Welcome to the Sedana Medical Audiocast with Teleconference Q3 2022. Throughout the call, all participants will be in listen-only mode, and afterwards, there'll be a question-and-answer session. Today, I am pleased to present CEO and President, Johannes Doll, CFO, Johan Spetz, and CMO, Peter Sackey. Please begin your briefing.
Good afternoon, everyone. Welcome to Sedana Medical's Q3 report. Thank you very much for taking the time with us today. As usual, I will start by giving an update on the business, then Peter Sackey will talk us through our clinical and medical activities, and Johan will take us through the financial update before I will close, and we'll open it up for your questions. On page 2, as always, I recommend that you give a quick read to our disclaimer, as we will, of course, be talking about the future in this presentation. Let's turn to page 3, please. Before going into the quarter performance and the operational progress, I would like to take a moment again to look at the bigger picture. We are living through a year where more is going on at the same time than is sometimes possible to digest.
This is true for the world in general, where we are dealing with too many crises in parallel, Ukraine, inflation, energy prices, recession, supply chain issues, et cetera. It is also true for our market, the intensive care unit specifically. So far, we have seen a transition year after COVID-19, where the ICU world, the intensive care unit world, is on its way to find the new normal. On that way, we have seen and are still seeing a temporary contraction of the addressable market. Less ventilated patients in the ICUs, both COVID-19 patients and those with other indications, and significant staff shortages that our ICU customers are suffering from as well. All of this is, of course, affecting our performance as a company.
It is affecting how analysts look upon us, and it's of course also affecting how you as investors are taking investment decisions. Therefore, I would like to take a step back and remind ourselves what Sedana Medical is about. We have a business with attractive gross margins. This quarter 70%, up from 68% the year before, despite the price pressures we have seen in the supply chain, which by definition can lead to a very profitable business when we reach scale. We have already shown proof of concept for that in Germany. We don't disclose profitability on a country level, as you know, but already today, and in spite of the lower sales than last year, we are generating EBITDA margins on a local level that are quite a bit above our long-term guidance of 40%. It can be done.
The key question here is: will we reach sufficient scale? Do we believe in inhaled sedation as a concept? Do we believe in our technology? Do we believe we can convince enough intensive care units to use inhaled sedation as the new standard of care? Here I think we have all the ingredients in place. In our Z001 trial, we have shown clear clinical benefits over intravenous sedation, so less opiate use, more spontaneous breathing, faster wake-up times. In a post-hoc analysis based on the same study, we have even shown that our patients leave the ICU four days earlier than a propofol patient. We've also shown health economic benefits, which were even confirmed by NICE in the U.K. We are also targeting the U.S. with a big clinical program, which will one day become our most important market.
We have everything that it takes to play an important role in the world of ICU sedation. Yes, sales have been down year to date, and they have been down significantly in the first half of the year, Q1 and Q2. If you look one level deeper, you can see some positive indicators. Year to date, we have sold roughly 70% more than in 2019, so the last year before COVID. In Q3, we have grown the business in our direct markets, including Germany, and we are adding on average three new customers per week, and we are very successful at keeping our customers as well. To me, all of this taken together is implying that the underlying performance is solid, and once we return to a normal state in the ICU, this should also translate into steady growth again.
Lastly, but very, very importantly, we have enough money in the bank to execute our plan. We have our destiny in our own hands and don't need to ask the market for new money, which in these days is super important and sets us apart from quite a few other companies of our size. Let's move to page 4 please, which shows a summary of the quarter. We have reported net sales of 26 and a half million SEK, down 6% from last year. Still a sales gap, but one that is smaller than in the first two quarters this year. What I'm very pleased about, the decline is explained only by the distributor markets. Actually one individual distributor while we were able to grow sales in Germany and also in our other direct markets as well. Gross margin was 70%.
We'll come back to that. We have a robust cash balance of SEK 676 million, which as I said allows us to execute our plan without needing to go to the market for new money in this environment. On the operational side, we have seen more launches of the drug, Sedaconda isoflurane, the most important country being France. At the same time, we're making progress with the local pricing and reimbursement processes. The main focus here is on Spain, where things are progressing according to plan. Assuming we won't get any delays from the authority side, we're expecting to be able to launch towards the end of the year or early next year should we get too close to Christmas.
We have received market authorization in Switzerland and are getting feedback from the Polish authorities that we are finally very close in Poland now as well. In Italy and specifically U.K. however, the authorities caused us some delays, which I will come back to. Another important milestone, even if maybe not too surprising, we did receive MDR certification for our Sedaconda device during the quarter, which was well ahead of the deadline in 2024. This will secure long-term market access from a regulatory perspective. Our U.S. trials are progressing. We have the majority of sites up and running and actively recruiting. Of course, we continue to believe that if we can recruit patients according to plan, we can submit to the FDA in 2024 and then look at a launch in early 2025.
Given the importance of the U.S. market for our company, this is of course very, very exciting for us to follow. Let us move to the next page 5, please. As we anticipated, we continue to see lower number of ventilated patients in ICUs compared to last year, but the gap is a bit smaller than in the first half of the year. This is simply due to the fact that the third quarter has been the one that has always been least affected by COVID-19, simply because there's less respiratory infections during the summer. If you look at ICU patients in Germany, for instance, on the left side of this slide, you see the high care and ECMO patients, which are the segments where our products could be sold.
There were on average 10% less patients in the ICU in the third quarter on a given day compared to last year. Now, these are all ICU patients. The publicly available data doesn't say how many of them were ventilated. When we are looking only at mechanically ventilated COVID-19 patients in Germany, so this is now only COVID-19, that number has decreased 20%. As in the previous quarters, we don't have exact data about all ventilated patients and how they have developed. From our experience, the decline should be somewhere between these two data points, so somewhere between 10%-20%. On page 6, as we have talked about before, ICUs are still confronted with significant staff shortages for a number of different reasons, including COVID-19, burnout, sick leaves on top of already high staff turnover to start with.
In Germany, again, our main markets, most ICUs report on a daily basis, whether they have normal operations, restricted operations or partly restricted operations. What we can see is that the restrictions were on a quite high level in Q3 with almost two-thirds of ICUs operating under restricted or partly restricted operation. Of course, you have to look a little bit behind the drivers of these levels as otherwise they don't mean much. In Q4 of last year, for example, we had even more ICUs with restrictions, and we had the best quarterly sales that we've ever had. But at that time, the high level of restriction was mostly because there were so many COVID-19 patients in the ICUs. Now the problem is not the number of patients, but the shortage of nurses.
On page 7, we are seeing how our net sales have developed compared to Q3 of last year. On the positive side, despite the lower number of patients and despite the hospital restrictions, we have seen growth both in Germany and in our other direct markets as well, especially in Spain and U.K., where we're seeing very nice momentum. On the less positive side, we have a significant decline in distributor markets. What's happening here is that we have not had any purchases from our main distributor in South America during the quarter, a little bit like we've already seen in the first half of the year. While if you remember in Q3 of last year, Colombia, one of the countries that is covered by this distributor, was the second-largest market after Germany.
The reason is that they are still sitting on quite high stock levels. If we actually take out that effect from this one distributor, which admittedly is a very big effect, we actually did see growth in the remaining distributors in aggregate. If we move to page 8, please. This picture I think shows pretty well the dynamic we have been through as it is showing the first nine months sales of the last years. Steady growth before COVID-19, followed by a real trend break during the COVID-19 years, and then a correction downwards in 2022 as we're going through this transition year after COVID.
If you take this through cycle perspective as you see it here on the slide, it's still quite visible that we are roughly 70% above the levels we have seen before COVID. If you turn to the next page, 9 please, you will see that we are still seeing positive underlying momentums despite the year-to-date sales decline. As I said, we did see growth in Q3 in several regions. In local currencies, that was 6% in Germany, 15% in the other direct markets. Actually, if we excluded the one South American distributor that I was talking about, we also saw 17% growth in the other distributor markets. On top of that, we have added three new customers per week on average.
Q3 was a little bit slower than the first two quarters, as every country tends to have a month in the summer where not much is going on, like August in France or Spain. On average, year to date, it's still three per week, which is a very good number. As you have seen before, we have been very successful in keeping the customers that we have. In Germany, for example, we have not lost a single one of our top 100 customers from 2021. If I take all of this together, some at least modest growth despite a lower number of patients, steady inflow of new customers and very little churn. This is a real reason for me to be looking optimistically into the future. On the next page 10, please.
We see the progress that we have made with our pharmaceutical, Sedaconda isoflurane in Europe. We have now also launched in France in September, so the product is now available in Germany, France, the Netherlands, Sweden, Norway, and through a distributor also in Slovenia. There are a few countries where the pricing and reimbursement process is still going on. Here, the most important one is Spain, where things are progressing according to plan. Assuming that the authorities stick to the expected timeline, we should be able to launch in late 2022 or early 2023, adding another important country to the list. Some mixed messages in the countries where we are still waiting for approval. First, on the positive side, we have received market authorization in Switzerland, bringing the number of countries up to 15.
We are finally hearing from the Polish authorities that we seem to be very close to that approval as well. In Italy, it's our understanding that there's been some internal handover and communications problems inside the Italian authorities, so we landed on the agenda of a later meeting that we had hoped, but it's still our understanding that we will get approval towards the end of the year, so pretty much exactly one year after we submitted. The one country where we are waiting for approval most eagerly, as you know, is the U.K., because we received the fantastic NICE guidance already back in January of this year, so more than 9 months ago.
While MHRA unfortunately has made us wait with the approval, not because something has gone wrong, but because they are so overburdened still as a consequence of COVID-19 and Brexit. This delay will now be even longer, as MHRA, after our attempts to follow up and learn more about the timelines, has just let us know that we will receive an update in January, and that update will also include a timeline for approval. Now, hopefully, the approval will not be too far away from the update in January, but it seems quite certain that we will not receive the approval this year, as we had previously hoped and of course also expected. Again, this is not because there are issues with our application or we have received a lot of questions that we couldn't answer, nothing of the like.
It is unfortunately only the authorities that simply have too much to do. On page 11, of course, Sedana Medical is not immune to the cost pressures that basically all businesses experience in the supply chain these days. We are finding the same effects as everybody else. In that light, I'm very pleased that at least so far, we've been able to keep the gross margin at a good level, 70%, and even grow it, despite the lower sales level this year. That's due to a number of targeted initiatives that we have put in place, including price adjustments, managing our transportation towards sea freight away from air transport, and of course, quite a few negotiations with our suppliers as well.
With this, I will hand it over to Peter, our Chief Medical Officer, to give a brief update from the medical side in the U.S. and around the world.
Sorry, are we on page 12 now?
Yes, we are.
Okay. Thank you. Thank you. In the U.S., the 2 INSPiRE-ICU trials underway, and these are two identical phase III studies across approximately 25 study sites. In total, the two studies will enroll 470 patients in addition to the three -five run-in training patients at each study site. The primary endpoint is the proportion of time at target RASS, and assessments of RASS are performed by assessors blinded to treatment arm. Key secondary endpoints are opioid use, wake-up time after end of treatment, cognitive function 1 hour after end of treatment, and spontaneous breathing during sedation. If we go to page 13, there's a lot of excitement in the participating institutions, and the majority of the study sites are now actively recruiting patients. More information can be found on ClinicalTrials.gov.
We anticipate to have the last patient in the trial in Q4 2023, submitting the NDA in the spring of 2024 and launching in early 2025. If we go to page 14, a few words about the investigator-initiated trials. INNOSEAD has recruited approximately 110 patients, and there was a recent investigator meeting in Paris to boost recruitment. SESAR has included over 525 patients, and the interim analysis is underway. These interim results will be reviewed by a data monitoring committee that will determine if the study is to continue or be terminated for safety, utility, or superiority reasons. We have the ISCOUT, which has been completed with 196 patients, and the manuscript has been submitted for peer review. Now we can move to page 15, please.
In the third quarter of 2022, we continued to increase our activities after COVID, organizing workshops, symposia, and exhibition booths at congresses and intensive care meetings in Europe, Asia, and Latin America. Now if we can go to the next slide, I think that's back to you, Johannes.
Okay, can I just confirm that we have both speaker lines unmuted? You're still dialed into the conference. I just want to confirm that you're both still connected.
Yes. Can you hear me?
I can hear you, yep.
Yes. I think, is it Johannes or Johan? They haven't been able to hear.
Can you hear us?
Yep, we can hear you.
Have you heard anything from slide 16, or should we go back to the top? Yeah. We could just start over on the financial section. Going back to the top of slide 16, where we can see our financial results for Q3 2022. We report net sales of SEK 27 million for the quarter. That is down 6% relative to a year ago, and down 10% in local currencies. As Johannes has already described, the underlying dynamic here is that we see growth in Germany and our other direct markets, but a decline in sales year-over-year from our main South American distributor, which is this aggregate decline.
If you look at the gross profits, we report SEK 8 million in gross profit for Q3 2022. That's also a slight decline relative to a year ago. The gross margin remains at a robust 70%. That is up relative to 68% in Q3 of last year. The improved gross margin here is mainly an effect of higher prices for our main products and also lower freight costs relative to a year ago. EBIT for the third quarter, we report SEK 25 million. That is the result of OpEx for the quarter. Selling admin and R&D costs of SEK 50 million in total. That is up from SEK 35 million in Q3 of 2021.
The increase here is driven by the fact that we've started depreciating on our European registration. We have U.S. commercialization efforts that are ramping up, still in the early phases, of course, but coming in here. We have some non-recurring costs in the quarter related mainly to our Nasdaq uplisting project. We can move to the next slide 17, please, to take a look at our cash flow and cash balance. The cash flow from operations during Q3 was SEK 27 million, and cash flow from investments, SEK 40 million. The cash flows from investments, as you know, are mainly related to clinical studies and registration work taking place in the United States, as well as our pediatric study in Europe.
In total, we report cash flow for Q3 of SEK 67 million, which takes us to a cash balance at the end of the quarter of SEK 676 million. That's down from SEK 722 million at the beginning of the quarter. It could be interesting also to add that out of this SEK 676 million that we have in the bank today, we have roughly $25 million. Roughly, SEK 275 million out of this total cash position is already converted into dollars. With this cash, we expect to be fully financed until break even.
As we described in the Q2 report and earnings call, we have initiated a cost savings program and these efforts continue. We look at various ways of increasing the efficiency of our operating cost base. To some extent, our efforts here are a bit obscured in Q3. If you look at the total OpEx number in Q3 relative to Q2, there are some one-off items in the Q3 numbers that means that, as I said on the previous slide, we have SEK 50 million in OpEx in Q3 of this year, which is up from SEK 46 million in Q2. There we have a couple of non-recurring costs behind that, related to organizational changes and again, the upcoming move to the Nasdaq main list.
We are confident that we are on the right track with regards to reviewing and trimming some of our operating costs to become more efficient. As a reminder, we don't have any long-term debt on our balance sheet. As a final update on this slide, the move to the Nasdaq main list is progressing according to plan. We continue to expect to start trading on the main market here in Stockholm before the end of the year. Then just very briefly on slide 18, you can see our current largest shareholders. Not much change there during the quarter. We are, of course, very grateful for the support of the shareholders on this list and other shareholders as well.
Okay. With that, I will turn the call back to Johannes.
Yes. Thank you, Johan. Let's take page 19 please. Trying to close the loop to where we started. We have seen, and to some extent are still seeing, a very special year with a large number of external factors and uncertainties impacting our performance. This has made it quite difficult for you to assess our performance in an objective way, because there are so many factors at play, and comparisons were difficult with the last year as it was so heavily influenced by COVID-19 effects, such as inflated patient numbers, irregular purchasing patterns, stock building, et cetera. The big question that a lot of companies are trying to give an answer to is how long will this last? When can we expect to come back to whatever the new normal looks like?
Now of course, we don't have a crystal ball either, but here's what we are expecting. We know that Q4 of last year was the last quarter that we saw that had a very, very high number of COVID-19 patients in the ICUs. There were more COVID-19 waves after that, but the patients did not get so sick. The ICUs were less affected. In Q4 we are still up against a tough comparator for that quarter. What most of our customers expect, and they are of course on the front lines, is that we should see more normal patient numbers from early next year, which should then also make comparisons of our sales versus last year much more meaningful as we are no longer comparing two quarters with a high degree of COVID-19 impact.
Some issues, most notably the staff shortages we will probably have to live with for a little longer, but we're expecting that we are in a much more normalized situation from 2023 onwards. At the end of the day, the success of Sedana Medical will of course not depend on whether we will be back to a normal life a quarter earlier or later. Thankfully, as we've said, we have a cash balance that allows us to deal with different scenarios here. It's also not about whether or not we will get a very severe flu season this year. We are here to change behavior in the ICU and establish a new paradigm, which is to make enhanced sedation the new standard of care in ICUs.
I hope that we have brought across that we are working hard on that, and that we are making good progress to turn this vision into reality. With that, I would be very happy to take your questions. For now, thank you very much for listening.
Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find your question has been answered before it's your turn to speak, you can dial zero two to cancel. Our first question comes from the line of Oscar Bergman of Redeye. Please go ahead. Your line is open.
Hello, guys, and thanks for taking my question. I have a few for you today, but I guess I can start off with asking two and then moving on to the two other questions. First off, I'm wondering about the U.K. market approval and specifically how long you think it will take between approval and first sales. Second, I'm wondering if you can give some more details on label conversion in Germany and also if you think that it will be less burdensome to get customers outside of Germany to start using on label rather than off label.
Yes. Thank you very much. Good questions. I'll take them one by one. U.K., as I said, just to briefly repeat, in January MHRA has told us they will give us an update. That update should then include when we can expect approval. Of course, to some extent it's still a little bit speculative of when that will happen. I'm of course really hoping, since they've made us wait so long without a real reason or content reason behind it, that it will not be too far after that January update. Now your second part of that question, how long will it take between the approval and first sales?
The approval in the U.K. for me is important for two different reasons. One, the obvious one is, we can start selling Sedaconda isoflurane, the gas, in the U.K. as well, which today we can't. Secondly, and probably even more importantly, we can benefit more from the tailwind that we should be getting from the NICE guidance that we already got back in January of this year. Which not only recommended Sedaconda ACD for the use of enhanced sedation in ICUs, but it also confirmed a health economic benefit. So hospitals saving money if they're using our therapy. And that is almost the larger effect because we've lived in this weird situation where we have a recommendation for a therapy that is not yet approved.
The first effect of when can we start selling the gas that should be relatively soon after we get the approval. You should not expect a long pricing and reimbursement process that we can be up and running basically as soon as we have supply ready for the U.K. Second question around on-label conversion in Germany and how that is developing. It's in line with what we have been previously saying. That it's a multi-step process and we're making good progress.
First of all, of course, we need to make sure we are listed with all the hospital chains, all the purchasing organizations. There's been quite a few negotiations during especially the first half of the year. A lot of that work is done. We have been successful in getting the product listed with the most important hospital chains and so forth. Then it becomes a kind of account by account undertaking to convert off-label to on-label. As we predicted, we see the full range. There's been a few customers that have converted quite fast. For them, it was a little bit of a no-brainer. If there's an on-label version available, why should we keep using the off-label isoflurane?
Some of them have been very fast. Others that also relate to the third question that you had asked say, "Look, we've used off-label isoflurane for so long, nothing has really happened. We didn't have problems with that, so why should we pay a premium here?" We are seeing progress. We are seeing the conversion is increasing over time. Of course, as we've previously said, it's not an overnight switch. Your last question, which I find an interesting one, will it be less burdensome in other countries to convert? Now, we have not too much experience in these other markets, but from what we have seen, it's probably fair to say yes.
The reason for that is that we have seen faster uptake, or faster conversion of the customers, for instance, in Sweden and some of the other markets where we've launched already. The issue is that these tend to be the smaller markets, so it's not super visible in the numbers. The reason for that conversion being a little bit easier is that those countries don't tend to have the same track record of using the product off-label for so long. For them, it's more, okay, we're establishing in sedation, and that comes with on-label isoflurane. It's not so much a switching over from off-label.
To an extent, yes, it's a little bit easier to convert in markets outside Germany.
Thank you. Just going back to the question about conversion in Germany. Is it possible for you to give some sort of ballpark figure in terms of portion of sales in Q3 that was on-label and/or off-label?
No. We are not disclosing how our sales break down into devices and pharmaceuticals. Unfortunately, I can't give you that breakdown. You can, of course, assume that the vast majority of sales still comes from the device side.
It's my two last questions. The first one, staffing shortages. I'm just wondering if you can give some more color on how that has developed in Q3 versus Q2 and how it looks in Q4.
Yeah. These are publicly available data. There's a daily survey, basically, that most, not all, but most ICUs in Germany fill out. They have three choices. One is we are operating according to normal. We are operating under partly restricted operations or restricted operations. It's also further information about whether that's due to staffing, whether that's due to equipment that is missing or other reasons. What you will typically see these days, it's almost always because of staffing. After COVID, of course, it's quite rare that an ICU is not fully equipped with ventilators and so forth.
The development we've seen this year, if you take the ICUs that report that they are operating under restricted or partly restricted operations, so things are not normal, if you like. In the first three quarters of this year, this number has always been above 60%. So there's more ICUs being restricted than of ICUs operating under normal conditions. Between Q2 and Q3, your question, it's gone up a little bit, but that's in the area of 3%, so I wouldn't overinterpret that. I would rather say the situation has not yet relaxed. We're still seeing quite high level of restriction.
The trend in the beginning of the fourth quarter here, which again is public data, so I'm not giving you any secrets here. It seems like more ICUs are seeing restrictions, which is a function of the staffing issues not being fully resolved. At the same time, you see the seasonality that more patients are in the ICUs again. Once you enter the winter months, there's more respiratory infections, not necessarily only COVID, but also flu and pneumonia and so forth. You always see more of those in October, November, December than in the previous months. That combination of less nurses, more patients causes more ICUs to be a bit restricted.
All right. Thank you, Jonas. Just a last question before I hand back into the queue. In the report, you give some optimism about high interest at the U.S. centers. I'm just wondering if you can say anything about the feedback, if you've got any.
Are you talking about the U.S. trial or are you talking about commercial?
Yeah. No, the trial.
Yeah. Maybe Peter can give a little bit of an update.
I'm sorry. Could you please repeat the question? Can you hear me?
The actions we're getting from the different trial sites in the U.S.
Yes. No, there's a lot of excitement. Can you hear me okay?
Yeah.
This therapy is something that they have known about for years, many of these clinics. Unfortunately, it hasn't been approved, so they haven't been able to use it. They're very excited about bringing this to the U.S. The past experiences that each site has with these running patients, they're the open label patients, so they actually get to see how the effectiveness of this therapy and also how quickly patients wake up. That's created lots of excitement about getting these studies done. We're very happy about the way these interactions have been with these study sites and also for future ambassadorship, you could say.
Thank you. Just a final question before I let the other analysts ask their questions. In general speaking terms, is the U.S. market dynamic different from the EU? Would it be easier to see a sales ramp-up of your product there? I mean, are they more interested in using inhaled sedation compared to intravenous?
This is a very, very comprehensive question, of course. Is it different? Yes, of course, it's different. When it comes to what ramp-up to expect, there's maybe two things to keep in mind. One is the U.S. does not have the same experience, off-label experience that we could build on in Europe. We're really launching something completely new. That is something for us to keep in mind from what we need to do from an education perspective, market preparation perspective, awareness creation perspective, and so forth. At the same time, this is also a very positive thing for us because it really allows us to launch inhaled sedation as a complete concept.
We can come with a convincing product offering, hopefully with good convincing clinical data, hopefully with convincing health economic benefits. There's not so much history around using off-label or et cetera. From that perspective, I'm really looking forward to that. We're very encouraged by the feedback we are getting from, as Peter was saying, from the clinical trial sites, which of course, as we know, these are very reputable institutions.
A lot of the important opinion leaders are involved, and getting the quality stamp from those people, and hearing the excitement and hearing that they can really tell the difference in with those patients that they've seen, that encourages me a lot, that we should not just come with kind of a me-too product here as an alternative way of sedating the ICU patients, but really something that can make a difference. As we've talked about before, the space of sedation in the ICU is one that hasn't seen much innovation in a very long time. If this is something that you're dedicating your academic or clinical career to, you absolutely have to be part of this movement, and that's the excitement that we're seeing with these study teams right now.
Hopefully we will see the same level of excitement once we launch with our future customers.
Okay. Thank you. That's all from my part. Thanks.
Thank you.
Thank you. We have one further question in the queue at this time, and that's from Peter Östling at Berenberg Securities. Please go ahead. Your line is open.
Thank you very much. Good afternoon, guys. First, a quick question on, there is some evidence of that we are maybe entering a normal to maybe more severe flu season. I'm just curious to see. I mean, you alluded to that we had this situation with a lot of restricted ICUs in Q4 2021, and yet you had this fantastic sales. In practice, how does it work when you get this situation with a huge inflow of patients, but you have restricted ICUs?
Yes. What's typically happening is that hospitals start moving elective surgeries. It's not the case that kind of you have patients showing up at the hospital that need to be intubated and need life-saving support. Of course, they're not being sent away. Usually, the capacity utilization is so high that then they wouldn't run surgeries that they could also postpone. For some surgeries you don't know whether that patient will need intensive care after the surgery, whether there will be need for a ventilator for intubating that patient and ventilating them for a while.
It's safer from a hospital's perspective if it's not a life-threatening situation and you can move the surgery, then that is typically what they do.
Okay. Elective surgeries is the way to balance the inflow and capacity in that situation. Okay. That's clear. I'm just a little bit curious. You've said that you will have around 25 sites in the U.S. for the U.S. trials. I believe you have 19 sites now listed on ClinicalTrials.gov. Do you think that, or do you expect that all the 25 sites will be listed or up and running before year-end or around year-end early 2023?
Yeah. As you know, as always, you have done your homework very thoroughly, Peter. Yes, you can indeed see the list on ClinicalTrials.gov. You have a list of, I think, 19 right now. Yes, the plan is to open quite a few sites over the next coming weeks. It doesn't mean that we will not consider opening more sites if that makes sense next year. Yes, we should reach that number relatively soon.
Do you expect, if we get this situation with a severe flu season and maybe some add-on of a COVID spread or maybe RSV spread, how will that affect your recruitment pace Q4 and Q1?
That's a balancing act, of course, Peter here. It's always good to have patients in the ICU that are eligible for a trial. I think the net effect will likely be that it's the benefit for the trial that more patients are in there intubated. At the same time, if staff get very stretched, that can, of course, impact the ability to run a clinical trial if the ICUs are overfilled with patients. I doubt that that's going to be the case, though.
Okay. Okay, great. Could you say anything about, I'm back to Europe now. Could you say anything about the balance between. You mentioned that you had made some price adjustments in the quarter. The balance between price and volume when you come to these growth numbers in Germany and other direct markets. Is it mainly price or is it mainly volume, or is it more 50\50?
Yes. As you know, we are, of course, not disclosing the prices on a product level. The reason for that is that we have different prices and different customers also between countries. There's, of course, differences. We have adjusted prices this year, as you say, not to a crazy extent, but mostly to compensate for the fact that during COVID, we made a conscious decision not to raise prices because we wanted to support customers. We didn't want to benefit off of that crisis situation. In return, we have raised the prices this year more than we would usually have.
However, of course, our ambition is to become standard of care, and that you can only become if it still makes sense from a customer perspective when you look at the prices. Of course, we will always charge more than you would pay for intravenous sedation if you only look at the product cost because we bring a better product. We also don't want to be in a situation where we charge ten times that because then we believe we would end up in a niche, and not as many patients would benefit from our therapy as we think they should.
I can't give you an exact breakdown between price and volume in the numbers that we've seen. Of course, what we are looking at and what we're very focused on is to see volume growth and especially an increase in the penetration. The share of ventilated patients that get inhaled sedation is a key metric for me. It's not just raising prices and hoping that's being reflected in the sales. It's really driving the volume.
That market share has probably increased during Q3 since patients in the ICU is dropping 10%, but you still have some volume within the 6%, for instance, in Germany.
Yes. That's correct. Unfortunately, we don't have kind of market share numbers as you know. Otherwise, it would be much easier to communicate. Yes, the penetration has increased, as by the way, it had already during the second quarter, even though we saw a quite sharp sales decline. That sales decline was less dramatic than the decline in the number of patients.
Yes.
The underlying trend is correction.
Yeah. You're talking about, well, like all companies are talking about problems or disturbances in the supply chain. In your case, what exactly is the problem in your supply chain or has been?
It's if you call it a problem, it's probably a good problem to have because at least we've still been able to grow the gross margin, which I think sets us apart from many other companies. Of course, what we are experiencing, we depend on a number of suppliers. We don't have our own manufacturing. It wouldn't make sense either for a company our size. Of course, like everybody else, they are trying to increase prices. There's a lot of negotiations with our suppliers ongoing. The overall trend is for raw materials, for components, for parts, for manufacturing services, those costs tend to go up rather than down these days.
Is it plastics or is it, because, I mean, the device is mostly plastic and some membranes inside the device.
Oh, I'm hoping that my engineers are not listening, that you're saying it's mostly plastic.
Okay. I'm simplifying things now.
No, but I mean, there's of course some key components, and there is some cost pressures on in certain elements of that. As you've seen in the numbers so far, we've been able to compensate for that and actually overcompensate for that, given the price adjustments and the freight cost management.
Have you felt that this pressure has been worse in Q3 or started to ease in Q3 in going into Q4? Or is it more of the same? Do you expect to be able to compensate for any increase?
Yeah. Well, yeah, that is, of course, always an option, right? We need to make sure that we have a sustainable business. At the same time, it's a balance as, of course, we don't wanna price ourselves out of the market. There's, of course, also differences between the different products we are offering. The Sedaconda ACD is a very innovative product where we don't have much competition, so our pricing power is a bit higher. If you look at certain adapters or syringes or scavenging systems where you could use an alternative supplier as well, we can't raise the price in an unlimited way. Has it changed much? I mean, we're not dealing with thousands of suppliers, right?
We're in constant exchange with them, and the dialogues have been going on for a few quarters now. I wouldn't say that there has been a massive change between the quarters.
Okay. My last question. I guess the plans to establish a second source in Europe has been put on hold, maybe due to the war in Ukraine.
No. Well, second source is already up and running for the syringe, so one of the important accessories. We are working on establishing it also for the main product. We are basically ready to do that. Of course, now we've seen a year where the sales have been a bit on the lower end. Of course, you have to be a little smart about the timing of when to introduce a second source, because otherwise you are distributing low volumes over two sides, and then you haven't gained much, especially in a situation where the inventory levels are a little bit higher.
Yes, we are making progress on that. We are basically ready to move. It's more about the right timing from an inventory and demand perspective.
Okay. Thank you, guys. I jump back into the queue.
Thank you. Once again, if there are any further questions on the line, please dial zero one on your telephone keypads now. Once again, any further questions, please dial zero one on your telephone keypads now.
In the meantime, I can get to two quick questions that we received via the chat. One was around the inventory levels in South America and what we can say about that and when we're expecting that to normalize. Yes, of course, we can comment on that. What happened here is, in Q4 of last year, that specific distributor, like probably a lot of people in the world, were anticipating a big COVID wave that would be hitting the ICUs, which turned out to be the Omicron wave, where very few people were ending up in the ICU. They had very high stock levels, which they have been working through during the year.
We still have slightly higher stock levels than we would want it to be. At the same time, South America and specifically that distributor is one where we see a lot of potential. The demand in the market in light of the number of patients is still going very well. It's a dedicated team that is only focused on our products within that distributor, and they are really doing a good job. It's one that we're really focused on. We've actually hired a person in Brazil. We've added Brazil to the number of countries that distributor is covering. Overall, things will look bright for that distributor.
In all likelihood, and of course, I don't have a crystal ball exactly, but what I would expect is that the demand, in the sense of, not in market demand, but the repurchases we will see from that distributor, will still be low in Q4, and then we should be back to a normal situation in Q1. So that's as much as I can say about that. There was a second question around the SHIVA trial, whether we could give a little bit of an update. I think Peter has done that during the presentation, but maybe Peter, you can say a few words again about where we are with the SHIVA trial.
Yeah, as you can see from the numbers, they have a little bit more than 100 patients left to enroll, and the interim analysis is with the statisticians, and it will not be a presentation of the actual data. It will only be a guidance whether they should continue the trial or whether they should stop the trial because of superiority or safety or utility. We're waiting, of course, to hear what the interim analysis will show. Of course, we're waiting to see that trial wrap up and the data be presented.
Okay. Currently, there are no questions from the phones at this time.
Okay. Perfect. I would like to thank you for spending the time with us. I understand there was a little technical issue in the middle here, so apologies for that. Thanks a lot, and you all have a great day.