Thank you. Hi, and welcome everyone. For today's report, I will be joined by our CFO, Susanne Andersson, and our Chief Medical Officer, Peter Sackey. With that, let's get on with it, and we can move to the next slide, please, which is our disclaimer slide, which I guess we can move through relatively quickly. Is it possible to move the slides, please? It could be at the moment. There we go. Then the disclaimer slide, we can move to the next one as well, I'll start with the quarterly highlights. This year, if we look at Q2 and we look back, a couple of things. Clearly, first and foremost, quite happy about sort of the approval of Sedaconda. We received the DCP approval in July subsequently, the first national approval in France. We anticipate the other 14 countries to follow through in the coming month-ish. We'll talk a bit more in terms of what this means for timelines later. Sales continues to be strong compared to an artificially high Q2 last year in Europe. It's a difficult comparison, but we're quite happy with where we are from a sales perspective. Most importantly, we see a lot of new customers come on board and the broadening of the use to beyond the COVID-19 patient population, and we'll show a bit more details on this as well. The U.S. clinical work continues on track for IND towards the end of the year or in Q4, and startup of the U.S. study program in end Q1, beginning Q2 next year. As we are moving towards launch, we're continuing to build the organization to launch Sedaconda in Europe and also to be able to execute on the U.S. programs, and we'll give you a bit more detail on that as well. Overall, nice progress in Q2, and we feel quite good about where we are looking ahead to launch in the U.S. program. With that, if we move to the next slide, please. Now that we have the 1st approval, basically it's a very good step towards realizing our vision, which is to make inhaled sedation a global standard therapy for critical care patients. If we move slides, please. We can move one more slide. As those of you who followed us probably can see from the presentation today, next slide, please. You can see that we have a slightly new visual outlook. Next slide, please. Yes, please. Oh, now we see. What you can see is that there's a slightly different visual outlook here, and that is from a logo perspective, a slight update, but more importantly, we've now been able, through the approval of Sedaconda in Europe, we are now one step further towards reaching or sort of being able to realize our vision, i.e., the tagline has changed with regards to bringing inhaled sedation to intensive care. There's an update to that visual identity, and two, we've added a symbol as well to our logo, and that symbol symbolizes the combination of drug and device, Sedaconda and Sedaconda ACD. That's another change that we start to see today. We can move to the next slide, and for the sake of time, I will actually skip that one. Let's move two slides ahead. Okay. To the sales development slide on page seven. From a sales development perspective, sales, we reached sort of SEK 40 million in Q2. We have an organic growth of 3% year-on-year in reported numbers. Oops. Which page are you on? I am on page seven. Okay, cool. Thank you - 2 in reported numbers due to currency fluctuations. We see quite substantial growth in Latin America and with Mexico being the second largest market in Q2, and continued strong sales in Germany despite COVID numbers or COVID patient numbers dropping quite drastically, and I'll show a bit more detail on that as well in a little bit. If we go to the next slide, please, slide eight. As we've talked about in the past, we continue to see rapid increasing adoption despite the off-label status. In Germany, our biggest market, we now have over 900 ICUs that are using it regularly, an increase from previous. We talked about Mexico being our second-largest market, and on the right-hand side, you see that map as well of the world, where the number of blue countries where we are in present are increasing. We also have additional countries coming on board that are in registration process. There are additional countries where we are also working with distributors to sort of further expand. What we have seen over the past two couple of quarters is distributors around the world are now approaching us with the opportunity of working with us and selling AnaConDa and our disposables. That interest has increased dramatically over the past couple of quarters. We move to the next slide, please, which is slide nine. Yeah. If we move to slide nine, sort of as I said, we see a continued influx of customers during Q2. If you look at our European direct sales markets, our pace of adding 1 ICU per day has persisted in Q2. We also see we're able to equip more and more hospital beds with gas monitors, which is an enabler for the use of inhaled sedation. We have covered 10% of the beds in Q1. That's up to 11% in Q2, so we continue to have that up and running. If we move to slide 10, please, and I'll show a bit more detail on the German sales, and we'll look at the other markets as well to talk through a bit of the dynamic that we've seen. On the left-hand side, you see the number of COVID-19 patients from outbreak in Germany. What you can see here is that we had a peak in early Q2 on 26 April, then we've seen quite a dramatic drop-off from 26 April. What we look, trying to understand is how much of our usage is coming from COVID-19 and how much is coming from non-COVID patients. The interesting piece is when you look on the right-hand slide here, we see the monthly sales in 2019, 2020, and 2021, and a couple of things to highlight. Last year, we had quite a fluctuation. In the first wave, we had quite a few number of hospitals that were in somewhat of a panic sense of urgency mode, were buying large quantities, so a bit of an artificially high number. This year, we see a high and stable level. We're at a much of a higher and stable level. They're using it on demand. More importantly, it's not being affected by the COVID waves up and down. Most importantly, even with the drastic drop from 26 April, we still have quite a high and stable sales level. A bit of seasonal fluctuation in June. That tells us that customers are broadening their use. They're using it much more outside of not only in COVID-19 patients, which gives us confidence for the future. Two, the other piece to highlight is that compared to 2019, we are at a much higher level. We've taken another step in terms of where we are in usage. This pattern is even clearer when you go to the next slide, when we look at the non-German markets. The left-hand side, similar graph. These are the ventilated patients in the U.K., and here you can see a similar peak, but a peak a bit earlier in January, and then a drop-off. Again, we're looking to understand how does that affect our sales. If we then look on the right-hand side, we can see a couple of different things, and this is the first half-year sales in our other direct sales markets, and we can see a couple of different things. One, we did have a similar artificially high sales figure in the first half of last year. If we look on the 2020 graph, we actually have more than 50% of our sales in April. Again, a lot of stocked up artificial. We're actually seeing some of that use is coming now. Some hospitals still have stock. The other part is that despite the COVID patient numbers going down in first half this year, our sales figures are still at quite a high level. If you compare to 2019, we're talking three, four times higher. Again, we've made quite a big jump with more hospitals coming on board using inhaled sedation in both COVID patients, but most importantly, in non-COVID patients. We feel quite good about where we are from the sales perspective, even though it might look like it's not super positive compared to Q2 last year. The other part that makes us sort of excited for the future from the European perspective, if you go to next slide. Regulatory approvals, faster than anticipated. The first national approval came faster than we anticipated in 20 days. Also equally importantly, which Peter will touch on in a little bit, the product label is quite a strong product label in terms of helping us from a promotional perspective. We can actually skip this one, go to the next slide, please, we'll go through a little bit of detail on that slide 14. What will happen now is that we do have the national approvals now in August, September. Yeah, thank you. What will happen is that there will be a number of markets where we could theoretically start to sell from day one, but there's also a process of getting the product on shelf with patient information leaflets, et cetera, all the translations, that will take about three months. Nordics, Germany, Netherlands. We'll have product on shelf in about three months, then we can start to sell. Then there are a couple of markets where we have price and reimbursement processes that take longer, that is France, Spain, and Belgium, and they take about 6 months. There will be sort of a slightly longer delay for those markets. That's roughly how this is going to play out, depending on how quick the national regulatory authorities are. Then finally, from a commercial perspective, next slide, we continue to build up our sales organization. We continue to prepare for launch. A couple of things to mention here is that, 1, our sales team is growing in Q3 to prepare for the launch. Two, we have also, which we talked about in the press release, we do have sales costs that have gone up quite a bit this year, and a good chunk of that is driven by price and reimbursement processes in the different countries, which are processes you need to do in order to launch. You do it once, and then you've done it. A number of those costs is not going to come back next year, but they are super important in order to be able to go to market. With that, I will stop there from a commercial perspective, and I'll hand over to Peter talk about the medical highlights. If you move to the next slide, number 17, the Sedaconda study. The study that was the foundation for our regulatory approval has been presented as a poster and will soon be published. The main findings from the poster I'll share with you now. If you move to slide 18. This was a poster that won an award at the Austrian and German Annual Joint Meeting this year. The first slide is that you're looking at now is showing the primary endpoint that was met in the trial, showing non-inferiority for isoflurane with regard to sedation efficacy compared to the number 1 IV sedative propofol, well away from the non-inferiority margin. Can we move to the next slide, please? Looking into other efficacy measures, the opioid requirements were found to be lower for the isoflurane group, 29% lower opioid use for isoflurane patients compared to propofol. This translates into a number of benefits to ICU patients, including reduced risk of constipation and also reduced risk of inhibited spontaneous breathing. This was also found an increase in spontaneous breathing for the isoflurane compared to the propofol group. This is considered to be clinically significant and beneficial for the patient. Moving over to the next slide. Looking at wake-up times. A feature of inhaled sedation described earlier was confirmed with this largest inhaled sedation study to date, where we could see that wake-up times were shorter and more predictable for isoflurane, significantly different day two. Day one, there was no statistically significant difference, although the absolute numbers were in favor of isoflurane. This is something that is needed to be true for longer periods of sedation. You actually see a shorter time to wake up, and that has clinical significance in that patients can be mobilized earlier, which could be very important, and also potentially also the ICU run. The next slide, please. Adverse events in the study. No serious adverse events that would need to be treatment-related. Looking at the most commonly reported adverse events, the one adverse event that was different between the groups was hypotension. That was more common after end of treatment with isoflurane, which is believed to be due to the rapid washout of the drug. Move on to the next slide, please. The summary of findings, so that's slide number 22, is that the time spent in the target depth of sedation range without resuscitation was similar in the groups. Opioid requirements were lower with isoflurane. Spontaneous breathing more frequent. Wake-up times shorter and more predictable with isoflurane, and that the drug device combination was well-tolerated. This, if you move to the next slide, number 23, translates into a strong SmPC, which is the base for our marketing and communication. Among others, these are the highlights from the SmPC that we'd like to mention. One is that we were not made to limit the allowed duration in the indication. There's no 48-hour limitation. The study that we ran had a 48-hour exposure, ±6 hours. A number of patients were treated longer than that after the end of study drug, and that's one of the reasons. Published literature that supports the safe use of this therapy more than 48 hours. That means a lot, of course. The Sedaconda ACD is the only approved device to deliver Sedaconda. That's also a strength for us, obviously. There's a statement that no effects of prolonged exposure of isoflurane in patients with impaired hepatic or renal function is something that is very important considering the critical care patient that often has impaired organ function. Rapid and predictable onset and recovery from sedation is something that is a clinically important benefit that we'll be able to discuss now that we have the market authorization. Finally, there's return of wakefulness and cognitive recovery, which is also very important for the mobilization of patients and the discharge of them from the ICU. All these things are in the SmPC, and we'll be able to speak freely about them in the near future. Moving over from this to the early stages in the U.S., clinical development and our program there. I'd like to move to slide 25. As we communicated before, we will have a combination registration of Sedaconda and ACD in the U.S. Before we can start our clinical trial, we have got some non-clinical data to provide to the FDA, and we also have to have a CTD as well as the NDA submission, and the commercialization plan will be decided at some point next year. Next slide, please. Looking at the non-clinical data we need to supply for our IND and NDA, that is considered two different portions. One is the pre-IND part, which is two species that need to be exposed to the intended duration of the trial. That's 48 hours. We have reached far with these studies. We almost completed them, and so far there are no findings of concern, and this project is on track for our IND in Q4 this year. Besides these studies, we also are committed to perform a full program, so we will be doing pre and post-natal development study, and that's just started. A repeat exposure study in rodents and dogs 28 hours, I'm sorry, 28 days. These studies are in planning. They need to be finalized before we submit our NDA in 2023. That's all on track. Next slide, please. The other non-clinical data that we need to supply besides the animal study, the human factors program. This is also two portions, one before IND, one before the NDA. The first portion covers the formative phases of the [inaudible], which is about testing the device, the design, the training, and safety measures on volunteers. I mean, our users. We have developed from a first formative study, we have developed split roles based on the U.S. ICU staffing, and we are going to test this in the second formative phase in September this year. That will inform the training program for the clinical trial and also for our validation study, which does not need to be completed for our IND, but it needs to be ready for the NDA. There's actually a benefit of not doing the validation phase before pivotal trial, because today will also give us information that will be valuable for that validation. That's all also on track, and we move over from that to the next slide, please. The timeline there, where you can see the top two boxes there, the colored boxes, show our two European trials, the Sedaconda study that was completed last year and will be published very soon. We have the ICE-COPD study, IsoConDa pediatric study. We go down, and we see the SED003 and SED004, the U.S. adult studies, where we anticipate the first patient in quarter one or quarter two next year. Besides the fully sponsored studies, we have some investigator-initiated trials that support the general use of propofol, sedation, and the AnaConDa. There are two of them. The SESAR study and the [inaudible] study are running currently in France. We have the ISCA trial, which is a multinational observational study of COVID patients. We move on to the next slide 29. Looking at the timeline for Europe and the U.S. In 2021 in Europe, we have the marketing approval around the corner with the product in France, as Jens mentioned. The ICE-COPD is ongoing. We expect that to end next year, also then to submit more authorized marketing applications in other countries that we did not include in the first round. By 2023, we should have European market approval for the pediatric indications. In the U.S., we had our end-of-phase II meeting earlier this year, and that was successful in that we were able to get through a few things among others, a more favorable non-inferiority margin than we had in the European study. It's 15 absolute% non-inferiority margin from the comparator. We also were able to include safety data from patients receiving a large AnaConDa that will not be marketed in the U.S., and also to include training patients before we start our clinical trials. As I mentioned, we have three types of studies. The pre-IND study will be soon completed. The human factors study is pending as well. We have been very successful in defining ICUs that want to run the trials. We established a subsidiary in the U.S., they're going to our first clinical educators to other medical people in the U.S., we will submit the IND in Q4. Next year, we'll then be able to start the study and do the final human factors validation and start planning our U.S. launch. By 2023, we should complete the pivotal clinical study and seek our NDA application for approval late 2024. That slide, just to show a map of the U.S. and the institutions that currently are interested to join the trial. These institutions are not yet committed, but we will have contracts in place which will be put after the IND, but it gives a feeling of the geography of the clinical trial, which is basically similar to the demography of the U.S. With that, I end my part. Thank you. I'll hand over to Susanne Andersson. Yes. Thank you, Peter. Next slide, we have the financial highlights. If you change slide to 32 with financial results, I can pick up a little bit from where Jens left it, that we had a good sales in the quarter and growing 3% in local currencies with a tough comparison with last year. Germany is still a stable country with like being the locomotive for the sales. We have had a very good sales growth in rest of world, Latin America which also is a great contribution to our gross profit. However, it being a distributor market, it comes with somewhat lower margins. Despite this, we actually improved our gross margin by two percentage points, and this is mainly due to that we had large proportion of freight by sea in the quarter. What we see, though, in the market is that costs are still high and given the Suez Canal or channel issues during the quarter and also the general supply sourcing issues around the world, we do foresee some more air freight in the second half coming back. We will, however, of course, try for as much as possible by sea, and we work daily on trying to find the best solutions for this. Our EBITDA came in at negative SEK 14. It is again coming back to what Jens previously said. We are building the organization. Also in order to help you when analyzing our numbers, we have tried to break out costs in terms of or related to the Sedaconda launch and including the MDR approval, just for you to get a better understanding for our underlying running costs. We are building the company both in terms of organizations. There are market approvals, registrations, et cetera, to address. As a result, by end of June this year, we had 91 people on our payrolls and consultants. This is including consultants. The FTE, full-time equivalent, were roughly 70, 68, compared to 48 last year. We are building the organization for our future growth. Next slide, please. Cash. What we can say here is again, given that we are building the organization, the cash flow from operations came in at negative SEK 12 for the quarter. The investment is also larger than last year. We had negative SEK 23 in the quarter, the vast majority is then related to our product development here. Right now, we have roughly SEK 200 million on our balance sheet. About half of that is related to our EU registration and the EU approvals. If we get all these approvals during the second half, we will start our depreciation. We do have a very strong balance sheet. Our cash balance is SEK 308 by end of June. I also like to remember all of you that we are a debt-free company. There's a very strong balance sheet that we are very proud of. Next slide, please. Our largest shareholders as of 30 June. It is not so many changes since last quarter. We have listed them all here. What I just wanted to comment here is that we did perform a split that was ended by end of May. Now there are 4x more shares within the company. With that's actually what I have to put as financial highlights. With that, I hand over to Jens again. On the next slide, to just have a quick repeat on our highlights. Before going to questions, just a couple of things to mention. One, not a highlight, but apologize for a little bit of the wobble in the beginning with slide transitions and kind of on sort of a bit of slowness from our end. Rounding up three things to mention here. One, we feel we're in a quite a good position, and we're quite happy with Q2 and where we are. One, on the back of the regulatory approvals for Sedaconda that came through faster than anticipated with a very sort of strong product label that will sort of allow us to commercialize the drug and the combination with the device and making inhaled sedation therapy. Two, we are very happy with sales performance. First half of the year, we have a 20% growth in local currencies, and that's even with an artificially high comparison from last year. Even with that, we're growing 20% on the back of many new customers coming on board and customers using it well beyond the COVID-19 patient population. three, looking ahead, U.S. plans progressing very nicely with regards to IND and then study inclusion next year. We have recruited our first employees to help us drive the studies. As Peter mentioned earlier, we are getting very strong interest from the right hospitals and key opinion leaders in the U.S. with regards to participating in our study. That will be super important going forward. All in all, we feel we're in a quite good place. With that, I'll stop, and then if there are any questions, please ask. Thank you. If you do wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. We have a question from the line of Peter Östling from Pareto Securities. Please go ahead. Okay. Thank you. A couple of questions. You say that of the SEK 200 million in capitalized development costs, about 50% relates to the European venture so far. What does the rest relate to since you have just started your U.S. journey? It's all various projects, and we have started at the U.S. projects as well. I don't want to break them out, but they are all other projects we are working on. Okay. The part that will be amortized now when the approvals are getting in, that's roughly around SEK 100 million then? Peter, can you just repeat the last one again? Sorry. Yeah. The basis that you are going to amortize will be around SEK 100 million then? Yes, correct. Sorry. Yes. Okay. It is from when we have these approvals now during the second half. This will start now. Yeah. Okay. Yes. Could you talk a little bit about what's happening, what's going on in China? In China, the short version is that we are working with the local distributor in China with regards to preparing the registration and the filing, and we are just at the end of it. It has taken a slightly longer time to do it than initially anticipated. Most primarily driven by the COVID-19 situation with regards to not being able to travel to China and be face-to-face with the distributors and do some of the testing, et cetera. It provided a bit of pressure from a timing perspective, but it's all progressing nicely in terms of preparing the file and the registration. It's progressing slightly slower than initially anticipated, driven by some of these timeline delays, but no other reason for it, to put it that way. Okay. Do you still expect approval this year? I think you have said that in the past. That's our hope and aim. Clearly, if there is a bit of a delay here, could it also be that, but we're still aiming for that, yes. Okay, great. Could you talk a little bit about the timing of the second wave of submissions, both in the EU and then, of course, for other countries where the EU dossier can be accepted, except Canada, for instance? Now that we have the DCP dossier, when we have the DCP approval, that takes us into the next step of filing in the other EU countries. There's always a lot of changes in the DCP process. That means that the initial dossier that we submitted, which is the same dossier that we submit to other countries, needs to be reworked and revised. It does take a little bit of time. That's why we've said that we will submit in second wave of European markets before end of year. What we have said in the past that we will clearly go to Italy because Italy was part of the first wave. They couldn't commit to the same timelines as the other markets. We left Italy out. Italy will be part of the second wave, and we are now working through which other countries will be part. Italy is the one that we've communicated it will. The other markets we're still revising a bit over the next few months. We are in dialogue with the Canadian authorities and also looking at other markets like Australia where similarly a European dossier can be used to see if now that it's been approved, then we need to reassess with them to see if this good enough, and will this fulfill the requirement for regulatory filing. When we've had those discussions and then we've had a clear feedback, then we will communicate when and if we are able to go already now in some of those markets. Okay. Lastly, one of my standard questions, could you provide an update on the studies that you're sponsoring, especially the SESAR study? The last time we heard from them was in, I think it was in the middle of April when they had recruited around 260 patients. Can you say anything about that? Yeah. This is not our study and the investigators are getting some support from us. Our questions are usually quite cautious, but we've been able to understand that they've exceeded 300 patients, and that they anticipate to be doing an interim analysis towards the end of the year. Okay. Do you know why the recruitment has slowed down over the last couple of months? Yes. It starts with a V and ends with an X. That's the severe COVID-19 patient has reduced. They had a really high recruitment rate, higher than anticipated, and that's unprecedented, I would say, the recruitment rate in the SESAR study that they had last year. That's the explanation why they're slightly above 300, but they need to have, I think, 360 or 370 before they do the interim analysis. They anticipate this to happen before. This is what they anticipate. I promise just to make it clear, their hope is to have the interim analysis by the end of the year. They expanded the study to recruit also non-COVID patients. Oh, absolutely. With or Yeah. The SESAR study was never intended. It started before COVID even was invented, the need. Actually the study has had a recruitment of a patient group that wasn't actually initially planned. That of course may impact the outcome because these patients are somewhat different than the average ARDS patient. That remains to be seen what the outcome will be. I don't know if they're going to do a sub-analysis on COVID and non-COVID ARDS, obviously, from a scientific perspective, that would be very interesting. Okay. Thank you. I give back in the queue. Just as a final reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. As there are no further questions, I'll hand it back to the speakers. Okay. Thank you everyone. With that, I would just thank everyone for dialing in and for the questions coming through. We close the call here and we close the call on the same note that I previously from a highlights perspective. Overall, considering both current performance and looking ahead to sort of short-term launch in Europe and longer-term filings and program in the U.S., we feel like we are in a very good position and with a very positive outlook on the future. With that, we close the call today, and thank you everyone for dialing in. This concludes our conference call. Thank you all for attending. You may now disconnect your lines.
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