Sedana Medical AB (publ) (SEDANA) Earnings Call Transcript & Summary
February 12, 2026
Earnings Call Speaker Segments
Operator
OperatorHello, 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.
Johannes Doll
ExecutivesThank 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.
Johan Spetz
ExecutivesThank 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.
Johannes Doll
ExecutivesYes. 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.
Operator
OperatorSince there is no one on the line for questions, you can go ahead with your written question that you received.
Johannes Doll
ExecutivesOkay. 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.
Operator
OperatorYes, so there are no more questions now. So thank you for listening. And bye. Thank you.
Johannes Doll
ExecutivesThanks a lot.
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