Okay, thank you very much. Welcome all to the Q1 report for Sedana Medical. With me here today, I have our CMO, Peter Sackey, our CFO, Susanne Andersson, and our Commercial Director, Jens Lindberg. We are the ones that will present the first quarter report today. I will start. I will give you some guidance about Sedana Medical. Most of you have heard some of this before. We will go into the commercial, what we have done during the quarter. Yes, we go through that. Clinical development will be done by Peter. We will end the presentation with a financial highlights presentation by Susanne. I will wrap it up in the end. Anyway, the first quarter, we can go to slide three directly. This quarter as well as 2020 was very much strongly influenced by COVID-19. Also during this quarter, we have prepared ourselves for the launch of the treatment in inhaled sedation and Sedaconda around the corner here in Europe. We have prepared ourselves for the clinical development in the U.S. Together with that, we have also seen an interesting sales increase by 40% during the quarter compared to the first quarter last year. Let's go into the company little bit more in detail. We have on to the next slide showing our ambition, our vision with this company is that we are working in intensive care. We definitely believe that we have a unique treatment in inhaled sedation that could change the paradigm in how to sedate the patient in the intensive care unit around the world. We are definitely confident that we can do that very much dependent on the features of the treatment, which we have seen before. Just a summary of it, we have with our drug and delivery device a possibility to reduce the ICU stay for patients thanks to the on/off effect and the reliable wake-up time compared to IV treatment that takes very long time. The longer you are sedated, the longer time it takes to wake up the patient. It could take a very long time and very unpredictable. We also, thanks to the motor effect of the drug, a reliable effect, and also a nice safety profile of the product. We can also see that we have a better cognitive recovery versus IV and less cognitive side effects like delirium and hallucination. Interestingly, we have also seen that we can reduce the usage of opiates during the treatment as well. That's of course of interest in many countries around the world. Lastly, it's more of a therapeutic effect that we might actually have seen it also in studies on humans lately, not only in animals. We have seen that we have a potential in organ protective properties, especially in the lung where we can see improved gas exchanges and improved oxygenation. That of course will have a potential of catching two birds with one stone with a good sedation drug as well as an organ protective possibility as well. Going down to the potential of the market. You have seen it before, this is a normal year without COVID-19, with a potential of EUR 2 billion-EUR 3 billion annually divided into three different regions of approximately one third in each region. Of course, what you see now, there will be more ventilated beds around the world after COVID-19. The annual growth this year or last year was most likely quite dramatically higher compared to what we're seeing here with 5.5%. Also positive we have a sign in the U.S. is that the reimbursement situation is promising for us where they are paid per patient instead of the length of the stay in the ICU. Since we are having potential of reducing the ICU stay, that is of course interesting from a reimbursement perspective and the potential of a premium price. We will come back to that in the future when we are coming close to the registration in the U.S. Future-wise, when it comes to strategic priorities, there are no changes. We are fully occupied to prepare ourselves for the launch of Sedaconda in inhaled sedation in Europe during the second half year in 2021, this year. As well as preparing the clinical studies in U.S. and also the registration process overall in U.S. is ongoing, hard work. Still we are looking to have registration in U.S. by 2024. Peter will come back more in detail to that shortly. Also, of course, we have the rest of the world, not to forget. Where we have of interest, of course, Asia is interest. China is on ongoing registration of AnaConDa there. Hopefully, we have a registration this year. Also something that is coming up now lately is Latin America. Also interesting market to follow. The near future looks into the U.S. and after the launch of Sedaconda in Europe, and we have guided actually to reach closer to 10% of the market potential in Europe, which will give us EUR 50 million in, say, three years. That will be hopefully around 2024. Also you can see in this report, we have seen little bit reduced gross margin unfortunately, but that's the reason of COVID-19. I would say it's COVID-19 related with high increased cost of freight. With 70% that is this target, we will have a nice EBITDA margin as well. At 70% gross margin, we will also get a very nice EBITDA margin when the volumes build up later on. That is target and the guidance we have given the market. The strategic development of the company, as I mentioned, we become the new standard of sedation patient in ICUs, and we will reach that through these levels. Firstly, of course, to establish AnaConDa everywhere in the world to be a delivery system for volatile anesthesia. Same time, we will have the therapy for the label and registered in relevant markets around the world. Europe is the first region where we will reach that level. That entrance ticket to the market, I would say. Next step is of course to show superiority versus IV treatment. That is done through solid clinical studies. Evidence-based medicine is important for us, and we will support investigatory and patient trials, which we are already doing, but also phase IV and other phase III studies as well. When we have reached this outcome and the endpoint that we are looking for with superiority versus IV, that plan will roll out getting into the guidelines as a first-line treatment. That's our aim and the strategy how to reach the new standard of care. What have we delivered during the quarter, and just before that? Go into slide nine. Sorry, I should have told you when you should slide nine now. What have we delivered? We have approved AnaConDa in many markets as you see. We are working on the U.S. market as well, but we come back to that. Interesting during the first quarter is that we have seen a dramatic uptake in Latin America, Mexico, Ecuador, Colombia, and a huge interest in the rest of South America. We also have started up ICUs, many ICUs, thanks to the registration in Middle East as well. These two markets have been interesting to follow during the third quarter. Of course, Europe has also been successful. Now Jens will take over and let us know a little bit more about the commercial situation. Thank you, Christer. We can move ahead one slide to slide 10, please, to sort of start the sales journey. We look back at what we believe to be a very good quarter one this year. Germany continues to be our engine with regards to the sales perspective, we're seeing more and more ICUs that have come on board in Germany as well. We can also see that the penetration rate for the share of patients sedated in the ICU, a larger share getting inhaled sedation today than just six months back. We're seeing a 1.5 percentage points or more growth in this period. The other element to highlight here is that we've seen looking back at Q1, we are opening up one new ICU per day across our direct sales markets in Western Europe. The context on that is that we already saw from the beginning of COVID last year many new hospitals come on board. Last year, there was quite a bit of fear of propofol shortage that drove new hospitals to us. That fear has gone away. What we see now is more of a long-term commitment to inhaled sedation in the number of ICUs and hospitals coming on board. Also being able to start up one new ICU per day under these very strict rules of lockdown. It's been quite strong performance by the team. If we move forward one slide to slide 11. One other element or one other enabler of driving inhaled sedation is the availability of gas monitors in the market. What you see on the left-hand side is that number of ICU beds that now have a gas monitor attached to it in our direct sales markets. You can see the growth in the period from before COVID-19 and up until April. Quite strong growth. Today, that means that one out of 10 beds is now equipped with a gas monitor and able to use inhaled sedation. What we are also doing in order to further accelerate it, is that we've just in March launched our own gas monitor. The early feedback and the early signs are quite positive, that will also help us further accelerate this increase going forward. One slide forward, please. Looking at the sales development, as mentioned, we feel we're coming off a very good quarter one with a 40% sales growth year-on-year in local currencies. That's being fueled by a couple of different things. As you can see on the sales mix here, as Christer mentioned, we've seen quite strong sales in the distributor market, particularly Latin America. COVID continues to drive sales, of course, and then as I mentioned, the number of new customers that we're seeing across all the regions where we are present. The one comment to make here, and as I have received the question earlier in the day regarding Germany and COVID, I think one thing to mention here is that the Germany sales in Q1 is quite strong, and it's particularly strong looking at the dynamics of ICU patients. What we saw in Q4 was a very rapid increase of COVID patients in Germany, and that number peaked on December 31st, basically. That will drive purchases to stock up, make bigger purchases to make sure that in an escalating period, they have stock on hand. Then you also have the end year effect in terms of purchasing. Last year ended quite strongly. Then what happens in the beginning of Q1 is that the COVID numbers actually decelerated all throughout March, dropped about 50%. What we're seeing is that, again, more and more patients that are sedated in Germany and also across the other markets are getting inhaled sedation. The penetration rates go up. Then finally, let's go to the next slide. Slide 13, please. Yes. Just to make a note that what we are also quite occupied with at the moment is preparing for the launch of Sedaconda, finally going from off-label to on-label. We are preparing in terms of training the organization, but also growing the organization across our markets. That work is well underway. Spending quite a bit of time preparing for price and reimbursement discussions and submissions and negotiations in the market. In addition to that, we've also mentioned that we've submitted in Switzerland and U.K. as well, expecting approval and launch in the first half of next year. As mentioned, we anticipate a launch in the 15 first EU countries already this year. With that, I'll hand over to Peter on the clinical side. Thank you. We'll move to the next slide 14. In parallel with the preparing for the launch of Sedaconda on the adult indication, we are working on our clinical trials and the support of the investigate-initiated trial to support this therapy. We have started recruiting patients in the European pediatric trial that's running in four countries in Europe in about 20 ICU. We can move over to the next slide. Looking at the top-line results from the Sedaconda study, formerly known as the IsoConDa study, the registration study that was performed in Germany and Slovenia. On to the next slide, please. Slide 16. As some of you may know, the study was successful in demonstrating non-inferiority when sedation efficacy of Sedaconda versus propofol. Both drugs were efficacious in sedating patients to the RASS target range that was set for the study. Isoflurane was compared to the gold standard propofol with a proportion of time in the target range of 90.7 for isoflurane and 91.1 for propofol with tight confidence intervals well above the non-inferiority margin, set 15% below the propofol. On to the next slide 17. We also had a number of superiority endpoints that we were looking at. The ones that I would like to mention here today that were demonstrated to be superior for isoflurane were, as Christer mentioned, reduced opioid requirements during isoflurane sedation, about a 30% decrease in the dose of opioid during isoflurane sedation. We also found a higher proportion of time with spontaneous breathing with isoflurane, which is beneficial to the lung and the diaphragm. Finally, after 48 hours of sedation, patients receiving isoflurane had a shorter time to wake up than propofol patients, which is very useful from a clinical care perspective. Next slide, please. Now we're on slide 18. Looking at the safety aspects, we're looking at organ functions and found no differences in the groups. We also looking at adverse events, and there were relatively few serious adverse events in the two groups, and none of the serious adverse events that were found were related to the use of Sedaconda but rather to their critical illness itself. Adverse events that were noted were generally not related to sedation or to the device, and there were no new safety concerns raised for the use of Sedaconda in the study. A successful study from a registration perspective and also from clinical use perspective. Moving now to the U.S., clinical development with U.S. In 2019, we received feedback from the FDA, and we've been following that feedback. That included the conduct of a human factors program and non-clinical studies prior to the clinical trial, and thereafter two clinical trials to confirm the efficacy of isoflurane for ICU sedation and the establishment of a safety database. We are then moving from that to an early submission and commercialization. Move to the next slide to look at the timeline. 21. Sorry. Thanks. 21. Slide 21. What we see in Europe, I've told you that the Sedaconda study was finalized last year, and we have presented the high-level data at a press meeting and also as an abstract. We had opened up the pediatric study site and submitted our marketing authorization application, and we expect to have an approval in the second half year of 2021. We've started recruitment in the IsoCOMFORT study. By next year, second half year, we should have completed pediatric studies in order to get approval for the pediatric indication in 2023. For the U.S., the human factors formative study will be completed this year, and the preclinical studies needed for starting clinical trials will also be completed this year. That will enable us to receive our IND by sometime after the summer, in the early autumn, and start recruiting patients early next year. We are currently recruiting ICUs and been very successful so far to get the ICUs that are generally known to be successful in recruiting patients and that have sedation interest as well. In 2022, as I said, we start the clinical trials and decide how to launch in the U.S. in 2024. In 2023, we expect to end the clinical trials and submit our NDA and have an approval by 2024. Now I hand over to Susanne. Slide 23. Thank you. Financial results. Christer has already been through some of the slides. We had a continued strong solid quarter, first quarter with a yearly growth of 40% in local currencies. Of course, resulted in a higher gross profit. However, the gross margin somewhat was hurt by the continued high costs for freight. Excluding this, the gross margin would actually have been higher year-on-year. We're still working on that for Q4 and Q1. We had seen a lot transported by air. Going into Q2, we will have the vast majority transported by sea. Even though the cost for sea freight actually increased in Q1, but it's still a lot less compared to the air freight. We are working on that. Of course, we've also been on to the mix, given that we had a very good development in our distributors markets, but that actually has a somewhat lower margin. This mix in together came up with a gross margin of 64%, but we're still targeting, like Christer from just beginning of the talk, 70% in the future. That's really our target moving forward. In terms of the EBITDA, the margin came to -18%. We do have increased OpEx, the main reason for that is really the build-up of the organization. Like Jens was on to, we are increasing sales and also preparing for the Sedaconda launch. Of course, also the supporting units. We did have in the first quarter some overlap in stock costs. We were three new persons in the management team, so there were certain overlaps there. Given that we are targeting to actually have employees and only have consultants where we really need it for an interim purpose. There has also been a transition from consultants to employees, and there's an overlap in that. There's also been some timings in between the quarters, plus slightly lower capitalizations within R&D. This all together has made OpEx to increase. In the quarter, we did have a one-time impact from moving of the logistics center in the quarter. We are monitoring this carefully and targeting to have a cost-efficient organization. By end of March, we were 85 people together, 72 employees and 13 consultants. We believe that this is somewhere the level going forward. We've been talking previously about being roughly around 100 persons when we're getting the EU market approval and going forward. We are on track on the target. Next slide, please. Slide 24. Moving on over to the cash and financial balances. We still have a strong cash balance of SEK 344 million. It's a debt-free company, which is also strong. We did burn SEK 33 million in the quarter, and you can see the split where the money is spent. It's both in terms of investing and also from the operations. We are, again, monitoring this carefully, and we still believe we have a very strong balance sheet in terms of cash. Next slide, please. Slide 25. Our largest shareholders as of last of March is pretty much the same as previously. I'm not really surprised to say we do have a good mix of institutional owners and a few retail shareholders. That was about what I had to say. I'm handing over back to you, Christer. Yeah, we can go to the slide 26. That is the last slide. Open up for questions. Please, if there are any questions, I don't know how to handle that. Please help me. Thank you. If you wish to ask a question, please press zero one on your telephone keypad. There'll be a brief pause while we register any questions. There are no questions from the lines at the moment, so I'll hand back over to our speakers. I have some questions from the web here. I can raise them. When do we expect the results from the tox study? I think maybe that's a question for you, Peter. We have some tox studies that need to be done before the clinical trials and others that need to be done before our NDA, but not on the critical timeline for the clinical trial. Two out of the three studies that are being done before the clinical trials have been completed, and the results are good. Other tox studies are underway and will not be delaying our program. The delay is due to the long FDA timeline for meetings, really. The full tox study program will not be ready until about two years' time. For the clinical trials, we are on track and expect to have that study completed after the summer. Perfect. Thank you. There is another question to you, Jens. Q2 revenue on target? I think we have problem to answer that because we are not expected to guide you. We don't answer that for the time being. No, if nothing else, it will even be less of a dilute considering the situation with COVID and how long will this wave continue et cetera. It's a very difficult to say something. Yeah. I have another question. Visibility on appointment of a new CEO. Maybe I should answer that. Well, it looks good. Hopefully we will announce anything. I don't know. It will come anyway. It looks promising. Okay. That's about that. Another question? I have another one here, actually. Update on China. Yes, I can. We are working on it, and Chinese authorities are very complex and complicated, I have to say. It's the most complicated authorities when it comes to regulation. Anyway, it looks good, and we expect to have an approval this year as we have communicated earlier. Okay. That's it. I don't think there are any other questions. There are no more questions from the audio. Okay. Thank you very much. We stop this webcast and wish you all a good day, and thank you for listening to this. Bye-bye.
Loading workspace