and then let's see what the FDA comes with. But this is not a defense move because we see something coming. This is just to be prudent that in a scenario where questions come up that we haven't foreseen or that cost more money than we have foreseen that we are ready for that.

Okay. Yes. Maybe my question was a bit unclear, but I think you answered it anyway.

So there are no more questions at this time. So I give the word to you for some closing remarks.

Thanks a lot for listening. Thanks a lot for the good questions. I know that a lot of you have taken time out of their vacation to be with us today. So thank you very much for that as well, and I wish you a very good weekend when it comes and a nice summer.

Hello, and welcome to today's FinWire broadcast presentation with Sedana Medical.

[Operator Instructions]

With that said, I'll hand the floor to you. Please go ahead.

Thank you for the introduction, and a warm welcome to our Q1 report 2026. Sometimes the development of a company is shown best in quarters where you're facing some headwinds or adverse conditions. We have been through such a quarter in Q1 with significantly less patients in intensive care units in several of our main markets and also a nationwide strike that is affecting our operations in Spain.

So for the first time since the year after COVID-19, we are seeing a slight sales decline. But despite all of these factors, we have delivered a positive EBITDA on the group level and double-digit EBITDA even in our ex-U.S. business. And of course, I prefer quarters where things go a bit more in our favor or the market environment is at least neutral, but this Q1 really demonstrates that all the work we have done in transforming Sedana Medical into a fully customer-focused company with a very lean backbone and cost structure is now really paying off.

So let's jump right in on Page 3 with the highlights of the quarter and the progress against our 3 priorities: sales growth, profitability and our U.S. journey. Starting with sales. Last year, we reached a new all-time high with SEK 200 million net sales for the full year 2025. That was a good result, but also a very unusual pattern that we saw during the year with 2 very different halves of the year. In the first half, we sold for SEK 107 million. And in the second half, we sold for SEK 93 million. So the first half was 15% higher than the second half.

This follows the pattern we have seen in ICU occupancy last year with a very long and severe flu season with a lot of ICU patients in the first part of 2025, but then low levels from May on all the way to the end of the year. So for this year, this means that we are up against an unusually strong comparator in Q1 and Q2, while the comparator in the second half of this year will be lower. And against that comparator, we had sales of SEK 53 million in Q1, which is an improvement compared to Q4 2025 and still the second best quarter we've ever had, but a slight decline of 2% at constant exchange rates compared to Q1 2025.

Despite that sales decline, we are looking at a profitability situation that I am very pleased with. Group EBITDA was positive with 3% in reported numbers, would have been 5% without the FX headwinds in the quarter. And our ex-U.S. EBITDA was even double digit with 10% in reported numbers or 11% at constant exchange rates. And again, this really shows that we are capable of delivering good bottom line even when the market is going against us. And conversely, once we are looking at a more favorable market conditions again, and we will be back to growth, our profitability has the potential to scale very nicely, thanks to our healthy gross margins.

Gross margins were at 71% in the quarter, which is flat compared to last year, but this is also masking the full truth here because both our lower-margin businesses, so distributor markets and our contract manufacturing represented a higher share of sales this time, which had a negative gross margin effect. But in reality, we are now enjoying significantly lower cost of goods for our main device following the acquisition of Innovatif Cekal, and that has a very positive effect on our gross margin. And we had SEK 81 million on the bank account at the end of the quarter, which will be enough to get us to the U.S.

Speaking about the U.S., this should be actually our last quarterly report before our U.S. submission. Everything is on track. We're still aiming to submit the dossier midyear. And with our 2 successful clinical trials with our Fast Track Designation and a positive pre-NDA meeting, we're very much looking forward to taking the next steps towards approval. During the quarter, we also kicked off our Early Access Program with the first U.S. patients now being treated at Vanderbilt University before the actual market authorization.

If we move to Page 4, please. You see all the work that we have done over the last years condensed in one picture. Starting with the year 2022, the year after COVID-19, when we incurred the biggest loss in the company's history. That was the time when we made it a priority to reach profitability outside the U.S. before launching in the U.S., and we started a turnaround program in which we fundamentally changed how we invest our money. So we made significant cuts in everything that is noncustomer-facing and administrative in nature. Our Swedish headquarter, for example, operates now with less than half of the number of people. And part of that freed up cash, we have then reinvested into strengthening the sales team. So we are much more focused on commercial execution today. We're much more customer-centric as a company, and we have more people in the field overall.

But also here, we've applied a very disciplined and differentiated investment approach where we increased spend in countries that are meeting our profitability targets and show good momentum, but we also cut back rigorously where that is not the case yet. And now you can see the results on this slide, we saw a consistent improvement of our bottom line and actually a bottom line that improved faster than sales grew. So every year, so far, we've been able to do more with less.

We reached EBITDA profitability for the full year 2025 outside the U.S. and now we are looking at double-digit ex-U.S. EBITDA margin and a positive group EBITDA in Q1, which makes this Q1 the best quarter from a profitability perspective that we've ever had.

As you will see on Page 5, this puts us very well on track to deliver on our financial targets for the year. We guided for mid- to high single-digit full year ex-U.S. EBITDA, and now we started the year with 10% or 11% at constant exchange rates. And we also said that we would aim to approach even group level EBITDA breakeven this year, and now we stood at positive 3% after Q1 or 5% at constant exchange rates. And as every year, we are likely to see some seasonality around these numbers, but we are very confident to meet our guidance for the full year.

Then let's look at the performance per region. Let's start with Germany on Page 6. When you have a 15% sales decline in a country where your ambition is to grow sales, you obviously have to analyze very, very closely to what extent this performance is explained by external market factors, but then also very quickly focused back on what you can actually control and what you can change to turn around the trend. The short answer here is that this quarter was heavily influenced by a very different situation in the ICUs during this quarter in Germany compared to last year with significantly less patients being treated.

I will show you the data around this on the next page, so you can more easily calibrate our performance. But internally, we have not spent much time at all complaining about the adverse market conditions, but instead focused on things within our control that will accelerate growth and make us more immune against quarters with low ICU occupancy. So for example, we have strengthened our leadership team with a new colleague who comes with a very impressive track record in growing sales, who will be working across all of our countries actually, so not just Germany. We are working on a territory realignment in Germany to allow for even better focus on high potential accounts, which are typically those who are already customers but don't use our products as much yet as their patient demographics would suggest.

We know that our customers in Germany cover around 70% of ventilator beds in Germany. So this is where most of the growth potential sits. We are also investing more in sales training since many of our field force colleagues are former ICU nurses. They are excellent clinically and probably better than most field forces actually when it comes to clinical skills that are active in intensive care, but there's more we can do in optimizing sales techniques to complement those clinical capabilities. With all of this going on, we will hopefully see the impact, especially in the second half of the year when the comparators, as I said, will become more normalized again.

On the next page, you see a comparison of how the flu season 2024, '25 and the flu season '25, '26 have translated into ICU admissions. It would be obviously wrong to say that there was no flu season this year. There absolutely was, even one with quite high incidents. But what is relevant for us is how many of these patients are becoming so severely sick that they need ICU care and need to be mechanically ventilated. There are different data sources for hospital admissions, ICU occupancy and so forth.

We have analyzed all of them, and we know that the best correlation with our sales is the data you see here. This is Robert Koch Institute reporting weekly numbers of ICU admissions with severe acute respiratory infections. And here, you see those data for this flu season in dark blue compared to the previous flu season in light blue. And what you can clearly see that on average, there were less ICU admissions in Q4 2025 and in Q1 2026 than the year before.

Around the turn of the year, there was a brief period when it looked like this season could become worse than the previous one, and there was also a lot of press coverage around this, as you might have seen. But eventually, we never reached the peak from last year and the decline started much earlier. Bottom line was that we had 22% lower level in Q4 and 15% lower level in Q1. Now our Q1 sales in Germany were affected a bit by a mix of both of these because we typically see a few weeks lag until higher or lower ICU occupancy translates into higher or lower orders. And when the ICUs are more empty, then ICUs tend to order less and also later, which is exactly what happened in Q1. And what came on top here is that this, I would say, mini peak in the end of 2025.

During that period, we had some larger orders come in just before year-end in anticipation of a really bad season, which then didn't materialize and affected reorders in Q1. So that explains why we had a 15% lower sales in Q1. But again, quarters like this will happen. There will also be quarters that go the other way. But in both cases, our focus must be on what we can control. There's nothing we can do about ICU occupancy. So we need to become as independent from this as we possibly can through strong execution and beating the market through some of the initiatives I've been talking about.

On Page 8, you see the performance of our other direct markets. We grew 7%, which is less than the numbers that you're used to. A major factor here is that the country where we typically see most of our growth come from. So Spain was affected by nationwide doctor strikes. Since January, doctors across specialties actually went on strike for 1 week every month, protesting for better working conditions and also better pay. And from what we can see, a resolution of this conflict does not seem very likely in the short term as the demands are quite a bit beyond what the government will be able to accept and the strike weeks have actually already been scheduled into the summer. And during these strike weeks, what happens is that ICUs operate at minimum capacity.

For us, it has been very difficult to get access to customers. We cannot schedule trainings. We cannot follow up. So that's what's been affecting us in the first quarter. What's very, very positive in all of this is that we still saw growth in Spain during the quarter, not maybe as much as previously, but still solid double-digit growth, which shows the strength of the business we've really built here and the resilient demand even with reduced sales pressure during those strike periods.

France and the U.K. were not fully able to compensate for the Spanish shortfall in the U.K. because the numbers are overall still quite small and in France because we are currently going through a planned restructuring, which has resulted in reduced field presence. The restructuring has the goal to accelerate our growth in France and ideally turn the country into the next Spain, and the measures are progressing well. What's worth mentioning also in France is an important win with AP-HP. AP-HP is a network of 38 university hospitals in and around Paris, where our pharmaceutical Sedaconda (isoflurane) has so far been blocked.

So until now, these hospitals -- and again, we're talking about 38 university hospitals, so big potential could either not use inhaled sedation at all. That was actually most of them or only with sevoflurane. And as you probably remember, since the SESAR trial, we've seen a decline in sevoflurane accounts, especially in France and generally a shift away from sevoflurane to isoflurane. So now these hospitals are open for business for us, which is a tremendous growth opportunity for our French team.

With Germany being a bit weak in Q1, these countries now represented more than 40% of our core business, so excluding the contract manufacturing business, which is a huge shift compared to the situation only a few years ago where we essentially had Germany and nothing else. So even with a slower growth quarter like this one, the development in our other direct markets remains a great success story.

Positive development also in our distributor business on Page 9, with 23% growth. We've laid a lot of groundwork last year with a much stronger focus on key partners and also a cleanup, I would say, among low-performing partners. This is now showing results. Our prioritized partners are performing well, and we also see good growth in Saudi Arabia, where we have been awarded a tender last year. You know that the sales in that business are a bit more volatile than in our direct markets. But with these achievements, I'm expecting solid growth for the full year as well.

Then let's go to the next page and switch gears to the United States. As you know, the U.S. is our largest growth opportunity that becomes very, very visible when you compare the addressable market in the direct markets where we operate today with the addressable market in the U.S. We have estimated the U.S. market potential for our products to be around SEK 10 billion to SEK 12 billion, which is 3x the European potential of our direct markets today. So in other words, the day we will hopefully receive approval in the U.S., our addressable market would instantly quadruple.

The higher potential in the U.S. is because of a high number of ventilator beds, a different medical practice that favors intubation and mechanical ventilation more than in Europe and also an overall higher price level, even though we have not yet built in higher prices into that addressable market number here. So that may represent additional upside.

Let's go to Page 12, please. It goes without saying that we are very convinced of the benefits of inhaled sedation that we have seen over many years in hundred thousands of patients. So it will be very, very exciting to bring this therapy to the U.S. when it comes to the right launch approach, we continue to believe that we can create the most value if we launch ourselves in the U.S., capture more of the upside, generate proof that this therapy can be successful in the U.S. and make money in the U.S. while maybe over time, keeping the option open to complement our presence with a partnership if we deem that to create even more value.

This strategy will create the most value because the large addressable market that I've been talking about is quite concentrated with less than 5,000 hospitals in the U.S. that have intensive care units and the number of high potential hospitals is much smaller than that. So we can go for a relatively targeted launch approach, building around the great network of KOLs and supporters that we already have in place, thanks to our clinical trials.

We also see a very good product market fit, for example, of the proven opioid reduction that our therapy has shown to provide in all of our studies so far, for example, because a reduction in the ICU length of stay is generally an effective driver of adoption in the U.S. and also, for example, because the guiding thought behind existing treatment guidelines that they have in the U.S. So things like fast wake-up, early mobilization, early ICU discharge are quite in line with some of the characteristics of inhaled sedation with isoflurane. So lots of excitement about the U.S. with the submission coming up very soon.

So let me hand over to Peter to take us through our progress in the U.S.

Thank you, Johannes. So our preparations for NDA submission are on track. We have our 2 U.S. pivotal studies that showed that the primary endpoint was met, and we did not see any new -- there were no new safety signals in any of these trials. And based on the timing of the study, we expect a good level of differentiation with our primary and key secondary endpoints and also the pharmacokinetic and pharmacodynamic profile of isoflurane. As you know, we have a Fast Track Designation with the FDA, and we had a successful pre-NDA meeting with the FDA in the end of 2025. We have the Early Access Program that is ongoing, and we are expecting to submit our NDA to the FDA in the middle of this year. And the standard review time after 2-month validation is 10 months. In the case of priority review, it's 6 months.

There are also medical affairs activities ongoing in the U.S. where some are driven by investigators. For example, we have only this spring, we have 3 inhaled sedation reviews published by 2 by trial investigators and 1 by an institution that was not part of our trial with a positive view on inhaled sedation and sort of preparing the market and it is completely independent from us. We also have investigators from the U.S. trials presenting at major congresses, both in Europe at the ISICEM Congress in Brussels, and Jeremy Beitler presented inhaled sedation and the U.S. preliminary data. And we have also investigators presenting at the Society of Critical Care Anesthesiologists in Montreal, early May and at the American Thoracic Society in mid-May in Orlando.

We're planning to organize a clinical Scientific Advisory Board in Q3, and this will be focusing on target population, patient categories where inhaled sedation is considered to bring -- provide most value. We'll also be looking at the science -- available science, the current data and discussing with advisers about what's available and what might be additional research that they consider to be relevant. And we'll also be discussing implementation and training such as education curriculums and continuing medical education activities to include when inhaled sedation is launched in the U.S.

And if we move to the next slide, Slide 13. So looking at the trial results, our secondary endpoints showed some benefits. And the most important one is our first key secondary endpoint, where we found that there was a greater opioid reduction with isoflurane in both our trials. And this was also confirmed in our European trials, both the Sedaconda study and the IsoCOMFORT study showed the same pattern of opioid reduction. There is a pharmacological explanation to this.

The consequence of reduced opioids is that dose-dependent side effects can be expected to be reduced side effects such as constipation, respiratory depression, iatrogenic withdrawal syndrome, delirium, also interestingly, a large U.S. cohort studies demonstrated that the opioid dose during mechanical ventilation, the very measure we showed reduction with isoflurane, that dose is -- correlates with the likelihood of development of persistent opioid use in the year after ICU discharge in nonsurgical patients. So that makes an opioid reduction even more attractive in the U.S.

The studies demonstrated also fast return to wakefulness. Almost 80% of patients receiving isoflurane were awake within 60 minutes after the end of treatment. And we know that with IV sedation, especially after deep and prolonged IV sedation, long and unpredictable wake up times are common. And this implies -- impedes the workflow in the ICU, a long time to wait to be able to do neurological assessments or to extubate patients. It leads to patients having to go for CT scans to investigate if there's anything else than sedation that lies behind poor wakefulness. And so this is also a unique aspect of isoflurane, which is rapidly eliminated by the airways.

We did see some nonstatistical trends that are reassuring and potentially beneficial for uptake in the U.S. So for example, numerically lower mortality in both the 2 U.S. studies despite this being a novel potent therapy. Investigators use this and in both studies, we're talking about 4% to 5% lower mortality, 30-day mortality in the 2 trials. And then we have some other potential benefits. And all of these things are nonstatistically significant will be subject to discussion with the FDA if they merit placement in the label, but we saw on average 1 ICU-free day more with isoflurane in the U.S. trials together with our European trial and also the U.S. trial alone. And this, of course, is one ICU-free day more means a lot for patients, for families and also for health care in terms of work and cost.

The pharmacological features of isoflurane imply that there's minimal metabolism that elimination is via the airways and completely independent of renal and hepatic function. And those are functions that are impaired in somewhere between 1/3 and 50% of mechanically ventilated ICU patients. So the features alone of the therapy explain a lot of the benefits that we are seeing in our trials that will be unique the day we launch.

And on the next slide, Slide 14, we can see the U.S. map, where you see the trial sites from the INSPiRE-ICU studies. We have interacted with many of these investigators still. Some are in the Expanded Access Program and some are advisers or part of advisory board ahead. And there is interest and looking forward to the time that inhaled sedation will be launched. Many of them clearly wanted to speak about inhaled sedation and that, of course, will be possible the day we launch.

If we move to the next slide, Slide 15. As Johannes mentioned, our Early Access Program has started and the Early Access Program is FDA granted us the possibility to give away our products to hospitals that are struggling with difficult sedated patients when intravenous sedation fails or when there are significant risks with IV sedation for the patient. And this EAP is open to all interested hospitals in the U.S. And besides helping these patients that are struggling and that at risk of adverse events, the Early Access Program brings value because it includes the use in a broad range of conditions, including such that were not studied in our trial, for example, patients on heart-lung machine, on ECMO, just one example.

It implies that inhaled sedation, the practice, the experience that has been gained in the trial sites will not be lost and that is, of course, an advantage the day the therapy will be launched. There will be units that have proficiency and expertise that we can leverage at launch. And for us, it's also an opportunity to practice all the aspects of implementing the therapy in a U.S. hospital. And currently, we have 9 hospitals that are interested in the EAP. So we're adding on new hospitals. Currently, we have Vanderbilt University Hospital that has treated the first patient, and we have 2 more hospitals that are going live as we speak.

We move over to the next slide from there. So that's Slide 16. And here, I hand over to Johan.

Thank you, Peter. Yes. So if we switch focus to our financial results for the quarter, starting with net sales, and Johannes has already discussed these aspects here, but just to reiterate the main points. So our net sales for the quarter was SEK 53.4 million. That's 7% down relative to the same period last year or 2% lower if we look at it in constant exchange rates. And as Johannes described, sales decreased in Germany, 15% excluding exchange rates, largely driven by the low ICU occupancy rates that we saw during the period.

Other direct markets saw some growth, 7% at constant exchange rates, which is good, but we've seen higher growth rates in recent quarters. Johannes described the dynamics there as well. Despite the strike in Spain, there is still a good growth contribution from that market in these numbers.

On the distributor market side, sales increased by 23% at constant exchange rates. And we saw contract manufacturing sales of SEK 2.7 million for the quarter, which is quite an increase compared to the same period of last year. That's mainly due to timing effects in the comparator period of last year, phasing effects during the year 2025 essentially. If we look at gross profit, we report SEK 37.8 million for the quarter. That's down slightly from SEK 40.7 million in the same period last year. But importantly, as Johannes also pointed out already, the gross margin remains stable at 71% for the quarter.

What we see here is still that we have a positive effect from the reduced cost of goods for our main product, the Sedaconda ACD. That's a result of the acquisition and was essentially one of the key rationales behind the acquisition of our supplier in Malaysia. And -- but in Q1 this year, this was offset by the mix effect of having a relatively large share of contract manufacturing sales and also, to some extent, distributor sales in the overall sales mix for us.

So the -- for example, the contract manufacturing part of sales was 5% in Q1 of this year compared to only 3% in the comparator period. EBITDA for Q1 2026, SEK 1.8 million. So positive group EBITDA, 3% group EBITDA margin, ex-U.S. EBITDA for the same period, SEK 5.1 million, also an improvement to 10% margin -- EBITDA ex-U.S. What we see is that we are able to continue to reduce our OpEx. So in this period, Q1 2026, it came in at SEK 43 million, which is down from SEK 46 million in the same period of 2025.

And this is really a proof that we are able to continue to find efficiencies in the organization and really limit cost increases that you would be expecting given the fact that we are growing sales, but we're able to really contain costs in a good way, which enable us to show this improving EBITDA while having these market headwinds that Johannes has described in the first quarter of this year.

At the bottom of this slide, you can see how our organization has developed. So at the end of Q1 2026, we had 130 colleagues in the Sedana Medical Group compared to 126 at the end of Q1. So this includes both regular employees, part-time factory operators in Malaysia and also consultants. So I think what's also important to note when we think about the cost savings that we're able to do in the organization is if we exclude Innovatif Cekal, our contract manufacturing or our manufacturing site in Malaysia and look just at the organization, excluding those colleagues, we see that the number of employees and consultants at the end of Q1 2026 was 80 compared to 86 at the end of the same quarter of last year. So there, you can see the way that we've further streamlined the organization, in particular, in the sense of a leaner headquarter over the past year.

On the next slide, we have our cash flow and available funds. So cash at the end of the quarter was SEK 81 million compared to SEK 91 million at the start of the year. And the change in cash here, as you can see, is negative SEK 10 million, and that's really mainly driven by investments in intangible assets of SEK 13 million, which is in turn, mainly U.S. related as we prepare for the NDA submission at midyear. Cash flow from operations during the quarter, positive SEK 3 million compared to positive SEK 6 million in the same quarter of last year. So I continue to see a positive cash flow from operations. The reason why it's slightly lower than the comparator period is mainly due to increased inventory.

Cash flow from investing activities in Q1 2026 of minus SEK 14 million, down slightly from minus SEK 17 million in the same period of last year. And again, this is driven by U.S. CapEx related to the NDA submission preparations. So total cash flow for the quarter of minus SEK 12 million, same level as the first quarter of last year. And we expect CapEx to remain at the new and lower level over the coming year. And really, once we're through the FDA review period, we expect really quite limited R&D-related CapEx beyond that period. So we expect to be sufficiently financed to achieve U.S. approval.

And just to point you to the charts briefly on the right-hand side of this slide, where you can really see how the reduced cash burn that we've seen in recent quarters has contributed to shoring up the cash position as we now also have reported SEK 81 million for the end of Q1 2026.

On the next slide, as usual, you can see our main shareholders at the end of the period. We remain thankful for the support that you provide. And we've also noted an increased holding by a few of the largest shareholders in recent months, which is, of course, very appreciated. And also, I'd just like to add that this is my last quarterly earnings call as CFO of Sedana Medical. So I would like to take this opportunity to thank all our investors and analysts for great conversations and interactions over these past several years. So thank you and look forward to staying in touch in the future.

And with that, I will hand the word back to Johannes.

Yes. Thank you, Johan. So on that last point, we will have Johan around until approximately mid-June. His successor is already gearing up to take office around that same period of time. And of course, before that, we will ensure a smooth and successful handover.

But now to wrap up this presentation before we head up -- open it up for questions, and we look at the last page, I see 3 big reasons to believe in Sedana Medical's success. Number one and the foundation of it all is a therapy that makes a difference for critically ill patients every single day. We help them wake up faster, recover faster, communicate with their families earlier and leave the intensive care unit earlier eventually and with several hundred thousands of patients in more than 1,000 hospitals around the world treated and more than 1 million sedation days under our belts, we can safely say with some confidence that we are living up to our purpose of improving life during and beyond sedation.

And every ICU patient has a life that is worth getting back to and no one should be in the ICU longer than necessary. So true patient benefit and cost saving for the hospital as well. Number two, we have a growing and profitable core business in Europe and now even showed positive EBITDA on a group level in Q1. This provides proof of concept that we can make money with this therapy and of course, a stable platform for the U.S. launch as we had aimed for all along.

And number three, we're now getting closer and closer to the U.S., which one day should become our largest market as we would quadruple our addressable market upon U.S. approval. And with 2 successful U.S. studies that Peter has talked about, the Fast Track Designation from FDA, the Early Access Program that is underway, there is a lot of positive indicators. So we are hoping that inhaled sedation with isoflurane will benefit also U.S. patients as an approved therapy in the very near future.

With that, thank you very much for listening, and we will now open it up for your questions.

[Operator Instructions]

But now we can start with you, Johannes, Johan and Peter and all the written questions that you received.

Okay. So let's go through those.

So we got a question from Scott Wright. So Scott, thanks for submitting that question. It says, what are Sedana Medical's key growth drivers and strategic priorities for Q1 2026.

I can see this question was submitted in the first minute of the call. So I'm hoping that the call has answered those questions already, but maybe in very brief sales performance, difficult quarter in Germany with the sales decline because of less patients in the ICU, lower growth than usual in other direct markets due to the strike in Spain. And on the other hand, a strong quarter in both distributors and contract manufacturing, overall a 2% decline.

But what's really standing out, I think, about this report is that nevertheless, we delivered a positive EBITDA on group level. And in terms of priorities, we are big believers of focus. So we are focused on 3 priorities always. One is sales growth. The second one is getting to profitability and the third one is getting to the U.S. And over the last years, as you've seen in the call, we've made very good progress across all these priorities.

Then I will move to the questions from Mattias. Thanks, Mattias, for submitting those. The first one, I'll hand over to Peter. Keen to hear any feedback from professionals at Vanderbilt University so far.

So we do not have any formal feedback in terms of protocol or results from the patients, but only before the Expand Access Program, they were very enthusiastic about using inhaled sedation in this very patient group. So the feedback has been positive.

All right. I'll move on to the next. What -- how long does it take to reap the benefits of the initiatives you are taking in France and the U.K.

So we are making interventions at different levels. One is kind of across all of our countries with new sales leadership, intensified sales training a refresher on how to ensure we focus our activities on high potential accounts and don't spend too much time on lower potential accounts and so forth. All of that is being implemented while at the same time, we're also making structural changes, for example, in France. And the beauty about sales is that you can see the effect of these things relatively quickly, meaning after a few months, you know whether things are working or they're not working. So I'm very optimistic about especially the second half of this year.

Again, there's a bit of an imbalance in how last year has looked from a sales perspective with a very, very strong first half last year, which we're now up against as a comparator and then a weaker second half. So in the second half, with all the things we put in place and a more realistic comparator, I think we will see numbers that are closer to what we're used to.

So then there's another question from Mattias. What would you -- would you perceive the Q2 comparator quarter in Germany as even more difficult to face? I would guess that the high number of admissions in Q1 2025 helped sales for Sedana in Q2 with a lag.

Yes, that is true. So there's a lag of a couple of weeks in between what we see in the ICU in terms of patient numbers and the orders. The quarter 2 last year in Germany was the strongest one from a sales growth perspective. So we grew 19% in that quarter. So we are again up against a tough comparator in Q2. But then similarly to what I said on the company level, we, in the second half are facing an easier comparator, I would say, the difference between the 2 halves of the year in Germany was even more pronounced than on a company level. So on a company level, first half was 15% higher than the second half in Germany, that same number was 19%. So 19% higher sales in Q1 than -- sorry, in the first half than in the second half, which is a quite unusual pattern. So yes, Q2, a tough comparator, but after that, it's going to get better.

And then there's an additional question from Mattias. One additional ICU-free day shown as potential benefit. Why is that? Is it something you can do to prove inhaled sedation -- to prove inhaled sedation is numerically favored by 1 day over standard of care?

So if you talk to customers that have been using our therapy, I think what they will tell you is that all these benefits go hand-in-hand. So patients wake up faster, they are extubated faster, they recover better and faster, and that then eventually leads to them also leaving the ICU earlier. And based on our European trial, we had our post-hoc analysis showing a 3.5-day difference. And now in the U.S. studies, we also saw a consistently better ICU-free days for isoflurane compared to propofol, but we found 1 day difference. And the difference here that is important to note between the studies is in the German study, the European study, doctors were allowed to leave patients on isoflurane beyond the 48 hours of study duration.

So we had patients that were on isoflurane for the full length of sedation and we had patients that were on propofol for the same period of time. So we were comparing apples with apples essentially, and that gave us a 3.5-day difference. In the U.S., the way the study was agreed with the FDA, everybody was switched back to propofol after 48 hours. So essentially, we are comparing one group that was on propofol throughout with a group that was on isoflurane for maximum 48 hours and then propofol afterwards. So that naturally leads to a smaller difference, but I still think intuitively, it's quite impressive that with a change of the sedative for 48 hours maximum and everything else being equal, you still get these patients out of the ICU for a day earlier on average.

So that, I think, is going to be a key element of how we will be commercializing this drug, not necessarily to the clinical stakeholders only, but also to the purchasing groups and the more administrative parts of the hospitals.

Then there is a question from Johnny. What is the estimated total cost of the Early Access Program? So we've not disclosed exactly what that would cost. The way to think about it is we are supplying the products free of charge. So these are not commercial sales, but we are providing them for free. Of course, not -- the cost to us is, of course, much lower than it would be to a customer because we only book the cost of goods. So the more patients we have in the program, the more expensive it will become. But in the grand scheme of things, it's not going to move the needle too much.

But at the same time, as Peter was describing, it's a very effective way for us to get hospitals up and running before the actual approval. It's a way for us to test our processes. It's a way for us to find our way around internal -- hospital internal processes and so forth. So it's a well-made investment from that perspective, I think, even though we don't disclose the exact amounts.

Then there's another question from Peterson. Thank you for that as well. How do you see your pricing possibilities in the U.S. if approved?

Nice to see the great savings with Sedana therapy, but not so conclusive in the trials. So there's kind of a general and a more specific answer to that. Generally, what you see in the U.S. is that the medical device prices are quite a bit higher than in Europe for different reasons. Differences can be different in different segments of the market. But if you look at sedation therapies, for example, sometimes the U.S. pays double or sometimes even triple of what is the case in Europe, that's no guarantee that we will see the same for our therapy, of course. But I think the way to think about it is if -- even if we can only talk about one only "1 day, 1 additional ICU-free day." An ICU day in the U.S. costs between $5,000 and $11,000 depending on the exact care setting.

So there is a significant saving by using our therapy. As a reminder, the NICE, National Institute for Health and Care Excellence in the U.K. has confirmed a health economic benefit of GBP 3,800 compared to using intravenous sedation and that is per patient. So also a quite significant savings, so quite in line with potentially an even higher saving in the U.S. because everything is more expensive in the U.S. So that will be a very powerful argument, especially since in the U.S., hospitals are much more effective in understanding the P&L impact of introduction of a new therapy on their own P&L. So they're much more trained to look for differences in length of stay.

Those were the questions that I have received through the chat here, but I also see that there's a hand raised on the phone as well.

Yes, there is a number ending with 771. Please introduce yourself.

This is Filip from Pareto. So I just had a few questions today, but I'll take them one by one. So firstly, perhaps on the strikes in Spain. So if you could elaborate a little bit, has that mainly affected the usage of the device to -- you talked about this minimum capacity. So I guess that means fewer patients during the quarter. So is it mainly that? Or is it more the ability to further penetrate the market with sales activities that have been -- have had the highest impact?

Yes. Filip, thanks for the question. That -- it's a combination of both. So this is a nationwide strike across all specialties. So it's not ICU specific. It's doctors in Spain complaining about working conditions, 24-hour shifts, the pay, of course, and so forth. And I think if you follow the news a little bit, I think this must be probably the largest strike in health care that Spain has seen in a long time, and there's talk about, I think, 1.5 million medical appointments that have not happened that should have happened because of that strike and so forth.

So overall, big impact on the country. The way it affects us in these weeks, so again, 1 week every month where they're out of business, it's, of course, patients are still being treated in the ICU, but at like -- at a reduced capacity. So less patients overall. So unless it's totally necessary, people will not be in the ICU. And the main impact for us is that our salespeople cannot do their daily job. So there's no doctors to talk to during that week. You cannot come for trainings because there's no time for that. If you're starting up accounts, there's no way to follow up and be with the teams to help them treat patients because overall, just the access is very, very restricted. So it's both less patients, but also mostly the access that is the problem for us. But again, despite that, I mean, we have essentially Spain was on strike for 1 in 4 weeks every month, right?

So 25% or so of the time was not effective in that sense for us. And still, we were able to deliver growth, which I think is also -- there's a very positive message in that as well. Now of course, we're hoping that these strikes will be over quickly, the way it looks right now, it's more likely that it will take some time because the demands and what the government is ready to offer is still very far apart.

Okay. Yes, that makes very good sense. So the kind of limited ability to like get back to growth in Q2 as well? Or do you see it could go into Q3, Q4 as well or...

Well, now this is pure speculation. Q2, probably we will see a similar situation also because these -- the weeks have already been scheduled. So the doctors already know when they will be on strike. So recommendation is not to get sick while on vacation in Spain. At some point, I guess, one of the parties has to move and the comments -- like the comments you get from people who are closer to this than I am is that since doctors get less money during the strike weeks, at some point, the demand will have to become more realistic from a perspective of what the government can meet. So probably we will see the same in Q2 and then Q3 will hopefully be solution mode more than strike mode. But again, speculation because I can't look into the future.

Then just a question on the gross margin. So 71%, which is in line with last year and then back at levels that you had before the acquisition. So you covered the reasons, the product mix, but can you say what the gross margin would have been if you would have had the same mix as last year?

Well, we typically don't provide that type of granularity on the gross margin. But I think one guidance that perhaps could be useful to you as an analyst would be to say that the contract manufacturing margin that we have is roughly half of what we have for our core business. So then, of course, if we have 1 quarter such as Q1 2026, where the contract manufacturing accounted for 5% of total sales instead of like last year, 3%. Of course, that has a bit of an overall headwind for the gross margin.

All right. Then perhaps another question to you, Johan. I don't know if you want to answer this, but the increase in inventories, you talked about that a little bit, and I saw it in the report as well. So are there any like specific effects of this? Are you increasing the inventory ahead of the U.S. launch? Or is it to have some buffer for potential supply disruptions with everything that's going on at the moment?

Yes. So it's 2 things really. One thing is that, as you know, we are continuously working with trying to find improved efficiencies and lower prices in our supply chain. When you make changes there temporarily, you might need to increase your inventory to have a bit more buffer when, say, you -- basically, you make changes to the supply chain essentially. So that's part of it. And then another part is actually that when we were in negotiations with our supplier in Malaysia leading up to the acquisition, we draw down inventories that we are now replenishing to some extent at this point. So it's not yet any inventory buildup ahead of the U.S. So it's more sort of temporary corrections.

Great. And then I think the last question that I have around potential publications from the results, the U.S. results. Are you expecting any sort of publications in the near term?

Yes, I can answer that. So not in the near term, but they are in the process of being submitted for publication. That, of course, is a little bit unpredictable depending on sort of the impact level you aim for and review time, et cetera. But we do definitely expect to see them published well before launch.

So there are no more questions at this time. So I give the word to you for some closing remarks.

Yes. Thank you very much for listening. Thank you very much for the good questions and discussions, and I wish you a nice afternoon.

Hello, and welcome to today's FinWire broadcast presentation with Sedana Medical. [Operator Instructions]

With that said, I'll hand the floor to you. Please go ahead.

Thank you for the introduction, and a warm welcome to our Q4 and full year report 2025. This report stands out for me in a very positive way because we delivered on an ambitious goal that we set for ourselves.

Coming out of the COVID-19 pandemic and being faced with a sharp revenue decline and the biggest loss in Sedana Medical's history in 2022, we committed to the goal to reach profitability in our core business before we launch inhaled sedation in the U.S., because we believe that it was essential to build our U.S. expansion on a stable, cash-generating platform to demonstrate proof-of-concept, but also to help finance the launch investments in the U.S.

Now a few years later, I'm proud to say that we have delivered on that ambition, and we have reached a positive EBITDA in our ex-U.S. business for the full year 2025. This is the first time for Sedana Medical in its history as a listed company.

So let's jump into the slides on Page 3, which shows our progress in our 3 priority areas: sales growth; profitability; and the U.S. On the sales side, we've ended the year at SEK 200 million, which represents a year-over-year growth of 16%, excluding exchange rate effects. 12% out of this 16% was organic and the remaining 4% stemmed from our contract manufacturing business in Malaysia. This marks an all-time high in sales for the full year and also our Q4 numbers are the highest we've ever had with SEK 52 million.

On the profitability side, as I already said, we are proud to report a positive EBITDA ex-U.S. for the year of 3% and 8% for the quarter. And also on the Group level, we've improved our EBITDA by 12 percentage points for the year, which is very good to see and even had a slightly positive Group level EBITDA in Q4, amounting to 0.1%.

Also, the gross margin looked good in Q4 with 73% as we now see the cost of goods improvement in our main device come through as a consequence of the acquisition of our supplier in Malaysia. And the end of year cash balance was SEK 91 million.

If we look at our progress in the U.S., the big achievement for the year 2025 is that we have made several important advances to reduce the risk associated with U.S. approval. Both our pivotal trials met their primary endpoint and showed no new safety findings, and also the secondary endpoints offer several potential ways to reach differentiation, both in terms of clinical benefits and also on the health economic side for hospitals.

We were also encouraged by the FDA authorizing an early access program, which allows us to treat patients even ahead of the official marketing authorization. And we also had a very positive pre-NDA meeting with the FDA in Q4, during which the FDA confirmed that the efficacy and safety data that we have collected appear appropriate to submit the NDA, which we're now working towards and as previously communicated, expect to complete midyear.

The next page shows all the work we have done over the last year's condensed in only one picture. You can see how sales dropped after COVID and in line with that, the EBITDA loss 2022 grew to SEK 83 million. And as a reaction, we started a turnaround program in which we have really fundamentally changed how we invest our money. We have made significant cuts in everything that is noncustomer-facing and administrative in nature.

Just to give you an idea, our Swedish headquarter operates with less than half of the people today. And part of that freed up cash we have then reinvested into strengthening the frontline team. So we are much more focused on commercial execution today. We are much more customer-centric company, and we have more people in the field.

But also here in the field, we have applied a very disciplined and differentiated investment approach where we increased spend in countries that are meeting our profitability targets and show good growth momentum, but we also cut back fairly rigorously where that is not yet the case.

And this slide summarizes quite nicely the results. This year, for the first time, we show a positive ex-U.S. EBITDA for the full year. And also on the Group level, we have consistently seen good improvements. And if you compare the pace of sales growth with the pace of bottom-line improvement, it also shows that every single year we have done more with less, so growing sales while simultaneously reducing the cost.

If we then go to the next page, Page 4, with this very positive outcome, we've also met our financial target for the year. We guided for low to mid-single-digit positive EBITDA ex-U.S. We landed on 3%. There was some exchange rate headwinds during the year to our P&L. And without those, it would have been 4%. And based on that, we have updated our guidance now for this year. When it comes to ex-U.S. EBITDA, we will continue to grow that and expect to deliver positive EBITDA in the mid to high single-digit range now. And also on the Group level, we anticipate further improvement and actually get closer to breakeven for the full year.

What could potentially affect that Group level target is a potential acceleration of the upcoming FDA review. So if we were to get priority review, for instance, then it becomes clear that the launch in the U.S. may happen earlier, then we will, of course, also start building up in the U.S. earlier, which may then impact the Group level target. If that happens, would, of course, clearly be a luxury problem to have.

Then let's look at the sales performance per region on the next page. Thank you. The strongest growth we have once again seen in our other direct markets, so our direct markets outside Germany, which delivered 32% growth for the full year and 31% growth in the quarter, both numbers excluding exchange rate effects. The growth was once again led by our Spanish team, which has shown really fantastic growth for the last years and has actually quintupled sales since 2022. That was again the case in Q4 based on a very strong execution, but also based on a strong network of believers and opinion leaders in the customer side.

And what has worked really well in Spain is that we do not just have the academic key opinion leaders who are oftentimes not treating so many patients anymore, but we have a lot of what we call bedside ambassadors. So oftentimes younger doctors who treat a lot of patients, see the benefits of inhaled sedation in real-life, and not just in studies and who are at the same time very, very influential for their peers. So other doctors who seek advice on the best treatment options.

And what the Spanish success story really also demonstrates is that very focused approach targeted at establishing inhaled sedation as a standard therapy in select high potential hospitals and then building from there is the most effective way to reach rapidly increasing adoption. And that's a model that we are trying to replicate in other geographies, of course, as well.

In the U.K., we were unfortunately hit by a temporary staff absence during part of 2025, which in a small team leads to quite significant reduction in field presence. So we could not continue on the strong growth path that we had just seen the year before, but instead had a rather flat development. What happened here besides the staff absence was something you often see when you have reduced resources, but still have a lot of incoming demand from potential new customers. You run into the problem that a lot of time is taken up by responding to potential new customer requests and you neglect a little bit to maintain and nurture and drive the growth in your existing customers or customers that you've just opened the year before.

And we've suffered a bit from this phenomenon in 2025, but now have the team fully staffed again and are also focusing our energy on the right balance again between new customers and existing customers. What's also helping a bit in the U.K. is the MHRA has now approved our pediatric indication as well, which provides some upside as well. So -- And Q4 already looked better than the previous quarters, and we saw some good solid growth again.

In France, we continue to see a quite split performance with isoflurane customers performing very well, but in customers that are still using our device with off-label sevoflurane, we continue to see sales decline following the SESAR study. Overall, this has resulted in a almost flat development for the full year, which is obviously not good enough. So the plan for France is quite self-evident, focused on switching remaining sevoflurane users to isoflurane and focusing on commercial execution, of course. And there, we are making good progress.

If you look at the SESAR clinical trial sites, which you would imagine are the hardest nuts to crack given the SESAR results, more than 60% of those hospitals are today using isoflurane. So the conversion is progressing well, and I'm hoping for a good year 2026.

Overall, I see our other direct markets, obviously, as big success stories. Only a few years ago, Sedana Medical was essentially Germany and not much else, but now we've really built a business in these countries that represents 35% of our core business sales already, and we will see that share continue to grow with Spain continuing on a strong trend, and U.K. and France finding their way back to strong growth over time.

Then we move to Page 7, please, and have a look at our largest market, Germany. Here, we have a very mixed picture for 2025. It's almost like we had 2 completely different halves of the year. The first half was great with 13% growth in local currency, and we were very happy that the sales acceleration plan we had implemented was showing good impact. But then the picture in the second half looked very different with a sales decline of 7% in local currency. And in Q4, it was minus 6%, as you see on the slide.

So what has happened here? We are always fully focused on what we can control, which is commercial execution and look for ways we can improve that. But the truth is we did not do things massively different in the second half. The team is fully staffed and is executing according to plan. But what you will see on the next page in just a second is that we had very different levels of ICU occupancy during the 2 halves of the year with considerably less patients in the second half, which has impacted our performance.

Now it's tempting to simply blame the performance on external factors outside our control and simply trust that the markets will swing in our favor again. But for us, that's, of course, not good enough. So we have to accept that sometimes the market goes against us, sometimes it will go for us. But for us, that's even more reason to double down on commercial execution, maximize time in the field, be very sharp in our targeting where we spend our time and be as impactful in every single customer interaction as we can be.

And one thing, for instance, we can actively work on is to improve our penetration in patient groups that are less subject to seasonal swings than respiratory patients. So for example, neurocritical patients, surgery patients or cardiac arrest patients, you see less of these seasonal swings compared to the respiratory patients.

And with 14% penetration in Germany, we still have lots of places to grow. So the customers we have today represent a bit more than half of German hospitals with ICUs. But since we focus on the high potential accounts, 70% of all ventilator beds in Germany are represented by our customers. So that also shows you where the focus has to be. The biggest opportunity lies in increasing penetration in existing accounts, while simultaneously opening a few high potential accounts where we are not yet present.

On the next page, Page 8, you see what I've already been touching on. So this is data from the Robert Koch Institute in Germany based on a representative sample of 67 Sentinel hospitals and shows the development of the weekly number of patients with severe acute respiratory infections that did require intensive care.

It's not perfect data as it's -- there are other patients in the ICU as well and the fact that they are in intensive care unit does not necessarily mean that they were incubated and sedated. But these are the majority of patients in the ICU, especially this time of the year. And therefore, this is a fairly good indicator of how our relevant market is developing.

And what you can see here is the typical seasonal pattern with more patients in the ICU during the winter months and less during the summer months, but you also clearly see the differences between the seasonal patterns in 2024 and 2025. So between January and end of April, beginning of May 2025, we had a long and quite strong flu season in Germany. And that time, we had 12% more respiratory ICU patients than the year before. But then it flipped. And between May and December, with the exception of, as you can see, maybe 2 weeks, we had considerably less respiratory patients in German ICUs, 25% less over that period, which is obviously very significant.

And now again, in the first half, we grew 13% because usage in the hospitals were high and then reorders usually come earlier and also customers tend to order more. But when the usage then declined from May with less patients, hospitals were still working down their inventories built in the first half and orders came later and tend to be smaller. So that's why we saw that sales decline in the second half of the year.

Now we will have these swings from time to time. But as I said before, it should not distract ourselves from keeping the focus on what we can control.

Then let's move on to Page 9 and look at the distributor business. At first glance, it looks like a rather boring year with 4% growth. But during this year, we have done a lot of good work under new leadership for that business that will lay the foundation for future growth. We are now much more clear where to focus, and which key partners to really support, and how we are much more professional in the performance dialogues with our partners and also hold lower performing partners much more accountable. So for example, we terminated also contracts with 5 distributors during the year that were not meaningfully distributing, to be more focused.

So with that, sharpened focused, I'm looking forward to a hopefully successful 2026 in that business. And Q4 was already promising with a strong 44% growth versus the year before.

Let's go to Page 10 and switch gears to the United States. As you know, the U.S. is our largest growth opportunity. That becomes very evident when you compare the addressable market in the direct markets where we operate today with the addressable market in the U.S. We have estimated the U.S. market potential for our products to SEK 10 billion to SEK 12 billion, which is 3 times the European potential today.

So in other words, the day we will hopefully receive approval in the United States, our addressable market would instantly quadruple, and the higher potential in the U.S. is because of a high number of ventilator beds, a different medical practice that favors intubation, and mechanical ventilation more than in Europe and also an overall higher price level, even though we have not yet built that into the numbers here.

Let's go to the next page, Page 11, have a look at the status and the progress we have made during the year. If I compare to where we were going into the year 2025, it becomes very clear that we have taken several very important steps that contribute to reducing the risk associated with the U.S. approval. First and foremost, we received the results of our 2 clinical trials. We met the primary endpoint in both studies in the primary analysis as well as all supplementary and sensitivity analysis. There was no surprising safety findings and also the secondary endpoints came out such that we believe we will have compelling benefits to talk about both on the clinical and the health economic side, all, of course, subject to FDA review.

We are now in the final stretches of completing the dossier, which we are planning to submit midyear, and we are encouraged by the fact that the FDA saw enough value in our therapy to approve Fast Track designation and also authorize an early access program.

We also had a number of important regulatory interactions with the FDA during the year with the highlight being the pre-NDA meeting in the fall. We perceived the agency to be very collaborative, and constructive and helpful in their feedback, and we got confirmation from the agency that the safety and efficacy data we've collected in our studies seem appropriate for submitting the NDA, so we can now proceed towards that, which is, of course, very, very exciting.

And on the next page, Page 12, goes, of course, without saying that we are very convinced of the benefits of inhaled sedation that we have seen over many years in hundred thousands of patients. So it will be very, very exciting to bring this therapy to the U.S. And what this page shows is some of the potential benefits that we hope to be able to use in the U.S. What I have to make very clear, of course, here is that we are not yet approved. We have not even started the review process, which will come later this year. And things like the label we will receive are, of course, fully subject to the FDA's decision.

So what this page shows is things that we see based on our clinical trial results. We did, for instance, show in both trials that our patients had a higher reduction in opioids than that was the case for propofol patients. The reason that matters in the U.S. is that the U.S. is plagued with an addiction epidemic and there is a clear established correlation between how much opioids you receive in the hospital and how much opioids you get discharged, which then leads to the addiction risk. So less opioids in the hospital is a good contributor to avoid addiction.

But there's also very practical problems with opioids in the ICU, such as managing withdrawal and constipation, which you could assume you would see less of with less opioids being used.

What we also saw in the trial is that 75% of our patients were awake within 1 hour of treatment termination, which is in line with what we have in the European label, for example. Now this was not statistically better than propofol in the trial, as propofol patients also woke up fast, but physicians also often perceive long wake-up times in the range of many hours or sometimes days as a big problem in ICU. So fast and reliable wakeup is an important feature for a sedative.

Another important outcome we were very happy about was the mortality numbers. You remember that there was some noise around the SESAR trial last year, where the off-label use of sevoflurane was associated with higher mortality than propofol. Now in the study with isoflurane, so the right drug in our opinion, we did not see any increased mortality. On the contrary, we even saw at least a numerical advantage in favor of isoflurane of 4 and 5 percentage points in both studies, respectively.

Now the studies were not powered to show statistical significance here, but still this is very reassuring results and a clear contrast to sevoflurane results from SESAR.

On the health economic side, hospitals care a lot about the ICU length of stay as a shorter ICU stay in the DRG system means a better profitability on -- of that patient from the hospital's P&L perspective. We did see a higher number of ICU-free days for isoflurane in the European study and in both U.S. studies. On average, that effect is around 1 day based only on the patients that received isoflurane for a maximum 48 hours.

And for launch, when we are discussing with purchasing departments, we will have a full version of these data and for reference, 1 day difference, so saving 1 ICU day corresponds to USD 4,000 to USD 11,000 in the United States system.

It's also well established that isoflurane is eliminated almost exclusively through the lungs and metabolism is minimal. This means that, for example, the kidneys and liver do not get affected as they could be with IV sedatives. And what we see in Europe is that many doctors appreciate that feature and like using isoflurane in renally or hepatically impaired patients, and there are a lot of those patients in your typical intensive care unit, of course.

Next page, Page 13, shows the list of clinical trial sites we had in the clinical studies. You will see many familiar names such as Vanderbilt at Israel; Cleveland Clinic and others. And those centers form our support network for the U.S. already today with many of the key opinion leaders already actively speaking at conferences and working on publications.

Then let's move to Page 14, please, and the Early Access Program. So the FDA authorized an expanded Access Program for us. What that means is that patients who don't have a great alternative today, in our case, because they struggle with IV sedatives, so-called difficult to sedate patients can get access to our therapy already before market approval. And this is great news for patients and caregivers who are struggling with these patients, but it is also good news for us, because by the time of commercial launch, we will already have several hospitals trained and up and running, and we will have gathered a lot of learnings and tested our own processes, which will be beneficial for a successful launch.

We were working towards starting the program in Q4. Now we have moved that to Q1. But since the submission also had moved by a few months as a result of some extra homework from the FDA that we got in the pre-NDA meeting, hospitals will still have a lot of time to benefit from this program before the actual approval.

Let's go to Page 15 to briefly recap our strategic plan for the U.S. As you know, the U.S. is our largest growth opportunity. We've estimated the U.S. market potential for our products to SEK 10 billion to SEK 12 billion. So as I said, the market entry in the U.S. would quadruple our addressable market. We also see a very good product market fit, for example, because of the proven opioid reduction that our therapy has been shown to provide, for example, because a reduction in the ICU length of stay is generally an effective driver of adoption in the U.S., because the guiding thoughts behind existing treatment guidelines of fast wake-up, early mobilization, early ICU discharge are quite in line with some of the characteristics of inhaled sedation that our customers in Europe value already today.

And on top of that, we've already built a network of key opinion leaders in our clinical trial sites. So therefore, we continue to believe that we can create the most value if we launch ourselves in the U.S., capture more of the upside and generate proof-of-concept that this therapy can be successful, while over time, keeping the option open to complement our presence with a partnership if we deem that to create even more value.

Now let me pause here and hand over to Johan to take a more detailed look at our financials.

Thank you, Johannes.

So on Slide 16, you can see our financial results for the quarter in some more detail, and you can also see the positive development that we can show in terms of sales and gross profits over time in the charts to the right here on the slide.

So for the quarter, we reported net sales of SEK 52 million, which is up from SEK 49 million in the same quarter last year. So that's 5% increase in reported currency or 11% increase excluding exchange rate effects.

So we have organic growth, if we exclude our contract manufacturing business of 10%. And as Johannes has described, there is some differences between the core markets that we have. So as described, we see some market headwinds resulting from low ICU occupancy rates in Germany. So Germany decreased 6%, excluding FX for the quarter, while both the other direct markets and the distributor markets grew strongly. So 31% increase from the other direct markets, mainly driven by Spain, as Johannes has described already, and the distributor markets sales increased by 44%, excluding exchange rate effects. So this means that we are seeing a good, positive development also for our gross profit.

So the gross margin improved in Q4 by 3.2 percentage points to 72.7% and that results in a gross profit of SEK 38 million for the quarter. That's up from SEK 34 million in the same quarter last year.

As what we're seeing here, if we look at the gross margin improvement is that it's very much driven by the reduced cost of goods for our main product, the Sedaconda ACD, which follows from the acquisition of our main supplier in Malaysia, which was concluded at the end of 2024. So now in -- Over the course of 2025, we've seen more of that effect come through. And now in Q4 2025, specifically, we see a positive effect of 2.4 percentage points coming from this acquisition of the supplier, out of those 3.2 percentage points increase in total.

If we look at the OpEx, so total OpEx for the quarter of SEK 45 million, which is very much in line with the same quarter last year. So what we are basically seeing is that we continue to find efficiencies in our organization, and we're able to contain cost increases while we are increasing revenue, which is, of course, very encouraging to see.

And this means that EBITDA continues to improve for us. And that's, again, despite the market headwinds that we've seen during the second half of 2025, in particular, in our core market in Germany.

So for Q4 specifically, we report positive EBITDA even at the Group level, so slightly positive at the Group level compared to negative SEK 6 million in the same quarter of last year. And EBITDA for the ex-U.S. business, again, for the quarter is a positive SEK 4 million that can be compared to negative SEK 1 million in Q4 of 2024.

And that means that for the full year 2025, we report Group EBITDA of minus SEK 10 million, which is a clear improvement compared to 2024 when we had minus SEK 31 million. And at the ex-U.S. level, we now report EBITDA for the full year of SEK 6 million compared to negative SEK 17 million in 2024.

So finally, on this slide, and that's also as Johannes has already described, what we have been doing for a number of years now, and that was also very much the case during 2025 is that we are growing the business by reallocating resources to customer-facing functions, while we are streamlining support function and administration functions in the company, in particular, in the headquarter. So that, of course, means that we are shifting also where we see our headcount within the Group.

So at the overall level, it's relatively stable. So slight increase in total headcount during 2025 to 127 from 125 at the start of the year. But if we look at the company, excluding our contract manufacturing, our manufacturing site in Malaysia, we see a decrease in headcount to 77 at the end of 2025 compared to 87 at the start of the year.

So then we can turn to Slide 17, where we show our -- an overview of our cash position and cash flow. So starting with the cash position, at the end of the year 2025, we had SEK 91 million in the bank compared to SEK 112 million at the end of Q3. So this change in cash of SEK 21 million is mainly driven by investments in intangible assets of SEK 11 million during the fourth quarter, and that is mainly related to the U.S. NDA preparations.

Cash flow from operations during Q4 was negative SEK 5 million compared to positive SEK 7 million in the same quarter of last year. And the change there compared to the same period last year is that -- due to the fact that while we have an improving operating income, we have some negative cash flow effects from less interest received during the period and also changes in working capital where we have increased operating receivables and decreased operating liabilities to make that comparison to the same period last year.

Cash flow from investing activities for the quarter, negative SEK 13 million compared to negative SEK 55 million in the fourth quarter of 2024. So what this change reflects is the fact that we are now spending less on U.S. CapEx, again, related to the NDA submission preparations compared to 2024. And also, it should be noted that the comparator period here includes the cash flow related to the acquisition of Innovatif Cekal, which closed in late 2024. So that's negative SEK 25 million in the comparator period.

So that brings us to a total cash flow for the fourth quarter of 2025 of minus SEK 19 million compared to minus SEK 49 million in Q4 of 2024.

So we now expect CapEx to stabilize at this new and lower level over the coming year as we are now, as Johannes has described, in the final stretch before NDA submission, which is expected around the middle of this year, 2026. And we continue to expect to be sufficiently financed to achieve U.S. approval.

And then briefly on Slide 18, you can see our main shareholders as of year-end 2025, and we continue to be grateful for your support.

And with that, I will hand it back over to Johannes.

Yes. Thanks, Johan.

So before we go into the Q&A, let me just briefly wrap it up. I see 3 big reasons to believe in Sedana Medical's success. Number one, and the foundation of it all is a therapy that makes a difference for critically ill patients every day. We help them wake up faster, recover faster, communicate with their families earlier and leave the intensive care unit earlier. And with more than 100,000 patients in more than 1,000 hospitals around the world treated and more than 1 million sedation days under our belt, we can say with some confidence that we are living up to our purpose of improving life during and beyond sedation. And every ICU patient obviously has a life that is worth getting back to and no one should be in the ICU longer than necessary. So true patient benefit and cost savings for the hospital as well.

Number two, we have a growing and now profitable core business mostly in Europe. We've now had all-time highs in quarterly sales in 12 quarters in a row. And as we said in the beginning of the call, we are now at a point where that business is generating positive EBITDA, so provides a proof-of-concept and a stable platform for the future U.S. launch.

And number three, we are getting closer and closer to the U.S., which one day should become our largest market in terms of sales as we would, as I said, quadruple our addressable market upon U.S. approval with 2 successful U.S. studies, FDA Fast Track designation, and then Early Access Program kicking off and a positive pre-NDA meeting. There are a lot of positive good indicators. So we're hoping that inhaled sedation with isoflurane will benefit also U.S. patients in the near future.

So with that, thank you very much for listening up to this point, and we will now open it up for your questions.

Since there is no one on the line for questions, you can go ahead with your written question that you received.

Okay. So you sent those over. Just one second. We've actually got quite a number of questions here. So one is from Mike Ryan.

When do you anticipate full approval and launch in the U.S.?

So the time line is that we will submit the NDA midyear, so mid-2026. What follows then is a 2-month validation period where the FDA essentially checks whether we have ticked all the boxes that we were asked to tick. And this is also the period, for example, where they make a determination of whether we get priority review, yes or no.

So the Fast Track designation allows us to apply for a priority review. And in these 2 months, the FDA will decide whether we will get it or not. Should we get priority review, the review time for that would be 6 months. Should we not get it, the standard review period that applies is 10 months. And then, of course, it's subject to the FDA on how many questions they will come with. But my base case assumption is that we would get approval either early or in the middle of 2027, depending on whether we get a priority review, yes or no.

And then the launch will not be the next day because, for example, the approval will define the label and then there's some production lead time to put the last touches on the launch stock, but relatively soon thereafter. So we are expecting a launch in 2027.

So that was question number one.

Then we had a question, can you talk about intravenous versus inhalation sedation? What's your current penetration in different European markets? And what are the clear benefits that will drive penetration going forward?

So this is one of these markets since we are dealing with mechanically ventilated and sedated patients in ICU setting. It's a quite well-defined niche where there's limited publicly available data available. So it's not like you can buy data that shows Sedana has a penetration of X. But of course, we triangulate our penetration as well as we can in the different markets based on the number of sedation days you have in a country, and we put that in relation to the number of Sedaconda ACDs that we sell because that's a 24-hour device. So it gives us a good idea of how many sedation days our therapy was used.

In Germany, for instance, our 2025 penetration was 14%, so roughly one in 7 patients at any given point in time is sedated with inhaled sedation and 6 are still on IV sedation, which also gives us an idea of there's still -- even in our largest market today, there's still a lot of growth potential.

In the other European markets, the penetration is still a bit lower. But Spain, for example, is one where the trend points towards higher penetration than what we see in Germany today because, for example, indicators like the sales per account shows that an average Spanish customer already has higher sales today than an average German customer because they use the product more broadly in more patient populations.

And that is also to answer the question for how to increase penetration. That is the model that has worked the best for us. So pick high potential accounts, try to establish inhaled sedation as a mainstay therapy, not just as a niche therapy and then grow from there.

Next question comes -- this is anonymous.

The question is, can you talk a bit about competition? Who are your biggest competitors? Dexdor, Precedex in the U.S., midazolam [indiscernible], are they comparable since they are also easy to control?

So the drugs that are relevant on the intravenous side, I would say, is the top 3, propofol, midazolam and dexmedetomidine. What you see very often is that when you ask doctors what they're using, they will always say it's propofol and nobody is using midazolam because those are benzodiazepines with all the downsides that come with it. But when you walk through ICUs, you actually still in a lot of places see a lot of midazolam being used. So it's still around there.

And dexmedetomidine is used mostly for lighter sedation. But what is very typical is anesthesiologists like mixing cocktails. So it's not uncommon that they do not go with only one IV sedative. So it's quite normal for a propofol patient to also have dexmedetomidine mixed in or midazolam mixed in. And then if you have difficult to sedate patients, very easily you have a cocktail of maybe 5 IV drugs, which is one of the big advantages of the gas isoflurane, because you don't need that polypharmacy. So when we switch someone from IV sedatives to inhaled sedation, usually, it's enough to only sedate them with isoflurane.

And in terms of how comparable they are, so in terms of clinical data, we have most evidence versus propofol because our clinical trials have been head-to-head versus propofol. The Sedaconda study in Europe showed that isoflurane patients need less opioids, they woke up faster, there was more spontaneous breathing. So there's clear benefits versus propofol and also easier -- earlier ICU discharge.

There's less evidence versus midazolam, but there is a few older studies that show that those effects are actually more pronounced versus midazolam. So propofol is considered the better drug, if you like, compared to midazolam. And then dex is a little bit -- dexmedetomidine is a bit of a special drug that we use for light sedation. So it's not fully comparable one-to-one.

Let's see if we have more questions. No questions on the line. No, I think then we have answered all the questions.

So with that, thank you very much again. Wishing you a nice day. And handing it back to the moderator.

Yes, so there are no more questions now. So thank you for listening. And bye. Thank you.

Thanks a lot.

Hello, everyone, and welcome to today's Finwire webcast presentation with Sedana Medical. With us presenting today, we have the CEO, Johannes Doll; CFO, Johan Spetz; and CMO, Peter Sackey. We'll do a Q&A after the presentation. [Operator Instructions] And with that said, please go ahead with your presentation.

Thank you for the introduction, and welcome to our Q3 report presentation today. Let's dive straight in on Page 3 with the highlights of the quarter, please. Thank you. The short version of this report is this. If I compare to the analyst expectations ahead of the report, sales have come in lower than expectations, also lower than our own ambitions. But despite that shortfall in sales, our bottom line was actually better than people expected. Year-to-date, we are still showing a profitable ex U.S. business, and I'm very confident that we will deliver on our financial guidance for the full year.

And this is exactly what I am hoping you will take away from today's call. We have now reached a scale and put in place a cost structure that allows us to keep our ex U.S. EBITDA in the positive territory even when we have quarters like this one where market circumstances lead to no or quite low growth, because the truth is this, our business is subject to seasonal swings every year. And sometimes, the seasonal swings differ quite a bit between years. Sometimes this will be in our favor. And from time to time, as we see it today, we will see quarters like this one where we have much less patients with respiratory problems in the ICUs, which will then affect our sales.

What is important for me, though, is that we show consistent growth when we take a bit of a through-cycle perspective and look at longer periods than just 1 quarter. And also that we stay so disciplined on the cost side that lower sales quarters will not affect our goal of achieving positive EBITDA levels outside the U.S.

Looking at the numbers, we grew net sales by 7%, of which 1% was organic and the rest was contributed by our acquired contract manufacturing business. This is quite a difference, obviously, compared to the strong growth in the first half of the year. But despite the low growth, we still stand at 18% growth year-to-date, of which 12% is organic. And again, our ex U.S. EBITDA year-to-date is still positive with 1% and actually would have been 3% without the exchange rate headwinds that we had. So we are fully on track to deliver on our promise to show positive ex U.S. EBITDA for the full year. And with Q4 coming up, which has traditionally been a stronger quarter for us than the summer quarters, I'm quite confident that this will happen.

What we're seeing here is the result of the cost savings measures we have implemented, especially in our noncustomer-facing functions in the corporate headquarters and also the acquisition of our main supplier in Malaysia starting to show positive effects on the gross margin.

On the U.S. side, it's very exciting times now. We are gearing up for the upcoming pre-NDA meeting. Pre-NDA meeting is a formal meeting with the FDA ahead of the submission to create alignment on format and content of the submission, and to ensure we have ticked all the boxes that FDA has asked us to tick. If we receive positive feedback on all our questions, we can move ahead towards submission. The preparations are on track and are going full steam, but also if the FDA has further comments or requests, we will have a chance to address them ahead of the submission. So it's an important meeting to try and reduce the risk of delays or a possible rejection during the review process, which, of course, we want to avoid.

And looking at our U.S. endeavor overall, it's worth reminding ourselves that we have met the primary endpoints in both studies. There was no new safety signals. The secondary endpoint outcomes offer several results that we are hoping to convert into compelling label claims. FDA has given us Fast Track designation and have authorized an early access program, in which we are expecting the first patient to be treated this year. So it's, of course, always a bit advisable to be a bit humble in a process like this, especially when the FDA is involved, but the individual pieces are really coming together quite nicely.

So let's move on. Look at Page #4, please, which shows the longer-term sales development. You can see that we are now operating at sales levels that are higher than the COVID-19 years. And also this year, we are on track to set a new all-time high in sales. Even though Q3 was a bit soft in sales, it was still the best Q3 we've ever had, just like Q1 was the best Q1 and Q2 was the best Q2. Overall, in the first 9 months of 2025, we saw a sales growth of 18%, of which 12% came from the core business, and the remaining 6% were contributed by contract manufacturing revenue from Malaysia.

Again, the return to growth after the quite dramatic decline in 2022 following the COVID-19 period was a result of a quite decisive shift in how we use our resources away from noncustomer-facing functions into the front line. And just to illustrate, our headquarter team is now less than half the size compared to 2021. And instead, we have a much more forceful frontline team in our core markets.

On the next page, Page 5, you can see the effect on the bottom line. There is some cyclicality in our business with the winter quarters, Q1, Q4 being the strongest one sales-wise and the summer quarters showing lower sales and profitability. But you can see the clear trajectory of steadily improving EBITDA, both ex U.S. and on the company level. Again, we see a positive ex U.S. EBITDA year-to-date and also the group level EBITDA has improved quite well in the quarter, 8 percentage points, which actually would have been 11% without the exchange rate headwinds.

On Page 6. No change on how we see our addressable market. The market where we are active today represents a market potential of approximately SEK 3 billion to SEK 4 billion, and we see 3x the potential in the U.S. market, which we will talk about in just a minute. But it goes without saying that the U.S. could mean a step change for the company with a potential quadrupling of our addressable market once we have the approval.

And for the more short term, we have communicated a very simple financial target for the year, which is to deliver full year positive EBITDA ex U.S. in the low to mid-single-digit range. Year-to-date, we stand at 1% with the weaker quarters Q2 and Q3 behind us now, actually will have been 3% without the exchange rate, which gives me very good confidence that we will meet this target for the full year because, as usually, I would expect Q4 to be stronger than Q3.

If we then look at the performance by country, starting on Page 7 with Germany. Minus 9% in net sales is, of course, not what we want to see, especially not after our acceleration program has delivered good results in the first half of the year with 13% growth in the first half and even 19% growth in the second quarter. Year-to-date, we now stand at 6% higher sales than last year. So it deserves a closer look at what happened here.

So on Page 8, what we see here is data from the Robert Koch Institut. This is hospitalization rates for severe acute respiratory infections. This is not exactly our market, which is mechanically ventilated and sedated patients in intensive care, but it's a very relevant indicator, as a part of these patients will end up being relevant patients for us.

And what you see here is the comparison between 2024 and 2025. Both curves are higher in Q1 and lower in Q2 and Q3. And you don't have to be a visionary to predict that they will increase again in Q4. That is the normal seasonal pattern we see every year. But what's also quite evident here is that the yields are still quite different. So the flu season this year was more extensive and longer than last year, which has given us some good tailwinds in Q1 and Q2. But then the situation flipped and hospitalization rates have been significantly lower than last year since approximately May.

So if you look at Q3 in isolation, 34% less patients were admitted to German hospitals with severe acute respiratory infections. And Robert Koch Institut actually also publishes how many of these patients end up requiring intensive care. We don't have access to the raw data. So we can give slightly less accurate numbers, but also that group has decreased between 20% and 25% compared to last year.

We also collect our own data. So we're tracking a sample of hospitals, and that also shows that the ICU occupancy rate has decreased in Q3 compared to the previous quarter. The effect that this market development has on us after a quite strong beginning of the year is that less products have been used in intensive care during the end of Q2 and Q3, leading to later and then oftentimes also smaller reorders by many of our customers, which explains our sales decline.

The truth is we will have quarters like this every once in a while, because we cannot influence how the market develops. What's important from an execution perspective is that we stay focused on what we can control, and that is to maximize the time in the field, that is to focus on the right balance between new customers and increasing penetration in existing high potential accounts.

And these measures, by the way, are also exactly the measures that are going to be helpful in mitigating some of this volatility going forward. You will never be able to fully avoid it because respiratory patients are the majority of patients in the ICU, but expanding the use in more patient diagnosis, so we are less dependent on respiratory patients opening new accounts, so you're less dependent again and focusing on big university hospitals that are typically quite well occupied even when there's overall less patients.

In other direct markets, on the next page, we were up 22%, even though we saw some of the same market dynamics as in Germany, so less patients overall. The growth was once again led by our Spanish team, which has really shown fantastic growth over the last 2 years now. That was again the case in Q3 based on a good execution, but also based on a very, very strong network of believers and opinion leaders that the team has built on the customer side. And what's worked really well in Spain is that we do not just have the academic key opinion leaders who are oftentimes not treating so many patients anymore, but we have a lot of what we call bedside ambassadors, oftentimes younger doctors who treat a lot of patients, see the benefits of inhaled isoflurane sedation in real life every day and not just in studies, and who are at the same time very influential for their peers, so other doctors who seek advice on the best treatment options.

In the U.K., we were unfortunately hit by a temporary staff absence in the third quarter, which in a small team has a big impact because it leads to a quite significant reduction in field presence, so we could not deliver the growth that we were planning for. And when you have reduced resources, you often run into a typical problem that a lot of time is taken up by responding to the very good demand from potentially new customers, and you then have to neglect a little bit to maintain and drive the growth in your existing customers, and that is exactly what's happened in Q3 here. We have suffered from this phenomenon a little bit, but we'll soon have the team fully staffed again, and then also focus our energy on the right balance between new customers and existing customers.

What will also help a bit is that the MHRA has now also approved our pediatric indication in the U.K. as we now got some approval for the pediatric indication in all countries where we asked for it, which provides some upside as well. And in fact, we just went live in a new pediatric unit just this week.

In France, we continue to see a quite split performance with isoflurane customers performing very well, but in customers that are still using our devices with off-label sevoflurane, we continue to see sales decline following the SESAR study. Overall, this results in a rather flattish development, which is not good enough. So the plan for France is quite self-evident, focus on switching remaining sevoflurane users to isoflurane, and there we are really making good progress. If you look at the SESAR clinical trial sites, for example, which you would Imagine are the hardest nuts to crack given the seasonal results, 60% of those hospitals are today using isoflurane. So the conversion is progressing well.

Overall, I see our other direct markets or the direct markets outside Germany as a big success story. Of course, only a few years ago, Sedana was essentially Germany and not much else. Now we have built a business in these countries that represents more than 1/3 of our core business sales.

On the next page, on Page 9, we see our distributor business. This is the smallest part of our business, and you are right now used to seeing a bit of an up and down, because most distributor partners order less frequently and stocking effects tend to influence the order patterns more than in our direct markets. In Q1, if you remember, we had seen a decline in sales because we had a big order from South America falling into the comparative time frame. In Q2, then we were up 32%. And this time, we're relatively flat with a growth of 4%. And from an execution perspective, we are still pushing ahead with enhancing our focus and offer the best possible support to a few select key partners where we can jointly drive the most value.

Let's go to Page 11 and switch gears to the United States. Before I will ask Peter to take us through the details, let me briefly recap our strategic plan for the U.S. As you know, the U.S. is our largest growth opportunity. We have estimated the U.S. market potential for our products to roughly $1 billion, so SEK 10 billion to SEK 12 billion. So a market entry in the U.S. would instantly quadruple our addressable market. This is because of a high number of ventilator beds in the U.S., but also a medical practice that favors intubation and mechanical ventilation much more than in Europe, and also an overall quite attractive price level.

We do see a very good product market fit, for example, because of the proven opioid reduction that our therapy has been shown to provide, for example, because a reduction in the ICU length of stay is generally a very effective driver of the adoption in the U.S. more so than in Europe. And also because the guiding thoughts behind existing treatment guidelines such as fast wake-up, early mobilization, early ICU discharge are quite in line with some of the benefits of inhaled sedation with isoflurane.

And on top of that, as we've discussed before, Peter and his team have done a really excellent job in building a network of key opinion leaders in our clinical trial sites that are very support of our therapy and already very active speaking about inhaled sedation at different global conferences.

So we have a high market potential, a good product market fit, a KOL network you got to get started, and also an early access program that will allow hospitals to get trained and started before the actual approval. Therefore, we continue to believe that we can create the most value if we launch ourselves in the U.S., capture more of the upside and generate proof that this therapy can be successful, while then over time keeping the option open to either scale up ourselves and take it all the way or at some point to complement our presence with a partnership if we deem that can create more value.

Now with this, let's move to the next slide, and I will hand over to Peter for our U.S. and medical update.

Thank you. Yes. So as Johannes mentioned, we have the clinical trial sites that were very active in the trial, 31 different hospitals across the U.S. that enrolled 555 patients over the course of 2 years, and they continue to be very excited and interested in inhaled sedation, which, of course, is nice to see.

We can move over there to the next slide, please. So as Johannes alluded to, we are sort of on a good track towards our NDA submission with the 2 Phase III trials that both showed noninferiority for the primary endpoint and opioid reduction and other benefits that we know of when it comes to inhaled sedation such as fast time to wake up and positive data when it comes to ICU stay and mortality. And these studies are being prepared now together with the pooling analysis and it will be submitted early next year. And in parallel with that, we have the early access program that is being initiated, and we're looking forward to the pre-NDA meeting later this year, and we'll get guidance for the FDA on how they want to see the submission.

And if we move to the next slide. So the early access program, for those who haven't heard of it before, it's something that you get for patients that have a life-threatening condition and where the current therapies are not successful enough. And we have applied for this with the FDA and got a green light for providing a therapy free of charge to hospitals who request it. And the patient category is the difficult-to-sedate patient group, which is a patient group that occurs -- you see these patients with different kinds of conditions that are typically mechanically ventilated and with different background diagnoses, but do require high doses and different combinations of IV drugs. And in this scenario, inhaled isoflurane sedation has been shown to work clinically the most popular indication across all ICUs that use our therapy.

And this is something that we can do until we get a marketing approval, and it's open to all interested hospitals, expanded access program. And this, besides being something that's helpful for patients that are struggling to be comfortable and safe in the ICU, it also offers an opportunity for us to continue training physicians and ICUs when it comes to inhaled sedation. And that, of course, gives us a very good start at the launch, because these hospitals will be proficient and there will be experts in inhalation. And also, it's an opportunity for us to refine our training and the whole supply chain, et cetera ahead of launch.

And currently, we have 11 hospitals that have expressed interest, and we're taking them one by one. So we're working with the finalization of the contracts for the first hospitals and also have set up a supply chain for all our products, and we expect to see the first patients treated within the EAP before the end of this year.

We can go to the next slide, please. And so in par with this, we are driving a lot of medical activities around the globe, mostly focusing on Europe, of course. So a lot of different activities ongoing in its workshops, round tables, symposia and webinars that we've been running. And they've been one of the activities, of course, after the SESAR study in the spring was to educate people on the differences between off-label sevoflurane and on-label Sedaconda (isoflurane). And it's also been about diversifying from patient groups such as a difficult-to-sedate patient or respiratory patients to other patient categories that are intubated and require sedation.

And most recently, this week, we did a round tour in the U.K. where we met clinicians together with one of the authors actually of the SESAR study, who was also helping describe the difference between sevoflurane and Sedaconda (isoflurane) and also local ambassadors. So we met representatives from 10 different hospitals in London, Liverpool and Bristol.

And with that, I'd like to move over to Slide 16, which is you, Johan. Please.

Thank you, Peter. Yes. So on the next slide here, we present our financial results for the quarter in some more detail. So we report net sales for the quarter of SEK 41 million, which is up 4% in reported currency or 7%, excluding exchange rate effects. And if we were to exclude our contract manufacturing business in Malaysia that we acquired last year, sales would have been SEK 39 million, so down 2% in reported currency and only slightly up excluding exchange rates.

So as Johannes has described, we have seen low ICU occupancy during the summer months and through Q3, in particular, across our main markets. In particular, this was the case in Germany, as you have seen, where we saw sales decreasing 12% in the quarter compared to the same period last year. And excluding currency effects, sales were down 9%.

Our other direct markets performed better despite some of the same market headwinds. So overall, our other direct markets report growth of 18% in reported currency or 22% excluding FX. And as has been the case for some quarters now, the main growth engine in this group of countries is Spain. Our distributor markets showed essentially flat growth in the quarter compared to last year in reported currency, 4% growth if we exclude exchange rates.

On the gross profit side, we report close to SEK 30 million gross profit for the quarter, which is up slightly compared to a year ago. And if we look at the gross margin, we report 71.6% gross margin in Q3 this year. That's up from 71.2% in the same quarter last year. So what we're seeing with regards to the gross margin is that we are now experiencing the positive effect from reduced cost of goods for our main product, the Sedaconda ACD, following the acquisition of our main supplier in Malaysia, Innovatif Cekal, last year.

But important to note that at the same time, we have, of course, added contract manufacturing to our overall business, which introduces a slight headwind because, of course, the contract manufacturing business has a lower gross margin than our core business. So important to be aware of that. But of course, over time, as we've discussed previously, we expect the positive effect on the gross margin to dominate, and we're well on track on realizing that.

If we look at EBITDA in Q3, we report for the group minus SEK 5.6 million EBITDA. That's an improvement by SEK 3 million compared to a year ago. And if we look at EBITDA ex U.S., which is what we base our full year financial target on, we report a negative SEK 1.7 million for the quarter despite the market headwinds that we are experiencing. So a clear improvement also there by slightly more than SEK 3 million compared to a year ago. So we are seeing a good reduction in operating costs in this quarter compared to a year ago. And we continue, of course, to look for cost savings and find efficiencies where we can find them, especially in our headquarter functions to be able to continue to reallocate resources as much as possible to the front line.

And if we look at the size of the staff, that has increased. So a bit counterintuitive to show these kind of cost reductions at the same time that we increased the staff quite a bit, but that's a function, of course, of the acquisition of our new manufacturing facility in Malaysia, which is behind the increase in staff.

And then on the next slide, we can look more closely on our cash flow and cash situation. So cash at the end of the quarter stood at SEK 112 million compared to SEK 131 million at the end of Q2. So the change in cash position is negative SEK 19 million for the quarter, and that's driven very much by our U.S. CapEx. So as you know, we are still spending money in the U.S. in preparation of our NDA submission. If we look at the cash flow from operations for the quarter, negative SEK 1.1 million. That's a pretty significant change relative to a year ago when it was negative SEK 29.3 million.

So if we break that down, we have cash flow from operations before changes in working capital, which has improved to now being negative SEK 4.7 million for Q3 this year compared to negative SEK 9 million last year. And then in addition to that, of course, we have some cash flow resulting from changes in working capital. So that includes, as you know, changes in inventory, changes in short-term receivables and short-term liabilities, which then add up to the remaining delta there in the cash from operations this year relative to last. But clear improvement, which is important, of course, in the cash that we're generating from our operations in Europe.

Cash flow from investing activities for the quarter, negative SEK 15 million compared to negative SEK 37 million in the same period last year. So that change or the reduction in CapEx is very much a reflection of the fact that we're now spending significantly less in U.S. CapEx, but there is, of course, some U.S. CapEx remaining related to our NDA submission preparations, and we expect CapEx related to U.S. now to stabilize at this new and lower level over the coming several quarters going forward. So a clear difference, of course, to what you've seen in recent quarters and especially the recent few years when the U.S. clinical trials were up and running. So total cash flow for the third quarter of this year of negative SEK 17 million compared to negative SEK 67 million in the same quarter last year. And in terms of liquidity management, we still have over half of our remaining cash in U.S. dollars, and we continue to expect to be sufficiently financed to achieve U.S. approval.

And then on the next slide, we have our current shareholder list and, of course, continue to be thankful for the support and hope to continue to engage with all these partners going forward as well.

With that, I will hand the call back to Johannes.

Thanks, Peter and Johan. We've arrived at the last slide here. For me, I see 3 big reasons to believe in Sedana Medical success. Number one, and the foundation of it all is a therapy that makes a difference for critically ill patients every day. We help them wake up faster, we help them recover faster, communicate with their families earlier, and leave the intensive care unit earlier.

And with more than -- or actually several hundred thousand patients and more than 1,000 hospitals around the world treated and more than 1 million sedation days under our belt, we can say with some confidence that we are truly living up to our purpose, which is to improve life during and beyond sedation. Every single ICU patient has a life that is worth getting back to after ICU and no one should be in the ICU longer than necessary. So true patient benefits and cost savings for the hospital as well.

Number two, we have, as you've seen, a growing core business mostly in Europe. We've had all-time highs in quarterly sales now in 11 quarters in a row, and we are now at a point where this business is generating positive EBITDA, so provides proof of concept and also a stable platform for a future U.S. launch.

And number three, as we've discussed, as you have heard, we are getting closer and closer to the U.S., which one day should become our largest market as we would quadruple our addressable market upon U.S. approval. With 2 successful U.S. studies, FDA Fast Track designation and an early access program kicking off, there are a lot of positive indicators. So we are very confident that inhaled sedation with isoflurane will benefit also U.S. patients in the near future.

Thank you very much for listening, and we will now open it up for your questions.

[Operator Instructions] The first caller in, we have Filip from Pareto.

I've got a few questions here, but I'll take them one by one. So the first one is about Germany. So you had quite strong headwinds here from the market. But if we look beneath that, how has the underlying progress been? So I'm thinking more about increased penetration rates, et cetera.

Yes. So that's a very good question. And it's not always easy to differentiate between market circumstances and execution. So sometimes when you have market headwinds, it's a little too easy to blame everything on that and then you forget about the execution. So you know, of course, that after the last year, we have focused a lot on execution in Germany. We've put in place an acceleration program, which has shown good results in the first half. In the first half, we grew 13%. So these were things like making sure we spend as much time in the field as possible.

Let's make sure we spend the time with the right customers, so the ones that we can we can grow the most. Let's also make sure we have the right balance between opening new customers and increasing penetration. So all of these things have been going on since the beginning of the year, and we're seeing good progress with it. And of course, it's quite striking that the same team doing the same things has grown 19% in Q2, and then it has been shrinking 9% in Q3. So it's very obvious that the main contributor to this performance is -- or the difference in performance is the market. But of course, we need to be fully focused on execution as well. So overall, there's nothing to be concerned about on the execution side. We will carry on, but at the same time, not lose focus on the execution.

Yes. Okay. And then I also noticed, based on the data you showed on Slide 8, that last year, 2024, there had already been an uptick in the ICU patients, while it has remained flat this year. So is it possible to give any sort of indication around the start in Q4 if the headwinds have remained or have eased?

Yes. So if you were to -- so these data are publicly available, right? So you can basically update them every week. What we have seen in October is a bit of a continuation. So in 2024, you see that these respiratory infections, hospital admissions have started to increase. We are not fully seeing that to the same extent yet as we're still a little bit behind. But for what is worth my own sentiment from -- the ICUs seem to be filling up. So we see the normal seasonal increase, even though it's maybe a bit weaker than last year.

Okay. Good. Then a few questions around the pre-NDA meeting that you have upcoming. So firstly, do you have a specific date for it yet? Can you share whether it's early or late in the quarter?

Yes, it's relatively early in the quarter. So we will get updated on that reasonably soon.

Okay. And is it possible to also share a little bit more details around what you will be discussing. So I'm thinking mostly around like what sort of risk you see related to the topics that you're going to discuss, potential things that could come up that could have an impact on the submission time line.

Yes. So the very idea of a pre-NDA meeting or at least how we are using it is to reduce the risk, because the one thing that we want to avoid is we submit a file and then we get sent into an extra round, either causing delays or a complete response letter, as you've, of course, seen too many examples of, especially in Sweden lately. And that we want to avoid. So we have asked very concrete questions that is around the format, the contents, the presentation of the data and so forth in the file.

An example is the pooling analysis that the FDA has requested. So we are presenting what we've done in the feasibility studies, which of the endpoints we have pooled the results and so forth and trying to get confirmation that this meets the expectations. And the hope is that with positive responses on these questions, we have reduced the risk of the submission and can follow our time plan.

So things for the preparation are progressing according to plan. But even if you have a scenario where the FDA has more requests or they want things differently or they have maybe additional wishes that they didn't have before, then it's also much better to have a chance to address that before the submission, because then you will put in a better file and you avoid delays and additional costs further on. So you used that in your question yourself, it's a risk-reducing meeting.

Yes. All right. But you're also going to talk about potential Fast Track benefits, right? So I was just also curious around like what are the arguments for and against you receiving any sort of those benefits?

Yes. So the decision of -- so we have Fast Track designation from the FDA. What that means these days is mostly that we have a little bit easier access and it's easier for us to communicate with the FDA. And unlike maybe what you hear in other places, our experience is a very constructive and good dialogue. So that's the main benefit now. But when it comes to the review, we have the right to apply for priority review, which would reduce the review period from 10 months to 6 months, which is, of course, a big benefit. That is a decision that the FDA will take.

We will apply for this with the submission. So when the file goes in, you put your application. And then, as you probably know, the submission is followed by a 2-month validation period where the FDA is checking whether the file is complete, whether it makes sense for them to review and so forth. And as part of that validation period, they also take a decision on whether the priority review is granted yes or no. And if it is granted, then you get a PDUFA date in 6 months. And if it is not granted, then you follow the standard time line of 10 months. This is a decision that the FDA takes.

An argument for receiving it is that this is a therapy that at least we believe and, based on the Fast Track designation, also the FDA seems to believe that brings potential benefits to U.S. patients, and it's worth bringing this therapy to the market faster. Arguments against could be anything from capacity constraints to complexity of the file that needs more time. So this is really a decision that we cannot influence. But of course, we will try to put the best case forward.

Okay. Perhaps just a question around the pooling analysis, which is now completed, if I understand correctly. So my question is, have the results aligned with your expectations? Have there been any surprises, so to say, or...

Yes, I can answer that one. So no, I would say there haven't been any surprises. Just to mention, at the time when we were requested to consider pooling of our efficacy endpoints with the SED001 study, that was a positive surprise to us because we knew the results from SED001, which were in favor of isoflurane. We didn't know the results of the U.S. study. So you could say, it was a sort of insurance to be able to pool in those data in case any of the U.S. study didn't show a noninferiority or didn't show opioid reduction or there was something else that didn't turn out the way we had expected. And now they did. So in some sense, you could say that part of the sort of excitement about having getting to pool SED001 with the U.S. studies was sort of neutralized by good data from the U.S., but the other aspect is the possibility to get better power and more precision in the estimates and also to look at subgroups.

And where those analysis are just dropping in now as we speak. And to date, there have not been any unpleasant surprises. I think that the data show that our treatment does pretty much the same if you're in Europe or if you're in the U.S. And that, of course, is a very robust statement for us to make to the FDA.

Okay. Have there been any positive surprises or any of the endpoints that have tilted into significance?

No. No new -- sort of no bad nor good news. I'd say we have a stronger case now that we have pooled the data and can look into the subgroups. So I would say, for example, looking at subgroups, looking at opioid reduction, for example, when you look at the pooled data, you see that all subgroups have opioid reduction. And that, of course, is very valuable because it shows that it's not just one patient group, for example, surgical patients that benefit from having isoflurane. It's all kinds of patients, old and young and very sick and more healthy patients. So I would say, in some sense, I would say, it's reassuring, I would say. No big surprises in any direction, but reassuring the data when you look at the pooled estimates.

Okay. And we'll move on to Mattias from SEB.

I will stay with the previous question here for a bit and ask if you can share anything on mortality or ICU-free days or anything around the pooling analysis?

Yes, those are areas that will be quite useful. So I mean, the health economic endpoints such as ICU-free days, that will make for a very, very useful publication, right? Because we had very consistent results between the European study and the 2 U.S. studies. We saw less time in the ICU across the board, more ICU-free days. So if we have a publication based on -- here we pooled 3 randomized controlled trials in Europe and in the U.S. and you're saving -- or you have 1 more ICU-free days or 1 point, whatever it will be in the publication. And that translates into, depending on the situation, between $5,000 and $11,000. That is, of course, a very powerful tool that you can use with procurement departments in hospitals.

So that's an example where the pooled analysis will be translated into a very valuable publication besides the fact that, hopefully, it will also contribute to the FDA seeing this as a very robust data for approving the drug. And the same approach goes for mortality, of course, as well, if there's a way for us to build that into a publication, that can be very supportive for the launch.

So while you answered that you do not see any positive nor negative surprises, it is still possible that something could come out of this analysis that support those statements? Or how should I...

If you have a publication showing a day difference in the ICU length of stay, maybe that's not kind of a traditional FDA outcome that will make the difference between getting approval or not. But we all know that the approval and the clinical benefits alone is not what is going to drive the uptake, and people are going to look at the health economics in the U.S. much more. So maybe it is not surprising in that sense because we knew that our therapy will reduce the time that patients spend in the ICU, but that doesn't make the message less powerful. So that will be an important tool when we launch.

So I could just add to what I said, I maybe didn't spell it out enough when I responded, that there's nothing new. If you look at the results from Sedaconda study and you look at the individual U.S. studies, for example, you will find that ICU-free days are more for isoflurane, not statistically significant. And that means, obviously, that when you pool the 3 studies, you will find similar results. And that, of course, is also very reassuring. And as Johannes was alluding to, even without statistical significance, you can have something that's clinically significant or significant from a health economics perspective.

If we talk about mortality, for example, we had a 5% difference in mortality in one of the U.S. studies, 4.3% difference in the other study, which favor isoflurane. So overall, I mean, we are very happy with the results. Even though many of them maybe are not translatable into a label claim, they will be very useful when we launch from a medical affairs perspective and from a health economics perspective.

Okay. And just as a follow-up on the pooling analysis, when is it possible that we can see the results? Or how will this be presented?

The pooled results are not results that we normally post on sort of clinical trials or anything like that. But there is an intent to liaise with an academic center and make a publication out of the pooled results. So that will be peer-reviewed publication, which I think is the strongest way that we can present the data.

Perfect. And then if you look at the U.S. submission, it sounds like everything is intact. Could you maybe speak a little bit about the time after submission? You talked on previous questions quite in detail about this, but it sounds like maybe you can have the product launched towards the latter parts of 2026? Or is it rather 2027 that you see likely for the product to be launched in the event of an approval?

Yes. I mean, as we have discussed before, it's always -- if you are in an FDA process, it's always, to some extent, speculation to talk about approval times and launch time lines, right? What I can say is if everything goes optimally, so pre-NDA meeting goes perfect, we have alignment on everything, we file the submission as we have planned, and then get Fast Track or get Priority Review or a 6-month review time and that goes well, then there's a scenario where we would get approval towards the end of next year, which is very soon. It is, of course, a very nice scenario, but it's also part of the truth that we are fully in the FDA's hands. And unforeseen surprises can come up. We're trying to mitigate them as much as we can. Of course, as I've said, we're trying to derisk this as much as possible before submission. But it is possible, yes. The base case assumption is probably a launch in 2027.

Then I want to follow up a little bit on Germany, if that's okay. If it is clear to you that you are taking market share in Germany with growth of sort of 5% to 6% in local currencies, if you look on 2024 and this year, I'm also asking if you could talk about the scope to further increase the market shares in Germany in coming years? And what sort of brings you comfort that it is not sort of the market shares that we are looking at in Germany? I think that would be helpful to cover on this one.

Yes. So we communicated these penetration levels on a yearly basis. The reason for that is that there's no perfect data that gives us exactly the size of the market that we operate in. So you would need the number of patients in intensive care that are intubated and sedated. And you can get things like how many patients are in the ICU, but you don't know how many of those have a tube in their throat and how many are just not receiving ventilation or are receiving noninvasive ventilation. So there's no perfect data there. So if we were to communicate this on a quarterly basis, there's a bit of a risk of not being precise enough. So that's why we do this on a yearly basis. We are seeing progress. Last year, the penetration was 13%. What we mean by penetration is how many days of all the sedation days in Germany was our products used. That's around about 13% last year. We see an increase this year.

And to your question, how high can this go, or have we reached a ceiling? We do, also in Germany, even though it's maybe a bit more mature market than other markets, we do see quite substantial regional differences. And some regions are upwards of 20% penetration and even more and some are much lower than that. And then you see hospitals that have 50% penetration, some have 80% penetration. So there's no reason to believe that 13% should be the limit. So what I usually like as a proxy is if you can reach certain penetration levels in a region, so individual hospitals is something else because you will always have outliers, but if you can have penetration of whatever, 25% in an entire sales territory in Germany, which can easily be, I don't know, EUR 2 million sales or so, that gives you an idea of what should be achievable as a national average as well by transferring best practices and making sure we have the same good execution and continuity in the sales rep position. So 13% is definitely not the ceiling.

I think that's a good answer. And then lastly, sorry for having a lot of questions, around the lower costs in the quarter, if those can be extrapolated. I know you have seasonally higher costs in Q4 typically. But in general, sort of should we expect cost to be sort of stable or slightly down, excluding the U.S. OpEx, of course? Or how do you see it?

Yes. No, that's fair. The one thing to think of -- so we have worked or continue to work on our cost structure in the first half of the year, and we see some of these efficiencies come through in Q3. What you have in Q3 is a vacation period, so then the activity level is typically a bit lower. So there's less conferences, less travel. So that shows a little bit. So sometimes you have -- if you look at historical years, you will see that the cost level in Q3 is often a bit lower, but it is also a function of us having continued to work on the cost structure.

Okay. And that concludes the Q&A. Thank you very much, Johannes, Johan and Peter for your presentation and answers. And thanks to everyone for joining this Finwire presentation with Sedana Medical. And I wish you all a great rest of the day. Thank you.

Thanks a lot. Have a good weekend when it comes.