Hello, and Welcome to today's Finwire Broadcast Presentation with Sedana Medical. After the presentation, there will be a question- and- answer session. If you have any questions, you can submit them in English using the form on the right. 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. For the first time since the year after COVID-19, we're seeing a slight sales decline. 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. Of course, I prefer quarters where things go a bit more in our favor, or the market environment is at least neutral.
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. Let's jump right in on page 3 with the highlights of the quarter, and the progress against our three 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 two 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. The first half was 15% higher than the second half.
This followed 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. 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. 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%, and reported numbers would have been 5% without the FX headwinds in the quarter. Our ex-U.S. EBITDA was even double digit with 10% in reported numbers or 11% at constant exchange rates. Again, this really shows that we are capable of delivering good bottom line even when the market is going against us. 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.
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. 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 mid-year. With our two 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. We made significant cuts in everything that is non-customer facing and administrative in nature. Our Swedish headquarters, for example, operates now with less than half of the number of people. Part of that freed up cash we have then reinvested into strengthening the sales team. 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.
Also here we've applied a very disciplined and differentiated investment approach where we increase spend in countries that are meeting our profitability targets and show good momentum. We also cut back rigorously where that is not the case yet. 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. 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're 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. 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. As every year, we are likely to see some seasonality around these numbers, but we're very confident to meet our guidance for the full year. 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 closely to what extent this performance is explained by external market factors, but then also very quickly focus 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.
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. 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. 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 trainings, 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. 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 2024/2025 and the flu season 2025/2026 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 incidence.
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. Here you see those data for this flu season in dark blue compared to the previous flu season in light blue. 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. 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. When the ICUs are more empty, then ICUs tend to order less, and also later, which is exactly what happened in Q1.
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. That explains why we had a 15% lower sales in Q1. Again, quarters like this will happen. There will also be quarters that go the other way. 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 one week every month, protesting for better working conditions and also better pay. 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. During these strike weeks, what happens is that ICUs operate at minimum capacity. For us, it is then very difficult to get access to customers. We cannot schedule trainings, we cannot follow up.
That's what's been affecting us in the first quarter. What's 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 U.K. were not fully able to compensate for the Spanish shortfall in 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, had so far been blocked. Until now, these hospitals, and again, we're talking about 38 university hospitals, so big potential could either not use inhaled sedation at all, and that was actually most of them, or only with sevoflurane. As you probably remember, since the CESAR trial, we've seen a decline in sevoflurane accounts, especially in France, and generally a shift away from sevoflurane to isoflurane. 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. 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. 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. With these achievements, I'm expecting solid growth for the full year as well. 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 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-SEK 12 billion, which is three times the European potential of our direct markets today. 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 markets number here. 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 hundreds of thousands of patients. It will be 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. 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. of things like fast wake up, early mobilization, early ICU discharge are quite in line with some of the characteristics of inhaled sedation with isoflurane. Lots of excitement about the U.S. with the submission coming up very soon. Let me hand over to Peter to take us through our progress in the U.S.
Thank you, Johannes. Our preparations for the submission are on track. We have our two U.S. pivotal studies that showed that the primary endpoint was met. There were no new safety signals in any of these trials. Based on the findings of the study, we expect a good level of differentiation with our primary and key segment 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. The standard review time after two-month validation is 10 months. In the case of a 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, only this spring, we have three inhaled sedation reviews published, two by trial investigators and one by an institution that was not part of our trial, with a positive view on inhaled sedation and preparing the market, and is completely independent from us. We also have investigators from the U.S. trials presenting at major congresses both in Europe at the ESICM Congress in Brussels. Jeremy Beitler presented inhaled sedation and the U.S. preliminary data. 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 the target population, patient categories where inhaled sedation is considered to provide most value.
We'll also be looking at the available science, the current data, and discussing with advisors about what's available and what might be additional research that they consider to be relevant. We'll also be discussing implementation training, such as education curriculums and continuing medical education activities to include when inhaled sedation is launched in the U.S. If we move to the next slide 13. Looking at the trial results, our secondary endpoints showed some benefits. 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 those dependent side effects, such as constipation, respiratory depression, iatrogenic withdrawal syndrome, delirium, can be expected to be reduced. Interestingly, a large U.S. cohort study has demonstrated that the opioid dose during mechanical ventilation, the very measure we showed reduction with isoflurane, that dose correlates with the likelihood of development of persistent opioid use in the year after ICU discharge in nonsurgical patients. 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 end of treatment.
We know that with IV sedation, especially after deep and prolonged IV sedation, long and unpredictable wake-up times are common, and this 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. This is also a unique aspect of isoflurane, which is rapidly eliminated via the airways. We did see some non-statistical trends that are reassuring and potentially beneficial for uptake in the U.S. For example, numerically lower mortality in both the two U.S. studies, despite this being a novel potent therapy. Investigators use this, and in both studies, we're talking about 4%-5% lower 30-day mortality in the two trials. We have some other potential benefits.
All of these things that are non-statistically significant will be subject to discussion with the FDA if they merit placement in the label. We saw on average one ICU-free day more with isoflurane in the U.S. trials together with our European trial, and also the U.S. trials alone. This, of course, is one ICU-free day more means a lot for patients, for families, and also for healthcare in terms of work and cost. The pharmacological features of isoflurane imply that there's minimum 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 one-third and 50% of mechanically ventilated ICU patients. 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.
On the next 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 part of advisory boards already. There is interest, and they're looking forward to the time that inhaled sedation will be launched. Many of them clearly want to speak about inhaled sedation, and that, of course, will be possible the day we launch. If we move to the next slide 15. As Johannes mentioned, our Early Access Program has started, and the Early Access Program is FDA has granted us the possibility to give away our product 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.
This EAP is open to all interested hospitals in the U.S. Besides helping these patients that are struggling and that are 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. 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. For us, it's also an opportunity to practice all the aspects of implementing the therapy in a U.S. hospital. Currently we have nine hospitals that are interested in the EAP.
We're adding on new hospitals. Currently, we have Vanderbilt University Medical Center that has treated the first patients, and we have two more hospitals that are going live as we speak. We move over to the next slide from there. That's slide 16, and here I hand over to Johan.
Thank you, Peter. Yes. If we switch focus to our financial results for the quarter, starting with net sales, and Johannes has already discussed these aspects here. Just to reiterate the main points. 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. 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. We've seen higher growth rates in recent quarters. Johannes described the dynamics there as well. Despite the strikes 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. 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, facing 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. 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.
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. 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. Positive group EBITDA, 3% group EBITDA margin. Ex-US EBITDA for the same period, SEK 5.1 million. Also an improvement to 10% margin EBITDA ex-US. What we see is that we are able to continue to reduce our OpEx. 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.
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. At the end of Q1 2026, we had 130 colleagues in the Sedana Medical group, compared to 126 at the end of Q1.
This includes both regular employees, part-time factory operators in Malaysia, and also consultants. 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's accounts or 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. There you can see the way that we've further streamlined the organization, in particular in the sense of a leaner headquarters over the past year. On the next slide, we have our cash flow and available funds.
Cash at the end of the quarter was SEK 81 million compared to SEK 91 million at the start of the year. The change in cash here, as you can see, is -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 mid-year. Cash flow from operations during the quarter was + SEK 3 million compared to +SEK 6 million in the same quarter of last year. 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 was SEK -14 million, down slightly from SEK -17 million in the same period of last year.
Again, this is driven by U.S. CapEx related to the NDA submission preparations. Total cash flow for the quarter was SEK -12 million, same level as the first quarter of last year. We expect CapEx to remain at the new and lower level over the coming year. Really, once we're through the FDA review period, we expect really quite limited R&D-related CapEx beyond that period. We expect to be sufficiently financed to achieve U.S. approval. 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 have 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. I'd just like to add, this is my last quarterly earnings call as CFO of Sedana Medical. I would like to take this opportunity to thank all our investors and analysts for great conversations and interactions over these past several years. Thank you, and look forward to staying in touch in the future. With that, I will hand the word back to Johannes.
Yes. Thank you, Johan. 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. Of course, before that, we will ensure a smooth and successful handover. Now to wrap up this presentation before we open it up for questions, and we look at the last page. I see three 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.
With several hundred thousand of patients in more than 1,000 hospitals around the world treated and more than a million sedation days under our belt, we can safely say with some confidence that we are living up to our purpose of improving life during and beyond sedation. Every ICU patient has a life that is worth getting back to, and no one should be in the ICU longer than necessary. 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. Of course, a stable platform for the U.S. launch as we had aimed for all along.
Number 3, we are 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. 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. 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.
Thank you for your presentation. Now we open up for questions. As a reminder, if you are following the report on the phone, you can ask a question by pushing star nine to raise your hand, and I will give you the word. Now we can start with you, Johannes, Johan, and Peter, and all the written question that you received.
Okay. Let's go through those. We got a question from Scott Wright. 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. Maybe in very brief, sales performance, difficult quarter in Germany with a sales decline because of less patients in the ICU, lower growth than usual in other direct markets due to the strike in Spain. On the other hand, strong quarter in both distributors and contract manufacturing. Overall, a 2% decline. What's really standing out, I think, about this report is that nevertheless, we delivered a positive EBITDA on group level.
In terms of priorities, we are big believers of focus, so we are focused on three priorities always. One is sales growth, the second one is getting to profitability, and the third one is getting to the U.S. Over the last years, as you've seen in the call, we've made very good progress across all these priorities. 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.
We do not have any formal feedback in terms of protocol or results from the patients. Already before the expanded access program, they were very enthusiastic about using inhaled sedation in this very patient group. The feedback has been positive.
All right. I'll move on to the next. "How long does it take to reap the benefits of the initiatives you are taking in France and the U.K.?" 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. 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. I'm very optimistic about especially the second half of this year.
Again, there's a bit of an imbalance in how last year's looked from a sales perspective with a very strong first half last year, which we're now up against as a comparator, and then a weaker second half. In the second half, with all the things we put in place and a more realistic comparator, I think we'll see numbers that are closer to what we're used to. There's another question from Mattias. "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. 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 two last year in Germany was the strongest one from a sales growth perspective. We grew 19% in that quarter. We are again up against a tough comparator in Q2. 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 two halves of the year in Germany was even more pronounced than on a company level. On a company level, first half was 15% higher than the second half. In Germany, that same number was 19%. 19% higher sales in the first half than in the second half, which is a quite unusual pattern. Yes, Q2, tough comparator, but after that it's going to get better. 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 is numerically favored by one day over standard of care?" 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. Patients wake up faster, they're extubated faster, they recover better and faster, and that then eventually leads to them also leaving the ICU earlier. Based on our European trial, we had our post-hoc analysis showing a 3.5-day difference. Now in the US studies, we also saw consistently better ICU-free days for isoflurane compared to propofol, but we found one day difference.
The difference here that is important to note between the studies is in the German study, the European study, the doctors were allowed to leave patients on isoflurane beyond the 48 hours of study duration. We had patients that were on isoflurane for the full length of sedation. We had patients that were on propofol for the same period of time. 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. 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.
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. 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. There is a question from Johnny, "What is the estimated total cost of the early access program?" We've not disclosed exactly what that would cost. The way to think about it is we are supplying the products free of charge. These are not commercial sales, but we are providing them for free.
Of course, the cost to us is much lower than it would be to a customer because we only book the cost of goods. The more patients we have in the program, the more expensive it will become. In the grand scheme of things, it's not going to move the needle too much. 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 hospital internal processes and so forth. It's a well-made investment from that perspective, I think, even though we don't disclose the exact amounts. There's another question from Per Pettersson. 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." There's kind of a general and a more specific answer to that. Generally, what you see in the U.S. is that 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 even if we can only talk about one, only in quotation mark, one additional ICU-free day. An ICU day in the U.S. costs between $5,000-$11,000, depending on the exact care setting.
There is a significant saving by using our therapy. As a reminder, the NICE, so 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. Also a quite significant saving. Quite in line with potentially an even higher saving in the U.S. because everything is more expensive in the U.S. 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. 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.
Hi, yeah, this is Philip from Pareto. Just had a few questions today, but I'll take them one by one. Firstly, perhaps on the strikes in Spain. If you could elaborate a little bit, has that mainly affected the usage of the device through. You talked about this minimum capacity, so I guess that means fewer patients during the quarter. Is it mainly that, or is it more the ability to further penetrate the market with sales activities that have had the highest impact?
Yeah. Hi Philip. Thanks for the question. It's a combination of both. 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. I think if you follow the news a little bit, I think this must be probably the largest strike in healthcare that Spain has seen in a long time. 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. Overall, big impact on the country. The way it affects us in these weeks, so again, one week every month where they're out of business, of course, patients are still being treated in the ICU, but at a reduced capacity, so less patients overall.
Unless it's totally necessary, people will not be in the ICU. The main impact for us is that our salespeople cannot do their daily job. 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. It's both less patients but also mostly the access that is the problem for us. Again, despite that, essentially, if Spain was on strike for one in four weeks every month, 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 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 us is still very far apart.
Okay. Yeah, that makes very good sense. The kind of limited ability to 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 the weeks have already been scheduled, so the doctors already know when they will be on strike. 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 you get from people who are closer to this than I am, is that since doctors get less money during these strike weeks, at some point, the demands will have to become more realistic from a perspective of what the government can meet. Probably we will see the same in Q2, and then Q3 will hopefully be solution mode more than strike mode. Again, speculation, because I can't look into the future.
I know. Thanks for that. Just a question on the gross margin. 71%, which is in line with last year, and then back at levels that you had before the acquisition. 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. 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. Of course, if we have one quarter, such as Q1 2026, where the contract manufacturing accounted for 5% of total sales instead of last year, 3%, of course, that has a bit of an overall headwind for the gross margin.
All right. Thanks. 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. Were there any 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. It's two 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, basically, you make changes to the supply chain, essentially. That's part of it. 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. It's not yet any inventory build-up ahead of the US. It's more sort of temporary corrections.
Great, thanks. 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?
Yeah, I can answer that. Not in the near term, but they are in this 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. We do definitely expect to see them published well before launch.
All right, good. Thanks. That was all from me.
There are no more questions at this time. I give the word to you for some closing remarks.
Yeah. Thank you very much for listening. Thank you very much for the good questions and discussions, and I wish you a nice